Catheter for generating a shock wave

Abstract

The utility model relates to a kind of catheter for generating shock wave, the catheter includes: first slender member;Shell is installed on the first slender member;At least one shock wave emitter, the at least one shock wave emitter is carried by the first slender member and is arranged in the shell;First set of radiopaque markers on the first slender member in the shell;Second slender member;Expandable member is installed on the second slender member, the expandable member is configured to be inflatable to contact the shell installed on the first slender member;And second set of radiopaque markers on the second slender member in the expandable member, wherein the second set of radiopaque markers has different radiopaque marker arrangement with the first set of radiopaque markers.

Description

Technical Field

[0001] This invention generally relates to the field of medical devices and methods, and more specifically, to a shockwave catheter device for treating calcified lesions in body lumens and tissues, such as calcified lesions and occlusions within the cardiovascular system or cardiac structural anatomy. More particularly, this invention relates to a catheter for generating shock waves. Background Technology

[0002] The accumulation of calcium in a patient's blood vessels, tissues, or other organs can lead to calcification, which can impair organ function and cause health problems. For example, when plaque builds up along and within the walls of coronary arteries, it narrows the blood vessel (a condition called stenosis) and restricts blood flow to the heart muscle, which can eventually lead to a heart attack. Treating stenosis becomes even more challenging when the plaque hardens due to calcification.

[0003] A wide variety of catheters have been developed to treat narrowed blood vessels caused by the gradual growth and accumulation of plaque, a condition also known as atherosclerosis. For example, treatment systems used in percutaneous coronary angioplasty or peripheral angioplasty use an angioplasty balloon to dilate calcified lesions and restore normal blood flow to the vessel. In these types of procedures, a catheter carrying a balloon is advanced along a guidewire into the vascular system until the balloon is aligned with the target lesion. The balloon is then inflated (typically greater than 10 atmospheres) within the vessel, pushing the plaque back into the vessel wall and dilating the occluded area of ​​the vascular system. A particular focus is the treatment of calcified lesions of the vascular system associated with arterial disease. When treating calcified lesions, it is important to minimize damage to the surrounding soft tissues while breaking up the lesion as much as possible.

[0004] However, conventional dilatational balloon angioplasty may be ineffective against calcified tissue because the calcium in atherosclerotic plaques hardens the lesion, resisting the mechanical forces of balloon inflation. This resistance leads to more surgical complications and vascular damage because high-pressure balloons preferentially inflate away from hardened calcified tissue. The tendency of the balloon to inflate in the direction of lower resistance increases the risk of large incisions or perforations of the vessel, which often occur at the end of the lesion where the healthy tissue and calcified tissue meet (i.e., where the balloon encounters soft tissue). In cases of eccentric calcified lesions where the hardened area is biased towards one side of the vessel, the inflation preferentially terminates in the opposite direction to the calcified area of ​​the lesion, thus tightening and incising the healthy side of the vessel. Furthermore, in cases of nodular calcification, inflation of a standard angioplasty balloon may push the nodule of calcified material in a manner that could potentially puncture the vessel.

[0005] Another approach to treating calcified, narrowed plaques is to excise them at the site of the calcification using a cutting or slicing balloon, i.e., an angioplasty balloon with raised structures on its surface (e.g., an angioplasty balloon with blade-like structures on the outside). The inflation of an angioplasty balloon with raised structures allows mechanical forces on the lesion to be concentrated at the location of the raised structures; however, these devices still do not provide any protection against incision or perforation due to preferential inflation of the balloon away from the sclerotic tissue. Another technique for excising calcified lesions is using an atherosclerotic resection device, which typically includes a motor-driven rotating or oscillating blade that is pushed in and cuts through the occlusion (also known as “resection” or “removal”). Because these treatments work by releasing calcified tissue from the vessel wall, the risk of embolism increases if a free-floating mass of calcified tissue may travel along the blood flow. Such systems may include a basket for capture or a negative pressure lumen for aspirating such unanchored emboli as necessary additional structures to ensure the safety of the device. Another problem with atherosclerotic resection devices is that the movement or rotation of the atherosclerotic catheter blade generates frictional heat, and simply operating the device can lead to related thermal damage. This heat can directly damage the inner wall of the blood vessel and increase the risk of blood clotting. Naturally, the movement of the blade within the vascular system also significantly increases the likelihood of the blade itself making large incisions and perforations into the vessel.

[0006] Therefore, there is a continuous need for improved medical devices and treatments to address calcification and restore organ function. One such treatment is intravascular lithotripsy (IVL), which uses sound pressure to break up calcified areas. In IVL, a device, such as a catheter, is advanced within the patient to a location adjacent to the treatment area. The IVL device is configured to generate sound waves, specifically short-pulse ultrasound waves (also known as “shock waves”), which propagate outward from the IVL device to modify the calcified area. The sound pressure of the shock wave can rupture and destroy the calcified area near the IVL device without damaging surrounding blood vessels, tissues, or other organs. In particular, IVL can resolve and treat calcified plaques and stenosis with a safety profile that minimizes the risk of vascular injury, and its efficacy provides lasting circulatory restoration.

[0007] Conventional shockwave catheters may be less effective for treating lesions in large vessels and valves. The catheter needs to be small enough to reach the large vessels and valves through the vessels it passes through. Once positioned in the large vessels and valves, the balloon of the catheter is inflated to a relatively large diameter, which keeps the balloon walls away from the transmitter inside the balloon, which is typically positioned along a central tube extending along the longitudinal axis of the catheter. Therefore, when shock waves are emitted, they may need to travel further in larger vessels than in smaller vessels to reach the lesion, potentially reducing the force applied to rupture the lesion. To address the relatively low force of the shock waves as they propagate further from the transmitter within the large balloon, some systems increase the power supplied to the transmitter to generate higher amplitude shock waves within the balloon. However, increasing the amplitude of the shock waves requires increased power and may introduce other problems, such as increased wear on the transmitter and the risk of the balloon walls rupturing due to the high-pressure shock waves. Other treatment options for large vessels and valves may require longer shockwave therapy, which carries the risk of local ischemia and other complications during angioplasty. Utility Model Content

[0008] This document discloses apparatus, systems, and methods for positioning shockwave emitters closer to a target lesion in vivo compared to conventional shockwave catheters. The catheter described herein includes an expandable member configured to, upon expansion, push an elongated member carrying at least one shockwave emitter closer to the target lesion. Radiopaque markers / radioisotope markers may be disposed on the catheter and arranged such that a user can observe the orientation of one or more shockwave emitters and, if necessary, reorient the catheter to position the one or more shockwave emitters closer to the target lesion.

[0009] According to one aspect, an exemplary conduit for generating a shock wave includes: a first elongated member; a housing mounted on the first elongated member; at least one shock wave emitter carried by the first elongated member and disposed within the housing; a first set of radiopaque markings located on the first elongated member within the first housing; a second elongated member; an expandable member mounted on the second elongated member, the expandable member being configured to expand to contact the housing mounted on the first elongated member; and a second set of radiopaque markings located on the second elongated member within the expandable member, wherein the second set of radiopaque markings has an arrangement different from that of the first set of radiopaque markings.

[0010] Optionally, the first elongated member extends distally from the catheter body. Optionally, the first elongated member is the distal portion of the catheter body. Optionally, different arrangements of radiopaque markers include different numbers of radiopaque markers. Optionally, different arrangements of radiopaque markers include different spacing between radiopaque markers. Optionally, a first set of radiopaque markers and a second set of radiopaque markers are arranged on the first and second elongated members such that: when viewed from a first viewpoint using radiographic imaging, the first set of radiopaque markers and the second set of radiopaque markers are collinear. Optionally, when viewed from a second viewpoint using radiographic imaging, the first set of radiopaque markers and the second set of radiopaque markers are not collinear. Optionally, the housing is non-compliant. Optionally, the expandable member mounted on the second elongated member is a housing configured to expand upon fluid expansion / when injected with fluid. Optionally, the catheter includes a first fluid channel for filling a housing mounted on a first elongated member and a second fluid channel for filling a housing mounted on a second elongated member, such that the housing mounted on the first elongated member can be filled independently of the housing mounted on the second elongated member. Optionally, the first elongated member includes a guidewire lumen. Optionally, the second elongated member includes a guidewire lumen. Optionally, either or both of the first and second elongated members include a guidewire lumen. Optionally, the distal end of the first elongated member is detached from / not connected to the distal end of the second elongated member. Optionally, the first elongated member and the second elongated member extend proximally within the same lumen along at least a portion of the length of the catheter body. Optionally, the at least one shock wave emitter is located on the side of the first elongated member opposite to the second elongated member. Optionally, the expandable member mounted on the second elongated member is an expandable frame configured to allow fluid to pass through the expandable frame when it expands. Optionally, the conduit includes a movable shaft configured such that translation of the movable shaft in a first direction causes the expandable frame to expand, and translation of the movable shaft in a second direction causes the expandable frame to collapse. Optionally, the expandable frame includes at least one of a wire frame and a mesh / reticulated structure. Optionally, the expandable frame is configured to be self-expanding. Optionally, the distal end of the expandable member is located proximal to the distal end of the housing.

[0011] According to one aspect, an exemplary method for positioning a shock wave generating catheter closer to a target lesion includes: advancing the catheter into the lumen to the target lesion; orienting the catheter within the lumen such that a first elongated member including a first set of radiopaque markers is positioned relatively closer to the target lesion than a second elongated member including a second set of radiopaque markers; moving the first elongated member of the catheter closer to the target lesion by inflating an expandable member such that the expandable member pushes the first elongated member closer to the target lesion; and generating one or more shock waves using at least one shock wave emitter located on the first elongated member of the catheter.

[0012] Optionally, the method includes rotating the catheter to position a first elongated member of the catheter near a target lesion. Optionally, the expandable member includes a housing, wherein expanding the expandable member connected to the second elongated member includes expanding the housing mounted on the distal end of the second elongated member to contact the housing mounted on the first elongated member. Optionally, the expandable member includes an expandable frame, wherein expanding the expandable member includes moving a movable shaft connected to the expandable frame in a proximal direction. Optionally, the at least one shock wave emitter of the catheter is located within the housing connected to the first elongated member.

[0013] A conduit for generating a shock wave, the conduit comprising: a conduit body; a tubular housing sealed to a distal end of the conduit body, the tubular housing including an outer cylindrical wall, an inner cylindrical wall, and a fillable region between the outer and inner cylindrical walls, the fillable region being configured to be filled with fluid, wherein a distal portion of the conduit body is positioned within the fillable region; and at least one shock wave emitter disposed on the conduit body within the fillable region located between the outer and inner cylindrical walls.

[0014] Optionally, when the tubular housing is filled with fluid, the inner cylindrical wall defines an open channel. Optionally, the open channel is configured to allow bodily fluid flowing within the bodily lumen to pass through the open channel when the catheter is placed in a body lumen and the tubular housing is filled with fluid. Optionally, the tubular housing is semi-compliant. Optionally, the tubular housing is a non-compliant balloon. Optionally, the compliance of the outer cylindrical wall differs from the compliance of the inner cylindrical wall. Optionally, the distal portion of the tubular housing includes a tapered region. Optionally, the diameter of the outer cylindrical wall is in the range of 10 mm to 30 mm. Optionally, the inner cylindrical wall has a diameter of at least 6 mm. Optionally, the tubular housing includes a proximal cylindrical wall located at the proximal end of the balloon and a distal cylindrical wall located at the distal end of the balloon, wherein the proximal cylindrical wall and the distal cylindrical wall are sealingly connected to the catheter body. Optionally, the tubular housing comprises / is made of shape memory material. Optionally, the conduit includes a braided outer shaft on the proximal portion of the conduit body. Optionally, the at least one shock wave emitter is configured to emit a shock wave toward the outer cylindrical wall. Optionally, the at least one shock wave emitter is positioned at the circumferential location of the conduit body closest to the outer cylindrical wall.

[0015] According to one aspect, an exemplary method for positioning a shock wave generating catheter closer to a target treatment area includes: advancing the catheter within a lumen, the catheter including a tubular housing mounted on a catheter body; positioning a distal portion of the catheter such that at least one shock wave emitter of the catheter is positioned near the target treatment area; filling the tubular housing to form an open channel through which bodily fluids flow; and generating one or more shock waves using at least one shock wave emitter of the catheter.

[0016] Optionally, the method includes: retracting the tubular shell; rotating the catheter to position the at least one shock wave emitter near different target treatment areas; filling the tubular shell; and using the at least one shock wave emitter of the catheter to generate one or more additional shock waves. Optionally, positioning the distal portion of the catheter such that the at least one shock wave emitter of the catheter is positioned near the target treatment area includes: positioning the distal portion of the catheter across the valve annulus. Optionally, positioning the distal portion of the catheter such that the at least one shock wave emitter of the catheter is positioned near the target treatment area: positioning the distal portion of the catheter near the aortic valve leaflet or the mitral valve leaflet.

[0017] According to one aspect, an exemplary conduit for generating a shock wave includes: an elongated member; a housing mounted on the elongated member; at least one shock wave emitter carried by the first elongated member and disposed within the housing; a first expandable member extending away from the elongated member in a first direction and configured to expand to contact the housing mounted on the elongated member; and a second expandable member extending away from the elongated member and the first expandable member in a second direction and configured to expand to contact the housing mounted on the elongated member.

[0018] Optionally, the first expandable member is mounted on the second elongated member, and the second expandable member is mounted on the third elongated member. Optionally, when filled with fluid, the first expandable member and the second expandable member have substantially equal outer diameters. Optionally, when filled with fluid, the housing has substantially the same outer diameter as the first expandable member and the second expandable member. Optionally, at least one radiopaque marker is located on the elongated member. Optionally, the distal ends of the first expandable member, the second expandable member, and the housing are connected.

[0019] According to one aspect, an exemplary system for generating a shock wave includes: a shock wave energy generator; and a conduit of any example described herein.

[0020] According to some aspects, a conduit for generating a shock wave includes: a first elongated member; a housing mounted on the first elongated member; at least one shock wave emitter carried by the first elongated member and disposed within the housing; a second elongated member; and an expandable frame mounted on the second elongated member, the expandable frame being configured to expand to contact the housing mounted on the first elongated member, wherein the expandable frame is configured such that blood can flow through the expandable frame when the conduit is located in a blood vessel and the expandable frame expands. Optionally, the expandable frame includes a plurality of expandable members. Optionally, the expandable frame includes a helical member, a wire / line frame, or a mesh. Optionally, the conduit includes a movable shaft connected to the expandable frame, the movable shaft being configured to allow the expandable frame to expand and collapse.

[0021] According to some aspects, a conduit for generating a shock wave includes: an inner elongated member; an outer elongated member extending radially outward of the inner elongated member, wherein the outer elongated member is translatable relative to the inner elongated member between a retracted position and an extended position; at least one support member, which is at least partially located between the inner and outer elongated members when the outer elongated member is in the extended position, wherein the at least one support member is configured to move outward from the inner elongated member as the outer elongated member translates from the extended position to the retracted position; and at least one shock wave emitter mounted on the at least one expandable emitter support member.

[0022] Optionally, at least one support member includes a pre-formed memory material configured to move outward from the inner elongated member as the outer elongated member translates from the extended position to the retracted position. Optionally, the at least one support member includes a cavity in which the pre-formed memory material is positioned. Optionally, a user-engageable locking member is included, configured to lock the outer elongated member to the inner elongated member such that the outer elongated member cannot translate relative to the inner elongated member. Optionally, rotating the locking member in a first direction locks the outer elongated member to the inner elongated member. Optionally, the at least one support member is positioned within at least one recess in the inner elongated member. Optionally, a housing is included for mounting to the at least one expandable member, wherein the at least one shock wave emitter is positioned within the housing.

[0023] According to some aspects, a method for treating lesions in vivo includes: advancing a catheter within a body lumen to a target lesion; sliding an elongated member proximally to deploy one or more elongated support members such that the one or more elongated support members move outward from the longitudinal axis of the catheter; introducing a conductive fluid into one or more housings disposed on the one or more elongated support members; and generating one or more shock waves using at least one shock wave emitter located on at least one of the one or more elongated support members.

[0024] Optionally, the method includes rotating a locking member to unlock the outer elongated member from the second / inner elongated member before sliding the outer elongated member proximally. Optionally, the method includes manipulating a catheter to position a portion of each of the one or more elongated support members within the corresponding valve apex. Optionally, the method includes sliding the elongated member distally to cause the elongated support member to collapse inward. Optionally, each of the one or more housings is introduced with fluid independently of one or more other housings. Optionally, fluid is introduced into each of the one or more housings simultaneously.

[0025] In some implementations, shockwave therapy of the heart valve anatomy can be used as a preparatory procedure to optimize the tissue area for receiving and implanting a replacement heart valve.

[0026] According to some aspects, the conduit for generating a shock wave includes: an inner elongated member; an outer elongated member extending radially outward of the inner elongated member, wherein the inner elongated member is translatable relative to the outer elongated member between a retracted position and an extended position; at least one support member, which is at least partially positioned between the inner elongated member and the outer elongated member when the inner elongated member is in the retracted position, wherein the at least one support member is configured to move outward from the inner elongated member as the inner elongated member is translated from the retracted position to the extended position; and at least one shock wave emitter mounted on at least one expandable emitter support member.

[0027] Optionally, at least one support member includes a pre-formed memory material configured to move outward from the inner elongated member when the inner elongated member translates from the retracted position to the extended position, or configured to move outward from the inner elongated member when the outer elongated member translates from the extended position to the retracted position. Optionally, the at least one support member includes a lumen in which the pre-formed memory material is positioned. Optionally, a user-engageable locking member is included, configured to lock the outer elongated member to the inner elongated member such that the inner elongated member cannot translate relative to the outer elongated member. Optionally, rotating the locking member in a first direction locks the outer elongated member to the inner elongated member. Optionally, rotating the locking member in a second direction unlocks the outer elongated member from the inner elongated member. Optionally, at least one support member is located within at least one recess in the inner elongated member. Optionally, the conduit includes a housing mounted on at least one expandable member, wherein at least one shock wave emitter is located within the housing.

[0028] In some embodiments, any one or more features of any of the above-described systems and methods may be combined, in whole or in part, with each other and / or with any other features or characteristics described elsewhere herein. Attached Figure Description

[0029] The present invention will now be described by way of example only, with reference to the accompanying drawings, in which:

[0030] Figure 1 An exemplary system for generating shock waves is shown, based on some examples.

