Shockwave guide with telescoping housing

Abstract

A shockwave catheter for treating a lesion within a body lumen includes a shockwave emitter assembly and a retractable housing. In a first configuration of the catheter, the retractable housing is sealed to a distal member of the catheter and the lesion is treated by shockwaves propagating through a wall of the housing. In a second configuration of the catheter, the retractable housing is retracted from the distal member of the catheter and the lesion is treated directly by shockwaves emitted from the shockwave emitter assembly.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority and interest in U.S. non-provisional application No. 18 / 596,388, filed March 5, 2024, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This invention relates generally to the field of medical devices and medical methods, and more specifically to shock wave catheter devices for treating calcified lesions in the body lumens, such as calcified lesions and occlusions in the vascular system and kidney stones in the urinary system. Background Technology

[0004] Various catheters have been developed for treating calcified lesions, such as those associated with arterial disease in the vascular system. For example, treatment systems used in percutaneous coronary angioplasty or peripheral angioplasty use an angioplasty balloon to dilate the calcified lesion and restore normal blood flow to the vessel. In these types of procedures, a catheter carrying a balloon is inserted along a guidewire into the vascular system until the balloon is aligned with the calcified plaque. The balloon is then inflated (typically to above 10 atmospheres) to push the calcified plaque back into the vessel wall and dilate the occluded area of ​​the vascular system.

[0005] Recently, techniques and treatments for intravascular lithotripsy (IVL) have been developed, an interventional procedure to improve calcified plaques in diseased arteries. The mechanism of plaque improvement involves the use of a catheter with one or more acoustic shock wave generators located in a fluid, capable of producing acoustic shock waves that improve the calcified plaques. IVL devices differ in design from the energy sources used to generate the acoustic shock waves; two exemplary energy sources are an electro-hydraulic generator and a laser generator.

[0006] For acoustic shock waves generated by an electro-hydraulic generator, a conductive solution (such as saline) can be contained within a housing surrounding the electrodes or flushed through / flowing through a tube surrounding the electrodes. Improvement of calcified plaques is achieved by generating acoustic shock waves within the catheter through electrode discharge. This discharge produces one or more rapidly expanding vapor bubbles, thus generating acoustic shock waves. These shock waves propagate radially outward and improve calcified plaques within the blood vessel. For laser-generated acoustic shock waves, a laser pulse is transmitted to and absorbed by the fluid within the catheter. This absorption process rapidly heats and evaporates the fluid, generating rapidly expanding vapor bubbles and acoustic shock waves that propagate outward and improve calcified plaques. The intensity of the acoustic shock waves will be higher if a fluid exhibiting strong absorption at the laser wavelength used is selected. These examples of IVL devices are not intended as a comprehensive list of potential energy sources for generating IVL shock waves.

[0007] IVL can be considered different from standard atherosclerotic resection because it breaks down calcium deposits but does not release the broken calcium from the tissue. Therefore, IVL generally does not require aspiration or embolization protection. Furthermore, due to the compliance of normal vessels and uncalcified plaques, the shockwave generated by IVL does not improve normal vascular tissue or uncalcified plaques. In addition, IVL does not carry the same risk of perforation, dissection, or other vascular system damage as angioplasty using cutting or scribing balloons.

[0008] More specifically, catheters for delivering IVL therapy have been developed that include electrode pairs for generating shock waves electro-hydraulically within an angioplasty balloon. Shock wave devices may be particularly effective for treating calcified plaque lesions because the acoustic pressure from the shock wave can rupture and destroy the lesion near the angioplasty balloon without damaging surrounding tissue. In these devices, the catheter is advanced over a guidewire through the patient's vascular system until it is positioned near and / or aligned with a calcified plaque lesion within the body's lumen. The balloon is then inflated with a conductive fluid (using a relatively low pressure of 2-4 atmospheres) to contact the lesion, but the inflation pressure does not substantially move the lesion. Voltage pulses can then be applied to the electrodes of the electrode pair to generate an acoustic shock wave that propagates through the wall of the angioplasty balloon and into the lesion. Once the lesion has been ruptured by the acoustic shock wave, the balloon can be further inflated to increase the cross-sectional area of ​​the lumen and improve blood flow through the lumen. Alternative devices for delivering IVL therapy can be located in a closed volume other than angioplasty balloons, such as caps, various compliant balloons, or other shells.

[0009] To date, commercially available IVL catheters include a shockwave emitter housed within an angioplasty balloon. While effective for treating calcified lesions, improvements are needed for lesions targeting other tissue types (such as fibrotic or thrombus masses) or lesions with multiple tissue types. Furthermore, for treating lesions other than stenotic lesions (e.g., thrombi, fibrotic tissue within anastomoses, or cancerous tumors), an angioplasty balloon or another type of housing may not be necessary. Summary of the Invention

[0010] This document describes an apparatus and method for generating shock waves in a body lumen. In some embodiments, the shock wave catheter includes a retractable outer shell located in its distal region, the retractable outer shell being configured to enclose a shock wave emitter assembly in a closed configuration or to expose the shock wave emitter assembly to a vascular system (e.g., circulating blood) in an open configuration. In some embodiments, the catheter includes perfusion capability for circulating fluid at a treatment site.

[0011] According to one aspect of the invention, a catheter for emitting shock waves within a body lumen is provided, the catheter comprising: a distal member; a slidable elongated member having a proximal end and a distal end; an inner elongated member at least partially located inside the slidable elongated member and extending to the distal member; a shock wave emitter assembly located on the inner elongated member and positioned distal to the distal end of the slidable elongated member; and a retractable outer shell having a distal end, wherein, in a closed configuration, the distal end of the retractable outer shell extends to the distal member of the catheter, and in an open configuration, the distal end of the retractable outer shell retracts from the distal member of the catheter.

[0012] According to some aspects, the conduit further includes a proximal handle having a switch operably coupled to a retractable housing to move the retractable housing between a closed configuration and an open configuration. According to some aspects, in the closed configuration, a seal is formed between the distal end of the retractable housing and a distal member of the conduit. According to some aspects, the distal member includes an expandable member, the distal end of the retractable housing includes a polymer liner, and in the closed configuration, a seal is formed between the expandable member and the polymer liner. According to some aspects, the polymer liner includes polytetrafluoroethylene (PTFE). According to some aspects, in the closed configuration, the conduit further includes a chamber surrounding the shock wave emitter assembly and having an internal pressure of not less than 1 atm. According to some aspects, the distal member includes an expandable member located distal to the retractable housing. According to some aspects, the retractable housing includes at least one of polyether block amide, nylon, thermoplastic polyurethane, fluorinated ethylene propylene, and polytetrafluoroethylene. According to some aspects, the distal member includes an elastic end. According to some aspects, the conduit further includes at least one fluid lumen having a distal opening near the shock wave emitter assembly. According to some aspects, in the open configuration, the distal end of the retractable housing is spaced from the distal member of the duct by a distance greater than or equal to 5 mm. According to some aspects, in the open configuration, the distal end of the retractable housing is at least partially located near the shock wave emitter assembly.

[0013] According to one aspect of the invention, a conduit is provided for emitting a shock wave within a body lumen, the conduit comprising: a distal portion; an elongated member extending to the distal portion; a shock wave emitter assembly located on the elongated member; and a retractable housing having a distal opening, wherein: in a closed configuration, the distal opening of the retractable housing extends to the distal portion, and in an open configuration, the distal opening of the retractable housing retracts from the distal portion.

[0014] According to some aspects, the retractable shell includes an angioplasty balloon. According to some aspects, the distal opening of the retractable shell has an inner diameter not less than the maximum outer diameter of the shock wave emitter assembly. According to some aspects, the distal opening of the retractable shell has an inner diameter not less than 5 mm. According to some aspects, the catheter further includes a proximal handle having a switch operatively coupled to the retractable shell to move the retractable shell between a closed configuration and an open configuration. According to some aspects, in the closed configuration, the distal opening of the retractable shell and the distal member of the catheter form a seal. According to some aspects, the distal member includes an expandable member, the distal opening of the retractable shell includes a polymer liner, and in the closed configuration, the expandable member and the polymer liner form a seal. According to some aspects, the polymer liner includes polytetrafluoroethylene (PTFE). According to some aspects, in the closed configuration, the retractable shell surrounds the shock wave emitter assembly and has an internal pressure not less than 1 atm and not greater than 4 atm. According to some aspects, the retractable shell comprises at least one of polyether block amide and polytetrafluoroethylene. According to some aspects, the distal member includes a resilient end. According to some aspects, the conduit also includes at least one fluid lumen having a distal opening near the shock wave emitter assembly. According to some aspects, in the open configuration, the distal opening of the retractable housing is spaced from the distal member of the conduit by a distance greater than or equal to 5 mm. According to some aspects, in the open configuration, the distal opening of the retractable housing is at least partially located proximal to the shock wave emitter assembly.

