Catheter for treating lesions in body lumen

Abstract

The utility model provides a catheter for treating lesions in a lumen of a body, which comprises a slender member extending from a proximal region of the catheter to a distal region of the catheter; a distal shock wave generating region having a distal outer diameter and located at the distal region of the elongate member; and a proximal shock wave generating region having a proximal outer diameter and located proximal to the distal shock wave generating region, where the distal outer diameter is smaller than the proximal outer diameter.

Description

Technical Field

[0001] This invention generally relates to the field of medical devices, and more specifically to a sound pressure wave generating component included in a catheter device for treating lesions in body lumens, such as calcified lesions and occlusions in the vascular system. More particularly, this invention relates to a catheter for treating lesions in body lumens. Background Technology

[0002] Intravascular lithotripsy (IVL) is an interventional procedure used to improve calcified plaques in diseased arteries. The mechanism of plaque improvement involves using a catheter with one or more acoustic shock wave generators located in a fluid environment, capable of producing acoustic shock waves that improve the calcified plaques. IVL devices differ in design from the energy sources used to generate these acoustic shock waves; two exemplary energy sources are an electro-hydraulic generator and a laser generator.

[0003] For electro-hydraulic generation of shock waves, voltage is applied to an electrode pair enclosed in a fluid-filled shell, causing an energy discharge that propagates into the surrounding fluid at a speed exceeding the speed of sound, generating a shock wave. The shock wave propagates radially outward and improves calcified plaque within the blood vessel. For laser generation of shock waves, a laser pulse is transmitted into the fluid within the catheter and absorbed by it. This absorption process rapidly heats and evaporates the fluid, generating rapidly expanding bubbles and a shock wave. Other energy sources, including piezoelectric power sources, can also generate IVL shock waves.

[0004] The difference between IVL and standard atherosclerotic resection can be considered in that IVL ruptures calcium without releasing the ruptured calcium from the tissue. This is typically observed in closed-system IVL devices, where vapor bubbles are generated within a closed space (e.g., balloon, flexible cap, etc.), thus eliminating the need for aspiration or embolization protection. Furthermore, due to the compliance of normal vessels and uncalcified plaques, the shockwave generated by IVL does not alter normal vascular tissue or uncalcified plaques. Additionally, IVL does not carry the same risk of perforation, dissection, or other vascular system damage as angioplasty using cutting or scribing balloons.

[0005] 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 waves 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. Such devices can be replaceable (“Rx”) or “through-wire” (“OTW”) delivered via a wire. The balloon is then inflated with fluid, causing it to expand (e.g., to a relatively low pressure of 2-4 atm) to contact the lesion, but not to expand to pressures that significantly displace the lesion. Voltage pulses can then be supplied to a transmitter (e.g., by applying voltage to one or more electrode pairs of the transmitter) to generate acoustic shock waves that propagate through the walls of the angioplasty balloon and into the lesion. Once the lesion is 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 enclosed volumes other than angioplasty balloons, such as caps, various compliant balloons, or other shells.

[0006] However, a shockwave catheter design is still needed to access highly stenotic vessels. Due to the multiple components of a shockwave catheter (e.g., wire, electrode, lumen, balloon), its minimum cross-sectional profile is larger than that of a conventional angioplasty balloon catheter. Therefore, in some cases, physicians treating highly stenotic vessels may choose to treat the lesion first with a very narrow conventional angioplasty balloon catheter before attempting IVL therapy.

[0007] In particular, a narrower profile at the distal end of the catheter may be desired for improved delivery capability and seaworthiness. However, significantly reducing the distal profile may negatively impact performance, such as the uniformity of acoustic output along the length of the IVL catheter treatment area, which is generally preferred for shock wave devices. Utility Model Content

[0008] In several aspects of this invention, the distal emitter of the shock wave duct has a smaller outer diameter than the proximal emitter in order to provide improved flexibility and seaworthiness at the distal end.

[0009] According to one aspect of the present invention, a catheter for treating lesions in a body lumen includes an elongated member extending from a proximal region of the catheter to a distal region of the catheter; a distal shock wave generating region having a distal outer diameter and located at the distal region of the elongated member; and a proximal shock wave generating region having a proximal outer diameter and located proximal to the distal shock wave generating region, wherein the distal outer diameter is smaller than the proximal outer diameter.

