Shockwave catheter for treating lesion of body lumen and system for delivering and removing fluid from shockwave catheter

Abstract

The utility model provides a shock wave catheter used for treating lesions of a body lumen. The shockwave catheter includes at least one shockwave emitter disposed within a distal portion of the shockwave catheter and configured to generate shockwaves. The end of the wire extending within the elongated tube may form a shock wave emitter. The shockwave emitter may be surrounded by a housing that may be filled with a conductive fluid delivered by a lumen of the elongate tube. The elongate tubes may include helical coils or slits therein that enable the shockwave catheters to have flexibility in conjunction with the narrow profile of the shockwave catheters described herein such that they can be used to navigate and treat small tortuous blood vessels. The utility model further provides a system for conveying fluid through the shock wave catheter and removing the fluid from the shock wave catheter.

Description

Technical Field

[0001] The present utility model generally relates to the field of medical devices and medical methods, and more particularly, to a shock wave catheter for treating calcified lesions within a body lumen, such as calcified lesions and occlusions in the vasculature and kidney stones in the urinary system. Background Art

[0002] A variety of catheters have been developed for treating calcified lesions, such as calcified lesions associated with arterial diseases in the vasculature. For example, treatment systems for percutaneous coronary angioplasty or peripheral angioplasty use an angioplasty balloon to dilate a calcified lesion and restore normal blood flow in the blood vessel. In these types of procedures, a catheter carrying the balloon is advanced into the vasculature along a guide wire until the balloon is aligned with the calcified plaque. The balloon is then pressurized (usually to a pressure above 10 standard atmospheres), causing the balloon to expand within the blood vessel to push the calcified plaque back into the vessel wall and dilate the occluded area of the vasculature.

[0003] Recently, the techniques and treatments of intravascular lithotripsy (IVL), an interventional procedure for improving calcified plaques in diseased arteries, have been developed. The mechanism of plaque improvement is by using a catheter having one or more acoustic shock wave generating sources located within a fluid, which can generate acoustic shock waves for improving the calcified plaque. IVL devices differ in design with respect to the energy source used to generate the acoustic shock waves, with two example energy sources being an electrohydraulic generator and a laser generator.

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

[0005] The IVL process can be considered different from standard atherectomy because it fractures calcium but does not release the fractured calcium from the tissue. Thus, generally speaking, IVL does not require aspiration or embolic protection. Additionally, due to the compliance of normal blood vessels and uncalcified plaques, the shock waves generated by IVL do not improve normal vascular tissue or uncalcified plaques. Moreover, IVL does not pose the same degree of risk of perforation, dissection, or other vascular injuries as angioplasty atherectomy using cutting or scoring balloons.

[0006] More specifically, catheters have been developed for delivering IVL therapy that include electrode pairs for generating shock waves electrohydraulically within an angioplasty balloon. The shock wave device may be particularly effective in treating calcified plaque lesions because the acoustic pressure from the shock wave can fracture and disrupt the lesion near the angioplasty balloon without harming the surrounding tissue. In these devices, the catheter is advanced over a guide wire through the patient's vasculature until it is positioned near and / or aligned with the calcified plaque lesion within the body lumen. The balloon is then inflated with a conductive fluid (using a relatively low pressure of 2 - 4 atmospheres) such that the balloon expands to contact the lesion, but the inflation pressure does not substantially displace the lesion. A voltage pulse can then be 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 fractured by the acoustic shock wave, the balloon can be further inflated to increase the cross-sectional area of the lumen and improve blood flow through the lumen. Alternative devices for delivering IVL therapy can be within an enclosed volume other than an angioplasty balloon, such as a cap, balloons of various compliances, or other sheaths.

[0007] Treating an occluded area of a blood vessel using a shock wave device typically involves a surgeon threading a guide wire through the blood vessel, including through the occluded area. The guide wire is typically very narrow (e.g., as small as about 0.35 mm in diameter) and has a soft, flexible tip to avoid penetrating the blood vessel wall when passing through the vessel. Once the guide wire has passed through the occlusion, the angioplasty balloon is then moved along the guide wire to the occluded location. Unfortunately, in cases where the blood vessel is completely or almost completely occluded (e.g., chronic total occlusion), even the guide wire may not be able to pass through the occlusion. For example, the occlusion may be too tight and solid for the soft guide wire to pass through. In these cases, stiffer guide wires can be used, but they increase the risk of the guide wire penetrating the blood vessel wall. It has been proposed to use guide wires that utilize radiofrequency energy to open the occlusion as the guide wire passes through the occluded blood vessel. However, the heat generated by the radiofrequency energy is typically too strong and poses a risk of damaging the blood vessel wall. The difficulty of passing the guide wire through the occlusion becomes greater when the occluded blood vessel is narrow and / or tortuous. The surgeon must be extremely careful in such cases and must continuously move the guide wire without pausing to avoid vascular injury. Summary of the Utility Model

[0008] The present disclosure relates to a shock wave catheter for intravascular lithotripsy (IVL) and methods of using the same that do not use a guide wire to manipulate and position the shock wave catheter (referred to herein as a “wireless” shock wave catheter). The wireless shock wave catheter disclosed herein may include a core wire that enables a user to manipulate and position the shock wave catheter. The wireless shock wave catheter may be configured to be flexible to allow manipulation of the catheter in tortuous regions of the vasculature. The flexibility of the shock wave catheter may be achieved by a helical coil or slit in the elongate tube of the shock wave catheter surrounding the core wire. Since the wireless shock wave catheter does not include a lumen for a guide wire, the wireless shock wave catheter may have a lower / thinner profile than a catheter that uses a guide wire while still being able to effect navigation in narrow and tortuous lumens. In other words, the catheter disclosed herein may be deployed as a vascular wire with the added functionality of providing IVL treatment.

[0009] The wireless shock wave catheter includes a shock wave emitter configured to facilitate the flexibility and maneuverability of the catheter. For example, the wireless shock wave catheter may include a pair of wires that form a pair of electrodes at their distal tips. The pair of electrodes may be positioned at an opening in the catheter body such that a shock wave can propagate outwardly and / or distally from the catheter. In another example, the wireless shock wave catheter includes a shock wave emitter assembly within the distal portion of the catheter that is capable of bending and deflecting to maneuver the shock wave catheter through a body lumen. The shock wave emitter assembly may include each of a distal shock wave emitter and a lateral shock wave emitter. In another example, the wireless shock wave catheter includes a conductive elongate tube and a conductive core wire extending within the tube that form a shock wave emitter at the distal ends of the elongate tube and the core wire.

[0010] In some examples, there is provided a shock wave catheter for treating a lesion in a body lumen, the shock wave catheter including: an elongate tube; at least one shock wave emitter disposed distally of the elongate tube and configured to generate at least one shock wave; a distal tip disposed at or near the distal end of the at least one shock wave emitter; and a housing surrounding at least the at least one shock wave emitter.

[0011] In some examples, there is provided a shock wave catheter for treating a lesion in a body lumen, the shock wave catheter including: an elongate tube including at least one window; a core wire extending within the elongate tube and fixed to the distal end of the elongate tube; at least one shock wave emitter at least partially surrounded by the elongate tube and configured to generate at least one shock wave that propagates through the at least one window; and a housing surrounding at least a portion of the elongate tube and surrounding at least one shock wave emitter.

[0012] In some examples, a shock wave catheter for treating a lesion in a body lumen is provided. The shock wave catheter includes: a shock wave emitter assembly including: a first shock wave emitter configured to emit at least one distally-directed shock wave; and a second shock wave emitter disposed proximally to the first shock wave emitter and configured to emit at least one laterally-directed shock wave; an elongate tube coupled to the shock wave emitter assembly; and a housing surrounding the coupled shock wave emitter assembly and the elongate tube.

[0013] In some examples, a method for treating a lesion in a body lumen is provided, including: advancing a shock wave catheter through the body lumen without using a guide wire such that at least one shock wave emitter enclosed within a housing of the shock wave catheter is positioned near the lesion in the body lumen; and generating at least one shock wave by the at least one shock wave emitter to treat the lesion.

[0014] In some examples, a system for treating a lesion in a body lumen is provided, including: a shock wave catheter including: an elongate tube; at least one shock wave emitter disposed distally of the elongate tube and configured to generate at least one shock wave; a core wire extending within the elongate tube and terminating near the shock wave emitter; a distal tip disposed at or near a distal end of the shock wave emitter; and a housing surrounding at least the shock wave emitter; and a pulse generator coupled to the at least one shock wave emitter and configured to generate an energy pulse to cause the at least one shock wave emitter to generate the at least one shock wave.

[0015] In some examples, a system for delivering fluid and removing fluid from a shock wave catheter is provided, including: a shock wave catheter, which includes: an elongated tube, the elongated tube including at least one opening leading to the lumen of the elongated tube at a proximal portion of the elongated tube; a wire, the wire extending within the elongated tube and terminating near the distal end of the elongated tube; a shock wave emitter, the shock wave emitter formed by the distal end of the elongated tube and at least a portion of the wire and configured to be capable of generating at least one shock wave; and a housing surrounding the shock wave emitter and fluidly connected to the lumen of the elongated tube; and a control handle, which is connected to the proximal portion of the elongated tube, the control handle including: at least one pressure seal, which seals the at least one opening of the elongated tube; and a fluid port, which is fluidly connected to the at least one opening of the elongated tube, a vacuum pressure source, and a conductive fluid source to (a) reduce the pressure in at least one of the lumen of the elongated tube and the housing, and (b) subsequently draw the conductive fluid into at least one of the lumen of the elongated tube and the housing. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] The present utility model will now be described by way of example only with reference to the accompanying drawings, wherein:

[0017] Figure 1 An exemplary shock wave catheter system according to one or more aspects of the present utility model is shown.

[0018] Figure 2A A perspective view of a distal portion of an exemplary shock wave catheter including a laterally emitting shock wave emitter according to one or more aspects of the present utility model is shown.

[0019] Figure 2B Shown is according to one or more aspects of the present utility model Figure 2A an enlarged view of the laterally emitting shock wave emitter.

[0020] Figure 3A A perspective view of a distal portion of an exemplary shock wave catheter according to one or more aspects of the present utility model is shown, the shock wave catheter including a shock wave emitter located at the distal end of the elongated tube of the shock wave catheter.

[0021] Figure 3B Shown is according to one or more aspects of the present utility model Figure 3A an enlarged view of the shock wave emitter.

[0022] Figure 4 A cross-sectional view of an exemplary shock wave catheter including a shock wave emitter according to one or more aspects of the present utility model is shown.

[0023] Figure 5A perspective view of a distal portion of an exemplary shock wave catheter in accordance with one or more aspects of the present utility model is shown, the shock wave catheter including a conductive core wire disposed within a conductive elongate tube.

[0024] Figure 6 A cross-sectional view of an exemplary shock wave catheter in accordance with one or more aspects of the present utility model is shown, the shock wave catheter including a conductive core wire disposed within a conductive elongate tube.

[0025] Figure 7A A perspective view of a distal portion of an exemplary shock wave catheter including a shock wave emitter assembly in accordance with one or more aspects of the present utility model is shown, the shock wave emitter assembly including a laterally emitting shock wave emitter and a distally emitting shock wave emitter.

[0026] Figure 7B Another perspective view of a distal portion of an exemplary shock wave catheter including a shock wave emitter assembly in accordance with one or more aspects of the present utility model is shown.

[0027] Figure 7C A side view of a distal portion of an exemplary shock wave catheter including a shock wave emitter assembly in accordance with one or more aspects of the present utility model is shown.

[0028] Figure 7D Another side view of a distal portion of an exemplary shock wave catheter including a shock wave emitter assembly in accordance with one or more aspects of the present utility model is shown.

[0029] Figure 7E An enlarged view of a mechanism for connecting a shock wave emitter assembly to an elongate tube of an exemplary shock wave catheter in accordance with one or more aspects of the present utility model is shown.

[0030] Figure 8 A side view of an elongate tube of an exemplary shock wave catheter in accordance with one or more aspects of the present utility model is shown, as well as enlarged views of different portions of the elongate tube.

[0031] Figure 9A A perspective view of a shock wave emitter assembly of an exemplary shock wave catheter in accordance with one or more aspects of the present utility model is shown.

[0032] Figure 9B Another perspective view of a shock wave emitter assembly of an exemplary shock wave catheter in accordance with one or more aspects of the present utility model is shown.

[0033] Figure 10A A perspective view of a distal portion of an exemplary shock wave catheter including a distally emitting shock wave emitter in accordance with one or more aspects of the present utility model is shown.

[0034] Figure 10B Another perspective view of a shock wave catheter according to one or more aspects of the present invention, in which the outer shell of the shock wave catheter is removed. Figure 10A

[0035] Figure 10C Another perspective view of a shock wave catheter according to one or more aspects of the present invention Figure 10A - 10B Cross-sectional view of the shock wave catheter according to one or more aspects of the present invention, taken through the distal tip of the shock wave catheter.

[0036] Figure 11 An exemplary shock wave catheter having a braided elongate tube according to one or more aspects of the present invention.

[0037] Figure 12 An exemplary shock wave catheter having a non-helical elongate tube at least partially surrounded by an outer member according to one or more aspects of the present invention.

[0038] Figure 13 Perspective view of an exemplary control handle according to one or more aspects of the present invention, the control handle being attached to the catheter and receiving a switch for controlling the catheter.

[0039] Figure 14 Perspective view of an exemplary control handle according to one or more aspects of the present invention, the control handle being attached to the catheter and including a fluid outlet having a check valve for controlling the removal of fluid from the catheter.

[0040] Figure 15A Side view of an exemplary control handle according to one or more aspects of the present invention, the control handle being attached to the catheter and receiving a stopcock for controlling the flow of fluid into and out of the catheter.

[0041] Figure 15B Perspective view of a control handle according to one or more aspects of the present invention, the control handle being attached to the catheter and receiving a stopcock for controlling the flow of fluid into and out of the catheter.

