WO2024114150A1 - Shock wave generating device, shock wave generating system, and method - Google Patents

Abstract

Provided are a shock wave generating device, a shock wave generating system, and a method. The device comprises: an axially extending catheter (1); a balloon (30) surrounding a portion of the catheter (1), the balloon (30) being capable of being filled with a conductive fluid; and one or more electrode assemblies. The electrode assembly comprises at least one electrode pair. Each electrode pair comprises an inner electrode (3), an outer electrode (2) arranged on the inner electrode (3), and an insulating layer (5) arranged between the inner electrode (3) and the outer electrode (2). The insulating layer (5) is provided with a first opening (6). The outer electrode (2) is provided with a second opening (7) coaxially aligned with the first opening (6). The device is configured as follows: when the balloon (30) is filled with the conductive fluid and at least one electrode pair is controlled to apply a voltage to form a shock wave pulse, the electrode pair generating the shock wave pulse has directivity to discharge. By means of controlling the electrode pairs in different electrode assemblies or controlling different electrode pairs in the same electrode assembly to alternately discharge within a preset time difference, the electrode pairs alternately generate pulse sound pressure within the time difference to accurately control the occurrence direction of a shock wave in a circumferential direction of the balloon.

Description

Shock wave generating device, shock wave generating system and method Technical Field

The invention relates to the field of shock wave generation, and in particular to a shock wave alternating generation device and a shock wave generation system.

Background technique

With the trend of population aging and signs of younger cardiovascular diseases, the incidence of arterial calcification is increasing year by year. For arterial calcified lesions, commonly used clinical treatment methods include non-compliant balloons, cutting balloons, scoring balloons, plaque atherectomy, excimer laser, etc. These traditional methods for treating calcified plaques have certain limitations, especially in the treatment of media calcification, eccentric calcified nodules or severe calcification. It is difficult to play an effective role, or even powerless. How to use more effective means to fully pre-treat calcified lesions is the focus of attention of clinical physicians at home and abroad. IVL is a new technology for the clinical treatment of arterial calcified lesions, which provides a more ideal solution for calcified plaques that were previously untreatable.

IVL (Intravascular Shock Wave Calcification Release) technology draws on the extracorporeal lithotripsy of urology. Its working principle is to perfectly combine the acoustic wave calcification fracturing technology with the balloon catheter. The flexible balloon is equipped with a miniature high-voltage discharge device. During treatment, the balloon is first expanded at low pressure at the calcified lesion, fitting tightly against the blood vessel wall at the lesion. Then the shock wave pulse power supply is controlled by the treatment switch to output intermittent high-voltage excitation electric pulses. Under the excitation of the high-voltage electric pulse, the miniature high-voltage discharge device acting in the balloon discharges high voltage in a short period of time, generating electric sparks, causing part of the mixed solution of saline and contrast agent in the balloon to be cavitated instantly, generating non-focused, circumferential pulsed sound pressure waves. Due to the difference in acoustic impedance, the sound pressure wave mainly acts selectively on the solid calcified substances that cause arterial vascular lesions, while passing through soft tissues such as human blood vessels and muscles whose density is close to that of saline almost without loss. Therefore, the sound pressure The wave can efficiently and safely impact and destroy superficial and deep vascular calcification lesions, causing the calcification to rupture and loosen, and the blood vessels to be moderately softened to maximize the inner diameter of the lumen, thereby significantly improving vascular compliance and facilitating the subsequent implantation of stents or drug-eluting balloons.

In existing medical IVL systems, the shock wave generating device generally includes an electrode assembly, which may have: an inner electrode; an insulating layer, which is arranged on the inner electrode so that the opening in the insulating layer is aligned with the inner electrode; and an outer electrode, which is arranged on the insulating layer so that the opening in the outer electrode is coaxially aligned with the opening in the insulating layer. This layered configuration allows the generation of shock waves that are triggered and/or propagated outward from the side of the catheter, connecting multiple groups of electrodes. In this system, the current loop is only turned on when all electrodes are punctured at the same time; at the same time, lesions in the same part are subjected to pulse shocks from two or more groups of electrodes, which can easily cause damage (such as intimal tearing, media displacement, or vascular perforation, etc.). In addition, during surgery, there is a problem of inaccurate control by manually twisting the catheter to switch the effect on lesion tissues in different positions.

Summary of the invention

The object of the present invention is to provide a shock wave generating device, a shock wave generating system and a method to solve the above-mentioned problem of inaccurate control.

The first aspect of the present invention is a shock wave generating device, comprising:

an axially extending catheter;

a balloon surrounding a portion of the catheter, the balloon being fillable with a conductive fluid,

One or more electrode assemblies, the electrode assemblies include a plurality of electrode pairs, each electrode pair includes an inner electrode, an outer electrode arranged on the inner electrode, and an insulating layer arranged therebetween, the insulating layer has a first opening, and the outer electrode has a second opening coaxially aligned with the first opening; and are configured such that: when the balloon is filled with a conductive fluid and a voltage is applied between at least one group of electrode pairs to form a shock wave pulse, the discharge of the electrode pairs generating the shock wave pulse is directional, and the electrode pairs in different electrode assemblies are controlled or different electrode pairs in the same electrode assembly are controlled to discharge alternately within a preset time difference, and the electrode pairs alternately generate pulse sound pressure within the time difference, so as to accurately control the direction of the shock wave in the circumferential direction of the balloon.

