Catheter apparatuses having multi-electrode arrays for renal neuromodulation and associated systems and methods

Catheter device with multi-electrode array for renal tubule nerve coordination, related systems and methods

The technical system of the present invention relates to renal nerve coordination and related systems and methods. In particular, various embodiments are directed to multi-electrode radiofrequency (RF) ablation catheter devices and related systems and methods for intravascular renal nerve coordination.

Cross reference of related applications

This application claims the rights of the following applications that are currently under application:

(a) U.S. Provisional Application No. 61/406,531, filed on October 25, 2010;

(b) U.S. Provisional Application No. 61/406,960, filed on October 26, 2010;

(c) U.S. Provisional Application No. 61/572,290, filed on January 28, 2011;

(d) U.S. Provisional Application No. 61/528,001, filed on August 25, 2011;

(e) U.S. Provisional Application No. 61/528,086, filed on August 26, 2011;

(f) U.S. Provisional Application No. 61/528,091, filed on August 26, 2011;

(g) U.S. Provisional Application No. 61/528,108, filed on August 26, 2011;

(h) U.S. Provisional Application No. 61/528,684, filed on August 29, 2011; and

(i) U.S. Provisional Application No. 61/546,512, filed on October 12, 2011.

All the above-mentioned applications are incorporated herein by reference in their entirety. In addition, the components and features of the embodiments disclosed in these applications incorporated by reference can be combined with the various components and features disclosed and claimed in this application.

The sympathetic nervous system (SNS) is the main involuntary body control system, which is typically related to stress responses. SNS fibers are distributed in the tissues of almost all organ systems of the human body and can affect characteristics such as pupil diameter, intestinal motility and urine output. This adjustment can be used adaptively to maintain constancy or prepare the body for rapid response to environmental factors. However, long-term SNS activity is a common reaction that is not conducive to adaptation, which can drive the progression of a variety of disease states. In particular, the overactivity of renal SNS has been identified experimentally and in humans as possible factors leading to complex pathophysiological phenomena such as hypertension, volume overload conditions (such as heart failure) and progressive nephropathy. For example, the dilution of radiotracers has shown that renal norepinephrine (NE) spillover rate in patients with essential hypertension is increased.

Hyperactivity of the heart and kidney sympathetic nerves can be particularly pronounced in patients with heart failure. For example, in these patients, it is often found that the spillage of NE from the heart and kidneys into the plasma is enlarged. Increased SNS activity is a common feature of chronic kidney disease and end-stage renal disease. In patients with end-stage renal disease, it has been proved that plasma NE content exceeding the median value indicates a variety of causes of cardiovascular disease and death. This finding is also correct for patients suffering from diabetic nephropathy or nephropathy caused by contrast agents. There is evidence that sensory afferent signals from diseased kidneys are the main factor leading to the initiation and continuous increase of central sympathetic nerves.

The sympathetic nerves distributed in the kidney terminate in blood vessels, juxtaglomerular apparatus and renal tubules. Stimulating renal sympathetic nerves can cause increased renin release, increased sodium (Na+) reabsorption, and decreased renal blood flow. These neuroregulatory components of renal function are greatly stimulated in disease states characterized by increased sympathetic tone, and may lead to an increase in blood pressure in hypertensive patients. Decreased renal blood flow and glomerular filtration rate caused by the stimulation of renal sympathetic nerves may be the basic cause of decreased renal function in cardiorenal syndrome (ie, renal dysfunction, which is a progressive complication of chronic heart failure) . Pharmacological strategies to counteract the effects of sympathetic nerve stimulation from the kidneys include centrally acting sympathetic nerve blockers beta blockers (designed to reduce renin release), angiotensin converting enzyme inhibitors, and receptor blockers ( Designed to block the activity of angiotensin II and the activation of aldosterone after the release of renin) and diuretics (designed to counteract the sympathetic-mediated sodium and water retention in the kidney). However, these pharmacological strategies have obvious limitations, including limited efficacy, compliance issues, side effects, and other issues. Therefore, there is a strong need for alternative treatment strategies for public health.

Many aspects of the invention can be better understood with reference to the following drawings. The components in the drawing are not necessarily drawn to scale. In fact, the emphasis is on clearly explaining the principle of the present invention.

The technology of the present invention is aimed at achieving electrical and/or thermal-induced renal nerve coordination through percutaneous transluminal intravascular access (that is, making the nerve fibers distributed in the kidney inert or inactive or otherwise making it functional Fully or partially reduced) devices, systems and methods. In particular, the embodiments of the technology of the present invention are related to devices, systems and methods incorporating catheter treatment equipment that can be in a delivery or low-profile state (e.g., a generally straight shape) and an expanded state (e.g., radial It is a multi-electrode array that varies between the general spiral shape of the extension. The electrodes or energy delivery elements carried by the array are configured to follow a percutaneous transluminal path (e.g., femoral artery puncture, iliac artery and aorta, radial artery or other suitable intravascular path) through a catheter Energy (e.g., electrical energy, radio frequency (RF) electrical energy, pulsed electrical energy, thermal energy) is delivered to the renal arteries. The multi-electrode array is sized and shaped so that when the array is in a deployed (e.g., spiral) state in the renal artery, the electrodes or energy transfer elements contact the inner wall of the renal artery. In addition, the spiral-shaped expanded array allows blood to flow through the spiral body, which is expected to help prevent renal artery blockage during activation of the energy transfer element. In addition, the blood flow in and around the array can cool the relevant electrodes and/or surrounding tissues. In some embodiments, cooling the energy transfer element allows higher power levels to be delivered at lower temperatures than the power levels that can be achieved without cooling. This feature is expected to help produce deeper and/or greater damage during treatment, reduce the temperature of the inner membrane surface, and/or allow a longer start-up time, and reduce the risk of overheating during treatment.

The specific details of several embodiments of the technology of the present invention are described below with reference to FIGS. 1 to 32B. Although many embodiments described below are about devices, systems and methods for intravascular renal nerve coordination using multi-electrode arrays, other applications and other embodiments besides those described herein also fall within the technical scope of the present invention. In addition, several other embodiments of the present technology may have configurations, components, or procedures other than those described herein. Therefore, those of ordinary skill will accordingly understand that other embodiments of the technology of the present invention may have additional elements, or other embodiments of the technology of the present invention may not have several features shown and described below with reference to FIGS. 1 to 32B.

As used herein, the terms "distal" and "proximal" define the position or direction relative to the treating clinician or clinician's control device (eg, handle assembly). "Remote" or "Remote" refers to a location far away from the clinician or clinician's control equipment in distance or direction. "Proximal end" and "at the proximal end" are the positions approaching or facing the clinician or the clinician's control equipment.

I.<u style="single">Kidney nerve coordination</u>

Renal nerve coordination is to partially or completely disable the nerves distributed in the kidney or cause other effective damage. Specifically, renal nerve coordination includes inhibiting, reducing, and/or blocking nerve connections along nerve fibers (ie, efferent and/or afferent nerve fibers) distributed in the kidney. This disability can be long-term (e.g., permanent or a period of months, years, or decades) or short-term (e.g., a period of minutes, hours, days, or weeks). It is expected that renal nerve coordination can effectively treat a variety of clinical conditions characterized by increased overall sympathetic nerve activity, especially those related to central sympathetic nerve overstimulation, such as hypertension, heart failure, acute myocardial infarction, metabolic syndrome, and insulin resistance Syndrome, diabetes, left ventricular hypertrophy, chronic kidney disease and end-stage renal disease, improper body fluid retention in heart failure, cardiorenal syndrome, and sudden death. Reducing afferent nerve signals helps to reduce sympathetic nervousness/impulsion systemically, and renal nerve coordination is expected to be suitable for the treatment of a variety of conditions related to systemic sympathetic overactivity or hyperactivity. The coordination of renal nerves can potentially benefit the various organs and body structures where sympathetic nerves are distributed. For example, reducing central sympathetic nerve impulse can reduce insulin resistance in patients suffering from metabolic syndrome and type II diabetes. In addition, active sympathetic nerves can produce osteoporosis, and downregulation of sympathetic nerve impulses (accompanied by renal nerve coordination) can be beneficial to osteoporosis. A more detailed description of the patient's anatomy and physiology is provided in Section IX below.

Various techniques can be used to partially or completely disable neural pathways, such as those distributed in the kidney. The purposeful application of energy (for example, electrical energy, heat) to tissues by energy transfer elements can induce one or more on the local area of the renal artery and the adjacent area of the renal nerve plexus RP closely arranged in or near the adventitia of the renal artery. Various desired thermal heating effects. Purposeful application of thermal heating effect can achieve nerve coordination along all or part of the renal nerve plexus RP.

Thermal heating effects may include thermal removal and non-removal thermal alteration or damage (for example, via continuous heating and/or resistive heating). The desired thermal heating effect may include increasing the temperature of the target nerve fiber to exceed a predetermined threshold value to achieve non-removal thermal alteration, or to exceed a higher temperature to achieve removal thermal alteration. For example, for non-removal thermal alteration, the target temperature may be higher than body temperature (for example, about 37°C) but less than about 45°C; or for enucleation thermal alteration, the target temperature may be about 45°C. °C or higher than 45°C.

More specifically, exposure to heat (heat) exceeding about 37°C body temperature but lower than about 45°C can induce thermal alteration by moderately heating the target nerve fiber or perfusing the blood vessel structure of the target fiber. In the case of affecting the vascular structure, the perfusion of the target nerve fiber is blocked, which leads to the necrosis of the nerve tissue. For example, this can induce non-removal thermal alteration of fibers or structures. Exposure to heat above about 45°C or above about 60°C can induce thermal alteration through substantial heating of the fiber or structure. For example, these higher temperatures can thermally remove target nerve fibers or vascular structures. In some patients, it may be necessary to achieve a temperature of less than about 90°C or less than about 85°C or less than about 80°C and/or less than about 75°C to thermally remove the target nerve fiber or vascular structure. Regardless of the type of heat exposure used to induce thermal nerve coordination, it is expected to reduce renal sympathetic nerve activity ("RSNA").

II.<u style="single">Selected embodiment of catheter device with multi-electrode array</u>

FIG. 1 illustrates a renal nerve coordination system 10 ("system 10") configured according to an embodiment of the technology of the present invention. The system 10 includes an intravascular treatment device 12 operatively coupled to an energy source or energy generator 26. In the embodiment shown in FIG. 1, the treatment device 12 (for example, a catheter) includes an elongated shaft 16 having a proximal portion 18, a handle 34 located in a proximal region of the proximal portion 18, and a handle 34 relative to the proximal portion 18. A distal portion 20 extending at the distal end. The treatment device 12 further includes a treatment assembly or treatment section 21 located at the distal end portion 20 of the shaft 16. As explained in more detail below, the treatment component 21 may include an array of two or more electrodes or energy transfer elements 24 configured to be delivered to a renal blood vessel (eg, a renal artery) in a low-profile configuration. The treatment component is further configured to expand into an extended state (for example, a generally spiral configuration) when delivered to the target treatment site in the blood vessel of the kidney to deliver energy at the treatment site and provide therapeutically effective electricity and/or Heat-induced renal nerve coordination. Alternatively, the unfolded state may not be spiral, and its limitation is that the unfolded state transmits energy to the treatment site. In some embodiments, the treatment assembly 21 can be placed or transformed into a deployed state or configuration via a distal actuation (eg, via an actuator 36, such as a handle, pin, or rod carried by the handle 34). However, in other embodiments, the treatment assembly 21 may use other suitable mechanisms or techniques to switch between the delivered state and the expanded state.

The proximal end of the treatment component 21 is carried or adhered to the distal portion 20 of the elongated shaft 16. The distal end of the treatment assembly 21 may terminate in the treatment device 12, which has, for example, an atraumatic round head or cap. Alternatively, the distal end of the treatment assembly 21 may be configured to engage with another element of the system 10 or the treatment device 12. For example, the distal end of the treatment component 21 may define a channel for engaging a wire (not shown), so that the treatment device can be delivered using warp insertion ("OTW") or rapid exchange ("RX") technology. More details about this configuration are described below with reference to FIGS. 9A to 17E.

The energy source or energy generator 26 (for example, an RF energy generator) is configured to generate energy of a selected form and amount for delivery to the target treatment site via the energy delivery element 24. The energy generator 26 may be electrically coupled to the treatment device 12 via a cable 28. At least one power supply line (not shown) passes along the elongated shaft 16 or through the lumen of the elongated shaft 16 to reach the energy transfer element 24 and transmit therapeutic energy to the energy transfer element 24. In some embodiments, each energy transfer element 24 includes its own power supply line. However, in other embodiments, two or more energy transfer elements 24 may be electrically coupled to the same power supply line. A control mechanism (such as a foot switch 32) can be connected (for example, pneumatically connected or electrically connected) to the energy generator 26 to allow the operator to start, stop and adjust various operating characteristics of the generator as appropriate, including (but not limited to) ) Power transmission. The system 10 may also include a remote control device (not shown). The remote control device may be located in a sterile field and operatively coupled to the energy transfer element 24. The remote control device is configured to allow the electrodes to be selectively turned on/off. In other embodiments, the remote control device may be built in the handle assembly 34. The energy generator 26 may be configured to deliver therapeutic energy via an automated control algorithm 30 and/or under the control of a clinician. Additionally, the energy generator 26 may include one or more evaluation or feedback algorithms 31 to provide feedback to the clinician before, during, and/or after treatment. More details on the suitable control algorithm and the evaluation/feedback algorithm are described below with reference to Figs. 20-27.

In some embodiments, the system 10 can be configured to provide unipolar electric field transfer via the energy transfer element 24. In these embodiments, the neutral or dispersive electrode 38 may be electrically connected to the energy generator 26 and attached to the outside of the patient (as shown in Figure 2). In addition, one or more sensors (not shown), such as one or more temperature (e.g., thermocouples, thermistors, etc.), impedance, pressure, light, flow, chemical, or other sensors, can be positioned at energy The transfer element 24 is adjacent to or within the energy transfer element 24 and is connected to one or more power supply lines (not shown). For example, a total of two power supply lines may be included, both of which can transmit signals from the sensor, and one line can be used for dual purposes and can also deliver energy to the energy transfer element 24. Alternatively, a different number of power supply lines may be used to transmit energy to the energy transfer element 24.

The energy generator 26 may be part of a device or monitor that may include a processing circuit (such as a microprocessor) and a display. The processing circuit can be configured to execute stored instructions related to the control algorithm 30. The monitor may be configured to communicate with the treatment device 12 (eg, via the cable 28) to control the power delivered to the energy transfer element 24 and/or obtain signals from the energy transfer element 24 or any related sensor. The monitor can be configured to provide indications of power levels or sensor data, such as audio, video, or other indications, or can be configured to convey information to another device. For example, the energy generator 26 can also be configured to be operatively coupled to a catheter experiment screen or system that displays treatment information.

Figure 2 (see also Figure 30) illustrates the use of an embodiment of the system 10 to coordinate renal nerves. The treatment device 12 approaches the renal nerve plexus RP via an intravascular path P (such as a percutaneous entry site of the femoral artery (illustrated), brachial artery, radial artery, or axillary artery to a target treatment site in the respective renal artery RA). As illustrated, a section of the proximal portion 18 of the shaft 16 is exposed to the outside of the patient. By manipulating the proximal portion 18 of the shaft 16 from outside the intravascular path P, the clinician can advance the shaft 16 through the sometimes twisted intravascular path P and manipulate the distal portion 20 of the shaft 16 distally. To facilitate the manipulation by clinicians, image-guided techniques can be used, such as computerized tomography (CT), fluoroscopy, intravascular ultrasound (IVUS), optical coherent tomography (OCT) or other suitable guidance methods , Or a combination thereof. In addition, in some embodiments, the treatment device 12 itself may incorporate image guiding components (for example, IVUS, OCT). After the treatment component 21 is fully positioned in the renal artery RA, the handle 34 or other suitable methods can be used to radially extend or otherwise expand the treatment component 21 until the energy transfer element 24 is in stable contact with the inner wall of the renal artery RA. Then, the energy from the energy transfer element 24 is purposely applied to the tissue to induce one or more on the local area of the renal artery and the adjacent area of the renal nerve plexus RP that is closely arranged in, near or in the vicinity of the outer membrane of the renal artery RA. A variety of desired neural coordination effects. Purposeful application of energy can achieve nerve coordination along all or at least a portion of the renal nerve plexus RP.

The nerve coordination effect is generally (at least in part) a function of power, time, contact between the energy transfer element 24 and the vessel wall, and blood flow through the vessel. Nerve coordination effects may include denervation, thermal ablation, and non-ablative thermal alteration or damage (e.g., via continuous heating and/or resistive heating). The desired thermal heating effect may include increasing the temperature of the target nerve fiber to exceed a predetermined threshold value to achieve non-removal thermal alteration, or to exceed a higher temperature to achieve removal thermal alteration. For example, for non-removal thermal alteration, the target temperature may be higher than body temperature (for example, about 37°C), but less than about 45°C; or for removal thermal alteration, the target temperature may be about 45°C Or higher than 45°C. The desired non-thermal nerve coordination effect may include altering the electrical signals transmitted in the nerves.

In some embodiments, the energy transfer element 24 of the treatment component 21 may be adjacent to, close to, or carried (for example, glued to, screwed on, wound on, and/or crimped on) the support structure 22. The proximal end of the support structure 22 is preferably coupled to the distal end portion 20 of the elongate shaft 16 via a coupling member (not shown). The coupling member may be an integral component of the elongated shaft 16 (that is, it may not be a separate component), or the coupling member may be a separate component, such as being wound on the outer surface of the elongated shaft 16 to fasten the support structure 22 The collar of the elongated shaft 16 (for example, a radiopaque cable tie). However, in other embodiments, the support structure 22 may be coupled to the elongate shaft 16 using another configuration and/or different features.

In yet another embodiment, the energy transfer element 24 may form or define a selected part or all of the support structure 22 itself. That is, as described in more detail below, the support structure 22 may be capable of transferring energy. In addition, although in some embodiments, the treatment assembly 21 can utilize a single energy transfer element to function, it should be understood that the treatment assembly 21 preferably includes a plurality of energy transfer elements 24 coupled with or defining the support structure 22. When a plurality of energy transfer elements 24 are provided, the energy transfer elements 24 can simultaneously, selectively or sequentially independently transfer power (that is, can be used in a monopolar manner), and/or can be used in any combination of elements Transfer power between (that is, it can be used in a bipolar manner). In addition, the clinician may choose which energy delivery element(s) 24 to use to deliver power as appropriate, so as to form highly customized lesions with various shapes or patterns in the renal arteries.

3A is a cross-sectional view illustrating an embodiment of the distal portion 20 of the shaft 16 and the treatment component 21 located in the renal artery RA and in a transmission state (for example, a low-profile or folded configuration), and FIGS. 3B and FIGS. 3C illustrates the treatment component 21 located in the renal artery and in an expanded state (for example, an extended or spiral configuration). Referring first to FIG. 3A, the folding or transferring configuration of the treatment component 21 defines a low profile around the longitudinal axis AA of the component, so that in order to define the gap distance between the arterial wall 55 and the treatment device 12, the lateral dimension of the treatment component 21 is sufficiently small. The delivery state facilitates the insertion and/or removal of the treatment device 12 and, when necessary, the repositioning of the treatment component 21 in the renal artery RA.

In the folded configuration, for example, the geometry of the support structure 22 facilitates the movement of the treatment component 21 via the guiding catheter 90 to the treatment site in the renal artery RA. In addition, in the folded configuration, the treatment component 21 is sized and shaped to fit in the renal artery RA, and has a diameter smaller than the inner diameter 52 of the renal artery and a length smaller than the length 54 of the renal artery (from the proximal end of the treatment component 21). To the distal end of the treatment component 21). In addition, as described in more detail below, the geometric shape of the support structure 22 is also configured to define (in the transmission state) the minimum lateral dimension (less than the internal diameter of the renal artery 52) around its central axis and the maximum length in the direction of the central axis. (Preferably less than the renal artery length 54). In one embodiment, for example, the smallest diameter of the treatment component 21 is approximately equal to the inner diameter of the elongated shaft 16.

The distal portion 20 of the shaft 16 can be flexed in a substantial manner to follow the path defined by the guiding catheter, the guide wire, or the outer sheath into the respective left/right renal arteries. For example, the flexure of the distal portion 20 can be performed by a guide catheter 90 (such as a guide shaft 16 along the desired path from the percutaneous insertion site to the renal artery RA, and a renal guide catheter with a pre-shaped bend near the distal end). Give. In another embodiment, the treatment device 12 can be guided to the treatment site in the renal artery RA by engaging and tracking a guide wire (eg, guide wire 66 in FIG. 2) inserted into the renal artery RA and extending to the percutaneous entry site. point. In operation, it is preferable to first pass the guidewire into the renal artery RA, and then pass the elongated shaft 16 containing the guidewire lumen into the renal artery RA through the guidewire. In some wire procedures, the tubular delivery sheath 1291 (described in more detail below with reference to FIGS. 16A and 16B) is passed through the guide wire (ie, the lumen defined by the delivery sheath slides over the guide wire) into the renal artery RA. Once the delivery sheath 1291 (FIG. 16A) is placed in the renal artery RA, the wire can be removed and exchanged for a treatment catheter (eg, treatment device 12) that can be delivered into the renal artery RA via the delivery sheath 1291. Additionally, in some embodiments, the distal portion 20 may be introduced or "drived" into the renal artery RA via the handle assembly 34 (FIGS. 1 and 2), for example, by the actuatable element 36 or by other control elements. Specifically, the flexure of the elongated shaft 16 can be provided by U.S. Patent Application No. 12/545,648 ("Apparatus, Systems, and Methods for achieving Intravascular, Thermally-Induced Renal Neuromodulation") issued to Wu et al. Achieved, the case is incorporated into this article by reference in its entirety. Alternatively or in addition, the treatment device 12 and its distal portion 20 can be flexed by inserting a steerable guide catheter (not shown) that includes a pre-shaped or steerable bend near its distal end , The bend can be adjusted or reshaped by the proximal manipulation of the self-guided guide tube.

The maximum outer dimension (eg, diameter) of any section of the treatment device 12 including the elongated shaft 16 and the energy transfer element 24 of the treatment assembly 21 can be defined according to the inner diameter of the guide catheter 90 through which the device 12 passes. In a specific embodiment, for example, an 8-French guide catheter with an inner diameter of about 0.091 inches (2.31 mm) can be used as the guide catheter for entering the renal artery. Considering the reasonable gap tolerance between the energy transfer element 24 and the guiding catheter, the maximum outer dimension of the treatment component 21 is generally less than or equal to about 0.085 inches (2.16 mm). For therapeutic components having a substantially spiral support structure to carry the energy transfer element 24 in a portable manner, the extension or spiral configuration preferably defines a maximum width less than or equal to about 0.085 inches (2.16 mm). However, the use of a smaller 5-French guide catheter may require the use of a smaller outer diameter along the treatment device 12. For example, the treatment component 21 having the spiral support structure 22 that can pass into the 5-French guide catheter preferably has an outer dimension or maximum width of no more than about 0.053 inches (1.35 mm). In other embodiments, it may be necessary for the maximum width of the treatment component 21 to be substantially less than 0.053 inches (1.35 mm), the restriction condition is that there is sufficient gap between the energy transfer element and the guiding tube. In addition, in some embodiments, a configuration in which the diameter ratio of the guiding catheter to the treatment component 21 is defined as approximately 1.5:1 may be required. In another example, the spiral structure and the energy transfer element 24 to be transferred in the 6-French guide tube have an outer dimension not greater than 0.070 inches (1.78 mm). In other examples, other suitable guiding catheters can be used, and the external dimensions and/or configuration of the treatment device 12 can be changed accordingly.

After the treatment component 21 at the distal portion 20 of the shaft 16 is positioned in the renal artery RA, the treatment component 21 is transformed from its delivery state to its expanded state or expanded configuration. This transformation can be initiated using the configuration of the device components as described herein with reference to the specific embodiment and its various expansion modes. As described in more detail below and according to one or more embodiments of the technology of the present invention, the treatment component can be transformed into a component by internally engaging or externally engaging with the supporting structure of the treatment component to apply a deforming force or a forming force to the component The control member in the unfolded state (such as a pull wire or extension wire, a wire, a shaft or a pin) is unfolded. Alternatively, the treatment assembly 21 may be self-expanding or self-expanding, so that removal of the radial constraint causes the assembly to expand. In addition, in most embodiments, the method used to transform the treatment component 21 from the delivery state to the deployed state can conversely cause the treatment component 21 to change back from the deployment state to the delivery state.

Further manipulation of the support structure 22 and the energy transfer element 24 located in the respective renal artery RA can cause the energy transfer element 24 to be juxtaposed against the tissue along the inner wall of the respective renal artery RA. For example, as shown in FIG. 3B and FIG. 3C, the treatment component 21 is extended in the renal artery RA so that the energy transfer element 24 is in contact with the renal artery wall 55. In some embodiments, manipulation of the distal portion 20 will also promote contact between the energy transfer element 24 and the renal artery wall. The support structure embodiments described herein (for example, the support structure 22) are expected to ensure that the contact force between the renal artery inner wall 55 and the energy transfer element 24 does not exceed the maximum value. In addition, the support structure 22 or other suitable support structures described herein preferably provide a consistent contact force against the arterial wall 55, thereby allowing consistent damage.

Alignment can also include alignment of the geometry of the energy transfer element 24 with the renal artery wall 55. For example, in an embodiment where the energy transfer element 24 is cylindrical and has rounded ends, the alignment may include the alignment of the longitudinal surface of the individual energy transfer element 24 with the artery wall 55. In another example, an embodiment may include an energy transfer element 24 having a structured shape or blunt surface, and aligning may include aligning the energy transfer element 24 so that this structured shape or blunt surface does not contact the arterial wall 55.

As best shown in FIGS. 3B and 3C, in the unfolded state, the treatment component 21 defines a substantially spiral support structure 22 that is in contact with the renal artery wall 55 along a spiral path. One of the advantages of this configuration is that the pressure from the spiral structure can be applied in a wide range of radial directions instead of applying pressure to the circumference of the blood vessel. Therefore, when the arterial wall moves in any direction, the spiral treatment assembly 21 is expected to make stable contact between the energy transfer element 24 and the arterial wall 55. In addition, the pressure applied to the blood vessel wall 55 along the spiral path is unlikely to stretch or expand the circumference of the blood vessel, thereby damaging the blood vessel tissue. Another feature of the extended spiral structure is that it can contact the blood vessel wall in a large radial direction and maintain sufficient patency of the vessel lumen, thereby allowing blood to flow through the spiral body during treatment.

As best shown in FIG. 3B, in the expanded state, the support structure 22 defines the renal artery whose maximum axial length of the treatment component 21 is approximately equal to or less than the main renal artery (ie, a segment of the renal artery proximal to the bifurcation point) Length 54. Because this length can vary from patient to patient, it is envisaged that the unfolded spiral support structure 22 can be made of different sizes suitable for different patients (for example, the changed length L and/or diameter D as shown in 4A). Referring to FIGS. 3B and 3C, in the unfolded state, the spiral treatment assembly 21 provides a circular discontinuous contact between the energy transfer element 24 and the inner wall 55 of the renal artery RA. That is, the spiral path may include a partial arc (ie, &lt;360°), a complete arc (ie, 360°), or more than a complete arc (ie, &gt;360°) along the inner wall of the blood vessel, around the longitudinal axis of the blood vessel ). However, in some embodiments, the arc is not substantially in a plane perpendicular to the central axis of the artery, but preferably defines an obtuse angle with the central axis of the artery.

A.<u style="single">Spiral structure</u>

4A is a plan view of an embodiment of a treatment component 21 for a treatment device (for example, the treatment device 12) according to an embodiment of the present technology, and FIG. 4B is an isometric view of the treatment component 21 of FIG. 4A. The energy transfer elements 24 depicted in FIGS. 4A and 4B are for illustrative purposes only, and it should be understood that the treatment assembly 21 may include different numbers and/or configurations of energy transfer elements 24.

As shown in Figures 4A and 4B, the spiral body can be at least partially characterized by its full diameter D, length L, helix angle α (the angle between the tangent and the spiral body and its axis), and the pitch HP (parallel to The longitudinal distance of a complete spiral rotation measured by the shaft) and the number of revolutions (the number of times the spiral body completes 360° rotations around its axis).

In particular, the unfolded or extended configuration of the spiral body can be characterized by its axial length L along the elongated axis in free space (for example, without being constrained by blood vessel walls or other structures). When the spiral support structure 22 extends radially from its transmission state, its diameter D increases and its length L decreases. That is, when the helical structure is deployed, the distal end 22a moves axially toward the proximal end 22b (or vice versa). Therefore, the expanded length L is less than the unexpanded or transferred length. In some embodiments, only one of the distal portion 22a or the proximal portion 22b of the support structure 22 is fixedly coupled to the elongate shaft 16 or its extension. In other embodiments, the support structure 22 can be transformed into its expanded or extended configuration by twisting the distal portion 22a and the proximal portion 22b relative to each other.

Referring to FIG. 4B, the unfolded spiral support structure 22 optionally includes a distal extension 26 a located at the distal end of the spiral portion, which is relatively straight and can be terminated with an atraumatic (eg, rounded) tip 50. When the spiral structure is extended and/or when retracting to deliver the outer sheath, the distal extension 26a including the tip 50 can reduce the risk of damaging the blood vessel, and when the spiral structure is extended, it can facilitate its alignment in the blood vessel. In some embodiments, the distal extension 26a is generally straight (and flexible) and has a length less than about 40 mm (eg, between 2 mm and 10 mm). The tip 50 may be made of polymer or metal, and is fixed to the end of the structural element by adhesive, welding, crimping, overmolding, and/or soldering. In other embodiments, the tip 50 may be made of the same material as the structural element, and the tip 50 may be made by machining or melting. In other embodiments, the distal extension 26a may have different configurations and/or characteristics. For example, in some embodiments, the tip 50 may include an energy transfer element or a radiopaque marker. In addition, the distal extension 26a is an optional feature that may not be included in all embodiments.

The spiral structure may optionally have a proximal extension 26b, which is relatively straight compared to the spiral region of the support structure 22. The proximal extension 26b may be, for example, an extension of the support structure 22, and may have a length between 0 mm and 40 mm (for example, between about 2 mm and 10 mm). Alternatively, the proximal extension 26b may include a separate material (eg, polymer fiber) that is more flexible than the rest of the support structure 22. The proximal extension 26b is configured to provide a flexible connection between the helical area of the support structure 22 and the distal end of the elongate shaft 16 (Figure 1). It is expected that this feature promotes the alignment of the unfolded spiral support structure 22 with the vessel wall by reducing the force transmitted from the elongated shaft 16 to the spiral region of the spiral structure 22. This feature may be applicable, for example, when the elongated shaft is deflected to the side of the blood vessel wall or when the elongated shaft is moved relative to the blood vessel wall, so that the spiral structure remains in position.

Referring back to Figs. 4A and 4B (and Figs. 3A and 3B) together, the size of the unfolded spiral structure 22 is affected by its physical characteristics and its configuration (for example, the extended configuration relative to the unextended configuration) Influence, its physical characteristics and configuration can be selected according to the geometry of the renal artery. For example, the axial length L of the unfolded spiral structure can be selected not to be longer than the patient's renal artery (for example, the length 54 of the renal artery RA in FIGS. 3A and 3B). For example, the distance between the entry site and the opening of the renal artery (for example, the distance from the femoral entry site to the renal artery is typically about 40 cm to about 55 cm) is generally greater than the length of the aortic artery to the farthest along the renal artery The length of the renal artery at the end of the treatment site, which is typically less than about 7 cm. Therefore, it is expected that the elongated shaft 16 (FIG. 1) is at least 40 cm, and the unstretched length L of the spiral structure is less than about 7 cm. The length of no more than about 4 cm in the unextended configuration is suitable for larger patient populations, and provides a longer contact area when in the extended configuration, and in some embodiments provides that multiple energy transfer elements can be placed However, the shorter length (for example, less than about 2 cm) in the unstretched configuration can be used for patients with shorter renal arteries. The spiral structure 22 can also be designed for a typical renal artery diameter. For example, the diameter 52 of the renal artery RA (Figure 3A) can be between about 2 mm and about 10 Change between mm. In a specific embodiment, the placement of the energy transfer element on the spiral structure 22 can be selected according to the estimated position of the renal nerve plexus RP relative to the renal artery RA.

In another specific embodiment, the section or support structure of the treatment component 21 when allowed to fully expand into an unconstrained configuration (that is, located outside the body, as shown in FIGS. 4A and 4B), includes a spiral shape Have a diameter D of less than about 15 mm (for example, about 12 mm, 10 mm, 8 mm, or 6 mm); less than or equal to about 40 mm (for example, less than about 25 mm, less than about 20 mm, less than about 15 mm) Length L; helix angle α between about 20° and 75° (for example, between about 35° and 55°); rotation between 0.25 and 6 (for example, between 0.75 and 2, between 0.75 and 1.25) Number range; and a pitch HP between about 5 mm and 20 mm (for example, between about 7 mm and 13 mm). In another example, the treatment component 21 may be configured to extend radially from its delivery state with a diameter around its central axis of about 10 mm to a delivery state in which the energy delivery element 24 is in contact with the artery wall. The above-mentioned dimensions/angles are related to specific embodiments of the technology of the present invention, and it should be understood that treatment components according to other embodiments of the technology of the present invention may have different configurations and/or configurations.

In some embodiments, the expanded spiral support structure 22 may be generally cylindrical (ie, the spiral diameter may be substantially uniform along most of its length). However, it is also contemplated that the structure 22 may have different forms, such as a conical spiral shape, a tapered structural element, a clockwise or counterclockwise path, a uniform or varying pitch.

In one embodiment, the support structure 22 may include solid structural elements, such as wires, tubes, crimped cables, or braided cables. The support structure 22 may be formed of biocompatible metals and/or polymers, including polyethylene terephthalate (PET), polyamide, polyimide, polyethylene block copolymer, polypropylene or Polyetheretherketone (PEEK) polymer. In some embodiments, the support structure 22 may be a non-conductive material, a conductive material (for example, stainless steel, nitinol, silver, platinum, nickel-cobalt-chromium-molybdenum alloy), or a combination of a conductive material and a non-conductive material. For example, in a particular embodiment, the support structure 22 may be formed of a pre-formed material, such as spring tempered stainless steel or Nitinol. In addition, in certain embodiments, the structure 22 may be at least partially formed of a radiopaque material, which can be imaged on a fluorescent microscope, thereby allowing the clinician to determine whether the treatment component 21 is properly placed and/or Expanded in the renal artery. Radiopaque materials can include, for example, barium sulfate, bismuth trioxide, bismuth subcarbonate, powdered tungsten, powdered tantalum or various formulations of certain metals (including gold and platinum), and these materials can be directly incorporated In the structural element 22, a partial or complete coating may be formed on the spiral structure 22.

Generally speaking, the spiral structure 22 can be designed to apply a desired outward radial force to the renal artery wall 55 (FIGS. 3A and 3B) when inserted and extended to contact the inner surface of the renal artery wall 55 (FIGS. 3A and 3B) 3B). The radial force that does not stretch or expand the renal artery RA to avoid injury when the spiral structure 22 stretches against the arterial wall 55 in the patient's body can be selected. The radial force that avoids renal artery RA damage but provides sufficient stability can be determined by calculating the radial force that typical blood pressure acts on the arterial wall. For example, the suitable radial force may be less than or equal to about 300 mN/mm (e.g., less than 200 mN/mm). Factors that can affect the radial force applied include the geometry and stiffness of the support structure 22. In a specific embodiment, the diameter of the support structure 22 is about 0.003 inches to 0.009 inches (0.08 mm to 0.23 mm). Depending on the composition of the supporting structure 22, the diameter of the structural element can be selected that will cause the desired shape to be conformable and/or against the radial force of the renal artery when the extension time is delayed. For example, the support structure 22 formed of a harder material (for example, metal) can be thinner than the support structure 22 formed of a highly flexible polymer to achieve similar flexibility and radial force distribution. The outward pressure of the spiral support structure 22 can be evaluated in vivo by the relevant pressure transducer.

In addition, certain secondary processes (including heat treatment and annealing) can harden or soften the fiber material to affect the strength and hardness. In particular, for shape memory alloys such as Nitinol, these secondary processes can be modified to obtain the same starting material but different final properties. For example, the elastic range or softness can be increased to impart improved flexibility. Secondary processing of the shape memory alloy will affect the transformation temperature, which is the temperature at which the structure exhibits the desired radial strength and hardness. In embodiments using shape memory properties (such as shape memory Nitinol), this transition temperature can be defined as normal body temperature (for example, about 37°C) or in a range between about 37°C and 45°C. In other embodiments including superelastic nitinol, the transition temperature can be much lower than body temperature, for example, below 0°C. Alternatively, the spiral structure may be formed of an elastic or superelastic material, such as Nitinol, which can be thermally processed into the desired spiral shape. Alternatively, the spiral structure 22 may be formed of a variety of materials, such as one or more polymers and metals.

Referring back to FIGS. 3B and 3C together, it should be understood that the support structure 22 of the treatment assembly 21 can be expanded to a maximum diameter larger than the diameter in the delivery state when not inserted into the patient. In addition, the spiral structure 22 can be sized so that the maximum diameter is greater than the lumen diameter 52 of the renal artery RA. However, when the spiral structure 22 is inserted into the patient and transformed into the expanded state, it expands radially across the renal artery lumen, and its largest circumferential section is close to or slightly smaller than (for example, the energy transfer element 24 is filled with some In the spatial example) the diameter 52 of the renal artery RA. It may cause a small amount of vasodilation without undue damage, and the structure 22 can be stretched so that its largest circumferential section is slightly larger than the diameter 52 of the renal artery RA, or one or more energy transfer elements 24 can slightly press against the kidney The wall of the artery RA 55. The spiral component or array that causes the artery wall 55 to expand slightly and harmlessly can advantageously provide a stable contact force between the energy transfer element 24 and the artery wall 55 and/or keep the energy transfer element 24 in place, even when the artery follows This is also true when moving with respiratory movement and pulsed blood flow. Because the diameter 52 of the renal artery RA varies from patient to patient, the treatment component 21 can adopt a diameter range between the transmission diameter and the maximum diameter.

As provided above, one of the features of the unfolding treatment assembly 21 in the spiral configuration is that the energy transfer element 24 combined with the spiral structure can be placed in stable contact with the blood vessel wall to reliably produce consistent damage. In addition, a plurality of energy transfer elements 24 can be arranged along the spiral structure at appropriate intervals to achieve the desired damage configuration in the target blood vessel. Another feature of the various embodiments of the treatment component 21 having the above-mentioned spiral configuration is that the component can be extended to fit a relatively wide range of different blood vessel diameters and/or various twists.

B.<u style="single">The size and configuration of energy transfer components</u>

It should be understood that the embodiments provided herein can be used in conjunction with one or more energy transfer elements 24. As described in more detail below, the unfolded helical structure carrying the energy transfer element 24 is configured to provide therapeutic energy transfer to the renal artery without any repositioning. An illustrative embodiment of the energy transfer element 24 is shown in FIGS. 5A to 5D. The energy transfer element 24 combined with the spiral structure 22 may be a separate element or may be an integral part of the spiral structure 22. In some patients, it may be necessary to use the energy transfer element 24 to produce a single lesion or multiple focal lesions spaced around the circumference of the renal artery. Alternatively or in addition, a single focal damage with the desired longitudinal and/or circumferential size, one or more full circle damages, multiple focal damages with circumferential intervals located in a general longitudinal position, spiral damage, Truncated spiral lesions, generally linear lesions, and/or multiple discrete focal lesions in a longitudinal interval located in a general circumferential position. In other embodiments, the energy transfer element 24 can be used to produce damage with a variety of other geometric shapes or patterns.

Depending on the size, shape, and number of the energy transfer elements 24, the resulting damage can be separated by a certain distance around the circumference of the renal artery, and the above-described damage can also be separated by a certain distance along the longitudinal axis of the renal artery. In a specific embodiment, it is necessary for each damage formed to cover at least 10% of the circumference of the blood vessel to increase the probability of damage to the renal nerve plexus. In addition, in order to remove the renal nerves, it may be necessary for the formed damage pattern (viewed from the proximal or distal end of the blood vessel) to extend at least approximately the entire circumference of the renal artery. In other words, each damage formed covers an arc of the circumference, and each damage viewed from the end of the blood vessel adjoins or overlaps with adjacent or other damages in the pattern to produce actual hoop damage or substantial hoop damage. The resulting damage that defines the actual circumferential damage exists in a single plane perpendicular to the longitudinal axis of the renal artery. Substantial hoop damage can define multiple damages that are not all located in a single vertical plane, although more than one damage pattern can be formed. At least one of the damages including the substantial hoop damage is axially separated from the other damages by a certain distance. In a non-limiting example, the parenchymal circumferential damage may include six damages that are produced in a single spiral pattern along the renal artery, so that the arc length spanned by each damage is at least one-sixth of the circumference of the blood vessel, so it is considered to be from the blood vessel. When viewed at the end, the resulting damage pattern completely contains the circumference of the blood vessel. However, in other examples, substantial hoop damage may include a different number of damages. It is also necessary that the depth of each damage is sufficient to penetrate and exceed the adventitia, thereby damaging the renal nerve plexus. However, damage that is too deep (for example, &gt;5 mm) has the risk of interfering with non-target tissues and tissue structures (for example, renal veins), so it is also necessary to control the depth of energy treatment.

As shown in FIGS. 4A and 4B, the energy transfer elements 24 can be distributed on the spiral structure 22 as desired. For example, the axial distance between the energy transfer elements 24 may be selected so that the edges of the damage formed by the individual energy transfer elements 24 on the renal artery wall 55 overlap or do not overlap. One or both of the axial distances xx or yy may be about 2 mm to about 1 cm. In a specific embodiment, the axial distance xx or yy may be in the range of about 2 mm to about 5 mm. In another embodiment, the energy transfer elements 24 may be about 30 mm apart. In another embodiment, the energy transfer elements 24 may be about 11 mm apart. In another embodiment, the energy transfer elements 24 may be about 17.5 mm apart. In addition, the axial distance xx may be less than, approximately equal to, or greater than the axial distance yy.

The distance between the energy transfer elements 24 can be characterized by the spiral length distance zz, that is, the distance between the energy transfer elements along the path of the spiral structure 22. The spiral length distance zz can be selected according to the size of the damage generated by the energy transfer element 24, so that the damage overlaps or does not overlap. In some embodiments, the energy transfer element 24 is offset from each other in the longitudinal direction and the ring direction. For example, FIG. 4C is an end view of the spiral structure 22, which shows the angular offset or spacing of the energy transfer elements 24 around the circumference of the unfolded spiral structure 22. Specifically, the energy transfer element 24c deviates from the energy transfer element 24a by an angle 150, and the energy transfer element 24b deviates from the energy transfer element 24b by an angle 152. The offset angle can be selected so that when energy is applied to the renal artery via the energy transfer elements 24a, 24b, and 24c, the damage can overlap circumferentially or not.

FIG. 4D is a side view of a blood vessel with damage 340 formed thereon. These damages overlap circumferentially and/or longitudinally, but do not overlap along a spiral path. More specifically, the damage 340 can be formed by the energy transfer element 24 to have a circular overlap 341 (viewed from the end of the blood vessel) (for example, FIG. 4C) and/or a longitudinal overlap 342, but the spiral length overlap may not be generated, and the change To form a spiral length gap 343. For example, the energy transfer element 24 may take the form of an electrode to apply an electric field of RF energy to the blood vessel wall, and is configured to use electrodes separated by a spiral length distance of about 6 mm to 7 mm to produce damage with a diameter of about 5 mm. Depending on the number and positioning of the energy transfer elements 24, a spiral damage pattern with any suitable number of turns can be formed. Thus, the treatment device 12 can use a single energy application to form a complex damage pattern. It should be noted that the embodiments illustrated in FIGS. 4A to 4C are exemplary, may be schematic in nature, may not be completely related to each other, and the purpose of illustration is only to illustrate certain aspects of the technology of the present invention. Therefore, the number and spacing of the energy transfer elements 24 are different in FIGS. 4A to 4C, and the damage formed by the illustrated embodiment may not produce an overlapping pattern sufficient to achieve the above-mentioned substantial circular damage, especially when treating When the assembly 21 applies energy in only one unfolded state without repositioning.

Referring again to FIG. 3B, the individual energy transfer elements 24 are connected to the energy generator 26 (FIG. 1), and are sized and configured to contact the inner wall of the renal artery. In the illustrated embodiment, the energy transfer element 24 may be operated in a unipolar mode. In this configuration, the return path of the applied RF electric field is established, for example, by an external dispersion electrode (shown as element 38 in FIGS. 1 and 2) (also referred to as a reference electrode or a neutral electrode). A unipolar RF electric field can be used for ohmic or resistive heating of tissues close to the electrode. The application of an RF electric field can thermally damage the tissue. The treatment goal is heat-induced nerve coordination in the target nerve fibers (for example, necrosis, thermal alteration, or removal). Thermal damage can form damage in the walls of blood vessels. Alternatively, the RF electric field can be transmitted without thermally damaging the tissue by vibration or pulse intensity, thereby achieving nerve coordination in the target nerve through electrical adjustment of nerve signals.

The effective surface area of the energy transfer element 24 is defined as the energy emitting area of the element 24 that can be placed in close contact with the tissue. An excessively large contact area between the energy transfer element and the blood vessel wall may generate undue high temperatures at or around the interface between the tissue and the energy transfer element, resulting in excessive heat generation at this interface. This excessive heat can cause excessive hoop damage. This will also cause undesired heat on the blood vessel wall. Sometimes, too much contact can also cause small and shallow damage. Too little contact between the energy transfer element and the blood vessel wall can cause superficial heating of the blood vessel wall, resulting in too little damage (for example, less than 10% of the blood vessel circumference) and/or too shallow.

The effective contact surface area (ASA) between the energy transfer element 24 and the inner wall of the blood vessel (for example, the renal artery wall 55) is largely related to the thermal damage to the target nerve fiber in the renal nerve plexus (RP) and the generation of cross-vascularization. The efficiency and control of the thermal energy field of the wall are related. Although the ASA of the energy transfer element plays an important role in forming the damage of the desired size and depth, the ratio between the ASA and the total surface area (TSA) of the energy transfer element 24 and the electrode 46 also plays an important role. The ratio of ASA to TSA affects damage formation in two ways: (1) the degree of resistance heating via an electric field, and (2) the effect of blood flow or other convective cooling components (such as injection or infusion of saline). For example, the RF electric field promotes the formation of damage through resistive heating of tissue exposed to the electric field. The higher the ratio of ASA to TSA (that is, the greater the contact between the electrode and the tissue), the greater the resistance heating, for example, the greater the damage will be. As discussed in more detail below, blood flowing through the non-contact portion of the electrode (TSA minus ASA) can conduct conductive and convective cooling of the electrode, thereby taking away the excess heat energy at the interface between the blood vessel wall and the electrode. If the ratio of ASA to TSA is too high (for example, more than 50%), the resistance heating tissue may be too invasive and cannot take away enough excess heat energy, leading to overheating and increasing stenosis damage, thrombosis, and unnecessary damage Possibility of size. If the ratio of ASA to TSA is too low (for example, 10%), the tissue will receive too little resistance heating, resulting in superficial heating and less shallow damage. In a representative embodiment, the ASA of the energy transfer element 24 in contact with the tissue can be expressed as

0.25 TSA<img file="TW201223584A_D0001.tif" />ASA<img file="TW201223584A_D0002.tif" />0.50 TSA

By compensating with a reduced power transfer algorithm and/or using convective cooling electrodes (by exposure to the bloodstream), the ratio of ASA to TSA over 50% can still be effective without generating too much heat. As discussed further below, electrode cooling can be achieved by injecting or infusing a cooling fluid, such as normal saline (eg, room temperature normal saline or frozen normal saline) through the electrode and into the bloodstream.

Due to clinical reasons, the maximum required size of the guiding catheter and the size and anatomy of the renal artery lumen itself can be various size constraints of the energy transfer element 24. In some embodiments, such as the embodiment shown in FIGS. 13 and 25, the maximum outer diameter (or the cross-sectional dimension of a non-circular cross-section) of the energy transfer element 24 may be along the distal end of the handle assembly 34 The maximum diameter encountered by the length of the elongated shaft 16. As discussed above, for clinical reasons, the maximum outer diameter (or cross-sectional size) of the energy transfer element 24 is limited by the maximum inner diameter of the guide catheter through which the elongate shaft 16 passes through the intravascular path 14. Assuming that from a clinical perspective, the 8 French guide catheter (which has an inner diameter of about 0.091 inches (2.31 mm)) is the largest catheter required for access to the renal artery, and allows the energy transfer element 24 and the guide catheter to be If there is a reasonable gap tolerance between them, the maximum diameter of the electrode 46 is limited to about 0.085 inches (2.16 mm). If a 6 French guide tube is used instead of an 8 French guide tube, the maximum diameter of the energy transfer element 24 is limited to about 0.070 inches (1.78 mm), for example, about 0.050 inches (1.27 mm). If a 5-French guide tube is used, the maximum diameter of the energy transfer element 24 is limited to about 0.053 inches (1.35 mm).

Based on these constraints and the aforementioned power transmission considerations, the energy transfer element 24 may have an outer diameter of about 0.049 inches to about 0.051 inches (1.24 mm to 1.30 mm). The energy transfer element 24 may also have a minimum outer diameter of about 0.020 inches (0.51 mm) to provide sufficient cooling and damage dimensions. In some embodiments, the energy transfer element 24 may have a length of about 1 mm to about 3 mm. In some embodiments where the energy transfer element 24 is a resistance heating element, the energy transfer element 24 has a maximum outer diameter of about 0.049 inches to 0.051 inches (1.24 mm to 1.30 mm) and a length of about 10 mm to 30 mm. For example, one embodiment of the energy transfer element 24 provides a multi-electrode array of 4 to 6 electrodes placed around a support structure (e.g., a tubular structure). For example, the energy transfer element 24 may be a gold electrode or platinum, platinum iridium or another suitable material. In a specific embodiment, the electrode can be measured to be about 0.030 inch ID×0.0325 inch OD×0.060 inch length (0.76 mm×0.83 mm×1.52 mm). In another specific embodiment, the electrode can be measured to be 0.029 inch ID × 0.033 inch OD × 0.060 inch length (0.72 mm × 0.83 mm × 1.52 mm). In another specific embodiment, the electrode can be measured to be 0.038 inch ID×0.042 inch OD×0.060 inch length (0.97 mm×1.07 mm×1.52 mm). In addition, the electrodes and the support structure can be properly electrically insulated, wherein the power supply line array of each electrode is wrapped in a polymer sheath to provide a compact package electrode array assembly surrounding the support structure 22.

In other embodiments, the outer diameter of the treatment device 12 may be defined by one or more energy transfer elements 24, and may be further defined by elements such as a control wire 168 (as shown in FIG. 8A). For example, a specific embodiment can be used in conjunction with an 8 French guide catheter, and can include an energy transfer element 24 with a diameter of about 0.049 inches to 0.053 inches (1.24 mm to 1.35 mm) and a diameter of about 0.005 inches to 0.015 inches (0.13 mm to 0.38 mm) control line. However, in other embodiments, the configuration and/or size of the energy transfer element 24 and/or the control wire may vary.

In some embodiments, the spiral structure 22 may be formed of a conductive material. For example, the spiral structure 22 may be made of Nitinol wires, cables, or pipes. As shown in FIG. 5E, the wire 19 may connect the spiral structure 22 to the energy generator 26. The spiral structure 22 forms a contact area with the renal artery wall and serves as an energy transfer element 24. In this configuration, the spiral structure 22 can produce continuous spiral damage. The spiral structure 22 configured as the energy transfer element 24 may optionally include a sensor 33 positioned on, in, and/or adjacent to the spiral structure 22 and can be electrically connected to the power supply line 35.

In other embodiments, the conductive spiral structure 22 is at least partially insulated. That is, the conductive spiral structure is partially covered by an electrically insulating material, and the exposed part of the spiral structure 22 serves as one or more conductive energy transfer elements 24. The energy transfer elements 24 can have any size, shape, or number, and can be positioned relative to each other as provided herein.

The energy transfer element 24 can be configured to transfer thermal energy, that is, heat tissue and conduct thermal energy to the tissue. For example, the energy transfer element may be a resistive element, such as a thermistor, or a coil made of resistance wire, so that heat is generated when current passes through the energy transfer element. The resistance wire may be, for example, an alloy, such as nickel chromium, with a diameter between, for example, 48 AWG and 30 AWG. The resistance wire can be electrically insulated with, for example, polyimide enamel.

In certain embodiments, during treatment, the energy delivery element 24 may be repositioned angularly relative to the renal artery. Referring again to FIGS. 1 and 2, for example, this angular repositioning can be achieved by compressing the treatment assembly 21 and rotating the elongated shaft 16 of the treatment device 12 through the handle assembly 34. In addition to the angular or circular repositioning of the energy transfer element 24, the energy transfer element 24 can also be repositioned along the longitudinal or longitudinal dimension of the renal artery as appropriate. This longitudinal repositioning can be achieved, for example, by translating the elongate shaft 16 of the treatment device 12 by the handle assembly 34, and can be performed before, after, or simultaneously with the angular repositioning of the energy transfer element 24. 3B, repositioning the energy transfer element 24 along the longitudinal and angular dimensions can place the energy transfer element 24 in contact with the inner wall 55 of the renal artery RA at the second treatment site to treat the renal nerve plexus RP. In operation, energy can then be transferred via the energy transfer element 24 to form a second focal lesion at this second treatment site. For embodiments in which multiple energy transfer elements 24 are associated with a helical structure, the initial treatment may produce two or more damages, and repositioning may allow additional damage to be formed.

In some embodiments, the damage caused by the repositioning of the spiral support structure 22 is angularly and longitudinally deviated from the initial damage surrounding the angular and longitudinal dimensions of the renal artery RA, respectively. The composite damage pattern formed by the initial energy application and all subsequent energy applications after any repositioning of the energy transfer element 24 along the renal artery RA can effectively produce discontinuous damage (that is, it consists of multiple longitudinal and Angularly spaced treatment sites are formed).

In an alternative embodiment, the energy transfer element 24 may be in the form of an electrical wire. As shown in FIG. 5D, for example, the wire 500 may be wound around the spiral structure 22 to form a crimped electrode 24'. The crimped electrode 24' can provide an increased surface area for energy transfer. For example, the crimped electrode 24' can form a substantially continuous spiral damage in a single application of energy. The coiled electrode 24' can be wound around the helical structure 22 in any manner, depending on the damage to be desired. For example, the curled electrode 24' may form a continuous path along the length of the spiral, or the curled structure may form one or more discrete short electrodes separated by non-conductive sections. In other embodiments, a portion of the coiled electrode 24' can be positioned on the spiral structure so as to contact the blood vessel wall when the spiral structure is extended, and the other portion of the coiled electrode 24' can be positioned away from the blood vessel wall so that when the spiral structure is extended, Allow the damage to be discontinuous. In addition, in this configuration, the area of the crimped electrode 24' that does not touch the renal artery can contribute to the cooling of the energy transfer element 24', as described in more detail below. The location and number of conductive parts forming the energy transfer element 24' can be selected according to the desired damage pattern.

In the embodiment shown in FIGS. 5A and 5B, the energy transfer element 24 preferably includes a metal electrode having a rounded end and a lumen. The nitinol spiral support structure 22 is preferably electrically insulated (eg, electrically insulated by PET), and the electrode 24 is mounted on the insulator. The power supply line 25 connects the electrode to an energy source (not shown) and transfers energy (for example, RF current) to the electrode 24. The rounded end can reduce the mechanical stimulation to the blood vessel wall and provide a more consistent current density when delivering energy compared to electrodes with square or sharper ends. The energy transfer element 24 may alternatively comprise other forms as indicated, such as the crimped electrode 24' described above with reference to FIG. 5D. In another embodiment, the structural element 510 forming the spiral structure 22 may be the energy transfer element 24' itself, as shown, for example, in FIG. 5C.

III.<u style="single">Selected Examples of Renal Nerve Removal System</u>

The representative embodiments provided herein include features that can be combined with each other and with features of other disclosed embodiments. In an effort to provide a concise description of these embodiments, this specification does not describe all the features of actual embodiments. It should be understood that in the development of any such actual embodiment, such as any engineering or design project, many implementation specific decisions should be made to achieve the developers specific goals, such as meeting system-related constraints and business-related constraints, such goals May vary from embodiment to embodiment.

FIG. 6A illustrates an embodiment of the treatment device 112, which includes an elongated shaft 116 with different mechanical and functional areas configured in accordance with an embodiment of the technology of the present invention. For example, the elongated shaft 116 of the treatment device 112 includes a distal region with a therapeutic or therapeutic component 121 for delivery and deployment at the site of the renal artery for treatment, especially for the removal of renal nerves. The handle assembly 134 for manipulating the elongated shaft 116 and the treatment assembly 121 is disposed at the proximal end of the elongated shaft 116. More specifically, the handle assembly 134 is configured to have an actuator 136 (schematically shown) to provide remote operation of the control member (such as the control wire 168 of FIG. 6E or 8A) to transfer the treatment assembly 121 Control or change between the state and the expanded state. More details about suitable handle assemblies can be found in, for example, Clark et al., US Patent Application No. 12/759,641 ("Handle Assemblies for Intravascular Treatment Devices and Associated System sand Methods"), which is incorporated by reference in its entirety. In this article.

The treatment device 112 is configured to transfer the treatment component 121 to the treatment site in a transfer (for example, low profile) state, wherein the component 121 is substantially linear (for example, straight), so that the support structure 122 of the treatment component 121 is carried The loaded energy transfer element (not shown) is substantially axially aligned along the supporting member 122. Once positioned at the treatment site in the renal artery, the handle assembly 134 can be operated to actuate the control member to transform the treatment assembly 121 from the delivery state to the deployed state. For example, in one embodiment, the control member includes a control wire 168 disposed in the inner lumen of the tubular support structure 122 (Figure 8A). One end of the control wire 168 can be adhered to or near the distal end of the support structure 122, and the opposite end of the control wire 168 terminates in the handle assembly 134. As mentioned above, the handle assembly 134 is configured to manipulate the control line 168 to change the treatment assembly 121 between the delivery state and the deployed state. The pulling control wire 168 provides a proximally directed axial force acting on the support structure 122. Under the influence of the tension of the control wire 168 and the radial restraint conditions of the renal artery wall of the patient, when operating in the patient, the support structure 122 deforms to expand into a spiral geometry to stabilize the energy transfer element and the renal artery wall get in touch with.

In order to provide the desired deformation during deployment, the support structure 122 may be a tubular member having a plurality of slits, cuts, through holes, and/or openings selectively formed or disposed around the support structure 122. The tubular support structure 122 may have multiple features substantially similar to those of the support structure 22 described above. For example, the support structure 122 may be formed of biocompatible metals and/or polymers, including PET, polyamide, polyimide, polyethylene block amide copolymer, polypropylene or PEEK polymer, and narrow The slit is preferably laser cut into a tubular structure in the desired configuration. In certain embodiments, the support structure 122 may be a non-conductive material, a conductive material (for example, stainless steel, Nitinol, silver, platinum, nickel-cobalt-chromium-molybdenum alloy), or a combination of a conductive material and a non-conductive material. In a particular embodiment, the support structure 122 may be formed of a pre-formed material, such as spring tempered stainless steel or Nitinol. In addition, in some embodiments, the support structure 122 may be at least partially formed of a radiopaque material, which can be imaged on a fluorescent microscope, thereby allowing the clinician to determine whether the support structure 122 is properly placed and/ Or spread out in the renal artery. Radiopaque materials can include barium sulfate, bismuth trioxide, bismuth subcarbonate, powdered tungsten, powdered tantalum or various blends of certain metals (including gold, platinum and platinum iridium), and these materials can be directly used Incorporated into the support structure 122 or can form a partial or complete coating on the support structure 122.

The position, orientation, and/or configuration of the slits, cuts, through holes, and/or openings formed or arranged around the support structure 122 define the deformation of the structure. In addition, the slits, cuts, through holes, and/or openings can vary along the tubular structure 122 so as to define different deformation regions along the structure. For example, in the embodiment illustrated in FIG. 6A, the tubular structure 122 includes a distal deflection zone 122a, an intermediate orientation zone 122b located at the proximal end of the distal deflection zone 122a, and a transition zone located at the proximal end of the orientation zone 122b or Flex zone 122c. As described in more detail below, the deflection zone 122a is configured to have a substantially spiral geometry when deployed. The orientation zone 122b is configured so that the deflection zone 122a is positioned or deviated from the longitudinal axis B of the elongate shaft 116 toward the renal artery wall. The transition zone 122c is configured to provide flexibility to the treatment device 112 when the elongated shaft 116 is advanced from the percutaneous entry site via the sometimes twisted intravascular path to the target treatment site in the respective renal artery (see reference above) Figure 2). More details about the various mechanical and functional aspects of the different areas of the treatment device 112 are described below.

Fig. 6B is a plan view of a slit pattern according to an embodiment of the technology of the present invention. For example, referring to FIGS. 6A and 6B together, the deflection area 122 a may be defined as a plurality of substantially equal-length transverse slits 128 arranged along the spiral support structure 122. The orientation zone 122b may be defined as a plurality of axially spaced transverse slits 130, wherein at least two of the slits have different lengths. In addition, as best shown in FIG. 6A, the orientation zone 122b may have an axial length smaller than the deflection zone 122a. The transition zone 122c is positioned at the proximal end of the orientation zone 122b and has an axial length greater than each of the deflection zone 122a and the orientation zone 122b. In the illustrated embodiment, the transition zone 122c may include a continuous spiral cut or slit 132 having a varying pitch along the support structure 122. For example, in one embodiment, the pitch of the spiral incision 132 can be increased at the proximal end along the elongated shaft 116. More details about the different mechanical and functional aspects of each area of the treatment device 112 are described below.

6C is a perspective view of the treatment device 112 including the support structure 122' in a transfer state (for example, a low-profile or folded configuration) located outside the patient's body according to an embodiment of the technology of the present invention, and FIG. 6D is the support structure 122 'Perspective view in expanded state (for example, stretched configuration). For ease of understanding, the supporting structure 122' is shown in FIGS. 6C and 6D, in which the energy transfer element is not arranged around the supporting structure 122'.

6C and 6D together, the support structure 122 includes a tubular member having a central lumen to define a longitudinal axis BB. As described above, the support structure 122' includes a proximal general flexibility transition zone 122'c, an intermediate orientation zone 122'b, and a distal deflection zone 122'a. The support structure 122' can be selectively changed between the transmitting state (FIG. 6C) and the deployed state (FIG. 6D) by having an axial component directed at least to the proximal end, and this force is preferably applied to the distal end 126'a At or near to transform the distal deflection zone 122'a and the intermediate orientation zone 122'b. For example, in one embodiment, an axial force applied at or near the distal end 126a, at least partially directed in the proximal direction, can deflect the distal end deflection zone 122'a of the support structure 122' so that it is formed as shown in FIG. The spiral support structure shown in 6D (for example, in the renal artery) allows one or more energy transfer elements (not shown) to contact the inner wall of the renal artery.