[0042] Figure 16 An exemplary method for controlling the flow of fluid into and out of a catheter using a stopcock fluidly connected to the catheter according to one or more aspects of the present invention.

[0043] Figure 17A Showing the attachment of a stopcock to a control handle, the control handle being attached to the catheter, according to one or more aspects of the present invention.

[0044] Figure 17B Showing the introduction of a vacuum pressure into the control handle and the attached catheter via the stopcock according to one or more aspects of the present invention.

[0045] Figure 17C Illustrates the introduction of fluid into a control handle and an attached conduit via a stopcock valve, according to one or more aspects of the present invention.

[0046] Figure 18 Illustrates an exemplary computing system, according to one or more aspects of the present invention. Detailed Description

[0047] The following description is presented to enable a person having ordinary skill in the art to make and use the various embodiments and aspects disclosed herein. The description of specific devices, components, techniques, and applications is provided only as an example. Various modifications to the examples described herein will be apparent to a person having ordinary skill in the art, and the general principles described herein may be applied to other examples and applications without departing from the spirit and scope of the various embodiments and aspects. Thus, the various embodiments and aspects are not intended to be limited to the examples described and illustrated herein, but are to be accorded a scope consistent with the claims.

[0048] A shock wave catheter and method of using the same are described herein that do not use a guide wire to manipulate and position the shock wave catheter within a body lumen. In other words, the shock wave catheter described herein is "guide wireless". The guide wireless shock wave catheter may include a core wire for manipulating and positioning the shock wave catheter, rather than sliding the catheter over a guide wire. By eliminating the guide wire lumen, the overall profile of the shock wave catheter can be narrow enough (e.g., similar to the profile of a guide wire) such that the guide wireless shock wave catheter can be guided through tortuous and narrow body lumens. The guide wireless shock wave catheter can be flexible to enable manipulation of the shock wave catheter through these body lumens. For example, the elongate tube of the shock wave catheter surrounding the core wire may include one or more helical coils or slits along the elongate tube of the shock wave catheter.

[0049] The wire-free shock wave catheter described herein achieves a narrow, flexible profile while still incorporating the features of a shock wave delivery device capable of generating and delivering shock waves. Accordingly, the wire-free shock wave catheter can be utilized to achieve acute lumen gain in severely occluded lesions such as chronic total occlusions. Additionally, the wire-free shock wave catheter incorporates components for generating shock waves in a manner that facilitates the flexibility and maneuverability of the shock wave catheter. For example, the wire-free shock wave catheter can include a pair of wires extending therein, with the ends of the pair of wires forming a shock wave emitter. The shock waves can propagate outwardly and / or distally from the shock wave emitter of the catheter. In another example, the elongate tube and the core wire of the shock wave catheter can themselves be conductive to form a shock wave emitter at their distal ends. In another example, the wire-free shock wave catheter can include a shock wave emitter assembly within the distal portion of the catheter, and the shock wave emitter assembly can be bent and deflected to maneuver the shock wave catheter. The shock wave emitter assembly can include a number of shock wave emitters such as a distal-emitting shock wave emitter and a laterally-emitting shock wave emitter.

[0050] The use of a wire-free shock wave catheter can reduce the procedure time because it can reduce the number of procedure steps. By reducing the number of procedure steps and the total time spent in the procedure, the risk associated with procedure complications can also be reduced. Using the shock wave catheter described herein can be as simple as advancing the shock wave catheter through a body lumen to position one or more shock wave emitters of the shock wave catheter near a lesion in the body lumen.

[0051] As used herein, the term "electrode" refers to a conductive element (usually made of metal) that receives an electric current and then releases the current to another conductive element. In the context of the present utility model, the electrodes can be positioned relative to each other, for example, in an arrangement of internal electrodes and external electrodes. Thus, as used herein, the term "electrode pair" refers to two electrodes that are adjacent to and spaced apart from each other such that applying a sufficiently high voltage to the electrode pair will cause an electric current to be transmitted across the gap between the two electrodes (also referred to as the "spark gap") (e.g., from the internal electrode to the external electrode, or vice versa, optionally, the current passes through a conductive fluid or conductive gas therebetween). More information regarding the physical properties of shock wave generation and its control can be found in U.S. Patents US 8,728,091, US 9,522,012, and US 10,226,265, all of which are incorporated herein by reference in their entirety. In some cases, one or more electrode pairs may also be referred to as an electrode assembly. In the context of the present utility model, the term "shock wave emitter" generally refers to such a region of the electrode assembly in which an electric current is transmitted across the electrode pair, thereby generating a shock wave. The term "emitter strip" refers to a continuous or discontinuous strip of conductive material that can be formed as one or more electrodes in one or more electrode pairs, thereby forming the location of one or more emitters. One or more emitters, emitter strips, and / or electrodes can be formed of a metal, such as stainless steel, copper, tungsten, platinum, palladium, molybdenum, cobalt, chromium, iridium, or an alloy thereof, such as a cobalt-chromium alloy, a platinum-chromium alloy, a cobalt-chromium-platinum-palladium-iridium alloy, or a platinum-iridium alloy, or a mixture of these materials.

[0052] Although the shock wave catheter described herein generates shock waves based on a high voltage applied to the electrodes, it should be understood that the shock wave catheter can additionally or alternatively include a laser and an optical fiber as a shock wave emitter system, whereby a laser source delivers energy through the optical fiber into a fluid to form shock waves and / or vapor bubbles.

[0053] In the following description of various different embodiments with reference to the accompanying drawings, specific embodiments that can be implemented are shown by way of example in the drawings. It should be understood that other embodiments and examples can be implemented and changes can be made without departing from the scope of the present utility model.

[0054] In addition, it should also be understood that, unless the context clearly indicates otherwise, the singular forms "a", "an", and "the" used in the following description are also intended to include the plural forms. It should also be understood that the term "and / or" as used herein refers to and encompasses any and all possible combinations of one or more of the associated listed items. It should also be understood that the terms "comprises" and / or "comprising" when used herein specify the presence of the stated features, integers, steps, operations, elements, components, and / or units, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, units, and / or groups thereof. As described herein, it should be understood that any disclosure of a numerical range describing a dimension or measurement (such as thickness, length, weight, time, frequency, temperature, voltage, current, angle, etc.) includes any numerical increment or gradient within the range provided relative to the given dimension or measurement.

[0055] The wireless shock wave catheter can be configured to be used with an angioplasty balloon, such as those described in U.S. Patents US 9,730,715 and US10,420,569, all of which are incorporated herein by reference in their entirety. The wireless shock wave catheter can be configured to direct shock waves in different directions. For example, according to the principles described herein, a forward-biased shock wave catheter, such as those described in U.S. Patent US10,966,737 and U.S. Patent Application Publication No. US2019 / 0388110, directs shock waves in a generally forward direction (e.g., distally from the distal end of the catheter) and can be configured to be used without a guide wire, both of which patent documents are incorporated herein by reference in their entirety. The wireless shock wave catheter can be configured to generate constructively interfering shock waves emitted from multiple locations, such as those described in U.S. Patent Application Publication No. US2023 / 0123003, which is incorporated herein by reference in its entirety. The wireless shock wave catheter can be configured to deliver a number of high voltage pulses in groups (i.e., can operate in a "burst mode / point firing mode") over a short duration, such as those described in U.S. Patent Application No. US18 / 595,148, the entire content of which is incorporated herein by reference. The wireless shock wave catheter can be configured to include an array of low-profile electrode assemblies that reduce the cross-section of the catheter and allow the catheter to more easily pass through narrow body lumens, such as those described in U.S. Patents US8,888,788 and US10,709,462 and U.S. Patent Application Publication No. US2021 / 0085347, all of which are incorporated herein by reference in their entirety. In some examples, the wireless shock wave catheter described herein can be used as a guide wire for other intravascular systems. For example, the wireless shock wave catheter can be used as a guide wire for delivering a balloon catheter, including but not limited to a balloon IVL catheter.

[0056] The following description refers to an exemplary wire-free shock wave catheter and its method of use with reference to multiple drawings. For example, throughout the text, reference is made to Figure 1 to describe an exemplary shock wave system that does not use a guide wire. Reference is made to Figure 2A - 2B 、 Figure 3A - 3B 、 Figure 4 、 Figure 5 、 Figure 6 、 Figure 7A - 7E 、 Figure 8 、 Figure 9A - 9B 、 Figure 10A - 10C 、 Figure 11 and Figure 12 to describe an exemplary wire-free shock wave catheter and its components. Reference is made to Figure 13 、 Figure 14 and Figure 15A - 15B to describe an exemplary control handle that facilitates the connection of the shock wave catheter to each of a pulse generator and a fluid source. An exemplary method for filling and removing fluid from the shock wave catheter is shown in Figure 16 and is described with reference to the block diagram in Figure 17A - 17C .

[0057] Figure 1 FIG. shows an exemplary shock wave system 150 that includes a shock wave catheter 100 for treating a stenotic lesion (e.g., occlusion) in a body lumen (e.g., a blood vessel). The shock wave catheter 100 advances through the vasculature to the stenotic lesion without using a guide wire. Shock waves can be emitted from one or more shock wave emitters 104 disposed within the distal portion 102 of the shock wave catheter 100 to disrupt the lesion. The shock wave emitter 104 is configured to enable the shock wave catheter 100 to be flexible and maneuverable within the body lumen. The shock wave catheter 100 can be filled with a conductive fluid, such as saline. The conductive fluid is capable of generating shock waves that propagate from within the distal portion 102 of the shock wave catheter 100 into the stenotic lesion to open the lesion.

[0058] The shock wave catheter 100 can be used to treat lesions in small and / or tortuous body lumens (such as coronary arteries, below the knee, etc.), arteries, and / or other blood vessels. Accordingly, the size of the shock wave catheter 100 can be determined such that the catheter can pass through the body lumen safely and simply. For example, the outer diameter of the shock wave catheter 100 can be no greater than about 0.356 mm (i.e., about 0.014 inches). In some examples, the outer diameter of the shock wave catheter 100 can be in the range of about 0.25 mm - 1 mm, 0.25 mm - 0.75 mm, 0.25 mm - 0.5 mm, or 0.25 mm - 0.4 mm. This diameter can apply at least to the distal portion 102 of the shock wave catheter 100 that is close to the stenosis lesion. The ability to assemble all the necessary components of a functional shock wave emitting device (such as wires, lumens, electrodes, etc.) within a catheter of this size has been a challenge that has not been solved to date.

[0059] The shock wave catheter 100 includes a proximal portion 106 connected to a control handle 108 (or grip), which is held outside the patient during the procedure. The control handle 108 includes a fluid port 110 for filling fluid into and removing fluid from the shock wave catheter 100. The control handle 108 includes a port 112 that facilitates the connection between the pulse generator 114 and the shock wave emitter 104. The pulse generator 114 can be a high voltage source or a laser source. The energy pulse generated by the pulse generator 114 can cause a shock wave to be generated at the shock wave emitter 104 of the shock wave catheter 100.

[0060] To treat a stenotic lesion, the shock wave catheter 100 can be advanced through the vasculature to the lesion site. During the procedure, the position of the distal portion 102 of the shock wave catheter 100 within the vasculature can be observed in any suitable manner, including, for example, by using X-ray imaging or fluoroscopy to view at least the distal portion 102 of the shock wave catheter 100. For example, the distal portion 102 of the shock wave catheter 100 (e.g., the distal tip of the shock wave catheter 100) can include a radiopaque marker visible under fluoroscopy. The distal portion 102 of the shock wave catheter 100 is then filled with a conductive fluid (e.g., saline) introduced via the fluid port 110. After introducing the fluid, an energy pulse from the pulse generator 114 is transmitted to the shock wave emitter 104 within the distal portion 102 of the shock wave catheter 100. The energy pulse can be a voltage pulse that causes a spark gap discharge across the electrodes of a given shock wave emitter 104. This discharge generates an acoustic shock wave that propagates outwardly and through the shock wave catheter 100 to modify the stenotic lesion. In some variations, light energy (e.g., laser energy) is used to generate the shock wave. The pulse generator 114 can be a laser source that produces laser pulses that are transmitted via one or more optical fibers to the shock wave emitter 104 of the shock wave catheter 100. The laser pulses emitted from the shock wave emitter 104 can be absorbed by the fluid within the distal portion 102 of the shock wave catheter 100. This absorption process rapidly heats and vaporizes the fluid, thereby creating a rapidly expanding vapor bubble and an acoustic shock wave that propagates outwardly and modifies the stenotic lesion. Once the lesion has been adequately treated, the shock wave catheter 100 can be withdrawn from the patient's body.

[0061] In some examples, the shock wave catheter 100 described herein can be used to traverse a calcified stent that has been embedded within a body lumen. A stent previously implanted within a body lumen can become embedded within the body lumen and can potentially cause occlusion of the body lumen. Accordingly, the shock wave catheter 100 can be configured to be able to traverse such an embedded stent within the body lumen. The shock wave catheter 100 can be advanced through the body lumen to the stent such that the shock wave emitter 104 of the shock wave catheter 100 is positioned adjacent to the stent. As described herein, the shock wave catheter 100 can be advanced through the body lumen without the use of a guide wire. Once properly positioned within the body lumen, the shock wave emitter 104 can be configured to generate at least one shock wave, thereby opening the occlusion and enabling the shock wave catheter 100 to traverse the embedded stent.

[0062] As described above, the shock wave catheter 100 advances through the stenotic lesion without the use of a guide wire. A number of different features of an exemplary shock wave catheter that does not use a guide wire are described in Figure 2A - 2B , Figure 3A - 3B , Figure 4 , Figure 5 , Figure 6 , Figure 7A - 7E, Figure 8 , Figure 9A - 9B , Figure 10A - 10C , Figure 11 and Figure 12 are shown in and described with respect to these figures. Unless otherwise explicitly stated, it should be understood that the various features of these shock wave catheters may be incorporated into the shock wave catheter 100 in any combination.

