Excitation method for shockwave balloon catheter, and shockwave balloon catheter system

Abstract

An excitation method for a shockwave balloon catheter, and a shockwave balloon catheter system (20). The shockwave balloon catheter system (20) comprises a shockwave balloon catheter (21) and a multi-mode energy generator (22), wherein the shockwave balloon catheter (21) comprises a plurality of separated electrode groups (120), which face different directions. In the excitation method for a shockwave balloon catheter, objects required to be excited are determined by parsing a mode control instruction, and separated electrode groups (120) in the excitation objects are connected in series as required, such that circumferential shockwaves can be formed when all the separated electrode groups (120) are excited; and when each excitation object comprises at least one separated electrode group (120), but does not comprise all the separated electrode groups (120), by controlling the excitation objects to be connected in series and the remaining separated electrode groups (120) to be connected in parallel to the excitation objects, excitation signals only excite the excitation objects, thereby forming lateral shockwaves.

Description

Shock wave balloon catheter excitation method and shock wave balloon catheter system Technical Field

[0001] The present application belongs to the field of medical device technology, and in particular relates to a shock wave balloon catheter excitation method and a shock wave balloon catheter system. Background Art

[0002] Electrodes currently used in shock wave balloon catheters typically have a monolithic structure with electrode assemblies in all directions along the same axial plane: connected in series and driven by the same voltage. When used for centripetal calcified lesions, the circumferential shock waves generated by the excitation electrode assembly have essentially the same energy in all directions. Because the relatively uniform calcified ring captures the same amount of energy, there is no way for it to dissipate except by rupturing, making it an effective treatment for centripetal calcified lesions. However, the calcium deposits in real lesions are not uniform, and if the same uniform circumferential energy is used, thicker areas will be difficult to rupture.

[0003] The preceding description is intended to provide general background information and does not necessarily constitute prior art.

[0004] Summary of the Invention

[0005] Based on this, it is necessary to address the above problems and propose a shock wave balloon catheter excitation method and a shock wave balloon catheter system, which can directionally configure the emission energy and control the shock wave balloon catheter to generate circumferential or lateral shock waves as needed.

[0006] The present application solves the technical problem by adopting the following technical solutions:

[0007] The present application provides a shock wave balloon catheter excitation method, which is applied to a shock wave balloon catheter system. The shock wave balloon catheter system includes a shock wave balloon catheter and a multi-mode energy generator. The shock wave balloon catheter includes a plurality of separate electrode groups, and the separate electrode groups have different orientations. When the separate electrode groups are excited by the multi-mode energy generator, discharges are generated, generating shock waves in the directions in which the separate electrode groups are oriented. The method includes the following steps: obtaining and parsing a mode control instruction to determine an excitation object and excitation constraints. The excitation object is the electrode group to be excited this time. The excitation constraints include output channel constraints, signal amplitude constraints, frequency constraints, and pulse duration constraints. At least one item; controlling the multi-mode energy generator to output high-voltage pulse signals of different modes to the excitation object according to the excitation constraint; when the excitation object includes all the separate electrode groups, controlling all the separate electrode groups to be connected in series; exciting the excitation object to generate discharge in all directions to form a circumferential shock wave; when the excitation object includes at least one group of separate electrode groups but does not include all the separate electrode groups, controlling the separate electrode groups in the excitation object to be connected in series, and the remaining separate electrode groups are connected in parallel with the excitation object; exciting the excitation object to generate discharge in the direction toward which the excitation object is facing, and the remaining separate electrode groups do not generate discharge, thereby forming a lateral shock wave.

[0008] In an optional embodiment of the present application, the separable electrode group includes a first electrode pair, a second electrode pair, a third electrode pair and a fourth electrode pair; the first electrode pair and the third electrode pair are connected in series and face the same direction to form a first separable electrode group; the second electrode pair and the fourth electrode pair are connected in series and face the same direction to form a second separable electrode group; the first separable electrode group and the second separable electrode group are connected in an unexcited state to different channel output ends of the multi-mode energy generator; forming a circumferential shock wave includes: controlling the first separable electrode group and the second separable electrode group to be connected in series so that the high-voltage pulse signal simultaneously excites the first separable electrode group and the second separable electrode group; after the first separable electrode group and the second separable electrode group are excited, they discharge in all directions to form a circumferential shock wave; forming a lateral shock wave includes: controlling the first separable electrode group and the second separable electrode group to be connected in parallel so that the high-voltage pulse signal only excites the first separable electrode group or the second separable electrode group; after the first separable electrode group or the second separable electrode group is excited, they discharge in the direction they are facing to form a lateral shock wave.

[0009] In an optional embodiment of the present application, a multi-mode energy generator is controlled to output a high-voltage pulse signal to the excitation object according to the excitation constraints, including: when most excitation objects include multiple separate electrode groups, determining whether the excitation constraints of each excitation object are the same; if the excitation constraints of each excitation object are the same, controlling the excitation objects with the same excitation constraints to be connected in series; if the excitation constraints of each excitation object are not the same, controlling the excitation objects with the unequal excitation constraints to be connected in parallel.

[0010] In an optional embodiment of the present application, after controlling the multi-mode energy generator to output a high-voltage pulse signal to the excitation object according to the excitation constraint, the method further includes: obtaining feedback information of the shock wave balloon catheter, the feedback information including at least one of current information, voltage information, temperature information or pressure information; judging whether the shock wave balloon catheter is in a normal working state based on the feedback information; if the shock wave balloon catheter is not in a normal working state, matching and executing a corresponding protection mode based on the feedback information.

[0011] The present application also provides a shock wave balloon catheter system, comprising: a shock wave balloon catheter and a multi-mode energy generator; the shock wave balloon catheter is arranged at one end of the shock wave balloon catheter system, and includes a shock wave balloon catheter electrode assembly and a shock wave balloon; the shock wave balloon catheter electrode assembly is composed of multiple separate electrode groups, and the separate electrode groups have different orientations; when the separate electrode groups are excited, they will generate discharges in the directions of the separate electrode groups; the shock wave balloon is a sealed expandable or contractible cavity, arranged at one end of the shock wave balloon catheter system, used to accommodate the shock wave balloon catheter electrode assembly, and the shock wave balloon is filled with physiological saline; when the separate electrode groups discharge, they can induce a hydroelectric effect inside, generating circumferential or lateral shock waves, causing the shock wave balloon to expand and conform to the blood vessel wall; the multi-mode energy generator is arranged at the other end of the shock wave balloon catheter system, connected to the shock wave balloon catheter circuit, and used to control the shock wave balloon catheter electrode assembly inside the shock wave balloon to implement the method described above.

[0012] In an optional embodiment of the present application, the shock wave balloon catheter electrode assembly includes: an electrode pair, the electrode pair is composed of an inner electrode and an outer electrode, and the direction of the inner electrode toward the outer electrode is the direction of the electrode pair; a separate electrode group, a plurality of electrode pairs facing the same direction constitute a group of separate electrode groups, all electrode pairs in the separate electrode group are connected in series; the direction of all electrode pairs in the separate electrode group is the direction of the separate electrode group.

[0013] In an optional embodiment of the present application, it includes: a first electrode pair consisting of a first inner electrode and a first outer electrode; a second electrode pair consisting of a second inner electrode and a second outer electrode; a third electrode pair consisting of a third inner electrode and a third outer electrode; a fourth electrode pair consisting of a fourth inner electrode and a fourth outer electrode; the first electrode pair and the third electrode pair face the same direction to constitute a first detachable electrode group; the second electrode pair and the fourth electrode pair face the same direction to constitute a second detachable electrode group; the first detachable electrode group and the second detachable electrode group face different directions; the shock wave balloon catheter electrode assembly also includes a wire, the wire includes a first wire, a second wire and a third wire; the first wire extends from the multimode energy generator to sequentially connect the first outer electrode, the first inner electrode, the third inner electrode, and the third outer electrode in the first detachable electrode group, and extends out of the first detachable electrode group and is connected back to the multimode energy generator through the third wire, the multimode energy generator is used to control the shock wave balloon catheter electrode assembly; the second wire extends from the multimode energy generator to sequentially connect the first outer electrode, the first inner electrode, the third inner electrode, and the third outer electrode The second outer electrode, the second inner electrode, the fourth inner electrode, and the fourth outer electrode in the two separate electrode groups are extended and connected back to the multi-mode energy generator through the third wire; the electrode pairs in the first separate electrode group and the second separate electrode group are connected in series through the connection of the wires, and the first separate electrode group and the second separate electrode group are connected in parallel; when the first wire or the second wire is connected to the positive pole of the multi-mode energy generator, the third wire is connected to the negative pole of the multi-mode energy generator, and the first separate electrode group or the second separate electrode group is excited according to the excitation of the multi-mode energy generator to discharge in the direction of the excited separate electrode group to induce a lateral shock wave; when the first wire or the second wire is connected to the positive pole of the multi-mode energy generator, the second wire or the first wire is connected to the negative pole of the multi-mode energy generator, and the first separate electrode group and the second separate electrode group are excited according to the excitation of the multi-mode energy generator to discharge in the direction of the first separate electrode group and the second separate electrode group to induce a circumferential shock wave.

[0014] In an optional embodiment of the present application, the electrode pair also includes an insulating layer; the insulating layer is provided with a first opening, the first opening is aligned with the inner electrode, so that the inner electrode is partially exposed; the outer electrode is arranged on the insulating layer, the outer electrode is provided with a second opening, and the second opening is coaxially arranged with the first opening.