<u style="single">Deflection zone</u>

As described above, in order to provide the supporting structure 122' with the desired deflection configuration and unfolding configuration, the deflection area 122'a includes a plurality of slits 128a, 128b, 128c, ... 128n. In addition, a plurality of slits 128a to 128n can be selectively formed, spaced, and/or oriented around the longitudinal axis BB, so that the distal deflection zone 122'a is deflected in a predictable manner, thereby forming an expanded spiral geometry in the renal artery . Outside the renal artery or other lumen that can radially constrain the deflection of the distal region 122'a, the distal region 122'a can be defined as a non-helical geometry in a fully extended configuration, such as the one shown in FIG. 6E Substantially circular geometric shape. As shown in FIG. 6E, the control wire 168 is disposed in the central lumen of the support structure 122' and anchored at or near the distal end 126a. When the control wire 168 is placed to pull in the proximal direction, at least a part of the deflection zone 122'a (without any limitation in the radial direction) deviates from the substantially straight shape of FIG. 6C to form the substantially circular shape of FIG. 6E. More specifically, referring to FIGS. 6C to 6E together, a part of the deflection zone 122'a is deflected, so that the deflection slits 128a to 128n are deformed and closed or substantially closed (as shown schematically in FIG. 6E), and provide configuration for each narrow The contact between the edges of the support structure 122 of the frame in the central area of the slit 128'. More details about the slit configuration are described below.

The deflection zone 122'a is configured to deflect around the center of curvature Z to define a first radius of curvature relative to the first surface 122'd of the support member 122'<i>r</i>, And the second radius of curvature relative to the second surface 122'e<i>R</i>. Second radius of curvature<i>R</i>Greater than the first radius of curvature<i>r</i>, The width or diameter of the support member 122' measured on the outer surface<i>d</i>different. For example, under the radial constraint of the inner wall of the renal artery, the deflection zone 122'a deforms to define a substantially spirally expanded shape (as depicted in FIG. 6D), rather than the substantially circular shape defined when the radial constraint does not exist. Shape (as depicted in Figure 6E). Therefore, the ratio of the substantially spirally expanded shape (for example, the diameter and pitch of the spiral body) can be changed according to the inner diameter of the lumen (for example, the renal artery lumen) in which the deflection zone 122'a is deformed.

The configuration and configuration of the slits 128a to 128n (FIG. 6C) further define the geometry of the deflectable distal region 122'a'. For example, FIG. 6F schematically illustrates the slit pattern of the slit 128 according to an embodiment of the present technology to illustrate the slit spacing and orientation of the deflection region 122a surrounding the support member 122'. Although only four slits 128a to 128d are shown in FIG. 6F, it should be understood that the deflection zone 122a may have any number of slits 128 as desired. Referring to FIGS. 6E and 6F together, the centers of the slits 128 are arranged and spaced along the progressive axis CC. The progressive axis CC and the longitudinal axis BB of the support structure 122 define the progressive angle θ (FIG. 6A) to define the angular interval γ around the center of curvature Z (FIG. 6E) in the unconstrained deployment state. The centers of the slits 128a to 128d are shown as being substantially equidistantly separated by a distance x. However, alternatively, the center-to-center spacing of the slits may be changed along the progressive axis CC (x1, x2, etc.). Each slit 128 further defines a maximum arc length L around the longitudinal axis BB and a maximum slit width W in the direction of the longitudinal axis BB.

The total number of slits 128 in the area 122'a under deflection multiplied by the slit width W divided by a specific length can define the first radius of curvature in the deflection portion of the deflection zone 122'a<i>r</i>(When placed in an unconstrained expanded state). For example, in a particular embodiment, each slit may have a width in the range of about 0.0005 inch to 0.010 inch (0.01 mm to 0.25 mm) and a slit of about 0.0005 inch to 0.010 inch (0.01 mm to 0.25 mm). The arc length of the slit is L, so that the first radius of curvature in the unconstrained deflection state<i>r</i>It is defined in the range of approximately 3.5 mm to 6 mm (7 mm to 12 mm diameter). When the maximum axial force is applied through the deflection zone 122'a of the support member 122, the first radius of curvature r is minimized, thereby defining the flexibility of the deflection zone 122'a. Therefore, the smaller the first radius of curvature r, the greater the degree of flexibility; the larger the first radius of curvature r, the greater the stiffness. Therefore, the flexibility and/or stiffness of the deflection area 122'a of the support member 122' can be defined by selecting the number and/or width of the slits of the distal region 122a. For example, in one embodiment, the deflection zone 122a may include about 2 to 100 slits, wherein each slit has a slit width in the range of about 0.0005 inch to 0.010 inch (0.01 mm to 0.25 mm) and about The arc length L of the slit is 0.0005 inch to 0.010 inch (0.01 mm to 0.25 mm), so that the first radius of curvature in the unconstrained deflection state<i>r</i>It is defined in the range of approximately 3.5 mm to 6 mm (7 mm to 12 mm diameter).

Because the first radius of curvature r of the deflection zone 122'a is directly related to the number of slits 128, the number of slits 128 can be a smaller number so that the section of the deflection zone 122a has a discontinuous radius of curvature, so that the zone The segments are substantially polygonal. For example, FIG. 6G is a schematic plan view of a treatment device 112' according to another embodiment of the technology of the present invention. The deflection zone 122'a of the treatment device 112' may include a lower or smaller number of deflection slits 128 (for example, three slits 128a to 128c are shown), so that the deflection zone 122'a is stretched when its distal end is When under extended load (ie, via the control line 168), a substantially polygonal geometric shape is defined. In other embodiments, a different number of slits 128 may be used to selectively form a desired geometric shape for the treatment device 112'.

Referring back to FIGS. 6B and 6C, and as described above, the deflection area 122a defines a plurality of deflection slits 128, wherein each slit 128 extends substantially transversely to the longitudinal axis BB of the support structure 122, and the slit 128 has substantially Similar arc length. In addition, referring to FIG. 6F, the center of the slit 128 of the deflection zone 122a is substantially spaced along the progressive axis CC, and the progressive axis CC is offset from the longitudinal axis BB, so that the slit 128 of the deflection zone 122a is substantially helical along the axis of the support structure 122 Go forward (best as shown in Figure 6C). The slits 128 of the deflection zone 122a can be selectively formed, spaced, and/or oriented around the longitudinal axis BB, so that the deflection zone 122a is deflected or deformed in a predictable manner so that when in a deployed state (for example, in a renal artery) ) It is preferable to form a spiral geometry.

For example, referring to FIG. 6B again, the deflection area 122a includes a pattern of deflection slits 128 configured according to an embodiment of the technology of the present invention to illustrate the slit spacing and orientation around the support member 122 (FIG. 6A ). The centers of the deflection slits 128 are arranged and spaced along the progressive axis CC. The progressive axis CC and the longitudinal axis BB of the support structure 122 define the progressive angle θ1 (FIG. 6A ). The progressive angle θ1 is defined, and more specifically, directly corresponds to the pitch angle of the spiral geometry defined by the support structure 122 when it is in the expanded state. Asymptotic angle θ₁The range may be, for example, about zero degrees (0°) to about 6 degrees (6°), such as one-half degree (0.5°), 2 degrees (2°), and the like. The centers of the deflection slits 128 are shown as being substantially equidistant apart. However, in other embodiments, the center-to-center spacing of the slits 128 can be changed along the progressive axis CC. The total number of slits 128 defined by the deflection zone 122a may be about 2 to 100 slits (for example, about 80 slits). In a specific embodiment, the total axial length of the deflection zone 122a is about 1 inch (2.54 cm). However, in other embodiments, the deflection region 122a may have a different number of slits 128, and/or the slits may have different sizes or configurations relative to each other.

In one embodiment, each deflection slit 128 includes a substantially rectangular central area 129 a, and the central area 129 a thereof is substantially perpendicular to and extends around the central longitudinal axis BB of the shaft 116. The elongated sidewalls of the central area 129a define the slit width W therebetween (for example, about 0.0015 inches (0.038 mm)) to define the maximum gap that can be closed when the slit 128 deforms during the deflection of the area 122a. Each slit 128 further includes a lateral area 129b communicating with or adjacent to the central area 129a. In one embodiment, the lateral area 129b is substantially circular and has a diameter (for example, 0.0060 inches (0.15 mm)) that can define an area for releasing stress at the distal end of the slit 128. The center-to-center spacing of the substantially circular lateral region 129b defines the arc length L (for example, about 0.040 inches (1.02 mm)) around the longitudinal axis of the structure 122. In some embodiments, these lateral regions 129b may be formed as elliptical cuts, which are not at right angles to the longitudinal axis BB of the supporting structures 122, 122', 122".

Alternative configurations of deflection slits are possible. For example, a deflection slit can be formed more specifically to provide the desired flexibility and deflection to the deflection region 122a of the support member 122. For example, FIGS. 6H and 6I illustrate the deflection zone 122a", which has a deflection slit 128' configured according to another embodiment of the technology of the present invention. In this embodiment, the deflection slit 128' is substantially It extends transversely to the progressive axis CC and is substantially symmetrical around the progressive axis CC. For example, the slit 128' may be generally "I-shaped" and includes a central area 129a extending perpendicular to the progressive axis CC, two of which extend The lateral area 129b is arranged around the central slit area 129a. In addition, the wall of the support structure 122" forming the periphery of each lateral area 129b defines a substantially rectangular geometric shape, which preferably extends substantially parallel to the longitudinal axis BB of the support structure 122", and the corners of the rectangular opening have been rounded . The central area 129a of the slit 128' may include a substantially circular cut-out area 129c formed by communicating with the lateral area 129b. Alternatively, in some embodiments, the central area 129c of the slit 128' may be generally rectangular, and does not include a circular cut-out area.

As best shown in FIG. 6I, the distal slit 128' extends around the longitudinal axis BB of the support structure 122", for example, with an arc length L'of less than about 0.05 inches (1.27 mm), for example, about 0.04 inches (1.02 mm) The transverse region 129b defines the maximum width W'of the deflection slit 128' to be, for example, about 0.03 inches (0.76 mm). The circular portion 129c of the central region 129a is adjacent to or communicated with the transverse region, and includes, for example, about 0.01 inches (0.25 mm). ) Diameter of the central circular resection area 129c. The central area 129a defines the minimum width of the support structure in the longitudinal direction of, for example, about 0.02 inches (0.51 mm). In a particular embodiment, the slit 128' in the distal region The total number is less than 30 slits (for example, 25 slits), the slit spacing is about 0.03 inch to 0.04 inch (0.76 mm to 1.02 mm), and the slit spacing in the distal deflection zone 122" is equal. However, in other embodiments, the distal region may have a different number of slits, and/or the slits may have different configurations (eg, different sizes, different or unequal slit spacing, etc.).

Alternative slits, cuts, and/or opening configurations can provide the desired flexibility, stress relief, or other performance characteristics. For example, FIG. 6J shows an alternative slit configuration 128" that can be used, for example, in the deflection zone 122a or orientation zone 122b of the support structure 122 (described in more detail below). The illustrative slit 128" includes substantially perpendicular to and surrounding the support The central area 129'a where the longitudinal axis BB of the structure 122 extends. The opposed side walls of the central area 129'a are generally arcuate, each defining a radius of curvature (for example, about 0.06 inch (1.52 mm)), and the maximum gap WWW (for example, about 0.005 inch (0.13 mm)) between them is defined in the supporting structure 122 The largest slit gap that can be partially or completely closed during deflection. In addition, the lateral area 129 b connected to or adjacent to the central area 129 a is arranged around the longitudinal axis BB of the support structure 122. The lateral regions 129'b are substantially circular, and each has a diameter (for example, 0.005 inch (0.13 mm)) that can define an area for stress relief. The center-to-center spacing of the curved lateral regions 129'b defines the length LLL (for example, about 0.04 inches (1.02 mm)) around the longitudinal axis BB of the support structure 122. These lateral regions 129'b may be formed as, for example, elliptical cuts which are not at right angles to the longitudinal axis of the elongated shaft.

The slit configuration in the deflection zone 122a and/or the orientation zone 122b of the elongated shaft can affect the flexibility of the support structure 122. For example, as shown in FIGS. 6K and 6L, the central area 129a of the slits 128, 128" includes (or lacks) a circular cut-out area 129c, which can change the sidewalls of the slits arranged around the bisecting axis of the slits. The number of contact points between. For example, FIG. 6K illustrates a portion of the distal region 122a" in a deflected or curved configuration. The central circular cut-out area 129c provides two contact points 602 between the side walls of the central area 129a: one contact point between each lateral area 129b and the central circular cut-out area 129c. In contrast, referring to Figure 6L, the lack of a central circular cut-out area 129c can provide a single contact point 602 between the walls of the central region 129c (along the deflected portion of the distal region 122").

It should also be noted that in order to facilitate the manufacture of the supporting members 122, 122', 122", the above-mentioned deflection slits 128, 128", 128"" can be formed vertically or substantially perpendicular to the longitudinal axis BB or the progressive axis CC without damaging the supporting member The ability of 122, 122', 122" to form the desired spiral geometry when in the expanded state.

In addition, as described above with reference to FIG. 6E, when the support structure 122 transforms from the transfer state to the expanded state, the slits 128, 128", 128"" are deformed, so that the central regions 129a, 129"a are defined (e.g., FIG. 6B, The walls shown in 6I and 6J are close to each other so that the corresponding gap widths W, WW, WWW are narrowed (until and including the gap is completely closed), and one or more pairs of opposed contact points are in contact with each other (schematically in Fig. 6E Shown and as described above with reference to Figure 6K and Figure 6L).

<u style="single">Orientation zone</u>

Referring again to FIGS. 6A to 6D, and as described above, the orientation region 122b defining the plurality of orientation slits 130 is disposed at the proximal end of the deflection region 122a. It may be necessary to control the orientation of the spiral axis of the support structure 122 relative to the longitudinal axis BB. For example, in a treatment assembly incorporating a support structure 122, the treatment assembly may need to be directed in a selected direction away from the longitudinal axis BB, so that at least a portion of the deflection zone 122a is laterally deviated from the proximal end 126b and/or elongated of the support structure 122 The distal end of the shaft 116. As best shown in FIG. 6D, for example, the orientation zone 122b may include orientation slits or openings 130 whose formation, spacing, and/or orientation may provide deviation (eg, about 45 degrees (45°) to about 90 degrees (90°). °)) The orientation axis B'-B' of the longitudinal axis BB, and the spiral geometry of the deflection zone 122a adjacent to the renal artery wall is oriented such that the spiral axis is aligned with the renal artery axis.

The orientation slit 130 can have a variety of different configurations/configurations. For example, referring to FIG. 6B (and referring to FIG. 6M), the centers of the orientation slits 130 are arranged and spaced along the orientation axis DD, and the orientation axis DD is radially deviated from the progressive axis CC (for example, deviated around the longitudinal axis BB of the support structure 122). About 90°). The orientation axis DD may generally extend parallel to the longitudinal axis BB, or alternatively deviate from the longitudinal axis BB by a selected angle (as described in more detail below with reference to FIG. 6N). In the illustrated embodiment, the centers of the orientation slits 130 are shown to have substantially equal spacing. However, in other embodiments, the distance between the individual slits 130 may be changed along the orientation axis DD. Each slit 130 defines a maximum arc length LL around the longitudinal axis BB and a maximum slit width WW in the direction of the longitudinal axis BB.

Referring to FIG. 6B, in one embodiment, the orientation slit 130 may include a set of slits having different arc lengths LL around the longitudinal axis BB. For example, the orientation slit 130 may include a first group of orientation slits 130a having a first arc length, and a second group of orientation slits having a second arc length smaller than the first arc length of the first group of orientation slits 130a. 130b and a third group of oriented slits 130c having a third arc length smaller than the second arc length of the group 130b. For example, in a specific embodiment, the first set of oriented slits 130a has an arc length of about 0.038 inches (0.97 mm), and the second set of oriented slits 130b has an arc length of about 0.034 inches (0.86 mm), and The third set of oriented slits 130c has an arc length of about 0.03 inches (0.76 mm). However, in other embodiments, the orientation slits 130 may have different sizes and/or configurations relative to each other. For example, in some embodiments, one or more sets of oriented slits 130 may have different slit widths (in addition to different arc lengths, or as an alternative to different arc lengths).

In one embodiment, the total number of slits 130 defined by the orientation zone 122b is less than 20 slits (for example, about 5 to 15 slits, about 6 to 12 slits, etc.) with equal spacing on the orientation zone 122b. . In addition, in a specific embodiment, the total axial length of the orientation zone 122b is about 0.2 inches to 0.25 inches (5.08 mm to 6.35 mm). In other embodiments, the orientation region 122b may have a different number of slits and/or different configurations and/or sizes.

Alternative configurations of oriented slits are possible. For example, referring back to the pattern illustrated in FIG. 6I again, the orientation slit 130' may be substantially elongated, which preferably defines the maximum arc length LL' around the longitudinal axis BB and the maximum slit width in the direction of the longitudinal axis BB WW. For example, in a specific embodiment, each orientation slit 130' has a width W'in the range of about 0.0005 inches to 0.010 inches (0.01 mm to 0.03 mm) and about 0.0005 inches to 0.010 inches (0.01 mm to 0.03 mm). ) Of the slit arc length LL', so that the first radius of curvature in the unconstrained deflection state<i>r</i>Defined in the range of about 7 mm to 12 mm. However, in other embodiments, the orientation slit 130' may have other sizes and/or configurations.

In the illustrated embodiment, the orientation slit 130 generally extends perpendicular to the orientation axis DD and is substantially symmetrical around the orientation axis DD. The orientation slit 130' is generally "I-shaped" and has a central area 131a extending perpendicular to the orientation axis DD, and two expanded lateral areas 131b arranged around the central slit area 131a for stress relief. In this embodiment, the wall of the support structure 122" forming the periphery of each lateral area 131b can define, for example, a substantially rectangular geometric shape, which extends substantially parallel to the longitudinal axis BB of the support structure 122", and the corners of the rectangular opening It has been rounded (not shown). In addition, the central area 131a of the individual orientation slit 130' may generally be rectangular, or may have other suitable shapes.

Each of the orientation slits 130 depicted in FIG. 6I may include a substantially rectangular central area 131 a that is substantially perpendicular to and extends around the longitudinal axis BB of the support structure 122. The elongated sidewalls of the central region 131a define a gap (for example, about 0.0015 inches (0.038 mm)) therebetween to define the maximum closed gap of the slit during the deflection of the structure 122. Each slit 130' may also include a lateral area 131b arranged around the longitudinal axis BB and communicating with or adjacent to the central area 131a. The lateral area 131b defines a substantially rectangular geometric shape, which preferably extends substantially parallel to the longitudinal axis BB of the support structure 122", and the corners of the rectangular opening have been rounded to define the area for stress relief. The substantially rectangular lateral area The center-to-center distance of 131b defines the arc length L (for example, about 0.04 inches (1.02 mm)) around the longitudinal axis BB of the support structure 122". Alternatively, the lateral area 131b may be formed as an elliptical cut, which is not at right angles to the longitudinal axis BB of the supporting structure 122, 122', 122".

In some embodiments, the total number of slits 130' in the orientation zone is generally less than ten slits, such as five slits. The slit spacing can be, for example, about 0.03 inches to 0.04 inches (0.76 mm to 1.02 mm), and the slits 130' The slits 130' may be equally spaced. In addition, in some embodiments, the orientation axis DD may be generally parallel to the longitudinal axis BB, and the minimum arc length distance radially deviated from the progressive axis CC is, for example, about 0.01 inches (0.25 mm), surrounding the longitudinal axis BB of the support structure 122" The angle range is about 50° to less than 90°.

In yet another embodiment, the orientation slit 130 may be disposed along an orientation axis that is substantially deviated from the longitudinal axis BB. FIG. 6N is, for example, a plan view of a slit pattern according to another embodiment of the technology of the present invention. In this embodiment, the orientation slit 130 is disposed on the orientation axis D₂-D₂Up, orientation axis D₂-D₂Can deviate from the vertical axis BB angle θ₂, Angle θ₂The range is, for example, about 0 degrees (0°) to about 45 degrees (45°). Tilted orientation axis D₂-D₂An orientation zone 122'b having a tapered spiral geometry when the support structure 122 is unfolded is provided. FIG. 60 is, for example, a schematic diagram of a part of a treatment device located in a patient's renal artery, which has a supporting structure in an expanded state and including the slit pattern of FIG. 6N.

<u style="single">Flexible/transition zone</u>

Referring again to FIG. 6A, the flexible or transition zone 122c is disposed at the proximal end of the orientation zone 122b. As described above, the flexible zone 122c may include, for example, a transitional spiral slit or cut 132 having a variable pitch over its length. The variable pitch of the spiral cut 132 along the length of the flexible zone 122c provides a support structure 122 with variable flexibility along the length of the elongated shaft 116. For example, in one embodiment, the transitional incision 132 extends over an axial length (e.g., an axial length of approximately 170 mm from the proximal end of the orientation zone). However, in other embodiments, the conversion cut 132 may have a different length.

As illustrated in FIGS. 6C and 6D, in some embodiments, the pitch of the transformable incision 132 may vary with the length of the transformable incision to define a plurality of different transition regions (four transition regions 132a are shown in FIG. 6C , 132b, 132c and 132d). More specifically, in one embodiment, the cutout 132 defines a first transition portion 132a having a first pitch (which is achieved by forming, for example, five circles around the tubular support structure 122 with a pitch of 0.02 inches (0.51 mm)) And the transition to the second transition portion 132b with a second pitch (defined as five turns with a pitch between 0.040 inches (1.02 mm)). The notch 132 continues to define a third transition portion 132a with a third pitch (defined as ten turns with a pitch of 0.06 inches (1.52 mm)) and a fourth pitch (defined as twenty turns with a pitch of 0.08 inches (2.03 mm))The change. The transformation. It should be understood that, in the above example, considering each successive transition portion 132 from the distal end to the proximal end of the transition region 122'c, the slit pitch increases and the flexibility of the tubular support structure 122 decreases.

The transformable incision 132 may have a substantially constant width over its length, for example, about 0.0005 inches (0.01 mm), or the width of the transformable incision 132 may vary with its length. The transformable incision 132 may also include a substantially circular void adjacent to or communicating with the transformable incision at each end. However, in other embodiments, the transformable incision 132 may have a different configuration and/or different size. For example, the transitional incision 132 may have a continuously increasing pitch from the distal end to the proximal end of the transition zone 122'c, instead of gradually increasing the pitch.

The alternative slit, cut, and/or opening configuration can provide the desired flexibility, stress relief, or other performance characteristics of the flexible region 122c instead of the transformable cut 132. For example, in some embodiments, openings or apertures can be selectively formed in the elongated shaft 116 to provide the desired flexibility. The individual openings or pores of the flexible region 122c may, for example, have a center disposed along an axis extending parallel to the central longitudinal axis BB of the support structure 122. 7A and 7B, for example, illustrate that the flexible region 122c has an alternative configuration of the support structure 122, which has through holes or openings 132'a, 132'b, 132'c each extending through the tubular support structure 122. The openings 132 may be alternately arranged on axes that are angularly spaced from each other and surround the longitudinal axis BB of the support structure 122, for example. For example, in the illustrated embodiment, the opening 132'b is disposed at an angle of 90° with respect to the axially adjacent openings 132'a and 132'c. However, in other embodiments, the opening 132' may have a different configuration.

Fig. 8A is an interrupted perspective view of a partial cross-section of a treatment device 100 including a catheter with an elongated shaft 116. The distal region 120 of the elongated shaft 116 has a support structure 122 for delivering therapeutic or therapeutic components 121 and in the lumen The therapeutic or therapeutic component 121 is deployed at the target treatment site, especially for performing renal nerve removal in the renal artery. As shown schematically in the figure, a handle assembly 134 for manipulating the elongated shaft 116 and the treatment assembly 121 is disposed at the proximal end of the elongated shaft 116. More specifically, the handle assembly 134 is configured to provide remote operation of the control member 168 (for example, a control wire) in order to control the treatment assembly 121 or to change the treatment assembly 121 between the delivery state and the deployed state (shown in FIG. 8A).

The system 100 is configured to deliver the treatment component 121 to the treatment site in a substantially linear (eg, straight) delivery state (not shown) of the treatment component 121, so that the energy transfer element 124 is substantially along the axis of the support member 122 To align. The energy supply line 25 may be arranged along the outer surface of the support member 122 and coupled to each energy transfer element 124 so as to supply treatment energy to the respective energy transfer element 124. Once positioned at the treatment site in the renal artery, the control member 168 is actuated to transform the treatment assembly 121 from the delivery state to the expanded state, as shown in the figure. In the illustrated embodiment, the control wire 168 is disposed within the tubular support structure 122. One end of the control member 168 may be adhered to or near the distal end 126a of the support structure 122 (e.g., terminate at the end member 174). The other end of the control member 168 can be terminated in the handle assembly 134, and is operatively coupled to the actuator to make the treatment assembly 121 switch between the delivery state and the deployed state.

The pulling control member 168 can provide a proximally directed and/or axially directed force to the distal end 126a of the support structure 122. For example, under the influence of the pulling force of the control member 168, the distal end region 122b of the support structure 122 deflects. The distal deflection zone 122a preferably includes a plurality of slits 128 (only two are shown in the figure: 128'a and 128'b). As described above, the slits 128'a and 128'b are arranged along the progressive axis. The slits 128'a and 128'b formed in the distal region 122a of the support structure can deflect the distal region 122a so as to form one or more curved portions, and the radius of curvature of each curved portion is preferably determined by the deflection slit 128 Defined by number, individual slit width, slit configuration and/or slit configuration. As the distal region 122a continues to deflect, it expands radially so that one or more spaced energy elements 124 are placed in contact with the inner wall 55 of the renal artery. The support structure 122 is configured to form a substantially spiral shape when subjected to the pulling force of the control wire 168 and the radial constraint of the blood vessel wall 55, so that the energy transfer elements 124 are axially spaced from each other and radially deviated. In addition, because the deflection zone 122a of the support structure 122 is configured to form a spiral geometry in the renal artery when under tensile load, it is expected that the treatment component 121 will not overload the renal artery wall 55 in the radial direction. The fact is that the supporting structure 122 deforms to form a spiral body under continuously increasing tensile loads.

As described above, the progressive angle of the axis along which the deflection slits 128, 128', 128" are arranged (for example, the progressive axis CC) defines the helix angle of the resulting deployment configuration. In one embodiment, the treatment assembly 121 The amount of fully deployed traction is typically less than the traction applied to the distal end 126a of the treatment assembly 121, such as about 1.5 lbf (pound-force) (0.68 kgF), such as about 1 lbf (0.45 kgF) to about 1.5 lbf (0.68 kgF) In the spirally expanded state of FIG. 8A, the slit 128' is arranged along the inner surface of the spiral body, and the power supply line 25 for the energy transfer element 24 is arranged on the outer surface of the spiral body to form the "spine" of the component. The power supply line 25 can extend along the length of the treatment device 112 to a suitably configured energy generator (not shown).

The support structure 122 of the treatment component 121 includes a proximal portion that defines the orientation zone 122b of the component so that the treatment component is positioned close to the renal artery wall. As shown in FIG. 8A, the proximal region of the support structure 122 includes a plurality of orientation slits 130'. In operation, when the handle assembly 134 is actuated to place the control wire 168 in a stretched state, the orientation zone 122b is deflected radially outward within the renal artery to position the treatment assembly 121 in contact with the artery wall 55. More specifically, the slit 130 is deformed under tension so as to deflect the orientation zone 122 b radially outward from the longitudinal axis BB of the support structure 122. In the fully deployed state, the spiral geometry generated by the treatment component 121 at the distal end of the support structure 122 is preferably offset from the longitudinal axis BB at the proximal end of the support structure 122, so that the spiral axis HH of the support structure 122 is different from the longitudinal axis BB . The axes HH, BB may be parallel to each other or offset relative to each other.

The proximal end of the support structure 122 may be coupled to a separate member that forms the elongate shaft 116 of the device 112. Alternatively, the support structure 122 and the elongated shaft 116 may be a single integral member that extends from the distal end 126a to the proximal end to the handle assembly 134. In one embodiment, the tubular support structure 122 is formed of a shape memory metal material (for example, Nitinol). In addition, in one embodiment, the supporting structure 122 may have an axial length of less than 5 inches (12.7 cm), more specifically about 2 inches (5.08 cm); about 0.020 inches (0.57 mm), more specifically The outer diameter is in the range of about 0.016 inch (0.41 mm) to about 0.018 inch (0.46 mm); the wall thickness of the tube is less than 0.005 inch (0.13 mm), more specifically about 0.003 inch (0.08 mm). In various embodiments, the elongated shaft 116 may have, for example, about 0.020 inches (0.57 mm) to about 0.060 inches (1.52 mm). mm) The outer diameter of the stainless steel metal tube is formed. When the proximal end of the support structure 122 is coupled to the elongated shaft 116, a joint 119 may be provided therebetween to transfer the required torque from the elongated shaft 116 to the support structure 122 when passing to the treatment site. More specifically, each end of the support structure 122 and the elongated shaft 116 may respectively include mating recesses that allow the ends of the tubular members to interlock with each other, as shown in the joint assembly 120. In some embodiments, a stainless steel sleeve is placed around the joint 119, which is crimped around the joint to provide additional support to the joint 119.

As described above, the control member 168 may be a control rod or wire that extends the axial length of the catheter device 112 from at or near the distal end 126a of the support structure 122 toward the handle assembly 134. The control thread 168 may comprise ultra-high molecular weight (UHMW) fibers, such as gel-spun high-strength fibers (sold under the trademark SPECTRA) or other sufficiently strong polyethylene fibers. Alternatively, Nitinol, para-aromatic polyamide synthetic fibers (sold under the trademark KEVLAR) or other monofilament or multifilament types can be used, as long as they are compatible with the application and can transmit tension through the length of the treatment device 112 To the distal end of the treatment component 121.

To provide the desired pulling force at the distal end of the treatment assembly 121, the control wire 168 may be anchored at or near the distal end 126a of the support structure 122. For example, FIGS. 8B to 8D illustrate various anchoring configurations for the control line 168. More specifically, as shown in FIG. 8B, the distal end 126a of the support structure includes a slit adjacent to the axial opening to tie and anchor the control wire 168 therethrough. In the alternative anchoring configuration shown in Figure 8C, the control wire 168 extends through an axial opening at the distal end 126a. The control wire 168 may be embedded in the material of the coil 174 to prevent the control wire 168 from sliding from the proximal end into the distal portion of the support structure. Figure 8D illustrates another tip 174 according to an embodiment of the invention. In this configuration, the control wire 168 can be twisted into three knots to enlarge the surface of the control wire 168, and a polymer material is coated on this surface to form an end.

Referring again to FIG. 8A, the control wire 168 may extend through the elongated shaft 116 to the handle assembly 134. When the handle assembly 134 is operated to pull and release the control wire 168 while changing the treatment assembly between the deployed state and the delivery state, friction occurs between the moving control wire 168 and the inside of the relatively fixed elongated shaft. One embodiment of the control wire 168 component is configured to minimize frictional contact between the control wire 168 and the interior of the elongate shaft 116. For example, as shown in FIG. 8A, the sleeve 170 may be positioned and bonded to the control wire 168 to provide a relatively low friction outer surface. The sleeve 170 preferably has an axial length smaller than the axial length of the elongated shaft 116, and preferably covers the substantially proximal portion of the control wire 168 in the elongated shaft 116. During the operation of the handle assembly 134 to pull and release the control wire 168, the tubular sleeve 170 is configured to move with the control wire 168 and act as a support surface against the inside of the elongated shaft 116, thereby reducing the control wire 168 and Friction between the elongated shafts 116.

In various embodiments, the control member may be configured to be located outside the support structure of the treatment assembly carrying the energy transfer element. For example, the support structure of the treatment component can be changed to wind or wind the control member on the outside. In this configuration, the control member engages with a part of the support structure to apply force, thereby switching the support structure and the treatment assembly between its delivery state and the deployed state.

