Shock wave catheter capable of penetrating high-resistance lesion

Abstract

A forward shock wave device is provided that includes an inner electrode and an outer electrode, and a wire connected to the electrodes. The electrodes are arranged to form a spark gap between the electrodes. In response to a high potential difference applied across the wire, an arc discharge is generated across the spark gap, and a shock wave propagates forward from the spark gap through the conductive fluid in the spark gap in a distant direction. The invention further discloses a forward shock wave guide pipe comprising the forward shock wave device. According to the forward shock wave catheter of the forward shock wave device, the operation step of turning into rotary grinding due to the fact that a traditional shock wave balloon cannot be in place is reduced when the forward shock wave catheter is used for treating high-resistance lesions of a human body pipeline system such as a blood vessel, so that the operation process is simplified, and the treatment efficiency is improved.

Description

Technical Field

[0001] The invention relates to the technical field of medical equipment, in particular to a shock wave device for penetrating high-resistance lesions in a forward direction and a forward shock wave catheter comprising the shock wave device. Background Art

[0002] A catheter is a medical device that can be inserted into the body to treat a disease or perform a medical procedure. For example, a patient may have atherosclerosis, which causes narrowing of the blood vessels. Atherosclerosis is usually treated by performing angioplasty. During angioplasty, a balloon is inserted through a catheter into a narrowed blood vessel and inflated to dilate the vessel, while a stent is inserted through a catheter into the lesion and inflated to dilate and support the lesion, ultimately restoring forward blood flow in the coronary artery.

[0003] At present, the difficulty caused by high-resistance coronary artery lesions (calcified lesions) is far beyond imagination. The difficulty of calcified lesions is often not that the guidewire passes through the lesion to reach the distal blood vessel, but that after the guidewire is in place, balloons, stents and other devices cannot be effectively put in place and expanded through the catheter. The current treatment methods for calcified lesions include high-pressure balloon dilatation, rotary atherectomy (RA) and intravascular shock wave lithotripsy (IVL). The IVL technology, which has developed rapidly in recent years, is mainly reflected in the development of shock wave balloon devices. For example, the patent document with publication number CN112842460A reports a shock wave generating system with hydraulic monitoring and replenishment for cardiovascular stenosis, the shock wave generating system including a liquid medium, a hydraulic sensor, a shock wave generator, an operating handle, a catheter and a balloon, wherein an electrode pair is arranged inside the balloon; the patent document with publication number CN113332570A reports a balloon catheter and a shock wave generating system, including a catheter body, a balloon connected to the distal end of the catheter body, an electrode device, etc.; the patent document with publication number CN115192122A reports a shock wave balloon catheter device, including a catheter body and a balloon, wherein the balloon is connected to the distal end of the catheter body, and the catheter body has a plurality of electrodes extending along its own axial direction. A liquid-passing cavity is set; the patent document with publication number CN114916992A reports a pressure wave balloon catheter with integrated pulse focused ultrasound; the patent document with publication number CN117297713A reports a directional shock wave balloon catheter, including a balloon and a tube body, the proximal end of the balloon is connected to the distal end of the tube body, the balloon has a chamber, the tube body has a channel connecting the chamber, and also includes an electrode assembly and an elastomer arranged in the chamber and a control magnet arranged outside the balloon; the patent document with publication number CN118203389A reports a shock wave balloon and a shock wave balloon assembly, the shock wave balloon includes a first balloon and a second balloon, and a shock wave emitting element for releasing radial shock waves along the radial direction of the second balloon is arranged inside the second balloon.

[0004] The purpose of high-pressure balloon dilatation is to rupture calcified lesions through high pressure, but its effect is often poor because the hardness and thickness of calcified lesions may exceed the bearing capacity of the balloon. Rotational atherectomy is a method of removing calcified lesions by rotating a grinding head at high speed. Although it is effective, it has a high risk factor and may cause vascular damage and other complications. Shock wave balloons break up calcified lesions by generating shock waves and have developed rapidly in recent years. The principle is to add a shock wave device that helps to crush calcified lesions in blood vessels to the catheter. The shock wave device generates shock waves to hit the calcified lesions around the device, breaking up hard and brittle calcium, making it easier for the balloon catheter to dilate the blood vessel. The shock wave generated by the device propagates circumferentially in the vertical direction with the catheter as the axis (forming a cylindrical surface), and the effect is better when the lesion surrounds the device. However, this requires the balloon to be placed in the calcified lesion for shock wave operation after the guidewire is passed. However, in some cases, the vascular lesion is heavily loaded (such as the calcified cap is extremely thick), making the vascular lesion too narrow or the lesion too hard, so that the balloon catheter and shock wave device cannot pass through it. Balloon catheters and shock wave devices can only reach the entrance of tight and difficult-to-penetrate lesions. At this time, if the shock wave device only releases longitudinal shock waves perpendicular to the long axis of the balloon catheter at the entrance of the lesion, it will not be effective in breaking up the lesions (such as calcified caps) at the front end. Summary of the invention

[0005] In view of the above-mentioned defects of shock wave devices in the prior art, such as shock wave devices including balloons and catheters, we have combined a large number of clinical surgical practices and postoperative follow-up results, and considering that the diameter of the catheter is smaller than that of the balloon and is easier to pass through the lesion area, we have conceived a catheter shock wave form in which the shock wave energy release direction is forward (forward) along the long axis of the catheter to replace the longitudinal (perpendicular to the long axis of the balloon catheter) release form of the shock wave energy of the balloon, thereby providing a "drilling type" shock wave device different from the prior art and a shock wave catheter including the new shock wave device, which can generate forward shock waves during surgical operations so as to dig forward after breaking the cap of the high resistance lesion of the blood vessel (such as the calcified cap). In view of this, the present invention provides the following technical solutions.

[0006] A shock wave device comprising:

[0007] an inner electrode disposed about a longitudinal axis and extending axially along the longitudinal axis;

[0008] an outer electrode disposed around the inner electrode and radially away from the inner electrode and extending axially along the longitudinal axis;

[0009] a first wire electrically connected to the inner electrode and electrically insulated from the outer electrode;

[0010] a second lead electrically connected to the outer electrode and electrically insulated from the inner electrode; and

[0011] a spark gap formed between an uninsulated portion of the inner electrode and an uninsulated portion of the outer electrode;

[0012] Wherein, in response to the potential difference applied across the first conductor and the second conductor, an arc discharge is generated across the spark gap, so that the arc discharge generates a single shock wave, and the single shock wave propagates forward from the spark gap through the conductive fluid in the spark gap in a moving away direction.

[0013] Preferably, the shock wave device further comprises one or more peripheral cavities, wherein the one or more peripheral cavities are located between the inner electrode and the outer electrode, wherein the peripheral cavities may be filled with a conductive fluid.

[0014] Furthermore, the shock wave device further comprises an outer insulating layer, which is located between the inner electrode and the outer electrode and is used to insulate the outer electrode from the first wire and to insulate the inner electrode from the second wire.

[0015] In one embodiment, the outer insulating layer comprises a polymer, an adhesive or a plastic insert.

[0016] The uninsulated portion of the outer electrode is formed at a distal end portion of the outer electrode, and the uninsulated portion of the inner electrode is formed at a distal end portion of the inner electrode.

[0017] The distal end portion of the inner electrode is axially misaligned with the distal end portion of the outer electrode; or

[0018] The distal end portion of the inner electrode is aligned with the distal end portion of the outer electrode.

[0019] Preferably, the uninsulated portions of the inner electrode and the outer electrode comprise chamfered distal ends.

[0020] Further, the inner electrode and the outer electrode include an insulating coating for insulating the outer electrode from the first lead and for insulating the inner electrode from the second lead, the insulating coating including holes forming uninsulated portions of the electrodes and forming the spark gap.

[0021] In a preferred embodiment, the inner electrode comprises two, namely a first inner electrode and a second inner electrode, so that the forward shock wave device is used to generate a forward double shock wave. Correspondingly, a shock wave device comprising one inner electrode can generate a forward shock wave.

