Electrosurgical sphincter treatment apparatus

Description: TECHNICAL FIELD [Detailed description of the invention]

【0001】

(Background of invention) (Interrelated application) This application is a partial continuation of U.S. Patent Application No. 08 / 731,372 filed October 11, 1996, and this application is U.S. Patent Application No. 08 / 319,373 filed October 6, 1994. This application is a partial continuation application of U.S. Patent Application No. 08 / 286,862 filed on August 4, 1994, and this application was filed on July 7, 1994. A partial continuation of U.S. Patent Application No. 08 / 272,162 filed, which is a partial continuation of U.S. Patent Application No. 08 / 265,459 filed on June 24, 1994. , Related to a simultaneously filed application entitled "GERD Treatment MFP and Method" (which has been confirmed as Attorney Case No. 14800-748), all of which was inventor Stuart D. Edwards. Made in the name of, all of these contents are incorporated herein by reference. [0002]

(Field of invention) The present invention generally relates to a device for treating the sphincter muscle, and more particularly to a device for treating the esophageal sphincter muscle. [0003]

(Explanation of related technology) Gastroesophageal reflux disease (GERD) is a common gastroesophageal disorder in which the contents of the stomach are expelled into the lower esophagus due to dysfunction of the lower esophageal sphincter (LES). Due to their high acidity, these contents can be esophageal injurious, resulting in a number of possible complications of varying medical severity. The incidence of GERD reported in the United States is around 10% of the population (Castell DO; Johnston BT: Gastroesophageal Reflux Disease: Current Strategies For Patient Management. Arch Fam Med, 5 (4): 221-7; (1996). April of the year)). [0004]

Acute symptoms of GERD include heartburn, lung damage and chest pain. In the chronic state, GERD causes the esophagus to develop ulceration or esophagitis, which can cause more severe complications (including esophageal obstruction, significant blood loss and esophageal perforation). Severe esophageal ulceration occurs in 20-30% of patients age 65 and older. In addition, GERD causes adenocarcinoma, or esophageal cancer, which has a faster increase in incidence than any other cancer (Reynolds JC: Influence Of Pathophysiology, Severity, And Cost On The Medical Management). Of Gastroesophageal Reflux Disease.Am J Health Syst Pharm, 53 (22 Suppl 3): S5 ~ 12 (November 15, 1996)). [0005]

One of the potential causes of GERD can be an abnormal electrical signal in the gastric LES or cardia. Such signals can cause a higher frequency of LES relaxation than normal, the acidic gastric contents can be repeatedly excreted into the esophagus, and can cause the above complications. Studies have shown that abnormal electrical signals in the stomach and intestines can cause reflux in these organs (Kelly KA et al .: Duodenal-gastric Reflux and Slowed Gastric Emptying by Electrical Pacing of the Canine). Duodenal Pacesetter Potential.Gastroenterology.1977 Mar; 72 (3): 429 ~ 433). In particular, medical studies have shown that sites of abnormal electrical activity or foci can carry these signals (Karlstrom LH et al .: Ectopic Jejunal Pacemakers and Entergastric Reflux after Roux). Gastrectomy: Effect Intestinal Pacing.Surgery.1989 September; 106 (3): 486 ~ 495). Similar abnormal electrical sites in the heart that cause myocardial contraction and exhibit life-threatening patterns or rhythm abnormalities can be identified, and as described in US Pat. No. 5,509,419, using mapping and excision devices, Being treated. However, there are no devices or associated medical procedures currently available for the treatment of electrical mapping and abnormal electrical sites in the LES and stomach as a means of treating GERD. [0006]

Current drug therapies for GERD include histamine receptor blockers that reduce gastric acid secretion, and other drugs that can completely block gastric acid. However, although pharmacological drugs can provide short-term relief, they do not address the root cause of LES dysfunction. [0007]

Surgical correction of GERD has an invasive procedure that requires percutaneous introduction of the device into the abdomen. One such procedure, Nissen fundus wrinkle plasty, involves building a new "valve" to support the LES by wrapping the fundus around the lower esophagus. Although successful, this surgery is a procedure for abdominal incision with the usual risks of abdominal surgery, including postoperative infection, hernia formation at the surgical site, internal bleeding and perforation of the esophagus or cardia. In fact, in the last 10 years, a study of 344 patients reported a morbidity rate of 17% and a mortality rate of 1% for this procedure (Urschel, JD: Complications Of Antireflux Surgery, Am J). Surg 166 (1): 68 ~ 70; (July 1993)). This complication rate raises both medical costs and the recovery phase of this procedure and cannot be applied to certain patient populations (eg, elderly and non-immunized). [0008]

Laparoscopic Nissen fundus folds have been developed through efforts to perform Nissen fundus folds with less invasive techniques. Laparoscopic Nissen fundus wrinkle plasty is performed by Dallemagne et al. (Surgical Laparoscopy and Endoscopy, Vol.1, No.3, (1991), pp. 138-43) and Hindler et al. (Surgical Laparoscopy and Endoscopy, Vol.2, No. 3, (1992), pp. 265-272), except that the surgical operation is performed by multiple surgical cannulas introduced with laparoscopic needles inserted in various parts of the abdomen. , Nissen Includes virtually the same steps as fundus laparoscopic surgery. [0009]

Other attempts to perform fundic fold plasty with a less invasive technique are reported in US Pat. No. 5,088,979. In this procedure, an invagination device with multiple needles is orally inserted into the esophagus with the needles in the retracted position. These needles are stretched to engage the esophagus and wrap around the tied esophagus beyond the gastroesophageal junction. A remotely operated staple device, which is transdermally introduced through an operating channel in the gastric wall, is activated to enclose the invaginated gastroesophageal junction with the involuted gastric wall. To stay in. [0010]

Yet another attempt to perform fundic fold plasty with a less invasive technique is reported in US Pat. No. 5,676,674. In this procedure, an incision is made by a jaw-like device and fastening of the incised gastroesophageal junction to the fundus is performed by an oral method using a remotely operated fastening device and is performed in the abdomen. Eliminates the need for incisions. However, this procedure still traumas the LES, and there is a postoperative risk of gastroesophageal leakage, infection and foreign body reaction, and the other two sequelae are foreign bodies (eg, surgical staples) transplanted into the body. Sometimes it happens. [0011]