9A and 9B, for example, illustrate the distal portion of the treatment device 212 configured according to other embodiments of the present technology. More specifically, FIGS. 9A and 9B illustrate a treatment assembly 221 having a tubular support structure 222, the support structure 222 is spirally wound around the control member 268, and a plurality of energy transfer elements 224 are arranged around the support structure 222. The support structure 222 may include various features substantially similar to the support structures 22 and 122 described above.

In the illustrated embodiment, the distal region or portion 222a of the support structure 222 terminates in an end piece (for example, a conical or bullet-shaped tip 250) or a collar, shaft, or cap. The tip 250 may include a rounded distal portion to facilitate the insertion of the treatment device 212 into the renal artery without trauma. The proximal region or portion 222 b of the support structure 222 is coupled to and adhered to the elongate shaft 216 of the treatment device 212. The elongate shaft 216 defines a central passage for the control member 268 to pass through. The control member 268 may be, for example, a solid wire made of metal or polymer. The control member 268 extends from the elongated shaft 216 and is adhered to the distal end region 222 a of the support structure 222 at the end 250. In addition, the control member 268 slidably passes through the elongated shaft 216 to the actuator 236 in the handle assembly 234.

In this embodiment, the control member 268 is configured to move distally and proximally via the elongate shaft 216 to move the distal region 222a of the support structure 222 accordingly. The movement of the distal region 222a to the distal end and the proximal end respectively extends and shortens the axial length of the spiral body of the support structure 222, so that the treatment component 221 can be changed between the delivery state (FIG. 9B) and the unfolded state (FIG. 9A), This causes the energy transfer element 224 to move a radial distance Y to engage the renal artery wall (not shown).

In an alternative embodiment, the treatment component may not adhere to the control member in the distal region of the tubular support structure. For example, FIG. 9C illustrates another embodiment of a treatment device 212 and a treatment assembly 221 having a spiral support structure 222, in which a plurality of energy transfer elements 224 are arranged around the spiral support structure 222. The distal end region 222a of the support structure 222 is coupled to the collar element 274, which includes a channel that is sized and shaped to slidably accommodate the control member 268 that terminates in the end piece 250. In this embodiment, the control member 268 includes a control wire that extends from the elongated shaft 216 and moves distally and proximally through the elongated shaft 216 and the collar element 274. The stop member 275 may be connected to the control wire 268 at the proximal end of the collar element 274.

The control wire 268 can promote the extension and/or contraction of the spiral support structure 222 when it is pulled or pushed to shorten or lengthen the spiral support structure 222. For example, pulling (ie, tension-enhanced) control wire 268 can cause spiral structure 222 to extend, while pushing (ie, compression-enhanced) control wire 268 can extend spiral support structure 222 to a compressed configuration. In some embodiments, the spiral structure 222 has elastic or superelastic properties such that when the force is removed, the spiral structure 222 elastically returns to a relaxed state. The end piece 250 or the stopping member 275 can be used to apply force to change the treatment assembly 221' between the delivery state and the unfolded state. For example, the control wire 268 can be pushed to the distal end, so that the stop member 275 engages the collar element 274 and moves it distally, so as to extend the support structure 222 and reduce its diameter, thereby placing it in a transmission state. Alternatively, the control wire 268 can be pulled proximally to cause the end piece 250 to engage the collar element 274 and move the collar element 274 proximally to shorten the spiral support structure 222 and increase its diameter, thereby placing it in deployment. state.

When the spiral support structure 222 has a preformed spiral shape memory, when the collar element 274 is not engaged with the stop member 275 or the end piece 250, the spiral support structure 222 elastically expands to its preformed shape. The spiral support structure 222 can be stretched in this way to contact the inner wall of the renal artery with a relatively uniform force. In addition, in some embodiments, the force of the pre-shaped spiral structure 222 on the renal artery wall may be less dependent on the operator's control of the handle assembly 234 (FIG. 9A).

Figures 9D and 9E illustrate another embodiment of the treatment device 212". In this embodiment, the control member 268' includes a hollow tube defining an internal channel for the guide wire 266 to facilitate the insertion of the treatment component into the kidney via an intravascular path In arteries. Therefore, the treatment device 212" has an OTW or RX delivery configuration as described herein. The control member 268' defines an internal lumen extending through the control member and is defined by, for example, a wall thickness of less than about 0.003 inches (0.08 mm) (e.g., about 0.001 inches (0.02 mm)) and a lumen diameter of less than about 0.015 inches (0.38 mm) (For example, about 0.014 inch (0.36 mm)) polyimide tube. In addition to engaging and tracking along the wire 266, the device 212" also makes the configuration of the treatment component 221 between the delivery state and the unfolded state in a manner similar to the treatment device 212 shown and described with reference to FIGS. 9A and 9B Transform.

Figures 10A and 10B are side views of another embodiment of a treatment device 310 having an OTW configuration and including a tubular control member 368 that defines a guidewire lumen that extends substantially along the entire length of the device. The control member 368 is configured to slidably receive the guide wire 366 so that the treatment device 310 can be tracked through the guide wire 366 using warp insertion technology. The control member 368 is slidably disposed in the elongated shaft 316. In one embodiment, the control member 368 is slid relative to the elongated shaft 316 in a thin-walled sleeve (not shown) attached to the inner surface of the elongated shaft 316 using a thermal bonding or adhesive bonding method. The thin-walled sleeve may be formed of a polymer material such as, but not limited to, polyimide. However, in other embodiments, the treatment device 310 may not include a cannula.

The treatment device 310 also includes a treatment assembly 312 extending between the distal end portion of the elongate shaft 316 and the distal end portion of the control member 368. The treatment assembly 312 can be deployed at a target location within the vascular structure, and includes a plurality of (e.g., six) energy transfer elements 324 (e.g., electrodes) to transfer energy from the energy generator 326 to the vessel wall. In some embodiments, the energy transfer elements or electrodes 324 may be equally spaced along the length of the support structure 322. However, in other embodiments, the number and/or configuration of the energy transfer elements 324 may vary. The axial length of the supporting structure 322 may be, for example, between about 17 mm and 20 mm. However, in other embodiments, the supporting structure 322 may have different lengths, as long as the structure is sufficient to support the number of electrodes in the desired electrode spacing pattern.

The energy transfer element 324 may be a series of separate strip electrodes spaced along the supporting structure 322. For example, ribbon or tubular electrodes can be used in some embodiments because they require less power for enucleation than disk or flat electrodes. However, in other embodiments, discs or flat electrodes are also suitable. In another embodiment, electrodes having a spiral or coil shape may be used. In one embodiment, the individual energy transfer elements 324 may have a length in the range of about 1 mm to 5 mm, and the distance between the energy transfer elements 324 may be in the range of about 1 mm to 10 mm. However, in other embodiments, the energy transfer element 324 may have a different size and/or configuration.

The energy transfer element 324 may be formed of any suitable metal material (for example, gold, platinum, an alloy of platinum and iridium, etc.). For example, in one embodiment, the energy transfer element 324 may be 99.95% pure gold with an inner diameter in the range of about 0.025 inches (0.64 mm) and 0.030 inches (0.76 mm) and an outer diameter of about 0.030 inches (0.76 mm) and 0.035 inches (0.89 mm). Electrodes of smaller or larger size (ie, diameter and length) are also suitable for use herein.

Each energy transfer element or electrode 324 is electrically connected to the generator 326 by a conductor or wire (not shown) extending through the lumen of the elongated shaft 316. Each electrode 324 can be welded or otherwise electrically coupled to the distal end of its energy supply line, and each line can extend through the entire length of the elongated shaft 316 so that its proximal end is coupled to the generator 326.

The support structure 322 may include a shape memory component, the extension of which is at least the length of the component 312. The shape memory support structure 322 is used to expand or transform the treatment component 312 from the delivery state shown in FIG. 10A (that is, the substantially straightened form) to the expanded state shown in FIG. 10B (that is, the preset spiral form) ). More specifically, the shape memory component of the support structure 322 can be constructed from a shape memory material that is preformed into an expanded state. Certain shape memory materials are able to restore a preset or predetermined shape when subjected to certain thermal conditions. When a shape memory material (such as Nitinol (Nitinol) or a shape memory polymer or an electroactive polymer) is at a relatively low temperature, the articles formed from it can usually be deformed into a new shape very easily, and this new shape is maintained Until it is exposed to a relatively high transition temperature, in the examples herein, the transition temperature is 37°C higher than the normal body temperature, and then the article returns to its pre-defined or predetermined shape maintained before deformation. In some embodiments, the support structure 322 can be formed from this shape memory material and inserted into the body in a deformed low-profile straightened state, and once the shape memory support structure 322 is exposed to the transition temperature in the living body, it will return to the "memorized" preset. Set the shape. Therefore, the shape memory support structure 322 has at least two stages of size or shape: a substantially straightened or stretched coil configuration, which has a sufficiently low profile to be delivered to the treatment site as shown in FIG. 10A; and energy The transfer element 324 is arranged in a spiral configuration in contact with the blood vessel wall 55, which is shown as a dashed line in FIG. 10B. The operator can also achieve the transfer state by pulling the shape memory support structure 322 mechanically or through a tensioning device. Referring to FIG. 10A, in one embodiment, the transmission diameter D1 of the shape memory support structure 322 may be between about 1 mm and 2 mm to allow transmission to a target blood vessel, such as a renal artery.

The treatment component 312 may also include an insulating component (not shown), which functions to electrically isolate the shape memory support structure 322 and the energy transfer element 324. For example, the insulating component may include a tubular outer sheath defining a lumen, which is formed of an electrically insulating material such as polyethylene block amide copolymer. In one embodiment, the insulating component may have an outer diameter of about 0.027 inches (0.69 mm) and an inner diameter of about 0.023 inches (0.59 mm). The insulating component is configured to accommodate the shape memory support structure 322 and the accommodating wire to provide additional protection thereto, and the electrode 324 is attached to or placed around the insulating component. The distal end of the insulating component can be attached to the distal end of the wire shaft 368 by any suitable method, such as adhesive, cannula, or other mechanical methods. In an embodiment depicted in FIG. 10A, the distal end of the insulating component is preferably attached to the distal end of the wire shaft 368 via a cyanoacrylate adhesive, and the polymer sleeve surrounds the distal end and is combined with the distal end The tapered end 350 of the treatment component 312 is formed. However, in other embodiments, the insulating component may have a different configuration than the treatment component 312.

The shape memory support structure 322 and the insulating component preferably extend along the length of the treatment component 312 and extend proximally to the distal end of the shaft 316, such as at least one or two centimeters, so that the proximal end of the shape memory support structure 322 Get rid of the energy transfer element 324 sufficiently to avoid any thermal effects from it.

When the shape memory support structure 322 of the treatment component 312 is in an expanded configuration, since the distal end of the insulation component is coupled to the distal end of the inner tubular shaft 368, the distal end of the insulation component retracts toward the proximal end, so that the treatment component 312 extends radially into contact with the blood vessel wall. The control member 368 also retracts slightly proximally within the elongate shaft 316 to allow the treatment assembly 312 to be deployed.

In the above-mentioned embodiments of the treatment device, the control member can be configured as a wire, a tubular shaft or other internal member, which exerts a force at or near the distal end of the support structure to make the configuration of the treatment component in the transmission state and unfold Change between states. However, in other embodiments, an actuation force can be applied at or near the proximal end of the treatment component to change the configuration of the component.

For example, Figures 11A and 11B illustrate an embodiment of a treatment device 612 configured to apply a deforming force to the proximal end of the treatment assembly. The treatment device 612 includes a tubular elongated shaft 616 having a proximal end coupled to the handle assembly 634 and a distal end coupled to the treatment assembly 621. The illustrated treatment assembly 621 includes a tubular support structure 622 that carries a plurality of energy transfer elements 624. The energy supply line (omitted for clarity) extends internally or externally along the support structure 622 to provide the energy transfer element 624 with therapeutic energy. The proximal end 622b of the support structure 622 is disposed in and adhered to the distal end of the tubular elongated shaft 616. The support structure 622 is preferably defined as a spiral shape wrapped around a tubular control member 668, which has an internal lumen for the passage of a wire 666, which can extend distally beyond the treatment assembly 621 and proximally beyond the handle assembly 634 . Therefore, the treatment device 612 is configured to pass through the warp. The support structure distal end 622a is coupled to the distal end region of the tubular control member 668. The control member 668 extends proximally within the elongated shaft 616 and is adhered to the inner surface of the handle assembly 634. Therefore, the distal end 622a of the supporting structure 622 can maintain a fixed distance from the handle assembly 634.

The elongate shaft 616 extends into the handle assembly 63 at the proximal end and is coupled to the actuator 636. In one embodiment, the actuator 636 provides linear displacement or straight longitudinal translation of the elongate shaft 616. The actuator 636 is shown schematically as a slider-in-groove assembly. In operation, the proximal translation of the actuator 636 causes the axial shaft 616 to translate proximally with respect to the handle assembly 634 and thereby to the inner member 668. The distal end of the elongated shaft 616 exerts a pulling force on the adjacent end 622b of the support structure 622 to which it is adhered. Because the distal end 622a of the support structure 622 is fixed to the control member 668, translation of the proximal end 622a of the support structure 622 toward the proximal end makes the structure slender so that the treatment component 612 can be placed in a low profile delivery state (FIG. 11A). Distal translation of the actuator 636 causes axial compression of the support structure 622 in order to position the treatment assembly in a deployed state (best shown in Figure 11B).

The alternative configuration of the handle assembly 634 can provide the desired axial translation of the elongated shaft 616. For example, FIG. 11C illustrates an alternative configuration of the handle assembly 634 that provides a pivot-type actuator 636 that allows the elongated shaft 616 to translate axially. The actuator 636' may include a pivotal connection point to the elongated shaft 616. Therefore, rotation of the actuator 636' around the angle of the pivotal connection point allows the elongated shaft 616 to translate linearly. The angular rotation of the actuator 636' can be controlled by the distance between the elongated shaft 616 and the pivot point. 11D illustrates another alternative configuration of the handle assembly 634, which includes a gear-type actuator 636" that can linearly translate the elongated shaft 616. For example, in one embodiment, the actuator 636" includes a connection to The ball handle or thumb wheel of the pinion. The elongated shaft 616 may be connected to a larger gear that meshes with the pinion gear to rotate the pinion gear, which in turn causes the larger gear to rotate and translate the elongated shaft 616. The different gear sizes allow the small rollers to rotate, resulting in greater translation of the elongated shaft 616.

In the above-mentioned embodiments of the treatment device, depending on the configuration, the treatment component of the device can be changed between the delivery state and the unfolded state by pushing or pulling the proximal end or the distal end of the supporting structure. It should be understood that the treatment device can be configured to selectively apply force at or near the proximal or distal end of the support structure, so that the clinician can select the end of the relevant movement, depending on, for example, the constraints surrounding the support structure .

In a number of alternative configurations, by inserting a control member (such as an insertion member, a stylus, a pre-formed member, etc.) into a part of the distal treatment section or a tubular support structure or retracting the control member, the treatment assembly can be delivered. Move between state and expanded state. For example, FIGS. 12A and 12B are side perspective views of a part of a treatment device 700 according to another embodiment of the technology of the present invention. More specifically, FIG. 12A illustrates the treatment device 700 outside the patient's body in a delivery state (e.g., a low profile or folded configuration), and FIG. 12B illustrates the treatment device 700 in an unfolded state (e.g., an extended configuration). Referring to FIGS. 12A and 12B together, the treatment device 700 includes an elongated shaft 701 having a distal portion 702 and a treatment section 704 at the distal portion 702. The treatment device 700 also includes a plurality of energy transfer elements 706 carried by the treatment section 704. The treatment device 700 further includes a control member 708 (schematically shown with a broken line) coupled to the treatment device 700 and slidable relative to the treatment segment 704. As will be described in more detail below, the treatment section 704 or the control member 708 includes a pre-shaped spiral shape, and other forms of the treatment section 704 and the control member 708 include a substantially straight shape. The treatment segment 704 and the control member 708 can move relative to each other, so that the treatment device 700 is changed between a low profile delivery state (FIG. 12A) and an extended delivery state having a pre-shaped spiral shape (FIG. 12B ). For illustration, the control member 708 is shown in FIGS. 12A and 12B. As described in more detail below, in various embodiments, the control member 708 may be inserted into or withdrawn from the treatment section 704 to change the treatment device 700 between the delivery state and the deployed state.

For example, in one embodiment described below, the control member 708 may include a stylus that extends along at least a portion of the length of the treatment device 700 and is configured to straighten the pre-shaped spiral treatment segment 704 of the treatment device 700 during delivery , Strengthening mandrel, straightening member or procedural wire. More specifically, when the control member 708 is pulled or pushed with respect to the treatment segment 704, respectively, the control member 708 facilitates the extension and/or contraction of the treatment segment 704. In another embodiment, a pre-shaped control member (such as a stylus or a pre-shaped member) may provide a spiral shape to the relatively flexible distal portion 702 of the treatment device 700.

FIGS. 13A to 15B are related to various embodiments of the treatment device, which include features substantially similar to the treatment device 700 described above with reference to FIGS. 12A and 12B. For example. 13A and 13B are cross-sectional views of a treatment device 712 including a treatment section or treatment assembly 721 having multiple energy transfers carried by a relatively flexible tubular support structure 722 defining a central lumen 729 Element 724. The tubular support structure 722 includes a distal end 722a that has an axial opening for a wire 766 (FIG. 13A) to extend through a lumen 729. The tubular support structure 722 has a proximal end 722b coupled or adhered to the distal end of the tubular elongated shaft 716. The elongate shaft 716 defines a central lumen that can receive the guide wire 766. Therefore, the configuration of the present invention provides meridian delivery from the entry site, where the wire 766 is initially inserted into the treatment site (for example, in the renal artery), and the treatment device 712 is placed through the wire 766. Inserting the substantially linear guide wire 766 into the entire flexible tubular support structure 722 can maintain the tubular support structure 722 in a normal straight shape, so that the treatment component 721 can be placed in a low-profile delivery state and delivered to the treatment site in the renal artery. The wire 766 may have a constant stiffness along its length, or may have a variable stiffness or flexibility along its length to provide enhanced flexibility, such as increased flexibility in the proximal to distal direction.

Once the treatment device 712 is delivered to the desired location in the renal artery via the guide wire 766, the guide wire 766 is completely retracted from the treatment device 712 and the elongated control member 768 (FIG. 13B) is inserted at the proximal end of the device 712 and advanced distally, The elongated shaft 716 is pushed into the central lumen 729 of the tubular support structure 722. The distal region of the control member 768 may have a predetermined expanded shape (for example, a spiral shape) when unconstrained to define the expanded state of the treatment component 721. The control member 768 may be made of a super-elastic Nitinol material having a preset or pre-shaped spiral shape. Alternatively, the control member may be made of a shape memory material.

The control member 768 has sufficient elasticity to be inserted at the proximal end of the device, for example, at the handle 734. The control member 768 can be directly inserted into the elongated shaft 716. Alternatively, the control member 768 may be first placed in a harder cannula 769 (FIG. 13B) to straighten the control wire 768 and facilitate the insertion of the control member 768 into the catheter device 712. In this embodiment, the treatment assembly 721 can be inserted into the proximal end of the elongated shaft 716, and once positioned at the treatment site in the renal artery, the cannula 769 can be retracted to allow the control member 768 to be deployed. As shown in FIG. 13B, the control member 768 generates a force on the tubular support structure 722, thereby deforming it into an extended spiral configuration and the treatment assembly 721 expands to position the energy transfer element 724 against the renal artery wall.

In a specific embodiment, the plurality of electrical energy transfer elements 724 are configured to be installed in a slightly expandable flexible tube 722 (e.g., made of polyethylene block amide copolymer (such as PEBAX)<img file="TW201223584A_D0003.tif" /> 5533D) or a plurality of electrodes 724 made of materials with lower hardness). In other embodiments, the tubular support structure 722 may be constructed of other polymers that provide the desired flexibility, such as PET, polyamide, polyimide, PEBAX, polypropylene, or PEEK polymers. In one embodiment, the tubular support structure 722 has an inner diameter of about 0.03 inches (0.76 mm), an outer diameter of about 0.04 inches (1.02 mm), and a length of about 4 cm. The electrode 724 may be a cylindrical electrode and, in one embodiment, may have an inner diameter of about 0.042 inches (1.07 mm), an outer diameter of about 0.046 inches (1.17 mm), and a length of about 1 mm. The electrodes 724 may be spaced 3 mm to 5 mm apart and bonded to the tubular support structure 722 using an adhesive. The electrode power conductive power supply line 725 may extend proximally along the outside of the tubular support structure 722.

In various embodiments, the proximal end 722b of the flexible support structure 722 with the electrode 724 is disposed at the distal end of the tubular elongated shaft 716 and bonded in place. The elongate shaft 716 may comprise a polyamide tube, for example. In one embodiment, the shaft 716 has an inner diameter of about 0.025 inches (0.64 mm), an outer diameter of about 0.03 inches (0.76 mm), and a length of about 100 cm. In other embodiments, the elongated shaft has an inner diameter of 0.026 inches (0.66 mm) and an outer diameter of 0.028 inches (0.71 mm) and/or other suitable dimensions. The outer tubular jacket 717 may surround the shaft 716 and abut or overlap the proximal end 722a of the tubular support structure 722.

The control member 768 used to deploy the treatment assembly 721 may include, for example, a preformed Nitinol wire having a spiral configuration at the distal end region of the control member 768. In one embodiment, the control member 768 has a diameter of about 0.015 inches (0.38 mm) and tapers distally to a tip having a diameter of 0.008 inches (0.20 mm). The multiple different diameters of the pre-shaped control member 768 can be adapted to different diameter renal arteries (each having a diameter in the range of about 4.0 mm to about 8.0 mm). The control member 768 may have a shape memory transition temperature slightly higher than body temperature (for example, austenite (austenite) end temperature A_f=42°C). Control member 768 is below A_fThe flexibility at the temperature is greater, so it is relatively easy to manually straighten the spiral area. Therefore, the control member 768 can then be inserted directly into the proximal end of the catheter without a "hard cannula 769". Once the distal region of the control member 768 is positioned in the tubular support structure 722 surrounded by the plurality of electrodes 824, the temperature of the shape memory control member 768 increases and exceeds A_fIt will be allowed to assume a helical configuration, deform the tubular support structure 722, and press the electrode 724 against the artery wall, allowing tissue removal to occur. Once the removal is completed and the energy source 26 is shut down, the surrounding blood flow can cool the electrode 724 and the control member 768 to be lower than A_fThis allows the control member 768 to be more flexible for removal from the catheter. Those skilled in the art will understand that various methods can be used to heat the control member 768 to change its shape.

In the embodiment illustrated in FIG. 13B, the control member 768 is placed in an optional cannula 769. The cannula 769 can be made of a variety of materials (including braided polyimide, PEEK, and/or stainless steel) and can have a size such that the cannula 769 can be easily slid through the elongated shaft 716. The pre-formed control member 768 has a total axial transmission length greater than the axial length of the cannula 769, so that the guide wire 766 can be advanced and retracted from the proximal end of the catheter device 712.

In the above embodiment in which the flexible tubular support structure 722 and the cannula 769 are used to deliver the treatment assembly and deploy the treatment assembly, the guide wire has been completely removed from the tubular support structure 722 before the pre-formed control member 768 is inserted because the guide wire 766 is received. And the elongated shaft of the catheter of the control member 768 only has a single lumen. However, other embodiments of the treatment device include an elongated shaft with multiple lumens to provide multiple channels in which control members, wires, power lines, and/or injectable fluids (such as contrast agents, drugs, or saline) can be accommodated . Therefore, these treatment devices use insertable components to provide the meridian delivery and deployment of the treatment components without the need to completely remove the guide wire from the catheter.

14A and 14B are, for example, interrupted longitudinal cross-sectional views of a treatment device 812 configured according to another embodiment of the technology of the present invention. As shown in FIG. 14A, the treatment device 812 includes a treatment assembly 821 having a plurality of energy transfer elements 824 carried by a relatively flexible tubular support structure 822 that defines a central lumen 829. The tubular support structure 822 includes a distal end 822a having an axial opening 823 for a wire 866 to extend through a central lumen 829. The tubular support structure 822 has a proximal end 822b coupled or adhered to the distal end of the tubular elongated shaft 816. The elongate shaft 816 can define a first internal lumen 813 for receiving a guide wire 866. The lead 866 exits at the proximal end via a conventional hub/luer fitting located at, for example, the handle 834. Therefore, the illustrated configuration provides OTW delivery from the entry site to the treatment site. Inserting the substantially straight wire 866 into the entire flexible tubular support structure 822 can straighten the tubular support structure 822 so that the treatment component 821 can be placed in a low-profile delivery state and delivered to the treatment site in the renal artery.

The tubular shaft 816 further includes a second internal lumen 814 that houses a control member 868 for deploying the treatment assembly 821. The tubular shaft 816 may have multiple lumens to accommodate a shaped insertion member, a power supply cord, and/or an injectable fluid (e.g., contrast agent, medicine, or saline). 14A and 14B show two lumens 813 and 814 formed inside the integral tubular shaft 816. As shown in FIG. Alternatively, the first lumen 813 and the second lumen 814 may be defined as respective tubular shafts disposed in the outer tubular shaft 816. Within the second inner lumen 814 of the tubular shaft 816, the control member 868 can maintain a substantially linear configuration. Once the treatment device 812 is placed at the desired position in the renal artery, the guide wire 866 is retracted from the tubular support structure 822 into the first lumen 813, and the control member 868 can be pushed distally into the center of the tubular support structure 822 Inside the lumen 829. Because the control member 868 and the guide wire 866 each have a separate lumen for them to reside, the guide wire 866 only needs to be retracted proximally enough to exit the tubular support structure 822 of the treatment assembly 821, so as to allow the control member 868 to fill the support structure 822 and The treatment component 821 is unfolded. For example, in various embodiments, the guide wire 866 can be retracted by 10 cm to 20 cm (eg, about 15 cm) to disengage the tubular support structure 822 so that the treatment assembly 821 can be deployed.

The control member 868 may have a preset expanded shape, which is defined as a spiral shape (when unconstrained) to define the expanded state of the treatment component 821. The control member 868 may be made of a super-elastic Nitinol material having a preset spiral shape. Once positioned in the support structure 822, the elastic control member 868 can exert a force on the tubular support structure 822 to deform it into an extended spiral configuration (for example, as shown in FIG. 14B), so that the treatment assembly 821 can be deployed And the energy transfer element 824 is positioned against the renal artery wall.

In other embodiments of the device with a multi-lumen elongated shaft, the tubular support structure may include at least two or more independent lumens or channels. For example, FIGS. 14C and 14D illustrate a treatment device 912 including a treatment assembly 921 having a plurality of energy delivery elements 924. The tubular support structure 922 defines at least two lumens. The first lumen 928 can include an axial opening at its distal end and can be adapted to receive a guidewire less than about 0.015 inches (0.38 mm) in diameter, insertable into and retractable from the first lumen 928 966. Therefore, the support structure 922 can be delivered into the renal artery using the OTW method as described above. In other embodiments, the distal end 922a of the tubular support structure 922 may terminate at a rounded distal end to facilitate the insertion of the treatment device into the renal artery without trauma. The second lumen 930 is adapted to accommodate a deployment member 968 having a predetermined distal region defined in a spiral shape in a deployed state.

By inserting the guide wire 966 into the entire first lumen 928 of the support structure 922, the treatment component 921 can be placed in a low-profile delivery state (for example, as shown in FIG. 14C) to deliver to the renal artery. The substantially linear guide wire 966 can overcome the preset spiral shape of the flexible deployment member 968 to maintain the treatment component 921 in a delivery state. The wire 966 may have a constant stiffness along its length, or may have a variable stiffness or flexibility along its length in order to provide enhanced stiffness, such as enhanced stiffness in the proximal to distal direction. Once the treatment component 921 is positioned at the target treatment site in the renal artery, the treatment component 921 can be deployed by retracting the guide wire 966 in the first lumen 928 of the support structure 922 so that it is generally positioned on the elongated shaft 916 (e.g., in one of the multiple lumens formed in the elongated shaft 916). When the lead 966 is removed from the support structure 922, the deployment member 968 can generate a deforming force on the tubular support structure 922 to deform it into a spiral shape, so as to deploy the treatment assembly 921 (for example, as shown in FIG. 14D). Therefore, the lead 966 provides a control member that can change the treatment assembly between the delivery state and the deployed state. The first lumen 928 can optionally be used to deliver fluid, such as saline, to the distal end to cool the energy delivery element 924 during energy delivery.

In another embodiment, the deployment member 968 can be retracted to control the delivery state and deployment state of the treatment component 921 and during deployment, the guide wire 966 or other straightening needles can be held in the first lumen 928. In this configuration, the rigidity of the guide wire 966 can be sufficient to place the treatment assembly 921 in a low-profile configuration for transmission, and the flexibility is sufficient to allow the deployment member 968 to exert a force on the assembly 921 to place the support structure 922 and the treatment assembly 921 in deployment. configuration.

Figures 15A and 15B illustrate another embodiment of the treatment device 1012 that allows the guidewire 1066 to be at least partially inserted into the elongate shaft 1016 during treatment. As shown in FIG. 15A, the tubular support structure 1022 and the elongate shaft 1016 of the treatment device 1012 each include a single lumen. The treatment device 1012 includes a treatment assembly 1021 having a plurality of energy transfer elements 1024 fixed to a tubular support structure 1022 that defines a single central lumen 1029. The support structure 1022 may be covered by an electrical insulator, for example, by a heat shrinkable tube of polymer (such as PET). The tubular support structure 1022 may also include a distal end 1022a having an axial opening 1023 that allows the wire 1066 to extend beyond the distal end 1022a. In some embodiments, the distal end 1022a may terminate in a rounded distal portion (e.g., as shown by a broken line). The tubular support structure 1022 may have a proximal end 1022b coupled to the distal end of the elongate shaft 1016. The central lumen 1029 of the support structure 1022 can extend through the elongated shaft 1016 to receive the wire 1066 and allow OTW delivery. In operation, the substantially straight wire 1066 is inserted into the entire tubular support structure 1022 to straighten the tubular support structure 1022, so that the treatment component 1021 is placed in a low-profile delivery state (for example, as shown in FIG. 15A) to deliver the treatment in the renal artery Site.

The tubular support member 1022 may be made of an elastic or super-elastic material, such as a Nitinol tube or a polymer composite tube including braided or crimped Nitinol wire. In various embodiments, the support structure 1022 may have an inner diameter less than or equal to about 0.015 inches (0.38 mm), such as about 0.010 inches (0.25 mm), and less than about 0.005 inches (0.13 mm), such as about 0.003 inches ( 0.76 mm) wall thickness. The tubular support structure 1022 may also be made of a shape memory material, such as Nitinol with a pre-formed spirally expanded shape. As an alternative to using a pre-formed shape, the tubular support structure 1022 may include a pre-formed internal member (for example, an inner tube) or an outer frame structure (not shown) that offsets the tubular support structure 1022 into a helical deployment configuration.

When the guidewire 1066 is placed in the central lumen 1029, the guidewire 1066 generates a straightening force on the tubular support structure 1022 so as to define the low profile or folded transfer configuration shown in FIG. 15A. The wire 1066 may have a constant stiffness along its length, or may have a variable stiffness or flexibility along its length to provide enhanced flexibility (e.g., in the proximal to distal direction). To deploy the treatment assembly 1021, the guide wire 1066 can be retracted into the elongate shaft 1016 at the proximal end to remove the guide wire 1066 from the support structure 1022. As shown in FIG. 15B, when there is no straightening force, the support structure 1022 can be expanded into a spiral configuration. Therefore, the guide wire 1066 acts as a control member that changes the configuration of the treatment assembly 1021 between the delivery state and the deployed state.