The second aspect provided by the present invention is a shock wave generating device, comprising:

an axially extending catheter;

a balloon surrounding a portion of the catheter, the balloon being capable of being filled with a conductive fluid;

At least two electrode assemblies, each electrode assembly further comprising at least two electrode pairs, the first electrode pair comprising at least the first inner electrode and the first outer electrode being one electrode pair, the second inner electrode and the second outer electrode being a second electrode pair, wherein:

The first inner electrode is located at a first side position of the catheter in the balloon, and the second inner electrode is located at a second side position of the catheter in the balloon; and one of the first inner electrode and the second inner electrode is located at a distal end of the catheter, and the other inner electrode is located at a proximal end of the catheter,

an insulating layer having a first hole and a second hole, the insulating layer being arranged around the first and second inner electrodes such that the first hole of the insulating layer is located above the first inner electrode and the second hole of the insulating layer is located above the second inner electrode; and a first outer electrode having a first hole and a second outer electrode having a second hole, the first outer electrode and the second outer electrode being arranged around the insulating layer such that the first hole of the first outer electrode is aligned with the first hole of the insulating layer and the second hole of the second outer electrode is aligned with the second hole of the insulating layer;

The electrode assembly is configured to: selectively control the voltage applied to a certain electrode assembly to form a shock wave pulse, the electrode pairs generating the shock wave pulse have a directionality in discharge, and by controlling the electrode pairs in different electrode assemblies to alternately discharge within a preset time difference, the electrode pairs in the current electrode assembly alternately generate pulse sound pressure within the time difference, so as to accurately adjust the directionality of the shock wave generated in the catheter.

The third aspect provided by the present invention is a shock wave generating system, comprising:

an axially extending catheter;

A balloon surrounding a portion of the catheter, the balloon may be filled with a conductive fluid,

One or more electrode assemblies, the electrode assemblies comprising a plurality of electrode pairs, each electrode pair comprising an inner electrode, an outer electrode disposed on the inner electrode, and an insulating layer disposed therebetween, the insulating layer having a first opening, the outer electrode having a second opening coaxially aligned with the first opening;

A voltage pulse generator having at least a first channel and a second channel, wherein the first channel and the second channel are selectively connected to different electrode assemblies,

The electrode assembly satisfies the condition that: when the balloon is filled with conductive fluid and a voltage is applied between at least one electrode pair to form a shock wave pulse, the discharge of the electrode pairs in the shock wave pulse has directionality, and the discharge of the electrode pairs in the shock wave pulse is directional by controlling different electrode pairs in the electrode assembly or controlling different electrode pairs in the same electrode assembly. The discharges are alternately performed within a set time difference, and the electrode pairs generate pulse sound pressure alternately within the time difference to accurately adjust the directionality of the shock wave generated in the catheter.

A fourth aspect of the present invention is a method for generating shock waves, comprising:

Using the shock wave generating device;

When the balloon is filled with a conductive fluid and a voltage is applied between at least one set of electrode pairs to form a shock wave pulse, the discharge of the electrode pairs generating the shock wave pulse has directionality;

The electrode pairs in different electrode assemblies or different electrode pairs in the same electrode assembly are controlled to discharge alternately within a preset time difference, and the electrode pairs alternately generate pulse sound pressure within the time difference, and the shock wave is used to accurately control the direction of the shock wave in the circumferential direction of the balloon.

Compared with the prior art, the advantages of the present invention are:

Considering the operation as one or several treatment processes, the electrode assembly in a VL system is controlled at a certain time point, and the position of the electrode pair at that time point is determined, the directionality of the pulse is determined, the amplitude of the voltage pulse, the duration, and the distance between the shock wave electrode and the return electrode can be determined. The directionality of the pulse and the position of the electrode pair at that time point can accurately determine the position of the treated tissue at the current time, and further generate shock wave pulses. The position information of the electrode pair to which the voltage is applied is related to the position of the sound pressure radiation area of this shock wave pulse: it is configured to control the voltage magnitude applied to the electrode assembly continuously to control the size of the sound pressure radiation area of the shock wave pulse. In this way, accurate control of the directionality of the shock wave generated, the position of the sound pressure radiation area of the pulse, and the size of the sound pressure radiation area can be achieved at a certain time point. Moreover, by controlling the electrode pairs in different electrode assemblies or controlling different electrode pairs in the same electrode assembly to discharge alternately within a preset time difference, the electrode pairs acted on can alternately generate pulse sound pressure within the time difference.

When the sound pressures of adjacent pulses do not overlap and are in opposite directions, the pressure of the opposite directions on the inner wall of the blood vessel is effectively relieved. When the device or system is used to perform directional control within a certain angle range, directional operations and treatments can be performed on some non-circular or small-scale local lesions.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG1 is a partial perspective view of an example of a shock wave generating device of the present invention;

FIG2 is a partial cross-sectional view of an example of a shock wave generating device of the present invention;

FIG3 is a diagram showing an example of the layout of two groups of electrode assemblies of the present invention;

FIG4 is a first equivalent circuit diagram of two groups of electrode assemblies of the present invention;

FIG5 is a second equivalent circuit diagram of two groups of electrode assemblies of the present invention;

FIG6A is an example diagram of a pulse signal acting on a sound pressure radiation area;

FIG6B is another example diagram of a pulse signal acting on the sound pressure radiation area;

FIG7A is an equivalent circuit diagram of a first electrode assembly and a second electrode assembly;

FIG7B is a diagram showing an example of the structural layout of the first electrode assembly and the second electrode assembly;

FIG8 is a diagram showing an example of a shock wave generating system according to the present invention.