[0015] According to one aspect of the invention, a catheter for treating lesions within a body lumen is provided, the catheter comprising: a distal member; an elongated member; a shock wave emitter assembly located in a distal region of the elongated member; a retractable housing having a distal end and configured to be retractably coupled to the distal member; and a proximal handle having a switch and located at the proximal end of the elongated member, wherein when the switch is in a closed position, the retractable housing is sealed to the distal member, and when the switch is in an open position, the retractable housing is spaced apart from the distal member.

[0016] According to some aspects, the elongated member includes a first lumen, and the proximal handle includes a first port in fluid communication with the first lumen. According to some aspects, the elongated member further includes a second lumen, and the proximal handle further includes a second port in fluid communication with the second lumen. According to some aspects, the proximal handle further includes a second port in fluid communication with the first lumen.

[0017] According to one aspect of the invention, a method for generating a shock wave within a body lumen is provided, the method comprising: advancing a shock wave catheter through the body lumen, the shock wave catheter having: a distal member; an elongated member; a shock wave emitter assembly located in a distal region of the elongated member; and a retractable housing having a distal end and configured to be retractably coupled to the distal member; positioning the shock wave emitter assembly close to a treatment site; retracting the retractable housing; and generating one or more shock waves at the shock wave emitter assembly.

[0018] According to some aspects, the method further includes closing the retractable housing such that the distal end of the retractable housing is sealed to the distal member. According to some aspects, the inner surface of the retractable housing includes a polymer liner that forms a fluid-impermeable seal with the distal member when the retractable housing is engaged with the distal member. According to some aspects, the method further includes depressurizing a chamber of the retractable housing such that the fluid-impermeable seal between the distal member and the retractable housing is disrupted. According to some aspects, the method further includes imaging the treatment site by one or more of X-ray fluoroscopy, intravascular ultrasound, and optical coherence tomography. According to some aspects, the method further includes determining, based on the imaging data, whether a shock wave is generated when the retractable housing is retracted or when the retractable housing is sealed to the distal member.

[0019] According to one aspect of the present invention, a method for generating a shock wave is provided, the method comprising: advancing a shock wave conduit through a body lumen, the shock wave conduit having a shock wave transmitter assembly; applying a first energy pulse to the shock wave transmitter assembly to generate a first shock wave having a first acoustic output; and, after applying the first energy pulse, applying a second energy pulse having the same power as the first energy pulse to the shock wave transmitter assembly to generate a second shock wave having a second acoustic output greater than the first acoustic output.

[0020] According to some aspects, the shock wave duct includes a distal member, an elongated component, and a retractable housing having a distal end and configured to be retractably coupled to the distal member. According to some aspects, the method further includes retracting the retractable housing between the application of a first energy pulse and the application of a second energy pulse, such that the retractable housing does not cover the shock wave emitter assembly.

[0021] According to one aspect of the invention, a conduit system for generating shock waves is provided, the conduit system comprising: an energy source configured to generate a plurality of energy pulses, each energy pulse having a predetermined power; and a conduit including a shock wave emitter assembly and an elongated energy guide extending from the energy source to the shock wave emitter assembly, wherein, in a first configuration of the conduit system, when a first energy pulse of the plurality of energy pulses is applied to the shock wave emitter assembly, the shock wave emitter assembly generates a first shock wave having a first acoustic output, and in a second configuration of the conduit system, when a second energy pulse of the plurality of energy pulses is applied to the shock wave emitter assembly, the shock wave emitter assembly generates a second shock wave having a second acoustic output greater than the first acoustic output.

[0022] According to some aspects, the catheter also includes a distal member and a retractable housing, the retractable housing being sealed to the distal member in a first configuration to define a chamber, and spaced apart from the distal member in a second configuration.

[0023] According to one aspect of the present invention, a method for generating a shock wave is provided, the method comprising: advancing a shock wave conduit through a body lumen, the shock wave conduit having a shock wave transmitter assembly and a retractable outer shell; applying a first energy pulse to the shock wave transmitter assembly to generate a first shock wave having a first acoustic output; retracting the retractable outer shell to expose the shock wave transmitter assembly if the retractable outer shell is in a closed configuration, or closing the retractable outer shell to surround the shock wave transmitter assembly if the retractable outer shell is in an open configuration; and applying a second energy pulse having a power different from the first energy pulse to the shock wave transmitter assembly to generate a second shock wave. Attached Figure Description

[0024] The illustrative aspects of the invention are described in detail below with reference to the accompanying drawings. The embodiments and drawings disclosed herein are intended to be illustrative and exemplary, and not restrictive.

[0025] Figure 1 A perspective view of an exemplary shock wave duct with a retractable member according to various aspects of the present invention is shown.

[0026] Figure 2A A side view of an exemplary shock wave duct with a retractable member in a sealed (closed) configuration according to various aspects of the present invention is shown.

[0027] Figure 2B It shows Figure 2A A side view of a shock wave duct in which the retractable component is in a retracted (open) configuration.

[0028] Figure 3AA perspective view of an exemplary shock wave duct with a retractable housing in a sealed (closed) configuration according to various aspects of the present invention is shown.

[0029] Figure 3B It shows Figure 3A A perspective view of a shock wave duct, in which the retractable housing is in a retracted (open) configuration.

[0030] Figure 4 A perspective view of an exemplary shock wave duct having an expandable distal component according to various aspects of the present invention is shown.

[0031] Figure 5 An exemplary shock wave duct proximal region according to various aspects of the present invention is shown.

[0032] Figure 6 An exemplary method for generating shock waves according to various aspects of the present invention is shown.

[0033] Figure 7 An exemplary method for generating shock waves according to various aspects of the present invention is shown.

[0034] Figure 8 An exemplary method for generating shock waves according to various aspects of the present invention is shown.

[0035] Figure 9 An exemplary computing system that can be used as part of a shock wave duct system according to various aspects of the present invention is shown. Detailed Implementation

[0036] The following description is presented to enable those skilled in the art to make and use the various embodiments and aspects thereof disclosed herein. The descriptions of specific apparatuses, components, techniques, and applications are provided by way of example only. Various modifications to the examples described herein will be apparent to those skilled in the art, and the general principles described herein can 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 illustrated herein, but are to be accorded the scope consistent with the claims.

[0037] Efforts have been made to improve the design of electrode assemblies included in shock wave and directional cavitation catheters. For example, low-profile / thin electrode assemblies have been developed that reduce the cross-section of the catheter and allow it to pass more easily through calcified vessels to deliver shock waves in areas of more severe occlusion in the vascular system. Examples of low-profile electrode designs can be found in U.S. Patents US 8,888,788, US 9,433,428, and US 10,709,462, and U.S. Patent Publication No. 2021 / 0085383, all of which are incorporated herein by reference in their entirety. Other catheter designs have improved shock wave delivery, for example, by using specific electrode constructions and configurations to guide the shock wave in the direction of travel to disrupt tighter and more difficult-to-pass occlusions in the vascular system. Examples of forward-launching duct designs can be found in U.S. Patents US10,966,737, US11,478,261, and US11,596,423, as well as U.S. Patent Publications US2023 / 0107690 and US2023 / 0165598, all of which are incorporated herein by reference in their entirety.

[0038] As used herein, the term "electrode" refers to a conductive element (typically made of metal) that receives current and subsequently releases it to another conductive element. In the context of this invention, electrodes may be positioned relative to each other, for example, in an arrangement of inner and outer electrodes. Thus, as used herein, the term "electrode pair" refers to two electrodes that are adjacent to each other and spaced apart, such that applying a sufficiently high voltage to the electrode pair will cause current to travel across the gap between the two electrodes (also called a "spark gap") (e.g., from the inner electrode to the outer electrode, or conversely, optionally, through a conductive fluid or gas). In some cases, one or more electrode pairs may also be referred to as an electrode assembly. In the context of this invention, the term "emitter" generally refers to such an area of ​​the electrode assembly where current travels across the electrode pair, thereby generating a shock wave. The terms "emitter sheath" and "emitter strip" refer to continuous or discontinuous strips of conductive material that may be formed as one or more electrodes in one or more electrode pairs, thereby forming the location of one or more emitters.

