Catheter for emitting shock waves in body lumen

Abstract

The utility model provides a catheter for emitting shock waves in a body lumen. The catheter comprises a shock wave emitter assembly and a telescopic shell. In a first configuration of the catheter, the retractable housing is sealed to a distal member of the catheter and a lesion is treated by shock waves propagating through a wall of the housing. In the second configuration of the catheter, the retractable housing is retracted from the distal member of the catheter and the lesion is treated directly by the shockwaves emitted from the shockwave emitter assembly.

Description

Technical Field

[0001] The utility model generally relates to the field of medical equipment and medical methods, and more particularly, to a shock wave catheter device for treating calcified lesions in body lumens, such as calcified lesions and occlusions in vascular systems and kidney stones in urinary systems. Background Art

[0002] A variety of catheters have been developed for treating calcified lesions, such as calcified lesions associated with arterial disease in the vascular system. For example, treatment systems for percutaneous coronary angioplasty or peripheral angioplasty use angioplasty balloons to dilate calcified lesions and restore normal blood flow in the blood vessels. In these types of surgeries, a catheter carrying a balloon is introduced into the vascular system along a guide wire until the balloon is aligned with the calcified plaque. The balloon is then pressurized (usually to greater than 10 atmospheres) to expand the balloon in the blood vessel to push the calcified plaque back into the vessel wall and dilate the occluded area of ​​the vascular system.

[0003] Recently, techniques and treatments for intravascular lithotripsy (IVL) have been developed, which is an interventional procedure to improve calcified plaque in diseased arteries. The mechanism of plaque improvement is through the use of a catheter having one or more acoustic shock wave generators located in a fluid that are capable of generating acoustic shock waves that improve calcified plaque. IVL devices vary in design with respect to the energy source used to generate the acoustic shock waves, with two exemplary energy sources being an electrohydraulic generator and a laser generator.

[0004] For acoustic shock waves generated by an electrohydraulic generator, a conductive solution (such as saline) may be contained within a housing surrounding the electrodes, or may be flushed through / flowed through a tube surrounding the electrodes. Improvement of calcified plaque is achieved by generating acoustic shock waves within the catheter through electrode discharge. This discharge produces one or more rapidly expanding vapor bubbles, thereby generating acoustic shock waves. These shock waves propagate radially outward and improve calcified plaque within the blood vessel. For laser generation of acoustic shock waves, laser pulses are transmitted to and absorbed by the fluid within the catheter. This absorption process rapidly heats and evaporates the fluid, thereby generating rapidly expanding vapor bubbles and acoustic shock waves that propagate outward and improve calcified plaque. If a fluid is selected that exhibits strong absorption at the laser wavelength employed, the acoustic shock wave intensity will be higher. These examples of IVL devices are not intended to be a comprehensive list of potential energy sources for generating IVL shock waves.

[0005] The IVL procedure can be considered different from standard atherectomy because it ruptures the calcium but does not release the ruptured calcium from the tissue. Therefore, IVL does not, in general, require aspiration or embolic protection. In addition, due to the compliance of normal vessels and non-calcified plaque, the shock waves generated by IVL do not improve normal vascular tissue or non-calcified plaque. In addition, IVL does not carry the same degree of risk of perforation, dissection, or other vasculature damage as angioplasty atherectomy using a cutting or scoring balloon.

[0006] More specifically, a catheter for delivering IVL therapy has been developed, which includes an electrode pair for generating shock waves in an angioplasty balloon in an electrohydraulic manner. 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 lesions near the angioplasty balloon without harming surrounding tissues. In these devices, the catheter is advanced through the patient's vascular system on a guide wire until it is positioned near and / or aligned with the calcified plaque lesions in the body lumen. The balloon is then inflated with a conductive fluid (using a relatively low pressure of 2-4 atmospheres) so that the balloon expands to contact the lesion, but the expansion pressure does not substantially move the lesion. A voltage pulse 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 enters the lesion. Once the lesion is broken 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 may be within a closed volume other than an angioplasty balloon, such as a cap, balloon of various compliances, or other enclosures.

[0007] To date, commercially available IVL catheters include a shock wave transmitter housed within an angioplasty balloon. While effective for treating calcified lesions, improvements are necessary for other tissue types (e.g., fibrotic or thrombotic masses) or lesions with multiple tissue types. In addition, for treating lesions other than stenotic lesions (e.g., thrombi, fibrotic tissue within anastomosis, or cancerous tumors), it may not be necessary to employ an angioplasty balloon or another type of housing. Utility Model Content

[0008] An apparatus and method for generating shock waves in a body lumen is described herein. In some embodiments, the shock wave catheter includes a retractable housing at a distal region thereof that is configured to enclose a shock wave transmitter assembly in a closed configuration or to expose the shock wave transmitter assembly to the vasculature (e.g., blood circulating in the body) in an open configuration. In some embodiments, the catheter includes a perfusion capability for circulating fluid at a treatment site.

[0009] According to one aspect of the utility model, a catheter for emitting shock waves in 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, the inner elongated member being at least partially located inside the slidable elongated member and extending to the distal member; a shock wave transmitter assembly, the shock wave transmitter assembly being located on the inner elongated member and at a position more distal than the distal end of the slidable elongated member; and a retractable housing having a distal end, wherein, in a closed configuration, the distal end of the retractable housing extends to the distal member of the catheter, and in an open configuration, the distal end of the retractable housing is retracted from the distal member of the catheter.

[0010] According to some aspects, the catheter further comprises a proximal handle having a switch, the switch being operably coupled to the telescopic housing to move the telescopic housing between a closed configuration and an open configuration. According to some aspects, in the closed configuration, the distal end of the telescopic housing and the distal member of the catheter form a seal. According to some aspects, the distal member comprises an expandable member, the distal end of the telescopic housing comprises 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 comprises polytetrafluoroethylene. According to some aspects, in the closed configuration, the catheter further comprises a chamber surrounding the shock wave transmitter assembly and having an internal pressure of not less than 1 atm. According to some aspects, the distal member comprises an expandable member distal to the telescopic housing. According to some aspects, the telescopic housing comprises at least one of polyether block amide, nylon, thermoplastic polyurethane, fluorinated ethylene propylene, and polytetrafluoroethylene. According to some aspects, the distal member comprises an elastic tip. According to some aspects, the catheter further comprises at least one lumen for fluid, the lumen for fluid having a distal opening proximal to the shock wave transmitter assembly. According to some aspects, in the open configuration, the distal end of the telescoping housing is spaced apart from the distal member of the catheter by a distance greater than or equal to 5 mm. According to some aspects, in the open configuration, the distal end of the telescoping housing is at least partially proximal to the shock wave transmitter assembly.