[0022] That is, the present invention also provides a shock wave device, which comprises:

[0023] a first inner electrode and a second inner electrode, the first inner electrode and the second inner electrode being arranged around a longitudinal axis and extending axially along the longitudinal axis, and the first inner electrode and the second inner electrode being staggered from each other in a circumferential direction;

[0024] an outer electrode disposed around the first inner electrode and the second inner electrode and away from the first inner electrode and the second inner electrode in a radial direction and extending axially along the longitudinal axis;

[0025] a first wire electrically connected to the first inner electrode and electrically insulated from the outer electrode;

[0026] a second wire electrically connected to the second inner electrode and electrically insulated from the outer electrode;

[0027] a first spark gap formed between an uninsulated portion of the first inner electrode and a first uninsulated portion of the outer electrode; and

[0028] a second spark gap formed between an uninsulated portion of the second inner electrode and a second uninsulated portion of the outer electrode;

[0029] Wherein, in response to the potential difference applied across the first conductor and the second conductor, an arc discharge is generated across the first spark gap and the second spark gap, so that the arc discharge generates a double shock wave, and the double shock wave propagates forward from the spark gap through the conductive fluid in the spark gap in a away direction.

[0030] Preferably, the outer electrode comprises an insulating coating, which is used to insulate the outer electrode from the wire, and the insulating coating comprises a first hole and a second hole, and the first hole and the second hole respectively form the first uninsulated portion and the second uninsulated portion of the outer electrode.

[0031] Furthermore, the shock wave device further comprises one or more peripheral cavities, wherein the one or more peripheral cavities are located between the outer electrode and the inner electrode, wherein the peripheral cavities may be filled with a conductive fluid.

[0032] Preferably, the shock wave device further comprises an outer insulating layer, wherein the outer insulating layer is located between the outer electrode and the wire and is used to insulate the outer electrode from the wire.

[0033] The outer insulating layer mentioned above comprises a polymer, an adhesive or a plastic insert.

[0034] The uninsulated portion of the outer electrode is formed at a distal end portion of the outer electrode, and the uninsulated portion of each of the inner electrodes is formed at a respective distal end portion of the inner electrode.

[0035] In one embodiment, the respective distal end portion of each of the inner electrodes is axially offset from the distal end portion of the outer electrode; or

[0036] The distal end portion of each of the inner electrodes is aligned with the respective distal end portion of the outer electrodes.

[0037] Preferably, the uninsulated portions of the inner electrode and the outer electrode comprise chamfered distal ends.

[0038] Further, each inner electrode includes an insulating coating, and each insulating coating includes a hole forming an uninsulated portion of the respective inner electrode.

[0039] A second aspect of the present invention provides a shock wave guide tube, which comprises the shock wave device as described above, and further comprises an inner extension piece and an outer extension piece, wherein:

[0040] The shock wave device is disposed at a distal portion of the shock wave guide tube and around the inner extension, the inner extension including an inner lumen along a longitudinal axis to receive a guide wire;

[0041] The shock wave device is configured to generate a shock wave that propagates forwardly in a direction away from the shock wave device.

[0042] Preferably, the shock wave guide tube further comprises an inner insulating layer, wherein the inner insulating layer is located between the inner extension member and the inner electrode.

[0043] Furthermore, the shock wave guide tube further comprises a distal end cover, wherein the distal end cover attaches the inner extension member and the outer extension member together, and the distal end cover comprises a tapered portion for guiding the shock wave forward.

[0044] Preferably, the shock wave guide further comprises a distal tip attached to the distal cap and the distal end portion of the inner extension, wherein the distal tip comprises a tapered portion to facilitate movement of the shock wave guide in the blood vessel.

[0045] In one embodiment, the distal cap is configured to contain the conductive fluid to fill one or more peripheral cavities and a spark gap of the shock wave device with the conductive fluid.

[0046] The shock wave catheter can be used to treat high-resistance vascular lesions, urinary system lesions such as ureteral lesions, etc.

[0047] Another aspect of the present invention provides a method for treating high-resistance vascular lesions (such as calcified plaques), comprising the following steps:

[0048] inserting a shock wave catheter into a patient's blood vessel, the shock wave catheter comprising the shock wave device described above;

[0049] Advancing the shock wave catheter in a distal direction into the blood vessel until the distal portion of the shock wave device is opposite the proximal end (or starting portion) of the treatment site;

[0050] applying a potential difference across the first lead and the second lead;

[0051] generating a shock wave at the spark gap in response to the applied potential difference;

[0052] propagating the shock wave forwardly in a away direction from the spark gap through the conductive fluid in the spark gap; and

[0053] The shock wave is used to impact the high-resistance lesion in the blood vessel (such as calcified plaque), thereby crushing the lesion at the treatment site and treating the vascular plaque or high-resistance lesion.

[0054] Furthermore, the above method also includes the following steps:

[0055] removing the shock wave guide tube from the blood vessel;

[0056] inserting a second medical device into the blood vessel;

[0057] The second medical device is advanced in a distal direction into the blood vessel to continue treating the vascular plaque or high resistance lesion at the treatment site.

[0058] Furthermore, the second medical device includes a balloon catheter and a stent, so as to be used in conjunction with the forward shock wave catheter of the present invention.

[0059] The forward shock wave device and the forward shock wave catheter including the forward shock wave device provided by the present invention can generate forward shock waves during surgical operations for treating high-resistance vascular lesions (such as calcified plaques) so as to shatter the cap of the high-resistance lesions and advance forward. It has the ability to advance forward in high-resistance calcified lesions comparable to that of a rotary grinding head, while also having the safety of the shock wave balloon itself. No balloon may be provided in the shock wave device and the shock wave catheter. The design of this simple catheter can reach the starting part of the lesion with a smaller size (compared to the balloon), and cooperate with the shock wave to effectively advance in the lesion. Therefore, it is more convenient and faster to operate when used in surgery, which can save precious surgical time, reduce surgical risks and the occurrence of medical accidents. In summary, such a device and mode can not only effectively treat heavy calcified lesions, but also reduce the risk of damage to blood vessels, and improve the safety and effect of treatment. BRIEF DESCRIPTION OF THE DRAWINGS

[0060] Figure 1 It is a schematic structural diagram of an embodiment of a forward shock wave guide tube including a forward shock wave device according to the present invention.

[0061] Figure 2 yes Figure 1 A longitudinal cross-sectional view of an embodiment of a forward shock wave guide is shown.

[0062] Figure 3 It is a schematic structural diagram of an embodiment of a dual shock wave device of the present invention.

[0063] Figure 4 yes Figure 3 A schematic cross-sectional view of an embodiment of a dual shock wave device is shown.

[0064] Figure 5 It is a schematic structural diagram of an embodiment of a forward shock wave guide tube including a dual shock wave device according to the present invention.

[0065] Figure 6 yes Figure 5 Another schematic structural diagram of a dual shock waveguide embodiment is shown.

[0066] Figure 7 yes Figure 5 Another schematic structural diagram of a dual shock waveguide embodiment is shown.

[0067] Figure 8 It is a schematic structural diagram of a single shock wave device embodiment of the present invention.

[0068] Fig. 9 It is a schematic structural diagram of another single shock wave device embodiment of the present invention.

[0069] Fig.10 It is a schematic structural diagram of an embodiment of a forward shock wave guide tube including a single shock wave device according to the present invention.

[0070] Fig.11 yes Fig.10 Another schematic structural diagram of a single shock waveguide embodiment is shown.

[0071] Fig.12 yes Fig.10 Another schematic structural diagram of a single shock waveguide embodiment is shown.

[0072] Fig.13 yes Fig.10 Another schematic structural diagram of a single shock waveguide embodiment is shown.

[0073] Fig.14 and Fig.15 It is a schematic diagram of an operation in which the shock wave catheter of the present invention is used to treat high-resistance vascular lesions (such as calcified plaques).

[0074] Fig.16 Schematic diagram of a method for treating high-resistance vascular lesions (such as calcified plaques) using a dual shock wave catheter.