[0063] Figure 2A shows a distal portion of an exemplary shock wave catheter 200 that can be used as the shock wave catheter 100. The shock wave catheter 200 includes an elongate tube 206 and a shock wave emitter 201 disposed at a distal region of the elongate tube 206. The shock wave emitter 201 can be formed by a pair of electrodes 202, 204. Each of the electrodes 202, 204 can be electrically connected to a pulse generator, for example, by a wire extending within the elongate tube 206. In some examples, one or more of the electrodes 202, 204 are provided by the ends of the wires. In other words, the wires extending along the elongate tube 206 can terminate at positions within the elongate tube 206, and the positions where the wires terminate can be the positions of the shock wave emitter within the elongate tube 206. This configuration of the electrodes 202, 204 can enable the maneuverability and flexibility of the shock wave catheter 200 through a narrow body lumen. Although the shock wave catheter 200 includes only a single shock wave emitter 201, it is contemplated that the exemplary shock wave catheters described herein can include more than one shock wave emitter, each shock wave emitter formed by a pair of electrodes. For example, the exemplary shock wave catheter can include a number of shock wave emitters such as 2, 3, 4, etc.

[0064] The shock wave catheter 200 includes a core wire 208 that extends within the elongate tube 206 and terminates outside the distal end 210 of the elongate tube 206 to form a distal tip 212 of the shock wave catheter 200. The core wire 208 can be a flexible wire that can be bent within a desired range of motion but can also maintain its elongate structure to maneuver the shock wave catheter 200 through a narrow and tortuous body lumen. For example, the core wire 208 can include platinum, platinum-iridium alloy, stainless steel, molybdenum, copper, or a combination thereof. The elongate tube 206 can be made of a material similar to the core wire 208. The elongate tube 206 can include platinum, platinum-iridium, stainless steel, nitinol, titanium, tool steel (i.e., carbon and alloy steel), or a combination thereof. In some examples, the elongate tube 206 can additionally or alternatively be made of polyimide, polyether block amide (e.g., ), nylon, polypropylene, polyester, or a combination thereof. Unless otherwise explicitly stated, it should be understood that the above materials for each of the elongate tube 206 and the core wire 208 can be applied to any other embodiment of a wireless shock wave catheter having an elongate tube and / or a core wire described herein.

[0065] The distal tip 212 formed by the core wire 208 at the distal end 210 of the elongate tube 206 may have a spherical or hemispherical (e.g., ball - tipped) geometry, which provides a rounded soft tip for the shock wave catheter 200 to pass through body lumens without damaging the walls of the lumen. The core wire 208 may be fixed to the distal end 210 of the elongate tube 206 at the surface of the distal tip 212. The ball - tipped geometry of the distal tip 212 may facilitate welding the core wire 208 to the distal end 210 of the elongate tube 206. The diameter of the distal tip 212 extending from the core wire 208 may be greater than the diameter of the elongate portion of the core wire 208 extending within the elongate tube 206. For example, the diameter of the distal tip 212 may be in the range of about 0.5 mm - 1 mm, such as about 0.9 mm, while the diameter of the elongate portion of the core wire 208 may be in the range of about 0.05 mm - 0.25 mm. The diameter of the distal tip 212 may be substantially the same as the diameter of the entire shock wave catheter 200.

[0066] In some examples, the core wire (e.g., core wire 208) of the shock wave catheter 200 may not have a ball - tipped distal tip. For example, the core wire 208 and the elongate tube 206 may have substantially the same length, both terminating at the distal tip 212 of the shock wave catheter 200. Instead of the distal tip 212 being formed by a ball - tipped portion extending from the core wire 208, the elongate tube 206 may (together with the core wire 208) extend to the distal tip 212 of the shock wave catheter 200 and form the rounded profile of the distal tip 212. The core wire 208 may be fixed (e.g., welded) to the elongate tube 206 at the distal tip 212. In this example, the elongate tube 206 may include a window (e.g., window 214) for allowing shock waves to propagate from the shock wave emitter 201, which will be described in more detail below.

[0067] The elongate tube 206 includes at least one window 214 in the body of the elongate tube 206 such that shock waves generated by the shock wave emitter 201 can propagate through the window 214 to the exterior of the elongate tube 206. The window 214 may be located on the side of the elongate tube 206 such that the shock waves generated by the shock wave emitter propagate outward from the shock wave catheter 200 in a lateral direction. The window 214 may be formed by a cut (or opening) in the body of the elongate tube 206. In some examples, the window 214 may include a material that allows the shock waves to pass through or semi - pass through. The window 214 may extend over about 10 - 90% of the circumference of the elongate tube 206. For example, the window 214 may extend over about 20 - 80%, 30 - 70%, or 40 - 60% of the circumference of the elongate tube 206. The angle / extent to which the window 214 extends along the circumference of the elongate tube 206 may affect the direction in which the shock waves generated by the shock wave emitter propagate outward from the shock wave catheter 200.

[0068] The shock wave catheter 200 includes a housing 216 that surrounds at least a portion of the elongate tube 206, particularly at least a portion of the elongate tube 206 having a window 214. The housing 216 may include a material that permits shock waves to enter the body lumen. For example, the housing 216 may include Teflon, polyether block amide (PEBA, e.g., ), polytetrafluoroethylene (PTFE), nylon, polyurethane (e.g., Tecothane TM ), polycarbonate, polyetheretherketone (PEEK), or another polymer. The material of the housing 216 may be a thermosetting or thermoplastic material. Unless otherwise expressly stated, it should be understood that the materials described herein with respect to the housing 216 are applicable to the housings of other wireless shock wave catheter embodiments described herein. The housing 216 may extend 20%, 40%, 60%, 80%, 90%, or substantially the entire length of the elongate tube 206. In some examples, the housing 216 surrounds the distal portion of the elongate tube 206, and the remainder of the elongate tube 206 is coated (e.g., with Teflon or another hydrophilic coating). In some examples, the elongate tube 206 is coated with an electrically insulating coating (e.g., polyimide, thermoplastic polyurethane (TPU), etc.). The housing 216 may be sealed to the elongate tube 206 to maintain a closed system within the shock wave catheter 200 to contain a fluid, such as an electrically conductive fluid, within the housing 216.

[0069] The inherent lumen 215 of the elongate tube 206 (shown in Figure 2B ) may be used to fill the housing 216 with a fluid. For example, the housing 216 may be filled with an electrically conductive fluid that facilitates the generation and propagation of shock waves generated by the shock wave emitter 201 within the housing 216 and outward into the body lumen. When filled, the housing 216 may expand within a predetermined limit. Alternatively, the housing 216 may not expand when filled. In either case, the overall diameter of the shock wave catheter 200 may be maintained below about 1 mm, e.g., below about 0.9 mm (e.g., about 0.035 inches).

[0070] The elongate tube 206 may include a helical coil 218 that permits at least a portion of the elongate tube 206 to bend and turn through tortuous blood vessels. The helical coil 218 may be attached (e.g., welded) to the remainder of the elongate tube 206. The pitch of the helical coil 218 may be constant or vary over the entire length of the helical coil 218. For example, the pitch of the helical coil 218 may be in the range of about 0.005 mm - 0.120 mm, such as in the range of about 0.005 mm - 0.015 mm, 0.015 mm - 0.05 mm, or 0.05 - 0.12 mm. In some examples, the elongate tube 206 may include slits cut (e.g., laser cut) into the elongate tube 206 that enable the elongate tube 206 to be flexible. The helical coil 218 (and / or the slits) may extend along about 20 - 80% of the length of the elongate tube 206. As Figure 2A shown, the helical coil 218 may terminate at a portion of the elongate tube 206 that is proximal to a window 214 on the tube. The remainder of the elongate tube 206 that is distal to the helical coil 218 may be rigid. By maintaining the rigidity of the distal portion of the shock wave catheter 200, the distal end of the shock wave catheter 200 can be easily guided through occlusions, including through soft thrombi and possibly hard occlusive material. Additionally, the rigidity of the distal portion of the elongate tube 206 may allow a physician to control the directionality of the shock waves generated within the distal portion of the shock wave catheter 200, thereby ensuring accurate and effective IVL treatment.

[0071] Figure 3A - 3B An exemplary shock wave catheter 300 is shown, which includes features similar to the shock wave catheter 200 and can also be used as the shock wave catheter 100 in the shock wave system 150. The shock wave catheter 300 differs from the shock wave catheter 200 in that it is configured to emit shock waves from the distal end 310 of the elongate tube 306 of the shock wave catheter 300, rather than from a window on the side of the elongate tube. The distal end 310 of the elongate tube 306 may be spaced apart (e.g., by a space 320) from the distal tip 312 of the shock wave catheter 300 to enable the shock waves to propagate radially and / or distally outward from the shock wave catheter 300.

[0072] A housing 316 surrounds a portion of the distal tip 312 and at least a portion of the distal end 310 of the elongate tube 306. The housing 316 is sealed to the elongate tube 306 to form a closed system at the distal portion of the shock wave catheter 300. The lumen 315 of the elongate tube 306 may convey a conductive fluid to the space 320 within the housing 316. As described above, the conductive fluid is capable of generating and propagating shock waves through the shock wave emitter 301. The housing 316 may be tensioned against the distal tip 312 and the elongate tube 306 to maintain a stable, secure connection between the distal tip 312 and the distal portion of the elongate tube 306.

[0073] Figure 4 It is a cross-sectional view of an exemplary shock wave catheter 400. The cross-sectional view of the shock wave catheter 400 may represent a cross-sectional view of the shock wave catheter 300 (e.g., at the distal end 310 of the elongated tube 306). The shock wave catheter 400 can be separately understood as representing a cross-sectional view of the shock wave catheter 200 (e.g., at the window 214 in the body of the elongated tube 206).

[0074] The shock wave emitter 401 may include a pair of wires extending within the lumen 415 of the elongated tube 406, and their distal ends form electrodes 402, 404. The pair of wires may extend along the core wire 408. The electrodes 402, 404 are located at the distal end of the elongated tube 406 and are separated by a spark gap 422. When an appropriate high-voltage pulse can be applied to the pair of electrodes 402, 404, current can flow through the conductive fluid contained within the housing 416 across the spark gap 422 between the electrodes 402, 404. The current generates a spark, and the spark generates one or more shock waves. Transmitting a series of energy pulses to the shock wave emitter 401 can generate a series of shock waves.

[0075] Figure 5 Another exemplary shock wave catheter 500 is shown that can be used as the shock wave catheter 100 in the shock wave system 150 and thus does not use a guide wire. The shock wave catheter 500 includes an elongated tube 502 and a core wire 504 that extends within the elongated tube 502 and terminates near the distal end of the elongated tube 502. Each of the elongated tube 502 and the core wire 504 is conductive. The ends of the elongated tube 502 and the core wire 504 can form a shock wave emitter 501. Thus, when an appropriate high-voltage pulse is applied to the shock wave emitter 501, a shock wave can be generated at the distal end 506 of the elongated tube 502 and the core wire 504. The configuration of the shock wave emitter 501 formed by the elongated tube 502 and the core wire 504 can contribute to the narrow profile of the shock wave catheter 500 as well as the maneuverability and flexibility of the shock wave catheter 500.

[0076] Each of the elongated tube 502 and the core wire 504 may include one or more materials described herein for alternative embodiments of the guide-wireless shock wave catheter (e.g., the shock wave catheter 200). For example, the elongated tube 502 may include nitinol (NiTi). The core wire 504 may include a distal tip made of a material having a high melting point (i.e., greater than 1500 degrees Celsius). In some embodiments, the core wire 504 may include copper wire along a portion of the core wire 504 and a distal end made of molybdenum. At least a portion of the elongated tube 502 (e.g., the inner surface and / or the outer surface of the elongated tube 502) may be coated (e.g., dip-coated) with an insulating coating (e.g., Teflon) to prevent premature release of the electric power traveling along the elongated tube 502. The core wire 504 may be additionally or alternatively coated.

[0077] The shock wave catheter 500 may include a housing 508 that surrounds at least the distal end 506 of the elongate tube 502 and the core wire 504 (i.e., the shock wave emitter 501). The housing 508 may be sealed to the distal portion of the elongate tube 502 and extend beyond the distal end 506 of the elongate tube 502 and the core wire 504. The portion of the elongate tube 502 that is not covered by the housing 508 (e.g., the proximal portion of the elongate tube 502) may be coated with an insulating coating as described above to prevent premature release of electricity from the elongate tube 502 and damage to the body lumen.

[0078] The lumen 510 of the elongate tube 502 may convey fluid to fill the housing 508. Filling the housing 508 may include pressurizing the housing 508, for example, to a pressure of about 1 - 6 standard atmospheres (atm). The shape (e.g., diameter) of the housing 508 may be substantially unchanged between the unfilled state and the filled state of the housing 508. Alternatively, the housing 508 may be expandable to accommodate filling the housing 508. The housing 508 may expand within a predetermined limit to maintain a narrow profile of the shock wave catheter 500. For example, when the housing is in its filled state, the diameter of the housing 508 may not be greater than about 4 mm. Expanding the housing 508 means that the material of the housing 508 undergoes elastic stretching when the housing is filled, but is not intended to be limited to this definition. The housing 508 may expand from the unfilled state to the filled state, and the material of the housing 508 may not stretch at all. When filling the housing 508 and applying energy at the shock wave emitter 501, a shock wave may be generated at the spark gap between the distal end 506 of the elongate tube 502 and the core wire 504, and the shock wave propagates outward through the housing 508 and distally to the body lumen outside the shock wave catheter 500.