[0011] According to one aspect of the utility model, a catheter for emitting shock waves in a body lumen is provided, the catheter comprising: a distal portion; an elongated member extending to the distal portion; a shock wave transmitter assembly located on the elongated member; and a telescopic shell having a distal opening, wherein: in a closed configuration, the distal opening of the telescopic shell extends to the distal portion, and in an open configuration, the distal opening of the telescopic shell is retracted from the distal portion.

[0012] According to some aspects, the telescopic housing comprises an angioplasty balloon. According to some aspects, the distal opening of the telescopic housing has an inner diameter that is not less than the maximum outer diameter of the shock wave transmitter assembly. According to some aspects, the distal opening of the telescopic housing has an inner diameter that is not less than 5 mm. According to some aspects, the catheter further comprises a proximal handle having a switch, the switch being operably coupled to the telescopic housing to move the telescopic housing between a closed configuration and an open configuration. According to some aspects, in the closed configuration, the distal opening of the telescopic housing and the distal member of the catheter form a seal. According to some aspects, the distal member comprises an expandable member, the distal opening of the telescopic housing comprises 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 comprises polytetrafluoroethylene. According to some aspects, in the closed configuration, the telescopic housing surrounds the shock wave transmitter assembly and has an internal pressure that is not less than 1 atm and not greater than 4 atm. According to some aspects, the telescopic housing comprises at least one of a polyether block amide and polytetrafluoroethylene. According to some aspects, the distal member includes an elastic tip. According to some aspects, the catheter further includes at least one lumen for fluid, the lumen for fluid having a distal opening proximal to the shock wave transmitter assembly. According to some aspects, in the open configuration, the distal opening of the telescoping housing is spaced apart from the distal member of the catheter by a distance greater than or equal to 5 mm. According to some aspects, in the open configuration, the distal opening of the telescoping housing is at least partially proximal to the shock wave transmitter assembly.

[0013] According to one aspect of the utility model, a catheter for treating lesions in a body lumen is provided, the catheter comprising: a distal member; an elongated member; a shock wave transmitter assembly located at 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 setting, the retractable housing is sealed to the distal member, and when the switch is in an open setting, the retractable housing is spaced apart from the distal member.

[0014] 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.

[0015] According to one aspect of the present invention, a method for generating shock waves in 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 transmitter assembly located at a distal region of the elongated member; and a telescopic housing having a distal end and configured to be retractably coupled to the distal member; positioning the shock wave transmitter assembly close to a treatment site; retracting the telescopic housing; and generating one or more shock waves at the shock wave transmitter assembly.

[0016] According to some aspects, the method also includes closing the telescopic housing so that the distal end of the telescopic housing is sealed to the distal member. According to some aspects, the inner surface of the telescopic housing includes a polymer liner, and when the telescopic housing is connected to the distal member, the polymer liner forms a fluid-tight seal with the distal member. According to some aspects, the method also includes depressurizing the chamber of the telescopic housing so that the fluid-tight seal between the distal member and the telescopic housing is destroyed. According to some aspects, the method also 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 also includes determining whether to generate a shock wave based on the imaging data when the telescopic housing is retracted or when the telescopic housing is sealed to the distal member.

[0017] According to one aspect of the utility model, a method for generating shock waves is provided, the method comprising: advancing a shock wave guide tube through a body lumen, the shock wave guide tube 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 wave 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 wave output, the second acoustic wave output being greater than the first acoustic wave output.

[0018] According to some aspects, the shock wave guide comprises a distal member, an elongated member, 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 comprises, 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.

[0019] According to one aspect of the utility model, a catheter system for generating shock waves is provided, the catheter system comprising: an energy source configured to generate a plurality of energy pulses, each energy pulse having a predetermined power; and a catheter comprising a shock wave transmitter assembly and an elongated energy guide extending from the energy source to the shock wave transmitter assembly, wherein, in a first setting 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 having a first acoustic wave output, and in a second setting 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 having a second acoustic wave output, the second acoustic wave output being greater than the first acoustic wave output.

[0020] According to some aspects, the catheter further includes a distal member and a telescoping housing sealed to the distal member to define the chamber in a first setting and spaced apart from the distal member in a second setting.

[0021] According to one aspect of the present invention, a method for generating shock waves is provided, the method comprising: advancing a shock wave guide through a body lumen, the shock wave guide having a shock wave transmitter assembly and a retractable housing; applying a first energy pulse to the shock wave transmitter assembly to generate a first shock wave having a first acoustic wave output; if the retractable housing is in a closed configuration, retracting the housing to expose the shock wave transmitter assembly, or, if the retractable housing is in an open configuration, closing the retractable housing to enclose the shock wave transmitter assembly; and applying a second energy pulse having a different power than the first energy pulse to the shock wave transmitter assembly to generate a second shock wave. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Illustrative aspects of the present invention are described in detail below with reference to the following drawings. The embodiments and drawings disclosed herein are intended to be considered illustrative and exemplary rather than restrictive.

[0023] Figure 1 A perspective view of an exemplary shock wave guide having a retractable member according to aspects of the present invention is shown.

[0024] Figure 2A A side view of an exemplary shock wave guide having a retractable member in a sealed (closed) configuration is shown in accordance with aspects of the present invention.

[0025] Figure 2B Shows Figure 2A Side view of a shock wave guide in which the retractable member is in a retracted (open) configuration.

[0026] Figure 3AA perspective view of an exemplary shock wave guide having a retractable housing in a sealed (closed) configuration is shown in accordance with aspects of the present invention.

[0027] Figure 3B Shows Figure 3A A perspective view of a shock wave guide with the retractable housing in a retracted (open) configuration.

[0028] Figure 4 A perspective view of an exemplary shock wave guide having an expandable distal member according to aspects of the present invention is shown.

