Methods and devices for cutting tissue

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DESCRIPTION

Methods and devices for cutting tissue.

BACKGROUND OF THE INVENTION

The present invention relates generally to systems for reducing the tumor volume of body lumens. More particularly, the present invention relates to atherectomy catheters for excising atheromas and other materials from blood vessels and stents.

Cardiovascular disease often results from the accumulation of atheromatous material on the interior walls of vascular lumens, particularly arterial lumens of the coronary and other vasculature, resulting in a condition known as atherosclerosis. Atherosclerosis occurs naturally as a result of aging, but it can also be aggravated by factors such as diet, hypertension, heredity, vascular injury, and the like. Atheromatous vascular and other deposits restrict blood circulation and can cause ischemia which, in acute cases, can result in myocardial infarction. Atheromatous deposits can have widely variable properties, some being relatively soft and others fibrous and / or calcified. In the latter case, the deposits are frequently referred to as plaque.

A conventional treatment for cardiovascular disease is the use of stents. Endoluminal stents are commonly used to treat blocked or weakened lumens of the body, such as blood vessels and other vascular lumens. Once deployed in the blood vessel, the stent can remain in the lumen of the body, where it will maintain the patency of the lumen and / or support the surrounding lumen walls. Another factor that prevents the success of stent technology in endoluminal treatments is the frequent occurrence of restenosis in the stent, characterized by the proliferation and migration of smooth muscle cells within and / or adjacent to the implanted stent, causing closing again or blocking the body lumen.

Atherosclerosis and restenosis can be treated in a variety of ways, including drugs, bypass surgery, and a variety of catheter-based methods that rely on reducing intravascular tumor volume or removing atheromatous or other occluding material. a blood vessel. Of particular interest to the present invention, a variety of methods have been proposed for cutting or dislodging material and for removing such material out of the blood vessel, which are generally referred to as atherectomy procedures. Atherectomy catheters intended to excise material from the blood vessel or lumen generally employ a rotatable and / or axially displaceable cutting blade, which can be advanced into or past the occlusive material in order to cut and separate said material from the occlusive material. blood vessel lumen. In particular, side cut atherectomy catheters generally employ a housing that has an opening on one side, a blade that is rotatable or movable through the opening, and a balloon to drive the opening against the material to be removed.

Although atherectomy catheters have shown great success in treating many types of atherosclerosis and stent restenosis, atherectomy catheters and methods are continually being investigated. For example, many currently available lateral cut atherectomy catheters have difficulty capturing occlusion material at the opening of the cut. To facilitate material capture, the cutting opening is often lengthened to increase the area that the material can penetrate. Such elongation typically requires an equivalent elongation of the blade housing. Since most blade housings are rigid, such elongation makes it more difficult to insert the distal end of the catheter through tortuous regions of the vasculature.

Another drawback of many currently available atherectomy catheters is that they typically require a balloon positioned opposite the cutting window to drive the cutting window into contact with occlusion material. However, such balloons unduly increase the size of the distal portion of the catheter. Even with the balloon, the amount of matter that can be removed by conventional atherectomy catheters is limited by the size of the short window. Other drawbacks of some catheters include cutters with less than ideal hardness, inadequate storage space within the catheter to contain removed material, suboptimal guidewire lumens, and / or the like.

For these reasons, it would be advantageous to have atherectomy catheters, and methods for their use, that could access tortuous narrow regions of the vasculature and remove atheromatous and other occlusive materials from within blood vessels and stents in a controlled manner. In particular, it would be desirable to have catheters and atherectomy methods that could facilitate the capture and invagination of atheromatous materials. Ideally, such catheters and methods would be acceptable for use in a variety of lumens in the body, including but not limited to coronary and other arteries. At least some of these objectives will be met by the present invention.

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WO 01/15609 describes catheters, kits and methods for removing material from a body lumen. The catheter can be used in a variety of body lumens including, but not limited to, coronary and other arteries. The catheter has a catheter body coupled to a distal slide tip. The slide tip extends remotely between a retracted position and an extended position to define an adjustable cutting window. The catheter has a rotatable cutting element positioned between the distal tip and the catheter body to cut material received at the cutting window. The axial movement of the rotating cutting element can cut the material received by the cutting window. In some embodiments, the rotating blade is movable outwardly from the catheter body to engage and cut material in the body lumen.

US-A-2002-0077642 describes the features of the preamble of claim 1 and describes a tumor volume reduction catheter comprising a tumor volume reduction assembly for reducing the tumor volume of a body lumen. The catheter has a flexible proximal portion coupled to a rigid distal portion. The tissue tumor volume reduction assembly is disposed within the rigid portion to reduce the tumor volume of the body lumen. The rigid portion is rotatably coupled to the flexible portion, such that rotation or deflection of the rigid portion relative to the flexible portion can expose the tumor volume reduction assembly through a window in the catheter to reduce the tumor volume of the body lumen.

BRIEF SUMMARY OF THE INVENTION

The present invention provides catheters for removing material (or "shrinking tumor" from a body lumen). The catheters of the present invention can be used in a variety of body lumens, including, but not limited to, intravascular lumens, such as coronary arteries. Typically, tumor bulking catheters are used to remove occlusive material, such as atherosclerotic plaque, from vascular lumens, but can alternatively be used to remove other materials. In general, tumor bulking catheters include a proximal portion, a distal portion having an opening (or "window"), and a cutter (or "tissue tumor bulking assembly"), which are can expose through the opening to contact material in a body lumen. The catheter reduces the tumor volume of a body lumen when it is moved while the cutting element is in contact with the material in the lumen.

The present invention provides a device for cutting tissue as defined in claim 1.

For a further understanding of the nature and advantages of the invention, reference should be made to the following description taken in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 is a perspective view of a tumor volume reduction catheter.

Figure 1A is a side view of a portion of a tumor volume reduction catheter, as in Figure 1, where the body has a rigid distal portion with a curvature.

Figure 2 is an exploded view of an exemplary distal portion of the tumor reducing catheter.

Figure 3A is an end view of the distal portion of the tumor bulking catheter of Figure 1, wherein the catheter is in a closed position in the catheter body.

