Intravascular lithotripsy catheter with a movable emitter - Patent Application 20070122997

Abstract

A catheter for treating an occlusion in a body cavity includes an elongated tube extending longitudinally from a distal region to a proximal region, a flexible enclosure at least partially secured to the distal region of the elongated tube, a first shock wave emitter disposed along the elongated tube, and a second shock wave emitter disposed along the elongated tube and longitudinally translatable relative to the first shock wave emitter. The flexible enclosure has a working length d, and the center-to-center distance between the first and second shock wave emitters is adjustable between 2 mm and d.

Description

[Technical Field]

[0001] Priority This application claims priority to U.S. Provisional Patent Application No. 63 / 442,980, filed February 2, 2023, and U.S. Nonprovisional Patent Application No. 18 / 428,976, filed January 31, 2024, the disclosures of which are incorporated by reference in their entireties. This application is related to U.S. Patent Application No. 18 / 428,752, filed January 31, 2024, entitled "INTRAVASCULAR LITHOTRIPSY CATHETER WITH MOVABLE EMITTERS," the disclosure of which is incorporated by reference in its entirety.

[0002] Field of Disclosure The present disclosure relates generally to the field of medical devices and methods, and more particularly to a shockwave catheter device for treating calcified lesions in body cavities, such as calcified lesions and occlusions in the vascular system, and kidney stones in the urinary system. [Background technology]

[0003] background A wide variety of catheters have been developed for treating calcified lesions, such as those in the vasculature associated with arterial disease. For example, treatment systems for percutaneous coronary intervention or peripheral angioplasty use angioplasty balloons to widen the calcified lesion and restore normal blood flow within the vessel. In these types of procedures, a catheter carrying the balloon is advanced through the vasculature along a guidewire until the balloon is aligned with the calcified plaque. The balloon is then pressurized (usually to more than 10 atmospheres) to expand the balloon within the vessel, pushing the calcified plaque back into the vessel wall and widening the blocked area of ​​the vasculature. However, conventional angioplasty balloons are not always successful in widening the calcified lesion or vasculature due to the stiffness and hardness of the calcified tissue and / or plaque.

[0004] More recently, catheters have been developed that include shock wave emitters (e.g., one or more electrode pairs) for generating shock waves inside an angioplasty balloon; this procedure is referred to as intravascular lithotripsy ("IVL"), a technology pioneered by the present applicant, Shockwave Medical, Inc. Shockwave devices can be particularly effective in treating calcified lesions because the acoustic pressure from the shock waves can crack and destroy lesions near the angioplasty balloon without damaging the surrounding tissue. In this device, a catheter is advanced over a guidewire through the patient's vascular system until it is positioned proximal to and / or aligned with the calcified lesion within a body cavity. The balloon is then inflated with a conductive fluid (using a relatively low pressure of 2-4 atmospheres) so that the balloon expands into contact with the lesion, thereby bringing the shock wave emitter into close apposition to the lesion. The shock wave emitter can then be activated to generate acoustic shock waves that propagate through the wall of the angioplasty balloon and into the lesion. Once the lesion has been disrupted by the acoustic shock waves, the balloon can be further expanded to increase the cross-sectional area of ​​the lumen and improve blood flow through the vessel.

[0005] For electrohydraulic generation of acoustic shock waves, a conductive solution (e.g., saline) may be contained within an enclosure surrounding the electrode or may be flowed to the electrode through a lumen. Modification of calcified plaque is achieved by generating acoustic shock waves within the catheter via an electrical discharge across the electrode. Energy released by the electrical discharge enters the surrounding fluid faster than the speed of sound, generating acoustic shock waves. Energy from the electrical discharge may also generate rapidly expanding and collapsing vapor bubbles, which result in additional shock waves. These shock waves propagate radially outward, modifying calcified plaque within the blood vessel. For laser generation of acoustic shock waves, a laser pulse is transmitted into the fluid within the catheter and absorbed by the fluid. This absorption process rapidly heats and vaporizes the fluid, thereby generating vapor bubbles that rapidly expand and collapse, and acoustic shock waves that propagate outward, modifying calcified plaque. Acoustic shock wave intensity can be increased if a fluid is selected that exhibits strong absorption at the laser wavelength used. These examples of IVL devices are not intended to be a comprehensive list of potential energy sources for generating IVL shock waves.

[0006] Conventional treatments for calcified lesions in a patient's vasculature often involve mechanical alterations to the blood vessel, particularly atherectomy surgical procedures, which carry a relatively significant risk of embolization (shedding of debris), abrupt closure (vascular collapse), avulsion (laceration of vascular tissue), and / or perforation (puncture of vascular tissue). The use of IVL in place of or in combination with conventional treatments for calcified lesions can significantly reduce the risks of embolization and perforation while providing improved therapeutic outcomes in the removal of calcified lesions.

[0007] Given these advances, currently available shockwave catheters are limited by the length of the balloon and the location of the emitter within that balloon. In patients with lesions longer than the standard length of a balloon, physicians may choose to proceed with repeated cycles of inflation, shockwave release, deflation, and balloon repositioning to provide shockwave treatment to the entire length of a given lesion. When used over repeated cycles, concerns arise regarding the structural integrity of the balloon and its ability to maintain a deflated profile to cross the lesion. Furthermore, any procedure or technique that adds more time than necessary to the patient on the table is likely to cause procedural complications and is therefore not well accepted in clinical cases.

[0008] Therefore, to reduce procedure time and costs, longer balloons are desired by physicians to treat longer lesions. Simply using a longer balloon may not be sufficient, as the distance from the emitter to the relatively distant portion of the longer balloon may result in insufficient shock wave intensity at the tip of the balloon. Furthermore, simply increasing the number of shock wave emitters may not be practical or possible, as adding emitters tends to increase the catheter's profile and complicate its design. Such catheters also require substantially higher energy output from the power source. Furthermore, a large number of emitters may reduce the flexibility and compliance of the balloon region of the catheter, limiting the treatment site that can be reached.

[0009] Thus, there is an unmet need for a catheter and emitter assembly design that can deliver shock waves to relatively long lesions within a patient, thereby minimizing the intraoperative time the patient is undergoing treatment. Summary of the Invention [Means for solving the problem]

[0010] Quick Overview The foregoing objectives are realized in a catheter including a set of movable emitters that can be repositioned while deployed within a patient. More specifically, the innovations of the present disclosure enable an end user (e.g., a physician) to physically move the emitters of an IVL device along the catheter inside a relatively long balloon and position the emitters at various locations alongside a desired long calcified lesion to destroy calcium with shockwave technology.

[0011] Various examples may allow a user to inflate a very long balloon (e.g., a balloon with a working length of 100 mm to 300 mm) and leave it in place within a long lesion, and then move any number of emitters to desired locations along the length of the calcified lesion inside the inflated balloon. Also, this process can be accomplished with a slightly inflated or semi-inflated balloon, depending on the calcium structure of the artery, without the need to reposition the balloon at all.

