Intravascular lithotripsy catheter with movable emitter

Abstract

A catheter for treating an occlusion within a body lumen, comprising: an elongate tube extending in a longitudinal direction from a distal region to a proximal region; a flexible housing at least partially secured to the distal region of the elongate tube; a first shock wave emitter positioned along the elongate tube; and a second shockwave emitter positioned along the elongated tube and translatable in a longitudinal direction relative to the first shockwave emitter.

Description

[0001] priority

[0002] This application claims priority to U.S. Provisional Patent Application Serial No. 63 / 442,980, filed February 2, 2023, and U.S. Non-Provisional Patent Application Serial No. 18 / 428,976, filed January 31, 2024, the entire contents of which are incorporated herein by reference. This application is related to U.S. Patent Application Serial No. 18 / 428,752, filed January 31, 2024, entitled "INTRAVASCULAR LITHOTRIPSYCATHETER WITH MOVABLE EMITTERS," the entire disclosure of which is incorporated by reference. Technical Field

[0003] The present invention relates generally to the field of medical devices and methods and, more particularly, to shock wave catheter devices for treating calcified lesions within body lumens, such as calcified lesions and occlusions in the vasculature and kidney stones in the urinary system. Background Art

[0004] A variety of catheters have been developed for treating calcified lesions, such as calcified lesions in the vascular system associated with arterial disease. For example, treatment systems for percutaneous coronary angioplasty or peripheral angioplasty use angioplasty balloons to dilate calcified lesions and restore normal blood flow in the blood vessels. In these types of surgeries, a catheter carrying a balloon is advanced into the vascular system along a guidewire until the balloon aligns with the calcified plaque. The balloon is then pressurized (typically greater than 10 atmospheres) so that it expands in the blood vessel to push the calcified plaque back into the vessel wall and dilate the occluded area of ​​the vascular system. However, due to the stiffness and hardness of calcified tissue and / or plaque, conventional angioplasty balloons are not always successful in dilating calcified lesions or vascular systems.

[0005] Recently, catheters have been developed that include shockwave emitters (e.g., one or more electrode pairs) for generating shockwaves within an angioplasty balloon—a treatment known as intravascular lithotripsy ("IVL"), a technology pioneered by Shockwave Medical, Inc., the applicant for the present application. Shockwave devices are particularly effective for treating calcified lesions because the acoustic pressure of the shockwaves can disrupt and destroy the lesion near the angioplasty balloon without harming surrounding tissue. In these devices, a catheter is advanced over a guidewire through the patient's vasculature until it is positioned near and / or aligned with a calcified lesion within a body lumen. The balloon is then inflated with a conductive fluid (using a relatively low pressure of two to four atmospheres), causing the balloon to expand into contact with the lesion, thereby attaching the shockwave emitter near the lesion. The shockwave emitter can then be activated to generate an acoustic shockwave, which propagates through the wall of the angioplasty balloon and into the lesion. Once the lesion has been disrupted by the acoustic shockwaves, the balloon can be further inflated to increase the cross-sectional area of ​​the lumen and improve blood flow through the vessel.

[0006] For electrohydraulic generation of acoustic shock waves, a conductive solution (e.g., saline) can be contained within a housing surrounding the electrodes, or can flow through the lumen to the electrodes. Modification of calcified plaque is achieved by forming an acoustic shock wave within the catheter via an electrical discharge across the electrodes. The energy released by the discharge enters the surrounding fluid at speeds exceeding the speed of sound, thereby generating an acoustic shock wave. The energy from the discharge can also cause the formation of rapidly expanding and contracting vapor bubbles, resulting in additional shock waves. These shock waves propagate radially outward and modify 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 it. This absorption process rapidly heats the fluid and vaporizes the fluid, thereby generating rapidly expanding and contracting vapor bubbles / steam bubbles and acoustic shock waves, which propagate outward and modify calcified plaque. If a fluid is selected that exhibits strong absorption at the laser wavelength employed, the acoustic shock wave intensity will be higher. These examples of IVL devices are not intended to be a comprehensive list of potential energy sources for generating IVL shock waves.

[0007] Conventional treatment of calcified lesions in a patient's vasculature typically involves mechanical alteration of the vessel, particularly surgical atherectomy, which carries a relatively large risk of embolism (removal of debris), abrupt closure (collapse of the vessel), dissection (tear of the vessel tissue), and / or perforation (perforation of the vessel tissue). Using IVL instead of or in combination with conventional treatment of calcified lesions can significantly reduce the risk of embolism and perforation while leading to improved treatment outcomes in terms of calcified lesion removal.

[0008] Based on these advances, currently available shock wave catheters are limited by the length of the balloon and the position of the transmitter within the balloon. In patients with lesions that are longer than the standard length of the balloon, physicians may choose to repeat cycles of expansion, shock wave delivery, deflation, and balloon repositioning in order to deliver shock wave therapy to the entire length of a given lesion. When repeated cycles are used, the structural integrity of the balloon and whether the balloon can maintain its deflated profile as it passes through the lesion need to be considered. In addition, any procedure or technique that increases the patient's time on the operating table beyond what is necessary is undesirable in clinical cases because it may lead to surgical complications.

[0009] Therefore, physicians need longer balloons to treat longer lesions to reduce procedure time and cost. 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 shockwave intensity at the balloon tip. Furthermore, simply increasing the number of shockwave emitters may be impractical or impossible, as adding emitters increases the catheter's profile and complicates its design. Such catheters also require significantly higher energy output from the power source. A large number of emitters also reduces the flexibility and trackability of the balloon region of the catheter, limiting the accessible treatment site.

[0010] Therefore, there is an unmet need for a catheter and emitter assembly design that can deliver shock waves to relatively long lesions within a patient's body and thereby minimize the time the patient is in the procedure receiving treatment. Summary of the Invention

[0011] The above objectives are achieved in a catheter that includes a set of movable emitters that are repositionable when deployed in a patient. More specifically, the innovation of the present disclosure allows an end user (e.g., a physician) to physically move the emitters of an IVL device along the catheter within a relatively long balloon as needed and position them in a variety of locations next to a long calcified lesion to destroy the calcium using shock wave technology.

[0012] Various embodiments may allow the user to keep a very long balloon (e.g., a balloon with a working length of 100-300 mm) inflated and in place within a long lesion, and alternatively, allow any number of transmitters to be moved to a desired position along the length of the calcified lesion within the inflated balloon. Depending on the calcium structure of the artery, this process may also be accomplished with a slightly inflated or semi-inflated balloon without requiring any repositioning of the balloon.