Although the methods reported above are less invasive than open Nissen fundus fold plasty, some still involve making an incision in the abdomen and therefore the high morbidity associated with abdominal surgery. Includes risk of death and risk of death and recovery period. Others pose a high risk of infection associated with placing foreign bodies in the body. All procedures involve trauma to the LES and also include the risk of leaks at the newly created gastroesophageal junction. [0012]

In addition to LES, there are other sphincter muscles in the body that, if not functioning properly, can cause a disease state or otherwise adversely affect the patient's lifestyle. Reduced muscle tension or otherwise abnormal relaxation of the sphincter muscles can lead to loosening disease states (including, but not limited to, urinary incontinence). [0013]

There is a need to provide equipment that treats the sphincter and reduces the frequency of sphincter relaxation. In addition, there is a need for devices that produce controlled cell necrosis in the sphincter tissue beneath the sphincter lamina propria. In addition, there is a need for devices that form cell necrosis in the sphincter and minimize damage to the mucosal layer of the sphincter. Others require a device that can control trauma to the sphincter without causing a permanent impairment of the sphincter's ability to achieve physiologically normal occlusion. In addition, there is a need for an instrument that causes the sphincter to tighten without permanently damaging the anatomy close to the sphincter. In addition, there is a need for devices that cause cell necrosis in the lower esophageal sphincter and reduce the frequency of regurgitation of gastric contents into the esophagus. [0014]

(Gist of the invention) Therefore, it is an object of the present invention to provide an apparatus for treating the sphincter muscle to reduce the frequency of relaxation of the sphincter muscle. [0015]

Another object of the present invention is to provide an instrument that causes controlled cell necrosis in the sphincter tissue beneath the sphincter lamina propria. [0016]

Yet another object of the present invention is to provide an apparatus that causes cell necrosis in the sphincter muscle and minimizes damage to the lamina propria of the sphincter muscle. [0017]

Yet another object of the present invention is to provide an instrument that results in controllable trauma at the sphincter without causing a permanent impairment of the sphincter's ability to achieve physiologically normal occlusion. [0018]

Yet another object of the present invention is to provide an instrument that causes sphincter tightening without permanently damaging the anatomical structure close to the sphincter. [0019]

Another object of the present invention is to provide an apparatus that causes cell necrosis in the lower esophageal sphincter to reduce the frequency of regurgitation of gastric contents into the esophagus. [0020]

Yet another object of the present invention is to provide an apparatus for reducing the frequency and severity of gastroesophageal reflux phenomenon. [0021] [0021]

These and other purposes of the present invention are provided in sphincter treatment devices. These instruments include an energy delivery device introduction member that includes a plurality of arms. Each arm has a distal end and a proximal end. The distal ends of these arms are connected as the proximal ends of these arms are connected. This energy delivery device introduction member is configured to be introduced into the sphincter in the undeployed state and then expanded into the deployed state to at least partially expand the sphincter. A plurality of energy delivery devices are connected to the energy delivery device introduction member. At least a portion of these plurality of energy delivery devices can be controlledly introduced from the energy delivery device introduction member to the sphincter muscle. [0022]

In another embodiment, the sphincter treatment device has an expandable basket structure. The expandable basket structure includes a first arm with distal and proximal parts, a second arm with distal and proximal parts, and a third arm with distal and proximal parts. Be prepared. The proximal parts of the first, second and third arms are connected to each other. The distal portions of the first, second and third arms are connected to each other. The expanded basket structure has an undeployed state and an expanded state, in which the first, second and third arms are extended apart from each other. A first energy delivery device is connected to this first arm, which comprises a distal portion that can controlfully advance from this first arm to the sphincter. [0023]

(Detailed explanation) Now referring to FIGS. 1 and 2, one of the sphincter treatment instruments 10 used to deliver energy to the treatment site 12 to cause trauma 14 in the sphincter 16 (eg, the lower esophageal sphincter (LES)). An embodiment comprises a flexible elongated shaft 18 (also referred to as a shaft 18), which is coupled to an expansion device 20 and then to one or more energy delivery devices 22. .. The energy delivery device 22 is configured to be connected to a power source 24. The expansion device 20 is configured to be displaceable in the sphincter 16 (eg, LES) or adjacent anatomical structure (eg, gastric cardia). The expansion device 20 is further configured to facilitate the placement of the energy delivery device 22 to a selectable depth in the sphincter wall 26 or adjacent anatomy. The expansion device 20 has a central longitudinal axis 28 and is substantially movable along it between the contraction position and the expansion position. This can be achieved by a pawl mechanism, as is known to those skilled in the art. At least a portion of the sphincter treatment device 10 can be sufficiently radiopaque to be visible under fluoroscopy and / or echogenic enough to be visible under ultrasonography. Can be. Also, as described herein, the sphincter treatment device 10 can be provided with visualization performance, including a viewing scope, a magnifying eyepiece, an optical fiber, video imaging, and the like. However, it is not limited to these. [0024]

With reference to FIG. 2, the shaft 18 is configured to be coupled to the expansion device 20 and has sufficient length to place the expansion device 20 in the LES and / or stomach using the oral method. .. Typical lengths relative to shaft 18 include, but are not limited to, the range of 40-180 cm. In various embodiments, the shaft 18 is flexible, articulated, and maneuverable, including optical fibers (lighting fiber and imaging fibers, liquid and gas paths, and sensor and electronic cables. ) Can be contained. In one embodiment, the shaft 18 can be a multiluminal catheter, as is well known to those of skill in the art. In another embodiment, the introduction member 21 (also referred to as the introducer) is used to introduce the sphincter treatment device 10 into the LES. The introducer 21 can also function as a sheath for the expansion device 20 to remain undeployed (ie, contracted) during introduction into the LES. In various embodiments, the introducer 21 is flexible, articulated, and maneuverable, and contains a continuous lumen of sufficient diameter to allow advancement of the sphincter treatment device 10. The typical diameter of the introducer 21 is 0.1 to 2 inches, while the typical length is 40 to 180 cm. Suitable materials for the introducer 21 include coil reinforced plastic piping, as is well known to those skilled in the art. [0025]