Figure 3B is a sectional view along the line AA of Figure 3A.

Figures 3C to 3D are views of the distal portion of a tumor volume reduction catheter, wherein the distal portion has a locking shuttle mechanism.

Figure 4A is an end view of the distal portion of the tumor volume reduction catheter of Figure 1, in which the blade is in an open position outside the cutting window.

Figure 4B is a sectional view along the line AA of Figure 4A.

Figures 4C and 4D are views of the distal portion of a tumor volume reduction catheter, wherein the distal portion has a locking shuttle mechanism.

Figure 5A is an end view of the distal portion of the tumor reducing catheter of Figure 1, in which the blade is in a packed position within a tip of the catheter.

Figure 5B is a sectional view along the line AA of Figure 5A.

Figures 6 to 8 illustrate a monorail delivery system.

Figure 9A is a perspective view of a blade.

Figure 9B is an end view of the blade of Figure 9A.

Figure 9C is a sectional view of the blade along line AA of the blade of Figures 9A and 9B.

Figure 10A is a perspective view of the restenosis blade in the stent.

Figure 10B is an end view of the blade of Figure 10A.

Figure 10C is a sectional view of the blade along line BB of the blade of Figures 10A and 10B.

Figure 11A is a perspective view of another restenosis blade on the stent.

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Figure 11B is an end view of the blade of Figure 11A.

Figure 11C is a sectional view of the blade along line CC of the blade of Figures 11A to 11B.

Figure 11D is a side view of another blade shown partially within a catheter body.

Figure 12 illustrates a proximal handle and blade driver.

Figure 13 illustrates a blade drive with a drive cover removed.

Figures 14 to 16 illustrate three positions of the lever for controlling the blade.

Figure 17 is a simplified flow chart illustrating a method of using the catheter.

Figures 18 and 19 illustrate a method of using the catheter.

Figure 20 schematically illustrates another method of using the catheter.

Figure 21 shows an embodiment of a device for cutting tissue with the device having a movable cover.

Figure 22 shows the device of Figure 21 with the cap in a stored position.

Figure 23 shows the device of Figure 21 with the cover in a working position, exposing part of the rotatable cutting element.

Figure 24 shows yet another device for cutting tissue having two pivot points on opposite cutting element sides.

Figure 25 shows the device of Figure 24 after articulation of the device at pivot points to place the cutting element in a cutting position.

Figure 26A is a side view of the elongated body or shank that forms a helix configuration.

Figure 26B is a perspective view looking at the distal end of the device.

Figure 27A shows a tube that forms part of the elongated body of Figure 26 in a straight configuration. Figure 27B shows the tube of Figure 27A in a bent configuration; Y

Figure 28 illustrates a kit of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

The catheters of the present invention are designed to reduce the volume of tumor and other occlusive material from diseased lumens of the body and, in particular, coronary arteries, new lesions and restenosis lesions in stents. However, the catheters are also suitable for treating stenosis of lumens of the body and other hyperplastic and neoplastic conditions in other lumens of the body, such as the urethra, bile duct, respiratory passages. The pancreatic duct, the lymphatic duct, and the like. Neoplastic cell growth will often occur as a result of a tumor surrounding and penetrating a lumen of the body. Reducing the tumor volume of such a material may therefore be beneficial in maintaining the patency of the body lumen. Although the remaining description relates to tumor volume reduction and passage through atheromatous or thrombolic occlusive material in a coronary artery, it will be appreciated that the systems of the present invention can be used to remove and / or pass through a variety of occlusive, steno or hyperplastic material in a variety of body lumens.

The apparatus according to the present invention will comprise catheters having catheter bodies adapted for intraluminal introduction to the lumen of the target body. The dimensions and other physical characteristics of the catheter bodies will vary to a significant extent depending on the lumen of the body to be accessed. In the case of the example of atherectomy catheters intended for intravascular introduction, the proximal portions of the catheter bodies will typically be very flexible and suitable for introduction over a guidewire to a target site within the vasculature. In particular, catheters may be intended for "over-the-wire" introduction when a guidewire channel extends fully through the catheter body or for "quick replacement" introduction where the guidewire channel extends. only through a distal portion of the catheter body. In other cases, it may be possible to provide a fixed or integral helical tip or guidewire tip over the distal portion of the catheter or even to dispense with the guidewire entirely. For convenience of illustration, guide wires will not be shown in all embodiments, but it should be appreciated that they can be incorporated into any of these embodiments.

Catheter bodies intended for intravascular introduction will typically have a length in the range of 50 cm to 200 cm and an outer diameter in the range of 1 French to 12 French (0.33 mm; 1 French), typically 3 French to 9 French. In the case of coronary catheters, the length is typically in the range of 125 cm to 200 cm, the diameter is preferably less than 8 French, more preferably less than 7 French, and most preferably in the range of 2 French to 7 French. Catheter bodies will typically be composed of an organic polymer, which is manufactured by conventional extrusion techniques. Suitable polymers include polyvinyl chloride, polyurethanes, polyesters, polytetrafluoroethylene (PTFE), silicone rubbers, natural rubbers, and the like. Optionally, the catheter body can be reinforced with braid, helical wires, coils, axial filaments, or the like, in order to increase rotational resistance, column resistance, toughness, pushability, and the like. Suitable catheter bodies can be formed by extrusion, one or more channels being provided when desired. The diameter of the catheter can be modified by thermal expansion and contraction using conventional techniques. The resulting catheters will therefore be suitable for introduction into the vascular system, often the

ES 2 387 807 T3 coronary arteries, by conventional techniques.

The distal portion of the catheters of the present disclosure can have a wide variety of shapes and structures. In many examples, a distal portion of the catheter is stiffer than a proximal portion, but in other examples the distal portion may be just as flexible as the proximal portion. An exemplary aspect provides catheters that have a distal portion with a reduced rigid length. The reduced rigid length can allow catheters to access and treat tortuous blood vessels and small diameter body lumens. In most devices, a rigid distal portion or housing of the catheter body will have a diameter that generally matches the proximal portion of the catheter body, but, in other devices, the distal portion may be larger or smaller than the flexible portion. catheter.