Although the above-mentioned embodiments of the treatment device or the catheter device include the configuration of the treatment component and the control member to place the component in a low-profile delivery state, the catheter device may further include a device that can be placed on the treatment component and retracted by the treatment component to change its delivery and Expand the outer sheath of the configuration. For example, as shown in FIGS. 16A and 16B, the treatment device 1212 can be used in conjunction with a delivery outer sheath 1291 that surrounds the treatment assembly 1221 and the elongated shaft 1216 to form an outer sheath. As mentioned, in certain embodiments, it may be advantageous to use a guiding catheter 1290 having a specific size to facilitate the insertion of the treatment device 1221 through the femoral artery. The delivery sheath 1291 can be used in conjunction with the guiding catheter 1290 to enter the renal artery and deliver the expandable spiral structure 1222 contained therein. Alternatively, the delivery sheath 1291 can be used in combination with a wire (not shown) as described above. When used in conjunction with the guiding catheter 1290, the working length of the elongated shaft 1216 can be about 40 cm to about 125 cm. For example, if a guide catheter with a length of 55 cm is used, the working length can be about 70 cm to about 80 cm. If a guiding catheter 1290 with a length of 90 cm is used, the working length can be about 105 cm to about 115 cm. In a representative embodiment, if the guiding catheter 1290 is not used, the working length may be about 40 cm to about 50 cm. In other embodiments, a variety of other different sizes and/or configurations may be used.

In the depicted embodiment, the treatment component 1221 includes a spiral structure 1222 that can be maintained in a low-profile delivery configuration by the delivery sheath 1291. Removal of the delivery sheath 1291 may allow the helical support structure 1222 to expand and place the energy delivery element 1224 in contact with the renal artery wall. The deployment of the support structure 1222 can be passive (for example, the structure has a predetermined deployment shape) or active (for example, the deployment is facilitated by a pre-formed stylus or a tension wire). Regardless of the extension type, the spiral support structure 1222 can be coupled to a control member (such as a control wire) of the compression spiral structure, and then the treatment device 1212 can be removed or repositioned. In a specific embodiment, depending on the placement and number of the energy transfer elements 1224, the spiral support structure 1222 can be gradually repositioned in the renal artery to provide energy transfer to multiple locations. Figure 16B shows an embodiment of the catheter with spiral structure 1222 of Figure 16A, in which the retracted delivery sheath 1291 allows spiral structure 22 to stretch flexibly in the renal artery to its deployed configuration. It should be noted that in FIG. 16A, the outer sheath 1291 and the treatment component 1221 are drawn enlarged in size for clarity.

In a specific embodiment, the outer sheath can be used to hold the components of the treatment assembly together, especially when the device is passed to the treatment site within the renal artery. 9A and 9B, the treatment component 221 may include a spine or support structure 222 made of Nitinol material, and a plurality of electrodes 224 are arranged nearby. The nitinol support structure 222 may be spirally wound around the braided polyamide inner member 268. In the delivery state of the treatment assembly 221 of FIG. 9B, the support structure 222 can be close to the inner member 268 over its length. An outer sheath may be placed on the treatment assembly 221 to minimize the substantial separation between the support structure 222 and the inner member 268 when the treatment assembly 221 is bent during delivery. The outer sheath can also be used with the treatment components described above with reference to FIGS. 10A to 11B and other suitable treatment components described herein.

The outer sheath can also be used to support the treatment component in a delivery configuration, even if the treatment component has a shaped insertion member disposed in the lumen of the flexible tubular support structure. For example, referring to FIGS. 13A and 13B, an outer sheath (not shown) may be placed on the supporting structure 722. When the guidewire 766 is retracted and the control member 768 is inserted into the lumen of the support structure 722, the outer sheath prevents the treatment assembly from expanding to its full lateral dimension. To allow the assembly 721 to fully expand into a predetermined spiral configuration, the outer sheath can be retracted. Alternatively or in addition, the stiffness of the tubular support structure 722 is preferably sufficient to allow guide insertion to the treatment site without the use of a stylus or shaping member, but flexible enough to assume the shape of the inserted control member 768 (once it is withdrawn) Outer sheath). In addition, the insertable control member 768 may alternatively or additionally be inserted into the sheath to minimize or eliminate premature deployment of the treatment assembly when the control member is inserted. Therefore, once the outer sheath is removed, the insertion member 768 can be extended to its fully deployed configuration.

In other embodiments, referring to FIGS. 13A and 13B, the port needle 768 is positioned within the distal end of the treatment component 721 of the device 712 while the device is at the treatment site (for example, in the renal artery). For example, in this embodiment, the stylus 768 is inserted into the sheath in a low profile configuration during insertion through the cannula 769. After insertion, the cannula 769 is removed from the preformed stylus 768, allowing the stylus 768 to assume its spiral shape in the manner described above. In this embodiment, the stylus 768 can provide the device 712 with structure and desired stiffness to help guide and position the device 712 during delivery and then give it the desired spiral configuration when deployed.

In some of the above-mentioned meridian insertion embodiments of the treatment catheter device, the guide wire is described as extending from at least the distal end of the treatment assembly to the positioning proximal end of the handle assembly within the elongated shaft of the catheter. In order to free the catheter from the guidewire, it is necessary to retract the entire length of the guidewire from the entry position to the proximal end. Therefore, the axial length of the guidewire can be greater than the axial length of the elongated shaft of the catheter and its distal treatment component. In order to provide the operation and manipulation of a shorter lead, especially to minimize the retraction distance of the catheter from the lead, it may be necessary to provide a rapid exchange configuration for the treatment catheter device. The quick exchange examples described below with reference to FIGS. 17A to 17E can also be used in conjunction with any treatment devices described herein that use wires and OTW delivery technology.

For example, FIG. 17A is an interrupted side view of a partial cross-section of a distal portion of a treatment device 1410 with a rapid exchange configuration according to an embodiment of the present technology. The treatment device 1410 includes a treatment assembly 1421 helically arranged around a tubular control member 1468, the control member 1468 defining an internal lumen for the guide wire 1466 to pass through. The tubular control member 1468 extends proximally within the elongate shaft 1416 of the treatment device 1410, and is shown at least partially disposed within the guiding catheter 1490. In order to provide a quick exchange configuration (where the wire 1466 extends externally at least partially parallel to the elongated shaft 1416), the tubular control member 1468 includes an opening 1470 located at the proximal end of the treatment assembly 1421, but the distal end of the handle assembly (not shown) For the withdrawal of wire 1466. The elongated shaft 1416 preferably also includes an opening 1472 for the wire 1466 to exit and pass into the guide tube 1490. Because the wire 1466 does not need to extend proximally to the handle assembly (not shown) via the elongated shaft 1416, its overall length can be reduced.

Figures 17B and 17C illustrate another embodiment of a treatment device 1600 with a fast exchange configuration according to another embodiment of the technology of the present invention. More specifically, FIG. 17B is an interrupted side view of a partial cross-section of the distal portion of the treatment device 1600 in the delivery state, and FIG. 17C is an interrupted side view of the treatment device 1600 in the deployed state. 17B and 17C together, the treatment device 1600 includes a treatment assembly 1621 having a tubular support structure 1622, in which a plurality of energy transfer elements 1624 are arranged around the support structure 1622. The support structure 1622 extends proximally within at least a portion of the elongated shaft 1616 of the treatment device 1600. The energy supply line 1625 preferably extends within the tubular support structure 1622 to provide each energy transfer element 1624 with energy from an external generator source (not shown). The tubular support structure 1622 extends distally around the tubular member 1680 in a spiral manner and terminates along the outer surface of the tubular member 1680, and is preferably bonded at the distal end region 1680a of the tubular member 1680.

The tubular member 1680 provides internal members to the treatment assembly 1621, which are arranged in the spiral body defined by the support structure 1622, and can be used to control the distal end area of the support structure 1622 so that the support structure 1622 of the treatment assembly 1621 is in the transfer configuration and deployment group. Change between states. The treatment device 1600 further includes a control member 1668 coupled to the proximal region of the tubular member 1680 for pushing the inner member 1680 distally and pulling the inner member 1680 proximally, so that the distal end 1622a of the tubular support structure 1622 is relative to the shaft 1616. The distal end moves in the distal and proximal directions respectively. The distal end 1622a of the support structure 1622 moves to the distal end to extend the axial length of the spiral support structure 1622 and place the treatment component 1621 in a transfer configuration (as shown in FIG. 17B). Similarly, moving the distal end 1622a of the support structure 1622 proximally can shorten the axial length of the spiral support structure 1622 so that the treatment component 1621 is placed in the expanded configuration shown in FIG. 17C. In one embodiment, the control member 1668 may be configured as a push-pull rod. For example, the push-pull rod may extend axially within the elongated shaft 1616 and, in some embodiments, an independent intraluminal shaft in the elongated shaft 1616 that is independent of the lumen of the power cord 1625 carrying the treatment component 1621 To extend.

The tubular inner member 1680 defines an inner lumen for the guide wire 1666 to pass through. Therefore, the tubular inner member 1680 includes an axial opening in the distal region 1680a for the guide wire 1666 to pass through. The proximal region 1680b of the tubular inner member 1680 is configured for the lead 1666 to pass and exit from the proximal end. The proximal region 1680b may terminate in, for example, an oblique elongated hole 1682 for the lead 1666 to exit. In some embodiments, the proximal region 1680b of the inner member 1680 can be adhered to the distal end of the push-pull member 1668, so that the push-pull member 1668 can control the axial distance between the wire outlet 1682 and the elongated shaft 1668. In addition, in some embodiments, the distal end of the push-pull member 1668 may include a tapered or angled end to increase the cross-sectional area of the push-pull member 1668 bonded to the inner tubular member 1680. Because the configuration of the inner member 1680 and the push-pull member 1668 maintains the wire exit opening outside of the elongated shaft 1616, this configuration provides a quick swap configuration.

In particular, the wire exit opening 1682 is configured such that the wire 1666 can extend in parallel to the elongated shaft 1616 on the outside. Therefore, manipulating the wire 1666 (eg, via a handle assembly) does not require the wire 1666 to extend proximally within the full length of the elongated shaft 1616 and exceed the full length of the elongated shaft 1616. Therefore, in some embodiments, the wire length 1666 may have a reduced length, for example, about 180 cm. In addition, as far as it may be necessary to disengage the treatment component 1621 from the guidewire 1666, the guidewire 1666 only needs to be retracted by an amount sufficient to retract the distal end of the guidewire proximally from the guidewire exit opening 1682.

In one embodiment, the elongated shaft 1616 is configured to engage the proximal region of the inner tubular member 1680 in the deployed configuration of the treatment assembly 1621. More specifically, the distal region of the elongated shaft 1616 is formed in order to form a tight fit with the outer portion of the proximal end 1680b of the tubular member 1680 in the expanded configuration. As shown in Figure 17C, in order to deploy the treatment assembly 1621, the push-pull member 1668 is fully retracted. Retracting the push-pull member 1668 positions the proximal end 1680b adjacent the distal end of the elongated shaft 1616. The distal end of the elongated shaft 1616 preferably includes a cone so that the internal lumen for the energy supply line 1625 and the linear portion of the tubular support structure 1622 extend distally beyond the internal lumen that accommodates the push-pull member 1668. A cone at the distal end of the elongated shaft 1616 (eg, a roll-on or inclined recess) is sized and shaped to receive the proximal end 1680b of the inner tubular member when positioned adjacent to the elongated shaft 1616.

In one embodiment, the treatment component 1621 may have a maximum delivery length in the range of, for example, about 8 mm to about 50 mm, for example, about 15 mm to about 50 mm. In the deployed configuration, the treatment component 1621 may have a maximum axial length of, for example, about 45 mm. The tubular member 1680 may have an axial length in the range of about 2 cm to 50 cm, and the opening 1682 has an axial length of, for example, about 2 mm to 8 mm. The push-pull rod 1668 is configured to change the axial distance between the distal end of the elongated shaft 1616 and the opening 1682 of the inner tubular member 1680 by a distance of, for example, 1 mm to about 30 mm. The elongated shaft 1616 and the guide wire 1666 may extend parallel to each other within the enclosed guide tube. The catheter device 1612 can be configured such that the opening 1682 is positioned inside or outside the guiding catheter 1690.

An alternative embodiment of the treatment device 1710 is shown in Figure 17D. In this embodiment, the treatment assembly 1721 includes a tubular support structure 1722 having a proximal end portion that extends proximally into the elongated shaft to carry the energy supply line of the energy transfer element 1724 disposed around the support structure 1722 . The control member 1768 including the push-pull rod extends parallel to the proximal portion of the tubular support structure 1722. The tubular member 1780 defining the internal lumen through which the guide wire 1766 passes is preferably also extended parallel to the push-pull control member 1768. The distal region 1722a of the support structure 1722 and the push-pull rod member 1768 are preferably each adhered to the tubular member 1780, so that the axial movement of the push-pull member 1768 allows the distal end of the tubular support structure 1722 and the tubular member 1780 to move along the guide wire 1766. The tubular support structure 1722 is preferably spirally wound around the tubular member 1780 so that the tubular member 1780 is located inside the spiral body defined by the support member 1722. The movement of the distal region 1722a to the distal end and the proximal end can extend and reduce the axial length of the spiral tubular support structure 1722, respectively, so as to place the treatment component 1721 in a transfer and deployment configuration. The opening 1782 is located at the proximal end of the treatment assembly 1721 and along the distal end of the handle assembly of the tubular member 1780 to provide a quick exchange configuration.

Because the push-pull member 1768 and the distal end 1722a of the tubular support structure are adhered to the tubular member 1780, the tubular support structure 1722 cannot rotate around the tubular member 1780 and the axial opening through which the wire passes. Therefore, to enable the distal end 1722a to rotate around the guidewire lumen of the member 1780, the push-pull member 1768 and the distal end 1722a of the tubular support member 1722a may be coupled to the tubular member 1780, but may be detachable, as shown, for example, in FIG. 17E. More specifically, the tubular member 1780 preferably detachably or independently rotates relative to the tubular support structure 1722 and the push-pull member 1768. Therefore, the rotatable distal region of the treatment assembly 1721 can rotate around the guide wire 1766. In addition, because the distal region of the treatment assembly 1721 can rotate around the tubular member 1780, the proximal guidewire outlet 1782 can remain fixed relative to the treatment assembly 1721 so that the rapid exchange configuration does not hinder the rotation of the treatment assembly.

In the embodiment shown in FIG. 17E, a sleeve 1785 is provided to co-adhere the distal end of the tubular support structure 1722 and the push-pull member 1768. The sleeve 1785 further defines an internal passage for slidably receiving the member 1780. The sleeve 1785 provides the tip assembly of the treatment assembly, which can slide axially and rotate around the tubular member 1780. This configuration further provides the support structure 1722 and the push-pull member 1768 of the assembly to rotate relative to the tubular member 1780, while maintaining a better general spiral shape, without the support structure 1722 "wrapping" the tubular member 1780 and losing the desired shape/configuration (manipulation) The treatment component in the blood vessel).

IV.<u style="single">Apply energy to tissues via energy transfer elements</u>

Referring back to FIG. 1, the energy generator 26 can supply a continuous or pulsed RF electric field to the energy transfer element 24. Although continuous delivery of RF energy is required, pulsed application of RF energy may allow the application of relatively higher energy levels (for example, higher power), longer or shorter total duration, and/or better controlled intravascular kidney Nerve coordination therapy. Pulsed energy also allows the use of smaller electrodes.

Although many of the embodiments described herein relate to electrical systems configured to deliver RF energy, it is expected that the desired treatment can be accomplished in other ways, such as coherent or incoherent light; direct thermal regulation (e.g., using heat or cold). Fluid or resistance heating element or cryogenic applicator); microwave; ultrasound (including high-intensity focused ultrasound); diode laser; radiation; tissue heating fluid; and/or cryogenic refrigerant.

As discussed above, the energy transfer can be monitored and controlled via data collected by one or more sensors, such as temperature sensors (e.g., thermocouples, thermistors, etc.), impedance sensors, pressure sensors, light sensors Sensors, flow sensors, chemical sensors, etc., can be incorporated into or on the energy transfer element 24, the support structure 22, and/or in or on the vicinity of the distal portion 20. The sensor can specify whether the sensor is in contact with the tissue at the treatment site and/or is incorporated into the energy transfer element 24 in a way that it faces the blood flow. Since the temperature gradient of the electrode from the side facing the blood flow to the side in contact with the blood vessel wall can be as high as about 15°C, it is fully possible to specify the placement of the sensor relative to the tissue and blood flow. It is expected that there will also be a significant gradient across the electrodes in other sensing data (for example, flow, pressure, impedance, etc.).

For example, the sensor may be incorporated into one or more energy transfer elements 24 during power and energy transfer at the treatment site contacting one side of the vessel wall or may be incorporated into one or more energy transfer elements 24 during energy transfer. The transfer period is toward the opposite side of the blood flow, and/or may be incorporated in certain areas of the energy transfer element 24 (for example, distal end, proximal end, tetrad, etc.). In some embodiments, multiple sensors may be provided at multiple locations along the electrode or energy transfer element array and/or relative to the blood flow. For example, a plurality of circumferential and/or longitudinally spaced sensors can be provided. In one embodiment, the first sensor may contact the blood vessel wall during the treatment, and the second sensor may face the blood flow.

Additionally or alternatively, various micro-sensors may be used to obtain data corresponding to the energy transfer element 24, blood vessel wall, and/or blood flow across the energy transfer element 24. For example, an array of miniature thermocouples and/or impedance sensors can be provided to obtain data along the energy transfer element 24 or other parts of the treatment device. When appropriate, the sensor data can be obtained or monitored before, at the same time or after the energy transfer or the energy pulse in between. Monitoring data can be used in a feedback loop to better control therapy, for example to determine whether to continue or discontinue therapy, and it can facilitate the controllable delivery of increased or decreased power or longer or shorter duration of therapy.

V.<u style="single">Blood flow around the energy transfer element</u>

Non-target tissues can be protected by the blood flow in the respective renal arteries. The blood flow in the respective renal arteries acts as a conductive and/or convective heat sink that takes away excessive heat energy. For example, referring to Figures 1 and 18 together, since the elongated shaft 16, the spiral treatment component 21 and the electrodes 24 carried by it cannot block blood flow, the natural blood circulation in the respective renal arteries can be used for self Non-target tissues and energy transfer elements remove excessive heat energy. The removal of excessive heat energy from the blood flow also allows higher power treatments, where more power can be transferred to the target tissue when the heat energy is taken away from the electrodes and non-target tissues. In this way, the heat energy transferred in the blood vessel heats the target nerve fibers located next to the blood vessel wall to coordinate the target nerve fibers, while the blood flow in the respective renal arteries protects the non-target tissues of the blood vessel wall to prevent excessive or undesired thermal damage .

It may also be necessary to additionally provide enhanced cooling by inducing blood to naturally flow through the energy transfer element 24. For example, a clinician can perform techniques and/or techniques that can increase the amount of perfusion through the renal artery or to the energy delivery element 24 itself. These techniques include positioning a partial occlusion element (e.g., a balloon) within an upstream vascular body (such as the aorta), or within a portion of the renal artery to increase the flow through the energy delivery element.

For example, Figure 18 illustrates hypothetical blood flow in the renal arteries. The blood flow (F) is regarded as, for example, a laminar flow exhibiting a gradient of flow velocity, so that the blood flow F in the area closest to the center of the artery (eg, area 2214) can be faster than the area closer to the renal artery wall 55, such as area 2215. Therefore, the blood flow F closest to the energy transfer element 24 is relatively slow. Because the cooling of the energy transfer element 24 is mediated by blood flow, the cooling can be improved by redirecting the blood flow F in the renal artery so that the blood flow around the energy transfer element 24 is relatively faster.

Figure 19A illustrates an embodiment in which the fluid redirecting element 2220 is positioned in the center of the renal artery. Accordingly, the flowing blood (including fast-flowing blood) indicated by arrow 2216 is redirected to flow toward the energy transfer element 24. The fluid redirection element can be any biocompatible material, such as a polymer, which can be positioned to promote blood flow to the energy transfer element 24 carried by the mesh structure 3422.

19A and 19B together, the fluid redirecting element 2220 may extend from the distal end region 20 of the elongate shaft 16 generally along the axis AA of the elongate shaft 16. In an embodiment using a wire (not shown), the fluid redirecting element 2220 may include an integral channel (not shown) with an internal member that can be sized and shaped to accommodate the wire. In addition, in some embodiments, the axial length of the fluid redirecting element 2220 may be at least 25%, at least 50%, or at least 75% of the axial length of the mesh structure 3422 in the extended configuration. In any case, to maximize the redirected blood flow, the fluid redirecting element 2220 may extend at least far enough into the mesh structure 3422 so that the imaginary axis passing through the energy transfer element 24 and orthogonal to the axis AA intersects the flow. Body redirection element 2220. The diameter 2228 of the fluid redirecting element 2220 can be extended, so that when it is in the unextended state, it is generally compatible with the insertion, repositioning and removal of the mesh structure 3422, and when in the extended state, it is configured to Redirect blood flow to areas closer to the renal artery wall, such as area 2215. As shown in FIG. 19B, in the folded configuration, the mesh structure 3422 can conform to the shape of the fluid redirecting element 2220. The diameter 2228 may be slightly larger, approximately equal to, or smaller than the diameter of the elongated shaft 16. In one embodiment, the diameter 2228 may be less than about 2.18 mm.

In addition to or as an alternative to passively using blood flow as a heat sink, active cooling can be provided to remove excess thermal energy and protect non-target tissues. For example, the hydrothermal infusion solution can be injected, infused or otherwise delivered into the blood vessel of the open circuit system. The hydrothermal infusion fluid used for active cooling may include, for example (room temperature or frozen) normal saline or some other biocompatible fluid. The hydrothermal infusion fluid can be introduced via the treatment device 12, for example, via one or more infusion lumen and/or orifices. When introduced into the bloodstream, the hydrothermal infusion fluid may be introduced, for example, through a guiding catheter at a location upstream of the energy transfer element 24 or at other locations relative to the tissue that is sought to be protected. For example, delivering hydrothermal infusions close to the treatment site (via an open circuit system and/or via a closed circuit system) can allow for enhanced/higher power therapy to be applied, and can allow the vessel wall to be maintained at a lower temperature during the energy delivery period. It is conducive to the formation of deeper or larger damage, can be conducive to reducing the treatment time, can allow the use of smaller electrode sizes, or a combination thereof.

Therefore, a treatment device according to an embodiment of the present technology may include features for an open-circuit cooling system, such as a lumen in fluid communication with an infusion fluid source and a pumping mechanism (for example, a manual syringe pump or a motor pump) to facilitate energy transfer during energy transfer. Injecting or infusing physiological saline or some other biocompatible hydrothermal fluid infusion into the bloodstream of the patient from outside the patient, and access to the energy transfer element 24 via the elongated shaft 16. In addition, the distal region 20 of the elongated shaft 16 may include one or more orifices for direct injection or infusion of saline to the treatment site.

VI.<u style="single">Use the system</u>

A.<u style="single">Intravascular delivery, deflection and placement of therapeutic equipment</u>

As mentioned above, any of the embodiments of the therapeutic devices described herein can be delivered using OTW or RX technology. When delivered in this manner, the elongated shaft 16 includes a channel or lumen through which a wire can pass. Alternatively, any of the treatment devices 12 described herein can be deployed using a conventional guiding catheter or a pre-curved renal guiding catheter (for example, as shown in FIGS. 3A and 3B). When using the guiding catheter, expose the femoral artery and insert the catheter at the base of the femoral triangle using known techniques. In an exemplary method, the wire is inserted through the entry site and passed through the femoral artery using image guidance, into the iliac artery and aorta, and into the left or right renal artery. The guiding catheter can be passed into the renal artery entered through the wire. Then remove the wire. Alternatively, a renal guiding catheter that is specifically shaped and configured to access the renal artery can be used to avoid the use of wires. Alternatively, the treatment device can use angiographic guidance to pass from the femoral artery to the renal artery without the need for a guiding catheter.

When using a guiding catheter, at least three delivery methods can be performed. In one method, one or more of the delivery techniques described above can be used to position the guiding catheter within the renal artery, just distal to the entrance of the renal artery. Then the treatment device is passed into the renal artery through the guiding catheter. Once the treatment device is correctly positioned in the renal artery, the guiding catheter is inserted from the renal artery into the abdominal aorta. In this method, the guiding catheter should be sized and configured for the passage of the treatment device. For example, a 6 French guiding catheter can be used.

In the second method, the first guiding catheter is placed at the entrance of the renal artery (with or without a guide wire). The second guiding catheter (also known as the delivery sheath) passes through the first guiding catheter (with or without a guide wire) into the renal artery. Then the treatment device is passed into the renal artery through the second guiding catheter. Once the treatment device is determined to be located in the renal artery, the second guiding catheter is retracted, thereby placing the first guiding catheter at the entrance of the renal artery. In this method, the first and second guiding catheters should be sized and configured for the second guiding catheter to pass through the first guiding catheter (that is, the inner diameter of the first guiding catheter should be greater than the first guiding catheter. The outer diameter of the second guide tube). For example, an 8-French guide catheter can be used for the first guiding catheter, and a 5-French guide catheter can be used for the second guiding catheter.

In the third method, the renal guiding catheter is positioned in the abdominal aorta, just proximal to the entrance of the renal artery. The treatment device 12 as described herein is passed into the approached renal artery via a guiding catheter. In response to applying force to the elongated shaft 16 via the handle assembly 34, the elongated shaft forms a non-traumatic channel via the guide tube.

B.<u style="single">Control the energy applied</u>

1.　<u style="single">Overview</u>

Referring back to Fig. 1, using the system 10 to administer treatment is equivalent to delivering energy to the inner wall of the renal artery via the energy delivery element or electrode 24 for a predetermined amount of time (e.g., 120 seconds). To achieve the desired coverage, multiple treatments (for example, 4 to 6 times) can be administered in the left and right renal arteries. The technical goal of treatment can be, for example, heating the tissue to a desired depth (for example, at least about 3 mm) to a temperature that can damage nerves (for example, about 65°C). The clinical goal of this procedure is typically to coordinate (eg, damage) a sufficient number of renal nerves (efferent or afferent nerves of the sympathetic renal plexus) to promote sympathetic tone reduction. If the technical goal of the treatment is achieved (for example, heating the tissue to a depth of about 65° C. to a depth of about 3 mm), there is a higher probability of renal nerve tissue damage. The greater the number of technically successful treatments, the greater the chance of coordinating a sufficient proportion of the renal nerves, and thus the greater the chance of clinical success.

Throughout the treatment, there may be multiple conditions indicating that the treatment may be unsuccessful. In some embodiments, the operation of the system 10 can be stopped or modified according to the indication of these states. For example, certain instructions may cause the energy transfer to cease, and appropriate messages may be displayed, such as on the display 33. Factors that can generate a display message and/or cause the treatment plan to be suspended or modified include (but are not limited to) impedance, blood flow, and/or temperature measurements or changes that exceed the accepted or expected threshold and/or range , These thresholds and/or ranges can be determined or calculated in advance. The message can indicate information such as the following: the patients condition type (for example, abnormal patient condition), parameter type and/or value outside the accepted or expected threshold range, indicating the action suggested by the clinician, or indicating that energy delivery has been stop. However, if no unexpected or abnormal measurement values are observed, the energy can be delivered at the target site for a specified duration according to the programmed curve to complete the treatment. After the treatment is completed, the energy transmission is stopped, and a message indicating the end of the treatment can be displayed.

However, treatment can be completed without initiating an indication of abnormal patient conditions, and events or combinations of events that change (eg, reduce) the probability of technically successful treatment may still occur. For example, the energy-transmitting electrode may move or be inadvertently placed so that the contact between the electrode and the renal artery wall is insufficient, resulting in insufficient damage depth or insufficient temperature. Therefore, even if the treatment is completed without indicating abnormal patient conditions, it may be difficult to assess the technical success of the treatment. Similarly, as far as the indication of abnormal patient condition can be reported by the system 10, it may be difficult to understand the cause of the abnormal patient condition (such as temperature and/or impedance value outside the expected range).

As described above, one or more evaluation/feedback algorithms 31 that execute on processor-based components of the system 10 (such as one or more components provided with the generator 26) may be provided. In these embodiments, one or more evaluation/feedback algorithms 31 can provide meaningful feedback to the user. This feedback can be used to evaluate specific therapies and/or can be used to understand the importance of certain types of abnormal patient conditions and How to reduce the incidence of these symptoms. For example, if certain parameters (such as impedance or temperature values) cause or indicate that the treatment cannot be performed as expected and (sometimes) may cause the treatment to be technically unsuccessful, the system 10 may provide feedback (for example, via the display 33). Warn clinicians. The warning clinician can range from simply notifying the unsuccessful treatment to suggesting to modify specific treatment parameters (for example, the impedance value during the treatment, the placement of the energy transfer element 24 in the patient, etc.) in the subsequent treatment. The system 10 can accordingly understand the entire treatment cycle, and modify subsequent treatment parameters based on this knowledge to improve efficacy. Non-exhaustive examples of measurement parameters of one or more evaluation/feedback algorithms 31 may be considered to include measurement parameters related to changes in the following: temperature during a specified time period, maximum temperature, maximum average temperature, minimum temperature, predetermined or calculated The temperature at time is relative to the predetermined or calculated temperature, the average temperature during the specified time period, the maximum blood flow, the minimum blood flow, the blood flow at the predetermined or calculated time is relative to the predetermined or calculated blood flow, a certain period of time The average blood flow, the maximum impedance, the minimum impedance, the impedance at a predetermined or calculated time relative to the predetermined or calculated impedance, the impedance change during a specific time period, or the impedance change during a specific time period relative to the temperature change. The measurement can be performed at one or more predetermined times, time ranges, calculated times, and/or when the measured event occurs or relative to the time when the measured event occurs. It should be understood that the above list only provides multiple examples of different measurement parameters, and other suitable measurement parameters can be used.

2.　<u style="single">Control the energy applied</u>

Using the therapies disclosed herein to deliver treatment to target tissues can be beneficial for delivering energy to target nerve structures in a controlled manner. Controlling energy transfer will allow the hyperthermia segment to extend into the renal fascia, while reducing undesired energy transfer or thermal effects on the vessel wall. Controlling energy delivery can also produce a more consistent, predictable, and effective comprehensive treatment. Therefore, the generator 26 preferably includes a processor that includes memory components and instructions for executing the algorithm 30 (see FIG. 1) to control the power and energy delivered to the energy delivery device. The algorithm 30 (a representative embodiment of which is depicted in FIG. 3) can be executed as a conventional computer program so as to be executed by a processor coupled to the generator 26. Clinicians who use step instructions can also manually execute the algorithm 30.

The operating parameters monitored according to the algorithm may include, for example, temperature, time, impedance, power, blood flow, flow rate, volume flow, blood pressure, heart rate, etc. Discontinuous temperature values can be used to induce changes in power or energy transfer. For example, a high temperature value (e.g., 85°C) may indicate tissue shrinkage. In this case, the algorithm may reduce or stop power and energy transfer to prevent undesired heating effects on target or non-target tissues. Additionally or alternatively, time can be used to prevent undesired thermal alteration of non-target tissues. During each treatment, check the defined time (for example, 2 minutes) to prevent unlimited power transfer.

Impedance can be used to measure tissue changes. Impedance represents the electrical properties of the treatment site. In the thermally induced embodiment, when an electric field is applied to the treatment site, the impedance will decrease as the resistance of the tissue cells to the electric current becomes weaker. If the applied energy is too high, tissue shrinkage or coagulation will occur near the electrode, which will increase impedance as the water holding capacity of cells decreases and/or the electrode surface area decreases (for example, through accumulation of coagulum). Therefore, the increase in tissue impedance can indicate or predict the undesired thermal alteration of the target or non-target tissue. In other embodiments, the impedance value can be used to evaluate the contact between the energy transfer element 24 and the tissue. In multiple electrode configurations (for example, when the energy transfer element 24 includes two or more electrodes), a relatively small difference between the impedance values of the individual electrodes may indicate a good contact with the tissue. In a single electrode configuration, a stable value can indicate good contact. Therefore, impedance information from one or more electrodes can be provided to a downstream monitor, which in turn can provide the clinician with an indication of the quality of the energy transfer element 24 contacting the tissue.