Now, referring to FIG. 3, the flexible elongated shaft 18 has a circular cross section and has proximal and distal ends (also referred to as ends) 30 and 32. The shaft 18 can also be connected to the proximal fitting 34 (also called the handle) at its proximal end 32, and the physician operates the sphincter treatment instrument 10 to reach the treatment site 12. Can be used for. The shaft 18 may have one or more cavities 36, which extend to the full length of the shaft 18 or a portion from the shaft proximal end 30 to the shaft distal end 32. Lumen 36 can be used as a path for catheters, guide wires, pull wires, insulated wires and cables, fluids and optical fibers. The lumen 36 is connected and / or accessed by a connection 38 on or adjacent to the proximal fitting 34. Connection 38 may include luer locks, lemo connectors, swages and other mechanical variants well known to those of skill in the art. Connection 38 also includes optical / video connections, which allow optical and electronic connections between fiber optics and / or visual scopes and illumination sources, eyepieces and video monitors. Can be done. In various embodiments, the shaft 18 may stop at the proximal end 40 of the expansion device 20 or extend to or beyond the distal end 42 of the expansion device 20. Suitable materials for the shaft 18 include, but are not limited to, polyethylene, polyurethane, and other medical materials known to those of skill in the art. [0026]

Now referring to FIG. 4, in one embodiment of the invention, the expansion device 20 comprises one or more elongated arms 44, which are coupled at their proximal and distal ends 48. To form the basket assembly 50. The proximal arm end 46 is mounted on a support structure, which can be the distal end 32 of the shaft 18, or the proximal cap 51. Similarly, the distal arm end 48 is also attached to a support structure that can be the basket cap 52 of the shaft 18. The mounted arm 44 can form a variety of geometric shapes, including, but not limited to, curves, rectangles, trapezoids and triangles. The arm 44 can have a variety of cross-sectional geometries, including, but not limited to, circular, rectangular and crescent shapes. Also, the number of arms 44 is sufficient (two or more) to prevent hernia formation of the sphincter wall 26 in the space 53 between the arms 44, while allowing treatment with the sphincter treatment device 10. Has sufficient spring force (0.01-0.5 lbs.force) to collectively apply sufficient force to the sphincter wall 26 to open and eliminate the wrinkles of the sphincter muscle 16. Suitable materials for the arm 44 include, but are not limited to, spring steel, stainless steel, and superelastic shape memory metals well known to those skilled in the art (eg, nitinol or wire reinforced plastic piping). [0027]

With reference to FIG. 5A, the arm 44 may have an outwardly curved shape memory to extend this basket assembly and engage with the sphincter wall 26, and the amount of curvature (ie, warp 54) is the basket. You can choose from a range of 0 to 2 inches from the longitudinal axis 28 of assembly 50. In the case of the curved arm 44', the expansion arms 44' are curved and symmetrically spaced apart. [0028]

In another embodiment shown in FIG. 5B, the expandable member 55, which can be a balloon, is connected to the inside or outside of the basket assembly 50. The balloon 55 is also coupled and dilated by the lumen 36 using a gas or liquid. In various other embodiments (not shown), the arms 44 can be placed asymmetrically spaced and / or in arcs less than 360 °. Also, the arm 44 may be preformed at the time of manufacture or may be molded by a physician. [0029]

Now, referring to FIG. 6A, the arm 44 can also be solid or hollow, with a continuous lumen 58 that can be connected to the shaft lumen 36. These connected cavities provide a path for delivery of the fluid or electrode delivery member 60 from the shaft 18 to any point on the basket assembly 50. In various embodiments, the electrode delivery member 60 can be an insulating wire, an insulating guide wire, a plastic coated stainless steel hypotube with an internal wire or a plastic catheter with an internal wire, all of which are known to those skilled in the art. As shown in FIG. 6B, the arm 44 may also have a partially open channel 62, which is also referred to as a track 62, which serves as a guide track for the electrode delivery member 60. Referencing back to FIG. 6A, the arm 44 may have one or more openings 64 at any point along its length, thereby delivering energy within or within the sphincter wall 26. The device 22 can be controlled and arranged. Now referring to FIG. 7, the opening 64 may have a tapered portion 66 or a stepped portion 68 in all or part of its length, which to the sphincter wall 26. It is used to control the penetration depth of the energy delivery device 22 of the. With reference back to FIG. 6A, the opening 64, in combination with the arm cavity 58 and the shaft cavity 36, delivers the coolant 70 or electrolyte 72 to the treatment site 12, as described herein. Can be used for. In addition, the arm 44 is also made of a suitable material, which is not shown in the drawings and is a radiopaque or echogenic marker or trace that is spaced apart in multiple longitudinal directions. ) Can be carried and the basket assembly 50 can be seen via fluoroscopy or ultrasonography. Suitable radiation opaque materials include platinum or gold, while suitable echogenic materials include US Pat. Nos. 5,688,490 and 5,205, As described in No. 287, gas-filled fine particles can be mentioned. The arm 44 can also be color coded to facilitate their identification via visual medical imaging methods and devices (eg, endoscopic methods) well known to those of skill in the art. [0030]

In another embodiment of the invention, the support member 74 is mounted on two or more arms 44. The support member 74, also referred to as the strut, can be attached to the arm 44 along the curvature of the basket assembly 50, as shown in FIG. The opening 64 can extend through the radial support member 74 at one or more locations. The radial support member 74 serves the following functions: i) facilitates the opening and elimination of wrinkles in the sphincter muscle 16; ii) enhances contact between the opening 64 and the sphincter muscle wall 26; and iii) the arm 44 Prevent or reduce the tendency to bundle. The cross-sectional geometry of the radial support member 74 can be rectangular or circular, but other geometric shapes have been found to be suitable as well. [0031]

In one embodiment shown in FIG. 9, the arm 44 is mounted on a basket cap 52, which then freely moves over the shaft 18, but is stopped distally by the shaft cap 78. One or more pullwires 80 are attached to the basket cap 52 and to the mobile fitting 82 at the proximal fitting 34 of the sphincter treatment device 10. When the pullwire 80 is pulled back with the mobile fitting 82, the warp 54 of the basket assembly 50 rises to 54', which increases the contact force and amount applied to the sphincter wall 26 or adjacent structures by the basket assembly 50. The basket assembly 50 can also be deflected from side to side by the deflection mechanism 80. This allows the physician to remotely point and maneuver this basket assembly within the body. In one embodiment shown in FIG. 10, the deflection mechanism 84 comprises a second pull wire 80', which is mounted on a shaft cap 78 and on a movable slide 86 integrated with a proximal fitting 34. Is also installed. [0032]

