Catheter for treating obstruction in body cavity

Abstract

The utility model relates to a catheter for treating blockage in a body cavity. The catheter comprises a movable emitter loader with one or more shock wave emitters. One or more shock wave emitters are movable along the inner shaft in a longitudinal direction of the catheter. In the first configuration of the catheter, the one or more shock wave emitters are retracted from the distal fluid-fillable enclosure. In the second configuration of the catheter, one or more shock wave emitters are inserted into the distal fluid-fillable enclosure.

Description

[0001] priority

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 442,980, filed on February 2, 2023, the entire disclosure of which is incorporated by reference. Technical Field

[0003] The utility model generally relates to the field of medical devices and methods, and more particularly to a shock wave catheter device for treating calcified lesions in body cavities (such as calcified lesions and obstructions in vascular systems and kidney stones in urinary systems). 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, the treatment system for percutaneous coronary angioplasty or peripheral angioplasty uses angioplasty balloons to expand calcified lesions and restore normal blood flow in the vessel. In these types of operations, the catheter carrying the balloon is advanced into the vascular system along a guide wire until the balloon is aligned with the calcified plaque. The balloon is then pressurized (usually greater than ten atmospheres) so that the balloon is inflated in the vessel to push the calcified plaque back to the vessel wall and expand the blocked area of ​​the vascular system. However, due to the stiffness and hardness of calcified tissue and / or plaque, traditional angioplasty balloons are not always successful in expanding calcified lesions or vascular system.

[0005] Recently, catheters have been developed that include shock wave transmitters (e.g., one or more electrode pairs) for generating shock waves within an angioplasty balloon—a treatment known as intravascular lithotripsy (“IVL”), a technology pioneered by Shock Wave Medical, Inc., the applicant for the present application. Shock wave devices can be particularly effective for treating calcified lesions because the acoustic pressure from the shock waves can rupture 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 in a body cavity. The balloon is then inflated with a conductive fluid (using a relatively low pressure of two to four atmospheres) so that the balloon is inflated to contact the lesion, thereby juxtaposing the shock wave transmitter near the lesion. The shock wave transmitter can then be activated to generate an acoustic shock wave that propagates through the wall of the angioplasty balloon and into the lesion. Once the lesion is ruptured by the acoustic shock waves, the balloon can be further expanded to increase the cross-sectional area of ​​the lumen and improve blood flow through the vessel.

[0006] For electrohydraulic generation of acoustic shock waves, a conductive solution (e.g., saline) may be contained within a capsule surrounding the electrodes, or it may be flushed to the electrodes through the lumen. Calcified plaque transformation is achieved by generating acoustic shock waves within the catheter using a discharge across / between the electrodes. The energy released by the discharge enters the surrounding fluid at a speed faster than the speed of sound, thereby generating acoustic shock waves. The energy generated by the discharge may also generate vapor bubbles that rapidly inflate and collapse, thereby generating additional shock waves. These shock waves propagate radially outward and transform calcified plaques within the blood vessels. For laser generation of acoustic shock waves, laser pulses are transmitted to the fluid within the catheter and absorbed by the fluid. This absorption process rapidly heats the fluid and vaporizes it, thereby generating rapidly inflated and collapsed vapor bubbles and acoustic shock waves that propagate outward and transform calcified plaques. If a fluid that exhibits strong absorption at the laser wavelength employed is selected, 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 treatments for calcified lesions in a patient's vasculature typically involve mechanical alterations to the vessel, particularly atherectomy, which carries a relatively large risk of embolism (displacement of debris), abrupt closure (collapse of the vessel), dissection (tear of the vascular tissue), and / or perforation (puncture of the vascular tissue). Using IVL instead of or in conjunction with conventional treatments for calcified lesions can greatly reduce the risk of embolism and perforation while improving the therapeutic outcome of removing the calcified lesions.

[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. For patients with lesions longer than the standard length of the balloon, physicians may choose to repeat cycles of inflation, shock wave delivery, deflation, and repositioning of the balloon in order to deliver shock wave therapy to the entire length of a given lesion. When used in repeated cycles, there are concerns about the structural integrity of the balloon and whether the balloon can maintain its deflation profile to traverse the lesion. In addition, any procedure or technique that increases the patient's time on the operating table beyond what is necessary is not well accepted in clinical cases because it may lead to surgical complications.

[0009] Therefore, physicians need longer balloons to treat longer lesions to reduce surgical time and cost. Simply using a longer balloon may not be enough because the distance from the emitter to the relatively far portion of the longer balloon may result in insufficient shock wave intensity at the end of the balloon. In addition, simply increasing the number of shock wave emitters may not be practical or possible because adding emitters tends to increase the profile of the catheter and complicate its design. Such catheters also require much higher energy output from the power source. A large number of emitters also reduces the flexibility and trackability of the balloon area of ​​the catheter, thereby limiting the treatment sites that can be reached.

[0010] Thus, there is an unmet need for a catheter and transmitter assembly design that is capable of delivering shock waves to relatively long lesions within a patient's body and correspondingly minimizes the time the patient is treated during the procedure. Utility Model Content

[0011] The above objects are achieved in a catheter including a set of movable emitters that can be repositioned when deployed in a patient. More specifically, the innovation of the present invention allows an end user (e.g., a physician) to physically move the emitters of an IVL device along a relatively long intra-balloon catheter and position the emitters at different locations along the long calcified lesion as needed to destroy the calcium with shock wave technology.

[0012] Various examples 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 in a long lesion, and instead move any number of transmitters within the inflated balloon to the desired location along the length of the calcified lesion. This process may also be accomplished with a slightly inflated or semi-inflated balloon, depending on the calcium structure of the artery, and without the need to reposition the balloon at all.

[0013] In one or more embodiments, a catheter for treating an obstruction in 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 customizable placement of transmitters in situ along the length of the balloon so that shock wave therapy can be optimally applied with minimal repositioning of the balloon required by the physician. Various embodiments of the catheter allow for effective application of acoustic energy to calcified regions of the vessel and avoid 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, traceability, and / or delivery capabilities of the catheter as a whole.