[0029] Figure 5 A proximal region of an exemplary shock wave guide according to aspects of the present invention is shown.

[0030] Figure 6 An exemplary method of generating shock waves according to aspects of the present invention is shown.

[0031] Figure 7 An exemplary method of generating shock waves according to aspects of the present invention is shown.

[0032] Figure 8 An exemplary method of generating shock waves according to aspects of the present invention is shown.

[0033] Fig. 9 An exemplary computing system that may be part of a shockwave guide system according to aspects of the present invention is shown. DETAILED DESCRIPTION

[0034] The following description is presented to enable one of ordinary skill in the art to make and use the various embodiments disclosed herein and their various aspects. Descriptions of specific devices, components, techniques, and applications are provided as examples only. Various modifications of 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 their various aspects. Therefore, the various embodiments and their various aspects are not intended to be limited to the examples described and shown herein, but to conform to the scope consistent with the claims.

[0035] 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 the catheter to more easily pass through calcified blood vessels to deliver shock waves in more severely occluded areas of the vascular system. Examples of low-profile electrode designs can be found in U.S. Patents 8,888,788, 9,433,428, and 10,709,462, and U.S. Patent Publication No. US2021 / 0085383, all of which are incorporated herein by reference in their entirety. Other catheter designs have improved the delivery of shock waves, for example, by specific electrode constructions and configurations, thereby directing shock waves in a forward direction to destroy tighter and more difficult-to-penetrate occlusions in the vascular system. Examples of forward-firing catheter designs can be found in U.S. Patents 10,966,737, 11,478,261, and 11,596,423, and U.S. Patent Publications 2023 / 0107690 and 2023 / 0165598, all of which are incorporated herein by reference in their entirety.

[0036] The term "electrode" as used herein refers to a conductive element (usually made of metal) that receives an electric current and then releases the electric current to another conductive element. In the context of the present invention, the electrodes can be positioned relative to each other in the arrangement of an internal electrode and an external electrode, for example. Therefore, as used herein, the term "electrode pair" refers to two electrodes adjacent to each other and spaced apart, so that applying a sufficiently high voltage to the electrode pair will cause the current to be transmitted across the gap (also called a "spark gap") between the two electrodes (for example, from the internal electrode to the external electrode, or vice versa, optionally, the current passes through the conductive fluid or conductive gas therebetween). In some cases, one or more electrode pairs may also be referred to as an electrode assembly. In the context of the present invention, the term "emitter" refers generally to such an area of ​​an electrode assembly, i.e., in this area, the current is transmitted across the electrode pair, thereby generating a shock wave. The terms "emitter sheath" and "emitter belt" refer to a continuous or discontinuous conductive material belt that can be formed as one or more electrodes in one or more electrode pairs, thereby forming the position of one or more emitters.

[0037] Figure 1A distal region of a shock wave guide tube 100 having a telescoping shell 110 according to one or more aspects of the present invention is shown. The telescoping shell 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 catheter 100 has a distal member 120 that includes an expandable member 122 that expands in response to an increase in internal pressure within the telescoping shell 110 when in a closed configuration. The expandable member 122 may be sized so that it fits tightly within the distal sealing region 114 in the closed configuration and then expands in volume when the pressure within the telescoping shell 110 increases. When the expandable member 122 is in a closed configuration such as Figure 1 In the expanded state shown, a fluid-tight seal is maintained between the distal member 120 and the distal sealing area 114 of the telescoping housing 110. The expandable member 122 can be made of a compliant material. The expandable member 122 can be made of a low durometer material. In some embodiments, the distal member 120 includes an atraumatic rounded elastic end / tip.

[0038] In one or more embodiments, the catheter 100 includes a proximal region ( Figure 1 In some embodiments, the elongated member 130 includes one or more fluid lumens / fluid lumens (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.

[0039] The catheter 100 includes a shock wave transmitter assembly 140, which is connected to an energy source (e.g., a high voltage power source or a light energy source) through one or more energy guides (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 pairs, a shock wave can be generated at the electrode pairs. Each of these electrode pairs can be electrically connected (e.g., in series or in parallel) to one or more electrode pairs of the one or more transmitters. Therefore, one high voltage pulse from the high voltage power source can generate multiple shock waves from the catheter 100. In some embodiments, one or more transmitters (e.g., through multiple channels) are respectively connected to the energy source so that a single high voltage pulse at one channel generates a shock wave only from the transmitter electrically connected to the one channel.

[0040] Figure 2AA closed configuration of the shock wave catheter 100 is shown, wherein the distal end of the retractable housing 110 extends to the distal member 120. In this configuration, the retractable housing 110 at least partially defines a chamber 112 that houses the shock wave transmitter assembly 140. In some embodiments, in the closed configuration, the chamber 112 is pressurized to a pressure of at least 1 standard atmosphere (atm) using a conductive fluid (e.g., saline). In some embodiments, the chamber 112 is pressurized to a pressure of no more than 5atm. In some embodiments, the chamber 112 is pressurized to a pressure of no less than 2atm and no more than 4atm. 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 of up to 5atm. The retractable housing 110 can extend distally from the distal end of a slidable slender member 135, which can extend to a proximal region of the catheter 100. In some embodiments, as Figure 2A and 2B As shown, the slidable elongate member 135 can form an outer layer of the catheter 100. In some embodiments, the slidable elongate member 135 is configured to slide longitudinally (in the distal-proximal direction) between two fixed concentric layers of the catheter 100.

[0041] In some embodiments, Figure 2A In the closed configuration shown, one or more shock waves are generated in the conductive fluid at the emitters 141, 142, 143, 144. The one or more shock waves propagate through the fluid in the chamber 112, through the retractable housing 110, and then to the target (e.g., a calcified lesion, a thrombus mass, or a fibrous mass), where the one or more shock waves fragment the target.

[0042] on the contrary, Figure 2B 1 shows an open configuration of the catheter 100 according to one or more embodiments. In the open configuration, the telescoping housing 110 is spaced apart from the distal member 230. For example, the distal end of the telescoping housing 110 can be spaced apart from the distal member 230 by a distance of 5 mm or more. In some embodiments, in the open configuration, the distal end of the telescoping housing 110 is positioned closer to the proximal side than at least a portion of the shock wave transmitter assembly 140. In some embodiments, and as Figure 2B As shown, the distal end of the retractable housing 110 is positioned more proximally than the transmitters 141 , 142 , 143 , 144 .