[0079] Figure 6 A cross - section of the distal end of an exemplary shock wave catheter 600 that may represent the distal end 506 of the shock wave catheter 500 is shown. Figure 6 It can be used to show the gap 612 between the distal end 606 of the conductive elongate tube 602 and the core wire 604 (i.e., the shock wave emitter 601), in which a shock wave can be generated. As described above, the lumen 610 of the elongate tube 602 (which surrounds the gap 612) may be filled with fluid in the housing 608 to enable the generation of an outward - propagating shock wave at the gap 612. The inner diameter of the elongate tube 602 may be in the range of about 0.1 mm - 0.4 mm. The diameter of the core wire 604 may be in the range of about 0.05 mm - 0.25 mm. The length of the gap 612 may be defined as half of the difference between the inner diameter of the elongate tube 602 and the diameter of the core wire 604. For example, the length of the gap 612 may be in the range of about 0.001 mm - 0.2 mm.

[0080] Figure 7A - 7EAnother exemplary shock wave catheter 700 is shown, which is used without a guide wire and can be used as the shock wave catheter 100 in the shock wave system 150. The shock wave catheter 700 includes a shock wave emitter assembly 702 having a plurality of shock wave emitters, and the plurality of shock wave emitters can emit a plurality of shock waves in the same direction or a plurality of different directions. The shock wave emitter assembly 702 includes a shock wave emitter 704 capable of emitting a distally directed shock wave and a shock wave emitter 706 capable of emitting a laterally (e.g., radially outwardly) directed shock wave. The shock wave emitter assembly 702 can be configured within the shock wave catheter 700 such that it can bend and deflect as the shock wave catheter 700 advances through a body lumen, thereby enabling the flexibility and maneuverability of the shock wave catheter 700.

[0081] Each of the shock wave emitters 704, 706 of the shock wave emitter assembly 702 can be coupled to a pulse generator that delivers energy to the shock wave emitters 704, 706. The shock wave catheter 700 includes a wire 710 that extends through the elongate tube 708 and terminates at the distally emitting shock wave emitter 704 to apply energy to the shock wave emitter 704. The distal end of the wire 710 can form one electrode of an electrode pair of the shock wave emitter 704. The shock wave emitter assembly 702 can include an emitter band 712 that forms the other electrode (e.g., return electrode) of the electrode pair of the shock wave emitter 704. The emitter band 712 can be a conductive material having an annular or semi-annular shape. In the shock wave catheter 700, the emitter band 712 is an annular band of conductive material that extends along the circumference of the outer housing 714. When a voltage is applied to the shock wave emitter 704 through the wire 710, current can flow from the end of the wire 710 to the emitter band 712, causing the shock wave emitter 704 to generate a distally directed shock wave.

[0082] The shock wave catheter 700 also includes a wire 720 that applies energy to the laterally emitting shock wave emitter 706. The wire 720 extends through the elongate tube 708 and terminates at the laterally emitting shock wave emitter 706. One electrode of the electrode pair of the shock wave emitter 706 can be formed by the distal end of the wire 720, and the other electrode (e.g., return electrode) of the electrode pair of the shock wave emitter 706 can be formed by an emitter band 718 of the shock wave emitter assembly 702. The emitter band, similar to the emitter band 712, the emitter band 718 can be a conductive material having an annular or semi-annular shape. In the shock wave catheter 700, the emitter band 718 has a semi-annular shape that terminates at an annular (or loop-shaped) electrode located on the side of the shock wave catheter 700. When a voltage is applied to the shock wave emitter 706 through the wire 720, current can flow from the end of the wire 720 to the emitter band 718, causing the shock wave emitter 706 to generate a laterally directed shock wave.

[0083] Shock wave emitters 704, 706 can be individually connected to a pulse generator so that energy can be delivered to the emitters separately, causing the emitters to emit separate shock waves. In this example, wires 710, 720 can be individually connected to the pulse generator. Alternatively, shock wave emitters 704, 706 can be connected to each other such that the energy applied to shock wave emitters 704, 706 causes the emitters to emit shock waves simultaneously or near simultaneously. In this example, wires 710, 720 can be connected to each other (e.g., at or near the pulse generator).

[0084] Each of shock wave emitters 704, 706 can be connected to a wire 716 that extends through shock wave catheter 700 and is coupled to a pulse generator to complete the circuit. In this way, shock wave emitters 704, 706 can be grounded to the pulse generator through wire 716. In some examples, shock wave catheter 700 can include more than one wire similar to wire 716 for grounding each shock wave emitter 704, 706.

[0085] Shock wave emitter assembly 702 is coupled to elongate tube 708 by a core wire 722. Core wire 722 can extend through elongate tube 708 and can terminate at a distal portion of shock wave catheter 700 that is proximal to the distal end of elongate tube 708. At its proximal end, core wire 722 can be coupled to a control handle (described in more detail below) to control the bending and deflection of the distal tip of shock wave catheter 700 that includes shock wave emitter assembly 702. In some examples, the distal end of elongate tube 708 can be welded to core wire 722 (e.g., at joint 724) such that the tip of shock wave catheter 700 can be deflected. In some examples, (e.g., instead of or in addition to wire 716), core wire 722 can be conductive such that energy received at a return electrode formed by shock wave emitter assembly 702 can travel through core wire 720 to the control handle.

[0086] Elongate tube 708 and shock wave emitter assembly 702 are surrounded (e.g., encircled) by a housing 714. Housing 714 can be filled with, for example, a conductive fluid that is delivered through the lumen of elongate tube 708 to the distal portion of shock wave catheter 700. Housing 714 can be closed at the distal end of shock wave catheter 700 to form a closed system for the conductive fluid delivered to the distal portion of shock wave catheter 700. Housing 714 can include a thermoplastic, thermoset, or other polymeric material that conforms to elongate tube 708 and shock wave emitter assembly 702. In some examples, housing 714 may not expand significantly when fluid is delivered through the lumen of elongate tube 708 to the portion of housing 714 that surrounds shock wave emitter assembly 702 in order to maintain the narrow profile of shock wave catheter 700.

[0087] The elongate tube 708 may include a helical coil and / or slits cut into the elongate tube 708 that enable the elongate tube 708 to be flexible. For example, the elongate tube 708 may include a flat wire helical coil having a consistent or varying pitch along the length of the elongate tube 708. Figure 8 An elongate tube 808 that may be used as the elongate tube 708 is shown. The elongate tube 808 includes a helical coil having a varying pitch that may enable the shock wave catheter to be flexible at the distal portion 808c of the tube, yet stiffen at the proximal portion 808a of the tube (e.g., where it attaches to the control handle). Thus, the pitch of the elongate tube 808 increases from the proximal portion 808a to the intermediate portion 808b to the distal portion 808c of the elongate tube 808. In some embodiments, the pitch of the helical coil at the distal portion 808c is at least twice as large as the pitch at the proximal portion 808a. The pitch of the intermediate portion 808b located between the distal portion 808c and the proximal portion 808a may be less than the pitch at the distal portion 808c and greater than the pitch at the proximal portion 808a. In some embodiments, the proximal portion 808a of the elongate tube 808 includes a helical coil that extends proximally to the deployment portion (i.e., the location where it attaches to the control handle).

[0088] In some embodiments, the distal portion 808c of the elongate tube 808 has a ductility similar to that of a conventional guide wire of a similar size (e.g., a guide wire that is 0.035 inches or about 0.9 millimeters thick). In use, these embodiments may advantageously allow a doctor to bend and shape the distal portion 808c of the elongate tube 808 in a manner similar to how they would bend and shape a conventional guide wire to access a target anatomical structure (e.g., the neurovascular system or the vasculature below the knee). In some embodiments, the distal portion of the elongate tube 808 may include a bend region that bends up to 90 degrees. In some embodiments, the distal portion of the elongate tube 808 may include a hook or U-shaped region.

[0089] Figure 9A - 9B A shock wave emitter assembly 902 that may be used as the shock wave emitter assembly 702 of the shock wave catheter 700 is shown. As described above, the shock wave emitter assembly 702 may form a distal shock wave emitter and a return electrode for a lateral shock wave emitter that may be in the form of an emitter strip. Refer to Figure 9A - 9B, the emitter strip 912 can form the return electrode of the distal shock wave emitter, and the emitter strip 918 can form the return electrode of the lateral shock wave emitter. When the shock wave emitter assembly 902 is disposed in the shock wave catheter, the emitter strip 912 is positioned close to the emitter strip 918. The emitter strips 912, 918 can be attached by the attachment portion 924 of the shock wave emitter assembly 902. The length of the attachment portion 924 can vary based on the desired waveform of the shock wave emitted by the shock wave emitter assembly 902. The length of the attachment portion 924 (i.e., the distance between the emitter strips 912, 918) can be limited such that the flexibility of the shock wave emitter assembly 902 is not adversely affected. In other words, a shorter length of the attachment portion 924 may be preferred over a longer length of the attachment portion 924 to prevent the shock wave emitter assembly 902 from being overly flexible.

[0090] The sizes of the emitter strips 912, 918 of the shock wave emitter assembly 902 can be set to fit a narrow wireless shock wave catheter. For example, the outer diameter of the emitter strips 912, 918 can be in the range of about 0.25 mm - 2 mm, such as in the range of about 0.5 mm - 1.5 mm. One or more of the emitter strips 912, 918 can be discontinuous emitter strips, which enables the shock wave emitter assembly 902 to be used in a variety of different sized shock wave catheters. In the shock wave emitter assembly 902, the emitter strip 912 extends from the attachment portion 924 in an annular shape that can mimic the circular profile of the shock wave catheter. The emitter strip 918 extends from the attachment portion 924 in a semi-annular shape that partially mimics the circular profile of the shock wave catheter, but terminates at the side of the shock wave emitter assembly 902 to form a discontinuous emitter strip. The diameter of at least the emitter strip 918 can be adjusted to fit a variety of different sized catheters, for example, by compressing the semi-annular emitter strip 918.

[0091] In some examples, the shock wave emitter assembly 902 may include a plurality of emitter bands 918 disposed along the length of the shock wave emitter assembly 902. One or more of the emitter bands 918 may be disposed on the same side of the shock wave emitter assembly 902. Additionally or alternatively, one or more of the emitter bands 918 may be disposed on opposite sides of the shock wave emitter assembly 902, e.g., to emit shock waves in different directions. One or more emitter bands 918 disposed on opposite sides of the shock wave emitter assembly 902 may be disposed in an alternating pattern. One or more emitter bands on the same side of the shock wave emitter assembly 902 may be disposed substantially adjacent to each other. Additionally or alternatively, one or more of the emitter bands 918 (on the same side and / or opposite sides of the shock wave emitter assembly 902) may be separated, e.g., by attachment portions (such as similar to the attachment portion 924 described above). Other configurations of shock wave emitter assemblies including one or more discontinuous emitter bands are described in more detail in U.S. Patent Application US63 / 599,950, the content of which is incorporated herein by reference in its entirety.

[0092] Figure 10A - 10C Another exemplary shock wave catheter 1000 is shown, which is used without a guide wire and may be used as the shock wave catheter 100 in the shock wave system 150. Figure 10B is shown Figure 10A the shock wave catheter 1000 shown, however, in Figure 10B which, the housing 1014 at the distal end of the shock wave catheter 1000 is removed. Figure 10C A cross-sectional view of the shock wave catheter 1000 through the distal tip 1012 of the shock wave catheter 1000 (where the housing 1014 is removed) is shown.

[0093] Similar to the above-described shock wave catheter, catheter 1000 includes at least one shock wave emitter 1001 disposed distally of the elongate tube 1006 within the shock wave catheter 1000. The at least one shock wave emitter 1001 may be spaced distally from the distal end of the elongate tube 1006. The shock wave emitter 1001 may be formed by a pair of electrodes 1002 and 1004. In some examples, the shock wave catheter 1000 includes only a single shock wave emitter 1001 formed by a single pair of electrodes 1002, 1004 to minimize the cross-sectional profile of the shock wave catheter 1000. Each of the electrodes 1002, 1004 may be electrically connected to a pulse generator, for example, by wires 1021 and 1023 that extend from a proximal portion of the shock wave catheter 1000 to a distal portion of the shock wave catheter 1000 within the shock wave catheter 1000. For example, wires 1021 and 1023 may extend from the distal tip 1012 through the elongate tube 1006 of the shock wave catheter 1000 to a control handle connected to the proximal portion of the shock wave catheter 1000. In some examples, one or more of the wires 1021 and 1023 may extend through the elongate tube 1006 to the at least one shock wave emitter 1001.

[0094] In some examples, electrodes 1002 and 1004 can be provided by the distal ends of wires 1021 and 1023. One of the distal ends of a wire (such as wire 1021) can form a positive electrode (such as electrode 1002), and the other of the distal ends (such as of wire 1023) can form a negative electrode (such as electrode 1004). In some embodiments, these polarities can be switched during use of the shock wave catheter 1000 so that electrodes 1002 and 1004 wear evenly. In some embodiments, the wire with the negative polarity (such as conductive member 1023) can be thicker than the wire with the positive polarity (such as conductive member 1021) so that the electrode with the negative polarity has a larger surface area than the electrode with the positive polarity. In some embodiments, one electrode (such as electrode 1004) has a surface area that is at least 25% larger than that of the other electrode (such as electrode 1002). In some embodiments, one electrode (such as electrode 1004) has a surface area that is up to 150% larger than that of the other electrode (such as electrode 1002). The wire with the negative polarity can be thicker than the wire with the positive polarity so that when a higher energy is applied to electrodes 1002 and 1004 connected to it (or formed by its distal end), the emitter gap between electrodes 1002 and 1004 remains constant for a longer time. Conversely, if the wire sizes are the same, the emitter gap may change adversely, thereby shortening the life of the shock wave catheter 1000 by rapidly reducing its possible acoustic output. In some embodiments, electrode 1004 (such as the negative electrode) has a larger surface area than electrode 1002 (such as the positive electrode). When a voltage pulse is applied to the spark gap defined by the space between electrodes 1002 and 1004 (such as the distal ends of wires 1021 and 1023), the shock wave emitter 1001 generates a shock wave that propagates away from the shock wave emitter 1001 (such as in the distal direction).