Detailed ways

The following is a further detailed description of a device and system for alternating shock wave generation proposed by the present invention in conjunction with the accompanying drawings and specific embodiments. The advantages and features of the present invention will become clearer according to the following description. Obviously, the described embodiments are part of the embodiments of the present invention, rather than all of the embodiments. The components of the embodiments of the present invention described and shown in the accompanying drawings can be arranged and designed in various different configurations.

Therefore, the following detailed description of the embodiments of the present invention provided in the accompanying drawings is not intended to limit the scope of the invention claimed for protection, but merely represents selected embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

It should be noted that similar reference numerals denote similar items in the following drawings, and therefore, once an item is defined in one drawing, further definition and explanation thereof is not required in the subsequent drawings.

In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", The directions or positional relationships indicated by "right", "vertical", "horizontal", "inside", "outside", etc. are based on the directions or positional relationships shown in the drawings, or are the directions or positional relationships in which the invented product is usually placed when in use. They are only for the convenience of describing the invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific direction, be constructed and operate in a specific direction, and therefore cannot be understood as limiting the invention. In addition, the terms "first", "second", "third", etc. are only used to distinguish the description, and cannot be understood as indicating or implying relative importance.

In addition, the terms "horizontal", "vertical" and the like do not mean that the components are required to be absolutely horizontal or suspended, but can be slightly tilted. For example, "horizontal" only means that its direction is more horizontal than "vertical", and does not mean that the structure must be completely horizontal, but can be slightly tilted.

In the description of this application, the “proximal end” refers to the end close to the operator, and the “distal end” refers to the end far from the operator.

First, the creation process of the present invention is introduced.

The lithotripsy or shock wave electrode can be sealed within an angioplasty or valvuloplasty balloon filled with a fluid (e.g., saline and/or contrast agent). The shock wave electrode can be attached to a high voltage pulse source varying from 100 to 10,000 volts for various pulse durations. This can generate bubbles on the surface of the electrode, prompting a plasma arc of electrical current to pass through the bubble and form a bubble that rapidly expands and collapses, which in turn forms a mechanical shock wave in the balloon. The shock wave can be mechanically conducted through the fluid and through the balloon to apply mechanical force or pressure to break apart any calcified plaque on or in the wall of the vascular system. The size, rate of expansion and collapse of the bubble (and the amplitude, duration, and distribution of the mechanical force thus caused) can vary based on the amplitude and duration of the voltage pulse and the distance between the shock wave electrode and the return electrode. The shock wave electrode can be made of a material that can withstand the high voltage electrical frequency and strong mechanical forces (e.g., about 500-2000 psi or 30-150 ATM ATM in a few microseconds) generated during use. For example, shock wave electrodes can be made of metals such as stainless steel, tungsten, nickel, iron, steel, etc. Made of material.

Conventional shock wave electrodes may be suitable for use in angioplasty or valvuloplasty balloons, however, when paired with a catheter, they may be positioned along the outer surface of an elongated member (e.g., the portion of the catheter in the balloon is referred to as the elongated member) and protrude no more than 0.015 inches from the outer surface of the elongated member. For example, the shock wave electrodes may only increase the cross-section of the elongated member by about 0.005 inches to about 0.015 inches, thereby minimally affecting the ability of the elongated member to approach and treat the target vascular tissue. However, in view of the thinner and smaller cross-sections, the current practice is to mainly arrange the inner electrode concavely along the elongated member. Since the amplitude, duration, and distribution of the mechanical force impinging on a portion of the tissue depend at least in part on the location and distance between the shock wave source and the tissue portion, a shock wave device having multiple shock wave electrodes may be arranged at various locations along the length of the elongated member to help provide a consistent or uniform mechanical force to the tissue region. The multiple electrodes may be distributed across the device (e.g., along the longitudinal length of the elongated member) so as to minimize the distance between the shock wave source and the location of the tissue being treated. For example, a calcified region of a vessel or artery may extend over some longitudinal distance of the vessel or artery, and a point source shock wave electrode will not be effective across the full extent of the calcified region due to the varying distances from the shock wave source to various portions of the calcified region. The size and shape of the elongated member may also be configured to distribute shock wave forces to non-linear anatomical regions. For example, the elongated member may be curved, and multiple shock wave electrodes may be positioned along the longitudinal length of the elongated member as is known in the art to distribute the shock waves across the length of the calcified plaque.

The applicant found in the research:

Two or even more groups of electrodes are connected to form a loop. In this system, the current loop is only conducted when all electrodes are punctured at the same time; the direct effect is that at the same time, the lesions in the same part are subjected to the pulse impact of two or more groups of electrodes. The advantages of this system are simple assembly and direct pulse effect; however, under the action of multiple pulses (usually more than 20 times), the normal blood vessel tissue will undergo A test of tolerance. Clinically, due to multiple pulses, there is a probability of adverse events such as vascular intima tearing or media displacement, vascular perforation, etc. In the peripheral vascular field, there are up to 5 electrode groups in the IVL system, which generally use a sequential discharge method to alleviate the impact pressure of the pulse on normal vascular tissue. However, locally, the inner wall of the blood vessel is still impacted at a certain high frequency, and there are still safety risks in use.