[0031] Figure 2AAn exemplary conduit with a shock wave emitter and an expandable component, as seen from a first-person perspective, is shown according to some examples.

[0032] Figure 2B This shows examples of observations from a second-person perspective. Figure 2A An example catheter.

[0033] Figure 3A An exemplary shock wave duct is shown according to some examples, which has a shock wave emitter and an expandable member in a collapsed configuration.

[0034] Figure 3B The following are examples. Figure 3A An exemplary shock wave duct in which the expandable member is in an expandable configuration.

[0035] Figure 4A An exemplary shock wave duct is shown according to some examples, which has a shock wave emitter and an expandable frame in a collapsed configuration.

[0036] Figure 4B The following are examples. Figure 4A An exemplary shock wave duct in which the expandable frame is in an expandable configuration.

[0037] Figure 5 Exemplary methods for positioning a shock wave emitter closer to the lesion and generating a shock wave are shown, according to some examples.

[0038] Figure 6A An isometric view of an exemplary conduit with a shock wave emitter and a tubular housing, according to some examples, is shown.

[0039] Figure 6B The example shown is an orientation based on some examples. Figure 6A A view of the distal end of the catheter.

[0040] Figure 7 Several aspects of a conduit located within a tubular shell are shown, based on some examples.

[0041] Figure 8 Several aspects of a conduit located within another tubular housing, according to some examples, are shown.

[0042] Figure 9 Another exemplary method for positioning a shock wave emitter closer to the lesion and generating a shock wave is shown, according to some examples.

[0043] Figures 10A-10B Several aspects of another shock wave emitter and expandable component are shown, based on some examples.

[0044] Figure 11An exemplary computing system based on some examples is shown.

[0045] Figure 12 Several aspects of an exemplary conduit, including an exemplary expandable frame, are shown according to some examples.

[0046] Figure 13 Several aspects of an exemplary conduit, including an exemplary expandable frame, are shown according to some examples.

[0047] Figures 14A-14D Several aspects of an exemplary catheter according to some examples are shown, the catheter including a laterally movable shock wave emitter support member, which can be used to position the shock wave emitter closer to the lesion.

[0048] Figure 15 Several aspects of the aortic valve are shown based on some examples.

[0049] Figure 16 A flowchart is shown, which represents the steps of a method for generating shock waves using one or more catheters disclosed herein, according to some examples.

[0050] Figure 17 Several aspects of exemplary methods for positioning a shock wave emitter relatively closer to the lesion are shown, according to some examples.

[0051] Figure 18 Several aspects of an exemplary conduit comprising multiple expandable components connected at a distal end are shown according to some examples.

[0052] Figure 19 Several aspects of exemplary methods for positioning a shock wave emitter relatively closer to the lesion are shown, according to some examples.

[0053] Figures 20A-20B Several aspects of an exemplary conduit, including an expandable frame located radially outside multiple shock wave emitters, are shown according to some examples.

[0054] Figure 21 Several aspects of an exemplary method for treating lesions using shock waves, based on some examples, are shown.

[0055] Figure 22 Several aspects of an exemplary catheter, including an expandable frame and an expandable shell, are shown according to some examples, for moving a shock wave emitter closer to the lesion. Detailed Implementation

[0056] The following description is presented to enable those skilled in the art to make and use the various embodiments and aspects thereof disclosed herein. The descriptions of specific apparatuses, components, techniques, and applications are provided by way of example only. Various modifications to the examples described herein will be apparent to those skilled in the art, and the general principles described herein can be applied to other examples and applications without departing from the spirit and scope of the various embodiments and aspects thereof. Therefore, the various embodiments and aspects thereof are not intended to be limited to the examples described and shown herein, but are accorded the scope consistent with the claims.

[0057] In recent years, techniques and treatments for intravascular lithotripsy (“IVL”) have been developed to treat atherosclerosis and related conditions. This is an interventional procedure used to alter calcified plaques in diseased vascular systems. More specifically, IVL is based on energy-generated ultrasonic pressure waves for altering, breaking, and fracturing calcified plaques in situ. The mechanism of plaque alteration is achieved by using a catheter with one or more short ultrasonic pressure pulses (commonly referred to as “shock waves”) emitted from a source located in a fluid, capable of generating acoustic ultrasonic shock waves that alter and break up calcified plaques. IVL can improve arterial compliance and achieve optimal luminal dilation during vascular interventional procedures. Various IVL devices differ in design regarding the energy source used to generate the acoustic shock waves; two exemplary energy sources are electro-hydraulic generation and laser generation. Furthermore, the broader application of IVL systems and techniques can be used to treat other tissues and organs within a patient's body, such as the treatment of cardiac structural anatomy as described in this disclosure.

[0058] For the electro-hydraulic generation of short ultrasonic pressure pulses, a conductive solution (e.g., saline) can be contained within a housing surrounding the electrodes or flushed / infused through a tube surrounding the electrodes. Alteration of calcified plaques is achieved by generating ultrasonic shock waves within the catheter through a discharge across the electrodes (e.g., a plasma arc). Energy from the discharge enters the surrounding fluid, generating acoustic shock waves, where the waves themselves are ultrasonic (i.e., waves with frequency components greater than 20,000 Hz). Furthermore, the discharge generates one or more rapidly expanding and collapsing vapor bubbles, which generate secondary shock waves due to cavitation of the collapsing vapor bubbles. The shock waves propagate radially outward and alter the calcified plaques within the blood vessel. Because the acoustic impedance of soft tissue is similar to that of water, the shock waves can penetrate deeply and safely through soft arterial tissue. Acoustic impedance is a function of the density and elasticity of a material and the speed at which sound travels through that material. When the shock wave encounters tissues with different acoustic impedances, such as intimal calcifications of plaques near the vessel surface or endothelium, or medical calcifications in the vascular smooth muscle layer, the leading edge of the shock wave applies compressive stress to the calcified tissue. As the shock wave passes through the calcification, shearing occurs on the lesion. When the shock wave reaches the distal boundary of the calcification, it is both transmitted and reflected, causing tensile stress that pulls the calcification apart. When the ultrasonic shock wave entering the calcium propagates faster than the remaining shock wave traveling outside the calcified area, compressive stress is further applied through compression that occurs under these conditions. These forces generated by IVL lead to multiplanar and longitudinal fractures of the calcification within the tissue.

[0059] More specifically, catheters for delivering IVL therapy have been developed that include paired electrodes for generating electro-hydraulic shock waves within an angioplasty balloon. Shock wave devices are 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. The balloon is then inflated with a conductive fluid (e.g., using a relatively low pressure of 2–4 atm), causing the balloon to expand to contact the lesion but not to the extent that it substantially moves the lesion. Voltage pulses are then applied across the electrodes of the electrode pair to generate an acoustic shock wave that propagates through the wall of the angioplasty balloon and into the lesion. Once the lesion has been broken up 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 include electrodes disposed within the enclosed volume of a non-angioplasty balloon, such as a cap, a variable compliance balloon, or other type of housing.

[0060] Crucially, calcified plaques remain in situ after the shock wave; for IVL, intimal calcium remains in the inner lining of the vessel, while medical-grade calcium remains in the surrounding muscle tissue. IVL typically does not cause plaque ablation / reduction or removal from the vessel wall tissue. Similarly, for calcifications in cardiac structures such as organ walls, arteries and veins, valve leaflets, and commissures, the calcified portions broken up by the short ultrasonic pressure pulse do not separate from the surface of the lesion but remain within the target tissue, which becomes more flexible and resilient.

[0061] Therefore, the IVL procedure can be considered different from standard atherosclerotic resection, and from cutting or scoring balloons, at least in that IVL breaks up calcium but does not release it from the tissue. Therefore, generally speaking, the IVL system does not require aspiration or embolization protection. Thus, IVL does not carry the same risks of embolism, perforation, anatomical or other vascular system damage as atherosclerotic resection or angioplasty using cutting or scoring balloons. Further compared to cutting techniques, the shockwave generated by IVL does not alter normal healthy vascular tissue or non-calcified plaques due to the compliance of normal vessels and non-calcified plaques. In other words, when treating sclerotic calcified anatomy, the shockwave from IVL does not have adverse clinical effects on soft tissue.

[0062] For the laser generation of ultrasonic shock waves, a laser pulse is transmitted into the fluid within a conduit, where the fluid absorbs the energy from the laser. Optionally, a target is used as a catalyst for laser absorption. This absorption process rapidly heats and vaporizes the fluid, generating rapidly expanding and collapsing vapor bubbles, and ultrasonic shock waves that propagate outward and alter calcified plaques. The intensity of the ultrasonic shock waves will be even higher if a fluid exhibiting strong absorption at the laser wavelength used is selected. These examples of electrohydraulic and laser-based IVL devices are not intended to be a comprehensive list of potential energy sources for generating ultrasonic IVL shock waves.

[0063] This document discloses apparatus, systems, and methods for positioning a shockwave transmitter near a target lesion in vivo. An exemplary apparatus includes an expandable member configured to push at least one shockwave transmitter closer to the target lesion. The apparatus may also include a radiopaque marker configured to enable a user to determine the position of the shockwave transmitter relative to the target lesion and to redirect a catheter as needed to reposition the shockwave transmitter closer to the lesion in vivo.

[0064] In some examples, the catheter includes a first elongated member and a second elongated member. A housing may be mounted to the first elongated member, and at least one shock wave emitter may be carried by the first elongated member and disposed within the housing. An expandable member may be mounted to the second elongated member and configured to expand to contact the housing mounted to the first elongated member. The expandable member may laterally / sideways push the first elongated member and thus one or more shock wave emitters on the first elongated member toward the target lesion.

[0065] The first and second elongated members may include radiopaque markers configured to allow a user to distinguish the two elongated members and determine their relative positions within the lumen. The radiopaque markers provide the user with a visual indication of the position of the elongated member carrying the shock wave emitter within the lumen, based on the relative positions of the two elongated members indicated by the radiopaque markers. A first set of radiopaque markers may be located on the first elongated member within a first housing, and a second set of radiopaque markers may be located on the second elongated member within an expandable member (e.g., radially inward). The second set of radiopaque markers may have a different arrangement than the first set (e.g., a different number, different spacing, etc.). When viewed from a first perspective using radiographic imaging, the first and second sets of radiopaque markers appear collinear. When viewed from a second perspective using radiographic imaging, the first set of radiopaque markers appears non-collinear with the second set. The user can rotate the catheter to reorient the shock wave emitter closer to the target lesion based on the positions of the two sets of radiopaque markers. Once reoriented to be closer to the target lesion, the shock wave emitter can use its expandable component to push laterally outward toward the lesion.

[0066] In some examples, the catheter includes a tubular housing that is sealed to the distal end of an elongated member of the catheter, such that the distal portion of the elongated member carrying at least one shock wave emitter is located within a fillable region of the tubular housing between its inner and outer walls. When the tubular housing is filled, the elongated member carrying the at least one shock wave emitter can be laterally pushed toward a target lesion within the body lumen. The inner wall of the tubular housing defines an open channel that allows fluid flowing within the body lumen to pass through the catheter when the tubular housing is filled. Thus, shock waves can be generated relatively closer to the lesion while still allowing flow through the body lumen.

[0067] As a treatment modality, shockwave therapy of the heart valve anatomy can be used as a preparatory procedure to optimize the tissue area for the reception and implantation of a replacement heart valve. More specifically, implanting and placing heart valve implants (whether mechanical or tissue-based) in target locations where the target tissue has hardened due to calcification is challenging. Applying short ultrasonic pressure pulses prior to the replacement valve implantation procedure can make the target location more flexible and resilient, allowing for easier access and positioning of the implant. Furthermore, the relatively flexible and resilient heart valve tissue allows the implant to be firmly positioned or anchored in and around the annular region of the valve, resulting in a better seal around the valve implant and reducing any leakage of fluid around the main channel of the valve implant. Therefore, applying in vivo lithotripsy to heart valves can improve valve implant performance and extend their lifespan.

[0068] It is worth noting that short-pulse ultrasound has a non-ablation mechanism of action, unlike other structural cardiac treatments such as radiofrequency ablation (thermal-based) or cryoablation. Of course, short-pulse ultrasound delivered to structural cardiac tissue can be appropriately combined with ablation-based therapies.

[0069] 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 disclosure, electrodes are typically positioned relative to each other, for example, in an arrangement of inner and outer electrodes. Thus, as used herein, the term "electrode pair" refers to two electrodes positioned adjacent to each other such that applying a sufficiently high voltage to the electrode pair will cause current to travel across a gap (also known as a "spark gap") between the two electrodes (e.g., from the inner electrode to the outer electrode, or, alternatively, current flowing through a conductive fluid or gas between them). In some cases, one or more electrode pairs may also be referred to as an electrode assembly. In the context of this disclosure, the term "emitter" generally refers to an area of ​​an electrode assembly where current travels across the electrode pair, thereby generating a shock wave. The terms "emitter sheath / emitter jacket" and "emitter strip" refer to continuous or discontinuous strips of conductive material that may be formed as one or more electrodes in one or more electrode pairs, thereby forming the location of one or more emitters.

[0070] The transmitter components (including electrodes and transmitter sheath / band) may be made of metal, such as stainless steel, copper, tungsten, platinum, palladium, molybdenum, cobalt, chromium, iridium or any one or any alloy thereof, such as cobalt-chromium alloy, platinum-chromium alloy, cobalt-chromium-platinum-palladium-iridium alloy or platinum-iridium alloy or any mixture of these materials.

[0071] To treat occlusions in blood vessels, voltage pulses applied by a power source typically range from about 500 to 3,000 volts (500V-3,000V), said power source including any power source described herein (which may also be referred to herein as a voltage source or pulse generator). In some embodiments, to treat stenosis in blood vessels or stenosis of another anatomical feature (e.g., structural cardiac tissue), voltage pulses applied by the voltage source can be as high as about 10,000 volts (10,000V), as high as about 15,000 volts (15,000V), or higher than 15,000 volts (15,000V). The pulse width of the applied voltage pulse ranges from 1 microsecond to 6 microseconds (1-6 μs). The repetition rate or frequency of the applied voltage pulse can range from about 1 Hz to 10 Hz. The total number of pulses applied by the power source can be, for example, sixty (60) pulses, eighty (80) pulses, one hundred and twenty (120) pulses, three hundred (300) pulses, or up to five hundred (500) pulses, or any pulse increment within that range. Alternatively or additionally, in some examples, the power source may be configured to deliver micropulse packets with sub-frequency of about 10 Hz to 10 kHz (e.g., 500 micropulses in one packet). Preferred voltage, repetition rate, and number of pulses may vary depending on, for example, the size of the lesion, the degree of calcification, the size of the blood vessel, the patient's attributes, or the stage of treatment. For example, a physician may start with a low-energy shockwave and increase the energy as needed during the procedure, or vice versa. During the procedure, the amount of energy delivered may be further altered by changing the amount of energy delivered in a predetermined sequence of energy increases or decreases, or by changing the amount of energy delivered in response to sensor data obtained before and / or during the IVL treatment procedure. The amplitude of the shockwave can be controlled by controlling the voltage, current, duration, and repetition rate of the pulse voltage from the power source.

[0072] In some embodiments, the IVL catheter may be a "rapid-exchange" ("RX") catheter with an opening through which a guidewire (e.g., through the longitudinally oriented middle portion of a central tube) can be guided. In some other embodiments, the IVL catheter may be an "over-the-wire" ("OTW") catheter, wherein the guidewire lumen is formed along the entire length of the catheter and the guidewire is guided through the proximal end of the manipulator. The guidewire lumen entry point of the catheter is located at or near the distal end of the catheter tip, and the guidewire lumen extends through a portion of the catheter to the exit port. Thus, in use, the guidewire is delivered into the patient's anatomy, the proximal end of the guidewire (outside the patient) is inserted into the distal opening of the catheter, and the catheter travels along the guidewire until it reaches the target tissue distal to the guidewire (inside the patient); the effective difference between an OTW catheter and an Rx catheter lies in the guidewire exit point. The choice between OTW and Rx designs is driven by factors including (but not limited to) the following: the anatomy to be treated (e.g., coronary system versus peripheral system); the length of the guidewire used; the traceability, stiffness, torque delivery, and deliverability of the catheter; the catheter profile / section and cross-section; the ability to change the guidewire / wire when the catheter passes through a stenosis; positioning the distal end of the catheter near the tip of the guidewire; and further confirmation of the catheter's position.

[0073] This document may use certain standard anatomical terms to refer to the anatomy of an animal (i.e., a human) in relation to exemplary embodiments. While certain spatially related terms such as “outer,” “inner,” “upper,” “lower,” “below,” “above,” “vertical,” “horizontal,” “top,” “bottom,” and similar terms are used herein to describe the spatial relationship of one element, device, or anatomical structure to another, it should be understood that these terms are used herein to describe the positional relationship between elements and structures for ease of description, as illustrated in the figures. It should be understood that, in addition to the orientations depicted in the figures, spatially relative terms are also intended to cover different orientations of elements or structures in use or operation. For example, an element or structure described as being “above” another element or structure may represent a position below or next to that other element or structure with respect to an alternative orientation of the subject patient, element, or structure, or vice versa. As used herein, the term “patient” can generally refer to a human, anatomical model, simulator, cadaver, or other living or non-living object.

[0074] Although the shock wave device described herein generates shock waves based on a high voltage applied to the electrodes, it should be understood that the shock wave device may additionally or alternatively include a laser and an optical fiber as a shock wave transmitter system, whereby the laser source delivers energy to the fluid through the optical fiber to form shock waves and / or cavitation bubbles.

[0075] In the following description of various embodiments, reference is made to the accompanying drawings, in which specific embodiments that may be implemented are illustrated by way of illustration. It should be understood that other embodiments and examples may be implemented, and changes may be made, without departing from the scope of this disclosure.

