Intravascular lithotripsy catheter with movable emitter

Abstract

A catheter for treating an occlusion within a body lumen includes a movable emitter carrier having one or more shock wave emitters. The one or more shock wave emitters are movable along the inner shaft in a longitudinal direction of the catheter. In a first configuration of the catheter, the one or more shock wave emitters are retracted from the distal fluid-fillable housing. In the second configuration of the catheter, the one or more shock wave emitters are inserted into the distal fluid-fillable housing.

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 / 428,752, 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 / 428,976, 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] The various examples described herein allow an end user to physically move IVL emitters within a very long balloon and position them at various locations within a long calcified lesion as needed to destroy the calcium. According to one aspect of the present disclosure, a catheter for treating an occlusion within a body lumen includes: an outer elongated member including a fluid lumen; a flexible housing secured to a distal region of the outer elongated member, the housing being fillable with a conductive fluid through the fluid lumen; an inner elongated member positioned within the outer elongated member and extending through the flexible housing to a distal region of the flexible housing; and a movable emitter member having an emitter assembly mounted thereon and connected to a power source, the movable emitter member being positioned between the inner elongated member and the outer elongated member and movable in a longitudinal direction between the inner elongated member and the outer elongated member.

[0016] In a first configuration of the movable transmitter member, the transmitter assembly may be located in a first position, and in a second configuration of the movable transmitter member, the transmitter assembly may be located in a second position that is more distal than the first position.

[0017] In the first configuration, the transmitter assembly may be located proximal to the flexible housing, and in the second configuration, the transmitter assembly may be located within the flexible housing.

[0018] The flexible housing may have a working length l, the transmitter assembly may include a plurality of shock wave transmitters, and a distance between the proximal-most shock wave transmitter and the distal-most shock wave transmitter may be less than or equal to 0.5 l.

[0019] The catheter may further include a proximal hub / proximal handle.The outer elongated member, the inner elongated member, and the movable transmitter member may extend to the proximal handle, and the movable transmitter member may translate the transmitter assembly along the inner elongated member at the proximal handle.

[0020] Translation of the movable member at the proximal handle a distance d may move the launcher assembly in the longitudinal direction by the distance d.

[0021] The proximal handle may include a distal opening fluid-tightly connected to the proximal end of the outer elongated member.

[0022] The inner elongated member of the catheter may include indicia relating to the longitudinal position of the transmitter assembly within the flexible housing.

[0023] The proximal handle may include a distal septum seal and a proximal septum seal. The inner elongated member and the movable transmitter member may each extend through the distal septum seal. The inner elongated member may extend through the proximal septum seal.

[0024] The proximal handle may include a position stabilizer having a first anchor at a first position of the handle and a second anchor at a second position more proximal to the handle than the first position, and the movable launcher member includes a proximal end translatable between the first anchor and the second anchor.

[0025] At least one of the inner elongate member and the movable emitter member may comprise polytetrafluoroethylene.

[0026] The inner elongate member may have an outer diameter d1 and the moveable transmitter member may include a lumen having a diameter d2 that is at least 0.002 inches greater than d1.

[0027] The transmitter assembly may include a transmitter centering member comprising: a proximal band; a distal band; and a plurality of flexible beams connecting the proximal ring to the distal ring, each strut having a central region extending radially outward.

[0028] The flexible shell may include an expanded state and a contracted state, and the central region may extend radially outward further when the flexible shell is in the expanded state than when the flexible shell is in the contracted state.

[0029] The launcher assembly may include one or more shock wave launchers, and the central region of the plurality of beams may space the launchers from the walls of the flexible housing.

[0030] The transmitter centering member may comprise one or both of a polymer and a metal.

[0031] The flexible housing may comprise an angioplasty balloon having a working length / of at least 50 mm.

[0032] According to one aspect of the present disclosure, a method for performing intravascular lithotripsy includes introducing a catheter into a body lumen, the catheter comprising: an elongated member extending from a proximal end to a distal end of the catheter; a movable emitter member movable along the elongated member and comprising a shockwave emitter assembly; and an expandable flexible housing secured to a distal region of the elongated member. The method further includes advancing the catheter through the body lumen until the flexible housing is adjacent to an occluded portion of the body lumen; expanding the flexible housing with a lumen fluid via a fluid in the catheter; moving the emitter member along the elongated member; and supplying power to the shockwave emitter assembly to generate one or more shockwaves.

[0033] Moving the launcher member may include moving the launcher member such that the shockwave launcher assembly moves between a first position proximal to the flexible housing and a second position within the flexible housing.

[0034] Moving the launcher member may include moving the launcher member such that the shockwave launcher assembly moves between a first position within the flexible housing and a second position within the flexible housing.

[0035] The method may further include imaging the body lumen using at least one of x-ray fluoroscopy, optical coherence tomography, and intravascular ultrasound.

[0036] Moving the launcher member may include moving a proximal end of the launcher member.

[0037] The method may further include correlating movement of the emitter assembly with moving the emitter member at the proximal end of the emitter member by using markings located along the proximal region of the elongated member.

[0038] According to one aspect of the present disclosure, a transmitter centering member for an IVL catheter includes a proximal band; a distal band longitudinally spaced apart from the proximal band; and a plurality of flexible beams connecting the proximal ring to the distal ring, wherein each flexible beam includes a central region that compressibly extends laterally outward.

[0039] According to one aspect of the present disclosure, a handle for an IVL device includes: a proximal end; an elongated member extending from the proximal end; a movable arm movably positioned on the elongated member and including a proximal diaphragm seal and a power port; a distal arm distal to the movable arm and including a distal diaphragm seal and a fluid port; and a stabilizing rod extending from the proximal end to the distal arm.