[0015] Various examples described herein allow an end user to physically move IVL transmitters within a very long balloon and position them as needed at various locations of a long calcified lesion in order to destroy the calcium. According to one aspect of the present invention, a catheter for treating an obstruction within a body cavity includes: an outer elongated member including a fluid lumen; a flexible capsule fixed to a distal region of the outer elongated member, the flexible capsule being fillable with a conductive fluid via the fluid lumen; an inner elongated member positioned within the outer elongated member and extending through the flexible capsule to a distal region of the flexible capsule; and a movable transmitter member having a transmitter assembly mounted thereon and connected to a power source, the movable transmitter member being located between the inner elongated member and the outer elongated member and being 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 at a first position, and in a second configuration of the movable transmitter member, the transmitter assembly may be located at a second position that is further away than the first position.

[0017] The transmitter assembly may be located proximal to the flexible enclosure in the first configuration and within the flexible enclosure in the second configuration.

[0018] The flexible enclosure may have an active length l, the emitter assembly may include a plurality of shock wave emitters, and a distance between a proximal-most shock wave emitter and a distal-most shock wave emitter may be less than or equal to 0.5l.

[0019] The catheter may also include a proximal hub. The outer elongated member, the inner elongated member, and the movable transmitter member may extend to the proximal hub, and translation of the movable transmitter member along the inner elongated member at the proximal hub may move the transmitter assembly.

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

[0021] The proximal hub may include a distal opening fluidly sealed 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 enclosure.

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

[0024] The proximal hub may include a position stabilizer having a first anchor at a first location of the hub and a second anchor at a second location of the hub closer to the first location, and the movable transmitter 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 moveable 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 at least 0.002 inches greater than d1.

[0027] The transmitter assembly may include a transmitter centering member including: 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 enclosure may include an inflated state and a deflated state, and the central region may extend radially outwardly further when the flexible enclosure is in the inflated state than when the flexible enclosure is in the deflated state.

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

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

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

[0032] According to one aspect of the present invention, a method for performing intravascular lithotripsy includes introducing a catheter into a body cavity, the catheter including: an elongated member extending from a proximal end of the catheter to a distal end of the catheter; a movable transmitter member that is movable along the elongated member and includes a shock wave transmitter assembly; and an inflatable flexible shell fixed to a distal region of the elongated member. The method also includes: advancing the catheter through the body cavity until the flexible shell is adjacent to an obstruction of the body cavity; inflating the flexible shell with a fluid via a fluid lumen of the catheter; moving the transmitter member along the elongated member; and supplying power to the shock wave transmitter assembly to generate one or more shock waves.

[0033] Moving the emitter member may include moving the emitter member such that the shock wave emitter assembly moves between a first position proximal to the flexible enclosure and a second position within the flexible enclosure.

[0034] Moving the launcher member may include moving the launcher member to move the shock wave launcher assembly between a first position within the flexible enclosure and a second position within the flexible enclosure.

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

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

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

[0038] According to one aspect of the present invention, 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 invention, a handle for an IVL device includes: a proximal end; an elongated member extending from the proximal end; a movable arm, which is movably positioned on the elongated member and includes a proximal diaphragm seal and a power port; a distal arm, which is located distal to the movable arm and includes 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 utility model, a catheter for treating obstruction in a body cavity comprises: an elongated member including a fluid lumen; a flexible shell fixed to a distal region of the outer elongated member, the flexible shell being fillable 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 comprising a plurality of transmitters, wherein a distance from the proximal transmitter to the distalmost transmitter is less than or equal to l / 2, and the movable transmitter member being longitudinally translatable within the flexible shell. BRIEF DESCRIPTION OF THE DRAWINGS

[0043] The illustrative aspects of the present invention are described in detail below with reference to the accompanying 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 invention is shown having a movable transmitter array within an angioplasty balloon at a proximal location.

[0045] Figure 1BAn exemplary catheter according to aspects of the present invention is shown having a movable transmitter array within an angioplasty balloon at a distal location.

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

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

[0048] Figure 1E An exemplary catheter according to aspects of the present invention is shown having a movable transmitter array within a lumen directly adjacent to an angioplasty balloon in a paired configuration in which the balloon is inflated and deflated.

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

[0050] Figure 1G An exemplary catheter having a movable emitter array within an angioplasty balloon configured for rapid exchange delivery is shown in accordance with aspects of the present invention.

[0051] Figure 1H An exemplary catheter having a movable emitter array within an angioplasty balloon configured for rapid exchange delivery is shown in accordance with aspects of the present invention.

[0052] Fig. 1I A cross-sectional view of an exemplary catheter having a movable array of transmitters according to aspects of the present invention is shown.

[0053] Figure 2A An exemplary catheter within a vasculature is shown having a movable transmitter array within an angioplasty balloon at a distal location in accordance with aspects of the present invention.

[0054] Figure 2B An exemplary catheter within a vasculature is shown having a movable transmitter array at a central location within an angioplasty balloon in accordance with aspects of the present invention.

[0055] Figure 2C An exemplary catheter within a vasculature is shown having a movable transmitter array within an angioplasty balloon at a proximal location in accordance with aspects of the present invention.

[0056] Figure 3 is a flow chart describing a sequence for shock wave therapy of a lesion using a movable emitter array within an angioplasty balloon according to aspects of the present invention.

[0057] Figure 4A An exemplary proximal handle for a catheter having a movable transmitter assembly according to aspects of the present invention is shown.

[0058] Figure 4B The invention is shown in the following aspects Figure 4A Detail of the proximal section of the stabilizer structure shown.

[0059] Figure 5A An exemplary proximal section of a movable transmitter carrier according to aspects of the present invention is shown.

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

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

[0062] Figure 6B The invention is shown in the following aspects Figure 6B An exemplary catheter wherein the transmitter centering feature structure is 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 invention is shown.

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

[0065] Fig. 6E An exemplary transmitter centering structure in accordance with aspects of the present invention is shown in a radially expanded configuration.