[0076] Furthermore, it should be understood that the singular forms “a,” “an,” and “the / described” used in the following description are also intended to include the plural forms, unless the context clearly indicates otherwise. 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 related listed items. It should also be understood that, as used herein, the terms “comprising,” “including,” “containing,” and / or “having” specify the presence of the stated features, integers, steps, operations, elements, parts, and / or units, but do not exclude the presence or addition of one or more other features, integers, steps, operations, elements, parts, units, and / or combinations thereof. As described herein, it should be understood that any disclosure describing a numerical range of dimensions or measurements (such as thickness, length, weight, time, frequency, temperature, voltage, current, angle, etc.) includes any numerical increments or gradients within the range provided relative to a given dimension or measurement. It should also be understood that any disclosure of a numerical range as a boundary term or inequality term also includes any numerical increment or grade within a given range; for example, the statement that the parameter is “at least a defined value, wherein the defined value ranges from 5% to 50%” supports disclosures that the parameter is “at least 5%”, “at least 50%”, “at least 37%”, “at least 42.4%”, etc. 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” transmitter can 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 this disclosure and can be modified and interchanged without departing from the present invention.

[0077] Figure 1 A system 100 for treating calcification within a body lumen is shown. The system includes a shock wave generating catheter 10. The catheter 10 can be used to break, rupture, or otherwise fragment stones within a body lumen, for example, to treat various occlusions within blood vessels. The catheter 10 includes a plurality of shock wave emitters 16 located within a housing 18. The catheter 10 is advanced through a guidewire 20 carried in a guidewire sheath to the site of the occlusion in the patient's vascular system, for example... Figure 1At the narrow lesion shown, a voltage pulse is applied to the shock wave emitter 16 to generate a shock wave. Each of the shock wave emitters 16 includes an electrode pair having first and second electrodes separated by a gap, at which a shock wave is formed when current flows across the gap between the electrodes (i.e., when a voltage is applied across the first and second electrodes).

[0078] The housing 18 is sealably attached to the distal end 14 of the catheter 10, thereby forming an annular channel around the body 12 of the catheter 10. The housing 18 surrounds a plurality of shock wave emitters 16. The housing 18 can be filled with a conductive fluid, such as saline, and expand using this conductive fluid. The housing 18 can be compliant (e.g., a low-profile flexible angioplasty balloon, an outwardly flexible tension polymer membrane, etc.) so that it expands when filled, or the housing can be non-compliant, so that it maintains a substantially constant volume and profile when filled. The conductive fluid allows current to flow across the two electrodes of the shock wave emitters to generate a shock wave. The shock wave propagates outward from the electrode pair of the shock wave emitters 16 in the conductive fluid, through the walls of the housing 18, and then into the target lesion. In one or more examples, the conductive fluid may also contain an X-ray contrast fluid for fluorescence observation of the catheter 10 during use. The housing 18 can mitigate thermal damage to soft tissue and reduce cavitation stress by limiting the expansion of vapor bubbles generated during shock wave generation. For example, vapor bubbles impact the shell wall before reaching their maximum potential size, causing them to collapse and reducing cavitation stress and preventing soft tissue damage caused by tensile stress during cavitation bubble collapse.

[0079] The catheter 10 includes a proximal end 22 (which may include or be formed as a handle) located outside the patient's vascular system during treatment. The proximal end 22 may include an inlet port for receiving a guidewire 20. The proximal end 22 may include at least one fluid port 26 for filling and emptying the housing 18 during treatment. An electrical connection port 24 is also located on the proximal end 22 to provide an electrical connection between the distal shockwave emitter 16 and an external voltage source 28.

[0080] The catheter body 12 extends from the proximal end 22 to the distal end 14 of the catheter. The catheter body 12 provides various internal conduits / channels for connecting the elements of the distal end 14 to the proximal end 22. The catheter body 12 includes an elongated tube comprising a lumen for receiving the guidewire 20. The elongated tube may include additional lumens extending through or along the outer surface of the catheter body 12. For example, a fluid lumen (e.g., a fluid inflow lumen and a fluid outflow lumen or a combination of flushing lumens) may be positioned along or within the catheter body 12 for delivering conductive fluid from the fluid port 26 into the housing 18.

[0081] In some examples, one or more sensors 17 are placed along the catheter 10. Sensors 17 can be located anywhere on the catheter 10. For example, sensors 17 can be positioned proximal to one or more shock wave emitters 16, distal to one or more shock wave emitters 16, and / or between one or more shock wave emitters 16 (or any combination thereof). Sensors 17 can be located outside the housing 18 and / or outside the patient. For example, certain sensors, such as pressure sensors, can be located outside the housing 18 and / or the patient to measure overall system pressure when components are in fluid communication. Sensors can include one or more of any suitable sensor devices such as pressure sensors, thermal sensors, electrical sensors (e.g., current, voltage, resistance, and / or impedance sensors), or visualization elements. Sensors 17 can provide feedback to the operator using the catheter 10 by measuring parameters in the surrounding environment, thereby indicating the status of the catheter 10 and its components, and further providing guidance on which further steps the operator can decide to perform with the catheter 10. For example, in embodiments where sensor 17 includes a pressure sensor, a slight drop in pressure can indicate successful rupture of a calcified lesion because the expandable member surrounding the transmitter can expand further without changing the fluid volume within the expandable member. Furthermore, a significant drop in pressure may indicate a rupture failure mode where the expandable member has lost its seal and fluid volume, thus guiding the withdrawal of the device. In embodiments where the sensor device includes a visualization element, the operator of catheter 10 can more clearly understand the position of catheter 10 relative to the target lesion or anatomical structure before, during, and after treatment delivery.

[0082] In some embodiments, the material of the primary surface through which the shock wave forming the shell 18 passes may be a non-compliant polymer. In several other embodiments, a rigid and non-flexible structure may be used instead of the shell 18. The shell 18 can mitigate thermal damage to soft tissue and reduce cavitation stress by limiting the expansion of vapor bubbles generated during shock wave generation toward the interior of the shell. For example, vapor bubbles impact the shell wall before reaching their maximum potential size, causing them to collapse and reducing cavitation stress and preventing soft tissue damage caused by tensile stress during cavitation bubble collapse.

[0083] Figure 2A and 2B It shows that it can be used Figure 1An exemplary catheter 200 of catheter 10 for generating shock waves within a body lumen. Catheter 200 includes an expandable member 204, which, when expanded, allows a user (e.g., a surgeon or other medical professional) to move at least one shock wave emitter closer to a lesion within the body lumen. Moving the at least one shock wave emitter closer to the lesion helps reduce energy attenuation between the shock wave source and the lesion. Therefore, catheter 200 can more effectively treat lesions within the body by allowing the user to impact the lesion with a relatively stronger shock wave.

[0084] Figure 2A A first view of the catheter 200 is shown. Figure 2A The view shown illustrates the conduit 200 as viewed from a first perspective using radiographic imaging. The conduit 200 includes a conduit body 201 and a first elongated member 202. A housing 203 is mounted on the first elongated member 202. Optionally, the housing 203 is also mounted to the conduit body 201. In some examples, the first elongated member 202 is formed as part of the conduit body 201. The housing 203 can be: compliant, such that it stretches when pressurized; non-compliant, such that it does not stretch or stretches minimally when pressurized with fluid; or semi-compliant. At least one shock wave emitter 208 is carried by the first elongated member and disposed within the housing 203. In some examples, the first elongated member 202 can be the distal portion of the conduit body.

[0085] The catheter 200 also includes a second elongated member 206. The second elongated member 206 may be oriented at least partially transverse to the first elongated member 202 and / or the catheter body 201. An expandable member 204 is mounted on the second elongated member 206 and configured to expand to contact the housing 203 mounted on the first elongated member 202. The expandable member may be configured to expand upon expansion using fluid. Thus, when expanded, the expandable member 204 can be used to push the first elongated member 202 in a direction away from the second elongated member 206 and toward the lesion within the body lumen. In some examples, the expandable member may be a compliant balloon. In some examples, the length of the expandable member 204 and / or the second elongated member 206 may be relatively short compared to the first elongated member 202 and / or the housing 203, such that the distal end of the expandable member is positioned proximal to the distal end of the housing. In many such examples, the expandable member 204 and / or the second elongated member 206 are relatively less likely to be bound to chordae tendineae.

[0086] When the expandable member 204 expands, one side 240 of the expandable member 204 pushes against the wall of the lumen within which the catheter 200 is placed, and the opposite side 242 of the expandable member pushes the first elongated member 202 along a side away from the second elongated member 206 and toward the wall of the lumen, opposite to the side pushed by the expandable member. This moves the at least one shock wave emitter 208 closer to the lesion within the lumen. The at least one shock wave emitter 208 may be located on the side of the first elongated member 202 opposite to the second elongated member 206, such that it faces the lesion. Positioning the at least one shock wave emitter 208 on the side of the first elongated member 202 opposite to the second elongated member 206, compared to the at least one shock wave emitter 208 being located on the same side of the first elongated member 202 as the second elongated member 206, causes relatively more shock wave energy emitted from the at least one shock wave emitter 208 to be directed away from the second elongated member (e.g., toward the lesion). Furthermore, when expanded, the angle formed between the catheter body 201 and the second elongated member 206 can be in the range of 5 to 75 degrees (5°-75°) (depending on the amount of expansion of the expandable member 204 and the shell 203 respectively) to suit the attachment of the shell 203 to the vicinity of the target tissue or lesion.

[0087] In some examples, multiple shock wave emitters 208 are located at corresponding longitudinal positions along the first elongated member 202. Some shock wave emitters 208 may be circumferentially aligned with each other. Some shock wave emitters 208 may be circumferentially offset / misaligned with each other around the circumference of the first elongated member 202. These shock wave emitters 208 may be located at any circumferential position of the first elongated member 202. In some examples, multiple shock wave emitters 208 are positioned at the same longitudinal position on the first elongated member 202 and are circumferentially spaced apart from each other around the circumference of the first elongated member 202 (e.g., 30 degrees, 45 degrees, 60 degrees, 75 degrees, 90 degrees, 180 degrees, etc.). Positioning multiple shock wave emitters at the same longitudinal position and spacing them apart from each other in the circumferential direction can generate shock waves with constructive interference.

[0088] Radiopaque markings can be provided on the catheter 200 to allow the user to determine the position of one or more shock wave emitters 208 relative to the target lesion and to reorient the catheter 200 before the expandable member 204 expands. Thus, the user can ensure that at least one shock wave emitter 208 is radially inward of the lesion before dilation, such that the at least one shock wave emitter 208 is pushed towards the lesion when the expandable member 204 expands. A first set of radiopaque markings 212 may be located on the first elongated member 202. The first set of radiopaque markings 212 may be located within the housing 203. A second set of radiopaque markings 210 may be located on the second elongated member 206. The second set of radiopaque markings 210 may be located within the expandable member 204.

[0089] The first set of radiopaque markers 212 and the second set of radiopaque markers 210 may be arranged on the first elongated member 202 and the second elongated member 206 such that when viewed from a first viewing angle using radiographic imaging (e.g., as...) Figure 2B As shown), the first set of radiopaque markers 212 and the second set of radiopaque markers 210 are collinear. The first set of radiopaque markers 212 and the second set of radiopaque markers 212 can be arranged on the first elongated member 202 and the second elongated member 206 such that when viewed from a second perspective using radiographic imaging (e.g., as shown...). Figure 2A As shown), the first set of radiopaque markers 212 appears to be non-collinear with the second set of radiopaque markers 210. Arranging the markers in this way—appearing to be in a straight line from a first viewpoint but not from a second viewpoint—can help a user determine the position of the first elongated member 202 and the second elongated member 206 within the body via radiographic imaging. For example, a radiographic imaging apparatus (such as an X-ray apparatus) can image a catheter from a first observation point and a second observation point (e.g., offset by 90 degrees relative to the first observation point) to determine the orientation of the device within the body. For example, the first image allows the user to narrow down the possible orientations of the shock wave emitter to two possible orientations (e.g., based on whether the two sets of radiopaque markers are aligned or offset in the first image). The imaging apparatus can then be rotated 90 degrees to capture a second image, which can confirm the orientation of the shock wave emitter. As an illustrative example, if the two sets of radiopaque markers are aligned in the first image (e.g., as shown in the second image), the orientation of the shock wave emitter can be confirmed. Figure 2B As shown in the image, this indicates whether the shock wave emitter is located "above" the expandable member (i.e., closer to the imaging device than the expandable member) or "below" the expandable member (i.e., farther from the imaging device than the expandable member). A second image, taken at a 90-degree offset relative to the first image, confirms whether the shock wave emitter is "above" or "below" the expandable member in the first image.

[0090] In some examples, the second set of radiopaque markers 210 has a different arrangement than the first set of radiopaque markers 212. For example, the second set of radiopaque markers 210 may include a different number of markers than the first set of radiopaque markers 212. The second set of radiopaque markers 210 may additionally or alternatively include different spacing between corresponding markers 210 that are different from the first set of radiopaque markers 212. The first set of radiopaque markers 212 may include at least two markers. At least one marker 212 may be located proximal to at least one shock wave emitter 208, and at least one marker 212 may be located distal to at least one shock wave emitter 208. In some examples, marker 212 is located proximal to the first elongated member of the plurality of shock wave emitters 208, while another marker 212 is located distal to the first elongated member of the plurality of shock wave emitters 208. The second set of radiopaque markers 210 may include at least three markers. In some examples, the at least three markers of the second set of radiopaque markers 210 may be evenly spaced along the second elongated member 206. In some examples, the at least three marks of the second set of transmissive markers 210 may be unevenly spaced along the second elongated member 206.

[0091] Arranging two sets of radiopaque markers differently on their respective elongated members allows the user to determine which elongated member is closer to the target lesion within the body lumen. For example, if the second set of radiopaque markers 210 (comprising three markers in this example) is closer to the lesion than the first set of radiopaque markers 212 (comprising two markers in this example), the user can determine that the at least one shock wave emitter 208 is not positioned close to the lesion, or vice versa. It should be understood that the different numbers of radiopaque markers described herein are merely exemplary. Any number and / or arrangement of the two sets of radiopaque markers is within the scope of this disclosure.

[0092] The shock wave generating catheter disclosed in this article can be used to treat lesions (such as calcification) in and around heart valves (such as aortic valve and mitral valve). Figure 3A and 3B An exemplary aspect of catheter 300 is shown, which can be used to position catheter 200 and / or catheter 10 within a heart valve 380. Figure 3A and 3B The internal structure of the catheter 300, which can be contained in the catheter 200, is also shown, including a guidewire lumen for positioning the catheter and a fluid channel for filling the housing of the catheter with fluid. Figure 3A and 3B It is also shown how an elongated member (e.g., a first elongated member 202) is attached to the catheter by being inserted into the lumen of the catheter (e.g., when the first elongated member 202 is not integrated into the catheter body 201).

[0093] like Figure 3A As shown, the conduit 300 includes a conduit body 301 and a first elongated member 302. A proximal portion of the elongated member 302 is insertable into a lumen 355 of the conduit 300 and extends within the lumen 355 along at least a portion of the conduit body 301. Alternatively, the first elongated member 302 may be inserted from the proximal end of the conduit body 301 and extend within the lumen 355 along the length of the conduit body 301. A housing 303 is mounted on the first elongated member 302. The housing 303 may be: compliant, such that it stretches when pressurized; non-compliant, such that it does not stretch or stretches minimally when pressurized with fluid; or semi-compliant. At least one shock wave emitter 308 is carried by the first elongated member and disposed within the housing 303.

[0094] The catheter 300 also includes a second elongated member 306. The second elongated member 306 may be connected to the catheter body 301 at a distal portion of the catheter body and may extend distally adjacent to the first elongated member 302. A proximal portion of the second elongated member 306 may be inserted into a lumen 365 and extend proximally into the catheter body 301. Alternatively, the first elongated member 302 may be inserted from a proximal end of the catheter body 301 and extend along the length of the catheter body 301 within the lumen 365. In some examples, the lumen 365 is merged with a lumen 355 such that the first elongated member 302 and the second elongated member 306 extend proximally within the same lumen along at least a portion of the catheter body 301. An expandable member 304 is mounted on the second elongated member 306 and configured to expand when filled with fluid to contact a housing 303 mounted on the first elongated member 302.

[0095] The catheter 300 may include a first fluid supply channel 320 for filling the housing 303 and a second fluid supply channel 330 for filling the expandable member 304. The housing 303 and the expandable member 304 can therefore be filled independently of each other. It may be desirable to fill the housing 303 with conductive fluid during shockwave therapy while independently contracting the expandable member 304 to reposition the catheter 300 within a heart valve 380 (or other body lumen), and then re-inflate (e.g., dilate) the expandable member 304, as further described below.

[0096] The first set of radiopaque markings 312 may be disposed on the first elongated member 302. The first set of radiopaque markings 312 may be disposed within the housing 303. The second set of radiopaque markings 310 may be disposed on the second elongated member 306. The second set of radiopaque markings 310 may be disposed within the expandable member 304. The first set of radiopaque markings 312 and the second set of radiopaque markings 310 may be disposed as described above. Figure 2A and 2BAny of the aforementioned arrangements, and can be used to orient the catheter 300 within the valve 380.

[0097] A guidewire lumen 350 may extend along the catheter body 301 and the first elongated member 302 to the distal end of the first elongated member 302. In some examples, another guidewire lumen 360 extends along the catheter body 301 and the second elongated member 306 to the distal end of the second elongated member 306. Thus, the guidewire may be received in the first elongated member 302 via the guidewire lumen 350 and exit the guidewire lumen 350 at the distal end of the first elongated member 302 to position the catheter 300 within a body lumen, such as within a heart valve 380. Additionally or alternatively, the guidewire may be received in the second elongated member 306 via the guidewire lumen 360 and exit the guidewire lumen 360 at the distal end of the second elongated member 306 to position the catheter 300 within a body lumen, such as within a heart valve 380. In some examples, the first elongated member 302 and the second elongated member 306 may be connected at their respective distal ends by an attachment member 370. In several other examples, the distal end of the first elongated member 302 is not connected to the distal end of the second elongated member 306.

[0098] During use of catheter 300, the user can insert a guidewire into guidewire lumen 350 and / or 360, and catheter 300 can be advanced within a body lumen to the target treatment site. For example, catheter 300 can be advanced within a body lumen to a heart valve 380, such as the mitral or aortic valve. Catheter 300 can be positioned such that the first elongated member 302 and the second elongated member 306 are radially medial to and longitudinally aligned with the leaflet 382 of valve 380 (or other target treatment site of the valve). Once positioned at valve 380, the user can rotate catheter 300 to reorient catheter 300 such that the at least one shock wave emitter 308 is positioned relatively closer to the lesion 390, which may be formed on the leaflet 382 or other aspect of valve 380. Fluid (e.g., conductive fluid) can be introduced into housing 303 through first fluid supply channel 320. Fluid can also be introduced into the expandable member 304 through the second fluid supply channel 330 to expand the expandable member 304.

