Uniform energy shock wave electrode structure and shock wave balloon catheter

Abstract

The present invention provides a uniform energy shock wave electrode structure and a shock wave balloon catheter, which relate to the field of interventional medical devices. The uniform energy shock wave electrode structure comprises an electrode structure body, a first electrode, a second electrode and an insulating layer, wherein the first electrode, the second electrode and the insulating layer are all arranged on the outer peripheral surface of the electrode structure body, the first electrode and the second electrode are arranged in parallel and spaced apart, and the insulating layer is arranged between the first electrode and the second electrode. The beneficial effect of the present invention is that the first electrode and the second electrode are arranged in parallel and spaced apart on the outer peripheral surface of the electrode structure body, so that the discharge distance between the first electrode and the second electrode is the same in the circumferential direction, or in the axial direction, or in the circumferential direction and in the axial direction, a single energy stable shock wave is obtained, and the shock wave energy is evenly distributed in the circumferential direction, in the axial direction, in the circumferential direction and in the axial direction, and even in any angle between the radial direction and the axial direction.

Description

Technical Field

[0001] The present invention relates to the technical field of interventional medical devices, and in particular to a uniform energy shock wave electrode structure and a shock wave balloon catheter. Background Art

[0002] The electrohydraulic shock wave is generated by electrodes in a conductive fluid. When a high-voltage pulse current is passed through two electrodes of different polarity in a conductive fluid, a high-temperature arc will be generated between the two closest points on the two electrodes of different polarity. While forming the shock wave, the high-temperature arc will generate a large amount of heat and form a strong mechanical impact force. The heat of the high-temperature arc can cause the two locations on the electrode where the shock wave is generated to melt and form ablation.

[0003] The current shock wave catheter has been marketed and its safety and effectiveness have been fully verified. It is used to loosen or crack the tissue to be treated (such as calcified lesion tissue) in the coronary artery or peripheral blood vessels, so that the balloon can be inflated to complete the expansion, thereby alleviating the degree of stenosis of the blood vessels or facilitating subsequent treatment. The existing shock wave electrode structure is similar to a point electrode, and the point electrode is provided with a concave accommodation space, and an effective shock wave is formed in the concave accommodation space. Since the structure of the existing shock wave electrode is similar to that of a point electrode, the shock wave energy distribution is uneven in the circumferential and axial directions of the electrode structure. In addition, the existing shock wave electrode is insulated by a polymer insulating material. However, under the action of the thermal energy of the shock wave, the polymer insulating material will quickly melt or crack to form a melt and a cracked product with an unknown molecular structure; on the one hand, these melts and cracked products will remain in the concave accommodating space, causing a significant change in the discharge conditions of the shock wave electrode; on the other hand, these melts and cracked products will further form a mixture with extremely weak conductivity with the molten part of the electrode (referred to as the metal melt), greatly reducing the conductivity of the electrode, and ultimately causing the electrode to be unable to discharge and break down, thereby causing the existing shock wave electrode to fail.

[0004] Currently, existing technologies cannot solve this problem. Summary of the invention

[0005] In view of this, the embodiments of this specification provide a uniform energy shock wave electrode structure and a shock wave balloon catheter to achieve a more uniform shock wave energy distribution.

[0006] The embodiments of this specification provide the following technical solutions: a uniform energy shock wave electrode structure, comprising an electrode structure body, a first electrode, a second electrode and an insulating layer, wherein the first electrode, the second electrode and the insulating layer are all arranged on the outer peripheral surface of the electrode structure body, the first electrode and the second electrode are arranged in parallel and spaced apart, and the insulating layer is arranged between the first electrode and the second electrode.

[0007] The present invention also provides a shock wave balloon catheter, comprising a covering layer and the above-mentioned uniform energy shock wave electrode structure arranged inside the covering layer.