[0066] Figure 7 An exemplary catheter having a transmitter centering feature according to aspects of the present invention 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 should conform to a scope 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, a low-profile / low-profile / thin (low-profile) electrode assembly has been developed, which reduces the cross profile of the catheter and allows the catheter to more easily pass through calcified vessels to deliver shock waves in more severe obstruction areas of the vascular system. Examples of low-profile electrode designs can be found in U.S. Patents US8,888,788, US9,433,428 and US10,709,462 and U.S. Publication US2021 / 0085383, all of which are incorporated herein by reference. An example of a low-profile catheter with an electrode configured to be inserted after balloon dilation can be found in U.S. Patent US10,357,264, which is incorporated herein by reference. Other catheter designs have improved the delivery of shock waves, for example, by specific electrode constructions and configurations, thereby directing shock waves forward to break tighter and more difficult to pass obstructions in the vascular system. Examples of forward-firing catheter designs can be found in U.S. Pat. Nos. 10,966,737, 11,478,261, and 11,596,423, and U.S. Publications Nos. 2023 / 0107690 and 2023 / 0165598, all of which are incorporated herein by reference. U.S. Pat. No. 11,779,363 describes the spacing of shock wave emitters to promote constructive interference of acoustic waves, and is incorporated herein by reference.

[0069] As used herein, the term "electrode" refers to a conductive element (usually made of a metal or alloy) that receives an electric current and then releases the electric current to another conductive element. Therefore, as used herein, an "electrode pair" refers to two electrodes that are positioned adjacent to each other so that the current provided to one electrode will be transmitted across a gap (also called a "spark gap") between the two electrodes (e.g., between a first electrode and a second electrode, or conversely, optionally with an insulator separating the two electrodes and with a current of a conductive fluid or gas passing therebetween). In addition, as used herein, a "transmitter" refers to a structure having one or more electrode pairs. Transmitters can be single, paired, or otherwise arranged together to be electrically connected as 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 challenges 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 surgery. 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 (100mm-300mm) in length and two to thirty millimeters in diameter when inflated.

[0072] In the case of current commercial IVL devices, the use of longer balloons presents different catheter profiles and therefore presents different requirements to ensure adequate therapeutic function. When considering modifications to achieve therapeutic performance in relatively long balloons, it must be noted that there is a direct correlation between the number of emitters (given a fixed energy source) and the effectiveness of IVL therapy. In other words, as the number of emitters increases to accommodate relatively long balloons 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 solved by adding more channels to IVL generators and systems, although this solution will result in catheters with more circuits and wires, resulting in a larger profile, which may be more difficult to reach smaller peripheral vascular systems or pass through severely obstructed lesions. Current commercial IVL devices have two to five emitters in the balloon, where the emitters are bonded by adhesives - and therefore fixed in place - on the catheter shaft. In addition, these devices have balloons with a diameter of about twelve millimeters to sixty millimeters (12mm-60mm), where the working length of the balloon along the catheter is one hundred and ten millimeters to one hundred and thirty-eight millimeters (110mm-138mm). This allows the physician to go through a cycle of positioning, inflation, shock wave therapy, and deflation, moving the balloon along the length of the lesion over the catheter guidewire to treat the entire length of the lesion. The transmitters on these devices can pulse one at a time, two at a time, all at the same time, and / or in an alternating or sequential pattern along the length of the catheter and balloon.

[0073] This article describes a catheter, balloon, and IVL circuit that incorporates design elements that allow the use of a capsule with a movable array of transmitters to treat relatively long calcified lesions. In such an embodiment, it is generally not necessary to undergo inflation and deflation cycles that require repositioning of the balloon to perform shock wave therapy as described above. Instead, a single balloon allows the transmitter to be moved within the balloon to deliver shock wave therapy to the target area of ​​a given long lesion. This can be accomplished with a slightly inflated or semi-inflated long balloon, depending on the calcium stenosis / constraint situation within the artery or other vessel.

[0074] Figure 1AAn exemplary catheter 100 is shown having a movable transmitter array 110 within an angioplasty balloon 108 at a proximal / near position according to one or more embodiments. The catheter 100 includes an outer shaft (or outer elongated member) 102, a movable transmitter carrier 104, and an inner shaft 106. The movable transmitter carrier 104 can be tubular and define an inner lumen. Similarly, the outer shaft 102 can be tubular and define a lumen. The movable transmitter carrier 104 can be concentric with the outer shaft 102. The movable transmitter carrier 104 can also be concentric with the inner shaft 106. The angioplasty balloon 108 is fixed (e.g., adhered) to the outer shaft 102 at a proximal end and fixed to the inner shaft 106 at a distal end. The balloon 108 is shown as inflated, wherein the volume of the balloon 108 is inflated 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 patient's target anatomical structure and lesions within the vessel. In the exemplary embodiment, a movable transmitter array 110 is shown, which has a first transmitter 112, a second transmitter 114, a third transmitter 116, and a fourth transmitter 118. In alternative embodiments, the movable transmitter array 110 can have more or fewer transmitters, for example, any number of transmitters from one to six transmitters. If there is 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 transmitter carrier within the balloon volume can reach the full length of the balloon. In some embodiments, the distance from the proximal-most transmitter to the distal-most transmitter can reach the full working length of the balloon.