[0043] 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, the shock wave emitter assembly 140 generates one or more cavitation bubbles when used in the open configuration, which expand to a larger size than is possible within the housing. In the open configuration, the collapse of the cavitation bubbles generates additional pressure waves (e.g., from high-speed microjets) that have greater energy than those generated from the cavitation bubbles within the housing. In some embodiments, depending on the acoustic properties of the housing, the acoustic output from the shock wave can be attenuated as it propagates through the housing. Therefore, the catheter 100 can be used in the open configuration when the shock waves generated in the closed configuration are insufficient or ineffective to effectively treat the target tissue.

[0044] In some embodiments, the catheter 100 (e.g., electrically or electromagnetically) is connected to an energy source. Depending on the intended use (e.g., in an open configuration or in a closed configuration), the power supplied to the catheter 100 by the energy source can be adjusted or modulated to more effectively treat the target tissue. In some embodiments, the energy source can be a high voltage power supply, and depending on the intended use, the performance of the supplied voltage pulse can be adjusted. For example, when the catheter 100 is converted from an open configuration to a closed configuration, the amplitude of the voltage pulse can be increased or decreased. In another example, the pulse width of the high voltage pulse 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 the catheter 100 is to be used in an open configuration or a closed configuration.

[0045] In some embodiments, the retractable housing 110 is made of a tubular film. The retractable housing 110 may be made of a 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 catheter 100 to pass through a narrower and / or more tortuous body lumen compared to a conventional IVL device. In some embodiments, the retractable housing 110 has a length (i.e., along the distal-proximal direction of the catheter) that is not less than the length of the shock wave transmitter assembly 140 (e.g., the distance from the proximal end of the transmitter 141 to the distal end of the transmitter 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.

[0046] Figure 3A and Figure 3B 2 shows a distal region of a shock wave guide tube 200 according to one or more embodiments of the present invention. The guide tube 200 includes a retractable housing 210 that can be extended from a closed configuration ( Figure 3A ) retracts to the open configuration ( Figure 3B 200 ). The telescoping housing 210 is attached to a distal region of a slidable elongated member 235 that extends to the proximal end of the catheter 200. In the closed configuration, the telescoping housing 210 surrounds and contains a shock wave transmitter assembly 240 located on the elongated member 220. In some embodiments, the telescoping housing 210 includes a central region 212 that expands in diameter when inflated with a fluid. In some embodiments, the telescoping housing 210 can be an angioplasty balloon. In some embodiments, the telescoping housing 210 includes a distal opening 216 having an inner diameter no less than the maximum profile of the shock wave transmitter assembly 240. In some embodiments, the inner diameter of the distal opening is no less than 5 mm.

[0047] In some embodiments, the telescoping housing 210 includes a polymer liner 214 at the inner surface of its distal end that forms a fluid-tight seal when coupled to the distal member 230 in a closed configuration. The fluid-tight seal can be formed by filling and pressurizing the telescoping housing 210 (e.g., to a pressure greater than 1 atm) such that the expandable member (e.g., an expandable dome or expandable cone) of the distal member 230 is sealed to the polymer liner 214. The polymer liner 214 can be made of a compliant, low-durometer material.

[0048] In some embodiments, the retractable housing 210 can be used to apply outward pressure at a treatment site (e.g., along the wall of a body lumen) after the shock waves are generated. For example, with the retractable housing 210 in a closed configuration, shock waves can be generated at the shock wave emitter assembly 240. These shock waves can be generated by inflating the retractable housing 210 with a conductive fluid (e.g., saline) to no more than 5 atm. After the shock waves are generated, the retractable housing 210 can be inflated to a pressure greater than 5 atm to achieve lumen expansion.

[0049] In another example, with the retractable housing 210 in the open configuration, a shock wave can be generated at the shock wave transmitter assembly 240. After the shock wave is generated, the retractable housing 210 can be moved distally to the closed configuration. When the retractable housing 210 is sealed to the distal member 230, the retractable housing 210 can be expanded (e.g., expanded to a pressure greater than 5 atm) to achieve lumen expansion.

[0050] Figure 4A distal region of another exemplary shock wave catheter 300 according to one or more embodiments is shown. Similar to the catheters 100 and 200 described above, the catheter 300 includes a retractable housing 310 that can be moved to generate shock waves from a shock wave transmitter assembly 340 in a closed configuration or an open configuration. The catheter 300 also includes an occlusion member 350 located distal to the shock wave transmitter assembly 340. The occlusion member 350 can be an expandable housing (e.g., an expandable balloon). In some embodiments, the occlusion member 350 is made of a compliant low-durometer material. The occlusion member 350 can be made of, for example, a polyether block amide or a nylon material. During travel through the body lumen and delivery to the treatment site, the occlusion member 350 can be in a deflated or contracted state. After the shock wave transmitter assembly 340 is positioned at the treatment site, the occlusion member 350 can be expanded 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 contracted diameter and an expanded diameter that is greater than the contracted diameter. In some embodiments, the occlusion member 350 may be expanded by filling the occlusion member with a fluid via a fluid lumen that may be separate from a fluid lumen used to fill (and / or expand) the retractable housing 310. In some embodiments, the IVL catheter may include a distal occlusion member (e.g., occlusion member 350) and a proximal occlusion member located proximal to the shock wave transmitter assembly. In some embodiments, one or more occlusion members may be required to block debris flow only when the IVL catheter is in an open configuration.

[0051] In some embodiments, an IVL catheter (e.g., catheter 100, 200, or 300) includes a fluid supply lumen and a return lumen for flushing the treatment site with a fluid (e.g., saline) during IVL treatment. In some embodiments, fluid supply and return to the distal region of the catheter can be performed with a single lumen. In other words, the lumen used to fill or expand the retractable housing can be used to discharge any debris generated during shock wave therapy. In particular, when the catheter is used in an open configuration, the housing is not positioned between the treatment site and the shock wave transmitter assembly, such infusion, suction, and aspiration structural features may be necessary. In such an example, in response to higher acoustic pressures (relative to the closed configuration), debris can be generated at the treatment site. Injecting a conductive fluid via a supply line can ensure consistent sparks at one or more electrode pairs of the transmitter assembly. In some embodiments, the infusion and / or suction rate at the treatment site is 5 mL / min to 25 mL / min.