[0039] Figure 1The distal region of a shock wave duct 100 having a retractable housing 110 according to one or more aspects of the present invention is shown. The retractable housing 110 may include a distal sealing region 114. The inner surface of the distal sealing region 114 may include a polymer liner / lining. The polymer liner may be made of a lubricating material, such as polytetrafluoroethylene (PTFE). According to some embodiments, the duct 100 has a distal member 120 including an expandable member 122 that expands in response to an increase in internal pressure within the retractable housing 110 when in a closed configuration. The expandable member 122 may be sized such that it fits tightly within the distal sealing region 114 in a closed configuration and then expands in volume when the pressure within the retractable housing 110 increases. When the expandable member 122 is in a closed configuration, such as Figure 1 In the inflated state shown, a fluid-impermeable seal is maintained between the distal member 120 and the distal sealing region 114 of the retractable housing 110. The inflatable member 122 may be made of a compliant material. The inflatable member 122 may be made of a low-hardness material. In some embodiments, the distal member 120 includes a damage-resistant, rounded, resilient end / tip.

[0040] In one or more embodiments, catheter 100 includes a portion extending from the proximal region ( Figure 1 An elongated member 130 (not shown) extends to the distal member 120. In some embodiments, the elongated member 130 includes one or more fluid lumen / fluid conduits (e.g., to supply fluid for expanding the expandable member 122). The elongated member 130 may include a guidewire lumen 132 extending to the expandable member 122 of the distal member 120.

[0041] The conduit 100 includes a shock wave transmitter assembly 140 connected to an energy source (e.g., a high-voltage power supply or a photovoltaic energy source) via one or more energy conductors (e.g., wires or optical fibers). In some embodiments, the shock wave transmitter assembly 140 includes one or more transmitters 141, 142, 143, 144. Each of the one or more transmitters 141, 142, 143, 144 may include one or more electrode pairs. When a sufficient voltage is applied to the electrode pair, a shock wave can be generated at the electrode pair. Each of these electrode pairs may be electrically connected (e.g., in series or in parallel) to one or more electrode pairs of the one or more transmitters. Thus, a single high-voltage pulse from the high-voltage power supply can generate multiple shock waves from the conduit 100. In some embodiments, one or more transmitters (e.g., via multiple channels) are connected to the energy source such that a single high-voltage pulse at one channel generates a shock wave only from the transmitter electrically connected to that one channel.

[0042] Figure 2AA closed configuration of a shock wave duct 100 is shown, wherein the distal end of a retractable housing 110 extends to a distal member 120. In this configuration, the retractable housing 110 at least partially defines a chamber 112 housing a shock wave emitter assembly 140. In some embodiments, in this closed configuration, the chamber 112 is pressurized to at least one atmosphere (atm) using a conductive fluid (e.g., saline). In some embodiments, the chamber 112 is pressurized to a pressure of up to 5 atm. In some embodiments, the chamber 112 is pressurized to a pressure of not less than 2 atm and not more than 4 atm. In some embodiments, the retractable housing 110 is made of a material that does not expand when the chamber 112 is pressurized to a pressure up to 5 atm. The retractable housing 110 may extend distally from the distal end of a slidable elongated member 135, which may extend to the proximal region of the duct 100. In some embodiments, such as Figure 2A and 2B As shown, a slidable elongated member 135 can form the outer layer of the conduit 100. In some embodiments, the slidable elongated member 135 is configured to slide longitudinally (in the distal-proximal direction) between two fixed concentric layers of the conduit 100.

[0043] In some embodiments, Figure 2A In the closed configuration shown, one or more shock waves are generated in a conductive fluid at emitters 141, 142, 143, and 144. The one or more shock waves propagate through the fluid in chamber 112 and through the retractable outer shell 110, and then reach the target (e.g., a calcified lesion, a thrombus, or a fibrous mass), where the one or more shock waves break the target.

[0044] on the contrary, Figure 2B An open configuration of the conduit 100 according to one or more embodiments is shown. In the open configuration, the retractable housing 110 is spaced apart from the distal member 230. For example, the distal end of the retractable housing 110 may be spaced apart from the distal member 230 by a distance greater than or equal to 5 mm. In some embodiments, in the open configuration, the distal end of the retractable housing 110 is positioned proximally closer than at least a portion of the shock wave emitter assembly 140. In some embodiments, and as... Figure 2B As shown, the distal end of the retractable housing 110 is positioned closer to the proximal side than the transmitters 141, 142, 143, 144.

[0045] In some embodiments, the effective acoustic output of the shock wave (i.e., the pressure applied at the treatment site) can be higher in the open configuration than in the closed configuration. In some embodiments, when used in the open configuration, the shock wave emitter assembly 140 generates one or more cavitation bubbles that expand to a size larger than possible within the housing. In the open configuration, the collapse of the cavitation bubbles generates additional pressure waves (e.g., from high-speed microjets) with greater energy than those generated from the cavitation bubbles within the housing. In some embodiments, the acoustic output from the shock wave can attenuate as it propagates through the housing, depending on the acoustic properties of the housing. Therefore, the catheter 100 can be used in the open configuration when the shock wave generated in the closed configuration is insufficient or ineffective in treating the target tissue.

[0046] In some embodiments, catheter 100 is connected to an energy source (e.g., electrically or electromagnetically). Depending on the intended use (e.g., in an open or closed configuration), the power supplied to catheter 100 by the energy source can be adjusted or modulated to more effectively treat the target tissue. In some embodiments, the energy source may be a high-voltage power supply, and the performance of the supplied voltage pulses can be adjusted depending on the intended use. For example, the amplitude of the voltage pulses may be increased or decreased when catheter 100 is switched from an open to a closed configuration. In another example, the pulse width of the high-voltage pulses can be adjusted to be compatible with the generation and propagation of shock waves for a specific type of tissue (e.g., calcified, fibrotic, or thrombotic) or through a specific medium (e.g., saline or blood). In some embodiments, other pulse parameters (e.g., the number of pulses, frequency, or number of IVL treatment cycles) can be optimized for the target tissue type and / or whether catheter 100 is used in an open or closed configuration.

[0047] In some embodiments, the retractable housing 110 is made of a tubular membrane. The retractable housing 110 may be made of polyether block amide (e.g., Pebax), nylon, thermoplastic polyurethane (TPU), fluorinated ethylene propylene (FEP), polytetrafluoroethylene (PTFE), or a low-hardness resin. The retractable housing 110 may have an outer diameter of less than 15 mm, thereby allowing the conduit 100 to pass through narrower and / or more tortuous body lumens compared to conventional IVL devices. In some embodiments, the retractable housing 110 has a length (i.e., along the distal-proximal direction of the conduit) that is not less than the length of the shock wave emitter assembly 140 (e.g., the distance from the proximal end of emitter 141 to the distal end of emitter 144). In some embodiments, the retractable housing 110 has a length between 3 mm and 100 mm. In some embodiments, the retractable housing 110 has a length between 10 mm and 50 mm.

[0048] Figure 3Aand Figure 3B The distal region of a shock wave duct 200 according to one or more embodiments of the present invention is shown. The duct 200 includes a retractable housing 210, which can be configured from a closed configuration (…). Figure 3A (As shown) retracts back to the open configuration ( Figure 3B (As shown in the diagram). A retractable housing 210 is attached to the distal region of a slidable elongated member 235 that extends to the proximal end of the catheter 200. In a closed configuration, the retractable housing 210 surrounds and houses a shock wave emitter assembly 240 located on the elongated member 220. In some embodiments, the retractable housing 210 includes a central region 212 whose diameter expands when expanded with fluid. In some embodiments, the retractable housing 210 may be an angioplasty balloon. In some embodiments, the retractable housing 210 includes a distal opening 216 whose inner diameter is not less than the maximum profile of the shock wave emitter assembly 240. In some embodiments, the inner diameter of the distal opening is not less than 5 mm.

[0049] In some embodiments, the retractable housing 210 includes a polymer liner 214 on its distal inner surface, which forms a fluid-impermeable seal when coupled to the distal member 230 in a closed configuration. The fluid-impermeable seal can be formed by filling and pressurizing the retractable housing 210 (e.g., to a pressure greater than 1 atm) such that an expandable member of the distal member 230 (e.g., an expandable dome or expandable cone) seals against the polymer liner 214. The polymer liner 214 may be made of a compliant, low-stiffness material.