[0076] In some embodiments as shown, each transmitter includes a cylindrical sheath (or ring or belt) mounted on and surrounding a movable transmitter carrier 104. The cylindrical sheath is formed of a conductive material (e.g., a metal or alloy), which forms a first electrode surface of the electrode pair accordingly. The sheath includes a cutout area (e.g., a central circular hole, an arcuate cutout on the edge of the sheath, etc.), which provides access to a second conductive material, particularly a conductive member (e.g., a copper wire, a flat coil, etc.) located below or inside the movable transmitter carrier 104, thereby forming a second electrode surface of the electrode pair. In this configuration of the transmitter, the conductive portion of the sheath can be referred to as an outer electrode, and the line / wiring can be referred to as an inner electrode. The current delivered through the transmitter can 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 electrode surface can be an anode or a cathode, depending on the polarity of the pulse delivered 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 transmitter will have two electrode pairs, where current can travel from one electrode pair on the transmitter to the other electrode pair by flowing through the conductive material of the sheath. The electrode pairs on each transmitter can be positioned to produce shock waves in directly opposite directions (i.e., arranged 180 degrees apart from each other around the catheter), or the electrode pairs can be positioned to produce shock waves in converging or offset directions (i.e., arranged less than 180 degrees apart from each other around the catheter). In alternative embodiments, the transmitter may have three, four, five, or six electrode pairs arranged around the circumference of the transmitter. The individual transmitters of the movable transmitter 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, a 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 wherein the distal end of the balloon 108 is attached to the inner shaft 106. The balloon 108 is attached at both locations so that the internal volume of the balloon 108 is sealed, for example, with an adhesive, with a clamp, by performing a heat seal, by performing a pressure seal, 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 passage for fluid to enter and inflate the balloon 108 (and also flow out of the balloon 108 and deflate the balloon 108 accordingly). In some embodiments, another type of sealing enclosure (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 in the patient's body with the balloon 108 in a deflated configuration, wherein all movable transmitter carriers 104 are located in a withdrawn 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 inflated at a pressure suitable for shock wave therapy (e.g., about 4 atm or a pressure sufficient to make the outer surface of the balloon 108 contact the surrounding tissue 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 fluids, contrast agents, or mixtures 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 transmitter 104. In alternative embodiments, a separate fluid lumen can be used to provide fluid. In some embodiments, the balloon is fixedly located at the distal region of the inner shaft, and only the movable transmitter lumen can translate between the outside and the inside 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] With the balloon 108 inflated, the movable emitter carrier 104 can then be moved to various 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 a segment 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, in order from the most distal transmitter to the most proximal transmitter located along the transmitter carrier 104. 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 one electrical channel so that current is provided to and across all transmitters during each transmission cycle, such as Figure 1AAs shown, this means that the first transmitter 112, the second transmitter 114, the third transmitter 116, and the fourth transmitter 118 are all on the same single electrical channel. Using only one electrical channel helps minimize the required physical wiring, minimizes the width of the catheter 100, and therefore helps minimize the profile of the entire catheter 100. In alternative embodiments, the transmitters can be wired on two or more electrical channels, for example, using Figure 1A , where a first emitter 112 and a second emitter 114 are wired on one channel, and a third emitter 116 and a fourth emitter 118 are wired on a second channel. Using two or more electrical channels allows for greater operational flexibility in firing the emitters, for example, firing only the more distal pair of emitters on the catheter to directionally bias the shock waves generated. Similarly, the operational flexibility of using two or more electrical channels can allow for extended life of the catheter device, for example, continuing to fire the more proximal pair of emitters if the more distal pair of emitters has ceased to function.

[0083] Figure 1B An exemplary catheter 100 is shown having a movable emitter array 110 within an angioplasty balloon 108 at a distal position. As shown, the movable emitter carrier 104 extends in a distal direction along the catheter 100, covering more of the surface of the inner shaft 106 while remaining within the volume of the balloon 108. In practical applications, a physician may choose to initiate a shock wave therapy regimen with the movable emitter array 110 in a position such as Figure 1B The distal position shown, in the Figure 1A The proximal position shown, or in an intermediate position, as deemed appropriate for the treatment of the subject patient and target tissue. Also shown are marker bands, particularly a proximal marker band 120 and a distal marker band 122, which are positioned near the proximal and distal ends of the balloon 108 and can be observed during surgery 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, allowing the operator to observe the position of the balloon and catheter 100 in the patient's body.

[0084] Figure 1C Shown as Figure 1B A cross-sectional view of an exemplary catheter 100 and one of the movable transmitters (as shown, the first transmitter 112) within an inflated angioplasty balloon 108 is shown. 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 rests within one of the grooves 128 formed in the movable emitter carrier 104 and is aligned with a first spark gap 112a formed in the emitter ring 112. Similarly, a second wire 126 rests within a separate one of the grooves 128 formed in the movable emitter carrier 104 and is aligned with a second spark gap 112b formed in the emitter ring 112c. Both the first wire 124 and the second wire 126 are insulated wires, except that at locations where the first wire 124 is aligned with the first spark gap 112a and the second wire 126 is aligned with the second spark gap 112b, the wires 124, 126 are exposed such that each constitutes an electrode surface that mates with a corresponding opposing electrode surface of the emitter ring 112c. Thus, the first emitter 112 has two electrode pairs: one electrode pair is located at the first spark gap 112a between the first wire 124 and the emitter ring 112c, and the other electrode pair is located at the second spark gap 112b between the second wire 126 and the emitter ring 112c. In alternative embodiments, the first wire 124 and the second wire 126 may be embedded within the material of the movable emitter carrier 104, thereby providing minimization of the cross-sectional profile of the entire catheter 100. In other alternative embodiments, the first wire 124 and the second wire 126 may be sandwiched or pressed between the movable emitter carrier 104 and each emitter. The first wire 124 and the second wire 126 may 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 with a polymer material surrounding the wires and lumen), or a combination thereof.

[0085] In some embodiments, each transmitter can be three to twenty millimeters apart from each other on a movable transmitter carrier. The transmitters can be electrically grouped together (wired together) on various channels of the circuit, where the transmitters can be wired individually, in pairs, in triplets, etc., and in series or in parallel. The power supply that powers the transmitters can provide power in the range of about 1,000V to about 15,000V.