[0040] The movable arm may include a second fluid port.

[0041] The movable arm may include a third fluid port.

[0042] According to one aspect of the present disclosure, a catheter for treating an occlusion in a body lumen includes: an elongated member including a fluid lumen; a flexible housing secured to a distal region of the outer elongated member, the flexible housing capable of being filled with a conductive fluid via the fluid lumen and having a working length l; and a movable transmitter member having a transmitter assembly mounted thereon and connected to a power source, the transmitter assembly including a plurality of transmitters, wherein a distance from a proximal-most transmitter to a distal-most transmitter is less than or equal to 1 / 2, and the movable transmitter member is capable of longitudinal translation within the flexible housing. BRIEF DESCRIPTION OF THE DRAWINGS

[0043] 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.

[0044] Figure 1A An exemplary catheter according to aspects of the present disclosure is shown having a movable transmitter array located proximally within an angioplasty balloon.

[0045] Figure 1B An exemplary catheter according to aspects of the present disclosure is shown having a movable transmitter array located at a distal position inside an angioplasty balloon.

[0046] Figure 1C Shown as Figure 1B A cross-sectional view of one of the movable transmitters inside an exemplary catheter and angioplasty balloon is shown.

[0047] Figure 1D Exemplary wiring configurations for an exemplary catheter and for a removable transmitter inside an angioplasty balloon are shown in accordance with aspects of the present disclosure.

[0048] Figure 1E An exemplary catheter according to aspects of the present disclosure is shown in a pair of balloon-expanded and balloon-deflated configurations, having a movable transmitter array positioned within the lumen at a location immediately proximal to an angioplasty balloon.

[0049] Figure 1F An exemplary catheter according to aspects of the present disclosure is shown having a movable transmitter array located at a distal position inside a tapered angioplasty balloon.

[0050] Figure 1G An exemplary catheter configured for rapid exchange delivery having a movable transmitter array located inside an angioplasty balloon according to aspects of the present disclosure is shown.

[0051] Figure 1HAn exemplary catheter configured for rapid exchange delivery having a movable transmitter array located inside an angioplasty balloon according to aspects of the present disclosure is shown.

[0052] Figure 1I 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 3 is a flow chart describing a procedure for shock wave therapy of a lesion using a movable emitter array within an angioplasty balloon in accordance with aspects of the present disclosure.

[0057] Figure 4A An exemplary proximal handle for a catheter having a removable transmitter assembly is shown in accordance with aspects of the present disclosure.

[0058] Figure 4B The present invention shows various aspects of the present invention. Figure 4A Detail of the proximal section of the stabilizer structure shown.

[0059] Figure 5A An exemplary proximal section of a movable launcher carrier is shown in accordance with aspects of the present disclosure.

[0060] Figure 5B An exemplary distal section of a movable launcher carrier is shown according to aspects of the present disclosure.

[0061] Figure 6A An exemplary catheter having a movable transmitter assembly with a transmitter centering feature in a radially collapsed configuration is shown according to aspects of the present disclosure.

[0062] Figure 6B The present invention shows various aspects of the present invention. Figure 6BAn exemplary catheter having a transmitter centering feature in a radially expanded configuration.

[0063] Figure 6C An exemplary catheter having a movable transmitter assembly with transmitter centering features according to aspects of the present disclosure is shown.

[0064] Figure 6D An exemplary transmitter centering structure is shown in a radially collapsed configuration according to aspects of the present disclosure.

[0065] Figure 6E An exemplary transmitter centering structure is shown in a radially expanded configuration according to aspects of the present disclosure.

[0066] Figure 7 An exemplary catheter having a transmitter centering feature according to aspects of the present disclosure is shown. DETAILED DESCRIPTION

[0067] 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.

[0068] 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.

[0069] 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."

[0070] These balloons for IVL applications may need to be formed from materials with higher tensile strength or greater elasticity than balloons of similar length currently used clinically.

[0071] Typically, long calcified lesions in arteries and other vasculature present a challenge to many interventional devices and users. A user (e.g., a 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, a 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 in diameter when expanded.

[0072] 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 centimeters to 138 millimeters (110mm-138mm). This allows the physician to go through cycles of 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.

[0073] 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.

[0074] Figure 1AAn exemplary catheter 100 is shown having a removable transmitter array 110 proximally positioned within an angioplasty balloon 108, according to one or more embodiments. The catheter 100 includes an outer shaft (or outer elongated member) 102, a removable transmitter carrier 104, and an inner shaft 106. The removable transmitter carrier 104 can be tubular and define an interior lumen. Similarly, the outer shaft 102 can be tubular and define a lumen. The removable transmitter carrier 104 can be concentric with the outer shaft 102. The removable transmitter carrier 104 can also be concentric with the inner shaft 106. The angioplasty balloon 108 is secured (e.g., adhered) to the outer shaft 102 at a proximal end and to the inner shaft 106 at a distal end. The balloon 108 is shown expanded, wherein the volume of the balloon 108 is expanded using a conductive fluid (e.g., saline), a contrast agent, or a combination thereof. In some embodiments, the inner shaft 106 is a hollow tube that can be moved around and along a guidewire (not shown), wherein the guidewire can pass through the inner shaft 106 and guide the catheter 100 to the target anatomical structure and lesion within the patient's blood vessel. The movable transmitter array 110 shown in an exemplary embodiment has a first transmitter 112, a second transmitter 114, a third transmitter 116, and a fourth transmitter 118. In various alternative embodiments, the movable transmitter array 110 can have more or fewer transmitters, for example, any number from one to six transmitters. Assuming sufficient power supply and corresponding circuitry, the movable transmitter array 110 can have more than six transmitters.