[0013] In one or more embodiments, a catheter for treating an occlusion within a body lumen includes an IVL balloon having an emitter mounted on a movable tube.

[0014] In one or more examples, the catheter is configured for in-situ customizable placement of the transmitter along the length of the balloon, enabling optimal application of shock wave therapy with minimal repositioning of the balloon by the physician. Various embodiments of the catheter allow for efficient application of acoustic energy to calcified regions of the vessel while avoiding indiscriminate application of shock wave therapy to non-calcified regions of the vessel. Various embodiments also allow for the development of longer IVL balloons with relatively low power requirements. Various embodiments of the catheter can improve the flexibility, trackability, and / or deliverability of the catheter as a whole.

[0015] In one or more embodiments, the IVL catheter includes one or more shock wave emitters located within the inflated IVL balloon, which can be pushed distally or pulled proximally within the balloon along the working length of the balloon to a location determined by a physician to require shock wave therapy. In some embodiments, these emitters can be repositioned individually. In some embodiments, a small number (e.g., pairs) of emitters are repositioned. In some embodiments, all of these emitters in a connected assembly are repositioned. Longitudinal adjustability can allow a relatively small number of emitters (e.g., one, two, three, four, or five emitters) to treat long lesions in a body lumen and provide optimized energy delivery to the target area, rather than a blanket dose over the entire length of the balloon regardless of the presence or absence of calcium at each emitter location. In some embodiments, safety stops are incorporated to prevent the emitters from being placed too close to each other.

[0016] In one or more embodiments, a large number of shockwave emitters (e.g., six, seven, eight, nine, or more) can be positioned along the length of the balloon, and an elongated member having a conductive region can be positioned translationally within the balloon to electrically connect selected shockwave emitters to a power source. In some embodiments, the elongated member can be connected to a handle at its proximal end for moving the elongated member in distal and proximal directions. Such embodiments can result in a lower profile catheter because fewer wires can be required to electrically connect each individual emitter to the power source, while still allowing for on-site customization by the physician. Such embodiments can also be advantageously used with a power source having a lower power output than would typically be required to generate shockwaves at a large number of shockwave emitters.

[0017] In one or more embodiments, a shockwave catheter can include a large number of emitters (e.g., twelve or more) located within the balloon and configured to generate shockwaves only at selected emitters. In some embodiments, the shockwave catheter can be limited to a smaller number of total emitters (e.g., eight) that can be emitted in each cycle via a connector cable or input at the generator, so the physician can select the most critical locations along the length of the balloon, and only those areas will receive energy in that cycle. This approach will allow for a longer balloon within the current generator output and allow the physician to optimize the treatment location.

[0018] The various examples described herein allow the end user to physically move IVL emitters within a very long balloon and position them at a variety of different locations within a long calcified lesion as needed to destroy the calcium.

[0019] According to one aspect of the present disclosure, a catheter for treating an occlusion within a body lumen includes: an elongated tube extending in a longitudinal direction from a distal region to a proximal region; a flexible housing at least partially secured to the distal region of the elongated tube; a first shock wave transmitter positioned along the central tube; and a second shock wave transmitter positioned along the central tube and translatable in the longitudinal direction relative to the first shock wave transmitter.

[0020] The flexible housing may have a working length d, and the center distance between the first shock wave transmitter and the second shock wave transmitter may be adjusted between 2 mm and d.

[0021] The first shockwave transmitter may include a first pair of shockwave transmitters and the second shockwave transmitter may include a second pair of shockwave transmitters, the second pair of shockwave transmitters being translatable as a pair relative to the first pair.

[0022] The first shockwave launcher may include a first plurality of shockwave launchers and the second shockwave launcher may include a second plurality of shockwave launchers, the second plurality of shockwave launchers being translatable as a unit relative to the first plurality of launchers.

[0023] The catheter may include a third shock wave transmitter that is independently translatable relative to the first and second shock wave transmitters.

[0024] The catheter may include a safety stop fixed to the elongated tube, the safety stop configured to space the first shock wave transmitter and the second shock wave transmitter apart by a center distance of no less than 2 mm.

[0025] The first shockwave transmitter is translatable in a longitudinal direction (ie, in a proximal-distal direction).

[0026] The catheter may include a proximal handle for controlling movement of the transmitter assembly.

[0027] The proximal handle may include a first thumb-wheel ratchet for controlling movement of the first shockwave transmitter and a second thumb-wheel ratchet for controlling movement of the second shockwave transmitter.

[0028] The flexible shell may be an angioplasty balloon having a working length of at least 50 mm.

[0029] Each of the first shock wave transmitter and the second shock wave transmitter 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.

[0030] According to one aspect of the present disclosure, a catheter for treating a lesion within a body lumen may include: an elongated tube extending in a longitudinal direction from a distal region to a proximal region; a housing circumferentially fixed around at least a portion of the distal region of the elongated tube; a proximal emitter assembly fixedly located on the central tube and within the interior of the housing; a distal emitter assembly fixedly located on the central tube and within the interior of the housing; and a longitudinally translatable elongated member having a distal region movably positioned along the central lumen, the elongated member being configured to power the proximal emitter assembly in a proximal configuration and to power the distal emitter assembly in a distal configuration.

[0031] The proximal transmitter assembly can include one or more proximal electrode pairs electrically connected, the one or more proximal electrode pairs including a first proximal electrode electrically connected to a power source, and, in the proximal configuration, a longitudinally translatable energy guide can be electrically connected to a second proximal electrode of the proximal electrode pair such that when a voltage pulse is applied from the power source to the proximal transmitter assembly, each of the one or more proximal electrode pairs generates a shock wave.

[0032] The distal transmitter assembly may include one or more electrically connected distal electrode pairs, the one or more distal electrode pairs including a first distal electrode electrically connected to a power source, and, in the distal configuration, a longitudinally translatable power supply member may be electrically connected to a second distal electrode of the distal electrode pair, such that when a voltage pulse is applied from the power source to the distal transmitter assembly, each of the one or more distal electrode pairs generates a shock wave.

[0033] The one or more proximal electrode pairs and the one or more distal electrode pairs may each include an outer electrode and an inner electrode made of a conductive sheath.

[0034] In the proximal configuration, shock waves may be generated at the proximal emitter assembly but not at the distal emitter assembly, and in the distal configuration, shock waves may be generated at the distal emitter assembly but not at the proximal emitter assembly.

[0035] The distal region of the translatable elongate member may include a radiopaque marker.