Now looking at the discussion of energy delivery, suitable power sources 24 and energy delivery devices 22 that can be used in one or more embodiments of the present invention include: (i) High Frequency (RF). RF source connected to electrodes; (ii) coherent light source connected to optical fiber; (iii) non-coherent light source connected to optical fiber; (iv) heating fluid, which is to accept the heating fluid. It is connected to a catheter with a configured closed channel; (v) a heating fluid, which is connected to a catheter with an opening channel configured to receive the heating fluid; (vi). ) Cooling fluid, which is coupled to a catheter with a closed channel configured to receive the cooling fluid; (vii) Cooling fluid, which is to receive the cooling fluid It is connected to a catheter with an open channel configured in; (viii) cryogenic fluid; (ix) resistance heating source; (x) microwave source, which provides energy from 915MHz to 2.45GHz. , And is coupled to a microwave antenna; (xi) is an ultrasonic output source, which is coupled to an ultrasonic emitter, where this ultrasonic output source is in the range of 300 KHz to 3 GHz. Produces energy; or (xii) microwave source. To simplify the discussion of the rest of the application, the power source used is an RF power source, and the energy delivery device 22 is one or more RF electrodes 88, which is also described as electrode 88. To. However, all of the other power and energy delivery devices mentioned herein are equally applicable to the sphincter treatment device 10. [0033]

For RF energy, the RF electrode 88, along with the ground pad electrode, can be operated in either bipolar or unipolar mode. The unipolar RF energy delivery mode uses a single electrode 88 in combination with an indifferent electrode patch, which is applied to the body to form other electrical contacts and complete the electrical circuit. To. Bipolar operation is possible when using two or more electrodes 88. Multiple electrodes 88 may be used. These electrodes can be cooled as described herein. The electrode 88 can be attached to the electrode delivery member 60 by using a soldering method well known to those skilled in the art. Suitable solders include the Megabond Solder supplied by the Megatrode Corporation (Milwaukee, Wisconsin). [0034]

Suitable electrolytes 72 include saline, calcium salt solutions, potassium salt solutions and the like. The electrolyte 72 increases the conductivity of the target tissue at the treatment site 12. When a highly conductive fluid (eg, electrolyte 72) is injected into a tissue, the electrical resistance of the injected tissue is low and then the conductivity of the injected tissue is high. As a result, the tissue surrounding the electrode 88 has little tendency to dry (as described herein, which increases the electrical resistance of the tissue), and this tissue is very capable of carrying RF energy. Referring to FIG. 11, the tissue zone injected with a large amount of concentrated electrolyte 72 can be conductive enough to actually act as a reinforcing electrode 88'. The effect of the reinforced electrode 88'is to increase the amount of current that can be conducted to the treatment site 12 so that a much larger volume of tissue can be heated over a period of time. [0035]

Also, when this energy source is RF, the power source 24, which is now referred to here as the RF energy source 24, may have multiple channels and deliver the modulated output to each electrode 88 separately. This happens when more energy is delivered to the higher conductive zone, with less heating around the electrode 88 placed in the less conductive tissue. Only happen). If the tissue hydration level or blood infusion rate in the tissue is non-uniform, a single channel RF energy source 24 can be used to provide an output that produces a relatively uniform trauma 14. .. [0036]

The electrode 88 can have various shapes and sizes. Possible shapes include, but are not limited to, circular, rectangular, conical and pyramidal. The electrode surface can be smooth or textured and can be concave or convex. The conductive surface area of the electrode 88 is 0.1 mm.²~ 100c m²Can be in the range of. Other contours and surface areas can be equally suitable I understand. In one embodiment, the electrode 88 may be needle-shaped with sufficient sharpness and length to penetrate smooth muscle, sphincter 16 or other anatomical structures of the esophageal wall. In this embodiment shown in FIGS. 12 and 13, the needle electrode 90 is mounted on the arm 44 and has an insulating layer 92 covering an insulating segment 94 other than the exposed segment 95. For the purposes of this disclosure, the insulator or insulating layer is a barrier to either thermal energy flow, RF energy flow or electrical energy flow. The insulation segment 94 is long enough to extend to the sphincter wall 26 and minimize RF energy transfer to the protection site 97 near or adjacent to the insulation segment 94 (see Figure 13). Typical lengths relative to the insulation segment 94 include, but are not limited to, 1 to 4 mm. Suitable materials for the needle electrode 90 include, but are not limited to, 304 stainless steel and other stainless steels known to those of skill in the art. Suitable materials for the insulating layer 92 include, but are not limited to, polyimide and polyamide. [0037]

During the introduction of the sphincter treatment device 10, the basket assembly 50 is in a contracted state. Once the sphincter treatment instrument 10 is correctly placed at the treatment site 12, the needle electrode 90 is unfolded by the expansion of the basket assembly 50, resulting in the needle electrode 90 projecting into the smooth muscle tissue of the sphincter wall 26 ( See Figure 14). Needle penetration depth can be selected in the range 0.5-5 mm, and the movable fitting 82 is aligned to change the warp 54 of the arm 44 in constant increments that can be selectable in the range 0.1-4 mm. It is achieved by doing. The needle electrode 90 is connected to the power supply 24 via an insulating wire 60. [0038]

In another embodiment of the sphincter treatment device 10 shown in FIG. 15, the needle electrode 90 is advanced from the opening 64 in the basket arm 44 to the smooth muscle of the esophageal wall or another sphincter 16. In this case, the needle electrode 90 is connected to the RF power supply 24 by the electrode delivery member 60. In this embodiment, the depth of needle penetration can be selected by means of a stepped portion 66 or a tapered portion 68 located at the opening 64. Referring to FIG. 16, the opening 64 and the needle electrode 90 have a penetration angle of the needle electrode 90 into the sphincter wall 26 during the time the needle electrode 90 is being inserted into the sphincter wall 26 (which is also shown in FIG. 16). Occurrence angle 96 (emergence) It is configured so that there is no tearing or unwanted trauma to the sphincter wall tissue so that (also called angle) remains sufficiently constant. This is facilitated by selecting the following parameters and criteria: i) Appearance angle of opening 64 96 (which can vary from 1 to 90 °); ii) Curved portion of opening 64 100 arc radius 98 (which can vary from 0.001 to 2 inches); iii) Amount of clearance between the opening inner diameter 102 and the needle electrode outer diameter 104 (this can be between 0.001 and 0.1 ); And iv) Use of a lubricious coating on the electrode delivery member 60 (eg, Teflon® or other coatings known to those of skill in the art). Also, in this embodiment, the insulating segment 94 may be in the form of a sleeve that can be adjustablely placed outside the electrode 90. [0039]

In another alternative embodiment shown in FIG. 17, the electrode delivery device 60 fitted with the needle electrode 90 can be placed at the distal shaft end 32, exiting the lumen 36 and in contact with the sphincter wall 26. This process can be facilitated by using a hollow guide member 101 known to those of skill in the art as a guide catheter through which the electrode delivery member 60 is advanced. The guide catheter 101 may also include a stepped portion 66 or a tapered portion 68 at its distal end to control the penetration depth of the needle electrode 90 into the sphincter wall 26. [0040]

The RF energy flowing through the tissue causes heating of this tissue due to the absorption of this RF energy into this tissue, and also causes ohm heating due to the electrical resistance of this tissue. This heating can cause damage to the affected cells and can be substantially sufficient to cause cell death (a phenomenon also known as cell necrosis). To simplify the rest of the discussion of the present application, cytotoxicity includes, from the effects of all cells resulting from energy delivery from electrode 88 to cell necrosis (including). Cytotoxicity can be achieved as a relatively simple medical procedure using local anesthesia. In one embodiment, cytotoxicity progresses to a depth of approximately 1-4 mm from the surface of the mucosal layer of the sphincter 16 or the surface of the adjacent anatomy. [0041]

Now referring to FIGS. 18A, 18B and 18C, the electrodes 88 and / or openings 64 vary along the expansion device 20 or basket assembly 50 to produce the desired placement and pattern of trauma 14. It can be distributed in a pattern. Typical electrode and aperture distribution patterns include, but are not limited to, radial distribution 105 (see FIG. 18A) or longitudinal distribution 106 (see FIG. 18B). It turns out that other patterns and geometries for the placement of electrodes and openings (eg, spiral distribution 108 (see Figure 18C)) may also be suitable. These electrodes can be cooled as described below. [0042]

FIG. 19 is a flowchart illustrating one embodiment of the procedure using the sphincter treatment device 10. In this embodiment, the sphincter treatment device 10 is first introduced into the esophagus under local anesthesia. The sphincter treatment device 10 is disclosed alone or endoscopically (not shown) (eg, US Pat. Nos. 5,448,990 and 5,275,608, the contents of which are incorporated herein by reference). It can be introduced into the esophagus through the lumen of the esophagus or through a similar esophageal access device known to those of skill in the art. The basket assembly 50 is extended as described herein. This helps to temporarily extend the LES to fully eliminate some or all of the LES wrinkles. In an alternative embodiment, esophageal dilation and subsequent LES wrinkle elimination is performed by gas injection of the esophagus using a gas introduced into the esophagus through a shaft lumen 36 or an endoscope or similar esophageal access device described above. ) To achieve this. Once the procedure is complete, the basket assembly 50 returns to its pre-deployed (ie, contracted) state, and the sphincter procedure device 10 is withdrawn from the esophagus. As a result, LES generally returns to its pre-treatment state and diameter. It can be seen that the above procedure, in whole or in part, can be applied to the treatment of other sphincters in the body. [0043]

The diagnostic steps of this procedure can be accomplished using a variety of diagnostic methods, including, but not limited to: (i) endoscopy or other vision inserted into the esophagus. Visualization of the inner surface of the esophagus with a device; (ii) Visualization of the internal morphology of the esophageal wall using ultrasonography to establish a baseline for the tissue to be treated; (iii) Esophageal mucosal layer and sphincter treatment device Impedance measurements to determine conductivity between 10; and (iv) LES potential at various times, which may include events such as depolarization, contraction and repolarization of LES smooth muscle tissue. Measurement and surface mapping. This latter technique acts as a focal point 107 or pathway 109 for LES or adjacent anatomical target treatment sites 12 (these are LES smooth muscle abnormalities or improper polarization and relaxation). ) Is done (see Figure 20). [0044]

During the treatment phase of this procedure, the delivery of energy to the treatment site 12 can be performed manually or in combination under feedback control. Feedback control (described herein) allows the sphincter treatment device 10 to be placed and held in the esophagus during the procedure with minimal physician care. Electrodes 88 can be multiplexed to treat all target treatment sites 12 or only a portion thereof. Feedback can be included, which is achieved by using one or more of the following methods: (i) visualization; (ii) impedance measurement; (iii) ultrasonography; (iv) temperature measurement; and (v) Measurement of sphincter contraction force by pressure detection. This feedback mechanism allows selected on / off switching of different electrodes 88 in the desired pattern, which can be continuous from one electrode 88 to adjacent electrodes 88 or active between non-adjacent electrodes 88. Can be done. The individual electrodes 88 are multiplexed and volume controlled by the control device. [0045]

The area and magnitude of cytotoxicity in the LES or sphincter 16 can vary. However, sufficient for the target treatment site 12 so that tissue temperatures in the range 55-95 ° C can be achieved and trauma 14 can occur at depths in the range 1-4 mm from the inner surface of the LES or sphincter wall 26. It is desirable to deliver energy. Typical energy delivered to the esophageal wall includes, but is not limited to, a range between 100 joules and 50,000 joules per electrode 88. Also, the resulting trauma 14 is of sufficient scale and area to cause infiltration of the trauma 14 by fibroblasts 110, myofibroblasts 112, macrophages 114 and other cells involved in the tissue healing process. It is desirable to deliver sufficient energy to have (see Figure 21). As shown in FIG. 22, these cells cause contraction of tissue around trauma 14 to reduce its volume or alter biomechanical properties at trauma 14, resulting in LES or sphincter 16 Tighten. These changes are reflected in the deformed trauma 14'shown in Figure 19B. The diameter of the trauma 14 can vary between 0.1 and 4 mm. Trauma 14 is preferably less than 4 mm in diameter to reduce the risk of thermal damage to the mucosal layer. In one embodiment, a 2 mm diameter trauma 14 in the center of the smooth muscle wall provides a 1 mm buffer zone to prevent damage to the mucosa, submucosa and adventitia, but still the smooth muscle wall thickness. Approximately 50% of the cells allow cell infiltration and subsequent tightening of the sphincter muscle (see Figure 23). [0046]

