Electrode assembly, balloon catheter and balloon shock wave device

Abstract

This application provides an electrode assembly for a balloon catheter, a balloon catheter, and a balloon shockwave device. The balloon catheter includes an inner balloon tube, and the electrode assembly includes a first electrode, an insulating layer, and a second electrode. The first electrode is disposed on the outer surface of the inner balloon tube; the insulating layer is disposed on the outer surface of the first electrode, and a first opening is provided at a side end of the insulating layer; the second electrode is disposed on the outer surface of the insulating layer, and a second opening is provided at a side end of the second electrode corresponding to the first opening. The relative position of the first and second openings along the circumference can be adjusted, and the first and second openings are used for precise control of the discharge position. The electrode assembly of this application, by providing openings on the outer electrode and the insulating layer, achieves precise control of the arc discharge position, thereby enhancing the lithotripsy effect of the electrode assembly in the precise area and effectively improving the lithotripsy efficiency of the electrode assembly.

Description

Technical Field

[0001] This application relates to the field of vascular disease treatment, and more particularly to an electrode assembly for a balloon catheter, a balloon catheter, and a balloon shockwave device. Background Technology

[0002] Intravascular balloon lithotripsy (IVL) devices can be divided into three key hardware components: electrodes, a balloon, and a main unit. It involves placing one or more electrodes inside a dilating balloon that generate shock waves, connecting them to a main unit via cables. The main unit then controls the simultaneous or time-sharing release of shock waves from these electrodes. In IVL, the design of the electrodes affects parameters such as the energy of the released shock waves, electrode lifespan, balloon size, the number of connecting cables, and wiring complexity.

[0003] Currently, the balloon catheter lithotripsy technology has unsatisfactory results, as it is difficult to precisely control the discharge location of the electric arc, resulting in low lithotripsy efficiency and causing many inconveniences for doctors and patients.

[0004] In the background section, the information disclosed above is only used to enhance the understanding of the background of this application, and therefore may include prior art information that does not constitute prior art information known to those skilled in the art. Summary of the Invention

[0005] At least one embodiment of this application provides an electrode assembly for a balloon catheter, a balloon catheter, and a balloon shockwave device.

[0006] In a first aspect, at least one embodiment of this application provides an electrode assembly for a balloon catheter, the balloon catheter including an inner balloon tube. The electrode assembly includes a first electrode, an insulating layer, and a second electrode. The first electrode is disposed on the outer surface of the inner balloon tube of the balloon catheter; the insulating layer is disposed on the outer surface of the first electrode, and a first opening is provided at a side end of the insulating layer; the second electrode is disposed on the outer surface of the insulating layer, and a second opening is provided at a side end corresponding to the first opening; the relative position of the first opening and the second opening in the circumferential direction can be adjusted, and the first opening and the second opening are used for targeted control of the discharge position.

[0007] Secondly, at least one embodiment of this application provides a balloon catheter. It includes an inner balloon tube and an electrode assembly as described in any embodiment of the first aspect, the electrode assembly being disposed on the outer surface of the inner balloon tube.

[0008] Thirdly, at least one embodiment of this application provides a balloon shockwave device that includes the balloon catheter in any embodiment of the second aspect.

[0009] For example, in some embodiments of the first, second, or third aspects of this application, the first opening has a first central axis along the axial direction of the electrode assembly, and the first opening is symmetrical about the first central axis; the second opening has a second central axis along the axial direction of the electrode assembly, and the second opening is symmetrical about the second central axis.

[0010] For example, in some embodiments of the first, second, or third aspects of this application, the first central axis and the second central axis are located in the same plane.

[0011] For example, in some embodiments of the first, second, or third aspects of this application, the first opening is one of a semi-circular hole, a semi-elliptical hole, a semi-rhomboid hole, and a triangular hole; the second opening is one of a semi-circular hole, a semi-elliptical hole, a semi-rhomboid hole, and a triangular hole.

[0012] For example, in some embodiments of the first, second, or third aspects of this application, the first electrode includes: a first discharge portion exposed to the second electrode through the first opening; and a first structural portion, wherein the first discharge portion is fixed to the first structural portion, and the insulating layer partially or completely covers the first structural portion.

[0013] For example, in some embodiments of the first, second, or third aspects of this application, the first electrode is prepared on the outer surface of the inner tube of the balloon by any one of weaving, spraying, chemical vapor deposition, electroplating, or ion sputtering; and / or the insulating layer is prepared on the outer surface of the first electrode by any one of printing, electroplating, CVD, PVD, or ion sputtering; and / or the second electrode is prepared on the outer surface of the insulating layer by any one of printing, electroplating, or magnetron sputtering.

[0014] For example, in some embodiments of the second or third aspect of this application, the balloon catheter includes: a first electrode assembly, including: a first inner electrode disposed on the outer surface of the balloon inner tube; a first insulating layer disposed on the outer surface of the first inner electrode, the side end of the first insulating layer having a first insulating layer opening; a first outer electrode disposed on the outer surface of the first insulating layer, the side end of the first outer electrode having a first outer electrode opening corresponding to the first insulating layer opening, the first insulating layer opening and the first outer electrode opening being used to control the discharge position of the first electrode assembly; and a second electrode assembly, including: a second inner electrode disposed at a distance from the first inner electrode on the outer surface of the balloon inner tube; a second insulating layer disposed on the outer surface of the second inner electrode, the side end of the second insulating layer having a second insulating layer opening; a second outer electrode disposed on the outer surface of the second insulating layer, the side end of the second outer electrode having a second outer electrode opening corresponding to the second insulating layer opening, the second insulating layer opening and the second outer electrode opening being used to control the discharge position of the second electrode assembly.

[0015] For example, in some embodiments of the second or third aspect of this application, the orientation of the discharge position of the first electrode assembly and the orientation of the discharge position of the second electrode assembly are different along the circumferential direction of the inner tube of the balloon.

[0016] The electrode assembly of this application achieves precise control of the arc discharge position by setting openings on the outer electrode and the isolation layer, thereby enhancing the stone-breaking effect of the electrode assembly in the fixed area and effectively improving the stone-breaking efficiency of the electrode assembly.

[0017] It should be understood that the above general description and the following detailed description are merely exemplary and do not limit this application. Attached Figure Description

[0018] To more clearly illustrate the technical solutions in the embodiments of this application, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0019] Figure 1 A schematic diagram of the structure of an electrode assembly according to an example embodiment of this application is shown.

[0020] Figure 2 A schematic diagram of the discharge position of an electrode assembly according to an example embodiment of this application is shown.

[0021] Figure 3 A schematic diagram of the structure of an electrode assembly according to some embodiments of this application is shown.

[0022] Figure 4 A schematic diagram of the structure of a balloon catheter according to an example embodiment of this application is shown.

[0023] Figure 5 A schematic cross-sectional view of a balloon catheter according to an example embodiment of this application is shown. Detailed Implementation

[0024] