CN117338373A

CN117338373A - Shock wave balloon catheter excitation method and shock wave balloon catheter system

Info

Publication number: CN117338373A
Application number: CN202311194597.3A
Authority: CN
Inventors: 肖杨
Original assignee: Shenzhen National Research Institute of High Performance Medical Devices Co Ltd
Current assignee: Shenzhen National Research Institute of High Performance Medical Devices Co Ltd
Priority date: 2023-09-14
Filing date: 2023-09-14
Publication date: 2024-01-05
Anticipated expiration: 2043-09-14
Also published as: CN117338373B

Abstract

The embodiment of the application discloses a shock wave balloon catheter excitation method and a shock wave balloon catheter system. Wherein, be applied to shock wave balloon catheter system, shock wave balloon catheter system includes shock wave balloon catheter and multimode energy generator; the shock wave balloon catheter comprises a plurality of groups of separated electrode groups, and the separated electrode groups are oriented differently. The impulse wave balloon catheter excitation method determines that an object to be excited needs to be excited through analyzing a mode control instruction, and the separated electrode groups in an excitation object are connected in series as required: thereby enabling the formation of a circumferential shock wave when all of the split electrode sets are excited; when the excitation object includes at least one group of split electrode groups but not all the split electrode groups, the excitation signal excites only the excitation object by controlling the excitation object to be connected in series and the rest of the split electrode groups to be connected in parallel with the excitation object, thereby forming a side shock wave.

Description

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

Technical Field

The application belongs to the technical field of medical instruments, and particularly relates to a shock wave balloon catheter excitation method and a shock wave balloon catheter system.

Background

Currently, the electrode assembly for the shock wave balloon catheter in all directions on the same axial plane is generally of an integral structure: the series connection and the driving voltage are the same. When used for central calcification lesions, the excitation electrode set will produce a circumferential shock wave of substantially the same energy in all directions. Since the relatively uniform calcified ring captures the same amount of energy, no other way other than cleavage can dissipate, and central calcification lesions can be treated effectively. However, the calcareous deposition in real lesions is not uniform, and thicker regions are difficult to fracture if the same uniform circumferential energy is used.

The foregoing description is provided for general background information and does not necessarily constitute prior art.

Disclosure of Invention

In view of the foregoing, it is desirable to provide a shock wave balloon catheter excitation method and shock wave balloon catheter system that directionally configures the emitted energy to control the shock wave balloon catheter to produce circumferential or lateral shock waves as desired.

The technical problem that this application solved is realized by adopting following technical scheme:

the application provides a shock wave balloon catheter excitation method which is applied to a shock wave balloon catheter system, wherein 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 separated electrode groups, wherein the directions of the separated electrode groups are different; when the separated electrode group is excited by the multi-mode energy generator, discharge is generated, and shock waves are generated in the direction of the separated electrode group; the method comprises the following steps: the method comprises the steps of obtaining and analyzing a mode control instruction to determine an excitation object and an excitation constraint, wherein the excitation object is an electrode group which needs excitation at this time, and the excitation constraint comprises at least one of an output channel constraint, a signal amplitude constraint, a frequency constraint and a pulse duration constraint; controlling the multi-mode energy generator to output high-voltage pulse signals of different modes to an excitation object according to excitation constraint; when the excitation object includes all the split electrode groups, controlling all the split electrode groups to be connected in series; exciting an excitation object to generate discharge in all directions to form a circumferential shock wave; when the excitation object comprises at least one group of separated electrode groups but not all the separated electrode groups, controlling the separated electrode groups in the excitation object to be connected in series, and connecting the rest of the separated electrode groups with the excitation object in parallel; the excitation object is excited to generate discharge in the direction of the excitation object, and the rest of the separated electrode groups do not generate discharge to form lateral shock waves.

In an alternative embodiment of the present application, the split electrode set 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 separated electrode group; the second electrode pair and the fourth electrode pair are connected in series and face the same direction to form a second separated electrode group; the first separated electrode group and the second separated electrode group are connected with different channel output ends of the multi-mode energy generator in an unexcited state; forming a circumferential shock wave comprising: controlling the first separated electrode group and the second separated electrode group to be connected in series, so that the high-voltage pulse signal simultaneously excites the first separated electrode group and the second separated electrode group; the first separated electrode group and the second separated electrode group are excited to generate discharge in all directions to form annular shock waves; forming a lateral shock wave, comprising: controlling the first separated electrode group and the second separated electrode group to be connected in parallel, so that the high-voltage pulse signal only excites the first separated electrode group or the second separated electrode group; the first separated electrode group or the second separated electrode group is excited to generate discharge in the direction to which the first separated electrode group or the second separated electrode group faces, so that lateral shock waves are formed.

In an alternative embodiment of the present application, controlling a multi-mode energy generator to output a high voltage pulse signal to an excitation target in accordance with an excitation constraint includes: when the plurality of excitation pairs comprise a plurality of separated electrode groups, judging whether the excitation constraint of each excitation pair is identical; if the excitation constraint of the excitation pairs is identical, controlling to connect the excitation objects with identical excitation constraint in series; if the excitation constraints of the excitation pairs are different, the excitation objects having different excitation constraints are connected in parallel.

In an alternative embodiment of the present application, after controlling the multi-mode energy generator to output the high voltage pulse signal to the excitation target according to the excitation constraint, the method further includes: acquiring feedback information of the shock wave balloon catheter, wherein the feedback information comprises 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 according to the feedback information; if the shock wave balloon catheter is not in a normal working state, matching the corresponding protection mode according to the feedback information and executing.

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 comprises a shock wave balloon catheter electrode assembly and a shock wave balloon; the shock wave balloon catheter electrode assembly consists of a plurality of separated electrode groups, wherein the directions of the separated electrode groups are different; when the separated electrode group is excited, discharge is generated in the direction of the separated electrode group; the shock wave balloon is a closed expandable or contractible cavity and is arranged at one end of the shock wave balloon catheter system and used for accommodating the shock wave balloon catheter electrode assembly, and physiological saline is filled in the shock wave balloon; when the separated electrode group discharges, the liquid electric effect can be induced in the separated electrode group, and circumferential or lateral shock waves are generated, so that the shock wave saccule is expanded and attached to the vascular wall; the multimode energy generator is arranged at the other end of the shock wave balloon catheter system, is connected with the shock wave balloon catheter circuit and is used for controlling the shock wave balloon catheter electrode assembly in the shock wave balloon to realize the method as described above.

In an alternative embodiment of the present application, a shock wave balloon catheter electrode assembly includes: the electrode pair consists of an inner electrode and an outer electrode, and the direction of the inner electrode towards the outer electrode is the direction of the electrode pair; a plurality of electrode pairs facing the same direction form a group of separated electrode groups, and all the electrode pairs in the separated electrode groups are connected in series; the direction in which all the electrode pairs in the split electrode group are oriented is the direction of the split electrode group.

In an alternative embodiment of the present application, the method includes: a first electrode pair formed by a first inner electrode and a first outer electrode; a second electrode pair formed by 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 formed by 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 separated electrode group; the second electrode pair and the fourth electrode pair face the same direction to form a second separated electrode group; the first separated electrode group and the second separated electrode group are different in orientation direction; the shock wave balloon catheter electrode assembly further comprises a wire, wherein the wire comprises a first wire, a second wire and a third wire; the first lead extends from the multi-mode energy generator to be sequentially connected with a first external electrode, a first internal electrode, a third internal electrode and a third external electrode in the first separated electrode group, and the first separated electrode group extends to be connected back to the multi-mode energy generator through the third lead, and the multi-mode energy generator is used for controlling the shock wave balloon catheter electrode assembly; the second lead extends from the multi-mode energy generator to be sequentially connected with a second outer electrode, a second inner electrode, a fourth inner electrode and a fourth outer electrode in the second separated electrode group, and the extended second separated electrode group is connected back to the multi-mode energy generator through a third lead; the first separated electrode group and the second separated electrode group are connected in parallel; when the first wire or the second wire is connected with the positive electrode of the multi-mode energy generator, the third wire is connected with the negative electrode of the multi-mode energy generator, and the first separated electrode group or the second separated electrode group is excited according to the excitation of the multi-mode energy generator so as to generate discharge in the direction of the excited separated electrode group, so that lateral shock waves are induced; when the first wire or the second wire is connected with the positive electrode of the multi-mode energy generator, the second wire or the first wire is connected with the negative electrode of the multi-mode energy generator, and the first split electrode set and the second split electrode set are excited according to the excitation of the multi-mode energy generator so as to generate discharge in the directions of the first split electrode set and the second split electrode set, so that the generation of the annular shock wave is induced.