[0095] In some examples, the shock wave catheter 1000 can include one or more energy guides (such as similar to wires 1021 and / or 1023) that are optical fibers configured to be electrically coupled to a laser source (such as a pulse generator configured to generate laser pulses). In this way, the shock wave catheter 1000 can be configured to generate a shock wave based on one or more laser pulses generated by a pulse generator coupled to at least one energy guide.

[0096] The wires 1021 and 1023 can be made of metal or metal alloy. In some embodiments, one or more of the wires 1021 and 1023 are at least partially made of refractory metal, such as molybdenum, niobium, or tantalum. In some embodiments, one or more of the conductive wires 1021 and 1023 are at least partially made of nickel-chromium superalloy. In some embodiments, one or more of the wires 1021 and 1023 are made of a conductive material having a melting point above 2000 degrees Celsius (°C). In some embodiments, one of the wires 1021 and 1023 (e.g., the wire having a negative polarity, such as wire 1023) is at least partially made of refractory metal, while the other wire (e.g., the wire having a positive polarity, such as wire 1021) is made of a non-refractory metal or alloy (such as copper, gold, or steel). In some embodiments, one or more of the wires 1021 and 1023 are partially formed of non-refractory metal and partially (e.g., at their distal ends to form the electrodes 1002 and 1004) of refractory metal. Using refractory metal as the electrodes of the shock wave catheter can effectively extend the device life because the degradation rate of refractory metal is much slower than that of non-refractory metals (such as steel or copper). However, in thicker conventional shock wave catheters, such an implementation of refractory metal may not be feasible because these metals generally have higher resistivity and hardness (and thus higher ductility) than typical wire materials such as copper. On the other hand, advantageously, using refractory metal wires along the entire length of the shock wave catheter (e.g., from the proximal region of the catheter to one or more electrodes) avoids the need for additional manufacturing steps for electrically connecting the wires to other non-refractory metal wires (e.g., to form the electrodes).

[0097] As Figure 10C shown, the shock wave catheter 1000 includes a pair of fluid lumens 1032 and 1034 that extend through the elongate tube 1006. The fluid lumen 1032 can be at least partially formed by an outer member 1060 surrounding the elongate tube 1008 and a housing 1014 surrounding at least the shock wave emitter 1001. The fluid lumen 1034 can be formed by a tubular member 1008 that extends within the elongate tube 1006 from a control handle at the proximal portion of the shock wave catheter 1000 to the distal tip 1012 of the shock wave catheter 1000. The fluid lumen 1032 can extend into the housing 1014 to introduce fluid (such as saline, contrast agent, or a mixture thereof) into the chamber surrounded by the housing 1014. The fluid lumen 1034 can also extend to the housing 1014, but can be used to remove fluid or bubbles formed by electrolysis during shock wave generation. In some embodiments, the functions of the fluid lumens 1032 and 1034 can be reversed. The fluid lumen 1032 can at least surround the fluid lumen 1034.

[0098] In some embodiments, as Figure 10BAs shown, the shock wave catheter 1000 may include a core wire 1009 that extends within the elongate tube 1006 and terminates at the distal end of the elongate tube 1006. The core wire 1009 may extend from a control handle coupled to the proximal portion of the shock wave catheter 1000, and the control handle includes a switch coupled to the core wire 1009 for bending and deflecting at least the distal tip 1012 of the shock wave catheter 1000.

[0099] The distal tip 1012 may include a lumen 1032 for fluid and additional lumens 1003, 1005 for receiving portions of the wires 1021 and 1023 (i.e., at least the electrodes 1002, 1004). In this way, the distal tip 1012 can at least partially surround the shock wave emitter 1001 formed by the ends of the wires 1021 and 1023. The distal tip 1012 may help maintain an appropriate distance between the ends of the wires 1021, 1023 (and thus the spark gap distance). In some examples, the distal tip 1012 helps maintain the position and orientation of the shock wave emitter 1001 during use such that the shock waves generated during treatment have a consistent power and propagation direction. As Figure 10A - 10B shown, the distal tip 1012 may be spaced apart from the distal end of the elongate tube 1006. In some examples, the distal tip 1012 may be made of a polymeric material. For example, the distal tip 1012 may be composed of a material having a Shore hardness less than (softer than) 100D. A radiopaque marker / indicator 1050 may be mounted on the surface of the distal tip 1012 to visualize the position of the shock wave emitter 1001 during use of the shock wave catheter 1000 (e.g., by fluoroscopy). For example, the radiopaque marker 1050 may be in the form of a band or loop that wraps around at least a portion of the distal tip 1012. In some embodiments, the radiopaque marker 1050 is longitudinally aligned with the electrodes 1002 and 1004 in the shock wave catheter 1000 to indicate the positions of the electrodes 1002 and 1004 of the shock wave emitter 1001 during use of the shock wave catheter 1000. In some examples, the radiopaque marker 1050 is disposed near the distal end of the shock wave emitter 1001 to prevent the radiopaque marker 1050 from interfering with the propagation of the shock waves from the shock wave emitter 1001.

[0100] The shock wave catheter 1000 may include an outer member 1060 that at least partially surrounds the elongate tube 1006 and forms an outer layer of the shock wave catheter 1000. The outer member 1060 may be made of a polymeric material. The outer member 1060 (surrounding the elongate tube 1006) and the housing 1014 (at least surrounding the shock wave emitter 1001) may be integrally formed or may be formed as separate members that adhere to each other. The housing 1014 may define a volume less than 1.5 cubic centimeters (cm 3)'s internal volume (which can be filled with fluid). In some embodiments, the internal volume of the outer shell 1014 is between 0.25 cm 3 –1.0 cm 3 .

[0101] At least a portion of the elongate tube 1006 can be a helical coil, which enables the shock wave catheter 1000 to bend and turn through tortuous blood vessels, similar to the elongate tube having the helical portion described above. The elongate tube 1006 can be a helical coil with a pitch that varies along its length. For example, the helical coil can have a larger pitch in its distal portion to provide greater flexibility to the distal portion of the elongate tube 1006. In some examples, the helical portion of the elongate tube 1006 can be formed from a stainless steel hypotube.

[0102] In some examples, in addition to or instead of including a helical coil, at least a portion of the elongate tube of the shock wave catheter described herein can include a braided portion. Figure 11 A shock wave catheter 1100 similar to the shock wave catheter 1000 is shown, but which includes a braided portion instead of an elongate tube 1108 having a helical portion. The shock wave catheter 1100 can be used as the shock wave catheter 1000 in the shock wave system 150. The braided portion of the elongate tube 1108 can be formed from a stainless steel hypotube. The braided portion can provide the elongate tube 1108 with greater stiffness than, for example, a helical coil. Thus, when the body lumen to be navigated is less tortuous, and / or when the target lesion site is far from the entry point and thus requires a longer navigation to reach the target lesion, the shock wave catheter 1100 can be more preferred than the catheter 1000.

[0103] Figure 12 A shock wave catheter 1200 similar to the shock wave catheters 1000 and 1100 is shown, but which includes a rigid or partially rigid elongate tube 1208. The shock wave catheter 1200 can be used as the shock wave catheter 100 in the shock wave system 150. The elongate tube 1208 can have a continuous surface (i.e., without any cuts or slits, such as those described for the helical and braided portions in the elongate tubes 1006 and 1108). The elongate tube 1208 can be stiffer than the elongate tubes having a braided portion and / or a helical portion described above, and can thus be used at least in relatively less tortuous vasculature.

[0104] As described above, the shock wave catheters described herein can be used with a control handle that facilitates the flow of fluid into and out of the shock wave catheter, as well as the connection between the pulse generator and the shock wave emitter within the distal portion of the shock wave catheter. Figure 13 The proximal region of an exemplary shock wave system 1350 is shown, which includes a control handle 1302 attached to the proximal end of the shock wave catheter 1300. The shock wave system 1350 can be used as described herein with reference toFigure 1 In the described shock wave system 150, the control handle 1302 may not include a port for receiving a guide wire, since the shock wave catheter used with the control handle 1302 and described herein may not include a lumen for receiving a guide wire.

[0105] The control handle 1302 includes a fluid inlet port 1304 and a fluid outlet port 1306 that aspirate and flush the shock wave catheter 1300, respectively. The fluid inlet port 1304 may be coupled to a fluid source, and the fluid outlet port 1306 may be coupled to a fluid reservoir. The fluid source may comprise a conductive fluid (such as saline, deionized water, etc.), an X-ray contrast agent, or a mixture thereof. The fluid inlet port 1304 and / or the fluid outlet port 1306 may be connected to a plumbing system and / or one or more connectors (such as luer connectors). In some examples, the fluid inlet port 1304 may be connected to a syringe that aspirates the lumen of the shock wave catheter 1300.

[0106] The shock wave system 1350 may include a controller 1308 that is coupled to a wire extending within the shock wave catheter 1300 to control the deflection and bending of at least the distal tip of the shock wave catheter 1300. For example, referring to the shock wave catheter 700 described above with reference to Figure 7A - 7E The controller 1308 may be coupled to the core wire 720. The controller 1308 may be disposed at the proximal end of the control handle 1302 such that the wire of the shock wave catheter 1300 extends through the control handle 1302 and protrudes from the proximal end of the control handle 1302, where the wire is connected to the controller 1308 at the proximal end. The controller 1308 includes a switch 1310 that a user can engage or slide between several positions on the controller 1308 to bend and deflect the distal tip of the catheter. The switch 1310 may be a slider, a knob, a thumbwheel, etc. The switch 1310 may move in a straight line, as Figure 13 shown by the dashed line in. Alternatively, the switch 1310 may move in a circular, arcuate, or other shape on the controller 1308 to control the deflection of the distal tip of the shock wave catheter 700. The switch 1310 may be disposed in a slot in the controller 1308, and the length of the slot limits the movement of the switch 1310. Accordingly, the extent to which the switch 1310 moves within the slot may be directly related to the amount of deflection (or bending) of the distal tip of the shock wave catheter 1300. In some examples, when the switch 1310 is in the final position within the slot of the controller 1308, the distal tip of the catheter may be bent maximally into a U-shape or a loop.

[0107] The handle 1302 includes a port 1312 that facilitates the connection between the shock wave emitter within the shock wave catheter 1300 and an external pulse generator 1314. One or more wires can extend within the shock wave catheter 1300 and can pass through the port 1312 to connect to the external pulse generator 1314. The shock wave system 1350 can include one or more cables 1316 that insulate the wires between the port 1312 and the pulse generator 1314 to prevent damage to the wires.

[0108] The pulse generator 1314 can generate energy pulses to cause the shock wave emitter of the shock wave catheter 1300 to generate shock waves. For example, the pulse generator 1314 can generate energy pulses that cause the shock wave emitter to generate shock waves according to a set frequency. Example frequencies can be in the range of 1 Hz - 5 Hz. In some examples, the pulse generator 1314 can be a high voltage power supply that generates one or more voltage pulses, and the amplitude of the voltage pulses is between about 0.5 kV and 10 kV. The pulse width of the applied voltage pulses is between 2 microseconds and 6 microseconds (2 - 6 μs). The repetition rate or frequency of the applied voltage pulses can be between about 1 Hz and 10 Hz. The total number of pulses applied by the power supply 1314 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 other increments of pulses within this range. In some examples, the pulse generator 1314 can generate one or more micro-pulse trains in quick succession (e.g., at a frequency in the range of about 100 Hz - 10 kHz). A series of micro-pulse trains can be generated according to the above-mentioned frequency of about 1 Hz - 5 Hz. Alternatively, the pulse generator 1314 can be a laser, and the wire extending between the shock wave emitter of the shock wave catheter 1300 and the pulse generator 1314 can be an optical fiber that couples the laser to the shock wave emitter. In this example, the pulse generator 1314 can generate one or more laser pulses that cause the shock wave emitter to generate shock waves. The preferred voltage, repetition rate, and number of pulses can vary according to, for example, the size of the lesion, the degree of calcification, the size of the blood vessel, patient attributes, or the treatment stage. For example, a doctor can start with low-energy shock waves and increase the energy as needed during the procedure, or vice versa. The amplitude of the shock wave can be controlled by controlling the voltage, current, duration, and repetition rate of the pulse voltage of the power supply 1314. The amplitude of the energy (e.g., voltage or laser) and the frequency of the pulses can vary according to, for example, the size of the lesion, the degree of calcification, the size of the blood vessel, patient attributes, the emitter being operated, and / or the treatment stage. For example, a doctor can start with low-energy shock waves and can increase the energy as needed during the procedure, or vice versa.

[0109] Figure 14shows a proximal region of another exemplary shock wave system 1450 including a control handle 1402 connected to the proximal end of a shock wave catheter 1400. The shock wave system 1450 can be used as the shock wave system 150 described herein with reference to Figure 1 The shock wave system 1450 differs from the shock wave system 1350 in that the system can include a fluid outlet port 1406 that includes a check valve for automatically purging / emptying bubbles generated due to lithotripsy from the distal end of the catheter and through the shock wave catheter 1400 when a threshold volumetric pressure is reached within the shock wave catheter 1400. Although Figure 14 not explicitly shown, it should be understood that the shock wave system 1450 can include a controller (e.g., similar to the controller 1308) for controlling the deflection of the distal tip of the shock wave catheter 1400. The control handle 1402 can facilitate the connection between the shock wave emitter within the shock wave catheter 1400 and an external pulse generator (not shown).

[0110] Figure 15A - 15B shows a proximal region of another exemplary shock wave system 1550 that includes a control handle 1520 for aspirating and flushing a shock wave catheter 1500 and for the connectivity between the shock wave emitter of the shock wave catheter 1500 and a pulse generator 1530. The shock wave system 1550 can be used for the shock wave system 150 described with reference to Figure 1 The control handle 1520 can be detachably attached to the proximal end of the shock wave catheter 1500. The control handle 1520 can be a hemostatic valve (e.g., Tuohy Borst valve) as it includes a chamber that is divided into different parts that receive specific parts of the shock wave catheter 1500 and facilitate a secure connection between these specific parts of the catheter and different devices. For example, the control handle 1520 includes a fluid receiving portion 1522 that fluidly connects the lumen of the shock wave catheter 1500 (e.g., via a fluid port 1224 extending therefrom) to a fluid source. The elongated tube 1502 of the shock wave catheter 1500 can include at least one opening 1504 that provides an inlet to the lumen of the elongated tube 1502 of the shock wave catheter 1500. The portion of the shock wave catheter 1500 including the opening 1504 is disposed within the fluid receiving portion 1522 of the control handle 1520 to enable aspiration and flushing of the lumen of the shock wave catheter 1500.