[0008] Compared with the prior art, the beneficial effects that can be achieved by at least one of the above-mentioned technical solutions adopted in the embodiments of this specification include at least: the first electrode and the second electrode are arranged in parallel and spaced apart on the outer circumferential surface of the electrode structure body, so that the discharge distance between the first electrode and the second electrode is the same in the circumferential direction, or in the axial direction, or in the circumferential and axial directions, so as to obtain a single energy stable shock wave, and make the shock wave energy uniformly distributed in the circumferential direction, in the axial direction, in the circumferential and axial directions, and even at any angle between the radial and axial directions.

[0009] The present invention allows ablation of electrodes and insulating layers, and the molten material from electrode ablation will not have a significant negative impact on the electrode structure. Compared with the prior art, the discharge distance can be increased to obtain a greater single energy; or when the discharge distance remains unchanged and the single energy obtained remains unchanged, a sufficient number of effective shock waves can be generated, thereby having a longer service life. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings required for use in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work.

[0011] Figure 1 is a front view schematic diagram of a first embodiment of the present invention;

[0012] Figure 2 is a three-dimensional schematic diagram of a first embodiment of the present invention;

[0013] Figure 3 is a perspective schematic diagram of a second embodiment of the present invention;

[0014] Figure 4 is a three-dimensional schematic diagram of a third embodiment of the present invention;

[0015] Figure 5 is a front view schematic diagram of a third embodiment of the present invention;

[0016] Figure 6 yes Figure 5 AA sectional view of FIG.

[0017] Figure 7 yes Figure 5 BB-direction cross-sectional schematic diagram;

[0018] Figure 8is a front view schematic diagram of a fourth embodiment of the present invention;

[0019] Fig. 9 is a front view schematic diagram of a fourth embodiment of the present invention;

[0020] Fig.10 yes Fig. 9 AA sectional view of FIG.

[0021] Fig.11 yes Fig. 9 BB-direction cross-sectional schematic diagram;

[0022] Fig.12 is a front view schematic diagram of a fifth embodiment of the present invention;

[0023] Fig.13 is a front view schematic diagram of a sixth embodiment of the present invention;

[0024] Fig.14 is a front view schematic diagram of a seventh embodiment of the present invention;

[0025] Fig.15 is a front view schematic diagram of an eighth embodiment of the present invention;

[0026] Fig.16 is a front view schematic diagram of a ninth embodiment of the present invention;

[0027] Fig.17 yes Fig.16 A three-dimensional schematic diagram of

[0028] Fig.18 is a front view schematic diagram of a tenth embodiment of the present invention;

[0029] Fig.19 yes Fig.18 A three-dimensional schematic diagram of

[0030] Fig. 20 is a front view schematic diagram of an eleventh embodiment of the present invention;

[0031] Fig.21 yes Fig. 20 A three-dimensional schematic diagram of .

[0032] Reference numerals in the figure: 1. electrode structure body; 2. first electrode; 3. second electrode; 4. insulating layer; 5. additional insulating layer. DETAILED DESCRIPTION

[0033] The embodiments of the present application are described in detail below with reference to the accompanying drawings.

[0034] It should be noted that, in the absence of conflict, the embodiments and features in the embodiments of the present application can be combined with each other. The present invention will be described in detail below with reference to the accompanying drawings and in combination with the embodiments.

[0035] Concepts and principles of the present application: "Distal end" refers to the end far away from the connection wire location, which may be one or two. "Proximal end" refers to the part where the connection wire is located, which may also be the end. Effective discharge breakdown refers to the single discharge breakdown between electrodes that can form an effective shock wave. Effective shock wave means that the shock wave energy released by the single shock wave has a therapeutic effect on the treated tissue. Single energy refers to the shock wave energy released by a single effective shock wave. The effective distance refers to the distance between the location where the effective shock wave occurs and the tissue to be treated. The service life refers to the total number of effective shock waves that can be released by the shock wave electrode structure. The discharge distance refers to the electrical gap between the positive and negative electrodes (when the two electrodes are only insulated by air) or the creepage distance (when there is an insulator between the two electrodes that affects the electrical gap). The exposed area of ​​the electrode refers to the surface area of ​​the positive electrode or the negative electrode that has discharge performance.