[0052] The supply and / or return lumen may extend from a distal region of the IVL catheter to a 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., a syringe pump or a peristaltic pump). The infusion port 510 may be in fluid communication with a fluid source for supplying a conductive fluid (e.g., saline) to a treatment site (e.g., to fill and / or expand a housing in a closed configuration or to flow fresh fluid 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).

[0053] In some embodiments, the proximal handle 500 includes a switch 530 operably connected to the retractable housing, e.g. Figure 3B The telescopic housing 210 of the catheter 200 can be configured to move the telescopic housing between a closed configuration and an open configuration. For example, the telescopic housing can be connected to or formed integrally with an elongated member that extends to the switch 530. Such an elongated member can be slidably located outside of the inner elongated member, such as Figure 3B The outside of the slender member 220 of the catheter 200.

[0054] 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 multiple embodiments of a shock wave launcher assembly having multiple launchers, multiple different stop positions for the switch can correspond to different numbers of launchers enclosed by the retractable housing.

[0055] Figure 6601 is a flow chart illustrating a method for using an IVL catheter having a retractable housing according to some embodiments. In step 601, an IVL catheter is advanced through a body lumen (e.g., a blood vessel). The retractable housing can be a tubular membrane, an angioplasty balloon, or another type of housing. In some embodiments, during delivery, the housing is in a closed configuration. In some embodiments, the housing can be in a retracted or contracted state to ensure a smaller cross-sectional profile during guidance through a potentially tortuous body lumen. In some embodiments, the housing is in an open configuration during delivery.

[0056] In step 602, the catheter is positioned so that the shock wave transmitter assembly of the catheter (enclosed by the retractable housing in the closed configuration) is proximate 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.

[0057] In some embodiments, in step 603, a user (e.g., a physician) or an automated algorithm may determine whether the housing should be in a closed configuration or an 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 to the target lesion, or other factors. In the open configuration, the effective acoustic wave output may be significantly greater than the effective acoustic wave output in the closed configuration.

[0058] 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 a 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 can include an expandable structural feature that can expand (e.g., by filling and pressurizing the housing with a fluid) to produce a seal that can withstand an internal pressure greater than 1 atm. The housing can be moved by a switch at the proximal handle of the catheter.

[0059] In step 605, the chamber is filled with a fluid (e.g., saline) via the fluid lumen of the catheter. In some embodiments, the chamber is pressurized with the fluid to a pressure of no greater than 5 atm. In some embodiments, the chamber is pressurized to a pressure of no less than 2 atm and no greater than 4 atm.

[0060] In step 606, a shock wave is generated in the housing by the shock wave emitter assembly. In some embodiments, the shock wave is generated by applying a high voltage across one or more electrode pairs of the shock wave emitter assembly. In other embodiments, the shock wave is generated by light energy directed to the shock wave emitter assembly (e.g., via an optical fiber).

[0061] At step 607, in some embodiments, the housing is optionally pressurized to a pressure greater than 4 atm to effectuate dilation of the body lumen.

[0062] In some embodiments, if the catheter is to be used with the housing in an open configuration, the housing may be retracted if it is in a closed configuration in step 614. The housing may be fully retracted to expose the entire shock wave transmitter assembly, or partially retracted to partially expose the shock wave transmitter assembly. The housing may be moved by a switch at the proximal handle of the catheter.

[0063] In step 615, a fluid (e.g., saline) may be infused to the target site. In some embodiments, the site is also aspirated. The catheter may include separate supply and return lumens to enable infusion and aspiration. In some embodiments, a single lumen is used for fluid supply and return. In some embodiments, prior to step 615, the treatment site may be isolated within the vasculature by one or more inflatable occlusion members (e.g., located distally and / or proximally of the treatment site) to ensure containment and aspiration of any debris generated during treatment.

[0064] In step 616, one or more shock waves are generated at the shock wave emitter assembly. As described above, the shock waves generated in the open configuration may have a more efficient acoustic wave output than in the closed configuration. That is, the acoustic pressure from the shock waves generated in step 616 may be higher than the acoustic pressure from the shock waves generated in step 606.

[0065] After the shock wave treatment, in some embodiments, the housing can optionally be moved to a closed configuration in step 617. As in step 604, a seal capable of withstanding an internal pressure greater than 1 atm can 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.

[0066] After the shock wave treatment in step 606 or 616, step 603 may optionally be repeated to switch shell configurations and generate additional shock waves, if desired.

[0067] Figure 7 701 is a flow chart illustrating a method of using an IVL catheter system including an IVL catheter configured to generate shock waves with different acoustic wave outputs according to some embodiments. In step 701, an IVL catheter having a shock wave transmitter assembly is advanced through a body lumen. In step 702, the shock wave transmitter assembly is positioned proximate to a treatment site (e.g., at a lesion in a body lumen).

[0068] In some embodiments, in step 702, the body lumen is imaged (e.g., by x-ray fluoroscopy, optical coherence tomography, or intravascular ultrasound) to help position the catheter proximate 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 therapy for treating an eccentric lesion may be different from the preferred therapy for treating a concentric lesion. In addition, different tissue types with different acoustic properties (e.g., calcified lesions or thrombotic lesions) may require different acoustic wave therapy curves to optimally treat a specific tissue type.

[0069] In step 703, a first energy pulse is applied to the shock wave launcher assembly to generate a first shock wave having a first acoustic wave output. The shock wave launcher assembly may include a plurality of shock wave launchers, wherein each shock wave launcher generates a separate shock wave.

[0070] At step 704, a second energy pulse is applied to the shock wave emitter assembly to generate a second shock wave having a second acoustic output higher than the first acoustic output. The second energy pulse has the same power as the first energy pulse; for example, the first energy pulse and the second energy pulse may have the same voltage.

[0071] 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 may be closed, and in the second configuration, the retractable housing may be open. In other embodiments, the IVL catheter system is changed from the first setting to the second setting by changing an electrical setting of the system.