[0050] In some embodiments, the retractable housing 210 can be used to apply outward pressure at the treatment site (e.g., along the wall of a body lumen) after a shock wave is generated. For example, when the retractable housing 210 is in a closed configuration, a shock wave can be generated at the shock wave emitter assembly 240. These shock waves can be generated by expanding the retractable housing 210 with a conductive fluid (e.g., saline) to a pressure not exceeding 5 atm. After the shock wave is generated, the retractable housing 210 can expand to a pressure greater than 5 atm to achieve lumen expansion.

[0051] In another example, with the retractable housing 210 in an open configuration, a shock wave can be generated at the shock wave emitter assembly 240. After the shock wave is generated, the retractable housing 210 can be moved distally to a closed configuration. When sealing the retractable housing 210 to the distal member 230, the retractable housing 210 can expand (e.g., expand to a pressure greater than 5 atm) to achieve lumen expansion.

[0052] Figure 4The distal region of another exemplary shockwave catheter 300 according to one or more embodiments is shown. Similar to catheters 100 and 200 described above, catheter 300 includes a retractable housing 310 movable to generate a shock wave from shockwave emitter assembly 340 in a closed or open configuration. Catheter 300 also includes an occlusion member 350 located distal to shockwave emitter assembly 340. Occlusion member 350 may be an inflatable housing (e.g., an inflatable balloon). In some embodiments, occlusion member 350 is made of a compliant, low-stiffness material. Occlusion member 350 may be made of, for example, polyether block amide or nylon material. Occlusion member 350 may be in a constricted or retracted state during travel through the body lumen and delivery to the treatment site. After the shockwave emitter assembly 340 is positioned at the treatment site, occlusion member 350 may be inflated to occlude the body lumen and prevent any debris generated during treatment from flowing to other parts of the patient's body. The occlusion member 350 may have a contraction diameter and an expansion diameter greater than the contraction diameter. In some embodiments, the occlusion member 350 may be expanded by filling the occlusion member with fluid via a fluid lumen, which may be separate from a fluid lumen used to fill (and / or expand) the expandable housing 310. In some embodiments, the IVL conduit may include a distal occlusion member (e.g., occlusion member 350) and a proximal occlusion member located near the shock wave emitter assembly. In some embodiments, one or more occlusion members may be needed to block debris flow only when the IVL conduit is in an open configuration.

[0053] In some embodiments, the IVL catheter (e.g., catheter 100, 200, or 300) includes a fluid supply lumen and a return lumen for flushing the treatment site with fluid (e.g., saline) during IVL treatment. In some embodiments, fluid supply and return to a distal region of the catheter can be performed using a single lumen. In other words, the lumen for filling or expanding the expandable shell can be used to drain any debris generated during shockwave therapy. This infusion, aspiration, and suction structural feature may be necessary, particularly when the catheter is used in an open configuration where the shell is not positioned between the treatment site and the shockwave transmitter assembly. In such examples, debris may be generated at the treatment site in response to higher sound pressure levels (relative to the closed configuration). Injecting conductive fluid via the supply line ensures a consistent spark at one or more electrode pairs of the transmitter assembly. In some embodiments, the infusion and / or aspiration rate at the treatment site is from 5 mL / min to 25 mL / min.

[0054] The supply and / or return lumen can extend from the distal region of the IVL catheter to the proximal region of the IVL catheter. Figure 5An exemplary proximal handle 500 located in the proximal region of an IVL catheter according to one or more embodiments is shown. The proximal handle 500 may include an infusion port 510 in fluid communication with the supply lumen of the catheter and an aspiration port 520 in fluid communication with the return lumen of the catheter. One or both of the infusion port 510 and the aspiration port 520 may be fluidly connected to one or more pumps (e.g., an infusion pump or a peristaltic pump). The infusion port 510 may be in fluid communication with a fluid source for supplying conductive fluid (e.g., saline) to the treatment site (e.g., to fill and / or expand a housing in a closed configuration or to allow fresh fluid to flow to a transmitter in an open configuration). The proximal handle includes a connector 540 through which an energy source (not shown) may be connected. In some embodiments, the energy source may be a high-voltage generator. In some embodiments, the energy source may be a light source (e.g., a laser).

[0055] In some embodiments, the proximal handle 500 includes a switch 530 operably connected to the retractable housing, for example... Figure 3B The retractable housing 210 of the conduit 200 allows the retractable housing to move between a closed configuration and an open configuration. For example, the retractable housing may be attached to or integrally formed with an elongated member that extends into the switch 530. This elongated member is slidably located outside the inner elongated member, for example... Figure 3B The exterior of the elongated member 220 of the conduit 200.

[0056] In some embodiments, the switch 530 can be moved (e.g., manually) to two or more stop points corresponding to different positions of the retractable housing. In some embodiments, the switch 530 can slide between two or more stop points corresponding to different positions of the retractable housing. In some embodiments, the switch 530 can be moved between a first stop point corresponding to a closed configuration of the retractable housing and a second stop point corresponding to an open configuration of the retractable housing. In some embodiments, the switch stop points can correspond to a fully closed position, a fully retracted position, and one or more partially retracted positions of the retractable housing. For example, in several embodiments of a shock wave emitter assembly having multiple emitters, the multiple different stop positions for the switch can correspond to different numbers of emitters surrounded by the retractable housing.

[0057] Figure 6This is a flowchart illustrating a method of using an IVL catheter with a retractable shell according to some embodiments. In step 601, the IVL catheter is advanced through a body lumen (e.g., a blood vessel). The retractable shell may be a tubular membrane, an angioplasty balloon, or another type of shell. In some embodiments, the shell is in a closed configuration during delivery. In some embodiments, the shell may be in a contracted or reduced state to ensure a smaller cross-sectional profile during guidance through a potentially tortuous body lumen. In some embodiments, the shell is in an open configuration during delivery.

[0058] In step 602, the catheter is positioned such that the shockwave emitter assembly of the catheter (enclosed by a retractable housing in a closed configuration) is close to the target treatment site. In some embodiments, the treatment site is imaged by one or more of X-ray fluoroscopy, intravascular ultrasound, or optical coherence tomography, and the catheter is positioned based on the imaging data.

[0059] In some embodiments, in step 603, a user (e.g., a doctor) or an automated algorithm may determine whether the housing should be in a closed or open configuration based on factors such as the type of target tissue, the thickness of the target lesion, the eccentricity of the target lesion, the distance from the target lesion, or other factors. In the open configuration, the effective acoustic output can be significantly greater than in the closed configuration.

[0060] If the catheter is to be used with a housing in a closed configuration, then in step 604, if the housing is in an open configuration, it is moved to the closed configuration. In the closed configuration, a seal can be formed between the distal end of the housing and the distal member of the catheter. The distal member may include an expandable structural feature that can expand (e.g., by filling and pressurizing the housing with fluid) to create a seal capable of withstanding an internal pressure greater than 1 atm. The housing can be moved via a switch at a proximal handle of the catheter.

[0061] In step 605, the chamber is filled with fluid (e.g., physiological saline) via the catheter lumen. In some embodiments, the chamber is pressurized with fluid to a pressure not exceeding 5 atm. In some embodiments, the chamber is pressurized to a pressure not less than 2 atm and not more than 4 atm.

[0062] In step 606, a shock wave is generated within the housing by the shock wave emitter assembly. In some embodiments, the shock wave is generated by applying a high voltage to one or more electrode pairs of the shock wave emitter assembly. In other embodiments, the shock wave is generated by light energy (e.g., via optical fiber) directed to the shock wave emitter assembly.

[0063] In step 607, in some embodiments, the outer shell is optionally pressurized to a pressure greater than 4 atm to achieve body lumen expansion.

[0064] In some embodiments, if the conduit is to be used with the housing in an open configuration, then in step 614, if the housing is in a closed configuration, the housing can be retracted. The housing can be fully retracted to expose the entire shock wave emitter assembly, or partially retracted to partially expose the shock wave emitter assembly. The housing can be moved via a switch at a proximal handle of the conduit.

[0065] In step 615, a fluid (e.g., saline) may be infused to the target site. In some embodiments, the site may also be aspirated. The catheter may include separate supply and return lumens to enable infusion and aspiration. In some embodiments, a single lumen is used for both fluid supply and return. In some embodiments, prior to step 615, the treatment site may be isolated within the vascular system by one or more expandable occlusive members (e.g., located distal and / or proximal to the treatment site) to ensure inhibition and aspiration of any debris generated during treatment.

[0066] In step 616, one or more shock waves are generated at the shock wave emitter assembly. As described above, the shock wave generated in the open configuration can have a more efficient acoustic output than that in the closed configuration. That is, the sound pressure from the shock wave generated in step 616 can be higher than the sound pressure from the shock wave generated in step 606.