In an alternative embodiment of the present application, the electrode pair further 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 outer electrode is arranged on the insulating layer, the outer electrode is provided with a second opening, and the second opening and the first opening are coaxially arranged.

In an alternative embodiment of the present application, the shock wave balloon catheter further comprises a feedback module; the feedback module is arranged in the shock wave balloon and above the shock wave balloon catheter electrode assembly; the feedback module comprises at least one of a temperature sensor, a pressure sensor, a voltage sensor and a current sensor, and is used for acquiring feedback information of the shock wave balloon catheter to feed back the multi-mode energy generator, wherein the feedback information comprises at least one of current information, voltage information, temperature information or pressure information.

In an alternative embodiment of the present application, the shock wave balloon catheter further comprises a catheter body and a catheter hub; the catheter body sequentially comprises from one end of the catheter body comprising a shock wave balloon catheter to one end of the catheter body comprising a multi-mode energy generator: a tip, an inner tube, an outer tube, and a hypotube; the tip is arranged at one end of the inner tube far away from the shock wave balloon, the outer diameter and the thickness of the tip gradually increase in the direction of the shock wave balloon, the inner tube is of an elongated tube structure with a cavity, the tip is arranged inside the outer tube and extends towards the distal end, and the shock wave balloon is arranged on the outer surface of the inner tube; the outer tube is of an elongated tube structure with a cavity and is arranged at the other end of the shock wave balloon and used for providing supporting force for the shock wave balloon catheter; the hypotube is of an elongated tube structure with a cavity and comprises a filling cavity and a wire cavity; a filling chamber for providing a delivery fluid for the shock wave balloon; the wire cavity is used for installing a wire led out by the shock wave balloon catheter electrode assembly; the catheter seat is connected with the shock wave balloon through a hypotube, a multi-mode energy generator can be arranged in the catheter seat, and the catheter seat is connected with the shock wave balloon catheter electrode assembly through a lead.

By adopting the embodiment of the application, the method has the following beneficial effects:

the present application provides for a series connection of a plurality of capacitors within an electrode set by innovatively paralleling the electrode set in a shock wave balloon catheter circuit according to the difference in direction. The electrode groups connected in parallel can be controlled independently, so that when the electrode groups are excited, the shock wave balloon containing the electrode groups can generate uniform circumferential shock waves and nonuniform lateral shock waves, and calcified lesions can be crushed comprehensively and without losing pertinence.

The foregoing description is only an overview of the technical solutions of the present application, and may be implemented according to the content of the specification, so that the foregoing and other objects, features and advantages of the present application can be more clearly understood, and the following detailed description of the preferred embodiments is given with reference to the accompanying drawings. It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the application.

Drawings

In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings that are required in the embodiments or the description of the prior art will be briefly described below, it being obvious that the drawings in the following description are only some embodiments of the present application, and that other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.

Wherein:

FIG. 1 is a flow chart of a method of shockwave balloon catheter activation according to one embodiment;

FIG. 2 is a schematic illustration of the structure of a shock wave balloon catheter system provided in accordance with one embodiment;

FIG. 3 is a schematic block diagram of a connection relationship between a multi-mode energy generator and a plurality of split electrode sets according to one embodiment;

FIG. 4 is a schematic block diagram of a connection relationship between a multi-mode energy generator and two direction separation electrode sets according to an embodiment;

FIG. 5 is a schematic diagram of a multi-mode energy generator according to one embodiment for exciting all separate electrode sets to form a circumferential shock wave;

FIG. 6 is a schematic diagram of a multi-mode energy generator provided by an embodiment for exciting a partially separated electrode set to form a side impact wave;

FIG. 7 is a schematic block diagram of a connection relationship between a multi-mode energy generator and four direction separation electrode sets according to an embodiment;

FIG. 8 is a block diagram of a shock wave balloon catheter system according to one embodiment;

FIG. 9 is a schematic block diagram of a shock wave balloon catheter electrode assembly according to one embodiment;

FIG. 10 is a schematic block diagram of an electrode structure including an insulating layer according to an embodiment;

FIG. 11 is a schematic block diagram showing a specific construction of a shock wave balloon catheter system of a bi-directional separation electrode set according to an embodiment;

FIG. 12 is a schematic diagram of an embodiment of an external electrode;

FIG. 13 is an assembled schematic view of a shock wave balloon catheter electrode assembly according to an embodiment;

FIG. 14 is a radial cross-sectional view of a shock wave balloon catheter electrode assembly provided by an embodiment;

fig. 15 is a physical schematic of a shock wave balloon catheter system according to an embodiment.

Detailed Description

The following description of the embodiments of the present application will be made clearly and fully with reference to the accompanying drawings, in which it is evident that the embodiments described are only some, but not all, of the embodiments of the present application. All other embodiments, which can be made by one of ordinary skill in the art based on the embodiments herein without making any inventive effort, are intended to be within the scope of the present application.

The electrode assemblies in all directions of the same axial surface in the conventional shock wave balloon catheter are generally of an integral structure, are connected in series, have the same driving voltage, generate the same energy of shock waves in all directions, generate uniform circumferential shock waves, and have the same emission energy of electrode pairs in all directions when the electrode assemblies are used for the central calcification lesions. However, if the uniform circumferential energy is adopted in lesions such as eccentric calcification and calcified nodules, the effective treatment effect of thicker parts is difficult to achieve, and the limitation exists. The conventional shock wave balloon catheter cannot emit shock waves in a targeted manner, so that the application improves an electrode assembly and correspondingly provides a shock wave balloon catheter excitation method. For a clear description of the shock wave balloon catheter excitation method provided herein, please refer to fig. 1-7.

The shock wave balloon catheter excitation method is applied to a multi-mode energy generator in a shock wave balloon catheter system. For structural arrangements of the shock wave balloon catheter system 20, reference may be made to fig. 2. Wherein the shock wave balloon catheter system 20 comprises a shock wave balloon catheter 21 and a multi-mode energy generator 22; the shock wave balloon catheter comprises a plurality of separated electrode groups 120, wherein the separated electrode groups 120 are oriented differently; when the split electrode set 120 is energized, an electrical discharge will be created, a shockwave will be created in the direction in which the split electrode set 120 is oriented, and a shockwave will be controllably generated in either the circumferential or lateral directions by the multi-mode energy generator 22. Reference may be made to fig. 3 for the connection of the split electrode set 120 and the multi-mode energy generator 22.

Further, for the multi-mode energy generator 22, which is the actual implementation subject of the present excitation method, specific functional modules therein may include, but are not limited to, power modules, control modules, man-machine interaction modules, multi-channel high voltage pulse generation modules, channel switching modules, monitoring and protection modules, catheter identification modules, and the like. Each module will each perform a corresponding function, for example, the power module includes a lithium battery that can be charged through an external network power adapter to provide a stable dc power supply for the system, and a power management module that converts the voltage generated by the lithium battery into the required dc voltage to power each module. And the man-machine interaction module is used for displaying a starting state, the residual electric quantity of a battery, the pulse emission times, the type of a catheter, a treatment mode and the like on the display screen, controlling the starting and the closing of the device by keys, selecting the treatment mode and starting the treatment, and controlling the pulse emission times by an operating handle or a pedal. For the functions that each functional module can implement, a specific description will be developed in connection with the implementation of the subsequent method.

Step S110: and acquiring and analyzing a mode control instruction to determine an excitation object and an excitation constraint, wherein the excitation object is an electrode group which needs to be excited at this time, and the excitation constraint comprises at least one of an output channel constraint, a signal amplitude constraint, a frequency constraint and a pulse duration constraint.

In one embodiment, the human-machine interaction module within the multi-mode energy generator 22 may be a functional module that is compiled from key instructions received from an operator. Specific modes of the parts of the man-machine interaction module for realizing interaction with an operator can comprise, but are not limited to, a touch display screen, a handle, a foot pedal and the like. For example, the power-on state, the remaining battery power, the pulse emission times, the catheter type, the treatment lesion type and the like can be displayed for the display screen, the power-on and power-off are controlled by the key, the treatment mode is selected, the treatment is started, and the pulse emission times are controlled by the operating handle or the pedal. The human-machine interaction module integrates the received commands into a mode control command, which is sent to the shock wave balloon catheter system 20 for receipt by the multi-mode energy generator 22. When the upper computer or the user operates and outputs the mode control command, the mode control command is sent to the shock wave balloon catheter 21 so that the shock wave balloon catheter 21 analyzes the mode control command. And determining the excitation object to be controlled and the excitation constraint of the specific control. As described previously, the shock wave balloon catheter 21 includes a plurality of separate electrode sets 120, each set of separate electrode sets 120 facing in a different direction from one another, so that the excitation target, i.e., the one or more separate electrode sets 120 that are determined to be excited. The excitation constraint comprises at least one of an output channel constraint, a signal amplitude constraint, a frequency constraint and a pulse duration constraint, wherein the amplitude range of a specific high-voltage signal is 200-5000V, the repetition frequency range is 0.5-10 Hz, and the pulse duration range is 0.5-20 mu s, and the specific output channel constraint determines which split electrode groups 120 are excitation objects, so that the split electrode groups 120 belonging to the excitation objects are connected in series with each other; for the split electrode set 120 not belonging to the excitation target, the split electrode set is connected in parallel with the excitation target, and does not receive an excitation signal, and the specific implementation process will be developed later. And further, since separate control of the split electrode sets 120 is achieved, i.e., the excitation received by each split electrode set 120 may be different, it is possible to define the generation of different lateral shock waves. Further, a catheter identification module may be included in the multi-mode power generator 22 to read catheter model information and the number of remaining pulses using a memory chip.