[0099] Figure 3B An expandable member 304 in an expanded configuration is shown. The expandable member 304 can expand such that a portion of the expandable member 304 contacts and presses against a portion of the body lumen, such as pressing against leaflet 382, ​​as shown. Figure 3BAs shown. When the expandable member 304 expands under the action of fluid, it pushes against the housing 303, causing the housing 303 and the first elongated member 302 to move away from the second elongated member 306 and toward the lesion 390. The plurality of shock wave emitters 308 carried by the first elongated member 302 are thus pushed laterally / sideways closer to the lesion 390. Figure 3B As illustrated in the example, when the expandable member 304 is in an expanded state, the housing 303 can press against the lesion within the lumen / valve 380, for example, against the lesion 390. After the expandable member 304 is expanded to move the shock wave emitter 308 laterally (e.g., radially) closer to the lesion 390, an energy pulse can be applied to the shock wave emitter 308, resulting in a shock wave 395 that impacts and alters (e.g., ruptures, breaks, or otherwise shatters) the lesion 390.

[0100] although Figure 3B The lesion on the valve leaflet 382 is depicted, but the lesion may be formed on any other surface of the body lumen / valve 380. For example, the lesion may be formed on the inner wall of the lumen / valve 380. The at least one shock wave emitter 308 may be positioned such that it is longitudinally aligned with the lesion on the inner wall of the lumen / valve 380. The expandable member 304 may then expand until a first portion of the expandable member 304 presses against a portion of the wall of the lumen / valve 380, and a second portion of the expandable member 304 presses the housing 303 against another portion of the lumen / valve 380 (e.g., by rotating 180 degrees around the circumference of the lumen / valve 380).

[0101] In some examples, expandable frames (e.g., mesh frames or wire frames) may be used for expandable members described herein (e.g., expandable members 204, 304). Figure 4A and 4B It shows that it can be used Figure 1 The exemplary catheter 400 of the catheter 10 includes several aspects, including an expandable frame 404. The catheter 400 includes a catheter body 401, a first elongated member 402, and a second elongated member 406. The first elongated member 402 may include any of the aspects described above with reference to first elongated member 202 and / or first elongated member 302, and may be connected to or formed as part of the distal portion of the catheter body 401. The second elongated member 406 may be connected to the distal portion of the catheter body 401 and may be oriented at least partially transverse to the first elongated member 402. The expandable frame 404 may be connected to the second elongated member 406. Figure 4A An expandable member 404 in a collapsed configuration is shown, while Figure 4B An expandable member 404 in an expanded configuration is shown.

[0102] The expandable frame 404 may include a plurality of laterally expandable members 414. Using a movable shaft 416 connected to the expandable frame 404, the laterally expandable members 414 can be configured in a collapsed configuration. Figure 4A ) and expansion configuration ( Figure 4B The movable axis 416 moves proximally toward the proximal end of the conduit 400, causing the expandable frame 404 to expand laterally. Moving the movable axis distally toward the distal end of the conduit 400 causes the expandable frame 404 to collapse laterally. The expandable frame 404 is configured to allow fluid to bypass or pass through the frame when it expands.

[0103] The movable shaft 416 may extend along the catheter body 401 (e.g., within the lumen, or along the outer surface of the catheter body 401) so that the user can control the shaft from the proximal end of the catheter. The movable shaft 416 may be connected at its distal end to a distal tip 418. The distal tip 418 may be connected to an inflatable frame 404 such that movement of the distal tip causes the inflatable frame 404 to expand or collapse.

[0104] Each laterally expandable member 414 may include a proximal region 414a, a distal region 414c, and a connecting region 414b between the proximal and distal regions 414a. The proximal region 414a of each expandable member 414 may be connected at its proximal end to a second elongated member 406. The proximal region 414a may extend distally to a first connection 440a at an angle transverse to the second elongated member 406. The first connection 440a may connect the proximal region 414a to the connecting region 414b and may be configured to bend when an axial force is applied to the movable shaft 416. The connecting region 414b may extend distally from the first connection 440a to a second connection 440b, which may also be configured to bend when an axial force is applied to the movable shaft 416. The connecting region 414b may be configured to remain parallel to the second elongated member 406 in both expanded and collapsed configurations. The second connecting portion 440b connects the connecting region 414b to the distal region 414c. The distal region 414c may extend distally from the connecting region 414b at an angle transverse to the second elongated member 406. The distal end of the distal region 414c may be connected to the distal tip 418. Therefore, moving the movable shaft 416 can move the distal tip 418, thereby causing the inflatable frame 404 to expand or collapse.

[0105] During the use of catheter 400, the user can advance catheter 400 within the body lumen to the target treatment site, for example... Figures 3A-3B The heart valve is shown. At the target treatment site, the user can cause the expandable frame 404 to deflatten from its collapsible configuration ( Figure 4A ) Expand to the expanded configuration ( Figure 4B As the expandable frame 404 moves into its expandable configuration, the expandable member 414 comes into contact with the housing 403 and pushes the housing 403 and the first elongated member 402 away from the second elongated member 406. Pushing the housing 403 and the first elongated member 402 away from the second elongated member 406 allows the user to move the multiple shock wave emitters 408 carried by the first elongated member 402 closer to the lesion within the body's lumen.

[0106] In various embodiments, the distance between the laterally expandable member 414 in its expanded configuration and the movable shaft 416 can be from 1 mm to 10 mm (1-10 mm). The degree of expansion of the expandable member 414 can be controlled to properly position the shock wave emitter 408 near the lesion or tissue. For example, as the movable shaft 416 moves proximally, the expandable member 414 can gradually expand with the movement of the movable shaft 416. Similarly, as the movable shaft 416 moves distally, the expandable member 414 can gradually deflate with the movement of the movable shaft 416. Therefore, the user can control the degree of expansion of the expandable member 414 using the movable shaft 416.

[0107] The first elongated member 402 and the second elongated member 406 may each carry a set of radiopaque markings, including a first set of radiopaque markings 412 on the first elongated member 402 and a second set of radiopaque markings 410 on the second elongated member 402. The aforementioned radiopaque markings (including the first set of radiopaque markings 412 and the second set of radiopaque markings 410) may be arranged in any of the aforementioned manner (e.g., see reference). Figure 2A-2B Transmissive marking may be advantageous for orienting the first elongated member 402 and the second elongated member 406 in vivo prior to shockwave therapy.

[0108] The catheter described in this article can be used to treat a variety of lesions (e.g., calcification, stenosis, chronic total occlusion (CTO)). Figure 5 An exemplary method 500 is shown for generating a shock wave using the catheter described herein to treat a lesion in the body after moving a shock wave emitter near the lesion.

[0109] In box 502, method 500 includes advancing a catheter within the lumen to a target lesion / target site. The catheter may be a reference catheter. Figure 1-4B The description may include any catheter or any of its features. Target lesions may include circumferential calcium, aortic calcification, or other occlusions or stones. In some examples, target lesions may include calcified plaques accumulated on the leaflets and / or annulus of the aortic valve, for example, as... Figure 3A and 3BAs shown. In several other examples, treatable target lesions include calcified plaques affecting the mitral, tricuspid, or pulmonary valves. Other heart wall and cardiac tissues with calcified lesions can also be treated.

[0110] The catheter may include a catheter body, a first elongated member, and a second elongated member. At least one shock wave emitter may be carried by the first elongated member and disposed within a housing mounted on the first elongated member. A first set of radiopaque markers may be positioned on the first elongated member, and a second set of radiopaque markers may be positioned on the second elongated member. The radiopaque markers may be arranged differently on the two elongated members, allowing the user to distinguish the two elongated members using radiographic imaging, thereby orienting the shock wave emitter closer to a target lesion within the lumen (e.g., by rotating the catheter to bring the elongated member carrying the shock wave emitter closer to the lesion).

[0111] In box 504, method 500 includes a directional catheter such that a first set of radiopaque markers is closer to the target lesion than a second set of radiopaque markers. The rotatable catheter is used to orient the first set of radiopaque markers, thereby orienting at least one shock wave emitter closer to the target lesion. Due to the different arrangement of the radiopaque markers on the first and second elongated members, radiographic imaging allows the user to determine which elongated member is positioned closer to the target lesion. As the user rotates the catheter within the lumen, the first and second sets of markers will appear collinear in certain orientations (e.g., as shown in the image). Figure 2B As shown), while in other orientations they exhibit non-collinearity (e.g., as shown). Figure 2A (As shown). Furthermore, markers arranged differently (e.g., in different numbers) than those on the second elongated member can be mounted on the first elongated member. This allows the user to use radiographic imaging to visualize the catheter within the body to determine which part of the lumen wall the at least one shockwave emitter is closest to. Thus, the user knows whether the at least one shockwave emitter is located near the lesion, or whether the catheter needs further rotation to position the at least one shockwave emitter for treatment. Orienting the catheter so that the first set of radiopaque markers is positioned relatively close to the target lesion can position the at least one shockwave emitter so that it faces the target lesion.

[0112] In some examples, before directional catheterization to orient the shockwave emitter toward the target lesion, an imager (e.g., a camera) of the catheter can be used to image the lesion for eccentricity or other morphological features. The user (e.g., a physician) can then position the catheter based on the morphology of the lesion to optimize treatment accordingly.

[0113] In block 506, method 500 may include moving a first elongated member of the catheter closer to a target lesion by inflating an expandable member connected to a second elongated member of the catheter, such that the expandable member pushes the first elongated member closer to the target lesion. In some examples, the expandable member may be a shell configured to expand when expanded by the action of fluid and push the first elongated member toward the target lesion (e.g., as shown in the image). Figures 2A-3B (As shown). Inflating the expandable member may include introducing fluid into the enclosed region defined by the expandable member. Fluid may be introduced until the expandable member inflates to the desired amount. In some examples, the expandable member may be an expandable frame. Inflating the frame may include moving a movable axis connected to the expandable frame proximally relative to the frame, for example, referring to... Figure 4A and 4B As stated above.

[0114] In block 508, method 500 includes generating one or more shock waves using at least one shock wave emitter of a catheter. The shock waves can be generated by providing energy pulses to a plurality of electrode pairs and / or optical fibers located on the catheter forming at least one shock wave emitter. The shock wave emitter may be configured such that the shock waves propagate outward away from a first elongated member and propagate towards a target lesion through the outer wall of a housing. The shock waves may impact and alter (e.g., split, rupture) the lesion in the target treatment area (e.g., Figure 3A The lesion portion of the middle valve 380 (390). Boxes 502 to 506 can be repeated any number of times.

[0115] In some cases, it may be necessary to move the shockwave emitter closer to the target lesion while minimizing interference with blood flow through the body's lumen. For example, it is advantageous to maintain blood flow through the aortic or mitral valve during treatment. Figure 6A A perspective view of an exemplary catheter 600 is shown, which includes a catheter body 601 and a tubular housing 603 sealed to the distal end of the catheter body. The tubular housing 603 is configured to allow blood to continue flowing within a body lumen when the tubular housing 603 is in an expanded configuration.

[0116] The tubular housing 603 includes an outer cylindrical wall 615, an inner cylindrical wall 605, and a fillable region 609 between the outer cylindrical wall 615 and the inner cylindrical wall 605. The outer cylindrical wall 615 and the inner cylindrical wall 605 may be formed as an elongated hollow structure defining the fillable region 609. The conduit body 601 is at least partially located within the fillable region 609 of the tubular housing 603, and at least one shock wave emitter 608 is disposed on the conduit body 601 within the fillable region 609 located between the outer cylindrical wall 615 and the inner cylindrical wall 605.

[0117] The fillable region 609 is configured to be filled with fluid, allowing the tubular shell to be in both a collapsed configuration (not shown) and an expanded configuration (in Figure 6A and Figure 6B (as shown in the diagram) switching between. When the tubular housing 603 is filled with fluid (e.g., in...) Figure 6A and 6B In the expanded configuration shown, the inner cylindrical wall 605 defines an open channel 607. The open channel 607 is configured to allow bodily fluids / body fluids flowing within the body lumen to pass through the open channel 607 when the conduit 600 is placed in the lumen and the tubular housing 603 is filled with fluid.

[0118] The longitudinal axis 682 of the tubular housing extends along the open channel 607. The longitudinal axis 681 of the catheter body 601 (and at least one shock wave emitter 608) is offset relative to the longitudinal axis 682 of the tubular housing, such that when the tubular housing 603 is in an expanded configuration, it can become centered in the body lumen, and the catheter body 601 can be offset to one side of the lumen.

[0119] The at least one shock wave emitter 608 may be configured to emit a shock wave toward the outer cylindrical wall 615 when an energy pulse is supplied. The at least one shock wave emitter 608 may be located at the circumferential position of the catheter body 601 closest to the outer cylindrical wall 615. Therefore, when an energy pulse is supplied to the at least one shock wave emitter 608, the shock wave may propagate radially outward toward the target lesion, away from the catheter body and through the outer cylindrical wall 615. In some examples, the at least one shock wave emitter 608 may be configured to emit a shock wave toward the inner cylindrical wall 605 of the tubular housing 603. The at least one shock wave emitter 608 may be located at the circumferential position of the catheter body 601 closest to the inner cylindrical wall 605. The at least one shock wave emitter 608 may be located at any circumferential position of the catheter body 601. In some examples, a plurality of longitudinally aligned shock wave emitters 608 are circumferentially spaced around the catheter body at the same longitudinal position. For example, two or more shock wave emitters can be circumferentially spaced apart from each other by 30 degrees, 45 degrees, 60 degrees, 90 degrees, 120 degrees, 160 degrees, 180 degrees, or any interval thereof. Positioning multiple shock wave emitters in the same longitudinal position but circumferentially spaced from each other allows shock waves to be emitted in multiple directions and promotes constructive interference of shock wave energy.

[0120] Prior to shockwave therapy, a tubular housing 603 can be used to move the catheter body 601 and at least one shockwave emitter 608 closer to the target lesion. The catheter 600 can advance within the body lumen such that the at least one shockwave emitter 608 is longitudinally aligned with the target lesion. The tubular housing 603 can then be filled with fluid to expand it, causing it to push the catheter body 601 and at least one shockwave emitter 608 laterally / transversely (e.g., radially) toward the target lesion. The tubular housing 603 can be filled until the outer cylindrical wall 615 contacts the inner wall of the body lumen, thereby positioning the catheter body 601 and at least one shockwave emitter immediately adjacent to the target lesion on the inner wall of the lumen.

[0121] One or more radiopaque markers 610 may be positioned proximally and / or distally on the catheter body 601 of the at least one shockwave emitter 608 and may guide the user to place the catheter 600 into the body lumen. For example, the catheter 600 may be positioned such that the distal marker 610 is positioned on one side of the valve annulus and another marker 610 is positioned on the other side of the valve annulus, thereby indicating that the at least one shockwave emitter is positioned within the valve annulus.

[0122] The catheter body 601 may include a tapered distal portion 602c, an elongated outer tube 602a proximal to the tapered distal portion 602c, and a transmitter support structure 602b located between the tapered distal portion 602c and the elongated outer tube 602a. The distal end of a tubular housing 603 is sealably connected to the tapered distal portion 602c of the catheter body 601, and the proximal end of the tubular housing 603 is sealably connected to the proximal elongated outer tube 602a. The transmitter support structure 602b may be located within a fillable region 609 of the tubular housing 603 and may extend proximally within the lumen of the proximal elongated outer tube 602a. The tapered shape of the tapered distal portion 602c of the catheter body reduces the cross-sectional profile of the catheter relative to a cylindrical shape and facilitates the passage of the catheter 600 within narrow lumens of the body.

[0123] Figure 6B An alternative view of the conduit 600 toward its distal end is shown. An outer cylindrical wall 615 forms the outer diameter 613 of the tubular housing 603. The outer diameter 613 can range from 10 mm to 30 mm when the tubular housing is filled with fluid. An inner cylindrical wall 605 forms the inner diameter 611 of the tubular housing 603. The inner diameter 611 can be at least 6 mm.

[0124] In some examples, the tubular housing 603 is made of a semi-compliant or non-compliant material such that it does not stretch or stretches minimally when filled with fluid. In some examples, the compliance of the outer tubular wall 615 may differ from that of the inner tubular wall 605. For example, the outer tubular wall may comprise a compliant material such that it can expand / expand when filled with fluid to contact the inner wall of the body lumen. The inner tubular wall 605 may be formed of a non-compliant or semi-compliant material such that it does not stretch or stretches minimally when filled with fluid to retain the open passage 607 when the tubular housing is filled with fluid. The tubular housing 603 may comprise a shape memory material. The shape memory material can help ensure that the tubular housing collapses and / or retains the shape of the open passage 607 when fluid is removed from the housing.

[0125] Figure 7 This is a side view that depicts several aspects of the catheter 700, including its potential use in... Figure 6A and Figure 6B The tubular housing 703 of the tubular housing 603 shown has several aspects. The catheter 700 includes a catheter body 701 and a tubular housing 703, the tubular housing 703 being configured to allow blood to continue flowing within the body lumen when the tubular housing 703 is filled with fluid.

[0126] The tubular housing 703 includes an outer cylindrical wall 715, an inner cylindrical wall 705, and a fillable region 709 between the outer cylindrical wall 715 and the inner cylindrical wall 705. The inner cylindrical wall 705 defines a channel through which body fluid can flow when the fillable region is filled with fluid. The outer cylindrical wall 715 includes a distal tapered portion 750 and a proximal tapered portion 752. A substantially straight portion 754 extends between the distal tapered portion 750 and the proximal tapered portion 752.

[0127] The distal tapered portion 750 may be advantageous for advancing a catheter within a body lumen. For example, after filling the tubular housing 703 with fluid, the tubular housing 703 may not return to its original unfilled size when the fluid is removed. The distal tapered portion 750 reduces the cross-sectional profile of the catheter 700 at its distal end, making it easier to travel within small lumens within the body. For the same reason, the proximal tapered portion 752 may be advantageous when removing the catheter 700 from the body and / or moving it proximally within a body lumen.

[0128] At least one shock wave emitter 708 is carried by the conduit body 701 and disposed within the fillable area. The at least one shock wave emitter 708 can be positioned at any circumferential location on the conduit body 701, including on the portion of the conduit body 701 facing the outer cylindrical wall 715. When the tubular housing is filled with fluid, the outer cylindrical wall 715 can expand to contact the inner surface of the body lumen. Therefore, the at least one shock wave emitter 708 can be positioned adjacent to and facing the inner wall of the body lumen.

[0129] It may be advantageous to allow the user to rotate the catheter 700 before the tubular housing 703 is filled with fluid, so that the at least one shock wave emitter can be oriented toward the lesion within the body lumen. A braided shaft 720 (e.g., formed of stainless steel, nitinol, etc.) may be disposed on or formed as part of the proximal portion of the catheter body 701. The braided shaft 720 can reinforce the catheter body 701, making it relatively easier for the user to rotate the catheter body 701 within the body lumen.

[0130] Figure 8 This is a side view depicting several aspects of another catheter 800, including those that can be used... Figure 6A and Figure 6B and / or Figure 7 The tubular housing 603 and the tubular housing 803 have multiple aspects. The catheter 800 includes a catheter body 801 and a tubular housing 803, the tubular housing 803 being configured to allow blood to continue flowing within the body lumen when the tubular housing 803 is filled with fluid.

[0131] The tubular housing 803 includes an outer cylindrical wall 815, an inner cylindrical wall 805, and a fillable region 809 between the outer cylindrical wall 815 and the inner cylindrical wall 805. The distal portion of the catheter body 801 lies within the fillable region 809 of the tubular housing 803. The tubular housing 803 includes a proximal opening 842 in a proximal wall 836 and a distal opening 840 in a distal wall 838. The proximal opening 842 and the distal opening 840 provide access to the fillable region of the tubular housing 803.

[0132] During assembly, the distal portion of the catheter body 801 can be inserted into the tubular housing 803 through the proximal opening 842 and withdrawn from the tubular housing 803 through the distal opening 840. A proximal-extending cylindrical wall 862 defining the proximal opening and a distal-extending cylindrical wall 860 defining the distal opening can be sealingly connected to the catheter body 801 to form a sealed housing configured to be filled with fluid. The proximal-extending cylindrical wall 862 and the distal-extending cylindrical wall 860 thus facilitate easy assembly of the tubular housing 803 to the catheter body 801.

[0133] The 600-800 catheter can be used to position the shock wave emitter closer to the lesion in the body, while allowing body fluids to continue flowing through the lumen of the body being treated. Figure 9 An exemplary method 900 for positioning a shock wave generating conduit closer to a target treatment area using a tubular housing formed with an open channel to allow continued blood flow during treatment is shown.

[0134] In block 902, method 900 may include advancing a catheter comprising a tubular housing mounted on a catheter body within a lumen. In block 904, method 900 may include positioning a distal portion of the catheter such that at least one shock wave emitter of the catheter is located near a target treatment area. The target treatment area may be a lesion within a body lumen (e.g., a site of calcified tissue accumulation). In some examples, the target treatment area may be a region of a valve, such as an aortic valve, mitral valve, or other heart valve. Examples of such valves are shown in... Figure 3A and Figure 3B This is explained in the text. The distal portion of the catheter can be positioned across the valve annulus such that at least one shock wave emitter of the catheter is located near a leaflet of the valve (e.g., leaflet 382 in Figure 3). The catheter may include radiopaque markers (e.g., Figure 6A The band 610 shown in the diagram helps to position the catheter across the valve ring.

[0135] In block 906, method 900 may include filling a tubular housing. Filling the tubular housing creates an open channel for the flow of bodily fluids and allows the at least one shockwave emitter to be moved closer to a target treatment area. The at least one shockwave emitter may be positioned on a portion of the catheter located within an infillable region of the tubular housing, which expands laterally / laterally outward when the housing is filled. Thus, filling the housing moves the shockwave emitter laterally outward toward the target treatment area of ​​the lumen (e.g., calcification on lobule 382). When filled, the outer wall of the tubular housing may contact the lobule / ring (e.g., lobule 382). The inner wall of the tubular housing is formed with an open channel for blood to pass through the center of the balloon (e.g., channel 607 of catheter 600).

[0136] In block 908, method 900 may include generating one or more shock waves using at least one shock wave emitter of the catheter. The shock waves can be generated by supplying energy pulses to multiple electrode pairs and / or optical fibers located on the catheter. The shock wave emitter may be configured such that the shock waves propagate outward toward the target lesion through the outer wall of the tubular housing. The shock waves may impact and alter (e.g., split, rupture) the lesion at the target treatment area (e.g., Figure 3A (380 valves).

[0137] In block 910, method 900 may include collapsing the tubular housing. After generating a shock wave to treat a first lesion, the tubular housing may be collapsed, allowing the catheter to be repositioned to treat different lesions and / or different areas of the same lesion. In block 912, method 900 may include rotating the catheter to position the at least one shock wave emitter near different target treatment areas. For example, the catheter may be initially oriented such that the at least one shock wave emitter faces the first leaflet of the valve (e.g., Figure 3A The left leaflet 382). The conduit can be rotated so that the at least one shock wave emitter faces the second leaflet (e.g., Figure 3A (Leaf 382 on the right). In block 914, method 900 may include filling the tubular housing, and in block 916, method 900 may include generating one or more additional shock waves using the at least one shock wave emitter of the catheter. Method 900 may be repeated any number of times until treatment is complete.

[0138] Figure 10A and 10B It shows that it can be used Figure 1 An exemplary shockwave catheter 1000 of the catheter 10 shown. The catheter 1000 includes a plurality of expandable members, including expandable members 1004a and 1004b, which, when expanded, allow a user (e.g., a surgeon or other medical professional) to move at least one shockwave emitter 1008 closer to a lesion within a body lumen, such as a valve. The catheter 1000 is configured such that the at least one shockwave emitter 1008 can be positioned close to a valve (e.g., Figure 3A and 3B The catheter 1000 can treat lesions within the valve shown in the diagram, without relying on typical localization methods such as manipulation or centering occlusion. The catheter 1000 can also be configured such that when the plurality of expandable members, including expandable members 1004a and 1004b, expand, blood flow is not completely blocked. Therefore, the catheter 1000 can more effectively treat lesions within the body by allowing the user to impact the lesion with a relatively stronger shock wave.

[0139] Figure 10AA first view of a catheter 1000 is shown. The catheter 1000 includes a catheter body 1001 and an elongated member 1002. A housing 1003 is mounted on the elongated member 1002. The housing 1003 may also be mounted on the catheter body 1001. In some examples, the elongated member 1002 is formed as part of the catheter body 1001. The housing 1003 may be: compliant, such that it stretches when pressurized; non-compliant, such that it does not stretch or stretches minimally when pressurized with fluid; or semi-compliant. At least one shock wave emitter 1008 is carried by the elongated member 1002 and disposed within the housing 1003. In some examples, the elongated member 1002 may be a distal portion of the catheter body. In some examples, the elongated member 1002 may extend within a lumen along at least a portion of the length of the catheter body 1001.

[0140] The catheter 1000 includes a plurality of expandable members, including expandable members 1004a and 1004b connected to the catheter body 1001. Expandable members 1004a and 1004b are configured to expand to contact the housing 1003 and push the housing 1003, the elongated member 1002, and the at least one shock wave emitter 1008 laterally toward the lesion. Figure 10B A second view of the catheter 1000 is shown. (See diagram) Figure 10B As shown, the first portion 1042 of each of the expandable members 1004a and 1004b can push against a body lumen or valve (e.g. Figure 3A and 3BThe surface of the valve (as shown), and the second portion 1040 of each of the respective expandable members 1004a and 1004b can push against the housing 1003 to laterally move the housing 1003 toward another portion of the lumen or valve. The plurality of expandable members (including expandable members 1004a and 1004b) may be configured to expand when filled with fluid. In some examples, the plurality of expandable members (including expandable members 1004a and 1004b) are: formed of a compliant material such that they stretch under pressure; formed of a non-compliant material such that they do not stretch or stretch to a minimal extent when pressurized with fluid; or they may be semi-compliant. Expandable members 1004a and 1004b may be mounted onto corresponding elongated members. Expandable member 1004a may be mounted to elongated member 1080, while expandable member 1004b may be mounted to another elongated member 1082 (it should be understood that in some examples, expandable members 1004a and 1004b may be empty balloons with no elongated members extending inside them). At least one fluid channel may extend along elongated members 1002, 1080, and / or 1082 to fill housing 1003, expandable member 1004a, and expandable member 1004b with fluid. In some examples, housing 1003, expandable member 1004a, and / or expandable member 1004b may be filled independently of each other.

[0141] The catheter body 1001 and the elongated member 1002 extend along the longitudinal axis 1091. The expandable member 1004a and the elongated member 1080 may extend away from the elongated member 1002 and the longitudinal axis 1091 in a first direction, and the expandable member 1004b and the elongated member 1082 may extend away from the elongated member 1002 and the longitudinal axis 1091 in a second direction.

[0142] Expandable member 1004a and elongated member 1080 extend away from the catheter body along different longitudinal axes 1093, which may at least partially transverse to longitudinal axis 1091. Expandable member 1004b and elongated member 1082 extend away from the catheter body along another longitudinal axis 1092, which may at least partially transverse to longitudinal axes 1091 and 1093. In some examples, longitudinal axis 1093 deviates from longitudinal axis 1091 and extends distally away from longitudinal axis 1091 at an angle. In some examples, longitudinal axis 1092 deviates from longitudinal axis 1091 and extends distally away from longitudinal axis 1091 at an angle. In some examples, longitudinal axis 1093 deviates from longitudinal axis 1092 and extends distally away from longitudinal axis 1092 at an angle. In some examples, expandable members 1004a and 1004b may not be attached to the elongated member. For example, expandable members 1004a and 1004b may be balloons extending directly from the catheter body 1001. The proximal ends of expandable members 1004a and 1004b may be connected to fluid channels in the catheter body 1001 at their respective proximal ends. In some examples, expandable members 1004a and 1004b have the same outer diameter when filled with fluid. In some examples, when both expandable members 1004a and 1004b are filled with fluid, the housing 1003 has the same outer diameter as expandable members 1004a and 1004b.

[0143] The at least one shock wave emitter 1008 may be located on the side of the first elongated member 1002 opposite to the expandable members 1004a and 1004b, such that the at least one shock wave emitter 1008 is relatively closer to the lesion than if it were located on the side of the first elongated member 1002 closest to the expandable members 1004a and 1004b. However, in some examples, the plurality of shock wave emitters 1008 may be circumferentially spaced apart from each other at one or more longitudinal locations on the elongated member 1002. In some examples, the plurality of shock wave emitters 1008 are positioned along the elongated member 1002 at corresponding longitudinal locations. Some shock wave emitters 1008 may be circumferentially aligned with each other. Some shock wave emitters 1008 may be circumferentially offset from each other around the circumference of the elongated member 1002. The shock wave emitters 1008 may be located at any circumferential location on the elongated member 1008. In some examples, multiple shock wave emitters 1008 are positioned at the same longitudinal location on an elongated member 1002 and are circumferentially spaced apart from each other around the circumference of the elongated member 1002 (e.g., 30 degrees, 45 degrees, 60 degrees, 75 degrees, 90 degrees, 180 degrees, or any other angle in the range of 1 degree to 180 degrees). Positioning multiple shock wave emitters at the same longitudinal location and circumferentially spaced apart from each other can generate constructive interference shock waves. For example, two shock wave emitters positioned 90 degrees apart from each other can each generate constructive interference shock waves at a location (e.g., 45 degrees) between the two shock wave emitters, resulting in a relatively stronger combined shock wave. In some examples, the at least one shock wave emitter includes a conductive emitter strip having elongated grooves formed in the emitter strip, which serves as an electrode of the at least one shock wave emitter, for example, as described in detail in U.S. Application No. 19 / 319,045, filed September 4, 2025, the contents of which are incorporated herein by reference in their entirety.

[0144] The housing 1003 may include a distal tapered portion 1050 and a proximal tapered portion 1052. A generally straight cylindrical portion 1054 extends between the distal tapered portion 1050 and the proximal tapered portion 1052. The distal tapered portion 1050 may facilitate the advancement of the catheter within a body lumen. For example, after the housing 1003 is filled with fluid, it may not return to its initial unfilled size when the fluid is removed. The distal tapered portion 1050 reduces the cross-sectional profile of the catheter 1000 at its distal end, making it easier to travel within small lumens of the body. For the same reason, the proximal tapered portion 1052 is also advantageous when the catheter 1000 is withdrawn from the body and / or moved proximally within a body lumen.

[0145] The housing 1003 may include a proximal opening 1066 in the proximal sidewall 1062 and a distal opening 1064 in the distal sidewall 1060. An elongated member 1002 may extend into the housing 1003 via the proximal opening 1066, and the distal end of the elongated member 1002 may exit the housing 1003 via the distal opening 1064. The proximal sidewall 1062 and the distal sidewall 1060 may be formed as tubular tubes extending from the proximal tapered portion 1052 and the distal tapered portion 1050, respectively. The proximal sidewall 1062 and the distal sidewall 1060 may be sealingly connected to the respective proximal and distal portions of the elongated member 1002.

[0146] Each of the plurality of expandable members (including expandable member 1004a and expandable member 1004b) may include a distal tapered portion 1070 and a proximal tapered portion 1072. A generally straight cylindrical portion 1074 may extend between the distal tapered portion 1070 and the proximal tapered portion 1072. The distal tapered portion 1070 may be advantageous for advancing the catheter within a body lumen. For example, after filling the respective expandable members 1004a and 1004b, the expandable members may not return to their original unfilled size when fluid is removed. The distal tapered portion 1070 reduces the cross-sectional profile of the expandable members at their respective distal ends, making them easier to travel within small lumens within the body. For the same reason, the proximal tapered portion 1072 is also advantageous when the catheter 1000 is withdrawn from the body and / or moved proximally within a body lumen.

[0147] In some examples, one or more radiopaque markers 1012 are mounted on the elongated member 1002. One or more radiopaque markers 1012 may be additionally or alternatively mounted on the elongated members 1080 and / or 1082. The one or more radiopaque markers 1012 may be configured to allow a user to position the at least one shock wave emitter 1008 close to a lesion within the body. The one or more radiopaque markers 1012 may be arranged in different ways on the elongated members (1002, 1080, and 1082) to allow the user to distinguish the individual elongated members and determine the position of the at least one shock wave emitter 1008 relative to a lesion within the body. For example, a first number of radiopaque markers 1012 may be positioned on the elongated member 1002, a second number (different from the first number) of radiopaque markers 1012 may be positioned on the elongated member 1080, and a third number (different from the first and second numbers) may be positioned on the elongated member 1082. As another example, the transmissive markings 1012 on the elongated member 1002 may be spaced apart by a first distance, the transmissive markings 1012 on the elongated member 1080 may be spaced apart by a second distance (different from the first distance), and the transmissive markings 1012 on the elongated member 1082 may be spaced apart by a third distance (different from the first and second distances).

[0148] During use of catheter 1000, the user can position catheter 1000 across a valve, such as the aortic valve. Expandable members 1004a, 1004b, and housing 1003 can be positioned within three valve sutures / connections (e.g., those of the aortic valve). One or more radiopaque markers 1012 mounted on the elongated member 1002 can aid in device positioning. For example, the user can position the device such that a first radiopaque marker 1012 is located on a first side of the valve (e.g., the first side of the valve annulus) and a second radiopaque marker 1012 is located on a second side of the valve. Once positioned, expandable members 1004a, 1004b, and housing 1003 can be filled with fluid, and one or more shock waves can be generated using the at least one shock wave emitter 1008 to alter lesions in or near the valve (or other body lumen). Then, the expandable member 1004a, expandable member 1004b, and housing 1003 can be collapsed, and the user can rotate the catheter 1000 to reposition the at least one shock wave emitter 1008. For example, the user can reposition each of the expandable member 1004a, expandable member 1004b, and housing 1003 in a different commissure, such that the at least one shock wave emitter 1008 can be used to treat lesions in different commissures. The expandable member 1004a, expandable member 1004b, and housing 1003 can then be re-expanded, and one or more additional shock waves can be generated. This process can be repeated to treat multiple different lesions or different portions of lesions. For example, the user can repeat the above process to treat each commissure of the aortic valve. Additionally or alternatively, treatment of the left ventricular outflow tract (LVOT) can be performed by advancing the device into the ventricle and applying one or more shock waves using the at least one shock wave emitter 1008. It should be understood that the catheter 1000 can be used for conditions other than treating lesions at the aortic valvular suture site, such as lesions in the ventricles, vascular system, or other body lumens. The catheter 1000 allows one or more shock wave emitters to be positioned closer to the lesion (e.g., within the valvular suture) without completely occluding the valve or eliminating the need for manipulatory devices. Furthermore, the catheter 1000 can be positioned using only fluoroscopy, without requiring more advanced imaging techniques.

[0149] Figure 11 An exemplary computing system 1100 according to one or more examples of the present invention is depicted, which may be formed as part of the system 100 described herein and may be used to control one or more aspects of the apparatus described herein and / or to perform various steps of the methods described herein. System 1100 may be a host computer connected to a network. System 1100 may be a client computer or a server. Figure 11As shown, system 1100 can be any suitable type of microprocessor-based device, such as a personal computer, workstation, server, or handheld computing device (i.e., portable electronic device), such as a telephone or tablet. The device may include, for example, one or more processors 1102, input devices 1106, sensor devices 1107, output devices 1108, memory 1110, and communication devices 1104. Input devices 1106 and output devices 1108 can generally correspond to the aforementioned devices and can be connected to or integrated with a computer.

[0150] Input device 1106 can be any suitable device providing directional input, such as a touchscreen, keyboard or keypad, mouse, or voice recognition device; in other words, input or indication provided or initiated by the user. Sensor device 1107 can be one or more of any suitable sensor devices, such as pressure sensors, thermal sensors, electrical sensors (e.g., current, voltage, resistance, and / or impedance sensors), or visualization elements. Output device 1108 can be any suitable device providing output, such as a touchscreen, haptic device, or speaker. Memory 1110 can be any suitable device providing storage, such as electrical, magnetic, or optical memory, including RAM, cache, hard disk drive, or removable storage disk. Communication device 1104 can include any suitable device capable of sending and receiving signals over a network, such as a network interface chip or device. Computer components can be connected in any suitable manner, such as via a physical bus or wirelessly.