[0067] Following shockwave therapy, in some embodiments, in step 617, the housing may optionally be moved to a closed configuration. As in step 604, a seal capable of withstanding internal pressures greater than 1 atm may be formed in the closed configuration. After closing the housing, in some embodiments, in step 607, the housing is pressurized / inflated to a pressure greater than 4 atm.

[0068] Following the shockwave treatment in step 606 or 616, step 603 may optionally be repeated, if necessary, to change the shell configuration and generate additional shockwaves.

[0069] Figure 7 This is a flowchart illustrating a method of using an IVL catheter system, including an IVL catheter configured to generate shock waves with different acoustic outputs, according to some embodiments. In step 701, the IVL catheter, having a shock wave emitter assembly, is advanced through a body lumen. In step 702, the shock wave emitter assembly is positioned close to the treatment site (e.g., at the lesion in the body lumen).

[0070] In some embodiments, in step 702, the body lumen is imaged (e.g., via X-ray fluoroscopy, optical coherence tomography, or intravascular ultrasound) to aid in catheter localization to the lesion. In some embodiments, the lesion is characterized (e.g., by imaging methods) to determine appropriate treatment for the lesion (e.g., IVL catheter pulse algorithm or IVL catheter configuration). For example, the preferred treatment for eccentric lesions may differ from the preferred treatment for concentric lesions. Furthermore, different tissue types with different acoustic properties (e.g., calcified lesions or thrombotic lesions) may require different acoustic therapy curves to optimally treat the specific tissue type.

[0071] In step 703, a first energy pulse is applied to the shock wave transmitter assembly to generate a first shock wave with a first acoustic output. The shock wave transmitter assembly may include multiple shock wave transmitters, wherein each shock wave transmitter generates a separate shock wave.

[0072] In step 704, a second energy pulse is applied to the shock wave transmitter assembly to generate a second shock wave with a second acoustic output higher than that of the first acoustic wave. The second energy pulse has the same power as the first energy pulse; for example, the first and second energy pulses may have the same voltage.

[0073] In some embodiments, between steps 703 and 704, the IVL catheter system is changed from a first setting to a second setting. In some embodiments, in the first setting of the system, the IVL catheter is in a first configuration. In the second setting, the IVL catheter may be in a second configuration. In the first configuration, the retractable housing of the IVL catheter can be closed, and in the second configuration, the retractable housing can be opened. In other embodiments, the IVL catheter system is changed from the first setting to the second setting by changing the electrical settings of the system.

[0074] Figure 8 This is a flowchart illustrating a method of using an IVL catheter system, including an IVL catheter, according to some embodiments, wherein the catheter is configured to generate shock waves with different acoustic outputs. In step 801, the IVL catheter, having a shock wave emitter assembly and a retractable housing, is advanced through a body lumen. In step 802, the shock wave emitter assembly is positioned close to the treatment site (e.g., a lesion in the body lumen).

[0075] In step 803, a first energy pulse is applied to the shock wave transmitter assembly to generate a first shock wave with a first acoustic output.

[0076] In step 804, the IVL catheter is changed from the first configuration to the second configuration.

[0077] In step 805, a second energy pulse having a different power than the first energy pulse is applied to the shock wave transmitter assembly to generate a second shock wave. In some embodiments, the second shock wave has an acoustic output equal to that of the first shock wave. In some embodiments, the second shock wave has an acoustic output greater than that of the first shock wave. The power of the energy pulse can be changed at the power generator.

[0078] According to various aspects of the present invention, a method for manufacturing a shock wave duct may include: providing an internal elongated member; mounting one or more shock wave emitters at a distal end of the internal elongated member; electrically connecting the one or more shock wave emitters to one or more wires; securing the one or more wires to the internal elongated member; providing a retractable member (e.g., a retractable housing) that, when in its most distal position, is slidable along the internal elongated member to surround the one or more shock wave emitters, and when retracted from the most distal position, is slidable along the internal elongated member to expose the one or more shock wave emitters; and providing an external member. The method may also include sterilizing components of the shock wave duct (e.g., by electron beam sterilization or other forms of radiation sterilization).

[0079] According to various aspects of the invention, a method for refurbishing / renovating a shock wave conduit may include replacing or repairing one or more components of the conduit, such as one or more of a telescopic member, a distal member, an internal elongated member, and a slidable elongated member. For example, a telescopic member may be replaced by removing the telescopic member from the slidable elongated member and attaching a new elongated member to the slidable elongated member. This may include sliding the slidable elongated member at least partially away from the conduit. In some variations, the telescopic member may be refurbished in place or after removal from the conduit. Refurbishment of the telescopic member may include, for example, replacing or repairing the distal sealing region of the telescopic housing. Refurbishment of the conduit may include replacing one or more components of the shock wave transmitter assembly. This may include replacing one or more wires or removing a portion of one or more wires and attaching a new wire to the remaining portion and / or replacing one or more transmitter sheaths. Optionally, the entire electrode assembly may be removed from the conduit, repaired, and reassembled into the conduit. Optionally, the entire electrode assembly may be removed and replaced. Optionally, refurbishing a shock wave emitter assembly may include testing one or more performance parameters of the refurbished shock wave emitter. Testing may include testing the ability of the retractable member to seal to a distal member of the conduit, for example by positioning the retractable member in a sealed position, applying pressure to the retractable member, and measuring the pressure to determine if the applied pressure exceeds a predetermined threshold pressure. Testing may include testing the shock wave emitter assembly, for example by applying one or more voltage pulses to the shock wave emitter assembly and observing whether a spark is formed and / or measuring the intensity of the generated shock wave. Testing may include testing the integrity of the retractable member by, for example, pressurizing the retractable member in a closed position and monitoring pressure loss.

[0080] Figure 9 An exemplary computing system 900, which can be included as part of a shock wave duct system according to some examples of the present invention, is shown. System 900 can be a client or a server. Figure 9 As shown, system 900 can be any suitable type of processor-based system, such as a personal computer, workstation, server, handheld computing device (portable electronic device) such as a telephone or tablet, or dedicated device. System 900 may include, for example, one or more of input device 920, output device 930, one or more processors 910, storage device 940, and communication device 960. Input device 920 and output device 930 can generally correspond to those devices described above and can be connected to or integrated with a computer.

[0081] Input device 920 can be any suitable device that provides input, such as a touchscreen, keyboard or keypad, mouse, gesture recognition component of a virtual / augmented reality system, or voice recognition device. Output device 930 can be or includes any suitable device that provides output, such as a display, touchscreen, haptic device, virtual / augmented reality display, or speaker.

[0082] Storage device 940 can be any suitable means of providing storage, such as electrical, magnetic, or optical memory, including random access memory (RAM), cache, hard disk drive, removable storage disk, or other non-transitory computer-readable media. Communication device 960 may include any suitable means of transmitting and receiving signals over a network, such as a network interface chip or device. Components of computing system 900 can be connected in any suitable manner, such as via a physical bus or wireless connection.

[0083] Processor 910 can be any suitable processor or combination of processors, including any one or any combination of a central processing unit (CPU), graphics processing unit (GPU), field-programmable gate array (FPGA), programmable system-on-a-chip (PSOC), and application-specific integrated circuit (ASIC). Software 950, which can be stored in storage device 940 and executed by one or more processors 910, may include programs embodying, for example, the functions or portions thereof of the present invention (e.g., as embodied in the aforementioned devices). One or more processors 910 can be configured to process data received from sensors (e.g., imaging sensors, pressure sensors, or temperature sensors). One or more processors 910 can be configured to control the movement of the retractable shell of the shock waveguide, at least in part, based on data received from sensors and / or input from the user.

[0084] Software 950 may also be stored and / or transmitted in any non-transitory computer-readable storage medium for use by or in connection with an instruction execution system, device, or apparatus (such as those described above), which may retrieve and execute instructions associated with the software from and execute such instructions. In the context of this invention, a computer-readable storage medium may be any medium, such as storage device 940, which may contain or store programs for use by or in connection with an instruction execution system, device, or apparatus.

[0085] The software 950 can also be propagated in any transmission medium for use by or in conjunction with an instruction execution system, device, or apparatus (such as those described above), which can retrieve and execute instructions associated with the software from and the transmission medium. In the context of this invention, the transmission medium can be any medium capable of transmitting, propagating, or transmitting a program used by or in conjunction with an instruction execution system, device, or apparatus. Transmission computer-readable media can include, but are not limited to, electrical, magnetic, optical, electromagnetic, or infrared wired or wireless propagation media.