A rigid distal portion of a catheter body can be formed of materials that are rigid or that have very low flexibilities, such as metals, hard plastics, composites, NiTi, steel with a coating such as titanium nitride, tantalum. ME-92®, diamond, or the like. More usually, the distal end of the catheter body will be formed of stainless steel or platinum / iridium. The length of the rigid distal portion can vary widely, typically in the range from 5mm to 35mm, more usually from 10mm to 25mm, and preferably between 6mm and 8mm. In contrast, conventional catheters typically have rigid lengths of about 16mm.

The side opening windows of the catheter will typically have a length of about 2mm. However, in other examples, the side opening cutting window may be larger or smaller, but should be large enough to allow the blade to penetrate a predetermined distance that is sufficient to reduce the tumor volume of the material from the body lumen. .

Catheters can include a flexible atraumatic distal tip coupled to the rigid distal portion of the catheter. For example, an integrated distal tip can increase the safety of the catheter by eliminating the seam between the distal tip and the catheter body. The integral tip can provide a smoother bore to facilitate movement of tissue in a collection chamber at the tip. During fabrication, the transition from the housing to the flexible distal tip can be completed with a polymer laminate on the material housing. No welding, crimping or threaded joint is normally required.

The atraumatic distal tip allows the catheter to be advanced remotely through the blood vessel or other body lumen, while reducing any damage caused to the body lumen by the catheter. Typically, the distal tip will have a guidewire channel to allow the catheter to be guided to the target lesion over a guidewire. In some exemplary configurations, the atraumatic distal tip comprises a coil. In some configurations, the distal tip has a rounded blunt distal end. The catheter body may be tubular and have a forward-facing circular opening that communicates with the atraumatic tip. A collection chamber may be housed within the distal tip to store material removed from the body lumen. The combination of rigid distal end and flexible distal tip is approximately 30mm.

A rotating blade or other tissue tumor volume reduction assembly may be provided on the distal portion of the catheter to cut material that is adjacent to or received within the cutting window. In an exemplary device, the blade is disposed movably in the distal portion of the catheter body and movable through a side opening window. A straight or serrated cutting blade or other element may be integrally formed along a distal or proximal edge of the cutting window to assist in cutting material from the body lumen. In a particular device, the blade has a diameter of approximately 1.14mm. However, it should be appreciated that the diameter of the blade will depend primarily on the diameter of the distal portion of the catheter body.

In exemplary devices, activation of an input device can bias a distal portion of the catheter relative to the proximal portion of the catheter. Angular deflection of the distal portion can serve one or more purposes in several examples. In general, for example, deflection of the distal portion increases the effective "diameter" of the catheter and causes the tumor volume reduction assembly to be propelled against material in a lumen, such as atherosclerotic plaque. In other devices, deflection of the distal portion can act to expose a tumor volume reduction assembly through a window to contact material in a lumen. In some devices, for example, activation of the input device moves the tumor volume reduction assembly over a ramp or cam, causing a portion of the rigid distal portion and flexible tip to fall out of the way. of the tumor volume reduction assembly to expose the tumor volume reduction assembly through the window. In some devices, deflection can drive a portion of the catheter into the material of a lumen and expose a tumor-reducing assembly.

Some devices further assist in bringing the tumor bulking assembly into contact with the target tissue by including a proximal portion of the catheter body having a rigid, shaped, or deformable portion. For example, some devices include a proximal portion with a curvature that urges the tumor volume reduction assembly to one side of the lumen that must be reduced in tumor volume. In

In other devices, one side of the proximal portion is less rigid than the other side. Therefore, when traction is applied on the catheter in a proximal direction (such as when the tumor reducing assembly is pulled on the proximal side for use), one side of the proximal portion is crushed more than the other side, causing cause the catheter body to bend and the tumor volume reduction assembly to move to one side of the lumen to be reduced in tumor volume.

In exemplary devices, the tumor bulking assembly comprises a rotating blade that is movable outside the window. By moving the blade out of the cutting window, beyond an outer diameter of the distal portion of the catheter, the blade is able to contact and cut material that is not invaginated in the cutting window. In a specific configuration, the rotating blade can be moved on the cam within the rigid or distal portion of the catheter body, such that the cutting edges move out of the window. By moving the rotating blade out of the cutting window and advancing the entire catheter body on the distal side, a large amount of occlusive material can be removed. Accordingly, the amount of material that can be removed is not limited by the size of the cutting blade.

As will be described in more detail below, in some situations it is preferable to provide a saw cutting edge, while in other situations it may be preferable to provide a smooth cutting edge. Optionally, the cutting edge of either or both blades can be hardened, for example by applying a coating. A preferred cutting material is chromium-based material, available from ME-92, Inc., which can be applied according to the manufacturer's instructions. In some examples, the blade includes a tungsten carbide cutting edge. Other axially movable and rotary cutting blades are described in United States Patents US 5,674,232; 5,242,460; 5,312,425; 5,431,674; and 4,771,774.

In some examples, a rotating blade includes a beveled edge to remove material from a body lumen, while preventing injury to the lumen. In still other examples, a tissue tumor volume reduction package may include alternative or additional features to reduce the tumor volume of a lumen. For example, the tumor bulking kit may include, but is not limited to, a radio frequency device, an abrasion device, a laser blade, and / or the like.

The catheters can include a monorail delivery system to assist in positioning the blade at the target site. For example, the catheter tip may include lumen (s) that are sized to receive a conventional guidewire (typically 0.356mm (0.014 ") in diameter) or any other suitable guidewire (for example, with diameters between 0.457 0.018 "and 0.813mm (0.032") and the flexible proximal portion of the catheter body may include a short lumen (eg, approximately 12 centimeters in length). Such a configuration moves the guidewire out of the rigid portion so as not to interfere with the tumor volume reduction assembly.