[0086] Figure 1DAn exemplary wiring configuration of an exemplary catheter and a movable transmitter for use inside an angioplasty balloon according to one or more embodiments is shown. The expanded view shows a first conductor 123 extending from a power source (not shown) to a proximal transmitter 118. The transmitter 118 is electrically connected to a first return conductor 127 extending proximally / immediately to the power source. The current from the high voltage pulse travels from the power source via the first conductor 123 to the proximal transmitter 118 to generate a shock wave at the transmitter 118 (as described above). The current then travels via the second conductor 125 to the second proximal transmitter 116 to generate a shock wave at the transmitter 116. This continues until a shock wave is generated at each electrode pair electrically connected to the transmitters 116, 118. The current then returns to the power source via the return wire / conductor (e.g., the first return conductor 127 and the second return conductor 129). Although only one hole is shown for each transmitter in the figure (indicating the location of the electrode pair that can generate the shock wave), there can be multiple electrically connected electrode pairs at each transmitter. In some embodiments, the conductors include insulated wires having conductive regions that are either connected to electrodes or whose conductive region surfaces form 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 is shown in a pair of configurations of balloon inflation and deflation according to one or more embodiments, having a movable array of transmitters 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 all located on a movable transmitter carrier 104 within an outer shaft 102 and at a position proximal to a balloon 108. The distal end of the movable transmitter carrier 104 may partially extend into the volume of the balloon 108 when inflated or deflated, or the movable transmitter carrier 104 may be fully withdrawn within the circumference of the outer shaft 102 before and / or after deployment.

[0088] The advantage of positioning the transmitter in the outer shaft 102 during deployment to the target tissue site is that the balloon 108 of the release can be folded or curled during delivery to have a diameter that is actually / effectively the same as the outer surface of the inner shaft 106. This diameter can be 5 to 8 French gauges / French. In some embodiments, the release outer diameter is at most 8 French. Therefore, the catheter 100 has a smaller cross-sectional profile for delivery to the vessel or lesion than the case where the transmitter exists and is statically located on the inner shaft 106 in the balloon 108. Although such transmitters used in IVL devices will only increase the diameter of the entire catheter by 1 French or less during deployment, this difference in cross-sectional profile is meaningful for both being able to pass through certain vascular lesions and being able to fit in other vascular delivery systems. In addition, keeping the transmitter withdrawn in the outer shaft 102 when in the released balloon 108 configuration reduces the risk that the material of the balloon may get stuck or torn on the transmitter when moving through the patient's vascular system.

[0089] Figure 1F An exemplary catheter is shown having a movable emitter array 110 within a tapered angioplasty balloon 109 at a distal position. Using a tapered angioplasty balloon 109 that is narrower at the distal end than the proximal end can provide improved access to vasculature that may be partially blocked by plaque (e.g., chronic total occlusion "CTO"), where the narrow end of the tapered angioplasty balloon 109 can be used as a wedge to push into and through the plaque. In such cases where the tapered angioplasty balloon 109 approaches or contacts the device-facing surface of the plaque, the movable emitter carrier 104 can be positioned at the distal position, and shock waves can be generated to disrupt the calcification of the surrounding lesion at the entry point of the plaque. Then, the relaxation or relaxation of the vasculature at this location can allow the tapered angioplasty balloon 109 to be pushed further along the vessel and through the plaque to ultimately allow shock waves to be generated along the entire length of the calcified lesion. The tapered angioplasty balloon can also be implemented in naturally tapering body cavities. 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 Figures 1A-1F In the example shown, the catheter can be configured to be advanced into a body cavity over a guidewire (not shown), commonly referred to as an "over the wire" or "OTW" deployment configuration. Figure 1G and 1H As shown, the catheter may be arranged as part of a "rapid exchange" or "Rx" configuration, wherein instruments are exchanged in and out of the patient's body during a procedure through a larger lumen. Figure 1G A catheter 100 is shown in accordance with one or more embodiments of the present invention. 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 in the lumen of the inner shaft 106, exit the inner shaft 106 distally of the balloon 108, re-enter the catheter 100 proximally of the balloon 108, and extend proximally inside the lumen of the outer shaft 102. Such a configuration can better facilitate the 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 the inner track 152, which is static and can extend proximally / close to the handle of the catheter. The inner track 152 can be coupled to the distal end of the balloon to keep the Rx guidewire stable during treatment. The rapid exchange guidewire exit 151 can be located proximal to the distal balloon 108 and 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 moving fluid from the interior of the balloon 108. It should be readily appreciated that such a fluid lumen may be used in the OTW configuration of the catheter 100 as well as the Rx configuration.

[0091] Figure 1H A 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, which extends through a balloon 108. A movable transmitter member 104 is slidably movable along the inner shaft 106 and can be retracted into the outer shaft 102. The catheter 100 includes a guidewire outlet 151, which is located at the proximal end of the catheter ( Figure 1H Advantageously, Figure 1G and Figure 1H The guidewire 150 in both configurations shown need not extend along the entire length of the catheter 100 .

[0092] Fig. 1IA cross-sectional view of an exemplary catheter 2000 according to one or more embodiments is shown at a region between a proximal handle and a movable transmitter assembly. The catheter 2000 includes an inner shaft 2010. In one or more embodiments, the inner shaft 2010 may be tubular and define a guidewire lumen that accommodates a guidewire (not shown) on which the catheter 2000 may be delivered. A movable transmitter carrier 2020 may be movably positioned on the inner shaft 2010. The movable transmitter carrier 2020 may be tubular and define a lumen. The movable transmitter carrier 2020 may include one or more wires (or another form of energy guide) that connect one or more transmitters to a power source. The movable transmitter carrier 2020 may be formed with a groove or lumen (described below) for a wire to reduce the overall profile of the catheter 2000. The movable transmitter carrier 2020 is located between the inner shaft 2010 and the outer shaft 2030. In one or more embodiments, the outer shaft 2030 can be at least partially formed of a hypotube. The outer shaft 2030 can also include an outer layer 2040. The outer layer 2040 can include a braided structure and provide structural support for the catheter 2000 when the catheter 2000 is guided through a body cavity. In some embodiments, the inner diameter of the movable transmitter carrier 2020 is greater than the outer diameter of the inner shaft 2010. In some embodiments, the inner diameter of the movable transmitter carrier is at least 50 microns (μm) greater than the outer diameter of the inner shaft 2010.