[0012] In one or more embodiments, a catheter for treating an occlusion in a body cavity includes an IVL balloon with emitters mounted on a steerable tube.

[0013] In one or more examples, the catheter is configured for in situ customizable placement of emitters along the length of the balloon, thereby enabling optimal application of shockwave therapy with minimal repositioning of the balloon required by the physician. Various catheter embodiments enable efficient application of acoustic energy to calcified regions of the vessel and avoid indiscriminate application of shockwave therapy to non-calcified regions of the vessel. Various embodiments also enable longer IVL balloons to be developed with relatively lower power requirements. Various catheter embodiments can improve the flexibility, trackability, and / or deliverability of the overall catheter.

[0014] In one or more embodiments, the IVL catheter includes one or more shockwave emitters within an inflated IVL balloon that can be pushed distally or pulled proximally along its working length to a location identified by a physician as requiring shockwave treatment. In some embodiments, the emitters can be repositioned individually. In some embodiments, the emitters can be repositioned in small numbers (e.g., pairs). In some embodiments, the emitters can be completely repositioned within a connected assembly. Longitudinal adjustment can allow a relatively small number of emitters (e.g., one, two, three, four, or five emitters) to treat long lesions in a body cavity, achieving optimized energy delivery to the target area rather than a blanket dose over the entire length of the balloon, regardless of whether calcium is present at each emitter location. In some embodiments, safety stops are incorporated to prevent the emitters from being placed too close together.

[0015] In one or more embodiments, multiple shock wave emitters (e.g., six, seven, eight, nine, or more) can be positioned along the length of the balloon, and an elongate member having conductive regions can be translatably positioned within the balloon to electrically connect select shock wave emitters to a power source. In some embodiments, the elongate member can be connected at its proximal end to a handle for moving the elongate member distally and proximally. Such embodiments can result in a lower-profile catheter because fewer wires may be required to electrically connect each individual emitter to the power source, while still allowing for in situ customization for the physician. Also, such embodiments can advantageously be used with a power source having a lower power output than would typically be required to generate shock waves with multiple shock wave emitters.

[0016] In one or more embodiments, the shockwave catheter may include multiple emitters (e.g., 12 or more) positioned within the balloon and configured to generate shockwaves only at select emitters. In some embodiments, the shockwave catheter may be limited to a smaller number of total emitters (e.g., 8) that can be activated each cycle via a connector cable or input at the generator, allowing the physician to select the most critical locations along the length of the balloon and ensure that only those areas receive energy during that cycle. This approach allows for longer balloons within the current generator output and allows physician optimization of treatment locations.

[0017] The various examples described herein allow the end user to physically move the IVL emitter inside a very long balloon to position it in various locations in a long calcified lesion as desired to destroy calcium.

[0018] According to one aspect of the present disclosure, a catheter for treating an occlusion in a body cavity includes an elongate tube extending longitudinally from a distal region to a proximal region, a flexible enclosure at least partially secured to the distal region of the elongate tube, a first shockwave emitter disposed along the central tube, and a second shockwave emitter disposed along the central tube and longitudinally translatable relative to the first shockwave emitter.

[0019] The flexible enclosure may have a working length d, and the center-to-center distance between the first shockwave emitter and the second shockwave emitter may be adjustable between 2 mm and d.

[0020] The first shockwave emitter may include a first pair of shockwave emitters and the second shockwave emitter may include a second pair of shockwave emitters that are translatable as a pair relative to the first pair.

[0021] The first shockwave emitter may include a first plurality of shockwave emitters and the second shockwave emitter may include a second plurality of shockwave emitters translatable as a group relative to the first plurality of emitters.

[0022] The catheter may include a third shockwave emitter that is independently translatable relative to the first and second shockwave emitters.

[0023] The catheter may include a safety stop fixedly disposed on the elongate tube and configured to separate the first and second shockwave emitters by a center-to-center distance of 2 mm or more.

[0024] The first shockwave emitter may be translatable longitudinally (ie, in the proximal-distal direction).

[0025] The catheter may include a proximal handle configured to control movement of the emitter assembly.

[0026] The proximal handle may include a first thumbwheel ratchet for controlling movement of the first shockwave emitter and a second thumbwheel ratchet for controlling movement of the second shockwave emitter.

[0027] The flexible enclosure may be an angioplasty balloon having a working length of at least 50 mm.

[0028] Each of the first and second shockwave emitters may include one or more electrode pairs, and each of the one or more electrode pairs may include an outer electrode and an inner electrode.

[0029] According to one aspect of the present disclosure, a catheter for treating a lesion in a body cavity may include an elongate tube extending longitudinally from a distal region to a proximal region, an enclosure fixed circumferentially around at least a portion of the distal region of the elongate tube, a proximal emitter assembly fixedly disposed on the central tube and inside the enclosure, a distal emitter assembly fixedly disposed on the central tube and inside the enclosure, and a longitudinally translatable elongate member having a distal region movably disposed along the central lumen, the longitudinally translatable elongate member configured to supply power to the proximal emitter assembly in a proximal configuration and to supply power to the distal emitter assembly in a distal configuration.

[0030] The proximal emitter assembly may include one or more electrically connected proximal electrode pairs including a first proximal electrode electrically connected to the power source, and in the proximal configuration, the longitudinally translatable energy guide may be electrically connected to a second proximal electrode of the proximal electrode pair such that each of the one or more proximal electrode pairs generates a shock wave upon application of a voltage pulse from the power source to the proximal emitter assembly.

[0031] The distal emitter assembly may include one or more electrically connected distal electrode pairs including a first distal electrode electrically connected to a power source, and in the distal configuration, the longitudinally translatable power source member may be electrically connected to a second distal electrode of the distal electrode pair such that each of the one or more distal electrode pairs generates a shock wave upon application of a voltage pulse from the power source to the distal emitter assembly.

[0032] The one or more proximal electrode pairs and the one or more distal electrode pairs may each include an inner electrode and an outer electrode fabricated with a conductive sheath.

[0033] In the proximal configuration, the shock waves may be generated in the proximal emitter assembly rather than the distal emitter assembly, and in the distal configuration, the shock waves may be generated in the distal emitter assembly rather than the proximal emitter assembly.

[0034] The distal region of the translatable elongate member may include a radiopaque marker.

[0035] The catheter may include a proximal handle for controlling movement of the elongate member between the proximal and distal configurations.

[0036] According to one aspect of the present disclosure, a method for treating an obstruction in a body cavity includes providing a catheter including: a central tube extending from a proximal region to a distal region and defining a longitudinal direction and having a central lumen; an enclosure sealed to and surrounding at least a portion of the distal region of the central tube; and a shock wave emitter assembly including a first shock wave emitter and a second shock wave emitter disposed along the central tube within the enclosure, the first and second shock wave emitters being longitudinally movable relative to one another; inserting the catheter into the body cavity and positioning the enclosure adjacent the obstruction; filling the enclosure with a conductive fluid and securing the enclosure to a wall of the body cavity; moving the shock wave emitter assembly longitudinally 1 mm or less away from the obstruction or restriction; and generating one or more shock waves from at least one shock wave source.