[0075] In some embodiments, the angioplasty balloon 108 has a diameter of at least 1 millimeter (mm) and up to 25 mm. In some embodiments, the angioplasty balloon has a working length of at least 10 mm and up to 350 mm. In some embodiments, the catheter 100 has a working length of at least 100 cm and up to 350 cm. The working length of the movable emitter carrier within the balloon volume can be up to the entire length of the balloon. In some embodiments, the distance from the proximal-most emitter to the distal-most emitter can be up to the entire working length of the balloon.

[0076] In some illustrated embodiments, each transmitter comprises a cylindrical sheath (alternatively referred to as a ring or belt) mounted on and surrounding the movable transmitter carrier 104. The cylindrical sheath is formed from a conductive material (e.g., a metal or alloy), thereby forming the first electrode surface of an electrode pair. The sheath includes 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 104. The second conductive material thereby forms the 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 can jump across the space between the two electrode surfaces (also referred to as the "spark gap") and generate a shock wave as described above. Either of the two electrode surfaces can be either the anode or cathode, depending on the polarity of the pulse transmitted across the transmitter. The spark gaps may be spaced so as to be offset circumferentially along the movable emitter carrier to provide a more uniform acoustic output in the circumferential direction.

[0077] 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 110 can be electrically connected to each other in series or in parallel on one or more electrical channels.

[0078] As part of the catheter 100, the balloon 108 has a proximal end and a distal end, wherein the proximal end of the balloon 108 is attached to the balloon shaft 102 and the distal end of the balloon 108 is attached to the inner shaft 106. The balloon 108 is attached at these two locations so that the internal volume of the balloon 108 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 108 is attached around the circumference of the balloon shaft 102 so that the space between the balloon shaft 102 and the movable transmitter carrier 104 can be used as a channel for fluid to enter and expand the balloon 108 (and also to deflate and deflate the balloon 108 accordingly). In some embodiments, another type of sealing housing (e.g., a cap or a flexible polymer tube) can be used instead of an angioplasty balloon.

[0079] The catheter 100 can be deployed to a target location within the patient's body with the balloon 108 in a deflated configuration, with all movable transmitter carriers 104 in a retracted position within the outer shaft 102. A guidewire can be used to guide the catheter 100 to the target tissue for treatment. The balloon 108 can then be expanded at a pressure suitable for shock wave therapy (e.g., approximately 4 atmospheres, or a pressure sufficient to allow the outer surface of the balloon 108 to contact and substantially conform to the shape of the surrounding tissue). In various embodiments, the fluid used to fill the volume of the balloon 108 can be saline or other conductive fluid, a contrast agent, or a mixture thereof. The fluid filling the balloon 108 can be delivered to the interior of the balloon 108 through a channel formed by the space between the balloon shaft 102 and the movable transmitters 104. In various alternative embodiments, a separate fluid lumen can be used to provide the fluid. In some embodiments, the balloon is fixedly positioned at the distal region of the inner shaft, and only the movable transmitter lumen can translate between the exterior and interior of the balloon volume.

[0080] Materials that can be used for components such as the outer shaft 102, the removable transmitter carrier 104, and the inner shaft 106 can be extruded or molded polymers, or functional equivalents that are safe for use in a patient's body. Such materials can include polyether block amides (e.g., Pebax), polytetrafluoroethylene (PTFE), nylon, or other polymers.

[0081] As the balloon 108 expands, the movable emitter carrier 104 can then be moved to different positions along the length of the inner shaft 106 (remaining within the volume of the balloon 108), where the emitters of the movable emitter array 110 can then be fired to generate shock waves at desired locations near multiple segments of target tissue (e.g., calcified blood vessels, aortic or mitral valve tissue, etc.).

[0082] As shown, the movable transmitter array 110 includes four individual transmitters, namely, a first transmitter 112, a second transmitter 114, a third transmitter 116, and a fourth transmitter 118, positioned along the transmitter carrier 104 in order from the most distal transmitter to the most proximal transmitter. In various embodiments, each transmitter of the movable transmitter array 110 can have one or more electrode pairs. In various embodiments, all transmitters of the movable transmitter array 110 can be wired on a single electrical channel so that current is provided to all transmitters and across all transmitters during each transmission cycle (e.g., Figure 1A), which means that the first emitter 112, the second emitter 114, the third emitter 116, and the fourth emitter 118 are all on the same single electrical channel. Using only one electrical channel helps minimize the necessary physical wiring required, minimizes the width of the catheter 100, and thus helps minimize the profile / cross-section of the entire catheter 100. In various alternative embodiments, the emitters can be wired on two or more electrical channels, for example using Figure 1A , wherein first emitter 112 and second emitter 114 are on one channel, and third emitter 116 and fourth emitter 118 are on a second channel. Using two or more electrical channels allows for greater operational flexibility in firing emitters, for example, firing only the more distal pair of emitters on the catheter to directionally bias the generated shock waves. Similarly, the operational flexibility of using two or more electrical channels can extend the life of the catheter device, for example, by continuing to fire the more proximal pair of emitters if the more distal pair of emitters has ceased functioning.