[0075] Fig.17 Schematic diagram of a method for treating high-resistance vascular lesions (such as calcified plaques) using a single shock wave catheter. DETAILED DESCRIPTION

[0076] The shock wave generated by the traditional shock wave balloon propagates circumferentially in the vertical direction with the catheter as the axis (forming a quasi-cylindrical surface), which requires the shock wave balloon to be located within the calcified lesion. However, if the entrance section of the lesion is extremely narrow and hard (high-resistance lesion), the shock wave balloon cannot enter the lesion, and the shock wave balloon that cannot be in place cannot start subsequent treatment. The excavation-type shock wave / shock wave device of the present invention can generate forward shock waves, which can more effectively treat high-resistance calcified lesions, especially lesions with extremely high resistance to the lesion opening (such as extremely thick calcification caps). Its ability to impact forward and break up high-resistance (or calcified) lesions allows it to continue to excavate forward after breaking the lesion opening, and its relatively small diameter also helps it to advance forward until the entire lesion is opened. This allows subsequent balloon or stent treatments to be in place and work smoothly.

[0077] The forward shock wave device has a highly efficient excavation capability. While maintaining the safety of the shock wave balloon itself, it provides an excavation capability comparable to that of the atherectomy head, reducing the risk of vascular damage and embolism caused by atherectomy. The forward shock wave device of the present invention also reduces the number of steps required to switch to atherectomy during surgery because the traditional shock wave balloon cannot be put in place, thereby reducing the risk of complications. In addition, the excavation-type forward shock wave device of the present invention simplifies the surgical process and improves treatment efficiency.

[0078] In terms of working principle, the present invention changes the direction of shock wave / shock wave energy release of the shock wave / shock wave surgical device with the same function used in similar "vascular dredging" operations in the prior art. Structurally, the forward shock wave device of the present invention includes an inner electrode and an outer electrode, and a wire connected to the electrodes. The electrodes are arranged to form a spark gap between the electrodes. In response to the high potential difference applied across the wire, an arc discharge is generated across the spark gap, and the shock wave propagates forward from the spark gap through the conductive fluid in the spark gap in a direction away from the spark gap. The structure of the present invention eliminates the need for the setting or matching of the balloon, so that the diameter of the device is reduced and easy to pass through, and does not hinder the subsequent high-voltage, cutting balloon expansion, and the surgical operation is more convenient and faster, which greatly saves precious surgical time, thereby reducing surgical risks and medical accidents.

[0079] In addition, in addition to being used for vascular "unblocking" surgery such as vascular high resistance disease (such as calcified plaque) treatment surgery, the shock wave device and shock wave device of the present invention can also be used for surgical treatment of other diseased organs such as the urinary system, such as ureteral "blockage / obstruction" diseases, such as the removal of ureteral stones.

[0080] For the convenience of description, the forward shock wave device / forward shock wave guide tube may be referred to herein as the shock wave device / shock wave guide tube, respectively, and collectively referred to as the "shock wave system".

[0081] The present invention provides two types of forward shock wave devices and forward shock wave guide tubes, one type uses one inner electrode to form a single shock wave / shock wave; the other type uses two inner electrodes to generate dual shock waves / shock waves.

[0082] For the convenience of description, the forward shock wave device / shock wave guide tube for forming a double shock wave may be referred to herein as a "double shock wave device / double shock wave guide tube", and collectively referred to as a "double shock wave system". Accordingly, the forward shock wave device / shock wave guide tube for forming a single (single) shock wave may be referred to herein as a "single (single) shock wave device / single (single) shock wave guide tube", and collectively referred to as a "single (single) shock wave system".

[0083] Relatively speaking, dual shock wave has certain advantages over single shock wave in some aspects. For example, compared with single shock wave system, some advantages of dual shock wave system include but are not limited to:

[0084] 1. Improve the efficiency of calcification crushing.

[0085] Increased acoustic pressure through pulse stacking: The Dual Shockwave device utilizes two pairs of electrodes to generate two overlapping acoustic pressure fields. This overlap results in a significant increase in the effective acoustic pressure at the site of calcification. The result is a more efficient and uniform fragmentation of calcium deposits. This synergy between the dual shockwaves allows for a higher peak pressure to be achieved, resulting in a more effective mechanical disruption of calcified plaques.

[0086] Crack extension: Double shock waves can generate multiple crack initiation points in the calcified plaque. This enhances the expansion of cracks in the calcified plaque, making it more thoroughly broken. This is more advantageous for treating thicker calcified plaques. A single shock wave can usually only generate surface cracks and cannot break up deep calcified plaques.

[0087] 2. Improve energy distribution and reduce the risk of vascular damage.

[0088] More even energy distribution: Dual shock waves can make the energy distribution on the entire lesion more even.

[0089] Reduced risk of thermal injury: Dual shock waves improve energy delivery efficiency, reducing the need for excessive energy, thereby reducing the risk of thermal injury. This is especially important in patients with fragile blood vessels.

[0090] The two types of shock waves can be summarized as follows:

[0091]

[0092] The various features and advantages of the present invention will become more apparent to those skilled in the art from the following detailed description of embodiments, which are presented by way of non-limiting example only, and the accompanying drawings.

[0093] For the sake of brevity and clarity, the description of the embodiments is directed to forward shock wave devices and shock wave guide tubes including these forward shock wave devices, according to the accompanying drawings. Although portions of the present invention will be described in conjunction with the embodiments provided herein, it should be understood that these embodiments are not intended to limit the present invention to these embodiments. On the contrary, the present invention is intended to cover alternatives, modifications and equivalents to the embodiments described herein, which are included within the scope of the present invention as defined by the appended claims. In addition, in the following detailed description, specific details are set forth to provide a thorough understanding of the present invention. However, a person of ordinary skill in the art, i.e., a general person, will recognize that the present invention can be implemented without these specific details, and / or with multiple details resulting from a combination of features according to a particular embodiment. In many cases, well-known systems, methods, procedures, and components are not described in detail to avoid unnecessarily hindering the understanding of the features of the embodiments of the present invention.

[0094] In embodiments of the present invention, the description of a given element or the use of a particular element number in a particular figure or reference in a corresponding description section may encompass the same, equivalent or similar elements or element numbers mentioned in another figure or description section related thereto.

[0095] References to "an embodiment / example", "another embodiment / example", "some embodiments / examples", "some other embodiments / examples", etc. indicate that the described embodiment / example may include specific features, structures, characteristics, attributes, elements, or limitations, but not every embodiment / example necessarily includes the specific features, structures, characteristics, attributes, elements, or limitations. In addition, repeated use of the phrase "in an embodiment / example" or "in another embodiment / example" does not necessarily refer to the same embodiment / example.

[0096] The expressions "comprise", "include", "have", etc. do not exclude the existence of other features / elements / steps that are not listed. The listing of certain features / elements / steps in different embodiments does not mean that these features / elements / steps cannot be used in combination in one embodiment. The definition of the expression "one" used in this article can be one or more. The use of " / " in the figures or related text is understood to be "and / or", unless otherwise stated. According to known mathematical definitions, the expression "set" is defined as a non-empty finite organization comprising at least one element (for example, the set defined in this article can correspond to a unit, a single-element set, or a multi-element set). The terms "first", "second", etc. are used only as labels or identifiers, and are not intended to impose numerical requirements on their related expressions.

[0097] Example

[0098] Please refer to Figure 1 , 2 , 3 and 8, the present invention provides a forward shock wave catheter 100 embodiment including a shock wave device 200, 300, which can be used to treat diseases and / or perform medical procedures. In particular, the forward shock wave catheter 100 can be used to treat high resistance lesions in a patient's human body pipeline network system. For example, the forward shock wave catheter 100 can be used in percutaneous coronary angioplasty to treat atherosclerosis (e.g., calcified lesions in the coronary arteries) or to treat urinary system diseases (e.g., kidney stones in the ureters). The forward shock wave catheter 100 includes shock wave devices 200, 300, and the shock waves generated by these devices propagate forward from the forward shock wave catheter 100 toward the distal direction to break up high resistance lesions (such as vascular calcified plaques). More specifically, one shock wave device 200 embodiment is configured to generate a dual shock wave, namely a first shock wave and a second shock wave, and can be referred to as a dual shock wave device 200, while another shock wave device 300 embodiment is configured to generate a single shock wave and can be referred to as a single shock wave device 300.