[0036] Only when the shock wave energy released by a single shock wave is large enough and the action distance is close enough can it have an effect on the treated tissue, and the single shock wave will be considered an effective shock wave. To have a therapeutic effect on the treated tissue with more serious lesions, a higher single energy of the effective shock wave is required. At the same time, more heat and greater mechanical impact force are generated by the shock wave. The factors that affect the single energy size in the discharge conditions of the shock wave electrode are mainly the discharge distance and the exposed area of ​​the electrode.

[0037] With other conditions unchanged:

[0038] 1. The exposed area of ​​the electrode remains unchanged: the greater the discharge distance, the greater the applied voltage required for the electrode to form an effective shock wave, and at the same time, the greater the single energy of the effective shock wave; vice versa; that is, keeping the exposed area of ​​the electrode unchanged, the size of the single energy can be changed by changing the discharge distance.

[0039] 2. The single shock wave energy when the electrode with a smaller exposed area is the positive electrode is greater than the single shock wave energy when the electrode with a smaller exposed area is the negative electrode. When the exposed area of ​​the positive electrode is equal to the exposed area of ​​the negative electrode, the ablation speed of the positive electrode will be faster during the release of the shock wave.

[0040] Reference Figures 1 to 21 As shown, an embodiment of the present invention provides a shock wave electrode structure with uniform energy, specifically comprising an electrode structure body 1, a first electrode 2, a second electrode 3 and an insulating layer 4, wherein the first electrode 2, the second electrode 3 and the insulating layer 4 are all arranged on the outer peripheral surface of the electrode structure body 1, the first electrode 2 and the second electrode 3 are arranged in parallel and spaced apart, and the insulating layer 4 is arranged between the first electrode 2 and the second electrode 3.

[0041] The first electrode 2 and the second electrode 3 are arranged in parallel and spaced on the outer circumference of the electrode structure body 1, and the discharge distance between the first electrode 2 and the second electrode 3 is the same. The single energy of the shock wave released by the embodiment of the present invention is basically the same, that is, a shock wave with stable single energy can be obtained, thereby obtaining a uniform shock wave energy distribution. If the first electrode 2 and the second electrode 3 are along the outer circumference of the electrode structure body 1 and form an angle of any angle from 0° to 90° with the axial direction, the embodiment of the present invention can obtain a uniformly distributed shock wave energy in the direction of any angle from 0° to 90° with the axial direction. When the first electrode 2 and the second electrode 3 are along the outer circumference of the electrode structure body 1 and form an angle of 0° with the axial direction, that is, the first electrode 2 and the second electrode 3 are distributed along the axial direction of the outer circumference of the electrode structure body 1, the embodiment of the present invention can obtain a uniformly distributed shock wave energy in the axial direction. When the first electrode 2 and the second electrode 3 are along the outer circumference of the electrode structure body 1 and form an angle of 90° with the axial direction, that is, the first electrode 2 and the second electrode 3 are distributed along the circumference of the outer circumference of the electrode structure body 1, the embodiment of the present invention can obtain a uniformly distributed shock wave energy in the circumferential direction. Since the ablation of the electrode and the insulating layer has a low negative impact on the effective discharge breakdown, the discharge distance can be increased so that the embodiment has a larger single energy, or, when the discharge distance and the obtained single energy remain unchanged, the embodiment can generate a sufficient number of effective shock waves and have a longer service life. Therefore, the embodiment of the present invention can generate more times, larger single energy and more stable shock waves, the shock wave energy is evenly distributed, and has a longer service life.

[0042] Preferably, the first electrode 2, the second electrode 3 and the insulating layer 4 are at least located on the same plane or convex surface (e.g., arc surface). When an effective shock wave is formed between the first electrode 2 and the second electrode 3, the effective shock wave is formed on the surface of the insulating layer 4, and the melt formed by the ablation of the first electrode 2 and the second electrode 3 and the melt formed by the melting of the insulating layer 4 are all located on the outer peripheral surface of the electrode structure body 1. At the same time, the mechanical impact force generated by the formation of the shock wave will also carry away the melt of the first electrode 2, the melt of the second electrode 3 and the melt of the insulating layer 4 through the impact (dispersed in the conductive liquid), so that the embodiment of the present invention has a self-cleaning function to avoid the accumulation of the melt of the electrode and the melt of the insulating layer to have a greater negative impact on the effective discharge breakdown, and completely avoid the failure of the embodiment of the present invention.

[0043] In one embodiment of the present invention, the rotation axis of the first electrode 2 is collinear with the rotation axis of the second electrode 3, and both are parallel to the rotation axis of the electrode structure body 1. In this embodiment, the energy distribution of the shock wave formed between the first electrode 2 and the second electrode 3 in the circumferential direction is uniform.

[0044] Specifically, the following implementations may be used:

[0045] For example: the first electrode 2 and the second electrode 3 are both closed annular structures. The first electrode 2 and the second electrode 3 are arranged at equal intervals along the axis of the electrode structure body 1 to form discharge gaps of the same length. The insulating layer 4 is disposed in the discharge gap between the first electrode 2 and the second electrode 3 to ensure electrical isolation between the electrodes. This design enables the embodiment of the present invention to release a single shock wave with equal energy, and obtain shock wave energy that is basically evenly distributed in the circumferential direction of the electrode structure body 1, thereby obtaining a better shock wave therapy effect. Furthermore, if the first electrode 2, the second electrode 3 and the insulating layer 4 are located on the same circumferential surface, such as Figure 1 and Figure 2 As shown, this embodiment also has a self-cleaning function. The effective shock wave released between the first electrode 2 and the second electrode 3 is formed on the outer surface of the insulating layer 4. The mechanical impact force brought by the shock wave can carry away the molten material of the electrode and the molten material of the insulating layer 4 through the impact, thereby avoiding the accumulation of the molten material of the electrode and the molten material of the insulating layer, which has a greater negative impact on the effective discharge breakdown. As a result, the embodiment of the present invention can generate more times, larger single energy and more stable shock waves, the shock wave energy is evenly distributed, and has a longer service life.

[0046] Preferably, the insulating layer 4 of this embodiment is made of a material with high dielectric strength and good thermal stability to withstand the high temperature and voltage generated during discharge. The electrode material is selected from corrosion-resistant, high-melting-point conductors such as tungsten alloys and platinum-iridium alloys to improve durability and discharge efficiency.

[0047] Specifically, the following implementations may also be used, for example:

[0048] The first electrode 2 is a closed circular ring structure, and the second electrode 3 is a circular ring structure surrounded by a plurality of arc segments arranged at intervals, or;

[0049] The first electrode 2 is a circular ring structure surrounded by a plurality of arc segments arranged at intervals, and the second electrode 3 is a closed circular ring structure, or;

[0050] The first electrode 2 and the second electrode 3 are both circular ring structures surrounded by a plurality of arc segments arranged at intervals. Preferably, the arc lengths of the arc segments of the first electrode 2 are equal, and the arc segments of the first electrode 2 are arranged one-to-one with the arc segments of the second electrode 3.

[0051] The above embodiments all divide the electrode into multiple independent segments, each of which is connected in parallel with a high-voltage power supply to allow the segments to discharge independently. If a certain segment of the electrode is blown, it will not affect the discharge of other segments, thereby improving the reliability and overall service life of the electrode structure. At the same time, the segmented design allows each electrode segment to be independently monitored and controlled, thereby improving the flexibility and adaptability of the system.

[0052] In the above embodiment, the plurality of arc segments arranged at intervals realizes precise control of the shock wave discharge position to ensure uniform current distribution.

[0053] In such Figure 3 In the embodiment shown, the separated sections in the above embodiment are symmetrical along the axis center. When discharging at the same time, since the single energy of the effective shock wave is almost the same, the mechanical impact force formed is almost the same and basically toward the axis center, which will keep the electrode stable during the process of releasing the shock wave.