[0037] The method may include imaging the body cavity with one or more of x-ray fluorescence, intravascular ultrasound, and optical coherence tomography, and the shockwave emitter assembly includes an imaging marker.

[0038] Each shockwave emitter may include an electrode pair, and generating the one or more shockwaves includes applying a high voltage pulse from a power source.

[0039] The high voltage pulse may include a voltage of 1 kV to 15 kV.

[0040] According to one aspect, a method for treating an occlusion in a body cavity includes providing a catheter having a central tube extending longitudinally from a distal region to a proximal region, an enclosure circumferentially fixed around at least a portion of the distal region of the elongated tube, a first emitter assembly fixedly disposed on the central tube, a second emitter assembly fixedly disposed on the central tube, and a longitudinally translatable elongated member having a distal region movably disposed along the central lumen; inserting the catheter into the body cavity to position the enclosure adjacent to the occlusion; filling the enclosure with a conductive fluid to secure the enclosure to a wall of the body cavity; moving the distal region of the elongated member toward the first emitter assembly; and supplying power to the first emitter assembly via the elongated member to generate one or more shock waves at the first emitter assembly.

[0041] When power is supplied to the first emitter assembly, one or more shock waves may not be generated in the second emitter assembly.

[0042] The method may include moving a distal region of the elongate member to a second emitter assembly, supplying power to the second emitter assembly via the elongate member, and generating one or more shock waves at the second emitter assembly.

[0043] The first emitter assembly may include one or more electrode pairs, and moving the distal region of the elongate member to the first emitter assembly may include electrically connecting the distal region of the elongate member to the first emitter assembly. [Brief explanation of the drawings]

[0044] Exemplary aspects of the present disclosure are described in detail below with reference to the following drawings: It is intended that the embodiments and figures disclosed herein should be considered illustrative and not restrictive.

[0045] [Figure 1A]FIG. 1A shows an exemplary catheter having a movable array of emitters inside an angioplasty balloon, the emitters being individually movable along the length of the catheter shaft, focusing an exemplary wiring configuration, according to an embodiment of the present disclosure.

[0046] [Figure 1B] FIG. 1B illustrates an exemplary catheter having a movable array of emitters biased toward a proximal side of the enclosure, according to an embodiment of the present disclosure.

[0047] [Figure 1C] FIG. 1C illustrates an exemplary catheter having an array of emitters movable in pairs along the length of the enclosure, according to an embodiment of the present disclosure.

[0048] [Figure 1D] FIG. 1D illustrates an exemplary catheter having an array of individually movable emitters along the length of the enclosure, according to an embodiment of the present disclosure.

[0049] [Figure 1E] FIG. 1E illustrates an exemplary catheter having a movable array of emitters biased toward a distal side of an enclosure, according to an embodiment of the present disclosure.

[0050] [Figure 1F] FIG. 1F illustrates an exemplary catheter having a movable array of emitters with stops, according to an embodiment of the present disclosure.

[0051] [Figure 1G] FIG. 1G shows a cross-sectional view of an exemplary catheter having a movable array of emitters according to an embodiment of the present disclosure.

[0052] [Figure 2A] FIG. 2A is a diagram illustrating an exemplary catheter within a vasculature, the catheter having a movable array of emitters inside an angioplasty balloon at a distal location, according to an embodiment of the present disclosure.

[0053] [Figure 2B] FIG. 2B is a diagram illustrating an exemplary catheter within a vasculature, the catheter having a movable array of emitters inside an angioplasty balloon at a central location, according to an embodiment of the present disclosure.

[0054] [Figure 2C] FIG. 2C is a diagram illustrating an exemplary catheter within a vasculature, the catheter having a movable array of emitters inside an angioplasty balloon at a proximal location, according to an embodiment of the present disclosure.

[0055] [Figure 3A] FIG. 3A shows a side view of a portion of an exemplary catheter having multiple movable emitter carriers, according to an embodiment of the present disclosure.

[0056] [Figure 3B] FIG. 3B shows a cross-sectional view of the catheter of FIG. 4A.

[0057] [Figure 4A] FIG. 4A illustrates a first configuration of an exemplary catheter having a longitudinally translatable member according to an embodiment of the present disclosure.

[0058] [Figure 4B] FIG. 4B shows a second configuration of the catheter shown in FIG. 4A.

[0059] [Figure 5A] FIG. 5A illustrates a first configuration of an exemplary catheter having a longitudinally translatable member according to an embodiment of the present disclosure.

[0060] [Figure 5B] FIG. 5B shows a second configuration of the catheter shown in FIG. 5A.

[0061] [Figure 6]FIG. 6 shows an exemplary flow chart for using a catheter having a movable array of emitters according to an embodiment of the present disclosure.

[0062] [Figure 7] FIG. 7 shows another exemplary flow chart for using a catheter having a movable array of emitters, according to an embodiment of the present disclosure.

[0063] [Figure 8] FIG. 8 illustrates an exemplary catheter having a tapered enclosure according to an embodiment of the present disclosure.

[0064] [Figure 9] FIG. 9 illustrates an exemplary catheter system having a rapid exchange port according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0065] Detailed Description The following description is presented to enable any person skilled in the art to make and use the various embodiments and aspects thereof disclosed herein. Descriptions of specific devices, assemblies, techniques, and applications are provided by way of example only. Various modifications to the examples described herein will be readily apparent to those skilled in the art, and the general principles described herein may be applied to other examples and applications without departing from the spirit and scope of the various embodiments and aspects thereof. Thus, the various embodiments and aspects thereof are not intended to be limited to the examples described and shown herein, but are to be accorded the scope consistent with the claims.

[0066] Efforts have been made to improve the design of electrode assemblies included in shock wave and directional cavitation catheters. For example, low-profile electrode assemblies have been developed that reduce the crossing profile of the catheter, allowing the catheter to more easily navigate calcified vessels and deliver shock waves into more severely occluded areas of the vasculature. Examples of low-profile electrode designs can be found in U.S. Pat. Nos. 8,888,788, 9,433,428, and 10,709,462, as well as U.S. Patent Application Publication No. 2021 / 0085383, all of which are incorporated herein by reference. An example of a low-profile catheter having electrodes configured for insertion after balloon dilation can be found in U.S. Pat. No. 10,357,264, which is incorporated herein by reference. Other catheter designs have improved shock wave delivery, for example, through specific electrode structures and configurations, thereby directing shock waves in a forward direction to disrupt tighter and more difficult-to-cross occlusions within the vasculature. Examples of forward-activation catheter designs can be found in U.S. Patent Nos. 10,966,737, 11,478,261, and 11,596,423, as well as U.S. Patent Application Publication Nos. 2023 / 0107690 and 2023 / 0165598, all of which are incorporated herein by reference. U.S. Patent No. 11,779,363, incorporated herein by reference, describes positioning a shockwave emitter to promote constructive interference of acoustic waves.