[0036] The catheter may include a proximal handle for controlling movement of the elongate member between the proximal and distal configurations.

[0037] According to one aspect of the present disclosure, a method for treating an occlusion in a body lumen includes providing a catheter comprising a central tube extending from a proximal region to a distal region, the central tube defining a longitudinal direction and having a central lumen, a housing sealingly connected to and surrounding at least a portion of the distal region of the central tube, and a shock wave emitter assembly comprising a first shock wave emitter and a second shock wave emitter positioned within the housing along the central tube, the first shock wave emitter and the second shock wave emitter being movable relative to each other in the longitudinal direction; inserting the catheter into the body lumen and positioning the housing proximate the occlusion; filling the housing with a conductive fluid and anchoring the housing to a wall of the body lumen; moving the shock wave emitter assembly 1 mm or less away from the blockage or restriction in the longitudinal direction; and generating one or more shock waves from at least one shock wave source.

[0038] The method may include imaging the body lumen using one or more of x-ray fluorescence, intravascular ultrasound, and optical coherence tomography, wherein the shock wave emitter assembly includes imaging the marker.

[0039] Each shock wave transmitter may include an electrode pair, and generating the one or more shock waves may include applying a high voltage pulse from a power supply.

[0040] The high voltage pulse may include a voltage in the range of 1 kV to 15 kV.

[0041] According to one aspect, a method for treating an occlusion in a body lumen comprises providing a catheter having a central tube extending in a longitudinal direction from a distal region to a proximal region; a shell circumferentially fixed around at least a portion of the distal region of the elongated tube; a first emitter assembly fixedly positioned on the central tube; a second emitter assembly fixedly positioned on the central tube; and a longitudinally translatable elongated member having a distal region movably positioned along the central lumen; inserting the catheter into the body lumen and positioning the shell proximate the occlusion; filling the shell with a conductive fluid and anchoring the shell to a wall of the body lumen; moving the distal region of the elongated member to the first emitter assembly; and supplying power to the first emitter assembly via the elongated member and generating one or more shock waves at the first emitter assembly.

[0042] When power is supplied to the first emitter assembly, one or more shock waves are not generated at the second emitter assembly.

[0043] The method may include moving a distal region of the elongated member to the second launcher assembly; and supplying power to the second launcher assembly via the elongated member and generating one or more shock waves at the second launcher assembly.

[0044] The first transmitter assembly may include one or more electrode pairs, and moving the distal region of the elongated member to the first transmitter assembly may include electrically connecting the distal region of the elongated member to the first transmitter assembly. BRIEF DESCRIPTION OF THE DRAWINGS

[0045] Illustrative aspects of the present disclosure are described in detail below with reference to the following drawings.The embodiments and drawings disclosed herein are intended to be considered illustrative rather than restrictive.

[0046] Figure 1A An exemplary catheter having a movable array of transmitters located inside an angioplasty balloon, wherein the transmitters are individually movable along the length of the catheter shaft, is shown, highlighting an exemplary wiring configuration, in accordance with aspects of the present disclosure.

[0047] Figure 1B An exemplary catheter having a movable transmitter array positioned proximally of a housing according to aspects of the present disclosure is shown.

[0048] Figure 1C An exemplary catheter having an array of emitters movable in pairs along the length of a housing is shown in accordance with aspects of the present disclosure.

[0049] Figure 1DAn exemplary catheter having an array of emitters that are individually movable along the length of a housing is shown in accordance with aspects of the present disclosure.

[0050] Figure 1E An exemplary catheter having a movable emitter array positioned distally of the housing is shown in accordance with aspects of the present disclosure.

[0051] Figure 1F An exemplary catheter having a movable emitter array with stops is shown according to aspects of the present disclosure.

[0052] Figure 1G A cross-sectional view of an exemplary catheter having a movable emitter array according to aspects of the present disclosure is shown.

[0053] Figure 2A An exemplary catheter within a vasculature is shown having a movable transmitter array located at a distal position within an angioplasty balloon according to aspects of the present disclosure.

[0054] Figure 2B An exemplary catheter within a vascular structure is shown having a movable transmitter array centrally located within an angioplasty balloon according to aspects of the present disclosure.

[0055] Figure 2C An exemplary catheter within a vasculature is shown having a movable transmitter array located proximally within an angioplasty balloon according to aspects of the present disclosure.

[0056] Figure 3A A side view of a portion of an exemplary catheter showing a plurality of movable transmitter carriers according to aspects of the present disclosure is shown.

[0057] Figure 3B Shown Figure 4A Cross-sectional view of the catheter.

[0058] Figure 4A A first configuration of an exemplary catheter having a longitudinally translatable member according to aspects of the present disclosure is shown.

[0059] Figure 4B Shown Figure 4A A second configuration of the catheter is shown.

[0060] Figure 5A A first configuration of an exemplary catheter having a longitudinally translatable member according to aspects of the present disclosure is shown.

[0061] Figure 5B Shown Figure 5A A second configuration of the catheter is shown.

[0062] Figure 6 An exemplary flow chart for using a catheter with a movable transmitter array according to aspects of the present disclosure is shown.

[0063] Figure 7 Another exemplary flow chart for using a catheter with a movable transmitter array according to aspects of the present disclosure is shown.

[0064] Figure 8 An exemplary catheter having a tapered housing according to aspects of the present disclosure is shown.

[0065] Figure 9 An exemplary catheter system with a rapid exchange port according to aspects of the present disclosure is shown. DETAILED DESCRIPTION

[0066] The following description is presented to enable one of ordinary skill in the art to make and use the various embodiments and aspects thereof disclosed herein. Descriptions of specific devices, components, techniques, and applications are provided as examples only. Various modifications to the examples described herein will be apparent to one of ordinary skill 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. Therefore, the various embodiments and aspects thereof are not intended to be limited to the examples described and shown herein, but are to the extent consistent with the claims.

[0067] 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 cross-section of the catheter and allow the catheter to more easily pass through calcified blood vessels to deliver shock waves in more severely occluded areas of the vasculature. Examples of low-profile electrode designs can be found in U.S. Patents Nos. 8,888,788, 9,433,428, and 10,709,462, and U.S. Publication No. 2021 / 0085383, all of which are incorporated herein by reference. An example of a low-profile catheter with electrodes configured to be inserted after balloon dilation can be found in U.S. Patent No. 10,357,264, which is incorporated herein by reference. Other catheter designs have improved the transmission of shock waves, for example, by improving the transmission of shock waves through specific electrode structures and configurations to direct the shock waves in a forward direction to break through tighter and more difficult-to-penetrate occlusions in the vasculature. Examples of forward-firing catheter designs can be found in U.S. Patent Nos. 10,966,737, 11,478,261, and 11,596,423, and U.S. 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 spacing of shock wave emitters to promote constructive interference of acoustic waves.