[0072] Figure 8 801 is a flow chart illustrating a method of using an IVL catheter system including an IVL catheter configured to generate shock waves with different acoustic wave outputs according to some embodiments. In step 801, an IVL catheter having a shock wave transmitter assembly and a retractable housing is advanced through a body lumen. In step 802, the shock wave transmitter assembly is positioned proximate to a treatment site (e.g., a lesion in a body lumen).

[0073] In step 803, a first energy pulse is applied to the shock wave transmitter assembly to generate a first shock wave having a first acoustic wave output.

[0074] In step 804, the IVL catheter is changed from a first configuration to a second configuration.

[0075] In step 805, a second energy pulse having a different power than the first energy pulse is applied to the shock wave emitter assembly to generate a second shock wave. In some embodiments, the second shock wave has an acoustic output equal to the first shock wave. In some embodiments, the second shock wave has an acoustic output greater than the first shock wave. The power of the energy pulse can be varied at the power generator.

[0076] According to aspects of the present invention, a method for manufacturing a shock wave guide may include: providing an inner elongated member; mounting one or more shock wave transmitters at a distal end of the inner elongated member; electrically connecting the one or more shock wave transmitters to one or more wires; securing the one or more wires to the inner elongated member; providing a retractable member (e.g., a retractable housing) that can slide along the inner elongated member to surround the one or more shock wave transmitters when the retractable member is in a distal-most position, and can slide along the inner elongated member to expose the one or more shock wave transmitters when the retractable member is retracted from the distal-most position; and providing an outer member. The method may also include sterilizing the components of the shock wave guide (e.g., by electron beam sterilization or other forms of radiation sterilization).

[0077] According to various aspects of the present invention, a method for refurbishing / renovating a shock wave catheter may include replacing or repairing one or more components of the catheter, such as one or more of a telescopic member, a distal member, an internal elongated member, and a slidable elongated member. For example, the telescopic member may be replaced by disassembling 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 catheter. In some variations, the telescopic member may be refurbished in place or after being removed from the catheter. The refurbishment of the telescopic member may include, for example, replacing or repairing a distal sealing area of ​​the telescopic housing. The refurbishment of the catheter may include replacing one or more components of a shock wave transmitter assembly. This may include replacing one or more wires or removing a portion of one or more wires and combining a new wire to the remaining portion and / or replacing one or more transmitter sheaths. Optionally, the entire electrode assembly is removed from the catheter, repaired, and reassembled to the catheter. Optionally, the entire electrode assembly may be removed and replaced. Optionally, refurbishing the shock wave transmitter assembly may include testing one or more performance parameters of the refurbished shock wave transmitter. Testing may include testing the ability of the telescopic member to seal to the distal member of the catheter, such as by positioning the telescopic member in a sealing position, applying pressure to the telescopic member, and measuring the pressure to determine whether the applied pressure is above a predetermined threshold pressure. Testing may include testing the shock wave transmitter assembly, such as by applying one or more voltage pulses to the shock wave transmitter assembly and observing whether sparks are formed and / or measuring the intensity of the generated shock wave. Testing may include testing the integrity of the telescopic member by, for example, pressurizing the telescopic member in a closed position and monitoring the pressure loss.

[0078] Fig. 9 9 shows an exemplary computing system 900 that can be included as part of a shock wave catheter system according to some examples of the present invention. The system 900 can be a client or a server. Fig. 9 As shown, the system 900 can be any suitable type of processor-based system, such as a personal computer, a workstation, a server, a handheld computing device (portable electronic device) such as a phone or a tablet, or a dedicated device. The system 900 can include, for example, one or more of an input device 920, an output device 930, one or more processors 910, a storage device 940, and a communication device 960. The input device 920 and the output device 930 can generally correspond to those devices described above and can be connected to or integrated with the computer.

[0079] Input device 920 may be any suitable device for providing input, such as a touch screen, a keyboard or keypad, a mouse, a gesture recognition component of a virtual / augmented reality system, or a voice recognition device. Output device 930 may be or include any suitable device for providing output, such as a display, a touch screen, a tactile device, a virtual / augmented reality display, or a speaker.

[0080] Storage device 940 may be any suitable device that provides storage, such as electrical, magnetic, or optical storage, including random access memory (RAM), cache, hard drive, removable storage disk, or other non-transitory computer-readable medium. Communication device 960 may include any suitable device capable of sending and receiving signals over a network, such as a network interface chip or device. The components of computing system 900 may be connected in any suitable manner, such as via a physical bus or wireless connection.

[0081] The processor 910 may be any suitable processor or combination of processors, including any one or any combination of a central processing unit (CPU), a graphics processing unit (GPU), a field programmable gate array (FPGA), a programmable system on a chip (PSOC), and an application specific integrated circuit (ASIC). The software 950 that may be stored in the storage device 940 and executed by one or more processors 910 may include, for example, a program that embodies the functions or part of the functions of the present invention (e.g., as embodied in the above-mentioned devices). The (one or more) processors 910 may be configured to process data received from a sensor (e.g., an imaging sensor, a pressure sensor, or a temperature sensor). The (one or more) processors 910 may be configured to control the movement of the retractable housing of the shock wave catheter based at least in part on the data received from the sensor and / or input from a user.

[0082] The software 950 may also be stored and / or transmitted in any non-transitory computer-readable storage medium for use by or in conjunction with an instruction execution system, device, or apparatus (e.g., those described above), which may retrieve instructions associated with the software from the instruction execution system, device, or apparatus / storage medium and execute the instructions. In the context of the present invention, a computer-readable storage medium may be any medium, such as storage device 940, which may contain or store a program for use by or in conjunction with an instruction execution system, device, or apparatus.

[0083] The software 950 may also be transmitted in any transmission medium for use by or in conjunction with an instruction execution system, device, or apparatus (such as those described above), which may obtain instructions associated with the software from the instruction execution system, device, or apparatus / transmission medium and execute the instructions. In the context of the present invention, a transmission medium may be any medium capable of conveying, propagating, or transmitting a program used by or in conjunction with an instruction execution system, device, or apparatus. Transmission computer-readable media may include, but are not limited to, electronic, magnetic, optical, electromagnetic, or infrared wired or wireless propagation media.