[0010] In any of these examples, the difference between the distal outer diameter and the proximal outer diameter may not be less than 0.001 inches (0.0254 mm).

[0011] In any of these examples, the difference between the distal outer diameter and the proximal outer diameter may not be less than 0.0015 inches (0.0381 mm).

[0012] In any of these examples, the distal outer diameter may not be greater than 98% of the proximal outer diameter.

[0013] In any of these examples, the distal outer diameter may not be greater than 97.5% of the proximal outer diameter.

[0014] In any of these examples, the longitudinal distance from the center of the distal shock wave generation area to the center of the proximal shock wave generation area can be no less than 6 mm.

[0015] In any of these examples, the longitudinal distance from the center of the distal shock wave generation area to the center of the proximal shock wave generation area can be no less than 7 mm.

[0016] In any of these examples, the distal shock wave generation region includes the distal electrode pair, and the proximal shock wave generation region may include the proximal electrode pair.

[0017] In any of these examples, the distal electrode pair may include a distal outer electrode and a distal inner electrode, and the proximal electrode pair may include a proximal outer electrode and a proximal inner electrode, and the outer diameter of the distal outer electrode may be smaller than the outer diameter of the proximal outer electrode.

[0018] In any of these examples, the distal shock wave generation area and the proximal shock wave generation area can be independently wired to the power supply.

[0019] In any of these examples, the distal shock wave generation region may include four distal shock wave generation regions, and the proximal shock wave generation region may include four proximal shock wave generation regions.

[0020] In any of these examples, the proximal shock wave generation region may include two proximal shock wave generation regions, and the distal shock wave generation region may include a single distal shock wave generation region.

[0021] According to one aspect of the present invention, a shockwave conduit for treating lesions in a body lumen using shockwaves comprises: an elongated member extending from a proximal region of the conduit to a distal region of the conduit; a plurality of shockwave generating regions located in the distal region of the conduit; and a shell surrounding the plurality of shockwave generating regions, the shell having: a distal portion; a proximal portion; and a central portion located between the distal portion and the proximal portion, wherein: in a first configuration, the shell is substantially contracted, and the proximal outer diameter of the conduit in the proximal part of the central portion is greater than the distal outer diameter of the conduit in the distal part of the central portion; and in a second configuration, the shell is fluid-expanded, and the proximal outer diameter of the conduit is not greater than the distal outer diameter.

[0022] In any of these examples, in the first configuration, the difference between the distal outer diameter and the proximal outer diameter may be no less than 0.001 inches (0.0254 mm).

[0023] In any of these examples, in the first configuration, the difference between the distal outer diameter and the proximal outer diameter may be no less than 0.0015 inches (0.0381 mm).

[0024] In any of these examples, in the first configuration, the distal outer diameter may not be greater than 98% of the proximal outer diameter.

[0025] In any of these examples, in the first configuration, the distal outer diameter may not be greater than 97.5% of the proximal outer diameter.

[0026] In any of these examples, the catheter may include a proximal shock wave emitter and a distal shock wave emitter, wherein the longitudinal distance from the center of the distal shock wave emitter to the center of the proximal shock wave emitter may be not less than 6 mm.

[0027] In any of these examples, the longitudinal distance from the center of the distal shock wave emitter to the center of the proximal shock wave emitter may be no less than 7 mm.

[0028] In any of these examples, the distal shock wave emitter may include a distal electrode pair, and the proximal shock wave emitter may include a proximal electrode pair.

[0029] In any of these examples, the distal electrode pair may include a distal outer electrode and a distal inner electrode, and the proximal electrode pair may include a proximal outer electrode and a proximal inner electrode, and the outer diameter of the distal outer electrode may be smaller than the outer diameter of the proximal outer electrode.

[0030] In any of these examples, the distal shock wave emitter and the proximal shock wave emitter can be wired to a power source independently.

[0031] In any of these examples, the distal shock wave generation region may include four distal shock wave generation regions, and the proximal shock wave generation region may include four proximal shock wave generation regions.

[0032] According to one aspect of the present invention, a shockwave catheter for treating lesions in a body lumen using shockwaves comprises: an elongated member extending from a proximal region of the catheter to a distal region of the catheter; a distal shockwave emitter having a distal inner band and a distal outer band, the distal outer band having a distal outer diameter; and a proximal shockwave emitter having a proximal inner band and a proximal outer band, the proximal outer diameter of the proximal outer band being larger than the distal outer diameter. Attached Figure Description

[0033] Exemplary aspects of the present invention are described in detail below with reference to the accompanying drawings. The embodiments and drawings disclosed herein should be considered exemplary rather than limiting.