Currently, during treatment, when some of the treated tissues are not affected by the pulse, the operator manually twists the catheter in the blood vessel. However, it is difficult to accurately control the direction of the catheter twisting operation during surgery.

To this end, after many reflections and studies, the applicant regards surgery as one or several treatment processes. At a certain time point, the electrode assembly in a certain IVL system is controlled. At this time point, the position of the electrode pair is determined, the directionality of the pulse is determined, the amplitude of the voltage pulse, the duration, and the distance between the shock wave electrode and the return electrode can be determined. The directionality of the pulse and the position of the electrode pair at this time point can accurately determine the position of the treated tissue at the current time, and further generate shock wave pulses. The location information of the electrode pair to which the voltage is applied is related to the position of the sound pressure radiation area of this shock wave pulse: it is configured to control the size of the voltage applied to the electrode assembly and the size of the shock wave aperture to control the size of the sound pressure radiation area of the shock wave pulse. In this way, accurate control of the directionality of the shock wave generated, the position of the sound pressure radiation area of the pulse, and the size of the sound pressure radiation area can be achieved at a certain time point. Moreover, by controlling the electrode pairs in different electrode assemblies or controlling different electrode pairs in the same electrode assembly to discharge alternately within a preset time difference, the electrode pairs alternately generate pulse sound pressure within the time difference, and the shock wave accurately controls the direction of the shock wave in the circumferential direction of the balloon. What is the concept of time difference? The minimum time for the sound pressure of adjacent pulses to have no overlapping effect, and the time difference should be greater than or equal to the minimum time. That is, the effect of the electrodes alternating pulse sound pressure within the time difference (TT′) is achieved. Since the period of a single pulse sound pressure is about 5 microseconds, and the discharge interval is usually 1 second; Therefore, the time difference (TT′) can be adjusted and controlled within the millisecond range. Within this time difference, the sound pressures of the two pulses do not overlap.

The shock wave is directional, and the electrode pair can be set at the corresponding two ends. For example, electrode pair A is set at one end of the balloon and the direction of the shock wave emitted by the electrode pair is the first direction of the catheter toward the balloon, and electrode pair B is set at the other end of the balloon and the direction of the shock wave emitted by the electrode pair is the second direction of the catheter toward the balloon. The first direction is opposite to the second direction. At time point T1, electrode pair A is controlled to discharge, and at time point T2, electrode pair B is controlled to discharge. (T2-T1) is greater than the minimum time mentioned above. In this case, when the sound pressures of adjacent pulses do not overlap and are in opposite directions, the pressure of the opposite direction forces on the inner wall of the tissue (such as the inner wall of the blood vessel, the intima/middle membrane) can be effectively alleviated.

When the device or system is used to perform directional control within a certain angle range, directional operations and treatments can be performed on some non-circular or small-scale local lesions. Moreover, in the setting of high energy output, the electrode pairs do not need to discharge continuously, and the durable life of the electrode group can be provided, thereby improving the safety, reliability and effectiveness of product use.

First embodiment

Please refer to Figures 1 and 2. Figure 1 is a partial stereoscopic view of an example of a shock wave generating device of the present invention. Figure 2 is a partial cross-sectional view of an example of a shock wave generating device of the present invention. It includes:

An axially extending catheter 1;

A balloon 30 surrounding a portion of the catheter 1, the balloon 30 may be filled with a conductive fluid,

One or more electrode assemblies, the electrode assemblies comprising a plurality of electrode pairs, each electrode pair comprising an inner electrode, an outer electrode arranged on the inner electrode, and an insulating layer arranged therebetween, the insulating layer having a first opening, the outer electrode having a second opening coaxially aligned with the first opening; and being configured such that: when the balloon is filled with a conductive fluid and a voltage is applied between at least one group of electrode pairs to form a shock wave pulse, the electrode pairs generating the shock wave pulse have a directionality in discharge, and the discharge is alternately performed within a preset time difference by controlling the electrode pairs in different electrode assemblies or controlling different electrode pairs in the same electrode assembly. The electrode pairs alternately generate pulse sound pressure within a time difference to accurately control the direction of the shock wave in the circumferential direction of the balloon.

Please also refer to Figures 1 and 2, which are examples of an electrode assembly. The electrode assembly may include a first electrode pair 10 and a second electrode pair 20, and the structures of the first electrode pair 10 and the second electrode pair 20 may be similar, and the structure of an electrode pair is now introduced. It includes an inner electrode 3, an outer electrode 2 stacked on the inner electrode 3, and an insulating layer 5 between them. Stacking the outer electrode 2 on the inner electrode 3 can form a layered electrode assembly, which can be formed on the side of the catheter 1 without significantly increasing the cross-sectional profile of the catheter. The stacked or layered electrode assembly located on the side of the catheter 1 can be capable of generating shock waves propagating from the side of the catheter 1. The insulating layer 5 can have a first opening 6, and the outer electrode 2 can have a second opening 7 coaxially aligned with the first opening 6. The coaxial alignment between the first opening 6 in the insulating layer 5 and the second opening 7 in the outer electrode 2 can include aligning the center of each opening along the same axis. The opening 6 in the insulating layer 5 and the opening 7 in the outer electrode 2 can be concentric, so that the center of the opening of the insulating layer 5 is aligned with the center of the opening of the outer electrode 2. In some variations, the shock wave device may include an elongated member (e.g., a catheter) and a shock wave electrode assembly having an inner electrode 3 substantially coplanar with the outer surface of the elongated member. A longitudinal channel or groove may be provided in the catheter to provide an electrical conductor to facilitate electrical connection between different electrode pairs. Also, the catheter may be provided with an electrical conductor directly along the outer surface. The opening of the insulating layer 5 is coaxially aligned with the opening of the outer electrode 2 to allow the generated shock wave to propagate from the side of the catheter. That is, when the arc breaks through the inner electrode 3 and the outer electrode 2, an arc is formed at the opening of the first opening 6 and the second opening 7, thereby generating a shock wave.