However, in other devices, the guidewire lumen may be disposed within or outside of the flexible proximal portion of the catheter body and may extend over a longer or shorter length and, in fact, may extend over the entire the length of the flexible portion of the catheter body. The guidewire can be disposed within the lumen over the flexible portion of the catheter body and exit the lumen at a point proximate the rigid portion of the catheter. The guidewire can then enter a proximal hole in the tip lumen and exit a distal hole in the tip lumen. In some devices, the catheter has a distal guidewire lumen on its flexible distal tip and a proximal guidewire lumen on its flexible body. For example, in some devices, the distal lumen can be between about 2.0 cm and about 3.0 cm in length and the proximal lumen can be between about 10 cm and about 14 cm in length. In still other devices, a guidewire lumen of the distal tip may be configured to telescope within a proximal guidewire lumen, or vice versa. A telescopic guidewire lumen can improve catheter performance by preventing a guidewire from being exposed within a body lumen.

The present disclosure may optionally employ any of a wide variety of conventional radiopaque markers, imaging devices, and / or transducers. In exemplary devices, the catheters may include a radiopaque distal portion and / or radiopaque markers disposed on a distal portion of the catheter body, such as in proximity or distance from the cutting window, on the cam or ramp, to allow the user follow the position of the blade, or similar. Catheters will also be particularly useful with ultrasonic transducers, such as IVUS, of a type that can be deployed linearly within the catheter body or circumferentially over the tumor reducing assembly. Linear deployment will allow viewing along a discrete length of the catheter shaft, preferably adjacent to the cut-off point, typically over a length in the range of 1mm to 30mm, preferably 2mm to 10mm. Circumferentially deployed phase arrays may comprise an arc of view in the range of 5 ° to 360 °, typically 180 ° to 360 °. For imaging transducers located within a housing or second cutter, the imaging field will generally be limited by the dimensions of the aperture. However, in some cases, it might be possible to manufacture all or a portion of the blade / knife housing from an ultrasonically translucent material. A more complete description of suitable imaging catheters is more fully described in US Patent Application

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US Patent No. 09 / 378,224, filed August 19, 1999 and entitled "Atherectomy Catheter with Aligned Image", now US Patent No. 6,229,622 B1. In addition to ultrasonic array transducers, the imaging devices of the present disclosure may comprise optical coherence tomography devices, such as disclosed in US Patent No. 5,491,525, as well as Huang et al. (1991) Science 254: 1178-1181; Brezinski et al. (1997) Heart 77: 397-403; and Brezinski et al (1996) Circulation 93: 1206-1213. In some cases, the present disclosure may provide optical imaging using optical waveguides and the like.

Referring now to FIG. 1, a catheter 20 comprises a catheter body 22 having a proximal portion 24 and a distal portion 26. The proximal portion 24 can be coupled to the distal portion 26 with a connection assembly 27 to allow connection. pivot or deflection of distal portion 26 relative to proximal portion 24. A proximal end of catheter body 22 may have a handle 40 for manipulation by a user, a luer fitting for connection to an aspiration or fluid delivery channel, or the like.

A tumor bulking assembly, such as a blade 28, abrasive member, or the like, is disposed within a lumen 30 of catheter body 22. Blade 28 is typically rotatable within distal portion 26 about an axis that it is parallel to the longitudinal axis of the distal portion 26 of catheter 20 and is axially movable along the longitudinal axis. The blade 28 can access the target tissue through a side opening window 32, which is typically large enough to allow the blade 28 to project through and move out of the window 32 by a predetermined distance. The blade is coupled to a blade driver 34 through a helical drive shaft 36. Actuation of a movable actuator or other input device 38 can activate drive shaft 36 and blade, move blade 28 longitudinally on a cam to bias the distal portion, and move blade 28 out of cutting window 32. The cam movement of the blade 28 may cause the distal portion 28 to pivot or deflect relative to the proximal portion 24, to deflect and push the blade into tissue in the body lumen.

In some devices, the distal portion 26 of the catheter may be moved to a configuration at an angle or offset from the longitudinal axis of the proximal portion 24 of the catheter and the blade 28. In some devices, the blade 28 may also be offset off the axis of the catheter. the proximal and / or distal portion of the catheter. Movement of distal portion 26 to an angled / deflected position may cause a portion of the catheter to push against target tissue, and may expose blade 28 through window 32, or both, in various devices.

In some catheters 20, proximal portion 24 is typically relatively flexible and distal portion 26 is typically relatively rigid. Additionally, many devices include a flexible distal tip 42. The flexible proximal portion 24 of the catheter is typically a torque shaft and the distal portion 26 is typically a rigid tubing. Torque shaft 24 facilitates transport of catheter body 22 and blade 28 to the diseased site. The proximal end of the torque shaft 24 is coupled to a proximal handle 40 and the distal end of the torque shaft is attached to the rigid distal portion 26 of the catheter through the connection assembly 27. The drive shaft 36 it is movably positioned within torque shaft 24 to rotate and move axially within torque shaft 24. Drive shaft 36 and torque shaft 24 are dimensioned to allow relative movement of each shaft without interference with the movement of the other shaft. The catheter body will have a biasing and twisting capability such that the proximal end twisting and biasing torque will transmit motion to the distal portion 26 of the catheter body 22.

Referring now to Figure 1A, a catheter 20 as in Figure 1 may have a flexible proximal portion 24 that further includes biasing means 25. As shown in Figure 1A, biasing means 25 may comprise a flex or shape rigidly curved toward the distal end of proximal portion 24, which may help to push blade 28 or other tumor volume reduction apparatus toward a wall of a body lumen to enhance treatment. Such rigid flexing increases the working range of the catheter by allowing the wire to be pushed into a lumen wall through a wider diameter lumen.

In other devices, the biasing means 25 may take other suitable forms. For example, a result similar to rigid bending can be achieved by including a rigid distal portion, which is not permanently bent, but which is stiffer on one side than on the opposite side of the catheter body 22. Therefore, when traction is applied proximate to proximal portion 24, as when force is applied proximate to the tumor volume reduction apparatus to expose blade 28 through window 32, biasing means 25 (i.e., the Rigid distal portion of proximal portion 24 will cause catheter body 22 to bend toward the less rigid side. The less rigid side will typically be the same side as window 32, such that window 32 and / or blade 28 will be pushed against a wall of a body lumen by flexing. In still other devices, an element configured into the catheter body may be inserted to act as a biasing means 25. Any suitable biasing means is contemplated.