[0151] Sensor device 1107 can provide feedback to the operator using system 1100 by measuring parameters in the surrounding environment and thereby indicating the status of the shockwave catheter device (such as catheter 10) connected to computing system 1100, and further guiding the operator to decide on further steps to be taken with the shockwave catheter device (such as catheter 10) connected to computing system 1100. For example, in an embodiment where sensor device 1107 includes a pressure sensor, a slight decrease in pressure can indicate successful rupture of a calcified lesion because the expandable member surrounding the shockwave emitter (e.g., housing 120) can expand further without changing the fluid volume within the expandable member. Furthermore, a significant decrease in pressure can indicate a rupture failure mode where the expandable member has lost its seal and fluid volume, thus guiding the withdrawal of the device (e.g., device 10). In embodiments where sensor device includes a visualization element, the operator of a catheter device such as catheter 10 can have a clearer understanding of the catheter's position relative to the target lesion or anatomical structure before, during, and after treatment delivery.

[0152] In some embodiments, sensor device 1107 includes surface electrodes of an electrocardiograph for synchronizing the shock wave with an "R" wave to treat blood vessels near the heart. Sensor device 1107 may include an R-wave detector and a controller to control a high-voltage switch. Mechanical electric shocks can stimulate the myocardium and may cause arrhythmias. While a shock wave of such short duration is unlikely to stimulate the heart by synchronizing the pulse (or pulse cluster) with an R wave, it can provide an extra level of safety when used on or near the heart vessels. In embodiments where the shock wave is generated by an open, unsealed transmitter, synchronization with the R wave will significantly improve safety against unwanted arrhythmias.

[0153] Processor 1102 can be any suitable processor or combination of processors, including any one or any combination of a central processing unit (CPU), a field-programmable gate array (FPGA), and an application-specific integrated circuit (ASIC). Software 1112, which can be stored in memory 1110 and executed by processor 1102, may include programs embodying, for example, the functions of this disclosure (e.g., as embodied in the apparatus described above). Software 1112 may also be stored and / or transferred in any non-transitory computer-readable storage medium for use by or in connection with an instruction execution system, apparatus, or device, such as those described above, which can retrieve and execute instructions associated with the software. In the context of this disclosure, a computer-readable storage medium can be any medium, such as memory 1110, which may contain or store programs used by or in connection with an instruction execution system, apparatus, or device. Software 1112 can also be propagated in any transmission medium for use by or in connection with an instruction execution system, apparatus, or device, such as those described above, which can retrieve and execute instructions associated with the software. In the context of this disclosure, the transmission medium can be any medium capable of transmitting, propagating, or transmitting a program used by or in connection with an instruction execution system, apparatus, or device. Transmission readable media can include, but are not limited to, electrical, magnetic, optical, electromagnetic, or infrared wired or wireless transmission media.

[0154] System 1100 can be connected to a network, which can be any suitable type of interconnected communication system. The network can implement any suitable communication protocol and can be protected by any suitable security protocol. The network may include any suitable network link arrangement capable of transmitting and receiving network signals, such as a wireless network connection, T1 or T3 lines, cable networks, DSL, or telephone lines. System 1100 can implement any operating system suitable for operation on the network. Software 1112 can be written in any suitable programming language, such as C, C++, Java, or Python. In various different embodiments, application software embodying the functions of this disclosure can be deployed in different configurations, such as in a client / server setup or via a web browser as a web-based application or web service.

[0155] System 1100 can be configured to selectively control the energy delivery from one or more energy sources (e.g., voltage pulse generators or light energy sources) to one or more acoustic energy transmitters (e.g., forward-emitting transmitters, radial-emitting transmitters, unsealed transmitters, or sealed transmitters) based on input from input device 1106.

[0156] System 1100 can be configured to adjust the energy characteristics delivered to one or more of the aforementioned transmitters based on tissue characteristics received from sensor device 1107. Tissue characteristics may include lesion tissue type (e.g., calcification, thrombosis, fibrosis) and lesion morphology (e.g., thickness, length, eccentricity).

[0157] For reference Figure 4A and Figure 4B In some examples, an expandable frame (e.g., a mesh frame or a wire frame) may be used for the expandable member described herein (e.g., expandable member 204, 304). Figure 12 Several aspects of an exemplary catheter 1200, including an exemplary expandable frame, are shown. The catheter 1200 can be used for... Figure 1 The catheter 10. The catheter 1200 includes an expandable frame 1204, which can be used to move one or more shock wave emitters 1208 closer to the treatment site (e.g., within a heart valve). Using an expandable frame such as expandable frame 1204 (and / or expandable frame 404 described above) to position the shock wave emitter 1208 closer to the treatment side facilitates allowing blood flow through the heart valve during use. When the catheter 1200 is located in the blood vessel and the expandable frame expands, blood can flow through the expandable frame 1204. Therefore, during use, the catheter 1200 does not obstruct or block blood flow through the blood vessel or heart valve being treated.

[0158] The catheter 1200 includes a catheter body 1201, a first elongated member 1202, and a second elongated member 1206. The first elongated member 1202 may include any of the aspects described above with reference to first elongated member 202 and / or first elongated member 302, and may be connected to a distal portion of the catheter body 1201 or formed as at least a portion of the distal portion of the catheter body 1201. The second elongated member 1206 may be connected to the distal portion of the catheter body 1201 and may be oriented at least partially transverse to the first elongated member 1202. An expandable frame 1204 may be connected to the second elongated member 1206. Figure 12 An expandable member 1204 in an expanded configuration is shown. The expandable member may be adjustable (e.g., manually adjustable by a user) to cause the expandable member to collapse into a collapsed configuration (e.g., similar to...). Figure 4B (The collapsed configuration of the expandable component depicted in the image).

[0159] The expandable frame 1204 may include a plurality of laterally expandable members 1214. The laterally expandable members 1214 can... Figure 12 The movement between the expanded and collapsed configurations shown is, for example, similar to the reference configuration. Figure 4A and 4B The movement is permitted in the manner described, and / or by any user-engageable mechanism for inflating and deflated of the expandable frame 1204. For example, the catheter 1200 may include a movable shaft 1216. Proximal movement of the movable shaft 1216 toward the proximal end of the catheter 1200 may cause the expandable frame 1204 to shorten and laterally expand. Distal movement of the movable shaft may cause the expandable frame 1204 to elongate and laterally deflate.

[0160] A movable shaft 1216 may extend along the catheter body 1201 (e.g., within the lumen, or along the outer surface of the catheter body 1201) to the proximal end of the catheter so that a user can control the shaft from the proximal end of the catheter. The movable shaft 1216 may be connected at its distal end to a distal tip 1218. The distal tip 1218 may be connected to an inflatable frame 1204 such that movement of the distal tip causes the inflatable frame 1204 to expand or collapse. In some examples, the catheter 1200 does not include a movable shaft 1216 for expanding or collapsing the inflatable member 1214. The inflatable member 1214 may be configured to self-expand, for example, by using a pre-formed shape memory material to form the inflatable member 1214.

[0161] Any or all laterally expandable members 1214 may include a proximal region 1214a, a distal region 1214c, and a connecting region 1214b between the proximal region 1214a and the distal region 1214c. The proximal region 1214a of each expandable member 1214 may be connected at its proximal end to the second elongated member 1206. In the expanded configuration, the proximal region 1214a may extend distally transversely to the second elongated member 1206 at an angle. The proximal region 1214a may extend distally to a first bending region 1240. The first bending region 1240 may connect the proximal region 1214a to the connecting region 1214b and may be configured to bend when an axial force is applied to the movable shaft 1216. The connecting region 1214b may extend distally from the first bending region 1240 to a second bending region 1240, which may also be configured to bend when an axial force is applied to the movable shaft 1216. The connecting region 1214b can be configured to remain parallel to the second elongated member 1206 in both expanded and collapsed configurations. A second curved region 1240 connects the connecting region 1214b to the distal region 1214c. The distal region 1214c can extend distally from the connecting region 1214b. In the expanded configuration, the distal region 1214c can extend distally transversely to the second elongated member 1206 at an angle. The distal end of the distal region 1214c can be connected to a distal tip 1218. Therefore, moving the movable axis 1216 can move the distal tip 1218, thereby causing the expandable frame 1204 to expand or collapse.

[0162] During the use of catheter 1200, the user can advance catheter 1200 into the body lumen to the target treatment site, for example... Figures 3A-3B The heart valve shown is in a collapsed configuration with the expandable frame 1204 in this position. At the target treatment site, the user can expand the expandable frame 1204 from the collapsed configuration to an expanded configuration (e.g., Figure 12 (As shown in the configuration). When the expandable frame 1204 moves to the expandable configuration, the expandable member 1214 can contact the housing 1203 and push the housing 1203 and the first elongated member 1202 away from the second elongated member 1206. Pushing the housing 1203 and the first elongated member 1202 away from the second elongated member 1206 allows the user to move the multiple shock wave emitters 1208 carried by the first elongated member 1202 closer to the lesion within the body lumen.

[0163] It should be understood that Figure 12 The expandable frame 1204 shown is exemplary. Other types of expandable frames (e.g., different shapes, sizes, etc.) are also within the scope of this disclosure. For example, Figure 13 Several aspects of an exemplary catheter 1300 are shown, which has an expandable frame 1304 of different shapes and can be used for Figure 1 The catheter 10. The catheter 1300 includes a catheter body 1301, a first elongated member 1302, and a second elongated member 1306. The first elongated member 1302 may include any of the aspects described above with reference to the first elongated member 202 and / or the first elongated member 302, and may be connected to or formed as part of the distal portion of the catheter body 1301. The second elongated member 1306 may be connected to the distal portion of the catheter body 1301 and may be oriented at least partially transverse to the first elongated member 1302.

[0164] The expandable frame 1304 can be connected to the second elongated member 1306. The expandable frame 1304 can be used to move one or more shock wave emitters 1308 closer to the treatment site (e.g., within a heart valve). The expandable frame 1304 can be adjustable (e.g., manually adjustable by a user) to allow the expandable frame 1304 to... Figure 13 The inflatable configuration shown collapses into a collapsed configuration. In the collapsed configuration, the maximum diameter of the inflatable frame 1304 can be less than [a certain value]. Figure 13 The maximum diameter of the expandable frame is shown. In some embodiments, the expandable frame 1304 may be formed of a material with shape memory or elasticity, such that when deployed at the treatment site, the expandable frame automatically expands to an operable size. In several other embodiments, a movable control member 1360 may be attached to the expandable frame, allowing an operator to manually change the configuration of the expandable frame between an expanded and a collapsed configuration. The movement of the control member may be rotation about the circumference of the device, longitudinal movement along the length of the device, or a combination thereof.

[0165] In various embodiments, the expandable frame 1304 in its expanded configuration may have a diameter of 1 mm to 15 mm (1-15 mm). In some examples, the expansion diameter of the expandable frame ranges from 25% to 150% of the diameter of the housing 1303. In some examples, the expansion diameter of the expandable frame 1304 is at least two times, at least three times, at least four times, at least five times, at least six times, at least seven times, at least eight times, at least nine times, or at least ten times the diameter of the housing 1303. The degree of expansion of the expandable frame 1304 can be controlled to properly position the shock wave emitter 1308 near the lesion or tissue. When the catheter 1300 is located in a blood vessel and the expandable frame expands, blood can flow through the expandable frame 1304.

[0166] Figure 13The expandable frame 1304 shown includes a helical member 1314. The helical member of the expandable frame 1304 may include a tapered proximal portion 1314a and a tapered distal portion 1314c. The tapered proximal portion 1314a and the tapered distal portion 1314c may have respective average diameters smaller than the (average) diameter of the portion of the helical member 1314 extending between the tapered proximal portion 1314a and the tapered distal portion 1314c. The tapered proximal portion 1314a and the tapered distal portion 1314c allow the user to more easily advance and withdraw the catheter 1300 within the body.

[0167] Figures 14A-14D It shows that it can be used Figure 1 Several aspects of the exemplary catheter 1400 of the illustrated catheter 10 are shown. The catheter 1400 includes laterally movable shock wave emitter support members, including shock wave emitter support members 1406a, 1406b, and 1406c, which can be used to position the shock wave emitter closer to a lesion, such as between the cusps of an aortic valve. The catheter 1400 may include an inner elongated member 1404 and an outer elongated member 1402. The inner elongated member 1404 and the outer elongated member 1402 may be configured such that they can translate relative to each other. For example, in some examples, the inner elongated member 1404 may be located radially inside the outer elongated member 1402 and configured such that a user can slide the inner elongated member 1404 distally and / or proximally relative to the outer elongated member 1402. Shock wave emitter support members 1406a, 1406b, and 1406c may be located between the inner elongated member 1404 and the outer elongated member 1402. Shock wave emitter support members 1406a, 1406b, and 1406c can be mounted onto the inner elongated member 1404 and can be configured to translate relative to the outer elongated member 1402 together with the inner elongated member 1404. When the inner elongated member 1404 is in the extended position (e.g., as...), Figure 14B As shown, shock wave emitter support members 1406a, 1406b, and 1406c can move outward away from the inner elongated member 1404. When the inner elongated member translates proximally toward a retracted position, shock wave emitter support members 1406a, 1406b, and 1406c can move inward toward the inner elongated member 1404 (e.g., when the outer elongated member 1402 pushes the shock wave emitter support members 1406a, 1406b, and 1406c toward the inner elongated member 1404).

[0168] In some examples, the outer elongated member 1402 may be located radially outside the shock wave emitter support member and may translate relative to the inner elongated member 1404 between an extended and retracted position. When the outer elongated member is in the extended position, the shock wave emitter support member may be at least partially located within the outer elongated member (e.g., a sheath), and the outer elongated member may restrict outward movement of the emitter support member. Thus, when the catheter travels within the vascular system and the outer elongated member is in the extended position (and / or when the inner elongated member 1404 is in the retracted position within the outer elongated member), the catheter 1400 may maintain a relatively low profile. When the catheter 1400 is positioned at a treatment site, the outer elongated member may retract to the retracted position (or the inner elongated member 1404 may translate distally to the extended position) to allow the emitter support member to move outward away from the longitudinal axis of the catheter, and the user may position the respective emitter support member near multiple target treatment sites for shock wave therapy.

[0169] The conduit 1400 includes an inner elongated member 1404 and a plurality of emitter support members distributed along the inner elongated member 1404, including emitter support members 1406a, 1406b, and 1406c. The conduit 1400 also includes an outer elongated member 1402 located radially outside the inner elongated member 1404. The outer elongated member 1402 extends along at least a portion of the inner elongated member 1404. The outer elongated member 1402 may surround / enclose at least a portion of the inner elongated member 1404. In some examples, the inner elongated member may be in an extended position relative to the outer elongated member 1402 of the inner elongated member 1404 (examples of which are shown in...). Figure 14B (shown in) and the retracted position of the internal elongated member 1404 (an example of which is shown in) Figure 14A The outer elongated member 1402 may be translated (e.g., slid) proximally or distally between the inner elongated member 1404 and the inner elongated member 1404 (examples of which are shown in the figure). In some examples, the outer elongated member 1402 may be in an extended position relative to the inner elongated member 1404 (examples of which are shown in the figure). Figure 14A (as shown in) and retraction position (examples of which are shown in) Figure 14B (as shown in the figure) translate (e.g., slide) between the proximal and distal sides.

[0170] Sliding the outer elongated member distally toward the distal end 1404a of the inner elongated member 1404 (or sliding the inner elongated member 1404 proximally) can cover at least a portion of the transmitter support members 1406a, 1406b, and 1406c, and positioning the distal portions 1408a, 1408b, and 1408c of the transmitter support members 1406a, 1406b, and 1406c within the outer elongated member 1402, such as... Figure 14AAs shown. The outer elongated member 1402 covers the distal portions 1408a, 1408b, and 1408c of the transmitter support members 1406a, 1406b, and 1406c to prevent the transmitter support members from moving outward away from the longitudinal axis 1481 of the inner elongated member 1404 and the conduit 1400. Figure 14B As shown, sliding the outer elongated member proximally (or the inner elongated member 1404 distally) towards the proximal end 1404b of the inner elongated member 1404 exposes the respective distal portions 1408a, 1408b, and 1408c of the transmitter support members 1406a, 1406b, and 1406c. When the respective distal portions 1408a, 1408b, and 1408c are exposed, each respective distal portion 1408a, 1408b, and 1408c can move outward away from the inner elongated member 1404. The transmitter support members 1406a, 1406b, and 1406c can each carry one or more shock wave transmitters in their respective distal portions 1408a, 1408b, and 1408c, as described in further detail below. As the distal portions 1408a, 1408b, and 1408c move outward, the one or more shock wave emitters can move closer to the target lesion (e.g., calcification within or near a heart valve).

[0171] At least the distal portions 1408a, 1408b, and 1408c of the transmitter support members 1406a, 1406b, and 1406c may be configured to bend or flex outward from the inner elongated member 1404 when the outer elongated member 1402 does not cover the distal portions 1408a, 1408b, and 1408c. At least a portion of the transmitter support members 1406a, 1406b, and 1406c (including the distal portions 1408a, 1408b, and 1408c) may be formed of or contain a shape memory material, such as pre-formed nitinol. In some examples, shape memory material such as pre-formed nitinol wire may be inserted into the respective lumens of the transmitter support members 1406a, 1406b, and 1406c, including along at least a portion of the distal portions 1408a, 1408b, and 1408c. When the outer elongated member 1402 is in the retracted position, such that the distal portions 1408a, 1408b, and 1408c are not covered, the preformed material can cause the distal portions 1408a, 1408b, and 1408c to move outward away from the inner elongated member 1404 (e.g., Figure 14B (As shown).