[0099] In an embodiment of the present invention, the forward shock wave guide 100 includes a dual shock wave device 200 for generating dual shock waves, or a single shock wave device 300 for generating a single shock wave. The forward shock wave guide 100 also includes an inner extension 110, which extends along the longitudinal axis and has an inner cavity 112. The forward shock wave guide 100 also includes an outer extension 120, which is arranged around the shock wave devices 200, 300 and extends along the longitudinal axis.

[0100] Two types of forward shock wave devices 200 and 300 and embodiments of a forward shock wave guide 100 including the forward shock wave devices 200 and 300 are introduced below.

[0101] Dual Shockwave Device 200

[0102] like Figure 3 and Figure 4 As shown in , the present invention provides a dual shock wave device 200 for generating dual shock waves and a forward shock wave guide 100 including the dual shock wave device 200 , wherein the dual shock waves include a first shock wave and a second shock wave.

[0103] The double shock wave device 200 includes a first inner electrode 210 and a second inner electrode 220, which are arranged around the longitudinal axis and extend axially along the longitudinal axis, and the first inner electrode 210 and the second inner electrode 220 are staggered from each other in the circumferential direction. When the forward shock wave guide 100 is used, the first inner electrode 210 and the second inner electrode 220 are arranged around the inner extension 110. For example, each of the first inner electrode 210 and the second inner electrode 220 has an arc-shaped profile around the inner extension 110. The double shock wave device 200 includes an outer electrode 230, which is arranged around the first inner electrode 210 and the second inner electrode 220 and is away from the first inner electrode 210 and the second inner electrode 220 in the radial direction, and the outer electrode 230 extends axially along the longitudinal axis. Preferably, the inner electrodes 210, 220 and the outer electrode 230 are coaxial along the longitudinal axis. The radial arrangement of the inner electrodes 210, 220 and the outer electrodes 230 forms an annular space 240 between the outer electrodes 230 and the inner electrodes 210, 220. The inner electrodes 210, 220 and the outer electrodes 230 may be made of suitable materials that can withstand high potential differences or voltage pulses, such as iron, nickel, steel, tungsten, etc. It is understood that the electrodes 210, 220, 230 may have various shapes and sizes, such as Figure 7 The shapes shown in .

[0104] The dual shock wave device 200 includes a first wire 250 that is electrically connected to the first inner electrode 210 and electrically insulated from the outer electrode 230. Preferably, the first wire 250 is electrically connected to the proximal portion 212 of the first inner electrode 210. The first wire 250 is mostly insulated except for its distal portion 252, which is uninsulated. For example, the first wire 250 is a copper wire with an insulating outer layer such as a polymer on the outside. For example, the copper at the uninsulated distal portion 252 of the first wire 250 is electrically connected to the proximal portion 212 of the first inner electrode 210. It is understood that the uninsulated distal portion 252 of the first wire 250 can be connected to other parts of the first inner electrode 210, such as the middle portion or a portion closer to the distal portion 214.

[0105] The dual shock wave device 200 includes a second wire 260 that is electrically connected to the second inner electrode 220 and electrically insulated from the outer electrode 230. Preferably, the second wire 260 is electrically connected to the proximal portion 222 of the second inner electrode 220. The second wire 260 is mostly insulated except for its distal portion 262, which is uninsulated. For example, the second wire 260 is a copper wire with an insulating outer layer such as a polymer on the outside. For example, the copper at the uninsulated distal portion 262 of the second wire 260 is electrically connected to the proximal portion 222 of the second inner electrode 220. It is understood that the uninsulated distal portion 262 of the second wire 260 can be connected to other parts of the second inner electrode 220, such as the middle portion or a portion closer to the distal portion 224.

[0106] The dual shock wave device 200 includes a first spark gap 242 formed between an uninsulated portion of the first inner electrode 210 and a first uninsulated portion of the outer electrode 230. For example, the uninsulated portion of the first inner electrode 210 includes an outer arcuate surface 216 at a distal end portion 214 of the first inner electrode 210, and the first uninsulated portion of the outer electrode 230 includes a first inner arcuate surface 236 at a distal end portion 234 of the outer electrode 230. The dual shock wave device 200 includes a second spark gap 244 formed between an uninsulated portion of the second inner electrode 220 and a second uninsulated portion of the outer electrode 230. For example, the uninsulated portion of the second inner electrode 220 includes an outer arcuate surface 226 at a distal end portion 224 of the second inner electrode 220, and the second uninsulated portion of the outer electrode 230 includes a second inner arcuate surface 238 at a distal end portion 234 of the outer electrode 230. It is noteworthy that the first spark gap 242 and the second spark gap 244 are formed in or near the annular space 240 .

[0107] When in use, a potential difference or voltage pulse is applied to the dual shock wave device 200 to generate a dual shock wave. The potential difference or voltage pulse should be high enough to cause an arc discharge to occur. For example, the voltage pulse can be between 100V and 10kV, and can be applied for various pulse durations. In response to the high potential difference or voltage pulse applied across the first wire 250 and the second wire 260, an arc discharge is generated across the first spark gap 242 and the second spark gap 244, so that the arc discharge generates a dual shock wave, which propagates forward from the spark gaps 242, 244 through the conductive fluid in the spark gaps 242, 244 in a direction toward the distal end. Specifically, the dual shock wave includes a first shock wave propagating forward from the first spark gap 242 in a direction toward the distal end and a second shock wave propagating forward from the second spark gap 244 in a direction toward the distal end.

[0108] For example, an arc discharge travels from the first inner electrode 210 across the first spark gap 242 to the outer electrode 230, thereby generating a first shock wave. The arc discharge may travel between any point on the uninsulated outer arc surface 216 of the first inner electrode 210 and any point on the uninsulated first inner arc surface 236 of the outer electrode 230. The arc discharge then travels along the outer electrode 230 and from the outer electrode 230 through the second spark gap 244 to the second inner electrode 220, thereby generating a second shock wave. The arc discharge may travel between any point on the uninsulated second inner arc surface 238 of the outer electrode 230 and any point on the uninsulated outer arc surface 226 of the second inner electrode 220. Notably, the first and second shock waves are generated almost simultaneously, thereby simultaneously propagating dual shock waves from the device 200.

[0109] In another example, the arc discharge passes from the second inner electrode 220 through the second spark gap 244 to the outer electrode 230, thereby generating a first shock wave. The arc discharge can propagate between any point on the uninsulated outer arc surface 226 of the second inner electrode 220 and any point on the uninsulated second inner arc surface 238 of the outer electrode 230. The arc discharge then travels along the outer electrode 230 and passes from the outer electrode 230 through the first spark gap 242 to the first inner electrode 210, thereby generating a second shock wave. The arc discharge can travel between any point on the uninsulated first inner arc surface 236 of the outer electrode 230 and any point on the uninsulated outer arc surface 216 of the first inner electrode 210. It can be understood that the first shock wave can be generated at the first spark gap 242 or the second spark gap 244, and similarly, the second shock wave can be generated at the first spark gap 242 or the second spark gap 244.

[0110] In addition, the conductive fluid in the spark gaps 242, 244 reduces the high resistance of air in the spark gaps 242, 244, allowing arc discharge to occur. The arc discharge forms cavitation bubbles in the conductive fluid, which rapidly expand and collapse, thereby generating a dual shock wave at the spark gaps 242, 244.

[0111] The arrangement of the inner electrodes 210, 220 and the outer electrode 230 enables the dual shock wave to propagate forward from the device 200 in a direction away from the device 200, that is, to propagate forward in a direction substantially away from the device 200. Specifically, the spark gaps 242, 244 are arranged in an annular space 240 defined by the electrodes 210, 220, 230, and the annular space 240 is channel-shaped, with an open front end and a closed rear end. The open front end of the annular space 240 is far away from the spark gaps 242, 244 and is defined by the farthest ends of the electrodes 210, 220, 230, for example, Figure 3. The shock wave propagating forward in the distal direction will leave through the open front end of the annular space 240, while the shock wave propagating backward in the approaching direction will be reflected forward from the closed rear end of the annular space 240. Therefore, the annular space 240 acts as a focusing channel to guide the shock wave in the direction of the distal end. For example, the angle of the forward-directed dual shock wave relative to the longitudinal axis is less than 45°. When used in a forward shock wave catheter 100 that is advanced through a patient's blood vessel, the dual shock wave propagates forward along the advancement direction of the forward shock wave catheter 100, so that the dual shock wave directly impacts and breaks high-resistance lesions (such as calcified plaques) in the blood vessel in front of the forward shock wave catheter 100. The forward-directed dual shock wave is more effective in breaking high-resistance lesions (such as calcified plaques) in the blood vessel in front because most of the shock wave energy is concentrated on the target lesion.