Figure 2 illustrates an exploded view of a distal end of the catheter. In such devices, catheter 10 includes a connection assembly 27, a rigid housing 26, a distal tip 42 that defines, at least partially, a collection chamber 53 for storing cut atheromatous material, and a lumen that can receive the delivery wire. guide. The distal tip 42 may have a distal hole 43 that is dimensioned to allow a

ES 2 387 807 T3 imaging guidewire or conventional guidewire not shown) is advanced on the distal side through the tip. In some devices, distal tip 42 may also include a distal guidewire lumen (not shown) to allow passage of a guidewire. For example, some examples may include a distal guidewire lumen that is between about 1.0 cm and about 5.0 cm in length, and preferably between about 2.0 cm and about 3.0 cm. Such a distal guidewire lumen can be used alone or in combination with a distal guidewire lumen located on another, more proximal portion of catheter 20.

In devices that include a distal guidewire lumen and a proximal guidewire lumen, the distal lumen may be configured to telescope partly within a portion of the proximal guidewire lumen, or vice versa. Such telescopic lumens can be used in devices in which the distal portion 26 of the catheter body 22 is movable relative to the proximal portion 24. A telescopic lumen can improve the performance of catheter 20 by allowing a guidewire to be held within a lumen for a long time and not exposed within the body lumen being treated. Telescopic lumens can have any suitable diameter configurations to allow sliding or otherwise engaging one lumen within another.

A ramp or cam 44 may at least partially fit within distal portion 26. As will be described in detail below, in many examples, proximal movement of blade 28 on ramp 44 causes deflection of distal portion 26. and guides the blade 28 out of the cutting window 32. (In other devices, a ramp can be used to deflect the distal portion without the blade extending out of the window). Attached to ramp 44 is a housing adapter 46 that can connect one or more articulation members 48 to the distal tip to create an axis of rotation of distal portion 26. Housing adapter 46 and articulation member 48 allow distal end of the catheter will pivot and deflect against the body lumen. In the illustrated device, there is only one housing adapter 46 and one articulation member 48, but it should be appreciated that the catheters can include two, three, or more joints (eg, axis of rotation), if desired. Furthermore, the axes of rotation can be parallel or not parallel to each other.

The catheter may also include a shaft adapter 50 and a collar 52 for coupling the hinge member 48 to the torque shaft 22. The shaft adapter 50 can connect the housing to the torque shaft and the collar 52 can be place over proximal end of shaft adapter and snap in for secure attachment. It should be appreciated by one of ordinary skill in the art that while an exemplary catheter has the components listed above, other catheters may include more or less of the components described above. For example, some components can be made integrated with other components and some components can be left out entirely. Therefore, instead of having a separate ramp 44, the ramp can be integrated with the distal tip to direct the blade out of the cutting window.

As shown in Figures 3-5, the blades 38 will generally be movable between two or more positions. During advancement through the body lumen, the blade will generally be in a neutral position (Figures 3A and 3B), in which blade 28 is remote from cutting window 32. In some devices, an imaging device (not shown) may be attached to blade 28 to image the body lumen through cutting window 32 when blade 28 is in the neutral position. Once catheter 20 has foreseen the target site, blade 28 can be moved to an open position (Figures 4A and 4B), in which blade 28 moves to a proximal end of cutting window 32 and will extend outside the cutting window 32 a distance L1 beyond an outer diameter D of the rigid portion 26. In most devices, in the open position, the blade will have offset the distal portion and the axis of rotation of the blade will generally be in line with the connection assembly 27, but at an angle or offset from the longitudinal axis of the blade. the distal portion of the catheter body.

Optionally, in some devices, the blade 28 can be moved to a park position, in which the blade is moved remotely, beyond the neutral position, to pack the cut tissue into a distal collection chamber 53 (Figures 5A and 5B). However, it should be appreciated that while the exemplary device moves the blade to the positions described above, in other devices the blade may be positioned in other relative positions. For example, instead of having the neutral position remote from the cutting window, the neutral position can be close to the window, and the open position can be along the distal end of the cutting window, or the like.

Referring again to Figures 4A and 4B, the interaction of the components of the rigid distal portions 26 in an exemplary device will be further described. As shown in Figure 4B, cutting window 32 is typically a recess that opens at distal portion 26. Although the size of the cutting window 32 can vary, the cutting window should be long enough to pick up tissue and wide enough in circumference to allow the blade to move out of the cutting window during cutting, but it should be dimensioned and configured not to expel clots within the vasculature. Cams or ramps 44 (shown more clearly in Figure 4B) may be provided in the distal portion of the catheter body to guide or otherwise pivot blade 28 out of cutter window 32 as blade 28 is drawn in. proximal side through drive shaft drive 36.

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A hinge is located proximal to cutting window 32 to provide a pivot point for cam movement of distal portion 26 relative to proximal portion 24. Flexing in a flexible hinge 49 is caused by the interaction of cams or cams. ramps 44 with blade 28 and pulling force provided through drive shaft 36. In the exemplary configuration, the joint includes a housing adapter 46 that is pivotally coupled to the rigid distal portion 26. As shown in Figures 4A and 4B, the resulting pivotal movement of the rigid distal portion 26 relative to the proximal portion causes a lifting effect, which urges the distal housing against the lumen wall of the body without the use of biasing means (eg, a balloon) that is positioned opposite the cutting window. Therefore, the overall cross-sectional size of the catheter body can be reduced to allow the catheter to access lesions in smaller lumens of the body. In exemplary devices, the distal housing can deflect off the axis of the proximal portion of the catheter, typically between 0 ° and 30 °, typically between 5 ° and 20 °, and more preferably between 5 ° and 10 °. The angle of deflection is directly related to the thrust. However, thrust is not necessarily related to force, but more to the overall profile of the catheter. For example, the greater the deflection angle, the greater the profile and the greater the lumen that can be treated. The ranges that have been chosen to allow treatment of blood vessels vary from less than 2 mm to more than 3 mm within the limits of the mechanical design of the components. However, it should be appreciated that the deflection angles will vary as a function of the size of the body lumen to be treated, the size of the catheter, and the like.