[0083] Figure 1B An exemplary catheter 100 is shown having a movable transmitter array 110 located at a distal position within an angioplasty balloon 108. As shown, the movable transmitter carrier 104 extends in a distal direction along the catheter 100, thereby covering more of the surface of the inner shaft 106 while remaining within the volume of the balloon 108. In practice, a physician may choose to position the movable transmitter array 110 at a distal position such as Figure 1B The distal position shown, Figure 1A Shock wave therapy is initiated at a proximal position as shown, or at an intermediate position deemed appropriate for the patient being treated and the target tissue. Marker bands are also shown, particularly a proximal marker band 120 and a distal marker band 122, which are located near the proximal and distal ends of the balloon 108 and can be observed during a procedure under radiography (e.g., x-ray fluoroscopy). In order to be observed under radiography, the marker bands can be made of a radiopaque material, such as iodine, barium, tantalum, bismuth, palladium, platinum, iridium, stainless steel, or alloys, oxides, sulfates, or other combinations thereof. The proximal marker band 120 and the distal marker band 122 are positioned at the proximal and distal ends of the balloon 108, respectively, to allow an operator to observe the position of the balloon and catheter 100 within the patient's body.

[0084] Figure 1C An exemplary catheter 100 and Figure 1B A cross-sectional view of one of the movable transmitters (shown as the first transmitter 112 ) is shown positioned within an expanded angioplasty balloon 108 . Figure 1CHow the wires are electrically connected to the emitters on the movable emitter carrier 104 is described in greater detail. A first wire 124 is positioned within a recess 128 formed in the movable emitter carrier 104 and aligned with a first spark gap 112a formed in the emitter ring 112. Similarly, a second wire 126 is positioned within a separate recess 128 formed in the movable emitter carrier 104 and aligned with a second spark gap 112b formed in the emitter ring 112c. Both first and second wires 124 and 126 are insulated wires, except at locations where first wire 124 is aligned with first spark gap 112a and second wire 126 is aligned with second spark gap 112b. Wires 124 and 126 are exposed, each forming an electrode surface that mates with a corresponding opposing electrode surface of the emitter ring 112c. Thus, the first emitter 112 has two pairs of electrodes: one pair located at the first spark gap 112a between the first wire 124 and the emitter ring 112c, and another pair located at the second spark gap 112b between the second wire 126 and the emitter ring 112c. In various alternative embodiments, the first and second wires 124, 126 can be embedded within the material of the movable emitter carrier 104, thereby minimizing the cross-sectional profile of the entire catheter 100. In various other alternative embodiments, the first and second wires 124, 126 can be inserted or extruded between the movable emitter carrier 104 and each emitter. The first and second wires 124, 126 can be secured to the movable emitter carrier 104 by adhering to the surface of the movable emitter carrier 104, wrapping the surface of the movable emitter carrier 104 with a coating (e.g., shrink-wrapping a polymer material around the wires and lumen), or a combination thereof.

[0085] In some embodiments, each transmitter can be spaced three to twenty millimeters 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.

[0086] Figure 1DAn exemplary wiring configuration for a removable transmitter within an exemplary catheter and angioplasty balloon is shown, according to one or more embodiments. This enlarged view shows a first conductor 123 extending from a power source (not shown) to a proximal-most transmitter 118. Transmitter 118 is electrically connected to a first return conductor 127, which extends near the power source. Current from the high-voltage pulse travels from the power source via first conductor 123 to proximal-most transmitter 118, generating a shock wave at transmitter 118 (as described above). Current then travels via second conductor 125 to second proximal-most transmitter 116, generating a shock wave at transmitter 116. This continues until a shock wave has been generated at each electrode pair electrically connected to transmitters 116, 118. Current then returns to the power source via return conductors (e.g., first and second return conductors 127, 129). Although only one aperture is shown for each transmitter in the figure (indicating the location of an electrode pair that may generate a shock wave), it is possible for multiple electrically connected electrode pairs to exist at each transmitter. In some embodiments, the conductors comprise insulated wires having conductive regions connected to the electrodes or to the conductive regions of the surfaces thereof formed as electrodes. In some embodiments, the conductors or wires are arranged so that the shock waves are generated continuously from the most distal emitter to the most proximal emitter.

[0087] Figure 1E An exemplary catheter 100 according to one or more embodiments is shown in a pair of balloon-expanded and -deflated configurations, having a movable transmitter array within the lumen directly adjacent to an angioplasty balloon. As shown, a first transmitter 112, a second transmitter 114, a third transmitter 116, and a fourth transmitter 118 are positioned on a movable transmitter carrier 104 within the outer shaft 102 and proximal to the balloon 108. When expanded or deflated, the distal end of the movable transmitter carrier 104 can partially extend into the volume of the balloon 108, or the movable transmitter carrier 104 can be fully retracted within the circumference of the outer shaft 102 before and / or after deployment.

[0088] An advantage of positioning the transmitter within the outer shaft 102 during deployment to the target tissue site is that, during delivery, the deflated balloon 108 can be collapsed / compacted to effectively the same diameter as the outer surface of the inner shaft 106. This diameter can be 5-8 French. In some embodiments, the reduced outer diameter is up to 8 French. Consequently, the catheter 100 has a smaller cross-sectional profile for delivery to a vessel or lesion than if the transmitter were present and stationary within the balloon 108 on the inner shaft 106. While such transmitters used in IVL devices may increase the overall catheter diameter by as little as 1 French or less during deployment, this difference in cross-sectional profile is significant for both traversing certain vascular lesions and being adaptable to other vascular delivery systems. Furthermore, keeping the transmitter retracted within the outer shaft 102 when in the deflated balloon 108 configuration reduces the risk of the balloon material becoming lodged in or tearing at the transmitter during passage through the patient's vasculature.

[0089] Figure 1F An 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.

[0090] exist Figure 1A In the example shown in FIG1F , the catheter may be configured to be advanced into a body lumen over a guidewire (not shown), generally referred to as an “over the wire” or “OTW” configuration. Figure 1G and Figure 1H As shown, the catheter can be arranged as part of a "rapid exchange" or "Rx" configuration, where instruments are passed in and out of the patient through a larger lumen during the procedure. Figure 1G A catheter 100 is shown in accordance with one or more embodiments of the present disclosure. Figure 1GThe catheter 100 includes a path for a guidewire 150 for a rapid exchange configuration. The guidewire 150 can extend from the distal end of the catheter 100 within the lumen of the inner shaft 106, exit the inner shaft 106 at the distal side of the balloon 108, re-enter the catheter 100 at the proximal side of the balloon 108, and extend proximally inside the lumen of the outer shaft 102. This configuration can better facilitate movement of the transmitter carrier 104 into and out of the balloon 108 and to different positions within the balloon 108. The transmitter carrier 104 moves back and forth on a stationary inner rail 152 and can extend proximally to the handle of the catheter. The inner rail 152 can be coupled to the distal tip of the balloon to keep the Rx guidewire stable during treatment. The rapid exchange guidewire exit 151 can be proximal to the distal balloon 108 and at the proximal end of the catheter 100 ( Figure 1G The catheter 100 may include a fluid lumen 160 extending through the outer shaft 102 for delivering fluid to 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.

[0091] Figure 1H Catheter 100 is shown in another configuration of a rapid exchange system according to one or more examples. Figure 1H The catheter 100 includes an inner shaft 106 having a lumen for a guidewire 150 that extends through a balloon 108. The movable transmitter member 104 is slidably movable along the inner shaft 106 and retractable into the outer shaft 102. The catheter 100 includes a guidewire outlet 151 located at the proximal end of the catheter ( Figure 1H Advantageously, at the distal end of Figure 1G and 1H In both configurations shown, the guidewire 150 need not extend along the entire length of the catheter 100 .

[0092] Figure 1IA cross-sectional view of an exemplary catheter 2000, according to one or more embodiments, is shown at the region between the proximal handle and the removable transmitter assembly. Catheter 2000 includes an inner shaft 2010. In one or more embodiments, inner shaft 2010 can be tubular and define a guidewire lumen for receiving a guidewire (not shown), over which catheter 2000 can be delivered. A removable transmitter carrier 2020 is movably positioned on inner shaft 2010. Removable transmitter carrier 2020 can be tubular and define a lumen. Removable transmitter carrier 2020 can include one or more wires (or another form of energy guide) that connect one or more transmitters to a power source. Removable transmitter carrier 2020 can be formed with grooves or lumens for the wires (as described below) to reduce the overall profile of catheter 2000. Removable transmitter carrier 2020 is positioned between inner shaft 2010 and outer shaft 2030. In one or more embodiments, outer shaft 2030 can be formed at least in part from a hypotube. Outer shaft 2030 can also include an outer layer 2040. Outer layer 2040 can include a braided structure and provide structural support for catheter 2000 as it passes through a body lumen. In some embodiments, the inner diameter of movable transmitter carrier 2020 is greater than the outer diameter of inner shaft 2010. In some embodiments, the inner diameter of movable transmitter carrier is at least 50 micrometers (μm) greater than the outer diameter of inner shaft 2010.

[0093] In various embodiments, a catheter having a removable emitter carrier with one or more shockwave 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. For example, the housing may have a working length of 1, and the distance between the proximal-most and distal-most shockwave emitters may be less than or equal to 0.5 1. 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 shockwave therapy. The movable emitter carrier can then be advanced further to a second position (e.g., at a position more distal than the first position) to treat a new lesion or a new area of ​​the same lesion. In some embodiments, treatment can be initiated at a distal region of the balloon or in a central region of the balloon. Advantageously, the shock wave therapy can be customized for 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 of the balloon, the emitters at more distal locations will generate more shock waves than at proximal locations. By tailoring the shock wave therapy in this manner, unnecessary excess shock wave generation can be avoided, thereby preserving the life of the device. Such a device is also less complex in design than would be the case if power were individually supplied (e.g., via wires) to a large number of emitters positioned along the length of the angioplasty balloon.

[0094] Figures 2A-2C An exemplary catheter within a vascular structure is shown 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 2A Initially, 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.

[0095] Go to Figure 2B , movable emitter carrier 104 has been pulled back in a proximal 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.

[0096] Finally, go to Figure 2C , movable emitter carrier 104 has been pulled back in a proximal direction along the length of catheter 100, bringing movable emitter array 110 adjacent to a calcification proximal to a lesion in vascular tissue of a subject. As shown, the emitters of movable emitter array 110 generate shock waves that fragment the calcification proximal to the lesion.

[0097] 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.

[0098] Figure 3This is a flowchart describing a procedure for shock wave therapy of a lesion using a removable emitter array within an angioplasty balloon, according to one or more embodiments. In step 301, an IVL device is deployed over a guidewire into a body lumen (e.g., a blood vessel). In step 302, the housing of the IVL device (e.g., a balloon) is positioned across or adjacent to the lesion to be treated. In step 303, the housing is expanded until the active area of ​​the balloon abuts / contacts and conforms to the wall of the body lumen and the lesion. In some embodiments, the housing is expanded to a pressure of less than 5 atmospheres. In some embodiments, the housing is expanded to a pressure of at least 1 atmosphere and no more than 4 atmospheres. In step 309, if the removable emitter array is in a retracted position within the outer shaft (i.e., proximal to the balloon), the emitters are advanced into the housing to a first target area within the lesion. In step 305, shock waves are generated at the removable emitter array (e.g., by delivering high-voltage pulses or laser pulses). In step 306, the user determines whether different areas of the lesion require shock wave therapy. If "yes", steps 304-306 are repeated; if "no", in step 307, the shell is deflated. After deflation, in step 308, the IVL device is withdrawn. Optionally, before withdrawing the IVL device and after the shock wave treatment, the shell is expanded to a pressure sufficient to radially expand the body lumen. In some embodiments, this second expansion pressure is higher than the pressure in step 303. In some embodiments, the second expansion pressure is greater than 5 atmospheres. In some embodiments, the second expansion pressure is at least 4 atmospheres and at most 12 atmospheres. In some embodiments, in step 310, the movable emitter array may be withdrawn into the outer shaft before the shell is deflated and the catheter is withdrawn. In some embodiments, the method further includes the step of imaging the lesion (e.g., by x-ray fluoroscopy, intravascular ultrasound and / or optical coherence tomography). The method may also include the following steps: between multiple rounds of shock wave treatment, deflation of the balloon and expansion of the balloon with liquid to remove any accumulated bubbles in the balloon.