Taking the precise control of the electrode assembly as an example, the different electrode pairs in the same electrode assembly are precisely controlled to alternately discharge within a preset time difference, and the electrode pairs alternately generate pulse sound pressure within the time difference. For example, controlling the first electrode pair 10, controlling the second electrode pair 20, and simultaneously controlling two control states of the first electrode pair 10 and the second electrode pair 20 to alternately control discharge (controlling which control states alternately discharge, the time difference between the control states, controlling the magnitude of the continuously applied voltage, etc.) can achieve the effect of accurately generating pulse wave pulses.

Please refer to FIG. 3 , when there are two electrode assemblies, for example, the first electrode assembly includes a first electrode pair 10 and a second electrode pair 20, and the second electrode assembly includes a third electrode pair 40 and a fourth electrode pair 50. In the example, one of the first electrode pair 10 and the second electrode pair 20 is located at the distal end of the balloon, and the other electrode pair is located at the proximal end of the balloon. The shock wave formed by the first electrode pair and the second electrode pair is at an angle of 90° or 180°. Of course, in other embodiments, the shock wave formed by the first electrode to the second electrode pair can also be at other angles such as 30°, 45°, 60°, etc.

FIG4 is a circuit implementation diagram of an electrode assembly. FIG5 is another circuit implementation diagram of two electrode assemblies. By controlling the electrode pairs in different electrode assemblies to discharge alternately within a preset time difference, the electrode pairs alternately generate pulse sound pressure within the time difference, and the shock wave accurately controls the direction of the shock wave in the circumferential direction of the balloon. Taking FIG4 as an example, the alternating discharge of the first electrode assembly 10 and the second electrode assembly 20 can be alternately controlled. Taking FIG6A as an example, the sound pressure radiation area when the first electrode assembly is working, when the second electrode assembly is discharged, the first group of electrode assemblies can form the sound pressure radiation effect of the second electrode assembly after the time difference (T-T′), as shown in b-2 in FIG6A. Taking FIG6B as an example, respectively control (1) the first electrode assembly and the second electrode assembly to discharge simultaneously, (2) the first electrode assembly to discharge, and (3) control the second electrode assembly to discharge. When (1), (2) and (3) are discharged alternately, the sound pressure acting on the radiation area shown in FIG6B will be formed.

Of course, the user or doctor can adjust the directionality of the catheter's shock wave according to the clinical situation. This function can be achieved by inputting corresponding commands (input T, input T', triggering the discharge of different electrode assemblies, inputting the duration of discharge, etc.) through the host interface, rather than manually twisting the catheter in the blood vessel. Twisting the catheter during surgery can accurately control the direction.

In this example, a high voltage input port and a high voltage output port are respectively added to the two ends of the first electrode assembly to form a high voltage channel. Similarly, a high voltage input port and a high voltage output port are also added to the two ends of the second electrode assembly to form another high voltage channel. Therefore, the present device may include at least two separate high voltage channels, and the two ends of each high voltage channel are respectively configured to connect an inner electrode and an outer electrode of the electrode assembly, and are configured to control the electrode pairs in different high voltage channels to discharge alternately at a preset time difference. Each high voltage channel is provided with at least two pairs of electrode pairs, and each pair of electrode pairs is connected by an electrical conductor in the catheter, and different electrode pairs are controlled to discharge alternately at a preset time difference. The two ends of each high voltage channel are respectively connected to a certain voltage input port and a certain voltage output port of the pulse generator, and are configured to: whether a voltage is applied to the high voltage channel, and whether the two ends of the high voltage channel have a choice at a certain time point. The electrodes are connected to different electrode assemblies or to different electrode pairs of the same electrode assembly to generate different shock wave pulses at the current time point.

It should be further explained that the two ends of the high voltage channel can also be connected to the inner electrode and the inner electrode of an electrode pair, respectively. Assuming that a certain electrode assembly includes an electrode pair A and an electrode pair B, the two ends of the first high voltage channel can be connected to the two ends of the electrode assembly, the two ends of the second high voltage channel are connected to the inner electrode and the outer electrode of the electrode pair A, respectively, and the two ends of the third high voltage channel are connected to the inner electrode and the outer electrode of the electrode pair B, respectively. The discharge at a certain time can select one of the first high voltage channel, the second high voltage channel and the third high voltage channel to discharge. When it lasts for a certain period of time, different channels can be selected to discharge, thereby generating different shock wave pulses. The selection of different high voltage channels can be pre-programmed in the software, or it can be selected by making an interactive module such as a button, switch, or knob (interactive module 70 as shown in Figure 8), and the system triggers the corresponding channel to discharge according to the selected high voltage channel. It should also be explained that when there are multiple groups of electrode assemblies, a certain electrode pair of the first electrode assembly and another electrode pair of the second electrode assembly can be selected as a certain high voltage channel, and high voltage can be directly applied for discharge.