[0054] like Fig.12 As shown, the first electrode 2 and the second electrode 3 extend in the same direction and are parallel to the axis of rotation of the electrode structure body 1. The discharge distance between the first electrode 2 and the second electrode 3 is the same, and the insulating layer 4 is arranged in the discharge gap between the first electrode 2 and the second electrode 3 to ensure electrical isolation between the electrodes. This design enables the embodiment of the present invention to release a single shock wave with equal energy, and obtain shock wave energy that is basically evenly distributed in the axial direction of the electrode structure body 1, thereby obtaining a better shock wave treatment effect.

[0055] Specifically, the specific implementation examples of the above-mentioned type of solution are as follows:

[0056] The first electrode 2 and the second electrode 3 are both strip electrodes with the same length, or;

[0057] The first electrode 2 is a strip electrode, and the second electrode 3 is a strip electrode composed of a plurality of strip electrode units arranged at intervals, and the strip electrodes have the same length, or;

[0058] The first electrode 2 is a strip electrode composed of a plurality of strip electrode units arranged at intervals, the second electrode 3 is a strip electrode and the strip electrodes have the same length, or;

[0059] The first electrode 2 and the second electrode 3 are both strip electrodes composed of a plurality of strip electrode units arranged at intervals.

[0060] The electrodes are designed as strip structures that are equally spaced along the axial direction to ensure that the energy is evenly distributed in the length direction. This layout allows continuous and uniform shock wave treatment of the inner wall of the blood vessel. The electrode material is selected from metals with high conductivity, corrosion resistance and appropriate melting point, such as tungsten or platinum-iridium alloy, to ensure stable performance and long life under high voltage.

[0061] The insulating layer 4 is disposed between the first electrode 2 and the second electrode 3, and is preferably made of a polymer insulating material to maintain the flexibility of the tube, such as polyimide or silica gel, which has good mechanical properties and thermal stability to ensure safety during operation.

[0062] In the third embodiment, the first electrode 2 and the second electrode 3 are both arranged obliquely relative to the rotation axis of the electrode structure body 1. The present invention is designed to form a specific angle (between 0°-90°, excluding 0° and 90°) between at least one group of annular or strip electrodes and the rotation axis of the electrode structure body 1 to obtain relatively uniform distribution of shock wave energy in both the circumferential direction and the axial direction.

[0063] The specific implementation scheme of this type of embodiment is as follows:

[0064] The first electrode 2 and the second electrode 3 are both closed elliptical ring structures, or;

[0065] The first electrode 2 is a closed elliptical ring structure, and the second electrode 3 is an elliptical ring structure surrounded by a plurality of arc segments arranged at intervals, or;

[0066] The first electrode 2 is an elliptical ring structure surrounded by a plurality of arc segments arranged at intervals, and the second electrode 3 is a closed elliptical ring structure, or;

[0067] The first electrode 2 and the second electrode 3 are both elliptical ring structures surrounded by a plurality of arc segments arranged at intervals, or;

[0068] The first electrode 2 and the second electrode 3 are both strip electrodes with the same length, or;

[0069] The first electrode 2 is a strip electrode, and the second electrode 3 is a strip electrode composed of a plurality of strip electrode units arranged at intervals, and the strip electrodes have the same length, or;

[0070] The first electrode 2 is a strip electrode composed of a plurality of strip electrode units arranged at intervals, the second electrode 3 is a strip electrode and the strip electrodes have the same length, or;

[0071] The first electrode 2 and the second electrode 3 are both strip electrodes composed of a plurality of strip electrode units arranged at intervals.

[0072] The above embodiments provide the present invention with more diverse energy distribution options to meet different treatment needs. At the same time, when designing the electrode structure, the melting point of the electrode material and the melting point of the insulating layer need to be considered to ensure stable performance during the discharge process.

[0073] By optimizing the electrode angle, the diseased tissue can be fully treated without increasing the complexity of the operation, thus improving the efficiency of the operation. It can also more effectively promote the loosening and cracking of the diseased tissue, which is helpful for the expansion of blood vessels and the subsequent treatment.