[0112] In some instances, such as Figure 5 As shown, the dual shock wave device 200 includes one or more peripheral cavities 270 located between the outer electrode 230 and the inner electrodes 210, 220. The peripheral cavity 270 can be filled with a conductive fluid, such as saline, which fills the spark gaps 242, 244 so that cavitation bubbles eventually form and collapse and generate dual shock waves. The dual shock waves propagate forward in a generally distal direction through the conductive fluid, and then impact the high resistance lesions (such as calcified plaques) in front of the forward shock wave catheter 100.

[0113] In some instances, such as Figure 3 As shown, the dual shock wave device 200 includes an outer insulating layer 280, which is located between the outer electrode 230 and the wires 250, 260, and is used to insulate the outer electrode 230 from the wires 250, 260. The outer insulating layer 280 extends from the proximal portion 232 of the outer electrode 230 along the outer electrode 230 in the axial direction. For example, the outer insulating layer 280 can be made of a polymer. For example, the outer insulating layer 280 includes an adhesive or a plastic insert. Figure 3 As shown in , the uninsulated portion of the outer electrode 230 may be formed at the distal end portion 234 of the outer electrode 230 , and the uninsulated portions of the inner electrodes 210 , 220 may be formed at the distal end portions 214 , 224 of the inner electrodes 210 , 220 , respectively.

[0114] In some instances, such as Figure 3 and Figure 5 As shown in FIG, the distal portions 214, 224 of the inner electrodes 210, 220 can be aligned with the distal portion 234 of the outer electrode 230. Specifically, the distal portions 214, 224, 234 include the distal-most ends of the electrodes 210, 220, 230, and these distal-most ends terminate in the same radial plane (perpendicular to the longitudinal axis).

[0115] In some instances, such as Figure 4 and Figure 6 As shown in FIG, the distal end portions 214, 224 of the inner electrodes 210, 220 are axially offset relative to the distal end portion 234 of the outer electrode 230. For example, the distal-most end of the inner electrodes 210, 220 is located in front of the distal-most end of the outer electrode 230. Alternatively, the distal-most end of the outer electrode 230 is located in front of the distal-most end of the inner electrodes 210, 220. The axial offset allows the position and boundary of the spark gaps 242, 244 to be controlled, thereby also allowing the angle of the dual shock waves relative to the longitudinal axis to be changed.

[0116] The outer insulating layer 280 may also be similarly aligned with or axially offset from the distal end portions 214, 224, 234 of the electrodes 210, 220, 230. Figure 5 As shown in FIG. 1 , the outer insulating layer 280 is aligned with the distal portions 214, 224 of the inner electrodes 210, 220 and the distal portion 234 of the outer electrode 230, i.e., their distal ends all terminate in the same radial plane. The uninsulated portion of the inner electrode 210 includes its distal end, and the uninsulated portion of the outer electrode 230 includes its distal end. The arc discharge will be generated across these distal ends, resulting in a double shock wave with an angle of nearly 90° relative to the longitudinal axis. In another example, as shown in FIG. Figure 6 As shown in FIG. 2 , the distal end of the outer electrode 230 is located in front of the distal end of the outer insulating layer 280. This will result in a double shock wave with a smaller angle relative to the longitudinal axis, such as 45°.

[0117] In some examples, as an alternative or in addition to the outer insulating layer 280, the outer electrode 230 may include an insulating coating for insulating the outer electrode 230 from the wires 250, 260. The insulating coating includes first and second holes that form first and second uninsulated portions of the outer electrode 230, respectively. Similarly, each of the first and second inner electrodes 210, 220 may include an insulating coating. Each insulating coating of the inner electrodes 210, 220 includes holes that form uninsulated portions of the respective inner electrodes 210, 220. By arranging the holes of the insulating coating, the position of the spark gaps 242, 244 can be changed, and thus the angle of the double shock wave relative to the longitudinal axis can also be adjusted.

[0118] In such Figure 3 and Figure 6In the example shown in FIG. 1 , spark gaps 242, 244 are formed between the uninsulated distal end portions 214, 224, 234 of the electrodes 210, 220, 230, respectively. Specifically, the first spark gap 242 is formed between the uninsulated outer arcuate surface 216 of the first inner electrode 210 and the uninsulated first inner arcuate surface 236 of the outer electrode 230. Similarly, the second spark gap 244 is formed between the uninsulated outer arcuate surface 226 of the second inner electrode 220 and the uninsulated second inner arcuate surface 238 of the outer electrode 230. The direct confrontation of the respective surfaces of the electrodes 210, 220, 230 defines the boundaries of the annular space 240 where the spark gaps 242, 244 are located, and is mainly used for the forward guidance of the dual shock wave. Furthermore, the axial offset between the distal portions 214, 224 of the inner electrodes 210, 220 and the distal portion 234 of the outer electrode 230 adjusts the boundaries of the annular space 240 and the locations of the spark gaps 242, 244, thereby also adjusting the angle of the dual shock waves relative to the longitudinal axis.

[0119] In some examples, the uninsulated portions of the inner electrodes 210, 220 and the uninsulated portions of the outer electrodes 230 may include chamfered distal ends. The chamfered distal ends of the electrodes 210, 220, 230 may reduce the angle and improve forward propagation of the dual shock waves. It is understood that the chamfered distal ends may be applied to various examples of the dual shock wave device 200 described herein. It is also understood that the distal ends may be modified in other ways, not limited to or in addition to chamfering, such as by rounding the distal ends. Figure 7 Another example of a dual shock wave device 200 is shown, where the inner electrodes 210, 220 and the outer electrode 230 have different configurations. For example, Figure 7 The shape of the middle outer electrode 230 reduces the surface area of ​​the uninsulated distal portion 234 of the outer electrode 230, thereby increasing the strength of the dual shock waves.

[0120] Single Shockwave Device 300

[0121] like Figure 8 and Fig. 9 As shown in FIG. 1 , the present invention provides a single shock wave device 300 for generating a single shock wave and a shock wave guide 100 including the single shock wave device 300 .

[0122] The single shock wave device 300 includes an inner electrode 310, which is arranged around the longitudinal axis and extends axially along the longitudinal axis. When used in the forward shock wave guide tube 100, the inner electrode 310 is arranged around the inner extension 110. For example, the inner electrode 310 has an arc-shaped profile around the circumference of the inner extension 110. The single shock wave device 300 includes an outer electrode 330, which is arranged around the inner electrode 310 and away from the inner electrode 310 in the radial direction, and extends axially along the longitudinal axis. Preferably, the inner electrode 310 and the outer electrode 330 are coaxially arranged along the longitudinal axis. The radial arrangement of the inner electrode 310 and the outer electrode 330 forms an annular space therebetween. The inner electrode 310 and the outer electrode 330 can be made of a suitable material that can withstand a high potential difference or voltage pulse, for example, made of iron, nickel, steel, tungsten, etc. It will be understood that the electrodes 310, 330 can have various shapes and sizes, for example, having shapes such as Fig.13 The shapes shown in .

[0123] The single shock wave device 300 includes a first wire 350 that is electrically connected to the inner electrode 310 and electrically insulated from the outer electrode 330. Preferably, the first wire 350 is electrically connected to the proximal portion 312 of the inner electrode 310. The first wire 350 is mostly insulated except for its distal portion 352, which is uninsulated. For example, the first wire 350 is a copper wire with an insulating outer layer such as a polymer. For example, the copper at the uninsulated distal portion 352 of the first wire 350 is electrically connected to the proximal portion 312 of the inner electrode 310. It is understood that the uninsulated distal portion 352 of the first wire 350 can be connected to other portions of the inner electrode 310, such as the middle portion or a portion closer to the distal portion 314.