[0172] The conduit 1400 may include a locking member 1410 configured to allow a user to selectively lock the outer elongated member 1402 to or unlock it from the inner elongated member 1404. The locking member 1410 may be configured to lock the outer elongated member 1402 to the inner elongated member 1404 when the locking member 1410 is rotated in a first direction, and to unlock the outer elongated member 1402 from the inner elongated member 1404 when the locking member 1410 is rotated in a second direction. In some examples, a first portion 1410a of the locking member 1410 may be rotated relative to a second portion 1410b of the locking member 1410 to lock and unlock the locking member 1410. Thus, when locked, the locking member prevents translation of the outer elongated member 1402 relative to the inner elongated member 1404. The locking member 1410 may be a Tuohy Brust or other locking mechanism.

[0173] Figure 14C Additional details of the distal end of the internal elongated member 1404 are depicted, including additional aspects of the transmitter support members 1406a, 1406b, and 1406c. The internal elongated member 1404 may include a plurality of recesses extending along the internal elongated member 1404, including recesses 1420a, 1420b, and 1420c. The transmitter support members including the transmitter support members 1406a, 1406b, and 1406c may each be positioned within a corresponding recess of the plurality of recesses 1420a, 1420b, and 1420c. For example, transmitter support member 1406a may be positioned within recess 1420a, transmitter support member 1406b may be positioned within recess 1420b, and transmitter support member 1406c may be positioned within recess 1420c. A portion (e.g., a proximal portion) of one or more of the transmitter support members 1406a-1406c may be glued or otherwise secured to a corresponding one of the recesses 1420a-1420c. The internal elongated member may also include a guidewire lumen 1450 extending along the length of the internal elongated member (e.g., from proximal end 1404b to distal end 1404a). During use, the catheter 1400 may advance along the guidewire located within the guidewire lumen 1450.

[0174] At least one shock wave transmitter may be mounted on each transmitter support member. The at least one shock wave transmitter may include any features of the shock wave transmitters disclosed herein, for example, as referenced... Figure 1The shock wave emitter 16 may have any of the features described herein. At least one shock wave emitter 1411a may be positioned on the distal portion 1408a of the emitter support member 1406a, at least one shock wave emitter 1411b may be positioned on the distal portion 1408b of the emitter support member 1406b, and at least one shock wave emitter 1411c may be positioned on the distal portion 1408c of the emitter support member 1406c. The shock wave emitters disposed on each emitter support member may be located within a corresponding housing mounted on each emitter support member. The housing may include one or more features described with reference to housing 18, expandable member 204, housing 203, expandable member 304, housing 303, tubular housings 603, 703, 803, expandable members 1004a-1004c and / or housings 1203 and 1303.

[0175] A first housing 1409a may be mounted on a transmitter support member 1406a. The first housing 1409a may surround at least a portion of the distal portion 1408a of the at least one shock wave transmitter 1411a and the transmitter support member 1406a. A second housing 1409b may be mounted to the transmitter support member 1406b. The second housing 1409b may surround at least a portion of the distal portion 1408b of the at least one shock wave transmitter 1411b and the transmitter support member 1406b. A third housing 1409c may be mounted to the transmitter support member 1406c. The third housing 1409c may surround at least a portion of the distal portion 1408c of the at least one shock wave transmitter 1411c and the transmitter support member 1406c. One or more housings mounted to the transmitter support member (including the first housing 1409a, the second housing 1409b, and the third housing 1409c) may be configured to expand when filled or infused with a conductive fluid. One or more of the first housing 1409a, the second housing 1409b, and the third housing 1409c may be formed of a semi-compliant or non-compliant material such that it does not stretch or stretches to a minimum when filled with fluid.

[0176] In some examples, multiple shock wave emitters may be located on one or more emitter support members. Figure 14DA detailed perspective view is shown, illustrating various aspects of the internal elongated member 1404 and the transmitter support members 1406a and 1406b. A first group of shock wave emitters 1411a are positioned within a housing 1409a along the transmitter support member 1406a. In some examples, these shock wave emitters 1411a are equidistant from each other along the length of the transmitter support member 1406a. In some examples, the distance between one or more of the plurality of shock wave emitters 1411a along the length of the transmitter support member 1406a may be closer than the distance between one or more of the other shock wave emitters 1411a along the length of the transmitter support member 1406a. A second group of shock wave emitters 1411b are positioned within a second housing 1409b along the transmitter support member 1406b. In some examples, the shock wave emitters 1411b are equidistant from each other along the length of the transmitter support member 1406b. In some examples, the distance between one or more of the plurality of shock wave emitters 1411b along the length of the emitter support member 1406b may be closer than the distance between one or more other shock wave emitters 1411b along the length of the emitter support member 1406b. The plurality of shock wave emitters 1411c may similarly be positioned on the emitter support member 1406c. Figure 14D (Not shown in the diagram). It should be understood that any number of transmitter support members can be provided on the conduit 1400, and any number of shock wave transmitters can be positioned on each corresponding transmitter support member.

[0177] As described above, shape memory materials, such as pre-formed nitinol wires, can be inserted into the respective cavities of transmitter support members 1406a, 1406b, and 1406c, including at least a portion along the distal portions 1408a, 1408b, and 1408c. Return Figure 14C The corresponding lumens are depicted extending along each of the emitter support members 1406a, 1406b, and 1406c. A first lumen 1413a extends along emitter support member 1406a, a second lumen 1413b extends along emitter support member 1406b, and a third lumen 1413c extends along emitter support member 1406c. When a portion of the inner elongated member 1404 is not covered by the outer elongated member 1402, a corresponding preformed member (e.g., preformed nitinol wire) can be inserted into one or more of the lumens, which can cause the emitter support members 1406a, 1406b, and 1406c to move outward (e.g., bend / bend) from at least a portion of the inner elongated member 1404.

[0178] As described above, the various catheters disclosed in this article can be used to treat lesions (such as calcifications) inside or around heart valves (such as aortic valves). Figure 15 Several aspects of an aortic valve 1500 are illustrated, and the catheter disclosed herein can be used to treat this aortic valve. Valve 1500 is a tricuspid valve, comprising three leaflets 1503a, 1503b, and 1503c. During use of catheter 1400, distal portions 1408a, 1408b, and 1408c of transmitter support members 1406a, 1406b, and 1406c can be positioned between the leaflets of valve 1500, respectively. For example, a first transmitter support member can be positioned in region 1502 of valve 1500, a second transmitter support member can be positioned in region 1504 of valve 1500, and a third transmitter support member can be positioned in region 1506 of valve 1500.

[0179] Figure 16 The flowchart shown represents the use of Figure 14A -E shows the catheter 1400 generating a shock wave, as per the steps of method 1600 for treating lesions formed between the leaflets of valve 1500. In box 1602, a user (e.g., a healthcare professional) can advance the catheter (e.g., catheter 1400) over a guidewire to a target treatment site, such as into the left ventricle or another heart valve, for example... Figure 15 Valve 1500 is depicted in the image. In frame 1604, the user can slide / translate the outer elongated member of the catheter proximally relative to the inner elongated member (e.g., referring to catheter 1400, from...). Figure 14A Slide / translate to the indicated extension position Figure 14B(The retracted position is shown). In some examples, before sliding the outer elongated member of the catheter proximally relative to the inner elongated member, the user can unlock the locking member of the catheter (e.g., locking member 1410) to unlock the outer elongated member from the inner elongated member. The user can unlock the locking member by rotating it. Sliding the outer elongated member of the catheter proximally relative to the inner elongated member can expose the distal portions of a plurality of transmitter support members (e.g., transmitter support members 1406a-1406c). Exposing the distal portions of the plurality of transmitter support members allows the distal portions of the plurality of transmitter support members to move outward from the longitudinal axis of the catheter and / or from the inner elongated member of the catheter toward the target treatment area. In an example where the target treatment site is a heart valve (e.g., valve 1500), the user can manipulate the catheter to place each distal portion of the catheter between the leaflets of the valve (e.g., within one of regions 1502, 1504, and 1506 of valve 1500). At block 1606, method 1600 may include introducing conductive fluid into one or more housings disposed on the one or more expandable elongated members. Each of the housings (e.g., housings 1409a-1409c of conduit 1400) may be introduced with conductive fluid independently of one or more remaining housings, or all of these housings may be introduced with conductive fluid simultaneously. At block 1608, one or more shock waves may be generated using at least one shock wave emitter located on at least one of the one or more emitter support members. After treatment, the user may translate / slide the outer elongated member distally relative to the emitter support member and / or the inner elongated member such that it covers the distal portion of the emitter support member, thereby pushing the emitter support member inward toward the longitudinal axis of the inner elongated member and / or the conduit.

[0180] Figure 17 The representative used Figure 14A A flowchart of the steps of method 1700, in which catheter 1400 generates a shock wave to treat, for example, a lesion formed between the leaflets of valve 1500, is shown. In box 1702, a user (e.g., a healthcare professional) can advance the catheter (e.g., catheter 1400) over a guidewire to the target treatment site, such as into the left ventricle or another heart valve, for example... Figure 15 Valve 1500 is depicted in the image. In frame 1704, the user can slide / translate the inner elongated member of the catheter distally relative to the outer elongated member (e.g., referring to catheter 1400, from...). Figure 14A The retraction position shown can be slid / translated to Figure 14B (The extended position is shown).

[0181] In some examples, before sliding the inner elongated member of the catheter distally relative to the outer elongated member, the user can unlock a locking member of the catheter (such as locking member 1410) to unlock the outer elongated member from the inner elongated member. The user can unlock the locking member by rotating it. Sliding the inner elongated member of the catheter distally relative to the outer elongated member can expose the distal portions of multiple transmitter support members (e.g., transmitter support members 1406a-1406c). Exposing the distal portions of the multiple transmitter support members allows them to move outward from the longitudinal axis of the catheter and / or from the inner elongated member of the catheter toward the target treatment area.

[0182] In an example where the target treatment site is a heart valve (e.g., valve 1500), the user can manipulate the catheter to position each distal portion of the catheter between the leaflets of the valve (e.g., within one of regions 1502, 1504, and 1506 of valve 1500). At block 1706, method 1700 may include introducing conductive fluid into one or more housings disposed on the one or more expandable elongated members. Each of the housings (e.g., housings 1409a-1409c of catheter 1400) may be introduced with conductive fluid independently of one or more remaining housings, or all of these housings may be introduced with conductive fluid simultaneously. At block 1708, one or more shock waves may be generated using at least one shock wave emitter located on at least one of the one or more emitter support members. After treatment, the user may translate / slide the inner elongated member proximally relative to the outer elongated member such that the outer elongated member covers the distal portion of the emitter support member, thereby pushing the emitter support member inward toward the longitudinal axis of the catheter and / or the inner elongated member.

[0183] Figure 18 It shows that it can be used Figure 1 An exemplary shockwave conduit 1800 of the conduit 10 shown. Conduit 1800 can be used with... Figures 10A-10B The catheters 1000 share one or more common features. The catheter 1800 includes multiple expandable members, including expandable member 1808 and expandable member 1810, which, when expanded, allow a user (e.g., a surgeon or other medical professional) to move at least one shockwave emitter 1806 closer to a lesion within the body lumen, such as a valve. The catheter 1800 is configured such that the at least one shockwave emitter 1806 can be brought close to a valve (e.g., Figure 3A and 3BThe catheter 1000 can locate lesions within the valve (as shown in the diagram) without relying on typical localization methods such as manipulation or centering occlusion. The catheter 1800 can also be configured such that blood flow is not completely blocked when multiple expandable members, including expandable members 1808 and 1810, expand. Therefore, the catheter 1000 can more effectively treat lesions within the body by allowing the user to impact the lesion with a relatively stronger shock wave.

[0184] The catheter 1800 includes a catheter body 1812 and an elongated member 1802. A housing 1804 is mounted on the elongated member 1802. Optionally, the housing 1804 is also mounted on the catheter body 1812. In some examples, the elongated member 1802 is formed as part of the catheter body 1812. The housing 1804 can be: compliant, such that it stretches when pressurized; non-compliant, such that it does not stretch or stretches minimally when pressurized with fluid; or semi-compliant. At least one shock wave emitter 1806 may be carried by the elongated member 1802 and disposed within the housing 1804. In some examples, the elongated member 1802 may be a distal portion of the catheter body. In some examples, the elongated member 1802 may extend within a lumen along at least a portion of the length of the catheter body 1812. Expandable members 1808 and 1810 are configured to expand to contact housing 1804 and laterally push housing 1804, elongated member 1802, and at least one shock wave emitter 1806 toward the lesion. The distal ends 1818 of expandable member 1808 and 1820 of expandable member 1810 can be connected to the distal end 1814 of housing 1804. Housing 1804, expandable members 1810, and expandable member 1808 can thus form a conductive fluid that can be introduced therein to expand the connected fillable / expandable space of expandable members 1808 and 1810, and also contribute to the generation of shock waves. Connecting the distal ends of expandable members 1808 and 1810 to the distal end of housing 1804 facilitates the passage of catheter 1800 within the vascular system. For example, connecting expandable members 1808 and 1810 to housing 1804 can prevent expandable members 1808 and 1810 from being jammed by certain aspects of the vascular system and / or prevent them from bending proximally away from housing 1804.

[0185] As described above, the catheter configuration with an expandable component for moving the shockwave emitter closer to the lesion site within the body makes it particularly suitable for treating lesions within heart valves. Different heart valves have different morphological characteristics. For example, some valves may have three leaflets and three corresponding cusps. Some valves may have two leaflets and two corresponding cusps. Some valves may have three leaflets but only two cusps. In use, the expandable component on the catheter disclosed herein can be selectively expanded to move the shockwave emitter closer to the lesion site based on the morphology of the valve being treated. Figure 19 Several aspects of a method 1900 for selectively inflating one or more expandable members of a catheter disclosed herein to treat a lesion within a valve are illustrated. At block 1902, method 1900 may include positioning the catheter near a target lesion on a heart valve. At block 1904, method 1900 may include filling a housing mounted on a support member carrying a plurality of shock wave emitters. At block 1906, method 1900 may include inflating at least one expandable member to move the support member carrying the plurality of shock wave emitters closer to the lesion. In some examples, no shock wave emitters are disposed within the at least one expandable member. In some examples, the heart valve may be a mitral valve having only two cusps, and in these examples, only one of the at least one expandable member is inflated. In some examples, the heart valve is an aortic valve having three cusps, and in such examples, at least two of the at least one expandable member is inflated. In any of these examples, the at least one expandable member is configured to expand to contact the housing mounted to the support member, thereby pushing the support member and the shock wave emitter closer to the lesion.

[0186] Figure 20A and 20B It shows that it can be used Figure 1 Multiple aspects of the exemplary catheter 2000 of the catheter 10 shown. The catheter 2000 may be configured to enable a user to treat lesions within or near a valve (e.g., a heart valve) without obstructing blood flow through the valve. The catheter 2000 may be configured to: enable a user to dilate or open a valve, for example, by pushing the valve leaflets outward; and be capable of generating one or more shock waves radially outward toward the valve leaflets and / or valve annulus from within the valve. The catheter 2000 may include a catheter body 2008 and an elongated member 2002 extending from a distal portion of an elongated member. A plurality of shock wave emitters 2006 may be located on the elongated member 2002 within a housing 2004 hermetically connected to the elongated member. The catheter 2000 may include an expandable frame 2012 at least partially surrounding the housing 2004. The expandable frame may be configured to... Figure 20A The collapsed position shown expands to Figure 20B The expanded position is shown. In the expanded position, the expandable frame can be positioned further away from the housing 2004 than in the collapsed position. The expandable frame 2012 can be a wire frame or a wire mesh. The expandable frame 2012 can be configured to self-expand when translated distally relative to the distal end of the outer sheath 2010. The expandable frame can be formed of a shape memory material such as nitinol. In some examples, the expandable frame is configured to collapse when translated proximally into the distal end of the outer sheath 2010. In some examples, the catheter 2000 includes one or more marking strips 2014 configured to allow a user to determine the location of the one or more shock wave emitters in the body (e.g., relative to the location of a lesion). For example, one marking strip 2014 may be located proximally to a plurality of shock wave emitters 2006, while another marking strip 2014 may be located distally to the plurality of shock wave emitters 2006. The catheter can be positioned such that a marking strip 2014 located distal to the plurality of shock wave emitters 2006 is positioned distal to the valve annulus, and a marking strip 2014 located proximal to the plurality of shock wave emitters 2006 is positioned proximal to the valve annulus. Therefore, the user can determine that the plurality of shock wave emitters are aligned with the valve annulus.

[0187] Figure 21 Several aspects of an exemplary method 2100 for generating shock waves to treat intravalvular lesions are illustrated. At block 2102, method 2100 may include positioning a catheter near a target lesion. The target lesion may be a calcified portion or other lesion on a valve (e.g., an aortic valve or mitral valve). The catheter may include an elongated member carrying one or more shock wave emitters and an expandable frame. The one or more shock wave emitters may be mounted radially inward on the elongated member of the expandable frame. At block 2104, method 2100 may include positioning the expandable frame across the valve annulus such that the plurality of shock wave emitters are aligned with the valve annulus. At block 2106, method 2100 may include inflating the expandable frame to radially outwardly move one or more valve leaflets. The expandable frame may be configured to allow fluid flow through it when inflated. For example, the expandable frame may be a wire frame or a mesh frame configured to allow fluid to bypass or pass through the frame. At block 2108, method 2100 may include generating one or more shock waves using the one or more shock wave emitters to treat the lesion.

[0188] Figure 22 It shows that it can be used Figure 1Several aspects of catheter 2200 of catheter 10 are shown. Catheter 1800 includes multiple expandable components, including expandable component 2208 and expandable component 2210, which, when expanded, allow a user (e.g., a surgeon or other medical professional) to move at least one shock wave emitter 2206 closer to a lesion such as a valve within the body lumen. Expandable component 2208 may be an expandable frame, such as a wire frame or mesh, which allows fluid to flow through or across the frame when expanded. Expandable component 2210 may be an expandable balloon or other shell configured to be filled / expanded with fluid. Using at least one expandable frame as one of the expandable components allows blood flow to continue during treatment as the expandable component expands. Therefore, catheter 2200 can more effectively treat lesions within the body by allowing the user to impact the lesion with a relatively stronger shock wave.