From a diagnostic point of view, it is desirable to image the inner surface and wall of the LES or other sphincter 16 including the size and location of the trauma 14 created. It is desirable to create a map of these structures that can be input to the controller and used to direct the delivery of energy to the treatment site. With reference to FIG. 24, this can be achieved by using ultrasonography (known procedure), which is coupled with one or more ultrasound transducers 118 placed on the expansion device 20 or basket assembly 50. Includes the use of ultrasonic power sources 116. The output is related to the ultrasonic power supply 116. [0047]

Each ultrasonic transducer 118 can include a piezoelectric crystal 120 mounted on a backing 122, which is then mounted on the expansion device 20 or basket assembly 50. The ultrasonic lens 124 is made on the electrically insulating material 126, but is mounted on the piezoelectric crystal 120. The piezoelectric crystal 120 is connected to the ultrasonic power supply 116 by an electric wire 128. Each ultrasonic converter 118 transfers ultrasonic energy to adjacent tissues. The ultrasound transducer 118 may be in the form of an imaging probe (eg, Model 21362 manufactured and sold by the Hewlett Packard Company (Palo Alto, California)). In one embodiment, the two ultrasound transducers 118 are placed on opposite sides of the expansion device 20 or basket assembly 50 to create an image depicting the size and location of the trauma 14 at the selected sphincter 16. .. [0048]

Trauma 14 is preferably located in the smooth muscle layer of the selected sphincter 16 at a depth ranging from 1 to 4 mm from the inner surface of the sphincter wall 26. However, trauma 14 can be both numbered and repositioned within the sphincter wall 26. It may be desirable to produce multiple trauma 14 patterns within the sphincter smooth muscle tissue to obtain the selected tightness of the LES or other sphincter 16. Typical trauma patterns shown in FIGS. 25A-D include, but are not limited to: (i) concentric trauma 14, all of which are at a constant depth in the smooth muscle layer. Now, they are uniformly spaced along the radial axis of the sphincter 16; (ii) wavy or folded circular trauma 14, which differ in the smooth muscle layer. At depth, they are evenly spaced along the radial axis of the sphincter 16; (iii) at smooth muscle, randomly distributed trauma 14 at different depths, these. Are evenly spaced in the radial direction; and (iv) eccentric pattern trauma in one or more radial positions on the smooth muscle wall 14. Therefore, the depth of the RF and thermal energy intrusive sphincter 16 can be controlled and selectable. The selective application of energy to the sphincter 16 can be a uniform penetration of RF energy into the entire target treatment site 12, a portion thereof, or a different amount of RF energy depending on the condition of the sphincter 16. Can be applied to different parts of the body. If desired, the area of the cytotoxicity can be substantially the same for each treatment case. [0049]

With reference to FIG. 26, it is desired to cool all or part of the area near the electrode-tissue interface 130 before, during and after delivery of energy to reduce the extent and area of cell damage. Can be rare. Specifically, the use of cooling preserves the mucosal layer of the sphincter wall 26 and protects or otherwise reduces the degree of cell damage to the cooled zone 132 in the vicinity of trauma 14. Let me. Now, referring to FIG. 27, this is the opening 64, which is in fluid communication to the shaft cavity 36, ie, then the fluid reservoir 134 and the control unit 136 (its operation of which is described herein). This can be achieved by using a coolant 70, which is described in the document and is delivered by (controlling the delivery of the fluid) and in fluid communication). [0050]

Similarly, cooling all or part of the electrode 88 may also be desired. Rapid delivery of heat through electrode 88 can result in the accumulation of charred biological material on electrode 88 (due to contact with tissue and fluid (eg, blood)), which is from electrode 88 to adjacent tissue. It obstructs the flow of both thermal and electrical energy and causes an increase in electrical impedance beyond the cutoff value set by the RF power supply 24. A similar situation can result from the drying of the tissue adjacent to the electrode 88. Cooling of the power source 88 can be achieved by the coolant 70 delivered by the opening 64 as described above. Now, referring to FIG. 28, the electrode 88 may also be cooled via the fluid channel 138 at the electrode 88, which fluid contacts the fluid reservoir 134 and the control unit 136. [0051]

As shown in FIG. 29, one or more sensors 140 may be placed adjacent to or above the electrode 88 to sense the temperature of the sphincter tissue at the treatment site 12. More specifically, the sensor 140 allows accurate determination of the surface temperature of the sphincter wall 26 at the electrode-tissue interface 130. This information can be used to control the delivery of both energy and coolant 70 to the inner surface of the sphincter wall 26. In various embodiments, the sensor 140 can be placed in any position on the expansion device 20 or basket assembly 50. Suitable sensors that can be used with the sensor 140 include thermocouples, optical fibers, resistive wires, thermocouple IR detectors and the like. Suitable thermocouples for the sensor 140 include T-type, J-type, E-type and K-type with copper constantene (these are well known to those skilled in the art). [0052]

The temperature data from the sensor 140 is fed back to the control unit 136 by an algorithm stored in the microprocessor memory of the control unit 136. An electrically controlled micropump (not shown) to deliver fluid through these fluid lines at an appropriate flow rate and duration to provide a controlled temperature at the electrode-tissue interface 130. , Instructions are sent (see Figure 27). [0053]

The reservoir of the control unit 136 may have the ability to control the temperature of the coolant 70 by either cooling or heating this fluid. Alternatively, a sufficiently large fluid reservoir 134 may be used, where the coolant 70 is introduced at or near normal body temperature. Sufficient control of this tissue temperature can be achieved using the thermally isolated reservoir 142 without the need for cooling or heating of the coolant 70. The flow of coolant 70 is controlled by control unit 136 or other feedback control system (described herein) to provide temperature control at the electrical-tissue interface 130. [0054]