Step S120: the multi-mode energy generator is controlled to output high-voltage pulse signals of different modes to the excitation object according to excitation constraint.

In one embodiment, after controlling the multi-mode energy generator to output a high voltage pulse signal to the excitation target according to the excitation constraint, the method further comprises: acquiring feedback information of the shock wave balloon catheter, wherein the feedback information comprises 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 according to the feedback information; if the shock wave balloon catheter is not in a normal working state, matching the corresponding protection mode according to the feedback information and executing.

In an embodiment, the multi-mode energy generator 22 may further be provided with a monitoring module, which is used to monitor the working state 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 correspondingly obtain relevant information, such as at least one of current information, voltage information, temperature information or pressure information, of the shockwave balloon in an excited state, so as to gather feedback information and send the feedback information back to the multi-mode energy generator 22. Judging whether the shock wave balloon catheter 21 is in a normal working state or not by the multi-mode energy generator 22 through feedback information: if the shock wave balloon catheter 21 is not in a normal working state, the corresponding protection mode is matched according to the feedback information and is executed, for example, power-off protection is performed, and the overvoltage, overcurrent and short circuit of the circuit are prevented.

In one embodiment, the split electrode set 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 separated electrode group; the second electrode pair and the fourth electrode pair are connected in series and face the same direction to form a second separated electrode group; the first split electrode set and the second split electrode set are connected to different channel outputs of the multi-mode energy generator in an unexcited state.

Further, a channel switching module may be included in the multi-mode energy generator 22, to switch the positive and negative of the multi-channel high-voltage pulse signal generated by the multi-channel high-voltage pulse generating module, to generate a single-channel or multi-channel output signal, to drive the split metal electrode assembly, and to generate the circumferential or lateral shock wave respectively by using a serial connection and a parallel connection. For clarity of description of the shock wave balloon catheter system 20 in this embodiment, reference is made to fig. 4. As shown in fig. 4, a channel switching module (not shown) in the multi-mode power generator 22 draws a wire, which is defined as a first wire D1. The first wire D1 connects the first electrode pair 1101 and the third electrode pair 1103, which are oriented in the same direction, in series, and then connects the third wire D3 to the return multi-mode power generator 22, which is connected to the channel switching module. The first electrode pair 1101 and the third electrode pair 1103 constitute a first split electrode group 1201. Likewise, one wire is led out of the channel switching module, defined as a second wire D2. The second wire D2 connects the second electrode pair 1102 and the fourth electrode pair 1104, which are oriented in the same direction, in series, and then connects the third wire D3 to the return multi-mode energy generator 22, which is connected to the channel switching module. The second electrode pair 1102 and the fourth electrode pair 1104 form a second split electrode set 1202. The specific implementation of a hoop or lateral shock wave will be specifically deployed hereinafter.

Step S130: when the excitation object includes all the split electrode groups, controlling all the split electrode groups to be connected in series; the excitation object is excited to generate discharge in all directions, forming a circumferential shock wave.

In one embodiment, forming a circumferential shockwave includes: controlling the first separated electrode group and the second separated electrode group to be connected in series, so that the high-voltage pulse signal simultaneously excites the first separated electrode group and the second separated electrode group; the first separated electrode group and the second separated electrode group are excited to generate discharge in all directions so as to form annular shock waves.

In one embodiment, an illustration of the formation of a circumferential shock wave may be referred to in FIG. 5. Forming a ring-shaped shock wave with the shock wave balloon catheter system 20 shown in fig. 4 requires that all of the split electrode sets 120 be connected in series. Specifically, the first wire D1 may be controlled by the channel switching module to connect 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 current will flow through the first electrode pair 1101, the third electrode pair 1103, the fourth electrode pair 1104 and the second electrode pair 1102 in that order as shown in fig. 5 and finally back to the multi-mode energy generator 22. That is, all the split electrode sets 120 are excited, and a uniform shock wave is induced in all directions, that is, a circumferential shock wave is formed, as shown in fig. 5. Further, to realize repeated shock wave generation, the third wire D3 may be fixedly connected to the negative electrode of the multi-mode energy generator 22, and the first wire D1 and the second wire D2 are alternately connected to the pulse generating positive electrode, so as to be switched to form a parallel circuit. The above-mentioned case of the positive and negative electrode switching between the lead and the multi-mode energy generator 22 can be implemented by a channel switching module in the multi-mode energy generator 22. Of course, the second lead D2 may be connected to the positive electrode in the opposite direction, and the first lead D1 may be connected to the negative electrode, as long as all the split electrode sets 120 are controlled to be connected in series and activated.

Step S140: when the excitation object comprises at least one group of separated electrode groups but not all the separated electrode groups, controlling the separated electrode groups in the excitation object to be connected in series, and connecting the rest of the separated electrode groups with the excitation object in parallel; the excitation object is excited to generate discharge in the direction of the excitation object, and the rest of the separated electrode groups do not generate discharge to form lateral shock waves.

In one embodiment, forming a side-impact wave includes: controlling the first separated electrode group and the second separated electrode group to be connected in parallel, so that the high-voltage pulse signal only excites the first separated electrode group or the second separated electrode group; the first separated electrode group or the second separated electrode group is excited to generate discharge in the direction to which the first separated electrode group or the second separated electrode group faces, so that lateral shock waves are formed.

In one embodiment, an illustration of the formation of a side-to-side shockwave may be referred to in FIG. 6. The formation of side-profile shockwaves with shockwave balloon catheter system 20 shown in fig. 4 requires that the separate electrode sets 120 of the connection control section be connected in series. Taking the excitation of the first split electrode set 1201 as an example, it may be controlled by a channel switching module in the multi-mode energy generator 22, so that 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 not connected. Thus, the current flows through the first electrode pair 1101 and the third electrode pair 1103 sequentially and returns to the multi-mode energy generator 22, so that only the first electrode pair 1101 and the third electrode pair 1103 in the direction of the first split electrode set 1201 are induced to emit arcs, and the electrode pair 110 in the second split electrode set 1202 is kept in a silent state, thereby realizing that only one side arc is emitted to realize side shockwaves, and both the current flow and the shockwave direction illustration can refer to fig. 6. 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 previous description, but the direction of the formed shock wave is opposite, and the detailed process will not be repeated.

In one embodiment, controlling the multi-mode energy generator to output a high voltage pulse signal to an excitation target in accordance with an excitation constraint includes: when the plurality of excitation pairs comprise a plurality of separated electrode groups, judging whether the excitation constraint of each excitation pair is identical; if the excitation constraint of the excitation pairs is identical, controlling to connect the excitation objects with identical excitation constraint in series; if the excitation constraints of the excitation pairs are different, the excitation objects having different excitation constraints are connected in parallel.

In an embodiment, the split electrode set 120 may be disposed in a manner of not only two split electrode sets 120 as shown in fig. 4. In fact, there may be more electrode groups, and for this embodiment, there is also provided a shock wave balloon catheter electrode assembly 100 as shown in fig. 7, where the shock wave balloon catheter electrode assembly 100 of the shock wave balloon catheter 21 is different from the previous embodiment in that there are only two separate electrode groups 120 in two directions, but includes four separate electrode groups 120 in four directions: an upper split electrode set 120s, a lower split electrode set 120x, a left split electrode set 120z, and a right split electrode set 120y.

It is noted that the excitation object generating the side-impact wave comprises at least one set, possibly all separate electrode sets 120. That is, in the present embodiment, even though the entire split electrode set 120 is controlled to be excited, a lateral shock wave can be generated, which can be different from the manner in the previous embodiment because of the technical features that the excitation constraint is introduced in the present embodiment. Thus, in general, if one wants to generate a side-shockwave, two ideas can be followed in this embodiment to achieve a multi-mode excitation: the first is the difference in excitation objects, and one is the difference in excitation constraints.

The first is the differential control of the excitation target, i.e. the general scheme described above. As shown in fig. 7, the shock wave balloon catheter 21 has four separate electrode groups 120 with different directions, so that at least side shock waves can be emitted in four directions (up, down, left, and right) individually, that is, individually controlled to excite any one of the separate electrode groups 120. Meanwhile, the excitation object can be provided with a plurality of groups, for example, two groups, such as the upper separation electrode group 120s and the left separation electrode group 120z which are synchronously excited, and the two groups are controlled to emit lateral shock waves in the left upper direction; but may be three groups, for example, the excitation target includes the upper split electrode group 120s, the left split electrode group 120z and the lower split electrode group 120x, so that excitation can achieve a wide range of lateral shock waves, except for the shock waves emitted from the right side. More combinations of more directions are difficult to be exhaustive, the above embodiments are only for simplicity of illustration, and the fact that lateral shock waves of different combinations in different directions can be controlled is based on realistically achievable, and is not limited here.

The lateral shock waves mentioned in the previous embodiment and the previous embodiments are all in fact implicit in the existence of a constraint, namely that each excitation object is output with a high-voltage pulse signal with the same excitation constraint. In practice, however, the excitation constraints imposed by each excitation target may be different, and thus for the second implementation, lateral shock wave emission may be achieved by the differences in excitation constraints. Specifically, also taking the shock wave balloon catheter 21 of fig. 7 as an illustration, if all the split electrode sets 120 are excited simultaneously, but the constraint for one or more of them is lower than that of the remaining split electrode sets 120, then the split electrode sets 120 with lower constraint will receive stronger high voltage pulse signals, and the effect of inflation of the shock wave balloon 220 is shown as follows: although all of the shockwave balloons 220 have expanded, the shockwave balloons 220 in one direction expand more than the other direction, thereby forming an uneven annular shockwave, also known as a side shockwave. Specifically, for example, when the upper split electrode group 120s, the left split electrode group 120z, and the lower split electrode group 120x output high-voltage pulse signals of the same excitation constraint, but the right split electrode group 120y emits high-voltage pulse signals of lower excitation constraint, that is, higher energy. Although the four directional shockwave balloons 220 are inflated to produce an annular shockwave, the right split electrode set 120y is inflated to a greater extent than the remaining directions, thereby producing a non-uniform annular shockwave for better therapeutic results in certain situations. Thus, to achieve a circumferentially non-uniform shockwave as described in this embodiment, it is actually necessary to send pulsed signals with different excitation constraints to all of the split electrode sets 120. Therefore, when a high-voltage pulse signal is output to the excitation target, it is possible to determine whether or not excitation constraints of each excitation target are equal: if the excitation constraint of the excitation pairs is identical, controlling to connect the excitation objects with identical excitation constraint in series; if the excitation constraints of the excitation pairs are different, the excitation objects having different excitation constraints are connected in parallel. For this function, reference is made to the manner of the series-parallel split electrode set 120 described above, so that it is likewise possible to combine different electrode sets by way of the channel switching module. For example, as exemplified in the present embodiment, the upper split electrode set 120s, the left split electrode set 120z, and the lower split electrode set 120x may be connected in series to form a large set, and a high-voltage pulse signal with the same excitation constraint may be output to the large set; the right split electrode set 120y may be divided into another large set by the channel switching module and connected in parallel with the former large set. The channel switching module is used for controlling the series-parallel connection of the separated electrode group 120, so that different control of different groups is realized.

Thus, the present application provides for the series connection of multiple capacitances within split electrode set 120 by innovatively paralleling split electrode set 120 in a shockwave balloon catheter 21 circuit, with the differences in direction. Wherein the split electrode sets 120 connected in parallel can be independently controlled, so that when the split electrode sets 120 are excited, the shock wave balloon 220 comprising the split electrode sets 120 can generate non-uniform lateral shock waves and uniform circumferential shock waves, and further can generate non-uniform circumferential shock waves according to different excitation constraints of different excitation objects, thereby being capable of completely and uninterruptedly breaking calcified lesions.

From the foregoing description, it will be appreciated that the method of the present application is accomplished primarily through control of the shock wave balloon catheter system 20. The present application thus proposes a new and improved shock wave balloon catheter system 20. For a clear description of the shock wave balloon catheter system 20 provided herein, please refer to fig. 2-15.

The present application also provides a shock wave balloon catheter system 20, and for clarity of description of the shock wave balloon catheter system 20 provided in this embodiment, reference may be made to a schematic block diagram of the shock wave balloon catheter system as shown in fig. 8.

In one embodiment, the shock wave balloon catheter system 20 comprises: 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, including the shock wave balloon catheter electrode assembly 100 and the shock wave balloon 220; the shock wave balloon catheter electrode assembly consists of a plurality of separated electrode groups 120, and the directions of the separated electrode groups 120 are different; when the split electrode set 120 is excited, discharge is generated in the direction in which the split electrode set 120 faces; the shock wave balloon 220 is a sealed expandable or contractible cavity, is arranged at one end of the shock wave balloon catheter system 20 and is used for accommodating the shock wave balloon catheter electrode assembly 100, and physiological saline is filled in the shock wave balloon 220; when the separated electrode set 120 is discharged, the liquid electric effect can be induced, and the circumferential or lateral shock wave is generated, and is conducted to the calcified lesion area of the blood vessel through the balloon 220, so that the calcified lesion is broken; a multi-mode energy generator 22 is disposed at the other end of the shock wave balloon catheter system 20, in electrical communication with the shock wave balloon catheter 21, for controlling the shock wave balloon catheter electrode assembly 100 within the shock wave balloon 220 to implement the method as described previously.

In one embodiment, a shock wave balloon catheter electrode assembly includes: the electrode pair consists of an inner electrode and an outer electrode, and the direction of the inner electrode towards the outer electrode is the direction of the electrode pair; a plurality of electrode pairs facing the same direction form a group of separated electrode groups, and all the electrode pairs in the separated electrode groups are connected in series; the direction in which all the electrode pairs in the split electrode group are oriented is the direction of the split electrode group.

In one embodiment, the electrode pair further comprises 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 outer electrode is arranged on the insulating layer, the outer electrode is provided with a second opening, and the second opening and the first opening are coaxially arranged.

In one embodiment, for clarity of description of the shock wave balloon catheter electrode assembly 100 provided herein, reference may be made to fig. 9. From small to large, the minimum structure of the shock wave balloon catheter electrode assembly 100 is an electrode pair 110, and the electrode pair 110 is formed by paired inner electrodes 111 and outer electrodes 112, which are disposed opposite to each other, and the structure will be described in detail later when describing the solid structure, and the related relationship will be described earlier herein. The inner electrode 111 and the outer electrode 112 are disposed opposite to each other, and it is noted that the direction of the inner electrode 111 toward the outer electrode 112 is set to be the direction of the electrode pair 110. The "direction of the electrode pair 110" is used herein only to classify the electrode pair 110 in different directions, and does not refer to the direction of the arc emitted when the electrode pair 110 is excited. In practice, the direction of arc emission is the direction in which the excited electrode of the electrode pair 110 is oriented towards the non-excited electrode. Therefore, the electrode pairs 110 in the same direction may have different excited electrodes and different arc emission directions. Therefore, in order to eliminate the misunderstanding that may be caused by the actual situation, the direction of the outer electrode 112, in which the inner electrode 111 faces, is defined as the direction in which the electrode pair 110 faces. For example, taking fig. 1 as an example, in a practical situation, because the wire connection or excitation manner is different, the direction in which the arc is discharged by the practical electrode pair 110 may be upward or downward, which is difficult to determine in a practical situation. Thus, as defined herein, the upper plurality of electrode pairs 110 are all oriented downward and the lower plurality of electrode pairs 110 are all oriented upward.

The shock wave balloon catheter electrode assembly 100 may include a plurality of electrode pairs 110, and the electrode pairs 110 facing in the same direction are connected in series by a line to form a separate electrode group 120. All of the electrode pairs 110 within the split electrode set 120 are oriented in the same direction, and thus all of the electrode pairs 110 are oriented in the same direction as the split electrode set 120. Also taking fig. 9 as an example, the direction of the upper split electrode set 120 is downward, and the direction of the lower split electrode set 120 is upward. All electrode pairs 110 within two separate electrode sets 120 are connected in series. As described above, the directions of the two split electrode sets 120 are different, and in fact, the directions in which each split electrode set 120 faces are different, and the split electrode sets 120 are connected in parallel. For example, as shown in fig. 9, the upper and lower split electrode sets 120 are finally connected by the same wire in the middle, and the two split electrode sets 120 are connected in parallel in circuit structure.

Specifically, the split electrode sets 120 are formed by connecting the electrode pairs 110 in the same direction in series, and the parallel circuit connection structure between the split electrode sets 120 in different directions is adopted, so that the separate control of each split electrode set 120 is realized, the arc release in any direction is realized, and the shock wave balloon catheter can generate uniform circumferential shock waves and nonuniform lateral shock waves. Specifically, as shown in fig. 9, when all the split electrode sets 120 are excited, that is, when the upper and lower electrode sets are excited, the arcs are emitted simultaneously upward and downward, so that the annular shock waves are uniformly formed. Because of the parallel relationship between the split electrode sets 120, any one of the split electrode sets 120 can be individually controlled to energize while the other set remains silent, thereby creating only upwardly or upwardly directed non-uniform lateral shock waves. Not only can the eccentric calcified lesions be treated, but also lateral shock waves with higher frequency and energy can be generated at the thick end of the eccentric calcified ring to disintegrate the eccentric calcified lesions, so that the requirements of treating different types of vascular calcified lesions can be met.

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

In one embodiment, an insulating layer 113 may be further provided between the inner electrode 111 and the outer electrode 112 in order to ensure the formation of an arc. For the correlation of the insulating layer 113 within the electrode pair 110, reference may be made to fig. 10: an insulating layer 113 is disposed between the inner electrode 111 and the outer electrode 112. Further, in the structure shown in fig. 9, the number of the electrode pairs 110 in one split electrode set 120 may be plural, and the insulating layer 113 does not actually participate in the circuit connection, but is only used for isolating the inner electrode 111 from the outer electrode 112, so that only one insulating layer 113 may be provided in one split electrode set 120 or one shock wave balloon catheter, and the isolation of the inner electrode 111 from the outer electrode 112 of all the electrode pairs 110 in the split electrode set 120 or in the shock wave balloon catheter may be uniformly achieved. For the specific arrangement, detailed description will be given later, and only the correlation between the insulating layer 113 and the inner and outer electrodes 112 in the electrode pair 110 is needed.

In one embodiment, the method comprises: a first electrode pair formed by a first inner electrode and a first outer electrode; a second electrode pair formed by 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 formed by 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 separated electrode group; the second electrode pair and the fourth electrode pair face the same direction to form a second separated electrode group; the first separated electrode group and the second separated electrode group are different in orientation direction; the shock wave balloon catheter electrode assembly further comprises a wire, wherein the wire comprises a first wire, a second wire and a third wire; the first lead extends from the multi-mode energy generator to be sequentially connected with a first external electrode, a first internal electrode, a third internal electrode and a third external electrode in the first separated electrode group, and the first separated electrode group extends to be connected back to the multi-mode energy generator through the third lead, and the multi-mode energy generator is used for controlling the shock wave balloon catheter electrode assembly; the second lead extends from the multi-mode energy generator to be sequentially connected with a second outer electrode, a second inner electrode, a fourth inner electrode and a fourth outer electrode in the second separated electrode group, and the extended second separated electrode group is connected back to the multi-mode energy generator through a third lead; the first separated electrode group and the second separated electrode group are connected in parallel; when the first wire or the second wire is connected with the positive electrode of the multi-mode energy generator, the third wire is connected with the negative electrode of the multi-mode energy generator, and the first separated electrode group or the second separated electrode group is excited according to the excitation of the multi-mode energy generator so as to generate discharge in the direction of the excited separated electrode group, so that lateral shock waves are induced; when the first wire or the second wire is connected with the positive electrode of the multi-mode energy generator, the second wire or the first wire is connected with the negative electrode of the multi-mode energy generator, and the first split electrode set and the second split electrode set are excited according to the excitation of the multi-mode energy generator so as to generate discharge in the directions of the first split electrode set and the second split electrode set, so that the generation of the annular shock wave is induced.

In one embodiment, the present embodiment specifically discloses the specific structure of the shock wave balloon catheter system 20 of the two-way separation electrode set in combination with the shock wave balloon catheter system 20 shown in fig. 4, and can be understood by referring to fig. 11. The structure formed by the first split electrode set 1201 and the second split electrode set 1202 is referred to as a shockwave balloon catheter electrode assembly 100. Specifically, the electrode includes a first electrode pair 1101 formed by a first inner electrode 1111 and a first outer electrode 1121, a second electrode pair 1102 formed by a second inner electrode 1112 and a second outer electrode 1122, a third electrode pair 1103 formed by a third inner electrode 1113 and a third outer electrode 1123, and a fourth electrode pair 1104 formed by a fourth inner electrode 1114 and a fourth outer electrode 1124. The first electrode pair 1101 and the third electrode pair 1103 face in the same direction, and constitute a first split electrode group 1201; the second electrode pair 1102 and the fourth electrode pair 1104 face in the same direction to form a second separated electrode group 1202; the first split electrode set 1201 and the second split electrode set 1202 are oriented differently.

The shock wave balloon catheter electrode assembly 100 further comprises a wire including a first wire D1, a second wire D2 and a third wire D3; the first lead D1 extends from the multi-mode power generator 22 to sequentially connect the first external electrode 1121, the first internal electrode 1111, the third internal electrode 1113, and the third external electrode 1123 in the first split electrode set 1201, and the first split electrode set 1201 is connected back to the multi-mode power generator 22 through the third lead D3. Similarly, a second wire D2 extends from the multi-mode energy generator 22 to connect the second outer electrode 1122, the second inner electrode 1112, the fourth inner electrode 1114, and the fourth outer electrode 1124 in the second split electrode set 1202 in sequence, and extends out of the second split electrode set 1202 to connect back to the multi-mode energy generator 22 via a third wire D3. The series connection between the electrode pairs 110 in the first split electrode group 1201 and the second split electrode group 1202 is achieved by connection of wires. And it can be seen that the first split electrode set 1201 and the second split electrode set 1202 are structurally connected in parallel as both the first split electrode set 1201 and the second split electrode set 1202 are led to the multi-mode energy generator 22 by the third wire D3.

In particular, for the shock wave balloon catheter electrode assembly 100 of this construction, reference should be made to the foregoing description, and to fig. 5 and 6 for a specific flow path if a lateral or circumferential shock wave is desired. For example, as shown in fig. 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, both the first split electrode group 1201 and the second split electrode group 1202 are controlled to be connected in series. The first split electrode set 1201 and the second split electrode set 1202 are both energized in response to the high voltage signal from the multi-mode energy generator 22 to emit an arc in the direction of the first split electrode set 1201 and the second split electrode set 1202 to induce the generation of a circumferential shock wave.

Similarly, taking fig. 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 not connected. The current flows through the first outer electrode 1121, the first inner electrode 1111, the third inner electrode 1113 and the third outer electrode 1123 in turn under the excitation state and returns to the multi-mode energy generator 22, so that only the first electrode pair 1101 and the third electrode pair 1103 in the direction of the first split electrode group 1201 are induced to emit arcs, and the electrode pair 110 in the second split electrode group 1202 is kept in the silence state, thereby realizing the technical scheme that only one side of arc is emitted to realize lateral shock waves. 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 specific treatment is realized in a similar manner to the above description, and the lateral shock wave is induced. The flow of current and shock wave generation is similar to that described above, and will not be described in detail here.

Further, in order to realize repeated shock wave generation, the third wire D3 may be fixedly connected to the negative electrode of the multi-mode energy generator 22, and the first wire D1 and the second wire D2 are alternately connected to the pulse generation positive electrode, so that a parallel circuit is switched to form, and shock waves alternately occur between the lateral shock wave and the circumferential shock wave, so that calcified lesions are bombarded more forcefully, and the treatment effect is improved.

In one embodiment, the shock wave balloon catheter further comprises a feedback module; the feedback module is arranged in the shock wave balloon and above the shock wave balloon catheter electrode assembly; the feedback module comprises at least one of a temperature sensor, a pressure sensor, a voltage sensor and a current sensor, and is used for acquiring feedback information of the shock wave balloon catheter to feed back the multi-mode energy generator, wherein the feedback information comprises at least one of current information, voltage information, temperature information or pressure information.

In one embodiment, the shock wave balloon catheter further comprises a catheter body and a catheter hub; the catheter body sequentially comprises from one end of the catheter body comprising a shock wave balloon catheter to one end of the catheter body comprising a multi-mode energy generator: a tip, an inner tube, an outer tube, and a hypotube; the tip is arranged at one end of the inner tube far away from the shock wave balloon, the outer diameter and the thickness of the tip gradually increase in the direction of the shock wave balloon, the inner tube is of an elongated tube structure with a cavity, the tip is arranged inside the outer tube and extends towards the distal end, and the shock wave balloon is arranged on the outer surface of the inner tube; the outer tube is of an elongated tube structure with a cavity and is arranged at the other end of the shock wave balloon and used for providing supporting force for the shock wave balloon catheter; the hypotube is of an elongated tube structure with a cavity and comprises a filling cavity and a wire cavity; a filling chamber for providing a delivery fluid for the shock wave balloon; the wire cavity is used for installing a wire led out by the shock wave balloon catheter electrode assembly; the catheter seat is connected with the shock wave balloon through a hypotube, a multi-mode energy generator can be arranged in the catheter seat, and the catheter seat is connected with the shock wave balloon catheter electrode assembly through a lead.

