CN119074132A

CN119074132A - A shock wave guide for penetrating high resistance lesions

Info

Publication number: CN119074132A
Application number: CN202411206365.XA
Authority: CN
Inventors: 陆浩; 葛均波; 胡亦清; 钱菊英; 程蕾蕾; 胡迪抆; 杨聪恩
Original assignee: Zhongshan Hospital Fudan University
Current assignee: Spectron Medical Technology Shanghai Co ltd
Priority date: 2024-08-30
Filing date: 2024-08-30
Publication date: 2024-12-06

Abstract

The invention provides a forward shock wave device comprising inner and outer electrodes, 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 in a direction away from the spark gap through the conductive fluid in the spark gap. The invention also discloses a forward shock waveguide tube comprising the forward shock wave device. The forward impact waveguide tube of the forward impact wave device reduces the operation steps that the traditional shock wave saccule can not be in place and needs to be rotated into rotary grinding in the high-resistance lesion operation for treating the human body pipeline system such as blood vessels, thereby simplifying the operation flow and improving the treatment efficiency.

Description

Impact waveguide tube penetrating high-resistance lesions

Technical Field

The invention relates to the technical field of medical equipment, in particular to a shock wave device capable of penetrating through high-resistance lesions forwards and a forward shock waveguide tube comprising the shock wave device.

Background

A catheter is a medical device that can be inserted into the human body to treat a disease or to perform a medical procedure. For example, a patient may have atherosclerosis, resulting in a stenosis of a blood vessel. Atherosclerosis is typically treated by performing angioplasty. In angioplasty, a balloon can be delivered through a catheter into a vessel stenosed by a lesion and inflated to dilate the vessel, while a stent can be delivered through a catheter into the lesion to dilate and support the vessel, ultimately restoring the forward blood flow of the coronary artery.

The difficulty caused by the existing high resistance lesions (calcified lesions) of the coronary arteries is far beyond imagination. The difficulty of calcified lesions often is that the guidewire reaches the distal vessel through the lesion, but after the guidewire is in place, the balloon, stent, etc. instruments cannot be effectively in place and expanded through the catheter. Current methods of treatment of calcified lesions include high pressure balloon dilation, rotational abrasion (Rotational Atherectomy, RA) and intravascular shock lithotripsy (Intravascular Lithotripsy, IVL). Whereas the rapidly developing IVL technology in recent years is mainly embodied in the development of the shock wave balloon apparatus. For example, patent document publication No. CN112842460A reports a shock wave generating system with hydraulic monitoring supply for cardiovascular stenosis, the shock wave generating system comprises a liquid medium, a hydraulic sensor, a shock wave generator, an operating handle, a catheter and a balloon, an electrode pair is arranged inside the balloon, patent document publication No. CN113332570A reports a balloon catheter and a shock wave generating system, the shock wave generating system comprises a catheter main body, a balloon connected to the far end of the catheter main body, an electrode device and the like, patent document publication No. CN115192122A reports a shock wave balloon catheter device, the shock wave balloon catheter device comprises a catheter main body and a balloon, the balloon is connected with the far end of the catheter main body, the catheter main body is provided with a through liquid cavity extending along the axial direction of the catheter main body, the patent document publication No. CN114916992A reports a pressure wave balloon catheter integrating pulse focusing ultrasound, the patent document publication No. CN117297713A reports a directional shock wave balloon catheter comprises a shock wave balloon and a tube body, the near end of the balloon is communicated with the far end of the tube body, the balloon has a cavity, an elastic component is arranged in the radial direction of the balloon component, and a balloon component is arranged in the radial direction of the balloon component 35A and is arranged inside the balloon component, and is arranged at the radial direction of the balloon component.

The role of high pressure balloon dilation is to rupture calcified lesions by high pressure, but its effect is often poor, as the hardness and thickness of calcified lesions may exceed the capacity of the balloon. Rotational grinding is a method for removing calcified lesions by a high-speed rotating grinding head, and has remarkable effect, but high risk coefficient, and can cause vascular injury and other complications. The shock balloon breaks up calcified lesions by generating shock waves, which have been rapidly developed in recent years. The principle is that a shock wave device which is helpful for crushing calcified lesions in blood vessels is added in the catheter. The shock wave device generates shock waves to strike calcified lesions around the device and break up hard and brittle calcareous material, making the balloon catheter easier to dilate the vessel. The shock wave generated by the device propagates circumferentially in the vertical direction (forms a cylinder-like surface) by taking the catheter as the axis, and the effect is better when the lesion surrounds the device. However, this requires a guidewire to be placed through the rear balloon into the calcified lesion for a shock wave operation. However, in some cases, the vascular lesions are heavily loaded (e.g., the calcified caps are extremely thick), making the vascular lesions too narrow or too stiff for the balloon catheter and shock wave device to pass therethrough. Balloon catheters and shock wave devices can only reach the entrance to tight and difficult-to-pass lesions. At this time, if the seismological device releases only a longitudinal shock wave perpendicular to the long axis direction of the balloon catheter at the lesion entrance, it has no effect on breaking up the lesion (such as calcified cap) located at the front end thereof.

Disclosure of Invention

In view of the above-described drawbacks of prior art shock wave devices such as shock wave devices including balloons and catheters, and in combination with a number of clinical surgical practices and post-operative return visit results, considering that the catheter is smaller in diameter than the balloon and more likely to pass through the lesion area, it is contemplated to employ as much as possible a release pattern of shock wave energy in the longitudinal direction of the catheter (perpendicular to the longitudinal direction of the balloon catheter) in the direction of the shock wave energy release of the catheter forward (forward) in place of the balloon, thereby providing a "tunneling" shock wave device and shock wave catheter including the novel shock wave device that is different from the prior art in that forward shock waves can be generated during the surgical operation so as to tunnel forward after shaking the cap (e.g., calcified cap) of the high resistance lesion of the blood vessel. In view of this, the present invention provides the following technical solutions.