[0015] In an optional embodiment of the present application, the shock wave balloon catheter also includes a feedback module; the feedback module is arranged in the shock wave balloon, above the shock wave balloon catheter electrode assembly; the feedback module includes at least one of a temperature sensor, a pressure sensor, a voltage sensor, and a current sensor, and the feedback module is used to obtain feedback information of the shock wave balloon catheter to feed back to the multi-mode energy generator, and the feedback information includes at least one of current information, voltage information, temperature information or pressure information.

[0016] In an optional embodiment of the present application, the shock wave balloon catheter also includes a catheter body and a catheter seat; the catheter body includes, in sequence from the end where the shock wave balloon catheter is located to the end where the multi-mode energy generator is located: a tip, an inner tube, an outer tube, and a hypotube; the tip is arranged at the end of the inner tube away from the shock wave balloon, and the outer diameter and thickness of the tip increase toward the shock wave balloon; the inner tube is a slender tube structure with a cavity, which is arranged inside the outer tube and extends toward the distal end, and the shock wave balloon is arranged on the outer surface of the inner tube; the outer tube is a slender tube structure with a cavity, which is arranged at the other end of the shock wave balloon and is used to provide support for the shock wave balloon catheter; the hypotube is a slender tube structure with a cavity, including a filling chamber and a wire chamber; the filling chamber is used to provide conveying liquid for the shock wave balloon; the wire chamber is used to install the wire led out of the shock wave balloon catheter electrode assembly; the catheter seat is connected to the shock wave balloon through the hypotube, and a multi-mode energy generator can be arranged in the catheter seat and connected to the shock wave balloon catheter electrode assembly through the wire.

[0017] The embodiments of the present application have the following beneficial effects:

[0018] This application innovatively connects electrode groups in parallel in different directions within the shock wave balloon catheter circuit, while connecting multiple capacitors within the electrode groups in series. The parallel-connected electrode groups can be independently controlled, so that when the electrode groups are activated, the shock wave balloon containing the electrode groups can generate both uniform circumferential shock waves and non-uniform lateral shock waves, thereby achieving comprehensive yet targeted fragmentation of calcified lesions.

[0019] The above description is only an overview of the technical solution of this application. In order to more clearly understand the technical means of this application, which can be implemented in accordance with the contents of the description, and to make the above and other purposes, features and advantages of this application more obvious and easy to understand, the following preferred embodiments are specifically described in detail with reference to the accompanying drawings. It should be understood that the above general description and the detailed description below are only exemplary and explanatory and do not limit this application. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without any creative work.

[0021] in:

[0022] FIG1 is a flow chart of a shock wave balloon catheter excitation method provided by one embodiment;

[0023] FIG2 is a schematic structural diagram of a shock wave balloon catheter system provided by one embodiment;

[0024] FIG3 is a schematic block diagram of the connection relationship between a multi-mode energy generator and a plurality of separate electrode groups provided by one embodiment;

[0025] FIG4 is a schematic block diagram of the connection relationship between a multi-mode energy generator and two-directionally separable electrode groups provided by one embodiment;

[0026] FIG5 is a schematic diagram of a multi-mode energy generator according to an embodiment stimulating all separate electrode groups to form a circumferential shock wave;

[0027] FIG6 is a schematic diagram of a multi-mode energy generator according to an embodiment stimulating a partially separated electrode group to generate a lateral shock wave;

[0028] FIG7 is a schematic block diagram of the connection relationship between a multi-mode energy generator and four directionally separable electrode groups provided by one embodiment;

[0029] FIG8 is a schematic block diagram of the structure of a shock wave balloon catheter system provided by one embodiment;

[0030] FIG9 is a schematic block diagram of the structure of a shock wave balloon catheter electrode assembly provided by one embodiment;

[0031] FIG10 is a schematic block diagram of an electrode pair structure including an insulating layer provided by one embodiment;

[0032] FIG11 is a schematic block diagram of the specific structure of a shock wave balloon catheter system with a bidirectional detachable electrode group provided by one embodiment;

[0033] FIG12 is a schematic diagram of an external electrode according to an embodiment;

[0034] FIG13 is a schematic diagram of the assembly of a shock wave balloon catheter electrode assembly according to an embodiment;

[0035] FIG14 is a radial cross-sectional view of a shock wave balloon catheter electrode assembly provided in one embodiment;

[0036] FIG15 is a schematic diagram of a shock wave balloon catheter system according to an embodiment. DETAILED DESCRIPTION

[0037] The following will be combined with the drawings in the embodiments of this application to clearly and completely describe the technical solutions in the embodiments of this application. Obviously, the embodiments described are only part of the embodiments of this application, not all of the embodiments. Based on the embodiments in this application, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of this application.

[0038] In existing shock wave balloon catheters, the electrode assemblies in all directions of the same axial plane are usually an integral structure, connected in series, with the same driving voltage, and the energy of the shock waves generated in all directions is basically the same, generating a uniform circumferential shock wave. When used for centripetal calcification lesions, the emission energy of the electrode pairs in each direction is the same. Since the relatively uniform calcification ring captures the same energy, there is no other way to dissipate it except to break it apart, and centripetal calcification lesions can be effectively treated. However, when used for lesions such as eccentric calcification and calcified nodules, if the same uniform circumferential energy is used, it is difficult to achieve an effective treatment effect in thicker areas, and there are limitations. Existing shock wave balloon catheters cannot emit shock waves in a targeted manner. For this reason, this application has made improvements to the electrode assembly and proposed a corresponding shock wave balloon catheter excitation method. To clearly describe the shock wave balloon catheter excitation method provided by this application, please refer to Figures 1 to 7.

[0039] The shock wave balloon catheter excitation method provided in the present application is applied to the multi-mode energy generator in the shock wave balloon catheter system. For the structural arrangement of the shock wave balloon catheter system 20, reference may be made to FIG2 . The shock wave balloon catheter system 20 includes a shock wave balloon catheter 21 and a multi-mode energy generator 22; the shock wave balloon catheter includes a plurality of detachable electrode groups 120, and the detachable electrode groups 120 have different orientations; when the detachable electrode groups 120 are excited, discharges will be generated, generating shock waves in the direction in which the detachable electrode groups 120 are facing, and the multi-mode energy generator 22 will controllably generate circumferential or lateral shock waves. For the connection relationship between the detachable electrode groups 120 and the multi-mode energy generator 22, reference may be made to FIG3 .

[0040] Furthermore, the multi-mode energy generator 22, which is the actual implementation of this stimulation method, may include, but is not limited to, a power module, a control module, a human-computer interaction module, a multi-channel high-voltage pulse generation module, a channel switching module, a monitoring and protection module, and a catheter identification module. Each module will perform its own corresponding functions. For example, the power module includes a lithium battery and a power management module. The lithium battery can be charged via an external network power adapter to provide a stable DC power source for the system. The power management module converts the voltage generated by the lithium battery into the required DC voltage to power each module. The human-computer interaction module includes a display that can display the power-on status, remaining battery charge, pulse transmission count, catheter model, treatment mode, etc., and buttons can be used to control power on and off, select treatment mode, and start treatment. A handle or foot pedal can be used to control the pulse transmission count. The specific functions implemented by each functional module will be elaborated in conjunction with the detailed implementation of the subsequent method.

[0041] Step S110: Acquire and parse the mode control instruction to determine the excitation object and excitation constraints. The excitation object is the electrode group that needs to be excited this time. The excitation constraints include at least one of output channel constraint, signal amplitude constraint, frequency constraint, and pulse duration constraint.

[0042] In one embodiment, the human-computer interaction module within the multi-mode energy generator 22 can be a functional module that receives key commands from the operator and compiles them. The specific components of the human-computer interaction module that interact with the operator may include, but are not limited to, a touch screen, a handle, a foot pedal, etc. For example, the display can display the power-on status, remaining battery power, number of pulse transmissions, catheter model, type of treated lesion, etc., and the buttons can control the power on and off, select the treatment mode, and start treatment. The handle or foot pedal can control the number of pulse transmissions. The human-computer interaction module integrates the received instructions into a mode control instruction and sends it to the shock wave balloon catheter system 20, which is then received by the multi-mode energy generator 22. When the host computer or user operates the output mode control instruction, it will be sent to the shock wave balloon catheter 21 so that the shock wave balloon catheter 21 can interpret the mode control instruction. The excitation object to be controlled this time and the specific excitation constraints to be controlled are determined. As described above, the shock wave balloon catheter 21 includes multiple separate electrode groups 120, each oriented in a different direction. Therefore, the excitation target is the one or more separate electrode groups 120 that need to be excited. Excitation constraints include at least one of output channel constraints, signal amplitude constraints, frequency constraints, and pulse duration constraints. Specifically, the high-voltage signal amplitude ranges from 200 to 5000 V, the repetition frequency ranges from 0.5 to 10 Hz, and the pulse duration ranges from 0.5 to 20 μs. The specific output channel constraints determine which separate electrode groups 120 are excitation targets, thereby connecting the separate electrode groups 120 that are excitation targets in series. Separate electrode groups 120 that are not excitation targets are connected in parallel with the excitation targets and do not receive excitation signals. The specific implementation process will be explained later. Furthermore, because each separate electrode assembly 120 is individually controlled, the excitation received by each separate electrode assembly 120 can be different, thereby defining and generating different lateral shock waves. Furthermore, the multi-mode energy generator 22 may further include a catheter identification module that uses a memory chip to read catheter model information and the number of remaining pulses.