In one embodiment, the shock wave balloon catheter 21 further has an outer tube 810, an inner tube 820, and a tip 830 disposed around the shock wave balloon 220. Wherein the outer tube 810 is disposed at the distal end of the shock wave balloon catheter 21, i.e. at the end where the shock wave balloon 220 is located. The outer tube 810 is an elongated tube structure having a cavity, and may have an outer diameter of between 0.3 and 2.0mm for a particular size, and an inner diameter extending axially from an outer surface of between 0.2 and 1.8 mm. The cavity of the outer tube 810 is referred to as an outer tube 810 cavity, and the outer tube 810 cavity is used for placing the inner tube 820 and the guide wire, and a central steel wire is added to enhance the supporting force so as to improve the pushing performance and the bending resistance of the shock wave balloon catheter 21. The outer tube 810 lumen may also be used to fill the lumen for delivering fluid into the shock wave balloon 220 at the distal end of the tube body. The tube body material for the outer tube 810 may include, but is not limited to, polyimide, polyetheretherketone, polyethylene, PEBA, PET, FEP, PTFE, PA, and the like.

Further, an inner tube 820 is provided within 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 may be longer than the axial length of the shock wave balloon 220. It could equally be an elongate tubular structure with a cavity. Specifically, the outer diameter of the inner tube 820 may be between 0.3 and 1.0mm, and the inner diameter may be between 0.2 and 0.9mm, and the inner tube 820 may be made of Polyurethane (PU), polytetrafluoroethylene (PTFE), low Density Polyethylene (LDPE), high Density Polyethylene (HDPE), polyvinyl chloride (PVC), nylon (PA), block polyether amide (Pebax), polyethylene terephthalate (PET) or a composite material. The inner tube 820 may also be provided with a guidewire port for placement of a guidewire into the lumen of the inner tube 820 to enable the distal end of the catheter to enter the calcified lesion within the body vessel.

At the end of inner tube 820 remote from shock wave balloon 220, a tip 830 is also provided. The tip 830 is the portion of the shock wave balloon catheter 21 that first contacts the calcified lesion region. The tip 830 as a whole may be presented as a tapered soft long head design, with the outer diameter and thickness of the tip 830 increasing in the direction toward the shock wave balloon 220. Specifically, the tip 830 has an outer diameter of 0.3-1.0 mm, an outer diameter of 0.4-1.2 mm, an inner diameter of 0.2-0.9 mm, a length of 5-15 mm, and a thickness of 0.1-0.5 mm. The transition from the main body of the tip 830 to the head of the shock wave balloon 220 is considered, the pushing capacity of the shock wave balloon is enhanced, and the damage of the catheter to the blood vessel is reduced by tortuous lesions. The material of the tip 830 may be made of a high molecular polymer material, and has a smooth surface and elasticity, so that the body of the tip 830 is smoothly transited to the shock wave balloon 220, and thus the shock wave balloon catheter 21 has better trafficability. High molecular polymer materials that may be employed for tip 830 may include, but are not limited to, polyurethane (PU), polytetrafluoroethylene (PTFE), low Density Polyethylene (LDPE), high Density Polyethylene (HDPE), polyvinyl chloride (PVC), nylon (PA), block polyether amide (Pebax), polyethylene terephthalate (PET), or composites. The end of the tip 830 near the inner tube 820 may be subjected to a surface treatment with roughness, and the connection manner with the shock wave balloon 220 may be glue bonding, thermal welding or laser welding, so that the tip 830 and the shock wave balloon 220 can be better connected, the welding firmness is improved, and the problem that the tip 830 and the shock wave balloon 220 fall off in use is avoided.

The shock wave balloon 220 is disposed on the outer surface of the inner tube 820, forming a closed space with the inner tube 820 to accommodate the shock wave balloon catheter electrode assembly 100 described previously. The shock wave balloon 220 may be filled with a liquid, which is primarily physiological saline. After the shock wave balloon 220 is filled with liquid, the separated electrode set 120 excited in the shock wave balloon catheter electrode assembly 100 will generate a circumferential or lateral arc after 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, and a hydro-electric effect can be induced in the liquid, thereby generating a circumferential or lateral shock wave. The shock waves are conducted through the shock wave balloon 220 to the calcified region, causing the calcified plaque to lyse. Specifically, the shock wave balloon 220 is designed in a single-layer or double-layer structure, the outer diameter needs to be reduced through regular folding, so that the outer surface is more regular and smooth, the minimum outer diameter of the shock wave balloon 220 after folding can be 0.5-1.0 mm, for example, a three-folding or five-folding mode can be adopted, and the severe stenosis can be more easily passed. The diameter of the expanded shock wave balloon 220 may be 2-6 mm, and the shock wave generated by the separate electrode assembly 120 inside the shock wave balloon 220 may be transmitted to the calcified lesion region through the shock wave balloon 220. The shock wave balloon 220 may be made of one or more of nylon, polyethylene terephthalate, polyethylene, polyvinyl chloride, polyurethane, silicone rubber or other polymer materials. The high polymer material coating is sprayed on the surface of the shock wave balloon 220, so that the surface of the shock wave balloon 220 becomes smoother and can more easily pass through narrow lesions.

In one embodiment, the shock wave balloon catheter 21 is generally an axially extending elongate structure including at least the shock wave balloon catheter electrode assembly 100 and the shock wave balloon 220. Wherein the focus of improvement is to the shock wave balloon catheter electrode assembly 100, which will be described in detail hereinafter, is not deployed here. The multi-mode energy generator 22 has been described in detail above, and reference is made to the above for details, which are not repeated here. The high-voltage pulse signal can be specifically transmitted according to control, the amplitude range of the specific signal for generating the shock wave is 200-5000V, the repetition frequency range is 0.5-10 Hz, the pulse duration range is 0.5-20 mu s, and the pressure of the shock wave is less than 20MPa.

In one embodiment, the shock wave balloon catheter 21 further comprises a temperature sensor and/or a pressure sensor; the temperature sensor is disposed in the shock wave balloon 220, and is used for acquiring the temperature inside the shock wave balloon 220; the pressure sensor is disposed in the shock wave balloon 220, and is used for acquiring the pressure inside the shock wave balloon 220.

In one embodiment, a temperature sensor may be disposed on the inner tube 820, specifically a thermistor, and a conversion device for converting the received temperature into an output electrical signal is used to monitor the temperature inside the shock wave balloon 220 in real time. Likewise, a pressure sensor, in particular an optical fiber pressure sensor, may be disposed on the inner tube 820, and a conversion device for converting the received pressure into an output electrical signal is used for monitoring the hydraulic pressure inside the shock wave balloon 220 in real time. May be disposed within shock wave balloon 220 for both components.

In one embodiment, the shock wave balloon catheter 21 further comprises a developing ring and/or a developing solution; developing rings are provided at both ends of the shock wave balloon 220, developing solution is filled in the shock wave balloon 220, and the developing rings and/or the developing solution are used for marking the working section of the shock wave balloon catheter 21.

In one embodiment, the visualization rings are provided as X-ray opaque metal rings on both ends of the shock wave balloon 220, and embedded markings may be used to reduce the outer diameter of the working section of the shock wave balloon catheter 21. Specifically, the outer diameter may be between 0.3 and 1.0mm, the inner diameter may be between 0.2 and 0.9mm, and the length may be between 1 and 3 mm. The developing ring can be made of gold, platinum, molybdenum, tungsten or platinum iridium alloy. The developer solution may be a liquid comprising particles of a developer ring material. Whether the developing ring or the developing solution is used for X-ray development, the working section of the shock wave balloon catheter 21 is marked, and the shock wave balloon 220 is positioned accurately intraoperatively.

In one embodiment, the shock wave balloon catheter electrode assembly 100 includes a plurality of separate electrode sets 120, wherein the plurality of separate electrode sets 120 are uniformly and circumferentially disposed in the shock wave balloon 220, and the directions of the separate electrode sets 120 are different from each other; each set of split electrode sets 120 is connected to a multi-mode energy generator 22, the multi-mode energy generator 22 being used to individually control any split electrode set 120; when the multi-mode energy generator 22 outputs high-voltage pulse signals to all the split electrode sets 120, the excitation generates electric arcs to form shock waves, and the shock waves expand towards the directions of all the split electrode sets 120 to generate annular shock waves; alternatively, when the multi-mode energy generator 22 outputs a high voltage pulse signal to at least one, but not all, of the split electrode sets 120, a lateral shock wave is generated, inducing the expansion of the shock wave balloon 220 in the direction in which the excited split electrode set 120 is oriented.