[0067] As used herein, the term "electrode" refers to a conductive element (typically made of a metal or alloy) that receives and then emits current to another conductive element. Thus, as used herein, an "electrode pair" refers to two electrodes positioned adjacent to one another such that current supplied to one electrode is transmitted across a gap (also called a "spark gap") between the two electrodes (e.g., between a first electrode and a second electrode, or vice versa, with an insulator separating the two electrodes if necessary, and through a conductive fluid or gas between them). Furthermore, as used herein, an "emitter" refers to a structure having one or more electrode pairs. Emitters may be singular, paired, or otherwise arranged together so as to be electrically connected as an emitter assembly. Shock waves can be generated at each electrode pair of an emitter. In some circumstances, one or more electrode pairs positioned across one or more emitters may be referred to as an "electrode assembly."

[0068] Typically, long calcified lesions in arteries and other vascular systems present challenges for many interventional devices and users. A user (e.g., a physician) must assess the length and diameter of the calcified lesion before determining the diameter and length of the balloon catheter they wish to use during the procedure. To treat relatively long calcified lesions, a user may prefer to use a single long balloon to treat such lesions and select a balloon having a length of approximately one hundred to three hundred millimeters (100 mm to 300 mm) and a diameter of two to thirty millimeters (2 mm to 30 mm) when inflated.

[0069] In the current market for IVL devices, the use of longer balloons presents different catheter profiles and therefore different requirements for ensuring proper treatment function. When considering modifications to achieve treatment performance with longer balloons, it is important to keep in mind that there is a direct correlation between the number of emitters (given a fixed energy source) and the effectiveness of IVL therapy. In other words, as the number of emitters increases to accommodate longer balloons for longer lesions, the available energy to satisfy the increased number of emitters decreases, potentially resulting in reduced IVL efficacy. While this problem can be partially addressed by adding more channels to the IVL generator and system, this solution results in a catheter with more circuits and wires, resulting in a larger profile that may have more difficulty reaching smaller peripheral vasculature or crossing severely occluded lesions. Currently available IVL devices have two to five emitters within the balloon, where the emitters are adhesively bonded to the catheter shaft and therefore fixed in place. Additionally, these devices have balloons with diameters of approximately twelve millimeters to sixty millimeters (12 mm to 60 mm), and the working length of the balloon along the catheter is between one hundred ten millimeters and one hundred thirty-eight millimeters (110 mm to 138 mm). This allows the physician to move the balloon over the catheter guidewire along the length of the lesion to treat the entire length of the lesion through cycles of positioning, inflation, shockwave therapy, and deflation. The emitters on these devices can deliver pulses one at a time, two at a time, all at the same time, and / or in an alternating or sequential pattern along the length of the catheter and balloon.

[0070] Described herein are catheters, balloons, and IVL circuits incorporating design elements that enable treatment of relatively long calcified lesions using an enclosure with an array of movable emitters. In such implementations, it is generally not necessary to undergo the inflation-deflation cycles that require repositioning the balloon for shockwave therapy as described above. Rather, a single balloon allows for movement of emitters within the balloon to deliver shockwave treatment to the target area of ​​a given long lesion. This can be accomplished with a slightly inflated or semi-inflated long balloon, depending on the calcium stenosis in the artery or other vessel.

[0071] In some embodiments, as shown, each emitter is mounted on a movable emitter carrier and includes a cylindrical sheath (also referred to as a ring or band) surrounding the movable emitter carrier. The cylindrical sheath is formed from a conductive material (e.g., a metal or alloy) that forms a first electrode surface of an electrode pair. The sheath may include a cutout area (e.g., a central circular hole, an arcuate cutout on the edge of the sheath, etc.) that provides an unobstructed electrical path to a second conductive material, specifically a conductive member (e.g., copper wire, a flat coil, etc.) positioned below or within the movable emitter carrier, thereby forming the second electrode surface of the electrode pair. In this emitter configuration, the conductive portion of the sheath may be referred to as the outer electrode, and the wiring may be referred to as the inner electrode. Current delivered across the emitter can jump across the space between the two electrode surfaces, also referred to as the "spark gap," generating the shock wave described above. Either of the electrode surfaces may be the anode or cathode, depending on the polarity of the pulse delivered across the emitter.

[0072] In many implementations, each emitter will have two electrode pairs, and current can pass from one electrode pair on the emitter to the other by flowing across the conductive material of the sheath. The electrode pairs on each emitter can be positioned to generate shock waves in opposite directions (i.e., arranged 180 degrees apart from each other around the catheter) or in converging or bias directions (i.e., arranged less than 180 degrees apart from each other around the catheter). In alternative implementations, the emitter can have three, four, five, or six electrode pairs arranged around the circumference of the emitter. The various emitters of the movable emitter array can be electrically connected to each other in series or parallel over one or more electrical channels.

[0073] 1A shows a catheter 200. As part of the catheter 200, a balloon 208 has a proximal end and a distal end, with the proximal end of the balloon 208 attached to an outer balloon shaft and the distal end of the balloon 208 attached to an inner shaft. The balloon 208 may be attached at both locations such that the interior volume of the balloon 208 is sealed, for example, by adhesives, clamps, heat seals, pressure seals, or a combination thereof. At the proximal end, the balloon 208 is attached around the balloon shaft such that the space between the balloon shaft and the movable emitter carrier can be used as a channel for fluid to enter and inflate the balloon 208 (and correspondingly, deflate the balloon 208). In some embodiments, another type of shielding enclosure (e.g., a cap or flexible polymer tubing) may be used in place of the angioplasty balloon.

[0074] The working length of the balloon along the catheter (e.g., working length 209) can be between fifty millimeters and five hundred millimeters (50 mm to 500 mm). The working length of the movable emitter carrier within the volume of the balloon can be up to the full length of the balloon. In some embodiments, the distance from the most proximal emitter to the most distal emitter can be up to the full working length of the balloon.

[0075] In some embodiments, on a movable emitter carrier, each emitter may be spaced three millimeters to twenty millimeters (3 mm to 20 mm) apart from one another. The emitters may be electrically grouped (wired together) on various channels of a circuit, where the emitters may be wired individually, in pairs, triplets, etc., and may be wired in series or in parallel. The power source supplying electricity to the emitters may provide a voltage in the range of about 1,000 V to about 15,000 V.