[0043] Step S120: controlling the multi-mode energy generator to output high-voltage pulse signals of different modes to the excitation object according to the excitation constraints.

[0044] In one embodiment, after controlling the multi-mode energy generator to output a high-voltage pulse signal to the excitation object according to the excitation constraint, the method further includes: obtaining feedback information from the shock wave balloon catheter, the feedback information including at least one of current information, voltage information, temperature information, or pressure information; judging whether the shock wave balloon catheter is in a normal working state based on the feedback information; if the shock wave balloon catheter is not in a normal working state, matching and executing a corresponding protection mode based on the feedback information.

[0045] In one embodiment, the multi-mode energy generator 22 may also be provided with a monitoring module for monitoring the operating status of the shock wave balloon in the shock wave balloon catheter 21. The monitoring module may specifically include, but is not limited to, a current detector, a voltage detector, a temperature sensor, or a pressure sensor to obtain relevant information within the shock wave balloon under excitation, such as at least one of current, voltage, temperature, or pressure information, thereby summarizing feedback information and transmitting it back to the multi-mode energy generator 22. The multi-mode energy generator 22 uses the feedback information to determine whether the shock wave balloon catheter 21 is operating normally. If the shock wave balloon catheter 21 is not operating normally, a corresponding protection mode is matched and executed based on the feedback information, such as power-off protection to prevent circuit overvoltage, overcurrent, or short circuit.

[0046] In one embodiment, the separable electrode group includes a first electrode pair, a second electrode pair, a third electrode pair and a fourth electrode pair; the first electrode pair and the third electrode pair are connected in series and face the same direction to form a first separable electrode group; the second electrode pair and the fourth electrode pair are connected in series and face the same direction to form a second separable electrode group; the first separable electrode group and the second separable electrode group are connected to different channel output ends of the multi-mode energy generator when not excited.

[0047] Furthermore, the multi-mode energy generator 22 may include a channel switching module that switches the positive and negative polarity of the multi-channel high-voltage pulse signals generated by the multi-channel high-voltage pulse generation module to generate a single or multi-channel output signal, drives the separate metal electrode assembly, and generates circumferential or lateral shock waves using series and parallel connection methods. To clearly describe the shock wave balloon catheter system 20 under this embodiment, please refer to Figure 4. As shown in Figure 4, the channel switching module (not shown in the figure) in the multi-mode energy generator 22 leads to a wire, defined as the first wire D1. The first wire D1 connects the first electrode pair 1101 and the third electrode pair 1103 in series and in the same direction, and then connects to the third wire D3 to return to the multi-mode energy generator 22 and connect to the channel switching module. The first electrode pair 1101 and the third electrode pair 1103 constitute a first separate electrode group 1201. Similarly, a wire is led out from the channel switching module, defined as the second wire D2. Second wire D2 connects second electrode pair 1102 and fourth electrode pair 1104, which face the same direction, in series. This is then connected to third wire D3, returning to multi-mode energy generator 22 and connecting to the channel switching module. Second electrode pair 1102 and fourth electrode pair 1104 form a second split electrode assembly 1202. The specific implementation of circumferential or lateral shock waves will be discussed in detail later.

[0048] Step S130: When the excitation object includes all the separate electrode groups, all the separate electrode groups are controlled to be connected in series; the excitation object is excited to generate discharges in all directions to form a circumferential shock wave.

[0049] In one embodiment, forming a circumferential shock wave includes: controlling a first detachable electrode group and a second detachable electrode group to be connected in series so that a high-voltage pulse signal simultaneously excites the first detachable electrode group and the second detachable electrode group; after being excited, the first detachable electrode group and the second detachable electrode group generate discharges in all directions to form a circumferential shock wave.

[0050] In one embodiment, a schematic diagram of forming a circumferential shock wave can be seen in Figure 5 . To form a circumferential shock wave using the shock wave balloon catheter system 20 shown in Figure 4 , all separate electrode groups 120 must be connected in series. Specifically, the first conductor D1 can be controlled by the channel switching module to connect to the positive electrode of the multi-mode energy generator 22, the second conductor D2 to the negative electrode of the multi-mode energy generator 22, and the third conductor D3 to be left unconnected. The current will then flow, as shown in Figure 5 , sequentially through the first electrode pair 1101, the third electrode pair 1103, the fourth electrode pair 1104, and the second electrode pair 1102, before ultimately returning to the multi-mode energy generator 22. This means that all separate electrode groups 120 are stimulated, inducing uniform shock waves in all directions, as shown in Figure 5 , thus forming a circumferential shock wave. Furthermore, to achieve repeated shock wave generation, the third conductor D3 can be fixedly connected to the negative electrode of the multi-mode energy generator 22, while the first and second conductors D1 and D2 are alternately connected to the positive electrode of the pulse generator, thereby switching to form a parallel circuit. The switching of the positive and negative poles of the aforementioned wires and the multi-mode energy generator 22 can be achieved by the channel switching module in the multi-mode energy generator 22. Of course, the second wire D2 can also be connected to the positive pole and the first wire D1 to the negative pole, as long as all the separate electrode groups 120 are controlled to be connected in series and energized.

[0051] Step S140: When the excitation object includes at least one group of separate electrode groups but does not include all separate electrode groups, the separate electrode groups in the excitation object are controlled to be connected in series, and the remaining separate electrode groups are connected in parallel with the excitation object; the excitation object is excited to generate discharge in the direction toward which the excitation object is facing, and the remaining separate electrode groups do not generate discharge, thereby forming a lateral shock wave.

[0052] In one embodiment, forming a lateral shock wave includes: controlling the first detachable electrode group and the second detachable electrode group to be connected in parallel so that the high-voltage pulse signal only excites the first detachable electrode group or the second detachable electrode group; after the first detachable electrode group or the second detachable electrode group is excited, discharges in the direction in which it is facing, forming a lateral shock wave.

[0053] In one embodiment, a schematic diagram of generating a lateral shock wave can be seen in FIG6 . For the shock wave balloon catheter system 20 shown in FIG4 , generating a lateral shock wave requires connecting the control portion of the separate electrode groups 120 in series. Taking the excitation of the first separate electrode group 1201 as an example, this can be controlled by the channel switching module in the multi-mode energy generator 22, so that the first wire D1 is connected to the positive terminal of the multi-mode energy generator 22, the third wire D3 is connected to the negative terminal of the multi-mode energy generator 22, and the second wire D2 is left unconnected. Therefore, the current flows sequentially through the first electrode pair 1101 and the third electrode pair 1103 before returning to the multi-mode energy generator 22. This induces arc emission only from the first electrode pair 1101 and the third electrode pair 1103 in the direction of the first separate electrode group 1201, while the electrode pairs 110 in the second separate electrode group 1202 remain silent, thereby achieving arc emission on only one side to produce a lateral shock wave. For a schematic diagram of the current flow and shock wave direction, see FIG6 . If the second wire D2 is connected to the positive pole of the multi-mode energy generator 22 and the third wire D3 is connected to the negative pole of the multi-mode energy generator 22, the actual situation is similar to the above description, but the direction of the shock wave formed is opposite, and the specific process will not be repeated.

[0054] In one embodiment, a multi-mode energy generator is controlled to output a high-voltage pulse signal to an excitation object according to excitation constraints, including: when most excitation objects include multiple separate electrode groups, determining whether the excitation constraints of each excitation object are identical; if the excitation constraints of the excitation objects are identical, controlling the excitation objects with identical excitation constraints to be connected in series; if the excitation constraints of the excitation objects are unequal, controlling the excitation objects with unequal excitation constraints to be connected in parallel.

[0055] In one embodiment, the arrangement of the separable electrode groups 120 may not only include the arrangement of two separable electrode groups 120 as shown in FIG4 . In fact, electrode groups in more directions may also be provided. To this end, this embodiment further provides a shock wave balloon catheter electrode assembly 100 as shown in FIG7 . Unlike the previous embodiment, the shock wave balloon catheter electrode assembly 100 of the shock wave balloon catheter 21 includes four separable electrode groups 120 in four directions: an upper separable electrode group 120s, a lower separable electrode group 120x, a left separable electrode group 120z, and a right separable electrode group 120y.

[0056] It is worth noting that the excitation targets for generating lateral shock waves include at least one group, and possibly all of the separate electrode groups 120. This means that in this embodiment, even if all of the separate electrode groups 120 are controlled for excitation, lateral shock waves can still be generated. This differs from the previous embodiments due to the technical feature of introducing excitation constraints in this embodiment. Therefore, in general, if one wishes to generate lateral shock waves, in this embodiment, two approaches can be followed to achieve multi-mode excitation: first, by varying the excitation targets, and second, by varying the excitation constraints.

[0057] The first is differential control of the excitation targets, which is the common approach described above. As shown in FIG7 , the shock wave balloon catheter 21 has four detachable electrode groups 120 in different directions, and thus can independently emit lateral shock waves in at least four directions (up, down, left, and right). This means that any one of the detachable electrode groups 120 can be individually controlled to excite. Multiple groups of excitation targets can also be configured simultaneously. For example, two groups can be configured, such as simultaneously stimulating the upper detachable electrode group 120s and the left detachable electrode group 120z to control both of them to emit lateral shock waves in the upper left direction. Alternatively, three groups can be configured, such as stimulating the upper detachable electrode group 120s, the left detachable electrode group 120z, and the lower detachable electrode group 120x. This excitation can achieve a wide range of lateral shock waves, emitting shock waves in all directions except the right side. Numerous combinations of directions are difficult to enumerate, and the above embodiments are merely illustrative. The actual control of lateral shock waves in different combinations in different directions is based on practical feasibility and is not limited here.