[0034] Figure 1 An exemplary shock wave duct according to one or more aspects of the present invention is shown;

[0035] Figure 2A A cross-sectional view of a conduit 100 according to one or more aspects of the present invention is shown at plane 2A-2A;

[0036] Figure 2B A cross-sectional view of a conduit 100 according to one or more aspects of the present invention is shown at plane 2B-2B;

[0037] Figure 3A A portion of a near-side emitter according to one or more aspects of the present invention is shown;

[0038] Figure 3B A portion of a remote transmitter according to one or more aspects of the present invention is shown;

[0039] Figure 4A The distal region of a shock waveguide in a contracted configuration according to one or more aspects of the present invention is shown; and

[0040] Figure 4B The distal region of a shock waveguide in an expanded configuration according to one or more aspects of the present invention is shown. Detailed Implementation

[0041] The following description is presented to enable those skilled in the art to make and use the various embodiments disclosed herein. The descriptions of specific catheters, systems, methods, and applications are provided by way of example only. Various modifications of 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. Therefore, the various embodiments and aspects thereof are not intended to limit themselves to the examples described and shown herein, but are to be accorded the scope consistent with the claims.

[0042] As described herein, it should be understood that any disclosure describing a range of dimensions or measurements such as thickness, length, weight, time, frequency, temperature, voltage, current, angle, etc., includes any numerical increments or gradients relative to the range provided for a given dimension or measurement. Furthermore, numerical indicators such as “first,” “second,” “third,” “fourth,” etc., are merely descriptive and do not indicate the relative order, position, or identity of the elements or features described by the indicator. 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” emitter 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 can be modified and interchanged without departing from the present invention.

[0043] Furthermore, it should be understood that, unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “described” used in the following description are also intended to include the plural forms. It should also be understood that the term “and / or” as used herein refers to and includes any and all possible combinations of one or more of the associated listed items. It should also be understood that the terms “comprising” and / or “including,” when used herein, specifically describe the presence of the stated features, integers, steps, operations, elements, components, and / or units, but do not exclude the presence or addition of one or more other features, integers, steps, operations, elements, components, units, and / or groups thereof.

[0044] As described herein, it should be understood that any disclosure describing a range of dimensions or measurements such as thickness, length, weight, time, frequency, temperature, voltage, current, angle, etc. includes any numerical increments or gradients relative to the range provided for a given dimension or measurement.

[0045] 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 US8,888,788, US9,433,428, and US10,709,462, and U.S. Patent Publication No. US2021 / 0085383, all of which are incorporated herein by reference in their entirety. Other catheter designs have improved 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.

[0046] 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 internal and external 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 be transmitted across the gap between the two electrodes (also called a "spark gap") (e.g., from the internal electrode to the external 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 ​​an electrode assembly where current is transmitted across the electrode pair, thereby generating a shock wave. The term "emitter strip" refers to a continuous or discontinuous strip of conductive material that may be formed as one or more electrodes in one or more electrode pairs, thereby forming one or more emitter locations. The term "shock wave generating region" refers to an area of ​​a conduit that has a shock wave generating structure, such as an emitter.

[0047] Figure 1 The distal region of a shockwave catheter 100 for treating lesions in body cavities according to some embodiments of the present invention is shown. The shockwave catheter 100 includes an elongated member 110 extending from a proximal region to a distal region of the catheter 100. The shockwave catheter 100 also includes a plurality of shockwave emitters 120a-120h disposed along the elongated member 110. The shockwave emitters 120a-120h are encapsulated within a housing 130. The housing 130 includes a distal side 132 and a proximal side 134.

[0048] In this document, the terms “distal” and “proximal” are used to refer to opposite directions relative to the distal and proximal ends of the catheter. The distal end of the catheter advances through a body lumen (e.g., a blood vessel) to the treatment site, and the proximal end extends from it, which may include a fluid port and a power port for supplying fluid and power to the treatment site.