[0076] In various embodiments, a catheter having a movable emitter carrier with one or more shock wave emitters may include a relatively long enclosure (e.g., an angioplasty balloon). For example, the enclosure may have a working length that is 50% to 200% longer than the end-to-end distance from the most proximal emitter to the most distal emitter. To use such a device, the balloon may be advanced through a body cavity to the lesion. The user may then inflate the balloon with a fluid (e.g., saline) to a relatively low pressure (e.g., less than 5 atm) or until the working area of ​​the balloon is in close proximity to (i.e., in contact with) the lesion. Upon inflation, an emitter assembly mounted on the movable emitter carrier may be advanced through the balloon volume to a first location (e.g., a location proximal to the balloon) to treat the lesion or a portion of the lesion at the first location with shock wave therapy. The movable emitter carrier may then be further advanced to a second location (e.g., a location distal to the first location) to treat a new lesion or a new region of the same lesion. In some embodiments, treatment can begin at the distal region of the balloon or at the central region of the balloon. Advantageously, shockwave therapy can be customized to any particular lesion. For example, if there is a greater degree of calcification in the distal region of the balloon than in the proximal region, more shockwaves may be generated by the emitter at the distal location than at the proximal location. By adjusting shockwave therapy in this manner, unnecessary excess shockwave generation can be avoided, preserving the life of the device. Furthermore, such a device is less complex to design than a device that separately supplies power (e.g., by wire) to multiple emitters positioned along the length of an angioplasty balloon.

[0077] 1A illustrates an exemplary catheter 200 according to one or more embodiments. The catheter 200 includes a movable array of emitters 210 inside an angioplasty balloon 208, where the emitters are individually movable along the length of the catheter shaft, focusing an exemplary wiring configuration. The movable array of emitters 210 may include emitters 211, 212, 213, and 214. In some examples, each emitter 211, 212, 213, and 214 is individually movable within the working length 209 of the balloon 208. For example, emitter 211 may be movable between the proximal end of the working length 209 and the location of emitter 212 relative to the locations of the other emitters.

[0078] As can be seen more clearly in the enlarged image of FIG. 1A, emitters 211, 212, 213, and 214 are connected by conductors (e.g., wires) 231, 232, 233, and 234, respectively, that are electrically connected at their proximal ends to a high-voltage power supply. Each of emitters 211, 212, 213, and 214 is also electrically connected to a common return wire (not shown) that is also connected to the high-voltage power supply. In embodiments in which each emitter is individually movable, each emitter is connected to a power supply by a conductor. In embodiments in which emitters are movable in electrically connected pairs or groups, each pair or group is connected to a power supply by a single conductor (e.g., as shown in FIGS. 1C and 1E).

[0079] In some embodiments, and as shown in FIG. 1F , one or more stops 230 may be provided between adjacent emitters to ensure the emitters are spaced apart from one another. In some embodiments, the stops 230 may have a proximal-to-distal length of at least 1 mm. In some embodiments, the length of the stops 230 from proximal to distal may be at least 2 mm. These stops may be translatable by the emitter (or emitter pair / group). In some cases, the stops may be provided on the proximal handle. For example, the proximal handle may be provided with a thumbwheel ratchet (or another type of control) to individually control the translation of each emitter (or emitter pair / group) within the balloon 208, and stops may be provided to ensure adjacent emitters are spaced apart from one another. Sufficient spacing between adjacent emitters (e.g., at least 2 mm) may ensure optimal pressure output during shockwave therapy.

[0080] 1B-1E show an exemplary catheter having a movable array of emitters inside an angioplasty balloon, where the emitters are movable along the length of the catheter shaft, and further show exemplary deployment configurations for the movable emitters within the angioplasty balloon.

[0081] FIG. 1B shows individually movable emitters configured to be biased toward the proximal end of the balloon to treat a lesion proximal to the balloon. Once treatment is performed on the proximal side of the balloon, one or more emitters can be moved distally to treat one or more lesions in more distal regions of the balloon. Advantageously, in these embodiments, the emitters are individually wired, so that shock waves do not need to be generated indiscriminately by all emitters within the balloon. In some embodiments, the emitters may be connected to different power outputs at the proximal end so that the emitters can generate higher or lower energy shock waves. Thus, an emitter (or multiple emitters) connected to a higher power output can be positioned at a more constricted lesion (or region of the lesion). Such energy distribution can help preserve the life of the device.

[0082] 1C shows emitters arranged in adjacent pairs biased toward the center of the balloon. In this embodiment, the emitters are configured to move in pairs (e.g., emitter pair 611 and 612). The emitters in each emitter pair may be physically and electrically connected.

[0083] FIG. 1D shows another embodiment of individually movable emitters spaced approximately equidistant from each other along the length of the balloon.

[0084] 1E shows another IVL catheter with movable emitters, according to one or more embodiments. Like some of the previous embodiments, this catheter includes a group of translatable shockwave emitters 613 within the working area of ​​the balloon. However, in contrast, the emitters 613 may not be retractable outside the balloon.

[0085] FIG. 1G shows a cross-sectional view of an IVL catheter 680 having a longitudinally movable emitter (i.e., movable along a proximal-distal axis x) according to one or more embodiments. The cross-section is taken at a proximal region (proximal to any emitters) of a balloon 681, which is shown in an inflated state in FIG. 1G. The catheter 680 includes an inner shaft 682 that is tubular in structure and defines a guidewire lumen 699. A first movable emitter carrier 683 is disposed externally of the inner shaft 682. A second movable emitter carrier 684 is disposed externally of the first movable emitter carrier 683. The first movable emitter carrier 683 is translatable along the x-axis across the inner shaft 682. The second movable emitter carrier 684 is longitudinally translatable across the inner shaft 682 and the first movable emitter carrier 683. In various embodiments, the two movable emitter carriers are independently movable to move a first emitter assembly positioned on the first emitter carrier and a second emitter assembly positioned on the second emitter carrier (similar to the two grouped emitters shown in FIG. 1E). Each emitter carrier includes one or more shockwave emitters at its respective distal region. Each emitter carrier may additionally include a groove or lumen for positioning an energy guide (e.g., a wire or optical fiber) extending distally from a power source (e.g., a high-voltage power supply or laser) to one or more emitters. Although only two emitter carriers are shown in FIG. 1G, additional concentric emitter carriers may be included, and in some embodiments, an IVL catheter has three, four, five, or more independently movable emitter assemblies (where each emitter assembly includes one or more shockwave emitters).

[0086] In some embodiments, the innermost movable emitter carrier is movable to the distal-most region of the balloon. For example, the first emitter carrier 683 can be translated to the distal-most region of the balloon. The second emitter carrier 684 can be translated to the location of the first emitter assembly, but cannot be translated more distally than the first emitter assembly. In other words, the first emitter carrier moves the more distal emitter assembly, and the second emitter carrier moves the more proximal emitter assembly.

[0087] 2A-2C illustrate an exemplary catheter 100 within a vasculature, the catheter having a movable array of emitters inside an angioplasty balloon, shown in a distal position in FIG. 2A, a central position in FIG. 2B, and a proximal position in FIG. 2C. As shown, calcified regions of the vascular tissue are indicated by "C," and regions of the vascular tissue where the calcification has been broken apart by shock waves are indicated by "B." Starting in FIG. 2A, an inflated balloon 108 extends along the entire length of the vascular tissue containing the calcification. A movable emitter carrier 104 extends along the length of the inner shaft 106 to the distal end of the balloon 108, and a movable emitter array 110 is positioned at the distal end of the movable emitter carrier 104. Thus, the movable emitter array 110 is adjacent to the calcification at the distal end of the target lesion within the vascular tissue. As shown, the emitters of the movable emitter array 110 generate shock waves that disrupt calcification in the distal portion of the lesion.