[0086] System 900 can be connected to a network, which can be any suitable type of interconnected communication system. The network can implement any suitable communication protocol and can be protected by any suitable security protocol. The network may include any suitable network link capable of transmitting and receiving network signals, such as wireless network connections, T1 or T3 lines, cable networks, DSL, or telephone lines.

[0087] Although the shock wave device described herein is based on generating shock waves by applying a high voltage to the electrodes, it should be understood that the shock wave device may additionally or alternatively include a laser and an optical fiber as a shock wave transmitter system, whereby the laser source transfers energy to the fluid through the optical fiber to form shock waves and / or cavitation bubbles.

[0088] Although the electrode assemblies and catheter devices described herein are primarily discussed in the context of treating coronary artery occlusions, such as lesions in the vascular system, the electrode assemblies and catheters described herein can be used for a variety of occlusions, such as those in the peripheral vascular system (e.g., above the knee, below the knee, iliac, or carotid arteries). For other instances, similar designs can be used to treat soft tissues, such as cancers and tumors (i.e., non-thermal ablation methods), thrombi, fibromas, cysts, organs, scars, and fibrotic tissue removal, or other tissue destruction and removal. Electrode assembly and catheter designs can also be used for neurostimulation therapy, targeted drug delivery, treatment of tumors in body lumens (e.g., tumors in blood vessels, esophagus, intestines, stomach, or vagina), wound treatment, non-surgical removal and destruction of tissue, or as an alternative to thermal therapy or cauterization for venous insufficiency and tubal ligation (i.e., for permanent female contraception).

[0089] In one or more examples, the electrode assemblies and conduits described herein can also be used in tissue engineering approaches, such as for mechanical tissue decellularization to create bioactive scaffolds in which new cells (e.g., exogenous or endogenous cells) replace old cells; introducing pores into the site to improve cell retention, cell infiltration / 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 SCI, the devices and assemblies described herein can facilitate the removal of scarred spinal cord tissue, which acts as a barrier to neuronal reconnection, prior to the infusion of an anti-inflammatory hydrogel containing lentiviruses and subsequent genetic engineering to regenerate spinal cord neurons.

[0090] Without departing from the present invention, the elements and features of the exemplary electrode assemblies and conduits described above can be rearranged, recombined, and modified. Furthermore, numerical indicators such as "first," "second," "third," and "fourth" are merely descriptive and do not indicate the relative order, position, or identity of the elements or features described by the indicators. For example, a "third" shock wave may appear immediately after a "first" shock wave, followed by a "second" shock wave. As another example, a "third" transmitter can be used to generate a "first" shock wave, or vice versa. Therefore, the numerical indicators of the various elements and features are not intended to limit the present invention and can be modified and interchanged without departing from the present invention.

[0091] It should be noted that the elements and features of the exemplary catheters shown in this specification and accompanying drawings can be rearranged, recombined, and modified without departing from the invention. For example, although this specification and accompanying drawings describe and illustrate catheters with several exemplary balloon designs, the invention is intended to include catheters with a variety of different balloon configurations. The number, position, and spacing of the electrode pairs of the shock wave generator can be modified without departing from the invention. Furthermore, the number, position, and spacing of the catheter balloons can be modified without departing from the invention.

[0092] It should be understood that the above description is merely an illustration of the principles of the invention, and those skilled in the art can make various changes, modifications, and combinations without departing from the scope and spirit of the invention. Any variation of the various catheters disclosed herein may include the features described by any other catheter or combination of catheters herein. Furthermore, any method may be used with any of the disclosed catheters. Therefore, the invention is not intended to be limited except by the appended claims.

[0093] Exemplary embodiments

[0094] The following embodiments are exemplary and are not intended to limit the scope of the invention.

[0095] Example 1: A catheter for emitting shock waves within a body lumen, the catheter comprising:

[0096] Distal component;

[0097] A slidable elongated member having a proximal end and a distal end;

[0098] An internal elongated member, the internal elongated member being at least partially located inside the slidable elongated member and extending to the distal member;

[0099] A shock wave emitter assembly, the shock wave emitter assembly being located on the internal elongated member and at a position further distal than the distal end of the slidable elongated member; and

[0100] A retractable housing having a distal end,

[0101] in:

[0102] In the closed configuration, the distal end of the retractable shell extends to the distal component of the conduit, and

[0103] In the open configuration, the distal end of the retractable housing retracts from the distal component of the conduit.

[0104] Example 2: The catheter according to Example 1 further includes a proximal handle with a switch, the switch being operatively coupled to the retractable housing to move the retractable housing between the closed configuration and the open configuration.

[0105] Example 3: The catheter according to Example 2, wherein the slidable elongated member includes a first lumen, and the proximal handle includes a first port in fluid communication with the first lumen.

[0106] Example 4: The catheter according to Example 3, wherein the slidable elongated member further includes a second lumen, and the proximal handle further includes a second port in fluid communication with the second lumen.

[0107] Example 5: The catheter according to Example 3 or 4, wherein the proximal handle further includes a second port in fluid communication with the first lumen.

[0108] Example 6: A catheter according to any one of Examples 1-5, wherein, in the closed configuration, the distal end of the retractable outer shell and the distal member of the catheter form a seal.

[0109] Example 7: The catheter according to Example 6, wherein the distal member includes an expandable member, the distal end of the retractable shell includes a polymer liner, and in the closed configuration, a seal is formed between the expandable member and the polymer liner.

[0110] Example 8: The catheter according to Example 7, wherein the polymer liner comprises polytetrafluoroethylene.

[0111] Example 9: The catheter according to any one of Examples 1-8, wherein, in the closed configuration, the catheter further includes a chamber surrounding the shock wave emitter assembly and having an internal pressure of not less than 1 atm.

[0112] Example 10: The catheter according to any one of Examples 1-9, wherein the distal member includes an expandable member located distal to the retractable housing.

[0113] Example 11: The catheter according to any one of Examples 1-10, wherein the retractable shell comprises at least one of polyether block amide, nylon, thermoplastic polyurethane, fluorinated ethylene propylene, and polytetrafluoroethylene.

[0114] Example 12: The catheter according to any one of Examples 1-11, wherein the distal member includes an elastic end.

[0115] Example 13: The catheter according to any one of Examples 1-12 further includes at least one fluid lumen, the at least one fluid lumen being located near the distal opening of the shock wave emitter assembly.

[0116] Example 14: The catheter according to any one of Examples 1-13, wherein, in the open configuration, the distal end of the retractable outer shell is spaced apart from the distal member of the catheter by a distance greater than or equal to 5 mm.

[0117] Example 15: The conduit according to any one of Examples 1-14, wherein, in the open configuration, the distal end of the retractable housing is at least partially located near the proximal side of the shock wave emitter assembly.

[0118] Example 16: The catheter according to any one of Examples 1-15, wherein the retractable outer shell comprises an angioplasty balloon.

[0119] Example 17: The conduit according to Example 16, wherein the retractable housing includes a distal opening having an inner diameter not less than the maximum outer diameter of the shock wave emitter assembly.

[0120] Example 18: The catheter according to Example 17, wherein the inner diameter of the distal opening of the retractable shell is not less than 5 mm.

[0121] Example 19: The conduit according to any one of Examples 16-18, wherein, in the closed configuration, the retractable outer shell surrounds the shock wave emitter assembly and has an internal pressure of not less than 1 atm and not more than 4 atm.

[0122] Example 20: The catheter according to any one of Examples 16-19, wherein the retractable shell comprises at least one of polyether block amide and polytetrafluoroethylene.

[0123] Example 21: The catheter according to any one of Examples 16-20 further includes at least one fluid lumen having a distal opening adjacent to the shock wave emitter assembly.

[0124] Example 22: The catheter according to any one of Examples 16-21, wherein, in the open configuration, the distal opening of the retractable housing is spaced from the distal member of the catheter by a distance greater than or equal to 5 mm.

[0125] Example 23: A method for generating a shock wave within a body cavity, the method comprising:

[0126] The shock wave catheter is advanced through the body lumen, the shock wave catheter having:

[0127] Distal component;

[0128] Slender components;

[0129] Shock wave emitter assembly located in the distal region of the elongated member; and

[0130] A retractable housing having a distal end and configured to retractably attach to the distal member;

[0131] Position the shockwave emitter assembly close to the treatment site;

[0132] Retract the retractable outer shell; and

[0133] One or more shock waves are generated at the shock wave emitter assembly.