A second diagnostic step can be included after this procedure is complete. This provides an indicator of the success of the LES tightening procedure and whether a second stage procedure should be performed on all or part of the esophagus at the current or later stage. This second diagnostic step is achieved by one or more of the following methods: (i) visualization; (ii) measuring impedance; (iii) ultrasonography; (iv) temperature measurement; Or (v) Measurement of LES tension and contraction force by ultrasound. [0055]

In one embodiment, the sphincter treatment device 10 is coupled to an open or closed loop feedback system. Now referring to FIG. 30, an open or closed loop feedback system connects the sensor 346 to the energy source 392. In this embodiment, the electrode 314 is one or more RF electrodes 314. [0056]

The temperature of this tissue or RF electrode 314 is monitored and the output of the energy source 392 is adjusted accordingly. The doctor can disable this closed or open loop system if desired. This closed or open loop system is equipped with and incorporated a microprocessor 394 not only to turn the output on and off, but also to regulate this output. This closed loop system serves as a controller, monitors this temperature, adjusts this RF output, analyzes the results, refeeds the results, and then adjusts this output. To use the microprocessor 394. [0057]

With the use of sensor 346 and this feedback control system, the tissue adjacent to the RF electrode 314 will generate this power due to excessive electrical impedance at the electrode 314 or adjacent tissue, as described herein. It can be maintained at the desired temperature for a selected period of time without causing interruptions to the electrodes 314 of the circuit. Each RF electrode 314 is connected to resources that generate independent outputs. This output maintains the selected energy at the RF electrode 314 for the selected time. [0058] [0058]

The current delivered through the RF electrode 314 is measured by the current sensor 396. The voltage is measured by the voltage sensor 398. Next, the output and impedance calculation device 400 calculates the impedance and output. These values are then displayed on the user interface and display 402. Signals representing output and impedance values are received by controller 404. [0059]

The control signal is generated by controller 404, which is proportional to the difference between the actual measured value and the desired value. This control signal is used by the power circuit 406 to regulate this output in an appropriate amount to maintain the desired output delivered by each RF electrode 314. [0060]

In a similar fashion, the temperature detected by sensor 346 gives feedback to maintain the selected output. The temperature at sensor 346 is used as a safety measure to block the delivery of energy when the maximum preset temperature is exceeded. Their actual temperatures are measured by the temperature measuring device 408 and these temperatures are displayed on the user interface and display 402. The control signal, generated by controller 404, is proportional to the difference between the actually measured temperature and the desired temperature. This control signal is used by the power supply circuit 406 to regulate this output in an appropriate amount to maintain the desired temperature delivered by sensor 346. In sensor 346, a multiplexer can be provided to measure current, voltage and temperature, and energy can be delivered to the RF power supply 314 in unipolar or bipolar mode. [0061]

The controller 404 can be a digital or analog controller, or a computer with software. When the controller 404 is a computer, it can include a CPU connected by a system bus. The system can be a keyboard, disk drive, or other non-volatile memory system, display, and other peripherals, as is known in the art. In addition, a program memory and a data memory are connected to this bus. [0062]

The user interface and display 402 include an operator control device and a display. The control device 404 can be connected to an imaging system, including, but not limited to, ultrasound, CT scanner, radiography, MRI, mammography, and the like. In addition, direct visualization and tactile imaging can be used. [0063]

The outputs of current sensor 396 and voltage sensor 398 are used by controller 404 to maintain the selected output level at RF electrode 314. The amount of RF energy delivered controls this amount of output. The profile of the output delivered to the electrode 314 can be provided on the controller 404, and the preset amount of energy to be delivered can also be profiled. [0064]

The network, software and feedback to controller 404 provide process control and maintenance of the selected output settings (which are independent of changes in voltage or current), which changes the following: Used for: (i) selected output settings, (ii) duty cycle (on-off time), (iii) bipolar or unipolar energy delivery, and (iv) fluid delivery (for this, flow rate and pressure). Includes). These process variables are controlled and altered based on the temperature monitored by sensor 346, while maintaining the desired delivery of output independent of changes in voltage or current. [0065]

Now referring to FIG. 31, the current sensor 396 and the voltage sensor 398 are connected to the input of the analog amplifier 410. The analog amplifier 410 can be a conventional differential amplifier for use with the sensor 346. The output of the analog amplifier 410 is continuously connected to the output of the A / D converter 414 by an analog multiplexer 412. The output of the analog amplifier 410 is a voltage that represents the perceived temperature of each individual. The digitized amplifier output voltage is supplied to the microprocessor 394 by the A / D converter 414. The microprocessor 394 can be a 68HCII type available from Motorola. However, it can be seen that any suitable microprocessor or versatile digital or analog computer can be used to calculate the impedance or temperature. [0066]

The microprocessor 394 continuously receives and stores digital images of impedance and temperature. Each digital value received by microprocessor 394 corresponds to a different temperature and impedance. [0067]

The calculated output and impedance values can be indicated on the user interface and display 402. Instead of or in addition to the numerical representation of the output or impedance, the calculated impedance and output value can be compared to the output and impedance limits by the microprocessor 394. Warnings can be given in the user interface and display 402 when these values exceed a given output or impedance value, and the delivery of RF energy can be reduced, modified, or blocked. The control signal from the microprocessor 394 can change the output level supplied by the energy source 392. [0068]

FIG. 32 illustrates a block diagram of the temperature and impedance feedback system to control the delivery of energy to tissue site 416 by the energy source 392 and to electrodes 314 and / or tissue site 416. It can be used to control the delivery of coolant 70 by the flow controller 418. The energy is delivered to the RF electrode 314 by the energy source 392 and applied to the tissue site 416. Monitor 420 confirms the tissue impedance based on the energy delivered to the tissue and compares the measured tissue impedance with the set value. If the measured impedance exceeds the set value, a nullification signal 422 is transmitted to the energy source 392 to stop further energy transfer to the RF electrode 314. If the measured impedance is within acceptable limits, then energy is subsequently applied to this tissue. [0069]

Control of the coolant 70 on electrodes 314 and / or tissue site 416 is performed in the following manner. During the application of energy, the temperature measuring device 408 measures the temperature of the tissue site 416 and / or the RF electrode 314. The comparator 424 receives a signal indicating the measured temperature and compares this value with a preset signal displaying the desired temperature. If this tissue temperature is too high, the comparator 424 signals a flow controller 418, which is connected to an electrically controlled micropump (not shown), and has a high coolant flow rate. If the temperature does not exceed the desired temperature, the comparator 424 signals the flow regulator 418 to maintain this flow rate at existing levels. [0070]

The aforementioned description of preferred embodiments of the present invention has been presented for purposes of explanation and description. It is not intended to be exhaustive or to limit the invention to the exact shapes disclosed. Obviously, many changes and variations are apparent to those skilled in the art. The scope of the present invention is intended to be defined by the claims and their equivalents.