[0068] As used herein, the term "electrode" refers to a conductive element (typically made of a metal or alloy) that receives an electric current and subsequently releases the electric current to another conductive element. Thus, as used herein, an "electrode pair" refers to two electrodes that are positioned adjacent to each other so that an electric current supplied to one electrode will be transmitted across a gap (also known as a "spark gap") between the two electrodes (e.g., between a first electrode and a second electrode, or conversely, the two electrodes are optionally separated by an insulator and the current passes through a conductive fluid or conductive gas therebetween). Furthermore, as used herein, a "transmitter" refers to a structure having one or more electrode pairs. These transmitters can be single, paired, or otherwise arranged together to electrically connect to form a transmitter assembly. Shock waves can be generated at each electrode pair of a transmitter. In some cases, one or more electrode pairs that can be positioned across one or more transmitters may also be referred to as an "electrode assembly."

[0069] Typically, long calcified lesions in arteries and other vasculature present a challenge to many interventional devices and users. The user (e.g., physician) will assess the length and diameter of the calcified lesion and then determine the diameter and length of the balloon catheter they want to use during the procedure. To treat relatively long calcified lesions, the user may prefer to use a single long balloon to treat such lesions, selecting a balloon that is approximately one hundred to three hundred millimeters (100 mm-300 mm) in length and two to thirty millimeters (2 mm–30 mm) in diameter when expanded.

[0070] In the context of current commercial IVL devices, the use of longer balloons creates a different catheter profile / cross-section, resulting in different requirements to ensure adequate therapeutic function. When considering modifications to achieve therapeutic performance in a relatively long balloon, it is important to note that there is a direct correlation between the number of emitters (given a fixed energy source) and the effectiveness of IVL treatment. In other words, as the number of emitters increases to accommodate a relatively long balloon for long lesions, the energy available to meet the increased number of emitters decreases, and IVL efficacy may therefore decrease. This problem can be partially addressed by adding more channels to the IVL generator and system, although this approach results in a catheter with more circuits and wires, and therefore a larger profile / cross-section, which may make it more difficult to reach smaller peripheral vasculature or cross severely occluded lesions. Current commercial IVL devices have two to five emitters in a balloon that are adhesively bonded to the catheter shaft and therefore fixed in position. In addition, these devices have a balloon with a diameter of approximately 12 millimeters to 60 millimeters (12mm-60mm), with the working length of the balloon along the catheter being 110 millimeters to 138 millimeters (110mm-138mm). This allows the physician to cycle through positioning, expansion, shock wave therapy, and deflation, moving the balloon over the catheter guidewire along the length of the lesion to treat the entire length of the lesion. The transmitters on these devices can be pulsed one at a time, two at a time, all at once, and / or in an alternating or sequential pattern along the length of the catheter and balloon.

[0071] This article describes a catheter, balloon, and IVL circuit that incorporates design elements that allow for the treatment of relatively long calcified lesions using a housing with a movable array of emitters. In this embodiment, there is generally no need to undergo the inflation and deflation cycles required to reposition the balloon for shockwave therapy, as described above. Instead, a single balloon allows the emitters to be moved within the balloon to deliver shockwave therapy to the target area of ​​a given long lesion. This can be achieved with a long balloon that is slightly inflated or semi-inflated, depending on the degree of calcium stenosis within the artery or other blood vessel.

[0072] In some illustrated embodiments, each transmitter comprises a cylindrical sheath (alternatively referred to as a ring or belt) mounted on and surrounding a movable transmitter carrier. The cylindrical sheath is formed from a conductive material (e.g., a metal or alloy), thereby forming a first electrode surface of an electrode pair. The sheath may include a cutout region (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, particularly a conductive member (e.g., copper wire, a flat coil, etc.), located beneath or within the movable transmitter carrier. The second conductive material thereby forms a second electrode surface of the electrode pair. In this transmitter configuration, the conductive portion of the sheath may be referred to as the outer electrode, while the wiring may be referred to as the inner electrode. Current transmitted across the transmitter may jump across the space between the two electrode surfaces (also referred to as a "spark gap") and generate a shock wave as described above. Either of the two electrode surfaces may be either the anode or the cathode, depending on the polarity of the pulse transmitted across the transmitter.

[0073] In many embodiments, each emitter will have two electrode pairs, where current can travel from one electrode pair on the emitter to the other electrode pair by traveling across the conductive material of the sheath. The two electrode pairs on each emitter can be positioned to generate shock waves in diametrically opposed directions (i.e., arranged 180 degrees apart from each other around the catheter), or the two electrode pairs can be positioned to generate shock waves in converging or offset directions (i.e., arranged less than 180 degrees apart from each other around the catheter). In various alternative embodiments, the emitter can have three, four, five, or six electrode pairs arranged around the circumference of the emitter. The emitters of the movable emitter array can be electrically connected to each other in series or in parallel on one or more electrical channels.

[0074] Figure 1A A catheter 200 is shown. As part of the catheter 200, a balloon 208 has a proximal end and a distal end, wherein the proximal end of the balloon 208 is attached to the outer balloon shaft and the distal end of the balloon 208 is attached to the inner shaft. The balloon 208 can be attached at these two locations so that the internal volume of the balloon 208 is sealed, for example, with an adhesive, with a clamp, by heat sealing, by pressure sealing, or a combination thereof. At the proximal end, the balloon 208 is attached around the circumference of the balloon shaft so that the space between the balloon shaft and the movable transmitter carrier can be used as a channel for fluid to enter and expand the balloon 208 (and also to deflate and deflate the balloon 208 accordingly). In some embodiments, another type of sealing housing (e.g., a cap or a flexible polymer tube) can be used instead of the angioplasty balloon.

[0075] The working length of the balloon along the catheter (e.g., working length 209) can be fifty millimeters to five hundred millimeters (50 mm to 500 mm). The working length of the movable transmitter carrier within the balloon volume can be up to the entire length of the balloon. In some embodiments, the distance from the proximal-most transmitter to the distal-most transmitter can be up to the entire working length of the balloon.