[0134] Example 24: The method according to Example 23 further includes closing the retractable housing such that the distal end of the retractable housing is sealed to the distal member.

[0135] Example 25: The method according to Example 23 or 24 further includes depressurizing the chamber of the retractable housing, thereby breaking the fluid-impermeable seal between the distal member and the retractable housing.

[0136] Example 26: The method according to any one of Examples 23-25 ​​further includes imaging the treatment site by one or more of X-ray fluoroscopy, intravascular ultrasound and optical coherence tomography.

[0137] Example 27: The method according to Example 26 further includes determining, based on imaging data, whether the shock wave is generated when the retractable housing is retracted or when the retractable housing is sealed to the distal member.

[0138] Example 28: A method for generating a shock wave, the method comprising:

[0139] The shock wave duct is advanced through a body cavity, the shock wave duct having a shock wave emitter assembly;

[0140] A first energy pulse is applied to a shock wave transmitter assembly to generate a first shock wave with a first acoustic output; and

[0141] After the first energy pulse is applied, a second energy pulse with the same power as the first energy pulse is applied to the shock wave transmitter assembly to generate a second shock wave with a second acoustic output that is greater than the first acoustic output.

[0142] Example 29: The method according to Example 28, wherein the shock waveguide includes a distal member, an elongated member, and a retractable housing, the retractable housing having a distal end and configured to be retractably coupled to the distal member.

[0143] Example 30: The method according to Example 29 further includes retracting the retractable housing between the application of the first energy pulse and the application of the second energy pulse, such that the retractable housing does not cover the shock wave transmitter assembly.

[0144] Example 31: A conduit system for generating shock waves, the conduit system comprising:

[0145] An energy source configured to generate multiple energy pulses, each having a predetermined power; and

[0146] The conduit includes a shock wave emitter assembly and an elongated energy guide extending from the energy source to the shock wave emitter assembly.

[0147] In the first configuration of the conduit system, when a first energy pulse from a plurality of energy pulses is applied to the shock wave transmitter assembly, the shock wave transmitter assembly generates a first shock wave with a first acoustic output. In the second configuration of the conduit system, when a second energy pulse from a plurality of energy pulses is applied to the shock wave transmitter assembly, the shock wave transmitter assembly generates a second shock wave with a second acoustic output, the second acoustic output being greater than the first acoustic output.

[0148] Example 32: The catheter system according to Example 31, wherein the catheter further includes a distal member and a retractable housing, the retractable housing being sealed to the distal member in the first configuration to define a chamber, and spaced apart from the distal member in the second configuration.

[0149] Example 33: A method for generating a shock wave, the method comprising:

[0150] The shock wave duct is advanced through a body cavity, the shock wave duct having a shock wave emitter assembly and a retractable outer shell;

[0151] A first energy pulse is applied to the shock wave transmitter assembly to generate a first shock wave with a first acoustic output.

[0152] If the retractable housing is in a closed configuration, the retractable housing is retracted to expose the shock wave transmitter assembly; or, if the retractable housing is in an open configuration, the retractable housing is closed to surround the shock wave transmitter assembly; and a second energy pulse having a power different from the first energy pulse is applied to the shock wave transmitter assembly to generate a second shock wave. Claims (as amended under Article 19 of the Treaty) 1. A catheter for emitting shock waves within a body lumen, the catheter comprising: Distal component; A slidable elongated member having a proximal end and a distal end; An internal elongated member, the internal elongated member being at least partially located inside the slidable elongated member and extending to the distal member; A shock wave emitter assembly, the shock wave emitter assembly being located on the internal elongated member and at a position further distal than the distal end of the slidable elongated member; and It features a retractable outer shell at the far end; in: In the closed configuration, the distal end of the retractable housing extends to the distal member of the conduit, and In the open configuration, the distal end of the retractable housing retracts from the distal member of the conduit. 2. The catheter of claim 1, wherein the catheter further comprises a proximal handle having a switch operably coupled to the retractable housing to move the retractable housing between the closed configuration and the open configuration. 3. The catheter of claim 2, wherein the slidable elongated member includes a first lumen, and the proximal handle includes a first port in fluid communication with the first lumen. 4. The catheter of claim 3, wherein the slidable elongated member further comprises a second lumen, and the proximal handle further comprises a second port in fluid communication with the second lumen. 5. The catheter of claim 3, wherein the proximal handle further comprises a second port in fluid communication with the first lumen. 6. The catheter of claim 1, wherein, in the closed configuration, the distal end of the retractable outer shell and the distal member of the catheter form a seal. 7. The catheter of claim 6, wherein the distal member includes an expandable member, the distal end of the retractable shell includes a polymer liner, and in the closed configuration, the seal is formed between the expandable member and the polymer liner. 8. The catheter of claim 7, wherein the polymer liner comprises polytetrafluoroethylene. 9. The catheter of claim 1, wherein, in the closed configuration, the catheter further comprises a chamber surrounding the shock wave emitter assembly and having an internal pressure of not less than 1 atm. 10. The catheter of claim 1, wherein the distal member comprises an expandable member located distal to the retractable housing. 11. The catheter of claim 1, wherein the retractable outer shell comprises at least one selected from polyether block amide, nylon, thermoplastic polyurethane, fluorinated ethylene propylene, and polytetrafluoroethylene. 12. The catheter of claim 1, wherein the distal member comprises a resilient end. 13. The conduit of claim 1, further comprising at least one fluid lumen having a distal opening adjacent to the shock wave emitter assembly. 14. The catheter of claim 1, wherein, in the open configuration, the distal end of the retractable outer shell is spaced from the distal member of the catheter by a distance greater than or equal to 5 mm. 15. The conduit of claim 1, wherein, in the open configuration, the distal end of the retractable housing is at least partially located proximal to the shock wave emitter assembly. 16. The catheter of claim 1, wherein the retractable outer shell comprises an angioplasty balloon. 17. The conduit of claim 16, wherein the retractable housing includes a distal opening having an inner diameter not less than the maximum outer diameter of the shock wave emitter assembly. 18. The catheter of claim 17, wherein the inner diameter of the distal opening of the retractable housing is not less than 5 mm. 19. The conduit of claim 16, wherein, in the closed configuration, the retractable outer shell surrounds the shock wave emitter assembly and has an internal pressure of not less than 1 atm and not more than 4 atm. 20. The catheter of claim 16, wherein the retractable outer shell comprises at least one of polyether block amide and polytetrafluoroethylene. 21. The conduit of claim 16, further comprising at least one fluid lumen having a distal opening adjacent to the shock wave emitter assembly. 22. The catheter of claim 16, wherein, in the open configuration, the distal opening of the retractable housing is spaced from the distal member of the catheter by a distance greater than or equal to 5 mm. 23. A method for generating a shock wave within a body lumen, the method comprising: The shock wave catheter is advanced through the body lumen, the shock wave catheter having: Distal component; Slender components; Shock wave emitter assembly located in the distal region of the elongated member; and A retractable housing having a distal end and configured to retractably connect to the distal member; Position the shockwave emitter assembly adjacent to the treatment site; Retract the retractable outer shell; and One or more shock waves are generated at the shock wave emitter assembly. 24. The method of claim 23, further comprising closing the retractable housing such that the distal end of the retractable housing is sealed to the distal member. 25. The method of claim 23, further comprising depressurizing the chamber of the retractable housing such that the fluid-impermeable seal between the distal member and the retractable housing is disrupted. 26. The method of claim 23 further comprises imaging the treatment site by one or more of X-ray fluoroscopy, intravascular ultrasound, and optical coherence tomography. 27. The method of claim 26, further comprising determining, based on imaging data, whether the shock wave is generated when the retractable housing is retracted or when the retractable housing is sealed to the distal member. 28. A method for generating a shock wave, the method comprising: The shock wave duct is advanced through a body cavity, the shock wave duct having a shock wave emitter assembly; A first energy pulse is applied to the shock wave transmitter assembly to generate a first shock wave with a first acoustic output; and After the first energy pulse is applied, a second energy pulse with the same power as the first energy pulse is applied to the shock wave transmitter assembly to generate a second shock wave with a second acoustic output greater than the first acoustic output. 29. The method of claim 28, wherein the shock waveguide includes a distal member, an elongated member, and a retractable housing having a distal end and configured to be retractably coupled to the distal member. 30. The method of claim 29, further comprising, between applying the first energy pulse and applying the second energy pulse, retracting the retractable housing such that the retractable housing does not cover the shock wave transmitter assembly. 31. A conduit system for generating shock waves, the conduit system comprising: An energy source configured to generate a plurality of energy pulses, each energy pulse having a predetermined power; and The conduit includes a shock wave emitter assembly and an elongated energy guide extending from the energy source to the shock wave emitter assembly. In a first configuration of the catheter system, when a first energy pulse from the plurality of energy pulses is applied to the shock wave transmitter assembly, the shock wave transmitter assembly generates a first shock wave with a first acoustic output; and in a second configuration of the catheter system, when a second energy pulse from the plurality of energy pulses is applied to the shock wave transmitter assembly, the shock wave transmitter assembly generates a second shock wave with a second acoustic output, the second acoustic output being greater than the first acoustic output. 32. The catheter system of claim 31, wherein the catheter further comprises a distal member and a retractable housing, the retractable housing being sealed to the distal member in the first configuration to define a chamber and spaced apart from the distal member in the second configuration. 33. A method for generating a shock wave, the method comprising: The shock wave duct is advanced through a body cavity, the shock wave duct having a shock wave emitter assembly and a retractable outer shell; A first energy pulse is applied to the shock wave transmitter assembly to generate a first shock wave with a first acoustic output; If the retractable housing is in a closed configuration, it retracts to expose the shock wave emitter assembly; or, if the retractable housing is in an open configuration, it closes to enclose the shock wave emitter assembly. A second energy pulse with a power different from the first energy pulse is applied to the shock wave transmitter assembly to generate a second shock wave.