[0058] The lateral shock waves described in the previous embodiment and above all imply a constraint, namely, that each excitation target is output with a high-voltage pulse signal with the same excitation constraint. However, in reality, the excitation constraints imposed on each excitation target can be different. Therefore, the second method of achieving lateral shock wave emission can be achieved by varying the excitation constraints. Specifically, using the shock wave balloon catheter 21 of FIG7 as an example, if all separate electrode assemblies 120 are excited simultaneously, but the constraints imposed on one or more separate electrode assemblies are lower than those imposed on the remaining separate electrode assemblies 120, the separate electrode assemblies 120 with the lower constraints will receive a stronger high-voltage pulse signal. This will manifest itself in the expansion effect of the shock wave balloon 220 as follows: although all shock wave balloons 220 expand, the shock wave balloon 220 in one direction will expand more than those in other directions, thereby forming an uneven annular shock wave, which can also be considered a lateral shock wave. Specifically, for example, when the upper, left, and lower split electrode groups 120s, 120z, and 120x output high-voltage pulse signals with identical excitation constraints, but a lower excitation constraint (i.e., a higher energy high-voltage pulse signal) is transmitted to the right split electrode group 120y, while the shock wave balloon 220 expands in all four directions to produce annular shock waves, the expansion in the direction of the right split electrode group 120y will have a greater amplitude than the shock waves in the remaining directions, thereby producing a non-uniform annular shock wave, which can achieve a better therapeutic effect in certain situations. Therefore, to achieve the annular non-uniform shock wave described in this embodiment, it is actually necessary to transmit pulse signals with different excitation constraints to all split electrode groups 120. Therefore, when outputting high-voltage pulse signals to the excitation targets, it is possible to determine whether the excitation constraints of each excitation target are identical: if the excitation constraints of the excitation targets are identical, the excitation targets with identical excitation constraints are connected in series; if the excitation constraints of the excitation targets are unequal, the excitation targets with unequal excitation constraints are connected in parallel. This function, similar to the previously described series-parallel connection of separate electrode groups 120, can also be combined using the channel switching module. For example, in this embodiment, the upper separate electrode group 120s, the left separate electrode group 120z, and the lower separate electrode group 120x can be connected in series to form a large group, to which a high-voltage pulse signal with the same excitation constraints is output; while the right separate electrode group 120y can be divided into another large group by the channel switching module and connected in parallel with the previous large group. By controlling the series and parallel connection of the separate electrode groups 120 via the channel switching module, different control modes can be achieved for different groups.

[0059] Therefore, the present application innovatively connects the separate electrode groups 120 in parallel according to different directions in the circuit of the shock wave balloon catheter 21, and connects multiple capacitors in the separate electrode group 120 in series. The separate electrode groups 120 connected in parallel can be independently controlled, so that when the separate electrode groups 120 are excited, the shock wave balloon 220 containing the separate electrode groups 120 can generate both non-uniform lateral shock waves and uniform circumferential shock waves. Moreover, due to different excitation constraints for different excitation targets, non-uniform circumferential shock waves can also be generated, thereby achieving comprehensive and targeted fragmentation of calcified lesions.

[0060] As can be seen from the foregoing description, the method of the present application is mainly implemented by controlling the shock wave balloon catheter system 20. Therefore, the present application proposes new improvements to the shock wave balloon catheter system 20. To clearly describe the shock wave balloon catheter system 20 provided by the present application, please refer to Figures 2 to 15.

[0061] The present application further provides a shock wave balloon catheter system 20 . To clearly describe the shock wave balloon catheter system 20 provided in this embodiment, reference may be made to the structural schematic diagram of the shock wave balloon catheter system shown in FIG. 8 .

[0062] In one embodiment, a shock wave balloon catheter system 20 includes a shock wave balloon catheter 21 and a multi-mode energy generator 22. The shock wave balloon catheter 21 is disposed at one end of the shock wave balloon catheter system 20 and includes a shock wave balloon catheter electrode assembly 100 and a shock wave balloon 220. The shock wave balloon catheter electrode assembly is composed of a plurality of separate electrode groups 120, each of which has a different orientation. When the separate electrode groups 120 are excited, they generate discharges in the direction in which the separate electrode groups 120 are oriented. The shock wave balloon 220 is a sealed, expandable or contractible cavity disposed at one end of the shock wave balloon catheter system 20 for accommodating the shock wave balloon catheter electrode assembly 100. The shock wave balloon 220 is filled with physiological saline. When the separate electrode groups 120 discharge, they induce a hydrodynamic effect therein, generating circumferential or lateral shock waves, which are transmitted through the balloon 220 to the area of ​​vascular calcification lesions, thereby fragmenting the calcified lesions. The multi-mode energy generator 22 is disposed at the other end of the shock wave balloon catheter system 20 and is connected to the shock wave balloon catheter 21 in an electrical circuit for controlling the shock wave balloon catheter electrode assembly 100 in the shock wave balloon 220 to implement the method described above.

[0063] In one embodiment, the shock wave balloon catheter electrode assembly includes: an electrode pair, the electrode pair is composed of an inner electrode and an outer electrode, and the direction of the inner electrode toward the outer electrode is the direction of the electrode pair; a separable electrode group, a plurality of electrode pairs facing the same direction constitute a group of separable electrode groups, all electrode pairs in the separable electrode group are connected in series; the direction of all electrode pairs in the separable electrode group is the direction of the separable electrode group.

[0064] In one embodiment, the electrode pair further includes an insulating layer; the insulating layer is provided with a first opening, the first opening is aligned with the inner electrode, so that the inner electrode is partially exposed; the outer electrode is arranged on the insulating layer, the outer electrode is provided with a second opening, and the second opening is coaxially arranged with the first opening.

[0065] In one embodiment, to clearly describe the shock wave balloon catheter electrode assembly 100 provided in this application, reference may be made to FIG9 . From small to large, the smallest structure of the shock wave balloon catheter electrode assembly 100 is an electrode pair 110 . The electrode pair 110 is composed of a paired inner electrode 111 and outer electrode 112 , which are arranged relative to each other. The structure will be described in detail later when describing the physical structure. Here, the relevant relationship is described first. The inner electrode 111 and the outer electrode 112 are arranged relative to each other, and the direction of the inner electrode 111 toward the outer electrode 112 is defined as the direction of the electrode pair 110 . It is important to note that the "direction of the electrode pair 110" described herein is only for the purpose of classifying electrode pairs 110 in different directions, and does not refer to the direction of the arc emitted when the electrode pair 110 is energized. In practice, the direction of the arc emission is the direction from the energized electrode in the electrode pair 110 toward the unenergized electrode. Therefore, for electrode pairs 110 in the same direction, different electrodes may be energized, resulting in different arc emission directions. To eliminate any misunderstandings that may arise from this actual situation, this application uniformly defines the direction in which the inner electrode 111 faces the outer electrode 112 as the direction in which the electrode pair 110 faces. For example, using Figure 1 as an example, in practice, due to differences in wire connection or excitation methods, the direction in which the arc is released by the electrode pair 110 may be upward or downward, making it difficult to determine the actual situation. Therefore, according to this application's definition, the upper multiple electrode pairs 110 are all facing downward, and the lower multiple electrode pairs 110 are all facing upward.

[0066] The shock wave balloon catheter electrode assembly 100 may include a plurality of electrode pairs 110, and the electrode pairs 110 facing the same direction are connected in series via a circuit to form a separate electrode group 120. All electrode pairs 110 in the separate electrode group 120 face the same direction, so the direction all electrode pairs 110 face is also the direction of the separate electrode group 120. Again, taking Figure 9 as an example, the upper separate electrode group 120 faces downward, and the lower separate electrode group 120 faces upward. All electrode pairs 110 in the two separate electrode groups 120 are connected in series. As mentioned above, the directions of the two separate electrode groups 120 are different. In fact, each separate electrode group 120 faces a different direction, and the separate electrode groups 120 are connected in parallel. For example, taking Figure 9 as an example, the upper and lower separate electrode groups 120 are ultimately connected by the same central wire, and the two separate electrode groups 120 are connected in parallel in terms of circuit structure.

[0067] Specifically, the circuit connection structure, in which the same-direction electrode pairs 110 are connected in series to form separate electrode groups 120, and the different-direction separate electrode groups 120 are connected in parallel, is designed to enable individual control of each separate electrode group 120, thereby enabling arc discharge in any direction. This ensures that the shock wave balloon catheter can generate both uniform circumferential shock waves and non-uniform lateral shock waves. Specifically, using Figure 9 as an example, when all separate electrode groups 120 are energized, that is, when the upper and lower electrode groups are energized, arcs can be simultaneously emitted in the upper and lower directions, thereby forming uniform circumferential shock waves. Because the separate electrode groups 120 are connected in parallel, any one of the separate electrode groups 120 can be individually energized while the other group remains inactive, thereby generating only non-uniform lateral shock waves directed upward or downward. This design not only treats centripetal calcified lesions, but also generates higher-frequency and higher-energy lateral shock waves at the thick end of the eccentric calcified ring, causing fragmentation, thereby meeting the treatment needs of different types of vascular calcification.