[0124] The single shock wave device 300 includes a second wire 360 ​​that is electrically connected to the outer electrode 330 and electrically insulated from the inner electrode 310. Preferably, the second wire 360 ​​is electrically connected to the proximal portion 332 of the outer electrode 330. The second wire 360 ​​is mostly insulated except for its distal portion 362, which is uninsulated. For example, the second wire 360 ​​is a copper wire with an insulating outer layer such as a polymer. For example, the copper at the uninsulated distal portion 362 of the second wire 360 ​​is electrically connected to the proximal portion 332 of the outer electrode 330. It is understood that the uninsulated distal portion 362 of the second wire 360 ​​can be connected to other portions of the outer electrode 330, such as the middle portion or a portion closer to the distal portion 334.

[0125] The single shock wave device 300 includes a spark gap 340 formed between an uninsulated portion of the inner electrode 310 and an uninsulated portion of the outer electrode 330. For example, the uninsulated portion of the inner electrode 310 includes an outer circumferential surface 316 at a distal end portion 314 of the inner electrode 310, and the uninsulated portion of the outer electrode 330 includes an inner circumferential surface 336 at a distal end portion 334 of the outer electrode 330. It is noteworthy that the spark gap 340 is formed in or near the annular space.

[0126] In use, a high potential difference or voltage pulse is applied to the single shock wave device 300 to generate a single shock wave. The potential difference or voltage pulse should be high enough to cause an arc discharge. For example, the voltage pulse can be between 100V and 10kV and can be applied at various pulse durations. In response to the high potential difference or voltage pulse applied across the first conductor 350 and the second conductor 360, an arc discharge is generated across the spark gap 340, so that the arc discharge generates a single shock wave, which propagates forward from the spark gap 340 through the conductive fluid in the spark gap 340 in a direction away from the spark gap 340.

[0127] For example, an arc discharge travels from the inner electrode 310 through the spark gap 340 to the outer electrode 330, thereby generating a single shock wave and propagating the single shock wave from the device 300. Alternatively, an arc discharge travels from the outer electrode 330 through the spark gap 340 to the inner electrode 310. The arc discharge may travel between any point on the uninsulated outer circumferential surface 316 of the inner electrode 310 and any point on the uninsulated inner circumferential surface 336 of the outer electrode 330.

[0128] In addition, the conductive fluid in the spark gap 340 reduces the high resistance of air that would otherwise exist in the spark gap 340, enabling an arc discharge to occur. The arc discharge forms cavitation bubbles in the conductive fluid that rapidly expand and collapse, thereby generating a single shock wave at the spark gap 340.

[0129] The arrangement of the inner electrode 310 and the outer electrode 330 enables a single shock wave to propagate forward from the device 300 in a direction away from the device 300, that is, to propagate forward in a substantially away direction. Specifically, the spark gap 340 is disposed in an annular space defined by the electrodes 310 and 330, and the annular space is channel-shaped, with an open front end and a closed rear end. The open front end of the annular space is far away from the spark gap 340 and is surrounded by the farthest ends of the electrodes 310 and 330, such as Fig. 9As shown in . The shock wave propagating in the distal direction will leave through the open front end of the annular space, while the shock wave propagating toward the proximal end will be reflected toward the front from the closed rear end of the annular space. Therefore, the annular space acts as a focusing channel to guide the shock wave toward the forward and distal direction. For example, the angle of the single shock wave directed forward is less than 45° relative to the longitudinal axis. When used in a forward shock wave catheter 100 that is advanced through a patient's blood vessel, the single shock wave propagates forward along the advancement direction of the forward shock wave catheter 100, so that the single shock wave directly impacts and breaks high-resistance lesions (such as vascular calcified plaques) in the blood vessel in front of the forward shock wave catheter 100. The forward-directed single shock wave is more effective in breaking high-resistance lesions (such as vascular calcified plaques) in the front because most of the shock wave energy is concentrated on the vascular plaques.

[0130] In such Fig.11 and Fig.12 In some examples, the single shock wave device 300 includes one or more peripheral cavities 370 located between the outer electrode 330 and the inner electrode 310. The peripheral cavity 370 can be filled with a conductive fluid, such as saline, which fills the spark gap 340 to form and eventually collapse cavitation bubbles, thereby generating a single shock wave. The single shock wave propagates forward in a generally away direction through the conductive fluid and then impacts a high-resistance vascular lesion (such as a calcified plaque) located in front of the forward shock wave catheter 100.

[0131] In such Figure 8 In some examples shown, the single shock wave device 300 includes an outer insulating layer 380 located between the inner electrode 310 and the outer electrode 330 for insulating the outer electrode 330 from the first lead 350 and insulating the inner electrode 310 from the second lead 360. The outer insulating layer 380 extends axially along the outer electrode 330 from the proximal portion 332 of the outer electrode 330. For example, the outer insulating layer 380 can be made of a polymer. For example, the outer insulating layer 380 includes an adhesive or a plastic insert. Figure 8 and Fig.10 As shown in , the uninsulated portion of the outer electrode 330 may be formed at the distal end portion 334 of the outer electrode 330 , and the uninsulated portion of the inner electrode 310 may be formed at the distal end portion 314 of the inner electrode 310 .

[0132] In such Figure 8 and Fig.11 In some examples shown in , the distal portion 314 of the inner electrode 310 can be aligned with the distal portion 334 of the outer electrode 330. Specifically, the distal portions 314, 334 include the distal-most ends of the electrodes 310, 330 that terminate in the same radial plane (perpendicular to the longitudinal axis).

[0133] In such Fig.10In some examples shown in , the distal portion 314 of the inner electrode 310 is axially offset relative to the distal portion 334 of the outer electrode 330. For example, the distal end of the inner electrode 310 is located in front of the distal end of the outer electrode 330. Alternatively, the distal end of the outer electrode 330 is located in front of the distal end of the inner electrode 310. The axial offset causes the uninsulated circumferential surfaces 316, 336 of the electrodes 310, 330 to directly oppose each other, thereby defining the boundaries of the annular space where the spark gap 340 is located and is mainly used for the forward propagation of the single shock wave. The axial offset thus allows the position and boundaries of the spark gap 340 to be controlled, thereby also changing the angle of the single shock wave relative to the longitudinal axis.

[0134] The outer insulating layer 380 may also be similarly aligned with or axially offset from the distal end portions 314, 334 of the electrodes 310, 330. Fig.11 As shown in FIG. 1 , the outer insulating layer 380 is aligned with the distal portions 314, 334 of the electrodes 310, 330, i.e., their distal ends terminate in the same radial plane. The uninsulated portions of the electrodes 310, 330 include their distal ends. The arc discharge will be generated across the distal ends, resulting in a single shock wave with an angle of approximately 90° relative to the longitudinal axis. In another example, as shown in FIG. Fig.10 As shown in FIG. 3 , the distal end of the outer electrode 330 is located in front of the distal end of the outer insulating layer 380. This will result in a single shock wave with a small angle relative to the longitudinal axis, such as 45°.

[0135] In such Fig. 9 In some examples shown in , as an alternative or in addition to the outer insulating layer 380, the inner electrode 310 and the outer electrode 330 may include an insulating coating 390 for insulating the outer electrode 330 from the first wire 350 and insulating the inner electrode 310 from the second wire 360. The insulating coating 390 includes holes for forming uninsulated portions of the electrodes 310, 330 and forming a spark gap 340. Specifically, the spark gap 340 is formed between the uninsulated outer circumferential surface 316 of the inner electrode 310 and the uninsulated circumferential surface 336 of the outer electrode 330. The direct facing of the circumferential surfaces 316, 336 of the electrodes 310, 330 defines the boundary of the annular space where the spark gap 340 is located and is used for the forward propagation of the single shock wave. The position of the spark gap 340 can be changed by arranging the holes of the insulating coating 390, so that the angle of the single shock wave relative to the longitudinal axis can also be adjusted. For example, moving the hole forward in the direction away from the angle will increase the angle, while moving the hole backward in the direction close to the angle will decrease the angle.