[0088] 2B, the movable emitter carrier 104 is pulled distally back along the length of the catheter 100 so that the movable emitter array 110 is adjacent to calcifications in the central region of a target lesion in the vascular tissue. As shown, the emitters of the movable emitter array 110 generate shock waves that destroy the calcifications in the central portion of the lesion. It should be understood that the central region of a long calcified lesion may require multiple repositioning of the movable emitter array 110 to provide treatment to the entire length of the central region of the calcified lesion.

[0089] 2C, the movable emitter carrier 104 is pulled distally back along the length of the catheter 100 so that the movable emitter array 110 is adjacent to the calcification proximal to the target lesion within the vascular tissue. As shown, the emitters of the movable emitter array 110 generate shock waves that destroy the calcification in the proximal portion of the lesion.

[0090] It should be understood that more than one cycle of shockwave generation can be used to break up the calcification in any given region of the calcified tissue, and that various regions of the calcified tissue may require relatively more or less shockwave treatment compared to one another. It should be further understood that the sequence of translating the movable emitter array 110 can proceed from distal to proximal as illustrated in Figures 2A-2C, but can alternatively proceed in a proximal-to-distal sequence, a medial-to-proximal sequence, or a medial-to-distal sequence. Furthermore, the movable emitter array 110 can be moved to repeat the treatment two or more times at locations along the calcified tissue.

[0091] Materials that can be used for components such as the outer shaft 102, the movable emitter carrier 104, and the inner shaft 106 can be extruded or molded polymers, or functional equivalents that are safe for use inside a patient's body. Such materials can include polyether block amides, polytetrafluoroethylene, nylon, or other polymers.

[0092] 3A and 3B show a portion of an IVL catheter 700 having independently movable emitters, according to one or more embodiments. As shown in the side schematic view of FIG. 3A, the catheter 700 includes first, second, third, and fourth movable emitter carriers 701-704. The first emitter carrier 701 extends to a first emitter 711, the second emitter carrier 702 extends to 712, the third emitter carrier 703 extends to an emitter 713, and the fourth emitter carrier 704 extends to an emitter 714. Each of the emitter carriers 701-704 is independently translatable relative to the other emitter carriers along a direction parallel to the longitudinal axis x. Rather than the emitter carriers being stacked concentrically on one another (as in the example shown in FIG. 1G), each of the emitter carriers of catheter 700 includes one or more legs arranged circumferentially next to one another, as shown in cross section in FIG. 1B. Each of emitter carriers 701-704 extends distally from a proximal handle or hub to an emitter assembly. While the example in FIG. 1A shows each emitter carrier extending to a single emitter, in other embodiments, each emitter carrier may extend to an emitter assembly having more than one emitter electrically connected to each other. Having such a slotted emitter carrier design can help reduce the catheter profile and make the device more navigable through narrow body cavities.

[0093] 4A and 4B illustrate an exemplary catheter 300 according to one or more aspects of the present disclosure. The catheter 300 includes multiple shockwave emitters 311-325 arranged along a central elongate member 330 and a longitudinally translatable member 340 electrically connected at its proximal end to a power source (not shown). While the longitudinally translatable member 340 is shown in the figures as being external to the emitters, in some embodiments, the translatable member 340 may be translatable within a groove or lumen in the central elongate member 330, which may help keep the translatable member 340 aligned during translation and positioning. Each of the shockwave emitters 311-325 includes an electrode pair with a spark gap, and the first electrode of the electrode pair is electrically connected to a return wire 302, which is electrically connected to a power source. The longitudinally translatable member 340 may include a conductive region 342. Figure 4A shows a configuration in which the translatable member 340 is positioned so that the conductive region 342 is in electrical contact with the second electrode of the electrode pair of the emitter 311. In this configuration, a high-voltage pulse from a power source can be delivered through the translatable member 340 across the electrode pair of the emitter 311 to generate shock waves. Figure 4B shows another configuration of the catheter 300 in which the translatable member 340 is advanced distally than in the configuration shown in Figure 4A so that the longitudinal translatable member 340 is electrically connected to the emitter 314. In this configuration, a high-voltage pulse is delivered to the emitter 314 to cause shock wave generation at the emitter 314.

[0094] 5A and 5B illustrate an exemplary catheter 400 according to one or more aspects of the present disclosure. The catheter 400 includes multiple shock wave emitters 411-424 and a longitudinally translatable member 440 electrically connected to a power source (not shown). Each emitter may be electrically connected to one or more other emitters such that when the translatable member 440 is electrically connected to that emitter, shock waves are generated in each of the connected emitters. FIG. 5A illustrates a first configuration in which the translatable member 440 is electrically connected to shock wave emitters 411-417 that are connected in series with each other and electrically connected to a first return wire 402. When a high-voltage pulse is applied to the shock wave emitters 411-417, shock waves are generated in each of the emitters 411-417. FIG. 5B shows a second configuration in which the translatable member 440 is electrically connected to shock wave emitters 418-424, which are connected in series with each other and electrically connected to a second return wire 404. When a high-voltage pulse is applied to the shock wave emitters 418-424, shock waves are generated in each of the emitters 418-424. In other embodiments, a longitudinally translatable member may power pairs of emitters. Emitters positioned adjacent thicker portions of the lesion may be supplied with relatively higher energy (e.g., higher voltage pulses) than emitters positioned adjacent thinner portions of the lesion. Additionally or alternatively, multiple emitters may be positioned adjacent thicker portions of the lesion than thinner portions. Steps 10004 and 10005 may be repeated to treat additional lesion sites. As with other IVL treatment methods, the enclosure may be deflated and inflated with saline (or other conductive fluid) to remove any accumulated air bubbles within the enclosure. After the procedure, in step 10006, the enclosure may be deflated and the IVL catheter may be withdrawn or moved to a different lesion.

[0095] In one or more embodiments, the positioning of the emitters can be imaged by imaging methods such as x-ray fluoroscopy. Thus, in some embodiments, each of the movable emitters (or individual emitter assemblies) may include a radiopaque marker. In some embodiments, the location of the emitters may be indicated by markings on the proximal end of the catheter.