[0049] Shockwave emitters 120a-120d are located on the proximal side of housing 130, while shockwave emitters 120e-120h are located on the distal side of housing 130. In several different embodiments, the size and / or shape of the distal shockwave emitters 120e-120h differs from that of the proximal shockwave emitters 120a-120d to provide greater flexibility and / or a narrower overall profile at the distal end of the device. For example, the outer diameter of the distal shockwave emitters 120e-120h may be smaller than that of the proximal shockwave emitters 120a-120d. In other embodiments, only the two distal emitters 120g and 120h have smaller outer diameters.

[0050] Shock wave emitters 120a-120h can be spaced apart to optimize the uniformity of sound wave output. In one or more embodiments, adjacent shock wave emitters are spaced apart by a distance of not less than 4 mm. In some embodiments, adjacent shock wave emitters can be spaced apart by a distance of not less than 6 mm. In some embodiments, adjacent shock wave ducts can be spaced apart by a distance of not less than 7 mm. In some embodiments, adjacent shock wave emitters can be spaced apart by a distance of not less than 10 mm. Here, the distance between emitters is measured along the longitudinal direction from the midpoint of one emitter to the midpoint of another emitter (i.e., from the proximal end to the distal end).

[0051] In some embodiments, the distance between adjacent transmitters can be selected to promote constructive interference from the generated shock waves. For example, the distance between adjacent transmitters can be no less than 1 mm and no more than 4 mm.

[0052] In some embodiments, the distance between adjacent transmitters can be selected to provide higher sound output in certain areas of the duct. For example, in Figure 1 In this configuration, shock wave emitters 120d and 120e can be spaced closer together than the other adjacent emitters of duct 100. By spaced closer together, the sound pressure level in the central region of housing 130 may be higher.

[0053] Figure 2A and Figure 2BCross-sectional views of the near-side emitter 120A and the far-side emitter 120h according to some aspects of the present invention are shown at planes 2A-2A and 2B-2B, respectively. Figure 3A and Figure 3B Side views of a near-side transmitter 120a and a far-side transmitter 120h are shown, respectively. The transmitter 120a includes an outer strip 1220 that at least partially surrounds an insulating layer 1230. The outer strip 1220 may include outer strip openings 1222 and 1224, and the insulating layer 1230 may include openings 1232 and 1234 that are at least partially aligned with the outer strip openings 1222 and 1224. Outer electrodes 1221 and 1223 may be formed at the inner edges of the outer strip openings 1222 and 1224. The insulating layer 1230 at least partially surrounds inner electrodes 1240 and 1242. The outer electrodes 1221 and 1240 form an electrode pair 1210. The outer electrodes 1223 and 1242 form an electrode pair 1212. The inner electrodes 1240 and 1242 may (e.g., by crimping) be electrically connected to wires 1241 and 1243. Leads 1241 and 1243 may then extend proximally along the elongated member 110 to the proximal end of the catheter 100 or distally along the elongated member 110 to an adjacent transmitter. The elongated member 110 may have one or more elongated recesses (e.g., recess 1252) along which the lead can extend. In other embodiments, the elongated member may have one or more lead-carrying lumens. The elongated member 1250 includes a central lumen 1255 for delivering the catheter 100 to the treatment site along a guidewire.

[0054] When a voltage pulse is applied to transmitter 120a, current can be delivered from the power supply to the inner electrode 1240. The voltage can then be applied across the spark gap formed between the inner electrode 1240 and the outer electrode 1221, generating a shock wave at electrode pair 1210. The current can further be delivered along the outer band 1220 to the outer electrode 1223 and across the spark gap formed between the outer electrode 1223 and the inner electrode 1242, thereby generating a shock wave at electrode pair 1212. The current can then be transmitted to an adjacent transmitter (e.g., transmitter 120b). Therefore, the electrode pairs of conduit 100 can be electrically connected in series. Other electrode pairs can be individually connected to the power supply, requiring separate wiring (e.g., wires 1245, 1246, 1247, or 1248).

[0055] Although transmitter 120a is illustrated as including two electrode pairs, other embodiments may include one electrode pair or three or more electrode pairs. And although electrode pairs 1210 and 1212 are... Figure 2AThe electrode pairs are shown on opposite sides of transmitter 120A, but in other embodiments, the electrode pairs may be substantially concentrated on one side or may be more circumferentially aligned and axially offset along the longitudinal length of the transmitter. Such a design may be advantageous for targeted therapies such as eccentric lesions or nodular lesions.