Second embodiment

A shock wave generating device, comprising:

an axially extending catheter;

a balloon surrounding a portion of the catheter, the balloon being capable of being filled with a conductive fluid;

At least two electrode assemblies, each electrode assembly further comprising at least two electrode pairs, a first electrode pair comprising at least a first inner electrode and a first outer electrode as one electrode pair, a second inner electrode and a second outer electrode as a second electrode pair, wherein:

The first inner electrode is located at a first side position of the catheter in the balloon, and the second inner electrode is located at a second side position of the catheter in the balloon; and one of the first inner electrode and the second inner electrode is located at a distal end of the catheter, and the other inner electrode is located at a proximal end of the catheter,

an insulating layer having a first hole and a second hole, the insulating layer being arranged around the first and second inner electrodes so that the first hole of the insulating layer is located above the first inner electrode and the second hole of the insulating layer is located above the second inner electrode; and a first outer electrode having a first hole and a second outer electrode having a second hole, the first outer electrode and the second outer electrode being arranged around the insulating layer so that the first outer electrode the hole is aligned with the first hole of the insulating layer and the second hole of the second external electrode is aligned with the second hole of the insulating layer;

The electrode assembly is configured to: selectively control the voltage applied to a certain electrode assembly to form a shock wave pulse, the electrode pairs generating the shock wave pulse have a directionality in discharge, and by controlling the electrode pairs in different electrode assemblies to alternately discharge within a preset time difference, the electrode pairs in the current electrode assembly alternately generate pulse sound pressure within the time difference, so as to accurately adjust the directionality of the shock wave generated in the catheter.

Compared with the first example, this example is a better solution of the present invention.

Please refer to FIG. 7A and FIG. 7B for another implementation example of the present invention. It includes a first electrode assembly and a second electrode assembly, the first electrode assembly includes a first electrode pair 10 and a second electrode pair 20, and the second electrode assembly includes a third electrode pair 40 and a fourth electrode pair 50. As shown in FIG. 7B. The first electrode pair 10 includes a first outer electrode 2-2 and a first inner electrode 3-4, the second electrode pair 20 includes a second outer electrode (not shown) and a second inner electrode 3-3, the third electrode pair includes a third outer electrode (not shown) and a third inner electrode 3-2, and the fourth electrode pair includes a fourth outer electrode 2-1 and a fourth inner electrode 3-1. Taking FIG. 7B as an example, the first inner electrode 3-4 and the third inner electrode 3-2 are arranged relative to each other with the catheter as the axis, the second inner electrode 3-3 and the fourth inner electrode 3-1 are arranged relative to each other, and the first inner electrode 3-4 and the third inner electrode 3-2 can be arranged on the same side, and the insulating layer can share one. At the same time, the second inner electrode 3-3 and the fourth inner electrode 3-1 can be arranged on the same side, and the insulating layer can also share one. Moreover, there is an angle deviation between them. Taking Figure 7 as an example, the first inner electrode 3-4 and the second inner electrode 3-3 have an angle of 90 degrees. There are multiple settings for the angle deviation, which is mainly related to the regional position of the tissue in our applicable scenario. In this example, the two electrode pairs are a first electrode pair close to the proximal/distal end of the balloon and a second electrode pair close to the distal/proximal end of the balloon. The first electrode pair and the second electrode pair are arranged on the catheter and located in the balloon. The shock wave formed by the first electrode pair and the second electrode pair is at an angle of 90° or 180°. The first side position and the second side position are the same side or opposite side, and the shock wave formed by the first electrode pair and the second electrode pair is at an angle of 90° or 180°.

Taking FIG. 7A as an example, one equivalent circuit is that VO1+ is electrically connected to the fourth inner electrode 3-1, the fourth outer electrode 2-1, the electrical conductor, the third outer electrode, the third inner electrode 3-2, and then connected to VO1-, forming the first high voltage channel. Another equivalent circuit is that VO1+ is electrically connected to the first inner electrode 3-4, the first outer electrode 2-2, the electrical conductor, the second outer electrode, the second inner electrode 3-3, and then connected to VO2-, forming the second high voltage channel. Two high voltage channels. By alternately discharging the high voltage channel and the high voltage channel, the electrode pairs alternately generate pulse sound pressure within the time difference to accurately control the shock wave, including the generation of pulse directionality control.

When the first electrode assembly and the second electrode assembly are configured so that within the time difference, the sound pressure radiation areas of adjacent pulses do not overlap and the electrode pairs generating the pulses discharge in opposite directions, the pressure on the target from forces in opposite directions can be alleviated.

In one embodiment, the circuit design can cooperate with the power control system to perform directional control within a specific angle range (such as an angle range of 180 degrees), and perform directional operation and treatment for some non-circular or small-scale local lesions.

The electrode assembly is further configured to satisfy the condition that: it is configured to control the magnitude of the voltage applied to the electrode assembly to affect the size of the sound pressure radiation area of the shock wave pulse. Different electrode pairs are arranged at different positions, and the position information of the electrode pair to which the voltage is applied when the shock wave pulse is generated is related to the position of the sound pressure radiation area of this shock wave pulse.

Third embodiment

This example protects a shock wave generating system, which adopts the shock wave generating device of the first embodiment or the shock wave generating device of the second embodiment.