[0084] System 900 may be connected to a network, which may be any suitable type of interconnected communication system. The network may implement any suitable communication protocol and may be protected by any suitable security protocol. The network may include any suitably arranged network link capable of transmitting and receiving network signals, such as a wireless network connection, a T1 or T3 line, a cable network, DSL, or a telephone line.

[0085] Although the shock wave device described herein generates shock waves based on a high voltage applied to an electrode, it should be understood that the shock wave device may additionally or alternatively include a laser and optical fiber as a shock wave transmitter system, whereby a laser source transmits energy into a fluid through an optical fiber to form shock waves and / or cavitation bubbles.

[0086] Although the electrode assembly and catheter device described herein are mainly discussed in the context of treating coronary artery occlusions, such as lesions in the vasculature, the electrode assembly and catheter described herein can be used for a variety of occlusions, such as occlusions in the peripheral vasculature (e.g., above the knee, below the knee, iliac or carotid arteries). For other examples, similar designs can be used to treat soft tissues, such as cancer and tumors (i.e., non-thermal ablation methods), thrombi, fibroids, cysts, organs, scars and fibrotic tissue removal, or other tissue destruction and removal. The electrode assembly and catheter design 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 for use in place of thermal treatment or cauterization for venous insufficiency and tubal ligation (i.e., for permanent female contraception).

[0087] 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 create a bioactive scaffold, in which new cells (e.g., exogenous or endogenous cells) can replace old cells; pores are introduced 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 method 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 components described herein can promote the removal of scarred spinal cord tissue before injecting an anti-inflammatory hydrogel containing a lentivirus to regenerate spinal cord neurons through genetic engineering, and the scarred spinal cord tissue acts as a barrier to neuronal reconnection.

[0088] The elements and features of the exemplary electrode assemblies and catheters described above may be rearranged, recombined, and modified without departing from the present invention. In addition, numerical indicators such as "first," "second," "third," "fourth," and the like 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 "first" shock wave may be immediately followed by a "third" shock wave, followed by a "second" shock wave. As another example, a "third" transmitter may be used to generate a "first" shock wave, or vice versa. Therefore, the numerical indicators 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.

[0089] It should be noted that the elements and features of the exemplary catheters shown in this specification and the accompanying drawings may be rearranged, recombined, and modified without departing from the present invention. For example, although the present specification and the accompanying drawings describe and illustrate catheters with several exemplary balloon designs, the present 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 may be modified without departing from the present invention. In addition, the number, position, and spacing of the catheter balloons may be modified without departing from the present invention.

[0090] It should be understood that the above is only an illustration of the principles of the present invention, and that those skilled in the art may make various changes, modifications, and combinations 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 combination of catheters herein. In addition, any method may be used with any catheter disclosed. Therefore, the present invention is not intended to be limited except by the appended claims.

[0091] Exemplary Embodiments

[0092] The following embodiments are exemplary and are not intended to limit the scope of the present invention.

[0093] Embodiment 1: A catheter for transmitting shock waves in a body lumen, the catheter comprising:

[0094] distal member;

[0095] a slidable elongated member having a proximal end and a distal end;

[0096] an inner elongate member at least partially disposed within the interior of the slidable elongate member and extending to the distal member;

[0097] a shock wave transmitter assembly located on the inner elongated member and located more distally than the distal end of the slidable elongated member; and

[0098] a retractable housing having a distal end,

[0099] in:

[0100] In the closed configuration, the distal end of the retractable housing extends to the distal member of the catheter, and

[0101] In the open configuration, the distal end of the retractable housing is retracted from the distal member of the catheter.

[0102] Example 2: The catheter of Example 1 further comprises a proximal handle having a switch operably coupled to the telescoping housing to move the telescoping housing between the closed configuration and the open configuration.

[0103] Example 3: The catheter of Example 2, wherein the slidable elongated member comprises a first lumen and the proximal handle comprises a first port in fluid communication with the first lumen.

[0104] Example 4: The catheter of Example 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.

[0105] Embodiment 5: The catheter of Embodiment 3 or 4, wherein the proximal handle further comprises a second port in fluid communication with the first lumen.

[0106] Embodiment 6: The catheter of any one of embodiments 1-5, wherein in the closed configuration, the distal end of the retractable housing and the distal member of the catheter form a seal.

[0107] Example 7: The catheter of Example 6, wherein the distal member comprises an expandable member, the distal end of the retractable housing comprises a polymer liner, and in the closed configuration, a seal is formed between the expandable member and the polymer liner.

[0108] Embodiment 8: The catheter of Embodiment 7, wherein the polymer lining comprises polytetrafluoroethylene.

[0109] Embodiment 9: The catheter of any one of Embodiments 1-8, wherein, in the closed configuration, the catheter further comprises a chamber surrounding the shock wave transmitter assembly and having an internal pressure of not less than 1 atm.

[0110] Example 10: The catheter of any one of Examples 1-9, wherein the distal member comprises an expandable member distal to the retractable housing.

[0111] Embodiment 11: The catheter of any one of embodiments 1-10, wherein the retractable housing comprises at least one of polyether block amide, nylon, thermoplastic polyurethane, fluorinated ethylene propylene, and polytetrafluoroethylene.

[0112] Example 12: A catheter according to any of Examples 1-11, wherein the distal member includes an elastic tip.

[0113] Embodiment 13: The catheter of any one of embodiments 1-12 further comprises at least one lumen for fluid, the at least one lumen for fluid being proximal to a distal opening of the shock wave transmitter assembly.

[0114] Embodiment 14: The catheter according to any one of embodiments 1-13, wherein, in the open configuration, the distal end of the retractable housing is spaced apart from the distal member of the catheter by a distance greater than or equal to 5 mm.

[0115] Embodiment 15: The catheter of any of Embodiments 1-14, wherein, in the open configuration, the distal end of the retractable housing is at least partially proximal to the shock wave transmitter assembly.

[0116] Example 16: The catheter of any of Examples 1-15, wherein the retractable housing comprises an angioplasty balloon.

[0117] Embodiment 17: The catheter of Embodiment 16, wherein the retractable housing includes a distal opening having an inner diameter no less than a maximum outer diameter of the shock wave transmitter assembly.

[0118] Embodiment 18: The catheter according to Embodiment 17, wherein the inner diameter of the distal opening of the retractable housing is not less than 5 mm.