[0096] FIG. 7 is a flowchart of a method for using an IVL catheter with a movable conductive member, according to one or more embodiments. The catheter in these embodiments is similar to that shown in FIGS. 4A, 4B, 5A, and 5B and includes multiple emitters (or emitter assemblies) that are not electrically connected to a power source. In step 11001, the catheter is advanced through a body lumen. In step 11002, an enclosure of the catheter is positioned adjacent to a lesion in the body lumen. In step 11003, the enclosure is inflated with a fluid to a relatively low pressure (e.g., less than 5 atm) so that the enclosure is apposed to the lesion and the vessel wall. In one or more embodiments, the enclosure is fabricated from a semi-compliant material so that it can conform to the shape of the lesion when inflated to the relatively low pressure. In step 11004, a conductive region of the movable conductor is moved to and electrically connected to a first emitter of the multiple emitters. In some embodiments, the movable conductor is retrieved into a location proximal to the enclosure during delivery before being inserted into the balloon in step 11004. This helps reduce the profile of the catheter during delivery and also improves flexibility of the distal region of the catheter. In step 11005, a high-voltage pulse is delivered to a first emitter, generating shock waves in the electrically connected emitters. In some embodiments, the first emitter is electrically connected to one or more emitters (e.g., in series or parallel) such that shock waves are generated in each of the connected emitters when the high-voltage pulse is delivered. In step 11006, the conductive member moves to a second emitter (or a second set of electrically connected emitters) at a different location within the enclosure. In step 11007, shock waves are generated in one or more electrically connected emitters. Steps 11006 and 11007 may be repeated with a different emitter (or emitter assembly) to generate shock waves in other regions of the enclosure. Between rounds of shock wave generation, the enclosure can contract and expand to remove any accumulated air bubbles.In step 11008, once shockwave therapy is completed at the lesion being treated, the enclosure is deflated.

[0097] 8 illustrates an exemplary catheter having a movable array of emitters 110 inside a tapered angioplasty balloon 109 at a distal location. The use of a tapered angioplasty balloon 109, whose distal end is narrower than its proximal end, can provide improved access to vascular systems that may be partially occluded by plaque (e.g., chronic total occlusion (CTO)), where the narrow end of the tapered angioplasty balloon 109 can act as a wedge to push into and through the plaque. In situations where the tapered angioplasty balloon 109 is in close proximity to or in contact with the device-facing surface of the vascular plaque, the movable emitter carrier 104 can be positioned at a distal location to generate shock waves at the entry point of the vascular plaque to disrupt the surrounding lesion calcification. Relaxing or loosening the vasculature at that location can then allow the tapered angioplasty balloon 109 to be pushed further along the vessel and through the vascular plaque, ultimately generating shock waves along the entire length of the calcified lesion. Tapered angioplasty balloons can also be implemented in body lumens that are naturally tapered, hi some embodiments, the tapered angioplasty balloon has a tapered working region with a taper angle (e.g., angle α) of up to 20 degrees.

[0098] In some examples described above, the catheter may be configured to be advanced into a body lumen over a guidewire, commonly referred to as an "over-the-wire" (OTW) configuration. In an alternative implementation, as shown in FIG. 9, the catheter may be arranged as part of a "rapid-exchange" (Rx) configuration, in which instruments are swapped in and out of the patient through a larger lumen during a procedure. In FIG. 9, a guidewire 150 and an inner shaft 106 are included, with the inner shaft 106 including a guidewire lumen. The guidewire 150 can exit the inner shaft 106 at a port 151 distal to the proximal end of the catheter (not shown) and proximal to the distal end of the balloon 108. The emitter carrier 104 moves back and forth on the stationary inner shaft 106. The inner shaft 106 may be coupled to the proximal tip of the balloon to keep the Rx guidewire stable during the procedure. The catheter 100 may include a fluid lumen extending through the outer shaft 102 to the proximal end of the catheter 100 for delivering and transferring fluid to and from the interior of the balloon 108. It should be readily understood that such a fluid lumen may be used in the OTW and Rx configurations of the catheter 100.

[0099] It should be noted that the elements and features of the example catheters shown herein may be rearranged, recombined, and modified without departing from the invention. For example, while the figures show example electrode assemblies, the present disclosure is intended to include catheters having a variety of electrode configurations, and the number, placement, and spacing of emitters and electrode pairs may be modified without departing from the subject invention.

[0100] Although the electrode assemblies and catheter devices described herein have been primarily discussed in the context of treating occlusions and lesions in the coronary vasculature, the electrode assemblies and catheters herein can be used for various occlusions and peripheral vasculature (e.g., above the knee, below the knee, iliac, carotid, etc.), and other anatomical structures can be treated using IVL. Further, for example, practice of the embodiments disclosed herein can be used to treat soft tissue, such as cancer and tumors (i.e., non-thermal ablation procedures), thrombus, fibroids, cysts, organs, scars, and fibrous tissue removal, polymorphous tissue, or other tissue destruction and removal. The electrode assembly and catheter designs can also be used for nerve stimulation procedures, targeted drug delivery, treatment of tumors within body cavities (e.g., tumors within blood vessels, the esophagus, the intestine, the stomach, or the vagina), wound treatment, non-surgical removal and destruction of tissue, and can be used in place of thermal procedures or cauterization for venous insufficiency and fallopian ligation (i.e., for permanent female contraception).

[0101] In one or more examples, the electrode assemblies and catheters described herein can also be used in tissue engineering methods, such as mechanical tissue decellularization to generate bioactive scaffolds in which new cells (e.g., exogenous or endogenous cells) can replace old cells; introducing porosity into a site to improve cell retention, cell infiltration / migration, and the diffusion of nutrients and signaling molecules to promote angiogenesis, cell proliferation, and tissue regeneration, as well as cell replacement therapy. Such tissue engineering methods can be useful for treating ischemic heart disease, fibrotic liver, fibrotic intestine, and traumatic spinal cord injury (SCI). For example, for the treatment of spinal cord injury, the devices and assemblies described herein can facilitate the removal of scarred spinal cord tissue, which acts as a barrier to neuronal reconnection, prior to the injection of a lentivirus-loaded anti-inflammatory hydrogel to genetically engineer spinal cord neurons to regenerate.

[0102] As provided herein, any disclosure of a numerical range describing a dimension or measurement, such as thickness, length, weight, time, frequency, temperature, voltage, current, angle, etc., should be understood to include any numerical increment or gradient within the stated range for the given dimension or measurement.

[0103] Additionally, while the emitters disclosed in the examples herein typically have a structure having two electrode pairs on each emitter, it is contemplated that emitters having three electrode pairs (e.g., 120 degrees circumferentially spaced from each other), four electrode pairs (e.g., 90 degrees circumferentially spaced from each other), five electrode pairs (e.g., 72 degrees circumferentially spaced from each other), six electrode pairs (e.g., 60 degrees circumferentially spaced from each other), etc. There may be physical limitations on the design of emitter assemblies with respect to wiring size and arrangement, ability to deliver sufficient power, electrode erosion profile, etc. It is within the scope of this disclosure that such emitters may be successfully developed with improved manufacturing capabilities.

[0104] Additionally, numerical designators such as "first," "second," "third," "fourth," etc. are merely descriptive and do not necessarily indicate the relative order, location, or identity of the elements or features described by the designators. For example, a "first" shockwave may be immediately followed by a "third" shockwave, which in turn is followed by a "second" shockwave. As another example, a "third" emitter may be used to generate a "first" shockwave, and vice versa. Thus, the numerical designators of various elements and features are not intended to limit the present disclosure and may be modified and interchanged without departing from the invention.