[0093] In various embodiments, a catheter having a removable transmitter carrier (which has one or more shock wave transmitters) can include a relatively long capsule (e.g., an angioplasty balloon). For example, the working length of the capsule can be 50% to 200% longer than the end-to-end distance from the most proximal transmitter to the most distal transmitter. For example, the capsule can have a working length l, and the distance between the most proximal shock wave transmitter and the most distal shock wave transmitter can be less than or equal to 0.5l. To employ such a device, the balloon can be advanced through a body cavity to a lesion. The user can then inflate the balloon with a fluid (e.g., saline) to a relatively low pressure (e.g., less than 5atm) or until the working area of ​​the balloon is juxtaposed (i.e., in contact) with the lesion. Upon inflation, the transmitter assembly mounted on the removable transmitter carrier can be advanced into the balloon volume to a first location (e.g., at a proximal location of the balloon) to treat the lesion or a portion of the lesion at the first location with shock wave therapy. The movable transmitter carrier can then be further advanced 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 begin at a distal region of the balloon or at a central region of the balloon. Advantageously, shock wave therapy can be customized for any particular lesion. For example, if there is a greater degree of calcification at a distal region of the balloon than at a proximal region of the balloon, a transmitter can be used to generate more shock waves at a more distal position than at a proximal position. By adjusting the shock wave therapy in this manner, unnecessary excess shock wave generation can be avoided, thereby extending the life of the device. Such devices are also less complex in design than providing power (e.g., via wires) to a large number of transmitters positioned along the length of an angioplasty balloon alone.

[0094] Figures 2A-2C An exemplary catheter within a vasculature is shown, with the catheter having a movable transmitter array in an angioplasty balloon. Figure 2A is shown in a distal position and in Figure 2B In the middle position, Figure 2C As shown in the figure, the calcified area of ​​the vascular tissue is represented by "C", and the calcified area of ​​the vascular tissue that has been subjected to the shock wave and broken is represented by "B". Figure 2A Initially, the inflated balloon 108 extends along the entire length of the vascular tissue having the calcification. The movable transmitter carrier 104 extends along the length of the inner shaft 106 to the distal end of the balloon 108, wherein the movable transmitter array 110 is positioned at the distal end of the movable transmitter carrier 104. Thus, the movable transmitter array 110 is adjacent to the calcification at the distal end of the target lesion in the vascular tissue. As shown, the transmitters of the movable transmitter array 110 generate shock waves that destroy the calcification at the distal portion of the lesion.

[0095] Go to Figure 2B , the movable transmitter carrier 104 has been pulled back in the proximal direction along the length of the catheter 100 so that the movable transmitter array 110 is adjacent to the calcification in the middle region of the subject / object lesion in the vascular tissue. As shown, the transmitters of the movable transmitter array 110 generate shock waves that destroy the calcification in the middle portion of the lesion. It should be understood that the middle region of a long calcified lesion may require multiple repositioning of the movable transmitter array 110 to deliver treatment to the entire length of the middle region of the calcified lesion.

[0096] Finally, move to Figure 2C , the movable transmitter carrier 104 has been pulled back in the proximal direction along the length of the catheter 100, so that the movable transmitter array 110 is adjacent to the calcification at the proximal end of the target lesion in the vascular tissue. As shown, the transmitters of the movable transmitter array 110 generate shock waves that destroy the calcification at the proximal portion of the lesion.

[0097] It should be understood that more than one cycle of shock wave generation may be used to destroy 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 should also be understood that the order in which the movable emitter array 100 is translated may be from distal to proximal, such as Figures 2A-2C , but may also be performed in a proximal to distal order, from medial to proximal, or from medial to distal order. In addition, the movable transmitter array 110 may be moved to repeat the treatment two or more times at locations along the calcified tissue.

[0098] Figure 3301 is a flowchart describing the sequence of shock wave treatment of a lesion using a movable array of emitters in an angioplasty balloon according to one or more embodiments. In step 302, the capsule (e.g., balloon) of the IVL device is positioned at both ends of the lesion to be treated or through / across the lesion. In step 303, the capsule is inflated until the working area of ​​the balloon is juxtaposed with the body cavity wall and the lesion and conforms to them. In some embodiments, the capsule is inflated to a pressure of less than 5atm. In some embodiments, the capsule is inflated to a pressure of at least 1atm and at most 4atm. In step 309, if the movable array of emitters is in a retracted position in the outer shaft (i.e., proximal to the balloon), the emitter is advanced into the capsule to reach the first target area of ​​the lesion. In step 305, shock waves are generated at the movable array of emitters (e.g., by delivering high voltage pulses or laser pulses). In step 306, the user determines whether shock wave treatment is required for different areas of the lesion. If "yes", repeat steps 304-306; if "no", deflate the capsule in step 307. After deflation, withdraw the IVL device in step 308. Optionally, before withdrawing the IVL device and after the shock wave treatment, the capsule is inflated to a pressure sufficient to radially expand the body cavity. In some embodiments, the second inflation pressure is higher than the pressure in step 303. In some embodiments, the second inflation pressure is greater than 5atm. In some embodiments, the second inflation pressure is at least 4atm and at most 12atm. In some embodiments, in step 310, the movable transmitter array can be withdrawn into the outer shaft before the capsule is deflated and the catheter is withdrawn. In some embodiments, the method also includes a step of imaging the lesion (e.g., by X-ray fluoroscopy, intravascular ultrasound and / or optical coherence tomography). The method may also include the step of defusing and inflating the balloon with liquid between rounds of shock wave treatment to remove bubbles accumulated inside the balloon.

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

[0100] The movable transmitter carrier 1302 extends to a proximal Y-shaped arm 1300 that is slidably located 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 transmitter assembly. For example, the transmitter assembly can be electrically connected to a high voltage power source via a conductive member 1310 via a connector 1320. In other embodiments, one or more optical fibers can be connected to a light source (e.g., a laser) for powering to generate shock waves. In some embodiments, the distance d of the translation of the proximal Y-shaped arm 1300 along the inner shaft 1010 is related to the longitudinal (in the distal-proximal direction) distance d of the transmitter assembly.

[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, which includes a rod 1202 extending from the distal region of the handle 1000 to the proximal region. In some embodiments, the rod 1202 can be connected to the distal Y-shaped arm 1100 at its distal end. In one or more embodiments, the rod 1202 has a length that is approximately the same as the working length of the balloon. The proximal Y-shaped arm 1300 can be slidably translated between the proximal region of the handle and the distal Y-shaped arm 1100 along the inner shaft 1010. When the proximal Y-shaped arm 1300 is in the most proximal position of the inner shaft 1010, the transmitter assembly can be completely withdrawn into the outer shaft 1500. The distal translation of the proximal Y-shaped arm 1300 moves the transmitter assembly distally toward the distal end of the balloon into the balloon.

[0102] In one or more embodiments, the proximal handle 1000 includes a connector 1340 in the proximal Y-shaped arm. The connector 1340 may include a Luer connection. In one or more embodiments, the connector 1104 and the connector 1340 include silicone seals and / or flexible valves that ensure fluid sealing and help maintain the internal pressure of the balloon. In some embodiments, the connector 1104 and the connector 1340 each include an O-ring to ensure fluid sealing. These connectors also help facilitate the movement of the movable transmitter carrier. Advantageously, the silicone or silicone-type seals at these connectors can be self-sealing, and their use ensures that a simple structure and mechanism are used to produce a fluid 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 is positioned at the proximal marking 1011 can be associated with withdrawing the transmitter assembly from the balloon. The proximal Y-shaped arm 1300 is positioned at the distal marking 1012 can be associated with the transmitter assembly being located in the distal region of the balloon.

[0104] Figure 4BAnother exemplary proximal handle 200 for a shock wave catheter according to some embodiments of the present invention is shown. The handle 200 includes a first fluid port 210, a second fluid port 220, and a third fluid port 230, each of which is fluidly connected to the inflatable enclosure through a separate fluid lumen. One or both of the first port 210 and the second port 220 can be used to remove air and irrigate the catheter for shock wave therapy.

[0105] Figure 5A shows an exemplary proximal section 510 of a movable transmitter carrier according to some embodiments, Figure 5B An exemplary distal section 520 of a removable transmitter carrier is shown. The proximal section 510 includes a plurality of conductor lumens through which conductors (e.g., wires) extend from a power source. Having a cylindrical shaft with conductor lumens helps provide a seal with a connector (e.g., a Luer connection) at the proximal handle described above. The distal section 520 includes a plurality of grooves for receiving these conductors. The grooves in the distal section 520 of the transmitter shaft can help provide a narrow 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 an emitter centering / centering feature comprising one or more shock wave emitter centering structures. Figures 6A-6C A catheter 3000 is shown having centering structures 3002 , 3004 , 3006 , 3008 , 3010 adjacent to a shock wave transmitter assembly including shock wave transmitters 3012 , 3014 , 3016 , 3018 . Fig. 6A The centering structure is shown in a radially compressed state. Figure 6B and Figure 6C The centering structure is shown in a radially expanded state, wherein for the sake of clarity, Figure 6CThe catheter 3000 is shown without a capsule. When the transmitter assembly of the transmitters 3012, 3014, 3016, 3018 is sheathed within the outer shaft 3100, the centering structures 3002, 3004, 3006, 3008, 3010 are in a radially compressed state. When the transmitter assembly is advanced out of the outer shaft 3100 and into the capsule 3200, the centering structures 3002, 3004, 3006, 3008, 3010 are in a radially expanded state. The centering structures 3002, 3004, 3006, 3008, 3010 can radially self-expand when not sheathed. When expanded, the centering structures 3002, 3004, 3006, 3008, 3010 contact the inner surface of the capsule to space the emitters 3012, 3014, 3016, 3018 from the inner surface of the capsule 3200. In some embodiments, when radially expanded, the centering structures 3002, 3004, 3006, 3008, 3010 space each of the emitters 3012, 3014, 3016, 3018 from the inner surface of the capsule 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 capsule 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 capsule by a distance of at least 2 mm. In some embodiments, the required spacing distance of one or more shock wave emitters from the inner surface of the capsule can depend on the material properties of the capsule (e.g., thermal degradation properties) and / or the energy output of the emitters.

[0108] In some embodiments, the IVL catheter includes a plurality of shock wave transmitters and a plurality of transmitter centering structures. The number of transmitter centering structures can be one more than the number of shock wave transmitters. The transmitter centering structure can be located closer than the most proximal transmitter. The transmitter centering structure can be located farther than the most distal transmitter.

[0109] During transport through a body cavity, the centering structure can be sleeved inside the outer shaft 3100 in a radially compressed state. When the capsule 3200 is adjacent to the lesion to be treated, the capsule can be expanded. The transmitter and the centering structure can then be moved inside the capsule. After introduction into the wider diameter capsule, the centering structure can self-expand until the centering structure contacts the inner surface of the capsule. Centering the transmitter, and therefore isolating the capsule from the intense heat associated with the generation of shock waves, can be important for maintaining the integrity of the capsule (e.g., an angioplasty balloon).

[0110] Fig.6D and 6E An exemplary centering structure 3001 is shown alone in accordance with one or more embodiments. Fig.6D The centering structure 3001 is shown in a radially compressed state. Fig. 6EA centering structure 3001 in a radially expanded state is shown. The 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). The first end 3020 and the second end 3022 may be connected by a self-expanding region 3030. The self-expanding region 3030 may include beams 3032, 3034, 3036, 3038. The beams 3032, 3034, 3036, 3038 may be flexible beams. The beams 3032, 3034, 3036, 3038 may be made of a material that can be radially compressed (i.e., straightened) and then restored to a radially expanded state. In some embodiments, the beams are made of nitinol, another nickel alloy, or another elastic material. The width of the beam may be 20-250 microns (μm). Although the centering structure 3001 is shown as having four beams, other numbers of beams are also possible, such as two, three, five, six or more beams. 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 of the first end 3020 and the second end 3022 may be fixedly attached to the movable transmitter shaft, or both may not be fixedly attached to the movable transmitter shaft. By having at least one free end, the centering structure 3001 is free to expand in the enclosure or to be compressed when enclosed in the outer shaft.