[0136] In such Figure 8 and Fig.12In some examples shown in , the uninsulated portion of the inner electrode 310 and the uninsulated portion of the outer electrode 330 can include chamfered distal ends. The chamfered distal ends of the electrodes 310, 330 can reduce the angle and improve the forward propagation of the single shock wave. It is understood that the chamfered distal ends can be applied to various examples of the single shock wave device 300 described herein. It is also understood that the distal ends can be modified in other ways, not limited to chamfering, or in other forms besides chamfering, such as rounded corners. Fig.13 Another example of a single shock wave device 300 is shown, where the inner electrode 310 and the outer electrode 330 have different configurations. For example, Fig.13 The shape of the middle outer electrode 330 reduces the uninsulated surface area of ​​the outer electrode 330, thereby increasing the strength of the single shock wave.

[0137] Forward shock wave guide 100

[0138] like Figure 1 and Figure 2 As shown, the forward shock wave guide 100 may include a dual shock wave device 200 for generating dual shock waves, or the forward shock wave guide 100 may include a single shock wave device 300 for generating a single shock wave. The forward shock wave guide 100 includes an inner extension 110 with an inner lumen 112 to receive a guide wire 160. The shock wave devices 200, 300 are arranged around the inner extension 110. For example, each inner electrode 210, 220, 230 is arranged coaxially with the longitudinal axis.

[0139] The inner extension 110 can be braided, non-braided, or coiled. For example, the inner extension 110 can be braided to improve mechanical strength and reduce kinking. The inner extension 110 can include an insulating outer layer to insulate from the inner electrodes 210, 220, 310. Alternatively or additionally, the forward shock wave guide tube 100 can include an inner insulating layer 130 located between the inner extension 110 and the inner electrodes 210, 220, 310. For example, the inner insulating layer 130 can be made of a polymer. The forward shock wave guide tube 100 further includes an outer extension 120 surrounding the shock wave device 200, 300. The outer extension 120 is a rigid structure to facilitate insertion and advancement into a blood vessel, and the outer extension 120 can be braided, non-braided, or coiled. For example, the outer extension 120 can be braided to improve mechanical strength and reduce kinking. It will be appreciated that the inner extension member 110 and the outer extension member 120 may be made of a variety of suitable materials, depending on the desired mechanical properties, such as stiffness.

[0140] In some examples, the outer extension 120 is directly attached to the inner extension 110. In some examples, the forward shock wave guide 100 includes a distal cap 140 that connects the inner extension 110 and the outer extension 120 together. The distal cap 140 is arranged around the shock wave device 200, 300 and has a tapered portion 142 for directing the dual shock waves (the first and second shock waves from the device 200) or the single shock wave (from the device 300) forward, that is, forward in a generally away direction. The forward shock wave guide 100 can also include a distal tip 150, which is attached to the inner extension 110 and the distal portion of the distal cap 140. The distal tip 150 has a tapered portion 152 to facilitate the movement of the shock wave guide 100 in the blood vessel. It will be appreciated that the distal cap 140 and the distal tip 150 can be made of a variety of suitable materials, depending on the desired mechanical properties, such as stiffness. For example, the distal cap 140 may be more flexible than the outer extension 120 .

[0141] In some examples, the shock wave device 200, 300 includes one or more peripheral cavities 270, 370, which can be filled with a conductive fluid. The distal cap 140 can be configured to contain the conductive fluid to fill the peripheral cavities 270, 370 and the spark gaps 242, 244, 340 with the conductive fluid. The distal cap 140 can be connected to appropriate fluid components (e.g., pumps and valves) to circulate the conductive fluid within the distal cap 140 and the peripheral cavities 270, 370 and the spark gaps 242, 244, 340. The circulation of the conductive fluid can prevent the accumulation and stagnation of cavitation bubbles generated by the shock wave device 200, 300. These cavitation bubbles, if trapped in the distal cap 140 due to accumulation and stagnation, can prevent subsequent shock waves from propagating from the device 200, 300. In addition, the circulation of the conductive fluid can also help cool the shock wave device 200, 300.

[0142] like Fig.14 and Fig.15 As shown in FIG. 1 , the forward shock wave catheter 100 can be used to treat a disease and / or perform a medical procedure in a patient's tubing system 400, particularly for treating a high resistance lesion 410. The tubing system 400 can include any tubing in the patient's body, such as a blood vessel or a ureter. The high resistance lesion 410 can include a calcified plaque lesion in a blood vessel or a kidney stone in a ureter. Shock waves propagate forward in a direction away from the shock wave device 200, 300 to treat the high resistance lesion 410 in the tubing system 400.

[0143] In such Fig.16In some examples shown in , a method 500 for treating a high resistance lesion 410 (such as a calcified plaque) in a blood vessel using a forward shock wave catheter 100 including a dual shock wave device 200 is provided. The method 500 includes a step 510 of inserting the forward shock wave catheter 100 into a tubing system 400 (here, a blood vessel) along a pre-buried receiving guide wire 160. The method 500 includes a step 520 of advancing the forward shock wave catheter 100 forward in a distal direction into the tubing system 400 (here, a blood vessel) until the distal end portion of the dual shock wave device 200 is opposite to the treatment site start section. The method 500 includes a step 530 of applying a high potential difference across the wires 250, 260. The method 500 includes a step 540 of generating a dual shock wave at a first spark gap 242 and a second spark gap 244 in response to the applied high potential difference. Method 500 includes step 550 of propagating dual shock waves forward in a direction away from spark gaps 242, 244 through the conductive fluid in spark gaps 242, 244. Method 500 includes step 560 of impacting high resistance lesions 410 (such as calcified plaques) in the blood vessel with dual shock waves, thereby achieving a therapeutic effect of pulverizing the lesions.

[0144] In such Fig.17 In some examples shown in , a method 600 for treating a high resistance lesion 410 (such as a calcified plaque) using a forward shock wave catheter 100 including a single shock wave device 300 is provided. The method 600 includes a step 610 of inserting the forward shock wave catheter 100 into a tubing system 400 (here, a blood vessel) along a pre-buried receiving guide wire 160. The method 600 includes a step 620 of advancing the forward shock wave catheter 100 forward in a distal direction into the tubing system 400 (here, a blood vessel) until the distal end portion of the shock wave device 300 is opposite to the treatment site start section. The method 600 includes a step 630 of applying a high potential difference across the wires 350, 360. The method 600 includes a step 640 of generating a single shock wave at the spark gap 340 in response to the applied high potential difference. The method 600 includes a step 650 of propagating the single shock wave forward from the spark gap 340 through the conductive fluid in the spark gap 340 in a distal direction. The method 600 includes step 660, which uses a single shock wave to impact a high-resistance lesion 410 (such as a calcified plaque) in a blood vessel, thereby achieving a therapeutic effect of crushing the lesion.

[0145] like Fig.14 and Fig.15As shown in , the shock wave 700 from the shock wave catheter 100 impacts the high resistance lesion 410 (such as calcified plaque) in the blood vessel and forms a crack 420 in the high resistance lesion 410 (such as calcified plaque) in the blood vessel. The crack 420 helps to break up and weaken the high resistance lesion 410 (such as calcified plaque) in the blood vessel, so that the treatment site can be expanded using, for example, a balloon catheter and a stent. It can be understood that the shock wave 700 can be repeatedly generated according to the needs of the clinician to treat the high resistance lesion 410 (such as calcified plaque) in the blood vessel at the treatment site. The method 500, 600 can also include the following steps: advancing the forward shock wave catheter 100 forward in the direction away from the blood vessel 400 until the shock wave device 200, 300 is opposite to the next treatment site. It is understood that the steps of methods 500 and 600 may be repeated to advance the shock wave catheter 100 into the tubing system 400 (here, a blood vessel) and treat high resistance lesions 410 (such as calcified plaques) in the blood vessel at one or more treatment sites in the blood vessel.