[0074] like Fig. 20 and Fig.21As shown, the embodiment of the present invention also provides a type of solution, in which the first electrode 2 and the second electrode 3 are both spiral structures. The double helix structure provides a continuous energy transfer path, so that the shock wave can be transmitted along the circumference and axial direction covered by the double helix structure on the electrode, thereby achieving a more uniform energy distribution. Compared with a traditional single or multiple electrodes, the double helix structure can cover a wider area, ensuring that the shock wave can reach all parts of the blood vessel wall.

[0075] Because the double helix structure can provide a wider coverage area and more uniform energy distribution, the same therapeutic effect can be achieved with fewer discharge times, thereby improving treatment efficiency.

[0076] Reference Figures 13 to 19 As shown, the first electrode 2 , the insulating layer 4 , and the second electrode 3 form an electrode group. The uniform energy shock wave electrode structure includes a plurality of electrode groups, and the plurality of electrode groups are distributed at intervals along the circumference or axial direction of the electrode structure body 1 .

[0077] By setting different electrode groups, the multiple electrode groups can be evenly distributed or unevenly distributed, so that electrodes can be distributed at intervals in different positions, and more uniform energy transfer can be achieved around the catheter, ensuring that the shock wave energy is evenly covered in the entire treatment area.

[0078] If an equally spaced distribution is adopted, the spaced electrodes allow for more precise control of the release point of the shock wave, so that the doctor can adjust the discharge point according to the specific location and size of the diseased tissue to achieve precise treatment.

[0079] If a non-equally spaced distribution is adopted, multiple groups of electrodes can be adjusted according to different vascular anatomical structures and lesion characteristics, thereby improving the adaptability and flexibility of the device.

[0080] At the same time, the spacing distribution between the multiple electrode groups helps the mechanical force generated by the shock wave to more effectively remove the molten material on the electrode surface and the molten material in the insulating layer, maintaining the cleanliness and discharge efficiency of the electrode.

[0081] Reference Figures 4 to 8 As shown, the uniform energy shock wave electrode structure of the present invention further includes an additional insulating layer 5, which covers the outer surface of the first electrode 2, the insulating layer 4 and the second electrode 3, and the distal ends of the first electrode 2 and the second electrode 3 are both exposed. When the additional insulating layer 5 is provided, only a very small exposed portion is retained at the distal end of the electrode (the farthest end away from the wire connection position), which effectively reduces the exposed area of ​​the electrode, increases the current on the electrode, and further increases the single energy.

[0082] Reference Figures 9 to 12As shown, the additional insulating layer 5 only covers the outer surfaces of the first electrode 2 and the second electrode 3 , and the distal ends of the first electrode 2 and the second electrode 3 are both exposed but not covered by the insulating layer 4 .

[0083] Since the electrode is thinner and the exposed area is smaller, the current on the electrode is larger, the single energy is larger, the heat generated by the shock wave is larger, and the mechanical impact force is larger, resulting in three phenomena: 1) the electrode ablation is faster, 2) the additional insulating layer melts faster, and 3) the ablated material of the additional insulating layer is carried away by the mechanical impact force faster. The above three phenomena enable the electrode to be gradually ablated from the far end to the near end of the electrode like an incense candle. During the whole process, the electrode will not melt, so the entire electrode can participate in the discharge breakdown, achieve complete ablation, and have a longer service life.

[0084] The beneficial effects of the above embodiment are as follows: when the electrode discharges, it will start to discharge from the far end. During the entire breakdown discharge process, as the additional insulating layer is melted by the heat accompanying the shock wave and the melt of the additional insulating layer is peeled off by the mechanical impact force, the electrode discharges in sequence from the far end to the near end. The lower the melting point of the additional insulating layer, the easier it is to melt. Preferably, the additional insulating layer is a polymer insulating material with a lower melting point. Under mechanical impact, the melt is easier to be peeled off than the additional insulating layer.