[0099] Figure 4A An exemplary proximal handle 1000 for a catheter having a removable transmitter assembly and a balloon assembly is shown, according to one or more embodiments. Handle 1000 can be used to advance or retract a removable transmitter carrier 1302, which includes a removable transmitter assembly at its distal region (not shown). Handle 1000 includes a fluid port 1102 extending from distal Y-arm 1100 and fluidically connected to the lumen of outer shaft 1500. Removable transmitter carrier 1302 is slidably positioned within outer shaft 1500 and extends proximally from the proximal end of outer shaft 1500 through a fluid-tight connector 1104. In one or more embodiments, connector 1104 may include a Luer connector.

[0100] The movable launcher carrier 1302 extends to a proximal Y-shaped arm 1300 slidably positioned on the inner shaft 1010. The proximal Y-shaped arm 1300 includes a power connector port 1304 through which a power source can be connected to the launcher assembly. For example, the launcher assembly can be electrically connected to a high-voltage power source via a connector 1320 via a conductive member 1310. In various other embodiments, one or more optical fibers can be connected to a light source (e.g., a laser) for providing the energy / power used to generate the shockwaves. In some embodiments, translation of the proximal Y-shaped arm 1300 along the inner shaft 1010 by a distance d results in / is related to translation of the launcher assembly longitudinally (in the distal-proximal direction) by a distance d.

[0101] The inner shaft 1010 extends to the proximal region of the handle 1000. In one or more embodiments, the handle 1000 includes a stabilizing structure 1200 comprising a rod 1202 extending from the distal region to the proximal region of the handle 1000. In some embodiments, the rod 1202 can be connected at its distal end to the distal Y-shaped arm 1100. In one or more embodiments, the length of the rod 1202 is approximately the same as the working length of the balloon. The proximal Y-shaped arm 1300 can slide and translate along the inner shaft 1010 between the proximal region of the handle and the distal Y-shaped arm 1100. When the proximal Y-shaped arm 1300 is in the proximal-most position of the inner shaft 1010, the transmitter assembly can be fully retracted into the outer shaft 1500. Distal translation of the proximal Y-shaped arm 1300 causes the transmitter assembly to move distally into the balloon, toward the distal end of the balloon.

[0102] In one or more embodiments, proximal handle 1000 includes a connector 1340 in the proximal Y-shaped arm. Connector 1340 may include a Luer connector. In one or more embodiments, connector 1104 and connector 1340 include silicone / polysiloxane (silicone) seals and / or flexible valves that ensure fluid sealing and help maintain the internal pressure of the balloon. In certain embodiments, connector 1104 and connector 1340 each include an O-ring to ensure fluid sealing. These connectors also help promote the movement of the removable transmitter carrier. Advantageously, the silicone or silicone-type seals at these connectors can be self-sealing, and their use has ensured the simple structure and mechanism of creating a fluid-tight seal.

[0103] In one or more embodiments, the proximal handle 1000 includes markings on the inner shaft 1010 or along the stabilizing rod 1202 to indicate to the user the position of the movable transmitter assembly. For example, the proximal Y-shaped arm 1300 located at the proximal marking 1011 can be associated with a transmitter assembly that is withdrawn from the balloon. The proximal Y-shaped arm 1300 located at the distal marking 1012 can be associated with a transmitter assembly located in the distal region of the balloon.

[0104] Figure 4B Another exemplary proximal handle 200 for a shock wave catheter according to some embodiments of the present disclosure is shown. Handle 200 includes a first fluid port 210, a second fluid port 220, and a third fluid port 230, each of which is fluidically connected to a fillable housing via a separate fluid lumen. One or both of the first port 210 and the second port 220 can be used to remove air and prime the catheter for shock wave therapy.

[0105] Figure 5A shows an exemplary proximal portion 510 of a movable launcher carrier according to some embodiments, Figure 5B An exemplary distal portion 520 of a removable transmitter carrier is shown. The proximal portion 510 includes multiple conductor lumens through which conductors (e.g., wires) extend from a power source. A cylindrical shaft with conductor lumens helps provide a seal with the connector (e.g., a Luer connector) at the proximal handle described above. The distal portion 520 includes multiple grooves for receiving the same multiple conductors. The grooves in the distal portion 520 of the transmitter shaft can help provide a narrower profile at the distal end. In one or more embodiments, two different shafts are joined together (e.g., thermally bonded) to form a removable transmitter carrier having one or more conductor lumens in the proximal region and one or more conductor grooves in the distal region.

[0106] In one or more embodiments, the IVL catheter with a removable transmitter has a diameter of 8 French or less. In some embodiments, the IVL catheter with a removable transmitter has a diameter of 5 French or less.