[0076] In some embodiments, each transmitter can be spaced three to twenty millimeters (3 mm–20 mm) apart on a movable transmitter carrier. The transmitters can be electrically grouped (connected together) on various channels of the circuit, where they can be connected individually, in pairs, in groups of three, etc., and in series or in parallel. The power supply that powers the transmitters can provide power in the range of approximately 1,000 V to approximately 15,000 V.

[0077] In various embodiments, a catheter having a removable emitter carrier with one or more shock wave emitters may include a relatively long housing (e.g., an angioplasty balloon). For example, the working length of the housing may be 50%-200% longer than the end-to-end distance from the proximal-most emitter to the distal-most emitter. To use such a device, the balloon may be advanced through a body lumen to a lesion. The user may then inflate the balloon with a fluid (e.g., saline) to a relatively low pressure (e.g., less than 5 atmospheres), or until the working area of ​​the balloon is in contact with (i.e., in contact with) the lesion. Following expansion, the emitter assembly mounted on the removable emitter carrier may be advanced to a first position within the balloon volume (e.g., proximal to the balloon) to treat the lesion or a portion of the lesion at the first location using shock wave therapy. The removable emitter carrier may then be further advanced to a second position (e.g., more distal to the first position) to treat a new lesion or a new region of the same lesion. In some embodiments, treatment may begin at the distal region of the balloon or in the central region of the balloon. Advantageously, shock wave therapy can be tailored to any specific lesion. For example, if there is a greater degree of calcification in the distal region of the balloon than in the proximal region of the balloon, emitters located more distally will generate more shock waves than those located proximally. By tailoring shock wave therapy in this way, unnecessary excess shock wave generation can be avoided, thereby preserving the lifespan of the device. Such a device also does not require the complexity of individually powering a large number of emitters located along the length of an angioplasty balloon (e.g., via wires).

[0078] Figure 1AAn exemplary catheter 200 is shown in accordance with one or more embodiments. Catheter 200 includes a movable array of emitters 210 positioned within an angioplasty balloon 208, wherein the emitters are individually movable along the length of the catheter shaft, centered in 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 balloon 208. For example, emitter 211 may be movable between a proximal end of the working length 209 and a position of emitter 212 relative to the other emitters.

[0079] from Figure 1A As can be seen more clearly in the enlarged image of FIG, emitters 211, 212, 213, 214 are connected by conductors (e.g., wires) 231, 232, 233, 234, respectively, which are electrically connected to a high voltage power supply at their proximal ends. Each emitter 211, 212, 213, 214 is also electrically connected to a common return line (not shown), which is also connected to the high voltage power supply. In embodiments where each emitter is individually movable, each emitter is connected to the power supply via a conductor. In embodiments where the emitters are movable as electrically connected pairs or groups, each pair or group is connected to the power supply via a conductor (e.g., Figure 1C and 1E shown).

[0080] In some embodiments, as Figure 1F As shown, one or more stops 230 may be provided between adjacent emitters to ensure that 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 proximal-to-distal length of the stops 230 may be at least 2 mm. These stops may translate along with the emitters (or emitter pairs / groups). In some examples, the stops may be provided on the proximal handle. For example, a thumbwheel ratchet (or another control) may be provided on the proximal handle to individually control the translation of each emitter (or emitter pair / group) within the balloon 208, and stops may be provided to ensure that 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 shock wave therapy.

[0081] Figures 1B-1E An exemplary catheter having an array of movable transmitters located inside an angioplasty balloon, wherein the transmitters are movable along the length of the catheter shaft, is shown, along with an exemplary deployment configuration for the movable transmitters within the angioplasty balloon.

[0082] Figure 1BMultiple independently movable emitters are shown, configured to be biased toward the proximal end of the balloon for treating lesions proximal to the balloon. After treatment is completed proximally to the balloon, one or more emitters can be moved distally to treat one or more lesions in a more distal region of the balloon. Advantageously, because the emitters in these embodiments are individually wired, shock waves do not need to be generated indiscriminately at all emitters in the balloon. In some embodiments, the emitters can be connected to different power outputs at their proximal ends, allowing them to generate higher or lower energy shock waves. Thus, the emitter (or emitters) connected to the higher power output can be positioned at a narrower lesion (or lesion region). This energy distribution can help maintain device longevity.

[0083] Figure 1C A plurality of emitters are shown arranged as emitter pairs that are offset toward the center of the balloon. In this embodiment, the emitters are configured to move in pairs (e.g., emitter pairs 611 and 612). The emitters of each emitter pair can be physically and electrically connected.

[0084] Figure 1D Another embodiment of individually movable transmitters is shown, with the transmitters being distributed approximately equidistant from one another along the entire length of the balloon.

[0085] Figure 1E Another IVL catheter with movable emitters according to one or more embodiments is shown. Similar to some of the above embodiments, this catheter includes a set of shock wave emitters 613 that can be translated as a group within the working area of ​​the balloon. However, in contrast, these emitters 613 may not be retractable outside the balloon.

[0086] Figure 1G A cross-sectional view of an IVL catheter 680 having multiple emitters that are longitudinally movable (i.e., movable along a proximal-distal axis x) according to one or more embodiments is shown. The cross-sectional view is taken from a proximal region of the balloon 681 (proximal to any emitter), Figure 1G68. The catheter 680 is shown in an expanded state. The catheter 680 includes an inner shaft 682 having a tubular structure and defining a guidewire lumen 699. A first movable launcher carrier 683 is located outside the inner shaft 682. A second movable launcher carrier 684 is located outside the first movable launcher carrier 683. The first movable launcher carrier 683 is translatable along the axis x on the inner shaft 682. The second movable launcher carrier 684 is translatable longitudinally on the inner shaft 682 and the first movable launcher carrier 683. In various embodiments, the two movable launcher carriers are separately movable for moving a first launcher assembly positioned on the first launcher carrier and a second launcher assembly positioned on the second launcher carrier (similar to two Figure 1E Each emitter carrier includes one or more shock wave emitters at its respective distal region. Each emitter carrier may also 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 source or a laser) to the one or more emitters. Although Figure 1G Only two emitter carriers are shown, but additional concentric emitter carriers may be included, and in some embodiments, the IVL catheter has three, four, five or more independently movable emitter assemblies (wherein each emitter assembly includes one or more shock wave emitters).

[0087] In some embodiments, the innermost movable launcher carrier can be moved to the most distal region of the balloon. For example, the first launcher carrier 683 can be translated to the most distal region of the balloon. The second launcher carrier 684 can be translated to the location of the first launcher assembly, but no more distal than the first launcher assembly. In other words, the first launcher carrier moves the more distal launcher assembly, while the second launcher carrier moves the more proximal launcher assembly.