[0111] The handle 1520 also includes an electrical connection portion 1526 that electrically connects the conductive portions 1506, 1508 of the shock wave catheter 1500 (e.g., via ports / interfaces 1528 extending therefrom) to the pulse generator 1530. The electrical connection portion 1526 of the handle 1520 can include a set of electrical contacts 1534, 1536 that are electrically connected to each of the conductive portions 1506, 1508, respectively. One electrical contact (e.g., electrical contact 1534) can transmit voltage from the shock wave catheter 1500, while the other electrical contact (e.g., electrical contact 1536) can transmit voltage from the pulse generator 1530 to the shock wave catheter 1500. The conductive portions 1506, 1508 of the shock wave catheter 1500 can be the elongate tube 1502 and the core wire 1510 themselves, e.g., in the case where the elongate tube 1502 and the core wire 1510 are conductive (e.g., as described above for the shock wave catheter 500 with respect to Figure 5 ). Alternatively, one or more of the conductive portions 1506, 1508 can be contact pads that enable electrical connection (respectively) between the conductive elongate tube 1502, the core wire 1510, and the electrical contacts 1534, 1536. In the shock wave system 1550, the elongate tube 1502 forms the conductive portion 1506, and the conductive portion 1508 is a contact pad that facilitates connection between the electrical contact 1536 and the narrow core wire 1510. The conductive portions 1506, 1508 of the shock wave catheter 1500 can be separated from each other by an insulator 1512 that prevents a short circuit in the circuit between the conductive portions 1506, 1508 (and the electrical contacts 1534, 1536). The insulator can be, but is not limited to, polyimide, thermoplastic polyurethane, PTFE, another insulating polymer, or ceramic.

[0112] The fluid receiving portion 1522 and the electrical connection portion 1526 of the handle 1520 can be separated from each other by a pressure seal 1532a. The electrical connection portion 1526 (and the port 1528 extending therefrom) can be disposed proximal to the pressure seal 1532a, while the fluid receiving portion 1522 (and the fluid port 1524 extending therefrom) can be disposed distal to the pressure seal 1532a. The pressure seal 1532a can receive the shock wave catheter 1500, but also prevents any fluid within the fluid receiving portion 1522 from entering the electrical connection portion 1526 and damaging the electrical connection. The handle 1520 can include another pressure seal 1532b at the distal end of the fluid receiving portion 1522, which is substantially the same as the pressure seal 1532a in that it receives the shock wave catheter 1500 and prevents any fluid from leaving the fluid receiving portion 1522 of the handle 1520. The pressure seals 1532a, 1532b can be polymers (e.g., PTFE) or rubber-like materials (e.g., silicone).

[0113] Although the above is directed toFigure 15A - 15B It is described that the handle 1520 includes a fluid receiving portion 1522 and an electrical connection portion 1526, but it should be understood that the exemplary handle 1520 may include only one of these portions. For example, the exemplary handle 1520 may include a fluid receiving portion 1522 that mates with a port 1528, which facilitates the connection between an external pulse generator 1530 and a wire extending within the shock wave catheter 1500. The port 1528 and the fluid receiving portion 1522 may be sealed to each other, for example, by a pressure seal 1532a. In this way, the handle 1520 can be used with other types of wireless shock wave catheters and is not limited to shock wave catheters that include a conductive elongate tube and a core wire (such as the shock wave catheter 500 described above for Figure 5 described shock wave catheter 500). For example, the handle 1520 can be used with a laser energy-based shock wave system in which the pulse generator 1530 is a laser and the shock wave catheter 1550 includes an optical fiber extending therein.

[0114] As described above, the fluid port 1524 of the handle 1520 can be directly connected to a fluid source or can be connected to a fluid source via a plumbing system and / or a connector. Alternatively, the fluid port 1524 can be connected to a fluid source using a stopcock valve that can control the flow of fluid into and out of the shock wave catheter 1500. Figure 16 A method 1600 for aspirating and flushing a shock wave catheter, such as the shock wave catheter 1500 in the shock wave system 1550, is shown. Figure 17A - 17C A handle 1720 and a stopcock valve 1740 are shown, which are used to illustrate multiple different steps of the method 1600. The handle 1720 can be used as at least a part of the handle 1520 in the shock wave system 1550.

[0115] At block 1610, the method 1600 may include attaching a conductive fluid source and a vacuum source to the proximal portion of the catheter via a stopcock valve. Figure 17A An example of attaching the stopcock valve 1740 to the shock wave catheter 1700 is shown, where the stopcock valve is connected to a vacuum source 1750 and a conductive fluid source 1760. The stopcock valve 1740 includes a conductive fluid path 1742, a vacuum path 1744, and a central path 1746 that is interchangeably connectable to the conductive fluid path 1742 and the vacuum path 1744 by engaging a valve 1748 of the stopcock valve 1740. For example, at least the central path 1746 of the stopcock valve 1740 can be perfused with saline (by Figure 17A(represented by the dot pattern in the central path 1746 of the stopcock valve 1740). The control handle 1720 removably attached to the proximal portion of the shock wave catheter 1700 includes a fluid receiving portion 1722 within which the opening 1704 in the elongate tube 1702 of the shock wave catheter 1700 is located. A fluid port 1724 extending from the fluid receiving portion 1722 of the control handle 1720 is capable of removably receiving (or capable of insertion into) the perfused stopcock valve 1740. The connection between the stopcock valve 1740 and the fluid port 1724 can be secured by pressure seals 1732a, 1732b within the chamber of the control handle 1720.

[0116] At block 1620, method 1600 includes opening the vacuum path of a stopcock valve fluidly connected to a vacuum source to reduce the pressure within the shock wave catheter. Figure 17B An example of opening the vacuum path 1744 of the stopcock valve 1740 to reduce the pressure within the shock wave catheter 1700 is shown. The valve 1748 of the stopcock valve 1740 can be actuated to block the electrically conductive fluid path 1742 and allow vacuum pressure from the connected vacuum source 1750 (represented by the arrow extending from the vacuum path 1744 into the central path 1746) to enter the elongate tube 1702 of the shock wave catheter 1700 via the opening 1704 in the tube. Blocking the electrically conductive fluid path 1742 can pressurize any electrically conductive fluid held within the electrically conductive fluid path 1742 to a high pressure level suitable for driving the electrically conductive fluid path 1742 into the shock wave catheter 1700 when the electrically conductive fluid path 1742 and the shock wave catheter 1700 are fluidly connected.

[0117] At block 1630, method 1600 includes closing the vacuum path and subsequently opening the electrically conductive fluid path of a stopcock valve fluidly connected to an electrically conductive fluid source to suction the electrically conductive fluid into the shock wave catheter. Figure 17CAn example of closing the vacuum path 1744 and opening the conductive fluid path 1742 of the stopcock valve 1740 to suck the conductive fluid into the shock wave catheter 1700 is shown. The valve 1748 can be actuated to block the vacuum path 1744, and then open the conductive fluid path 1742 to the central path 1746 of the stopcock valve 1740. The negative pressure in the elongated tube 1702 of the shock wave catheter 1700 and the fluid receiving portion 1722 of the control handle 1720 can cause the high-pressure conductive fluid from the conductive fluid source (represented by the fluid port 1724 and the dot pattern within the stopcock valve 1740) to be automatically sucked into the fluid receiving portion 1722 and through the opening 1704 into the elongated tube 1702 of the shock wave catheter 1700. The conductive fluid travels through the lumen of the elongated tube 1702 to the distal portion of the elongated tube, where a shock wave emitter is provided to generate a shock wave. The shock wave catheter 1700 can suck the conductive fluid into the elongated tube 1702 until the pressure among the shock wave catheter 1700, the fluid receiving portion 1722 of the control handle 1720, and the stopcock valve 1740 (i.e., the system) stabilizes to a constant pressure suitable for delivering a shock wave by the shock wave catheter 1700. For example, the pressure can be in the range of about 1 atm - 6 atm.

[0118] Figure 18 An exemplary computing device 1800 according to one or more examples of the present utility model is shown, which can form part of the above-described system 100 and can be used to perform various steps of the methods described herein. The device 1800 can be a host computer connected to a network. The device 1800 can be a client computer or a server. As Figure 18 shown, the device 1800 can be any suitable type of microprocessor-based device, such as a personal computer, a workstation, a server, or a handheld computing device (i.e., a portable electronic device) such as a phone or a tablet. The device can include, for example, one or more of a processor 1802, an input device 1806, a sensor device 1807, an output device 1808, a storage device 1810, and a communication device 1804. The input device 1806 and the output device 1808 can generally correspond to those described above and can be connected to or integrated with the computer.

[0119] The input device 1806 can be any suitable device that provides directional input, such as a touch screen, a keyboard or keypad, a mouse, or a voice recognition device, in other words, an input or indication provided or initiated by a user. The sensor device 1807 can be one or more of any suitable sensor devices, such as a pressure sensor, a thermal sensor, an electrical sensor (e.g., a current, voltage, resistance, and / or impedance sensor), or a visualization element. The output device 1808 can be any suitable device that provides output, such as a touch screen, a haptic device, or a speaker. The storage device 1810 can be any suitable device that provides storage, such as an electrical, magnetic, or optical memory, including a random access memory (RAM), a cache, a hard disk drive, or a removable storage disk. The communication device 1804 can include any suitable device capable of sending and receiving signals over a network, such as a network interface chip or device. The components of the computer can be connected in any suitable manner, such as via a physical bus or a wireless connection.

[0120] The sensor device 1807 can provide feedback to an operator using the device 1800 by measuring parameters in the surrounding environment and thereby indicating the state of the device 1800 and also providing guidance on which additional steps the operator can decide to perform with the device 1800. For example, in an embodiment where the sensor device 1807 includes a pressure sensor, a slight decrease in pressure can indicate the success of a rupture at a calcified lesion due to the fact that the expandable member around the emitter can further expand without changing the fluid volume within the expandable member. Additionally, a significant decrease in pressure can indicate a rupture failure mode where the expandable member has lost its seal and fluid volume and thus guide the device to be withdrawn. In an embodiment where the sensor device includes a visualization element, the operator of the device 700 can more clearly understand where the device 1800 is located relative to the target lesion or anatomy before, during, and after the delivery of the treatment.

[0121] Software 1812 that can be stored in storage device 1810 and executed by processor 1802 may include, for example, a program that implements the functions of the present utility model (e.g., as implemented in the device described above). Software 1812 may also be stored and / or transmitted in any non-transitory computer-readable storage medium for use by or in connection with an instruction execution system, apparatus, or device (such as those described above), which can obtain instructions associated with the software from the instruction execution system, apparatus, or device / storage medium and execute the instructions. In the context of the present utility model, a computer-readable storage medium may be any medium, such as storage device 940, that can contain or store a program for use by or in connection with an instruction execution system, apparatus, or device. Software 1812 may 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 obtain instructions associated with the software from the instruction execution system, apparatus, or device / transmission medium and execute the instructions. In the context of the present utility model, a transmission medium may be any medium that can convey, propagate, or transmit a program for use by or in connection with an instruction execution system, apparatus, or device. The transmission-readable medium may include, but is not limited to, electrical, magnetic, optical, electromagnetic, or infrared wired or wireless propagation media.

[0122] Device 1800 may be connected to a network, which may be any suitable type of interconnected communication system. The network may implement any suitable communication protocol and may be protected by any suitable security protocol. The network may include any suitable arrangement of network links capable of transmitting and receiving network signals, such as a wireless network connection, a T1 or T3 line, a cable network, DSL, or a telephone line. Device 1800 may implement any operating system suitable for operating on the network. Software 1812 may be written in any suitable programming language, such as C, C++, Java, or Python. In various embodiments, the application software embodying the functions of the present utility model may be deployed in different configurations, such as in a client / server arrangement or as a web-based application or web service, for example, via a web browser.

[0123] Exemplary embodiments

[0124] The following embodiments are exemplary and are not intended to limit the scope of the present utility model.

[0125] Embodiment 1: A shock wave catheter for treating lesions in a body lumen, the shock wave catheter comprising:

[0126] An elongated tube;

[0127] A core wire that extends within the elongated tube and is fixed to the distal end of the elongated tube;

[0128] At least one shock wave emitter, the at least one shock wave emitter being disposed distally of the elongate tube and configured to generate at least one shock wave; and

[0129] A housing that surrounds at least a portion of the elongate tube and encloses the at least one shock wave emitter.

[0130] Example 2: The shock wave catheter according to Example 1, wherein the elongate tube includes at least one window such that at least one shock wave can propagate through the at least one window.

[0131] Example 3: The shock wave catheter according to Example 2, wherein the at least one window is located on a side of the elongate tube such that at least one shock wave generated by the at least one shock wave emitter is emitted from the side of the elongate tube.

[0132] Example 4: The shock wave catheter according to any one of Examples 1 - 3, wherein the at least one shock wave emitter is disposed at the distal end of the elongate tube such that the at least one shock wave generated by the at least one shock wave emitter is emitted from the distal end of the elongate tube.

[0133] Example 5: The shock wave catheter according to any one of Examples 1 - 4, wherein the core wire includes an elongate portion extending within the elongate tube and a distal tip fixed to the distal end of the elongate tube, the distal tip having a diameter larger than that of the elongate portion of the core wire.

[0134] Example 6: The shock wave catheter according to any one of Examples 1 - 5, wherein at least a portion of the elongate tube includes a helical coil or a plurality of slits.