[0107] In some aspects of the invention, an IVL catheter includes emitter centering features including one or more shock wave emitter centering features. Figures 6A-6C A catheter 3000 is shown having centering structures 3002 , 3004 , 3006 , 3008 , 3010 adjacent a shock wave transmitter assembly including shock wave transmitters 3012 , 3014 , 3016 , 3018 . Figure 6A The centering structure is shown in a radially compressed state. Figure 6B and 6C The centering structure is shown in a radially expanded state for clarity. Figure 6CCatheter 3000 is shown without a housing. When the launcher assembly of launchers 3012, 3014, 3016, 3018 is embedded within outer shaft 3100, centering structures 3002, 3004, 3006, 3008, 3010 are in a radially compressed state. When the launcher assembly is pushed out of outer shaft 3100 and into housing 3200, centering structures 3002, 3004, 3006, 3008, 3010 are in a radially expanded state. When unsheathed, centering structures 3002, 3004, 3006, 3008, 3010 are radially self-expandable. When expanded, centering structures 3002, 3004, 3006, 3008, 3010 contact the inner surface of the shell to space emitters 3012, 3014, 3016, 3018 from the inner surface of shell 3200. In some embodiments, when radially expanded, centering structures 3002, 3004, 3006, 3008, 3010 space each emitter 3012, 3014, 3016, 3018 from the inner surface of shell 3200 by a distance of at least 0.1 mm. In some embodiments, the centering structures space one or more emitters from the inner surface of the shell by a distance of at least 0.5 mm. In some embodiments, the centering structures space one or more emitters from the inner surface of the shell by a distance of at least 2 mm. In some embodiments, the desired distance for spacing one or more shock wave emitters from the inner surface of the shell may depend on the material properties of the shell (e.g., thermal degradation properties) and / or the energy output of the emitters.

[0108] In some embodiments, an IVL catheter includes multiple shockwave emitters and multiple emitter centering structures. The number of emitter centering structures may be one greater than the number of shockwave emitters. One emitter centering structure may be located more proximally than the proximal-most emitter. One emitter centering structure may be located more distally than the distal-most emitter.

[0109] During delivery through a body lumen, the centering structure can be sleeved / built into the interior of the outer shaft 3100 in a radially compressed state. When the housing 3200 is adjacent to the lesion to be treated, the housing can expand. The emitter and the centering structure can then be moved into the interior of the housing. When introduced into the housing with a widened diameter, the centering structure can self-expand until the centering structure contacts the inner surface of the housing. Centering the emitter and thereby isolating the housing from the high heat associated with shock wave generation can be important for maintaining the integrity of the housing (e.g., an angioplasty balloon).

[0110] Figure 6D and 6E An exemplary centering structure 3001 is shown in isolation, in accordance with one or more embodiments. Figure 6D The centering structure 3001 is shown in a radially compressed state. Figure 6E Centering structure 3001 is shown in a radially expanded state. Centering structure 3001 includes a first end 3020 and a second end 3022. Each end may include a band (e.g., an annular band, a discontinuous band, or another type of band). First end 3020 and second end 3022 may be connected by a self-expanding region 3030. Self-expanding region 3030 may include beams 3032, 3034, 3036, 3038. Beams 3032, 3034, 3036, 3038 may be flexible beams. Beams 3032, 3034, 3036, 3038 may be made of a material that can be radially compressed (i.e., straightened) and then return to a radially expanded state. In some embodiments, the beams are made of nitinol, another nickel alloy, or another elastic material. The beam width may be 20-250 micrometers (μm). Although centering structure 3001 is shown as having four beams, other numbers of beams, such as two, three, five, six, or more beams, are also possible. When radially expanded, the centering structure may have a maximum diameter that is at least 0.5 mm greater than when radially compressed. In some examples, the maximum diameter of the centering structure in the radially expanded state is at least 0.75 mm greater than when radially compressed.

[0111] One or both of the first end 3020 and the second end 3022 may be loosely attached / adhered to the movable launcher shaft. By having at least one free end, the centering structure 3001 can be free to expand in the housing, or be compressed when sleeved in the outer shaft.

[0112] Figure 7 An IVL catheter 4000 is shown having a transmitter centering feature including one or more centering structures 4002, 4004, 4006, 4008, 4010, according to one or more embodiments. Each of the centering structures 4002, 4004, 4006, 4008, 4010 includes an expandable outer shell (e.g., a balloon) that is fluidly connected to a proximal fluid port via a fluid lumen. Figures 6A-6E The centering structures 4002, 4004, 4006, 4008, 4010 are used to space the shock wave transmitter from the shell. The expandable shell of these centering structures can be made of semi-compliant or non-compliant materials.

[0113] In one or more embodiments, the centering feature can include one or more radially expandable porous (e.g., fiber and / or polymer) structures positioned adjacent to and / or between the shock wave transmitters. Each porous structure can be configured to be in a radially expanded state and exert sufficient radial force when positioned within a relatively compliant housing (e.g., a semi-compliant or compliant angioplasty balloon), and to be in a radially collapsed state when positioned within a relatively non-compliant shaft or tube.

[0114] 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.

[0115] 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).

[0116] 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.

[0117] 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.

[0118] 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.

[0119] 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.

[0120] 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 outer elongated member including a lumen for fluid; a flexible housing secured to a distal region of the outer elongated member, the flexible housing being capable of being filled with a conductive fluid via the fluid lumen; an inner elongated member positioned within the outer elongated member and extending through the flexible housing to a distal region of the flexible housing; as well as A movable transmitter member having a transmitter assembly mounted thereon and connected to a power source is positioned between the inner and outer elongated members and is movable in a longitudinal direction therebetween.