[0088] Figures 2A-2C An exemplary catheter 100 is shown within a vascular structure having a Figure 2A The distal position of Figure 2B The central location and Figure 2C The proximal position of the movable transmitter array is located inside the angioplasty balloon. As shown in the figure, the calcified area of ​​vascular tissue is represented by "C", and the area of ​​vascular tissue where the calcification has been subjected to the shock wave and ruptured is represented by "B". Figure 2AInitially, the inflated balloon 108 is extended along the entire length of the vascular tissue containing calcifications. The movable transmitter carrier 104 is extended along the length of the inner shaft 106 to the distal end of the balloon 108, at which point the movable transmitter array 110 is positioned distally of the movable transmitter carrier 104. Thus, the movable transmitter array 110 is positioned adjacent to the calcifications distal to the lesion in the subject's vascular tissue. As shown, the transmitters of the movable transmitter array 110 generate shock waves that fragment the calcifications distal to the lesion.

[0089] Go to Figure 2B , movable emitter carrier 104 has been pulled back in a distal direction along the length of catheter 100, positioning movable emitter array 110 adjacent to a calcification in the middle region of a lesion in the subject's vascular tissue. As shown, the emitters of movable emitter array 110 generate shock waves that fragment the calcification in the middle portion of the lesion. It will be appreciated that a long middle region of a calcified lesion may require multiple repositioning of movable emitter array 110 to deliver therapy to the entire length of the middle region of the calcified lesion.

[0090] Finally, go to Figure 2C , movable emitter carrier 104 has been pulled back in a distal direction along the length of catheter 100, bringing movable emitter array 110 adjacent to a calcification in vascular tissue proximal to a lesion in a subject. As shown, the emitters of movable emitter array 110 generate shock waves that fragment the calcification proximal to the lesion.

[0091] It should be understood that more than one shock wave generation cycle may be used to break up the calcifications in any given area of ​​calcified tissue, and that different areas of calcified tissue may require relatively more or less shock wave treatment than one another. It is also contemplated that the sequence of translating the movable emitter array 110 may be performed from distal to proximal, as in Figures 2A-2C , but may also be performed in a proximal to distal order, a medial to proximal order, or a medial to distal order. In addition, the movable transmitter array 110 may be moved to repeat the treatment two or more times at multiple locations along the calcified tissue.

[0092] Materials that can be used for the outer shaft 102, movable transmitter carrier 104, and inner shaft 106 components can be extruded or molded polymers, or functional equivalents that are safe for use in a patient. Such materials can include polyether block amide, polytetrafluoroethylene, nylon, or other polymers.

[0093] Figure 3A and 3BA portion of an IVL catheter 700 having multiple independently movable emitters is shown in accordance with one or more embodiments. Figure 3A As shown in the side schematic diagram of FIG, catheter 700 includes first, second, third and fourth movable launcher carriers 701-704. First launcher carrier 701 extends to first launcher 711, second launcher carrier 702 extends to launcher 712, third launcher carrier 703 extends to launcher 713, and fourth launcher carrier 704 extends to launcher 714. Each launcher carrier 701-704 can be independently translated relative to the other launcher carriers in a direction parallel to the longitudinal axis x. Figure 1B As shown in the cross-sectional view of FIG, each launcher carrier of the catheter 700 includes one or more legs, and the legs of these launcher carriers are arranged one after another along the circumference, rather than a plurality of launcher carriers stacked concentrically on each other (such as Figure 1G Each launcher carrier 701-704 extends distally from a proximal handle or hub / handle to the launcher assembly. Figure 1A In the example shown, each emitter carrier is shown extending to a single emitter, but in various other embodiments, each emitter carrier can 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 profile of the catheter and make it easier to pass the device through narrow body lumens.

[0094] Figure 4A and Figure 4B An exemplary catheter 300 according to one or more aspects of the present disclosure is shown. Catheter 300 includes a plurality of shockwave emitters 311-325 distributed / positioned along a central elongated member 330 and a longitudinally translatable member 340, which is electrically connected at its proximal end to a power source (not shown). Longitudinally translatable member 340 is shown as being external to the emitter; in some embodiments, translatable member 340 can translate within a groove or lumen of central elongated member 330, which helps maintain alignment of translatable member 340 during translation and positioning. Each shockwave emitter 311-325 includes an electrode pair having a spark gap, a first electrode of the electrode pair being electrically connected to a return line 302, which is electrically connected to a power source. Longitudinally translatable member 340 may include a conductive region 342. Figure 4A A configuration is shown in which translatable member 340 is positioned so that conductive region 342 is in electrical contact with the second electrode of the electrode pair of transmitter 311. In this configuration, a high voltage pulse from a power source can be transmitted across the electrode pair of transmitter 311 via translatable member 340, thereby generating a shock wave. Figure 4B Another configuration of catheter 300 is shown in which the longitudinally translatable member 340 is larger than Figure 4A The illustrated configuration is advanced more distally such that translatable member 340 is electrically connected to emitter 314. In this configuration, a high voltage pulse is transmitted to emitter 314, resulting in the generation of a shock wave at emitter 314.

[0095] Figure 5A and 5B An exemplary catheter 400 according to one or more aspects of the present invention is shown. Catheter 400 includes a plurality of shock wave transmitters 411-424 and a longitudinally translatable member 440 electrically connected to a power source (not shown). Each transmitter can be electrically connected to one or more other transmitters such that when translatable member 440 is electrically connected to the transmitter, a shock wave is generated at each connected transmitter. Figure 5A A first configuration is shown in which translatable member 440 is electrically connected to shock wave transmitters 411-417, which are connected in series with each other and electrically connected to first return line 402. When a high voltage pulse is provided to shock wave transmitters 411-417, a shock wave is generated at each transmitter 411-417. Figure 5B A second configuration is shown in which translatable member 440 is electrically connected to shockwave emitters 418-424, which are connected in series with one another and electrically connected to second return line 404. When a high voltage pulse is provided to shockwave emitters 418-424, a shockwave is generated at each emitter 418-424. In various other embodiments, the longitudinally translatable member can power pairs of emitters. Emitters located near the thicker portion of the lesion can be provided with relatively higher energy (e.g., higher voltage pulses) than emitters located near the thinner portion of the lesion. Additionally or alternatively, a greater number of emitters can be located near the thicker portion of the lesion than the thinner portion of the lesion. Steps 10004 and 10005 can be repeated to treat additional lesions. As with other IVL treatment methods, saline (or other conductive fluid) can be used to contract and expand the shell to remove any accumulated air bubbles within the shell. After treatment, at step 10006, the housing may be deflated and the IVL catheter withdrawn or moved to a different lesion.