Additionally or alternatively, power is a monitoring parameter that is effective when controlling therapy delivery. Power is a function of voltage and current. The algorithm 30 can customize the voltage and/or current to achieve the desired power.

Derivatives of the above parameters (for example, rate of change) can also be used to induce changes in power or energy transfer. For example, the rate of temperature change can be monitored to reduce the power output if a sudden increase in temperature is detected. Similarly, the rate of impedance change can be monitored to reduce the power output if a sudden increase in impedance is detected.

As shown in FIG. 20, when the clinician initiates treatment (for example, via the foot switch 32 illustrated in FIG. 1), the control algorithm 30 includes the command generator 26 to gradually adjust its power output at a first time period t₁(For example, 15 seconds) the first power level P is reached during₁(For example, 5 watts). The power increase during the first time period is generally linear. Therefore, the generator 26 makes its power output at a generally constant rate P₁/t₁Increase. Alternatively, the power increase may be non-linear with a variable rate of increase (e.g., exponential or parabolic). Once reached P₁And t₁, Then the algorithm can be in P₁Maintain a predetermined period of time t₂-t₁(For example, 3 seconds) until the new time t2. At t₂, The power is in the predetermined time period t₃-t₂The period (for example, 1 second) increases to P in a predetermined increment (for example, 1 watt)₂. This power change with a predetermined increment of about 1 watt during a predetermined period of time can continue to reach the highest power P_MAXOr meet some other conditions. In one embodiment, P_MAXIs 8 watts. In another embodiment, P_MAXIs 10 watts. The power may be maintained at the highest power PMAX for a predetermined period of time or as long as a predetermined total treatment time (for example, up to about 120 seconds) depending on the situation.

In FIG. 20, algorithm 30 illustratively includes a power control algorithm. However, it should be understood that the algorithm 30 may alternatively include a temperature control algorithm. For example, the power can be gradually increased until the desired temperature (or temperatures) is obtained during the desired duration (or multiple durations). In another embodiment, a combination of a power control algorithm and a temperature control algorithm can be provided.

As discussed, the algorithm 30 includes monitoring certain operating parameters (e.g., temperature, time, impedance, power, flow rate, volume flow, blood pressure, heart rate, etc.). Operating parameters can be monitored continuously or periodically. The algorithm 30 checks the monitored parameters according to the predetermined parameter curve to determine whether the individual or combined parameters fall within the range defined by the predetermined parameter curve. If the monitored parameter falls within the range defined by the predetermined parameter curve, the treatment can be continued according to the commanded power output. If the monitored parameter exceeds the range defined by the predetermined parameter curve, the algorithm 30 adjusts the commanded power output accordingly. For example, if the target temperature (e.g., 65°C) is reached, the power transfer remains constant until the total treatment time (e.g., 120 seconds) ends. If the first temperature threshold (for example, 70° C.) is reached or exceeded, the power is reduced by a predetermined increment (for example, 0.5 watt, 1.0 watt, etc.) until the target temperature is reached. If the second power threshold (for example, 85°C) is reached or exceeded, thereby indicating an undesirable condition, the power transmission can be terminated. The system can be equipped with various audible and visual alarms to warn the operator of certain diseases.

The following is a non-exhaustive list of events by which algorithm 30 can adjust and/or terminate/interrupt the commanded power output:

(1) The measured temperature exceeds the maximum temperature threshold (for example, about 70°C to about 85°C).

(2) The average temperature derived from the measured temperature exceeds the average temperature threshold (for example, about 65°C).

(3) The rate of change of the measured temperature exceeds the threshold of the rate of change.

(4) The temperature rise during a certain period of time is lower than the minimum temperature change threshold, and the generator 26 has a non-zero output. Poor contact between the energy transfer element 24 and the arterial wall can produce this condition.

(5) The measured impedance exceeds or exceeds the impedance threshold (for example, &lt;20 ohms or &gt;500 ohms).

(6) The measured impedance exceeds the relative threshold (for example, the impedance decreases from the initial value or the baseline value and then rises beyond the baseline value).

(7) The measured power exceeds the power threshold (for example, &gt;8 watts or &gt;10 watts).

(8) The measured power transmission duration exceeds the time threshold (for example, &gt;120 seconds).

Compared with, for example, the power level used by electrophysiological therapy to achieve cardiac tissue removal (for example, a power level greater than about 15 watts, greater than about 30 watts, etc.), the technique of the present invention transmits the power level during the renal nerve coordination therapy The maximum power value is preferably relatively low (for example, less than about 15 watts, less than about 10 watts, or less than about 8 watts, etc.). Since relatively low power levels can be used to achieve this renal nerve coordination, it is necessary to maintain energy transfer elements and/or non-target tissues at or below the desired temperature (e.g., at or below about 50°C, or e.g. The necessary intravascular infusion fluid injection flow rate and/or total volume at or below about 45°C can also be relatively lower than the higher power levels used in electrophysiological treatments (for example, power levels higher than about 15 watts). ) The necessary injection flow rate and/or total volume. In embodiments using active cooling, the relative reduction in the flow rate and/or total volume of intravascular infusion fluid can advantageously promote the use of intravascular infusion fluid in higher-risk patient groups, which are contraindicated with higher power levels and Therefore, correspondingly higher infusion fluid flow rate/use volume is contraindicated (for example, patients with heart disease, heart failure, renal insufficiency and/or diabetes).

C.<u style="single">Technical evaluation of treatment</u>

FIG. 21 is a block diagram of a treatment algorithm 2180 configured according to an embodiment of the technology of the present invention. The algorithm 2180 is configured to evaluate events in treatment, determine the probability of technical success of the treatment, and display messages accordingly to provide feedback to the operator of the system 10 (or another suitable treatment system). If it is determined that the technical success of the treatment has the next best predetermined probability, a message indicating that the treatment cannot be performed as expected can be displayed. Alternative embodiments may divide the success probability of treatment into multiple ranges, such as a 1:5 ratio of success probability. Similarly, in some embodiments, the algorithm 2180 can evaluate whether the treatment belongs to the category of high probability of success, the category of very low probability of success, or a category in between.

The variables that characterize the treatment and can be used by the algorithm 2180 to evaluate the treatment include (but are not limited to): time (that is, treatment duration), power, temperature change, maximum temperature, average temperature, blood flow, temperature or impedance standards Difference, impedance change, or a combination of these or other variables. For example, some or all of the variables can be provided to the algorithm 2180 as the treatment data 2182. In this generalized description of the algorithm 2180, the treatment data 2180 can be evaluated according to the cascade or series of different categories or the level of the criterion 2184. If the treatment data 2182 is evaluated as good according to one of the criteria 2184, a message indicating that the treatment is acceptable or successful may be displayed (block 2186). If according to criterion 2184, the treatment data 2182 is found to be unacceptable, the treatment data can be reduced to the next evaluation criterion.

In the depicted embodiment, if the treatment data is found to be unacceptable according to all criteria 2184, then additional evaluations such as the depicted analysis and scoring step 2188 may be performed. The calculation result (block 2192) of the analysis and scoring step (such as scoring 2190) can be evaluated. According to this assessment 2192, the treatment can be considered acceptable and the screen has a corresponding display (block 2186), or it is unacceptable and the displayed screen 2194 indicates that the treatment did not proceed as expected. In other embodiments, the algorithm 2180 may include automatic actions (for example, the power level supplied to the energy source is automatically reduced) as a response to an indication that the treatment cannot be performed as expected.

FIG. 21 depicts a generalized and simplified embodiment of the treatment evaluation algorithm, and FIG. 22 depicts a more detailed embodiment of an embodiment of the treatment evaluation algorithm 2200. The treatment evaluation algorithm 2200 can be calculated using data and/or measurement results obtained during the treatment process after treatments up to 120 seconds (as depicted) or some other suitable duration are completed (block 2202).

In the depicted embodiment, when the electrode is inconsistent with the blood vessel wall, it can be considered that the probability of undesirable treatment is greatest. Correspondingly, the decision blocks 2204, 2206, 2208, and 2210 in the flowchart are associated with different criteria and eliminated in the entire treatment process based on the observed or measured data 2202 that seems to have one or more criteria that exceed the predetermined range (that is, They do not have a high probability of success). In the depicted embodiment, those treatments that are not eliminated in decision blocks 2204, 2206, 2208, and 2210 enter linear discriminant analysis (LDA) 2212 to further evaluate the treatment. In other embodiments, other suitable analyses may be performed instead of LDA as depicted. The values assigned to each step (ie, evaluated according to individual criteria) and the coefficient 2214 for LDA can be derived from data collected from experiences obtained from multiple treatments and/or animal studies.

In the depicted embodiment, the first decision block 2204 evaluates the initial temperature response to energy transfer by checking whether the average temperature change in the first 15 seconds is greater than 14°C. In one embodiment, the average temperature refers to an average value in a short time (for example, 3 seconds), which basically filters high-frequency fluctuations caused by pulsating blood flow. As will be understood, the temperature rise of the treatment electrode is the result of heat conduction from the tissue to the electrode. If the electrode does not have enough contact with the blood vessel wall, energy is transferred to the blood flowing around it and the temperature of the electrode does not increase much. For this reason, if the average temperature change in the first 15 seconds is greater than, for example, 14°C, this initial temperature response can indicate that there is sufficient electrode contact, contact force, and/or blood flow rate at least at the beginning of the treatment, and if the rest of the treatment is not encountered If the treatment cannot be performed as expected, the chance of treatment is not optimal or technically unsuccessful is not high. Therefore, the affirmative answer of the decision block 2204 can lead to the display of the message 2220 of "treatment complete". However, if the average temperature change in the first 15 seconds is less than or equal to, for example, 14° C., this initial temperature response may indicate that the contact between the electrode and the blood vessel wall may be insufficient. Therefore, the negative answer of the decision block 2204 can lead to the criterion 2206 for further evaluation.

In decision block 2206, the hottest temperature is evaluated by checking whether the highest average temperature is greater than, for example, 56°C. Regardless of the duration, a temperature rise exceeding a threshold (for example, 56°C) can be sufficient to be considered a technical success. Therefore, although in decision block 2204, the initial temperature rise does not indicate sufficient contact, the temperature exceeding the threshold may be sufficient to indicate successful damage. For example, the initial contact of the electrode may be insufficient, but the subsequent contact can be maintained for a sufficient time to cause the blood vessel wall to heat up so that the temperature sensor in the electrode reads more than 56°C. The affirmative result of the decision block 2206 can lead to the display of a message 2220 of "treatment complete". However, the negative result of the decision block 2206 indicates that the maximum average temperature rise is insufficient. Therefore, the algorithm 2200 proceeds to the decision block 2208 for further evaluation.

In decision block 2208, the average temperature during which the power is maintained at its maximum is evaluated (ie, the rise time is excluded from the average calculation). In one embodiment, this evaluation consists of determining whether the average instantaneous temperature between 45 seconds and 120 seconds is higher than 53°C. This criterion checks to determine whether the temperature during a specific period is higher than the threshold in this way. If the decision block 2208 produces a positive determination, although the initial temperature response and the highest average temperature are not sufficient to indicate the success of the technology (that is, the decision blocks 2204 and 2206 are negative), the average temperature during the last 75 seconds indicates sufficient contact maintenance Enough time. For example, sufficient damage may be formed, but the electrode heat is taken away due to the high blood flow, so the highest average temperature measured in the electrode is not greater than 56°C. Therefore, the affirmative result of the decision block 2208 can lead to the display of the message 2220 of "treatment complete". However, the negative result of the decision block 2208 indicates that the average real-time temperature in the power maintenance phase is insufficient, and the algorithm 2200 proceeds to the decision block 2210 to further evaluate the treatment.

In the decision block 2210, the impedance change is evaluated by checking whether the impedance change percentage during a predetermined period (for example, 45 seconds to 114 seconds) is greater than a predetermined value (for example, 14%) of the initial impedance. The initial impedance is taken as an impedance measurement shortly after the start of the treatment (for example, at the 6th second) to exclude possible reading errors in the impedance measurement before this period (for example, due to contrast injection). As will be appreciated, as the temperature of the tissue increases, the impedance of the tissue to radio frequency (RF) current decreases until the tissue receives enough heat to shrink it, at which point its impedance begins to rise. Therefore, a decrease in tissue impedance can indicate an increase in tissue temperature. The percentage of real-time impedance change during the power maintenance period can be calculated as follows:

<maths><img file="TW201223584A_D0004.tif" /></maths>

If the decision block 2210 produces a positive determination, although the previous three decision blocks did not show a sufficient increase in temperature (that is, the decision blocks 2204, 2206, and 2208 are negative), the impedance change can indicate that the tissue is sufficiently affected. Hot, but the temperature sensor in the electrode has not risen enough. For example, ultra-high blood flow can keep the electrode temperature relatively low, even if the tissue is heated. Therefore, the affirmative result of the decision block 2210 can lead to the display of the message 2220 of "treatment complete". However, the negative result of the decision block 2210 causes the algorithm 2200 to proceed to the execution of the LDA 2212.

In LDA 2212, evaluate the combination of events and the importance rating of each event. For example, in the depicted embodiment, the evaluation criteria of decision blocks 2204, 2206, 2208, 2210 are included in LDA 2212. In addition, in this embodiment, three additional criteria can be included: (1) the standard deviation of the average temperature (which can indicate the degree of slip motion caused by breathing); (2) the standard deviation of the instant temperature (which can indicate the variable blood flow and / Or contact force and/or intermittent contact); and (3) the adjusted average impedance change at the end of treatment (the impedance change can be further characterized and the tissue temperature change can be indicated). If this analysis determines that the variable combination has a significant impact on the success of the technique (for example, in the decision block 2222, the LDA score is &lt;0), the message 2224 of "unforeseeable treatment" is displayed. Otherwise, the message 2220 of "treatment complete" is displayed.

It will be understood that the various parameters described above are only representative examples related to one embodiment of the algorithm 2200, and one or more of these parameters may be changed in other embodiments. In addition, the specific values described above for the specific part of the treatment can be modified/changed in other embodiments according to, for example, different device configurations, electrode configurations, treatment plans, and the like.

As described above, the algorithm 2200 is configured to evaluate the treatment and display a message indicating that the treatment is complete or the treatment cannot be performed as expected. Based on the information describing the treatment evaluation situation, the clinician (or system using automated technology) can then determine whether further treatment is required and/or whether one or more parameters should be modified in the subsequent treatment. For example, in the above example, the algorithm 2200 can evaluate various situations that are usually related to poor contact between the electrode and the blood vessel wall to help determine whether the treatment is suboptimal. For example, poor contact may occur when the electrode slides back and forth with the patients breathing and arterial movement; when the electrode is displaced with the patients movement; when the catheter moves unintentionally; the catheter is not deflected between the electrode and the blood vessel wall. When sufficient contact or contact force is applied to the required degree; and/or when the electrode is placed in an unstable position. In addition, as described above, if a particular parameter or parameter set can cause or result in a suboptimal treatment, the system 10 (FIG. 1) can provide feedback to warn the clinician to modify one or more treatment parameters during subsequent treatments. It is expected that this assessment and treatment feedback can help clinicians learn to improve their placement techniques to improve contact and reduce the frequency of technically unsuccessful treatments.

D.<u style="single">Feedback related to high temperature conditions</u>

Although the general evaluation of the technical success of the treatment is described above, another form of feedback that can be applied to the operator of the system 10 (FIG. 1) is feedback related to a specific patient type or treatment condition. For example, the system 10 can generate information related to high temperature conditions. In particular, during treatment, while delivering energy, the temperature of the tissue may rise above a specified level. A temperature sensor (such as a thermocouple, thermistor, etc.) located in or near the electrode can indicate the temperature of the electrode, and to a certain extent, can indicate the temperature of the tissue. Because the energy is transferred to the tissue, the electrode does not heat directly. The reality is that the tissue is heated and the heat is conducted to the electrode and the temperature sensor in the electrode. In one embodiment, if the instantaneous temperature rise exceeds a predefined maximum temperature (for example, 85° C.), the system 10 may suspend energy transfer. In this event, the system can generate a message indicating high temperature conditions. However, depending on the situation, the clinician can appropriately perform different operations.

If the tissue becomes overheated, the established temperature threshold can be exceeded. High tissue temperature means that a sharp narrowing of the arteries or bulging of the arterial wall may occur. This can happen immediately or within a short time (for example, about 50 seconds to about 100 seconds) after recording the occurrence of high temperature and generating the message. When this occurs, the clinician can be instructed to image the treatment site to prevent constriction or bulge, and then start another treatment.

For example, FIG. 23 is a block diagram illustrating the algorithm 2250, according to an embodiment of the present technology, but when a high temperature condition is detected, the algorithm provides feedback to the operator. In one embodiment, the algorithm 2250 is executed in response to the high temperature condition (block 2252), and the treatment data is evaluated (decision block 2254) to determine whether the high temperature condition involves or does not involve a situation that includes sudden instability. Sudden instability can be caused by, for example, the following reasons: the patient or the catheter suddenly moves, thereby pushing the electrode closer (that is, the contact force is increased) to the blood vessel wall, and at the same time, it may also move to another position. If the sudden instability is not detected in the decision block 2254, the first message (block 2256) can be displayed, such as an indication that high temperature has been detected and an instruction to image the treatment site to determine whether the location has been damaged . If sudden instability is detected in decision block 2254, an alternative message can be displayed (block 2258). In addition to indicating the occurrence of high temperature and instructing the clinician to image the treatment site, it can also indicate that the electrode may have moved away from its original Location. This feedback can prompt the clinician to compare the above-mentioned images and avoid re-treatment at the original site or the site to which the electrode has been moved.

E.<u style="single">Feedback related to high impedance</u>

As with high temperature, under certain circumstances, the system 10 (FIG. 1) can generate a message related to the presence of high impedance. As will be appreciated, the impedance to the RF current from the treatment electrode through the body to the dispersive return electrode can be indicative of the characteristics of the tissue in contact with the treatment electrode. For example, an electrode positioned in the blood flow of a renal artery can measure the impedance lower than that of an electrode contacting the blood vessel wall. In addition, when the tissue temperature rises, its impedance decreases. However, if the tissue is heated too much, it will shrink and its impedance will increase. During treatment, as the tissue gradually heats up, it is expected that the impedance will decrease. The significant increase in impedance can be the result of undesirable conditions, such as dry tissue or electrode movement. In some embodiments, the system 10 can be configured to suspend energy transfer if the instantaneous impedance rise is higher than the predefined maximum impedance change relative to the initial impedance.

For example, FIG. 24 is a block diagram illustrating an algorithm 2270 for providing feedback to the operator when a high impedance condition occurs according to an embodiment of the technology of the present invention. In the depicted embodiment, the algorithm 2270 evaluates the treatment data and determines whether the detection of a high impedance event (block 2272) is likely to involve the following situations: (a) tissue temperature is high and may shrink, (b) electrode movement, Or (c) The electrode is in poor or no contact with the blood vessel wall. The algorithm 170 evaluates the data to determine whether any of these three situations has occurred, and displays one of the three messages 2274, 2276, or 2278 accordingly.

According to an embodiment of the algorithm 2270, when high impedance is detected (block 2272), the highest average temperature during treatment is evaluated (decision block 2280). If this temperature is higher than a certain threshold (for example, 60°C or higher), the high impedance can be attributed to the high tissue temperature that causes dry shrinkage. In this case, a message 2274 may be displayed, instructing the clinician to check for constriction or bulge (that is, to image the treatment site) and avoid re-treatment at the same location. Conversely, if the temperature is lower than the threshold (for example, lower than 60° C.), the algorithm 2270 proceeds to the decision block 2282.

In the depicted embodiment, at decision block 2282, the algorithm 2270 evaluates whether a high impedance event occurs early in the treatment (eg, within 20 seconds of the start of energy delivery) when the power is relatively low. If it is, the tissue temperature is unlikely to be high, and the electrode is likely to initially have poor or no contact and then establish a good contact, resulting in a sudden increase in impedance. In this case, a message 2276 can be displayed, instructing the clinician to work hard to establish better contact and repeat treatment at the same site. However, if the event occurs in subsequent treatments (for example, the time has passed more than 20 seconds), the algorithm 2270 proceeds to the decision block 2284.

At decision block 2284, the algorithm 2270 evaluates when a high impedance event occurs during treatment. For example, if the event occurs after a predetermined period of time (for example, 45 seconds), and the power has reached a high level at this time, the algorithm proceeds to decision block 2286. However, if the power is increasing at a constant rate when the event occurs and is not at its highest level (for example, between 20 seconds and 45 seconds), the algorithm proceeds to decision block 2288.

In decision block 2286, the algorithm 2270 calculates the percentage change (%ΔZ) of the impedance when the high impedance event occurs compared to the impedance at the specified time (for example, the 45th second). This time period is the period during which the power is maintained at a high level. In one embodiment, the impedance change percentage is calculated as follows:

%ΔZ=100*<img file="TW201223584A_D0005.tif" />

If %ΔZ is greater than or equal to a predetermined amount (for example, 7%), the tissue may begin to shrink due to high temperature. In this case, a message 2274 may be displayed, instructing the clinician to check for constriction or bulge (that is, to image the treatment site) and avoid re-treatment at the same location. Otherwise, tissue shrinkage is unlikely to occur and it is more likely to cause a high impedance event due to electrode movement. In this case, a message 2278 may be displayed to inform the clinician that the electrode may have moved. If the electrode has moved or may have moved, the tissue temperature is unlikely to reach a high level. Therefore, it is expected that if other locations for performing additional treatments do not exist or are limited, treatments can be performed at the same location.

At decision block 2288, the algorithm 2270 can determine whether sudden instability has occurred. If there is this instability, the electrode may move. In this case, a message 2278 may be displayed to inform the clinician that the electrode may have moved. As mentioned above, the clinician can show a warning and avoid treatment at the initial position or the position where the electrode is moved, or if there are no other sites for further treatment or the sites for further treatment are limited, the clinician can choose Treat in the same location. Otherwise, if sudden instability does not occur, it is likely that the electrode has poor contact. In this case, a message 2276 can be displayed, instructing the clinician to work hard to establish a better contact, and it is safe to perform treatment at the same site.

The same goal of detecting high impedance conditions can be achieved using alternative measurement methods and calculation algorithms. For example, in another embodiment of the algorithm 2270, temperature and impedance data are acquired every certain sampling time (for example, 20 seconds). Calculate the standard deviation of impedance and temperature data at shorter intervals. The first standard temperature of the interval is calculated by dividing the temperature standard deviation by the standard deviation of the temperature at the initial time interval. If the standard deviation of the impedance measurement value is greater than or equal to a predetermined value (for example, 10 ohms) and the first standard temperature is greater than a predetermined threshold value (for example, 3), the algorithm 2270 may display a message 2276 indicating poor electrode contact. However, if the standard deviation of the impedance measurement value exceeds the acceptable range but the first standard temperature is within the acceptable range, a message 2278 will be displayed to warn the clinician of electrode instability.

According to another embodiment of the algorithm 2270, the impedance of two or more electrodes 24 (for example, located on the treatment area 22 of the catheter 12 in FIG. 1) can each provide independent impedance readings. During the delivery of the treatment component 22 to the treatment site (for example, in the renal artery), the impedance reading of the electrode 24 typically differs due to the anatomy of the vascular structure, because the catheter 12 will cater to the path of least resistance, usually at the turn of the vascular structure Bend and touch only one wall of the renal artery. In some embodiments, once the treatment component 22 is at the treatment site, the treatment component 22 can be extended circumferentially to contact the entire circumferential surface of a section of renal artery wall. This extension can place multiple electrodes 24 in contact with the renal artery wall. When the treatment component 22 is extended into a treatment configuration and the contact between the electrode 24 and the renal artery wall increases, the impedance value of the individual electrode 24 may increase and/or approach the same value. The fluctuation of the impedance value also decreases with good stable contact, as described above. The energy generator 26 can continuously or continuously monitor individual impedance values. These values can then be compared to determine when contact is effectively formed, as an indication of successful treatment. In other embodiments, the moving average of impedance can be compared with a predetermined range of variable impedance values, where limit values are defined to guide stability measurements.

F.<u style="single">Feedback related to vasoconstriction</u>

In other embodiments, the system 10 may generate information related to the occurrence of vasoconstriction. In particular, despite positive delivery therapy, blood vessels can shrink to less than the optimal diameter. Vasoconstriction can reduce blood flow, increase the temperature of the treatment site, and increase blood pressure. Vascular contraction can be measured by sampling the amplitude of real-time temperature data ("envelope value"). The current envelope value can be compared with a previously collected envelope value sample (for example, the previous 200 ms). If the difference between the current envelope value and the envelope value at the previous time point is less than a predetermined value (for example, less than -0.5°C, or in other words, compared with the envelope value at the previous time point, the current envelope value is reduced by less than 0.5 degrees), then The measurement is performed at a point in time in the future (for example, within 5 seconds). If the average temperature difference between the future time point and the current time point is greater than the specified temperature threshold (for example, more than 1° C.), the algorithm 2500 can determine that there is an undesired high degree of shrinkage and can suspend/change the energy transfer. In this event, the system 10 can generate a message indicating a high contraction condition. However, depending on the situation, the clinician can appropriately perform different operations.

For example, FIG. 25 is a block diagram illustrating an algorithm 2500 for providing feedback to the operator when a height contraction of a blood vessel is detected according to an embodiment of the present technology. In one embodiment, the algorithm 2500 is executed (block 2502) in response to high contraction (for example, vasoconstriction is at or below a certain diameter) and the treatment data is evaluated (decision block 2504) to determine whether the high contraction Involves or does not involve situations that include sudden instability. The indication of sudden instability may indicate that the electrode 24 has moved.

If no sudden instability is detected in the decision block 2504, a first message (block 2506) may be displayed, such as indicating that a high contraction has been detected and instructing the clinician to reduce the treatment power. In other embodiments, the energy level can be changed automatically in response to the detected contraction. If sudden instability is detected in the decision block 2504, an alternative message can be displayed (block 2508). In addition to indicating the occurrence of high contraction and an instruction to the clinician, it can also indicate that the electrode 24 may have moved away from it. Initial site. This feedback can prompt the clinician to change or discontinue treatment.

G.<u style="single">Feedback related to cardiac factors</u>

1.　<u style="single">Feedback related to abnormal heart rate</u>

As with the other physiological conditions described above, in some cases, the system 10 may generate information related to the occurrence of abnormal heart rate. In particular, despite the positive delivery therapy, the heart rate can exceed or fall below desired conditions (for example, transient procedural or chronic bradycardia). The instantaneous heart rate can be measured by measuring the instantaneous temperature and impedance. More specifically, a second order Butterworth filter can be used to filter the instant temperature readings between 0.5 Hz and 2.5 Hz. Determine the local maximum value of the filtered signal. The local maximum is the peak value of the detected true temperature signal. Because the signal peak corresponds to the periodic variation of the heartbeat cycle, the instantaneous heart rate is the interval between the peaks.

In one embodiment, if the heart rate exceeds the predetermined range, the system 10 can suspend/change the energy delivery. In this event, the system can generate a message indicating a bad heart rate condition. However, depending on the situation, the clinician can appropriately perform different operations.

For example, FIG. 26A is a block diagram illustrating an algorithm 2600 for providing feedback/commands to the operator when detecting abnormal heart rate conditions according to an embodiment of the technology of the present invention. For example, in one embodiment, the algorithm 2600 may be executed in response to abnormal heart rate conditions (e.g., above or below a predetermined threshold) (block 2602). In decision block 2604, the algorithm 2600 evaluates the therapy data to determine whether the detected abnormal heart rate condition involves a situation that includes sudden instability. Indicating sudden instability can indicate electrode movement.

If no sudden instability is detected in the decision block 2604, a first message can be displayed to the clinician (block 2606), such as indicating that an abnormal heart rate has been detected and instructing the clinician to reduce the treatment power. In other embodiments, the energy level can be changed automatically in response to the detected bad heart rate. If sudden instability is detected in decision block 2604, an alternative message (block 2608) can be displayed. In addition to indicating the occurrence of abnormal heart rate and instructions to the clinician, it can also indicate that the electrode may have moved away from its original position. point. This feedback can prompt the clinician to change or discontinue treatment.

2.　<u style="single">Feedback related to low blood flow</u>

The system 10 can also be configured to generate messages related to low blood flow conditions. For example, if the blood flow falls below a certain level during treatment (or if there is an undesired narrowing of the blood vessel), the convective heat removed from the electrode 24 and the tissue surface is reduced. Excessive tissue temperature can produce the above-mentioned negative results, such as thrombosis, charring, and unreliable damage size. Reducing the power of the generator 26 to prevent the tissue from reaching unacceptable temperatures will result in insufficient damage depth and may not heat the nerve to a temperature sufficient for removal. Algorithms can be used to measure blood flow or heat loss to blood flow. In one embodiment, the blood flow can be used with a flow meter or Doppler sensor (Doppler sensor) measurement. In another embodiment, the heat loss or heat attenuation can be measured based on the transferred energy (such as RF energy) that increases the temperature of the blood, tissue, or substrate. Energy can be shut down and the algorithm can include monitoring temperature as a measure of thermal decay. Rapid thermal decay may indicate adequate blood flow, while gentle thermal decay may indicate low blood flow. For example, in one embodiment, if the slope of the instantaneous temperature measurement value with respect to the initial temperature exceeds the preset threshold (for example, 2.75) and the average temperature is greater than the preset temperature (for example, 65°C), then the calculation Method 2610 can indicate low blood flow. In other embodiments, the thermal attenuation and/or blood flow can be characterized by the temperature oscillations of RF or resistance heating delivered by the measuring electrodes. At a specified temperature or power delivery amplitude/quantity, a narrow oscillation range can indicate a relatively low heat decay/blood flow.

For example, FIG. 26B is a block diagram illustrating an algorithm 2610 for providing feedback/commands to the operator when a low blood flow condition occurs according to an embodiment of the technology of the present invention. In one embodiment, the algorithm 2610 is executed in response to the detected low blood flow condition (for example, the flow is below a predetermined threshold) (block 2612). In step 2614, the algorithm 2610 evaluates the therapy data to determine whether the low blood flow condition involves a situation that includes sudden instability. If no sudden instability is detected in the decision block 2614, a first message (block 2616) may be displayed, such as indicating that low blood flow has been detected and instructing the clinician to reduce the treatment power. If sudden instability is detected, an alternative message can be displayed (block 2618). In addition to indicating low blood flow and instructions to the clinician, it can also indicate that the electrode may have moved away from its original position. As mentioned above, this feedback can prompt the clinician to change or discontinue treatment.

In other embodiments, if the blood flow or thermal attenuation value is below a typical or predetermined threshold, the energy transfer algorithm 2610 may include automatically changing one or more conditions or characteristics of the treatment or catheter to increase the blood flow. For example, in one embodiment, the algorithm 2610 may respond to low blood flow by pulsing the energy provided to the energy delivery element 264 instead of providing continuous energy. This allows a lower blood flow to more fully remove the heat from the tissue surface, while still causing deep enough damage to remove the nerve.

In another embodiment, the algorithm 2610 may include cooling the electrode to respond to low blood flow, as described in further detail in the following document: International Patent Application No. PCT/US2011/033491 (filed on April 26, 2011) And U.S. Patent Application No. 12/874,457 (filed on August 30, 2010). The above-mentioned application is incorporated herein by reference in its entirety.

In another embodiment, the algorithm 2610 can respond to low blood flow by requiring an artificial increase in blood flow to the area. For example, a non-obstructive balloon can be stretched in the abdominal aorta to increase the pressure and flow in the renal artery. Balloons can be combined on the treatment catheter or on separate catheters.