2. The catheter according to claim 1, wherein In a first configuration of the movable launcher member, the launcher assembly is located in a first position, and in a second configuration of the movable launcher member, the launcher assembly is located in a second position that is more distal than the first position.

3. The catheter according to claim 2, wherein In the first configuration, the transmitter assembly is located proximal to the flexible housing, and in the second configuration, the transmitter assembly is located within the flexible housing.

4. The catheter of claim 2, wherein: The flexible housing has a working length l, The launcher assembly includes a plurality of shock wave launchers, and The distance between the nearest blast wave emitter and the farthest blast wave emitter is less than or equal to 0.5 l.

5. The catheter according to claim 1, wherein Also included is a proximal handle, wherein the outer elongated member, the inner elongated member, and the movable launcher member extend to the proximal handle, translation of the movable launcher member along the inner elongated member at the proximal handle moves the launcher assembly. The catheter according to claim 5 , wherein: Translation of the movable member at the proximal handle a distance d causes the launcher assembly to move the distance d in the longitudinal direction.

7. The catheter according to claim 5, wherein The proximal handle includes a distal opening fluid-tightly connected to the proximal end of the outer elongated member.

8. The catheter according to claim 5, wherein The inner elongated member includes indicia relating to a longitudinal position of the transmitter assembly within the flexible housing.

9. The catheter of claim 5, wherein: The proximal manipulation handle includes a distal diaphragm seal and a proximal diaphragm seal, The inner elongate member and the movable transmitter member each extend through the distal septum seal, and The inner elongate member extends through the proximal septum seal.

10. The catheter according to claim 5, wherein The proximal handle includes a position stabilizer having a first anchor located at a first position of the proximal handle and a second anchor located at a second position of the proximal handle more proximal than the first position, the movable launcher member including a proximal end translatable between the first anchor and the second anchor.

11. The catheter according to claim 1, wherein At least one of the inner elongated member and the movable emitter member comprises polytetrafluoroethylene.

12. The catheter according to claim 1, wherein The inner elongated member has an outer diameter d1 and the movable transmitter member includes a lumen having a diameter d2 that is at least 0.002 inches greater than d1.

13. The catheter according to claim 1, wherein The transmitter assembly includes a transmitter centering member, the transmitter centering member including: proximal band; distal band; and A plurality of flexible beams connect the proximal band to the distal band, each beam having a central region extending radially outward.

14. The catheter according to claim 13, wherein The flexible shell includes an expanded state and a contracted state, and the central region extends radially outward further when the flexible shell is in the expanded state than when the flexible shell is in the contracted state.

15. The catheter according to claim 13, wherein The launcher assembly includes one or more shockwave launchers, and the central region of the plurality of beams separates the one or more shockwave launchers from a wall of the flexible shell.

16. The catheter according to claim 13, wherein The transmitter centering member includes one or both of a polymer and a metal.

17. The catheter of claim 1, wherein The flexible housing comprises an angioplasty balloon having a working length l of at least 50 mm.

18. A method of performing intravascular lithotripsy, the method comprising: A catheter is introduced into a body lumen, the catheter comprising: an elongated member extending from the proximal end of the catheter to the distal end of the catheter; a movable emitter member movable along the elongated member and comprising a shockwave emitter assembly; and an expandable flexible housing secured to a distal region of the elongated member; advancing the catheter through the body lumen until the flexible housing is adjacent to an occluded portion of the body lumen; expanding the flexible shell with fluid via the fluid lumen of the catheter; moving the emitter member along the elongated member; and Power is supplied to the shockwave transmitter assembly to generate one or more shockwaves.

19. The method according to claim 18, wherein Moving the emitter member includes moving the emitter member such that the shockwave emitter assembly moves between a first position proximal to the flexible housing and a second position within the flexible housing.

20. The method according to claim 18, wherein Moving the launcher member includes moving the launcher member such that the shockwave launcher assembly moves between a first position within the flexible housing and a second position within the flexible housing.

21. The method of claim 18, further comprising imaging the body lumen using at least one of x-ray fluoroscopy, optical coherence tomography, and intravascular ultrasound.

22. The method according to claim 18, wherein Moving the transmitter member includes moving a proximal end of the transmitter member.

23. The method of claim 18, further comprising correlating movement of the emitter assembly to moving the emitter member at the proximal end of the emitter member by using markings positioned along a proximal region of the elongated member.

24. A launcher centering member for an IVL catheter, the launcher centering member comprising: proximal band; a distal band longitudinally spaced from the proximal band; as well as A plurality of flexible beams connect the proximal band to the distal band, wherein each flexible beam includes a compressibly laterally outwardly extending central region.

25. A handle for an IVL device, the handle comprising: proximal; an elongated member extending from the proximal end; a movable arm movably positioned on the elongated member and comprising a proximal septum seal and a power supply port; a distal arm located distal to the movable arm and comprising a distal septum seal and a fluid port; as well as A stabilizing rod extends from the proximal end to the distal arm.

26. The handle of claim 25, wherein: The movable arm includes a second fluid port.

27. The handle of claim 26, wherein: The movable arm includes a third fluid port.

28. A catheter for treating an occlusion in a body lumen, the catheter comprising: an elongated member including a lumen for fluid; a flexible housing fixed to the distal region of the elongated member, the flexible housing being capable of being filled with a conductive fluid via the fluid lumen and having a working length l; as well as a movable transmitter member having a transmitter assembly mounted thereon and connected to a power source, the transmitter assembly including a plurality of transmitters, The distance from the most proximal transmitter to the most distal transmitter is less than or equal to 1 / 2, and the movable transmitter component can translate longitudinally within the flexible housing.

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