[0096] 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 removable emitter (or individual emitter assemblies) can include a radiopaque marker. In some embodiments, the position of the emitter can be indicated by a marker on the proximal end of the catheter.

[0097] Figure 7 is a flow chart 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 Figure 4A 、4B , 5A, and 5B, and includes a plurality of 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, the housing of the catheter is positioned near a lesion in the body lumen. In step 11003, the housing is expanded with a fluid to a relatively low pressure (e.g., less than 5 atmospheres) such that the housing contacts the lesion and the vessel wall. In one or more embodiments, the housing is made of a semi-compliant material so that it can conform to the geometry of the lesion when expanded to a relatively low pressure. In step 11004, the conductive region of a movable conductor is moved and electrically connected to a first emitter of the plurality of emitters. In some embodiments, during delivery / transport, the movable conductor is withdrawn to a position proximal to the housing and then inserted into a balloon in step 11004. This helps reduce the profile / cross-section of the catheter during delivery and also improves the flexibility / flexibility of the distal region of the catheter. In step 11005, a high-voltage pulse is transmitted to a first emitter to generate shock waves at the electrically connected emitters. In some embodiments, the first emitter is electrically connected (e.g., in series or in parallel) to one or more emitters such that, when the high-voltage pulse is transmitted, a shock wave is generated at each connected emitter. In step 11006, the conductive member is moved to a second emitter (or a second set of electrically connected emitters) at a different location within the housing. In step 11007, shock waves are generated at the one or more electrically connected emitters. Steps 11006 and 11007 may be repeated on different emitters (or emitter assemblies) to generate shock waves in other areas of the housing. Between rounds of shock wave generation, the housing may be contracted and expanded to remove any accumulated air bubbles. In step 11008, after shock wave therapy is completed at the treated lesion, the housing is contracted.

[0098] Figure 8An exemplary catheter is shown having a movable emitter array 110 positioned within a tapered angioplasty balloon 109 at a distal position. The use of a tapered angioplasty balloon 109 with a narrower distal end than a proximal end can provide improved access to vasculature that may be partially obstructed by plaque (e.g., chronic total occlusions (CTOs)), where the narrow end of the tapered angioplasty balloon 109 can be used as a wedge to push into and through the plaque. With the tapered angioplasty balloon 109 nearing or contacting the device-facing surface of the plaque, the movable emitter carrier 104 can be positioned in the distal position and can generate shock waves to disrupt the calcification surrounding the lesion at the point of entry into the plaque. The relaxation or loosening of the vasculature in this position can allow the tapered angioplasty balloon 109 to be pushed further along the vessel and through the plaque, ultimately allowing shock waves to be generated along the entire length of the calcified lesion. The tapered angioplasty balloon can also be implemented in naturally tapered body lumens. In some embodiments, the tapered angioplasty balloon has a tapered working area with a taper angle (eg, angle α) of up to 20 degrees.

[0099] In some of the examples described above, the catheter may be configured to be advanced over a guidewire into a body lumen, which is generally referred to as an "over the wire" or "OTW" deployment. Figure 9 As shown, the catheter can be arranged as part of a "rapid exchange" (Rx) configuration, where instruments are passed through a larger lumen in and out of the patient during a procedure. Figure 9 In the embodiment of the present invention, a guidewire 150 and an inner shaft 106 are included, and the guidewire lumen is included. The guidewire 150 can leave the inner shaft 106 at a port 151, which is distal to the proximal end of the catheter (not shown) and proximal to the distal end of the balloon 108. The transmitter carrier 104 moves back and forth on the stationary inner shaft 106. The inner shaft 106 can be coupled to the proximal end of the balloon to keep the Rx guidewire stable during treatment. The catheter 100 may include a fluid lumen that extends through the outer shaft 102 to the proximal end of the catheter 100 for delivering fluid to the interior of the balloon 108 and removing fluid from the interior of the balloon 108. It should be readily understood that such a fluid lumen can be used in both the OTW configuration and the Rx configuration of the catheter 100.

[0100] 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 present invention. For example, the figures show example electrode assemblies, and the present disclosure is intended to encompass catheters having various electrode configurations, and the number, placement, and spacing of emitters and electrode pairs may be modified without departing from the present invention.

[0101] Although the electrode assemblies and catheter devices described herein are 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.), other anatomical structures treatable with IVL. For further examples, implementations of the embodiments disclosed herein can be used to treat soft tissues, such as cancers and tumors (i.e., non-thermal ablation methods), blood clots, fibroids, cysts, organs, scars and fibrotic tissue removal, polymorphic tissue or other tissue destruction and removal. The electrode assemblies and catheter designs can also be used for neurostimulation therapy, targeted drug delivery, treatment of tumors within body lumens (e.g., tumors within blood vessels, esophagus, intestine, stomach or vagina), wound treatment, non-surgical removal and destruction of tissue, or for use in place of heat treatment or cauterization of venous insufficiency and tubal ligation (i.e., for permanent female contraception).

[0102] In one or more examples, the electrode assemblies and catheters described herein can also be used in tissue engineering methods, for example, for mechanical tissue decellularization to produce a bioactive scaffold in which new cells (e.g., exogenous or endogenous cells) can replace old cells; introducing porosity to the site to improve cell retention, cell penetration / migration, and diffusion of nutrients and signaling molecules, thereby promoting angiogenesis, cell proliferation, and tissue regeneration, similar to cell replacement therapy. This tissue engineering approach can be used to treat ischemic heart disease, fibrotic liver, fibrotic intestine, and traumatic spinal cord injury (SCI). For example, for the treatment of spinal cord injury, prior to injecting an anti-inflammatory hydrogel loaded with a lentivirus to genetically engineer spinal cord neurons to regenerate them, the devices and assemblies described herein can promote the removal of scarred spinal cord tissue, which acts like a barrier to neuronal reconnection.

[0103] As provided herein, it is understood that any disclosure of a numerical range describing a dimension or measurement, such as thickness, length, weight, time, frequency, temperature, voltage, current, angle, etc., includes any numerical increment or gradient within the range relative to a given dimension or measurement.