Claims

1. A catheter for emitting shock waves within a body lumen, the catheter comprising: Distal component; A slidable elongated member having a proximal end and a distal end; An internal elongated member, the internal elongated member being at least partially located inside the slidable elongated member and extending to the distal member; A shock wave emitter assembly, the shock wave emitter assembly being located on the inner elongated member and at a position further distal than the distal end of the slidable elongated member; as well as It features a retractable outer shell at the far end; in: In the closed configuration, the distal end of the retractable housing extends to the distal member of the conduit, and In the open configuration, the distal end of the retractable housing retracts from the distal member of the conduit.

2. The catheter according to claim 1, wherein, The conduit also includes a proximal handle with a switch operably coupled to the retractable housing to allow the retractable housing to move between the closed configuration and the open configuration.

3. The catheter according to claim 2, wherein, The slidable elongated member includes a first lumen, and the proximal handle includes a first port in fluid communication with the first lumen.

4. The catheter according to claim 3, wherein, The slidable elongated member also includes a second lumen, and the proximal handle also includes a second port in fluid communication with the second lumen.

5. The catheter according to claim 3 or 4, wherein, The proximal handle also includes a second port that is in fluid communication with the first lumen.

6. The catheter according to any one of claims 1-5, wherein, In the closed configuration, the distal end of the retractable housing and the distal component of the conduit form a seal.

7. The catheter according to claim 6, wherein, The distal component includes an expandable component, the distal end of the retractable housing includes a polymer liner, and in the closed configuration, the seal is formed between the expandable component and the polymer liner.

8. The catheter according to claim 7, wherein, The polymer liner contains polytetrafluoroethylene.

9. The catheter according to any one of claims 1-8, wherein, In the closed configuration, the conduit also includes a chamber surrounding the shock wave emitter assembly and having an internal pressure of not less than 1 atm.

10. The catheter according to any one of claims 1-9, wherein, The distal component includes an expandable component located on the distal side of the retractable housing.

11. The catheter according to any one of claims 1-10, wherein, The retractable shell comprises at least one of polyether block amide, nylon, thermoplastic polyurethane, fluorinated ethylene propylene, and polytetrafluoroethylene.

12. The catheter according to any one of claims 1-11, wherein, The distal component includes an elastic end.

13. The catheter according to any one of claims 1-12, further comprising at least one fluid lumen having a distal opening adjacent to the shock wave emitter assembly.

14. The catheter according to any one of claims 1-13, wherein, In the open configuration, the distal end of the retractable outer shell is spaced from the distal component of the conduit by a distance greater than or equal to 5 mm.

15. The catheter according to any one of claims 1-14, wherein, In the open configuration, the distal end of the retractable housing is at least partially located near the shock wave emitter assembly.

16. The catheter according to any one of claims 1-15, wherein, The retractable shell includes an angioplasty balloon.

17. The catheter according to claim 16, wherein, The retractable housing includes a distal opening having an inner diameter not less than the maximum outer diameter of the shock wave emitter assembly.

18. The catheter according to claim 17, wherein, The inner diameter of the distal opening of the retractable housing is not less than 5 mm.

19. The catheter according to claim 16 or 17, wherein, In the closed configuration, the retractable outer shell surrounds the shock wave emitter assembly and has an internal pressure of not less than 1 atm and not more than 4 atm.

20. The catheter according to any one of claims 16-19, wherein, The retractable shell comprises at least one of polyether block amide and polytetrafluoroethylene.

21. The catheter according to any one of claims 16-20, further comprising at least one fluid lumen having a distal opening adjacent to the shock wave emitter assembly.

22. The catheter according to any one of claims 16-21, wherein, In the open configuration, the distal opening of the retractable housing is spaced from the distal component of the conduit by a distance greater than or equal to 5 mm.

23. A method for generating a shock wave within a body lumen, the method comprising: The shock wave catheter is advanced through the body lumen, the shock wave catheter having: Distal component; Slender components; Shock wave emitter assembly located in the distal region of the elongated member; as well as A retractable housing having a distal end and configured to retractably connect to the distal member; Position the shockwave emitter assembly adjacent to the treatment site; The retractable outer shell retracts; as well as One or more shock waves are generated at the shock wave emitter assembly.

24. The method of claim 23, further comprising closing the retractable housing such that the distal end of the retractable housing is sealed to the distal member.

25. The method of claim 23 or 24, further comprising depressurizing the chamber of the retractable housing such that the fluid-impermeable seal between the distal member and the retractable housing is disrupted.

26. The method according to any one of claims 23-25, further comprising imaging the treatment site by one or more of X-ray fluoroscopy, intravascular ultrasound, and optical coherence tomography.

27. The method of claim 26, further comprising determining, based on imaging data, whether the shock wave is generated when the retractable housing is retracted or when the retractable housing is sealed to the distal member.

28. A method for generating a shock wave, the method comprising: The shock wave duct is advanced through a body cavity, the shock wave duct having a shock wave emitter assembly; A first energy pulse is applied to the shock wave transmitter assembly to generate a first shock wave with a first acoustic output; as well as After the first energy pulse is applied, a second energy pulse with the same power as the first energy pulse is applied to the shock wave transmitter assembly to generate a second shock wave with a second acoustic output greater than the first acoustic output.

29. The method according to claim 28, wherein, The shock waveguide includes a distal member, an elongated member, and a retractable housing having a distal end and configured to retractably connect to the distal member.

30. The method of claim 29, further comprising, between applying the first energy pulse and applying the second energy pulse, retracting the retractable housing such that the retractable housing does not cover the shock wave transmitter assembly.

31. A conduit system for generating shock waves, the conduit system comprising: An energy source configured to generate multiple energy pulses, each energy pulse having a predetermined power; as well as The conduit includes a shock wave emitter assembly and an elongated energy guide extending from the energy source to the shock wave emitter assembly. In the first configuration of the catheter system, when a first energy pulse among the plurality of energy pulses is applied to the shock wave transmitter assembly, the shock wave transmitter assembly generates a first shock wave with a first acoustic output. Furthermore, in the second configuration of the catheter system, when a second energy pulse among the plurality of energy pulses is applied to the shock wave transmitter assembly, the shock wave transmitter assembly generates a second shock wave with a second acoustic output, the second acoustic output being greater than the first acoustic output.

32. The catheter system according to claim 31, wherein, The catheter also includes a distal member and a retractable housing, the retractable housing being sealed to the distal member in the first configuration to define a chamber, and spaced apart from the distal member in the second configuration.

33. A method for generating a shock wave, the method comprising: The shock wave duct is advanced through a body cavity, the shock wave duct having a shock wave emitter assembly and a retractable outer shell; A first energy pulse is applied to the shock wave transmitter assembly to generate a first shock wave with a first acoustic output; If the retractable housing is in a closed configuration, the retractable housing is retracted to expose the shock wave emitter assembly; or if the retractable housing is in an open configuration, the retractable housing is closed to enclose the shock wave emitter assembly. as well as A second energy pulse with a power different from the first energy pulse is applied to the shock wave transmitter assembly to generate a second shock wave.

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