In some devices, deflection of the distal portion 26 of the catheter biases the blade into position, such that distal advancement of the entire catheter body can move the rotating blade through the occlusive material. Because the blade moves a distance L1 beyond the outer diameter of the distal portion of the catheter and outside the cutting window, the user does not have to invaginate tissue within the cutting window. In some devices, for example, the blade can be moved between about 0.025mm and about 1.016mm, and preferably between about 0.025mm and about 0.64mm, beyond the outer dimension of the distal housing. It should be appreciated that the excursion of the blade is directly related to the depth of cut. The further the blade moves out of the cutting window, the deeper the cut. The ranges are chosen with efficiency in mind without risk of perforation of the body lumen.

Some examples of the catheter include a shuttle mechanism or other similar mechanism to temporarily lock the catheter in a cut position. Figures 3C and 3D illustrate such a device in the non-cutting neutral position. Such devices generally include a shuttle member 45 and a shuttle stop member 42. The shuttle stop member 42 is typically disposed at an angle relative to a longitudinal axis through the catheter. Figures 4C and 4D show the same device in the cutting position. When the blade 28 is moved into the cutting position in such devices, the shuttle member 45 falls into the shuttle stop member 42 and thus locks the tumor volume reduction apparatus in a cutting position. To unlock the tumor bulking apparatus, blade 28 may be remotely advanced forward to release shuttle member 45 from shuttle stop member 42.

Some devices that include a shuttle mechanism will also include two hinges in catheter body 22. Thus, catheter body 22 will include a proximal portion 28, a distal portion 24, and a middle portion. When the shuttle mechanism is activated to expose blade 28 through window 32, the middle portion can orient itself at an angle, relative to the proximal and distal portions, thereby allowing the blade to be pushed. to one side of a lumen. Such a two-joint configuration can provide improved performance of catheter 20 by providing improved contact of blade 28 with material to be reduced in tumor volume of a lumen body.

Pushing the entire catheter through a lesion removes all or part of the lesion out of the body lumen. Tissue cut from the lesion is directed into a collection chamber 53 at the tip through blade 28. Once the catheter and blade 28 have moved through the lesion, blade 28 can be remotely advanced. to a "out of the way" position, in which the blade is returned to the cutting window 32 (Figure 3B). The tissue is collected as the cut pieces of tissue are directed into a collection chamber 53 through the distal movement of the blade 28 and the catheter. Tip collection chamber 53 and distal portion 26 act as a receptacle for cut material to prevent cut occlusive material from entering the body lumen and possibly causing downstream occlusions. Blade 28 may interact with the distal end of the cutting window to retract tissue and then pack the cut tissue into collection chamber 53 (Figure 3B). In exemplary devices, the drive motor may be programmed to stop the rotation of the blade in the out of the way so that the blade 28 can be moved to a third position (Figure 5B) and to pack the material into the collection chamber at the non-rotating tip. Typically, the collection chamber 53 will be large enough to allow multiple cuts to be collected before the device is withdrawn out of the body lumen. When the collection chamber is full, or at the discretion of the user, the device can be removed, emptied, and reinserted onto the guidewire through a monorail system, as will be described below.

ES 2 387 807 T3

In various devices, improvements to the collection chamber 53 may be included. For example, in some devices, the collection chamber 53 may be configured to be partially or fully translucent or radiolucent and a portion of the catheter that surrounds or is adjacent to the window 32 will be radiopaque. This combination of radiolucent collection chamber 53 and adjacent radiopaque material window 32 will enhance a user's ability to determine the fill level of collection chamber 53, since the fill level of the collection chamber will be directly related to the distance that the blade 28 can advance forward in the harvesting chamber 53. By facilitating the assessment of the collection chamber fill level, these devices will reduce the need for manual catheter removal to examine the collection chamber 53.

In some devices, the collection chamber 53 can be connected to the rigid housing by means of interlocking components, which interlock with complementary components in the rigid housing. Such components can resemble a threaded configuration, for example. The interlocking components will provide a stable connection between the collection chamber 53 and the rigid housing, without at the same time increasing the outside diameter of the chamber 53 or the housing. In general, the collection chamber 53 can be of any suitable size, shape, or configuration. For example, the collection chamber 53 in Figures 6 to 8 has a helical configuration. Alternatively, the collection chamber 53 may include a series of circular members, straight linear members, a solid cylindrical member or a cone-shaped member or the like.

Figures 6 through 8 illustrate an example of a monorail delivery system to assist in positioning the blade 28 at the target site. For example, catheter tip 42 may include a lumen 54 that has a distal hole 43 and a proximal hole 55 that is dimensioned to receive a guidewire, which has a diameter of about 0.356mm (0.014 inches), about 0.457mm. (0.018 inch), about 0.813 mm (0.032 inch), or any other suitable diameter.

As shown in Figure 8, the flexible proximal portion of the catheter body may also include a short lumen 56 (eg, approximately 12 centimeters long). However, in some devices, the guidewire lumen 56 may be disposed within or outside of the flexible proximal portion of the catheter body and cover a longer or shorter length, and may in fact extend over the entire length of the catheter. the flexible portion 24 of the catheter body. In use, the guidewire may be disposed within lumen 56 over the flexible catheter body portion and exit the lumen at a point proximate the rigid portion 26 of the catheter. The guidewire can then re-enter proximal hole 55 into tip lumen 54 and exit through distal hole 43 into tip lumen. By moving the guidewire out of the rigid portion 26 of the catheter body, the guidewire will be prevented from entangling with the blade 28. Typically, tip lumen 54 will be disposed along a lower surface of the tip and lumen 56 will be disposed along one side of proximal portion 22 of the catheter body, such that the guidewire will be at a helical configuration. In various devices, tip lumen 54 and proximal lumen 56 can have any suitable combination of lengths. For example, in one device the tip lumen 54 can be between about 1 cm and about 5 cm in length, more preferably between about 2 cm and about 3 cm, and the proximal lumen can have a length between about 8 cm and about 20 cm. cm, more preferably between about 10 cm and about 14 cm.