[0189] The catheter 2200 includes a catheter body 2201 and an elongated member 2202. A housing 2204 is mounted on the elongated member 2202. Optionally, the housing 2204 is also mounted on the catheter body 2201. In some examples, the elongated member 2202 is formed as part of the catheter body 2201. The housing 2204 can be: compliant, such that it stretches when pressurized; non-compliant, such that it does not stretch or stretches minimally when pressurized with fluid; or semi-compliant. At least one shock wave emitter 2206 may be carried by the elongated member 2202 and disposed within the housing 2204. In some examples, the elongated member 2202 may be a distal portion of the catheter body. In some examples, the elongated member 2202 may extend within a lumen along at least a portion of the length of the catheter body 2201. Expandable members 2208 and 2210 can be configured to expand to contact housing 2204 and push housing 2204, elongated member 2202 and at least one shock wave emitter 2206 laterally toward the lesion.

[0190] Although the electrode assemblies and catheter devices described herein are primarily discussed for the treatment of coronary artery occlusions, such as lesions in the vascular system, the electrode assemblies and catheters described herein can be used for a variety of different occlusions, such as those in the peripheral vascular system (e.g., above the knee, below the knee, iliac, carotid arteries, etc.). As another example, various embodiments 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, 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).

[0191] 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 generate bioactive scaffolds in which new cells (e.g., exogenous or endogenous cells) replace old cells; introducing porosity to the site to improve cell retention, cell penetration / migration, and diffusion of nutrients and signaling molecules, thereby promoting angiogenesis, cell proliferation, and tissue regeneration, similar to cell replacement therapy. This tissue engineering approach can be used to treat ischemic heart disease, fibrotic liver, fibrotic intestine, and traumatic spinal cord injury (SCI). For example, in the treatment of spinal cord injury, the devices and assemblies described herein can facilitate the removal of scarred spinal cord tissue, acting as a barrier to neuronal reconnection, prior to the injection of an anti-inflammatory hydrogel loaded with lentiviruses to genetically engineer spinal cord neurons for regeneration.

[0192] It should be noted that the elements and features of the exemplary catheters shown in this specification and accompanying drawings can be rearranged, recombined, and modified without departing from this invention. For example, although this specification and accompanying drawings describe and illustrate catheters with several exemplary balloon designs, this invention is intended to include catheters with a variety of different balloon configurations. The number, placement / position, and spacing of the electrode pairs of the shock wave generator can be modified without departing from this invention. Furthermore, the number, placement / position, and spacing of the balloons in the catheter can be modified without departing from this invention.

[0193] It should be understood that the foregoing is merely an explanation of the principles of this utility model, and various modifications, alterations, and combinations can be made by those skilled in the art without departing from the scope and spirit of this utility model. Any variation of the various catheters disclosed herein may include the features described in any other catheter or catheter combination herein. Furthermore, any method may be used with any of the disclosed catheters. Therefore, this utility model is not limited to any of the appended claims.

[0194] entry

[0195] 1. A conduit for generating a shock wave, the conduit comprising:

[0196] First slender member;

[0197] The housing mounted on the first slender member;

[0198] At least one shock wave emitter, the at least one shock wave emitter being supported by a first elongated member and disposed within a housing;

[0199] A first set of non-transmissive markings located on a first elongated member within the first housing;

[0200] Second slender member;

[0201] An expandable member mounted on a second elongated member, the expandable member being configured to expand to contact a housing mounted on a first elongated member; and

[0202] A second set of radiopaque markings located on a second elongated member within an expandable member, wherein the second set of radiopaque markings has an arrangement different from that of the first set of radiopaque markings.

[0203] 2. The catheter according to item 1, wherein the first elongated member extends distally from the catheter body.

[0204] 3. The catheter according to any one of items 1-2, wherein the first elongated member is the distal portion of the catheter body.

[0205] 4. The catheter according to any one of items 1-3, wherein different arrangements of radiopaque markers include different numbers of radiopaque markers.

[0206] 5. The catheter according to item 4, wherein the different arrangements of the radiopaque markers include different spacing between the radiopaque markers.

[0207] 6. The conduit according to any one of items 4-5, wherein a first set of radiopaque markings and a second set of radiopaque markings are arranged on the first and second elongated members such that:

[0208] When viewed from a first-angle perspective using radiographic imaging, the first group of radiopaque markers is collinear with the second group of radiopaque markers.

[0209] 7. The catheter according to item 6, wherein, when viewed from a second perspective using radiographic imaging, the first set of radiopaque markers and the second set of radiopaque markers are not collinear.

[0210] 8. The conduit according to any one of items 1-7, wherein the housing is non-compliant.

[0211] 9. The conduit according to any one of items 1-8, wherein the expandable member mounted on the second elongated member is a housing configured to expand upon expansion by means of fluid.

[0212] 10. The conduit according to item 9, wherein the conduit includes a first fluid channel for filling a housing mounted on a first elongated member and a second fluid channel for filling a housing mounted on a second elongated member, such that the housing mounted on the first elongated member can be filled independently of the housing mounted on the second elongated member.

[0213] 11. The catheter according to any one of items 1-10, wherein the first elongated member includes a lumen for a guidewire.

[0214] 12. The catheter according to any one of items 1-11, wherein the second elongated member includes a lumen for a guidewire.

[0215] 13. The catheter according to any one of items 1-12, wherein the distal end of the first elongated member is detached from / not connected to the distal end of the second elongated member.

[0216] 14. The catheter according to any one of items 1-13, wherein the first elongated member and the second elongated member extend proximally along at least a portion of the length of the catheter body within the same lumen.

[0217] 15. The conduit according to any one of items 1-14, wherein the at least one shock wave emitter is located on the side of the first elongated member opposite to the second elongated member.

[0218] 16. A method for positioning a shock wave generating catheter closer to a target lesion, the method comprising:

[0219] The catheter is advanced into the target lesion within the lumen;

[0220] Orient the catheter within the lumen such that a first elongated member including a first set of radiopaque markers is positioned relatively closer to the target lesion than a second elongated member including a second set of radiopaque markers.

[0221] The first elongated member of the catheter is moved closer to the target lesion by expanding the expandable member so that the expandable member pushes the first elongated member closer to the target lesion; and

[0222] One or more shock waves are generated using at least one shock wave emitter located on the first elongated member of the conduit.

[0223] 17. The method according to item 16 includes rotating the catheter to position a first elongated member of the catheter near the target lesion.

[0224] 18. The method according to any one of items 16-17, wherein the expandable member includes a housing, wherein expanding the expandable member connected to the second elongated member includes expanding the housing mounted on the distal end of the second elongated member to contact the housing mounted on the first elongated member.

[0225] 19. The method according to any one of items 16-17, wherein the expandable member includes an expandable frame, wherein expanding the expandable member includes moving a movable shaft connected to the expandable frame in a proximal direction.

[0226] 20. The method according to any one of items 16-19, wherein the at least one shock wave emitter of the conduit is located within a housing connected to the first elongated member.

[0227] 21. A system for generating a shock wave, the system comprising:

[0228] Shock wave energy generator; and

[0229] The catheter according to any one of items 1-20.

[0230] 22. A conduit for generating a shock wave, the conduit comprising:

[0231] Catheter body;

[0232] A tubular housing, sealed to the distal end of a catheter body, includes an outer cylindrical wall, an inner cylindrical wall, and a fillable region between the outer and inner cylindrical walls, the fillable region being configured to be filled with fluid, wherein a distal portion of the catheter body is positioned within the fillable region; and

[0233] At least one shock wave emitter is disposed on the conduit body in a fillable region located between the outer cylindrical wall and the inner cylindrical wall.

[0234] 23. The conduit according to item 22, wherein when the tubular housing is filled with fluid, the inner cylindrical wall defines an open passage.

[0235] 24. The catheter according to item 23, wherein the open channel is configured to allow bodily fluid flowing within the bodily lumen to pass through the open channel when the catheter is placed in a body lumen and the tubular housing is filled with fluid.

[0236] 25. The conduit according to any one of items 22-24, wherein the tubular housing is semi-compliant.

[0237] 26. The catheter according to any one of items 22-25, wherein the tubular housing is a non-compliant balloon.

[0238] 27. The catheter according to any one of items 22-26, wherein the compliance of the outer cylindrical wall is different from the compliance of the inner cylindrical wall.

[0239] 28. The conduit according to any one of items 22-27, wherein the distal portion of the tubular housing includes a tapered region.

[0240] 29. The catheter according to any one of items 22-28, wherein the diameter of the outer cylindrical wall is in the range of 10 mm to 30 mm.

[0241] 30. The catheter according to any one of items 22-29, wherein the inner cylindrical wall has a diameter of at least 6 mm.

[0242] 31. The catheter according to any one of items 22-30, wherein the tubular housing comprises a proximal cylindrical wall located at the proximal end of the balloon and a distal cylindrical wall located at the distal end of the balloon, wherein the proximal cylindrical wall and the distal cylindrical wall are sealingly connected to the catheter body.

[0243] 32. The conduit according to any one of items 22-31, wherein the tubular housing comprises / is made of shape memory material.

[0244] 33. The catheter according to any one of items 22-32, wherein the catheter includes a braided outer shaft on the proximal portion of the catheter body.

[0245] 34. The conduit according to any one of items 22-33, wherein the at least one shock wave emitter is configured to emit a shock wave toward the outer cylindrical wall.

[0246] 35. The conduit according to item 34, wherein the at least one shock wave emitter is positioned at a circumferential location of the conduit body closest to the outer cylindrical wall.

[0247] 36. A method for positioning a shock wave generating catheter closer to a target treatment area, the method comprising:

[0248] A catheter is advanced within a lumen, the catheter comprising a tubular housing mounted on a catheter body;

[0249] Position the distal portion of the catheter such that at least one shock wave emitter of the catheter is positioned near the target treatment area;

[0250] The tubular shell is filled to form open channels through which body fluids flow;

[0251] One or more shock waves are generated using at least one shock wave emitter in the conduit.

[0252] 37. The method according to item 36, comprising:

[0253] This causes the tubular shell to contract;

[0254] Rotate the catheter to position the at least one shock wave emitter near different target treatment areas;

[0255] Filled tubular shell; and

[0256] The at least one shock wave emitter using the conduit generates one or more additional shock waves.

[0257] 38. The method according to any one of items 36-37, wherein positioning the distal portion of the catheter such that at least one shock wave emitter of the catheter is positioned near the target treatment area comprises:

[0258] The distal portion of the transvalvular positioning catheter.

[0259] 39. The method according to any one of items 36-38, wherein the distal portion of the catheter is positioned such that at least one shock wave emitter of the catheter is positioned near the target treatment area:

[0260] Position the distal portion of the catheter near the aortic or mitral valve leaflets.

[0261] 40. A system for generating a shock wave, the system comprising:

[0262] Shock wave energy generator; and

[0263] The catheter according to any one of items 22-39.

[0264] 41. A conduit for generating a shock wave, the conduit comprising:

[0265] Slender components;

[0266] A housing mounted on a slender component;

[0267] At least one shock wave emitter, which is supported by an elongated member and disposed within a housing;

[0268] A first expandable member extends away from the elongated member in a first direction and is configured to expand to contact a housing mounted on the elongated member; and

[0269] A second expandable member extends in a second direction away from the elongated element and the first expandable member, and is configured to expand to contact the housing mounted on the elongated element.

[0270] 42. The conduit according to item 41, wherein a first expandable member is mounted on a second elongated member, and a second expandable member is mounted on a third elongated member.

[0271] 43. The conduit according to any one of items 41-42, wherein, when filled with fluid, the first expandable member and the second expandable member have substantially equal outer diameters.

[0272] 44. The conduit according to item 43, wherein, when filled with fluid, the housing has a substantially the same outer diameter as the first expandable member and the second expandable member.

[0273] 45. The conduit according to any one of items 41-44, wherein at least one radiopaque marker is located on the elongated member.

[0274] 46. ​​A system for generating a shock wave, the system comprising:

[0275] Shock wave energy generator; and

[0276] The catheter according to any one of items 41-45.

[0277] 47. A conduit for generating a shock wave, the conduit comprising:

[0278] First slender member;

[0279] The housing mounted on the first slender member;

[0280] At least one shock wave emitter, which is supported by a first elongated member and disposed within a housing;

[0281] The second slender member; and

[0282] An expandable frame mounted on a second elongated member, the expandable frame being configured to expand to contact a housing mounted on a first elongated member, wherein the expandable frame is configured such that blood can flow through the expandable frame when the catheter is located in a blood vessel and the expandable frame expands.

[0283] 48. The conduit according to item 47, wherein the expandable frame comprises a plurality of expandable members.

[0284] 49. The catheter according to any one of items 47-48, wherein the expandable frame comprises a helical member.

[0285] 50. The catheter according to any one of items 47-49, comprising a movable shaft connected to an expandable frame, the movable shaft being configured to expand and collapse the expandable frame.

[0286] 51. A conduit for generating a shock wave, the conduit comprising:

[0287] Slender internal components;

[0288] An outer elongated member extending radially outward from the inner elongated member, wherein the outer elongated member is translatable relative to the inner elongated member between a retracted position and an extended position.

[0289] At least one support member, wherein when the outer elongated member is in the extended position, the at least one support member is at least partially located between the inner elongated member and the outer elongated member, wherein the at least one support member is configured to move outward from the inner elongated member when the outer elongated member is translated from the extended position to the retracted position; and

[0290] At least one shock wave emitter is mounted on the at least one expandable emitter support member.

[0291] 52. The conduit according to item 51, wherein at least one support member comprises a pre-formed memory material configured to move outward from the inner elongated member as the outer elongated member translates from the extended position to the retracted position.

[0292] 53. The conduit according to any one of items 51-52, wherein the at least one support member includes a lumen, wherein the pre-formed shape memory material is positioned within the lumen.

[0293] 54. The conduit according to any one of items 51-53, comprising a user-engageable locking member configured to lock an outer elongated member to an inner elongated member such that the outer elongated member cannot translate relative to the inner elongated member.

[0294] 55. The conduit according to item 54, wherein a locking member rotates in a first direction to lock the outer elongated member to the inner elongated member.

[0295] 56. The conduit according to any one of items 51-55, wherein the at least one support member is positioned within at least one groove of the internal elongated member.

[0296] 57. The conduit according to any one of items 51-56, comprising a housing mounted to the at least one expandable member, wherein the at least one shock wave emitter is positioned within the housing.

[0297] 58. A method for treating lesions in vivo, the method comprising:

[0298] The catheter is advanced into the target lesion within the body's lumen;

[0299] Slide the elongated member proximally to deploy one or more elongated support members, such that the one or more elongated support members move outward from the longitudinal axis of the conduit;

[0300] Introducing conductive fluid into one or more housings disposed on one or more elongated support members;

[0301] One or more shock waves are generated using at least one shock wave emitter located on at least one of the one or more elongated support members.

[0302] 59. The method according to item 58, comprising: rotating a locking member to unlock the outer elongated member from the second elongated member before sliding the outer elongated member proximally.

[0303] 60. The method according to any one of items 58-59, comprising: manipulating a catheter to position a portion of each of the one or more elongated support members in the corresponding valve apex.

[0304] 61. The method according to any one of items 58-60, comprising: sliding the elongated member distally to cause the elongated support member to collapse inward.

[0305] 62. The method according to any one of items 58-61, wherein each of the one or more housings is introduced with fluid independently of one or more other housings.

[0306] 63. The method according to any one of items 58-62, wherein fluid is introduced simultaneously into each of the one or more housings.

Claims

1. A conduit for generating shock waves, characterized in that, The catheter includes: First slender member; A housing mounted on the first elongated member; At least one shock wave emitter, the at least one shock wave emitter being carried by the first elongated member and disposed within the housing; A first set of non-transparent markings located on the first elongated member within the housing; Second slender member; An expandable member mounted on the second elongated member, the expandable member being configured to expand to contact the housing mounted on the first elongated member; and A second set of radiopaque markings is located on the second elongated member within the expandable member, wherein the second set of radiopaque markings has a different arrangement of radiopaque markings than the first set of radiopaque markings.

2. The conduit for generating shock waves according to claim 1, characterized in that, Different arrangements of radiopaque markers include different numbers of radiopaque markers.

3. The conduit for generating shock waves according to claim 2, characterized in that, Different arrangements of radiopaque markings include different spacing between radiopaque markings.

4. The conduit for generating shock waves according to claim 2, characterized in that, The first set of radiopaque markings and the second set of radiopaque markings are arranged on the first elongated member and the second elongated member in such a way that: When viewed from a first perspective using radiographic imaging, the first set of radiopaque markers and the second set of radiopaque markers are collinear.

5. The conduit for generating shock waves according to claim 4, characterized in that, When viewed from a second perspective using radiographic imaging, the first set of radiopaque markers and the second set of radiopaque markers are not collinear.

6. The conduit for generating shock waves according to claim 1, characterized in that, The expandable member mounted on the second elongated member is a shell configured to expand when injected with fluid.

7. The conduit for generating shock waves according to claim 6, characterized in that, The conduit includes a first fluid channel for filling a housing mounted on the first elongated member and a second fluid channel for filling a housing mounted on the second elongated member, such that the housing mounted on the first elongated member can be filled independently of the housing mounted on the second elongated member.

8. The conduit for generating shock waves according to claim 1, characterized in that, One or both of the first elongated member and the second elongated member include a lumen for guidewire.

9. The catheter according to claim 1, characterized in that, The distal end of the first elongated member is not connected to the distal end of the second elongated member.

10. The conduit for generating shock waves according to claim 1, characterized in that, The first elongated member and the second elongated member extend proximally along at least a portion of the length of the catheter body within the same lumen.

11. The conduit for generating shock waves according to claim 1, characterized in that, The at least one shock wave emitter is located on the side of the first elongated member opposite to the second elongated member.

12. The conduit for generating shock waves according to claim 1, characterized in that, The expandable member mounted on the second elongated member is an expandable frame configured to allow fluid to pass through the expandable frame when it expands.

13. The conduit for generating shock waves according to claim 12, characterized in that, The conduit includes a movable shaft configured such that translation of the movable shaft in a first direction causes the expandable frame to expand, and translation of the movable shaft in a second direction causes the expandable frame to collapse.

14. The conduit for generating shock waves according to claim 12, characterized in that, The expandable frame includes at least one of a wire frame and a mesh.

15. The conduit for generating shock waves according to claim 12, characterized in that, The expandable frame is configured to be self-expanding.

16. The conduit for generating shock waves according to claim 1, characterized in that, The distal end of the expandable member is located near the distal end of the housing.

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