Please refer to Figure 8, the shock wave generating system includes:

An axially extending catheter 1;

A balloon 30 surrounding a portion of the catheter 1, the balloon 30 may be filled with a conductive fluid,

One or more electrode assemblies, the electrode assemblies comprising a plurality of electrode pairs 10, 20, each electrode pair comprising an inner electrode, an outer electrode disposed on the inner electrode, and an insulating layer disposed therebetween, the insulating layer having a first opening, and the outer electrode having a second opening coaxially aligned with the first opening;

A voltage pulse generator 60 has at least a first channel and a second channel, wherein the first channel and the second channel are selectively connected to different electrode assemblies.

The electrode assembly satisfies the following conditions: when the balloon is filled with a conductive fluid and a voltage is applied between at least one group of electrode pairs to form a shock wave pulse, the discharge of the electrode pairs in the shock wave pulse is directional, and by controlling different electrode pairs in the electrode assembly or controlling different electrode pairs in the same electrode assembly to discharge alternately within a preset time difference, the electrode pairs alternately generate pulse sound pressure within the time difference, and the shock wave occurs in a circumferential direction of the balloon.

The electrode assembly is further configured to satisfy the condition that: it is configured to control the magnitude of the voltage applied to the electrode assembly so as to affect the size of the sound pressure radiation area of the shock wave pulse.

Different electrode pairs are set at different positions, and the position information of the electrode pairs to which voltage is applied when a shock wave pulse is generated is related to the position of the sound pressure radiation area of this shock wave pulse.

Fourth embodiment

A shock wave generating method, comprising:

Using the shock wave generating device provided above;

When the balloon is filled with a conductive fluid and a voltage is applied between at least one set of electrode pairs to form a shock wave pulse, the discharge of the electrode pairs generating the shock wave pulse has directionality;

The electrode pairs in different electrode assemblies or different electrode pairs in the same electrode assembly are controlled to discharge alternately within a preset time difference, and the electrode pairs alternately generate pulse sound pressure within the time difference, and the shock wave is used to accurately control the direction of the shock wave in the circumferential direction of the balloon.

Controlling the electrode pairs at different positions to which voltage is applied, generating the sound pressure radiation area position of the current shock wave pulse that matches the electrode pair position at the current time point;

The device is configured to control the duration of applying voltage to the electrode assembly to control the size of the sound pressure radiation area of the shock wave pulse.

The embodiments of the present invention are described in detail above in conjunction with the accompanying drawings, but the present invention is not limited to the above embodiments. Even if various changes are made to the present invention, if these changes fall within the scope of the claims of the present invention and their equivalents, they still fall within the protection scope of the present invention.

Claims (19)