A shockwave device, comprising:

an inner electrode disposed about and extending axially along a longitudinal axis;

An outer electrode disposed about 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 external electrode and electrically insulated from the internal electrode, and

A spark gap formed between the uninsulated section of the inner electrode and the uninsulated section of the outer electrode;

Wherein in response to a potential difference applied across the first and second wires, an arc discharge is generated across the spark gap such that the arc discharge generates a single shock wave that propagates forward in a direction away from the spark gap through the electrically conductive fluid in the spark gap.

Preferably, the above shock wave device further comprises one or more peripheral cavities located between the inner electrode and the outer electrode, wherein the peripheral cavities may be filled with an electrically conductive fluid.

Further, the shock wave device further includes an outer insulating layer between the inner electrode and the outer electrode for insulating the outer electrode from the first wire and for insulating the inner electrode from the second wire.

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

The uninsulated portion of the above-mentioned outer electrode is formed at the distal end portion of the outer electrode, and the uninsulated portion of the inner electrode is formed at the distal end portion of the inner electrode.

The distal end portion of the inner electrode is axially offset from the distal end portion of the outer electrode, or

The distal portion of the inner electrode is aligned with the distal portion of the outer electrode.

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

Further, the above-mentioned inner electrode and the outer electrode include an insulating coating for insulating the outer electrode from the first wire and for insulating the inner electrode from the second wire, the insulating coating including a hole that forms an uninsulated portion of the electrode and that forms the spark gap.

In a preferred embodiment, the inner electrodes comprise two inner electrodes, a first inner electrode and a second inner electrode, respectively, such that the forward shockwave device is adapted to generate forward dual shockwaves, and correspondingly, shockwave devices comprising one inner electrode may generate forward shockwaves.

That is, the present invention also provides a shock wave device comprising:

A first inner electrode and a second inner electrode disposed about and extending axially along a longitudinal axis, and the first and second internal electrodes are circumferentially offset from each other;

an outer electrode disposed around the first and second inner electrodes and distant from the first and second inner electrodes in a radial direction, and extends 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 the uninsulated section of the first inner electrode and the first uninsulated section of the outer electrode, and

A second spark gap formed between the uninsulated section of the second inner electrode and the second uninsulated section of the outer electrode;

Wherein in response to a potential difference applied across the first and second wires, an arc discharge is generated across the first and second spark gaps such that the arc discharge generates a dual shock wave that propagates forward in a direction away from the spark gap through the electrically conductive fluid in the spark gap.

Preferably, the external electrode includes an insulating coating for insulating the external electrode from the lead wire, the insulating coating including first and second holes forming the first and second uninsulated portions of the external electrode, respectively.

Further, the shock wave device further comprises one or more peripheral cavities located between the outer electrode and the inner electrode, wherein the peripheral cavities may be filled with an electrically conductive fluid.

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 for insulating the outer electrode from the wire.

The outer insulating layer comprises a polymer, adhesive or plastic insert.

The uninsulated portion of the above-mentioned outer electrode is formed at the distal end portion of the outer electrode, and the uninsulated portion of each of the inner electrodes is formed at the respective distal end portion of the inner electrode.

In one embodiment, the respective distal portion of each of the inner electrodes is axially offset from the distal portion of the outer electrode, or

The distal end portion of each of the inner electrodes is aligned with a respective distal end portion of the outer electrode.

Further, each of the inner electrodes includes an insulating coating, and each of the insulating coatings includes a hole forming an uninsulated portion of the respective inner electrode.

In a second aspect the invention provides an impact waveguide comprising an impact wave device as described above, further comprising an inner elongate member and an outer elongate member, wherein,

The shock wave device is disposed at a distal portion of the shock waveguide and around the inner elongate member, the inner elongate member including a lumen along a longitudinal axis to receive a guidewire;

the shock wave device is configured to generate a shock wave propagating forward in a direction away from the shock wave device.

Preferably, the shock waveguide further comprises an inner insulating layer located between the inner elongate member and the inner electrode.

Further, the shock waveguide described above further comprises a distal cap attaching the inner and outer elongate members together, the distal cap comprising a tapered portion for guiding shock waves forward.

Preferably, the above-described shock waveguide further comprises a distal tip attached to the distal end cap and the distal portion of the inner elongate member, the distal tip comprising a tapered portion to facilitate movement of the shock waveguide in the blood vessel.

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

The above-mentioned impact waveguide tube can be used for treating vascular high-resistance lesions, urinary system lesions such as ureteral lesions, etc. Thus, the first and second substrates are bonded together,

In another aspect, the invention provides a method of treating a vascular high resistance lesion (e.g., calcified plaque) comprising the steps of:

inserting an impulse waveguide into a vessel of a patient, the impulse waveguide comprising an impulse wave device as described above;

Advancing the shock waveguide in a distal direction into a blood vessel until a distal portion of the shock wave device is opposite a proximal (or initiation) end of a treatment site;

applying a potential difference across the first wire and the second wire;

Generating a shock wave at the spark gap in response to the applied potential difference;

Propagating the shock wave from the spark gap forward through the electrically conductive fluid in the spark gap in a direction away from the spark gap, and

Impacting the vascular high resistance lesion (e.g., calcified plaque) with the shock wave, thereby comminuting the lesion, treating the vascular plaque, or high resistance lesion at the treatment site.

Further, the method further comprises the following steps:

Removing the shock waveguide from the blood vessel;

Inserting a second medical device into the blood vessel;

advancing the second medical device into the blood vessel in a distal direction to continue treatment of the vascular plaque or high resistance lesion at the treatment site.

Still further, the second medical device includes a balloon catheter and a stent for use with the forward-impact waveguide of the present invention.

The forward shock wave device and the forward shock wave guide tube comprising the forward shock wave device can generate forward shock waves in the operation of treating vascular high-resistance lesions (such as calcified plaque) so as to drive forward when the caps of the high-resistance lesions are broken. The high-resistance calcified lesion has the forward tunneling capability of the rotary grinding head, and has the safety of the shock wave saccule. The shock wave device and the shock wave guide may not have a balloon. The simple catheter design can be used for achieving in-place lesion initiation with smaller size (compared with a balloon) and performing effective tunneling in the lesion by matching with shock waves. Therefore, the operation is more convenient and rapid when the device is used in operation, thereby saving precious operation time and reducing operation risks and medical accidents. In conclusion, the device and the mode can effectively treat thick calcified lesions, reduce the risk of damage to blood vessels and improve the safety and effect of treatment.