In one embodiment, to facilitate an understanding of how the shock wave balloon 220 emits lateral or circumferential shock waves, it is desirable to first know how the shock wave-inducing balloon catheter electrode assembly 100 is configured and operated. For ease of understanding, this embodiment is described with respect to the shock wave balloon catheter electrode assembly 100 previously provided in fig. 11. The inner electrode 111 is disposed on the inner tube 820, and has a sheet structure, a length of 0.2-3.0 mm, and a width of 0.1-3.0 mm, and the inner electrode 111 may be made of metal materials such as gold, silver, copper, stainless steel, platinum, molybdenum, tungsten, or platinum iridium alloy, and the connection manner of the inner electrode 111 and the wire may be conductive adhesive bonding, thermal welding, or laser welding.

An insulating layer 113 is disposed over the inner electrodes 111, and the insulating layer 113 may be disposed over each inner electrode 111 alone, as described above, since the insulating layer 113 does not directly participate in the electrical circuit, only one tubular structure may be disposed within the shock wave balloon catheter electrode assembly 100. The specific outer diameter can be between 0.4 and 2.0mm, and the thickness can be between 0.01 and 0.1 mm. 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 may include, but is not limited to, circular, rectangular, triangular, etc., and the diameter of the circular opening of the first opening 113a is between 0.01 and 0.5mm as an example.

The external electrode 112 is disposed on the insulating layer 113 in a ring-shaped or sheet-shaped structure, and reference is made to fig. 12 for the structure of the external electrode 112. Fig. 12 shows a shape that the external electrode 112 can take, and is not limited to the shape of the external electrode 112, and in actual practice, may be arbitrarily set according to the needs. The outer diameter of the ring-shaped structure of the outer electrode 112 shown in fig. 12 is between 0.4 and 2.0mm, and the thickness thereof is between 0.01 and 0.5mm, and is fixed to the insulating layer 113 by the ring-shaped arms. If the external electrode 112 takes a sheet-like structure having a length of between 0.5 and 3.0mm and a width of between 0.1 and 3.0mm, it is fixed to the insulating layer 113 by hook-tooth structures at both ends. Similarly, the outer electrode 112 has a circular hole coaxially aligned with the inner electrode 111, referred to as a second opening 112a. The specific shape of the second opening may include, but is not limited to, circular, rectangular, triangular, etc., and the circular opening is exemplified by the second opening 112a having a circular hole diameter of between 0.01 and 0.5mm, each direction corresponding to one external electrode 112, and the second openings 112a thereof are not connected to each other.

As described above, the inner electrode 111, the insulating layer 113, and the outer electrode 112 are sequentially disposed on the inner tube 820 from inside to outside, so as to form the structure shown in fig. 13, and fig. 13 is an assembly schematic diagram of the shock wave balloon catheter electrode assembly 100 according to an embodiment. It should be noted that the present application uses the integrated tubular insulating layer 113 and the two annular external electrodes 112 for convenience of description, and is not limited to the technology, but is exemplified in a practically applicable scheme. Meanwhile, the same is true for the sheet-shaped inner electrode 111, and the inner electrode 111 is disposed 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, so that the inner electrode 111 is not visible in fig. 14. For ease of understanding, reference may also be made to fig. 14 for installation of the shock wave balloon catheter electrode assembly 100, fig. 14 being a radial cross-sectional view of the shock wave balloon catheter electrode assembly 100 provided by an embodiment. As is clear from fig. 14, from inside to outside, the inner tube 820, the inner electrode 111, the insulating layer 113, and the outer electrode 112, respectively. It can be clearly seen that the inner electrode 111 and the outer electrode 112 are clearly divided into two groups, namely, an upper first split electrode group 1201 and a lower second split electrode group 1202, which correspond to the embodiment of fig. 11.

The first split electrode set 1201 and the second split electrode set 1202 shown in fig. 11 are connected in parallel with the multi-mode power generator 22, so that the multi-mode power generator 22 can individually control any one of the split electrode sets 120. When the multi-mode energy generator 22 outputs high voltage pulse signals to all the split electrode sets 120, all the split electrode sets 120 uniformly arranged in the shock wave balloon 220 will emit electric arcs in all directions, generate circumferential shock waves, and induce the shock wave balloon 220 to expand in the direction in which all the split electrode sets 120 are oriented.

Similarly, when the multi-mode energy generator 22 outputs a high voltage pulse signal to one of the split electrode sets 120, for example, to the first split electrode set 1201. The first split electrode set 1201 is stimulated by a high voltage signal, and the stimulated electrodes will emit electric arcs in opposite directions thereof, inducing rapid vaporization and expansion of the liquid in the shock wave balloon 220, generating shock waves, which reach the shock wave balloon 220 and expand the shock wave balloon 220 to one side.

In one embodiment, the shock wave balloon catheter system 20 may further include a catheter hub 850 and a catheter body 860, and reference may be made to fig. 15 for the physical structure of the shock wave balloon catheter system 20. The catheter hub 850 is disposed at an end of the multi-mode energy generator 22, and the multi-mode energy generator 22 is disposed within the catheter hub 850. The catheter body sequentially comprises from one end of the catheter body comprising a shock wave balloon catheter to one end of the catheter body comprising a multi-mode energy generator: a tip 830, an inner tube 820, an outer tube 810, a hypotube 840. The tip 830, inner tube 820, outer tube 810 have been described in detail hereinabove, and only hypotube 840 will be described herein. Hypotube 840 is an elongated tube structure having a cavity for connecting shock wave balloon 220 and catheter hub 850; a catheter channel is arranged in the cavity of the hypotube 840, and comprises a filling cavity and a wire cavity; the filling chamber is used to deliver liquid into the shockwave balloon 220 chamber; wires are disposed within the wire lumen for enabling electrical connection of the multi-mode energy generator 22 to the electrical circuit of the shock wave balloon catheter electrode assembly 100.

In one embodiment, the base is disposed at an end of the multi-mode energy generator 22, and the multi-mode energy generator 22 is disposed within the catheter hub 850. The base can be a branched luer seat, and the material can be polycarbonate PC, polyurethane, ABS plastic and the like. The hypotube 840 may be a body having a tubular hollow structure with a proximal face, a distal face, and a lateral peripheral face between the proximal face and the distal face. The side peripheral surface also comprises a non-cutting area and a cutting area, the spiral groove is formed on the cutting area by laser cutting, and the surface of the non-cutting area is smooth. Hypotube 840 is connected distally to outer tube 810 and proximally to catheter hub 850. The outer diameter of the hypotube 840 may be between 0.3 and 2.0mm, and the tube body material may be a metal material such as stainless steel, nickel titanium, etc. Meanwhile, a catheter channel is also arranged in the cavity of the hypotube 840, and the catheter channel comprises a filling cavity and a wire cavity. The inflation lumen is used to deliver fluid into the lumen of shock wave balloon 220, and may include, for example, at least saline and optionally a contrast fluid. Wires are disposed within the wire lumen for enabling electrical connection of the multi-mode energy generator 22 to the electrical circuit of the shock wave balloon catheter electrode assembly 100.

Thus, the present application provides for the series connection of multiple capacitances within split electrode set 120 by innovatively paralleling split electrode set 120 in a shockwave balloon catheter 21 circuit, with the differences in direction. Wherein the split electrode sets 120 connected in parallel can be independently controlled, so that when the split electrode sets 120 are excited, the shock wave balloon 220 comprising the split electrode sets 120 can generate uniform circumferential shock waves and nonuniform lateral shock waves, thereby being capable of completely and uninterruptedly crushing calcified lesions.

In one embodiment, the present application also proposes a computer-readable storage medium storing a computer program, which, when executed by a processor, causes the processor to perform the steps of the method as described above,

those skilled in the art will appreciate that all or part of the processes in the methods of the above embodiments may be implemented by a computer program for instructing relevant hardware, where the program may be stored in a non-volatile computer readable storage medium, and where the program, when executed, may include processes in the embodiments of the methods described above. Any reference to memory, storage, database, or other medium used in the various embodiments provided herein may include non-volatile and/or volatile memory. The nonvolatile 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 a variety of forms such as Static RAM (SRAM), dynamic RAM (DRAM), synchronous DRAM (SDRAM), double Data Rate SDRAM (DDRSDRAM), enhanced SDRAM (ESDRAM), synchronous Link DRAM (SLDRAM), memory bus direct RAM (RDRAM), direct memory bus dynamic RAM (DRDRAM), and memory bus dynamic RAM (RDRAM), among others.