[0068] In one embodiment, the electrode pair 110 further includes an insulating layer 113 ; the insulating layer 113 is disposed between the inner electrode 111 and the outer electrode 112 .

[0069] In one embodiment, to ensure arc formation, an insulating layer 113 may be provided between the inner electrode 111 and the outer electrode 112. For details on the relationship between the insulating layer 113 within the electrode pair 110, see Figure 10 : The insulating layer 113 is provided between the inner electrode 111 and the outer electrode 112. Furthermore, in the structure shown in Figure 9 , there may be multiple electrode pairs 110 within a separate electrode assembly 120, and the insulating layer 113 does not actually participate in the circuit connection, but only serves to isolate the inner electrode 111 from the outer electrode 112. Therefore, only one insulating layer 113 may be provided within a separate electrode assembly 120 or a shock wave balloon catheter, uniformly isolating the inner electrode 111 from the outer electrode 112 for all electrode pairs 110 within the separate electrode assembly 120 or shock wave balloon catheter. The specific configuration will be described in detail in the detailed structure section below; for now, it is sufficient to understand the relationship between the insulating layer 113 and the inner and outer electrodes 112 within the electrode pair 110.

[0070] In one embodiment, the invention comprises: a first electrode pair consisting of a first inner electrode and a first outer electrode; a second electrode pair consisting of a second inner electrode and a second outer electrode; a third electrode pair consisting of a third inner electrode and a third outer electrode; a fourth electrode pair consisting of a fourth inner electrode and a fourth outer electrode; the first electrode pair and the third electrode pair face the same direction to constitute a first detachable electrode group; the second electrode pair and the fourth electrode pair face the same direction to constitute a second detachable electrode group; the first detachable electrode group and the second detachable electrode group face different directions; the shock wave balloon catheter electrode assembly also comprises a wire, the wire comprising a first wire, a second wire and a third wire; the first wire extends from the multimode energy generator to sequentially connect the first outer electrode, the first inner electrode, the third inner electrode and the third outer electrode in the first detachable electrode group, and extends out of the first detachable electrode group and is connected back to the multimode energy generator through the third wire, the multimode energy generator is used to control the shock wave balloon catheter electrode assembly; the second wire extends from the multimode energy generator to sequentially connect the second detachable electrode group and the third electrode The second outer electrode, the second inner electrode, the fourth inner electrode, and the fourth outer electrode in the detachable electrode group are extended, and the second detachable electrode group is connected back to the multi-mode energy generator through the third wire; the electrode pairs in the first detachable electrode group and the second detachable electrode group are connected in series through the connection of the wires, and the first detachable electrode group and the second detachable electrode group are connected in parallel; when the first wire or the second wire is connected to the positive electrode of the multi-mode energy generator, the third wire is connected to the negative electrode of the multi-mode energy generator, and the first detachable electrode group or the second detachable electrode group is excited according to the excitation of the multi-mode energy generator to discharge in the direction of the excited detachable electrode group to induce a lateral shock wave; when the first wire or the second wire is connected to the positive electrode of the multi-mode energy generator, the second wire or the first wire is connected to the negative electrode of the multi-mode energy generator, and the first detachable electrode group and the second detachable electrode group are excited according to the excitation of the multi-mode energy generator to discharge in the direction of the first detachable electrode group and the second detachable electrode group to induce a circumferential shock wave.

[0071] In one embodiment, in conjunction with the shock wave balloon catheter system 20 shown in FIG4 , this embodiment specifically discloses the specific structure of the shock wave balloon catheter system 20 with a bidirectional detachable electrode group, which can be understood with reference to FIG11 . The structure formed by the first detachable electrode group 1201 and the second detachable electrode group 1202 is referred to as the shock wave balloon catheter electrode assembly 100 . Specifically, the structure includes a first electrode pair 1101 consisting of a first inner electrode 1111 and a first outer electrode 1121 , a second electrode pair 1102 consisting of a second inner electrode 1112 and a second outer electrode 1122 , a third electrode pair 1103 consisting of a third inner electrode 1113 and a third outer electrode 1123 , and a fourth electrode pair 1104 consisting of a fourth inner electrode 1114 and a fourth outer electrode 1124 . The first electrode pair 1101 and the third electrode pair 1103 face the same direction, constituting a first separable electrode group 1201 ; the second electrode pair 1102 and the fourth electrode pair 1104 face the same direction, constituting a second separable electrode group 1202 ; the first separable electrode group 1201 and the second separable electrode group 1202 face different directions.

[0072] The shock wave balloon catheter electrode assembly 100 also includes wires, including a first wire D1, a second wire D2, and a third wire D3. The first wire D1 extends from the multi-mode energy generator 22 to sequentially connect to the first outer electrode 1121, the first inner electrode 1111, the third inner electrode 1113, and the third outer electrode 1123 within the first detachable electrode group 1201. It then extends from the first detachable electrode group 1201 and connects back to the multi-mode energy generator 22 via the third wire D3. Similarly, the second wire D2 extends from the multi-mode energy generator 22 to sequentially connect to the second outer electrode 1122, the second inner electrode 1112, the fourth inner electrode 1114, and the fourth outer electrode 1124 within the second detachable electrode group 1202. It then extends from the second detachable electrode group 1202 and connects back to the multi-mode energy generator 22 via the third wire D3. The wire connections establish a series connection between the electrode pairs 110 within the first detachable electrode group 1201 and the second detachable electrode group 1202. It can also be seen that since the first separable electrode group 1201 and the second separable electrode group 1202 are both connected to the multi-mode energy generator 22 by the third wire D3, the first separable electrode group 1201 and the second separable electrode group 1202 are structurally connected in parallel.

[0073] Specifically, for a shock wave balloon catheter electrode assembly 100 of this structure that aims to generate lateral or circumferential shock waves, the specific process can be referred to the above description and Figures 5 and 6. For example, as shown in Figure 5, when the first wire D is connected to the positive electrode of the multi-mode energy generator 22, the second wire D2 is connected to the negative electrode of the multi-mode energy generator 22, and the third wire D3 is not connected, the first detachable electrode group 1201 and the second detachable electrode group 1202 are controlled to be connected in series. The high-voltage signal generated by the multi-mode energy generator 22 energizes both the first detachable electrode group 1201 and the second detachable electrode group 1202, emitting an arc in the direction of the first detachable electrode group 1201 and the second detachable electrode group 1202, thereby inducing the generation of a circumferential shock wave.

[0074] Similarly, taking Figure 6 as an example, when the first wire D1 is connected to the positive electrode of the multi-mode energy generator 22, the third wire D3 is connected to the negative electrode of the multi-mode energy generator 22, and the second wire D2 is left unconnected, the current in the excitation state flows sequentially through the first outer electrode 1121, the first inner electrode 1111, the third inner electrode 1113, the third outer electrode 1123, and then back to the multi-mode energy generator 22. This induces arc emission only from the first electrode pair 1101 and the third electrode pair 1103 in the direction of the first separable electrode group 1201, while the electrode pair 110 in the second separable electrode group 1202 remains inactive, thereby achieving the technical solution of emitting an arc on only one side to produce a lateral shock wave. If the second wire D2 is connected to the positive electrode of the multi-mode energy generator 22 and the third wire D3 is connected to the negative electrode of the multi-mode energy generator 22, the actual situation is similar to the above description, and the lateral shock wave is also induced to achieve targeted treatment. The specific current flow direction and shock wave generation are similar to the process described above and will not be repeated here.

[0075] Furthermore, in order to achieve repeated shock wave generation, the third wire D3 can be fixedly connected to the negative pole of the multi-mode energy generator 22, and the first wire D1 and the second wire D2 can be connected to the positive pole of the pulse generator in turn, thereby switching to form a parallel circuit. The shock waves are generated alternately between the lateral shock wave and the circumferential shock wave, thereby bombarding the calcified lesions more forcefully and improving the treatment effect.

[0076] In one embodiment, the shock wave balloon catheter also includes a feedback module; the feedback module is arranged in the shock wave balloon, above the shock wave balloon catheter electrode assembly; the feedback module includes at least one of a temperature sensor, a pressure sensor, a voltage sensor, and a current sensor, and the feedback module is used to obtain feedback information of the shock wave balloon catheter to feed back to the multi-mode energy generator, and the feedback information includes at least one of current information, voltage information, temperature information or pressure information.

[0077] In one embodiment, the shock wave balloon catheter also includes a catheter body and a catheter seat; the catheter body includes, in sequence from the end where the shock wave balloon catheter is located to the end where the multi-mode energy generator is located: a tip, an inner tube, an outer tube, and a hypotube; the tip is arranged at the end of the inner tube away from the shock wave balloon, and the outer diameter and thickness of the tip increase toward the shock wave balloon; the inner tube is a slender tube structure with a cavity, arranged inside the outer tube and extending toward the distal end, and the shock wave balloon is arranged on the outer surface of the inner tube; the outer tube is a slender tube structure with a cavity, arranged at the other end of the shock wave balloon, and is used to provide support for the shock wave balloon catheter; the hypotube is a slender tube structure with a cavity, including a filling chamber and a wire chamber; the filling chamber is used to provide conveying liquid for the shock wave balloon; the wire chamber is used to install the wire led out of the shock wave balloon catheter electrode assembly; the catheter seat is connected to the shock wave balloon through the hypotube, and a multi-mode energy generator can be arranged in the catheter seat and connected to the shock wave balloon catheter electrode assembly through the wire.

[0078] In one embodiment, an outer tube 810, an inner tube 820 and a tip 830 are further provided around the shock wave balloon 220 of the shock wave balloon catheter 21. The outer tube 810 is provided at the distal end of the shock wave balloon catheter 21, that is, the end where the shock wave balloon 220 is located. The outer tube 810 is a slender tube structure with a cavity. For a specific size, the outer diameter can be between 0.3 and 2.0 mm, and the inner diameter can be between 0.2 and 1.8 mm. The outer surface extends axially. The cavity of the outer tube 810 is called the outer tube 810 cavity. The outer tube 810 cavity is used to insert the inner tube 820 and the guide wire, and a central steel wire is added to enhance the support force to improve the pushing performance and anti-bending ability of the shock wave balloon catheter 21. The outer tube 810 cavity can also be used as a filling cavity for transporting liquid into the shock wave balloon 220 at the distal end of the tube body. The tube body material of the outer tube 810 may include but is not limited to polyimide, polyetheretherketone, polyethylene, PEBA, PET, FEP, PTFE, PA and the like.

[0079] Furthermore, an inner tube 820 is provided in the lumen of the outer tube 810, and the shock wave balloon 220 is provided on the outer surface of the inner tube 820. The inner tube 820 extends axially from the lumen of the outer tube 810 in a direction away from the multi-mode energy generator 22, and its length may exceed the axial length of the shock wave balloon 220. It may also be a slender tube structure with a cavity. Specifically, the outer diameter of the inner tube 820 may be between 0.3 and 1.0 mm, and the inner diameter may be between 0.2 and 0.9 mm. The material of the inner tube 820 may be polyurethane (PU), polytetrafluoroethylene (PTFE), low-density polyethylene (LDPE), high-density polyethylene (HDPE), polyvinyl chloride (PVC), nylon (PA), segmented polyetheramide (Pebax), polyethylene terephthalate (PET) or a composite material. A guide wire port may also be provided on the inner tube 820 for inserting a guide wire into the lumen of the inner tube 820 so that the distal end of the catheter can enter the calcified lesion area within the human blood vessel.

[0080] A tip 830 is also provided at one end of the inner tube 820 away from the shock wave balloon 220. The tip 830 is the part of the shock wave balloon catheter 21 that first contacts the calcified lesion area. The tip 830 as a whole can be designed as a conical soft long head, and the outer diameter and thickness of the tip 830 increase in the direction toward the shock wave balloon 220. Specifically, the introduction outer diameter of the tip 830 is between 0.3 and 1.0 mm, the passing outer diameter can be between 0.4 and 1.2 mm, the inner diameter can be between 0.2 and 0.9 mm, the inner diameter remains unchanged from the distal end to the proximal end, the length can be between 5 and 15 mm, and the thickness can be between 0.1 and 0.5 mm. The transition from the main body of the tip 830 to the head of the shock wave balloon 220 is taken into account, and its pushing ability is enhanced, which is conducive to passing through tortuous lesions and reducing the damage of the catheter to the blood vessels. Tip 830 can be made of a polymeric material with a smooth and elastic surface, allowing for a smooth transition from the main body of tip 830 to shockwave balloon 220, thereby improving the permeability of shockwave balloon catheter 21. Polymer materials that can be used for tip 830 include, but are not limited to, polyurethane (PU), polytetrafluoroethylene (PTFE), low-density polyethylene (LDPE), high-density polyethylene (HDPE), polyvinyl chloride (PVC), nylon (PA), segmented polyetheramide (Pebax), polyethylene terephthalate (PET), or composite materials. Furthermore, the end of tip 830 proximal to inner tube 820 can be treated for roughness. The tip 830 can be connected to shockwave balloon 220 by gluing, thermal welding, or laser welding, thereby achieving a better connection between tip 830 and shockwave balloon 220, improving weld security, and preventing the tip 830 from becoming detached from shockwave balloon 220 during use.

[0081] The shock wave balloon 220 is disposed on the outer surface of the inner tube 820, forming a sealed space with the inner tube 820 to accommodate the shock wave balloon catheter electrode assembly 100 described above. The shock wave balloon 220 can be filled with liquid, and the liquid filled is mainly physiological saline. After the shock wave balloon 220 is filled with liquid, the internal shock wave balloon catheter electrode assembly 100 is excited by the high-voltage pulse signal emitted by the multi-mode energy generator 22. The excited separate electrode group 120 in the shock wave balloon catheter electrode assembly 100 will generate a circumferential or lateral arc, which can induce a hydroelectric effect in the liquid, thereby generating a circumferential or lateral shock wave. The shock wave is transmitted to the calcified area through the shock wave balloon 220, causing the calcified plaque to lyse. Specifically, the shock wave balloon 220 is designed as a single-layer or double-layer structure. It needs to reduce the outer diameter through regular folding to make the outer surface more regular and smooth. The minimum outer diameter of the shock wave balloon 220 after folding can be 0.5 to 1.0 mm. For example, it can be folded in three or five ways, which makes it easier to pass through severe stenosis. The diameter of the shock wave balloon 220 after expansion can be 2 to 6 mm. The shock waves generated by the 120 separate electrode groups inside the shock wave balloon 220 can be transmitted to the calcified lesion area through the shock wave balloon 220. The material used for the shock wave balloon 220 can be made of nylon, polyethylene terephthalate, polyethylene, polyvinyl chloride, polyurethane, silicone rubber or one or more combinations of other polymer materials. The surface of the shock wave balloon 220 is sprayed with a polymer coating to make the surface of the shock wave balloon 220 smoother and easier to pass through stenotic lesions.

[0082] In one embodiment, the shock wave balloon catheter 21 as a whole presents an axially extending slender structure, and includes at least a shock wave balloon catheter electrode assembly 100 and a shock wave balloon 220. Among them, the shock wave balloon catheter electrode assembly 100 is the focus of improvement and will be described in detail later, so it will not be expanded here for the time being. The multi-mode energy generator 22 has been described in detail in the previous text. Please refer to the previous text for details and will not be repeated here. Specifically, a high-voltage pulse signal can be emitted according to control. The specific signal amplitude range of the shock wave is 200 to 5000V, the repetition frequency range is 0.5 to 10Hz, the pulse duration range is 0.5 to 20μs, and the shock wave pressure is less than 20MPa.

[0083] In one embodiment, the shock wave balloon catheter 21 further includes a temperature sensor and / or a pressure sensor; the temperature sensor is disposed inside the shock wave balloon 220 to obtain the temperature inside the shock wave balloon 220; the pressure sensor is disposed inside the shock wave balloon 220 to obtain the pressure inside the shock wave balloon 220.

[0084] In one embodiment, a temperature sensor can be disposed on the inner tube 820, specifically a thermistor, which converts the received temperature into an output electrical signal for real-time monitoring of the temperature inside the shock wave balloon 220. Similarly, a pressure sensor can be disposed on the inner tube 820, specifically a fiber optic pressure sensor, which converts the received pressure into an output electrical signal for real-time monitoring of the hydraulic pressure inside the shock wave balloon 220. Both components can be disposed within the shock wave balloon 220.

[0085] In one embodiment, the shock wave balloon catheter 21 further includes a developing ring and / or developing liquid; the developing ring is arranged at both ends of the shock wave balloon 220, and the developing liquid is filled in the shock wave balloon 220. The developing ring and / or developing liquid are used to mark the working section of the shock wave balloon catheter 21.

[0086] In one embodiment, the developing ring is an X-ray-proof metal ring provided at both ends of the shock wave balloon 220, and the outer diameter of the working section of the shock wave balloon catheter 21 can be reduced by embedding a mark. Specifically, the outer diameter can be between 0.3 and 1.0 mm, the inner diameter can be between 0.2 and 0.9 mm, and the length can be between 1 mm and 3 mm. The developing ring can be made of metal materials such as gold, platinum, molybdenum, tungsten or platinum-iridium alloy. The developing solution can be a liquid including particles of the developing ring material. Both the developing ring and the developing solution are used for X-ray development, marking the working section of the shock wave balloon catheter 21, and accurately positioning the shock wave balloon 220 during surgery.

[0087] In one embodiment, the shock wave balloon catheter electrode assembly 100 includes multiple groups of separate electrode groups 120, which are uniformly arranged in an annular direction within the shock wave balloon 220, and the directions of the separate electrode groups 120 are different from each other; each group of separate electrode groups 120 is connected to a multi-mode energy generator 22, and the multi-mode energy generator 22 is used to individually control any separate electrode group 120; when the multi-mode energy generator 22 outputs a high-voltage pulse signal to all the separate electrode groups 120, the electric arc is excited to form a shock wave, which expands in the direction of all the separate electrode groups 120, generating a circumferential shock wave; or, when the multi-mode energy generator 22 outputs a high-voltage pulse signal to at least one group, but not all of the separate electrode groups 120, a lateral shock wave is generated, inducing the shock wave balloon 220 to expand in the direction of the excited separate electrode group 120.

[0088] In one embodiment, to facilitate understanding of how the shock wave balloon 220 emits lateral or circumferential shock waves, it is necessary to first understand how the shock wave balloon catheter electrode assembly 100 is constructed and how it works. For ease of understanding, this embodiment is illustrated using the shock wave balloon catheter electrode assembly 100 provided in FIG. 11 . The inner electrode 111 is disposed on the inner tube 820 and is a sheet-like structure with a length of 0.2 to 3.0 mm and a width of 0.1 to 3.0 mm. The inner electrode 111 can be made of metal materials such as gold, silver, copper, stainless steel, platinum, molybdenum, tungsten, or a platinum-iridium alloy. The inner electrode 111 and the wire can be connected by conductive adhesive bonding, thermal welding, or laser welding.

[0089] An insulating layer 113 is provided over the inner electrode 111. The insulating layer 113 can be provided separately on each inner electrode 111. As mentioned above, since the insulating layer 113 is not directly involved in the circuit, only one tubular structure can be provided in the shock wave balloon catheter electrode assembly 100. The specific outer diameter can be between 0.4 and 2.0 mm, and the thickness can be between 0.01 and 0.1 mm. Specifically, the insulating layer 113 has a first opening 113a aligned with the inner electrode 111. The specific shape of the first opening 113a is not limited and can include but is not limited to circular, rectangular, triangular, etc. Taking the circular opening as an example, the diameter of the first opening 113a is between 0.01 and 0.5 mm.

[0090] The outer electrode 112 is arranged on the insulating layer 113 and has an annular structure or a sheet structure. For the structure of the outer electrode 112, please refer to Figure 12. Figure 12 shows a shape that the outer electrode 112 can take. It is not a limitation on the shape of the outer electrode 112. In actual situations, it can be set arbitrarily according to needs. The outer diameter of the annular structure of the outer electrode 112 shown in Figure 12 is between 0.4 and 2.0 mm, and the thickness is between 0.01 and 0.5 mm. It is fixed to the insulating layer 113 through an annular arm. If the outer electrode 112 adopts a sheet structure, the length of the sheet structure is between 0.5 and 3.0 mm, and the width is between 0.1 and 3.0 mm. It is fixed to the insulating layer 113 through the hook-shaped structures at both ends. Similarly, the outer electrode 112 has a circular hole coaxially aligned with the inner electrode 111, which is called the second opening 112a. The specific shape of the second opening is not limited and may include but is not limited to a circle, a rectangle, a triangle, etc. Taking the circular opening as an example, the diameter of the second opening 112a is between 0.01 and 0.5 mm. Each direction corresponds to an external electrode 112, and the second openings 112a thereon are not connected to each other.

[0091] As described above, the inner electrode 111, the insulating layer 113, and the outer electrode 112 are arranged on the inner tube 820 in a gradual manner from the inside to the outside, which can form a structure as shown in Figure 13. Figure 13 is a schematic assembly diagram of a shock wave balloon catheter electrode assembly 100 provided in one embodiment. It is worth noting that for the sake of convenience, this application adopts an integrated tubular insulating layer 113 and two annular outer electrodes 112. This is not a limitation of the technology, but an example of a practical solution. At the same time, the sheet-shaped inner electrode 111 is also the same, and the inner electrode 111 is arranged on the outer surface of the inner tube 820 in close contact with the inner tube 820 and is covered by the insulating layer 113. Therefore, the inner electrode 111 is not visible in Figure 14. For ease of understanding, the installation of the shock wave balloon catheter electrode assembly 100 can also be referred to Figure 14, which is a radial cross-sectional view of the shock wave balloon catheter electrode assembly 100 provided in one embodiment. As can be clearly seen in FIG14 , from the inside out, they are the inner tube 820, the inner electrode 111, the insulating layer 113, and the outer electrode 112. Furthermore, it can be clearly seen that the inner electrode 111 and the outer electrode 112 are clearly divided into two groups, upper and lower. Corresponding to the embodiment of FIG11 , the upper group is assumed to be the first separable electrode group 1201, and the lower group is assumed to be the second separable electrode group 1202.

[0092] As shown in FIG11 , the first detachable electrode group 1201 and the second detachable electrode group 1202 are connected in parallel to the multi-mode energy generator 22, so that the multi-mode energy generator 22 can independently control any of the detachable electrode groups 120. When the multi-mode energy generator 22 outputs a high-voltage pulse signal to all detachable electrode groups 120, all detachable electrode groups 120 evenly arranged within the shock wave balloon 220 will emit arcs in all directions, generating a circumferential shock wave, inducing the shock wave balloon 220 to expand in the direction toward which all detachable electrode groups 120 are directed.

[0093] Similarly, when the multi-mode energy generator 22 outputs a high-voltage pulse signal to one of the separate electrode groups 120, for example, to the first separate electrode group 1201, the first separate electrode group 1201 is stimulated by the high-voltage signal, and the stimulated electrodes will emit arcs in the opposite direction, inducing the liquid in the shock wave balloon 220 to quickly vaporize and expand, generating a shock wave. The shock wave reaches the shock wave balloon 220, causing the shock wave balloon 220 to expand to one side.

[0094] In one embodiment, the shock wave balloon catheter system 20 may further include a catheter adapter 850 and a catheter body 860. For the physical structure of the shock wave balloon catheter system 20, reference may be made to FIG15 . The catheter adapter 850 is disposed at the end where the multi-mode energy generator 22 is located, and the multi-mode energy generator 22 is disposed within the catheter adapter 850. The catheter body, from the end where the shock wave balloon catheter is located to the end where the multi-mode energy generator is located, includes, in sequence: a tip 830, an inner tube 820, an outer tube 810, and a hypotube 840. The tip 830, inner tube 820, and outer tube 810 have been described in detail above, and only the hypotube 840 will be described here. The hypotube 840 is a slender tube structure with a cavity, which is used to connect the shock wave balloon 220 and the catheter seat 850; a catheter channel is provided in the cavity of the hypotube 840, and the catheter channel includes a filling cavity and a wire cavity; the filling cavity is used to transport liquid into the cavity of the shock wave balloon 220; a wire is provided in the wire cavity for realizing the circuit connection between the multi-mode energy generator 22 and the shock wave balloon catheter electrode assembly 100.

[0095] In one embodiment, the base is disposed at one end where the multi-mode energy generator 22 is located, and the multi-mode energy generator 22 is disposed within the catheter adapter 850. The base may be a branched Luer adapter, and the material may be polycarbonate (PC), polyurethane, ABS plastic, or the like. The hypotube 840 may be a tubular hollow body having a proximal end face, a distal end face, and a lateral surface located between the proximal and distal ends. The lateral surface also includes a non-cutting area and a cutting area. The cutting area is laser-cut to form a spiral groove, and the non-cutting area has a smooth surface. The distal end of the hypotube 840 is connected to the outer tube 810, and the proximal end is connected to the catheter adapter 850. The outer diameter of the hypotube 840 may be between 0.3 and 2.0 mm, and the tube body material may be a metal material such as stainless steel or nickel titanium. A catheter channel is also disposed within the hypotube 840 cavity, comprising a filling chamber and a guidewire chamber. The filling chamber is used to deliver liquid into the shock wave balloon 220 cavity, for example, including at least saline solution and may also include a developer solution. A wire is provided in the wire cavity for realizing circuit connection between the multi-mode energy generator 22 and the shock wave balloon catheter electrode assembly 100 .

[0096] Therefore, the present application innovatively connects the separate electrode groups 120 in parallel according to different directions in the circuit of the shock wave balloon catheter 21, and connects multiple capacitors in the separate electrode group 120 in series. The separate electrode groups 120 connected in parallel can be independently controlled, so that when the separate electrode groups 120 are excited, the shock wave balloon 220 containing the separate electrode groups 120 can generate both uniform circumferential shock waves and non-uniform lateral shock waves, thereby being able to comprehensively and specifically fragment calcified lesions.

[0097] In one embodiment, the present application further proposes a computer-readable storage medium storing a computer program. When the computer program is executed by a processor, the processor executes the steps of the aforementioned method.

[0098] Those skilled in the art will appreciate that all or part of the processes in the above-mentioned embodiments can be implemented by instructing the relevant hardware through a computer program. The program can be stored in a non-volatile computer-readable storage medium. When the program is executed, it can include the processes of the embodiments of the above-mentioned methods. Among them, any reference to memory, storage, database or other media used in the embodiments provided in this application can include non-volatile and / or volatile memory. Non-volatile memory can include read-only memory (ROM), programmable ROM (PROM), electrically programmable ROM (EPROM), electrically erasable programmable ROM (EEPROM) or flash memory. Volatile memory can include random access memory (RAM) or external cache memory. By way of illustration and not limitation, RAM is available in various forms, such as static RAM (SRAM), dynamic RAM (DRAM), synchronous DRAM (SDRAM), double data rate SDRAM (DDRSDRAM), enhanced SDRAM (ESDRAM), synchronous link (Synchlink) DRAM (SLDRAM), memory bus (Rambus) direct RAM (RDRAM), direct memory bus dynamic RAM (DRDRAM), and memory bus dynamic RAM (RDRAM).

[0099] The technical features of the above embodiments can be combined arbitrarily. To make the description concise, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0100] The above-described embodiments merely represent several implementation methods of the present application. While the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the present invention. It should be noted that a person of ordinary skill in the art may make various modifications and improvements without departing from the spirit of the present invention, all of which fall within the scope of protection of the present invention. Therefore, the scope of protection of the present invention shall be determined by the appended claims.