Drawings

FIG. 1 is a schematic illustration of a forward shock waveguide embodiment of the present invention including a forward shock wave device.

Fig. 2 is a longitudinal cross-sectional view of the forward-impingement waveguide embodiment of fig. 1.

Fig. 3 is a schematic structural view of an embodiment of a dual shock wave device of the present invention.

Fig. 4 is a schematic cross-sectional view of the dual shock wave device embodiment shown in fig. 3.

Fig. 5 is a schematic structural view of a forward shock waveguide embodiment of the present invention including a dual shock wave device.

Fig. 6 is another structural schematic diagram of the dual impact waveguide embodiment of fig. 5.

Fig. 7 is a schematic view of yet another configuration of the dual impact waveguide embodiment of fig. 5.

Fig. 8 is a schematic structural view of an embodiment of a single shock wave device of the present invention.

Fig. 9 is a schematic structural view of another single shock wave device embodiment of the present invention.

Fig. 10 is a schematic structural view of a forward shock waveguide embodiment of the present invention including a single shock wave device.

FIG. 11 is another schematic structural view of the single-impact waveguide embodiment of FIG. 10.

Fig. 12 is another structural schematic view of the single-impact waveguide embodiment shown in fig. 10.

Fig. 13 is a schematic view of yet another configuration of the single-impact waveguide embodiment of fig. 10.

Fig. 14 and 15 are schematic illustrations of the use of the shock waveguide of the present invention for treating vascular high resistance lesions such as calcified plaque.

Fig. 16 is a flow chart of a method of treating vascular high resistance lesions (e.g., calcified plaque) using a dual-impact waveguide.

Fig. 17 is a flow chart of a method of treating vascular high resistance lesions (e.g., calcified plaque) using a single-shot waveguide.

Detailed Description

The shock waves generated by the conventional shock wave balloon are circumferentially propagated (forming a cylinder-like surface) in the vertical direction by taking the catheter as the axis, which requires the shock wave balloon to be positioned in the calcified lesion. If the lesion entrance section is extremely narrow and hard (high resistance lesion), the shock wave balloon cannot enter the lesion, and the shock wave balloon which cannot be in place cannot start subsequent treatment. The tunneling type shock wave/shock wave device can generate forward shock waves, and can more effectively treat high-resistance calcified lesions, especially lesions with extremely high lesion opening resistance (such as extremely thick calcified caps). Its ability to impact and break up high resistance (or calcification) lesions forward can continue to tunnel forward after breaking up the lesion opening, and its relatively small diameter also aids in its forward progress until the entire course of the lesion is broken through. This allows for subsequent balloon or stent treatment to be successfully put in place and acted upon.

The forward vibration wave device has high-efficiency tunneling capability, provides tunneling capability comparable to that of a rotary grinding head while maintaining the safety of a vibration wave balloon in the prior art, and reduces vascular injury and embolism risks caused by rotary grinding. The forward vibration wave device also reduces the operation steps of turning into rotary grinding because the traditional vibration wave saccule cannot be in place in operation, thereby reducing the risk of complications. The tunneling forward vibration wave device simplifies the operation flow and improves the treatment efficiency.

In principle, the present invention changes the direction of the release of the shock wave/shock wave energy of the same-function shock wave/shock wave surgical device used in the prior art for the same type of "vascular dredging" surgery. Structurally, the forward shockwave device of the present invention comprises inner and outer electrodes 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 in a direction away from the spark gap through the conductive fluid in the spark gap. The structure of the invention omits the arrangement or the matching of the sacculus, so that the diameter of the device is reduced, the device is convenient to pass, the subsequent high-pressure and cutting sacculus expansion is not hindered, the operation is more convenient and rapid, the precious operation time is greatly saved, and the operation risk and the medical accident are reduced.

In addition, the shockwave device and shockwave device of the present invention may be used for surgical treatment of other diseased organs, such as urinary systems, e.g., ureter "blocked/occluded" diseases, such as removal of stones in the ureter, etc., in addition to vascular "dredging" procedures, e.g., vascular high resistance disease (e.g., calcified plaque) treatment procedures.

For convenience of description, the forward shock wave device/forward shock waveguide may be referred to herein simply as a shock wave device/shock waveguide, respectively, collectively referred to as a "shock wave system".

The invention provides a forward shock wave device and a forward shock wave guide tube, wherein one type adopts one inner electrode and can form single shock wave/shock wave, and the other type adopts two inner electrodes and can generate double shock waves/shock waves.

For convenience of description, the forward shockwave device/shockwave guide for forming the dual shockwave may be referred to herein simply as a "dual shockwave device/dual shockwave guide," collectively referred to herein as a "dual shockwave system. Accordingly, the forward shock wave device/shock wave guide for forming a single (one) shock wave is simply referred to as a "single (one) shock wave device/single (one) shock wave guide", and is collectively referred to as a "single (one) shock wave system".

In contrast, dual shock waves have certain advantages over single shock waves in some respects. For example, some advantages of dual shock wave systems over single shock wave systems include, but are not limited to:

1. and the calcification crushing efficiency is improved.

Sound pressure is increased by pulse stacking-dual shock wave devices utilize two pairs of electrodes, producing two overlapping sound pressure fields. This overlap may promote a significant increase in the effective sound pressure at the calcified site. The result is a more efficient and uniform disruption of the calcium deposit. This synergy between dual shock waves may achieve higher peak pressures, thereby more effectively mechanically destroying calcified plaque.

Crack propagation-dual shock waves can create multiple crack initiation points within calcified plaque. This enhances the propagation of the crack in the calcified plaque, making it more complete in fragmentation. This is more advantageous for treating calcified plaques of greater thickness. A single shock wave typically can only produce surface cracks and cannot break down deep calcified plaque.

2. Improving energy distribution and reducing vascular injury risk.

The energy distribution is more uniform, and the dual shock waves can lead the energy distribution on the whole lesion to be more uniform.

The risk of thermal damage is reduced by improving the energy transfer efficiency through dual shock waves and reducing the need for excessive energy, thereby reducing the risk of thermal damage. This is particularly important in patients with fragile blood vessels.

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

the various features and advantages of this invention will become more fully apparent to those having ordinary skill in the art from the following detailed description of the embodiments, taken in conjunction with the accompanying drawings, which are given by way of non-limiting example only.

For simplicity and clarity, the description of the embodiments is directed to forward shock wave devices and shock waveguides including such forward shock wave devices, according to the accompanying drawings. While the invention will be described in conjunction with the embodiments provided herein, it will be understood that they are not intended to limit the invention to these embodiments. On the contrary, the invention is intended to cover alternatives, modifications and equivalents of the embodiments described herein, which are included within the scope of the invention as defined by the appended claims. Furthermore, in the following detailed description, specific details are set forth in order to provide a thorough understanding of the present invention. However, one of ordinary skill in the art, i.e., the general artisan, will recognize that the invention can be practiced without these specific details, and/or with a plurality of details that result from a combination of features according to a particular embodiment. In many instances, well-known systems, methods, procedures, and components have not been described in detail so as not to unnecessarily obscure aspects of the embodiments of the present invention.

In embodiments of the 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 element or element number as mentioned in another figure or description section related thereto.

References to "an embodiment/example," "another embodiment/example," "some embodiments/examples," "some other embodiments/examples," etc., indicate that the embodiment/example described may include a particular feature, structure, characteristic, attribute, element, or limitation, but every embodiment/example does not necessarily include the particular feature, structure, characteristic, attribute, element, or limitation. Furthermore, repeated use of the phrase "in an embodiment/example" or "in another embodiment/example" does not necessarily refer to the same embodiment/example.

The expression "comprising," "including," "having," etc. does not exclude the presence of other features/elements/steps than those listed. The mere listing of certain features/elements/steps in different embodiments does not indicate that these features/elements/steps cannot be used in combination in one embodiment. The definitions of the words "a" and "an" as used herein may be one or more. The use of "/" in the figures or related text is to be understood as "and/or" unless otherwise indicated. According to known mathematical definitions, the expression "set" is defined as a non-empty finite organization comprising at least one element (e.g., a set as defined herein may correspond to a unit, a set of unit elements, or a set of multiple elements). The terms "first," "second," and the like, are used merely as labels or identifiers and are not intended to impose numerical requirements on their associated expressions.

Examples

Referring to fig. 1, 2,3 and 8, the present invention provides a forward shock waveguide 100 embodiment including shock wave devices 200, 300 for use in treating disease and/or performing medical procedures. In particular, the forward shock waveguide 100 may be used to treat high resistance lesions in the patient's body piping network. For example, the forward shock waveguide 100 may be used in percutaneous coronary angioplasty to treat atherosclerosis (e.g., calcification lesions in the coronary arteries) or to treat urinary system diseases (e.g., kidney stones in the ureter). The forward shock waveguide 100 includes shock wave devices 200, 300 that generate shock waves that propagate forward and distally from the forward shock waveguide 100 to disrupt high resistance lesions (e.g., vascular calcified plaque). More specifically, one shock wave device 200 embodiment is configured to generate dual shock waves, i.e., a first shock wave and a second shock wave, and may 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, which may be referred to as a single shock wave device 300.

In an embodiment of the present invention, the forward shock waveguide 100 includes a dual shock wave device 200 for generating a dual shock wave, or a single shock wave device 300 for generating a single shock wave. The forward-impacting waveguide 100 also includes an inner elongate member 110, the inner elongate member 110 extending along a longitudinal axis and having an inner cavity 112. The forward shock waveguide 100 further includes an elongate member 120, the elongate member 120 being disposed about the shock wave devices 200, 300 and extending along a longitudinal axis.

Two types of forward shock wave devices 200, 300, respectively, and embodiments of the forward shock waveguide 100 including the forward shock wave devices 200, 300, respectively, are described below.

Dual shock wave device 200

As shown in fig. 3 and 4, the present invention provides a dual shock wave device 200 for generating dual shock waves, and a forward shock waveguide 100 including the dual shock wave device 200, wherein the dual shock waves include a first shock wave and a second shock wave.

The dual shock wave device 200 includes a first inner electrode 210 and a second inner electrode 220, the first inner electrode 210 and the second inner electrode 220 being disposed about and extending axially along a longitudinal axis, and the first inner electrode 210 and the second inner electrode 220 being circumferentially offset from one another. When the forward impingement waveguide 100 is in use, the first and second inner electrodes 210, 220 are disposed about the inner elongate member 110. For example, each of the first and second inner electrodes 210, 220 has an arcuate profile around the inner extension 110. The dual shock wave device 200 comprises an outer electrode 230, the outer electrode 230 being arranged around the first and second inner electrodes 210, 220 and being remote from the first and second inner electrodes 210, 220 in a radial direction, the outer electrode 230 extending 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 electrode 230 forms an annular space 240 between the outer electrode 230 and the inner electrodes 210, 220. The inner electrodes 210, 220 and the outer electrode 230 may be made of a suitable material capable of withstanding high potential differences or voltage pulses, and may be made of iron, nickel, steel, tungsten, etc., for example. It is understood that the electrodes 210, 220, 230 may have various shapes and sizes, such as the shape shown in fig. 7.

The dual shock wave device 200 includes a first wire 250 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 insulated for the most part except for its distal portion 252. For example, the first wire 250 is a copper wire having an insulating outer layer such as a polymer on the outside. For example, 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 will be appreciated that the uninsulated distal portion 252 of the first lead 250 may be connected to other portions of the first inner electrode 210, such as the middle portion or portions nearer than the distal portion 214.

The dual shock wave device 200 includes a second wire 260 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 that its distal portion 262 is uninsulated. For example, the second wire 260 is a copper wire having an insulating outer layer such as a polymer on the outside. For example, 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 will be appreciated that the uninsulated distal portion 262 of the second lead 260 may be connected to other portions of the second inner electrode 220, such as the middle portion or portions nearer than the distal portion 224.