[0056] Figure 2A Conductors 1245, 1246, 1247, and 1248 are shown for transmitting current to or from a transmitter remote from transmitter 120a. Conversely, as... Figure 2B As shown in the cross-section of transmitter 120b, only wires 1241' and 1243' extend to transmitter 120h. Since transmitter 120h is the most distant transmitter, no additional wires are needed to deliver current to the more distant transmitters. Wires 1241' and 1243' are electrically connected to inner electrodes 1240' and 1242', respectively (e.g., by crimping). Inner electrodes 1240' and 1242' form electrode pairs 1210' and 1212' with outer electrodes 1221' and 1223', respectively.

[0057] Because the more distant transmitter does not need to accommodate as many wires as the near-side transmitter, some components of the more distant transmitter can be made smaller to provide a narrower profile than the near-side transmitter. For example, one or both of the outer band 1220' and the insulation layer 1230' can be made to have a smaller outer diameter than the outer band 1220 and the insulation layer 1230.

[0058] Other sizes of emitters can be implemented according to several different embodiments of the IVL catheter of this invention. For example, an exemplary IVL catheter with eight emitters may have four proximal emitters having a first diameter, which is then followed by a second diameter of two sequentially distal emitters that is relatively larger, wherein the second diameter of these two distal emitters may then be relatively larger than a third diameter associated with the two most distal emitters of the catheter.

[0059] Different wire sizes can be used in various embodiments of the IVL catheter according to this invention. For example, the wires arranged to deliver current from the proximal transmitter to the distal transmitter can be smaller or thinner than the wires delivering current from the power source to the proximal end of the catheter, thereby further reducing the overall cross-sectional profile of the distal region of the catheter. Alternatively, different wire sizes can be selected based on the metal or alloy used for the wires. In other embodiments, different wire sizes, thicker or thinner, can be used to lead to or between transmitters in order to manage the current delivered to a given transmitter by means of the resistivity of the wires.

[0060] It should be understood that other variations in the number, wiring, and size of the transmitters, as well as combinations of wiring and size for the transmitter diameter along the IVL conduit length, are all covered within the scope of this invention.

[0061] Although catheter 100 is shown as having eight shock wave emitters, other embodiments of the IVL catheter may include fewer or more shock wave emitters. For example, in applications requiring shorter angioplasty balloons, only two shock wave emitters may be needed, and the distal emitter may be designed to have a smaller profile than the proximal emitter. In other relatively short balloon embodiments with three shock wave emitters, one embodiment may have one distal emitter with a smaller profile than two proximal emitters, while an alternative embodiment may have two distal emitters with a smaller profile than one proximal emitter.

[0062] In another embodiment, the IVL catheter may include two shock wave emitters, wherein the outer diameter of the proximal emitter is larger than the outer diameter of the distal emitter.

[0063] In another embodiment, the IVL conduit may include nine shock wave emitters. In this application, to deliver sufficiently uniform and high energy, one or more shock wave emitters may be wired to separate electrical channels. For example, in a conduit with nine shock wave emitters, the three closest emitters may be wired in series, the three intermediate emitters may be wired in series, and the three furthest emitters may be wired in series. In some embodiments, the three furthest emitters have a smaller profile than the other six emitters. In other embodiments, the six furthest emitters have a smaller profile than the other three emitters.

[0064] Figure 3A and Figure 3B Components of a proximal emitter 300 and a distal emitter 301 are shown separately. The proximal emitter 300 is positioned closer to the proximal side than the distal emitter 301 along an elongated member (e.g., elongated member 110). The proximal emitter 300 includes an outer strip 310 and an insulating layer 320. The outer strip 310 can be adhered to the insulating layer 320 with an adhesive 330. Similarly, the distal emitter includes an outer strip 311 and an insulating layer 321. The outer strip 311 can be adhered to the insulating layer 321 with an adhesive 331.