[Simple explanation of drawings]

[Figure 1]

FIG. 1 is a schematic side view of the placement of the sphincter treatment device of the present invention on the upper GI tract (which includes the esophagus and lower esophageal sphincter) and the lower esophageal sphincter. [Figure 2]

FIG. 2 is a side view of the present invention illustrating energy delivery devices, power supplies and expansion devices in expanded and contracted states. [Fig. 3]

FIG. 3 is a side view of the invention illustrating a component on a flexible shaft comprising a proximal fitting, a connection and proximal and distal shaft portions. [Fig. 4]

FIG. 4 illustrates a side view of the basket assembly used in embodiments of the present invention. [Fig. 5A]

FIG. 5A is a side view of the basket assembly, which illustrates the extent of warpage of the basket assembly. [Fig. 5B]

FIG. 5B is a perspective view illustrating a balloon attached to a basket assembly. [Fig. 6A]

FIG. 6A is a side view of the joint between the basket arm and the shaft, illustrating the path used for advancing or delivering fluid in its mobile wire. [Fig. 6B]

FIG. 6B is a front view of the basket arm in an alternative embodiment of the present invention, illustrating a track on the arm used to advance this mobile wire. [Fig. 7]

FIG. 7 is a cross-sectional view of a portion of the basket arm, illustrating a stepped and tapered portion of the basket arm opening. [Fig. 8]

FIG. 8 is a side view of the basket assembly, which illustrates the arrangement of its radial support members. [Fig. 9A]

FIG. 9A is a side view of the sphincter treatment device, which illustrates the mechanism used in one embodiment of the invention to increase the warpage of its basket assembly. [Fig. 9B]

FIG. 9B is similar to FIG. 9A, showing a basket assembly with increased warpage. [Fig. 10]

FIG. 10 is a side view of the sphincter treatment device, which illustrates its flexing mechanism. [Fig. 11]

FIG. 11 is a side view illustrating the use of an electrolytic solution to create a reinforced RF electrode. [Fig. 12]

FIG. 12 is a side view of a basket assembly illustrating the use of needle electrodes. [Fig. 13]

FIG. 13 is a side view illustrating the use of insulating segments on the needle electrodes to protect the tissue area from RF energy. [Fig. 14]

FIG. 14 is a side view illustrating the placement of the needle electrode on the sphincter wall by expansion of the basket assembly. [Fig. 15]

FIG. 15 is a side view illustrating the placement of the needle electrode on the sphincter wall by advancing the electrode delivery member through the opening in the basket arm. [Fig. 16]

FIG. 16 is a cross-sectional view illustrating the configuration of a basket arm opening used to select and maintain a penetration angle of the needle electrode into the sphincter wall. [Fig. 17]

FIG. 17 is a side view illustrating the placement of the needle electrode on the sphincter wall by advancing the electrode delivery member directly from the distal end of the shaft. [Fig. 18A]

FIG. 18A is a side view illustrating the radial distribution of electrodes on the expansion device of the present invention. [Fig. 18B]

FIG. 18B is a side view illustrating the longitudinal distribution of the electrodes on the expansion device of the present invention. [Fig. 18C]

FIG. 18C is a side view illustrating the spiral distribution of electrodes on the expansion device of the present invention. [Fig. 19]

FIG. 19 is a flowchart illustrating a sphincter muscle treatment method using the instrument of the present invention. [Fig. 20]

FIG. 20 is a side view of the sphincter smooth muscle tissue, illustrating electromagnetic foci and pathways for the generation and conduction of abnormal electrical signals in the smooth muscle of the lower esophageal sphincter or other tissue. [Fig. 21]

FIG. 21 is a side view of the sphincter wall, illustrating infiltration of tissue healing cells into trauma in the smooth tissue of the sphincter muscle following treatment with the sphincter treatment instrument of the present invention. [Fig. 22]

FIG. 22 is similar to FIG. 21, which illustrates the contraction of the traumatic site caused by cell infiltration. [Fig. 23]

FIG. 23 is a side view of the esophageal wall, illustrating the preferred placement of trauma in the smooth muscle layer of the esophageal sphincter. [Fig. 24]

FIG. 24 is a side view illustrating an ultrasonic converter, an ultrasonic lens, and a power supply according to an embodiment of the present invention. [Fig. 25A]

FIG. 25A is a side view of the sphincter wall, which illustrates various patterns of trauma created by the instruments of the present invention. [Fig. 25B]

FIG. 25B is a side view of the sphincter wall, which illustrates various patterns of trauma created by the instruments of the present invention. [Fig. 25C]

FIG. 25C is a side view of the sphincter wall, which illustrates various patterns of trauma created by the instruments of the present invention. [Fig. 25D]

FIG. 25D is a side view of the sphincter wall, which illustrates various patterns of trauma created by the instruments of the present invention. [Fig. 26]

FIG. 26 is a side view of the sphincter wall, which illustrates the delivery of coolant and the formation of cooling zones to its electrode-tissue interface. [Fig. 27]

FIG. 27 depicts the flow paths, fluid connections and control units used to deliver fluid to the electrode-tissue interface. [Fig. 28]

FIG. 28 depicts the flow paths, fluid connections and control units used to deliver fluid to the RF electrodes. [Fig. 29]

FIG. 29 is an enlarged side view illustrating the placement of the sensor on the expansion device or basket assembly. [Fig. 30]

FIG. 30 depicts a block diagram of a feedback control system that can be used with a sphincter treatment device. [Fig. 31]

FIG. 31 illustrates a block diagram of an analog amplifier, analog multiplexer and microprocessor used with the feedback control system of FIG. [Fig. 32]

FIG. 32 depicts a block diagram of the operations performed by the feedback control system depicted in FIG.