[0119] Embodiment 19: The catheter of any of Embodiments 16-18, wherein, in the closed configuration, the retractable housing surrounds the shock wave transmitter assembly and has an internal pressure of not less than 1 atm and not more than 4 atm.

[0120] Embodiment 20: The catheter of any of Embodiments 16-19, wherein the retractable housing comprises at least one of polyether block amide and polytetrafluoroethylene.

[0121] Example 21: The catheter of any of Examples 16-20, further comprising at least one lumen for fluid, the at least one lumen for fluid having a distal opening adjacent the shock wave transmitter assembly.

[0122] Example 22: The catheter of any one of Examples 16-21, wherein in the open configuration, the distal opening of the retractable housing is spaced apart from the distal member of the catheter by a distance greater than or equal to 5 mm.

[0123] Embodiment 23: A method for generating shock waves in a body lumen, the method comprising:

[0124] advancing a shock wave catheter through the body lumen, the shock wave catheter having:

[0125] distal member;

[0126] Slender member;

[0127] a shock wave transmitter assembly located at a distal region of the elongated member; and

[0128] a retractable housing having a distal end and configured to be retractably coupled to the distal member;

[0129] positioning the shock wave transmitter assembly proximate to a treatment site;

[0130] retracting the retractable housing; and

[0131] One or more shock waves are generated at the shock wave transmitter assembly.

[0132] Embodiment 24: The method according to Embodiment 23 further includes closing the telescopic housing so that the distal end of the telescopic housing is sealed to the distal member.

[0133] Embodiment 25: The method according to embodiment 23 or 24 further includes depressurizing the chamber of the telescopic housing so that the fluid seal between the distal member and the telescopic housing is destroyed.

[0134] Example 26: The method of any one of Examples 23-25, further comprising imaging the treatment site by one or more of x-ray fluoroscopy, intravascular ultrasound, and optical coherence tomography.

[0135] Embodiment 27: The method of Embodiment 26 further comprises determining, based on imaging data, whether to generate a shock wave with the telescopic housing retracted or with the telescopic housing sealed to the distal member.

[0136] Embodiment 28: A method for generating a shock wave, the method comprising:

[0137] advancing a shock wave guide having a shock wave transmitter assembly through a body lumen;

[0138] applying a first energy pulse to the shock wave transmitter assembly to generate a first shock wave having a first acoustic wave output; and

[0139] After applying the first energy pulse, a second energy pulse having the same power as the first energy pulse is applied to the shock wave emitter assembly to generate a second shock wave having a second sonic output that is greater than the first sonic output.

[0140] Embodiment 29: The method of Embodiment 28, wherein the shock wave guide comprises a distal member, an elongated member, and a retractable housing having a distal end and configured to be retractably coupled to the distal member.

[0141] Embodiment 30: The method according to Embodiment 29 further includes retracting the retractable shell between applying the first energy pulse and applying the second energy pulse so that the retractable shell does not cover the shock wave emitter assembly.

[0142] Embodiment 31: A catheter system for generating shock waves, the catheter system comprising:

[0143] an energy source configured to generate a plurality of energy pulses, each energy pulse having a predetermined power; and

[0144] a catheter including a shock wave transmitter assembly and an elongated energy guide extending from the power source to the shock wave transmitter assembly,

[0145] Wherein, in a first setting of the catheter 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 wave output, and in a second setting of the catheter 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 wave output, the second acoustic wave output being greater than the first acoustic wave output.

[0146] Example 32: The catheter system of Example 31, wherein the catheter further comprises a distal member and a retractable housing, the retractable housing being sealed to the distal member to define a chamber in the first setting and being spaced apart from the distal member in the second setting.

[0147] Embodiment 33: A method for generating a shock wave, the method comprising:

[0148] advancing a shock wave guide having a shock wave transmitter assembly and a retractable housing through a body lumen;

[0149] applying a first energy pulse to the shock wave transmitter assembly to generate a first shock wave having a first acoustic wave output;

[0150] retracting the retractable housing to expose the shock wave emitter assembly if the retractable housing is in the closed configuration, or closing the retractable housing to enclose the shock wave emitter assembly if the retractable housing is in the open configuration; and applying a second energy pulse having a different power than the first energy pulse to the shock wave emitter assembly to generate a second shock wave.

Claims

1. A catheter for emitting shock waves in a body lumen, characterized in that: The catheter comprises: distal member; a slidable elongated member having a proximal end and a distal end; an inner elongate member at least partially disposed within the interior of the slidable elongate member and extending to the distal member; a shock wave transmitter assembly located on the inner elongated member and located more distally than the distal end of the slidable elongated member; and a retractable housing having a distal end; in: In the closed configuration, the distal end of the telescoping housing extends to the distal member of the catheter, and In the open configuration, the distal end of the retractable housing is retracted from the distal member of the catheter.

2. The catheter according to claim 1, characterized in that The catheter also includes a proximal handle having a switch operably coupled to the telescoping housing to move the telescoping housing between the closed configuration and the open configuration.

3. The catheter according to claim 1, characterized in that In the closed configuration, the distal end of the telescoping housing and the distal member of the catheter form a seal.

4. The catheter according to claim 1, characterized in that In the closed configuration, the catheter further includes a chamber surrounding the shock wave transmitter assembly and having an internal pressure of no less than 1 atm.

5. The catheter according to claim 1, characterized in that The retractable housing comprises one of polyether block amide, nylon, thermoplastic polyurethane, fluorinated ethylene propylene and polytetrafluoroethylene.

6. The catheter according to claim 1, characterized in that The catheter also includes at least one lumen for fluid having a distal opening proximate the shock wave transmitter assembly.

7. The catheter according to claim 1, characterized in that In the open configuration, the distal end of the telescoping housing is spaced apart from the distal member of the catheter by a distance greater than or equal to 5 mm.

8. The catheter according to claim 1, characterized in that In the open configuration, the distal end of the retractable housing is at least partially proximal to the shock wave transmitter assembly.

9. The catheter according to claim 1, characterized in that The retractable housing includes an angioplasty balloon.

10. The catheter according to claim 1, characterized in that In the closed configuration, the retractable housing surrounds the shock wave launcher assembly and has an internal pressure of no less than 1 atm and no greater than 4 atm.

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