A shock wave generating device, characterized in that it comprises: an axially extending catheter; a balloon surrounding a portion of the catheter, the balloon being fillable with a conductive fluid, One or more electrode assemblies, wherein the electrode assembly includes at least one electrode pair, each electrode pair includes an inner electrode, an outer electrode, and an insulating layer arranged between the inner electrode and the outer electrode, the insulating layer has a first opening, and the outer electrode has a second opening coaxially aligned with the first opening; and is configured such that: when the balloon is filled with a conductive fluid and a voltage is applied to at least one group of electrode pairs to form a shock wave pulse, the discharge of the electrode pairs generating the shock wave pulse has directionality, and the electrode pairs in different electrode assemblies are controlled or different electrode pairs in the same electrode assembly are controlled to discharge alternately within a preset time difference, and the electrode pairs alternately generate pulse sound pressure within the time difference, and the shock wave can accurately control the direction of the shock wave in the circumferential direction of the balloon. The shock wave generating device as described in claim 1 is characterized in that the electrode assembly is configured to further satisfy the condition that: it is configured to continuously apply voltage to the electrode assembly to affect the size of the sound pressure radiation area of the shock wave pulse. The shock wave generating device as described in claim 1 is characterized in that different electrode pairs are arranged at different positions, and the position information of the electrode pairs to which voltage is applied for generating the shock wave pulse is related to the position of the sound pressure radiation area of this shock wave pulse. The shock wave generating device as described in claim 1 is characterized in that it includes at least two separate high-voltage channels, and the two ends of each high-voltage channel are configured to be respectively connected to the two ends of one of the electrode assemblies or respectively connected to an inner electrode and an outer electrode of one of the electrode pairs, and are configured to control the electrode pairs in different high-voltage channels to discharge alternately at a preset time difference. The shock wave generating device as described in claim 4 is characterized in that each high voltage channel is provided with at least two pairs of electrode pairs, each pair of electrode pairs is connected by an electrical conductor, and different electrode pairs are controlled to discharge alternately at a preset time difference. The shock wave generating device according to claim 4 or 5, characterized in that the two ends of each high voltage channel are respectively connected to a voltage input port and a voltage output port of the pulse generator, and are configured as follows: the high voltage channel is configured to be whether a voltage is applied, and the The two ends of the high voltage channel are selectively connected to different electrode assemblies or to different electrode pairs of the same electrode assembly at a certain time point to generate different shock wave pulses at the current time point. The shock wave generating device as described in claim 3 is characterized in that the electrode assembly is configured so that within the time difference, the sound pressure radiation areas of adjacent pulses do not overlap and the electrode pairs generating the pulses discharge in opposite directions to alleviate the pressure of the opposite direction forces on the target. The shock wave generating device as described in claim 5 is characterized in that the two pairs of electrodes include a first inner electrode, a first outer electrode, a second inner electrode and a second outer electrode, and when a voltage is configured, the current flows sequentially from the first inner electrode to the first outer electrode, and then from the second outer electrode to the second inner electrode after passing through the electrical conductor, forming a parallel circuit. The shock wave generating device as described in claim 5 is characterized in that the two electrode pairs are a first electrode pair and a second electrode pair, the first electrode pair and the second electrode pair are arranged on the catheter and located in the balloon, and the shock wave formed by the first electrode pair and the second electrode pair is at an angle of 90° or 180°. A shock wave generating device, characterized in that it comprises: an axially extending catheter; a balloon surrounding a portion of the catheter, the balloon being capable of being filled with a conductive fluid; At least two electrode assemblies, each electrode assembly further comprising at least two electrode pairs, the first electrode pair at least comprising a first inner electrode and a first outer electrode as one electrode pair, and a second inner electrode and a second outer electrode as a second electrode pair, wherein: The first inner electrode is located in the balloon at a first side position of the catheter, and the second inner electrode is located in the balloon at a second side position of the catheter; and one of the first inner electrode and the second inner electrode is located at a distal end of the catheter, and the other inner electrode is located at a proximal end of the catheter, an insulating layer having a first hole and a second hole, the insulating layer being arranged around the first and second inner electrodes so that the first hole of the insulating layer is located above the first inner electrode and the second hole of the insulating layer is located above the second inner electrode; and a first outer electrode having a first hole and a second outer electrode having a second hole, the first outer electrode and the second outer electrode surrounding the first and second inner electrodes the insulating layer is arranged so that the first hole of the first outer electrode is aligned with the first hole of the insulating layer and the second hole of the second outer electrode is aligned with the second hole of the insulating layer; The electrode assembly is configured to: selectively control the application of voltage on a certain electrode assembly to form a shock wave pulse, the electrode pairs that generate the shock wave pulse have directional discharge, and by controlling the electrode pairs in different electrode assemblies to alternately discharge within a preset time difference, the electrode pairs in the current electrode assembly alternately generate pulse sound pressure within the time difference, and the shock wave occurs in the direction of the circumference of the balloon. The shock wave generating device according to claim 10, characterized in that The electrode assembly is further configured to satisfy the condition that: it is configured to continuously apply a voltage to the electrode assembly to affect the size of the sound pressure radiation area of the shock wave pulse. The shock wave generating device as described in claim 10 is characterized in that different electrode pairs are arranged at different positions, and the position information of the electrode pairs to which voltage is applied for generating the shock wave pulse is related to the position of the sound pressure radiation area of this shock wave pulse. The shock wave generating device as described in claim 10 is characterized in that the two electrode pairs are a first electrode pair and a second electrode pair, the first electrode pair and the second electrode pair are arranged on the catheter and located in the balloon, and the shock wave formed by the first electrode pair and the second electrode pair is at an angle of 90° or 180°. A shock wave generating system, characterized in that it comprises: an axially extending catheter; a balloon surrounding a portion of the catheter, the balloon being fillable with a conductive fluid, One or more electrode assemblies, the electrode assemblies comprising a plurality of electrode pairs, each electrode pair comprising an inner electrode, an outer electrode disposed on the inner electrode, and an insulating layer disposed therebetween, the insulating layer having a first opening, the outer electrode having a second opening coaxially aligned with the first opening; a voltage pulse generator having at least a first channel and a second channel, wherein the first channel and the second channel are selectively connected to the different electrode assemblies, The electrode assembly satisfies the condition that: when the balloon is filled with a conductive fluid and a voltage is applied between at least one electrode pair to form a shock wave pulse, the discharge of the electrode pairs in the shock wave pulse has directionality, and the discharge of the electrode pairs in the electrode assembly is controlled by controlling different electrode pairs in the electrode assembly or controlling different pairs in the same electrode assembly. The electrode pairs discharge alternately within a preset time difference, and the electrode pairs generate pulse sound pressure alternately within the time difference, and the shock wave generates a direction in the circumferential direction of the balloon. A shock wave generating system as described in claim 14, characterized in that the first side position and the second side position are the same side or opposite sides, and the shock wave formed by the first electrode pair and the second electrode pair is at an angle of 90° or 180°. A shock wave generating system as described in claim 14, characterized in that the electrode assembly is configured to further satisfy the condition that it is configured to continuously control the magnitude of the voltage applied to the electrode assembly to affect the size of the sound pressure radiation area of the shock wave pulse. The shock wave generating system as described in claim 14 is characterized in that different electrode pairs are arranged at different positions, and the position information of the electrode pairs to which voltage is applied for generating the shock wave pulse is related to the position of the sound pressure radiation area of this shock wave pulse. A shock wave generating method, characterized in that it comprises: A shock wave generating device is provided by adopting any one of claims 1 to 9 or one of claims 10 to 13; When the balloon is filled with a conductive fluid and a voltage is applied between at least one set of electrode pairs to form a shock wave pulse, the discharge of the electrode pairs generating the shock wave pulse has directionality; The electrode pairs in different electrode assemblies or different electrode pairs in the same electrode assembly are controlled to discharge alternately within a preset time difference, and the electrode pairs alternately generate pulse sound pressure within the time difference, and the shock wave is used to accurately control the direction of the shock wave in the circumferential direction of the balloon. The method of claim 18, further comprising: Controlling the electrode pairs at different positions to which voltage is applied, generating the sound pressure radiation area position of the current shock wave pulse that matches the electrode pair position at the current time point; The device is configured to control the magnitude of the voltage continuously applied to the electrode assembly to control the size of the sound pressure radiation area of the shock wave pulse.