[0065] According to some embodiments, the proximal transmitter 300 includes a proximal transmitter outer diameter 302. The distal transmitter 301 has a distal transmitter outer diameter 303 that is smaller than the proximal transmitter outer diameter 302. In some embodiments, the distal transmitter outer diameter 303 is at least 0.0005 inches (0.0127 mm) larger than the proximal transmitter outer diameter 302. In some embodiments, the distal transmitter outer diameter 303 is at least 0.001 inches (0.0254 mm) larger than the proximal transmitter outer diameter 302. In some embodiments, the distal transmitter outer diameter 302 is at least 0.0015 inches (0.0381 mm) larger than the proximal transmitter outer diameter 303. In some embodiments, the distal transmitter outer diameter 303 is not greater than 0.04 inches (1.016 mm). In some embodiments, the distal transmitter outer diameter 303 is not greater than 0.0395 inches (1.0033 mm). Note that in these embodiments, the proximal transmitter outer diameter 302 corresponds to the outer diameter of the proximal outer band 310, and the distal transmitter outer diameter 303 corresponds to the outer diameter of the distal outer band 311.

[0066] To achieve a slimmer profile, one or both of the outer strip 311 and insulating layer 321 of the distal emitter 301 have a smaller outer diameter than the outer strip 310 and insulating layer 320 of the proximal emitter 300. In some embodiments, one or both of the outer strip 311 and insulating layer 321 have a smaller inner diameter than the outer strip 310 and insulating layer 320. Alternatively, one or more of the layers of the distal emitter 301 (e.g., the outer strip 311 or insulating layer 321) may be thinner than the proximal emitter 300. In some embodiments, elongated members of the catheter (e.g., elongated member 110) may be made thinner in a more distal region of the catheter to provide a slimmer profile and flexibility at the distal end.

[0067] like Figure 3A and Figure 3B As shown, the proximal emitter 300 has a length 304 (measured in the proximal-to-distal direction) and the distal emitter 301 has a length 305. The proximal outer strip 310 has a length 312, and the distal outer strip has a length 313. In some embodiments, one or both of the length 304 of the proximal emitter and the length 312 of the proximal outer strip are greater than the length 305 of the distal emitter and the length 313 of the distal outer strip, respectively. These features can provide additional flexibility and seaworthiness at the distal end of the shock wave duct.

[0068] The proximal emitter 300 includes notches 314 and 316 formed on the outer strip 310. These notches serve as visual indicators that distinguish the proximal emitter 300 from the distal emitter 301 during the manufacture of the shock waveguide. Other markings on the outer strip of the emitter are also possible, such as different colors, patterns, etched markings, or painted markings. In some embodiments, other features of the emitter strip and insulation assembly may differ to serve as visual indicators distinguishing the larger outer diameter proximal emitter from the smaller outer diameter distal emitter. For example, the insulation layer of the proximal emitter assembly (e.g., proximal insulation layer 320) may be a different color than the insulation layer of the distal emitter assembly (e.g., distal insulation layer 321). These markings do not need to be formed on the proximal emitter 300 but may be formed on the distal emitter 301. Alternatively, the insulation material on the lines connected to the transmitters may have different colors, patterns, or other such visual markings to distinguish which lines are electrically connected to the near-side transmitter 300 and the far-side transmitter 301 during the manufacture of the shock wave duct.

[0069] Figure 4A and Figure 4B Two configurations of the housing 400 of the shock wave duct according to one or more aspects of the present invention are shown. Figure 4A The shell 400 is shown in a contracted configuration, which has a larger diameter than the shell 400. Figure 4B The expanded (e.g., inflated) configuration shown has a smaller profile. However, further, the housing 400 in the contracted configuration has a smaller outer diameter 410 on the distal side than on the proximal side. In one or more embodiments, along the housing 400, at a location aligned axially with the shock wave emitter, the outer diameter on the distal side is not less than 0.001 inches (0.0254 mm) smaller than the outer diameter on the proximal side. In the expanded configuration, the proximal outer diameter 416 may be substantially the same as the distal outer diameter 414. In some embodiments, the housing 400 has a substantially uniform outer diameter along its working length 402. Alternatively, in some embodiments, the housing has a tapered outer diameter along its working length in its expanded configuration. In some embodiments, the housing may have a larger outer diameter on the proximal side of its working length than on the distal side.

[0070] Here, the distal side refers to the side of the housing 400 that is distal to the housing center 401, and the proximal side refers to the side of the housing 400 that is proximal to the housing center 401. The housing center 401 is located at the longitudinal midpoint of the working length 402 of the housing.

[0071] Despite Figure 4A Not shown, but the housing 400 may include folds and / or pleats in a contracted configuration. The housing 400 may be an angioplasty balloon. The housing 400 may be a semi-compliant angioplasty balloon.