[0112] Figure 7 An IVL catheter 4000 having a transmitter centering feature including one or more centering structures 4002, 4004, 4006, 4008, 4010 is shown according to one or more embodiments. Each of the centering structures 4002, 4004, 4006, 4008, 4010 includes an inflatable capsule (e.g., a balloon) fluidly connected to a proximal fluid port via a fluid lumen. Figures 6A-6E Similar to the centering structures shown, centering structures 4002, 4004, 4006, 4008, 4010 are used to separate the shock wave transmitter from the enclosure. The inflatable enclosure 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 near 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 inside a relatively compliant enclosure (e.g., a semi-compliant or compliant angioplasty balloon), and in a radially collapsed state when positioned inside a relatively non-compliant shaft or tube.

[0114] It should be noted that the elements and features of the exemplary catheters shown herein may be rearranged, recombined, and modified without departing from the present invention. For example, the accompanying drawings show exemplary electrode assemblies, and the present invention is intended to include catheters with various electrode configurations, and the number, placement, and spacing of transmitters and electrode pairs may be modified without departing from the present invention.

[0115] Although the electrode assemblies and catheter devices described herein are discussed primarily in the context of treating blockages and lesions in the coronary vasculature, the electrode assemblies and catheters herein can be used for a variety of blockages and peripheral vasculature (e.g., above the knee, below the knee, iliac-related, carotid, etc.), and other anatomical structures can be treated using IVL. Further, for example, the embodiments 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, myomas, cysts, organs, scars and fibrotic tissue removal, destruction and removal of polymorphic tissues or other tissues. The electrode assembly and catheter designs can also be used for neurostimulation therapy, targeted drug delivery, treatment of body cavity tumors (e.g., tumors in blood vessels, esophagus, intestines, stomach or vagina), wound treatment, non-surgical excision and destruction of tissue, or for heat treatment or cauterization in place of venous insufficiency and tubal ligation (i.e., 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 bioactive scaffolds, where new cells (e.g., exogenous or endogenous cells) can replace old cells; similar to cell replacement therapy, porosity is introduced at a certain site to improve cell retention, cell infiltration / migration, and diffusion of nutrients and signaling molecules to promote angiogenesis, cell proliferation, and tissue regeneration. Such tissue engineering methods 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, the devices and components described herein can facilitate the removal of scar spinal cord tissue that acts like a barrier to neuronal reconnection before injecting an anti-inflammatory hydrogel loaded with a lentivirus, so as to genetically modify the modified spinal cord neurons to regenerate them.

[0117] As provided herein, it should be understood that any disclosure of a numerical range describing a dimension or measurement (e.g., thickness, length, weight, time, frequency, temperature, voltage, current, angle, etc.) includes any numerical increment or gradient within the range set forth relative to a given dimension or measurement.

[0118] Furthermore, while the transmitters disclosed in the examples herein have a configuration with two electrode pairs generally on each transmitter, it is also contemplated to include transmitters with three electrode pairs (e.g., 120 degrees circumferentially spaced from each other), four electrode pairs (e.g., 90 degrees circumferentially spaced from each other), five electrode pairs (e.g., 72 degrees circumferentially spaced from each other), six electrode pairs (e.g., 60 degrees circumferentially spaced from each other), etc. The construction of such transmitter assemblies may have physical limitations related to the size and arrangement of wiring, the ability to deliver sufficient power, the corrosion profile of the electrodes, etc., and such transmitters may be successfully developed as manufacturing capabilities improve and are within the scope of the present invention.

[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. Designators. For example, a "first" shock wave may be followed by a "third" shock wave, which may then be followed by a "second" shock wave. As another example, a "third" launcher may be used to generate a "first" shock wave, and vice versa. Therefore, the numerical designators of various elements and features are not intended to limit the present invention, and may be modified and interchanged without departing from the present invention.

[0120] It should be understood that the foregoing is merely an illustration 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 by any other catheter or catheter combination herein. In addition, any method may be used with any catheter disclosed. Therefore, the present invention is not intended to be limited except as set forth in the appended claims.

Claims

1. A catheter for treating an obstruction in a body cavity, characterized in that The catheter comprises: an outer elongated member having a fluid lumen; a flexible capsule secured to a distal region of the outer elongated member, the flexible capsule being fillable with a conductive fluid via the fluid lumen; an inner elongate member positioned within the outer elongate member and extending through the flexible enclosure to a distal region of the flexible enclosure; and A movable transmitter member having a transmitter assembly mounted thereon and connected to a power source is positioned between the inner elongated member and the outer elongated member and is movable in a longitudinal direction between the inner elongated member and the outer elongated member.

2. The catheter according to claim 1, characterized in that: In a first configuration of the movable transmitter member, the transmitter assembly is located at a first position, and in a second configuration of the movable transmitter member, the transmitter assembly is located at a second position distal to the first position.

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

4. The catheter according to claim 2, characterized in that: The flexible capsule has a working length l, The launcher assembly includes a plurality of shock wave launchers, and The distance between the nearest shock wave transmitter and the farthest shock wave transmitter is less than or equal to 0.5l.

5. The catheter according to claim 1, characterized in that: Also included is a proximal hub, wherein the outer elongated member, the inner elongated member, and the movable transmitter member extend to the proximal hub, and translation of the movable transmitter member along the inner elongated member at the proximal hub moves the transmitter assembly.

6. The catheter according to claim 5, characterized in that: Translation of the movable transmitter member at the proximal hub by a distance d moves the transmitter assembly by a distance d in the longitudinal direction.

7. The catheter according to claim 1, characterized in that: At least one of the inner elongated member and the movable emitter member comprises polytetrafluoroethylene.

8. The catheter according to claim 1, characterized in that: The inner elongate member has an outer diameter d1 and the moveable transmitter member includes a lumen having a diameter d2 that is at least 0.002 inches greater than d1.

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

10. The catheter according to claim 9, characterized in that The flexible capsule has an inflated state and a deflated state, and when the flexible capsule is in the inflated state, the central region extends radially outward further than when the flexible capsule is in the deflated state.

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