[0085] For example: Example 1, the insulating layer is silicone, and the additional insulating layer is nylon. Example 2, the insulating layer is an inorganic insulating material, such as ceramic, and the additional insulating layer is a polymer (may include organic silicone). Since the thermal conductivity, melting point and impact strength of inorganic insulating materials are higher than those of polymer insulating materials, the insulating layer produces very little melt under the action of the heat accompanying the shock wave, and the insulating layer will not produce a large amount of melt and cracking products with unknown molecular structure, which completely solves the problem that the existing shock wave electrode uses polymer insulating materials, which will cause the discharge conditions of the shock wave electrode to change rapidly and significantly, thereby causing the shock wave electrode to fail and be unable to continue to discharge. Example 3, the insulating layer and the additional insulating layer are both polymers, which is conducive to maintaining the flexibility of the tube body.

[0086] According to different requirements, the additional insulating layer can be applied to all the above embodiments, for example, it can be selected to cover only the electrode part, or cover the electrode and the insulating layer part. And the melting point of the additional insulating layer can be lower than the melting point of the insulating layer.

[0087] In one embodiment, the present invention selects an electrode material with a higher melting point for the positive electrode.

[0088] The shock wave electrode structure that selects a material with a higher melting point as the positive electrode not only significantly improves the durability and service life of the electrode, but also enhances the thermal stability of the electrode under high-temperature discharge conditions, ensuring the high efficiency of the discharge process and the uniformity of energy conversion. This design optimizes the transfer and distribution of energy and improves the effectiveness of treatment. In addition, the application of high-melting-point electrode materials also expands the scope of application of the equipment, enabling it to adapt to the treatment needs of higher energy output, while promoting technological innovation and improving the overall treatment experience of patients.

[0089] In another embodiment, the positive and negative electrodes are exchanged during the discharge process. For example, the positive and negative electrodes are exchanged once for each shock wave. That is, when the shock wave is released for the first time, the first electrode 2 is the positive electrode and the second electrode 3 is the negative electrode. When the shock wave is released for the second time, the first electrode 2 is the negative electrode and the second electrode 3 is the positive electrode.

[0090] Implementing a positive-negative exchange strategy, that is, alternating the polarity of the electrode each time the shock wave is released, not only balances the electrode ablation rate and prolongs the service life of the electrode, but also improves the discharge efficiency and reliability of the device. This design effectively avoids local overheating of the electrode and material degradation, reduces the formation of hot spots, and ensures that each discharge can reach the expected energy level, thereby ensuring the consistency of the treatment effect.

[0091] The present invention also provides a shock wave balloon catheter, comprising a covering layer and the above-mentioned uniform energy shock wave electrode structure arranged inside the covering layer.

[0092] The uniform energy shock wave electrode structure and shock wave balloon catheter of the present application can achieve more uniform shock wave energy distribution, obtain greater single energy, have a longer service life, can stably generate shock waves with a sufficient number of times and strong enough single energy, and have sufficiently large cumulative shock wave energy, so that shock wave therapy can be completed without replacing the catheter during surgery, reducing the operator's operating difficulty and shortening the operation time.

[0093] The above is only a specific embodiment of the present invention, and cannot be used to limit the scope of the invention. Therefore, the replacement of equivalent components, or equivalent changes and modifications made according to the scope of protection of the patent of the present invention, should still fall within the scope of this patent. In addition, the technical features of the present invention can be freely combined with each other, with each other, and with each other.

Claims

1. A uniform energy shock wave electrode structure, characterized in that: The invention comprises an electrode structure body (1), a first electrode (2), a second electrode (3) and an insulating layer (4), wherein the first electrode (2), the second electrode (3) and the insulating layer (4) are all arranged on the outer peripheral surface of the electrode structure body (1), the first electrode (2) and the second electrode (3) are arranged in parallel and spaced apart, and the insulating layer (4) is arranged between the first electrode (2) and the second electrode (3); the uniform energy shock wave electrode structure further comprises an additional insulating layer (5), the additional insulating layer (5) covers the outer surfaces of the first electrode (2), the insulating layer (4) and the second electrode (3), or the additional insulating layer (5) covers the outer surfaces of the first electrode (2) and the second electrode (3), and only a very small exposed portion is retained at the farthest end of the first electrode (2) away from the wire connection position and the farthest end of the second electrode (3) away from the wire connection position; When the first electrode (2) and the second electrode (3) discharge, the discharge starts from the far end. During the entire breakdown discharge process, as the additional insulating layer (5) is melted by the heat accompanying the shock wave and the melt of the additional insulating layer (5) is peeled off by the mechanical impact force, the first electrode (2) and the second electrode (3) discharge in sequence from the far end to the near end.