[0072] During use, the shockwave catheter can be manipulated through body lumens (e.g., arteries) to the treatment site with the outer shell in a contracted configuration; therefore, it is important to have as thin an outer shell as possible for the contracted configuration profile, especially at the distal end of the outer shell. Once the distal region of the catheter has been delivered to the lesion, the outer shell 400 is filled with fluid to a relatively low pressure (e.g., less than 5 atm). In this expanded configuration, an outer shell with a uniform outer diameter may be advantageous. However, depending on the size and geometry of the lesion being treated, a non-uniform outer diameter (e.g., tapered) in the expanded configuration as described above may be advantageous.

[0073] It should be noted that the elements and features of the exemplary conduits shown in this specification and accompanying drawings can be rearranged, recombined, and modified without departing from this invention. For example, although this specification and accompanying drawings describe and illustrate conduits with several exemplary transmitter component designs, this invention is intended to include conduits with a variety of different transmitter component configurations. The number, position, and spacing of the electrode pairs of the shock wave generator can be modified without departing from this invention. Furthermore, the number, position, and spacing of the conduit housings can be modified without departing from this invention.

[0074] 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 occlusions in the peripheral vascular system (e.g., above the knee, below the knee, iliac, or carotid arteries), and other anatomical structures that can be treated with IVL. For further instances, implementations of the embodiments disclosed herein can be used to treat soft tissues, such as cancers and tumors (i.e., non-thermal ablation methods), thrombi, fibromas, cysts, organs, scar and fibrotic tissue removal, polymorphic tissue, 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 fallopian tube ligation (i.e., for permanent female contraception).

[0075] 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.

[0076] It should be understood that the above description is merely an illustration of the principles of this invention, and those skilled in the art can make various changes, modifications, and combinations without departing from the scope and spirit of this 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, this invention is not intended to be limited except by the appended claims.

Claims

1. A catheter for treating lesions in body cavities, characterized in that, The catheter includes: An elongated member extending from the proximal region of the catheter to the distal region of the catheter; A distal shock wave generating region, the distal shock wave generating region having a distal outer diameter and located at the distal region of the elongated member; and The proximal shock wave generating region has a proximal outer diameter and is located proximal to the distal shock wave generating region. The distal outer diameter is smaller than the proximal outer diameter.

2. The catheter for treating lesions in body cavities according to claim 1, characterized in that, The difference between the distal outer diameter and the proximal outer diameter is not less than 0.0254 mm.

3. The catheter for treating lesions in body cavities according to claim 1, characterized in that, The difference between the distal outer diameter and the proximal outer diameter is not less than 0.0381 mm.

4. The catheter for treating lesions in body cavities according to claim 1, characterized in that, The distal outer diameter is no greater than 98% of the proximal outer diameter.

5. The catheter for treating lesions in body cavities according to claim 1, characterized in that, The distal outer diameter is no greater than 97.5% of the proximal outer diameter.

6. The catheter for treating lesions in body cavities according to claim 1, characterized in that, The longitudinal distance from the center of the distal shock wave generation area to the center of the proximal shock wave generation area is not less than 6 mm.

7. The catheter for treating lesions in body cavities according to claim 6, characterized in that, The longitudinal distance from the center of the distal shock wave generation area to the center of the proximal shock wave generation area is not less than 7 mm.

8. The catheter for treating lesions in body cavities according to claim 1, characterized in that, The distal shock wave generation region includes a distal electrode pair, and the proximal shock wave generation region includes a proximal electrode pair.

9. The catheter for treating lesions in body cavities according to claim 8, characterized in that, The distal electrode pair includes a distal outer electrode and a distal inner electrode, and the proximal electrode pair includes a proximal outer electrode and a proximal inner electrode. The outer diameter of the distal outer electrode is smaller than the outer diameter of the proximal outer electrode.

10. The catheter for treating lesions in body cavities according to claim 1, characterized in that, The distal shock wave generating area and the proximal shock wave generating area are independently connected to the power supply.

11. The catheter for treating lesions in body cavities according to claim 1, characterized in that, The distal shock wave generation area includes four distal shock wave generation areas, and the proximal shock wave generation area includes four proximal shock wave generation areas.

12. The catheter for treating lesions in body cavities according to claim 1, characterized in that, The proximal shock wave generation region includes two proximal shock wave generation regions, and the distal shock wave generation region includes a single distal shock wave generation region.

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