[0104] Furthermore, while the transmitters disclosed in the examples herein have a configuration generally having two electrode pairs on each transmitter, transmitters having three electrode pairs (e.g., 120 degrees circumferentially separated from each other), four electrode pairs (e.g., 90 degrees circumferentially separated from each other), five electrode pairs (e.g., 72 degrees circumferentially separated from each other), six electrode pairs (e.g., 60 degrees circumferentially separated from each other), etc., are contemplated. The configuration of such transmitter assemblies may have physical limitations related to the size and placement of wiring, the ability to deliver sufficient power, the corrosion profile of the electrodes, etc., which transmitters may be successfully developed as manufacturing capabilities increase, and these physical limitations are within the scope of the present disclosure.

[0105] Furthermore, numerical designators such as "first," "second," "third," and "fourth" are merely descriptive and do not necessarily indicate the relative order, position, or identity of the elements or features described by the designators. For example, a "first" shock wave may be immediately followed by a "third" shock wave, and then by a "second" shock wave. As another example, a "third" transmitter may be used to generate the "first" shock wave, or vice versa. Accordingly, the numerical designators of the various elements and features are not intended to limit the present disclosure and may be modified and interchanged without departing from the invention.

[0106] It should be understood that the foregoing is merely illustrative of the principles of the present invention, and that various modifications, variations, and combinations may be made by those skilled in the art without departing from the scope and spirit of the present invention. Any variation of the various catheters disclosed herein may include features described herein with any other catheter or combination of catheters. Furthermore, any method may be used with any of the disclosed catheters. Therefore, the present invention is not intended to be limited except by the appended claims.

Claims

1. A catheter for treating an occlusion in a body lumen, the catheter comprising: an elongated tube extending in a longitudinal direction from a distal region to a proximal region; a flexible housing at least partially secured to a distal region of the elongated tube; a first shock wave transmitter positioned along the elongated tube; and A second shock wave transmitter is positioned along the elongated tube, the second shock wave transmitter being translatable in the longitudinal direction relative to the first shock wave transmitter.

2. The catheter according to claim 1, wherein The flexible housing has a working length d, and the center distance between the first shock wave transmitter and the second shock wave transmitter can be adjusted between 2 mm and d.

3. The catheter according to claim 2, wherein The first shockwave transmitter comprises a first pair of shockwave transmitters and the second shockwave transmitter comprises a second pair of shockwave transmitters, the second pair of shockwave transmitters being translatable as a pair relative to the first pair of shockwave transmitters.

4. The catheter according to claim 1, wherein The first shockwave launcher includes a first plurality of shockwave launchers and the second shockwave launcher includes a second plurality of shockwave launchers, the second plurality of shockwave launchers being translatable as a group relative to the first plurality of shockwave launchers.

5. The catheter of claim 1, further comprising a third shock wave transmitter independently translatable relative to the first shock wave transmitter and the second shock wave transmitter. 6 . The catheter of claim 5 , further comprising a safety stop fixedly disposed on the elongated tube, the safety stop configured to separate the first shock wave transmitter and the second shock wave transmitter by a center distance of no less than 2 mm.

7. The catheter according to claim 1, wherein The first shock wave transmitter is translatable along 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 shock wave transmitter and the second shock wave transmitter.

9. The catheter according to claim 8, wherein The proximal handle includes a first thumb-wheel ratchet for controlling movement of the first shockwave transmitter and a second thumb-wheel ratchet for controlling movement of the second shockwave transmitter.

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

11. The catheter according to claim 1, wherein Each of the first shock wave transmitter and the second shock wave transmitter includes one or more electrode pairs, each of the one or more electrode pairs including an outer electrode and an inner electrode.

12. A catheter for treating an occlusion in a body lumen, the catheter comprising: an elongated tube extending in a longitudinal direction from a distal region to a proximal region; a housing secured circumferentially around at least a portion of the distal region of the elongated tube; a proximal emitter assembly fixedly disposed on the elongated tube and located within the interior of the housing; a distal transmitter assembly fixedly disposed on the elongated tube and located within the interior of the housing; as well as A longitudinally translatable elongated member having a distal region movably positioned along the elongated tube, the elongated member being configured to power the proximal transmitter assembly in a proximal configuration and to power the distal transmitter assembly in a distal configuration.

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

14. The catheter according to claim 13, wherein The one or more proximal electrode pairs and the one or more distal electrode pairs each include an outer electrode and an inner electrode made of a conductive sheath.

15. The catheter according to claim 12, wherein In the proximal configuration, shock waves are generated at the proximal emitter assembly but not at the distal emitter assembly, and in the distal configuration, shock waves are generated at the distal emitter assembly but not at the proximal emitter assembly.

16. The catheter according to claim 12, wherein A 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 elongated member between the proximal configuration and the distal configuration.

18. A method for treating an occlusion within a body lumen, the method comprising: Providing a catheter that: including a central tube extending from a proximal region to a distal region, the central tube defining a longitudinal direction and having a central lumen, a housing sealingly connected to and surrounding at least a portion of the distal region of the base tube, and a shock wave transmitter assembly comprising a first shock wave transmitter and a second shock wave transmitter positioned within the housing along the center tube, the first shock wave transmitter and the second shock wave transmitter being movable relative to each other in the longitudinal direction; inserting the catheter into a body lumen and positioning the housing adjacent the occlusion; filling the housing with a conductive fluid and anchoring the housing to a wall of a body lumen; moving the shock wave transmitter assembly away from the obstruction in the longitudinal direction by 1 mm or less; as well as One or more shock waves are generated from the shock wave generator assembly.

19. The method of claim 18, further comprising imaging the body lumen using one or more of x-ray fluorescence, intravascular ultrasound, and optical coherence tomography, Wherein the shock wave transmitter assembly includes imaging the marker.

20. The method according to claim 18, wherein Each shock wave transmitter includes an electrode pair, and generating the one or more shock waves includes applying a high voltage pulse from a power supply.

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

22. A method for treating an occlusion within a body lumen, the method comprising: A catheter is provided, the catheter comprising: a central tube extending in a longitudinal direction from the distal region to the proximal region; a housing secured circumferentially around at least a portion of the distal region of the base 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 positionable along the central tube; inserting the catheter into a body lumen and positioning the housing adjacent to the occlusion; filling the housing with a conductive fluid and anchoring the housing to a wall of a body lumen; moving a distal region of the elongated member to the first launcher assembly; and Power is supplied to the first emitter assembly via the elongated member and one or more shock waves are generated at the first emitter assembly.

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

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

25. The method according to claim 22, wherein The first transmitter assembly includes one or more electrode pairs, and moving the distal region of the elongated member to the first transmitter assembly includes electrically connecting the distal region of the elongated member to the first transmitter assembly.

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