[0135] Example 7: The shock wave catheter according to any one of Examples 1 - 6, wherein the housing is fillable with an electrically conductive fluid.

[0136] Example 8: The shock wave catheter according to any one of Examples 1 - 7, wherein the housing encloses the distal end of the elongate tube.

[0137] Example 9: The shock wave catheter according to any one of Examples 1 - 8, wherein the housing extends along the length of the elongate tube to enclose the elongate tube.

[0138] Example 10: The shock wave catheter according to any one of Examples 1 - 8, wherein at least a portion of the elongate tube adjacent to the housing is coated.

[0139] Example 11: The shock wave catheter according to any one of Examples 1-10, wherein the shock wave catheter does not include a lumen for a guide wire.

[0140] Example 12: The shock wave catheter according to any one of Examples 1-11, including at least one wire configured to electrically connect the at least one shock wave emitter to a pulse generator.

[0141] Example 13: The shock wave catheter according to Example 12, wherein the at least one shock wave emitter includes an electrode pair, and the distal end of the at least one wire forms the electrodes of the electrode pair.

[0142] Example 14: The shock wave catheter according to Example 12, wherein the at least one wire includes an optical fiber configured to be electrically connected to a laser.

[0143] Example 15: A system for treating a lesion in a body lumen, comprising:

[0144] The shock wave catheter according to any one of Examples 1-14; and

[0145] A pulse generator coupled to the at least one shock wave emitter and configured to generate an energy pulse to cause the at least one shock wave emitter to generate the at least one shock wave.

[0146] Example 16: The system according to Example 15, wherein the pulse generator is configured to generate the energy pulse to cause the at least one shock wave emitter to generate a series of shock waves at a frequency between 1 Hz and 5 Hz.

[0147] Example 17: The system according to Example 15 or 16, wherein the pulse generator is configured to generate one or more voltage pulses to cause the at least one shock wave emitter to generate the at least one shock wave.

[0148] Example 18: The system according to Example 17, wherein the one or more voltage pulses include a voltage between 0.5 kV and 10.0 kV.

[0149] Example 19: The system according to Example 15 or 16, wherein the pulse generator is configured to generate one or more laser pulses to cause the at least one shock wave emitter to generate the at least one shock wave.

[0150] Example 20: A shock wave catheter for treating a lesion in a body lumen, the shock wave catheter comprising:

[0151] An elongate tube;

[0152] A wire that extends within the elongate tube and terminates near the distal end of the elongate tube;

[0153] A shock wave emitter formed by the distal end of the elongate tube and at least a portion of the wire and configured to generate at least one shock wave; and

[0154] A housing surrounding the shock wave emitter.

[0155] Example 21: The shock wave catheter according to Example 20, wherein at least the distal portion of the elongate tube includes a helical coil or a plurality of slits.

[0156] Example 22: The shock wave catheter according to Example 20 or 21, wherein the housing is fillable with an electrically conductive fluid.

[0157] Example 23: The shock wave catheter according to any one of Examples 20-22, wherein the housing includes at least one window such that the at least one shock wave can propagate through the at least one window.

[0158] Example 24: The shock wave catheter according to any one of Examples 20-23, wherein the housing surrounds at least a portion of the elongate tube.

[0159] Example 25: The shock wave catheter according to any one of Examples 20-23, wherein the elongate tube is coated with an electrically insulating coating.

[0160] Example 26: The shock wave catheter according to any one of Examples 20-25, wherein the elongate tube includes nitinol.

[0161] Example 27: The shock wave catheter according to any one of Examples 20-26, wherein the wire includes at least one of molybdenum, copper, or a mixture thereof.

[0162] Example 28: The shock wave catheter according to any one of Examples 20-27, wherein the outer diameter of the elongate tube is in the range of 0.25 mm to 0.5 mm.

[0163] Example 29: The shock wave catheter according to any one of Examples 20-28, wherein the inner diameter of the elongate tube is in the range of 0.1 mm to 0.4 mm.

[0164] Example 30: The shock wave catheter according to any one of Examples 20-29, wherein the wire includes an optical fiber configured to be electrically connected to a laser.

[0165] Example 31: The shock wave catheter according to any one of Examples 20-30, wherein the shock wave catheter does not include a lumen for a guide wire.

[0166] Example 32: A system for treating a lesion in a body lumen, comprising:

[0167] The shock wave catheter according to any one of Examples 20-31; and

[0168] A pulse generator, the pulse generator being connected to the shock wave emitter and configured to generate an energy pulse to cause the shock wave emitter to generate the at least one shock wave.

[0169] Example 33: The system according to Example 32, wherein the pulse generator is configured to generate the energy pulse at a frequency between 1 Hz and 5 Hz.

[0170] Example 34: The system according to Example 32 or 33, wherein the pulse generator is configured to generate one or more voltage pulses to cause the generation of the at least one shock wave.

[0171] Example 35: The system according to Example 34, wherein the one or more voltage pulses include a voltage between 0.5 kV and 10.0 kV.

[0172] Example 36: The system according to Example 32 or 33, wherein the pulse generator is configured to generate one or more laser pulses to cause the generation of the at least one shock wave.

[0173] Example 37: The system according to any one of Examples 32-36, wherein the proximal portion of the elongate tube includes at least one opening leading to the lumen of the elongate tube, the lumen being fluidly connected to the housing, and wherein the system comprises:

[0174] A control handle, the control handle being connected to the proximal portion of the elongate tube, the control handle comprising:

[0175] At least one pressure seal that closes the at least one opening of the elongate tube; and a fluid port fluidly connected to the at least one opening of the elongate tube, a vacuum pressure source, and a conductive fluid source to (a) reduce the pressure in at least one of the lumen of the elongate tube and the housing, and (b) subsequently draw the conductive fluid into at least one of the lumen of the elongate tube and the housing.

[0176] Example 38: The system according to Example 37, wherein the control handle includes a port configured to connect the pulse generator to the wire and the elongate tube.

[0177] Example 39: The system according to Example 38, wherein the port is proximal to the at least one pressure seal of the control handle to be electrically connected to the elongate tube and the wire at a position proximal to the at least one opening of the elongate tube.

[0178] Example 40: The system according to any one of Examples 37 - 39, wherein the fluid port is fluidly connected to the vacuum pressure source and the conductive fluid source via a stopcock valve.

[0179] Example 41: A shock wave catheter for treating a lesion of a body lumen, the shock wave catheter comprising:

[0180] A shock wave emitter assembly, comprising:

[0181] A first shock wave emitter configured to emit at least one distally directed shock wave; and

[0182] A second shock wave emitter disposed proximal to the first shock wave emitter, the second shock wave emitter configured to emit at least one laterally directed shock wave;

[0183] An elongate tube coupled to the shock wave emitter assembly; and

[0184] A housing surrounding the coupled shock wave emitter assembly and the elongate tube.

[0185] Example 42: The shock wave catheter according to Example 41, wherein the elongate tube comprises a flat wire helical coil with a variable pitch, the pitch of the proximal portion of the flat wire helical coil being greater than the pitch of the distal portion of the helical coil.

[0186] Example 43: The shock wave catheter according to Example 41 or 42, wherein the outer diameter of the elongate tube is not greater than 1 mm.

[0187] Example 44: The shock wave catheter according to any one of Examples 41 - 43, wherein at least one of the first shock wave emitter and the second shock wave emitter comprises an annular emitter band.

[0188] Example 45: The shock wave catheter according to any one of Examples 41 - 44, wherein the elongate tube comprises one or more of stainless steel, nitinol, tool steel, and titanium.

[0189] Example 46: The shock wave catheter according to any one of Examples 41 - 45, wherein the housing comprises nylon, Tecothane TM 、 and one or more of polyurethane.

[0190] Example 47: The shock wave catheter according to any one of Examples 41-46, wherein the outer diameter of the elongate tube is in the range of 0.75 mm to 1 mm.

[0191] Example 48: The shock wave catheter according to any one of Examples 41-47, wherein the distal end of the outer shell is closed.

[0192] Example 49: The shock wave catheter according to any one of Examples 41-48, wherein the shock wave catheter does not include a lumen for a guide wire.

[0193] Example 50: The shock wave catheter according to any one of Examples 41 to 49, comprising at least one wire configured to electrically connect the first shock wave emitter and the second shock wave emitter to a pulse generator.

[0194] Example 51: The shock wave catheter according to Example 50, wherein:

[0195] The first shock wave emitter includes a first pair of electrodes;

[0196] The second shock wave emitter includes a second pair of electrodes; and

[0197] The at least one wire includes:

[0198] A first wire including the distal ends of the electrodes forming the first pair of electrodes; and

[0199] A second wire including the distal ends of the electrodes forming the second pair of electrodes.

[0200] Example 52: The shock wave catheter according to Example 51, wherein the first wire and the second wire are separately connected to the pulse generator.

[0201] Example 53: The shock wave catheter according to Example 51, wherein the first wire and the second wire are connected to each other.

[0202] Example 54: The shock wave catheter according to Example 51, wherein the at least one wire includes at least one optical fiber configured to be electrically connected to a laser.

[0203] Example 55: A system for treating a lesion in a body lumen, comprising:

[0204] A shock wave catheter according to any one of Examples 41-54; and

[0205] A pulse generator, the pulse generator being coupled to the first shock wave emitter and the second shock wave emitter and configured to generate an energy pulse to cause the first shock wave emitter and the second shock wave emitter to generate the shock wave.

[0206] Example 56: The system according to Example 55, wherein the pulse generator is configured to generate the energy pulse to cause at least one of the first shock wave emitter and the second shock wave emitter to generate a series of shock waves at a frequency between 1 Hz and 5 Hz.

[0207] Example 57: The system according to Example 55 or 56, wherein the pulse generator is configured to generate one or more voltage pulses to cause at least one of the first shock wave emitter and the second shock wave emitter to generate a shock wave.

[0208] Example 58: The system according to Example 57, wherein the one or more voltage pulses include a voltage between 0.5 kV and 10.0 kV.

[0209] Example 59: The system according to Example 55 or 56, wherein the pulse generator is configured to generate one or more laser pulses to cause at least one of the first shock wave emitter and the second shock wave emitter to generate the shock wave.

[0210] Example 60: The system according to any one of Examples 55 - 59, comprising a switch, the switch being coupled via a core wire to a distal portion of the shock wave catheter, the core wire extending through the shock wave catheter and connected to the distal portion of the shock wave catheter to control the deflection of the distal portion of the shock wave catheter.

[0211] Example 61: The system according to Example 60, comprising a control handle, the control handle being connected to a proximal portion of the shock wave catheter and configured to receive the core wire coupling the switch and the distal portion of the shock wave catheter.

[0212] Example 62: The system according to Example 61, wherein the control handle comprises:

[0213] At least one fluid port connected to a lumen of the shock wave catheter to aspirate and clean the lumen; and

[0214] A port that facilitates connection of the pulse generator to the first shock wave emitter and the second shock wave emitter.

[0215] Example 63: A method for treating a lesion in a body lumen, comprising:

[0216] Advance the shock wave catheter through the body lumen without using a guide wire such that at least one shock wave emitter encapsulated within the outer housing of the shock wave catheter is located near the lesion site within the body lumen; and

[0217] Generate at least one shock wave by the at least one shock wave emitter to treat the lesion.

[0218] Example 64: The method according to Example 63, wherein the shock wave catheter is the shock wave catheter according to any one of Examples 1 - 62.

[0219] Example 65: The method according to Example 63, wherein the shock wave catheter includes a core wire that extends within the shock wave catheter and is coupled to the distal portion of the shock wave catheter and to a switch at the proximal end of the shock wave catheter, and the method includes engaging the switch to control the deflection of the distal portion of the shock wave catheter.

[0220] Example 66: The method according to any one of Examples 63 - 65, including filling the outer housing with an electrically conductive fluid prior to generating the at least one shock wave.

[0221] Example 67: The method according to any one of Examples 63 to 66, wherein generating the at least one shock wave by the at least one shock wave emitter includes generating one or more energy pulses by a pulse generator electrically coupled to the at least one shock wave emitter, the one or more energy pulses causing the at least one shock wave emitter to generate the at least one shock wave.

[0222] Example 68: The method according to Example 67, wherein generating the one or more energy pulses by the pulse generator includes generating a series of energy pulses, the series of energy pulses causing the at least one shock wave emitter to generate a series of shock waves at a frequency between 1 Hz and 5 Hz.

[0223] Example 69: The method according to Example 67 or 68, wherein generating the one or more energy pulses by the pulse generator includes generating one or more voltage pulses, the one or more voltage pulses causing the at least one shock wave emitter to generate the at least one shock wave.

[0224] Example 70: The method according to Example 69, wherein the one or more voltage pulses include a voltage between 0.5 kV and 10.0 kV.

[0225] Example 71: The method according to Example 67 or 68, wherein generating the one or more energy pulses by the pulse generator includes generating one or more laser pulses that cause the at least one shock wave emitter to generate the at least one shock wave.

[0226] Example 72: The method according to any one of Examples 63 - 71, wherein the lesion includes a stent embedded in the lumen.

[0227] Example 73: The method according to any one of Examples 63 - 72, including using a shock wave catheter as a guide wire for a balloon catheter device.

[0228] Example 74: A method for regulating pressure within a shock wave catheter, comprising:

[0229] Opening a vacuum path of a stopcock valve that fluidly connects to a vacuum source and a lumen of the shock wave catheter to reduce pressure in the shock wave catheter;

[0230] Closing the vacuum path of the stopcock valve; and

[0231] Opening a conductive fluid path of the stopcock valve, the conductive fluid path being fluidly connected to a conductive fluid source and the lumen of the shock wave catheter to draw conductive fluid from the conductive fluid source into the lumen of the shock wave catheter.