[0146] Methods 500 and 600 may also include: removing the shock wave catheter from the tubing system 400 (here, the blood vessel); inserting a second medical device into the tubing system 400 (here, the blood vessel); and advancing the second medical device forward in the distal direction into the tubing system 400 (here, the blood vessel) to continue treating the high resistance lesion 410 (such as a calcified plaque) at the treatment site. For example, the second medical device includes a balloon catheter and a stent for treating atherosclerotic lesions at the treatment site.

[0147] More specifically, after treating the intravascular high resistance lesions 410 (such as calcified plaques) at one or more treatment sites in the conduit system 400 (here, blood vessels), the shock wave catheter 100 is removed from the blood vessel, and a second medical device such as a balloon catheter is introduced to continue treating the high resistance lesions 410 (such as calcified plaques). The forward shock wave catheter 100 with the shock wave device 200, 300 is smaller in size than the balloon catheter, and can be inserted into lesions that are too narrow and hard due to the significant increase in the intravascular high resistance lesions 410 (such as calcified plaques) at the treatment site, and are difficult for the balloon catheter to pass through. The forward shock wave catheter 100 can even continue to crush the lesions and advance forward in the subsequent long-segment lesions after breaking through the cap-like structure at the beginning of the intravascular high resistance lesions 410 (such as calcified plaques) along the pre-buried receiving guide wire 160, and finally completely break through the entire lesion. A forward shock wave 700 is used to perform preliminary treatment on a high resistance lesion 410 (such as a calcified plaque) in a blood vessel, forming a crack 420 that destroys and weakens the high resistance lesion 410 (such as a calcified plaque) in a blood vessel. The forward shock wave catheter 100 is removed, and a balloon catheter or stent is sent into the human body's duct system 400 (here, a blood vessel). The high resistance lesion 410 (such as a calcified plaque) in a blood vessel weakened as above at the treatment site makes it easier for a subsequent balloon catheter or stent to pass through and expand and support the treatment site. In some cases, the high resistance lesion 410 in a blood vessel forms an annular and hard calcified ring around the blood vessel, and the balloon catheter cannot be effectively expanded without any preliminary shock wave treatment. The forward shock wave 700 helps to break through and weaken the calcium ring, so that a subsequent balloon catheter or stent can treat the weakened calcium ring and expand and support the lesion site. The subsequent balloon catheter can be a shock wave balloon catheter, and the weakened calcium ring can be further treated with omnidirectional shock waves before the conventional balloon dilation treatment site.

[0148] Therefore, the forward shock wave catheter 100 and the methods 500, 600 can be used in medical applications where there are high resistance lesions 410 (such as vascular plaques or urinary stones) in the human duct system 400, which make the human duct system 400 very narrow and hard, so that a second medical device such as a larger balloon catheter is difficult to pass through such a duct system 400 (such as a blood vessel, ureter). The forward shock wave catheter 100 is smaller than a balloon catheter and can more easily pass through high resistance lesions 410 that are tight and difficult for a balloon catheter to pass through. It can be understood that in the methods 500, 600, the guide wire 160 is received as part of a standard medical treatment procedure to guide the movement of the forward shock wave catheter 100 in the human duct system 400 (such as a blood vessel, ureter). It can also be understood that various guiding devices, such as imaging devices, can be used to position the forward shock wave catheter 100 at the desired treatment site.

[0149] As described in the various examples described herein, the forward shockwave 700 generated by the forward shockwave guide 100, shockwave devices 200, 300, and methods 500, 600 propagates forward in a distal direction to treat the high resistance lesion 410. The forward propagating forward shockwave 700 can more effectively target the high resistance lesion 410 in front of the forward shockwave guide 100, thereby weakening the high resistance lesion 410 for treatment by a second medical device.

[0150] In the above detailed description, embodiments of the present invention related to shock wave devices and shock wave guides including shock wave devices are described in conjunction with the provided illustrations. The description of the various embodiments described herein is not intended to be limited to specific or unique representations of the present invention, but is merely for the purpose of illustrating non-limiting examples of the present invention. The present invention is intended to solve at least one problem and issue associated with the prior art. Although only some embodiments are disclosed herein, it will be apparent to those of ordinary skill in the art after reading the present disclosure that various changes and / or modifications may be made to the disclosed embodiments without departing from the scope of the present invention. Therefore, the scope of the present invention, as well as the scope of the following claims, is not limited to the embodiments described herein.

Claims

1. A shock wave device, characterized in that: include: an inner electrode disposed about a longitudinal axis and extending axially along the longitudinal axis; an outer electrode disposed around the inner electrode and radially away from the inner electrode and extending axially along the longitudinal axis; a first wire electrically connected to the inner electrode and electrically insulated from the outer electrode; a second wire electrically connected to the outer electrode and electrically insulated from the inner electrode; as well as a spark gap formed between an uninsulated portion of the inner electrode and an uninsulated portion of the outer electrode; Wherein, in response to the potential difference applied across the first conductor and the second conductor, an arc discharge is generated across the spark gap, so that the arc discharge generates a single shock wave, and the single shock wave propagates forward from the spark gap through the conductive fluid in the spark gap in a moving away direction.

2. The shock wave device according to claim 1, characterized in that Also included is one or more peripheral cavities located between the inner electrode and the outer electrode, wherein the peripheral cavities may be filled with a conductive fluid.

3. The shock wave device according to claim 1, characterized in that An outer insulating layer is also included. The outer insulating layer is located between the inner electrode and the outer electrode and is used to insulate the outer electrode from the first wire and to insulate the inner electrode from the second wire.

4. The shock wave device according to claim 1, characterized in that The uninsulated portion of the outer electrode is formed at a distal end portion of the outer electrode, and the uninsulated portion of the inner electrode is formed at a distal end portion of the inner electrode.

5. The shock wave device according to claim 3, characterized in that: The distal portion of the inner electrode is axially misaligned with the distal portion of the outer electrode; or The distal portion of the inner electrode is aligned with the distal portion of the outer electrode.

6. The shock wave device according to claim 1, characterized in that The uninsulated portions of the inner electrode and the outer electrode include chamfered distal ends.

7. The shock wave device according to claim 1, characterized in that The inner electrode and the outer electrode include an insulating coating for insulating the outer electrode from the first lead and for insulating the inner electrode from the second lead, the insulating coating including holes forming uninsulated portions of the electrodes and forming the spark gap.

8. The shock wave device according to claim 1, characterized in that The inner electrode comprises two, namely a first inner electrode and a second inner electrode, so that the shock wave device is used to generate a double shock wave, that is, A shock wave device, characterized in that it comprises: a first inner electrode and a second inner electrode, the first inner electrode and the second inner electrode being arranged around a longitudinal axis and extending axially along the longitudinal axis, and the first inner electrode and the second inner electrode being staggered from each other in a circumferential direction; an outer electrode disposed around the first inner electrode and the second inner electrode and away from the first inner electrode and the second inner electrode in a radial direction and extending axially along the longitudinal axis; a first wire electrically connected to the first inner electrode and electrically insulated from the outer electrode; a second wire electrically connected to the second inner electrode and electrically insulated from the outer electrode; a first spark gap formed between an uninsulated portion of the first inner electrode and a first uninsulated portion of the outer electrode; and a second spark gap formed between an uninsulated portion of the second inner electrode and a second uninsulated portion of the outer electrode; Wherein, in response to the potential difference applied across the first conductor and the second conductor, an arc discharge is generated across the first spark gap and the second spark gap, so that the arc discharge generates a double shock wave, and the double shock wave propagates forward from the spark gap through the conductive fluid in the spark gap in a away direction.

9. The shock wave device according to claim 8, characterized in that The outer electrode includes an insulating coating for insulating the outer electrode from a lead wire, the insulating coating including a first hole and a second hole, the first hole and the second hole forming the first uninsulated portion and the second uninsulated portion of the outer electrode, respectively.

10. A shock wave guide tube, characterized in that: The shock wave device according to any one of claims 1 to 9, further comprising an inner extension member and an outer extension member, wherein: The shock wave device is disposed at a distal portion of the shock wave guide tube and around the inner extension, the inner extension including an inner lumen along a longitudinal axis to receive a guide wire; The shock wave device is configured to generate a shock wave that propagates forwardly in a direction away from the shock wave device.

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