Claims

1. A shock wave balloon catheter excitation method, characterized in that: Applied to a shock wave balloon catheter system, the shock wave balloon catheter system comprises a shock wave balloon catheter and a multi-mode energy generator; the shock wave balloon catheter comprises a plurality of separate electrode groups, and the separate electrode groups face different directions; when the separate electrode groups are excited by the multi-mode energy generator, discharges are generated to generate shock waves in the direction in which the separate electrode groups face; The method comprises the following steps: Acquire and parse the mode control instruction to determine the excitation object and excitation constraint, wherein the excitation object is the electrode group to be excited this time, and the excitation constraint includes at least one of output channel constraint, signal amplitude constraint, frequency constraint, and pulse duration constraint; Controlling the multi-mode energy generator to output high-voltage pulse signals of different modes to the excitation object according to the excitation constraint; When the excitation object includes all the separate electrode groups, controlling all the separate electrode groups to be connected in series; exciting the excitation object to generate discharge in all directions to form a circumferential shock wave; When the excitation object includes at least one group of the separate electrode groups but does not include all of the separate electrode groups, the separate electrode groups in the excitation object are controlled to be connected in series, and the remaining separate electrode groups are connected in parallel with the excitation object; the excitation object is excited to generate discharge in the direction toward which the excitation object is facing, and the remaining separate electrode groups do not generate discharge, thereby forming a lateral shock wave.

2. The shock wave balloon catheter excitation method according to claim 1, characterized in that: The separable electrode group comprises a first electrode pair, a second electrode pair, a third electrode pair and a fourth electrode pair; the first electrode pair and the third electrode pair are connected in series and face the same direction to form a first separable electrode group; the second electrode pair and the fourth electrode pair are connected in series and face the same direction to form a second separable electrode group; the first separable electrode group and the second separable electrode group are connected to different channel output ends of the multi-mode energy generator in an unexcited state; The forming of the annular shock wave comprises: Controlling the first separable electrode group and the second separable electrode group to be connected in series, so that the high-voltage pulse signal simultaneously excites the first separable electrode group and the second separable electrode group; after being excited, the first separable electrode group and the second separable electrode group generate discharges in all directions to form a circular shock wave; The forming of the lateral shock wave comprises: The first detachable electrode group and the second detachable electrode group are controlled to be connected in parallel so that the high-voltage pulse signal only excites the first detachable electrode group or the second detachable electrode group; after being excited, the first detachable electrode group or the second detachable electrode group generates discharge in the direction it is facing, forming a lateral shock wave.

3. The shock wave balloon catheter excitation method according to claim 1, characterized in that: The step of controlling the multi-mode energy generator to output a high-voltage pulse signal to the excitation object according to the excitation constraint comprises: When the majority of excitation objects include a plurality of the separable electrode groups, determining whether the excitation constraints of each of the excitation objects are the same; If the incentive constraints of the incentive objects are the same, controlling the incentive objects with the same incentive constraints to be connected in series; If the excitation constraints of the excitation objects are not identical, the excitation objects with the identical excitation constraints are connected in parallel.

4. The shock wave balloon catheter excitation method according to claim 1, characterized in that: After controlling the multi-mode energy generator to output a high-voltage pulse signal to the excitation object according to the excitation constraint, the method further includes: Acquiring feedback information of the shock wave balloon catheter, wherein the feedback information includes at least one of current information, voltage information, temperature information or pressure information; Determining whether the shock wave balloon catheter is in a normal working state according to the feedback information; If the shock wave balloon catheter is not in a normal working state, a corresponding protection mode is matched and executed according to the feedback information.

5. A shock wave balloon catheter system, characterized in that: include: shock wave balloon catheters and multi-mode energy generators; The shock wave balloon catheter is arranged at one end of the shock wave balloon catheter system, and comprises a shock wave balloon catheter electrode assembly and a shock wave balloon; The shock wave balloon catheter electrode assembly is composed of a plurality of separate electrode groups, and the separate electrode groups are oriented in different directions; When the separable electrode group is excited, discharge will be generated in the direction toward which the separable electrode group is facing; The shock wave balloon is a closed expandable or contractible cavity, which is arranged at one end of the shock wave balloon catheter system and is used to accommodate the shock wave balloon catheter electrode assembly. The shock wave balloon is filled with physiological saline. When the separate electrode assembly is discharged, a hydroelectric effect can be induced inside the shock wave balloon to generate a circumferential or lateral shock wave, so that the shock wave balloon expands and fits the blood vessel wall. The multi-mode energy generator is disposed at the other end of the shock wave balloon catheter system and connected to the shock wave balloon catheter circuit, and is used to control the shock wave balloon catheter electrode assembly in the shock wave balloon to implement the method as claimed in any one of claims 1 to 4.

6. The shock wave balloon catheter system according to claim 5, characterized in that: The shock wave balloon catheter electrode assembly comprises: An electrode pair, the electrode pair being composed of an inner electrode and an outer electrode, the direction of the inner electrode toward the outer electrode being the direction of the electrode pair; A separate electrode group, wherein a plurality of electrode pairs facing the same direction constitute a group of the separate electrode group, wherein all the electrode pairs in the separate electrode group are connected in series; and the direction facing all the electrode pairs in the separate electrode group is the direction of the separate electrode group.

7. The shock wave balloon catheter system according to claim 6, characterized in that: include: A first electrode pair consisting of a first inner electrode and a first outer electrode; a second electrode pair consisting of a second inner electrode and a second outer electrode; a third electrode pair consisting of a third inner electrode and a third outer electrode; and a fourth electrode pair consisting of a fourth inner electrode and a fourth outer electrode; The first electrode pair and the third electrode pair face the same direction to form a first separable electrode group; the second electrode pair and the fourth electrode pair face the same direction to form a second separable electrode group; the first separable electrode group and the second separable electrode group face different directions; The shock wave balloon catheter electrode assembly also includes a wire, and the wire includes a first wire, a second wire, and a third wire; The first wire extends from the multi-mode energy generator to sequentially connect the first outer electrode, the first inner electrode, the third inner electrode, and the third outer electrode in the first detachable electrode group, and extends out of the first detachable electrode group and is connected back to the multi-mode energy generator through the third wire. The multi-mode energy generator is used to control the shock wave balloon catheter electrode assembly; The second wire extends from the multi-mode energy generator to sequentially connect the second outer electrode, the second inner electrode, the fourth inner electrode, and the fourth outer electrode in the second separable electrode group, and extends out of the second separable electrode group and is connected back to the multi-mode energy generator through the third wire; the connection of the wire realizes the series connection between the electrode pairs in the first separable electrode group and the second separable electrode group, and the first separable electrode group and the second separable electrode group are connected in parallel; When the first wire or the second wire is connected to the positive electrode of the multi-mode energy generator, and the third wire is connected to the negative electrode of the multi-mode energy generator, the first split electrode group or the second split electrode group is excited according to the excitation of the multi-mode energy generator, so as to discharge in the direction of the excited split electrode group, so as to induce a lateral shock wave; When the first wire or the second wire is connected to the positive electrode of the multi-mode energy generator, and the second wire or the first wire is connected to the negative electrode of the multi-mode energy generator, the first separate electrode group and the second separate electrode group are excited according to the excitation of the multi-mode energy generator to discharge in the direction of the first separate electrode group and the second separate electrode group to induce a circumferential shock wave.

8. The shock wave balloon catheter system according to claim 6, characterized in that: The electrode pair also includes an insulating layer; The insulating layer is provided with a first opening, and the first opening is aligned with the inner electrode so that the inner electrode is partially exposed; The external electrode is arranged on the insulating layer, and the external electrode is provided with a second opening, and the second opening is coaxially arranged with the first opening.

9. The shock wave balloon catheter system according to claim 5, characterized in that: The shock wave balloon catheter also includes a feedback module; The feedback module is arranged in the shock wave balloon and on the shock wave balloon catheter electrode assembly; the feedback module includes at least one of a temperature sensor, a pressure sensor, a voltage sensor, and a current sensor, and the feedback module is used to obtain feedback information of the shock wave balloon catheter to feed back to the multi-mode energy generator, and the feedback information includes at least one of current information, voltage information, temperature information or pressure information.

10. The shock wave balloon catheter system according to claim 5, characterized in that: The shock wave balloon catheter also includes a catheter body and a catheter seat; The catheter body includes, from one end including the shock wave balloon catheter to one end including the multi-mode energy generator, a tip, an inner tube, an outer tube, and a hypotube; The tip is arranged at an end of the inner tube away from the shock wave balloon, and the outer diameter and thickness of the tip increase gradually in a direction toward the shock wave balloon; The inner tube is a slender tube structure with a cavity, which is arranged inside the outer tube and extends toward the distal end, and the shock wave balloon is arranged on the outer surface of the inner tube; The outer tube is a slender tube structure with a cavity, which is arranged at the other end of the shock wave balloon and is used to provide support for the shock wave balloon catheter; The hypotube is a slender tube structure with a cavity, including a filling cavity and a wire cavity; the filling cavity is used to provide a conveying liquid for the shock wave balloon; the wire cavity is used to install the wire led out of the shock wave balloon catheter electrode assembly; The catheter seat is connected to the shock wave balloon through the hypotube. The multi-mode energy generator may be arranged in the catheter seat and connected to the shock wave balloon catheter electrode assembly through the wire.

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