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

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 arcing to occur. For example, the voltage pulse may be between 100V and 10kV and may be applied for various pulse durations. In response to a high potential difference or voltage pulse applied across the first and second wires 250, 260, an arc discharge is generated across the first and second spark gaps 242, 244 such that the arc discharge generates a dual shock wave that propagates in a distal direction from the spark gaps 242, 244 forward through the electrically conductive fluid in the spark gaps 242, 244. Specifically, the dual shock waves include a first shock wave propagating forward in a distal direction from the first spark gap 242 and a second shock wave propagating forward in a distal direction from the second spark gap 244.

For example, the arc discharge passes 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 arcuate surface 216 of the first inner electrode 210 and any point on the uninsulated first inner arcuate 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 arcuate surface 238 of the outer electrode 230 and any point on the uninsulated outer arcuate surface 226 of the second inner electrode 220. Notably, the first and second shock waves are generated substantially simultaneously, thereby propagating dual shock waves simultaneously from the device 200.

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

In addition, the conductive fluid in the spark gaps 242, 244 reduces the high resistance that air would otherwise have in the spark gaps 242, 244, enabling arcing to occur. The arc discharge forms cavitation bubbles in the conductive fluid that expand and collapse rapidly, creating a dual shock wave at the spark gaps 242, 244.

The arrangement of the inner electrodes 210, 220 and the outer electrode 230 is such that the dual shock wave can propagate forward from the device 200 in a direction away, i.e. in a direction substantially away. Specifically, the spark gaps 242, 244 are disposed in an annular space 240 defined by the electrodes 210, 220, 230, the annular space 240 being channel-like with an open front end and a closed rear end. The open forward end of the annular space 240 is remote from the spark gaps 242, 244 and is defined by the distal-most end of the electrodes 210, 220, 230, such as the distal-most end of the outer electrode 230 shown in FIG. 3. The shock wave propagating forward in the far direction will exit through the open front end of the annular space 240, while the shock wave propagating backward in the near direction will reflect forward from the closed rear end of the annular space 240. Thus, the annular space 240 acts as a focusing channel to direct the shock wave in the distal direction. For example, the angle of the forward directed dual shock wave is less than 45 ° relative to the longitudinal axis. When used in a forward-shockwave guide 100 that is advanced through a patient's blood vessel, the dual shockwave propagates forward in the direction of advancement of the forward-shockwave guide 100, causing the dual shockwave to directly shock and break up high-resistance lesions (e.g., calcified plaque) in the blood vessel that is forward of the forward-shockwave guide 100. The forward directed dual shock wave is more effective in breaking up the vascular high resistance lesions (e.g., calcified plaque) ahead because most of the shock wave energy is concentrated on the target lesion.

In some examples, as shown in fig. 5, the dual shock wave device 200 includes one or more peripheral cavities 270 between the outer electrode 230 and the inner electrodes 210, 220. The peripheral cavity 270 may be filled with a conductive fluid, such as saline, that fills the spark gaps 242, 244 so that cavitation bubbles eventually form and collapse and create a dual shock wave. The dual shock wave propagates forward through the conductive fluid in a generally distal direction, and then impacts against high resistance lesions (e.g., calcified plaque) ahead of the forward impact waveguide 100.

In some examples, as shown in fig. 3, the dual shock wave device 200 includes an outer insulating layer 280 between the outer electrode 230 and the wires 250, 260 for insulating the outer electrode 230 from the wires 250, 260. The outer insulating layer 280 extends in an axial direction along the outer electrode 230 from the proximal portion 232 of the outer electrode 230. For example, the outer insulating layer 280 may be made of a polymer. For example, the outer insulating layer 280 includes an adhesive or a plastic insert. As shown in fig. 3, uninsulated portions of the outer electrode 230 may be formed at the distal end portion 234 of the outer electrode 230 and 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.

In some examples, as shown in fig. 3 and 5, the distal portions 214, 224 of the inner electrodes 210, 220 may 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).

In some examples, as shown in fig. 4 and 6, the distal portions 214, 224 of the inner electrodes 210, 220 are axially offset relative to the distal portion 234 of the outer electrode 230. For example, the distal-most ends of the inner electrodes 210, 220 are forward of the distal-most ends of the outer electrodes 230. Or the distal-most end of the outer electrode 230 is forward of the distal-most ends of the inner electrodes 210, 220. The axial staggering allows for control of the position and boundaries of the spark gaps 242, 244, thereby also allowing for varying the angle of the dual shock wave relative to the longitudinal axis.

The outer insulating layer 280 may also be similarly aligned with or axially offset from the distal portions 214, 224, 234 of the electrodes 210, 220, 230. For example, as shown in fig. 5, 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-most ends all terminate in the same radial plane. The uninsulated portion of inner electrode 210 includes its distal-most end and the uninsulated portion of outer electrode 230 includes its distal-most end. Arcing will occur across these distal-most ends, resulting in a double shock wave at an angle of approximately 90 ° with respect to the longitudinal axis. In another example, as shown in fig. 6, the distal-most end of the outer electrode 230 is located forward of the distal-most end of the outer insulating layer 280. This will result in a dual shock wave having a smaller angle, for example 45 deg., with respect to the longitudinal axis.

In some examples, the outer electrode 230 may include an insulating coating in place of or in addition to the outer insulating layer 280 for insulating the outer electrode 230 from the leads 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 electrode 210, 220. The position of the spark gaps 242, 244 can be varied by arranging holes in the insulating coating, so that the angle of the dual shock wave with respect to the longitudinal axis can also be adjusted.

In the example shown in fig. 3 and 6, spark gaps 242, 244 are formed between the uninsulated distal portions 214, 224, 234 of the electrodes 210, 220, 230, respectively. Specifically, a 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, a 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 facing of the respective surfaces of the electrodes 210, 220, 230 defines the boundary of the annular space 240 where the spark gaps 242, 244 are located and primarily serves for the forward direction of the dual shock wave. In addition, the axial offset between the distal end portions 214, 224 of the inner electrodes 210, 220 and the distal end portion 234 of the outer electrode 230 adjusts the boundary of the annular space 240 and the location of the spark gaps 242, 244, thereby also adjusting the angle of the dual shock wave with respect to the longitudinal axis.

In some examples, the uninsulated portions of the inner electrodes 210, 220 and the uninsulated portion of the outer electrode 230 may include a chamfered distal end. The chamfered distal ends of the electrodes 210, 220, 230 may reduce the angle and improve the forward propagation of dual shock waves. It is understood that the chamfered distal end may be applied to various examples of the dual shock wave device 200 described herein. It will also be appreciated that the distal end may be altered in other ways, not just or in addition to chamfering, such as by rounding the distal end. Fig. 7 shows another example of a dual shock wave device 200 in which the inner electrodes 210, 220 and the outer electrode 230 have different configurations. For example, the shape of the outer electrode 230 in FIG. 7 reduces the surface area of the uninsulated distal portion 234 of the outer electrode 230, thereby increasing the intensity of the double shock wave.

Single shock wave device 300

As shown in fig. 8 and 9, the present invention provides a single shock wave device 300 for generating a single shock wave and a shock waveguide 100 including the single shock wave device 300.

The single shock wave device 300 includes an inner electrode 310 disposed about and extending axially along a longitudinal axis. When used in the forward-impingement waveguide 100, the inner electrode 310 is disposed about the inner elongate member 110. For example, the inner electrode 310 has an arcuate profile around the circumference of the inner elongate member 110. The single shock wave device 300 comprises an outer electrode 330 arranged around the inner electrode 310 and remote from the inner electrode 310 in a radial direction and extending axially along a longitudinal axis. Preferably, inner electrode 310 and outer electrode 330 are coaxially disposed along a 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 may be made of a suitable material capable of withstanding a high potential difference or voltage pulse, for example, made of iron, nickel, steel, tungsten, etc. It is understood that the electrodes 310, 330 may have various shapes and sizes, for example, having the shape as shown in fig. 13.

The single shock wave device 300 includes a first wire 350 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 that its distal portion 352 is uninsulated. For example, the first wire 350 is a copper wire having an insulating outer layer such as a polymer. For example, 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 will be appreciated that the uninsulated distal portion 352 of the first lead 350 may be connected to other portions of the inner electrode 310, such as the middle portion or portions nearer than the distal portion 314.

The single shock wave device 300 includes a second wire 360 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 that its distal portion 362 is uninsulated. For example, the second wire 360 is a copper wire having an insulating outer layer such as a polymer. For example, copper at uninsulated distal portion 362 of second lead 360 is electrically connected to proximal portion 332 of outer electrode 330. It will be appreciated that uninsulated distal portion 362 of second lead 360 may be connected to other portions of outer electrode 330, such as the middle portion or portions closer than distal portion 334.

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

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 arcing. For example, the voltage pulse may be between 100V and 10kV, and may be applied with various pulse durations. In response to a high potential difference or voltage pulse applied across the first wire 350 and the second wire 360, an arc discharge is generated across the spark gap 340 such that the arc discharge generates a single shock wave that propagates from the spark gap 340 forward in a direction away from the conductive fluid in the spark gap 340.

For example, an arc discharge passes 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. Or the arc discharge passes from the outer electrode 330 to the inner electrode 310 through the spark gap 340. The arc discharge may travel between any point on uninsulated outer circumferential surface 316 of inner electrode 310 and any point on uninsulated inner circumferential surface 336 of outer electrode 330.

In addition, the conductive fluid in the spark gap 340 reduces the high resistance that air would otherwise have in the spark gap 340, enabling arcing to occur. The arc discharge forms cavitation bubbles in the conductive fluid that expand and collapse rapidly, creating a single shock wave at the spark gap 340.

The arrangement of inner electrode 310 and outer electrode 330 is such that a single impact wave can propagate forward from device 300 in a direction away, i.e., in a direction generally away. Specifically, the spark gap 340 is disposed in an annular space defined by the electrodes 310, 330, which is in the shape of a channel, open at the front end and closed at the rear end. The open front end of the annular space is remote from the spark gap 340, surrounded by the distal-most ends of the electrodes 310, 330, as shown in fig. 9. The shock wave propagating in the far direction will exit through the open front end of the annular space, while the shock wave propagating proximally will reflect from the closed rear end of the annular space towards the front. The annular space thus acts as a focusing channel to direct the shock wave in a direction away from the front. For example, the angle of the forward directed single shock wave is less than 45 ° relative to the longitudinal axis. When used in a forward-impact waveguide 100 that is advanced through a patient's blood vessel, the single-impact wave propagates forward in the direction of advancement of the forward-impact waveguide 100, causing the single-impact wave to directly impact and disrupt high-resistance lesions (such as vascular calcified plaque) in the blood vessel that is forward of the forward-impact waveguide 100. Forward directed single shock waves are more effective in breaking up high resistance lesions in front (such as vascular calcified plaque) because most of the shock wave energy is concentrated on the vascular plaque.

In some examples, as in fig. 11 and 12, single shock wave device 300 includes one or more peripheral cavities 370 located between outer electrode 330 and inner electrode 310. The peripheral cavity 370 may be filled with a conductive fluid, such as physiological saline, that fills the spark gap 340 to form and eventually collapse cavitation bubbles, thereby generating a single shock wave. The single shock wave propagates forward through the conductive fluid in a generally distal direction and then impacts a vascular high resistance lesion (e.g., calcified plaque) located forward of the forward shock waveguide 100.

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

In some examples as shown in fig. 8 and 11, the distal portion 314 of the inner electrode 310 may 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).

In some examples as shown in fig. 10, 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-most end of inner electrode 310 is forward of the distal-most end of outer electrode 330. Or the distal-most end of the outer electrode 330 is forward of the distal-most end of the inner electrode 310. The axial offset causes the uninsulated circumferential surfaces 316, 336 of the electrodes 310, 330 to be directly opposed, thereby defining the boundary of the annular space in which the spark gap 340 is located and primarily for forward propagation of a 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.

The outer insulating layer 380 may also be similarly aligned with or axially offset from the distal portions 314, 334 of the electrodes 310, 330. For example, as shown in fig. 11, the outer insulating layer 380 is aligned with the distal portions 314, 334 of the electrodes 310, 330, i.e., their distal-most ends all terminate in the same radial plane. The uninsulated portions of electrodes 310, 330 include their distal-most ends. An arc discharge will occur across the distal-most end resulting in a single shock wave at an angle of approximately 90 ° relative to the longitudinal axis. In another example, as shown in fig. 10, the distal-most end of outer electrode 330 is forward of the distal-most end of outer insulating layer 380. This will result in a single shock wave having a small angle, for example 45 deg., with respect to the longitudinal axis.

In some examples as shown in fig. 9, instead of 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 for forming the spark gap 340. Specifically, a spark gap 340 is formed between uninsulated outer circumferential surface 316 of inner electrode 310 and uninsulated circumferential surface 336 of outer electrode 330. The direct facing of the circumferential surfaces 316, 336 of the electrodes 310, 330 defines the boundary of the annular space in which the spark gap 340 is located and serves for the forward propagation of a single shock wave. The position of the spark gap 340 can be varied 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 a direction away from the hole enlarges the angle, and moving the hole backward in a direction closer to the hole reduces the angle.

In some examples as shown in fig. 8 and 12, the uninsulated portion of inner electrode 310 and the uninsulated portion of outer electrode 330 may include a chamfered distal end. The chamfered distal ends of the electrodes 310, 330 may be reduced in angle and improve forward propagation of the single shock wave. It is understood that the chamfered distal end may be applied to various examples of the single shock wave device 300 described herein. It will also be appreciated that the distal end may be modified in other ways, not limited to chamfering, or in other ways than chamfering, such as a fillet process. Fig. 13 shows another example of a single shock wave device 300 in which the inner electrode 310 and the outer electrode 330 have different configurations. For example, the shape of the outer electrode 330 in fig. 13 reduces the uninsulated surface area of the outer electrode 330, thereby increasing the intensity of the single impact wave.

Forward impingement waveguide 100

As shown in fig. 1 and 2, the forward shock waveguide 100 may include a dual shock wave device 200 for generating dual shock waves, or the forward shock waveguide 100 may include a single shock wave device 300 for generating single shock waves. The forward-impacting waveguide 100 includes an inner elongate member 110 with a lumen 112 to receive a guidewire 160. The shock wave devices 200, 300 are arranged around the inner elongate member 110. For example, each inner electrode 210, 220, 230 is arranged coaxially with the longitudinal axis.

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

In some examples, the extension 120 is directly attached to the inner extension 110. In some examples, the forward-impacting waveguide 100 includes a distal cap 140 that connects the inner and outer elongate members 110, 120 together. The distal cap 140 is disposed about the shockwave device 200, 300 and has a tapered portion 142 for directing dual shockwaves (first and second shockwaves from the device 200) or single shockwaves (from the device 300) forward, i.e., in a generally distal direction. The forward-impacting waveguide 100 may also include a distal tip 150 attached to the inner elongate member 110 and a distal portion of the distal cap 140. The distal tip 150 has a tapered portion 152 to facilitate movement of the shock waveguide 100 in a blood vessel. It will be appreciated that the distal cap 140 and distal tip 150 may 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 elongate member 120.

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

As shown in fig. 14 and 15, the forward shock waveguide 100 may be used to treat a disease and/or perform a medical procedure in a patient's tubing 400, particularly for treating high resistance lesions 410. Tubing 400 may include any tubing within the patient, such as a blood vessel or ureter. The high resistance lesions 410 may include calcified plaque lesions in blood vessels or kidney stones in the ureter. The shock wave propagates forward from the shock wave device 200, 300 in a distal direction to treat the high resistance lesion 410 in the tubing 400.

In some examples as shown in fig. 16, a method 500 of treating a high resistance lesion 410 (e.g., calcified plaque) in a blood vessel using a forward shock waveguide 100 comprising a dual shock wave apparatus 200 is presented. The method 500 includes the step 510 of inserting 510 the forward shock waveguide 100 into the tubing 400 (here, a blood vessel) along the pre-buried receiving guide wire 160. The method 500 includes a step 520 of advancing the forward shock waveguide 100 in a distal direction into the tubing 400 (referred to herein as a blood vessel) until the distal portion of the dual shock wave device 200 is opposite the treatment site initiation segment. 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 the first spark gap 242 and the second spark gap 244 in response to the applied high potential difference. The method 500 includes a step 550 of propagating a dual shock wave forward from the spark gaps 242, 244 through the conductive fluid in the spark gaps 242, 244 in a direction away from. The method 500 includes a step 560 of impacting the high resistance lesions 410 (e.g., calcified plaque) within the blood vessel with a dual shock wave to provide a therapeutic effect of comminuting the lesions.

In some examples, as shown in fig. 17, a method 600 of treating a high resistance lesion 410 (e.g., calcified plaque) using a forward shock waveguide 100 comprising a single shock wave device 300 is presented. The method 600 includes the step 610 of inserting 610 the forward shock waveguide 100 into the tubing 400 (here, a blood vessel) along the pre-buried receiving guide wire 160. The method 600 includes a step 620 of advancing the forward shock waveguide 100 in a distal direction into the tubing 400 (referred to herein as a blood vessel) until the distal portion of the shock wave device 300 is opposite the treatment site initiation segment. 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 a single shock wave forward from the spark gap 340 through the conductive fluid in the spark gap 340 in a direction away from. The method 600 includes a step 660 of impacting the high resistance lesions 410 (e.g., calcified plaque) within the blood vessel with a single shock wave to provide a therapeutic effect of comminuting the lesions.

As shown in fig. 14 and 15, the shock wave 700 from the shock waveguide 100 impacts the high resistance lesions 410 (e.g., calcified plaque) within the blood vessel and forms the crack 420 in the high resistance lesions 410 (e.g., calcified plaque) within the blood vessel. The slit 420 helps to break up and weaken the high resistance lesions 410 (e.g., calcified plaque) within the vessel, enabling subsequent use of the dilated treatment site, such as balloon catheters and stents. It is appreciated that the shock wave 700 may be repeatedly generated as desired by the clinician to treat high resistance lesions 410 (e.g., calcified plaque) within the blood vessel at the treatment site. The methods 500, 600 may further include the step of advancing the forward shock waveguide 100 in a distal direction into the vessel 400 until the shock wave device 200, 300 is opposite the next treatment site. It is appreciated that the steps of the methods 500, 600 may be repeated to advance the shock waveguide 100 into the tubing 400 (referred to herein as a blood vessel) and treat high resistance lesions 410 (e.g., calcified plaque) within the blood vessel at one or more treatment sites in the blood vessel.