H.<u style="single">Feedback display</u>

Figures 27A and 27B are screenshots illustrating representative generator display screens according to aspects of the technology of the present invention. For example, FIG. 27A is a display screen 2700 that tracks the enhanced impedance during treatment. The display 2700 includes a graphical display 2710 that tracks real-time impedance measurements during a selected time period (eg, 100 seconds). For example, the graphic display 2710 may be a dynamic scrolling display, which is updated regularly to provide the operator with instantaneous and historical tracking of impedance measurements. The display 2710 may also include an impedance display 2720 of the current impedance and an indication 2722 of the standard deviation of the impedance. In one embodiment, the standard deviation indicator 2722 is configured to flash when this value is greater than 10. This indicator can warn the operator that the contrast agent injection is affecting the measurement or the electrode may be unstable. Additional information about the contrast injection instructions is described below.

For example, FIG. 27B is another representative display screen 2730 with other information available to the operator. In this example, the display screen 2730 is configured to make the operator pay attention to the contrast agent injection and the system is waiting for the contrast agent to clear before starting (eg, turn off the RF for about 1 to 2 seconds until the contrast agent is cleared). In another embodiment, the display screen 2730 can be configured to provide other warning messages (for example, "the electrode may be unstable", etc.). The other information provided in the above-mentioned display screens 2710 and 2730 is expected to improve the contact evaluation before the RF is turned on, and improve the treatment efficiency and efficacy.

The other information described above with reference to FIGS. 27A and 10B can be generated according to the algorithm described herein or other suitable algorithms. For example, in one embodiment, the algorithm can continuously check contrast injection/stability during the pre-RF on period. If the electrode is stable and there is no contrast agent<img file="TW201223584A_D0006.tif" />1 second, the baseline impedance Z is defined as equal to the average impedance Z during 1 second. In a specific example, the real-time impedance is compared with two standard deviations of the average impedance value in a second window. In another specific example, the instantaneous impedance can be compared with a fixed value (for example, to determine whether the standard deviation is greater than 10). In other instances, other configurations can be used.

If the real-time impedance measurement value is within this range, no message will be displayed. However, if the real-time impedance is not within two standard deviations of the average value, the electrode may be unstable (that is, drift, move, etc.), and the user may be shown one or both of the above with reference to FIGS. 27A and 27B Message (for example, "Waiting for contrast agent removal", "Electrode may be unstable"). For example, when detecting contrast agent injection, in addition to the standard deviation of impedance, the algorithm can be configured to include the standard deviation of the real-time temperature measurement to find the drift of the real-time temperature below the initial body temperature. The exact value of the temperature drift cut-off can be changed. In a specific example, the system is configured so that if the impedance increases (eg standard deviation&gt;10) and the temperature decreases in real time, the system will prompt the contrast agent detection event, thereby displaying "waiting for the contrast agent to clear" to the operator. However, in other examples, other algorithms and/or ranges may be used to determine the contrast injection event and/or electrode stability. In addition, in some embodiments, the system can modify/adjust various treatment parameters according to the detected conditions without displaying such messages to the clinician.

VII.<u style="single">Pre-packaged kits of the disclosed devices and systems for distribution, transportation and sale</u>

As shown in FIG. 28, one or more components of the system 10 shown in FIG. 1 can be packaged together in a kit 276 for convenient delivery to and use by customers/clinical operators. Components suitable for packaging include the treatment device 12, a cable 28 for connecting the treatment device to the energy generator 26, a neutral or dispersive electrode 38, and one or more guiding catheters (eg, renal guiding catheters). The cable 28 can also be integrated in the treatment device 12 to pack the two components together. Each component can have its own aseptic packaging (for components that need to be sterilized), or the component can have a dedicated aseptic compartment in the kit packaging. This set may also include a step-by-step instruction manual 280, which provides the operator with industrial product features and operating instructions for using the system 10 and the treatment device 12, including all the insertion, delivery, placement and use methods of the treatment device 12 disclosed herein .

VIII.<u style="single">Other clinical uses of the disclosed technology</u>

Although certain embodiments of the technology of the present invention are related to at least partially removing the patient's renal nerves from the renal blood vessels (such as renal arteries) to block afferent and/or efferent nerve connections, the devices, methods and methods described herein The system can also be used for other endovascular treatments. For example, the above-mentioned catheter system or selected aspects of the system can be placed in other peripheral blood vessels to transmit energy and/or electric fields, thereby achieving nerve coordination by changing the nerves adjacent to these other peripheral blood vessels. The aorta sends out many arterial blood vessels, which move side by side with the abundant nerve plexus to the target organ. Using arteries to access and coordinate these nerves can have a clear therapeutic potential for a variety of disease states. Some examples include nerves surrounding the celiac trunk, superior mesenteric artery, and inferior mesenteric artery.

The sympathetic nerves adjacent to or surrounding the arteries (called celiac trunk) can be distributed in the stomach, small intestine, abdominal blood vessels, liver, bile ducts, gallbladder, pancreas, adrenal glands, and kidneys through the celiac ganglia and following the branches of the celiac trunk . Fully (or partially through selective coordination) coordination of these nerves can treat conditions, including (but not limited to) diabetes, pancreatitis, obesity, hypertension, obesity-related hypertension, hepatitis, liver and kidney syndrome, gastric ulcer, Gastric motility disorders, irritability of the large intestine, and autoimmune disorders such as Crohn's disease.

The sympathetic nerves adjacent to or surrounding the arterial vessel (called the inferior mesenteric artery) can be distributed in the colon, rectum, bladder, sexual organs, and external genitalia through the inferior mesenteric ganglion and following the branches of the inferior mesenteric artery. Fully (or partially through selective coordination) coordination of these nerves can treat conditions, including (but not limited to) GI dysfunction, colitis, urinary retention, overactive bladder, incontinence, infertility, polycystic ovary syndrome , Premature ejaculation, erectile dysfunction, dyspareunia and vaginismus.

Although accepted arterial access and treatment have been provided herein, the disclosed devices, methods, and systems can also be used to deliver treatment from peripheral veins or lymphatic vessels.

IX.<u style="single">Other discourses on anatomy and physiology</u>

The following discussion provides more details about the patient's anatomy and physiology. This section aims to supplement and expand the previous discussion on related anatomy and physiology, and to provide other content about the disclosed technology and the therapeutic benefits related to renal denervation. For example, as described above, the various properties of the renal vascular structure enable people to understand the design of treatment equipment and related methods to achieve renal nerve coordination through intravascular access, and to adopt specific design requirements for these equipment. Specific design requirements may include access to the renal artery, promoting stable contact between the energy transfer elements of these devices and the lumen surface or wall of the renal artery, and/or the effective coordination of the renal nerves with nerve coordination devices.

A.<u style="single">Sympathetic nervous system</u>

The sympathetic nervous system (SNS) is a branch of the autonomic nervous system together with the enteric nervous system and the parasympathetic nervous system. Its initiative is always at the basic level (called sympathetic nervousness) and becomes more active during periods of stress. Like other parts of the nervous system, the sympathetic nervous system operates through a series of interconnected neurons. Although many sympathetic neurons are located in the central nervous system (CNS), they are usually regarded as part of the peripheral nervous system (PNS). The sympathetic neurons of the spinal cord (a part of the CNS) communicate with peripheral sympathetic neurons through a series of sympathetic ganglia. In the ganglion, spinal cord sympathetic neurons and peripheral sympathetic neurons are connected via synapses. Therefore, spinal cord sympathetic neurons are called presynaptic (or preganglionic) neurons, and peripheral sympathetic neurons are called postsynaptic (or postganglionic) neurons.

At synapses within the sympathetic ganglia, preganglionic sympathetic neurons release acetylcholine (a chemical messenger that binds and activates nicotinic acetylcholine receptors located on postganglionic neurons). In response to this stimulus, postganglionic neurons mainly release noradrenaline (noradrenaline/norepinephrine). Prolonged activation can induce the adrenal medulla to release adrenaline.

Once norepinephrine and epinephrine are released, they bind to adrenergic receptors located on surrounding tissues. Binding to adrenergic receptors causes neuronal and hormonal responses. Physiological manifestations include pupil dilation, increased heart rate, occasional vomiting, and increased blood pressure. Because choline-stimulating receptors bind to sweat glands, increased sweating is also seen.

The sympathetic nervous system is responsible for up-regulating and down-regulating multiple constant mechanisms in living organisms. SNS fibers are distributed in the tissues of almost all organ systems and provide at least some adjustment functions for various events such as pupil diameter, intestinal motility and urine output. This reaction is also called the bodys sympathetic adrenal response, because the preganglionic sympathetic nerve fibers (and all other sympathetic nerve fibers) that terminate in the adrenal medulla secrete acetylcholine, which activates the secretion and positive effects of adrenaline/epinephrine. Adrenaline (noradrenaline/norepinephrine) is secreted to a lesser extent. Therefore, this response that mainly acts on the cardiovascular system is directly mediated by impulses transmitted by the sympathetic nervous system and indirectly mediated by catecholamines secreted by the adrenal medulla.

In science, SNS is usually regarded as an automatic adjustment system, that is, a system that operates without being disturbed by conscious thoughts. Some modified theorists have proposed that the sympathetic nervous system operates in the early organism to maintain survival, because the sympathetic nervous system is responsible for preparing for physical activity. An example of this preparation is the moment before waking up, the sympathetic effervescence spontaneously increases in preparation for activity.

1.　<u style="single">Sympathetic chain</u>

As shown in Figure 29, SNS provides a neural network that allows the brain to communicate with the body. The sympathetic nerve originates inside the spine, close to the middle part of the spinal cord that starts at the first thoracic segment of the spinal cord and is considered to extend to the mid-lateral cell column (or lateral horn) of the second or third lumbar segment. Because sympathetic nerve cells start in the thoracic and lumbar regions of the spinal cord, SNS is said to have thoracolumbar outgoing. The axons of these nerves leave the spinal cord via the anterior root. It passes near the spinal (sensory) ganglion and enters the anterior branch of the spinal nerve. However, different from the distribution of somatic nerves, the axons of these nerves are quickly separated by the white branch connecting body extending side by side with the spine. The white branch connecting system connects to the paravertebral (located near the spine) or anterior of the vertebrae (located near the bifurcation point of the aorta). )Ganglion.

In order to reach the target organs and glands, axons should travel long distances in the body, and for this, multiple axons transmit their messages to the second cell via synapses. The ends of the axons are connected to the dendrites of the second cell across the synaptic cleft. The neurotransmitter presented by the first cell (presynaptic cell) spans the synaptic cleft and activates the second cell (postsynaptic cell). Then send the message to the final destination.

In the SNS and other components of the peripheral nervous system, these synapses are formed at sites called ganglia. Cells that emit fibers are called preganglionic cells, and cells that leave the ganglion are called postganglionic cells. As mentioned above, the preganglionic cells of SNS are located between the first thoracic segment (T1) and the third lumbar segment (L3) of the spinal cord. Postganglionic cells have their cell bodies in the ganglia and send out their axons to target organs or glands.

Ganglia not only include sympathetic nerve trunks, but also cervical ganglia (upper neck, middle neck, and lower neck) that send sympathetic nerve fibers to the head and thoracic organs, as well as celiac ganglia and mesenteric ganglia (which send sympathetic nerve fibers to the intestine ).

2.　<u style="single">Renal nerve distribution</u>

As shown in Fig. 30, the renal nerve plexus (RP), which is tightly combined with the renal artery, is distributed in the kidney. The renal nerve plexus RP is the autonomic nerve plexus surrounding the renal artery and embedded in the outer membrane of the renal artery. The renal nerve plexus RP extends along the renal artery until it reaches the renal entity. The fibers that contribute to the RP of the renal nerve plexus originate from the celiac ganglia, superior mesenteric ganglia, aortic renal ganglia and aortic nerve plexus. Renal nerve plexus RP is also called renal nerve, which mainly contains sympathetic components. There is no (or at least very little) distribution of parasympathetic nerves in the kidneys.

The cell bodies of preganglionic neurons are located in the mid-lateral cell column of the spinal cord. The preganglionic axon passes through the paravertebral ganglion (which does not form synapses) and becomes the small visceral nerve (the smallest splanchnic nerve), the first lumbar splanchnic nerve, and the second lumbar splanchnic nerve, and migrate to the celiac ganglion and superior mesenteric nerve Sections and aortic renal ganglia. Postganglionic neuron cell bodies leave the celiac ganglion, superior mesenteric ganglion and aortic renal ganglion to the renal nerve plexus RP and are distributed in the renal vascular structure.

3.　<u style="single">Renal sympathetic nerve activity</u>

Messages are passed through SNS in a two-way stream. Outgoing messages can cause simultaneous changes in different parts of the body. For example, the sympathetic nervous system can speed up the heart rate; widen the bronchial passages; reduce the peristalsis of the large intestine (movement); constrict blood vessels; enhance esophageal peristalsis; cause pupil dilation, erect hair (goose bumps) and sweating (sweating); and increase blood pressure. Incoming messages transmit signals from various organs and sensory receptors in the body to other organs, and especially to the brain.

Hypertension, heart failure and chronic kidney disease are several of the various disease states caused by the long-term active SNS (especially the renal sympathetic nervous system). The long-term active SNS is an unfavorable response that drives the progression of these disease states. The renin-angiotensin-aldosterone medical management system (RAAS) is a long-existing but not very effective method to reduce SNS overactivity.

As mentioned above, the renal sympathetic nervous system has been identified as the main factor causing the complex pathophysiology of hypertension, volume overload conditions (such as heart failure) and progressive nephropathy in both experiments and humans. Studies using the radiotracer dilution method to measure the amount of norepinephrine spilled into the plasma from the kidneys have shown that the spillover rate of norepinephrine (NE) from the kidneys is higher in patients with essential hypertension, which is higher in childhood This is especially true in individuals with blood pressure, which is consistent with a higher cardiac NE overflow rate, consistent with the hemodynamic characteristics commonly seen in early hypertension, and is characterized by increased heart rate, increased cardiac output, and increased renal vascular resistance. It is now known that essential hypertension is generally neurogenic, usually accompanied by obvious sympathetic nervous system overactivity.

In heart failure, the activity of the heart and kidney sympathetic nerves is more active, as evidenced by the significant increase in the amount of NE spilled into the plasma from the heart and kidneys in this group of patients. Recently, the strong negative predictive value of renal sympathetic nerve activity in heart transplantation involving all causes of death and congestive heart failure patients proved to be consistent with this view. The predictive value is independent of overall sympathetic nerve activity, glomerular filtration rate and left ventricular ejection. Fraction. These findings prove that treatments designed to reduce renal sympathetic stimulation may increase the survival rate of patients with heart failure.

Both chronic kidney disease and end-stage renal disease are characterized by increased sympathetic nerve activity. It has been proven that plasma levels of norepinephrine in patients with end-stage renal disease exceeding the median value are predictive for deaths from all causes and deaths due to cardiovascular diseases. This finding is also correct for patients suffering from diabetic nephropathy or nephropathy caused by contrast agents. There is strong evidence that sensory afferent signals from diseased kidneys are the main factor that causes and maintains the increase in central sympathetic nerves in this group of patients, thereby promoting the occurrence of the well-known adverse consequences of long-term sympathetic hyperactivity, such as high Blood pressure, left ventricular hypertrophy, ventricular arrhythmia, sudden cardiac death, insulin resistance, diabetes and metabolic syndrome.

(i)<u style="single">Renal sympathetic efferent activity</u>

The sympathetic nerves going to the kidneys terminate in blood vessels, juxtaglomerular apparatus and renal tubules. Stimulating renal sympathetic nerves can cause increased renin release, increased sodium (Na+) reabsorption, and decreased renal blood flow. These components of the renal function of neuromodulation are greatly stimulated in the disease state characterized by increased sympathetic nervousness, and significantly increase the blood pressure of hypertensive patients. Decreased renal blood flow and glomerular filtration rate caused by the stimulation of renal sympathetic nerves may be the basic cause of decreased renal function in cardiorenal syndrome. As a progressive complication of chronic heart failure, cardiorenal syndrome is renal dysfunction , Its clinical course is usually fluctuating appearance of clinical symptoms and treatment of patients. Pharmacological strategies to counteract the effects of sympathetic nerve stimulation from the kidneys include centrally acting sympathetic nerve blockers beta blockers (designed to reduce renin release), angiotensin converting enzyme inhibitors, and receptor blockers ( Designed to block the activity of angiotensin II and the activation of aldosterone after the release of renin) and diuretics (designed to counteract the sympathetic-mediated sodium and water retention in the kidney). However, current pharmacological strategies have obvious limitations, including limited efficacy, compliance issues, side effects, and other issues.

(ii)<u style="single">Renal sensory afferent nerve activity</u>

The kidneys are connected to the overall structure of the central nervous system through the renal sensory afferent nerves. Various forms of "kidney damage" can induce active sensory afferent signals. For example, renal ischemia, reduced stroke volume or renal blood flow, or adenosine enzyme enrichment can cause active afferent nerve connections. As shown in Figure 31A and Figure 31B, this afferent connection may be from the kidney to the brain, or it may be from one kidney to the other (via the central nervous system). These afferent signals are integrated in the central nervous system and can cause increased sympathetic nerve transmission. This sympathetic nerve impulse is directed to the kidney, thereby activating RAAS and inducing enhanced renin secretion, sodium retention, volume retention, and vasoconstriction. The excessive activity of the central sympathetic nerve also affects other organs and body structures where the sympathetic nerves are distributed, such as the heart and peripheral vascular structures, causing the sympathetic nerves to be active and causing the aforementioned adverse effects. Many of them also lead to increased blood pressure.

Therefore, physiology proposes that (i) coordination of tissues with efferent sympathetic nerves will reduce inappropriate renin release, salt retention and reduced renal blood flow, and (ii) coordination of tissues with afferent sensory nerves will affect the posterior thalamus through it. The direct action of the lower part and the contralateral kidney reduces the systemic factors that cause high blood pressure and other disease states related to increased central sympathetic nervousness. In addition to the central hypotensive effect of removing afferent renal nerves, it is also expected that the central sympathetic nerve outgoing to various other organs with sympathetic nerves (such as the heart and vascular structures) will show a desired reduction.

B.<u style="single">Other clinical benefits of removing kidney nerves</u>

As provided above, removal of renal nerves may be beneficial in the treatment of a variety of clinical conditions characterized by increased overall sympathetic nerve activity (especially increased renal sympathetic nerve activity), such as hypertension, metabolic syndrome, insulin resistance, diabetes, and left ventricular hypertrophy , Chronic kidney disease and end-stage renal disease, improper body fluid retention in heart failure, cardiorenal syndrome and sudden death. Since reducing afferent nerve signals can reduce systemic sympathetic nervousness/impulsivity, removal of renal nerves can also be suitable for the treatment of other conditions related to systemic sympathetic overactivity. Therefore, removal of renal nerves can also benefit other organs and body structures where sympathetic nerves are distributed, including those organs and body structures identified in Figure 29. For example, as discussed above, reducing central sympathetic nerve impulse can reduce insulin resistance in patients suffering from metabolic syndrome and type II diabetes. In addition, the sympathetic nerves of patients with osteoporosis are also active and can also benefit from the downregulation of sympathetic nerve impulse caused by the removal of renal nerves.

C.<u style="single">To reach the intravascular access to the renal artery</u>

According to the technology of the present invention, nerve coordination can be achieved for the left and/or right renal nerve plexus (RP) tightly combined with the left and/or right renal artery through the intravascular access. As shown in Fig. 32A, the blood from the systole is transported from the left ventricle of the heart through the aorta. The aorta descends through the thoracic cavity and branches into the left and right renal arteries. Below the renal artery, the aorta is divided into two branches, the left and right iliac arteries. The left and right iliac arteries descend through the left and right legs respectively and connect to the left and right femoral arteries.

As shown in FIG. 32B, blood enters the iliac vein and the inferior vena cava via the femoral vein, collects in the vein and returns to the heart. The branches of the inferior vena cava are left and right renal veins. Above the renal veins, the inferior vena cava carries blood up to the right atrium of the heart. The blood is pumped from the right atrium, enters the lungs through the right ventricle, and combines with oxygen in the lungs. Oxidized blood is transported from the lungs to the left atrium. The oxidized blood from the left atrium is transported back to the aorta via the left ventricle.

As will be described in more detail later, the femoral artery can be approached and the catheter inserted at the base of the femoral triangle (just below the midpoint of the inguinal ligament). The catheter can be inserted subcutaneously into the femoral artery through this entry site, through the iliac artery and aorta, and placed in the left or right renal artery. This includes minimally invasive intravascular access to individual renal arteries and/or other renal blood vessels.

The wrist, upper arm, and shoulder areas provide other locations where the catheter can be introduced into the arterial system. For example, the radial artery, brachial artery, or axillary artery can be used to perform catheterization in selective cases. Using standard angiography techniques, the catheter introduced through these entry points can be guided through the subclavian artery on the left (or through the subclavian artery and brachiocephalic artery on the right), through the aorta, along the descending aorta, and into the kidney In the arteries.

D.<u style="single">The nature and characteristics of renal vascular structure</u>

Since the nerve coordination of the left and/or right renal nerve plexus RP can be achieved through intravascular access according to the technology of the present invention, the nature and characteristics of the renal vascular structure can restrict and/or inspire devices and systems for achieving this renal nerve coordination And method design. Some of these properties and characteristics may vary from patient to patient group and/or in a specific patients body over time, and may vary with disease states (such as hypertension, chronic kidney disease, vascular disease, end-stage renal disease, insulin resistance, diabetes, metabolic Syndrome, etc.). These properties and characteristics, as explained in this article, may involve the efficacy of the procedure and the specific design of the endovascular device. Related properties may include, for example, material/mechanical, spatial, hydrodynamic/hemodynamic, and/or thermodynamic properties.

As mentioned earlier, the catheter can be pushed subcutaneously into the left or renal artery via a minimally invasive intravascular route. However, determining the minimally invasive renal artery access can be challenging because, for example, the renal arteries are often extremely twisted, with relatively small diameters and/or relatively short lengths, compared to some other arteries that are routinely inserted using catheters. . In addition, renal atherosclerosis is common in many patients, especially those with cardiovascular disease. Renal artery anatomy may also vary significantly from patient to patient, making it more complicated to determine the least invasive pathway. Obvious inter-patient disparity can be seen in, for example, relative torsion, diameter, length, and/or atherosclerotic plaque load, as well as the deviation angle of the branches of the renal arteries. Devices, systems, and methods for achieving renal nerve coordination through intravascular access should address these and other aspects of renal artery anatomy and their differences among patient groups when entering the renal artery with minimal invasiveness.

In addition to determining the complexity of the renal artery pathway, the particularity of the renal anatomy also makes it complicated to establish a stable contact between the nerve coordination device and the lumen surface or wall of the renal artery. When the nerve coordination device includes an energy transfer element such as an electrode, applying consistent positioning and appropriate contact force to the blood vessel wall by the energy transfer element plays an important role in predictability. However, the tight space and the twisting of the arteries hinder the passage in the renal arteries. In addition, patient movement, breathing, and/or heartbeat cycles complicate the establishment of consistent contact, because these factors can cause significant movement of the renal artery relative to the aorta, and the heartbeat cycle will instantaneously expand the renal artery (ie, cause Arterial wall pulsation).

Even after entering the renal artery and promoting stable contact between the nerve coordination device and the surface of the arterial lumen, the nerves in and around the adventitia of the artery should be safely coordinated via the nerve coordination device. In view of the potential clinical complications of this therapy, effective application of hyperthermia from the renal artery plays an important role. For example, the intima and media of the renal arteries are highly susceptible to heat damage. As discussed in more detail below, the intima-media thickness separating the vascular lumen and its adventitia means that the distance between the target renal nerve and the surface of the artery lumen can be several millimeters. In order to coordinate the target renal nerves without excessively cooling or heating the blood vessel wall to the extent that the blood vessel wall freezes, shrinks, or otherwise potentially damages undesirably, sufficient energy should be delivered to the target renal nerve or heat removed from the target renal nerve Enough energy. The potential clinical complication of overheating is the clotting of blood flowing through the arteries and the formation of thrombi. In view of the fact that this thrombosis can cause kidney infarction, which leads to irreversible damage to the kidney, hyperthermia from the renal artery should be applied carefully. Therefore, the complex fluid dynamics and thermodynamic conditions that exist in the renal artery during treatment, especially those conditions that affect the heat transfer kinetics at the treatment site, are relevant to the application of energy (for example, heating heat) from the renal artery and/ Or it can have an important role in removing heat from the tissue (e.g., cooling thermal conditions).

The nerve coordination device should also be configured to adjust the positioning and repositioning of the energy transfer element in the renal artery, because the treatment site can also affect the clinical efficacy. For example, given that the renal nerves can be spaced around the renal arteries in the ring direction, it may be attractive to apply a complete ring treatment from within the renal arteries. In some cases, the full circle damage that may be caused by continuous hoop treatment can potentially be related to renal artery stenosis. Therefore, it may be necessary to relocate the nerve coordination device to multiple treatment locations along the longitudinal dimension of the renal artery through the mesh structure described herein and/or to form more complex damage. It should be noted, however, that the benefits of circular enucleation may outweigh potential renal artery stenosis or this risk is mitigated with certain embodiments or in certain patients, and circular enucleation may be the goal. In addition, the changeable positioning and repositioning of the nerve coordination device has been proven to be suitable for situations where the renal artery is particularly twisted or where there are proximal branches of the renal artery and the main blood vessel, which makes it challenging to treat in certain locations. . Manipulating the equipment in the renal arteries should also be considered as mechanical damage to the renal arteries caused by the equipment. Moving the device in the artery (eg, insertion, manipulation, over bending, etc.) may cause dissection, perforation, intimal erosion, or fragmentation of the internal elastic thin layer.

With minimal or no complications, the blood flowing through the renal arteries can be temporarily blocked temporarily. However, to prevent damage to the kidneys (such as ischemia), prolonged blockage should be avoided. It may be beneficial to avoid complete obstruction, or if obstruction is beneficial to the embodiment, the obstruction duration is limited to, for example, 2 minutes to 5 minutes.

According to the above challenges: (1) renal artery intervention; (2) consistent and stable placement of the treatment element against the blood vessel wall; (3) effective treatment across the blood vessel wall; (4) positioning of the treatment device and allowing multiple treatment positions (5) To avoid or limit the duration of blood flow obstruction, the various independent and related properties of renal vascular structure that can be concerned include (for example): (a) Vessel diameter, vessel length, intima-media thickness , Friction coefficient and torsion; (b) dilatation, stiffness and elastic modulus of blood vessel wall; (c) peak systolic, end-diastolic blood flow rate, and systolic peak diastolic peak average blood flow rate, average Value/Maximum volume blood flow rate; (d) Specific heat capacity of blood and/or blood vessel wall, thermal conductivity of blood and/or blood vessel wall and/or heat convection and/or radiation heat transfer of blood flow through the treatment site of blood vessel wall (E) The movement of the renal artery relative to the aorta induced by respiration, patient movement and/or blood flow pulsation: and (f) and the deviation angle of the renal artery relative to the aorta. These properties will be discussed in more detail with respect to the renal artery. However, depending on the device, system, and method used to achieve renal nerve coordination, these properties of the renal artery may also determine and/or constrain the design features.

As mentioned above, the device positioned in the renal artery should conform to the geometry of the artery. Renal artery diameter D_RATypically in the range of about 2 mm to 10 mm, most patient groups have a D of about 4 mm to about 8 mm_RAAnd about 6 mm average. Renal artery vessel length LRA (between its opening at the junction of the aorta/renal artery and its distal branch) is usually in the range of about 5 mm to 70 mm, and most patients are about 20 mm to 50 mm Within range. Since the target renal nerve plexus is embedded in the adventitia of the renal artery, the composite intima-media thickness IMT (that is, the radially outward distance from the surface of the artery lumen to the outer membrane containing the target nerve structure) is also significant and It is usually in the range of about 0.5 mm to 2.5 mm, with an average value of about 1.5 mm. Although a certain treatment depth is important for reaching the target nerve fibers, the treatment should not be too deep (for example, &gt;5 mm from the inner wall of the renal artery) to avoid non-target tissues and anatomical structures, such as renal veins.

Another interesting characteristic of the renal artery is the degree of movement of the kidney relative to the aorta induced by respiration and/or blood flow pulsation. The kidney of a patient located at the far end of the renal artery can move as far as 4" to the cranial side under respiratory drift. This can cause the renal artery connecting the aorta and the kidney to move significantly, which requires the stiffness and stiffness of the nerve coordination device. The flexibility achieves an excellent balance to maintain contact between the thermotherapy element and the blood vessel wall during the breathing cycle. In addition, the deviation angle between the renal artery and the aorta can vary significantly from patient to patient, and it can also vary in the patient's body. For example, the kidney moves significantly differently. The deviation angle can usually be in the range of about 30°-135°.

X.<u style="single">in conclusion</u>

The above detailed description of the embodiments of the present technology is not intended to be exhaustive or to limit the present technology to the exact form disclosed above. Although the specific embodiments and examples of the technology of the present invention have been described above for illustrative purposes, those skilled in the relevant art will realize that various equivalent modifications can be made within the scope of the technology of the present invention. For example, although the steps are presented in a specified order, alternative embodiments may perform steps in a different order. Multiple embodiments described herein can also be combined to provide other embodiments.

It will be understood from the foregoing that specific embodiments of the technology of the present invention have been described herein for illustrative purposes, but well-known structures and functions are not shown or described in detail, so as to avoid unnecessary obscurity in the description of the embodiments of the technology of the present invention. Place. Where the context permits, singular or plural words may also include plural or singular words, respectively.

In addition, when referring to a list of two or more items, unless the word "or" is specifically limited to mean only a single item and excludes other items, the use of "or" in this list can be interpreted as including (a) any single item in the list , (B) all items in the list, or (c) any combination of items in the list. In addition, the term "comprising" as used throughout the text means including at least the listed features, and therefore does not exclude any larger number of the same features and/or other types of other features. It will also be understood that specific embodiments have been described herein for illustrative purposes, but various modifications can be made without departing from the technology of the present invention. In addition, although the advantages associated with certain embodiments of the technology of the present invention have been described in the context of their embodiments, other embodiments can also exhibit these advantages, and not all embodiments necessarily exhibit the technology of the present invention. These advantages within the scope of the. Therefore, the present invention and related technologies may cover other embodiments that are not explicitly shown or described herein.

The present invention can be defined by one or more of the following:

1. A catheter device comprising: an elongated flexible tubular member extending along a longitudinal axis, wherein the elongated tubular member has a proximal end portion, a distal end portion and a central lumen located therein, and wherein the tubular member includes: located at the distal end A deflection zone at a portion, wherein the deflection zone includes a plurality of slits located in the wall of the tubular member and substantially transverse to the longitudinal axis; and adjacent to the deflection zone and located between the deflection zone and the proximal portion of the elongated tubular member The orientation zone between the distal ends of the tube, wherein the orientation zone includes a plurality of slits located in the wall of the tubular member and substantially transverse to the longitudinal axis; wherein the tubular member can be selectively changed between the following: A state in which the deflection zone generally extends straight along the longitudinal axis, and a second state in which the deflection zone includes a substantially spiral structure and the orientation zone has an elbow shape so that the proximal portion of the tubular member The distal end points through the inside of the spiral body; a plurality of energy transfer elements, which are carried by the deflection zone and include at least a first energy transfer element and a second energy transfer element, wherein when the tubular member is in the second state, the first energy transfer element An energy transfer element and the second energy transfer element are spaced apart from each other in the axial and radial directions around the longitudinal axis; and a control member operatively engaged with the tubular member to control the flexible tubular member in the first state and Move between this second state.

2. Such as the catheter device of item 1, wherein in the second state, the deflection zone defines a spiral axis substantially parallel to the longitudinal axis, and the spiral structure rotates around the spiral axis to define a plurality of turns and spiral diameters of the spiral structure, And the spiral structure has a distal end and a proximal end spaced along the spiral axis to define the length of the spiral body.