Figures 12 to 16 illustrate an exemplary knife driver 34 of the present disclosure. As shown in Figures 12 and 13, the blade driver 34 can act as the handle for the user to manipulate the catheters 20 of the present disclosure as well as a power source. Typically, the blade actuators 34 of the present disclosure include a single input device, such as a lever 38 that controls the major operations of the catheter (e.g., axial movement to cause thrust, rotation to cause shear, and axial movement to cause shear). packaging). As shown in Figures 13 and 14, the blade driver 34 includes a power source 72 (eg, batteries), a motor 74, a microswitch 76 for driving the motor 74, and a connection assembly (not shown). to connect the drive shaft 36 to the drive motor 74. In some examples, the drive motor may rotate the drive shaft 36 between 1,000 rpm and 10,000 rpm, or more, if desired.

Figures 14-16 illustrate an exemplary method of operation of the blade driver 34. In use, the catheter will be guided to the target site with the blade driver disconnected and the blade in the neutral position (Figure 3B). The knife driver can be connected to the push lever 38 in a neutral position (FIG. 14), which indicates that the knife is closed, but not in a packed position. The user can then move the catheter (and blade drive unit, if desired) to position the distal portion 26 of the catheter adjacent to the target tissue. As shown in Figure 15, to activate the rotation of the blade, the push lever 38 can be moved proximally from the neutral position to move the blade proximal and out of the cutting window 32 (Figure 4B) and at the same time press microswitch 76 to activate motor 74. At the end of the cutting procedure, as shown in Figure 16, the user can push the push lever 38 fully forward to a distal position to push the blade into the packed position (Figure 5B). After the push lever has passed halfway, the microswitch 76 can be released to deactivate the blade before it reaches the packing position, so that the packing can

ES 2 387 807 T3 occur without the blade rotating. It should be appreciated that, although the figures illustrate the use of a push lever or thumb switch as an input device, the present description may use any other type of input device, such as labeled buttons (eg close window , reducing the bulk of the fabric, and packaging), or the like.

Advantageously, the blade actuator 34 provides automatic on / off control of the blade 28 which is keyed to the blade position. Such a configuration frees the user from the complicated task of remembering the sequence of operations to activate and deactivate the rotation and axial movement of the blade.

Although the blade driver 34 is illustrated as a disposable battery power unit, it should be appreciated that, in other examples, the blade driver may utilize other sources of power to control the blade driver. Furthermore, it should be appreciated that other blade drivers can be used with the present disclosure. Although not preferred, it is possible to have separate controls to control axial movement of the blade and rotation of the blade.

Some exemplary methods of the present disclosure will be described below. One method of the present disclosure comprises delivering a catheter to a target site in the body lumen. A distal portion of the catheter may be deflected relative to a proximal portion of the catheter to expose a tissue volume reduction device in the catheter. The body lumen can be reduced in tumor volume with the exposed tumor volume reduction device. Specifically, as shown schematically in Figure 17, a specific method comprises advancing a catheter to a target site (step 100). A blade can be rotated and moved out of the cutting window (steps 102, 104). Preferably, a distal portion of the catheter can be pivoted or biased to position the blade adjacent to the target material. The catheter and rotary blade can then be moved through the body lumen to remove the target material out of the body lumen (step 106).

As shown in Figures 18 and 19, the catheter can be advanced percutaneously through a guide catheter or sheath and over a conventional or imaging guide wire using conventional interventional techniques. The tumor reduction catheter 20 can be advanced over the guidewire and out of the guide catheter to the diseased site. As shown in Figure 18, the window 32 will typically be closed (with the blade or other tumor reducing device 28 in a first distal position). As shown in Figure 19, catheter 20 will typically have at least one hinge or pivot connection to allow pivotal movement about one or more rotational axes to improve delivery of the catheter within the tortuous anatomy without dislodging the guiding catheter or other sheath. The blade can be positioned close to the injury. Optionally, a transducer, IVUS, or other imaging kit can be used to verify the position of the tumor reduction catheter.

Once the position of the catheter is confirmed, the blade 28 will be retracted proximally and moved out of the cutting window 32 to its second exposed position. In some examples, the movement of the blade can deflect the distal portion of the catheter to increase the profile of the catheter at the target site. Blade movement is typically caused by proximal movement of lever 38 and pulling of drive shaft 36. The lever movement can be scaled in any desired ratio or in a direct 1: 1 ratio of movement between the handle and the blade. As the blade moves to the proximal side, it contacts the ramp or cam surfaces to guide the blade up and at least partially out of the cutting window 32. Additionally, as shown by date 80, the distal portion of catheter body 26 rotates around hinge 49 to provide a biasing force for the blade (and catheter body) to move toward the diseased area.

Then, as shown by arrow 82, the operator can move the entire catheter body 22 through the lesion to dissect the tissue. As blade 28 and catheter body 22 are advanced remotely through the lesion, tissue that is trapped between cutting edge 52 and cutting window 32 is cut from the body lumen. To retract tissue, the operator can stop pushing the device on the distal side and the blade can be advanced on the distal side into the cutting window by advancing the handle 38. During distal movement of the blade, the blade 28 it recoils over ramps 44 and directs the blade rearward into cutting window 32. Such movement causes the distal portion 26 of the catheter to move in line with the blade and proximal portion 24 (Figure 5B). When the blade has moved to its distal position, the blade removes the cut tissue and pushes the cut tissue into a collection chamber 53 at the distal tip 42. Optionally, after the blade 28 has pushed the tissue away, the lever 38 and thus the non-rotating blade 38 can be advanced on the distal side to pack the tissue into the collection chamber 53 (Figure 5B). The use of the blade to pack the cut tissue will allow the operator to collect multiple samples prior to withdrawing catheter 20 out of the body lumen. When you have determined that the collection chamber is full, the catheter can be withdrawn out of the body lumen and the collection chamber can be emptied.

In other methods, as shown in Figure 20, an input device is arranged in a first position to position a tissue removal element in a neutral position (step 120). The input device is activated to rotate the tissue removal member and to move the removal device axially.

ES 2 387 807 T3 removal of tissue to an active position (step 122). The input device can then be activated again to move the tissue removal element to a packaging position (step 124). In an exemplary method, the input device is a thumb lever or switch that can be moved in correspondence with movement of a cutter over the catheter. Therefore, as the lever is moved to the proximal side, the blade is rotated and moved to the proximal side to an open position. When the lever is moved to a distal position, the rotation of the blade can be stopped and the blade can be remotely moved to pack counted tissue into the collection chamber.