The methods 500, 600 may also include removing the shock waveguide from the tubing 400 (referred to herein as a blood vessel), inserting a second medical device into the tubing 400 (referred to herein as a blood vessel), and advancing the second medical device in a distal direction into the tubing 400 (referred to herein as a blood vessel) to continue treatment of the high resistance lesion 410 (such as calcified plaque) at the treatment site. For example, the second medical device includes a balloon catheter and stent or the like for treating an atherosclerotic lesion at a treatment site.

More specifically, after treatment of the endovascular high resistance lesion 410 (e.g., calcified plaque) at one or more treatment sites in the vasculature 400 (referred to herein as a blood vessel), the impact waveguide 100 is removed from the blood vessel and a second medical device, such as a balloon catheter, is introduced to continue treatment of the high resistance lesion 410 (e.g., calcified plaque). The forward shock waveguide 100 with shock wave devices 200, 300 is smaller in size than the balloon catheter and can be inserted into lesions that are too narrow and stiff due to the significant increase in intravascular high resistance lesions 410 (e.g., calcified plaque) at the treatment site and difficult for the balloon catheter to pass. The forward impact waveguide 100 can continue to crush lesions and tunnel forward in the subsequent long-segment lesions even after breaking through the initial cap-like structure of the intravascular high-resistance lesions 410 (such as calcified plaque) along the pre-buried receiving guide wire 160, and finally completely breaks through the whole process of the lesions. The forward shock wave 700 is used to initially treat the endovascular high resistance lesion 410 (e.g., calcified plaque) creating a crack 420 that breaks and weakens the endovascular high resistance lesion 410 (e.g., calcified plaque). The forward shock waveguide 100 is removed and a balloon catheter or stent is delivered into the body tubing 400 (here a blood vessel). The intravascular high resistance lesions 410 (e.g., calcified plaque) weakened as above at the treatment site make subsequent balloon catheters or stents easier to pass through and expand and support the treatment site. In some cases, the endovascular high resistance lesion 410 forms a ring-like and stiff calcified ring around the vessel, and the balloon catheter cannot be effectively dilated without any preliminary shock wave treatment. The forward shock wave 700 helps to break through and weaken the calcium loop so that a subsequent balloon catheter or stent can treat the weakened calcium loop and dilate and support the lesion. The subsequent balloon catheter may be a shock wave balloon catheter, which may be further treated with an omnidirectional shock wave to weaken the calcium loop prior to conventional balloon dilation treatment sites.

Accordingly, the forward-impacting waveguide 100 and methods 500, 600 may be used in medical applications where high-resistance lesions 410 (e.g., vascular plaque or urinary tract stones) are present in the body tubing 400, such high-resistance lesions 410 render the body tubing 400 very narrow and stiff so that a second medical device, such as a larger balloon catheter, is difficult to pass through such tubing 400 (e.g., blood vessel, ureter). The forward impact waveguide 100 is smaller than a balloon catheter and may more easily pass high resistance lesions 410 that are compact and difficult for a balloon catheter to pass through. It is appreciated that in the methods 500, 600, the guidewire 160 is received as part of a standard medical procedure for guiding movement of the forward shock waveguide 100 in the body lumen system 400 (e.g., vessel, ureter). It will also be appreciated that a variety of guiding devices, such as imaging devices, may be used to position the forward-impacting waveguide 100 at a desired treatment site.

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

In the foregoing detailed description, embodiments of the invention are described in connection with a shock wave device and a shock waveguide comprising a shock wave device in connection with the illustrations provided. The description of the various embodiments described herein is not intended to be limited to the specific or particular representations of the invention, but is merely illustrative of non-limiting examples of the invention. The present invention is directed to solving at least one of the problems and problems associated with the prior art. Although only a few embodiments have been disclosed herein, it will be apparent to those of ordinary skill in the art after reading this disclosure that various changes and/or modifications can be made to the disclosed embodiments without departing from the scope of the invention. Accordingly, the scope of the invention is not limited to the embodiments described herein, except as by the following claims.

Claims

1. A shock wave device, which comprises a shock wave body, characterized by comprising the following steps:

2. The shockwave device according to claim 1, further comprising one or more peripheral cavities located between said inner electrode and said outer electrode, wherein said peripheral cavities are fillable with an electrically conductive fluid.

3. The shockwave device according to claim 1, further comprising an outer insulating layer between said inner electrode and said outer electrode for insulating said outer electrode from said first wire and for insulating said inner electrode from said second wire.

4. The shockwave device according to claim 1, wherein an uninsulated portion of said outer electrode is formed at a distal portion of said outer electrode and an uninsulated portion of said inner electrode is formed at a distal portion of said inner electrode.

5. The shock wave device of claim 3, wherein the distal end portion of the inner electrode is axially offset from the distal end portion of the outer electrode, or

6. The shock wave device of claim 1, wherein the uninsulated portions of the inner electrode and the outer electrode comprise chamfered distal ends.

7. The shock wave device according to claim 1, wherein the inner and outer electrodes comprise an insulating coating for insulating the outer electrode from the first wire and for insulating the inner electrode from the second wire, the insulating coating comprising holes forming uninsulated portions of the electrodes and forming the spark gap.

8. The shockwave device according to claim 1, wherein said inner electrodes comprise two, a first inner electrode and a second inner electrode, respectively, such that the shockwave device is adapted to generate a dual shockwave, i.e.,

A shock wave device, which comprises a shock wave body, characterized by comprising the following steps:

9. The shockwave device according to claim 8, wherein said outer electrode comprises an insulating coating for insulating said outer electrode from a wire, said insulating coating comprising a first hole and a second hole, said first hole and said second hole forming said first uninsulated portion and said second uninsulated portion of said outer electrode, respectively.

10. An impact waveguide comprising the impact wave device of any one of claims 1-9, further comprising an inner elongate member and an outer elongate member, wherein,