3. The catheter device of item 2, wherein the orientation zone is configured to substantially align the spiral axis with the longitudinal axis when the tubular member is in the second state, and wherein the slit of the orientation zone surrounds the longitudinal axis The shaft deviates radially from the slit of the deflection zone.

4. The catheter device of item 1, wherein the spiral structure includes at least two turns to define at least two contact points for engaging the peripheral blood vessel wall.

5. The catheter device of item 1, wherein: the slits of the deflection zone are elongated deflection slits substantially parallel to each other along the tubular member, and wherein the deflection slits extend completely through the wall of the tubular member; and The slits of the orientation zone are elongated orientation slits substantially parallel to each other along the tubular member, and the orientation slits extend completely through the wall of the tubular member.

6. The catheter device of item 5, wherein: the center points of the orientation slits in the orientation zone are spaced apart along a first progressive axis, the first progressive axis extending along the length of the tubular member; and in the deflection zone The center points of the deflection slits are spaced apart along a second progressive axis that extends along the length of the tubular member and deviates radially from the first progressive axis around the longitudinal axis.

7. Such as the catheter device of item 6, wherein in the first state: the first progressive axis is substantially parallel to the longitudinal axis; and the second progressive axis defines about 0.5 degrees (0.5°) with respect to a line parallel to the longitudinal axis ) Of the horns.

8. Such as the catheter device of item 6, wherein in the first state: the first progressive axis is substantially parallel to the longitudinal axis; and the second progressive axis defines about 2 degrees (2°) with respect to a line parallel to the longitudinal axis ) Of the horns.

9. The catheter device of item 6, wherein in the first state, the first progressive axis defines an angle between about 45 degrees (45°) and 90 degrees (90°) with respect to a line parallel to the longitudinal axis.

10. The catheter device of item 1, wherein the plurality of slits in at least one of the deflection zone and the orientation zone includes at least one circular elongated opening around the longitudinal axis and at an angle exceeding about 300°.

11. Such as the catheter device of item 10, wherein the at least one opening defines an arc length of about 0.04 inches (1.02 mm).

12. Such as the catheter device of item 10, wherein the at least one opening includes a central area and two end areas surrounding and adjacent to the central area, and wherein the central area and the two end areas each define an extension in the longitudinal direction The width of the opening, the width defined by the two end regions is greater than the width defined by the central region.

13. Such as the catheter device of item 12, wherein the two end regions are each substantially circular.

14. Such as the catheter device of item 12, wherein the two end regions and the central region are each substantially rectangular, and the two end regions are elongated parallel to the longitudinal axis, and the central region is elongated perpendicular to the longitudinal axis.

15. Such as the catheter device of item 12, wherein the two end regions are each substantially rectangular and extend parallel to the longitudinal axis, and the central region defines a circular portion centered on the opening.

16. Such as the catheter device of item 1, wherein the plurality of slits in the deflection zone include 30 or less than 30 deflection slits, and the individual deflection slits are separated from each other by about 0.03 inch (0.76 mm) to about 0.04 inch ( 1.02 mm) distance.

17. The catheter device of item 1, wherein the control member includes a wire disposed in the central lumen, and wherein the wire has a first end portion coupled to the distal end portion of the tubular member, so that the wire control member is enlarged The tension causes the deflection zone of the tubular member to be selectively changed between the first state and the second state.

18. The catheter device of item 17, further comprising a handle assembly located at the proximal end portion of the tubular member, and wherein the second end portion of the wire is operatively coupled to the handle to apply tension to the wire.

19. A catheter device comprising: an elongated shaft having a proximal portion and a distal portion, wherein the distal portion of the shaft is configured to be delivered to the renal artery of a human patient in a blood vessel; and is slidably disposed on the shaft A control wire within and fixed at or near the distal end portion of the shaft; a treatment assembly located at the distal end portion of the elongated shaft, the treatment assembly including a plurality of energy transfer elements, including at least a first energy transfer element and Second energy transfer element; and wherein via the control line, the treatment component can be changed between the following: a folded configuration, wherein the treatment component defines about 0.085 inches (2.16 mm) or less than 0.085 inches (2.16) around the central axis mm) transmission section, and extended configuration, in which the first energy transfer element and the second energy transfer element are spaced apart from each other in the axial direction along the central axis and in the radial direction around the central axis.

20. The catheter apparatus of Paragraph 19, into a further member comprising a tip located at the distal portion of the elongate shaft, wherein the control line is coupled to the tip member, and wherein the tip member was configured to be inserted into the atraumatic In the arteries of the kidneys.

twenty one. For example, the catheter device of item 19, further comprising a handle assembly located at the proximal end portion of the shaft and operatively coupled to the control wire, wherein the handle assembly is configured so that the treatment assembly is in a folded configuration and an extended set Change between states.

twenty two. The catheter device of item 19, wherein the distal region includes a plurality of slits formed in the distal portion of the elongated shaft, wherein the slits are substantially parallel to each other and are substantially transverse when the treatment component is in a folded configuration. On the central axis.

twenty three. Such as the catheter device of item 19, wherein the control wire comprises ultra-high molecular weight polyethylene.

twenty four. The catheter device of item 19, wherein the distal region includes a slit, and wherein the control wire is anchored to the slit.

25. The catheter device of item 19 further includes a coil located in the distal region, and wherein the control wire is anchored to the coil.

26. Such as the catheter device of item 19, wherein the distal end of the control wire is twisted and coated with a polymer material.

27. Such as the catheter device of item 19, wherein: the support structure is configured to change between: a substantially linear structure in a folded configuration; and a spiral structure in an extended configuration, the structure defining roughly A spiral axis parallel to the central axis, and the spiral structure rotates around the spiral axis to define a plurality of turns and spiral diameters of the spiral structure, and wherein the spiral structure includes a distal portion spaced along the spiral axis to define the length of the spiral body And the proximal part; and the control line is configured to operatively engage the support structure to control the movement of the support structure between the folded configuration and the extended configuration.

28. Such as the catheter device of item 27, wherein the control wire is substantially aligned along the spiral axis and is operatively coupled to the distal end of the spiral structure, so that the control wire is translated along the axial direction of the spiral axis, and the control support structure is in the folding group The movement between the state and the extended configuration.

29. Such as the catheter device of item 28, wherein the axial translation of the control wire in the distal direction can reduce the radial distance between the first energy transfer element and the second energy transfer element from the central axis.

30. Such as the catheter device of item 29, wherein the axial translation of the control wire in the distal direction can increase the length of the spiral body and reduce the diameter of the spiral.

31. Such as the catheter device of item 27, wherein the spiral structure is configured to rotate relative to the control wire.

32. Such as the catheter device of Item 27, further comprising a stop member arranged along the spiral axis to limit the axial translation of the control wire.

33. The catheter device of item 27, wherein the control wire includes a central lumen, and wherein the catheter device further includes a guide wire disposed in the central lumen of the control wire to position the support structure at a target treatment position along the renal artery.

34. A catheter device comprising: an elongated shaft having a proximal portion and a distal portion, wherein the distal portion of the shaft is configured to be delivered to the renal artery of a human patient in the blood vessel; located at the distal end of the elongated shaft Part of the treatment section and the control member slidably disposed therein; and a plurality of energy transfer elements carried by the treatment section, wherein one of the treatment section and the control member includes a pre-formed spiral shape, and the treatment section and The other of the control members includes a substantially straight shape, and wherein the treatment segment can be changed between: a substantially straight transfer configuration; and has a pre-shaped spiral shape to position the energy transfer element to be stable with the renal artery wall The treatment configuration of the contact.

35. The catheter device of item 34, wherein: the treatment segment includes a pre-shaped spiral member having a central lumen; and the control member includes a straightening member configured to be received in the central lumen.

36. The catheter device of item 34, wherein: the treatment segment includes a conformable central lumen; and the control member includes a pre-shaped spiral structure configured to be received in the central lumen and giving the treatment segment a spiral shape.

37. The catheter device of item 34, wherein the treatment segment has a first stiffness, and the control member has a second stiffness greater than the first stiffness.

38. The catheter device of item 34, wherein at least one of the control member or the treatment section includes a shape memory material.

39. Such as the catheter device of item 34, further comprising a retractable outer sheath, when the treatment segment is in the delivery configuration, the outer sheath at least partially surrounds at least one of the control member or the treatment segment.

40. The catheter device of item 34, further comprising a delivery wire removably positioned in the treatment segment and configured to deliver the treatment segment to the renal artery.

41. Such as the catheter device of item 34, wherein the distal portion of the elongated shaft, the treatment section and the energy transfer element are sized and configured to be delivered in the blood vessel via a 6 French or smaller guide catheter Into the kidney artery.

42. A catheter device comprising: an elongated shaft having a proximal portion and a distal portion, wherein the distal portion of the shaft is configured to be delivered to the renal artery of a human patient in a blood vessel; the distal portion of the elongated shaft The pre-formed section, wherein the elongated shaft and the pre-formed section comprise a central lumen configured to receive a control member; and a plurality of energy transfer elements carried by the pre-formed section, wherein the pre-formed section can be Change between the following: a low-profile configuration, in which the control member is positioned in the central lumen, and an extended configuration, in which the control member is at least partially retracted from the pre-formed section, and the pre-formed section It has a spiral shape so that the energy transfer element is positioned in stable contact with the renal artery wall.

43. The catheter device of item 42, wherein the control member includes a straightening member configured to be received in the central lumen, and wherein in the transfer configuration, the straightening member gives the distal portion of the elongated shaft low Sectional, usually linear shape.

44. Such as the catheter device of item 42, wherein the pre-formed section includes a self-expanding spiral structure.

45. The catheter device of item 42, further includes a wire configured to deliver the preformed segment to the renal artery of the patient.

46. Such as the catheter device of item 45, wherein the guidewire includes a control member, and in the extended configuration, the guidewire is at least partially drawn out or removed from the central lumen of the preformed section.

47. Such as the catheter device of item 42, wherein the pre-formed section comprises a Nitinol cable.

48. Such as the catheter device of item 42, wherein the pre-formed section is composed of a shape memory material.

49. The catheter device of item 42, wherein the pre-formed section includes a plurality of external supports configured to arrange the pre-formed section in a spiral shape.

50. Such as the catheter device of item 42, wherein the distal portion of the elongated shaft, the preformed section, and the energy transfer element are sized and configured to pass through a 6 French or less than 6 French guide catheter in the blood vessel Delivered to the renal artery.

51. For example, the catheter device of item 42, further comprises a retractable outer sheath. When the pre-formed section is in a low-profile configuration, the outer sheath at least partially surrounds the pre-formed section, wherein the retractable outer sheath is configured to form a self The patient's transitional curvature of the aorta to the renal artery.

52. A catheter device comprising: an elongated shaft having a proximal portion and a distal portion, wherein the distal portion of the shaft is configured to be delivered to the renal artery of a human patient in a blood vessel; at the distal portion of the shaft The conformable part of and the shaping member disposed through the conformable part, wherein the conformable part can move between: the transfer configuration when the shaping member is removed from the central lumen; and the storage of the shaping member The treatment configuration when in the central lumen; and the multiple electrodes carried by the conformable part.

53. The catheter device of item 52 further includes a delivery wire configured to deliver the conformable portion to the renal artery.

54. The catheter device of item 52, wherein the elongated shaft includes: a guidewire lumen configured to receive the guidewire; and a control member lumen configured to receive the shaping member, and wherein the guidewire lumen and the The control member lumens merge together to form a central lumen.

55. Such as the catheter device of item 52, wherein the shaped member includes a spiral structure.

56. Such as the catheter device of item 52, further comprising an outer sheath of a retractable forming member that at least partially surrounds the forming member and is configured to compress the forming member into a shape when the conformable portion is in a low-profile configuration The configuration is roughly straightened.

57. The catheter device of item 52, wherein the conformable portion has a first stiffness, and the forming member has a second stiffness greater than the first stiffness.

58. A catheter device comprising: an elongated shaft having a proximal portion and a distal portion; a treatment section located at the distal end of the elongated shaft and a control coupled to the treatment section and slidable relative to the treatment section And a plurality of energy transfer elements carried by the treatment section, wherein one of the treatment section and the control member includes a pre-formed spiral shape, and the other of the treatment section and the control member includes a substantially straight shape; and wherein The treatment segment and the control member are movable relative to each other to change the treatment device between a low-profile transfer configuration and an extended configuration with a pre-shaped spiral shape.

59. The catheter device of item 58, wherein: the treatment segment includes a preformed spiral member having a central lumen; and the control member includes a straightening member configured to be received in the central lumen.

60. The catheter device of item 58, wherein: the treatment segment includes a conformal central lumen; and the control member includes a pre-formed spiral structure configured to be received in the central lumen and giving the central lumen a spiral shape.

61. Such as the catheter device of item 58, wherein the distal portion of the elongated shaft, the treatment section, and the energy transfer element are sized and configured to be delivered in the blood vessel via a 6 French or less than 6 French guide catheter Into the renal artery.

62. Such as the catheter device of item 58, further comprising a retractable outer sheath. When the treatment segment is in a low-profile delivery configuration, the outer sheath at least partially surrounds at least one of the treatment segment or the control member.

63. Such as the catheter device of item 58, which further includes a delivery wire removably positioned through the treatment segment and configured to deliver the conformal portion to the renal nerve treatment site.

64. A catheter device for treating a human patient by removing renal nerves. The catheter device includes a treatment component having a central axis and a distal part and a proximal part axially spaced apart along the central axis, the treatment component comprising: a plurality of energies The transfer element includes at least a first energy transfer element and a second energy transfer element; and a formable area movable between a transfer state and an expanded state, wherein the plurality of energy transfer elements are carried by the formable area; control A member operatively coupled to at least a part of the treatment assembly and arranged along the central axis, so that the first energy transfer element and the second energy transfer element are spaced apart from each other in the axial direction and the radial direction around the control member, and wherein : The control member moves proximally relative to the distal part of the treatment assembly to place the treatment assembly in a delivery state; and the control member moves distally relative to the distal part of the treatment assembly to place the treatment assembly in an unfolded state.

65. The catheter device of item 64, wherein the control member includes a tubular member defining a central lumen, and the central lumen is configured to receive a guide wire.

66. The catheter device of item 64, further comprising a shaft having a guidewire lumen at the distal end, wherein the control member is slidably received in the guidewire lumen and is configured to advance and retract relative to the treatment component.

67. Such as the catheter device of item 64, wherein the treatment component includes a pre-shaped spiral structure.

68. Such as the catheter device of item 64, wherein the control member comprises a port needle.

69. A catheter device includes: a tubular elongated shaft defining at least one lumen; a treatment component disposed at the distal end of the elongated shaft, the treatment component defining a central axis and having a distal portion axially spaced apart along the central axis, and In the proximal part, the treatment component includes: a plurality of energy transfer elements, including at least a first energy transfer element and a second energy transfer element; and a support member that can move between a transfer configuration and an unfolded configuration; a control member, and its operability Coupled to the distal portion of the treatment assembly and arranged along the central axis, such that the first energy transfer element and the second energy transfer element are spaced apart from each other in the axial and radial directions around the control member, and wherein: the control member Distal movement relative to the elongated shaft to place the treatment assembly in a transfer configuration; and proximal movement of the control member relative to the elongated shaft to place the treatment assembly in an expanded configuration; and coupled to the treatment The guide assembly is arranged along the central axis of the treatment assembly, wherein the guide assembly includes a tubular member provided with an opening at the proximal end portion of the treatment assembly for insertion and removal of the wire.

70. Such as the catheter device of item 69, wherein the treatment assembly includes a plurality of spiral members arranged around the inner member.

71. Such as the catheter device of item 69, wherein the delivery configuration of the treatment component defines a delivery section of about 0.085 inches (2.16 mm).

72. The catheter device of item 69, wherein the distal end of the elongated shaft further includes a sharpened or inclined notch, which is sized and shaped to be sleeved with the proximal end of the control member.

73. Such as the catheter device of item 69, wherein the elongated shaft includes a first lumen and a second lumen, and wherein the control member is slidably disposed in the first lumen, and a plurality of energy transfer element leads are disposed in the first lumen Two lumen.

74. A catheter device for intravascular coordination of renal nerves, the catheter device comprising: an elongated shaft having a proximal portion and a distal portion, wherein the distal portion of the shaft is configured to be delivered to a human patient in the blood vessel Renal artery; a spiral structure placed at or adjacent to the distal portion of the elongated shaft, wherein the spiral structure is configured to change between a low-profile configuration and an expanded configuration; and at least two of the spiral structures Related energy transfer elements, wherein the energy transfer elements are configured to thermally inhibit the nerve connection along the renal artery, and the two energy transfer elements are fastened around the spiral structure, so that when in the unfolded configuration, The spiral structure and the energy transfer element define a transmission cross section of 0.085 inches (2.16 mm) or less than 0.085 inches (2.16 mm), and when in the expanded configuration, the energy transfer element of the spiral structure is configured to maintain contact with the renal artery Stable contact with the wall.

75. For example, the catheter device of item 74 further includes a control member that can move relative to the spiral structure to change the spiral structure between a low-profile configuration and an expanded configuration.

76. The catheter device of item 74, wherein the control member defines a central lumen, and wherein the central lumen is configured to receive a guide wire so that the spiral structure is positioned at a target location in the renal artery of the patient.

77. The catheter device of item 74 further includes a delivery sheath that at least partially surrounds the spiral structure in a low-profile configuration.

78. The catheter device of item 74, wherein the elongated shaft includes a guidewire lumen, and wherein the catheter device further includes a guidewire positioned in the guidewire lumen and extending to the treatment site in the renal artery.

79. Such as the catheter device of item 74, wherein the spiral structure includes a braided cable.

80. The catheter device of item 74, wherein the spiral structure includes a tubular support structure with a central lumen.

81. The catheter device of item 74, wherein the spiral structure includes a conductive material, and wherein the conductive material includes a part of an energy transfer element.

82. Such as the catheter device of item 81, wherein the conductive material is only partially covered by an electrically insulating material.

83. A catheter device comprising: an elongated shaft including an outer shaft and an inner shaft, wherein the elongated shaft has a proximal portion and a distal portion, and wherein the distal portion of the elongated shaft is configured to be in a blood vessel A renal artery delivered to a human patient; a treatment segment located at the distal portion of the elongated shaft, wherein the treatment segment extends between the distal end of the outer shaft and the distal end of the inner shaft, and wherein the treatment The distal end of the section is slidably coupled to the distal end of the inner shaft via a double-lumen sleeve; a plurality of energy transfer elements carried by the treatment section; and a preformed section coupled to the treatment section, wherein the The pre-formed section is configured to give a shape to the treatment section, thereby changing the self-straightening delivery configuration of the treatment section to an expanded configuration to place the energy delivery element in contact with the tissue at the treatment site.

84. Such as the catheter device of item 83, wherein the treatment section further includes an insulator disposed between the energy transfer element and the pre-formed section to electrically isolate the energy transfer element from the pre-formed section, and wherein the insulation system is configured to allow heat energy to be transferred in the energy The material transferred between the element and the shape memory component is formed.

85. Such as the catheter device of item 83, wherein the insulation system is formed of a thermoplastic material mixed with a ceramic filler.

86. The catheter device of item 83, wherein: the energy transfer elements are electrically connected to the energy source via at least one wire, the wire having a proximal end coupled to the energy source and a distal end coupled to the energy transfer element; and the at least One wire is a double-stranded wire, which includes a first copper conductor, a second copper or nickel conductor, and an insulator surrounding each of the first and second conductors to electrically isolate them from each other.

87. Such as the catheter device of item 86, wherein the treatment segment includes a series of strip electrodes.

88. Such as the catheter device of item 86, wherein the deployed configuration of the pre-formed section includes a spiral body.

89. Such as the catheter device of item 83, wherein the preformed section comprises Nitinol.

90. The catheter device of item 89, wherein the preformed section comprises a solid wire covered by a thin layer of insulating material.

91. Such as the catheter device of item 83, wherein the pre-formed section has a lumen sized to accommodate the guidewire passing therethrough.

92. Such as the catheter device of item 83, wherein the preformed section is a polymer.

93. The catheter device of item 83, wherein the pre-formed section comprises a shape memory material, which is configured to undergo a shape change at a shape change temperature between about 40°C and about 45°C.

94. The catheter device of item 83, further comprising an insulator coupled to the preformed section, wherein the insulator includes a tubular outer sheath having an insulator lumen.

95. Such as the catheter device of item 94, wherein the proximal end of the insulator is adhered to the inner surface of the outer sheath, and the distal end of the insulator is placed in a double-lumen sleeve.

96. Such as the catheter device of item 83, further comprising a guide wire shaft located in the double-lumen cannula.

97. A catheter device includes: a tubular elongated shaft defining at least one lumen; a treatment component disposed at the distal end of the elongated shaft, the treatment component defining a central axis and having a distal portion axially spaced apart along the central axis, and In the proximal portion, the treatment assembly includes: a plurality of energy transfer elements, including at least a first energy transfer element and a second energy transfer element; and a support member movable between a transfer configuration and an expanded configuration; a tubular shaft member, which Coupled to the distal portion of the treatment assembly and disposed along the central axis such that the axial movement of the first energy transfer element and the second energy transfer element of the tubular shaft member relative to the elongated shaft places the treatment assembly in a transfer configuration And one of the unfolding configurations; and the wire arranged in the tubular shaft member.

98. A catheter device for treating a human patient by removing renal nerves. The catheter device includes: a tubular elongated shaft; a treatment assembly having a central axis and a distal end portion and a proximal end portion axially spaced apart along the central axis, the treatment assembly It includes: a support structure that can be selectively changed between a transmission configuration and an unfolded configuration; a plurality of energy transmission elements carried by the support structure; and slidably received in the shaft and operatively coupled to the treatment The control member of the distal part of the assembly, wherein: the proximal movement of the control member places the treatment assembly in the deployed configuration; and the distal movement of the control member places the treatment assembly in the delivery configuration.

99. Such as the catheter device of item 98, wherein the treatment component includes six energy transfer elements.

100. The catheter device of item 98, wherein the tubular elongated shaft and the control member define a central lumen, and wherein the central lumen is configured to receive a guide wire to position the treatment component at a target in the patient's renal artery Location.

Figure 1 illustrates an intravascular renal nerve coordination system configured according to an embodiment of the technology of the present invention.

Figure 2 illustrates the use of a multi-electrode catheter device according to an embodiment of the technology of the present invention to coordinate renal nerves.

3A is a view of the distal portion of the catheter shaft and the multi-electrode array used in conjunction with the guiding catheter in the renal artery and in the delivery state (for example, low profile or folded configuration) according to an embodiment of the technology of the present invention .

FIG. 3B is a view of the distal portion of the catheter shaft and the multi-electrode array of FIG. 3A in an expanded state (for example, an extended configuration) in a renal artery according to an embodiment of the technology of the present invention.

Fig. 3C is a partial cross-sectional isometric view of a treatment device located in a renal artery and in an expanded state according to an embodiment of the technology of the present invention.

Fig. 4A is a plan view of a treatment component for a treatment device according to an embodiment of the technology of the present invention.

Figure 4B is an isometric view of the treatment component of Figure 4A.

4C is an end view of the spiral structure of FIG. 4B showing the angular offset of the energy transfer element in the treatment assembly according to an embodiment of the technology of the present invention.

Figure 4D is a side view of a blood vessel with damage that is expected to be formed by the treatment component and overlap circumferentially and longitudinally, but not along a spiral path.

Figures 5A to 5D illustrate various embodiments of energy delivery elements or devices that can be used with the treatment components of Figures 4A and 4B.

Figure 5E illustrates an embodiment of the treatment assembly in which the support structure is conductive and acts as an energy transfer element.

Figure 6A illustrates an embodiment of a treatment device that includes an elongated shaft with different mechanical and functional areas configured in accordance with an embodiment of the technology of the present invention.

Fig. 6B is a plan view of the slit pattern used in the treatment device of Fig. 6A.

FIG. 6C is a perspective view of the distal end portion of the treatment device of FIG. 6A located outside the patient's body and in a delivery state (for example, a low-profile or folded configuration) according to an embodiment of the technology of the present invention.

Fig. 6D is a perspective view of the treatment device of Fig. 6C located outside the patient's body and in an expanded state (e.g., an extended configuration).

Fig. 6E is a partial schematic plan view of the distal end region of the support structure of Fig. 6A in a generally spirally expanded state.

6F is a partial schematic plan view of the distal end portion of the treatment device in a polygonal expanded state according to another embodiment of the technology of the present invention.

6G is a plan view of the slit pattern used in the treatment device of FIG. 6A according to another embodiment of the technology of the present invention.

Fig. 6H is a perspective view of a supporting structure for a treatment device configured according to another embodiment of the technology of the present invention.

Fig. 6I is a plan view of an embodiment of the slit pattern used in the support structure of Fig. 6H.

Fig. 6J is a plan view of a slit pattern for a treatment device configured according to an embodiment of the technology of the present invention.

6K and 6L illustrate deformation slits of the support structure of FIG. 6H in an expanded state according to an embodiment of the technology of the present invention.

6M is a plan view of a slit pattern for a treatment device configured according to an embodiment of the technology of the present invention.

Fig. 6N is a plan view of a slit pattern for a treatment device configured according to an embodiment of the technology of the present invention.

Fig. 60 is a schematic diagram of a part of a treatment device located in a patient's renal artery, which has a supporting structure in an expanded state and including the slit pattern of Fig. 6N.

Fig. 7A is a plan view of a hole pattern for a treatment device configured according to an embodiment of the technology of the present invention.

Fig. 7B is a perspective view of the distal part of the treatment device located outside the patient's body, which includes a flexible region in a transmission state having the hole pattern of Fig. 7A.

FIG. 8A is an interrupted perspective view of a partial cross-section of a treatment device including the slit pattern of FIG. 6I configured in accordance with an embodiment of the technology of the present invention.

8B to 8D illustrate multiple configurations of the distal end of the support structure configured according to an embodiment of the technology of the present invention.

FIG. 9A illustrates a treatment device located outside the patient's body and configured in accordance with an embodiment of the technology of the present invention in an expanded state (for example, an extended configuration).

Figure 9B illustrates the treatment device of Figure 9A in a delivery state (e.g., low profile or folded configuration).

FIG. 9C illustrates another embodiment of a treatment device in an expanded state configured according to an embodiment of the technology of the present invention.

Fig. 9D illustrates another embodiment of the treatment device in the delivery state.

Figure 9E illustrates the device of Figure 9D in an expanded state.

Fig. 10A is an interrupted plan view of another treatment device located outside the patient's body and in a delivery state according to an embodiment of the technology of the present invention.

Fig. 10B is an enlarged detailed view of the distal portion of the device of Fig. 10A in an unfolded state.

Fig. 11A is an interrupted side view of a partial cross-section of a treatment device in a delivery state according to another embodiment of the technology of the present invention.

Fig. 11B is an interrupted side view of a partial cross-section of the treatment device of Fig. 11A in an expanded state.

11C is a longitudinal cross-sectional view of the handle assembly used in the device of FIG. 11A according to an embodiment of the technology of the present invention.

FIG. 11D is a longitudinal cross-sectional view of another handle assembly used in the device of FIG. 11A according to an embodiment of the technology of the present invention.

Fig. 12A is a side view of the distal end portion of the treatment device in a delivery state (for example, a low profile or folded configuration) located outside the patient's body according to an embodiment of the technology of the present invention.

Fig. 12B is a side view of the distal portion of the treatment device of Fig. 12B located outside the patient's body and in an expanded state (e.g., an extended configuration).

Fig. 13A is an interrupted side view of a partial cross-section of a treatment device in a delivery state according to an embodiment of the technology of the present invention.

Fig. 13B is an interrupted side view of a partial cross-section of the embodiment of Fig. 13A located in a renal artery and in a deployed state.

14A is a longitudinally interrupted cross-sectional view of another embodiment of a treatment device in a delivery state according to an embodiment of the technology of the present invention.

Fig. 14B is an interrupted side view of a partial cross-section of the embodiment of Fig. 14A located in a renal artery and in a deployed state.

14C is a longitudinal cross-sectional view of the distal end portion of another embodiment of a treatment device in a delivery state according to an embodiment of the technology of the present invention.

Fig. 14D is a longitudinally broken cross-sectional view of the embodiment of Fig. 14C in an expanded state in a renal artery.

15A is a longitudinal cross-sectional view of the distal end portion of another embodiment of a treatment device in a delivery state according to an embodiment of the technology of the present invention.

Fig. 15B is an interrupted side view of a partial cross-section of the embodiment of Fig. 15A located in a renal artery and in a deployed state.

Fig. 16A is a cross-sectional view of an embodiment of a treatment device located in a patient's renal artery and in a delivery state according to an embodiment of the technology of the present invention.

Fig. 16B is a cross-sectional view of an embodiment of a treatment device located in a patient's renal artery and in a deployed state according to an embodiment of the technology of the present invention.

Fig. 17A is an interrupted side view of a partial cross-section of a fast-exchange type distal portion of a treatment device configured in accordance with an embodiment of the technology of the present invention.

Fig. 17B is an interrupted side view of a partial cross-section of a fast-exchange type distal end portion of a treatment device in a delivery state according to an embodiment of the technology of the present invention.

Figure 17C is an interrupted side view of the distal portion of the treatment device of Figure 17B in a deployed state.

FIG. 17C is an interrupted side view of a partial cross-section of another embodiment of the rapid exchange type distal end of the treatment device according to an embodiment of the present technology.

FIG. 17D is an interrupted side view of a partial cross-section of another quick-exchange type distal portion of a treatment device according to an embodiment of the present technology.

Fig. 17E is an interrupted side view of a partial cross-section of a quick-swappable distal portion of another embodiment of a treatment device according to an embodiment of the technology of the present invention.

Figure 18 is a theoretical illustration of blood flow in the renal artery according to an embodiment of the technology of the present invention.

Figure 19A is a cross-sectional view of a treatment assembly including a fluid redirection element located in a renal artery according to an embodiment of the present technology.

19B is a side view of a support structure according to an embodiment of the present technology, which schematically illustrates a fluid redirecting element located outside the patient's body and in a transfer state (for example, a low profile or folded configuration).

Figure 20 is a graph depicting an energy transfer algorithm that can be used in conjunction with the system of Figure 1 according to an embodiment of the technology of the present invention.

21 and 22 are block diagrams illustrating the treatment evaluation algorithm according to an embodiment of the technology of the present invention.

FIG. 23 is a block diagram illustrating an algorithm for providing feedback to the operator when a high temperature condition occurs according to an embodiment of the technology of the present invention.

24 is a block diagram illustrating an algorithm for providing feedback to the operator when a high impedance condition occurs according to an embodiment of the technology of the present invention.

FIG. 25 is a block diagram illustrating an algorithm for providing feedback to the operator when a blood vessel height narrows occurs according to an embodiment of the technology of the present invention.

FIG. 26A is a block diagram illustrating an algorithm for providing feedback to the operator when an abnormal heart rate condition occurs according to an embodiment of the technology of the present invention.

FIG. 26B is a block diagram illustrating an algorithm for providing feedback to the operator when a low blood flow condition occurs according to an embodiment of the technology of the present invention.

27A and 27B are screen shots illustrating a representative generator display screen configured according to aspects of the technology of the present invention.

FIG. 28 illustrates a kit containing the package components of the system of FIG. 1 according to an embodiment of the technology of the present invention.

Figure 29 conceptually illustrates the way in which the sympathetic nervous system (SNS) and the brain communicate with the body through the SNS.

Figure 30 is an enlarged anatomical view of the nerves distributed in the left kidney to form the renal plexus surrounding the left renal artery.

Figures 31A and 31B respectively provide an anatomical diagram and a conceptual diagram of the human body, which depict the efferent and afferent connections between the brain and the kidney.

Figures 32A and 32B are anatomical diagrams of human arterial and venous vascular structures, respectively.