2. The uniform energy shock wave electrode structure according to claim 1, characterized in that: The rotation axis of the first electrode (2) and the rotation axis of the second electrode (3) are colinear, and both are parallel to the rotation axis of the electrode structure body (1).

3. The uniform energy shock wave electrode structure according to claim 2, characterized in that: The first electrode (2) and the second electrode (3) are both closed annular structures, or; The first electrode (2) is a closed circular ring structure, and the second electrode (3) is a circular ring structure surrounded by a plurality of circular arc segments arranged at intervals, or; The first electrode (2) is a circular ring structure formed by a plurality of circular arc segments arranged at intervals, and the second electrode (3) is a closed circular ring structure, or; The first electrode (2) and the second electrode (3) are both circular ring structures surrounded by a plurality of circular arc segments arranged at intervals.

4. The uniform energy shock wave electrode structure according to claim 1, characterized in that: The first electrode (2) and the second electrode (3) extend in the same direction and are both parallel to the rotation axis of the electrode structure body (1).

5. The uniform energy shock wave electrode structure according to claim 4, characterized in that: The first electrode (2) and the second electrode (3) are both strip electrodes with the same length, or; The first electrode (2) is a strip electrode, and the second electrode (3) is a strip electrode composed of a plurality of strip electrode units arranged at intervals, and the strip electrodes have the same length as the strip electrodes, or; The first electrode (2) is a strip electrode composed of a plurality of strip electrode units arranged at intervals, the second electrode (3) is a strip electrode and the strip electrode has the same length as the strip electrode, or; The first electrode (2) and the second electrode (3) are both strip electrodes composed of a plurality of strip electrode units arranged at intervals.

6. The uniform energy shock wave electrode structure according to claim 1, characterized in that: The first electrode (2) and the second electrode (3) are both arranged obliquely relative to the rotation axis of the electrode structure body (1).

7. The uniform energy shock wave electrode structure according to claim 6, characterized in that: The first electrode (2) and the second electrode (3) are both closed elliptical ring structures, or; The first electrode (2) is a closed elliptical ring structure, and the second electrode (3) is an elliptical ring structure surrounded by a plurality of circular arc segments arranged at intervals, or; The first electrode (2) is an elliptical ring structure surrounded by a plurality of arc segments arranged at intervals, and the second electrode (3) is a closed elliptical ring structure, or; The first electrode (2) and the second electrode (3) are both elliptical ring structures surrounded by a plurality of arc segments arranged at intervals, or; The first electrode (2) and the second electrode (3) are both strip electrodes with the same length, or; The first electrode (2) is a strip electrode, and the second electrode (3) is a strip electrode composed of a plurality of strip electrode units arranged at intervals, and the strip electrodes have the same length as the strip electrodes, or; The first electrode (2) is a strip electrode composed of a plurality of strip electrode units arranged at intervals, the second electrode (3) is a strip electrode and the strip electrode has the same length as the strip electrode, or; The first electrode (2) and the second electrode (3) are both strip electrodes composed of a plurality of strip electrode units arranged at intervals.

8. The uniform energy shock wave electrode structure according to claim 1, characterized in that: The first electrode (2) and the second electrode (3) are both spiral structures.

9. The uniform energy shock wave electrode structure according to any one of claims 1 to 8, characterized in that: The first electrode (2), the insulating layer (4) and the second electrode (3) form an electrode group, and the uniform energy shock wave electrode structure comprises a plurality of the electrode groups, and the plurality of the electrode groups are distributed at intervals along the circumference or axial direction of the electrode structure body (1).

10. A shock wave balloon catheter, characterized in that: The invention comprises a covering layer and a uniform energy shock wave electrode structure as claimed in any one of claims 1 to 9 arranged inside the covering layer.

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