Referring to Figures 21 through 24, still another device 102 for cutting and / or removing material is shown. Device 102 has a cutter 104 which can be any suitable cutter 104, as described herein. Device 102 has an elongated body 106 and a display element 114 that is coupled to body 106. A cap or tip 108 is provided at the distal end of device 102. The lid 108 is movable from the stored position of Figures 21 and 22 to the working position of Figure 23, in which at least part of the cutting element 104 is exposed.

Cap 108 can be movable relative to elongated body 106 in any way. For example, cap 108 and body 106 can be coupled to each other with a slot and pin arrangement 107, so that cap 108 translates linearly relative to body 106. Cap 108 can be naturally deflected or retained in position. stored with the user operating the device to move the lid 108 to the working position. For example, stage 108 may be coupled to a lumen 110, such as a guidewire lumen, with the user pulling, or even compressing, lumen 110 and / or body 106 to move cap 108 into position. work position. Cap 108 has a longitudinal axis that can remain substantially parallel to the longitudinal axis of elongated body 106. In addition, cap 108 can be movable to a number of different positions, exposing varying amounts of cutting element 104, so that the depth of cut can be selected or varied by the user. The cap or tip 106 may have a recess or cavity 112 in which the material to be removed is contained, as described herein.

The display element 114 can be any suitable display element, such as an optical fiber or a lens or an ultrasound element. Display element 114 may be movable or fixed relative to body 106. Display element 114 is positioned on a radially outer, and preferably outermost portion, of body 106 so that element 114 can be pressed against or moved adjacent to tissue of interest. This can provide advantages when using certain types of display elements 114, such as optical elements, that can emit or receive energy, which is partially absorbed by the blood or other fluids present. Various examples of a suitable display element are described in United States Patent Nos. 6,191,862, 6,445,939, 6,134,003, 5,459,570 and 5,321,501.

Referring to Figures 24 and 25, there is shown yet another device 130 for cutting and / or removing material, in which the same or similar reference numerals refer to the same or similar structure. Device 130 can be used to cut or remove material from a vascular location using any method described herein. Device 130 has cutting element 104 that can be coupled to torque transmitting element extending through elongated body 106. A first pivot point 132 and a second pivot point 134 are positioned on opposite sides of the cutting element 104. When moved to the working position of FIG. 25, cutting element 104 moves into engagement with the tissue to be cut or removed. The device 130 may also have the display element 114 positioned on the radially outermost portion of the device 130. The display element may be moved from the stored position of Figure 24 to the working position of Figure 25. The device 130 it has a tip 135 that has a recess or cavity 112 or other structure to receive material to be removed. Device 130 can be naturally deflected into the working position or stored position, the other position being created by pulling a pull wire 137 on either side of device 130.

Referring to Figures 26A and 26B, another device is shown having an elongated body 142, which is deformable into a generally helical shape. Elongated body 142 is moved to the deformed or helical shape to help stabilize device 140 within the blood vessel. Stabilizing device 140 can be particularly useful when moving the entire device 140 through the blood vessel when removing material, as described herein. The helical shape of the body can help stabilize the device, depending on the particular shape of the vasculature, and can help in a specific way to resist or reduce twisting of the device 140 within the vasculature when the device is advanced during cutting. . The helical shape can be formed in any suitable way. Referring to Figures 27A and 27B, for example, a tube 144 can be cut in a pattern that naturally forms the helical shape when a compressive force is applied to tube 144. Tube 144 is contained in a sleeve 146 that retains the tube. tube 144, but allows tube 144 to deform when necessary. As can be seen from Figures 26A and 26B, the helical shape can be somewhat subtle. Surface lines 145 have been added for clarity in visualizing the shape of the body 142. In one embodiment, the diameter of the body 142 is 1.0 to 2.5 mm, while the diameter of the helical shape is 2.0 to 7.5 mm. In still another aspect, the helical shape has less than 360 degrees of rotation over its length and preferably about 180 degrees. The deformed portion of the elongated body 142, 152 can be relatively long. For example, the deformed part may be less than 1 cm

ES 2 387 807 T3 and may even be at least 2 cm, when measured in a relaxed or stretched configuration. Naturally, the elongated body 142 may also be deformed into a generally S-shape rather than the helical shape.

The shaft or body of Figures 26A and 26B can be used with any of the devices or methods described herein. For example, helical body 142 can be used with device 102 of Figures 21.23. Initial compression of tube 144 can cause body 142 to assume the helical shape. Continued compression of tube 144 displaces tip or cap 108 to expose cutting element. The entire device 102 can then be moved through the blood vessel to cut a continuous piece of material that is directed to the recess or cavity 112 in the lid 108. Therefore, it can be appreciated that many combinations are within the scope of the present. invention, any of the working ends of the device being used with any of the handles or elongated bodies.

Referring now to Figure 28, the present disclosure will further comprise kits including catheters 200, instructions for use 202, and packages 204. Catheters 200 will generally be as described above, and instructions for use ( IFU) 202 will describe any of the methods described above. Package 204 can be any conventional medical device package, including bags, trays, boxes, tubes, or the like. Instructions for use 202 will normally be printed on a separate piece of paper, but may also be printed in whole or in part on a portion of package 204.

Although the entire description above is a complete description of the preferred embodiments of the description, various alternatives, modifications and equivalents may be used within the scope of the appended claims. For example, although the preferred blades move proximally to move the blade out of the cutting window, alternative embodiments may move the blade remotely to move the blade out of the cutting window.

Additionally, in some embodiments, the tumor bulking assembly can be exposed through the window without causing deflection of the distal portion of the catheter. Furthermore, instead of having a distal tip that is rotatable relative to the proximal portion of the catheter, the catheter may include a shape memory material, such that the catheter forms an elbow or pre-bent shape when it reaches its area. objective.

Although the above invention has been described in detail for the purpose of clarity of understanding, it will be apparent that certain modifications may be applied within the scope of the appended claims.