[0232] Example 75: The method according to Example 74, wherein the stopcock valve is fluidly connected to the lumen of the shock wave catheter via a control handle, the control handle comprising:

[0233] At least one pressure seal that seals at least one opening of the shock wave catheter, the at least one opening being fluidly connected to the lumen; and

[0234] A fluid port that is fluidly connected to the at least one opening and attached to the stopcock valve to fluidly connect the vacuum source and the conductive fluid source to the lumen of the shock wave catheter.

[0235] Example 76: The method according to Example 75, wherein the control handle includes a port that connects one or more conductive portions of the shock wave catheter to a pulse generator.

[0236] Example 77: The method according to Example 76, wherein the port is disposed proximal to the at least one pressure seal of the control handle to electrically connect to the one or more conductive portions of the shock wave catheter at a position proximal to the at least one opening of the shock wave catheter.

[0237] Example 78: A shock wave catheter for treating lesions in body lumens, the shock wave catheter comprising:

[0238] An elongate tube;

[0239] At least one shock wave emitter, the at least one shock wave emitter being disposed distally of the elongate tube and configured to generate at least one shock wave;

[0240] A distal tip, the distal tip being disposed at or near the distal end of the at least one shock wave emitter; and

[0241] A housing at least surrounding the at least one shock wave emitter.

[0242] Example 79: The shock wave catheter according to Example 78, wherein at least a portion of the elongate tube comprises a helical coil or a plurality of slits.

[0243] Example 80: The shock wave catheter according to Example 78 or 79, wherein at least a portion of the elongate tube comprises a braided portion.

[0244] Example 81: The shock wave catheter according to any one of Examples 78 - 80, comprising a core wire extending within the elongate tube and terminating near the distal end of the elongate tube, wherein the core wire is configured to control the deflection of at least the distal portion of the shock wave catheter.

[0245] Example 82: The shock wave catheter according to Example 81, wherein the distal end of the core wire comprises the distal tip, and the distal tip has a diameter larger than the diameter of the elongate portion of the core wire extending within the elongate tube.

[0246] Example 83: The shock wave catheter according to any one of Examples 78 - 82, wherein the internal volume of the housing is less than 1.5 cm 3 .

[0247] Example 84: The shock wave catheter according to any one of Examples 78 - 83, comprising at least one wire configured to electrically connect the at least one shock wave emitter to a pulse generator.

[0248] Example 85: The shock wave catheter according to Example 84, wherein the at least one shock wave emitter comprises an electrode pair, and the at least one wire comprises a pair of wires, wherein the distal end of each wire of the pair of wires forms an electrode of the electrode pair.

[0249] Example 86: The shock wave catheter according to Example 84 or 85, wherein the at least one wire extends through the elongate tube to the at least one shock wave emitter and comprises a refractory metal.

[0250] Example 87: The shock wave catheter according to any one of Examples 78 to 83, including an optical fiber optically coupled to the at least one shock wave emitter.

[0251] Example 88: The shock wave catheter according to any one of Examples 78-87, including a radio-opaque marker disposed near the at least one shock wave emitter for observing the at least one shock wave emitter.

[0252] Example 89: The shock wave catheter according to any one of Examples 78-88, including a first fluid lumen configured to fill the outer shell and a second fluid lumen configured to remove bubbles generated during shock wave generation from the outer shell.

[0253] Example 90: The shock wave catheter according to any one of Examples 78-88, wherein the at least one shock wave emitter is configured to emit at least one distally directed shock wave when an energy pulse is supplied to the at least one shock wave emitter.

[0254] Example 91: The shock wave catheter according to any one of Examples 78-90, wherein the outer diameter of the shock wave catheter is in the range of 0.25 mm - 1 mm.

[0255] Example 92: The shock wave catheter according to any one of Examples 78-91, wherein the shock wave catheter does not include a guide wire lumen.

[0256] Example 93: The shock wave catheter according to any one of Examples 78-92, wherein the distal tip is configured to hold the position and orientation of the at least one shock wave emitter during use.

[0257] Example 94: The shock wave catheter according to any one of Examples 78-93, wherein the elongated tube includes a flat wire helical coil with a variable pitch, and the pitch of the proximal portion of the helical coil is greater than the pitch of the distal portion of the helical coil.

[0258] Example 95: A system for treating a lesion in a body lumen, comprising:

[0259] A shock wave catheter, comprising:

[0260] An elongated tube;

[0261] At least one shock wave emitter, the at least one shock wave emitter being disposed distally of the elongated tube and configured to generate at least one shock wave;

[0262] A distal tip, the distal tip being disposed at or near the distal end of the shock wave emitter; and

[0263] At least a housing surrounding the shock wave emitter; and

[0264] A pulse generator, the pulse generator being coupled to the at least one shock wave emitter and configured to generate an energy pulse to cause the at least one shock wave emitter to generate the at least one shock wave.

[0265] Example 96: The system according to Example 95, wherein the pulse generator is configured to generate an energy pulse having a frequency between 1 Hz and 5 Hz.

[0266] Example 97: The system according to Example 95 or 96, wherein the pulse generator is configured to generate one or more voltage pulses having a voltage between 0.5 kV and 10.0 kV.

[0267] Example 98: The system according to Example 95 or 96, wherein the pulse generator is configured to generate one or more laser pulses to cause the at least one shock wave emitter to generate the at least one shock wave.

[0268] Example 99: The system according to any one of Examples 95 - 98, wherein the shock wave catheter includes a core wire that extends within the elongate tube and terminates near the distal end of the elongate tube, and the system includes a switch coupled to the core wire to control the deflection of the distal portion of the shock wave catheter.

[0269] Example 100: The system according to Example 99, including a control handle connected to the proximal portion of the elongate tube and configured to receive the core wire, the control handle including:

[0270] At least one fluid port, the at least one fluid port being connected to the lumen of the elongate tube via at least one opening in the elongate tube to aspirate and clean the lumen; and

[0271] A port that facilitates connection of the pulse generator to the at least one shock wave emitter.

[0272] Example 101: The system according to Example 100, wherein the control handle includes at least one pressure seal that closes the at least one opening of the elongate tube, and wherein the fluid port is fluidly connected to a vacuum pressure source and a conductive fluid source to (a) reduce the pressure in at least one of the lumen of the elongate tube and the housing, and (b) subsequently aspirate the conductive fluid into at least one of the lumen of the elongate tube and the housing.

[0273] Example 102: A method for passing through a stent embedded in a body lumen, the method comprising:

[0274] Advancing a shock wave catheter through the body lumen to the stent without using a guide wire such that at least one shock wave emitter of the shock wave catheter is disposed adjacent to the embedded stent; and

[0275] Generating at least one shock wave by the at least one shock wave emitter.

[0276] Example 103: A system for fluid delivery and removal from a shock wave catheter according to any one of Examples 78 to 94, comprising:

[0277] A shock wave catheter according to any one of Examples 78 to 94, wherein the elongate tube includes at least one opening in a proximal portion of the elongate tube leading to a lumen of the elongate tube, the lumen being fluidly connected to the outer housing; and

[0278] A control handle connected to the proximal portion of the elongate tube, the control handle comprising:

[0279] At least one pressure seal that closes the at least one opening of the elongate tube; and

[0280] A fluid port fluidly connected to the at least one opening of the elongate tube, a vacuum pressure source, and a conductive fluid source to (a) reduce the pressure in at least one of the lumen of the elongate tube and the outer housing, and (b) subsequently draw the conductive fluid into at least one of the lumen of the elongate tube and the outer housing.

[0281] Although the electrode assemblies and catheter devices described herein can be used to treat coronary occlusions such as lesions in arteries and other blood vessels, and various occlusions such as those in the peripheral vascular system (e.g., above the knee, below the knee, iliac, carotid, etc.). Catheters with small crossing profiles, such as those described above, can be used to treat smaller blood vessels or those that are generally difficult to access, such as the M1, M2, or M3 segments of the middle cerebral artery. For additional examples, similar designs can be used to treat soft tissues such as cancers and tumors (i.e., non-thermal ablation methods), blood clots, fibroids, cysts, organs, scar and fibrosis tissue removal, or other tissue destruction and removal. The electrode assemblies and catheter designs can also be used for nerve stimulation therapy, targeted drug delivery, treatment of tumors in body lumens (e.g., tumors in blood vessels, esophagus, intestine, stomach, or vagina), wound treatment, non-surgical removal and destruction of tissue, or for replacing thermal therapy or cauterization for venous insufficiency and tubal ligation (i.e., for permanent female contraception).

[0282] In one or more examples, the electrode assemblies and catheters described herein can also be used in tissue engineering methods, e.g., for mechanical tissue decellularization to create bioactive scaffolds where new cells (e.g., exogenous or endogenous cells) can replace old cells; introducing pores into sites to improve cell retention, cell infiltration / migration, and diffusion of nutrients and signaling molecules, thereby promoting angiogenesis, cell proliferation, and tissue regeneration, similar to cell replacement therapies. Such tissue engineering methods can be used to treat ischemic heart disease, fibrotic liver, fibrotic intestine, and traumatic spinal cord injury (SCI). For example, for the treatment of spinal cord injury, the devices and assemblies described herein can promote the removal of scar spinal cord tissue, which acts as a barrier to neuronal reconnection, before injecting an anti-inflammatory hydrogel containing lentivirus to genetically engineer the regeneration of spinal cord neurons.

[0283] Without departing from the present invention, the elements and features of the above-described exemplary electrode assemblies and catheters can be rearranged, recombined, and modified. Additionally, numerical indicators such as "first," "second," "third," "fourth," etc. are merely descriptive and do not denote the relative order, position, or identity of the elements or features being described. For example, a "third" shock wave may immediately follow a "first" shock wave, and then a "second" shock wave may occur. As another example, a "third" emitter can be used to generate a "first" shock wave, or vice versa. Thus, the numerical indicators of the various elements and features are not intended to limit the present invention and can be modified and interchanged without departing from the present invention.

[0284] It should be noted that, without departing from the present invention, the elements and features of the exemplary catheters shown in this specification and the drawings can be rearranged, recombined, and modified. For example, although this specification and the drawings describe and illustrate catheters having several exemplary electrode designs, the present invention is intended to include catheters having a variety of different electrode configurations. The number, position, and spacing of the electrode pairs of the shock wave generator can be modified without departing from the present invention.

[0285] It should be understood that the above is only an illustration of the principles of the present invention, and those skilled in the art can make various changes, alterations, and combinations without departing from the scope and spirit of the present invention. Any variant of the various catheters disclosed herein can include features described by any other catheter or combination of catheters herein. Additionally, any method can be used with any of the disclosed catheters. Thus, the present invention is not intended to be limited except as restricted by the appended claims.

Claims

1. A shock wave catheter for treating lesions in a body lumen, characterized in that: The shock wave guide comprises: Slender tube; at least one shock wave transmitter disposed distally of the elongated tube and configured to generate at least one shock wave; a distal tip disposed at or near a distal end of the at least one shock wave transmitter; and A housing surrounds at least the at least one shock wave transmitter.

2. The shock wave guide according to claim 1, characterized in that At least a portion of the elongated tube includes a helical coil or a plurality of slits.

3. The shock wave guide according to claim 1, characterized in that: At least a portion of the elongated tube includes a braided portion.

4. The shock wave guide according to claim 1, characterized in that The shock wave guide includes a core wire extending within the elongated tube and terminating near a distal end of the elongated tube, wherein the core wire is configured to control deflection of at least a distal portion of the shock wave guide.

5. The shock wave guide according to claim 4, characterized in that: The distal end of the core wire includes the distal tip, and the distal tip has a larger diameter than the elongated portion of the core wire extending within the elongated tube.

6. The shock wave guide according to claim 1, characterized in that The internal volume of the housing is less than 1.5 cm 3 .

7. The shock wave guide according to claim 1, characterized in that The shock wave catheter does not include a lumen for a guide wire.

8. The shock wave guide according to claim 1, characterized in that The shock wave guide comprises a pair of wires, wherein the at least one shock wave transmitter comprises an electrode pair, and the distal end of each wire of the pair of wires forms an electrode of the electrode pair.

9. The shock wave guide according to claim 8, characterized in that At least one of the wires extends through the elongated tube to the at least one shock wave transmitter and comprises a refractory metal.

10. The shock wave guide according to claim 1, characterized in that The shock wave guide includes an optical fiber optically coupled to the at least one shock wave transmitter.

11. The shock wave guide according to claim 1, characterized in that The shock wave guide includes a radiopaque marker disposed proximate the at least one shock wave emitter for viewing the at least one shock wave emitter.

12. The shock wave guide according to claim 1, characterized in that The shock wave guide includes a first lumen for fluid configured to fill the housing and a second lumen for fluid configured to remove air bubbles generated during shock wave generation from the housing.

13. The shock wave guide according to claim 1, characterized in that The at least one shock wave transmitter is configured to emit at least one distally directed shock wave when an energy pulse is supplied to the at least one shock wave transmitter.

14. The shock wave guide according to claim 1, characterized in that The outer diameter of the shock wave guide tube is in the range of 0.25 mm to 1 mm.

15. The shock wave guide according to claim 1, wherein: The distal tip is configured to maintain a position and orientation of the at least one shock wave transmitter during use.

16. The shock wave guide according to claim 1, characterized in that The elongated tube includes a variable pitch flat wire helical coil, wherein a proximal portion of the flat wire helical coil has a pitch greater than a distal portion of the flat wire helical coil.

17. A system for delivering fluid to and removing fluid from a shock wave guide according to claim 1, characterized in that: The system comprises: The shock wave guide of claim 1, wherein the elongated tube includes at least one opening to a lumen of the elongated tube at a proximal portion of the elongated tube, the lumen being fluidly connected to the housing; and a control handle connected to the proximal portion of the elongated tube, the control handle comprising: at least one pressure seal closing the at least one opening of the elongated tube; and A fluid port is fluidly connected to the at least one opening of the slender tube, a vacuum pressure source, and a conductive fluid source to (a) reduce the pressure within at least one of the lumen of the slender tube and the housing, and (b) subsequently draw the conductive fluid into at least one of the lumen of the slender tube and the housing.

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