[0105] The foregoing is merely illustrative of the principles of the present invention, and it will be understood that various modifications, variations, and combinations can be made by those skilled in the art without departing from the scope and spirit of the invention. Any of the various catheter variations disclosed herein may include features described with any other catheter or catheter combination herein. Furthermore, any method may be used with any of the disclosed catheters. Accordingly, the present invention is not intended to be limited except as by the appended claims.

Claims

1. 1. A catheter for treating an obstruction in a body cavity, the catheter comprising: an elongate tube extending longitudinally from a distal region to a proximal region; a flexible enclosure at least partially secured to the distal region of the elongate tube; a first shock wave emitter disposed along the elongated tube; a second shock wave emitter disposed along the elongated tube and longitudinally translatable relative to the first shock wave emitter; A catheter comprising:

2. 10. The catheter of claim 1, wherein the flexible enclosure has a working length d, and the center-to-center distance between the first shockwave emitter and the second shockwave emitter is adjustable between 2 mm and d.

3. 3. The catheter of claim 2, wherein the first shockwave emitter comprises a first pair of shockwave emitters and the second shockwave emitter comprises a second pair of shockwave emitters that are translatable as a pair relative to the first pair of shockwave emitters.

4. 10. The catheter of claim 1, wherein the first shockwave emitter comprises a first plurality of shockwave emitters and the second shockwave emitter comprises a second plurality of shockwave emitters translatable as a group relative to the first plurality of shockwave emitters.

5. The catheter of claim 1 , further comprising a third shockwave emitter that is independently translatable relative to the first and second shockwave emitters.

6. 6. The catheter of claim 5, further comprising a safety stop fixedly disposed on the elongate tube and configured to separate the first and second shockwave emitters by a center-to-center distance of 2 mm or greater.

7. The catheter of claim 1 , wherein the first shockwave emitter is translatable in the longitudinal direction.

8. The catheter of claim 1 , further comprising a proximal handle configured to control movement of at least one of the first shockwave emitter and the second shockwave emitter.

9. 9. The catheter of claim 8, wherein the proximal handle comprises a first thumbwheel ratchet for controlling movement of the first shockwave emitter and a second thumbwheel ratchet for controlling movement of the second shockwave emitter.

10. The catheter of claim 1 , wherein the flexible enclosure is an angioplasty balloon having a working length of at least 50 mm.

11. 10. The catheter of claim 1, wherein each of the first and second shockwave emitters comprises one or more electrode pairs, each of the one or more electrode pairs comprising an outer electrode and an inner electrode.

12. 1. A catheter for treating an obstruction in a body cavity, the catheter comprising: an elongate tube extending longitudinally from a distal region to a proximal region; an enclosure circumferentially secured around at least a portion of the distal region of the elongate tube; a proximal emitter assembly fixedly disposed on the elongated tube and inside the enclosure; a distal emitter assembly fixedly disposed on the elongated tube and inside the enclosure; a longitudinally translatable elongate member having a distal region movably disposed along the elongate tube, the longitudinally translatable elongate member configured to supply power to the proximal emitter assembly in a proximal configuration and to supply power to the distal emitter assembly in a distal configuration; A catheter comprising:

13. the proximal emitter assembly comprises one or more electrically connected proximal electrode pairs including a first proximal electrode electrically connected to a power source, and in the proximal configuration, the longitudinally translatable elongate member is electrically connected to a second proximal electrode of the one or more proximal electrode pairs such that each of the one or more proximal electrode pairs generates a shock wave when a voltage pulse is applied from the power source to the proximal emitter assembly; 13. The catheter of claim 12, wherein the distal emitter assembly comprises one or more electrically connected distal electrode pairs including a first distal electrode electrically connected to the power source, and wherein in the distal configuration, the longitudinally translatable elongate member is electrically connected to a second distal electrode of the one or more distal electrode pairs such that each of the one or more distal electrode pairs generates a shock wave when a voltage pulse is applied from the power source to the distal emitter assembly.

14. The catheter of claim 13 , wherein the one or more proximal electrode pairs and one or more distal electrode pairs each comprise an inner electrode and an outer electrode fabricated with a conductive sheath.

15. 13. The catheter of claim 12, wherein in the proximal configuration, shock waves are generated in the proximal emitter assembly rather than the distal emitter assembly, and in the distal configuration, shock waves are generated in the distal emitter assembly rather than the proximal emitter assembly.

16. The catheter of claim 12 , wherein the distal region of the translatable elongate member includes a radiopaque marker.

17. The catheter of claim 12, further comprising a proximal handle for controlling movement of the elongate member between the proximal and distal configurations.

18. 1. A method for treating an obstruction in a body cavity, comprising: Providing a catheter, said catheter comprising: a central tube extending from a proximal region to a distal region, defining a longitudinal direction, and having a central lumen; an enclosure sealed to and surrounding at least a portion of the distal region of the central tube; a shock wave emitter assembly including a first shock wave emitter and a second shock wave emitter disposed along the central tube within the enclosure, the first and second shock wave emitters being movable relative to one another in the longitudinal direction; and inserting the catheter into the body cavity and positioning the enclosure adjacent the occlusion; filling the enclosure with a conductive fluid and securing the enclosure to a wall of the body cavity; moving the shockwave emitter assembly 1 mm or less away from the occlusion in the longitudinal direction; generating one or more shock waves from the shock wave emitter assembly; A method comprising:

19. further comprising imaging the body cavity by one or more of x-ray fluorescence, intravascular ultrasound, and optical coherence tomography; The method of claim 18 , wherein the shockwave emitter assembly includes an imaging marker.

20. 20. The method of claim 18, wherein each shockwave emitter comprises an electrode pair, and generating the one or more shockwaves comprises applying a high voltage pulse from a power source.

21. 21. The method of claim 20, wherein the high voltage pulse comprises a voltage of 1 kV to 15 kV.

22. 1. A method for treating an obstruction in a body cavity, comprising: Providing a catheter, said catheter comprising: a central tube extending longitudinally from a distal region to a proximal region; an enclosure circumferentially secured around at least a portion of the distal region of the central tube; a first emitter assembly fixedly disposed on the central tube; a second emitter assembly fixedly disposed on the central tube; a longitudinally translatable elongate member having a distal region movably disposed along the central tube; and inserting the catheter into the body cavity and positioning the enclosure adjacent to the occlusion; filling the enclosure with a conductive fluid and securing the enclosure to a wall of the body cavity; moving the distal region of the elongate member toward the first emitter assembly; providing power to the first emitter assembly through the elongate member to generate one or more shock waves at the first emitter assembly; A method comprising:

23. 23. The method of claim 22, wherein when power is supplied to the first emitter assembly, one or more shock waves are not generated in the second emitter assembly.

24. 23. The method of claim 22, further comprising: moving the distal region of the elongate member to the second emitter assembly; supplying power to the second emitter assembly through the elongate member; and generating one or more shock waves at the second emitter assembly.

25. 23. The method of claim 22, wherein the first emitter assembly comprises one or more electrode pairs, and moving the distal region of the elongate member to the first emitter assembly comprises electrically connecting the distal region of the elongate member to the first emitter assembly.

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