The technical features of the above embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description.

The above examples only represent a few embodiments of the present application, which are described in more detail and are not to be construed as limiting the scope of the present application. It should be noted that it would be apparent to those skilled in the art that various modifications and improvements could be made without departing from the spirit of the present application, which would be within the scope of the present application. Accordingly, the scope of protection of the present application is to be determined by the claims appended hereto.

Claims

1. A method of shockwave balloon catheter excitation, characterized by being applied to a shockwave balloon catheter system comprising a shockwave balloon catheter and a multi-mode energy generator; the shock wave balloon catheter comprises a plurality of separated electrode groups, wherein the separated electrode groups are oriented differently; when the separated electrode group is excited by the multi-mode energy generator, discharge is generated, and shock waves are generated in the direction of the separated electrode group;

The method comprises the following steps:

the method comprises the steps of obtaining and analyzing a mode control instruction to determine an excitation object and an excitation constraint, wherein the excitation object is an electrode group which needs excitation at this time, and the excitation constraint comprises at least one of an output channel constraint, a signal amplitude constraint, a frequency constraint and a 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 target includes all of the split electrode groups, controlling all of the split electrode groups to be connected in series; exciting the excitation object to generate discharge in all directions so as to form a circumferential shock wave;

when the excitation target includes at least one group of the split electrode groups but does not include all the split electrode groups, controlling the split electrode groups within the excitation target to be connected in series, and the remaining split electrode groups to be connected in parallel with the excitation target; and exciting the excitation object to generate discharge in the direction of the excitation object, wherein the rest of the separated electrode groups do not generate discharge, so that lateral shock waves are formed.

2. The shock wave balloon catheter excitation method of claim 1, wherein the split electrode set 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 separated electrode group; the second electrode pair and the fourth electrode pair are connected in series and face the same direction to form a second separated electrode group; the first separated electrode group and the second separated electrode group are connected with different channel output ends of the multi-mode energy generator in an unexcited state;

the forming of the circumferential shock wave comprises:

controlling the first split electrode set and the second split electrode set to be connected in series, so that the high-voltage pulse signal simultaneously excites the first split electrode set and the second split electrode set; the first separated electrode group and the second separated electrode group are excited to generate discharge in all directions so as to form annular shock waves;

the forming of the lateral shock wave comprises:

controlling the first split electrode set and the second split electrode set to be connected in parallel, so that the high-voltage pulse signal only excites the first split electrode set or the second split electrode set; and after being excited, the first separated electrode group or the second separated electrode group generates discharge in the direction facing the first separated electrode group to form lateral shock waves.

3. The shock wave balloon catheter excitation method according to claim 1, wherein said controlling said multimode energy generator to output a high voltage pulse signal to said excitation target in accordance with said excitation constraints comprises:

determining whether excitation constraints for each of said excitation pairs are equivalent when a majority of the excitation pairs comprise a plurality of said split electrode sets;

if the excitation constraints of the excitation pairs are identical, controlling to connect the excitation objects identical to the excitation constraints in series;

if the excitation constraints of the excitation pairs are not identical, connecting the excitation objects with the excitation constraints not identical in parallel.

4. The shock wave balloon catheter excitation method according to claim 1, wherein after controlling the multimode energy generator to output a high voltage pulse signal to the excitation target in accordance with the excitation constraint, the method further comprises:

acquiring feedback information of the shock wave balloon catheter, wherein the feedback information comprises 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 according to the feedback information;

And if the shock wave balloon catheter is not in a normal working state, matching the corresponding protection mode according to the feedback information and executing.

5. 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 comprises a shock wave balloon catheter electrode assembly and a shock wave balloon;

the shock wave balloon catheter electrode assembly consists of a plurality of separated electrode groups, wherein the separated electrode groups are oriented differently; when the separated electrode group is excited, discharge is generated to the direction in which the separated electrode group faces;

the shock wave balloon is a closed expandable or contractible cavity, is arranged at one end of the shock wave balloon catheter system and is used for accommodating the shock wave balloon catheter electrode assembly, and physiological saline is filled in the shock wave balloon; when the separated electrode group discharges, the liquid electric effect can be induced in the separator to generate circumferential or lateral shock waves, so that the shock wave balloon is expanded to be attached to the vascular wall;

the multi-mode energy generator is disposed at the other end of the shock wave balloon catheter system, connected to the shock wave balloon catheter circuit, for controlling the shock wave balloon catheter electrode assembly within the shock wave balloon to implement the method of any one of claims 1 to 4.

6. The shock wave balloon catheter system of claim 5, wherein the shock wave balloon catheter electrode assembly comprises:

the electrode pair consists of an inner electrode and an outer electrode, and the direction of the inner electrode towards the outer electrode is the direction of the electrode pair;

a split electrode group, wherein a plurality of electrode pairs facing the same direction form a group of split electrode groups, and all the electrode pairs in the split electrode group are connected in series; all electrode pairs in the split electrode set are oriented in the direction of the split electrode set.

7. The shock wave balloon catheter system of claim 6, comprising: a first electrode pair formed by a first inner electrode and a first outer electrode; a second electrode pair formed by 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 formed by 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 separated electrode group; the second electrode pair and the fourth electrode pair face the same direction to form a second separated electrode group; the first separated electrode group and the second separated electrode group are oriented in different directions;

The shock wave balloon catheter electrode assembly further comprises a wire, wherein the wire comprises a first wire, a second wire and a third wire;

the first lead extends from a multi-mode energy generator to sequentially connect the first external electrode, the first internal electrode, the third internal electrode and the third external electrode in the first split electrode set, and extends out of the first split electrode set to be connected back to the multi-mode energy generator through the third lead, and the multi-mode energy generator is used for controlling the shock wave balloon catheter electrode assembly;

the second lead 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 split electrode set, and the second split electrode set extends to be connected back to the multi-mode energy generator through the third lead; the first separated electrode group and the second separated electrode group are connected in parallel;

When the first wire or the second wire is connected with the anode of the multi-mode energy generator, the third wire is connected with the cathode of the multi-mode energy generator, and 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 generate discharge in the direction of the excited split electrode group, so that lateral shock waves are induced;

when the first wire or the second wire is connected with the positive electrode of the multi-mode energy generator, the second wire or the first wire is connected with the negative electrode of the multi-mode energy generator, and the first split electrode set and the second split electrode set are excited according to the excitation of the multi-mode energy generator so as to generate discharge in the directions of the first split electrode set and the second split electrode set, so that the generation of the annular shock wave is induced.

8. The shock wave balloon catheter system of claim 6, wherein the electrode pair further comprises 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 outer electrode is arranged on the insulating layer, the outer electrode is provided with a second opening, and the second opening and the first opening are coaxially arranged.

9. The shock wave balloon catheter system of claim 5, wherein the shock wave balloon catheter further comprises a feedback module;

the feedback module is arranged in the shock wave balloon and above the shock wave balloon catheter electrode assembly; the feedback module comprises at least one of a temperature sensor, a pressure sensor, a voltage sensor and a current sensor, and is used for acquiring feedback information of the shock wave balloon catheter to feed back the multi-mode energy generator, wherein the feedback information comprises at least one of current information, voltage information, temperature information or pressure information.

10. The shock wave balloon catheter system of claim 5, wherein the shock wave balloon catheter further comprises a catheter body and a catheter hub;

the catheter body sequentially comprises from one end of the catheter body comprising the shock wave balloon catheter to one end of the catheter body comprising the multimode energy generator: a tip, an inner tube, an outer tube, and a hypotube;

the tip is arranged at one end of the inner tube far away from the shock wave balloon, and the outer diameter and the thickness of the tip are gradually increased in the direction towards the shock wave balloon;

The inner tube is of an elongated tube structure with a cavity, is arranged inside the outer tube and extends towards the distal end, and the shock wave balloon is arranged on the outer surface of the inner tube;

the outer tube is of an elongated tube structure with a cavity, is arranged at the other end of the shock wave balloon and is used for providing supporting force for the shock wave balloon catheter;

the hypotube is of an elongated tube structure with a cavity and comprises a filling cavity and a wire cavity; the filling cavity is used for providing a conveying liquid for the shock wave balloon; the wire cavity is used for installing a wire led out by the shock wave balloon catheter electrode assembly;

the catheter seat is connected with the shock wave balloon through the hypotube, the multimode energy generator can be arranged in the catheter seat, and the catheter seat is connected with the shock wave balloon catheter electrode assembly through the lead.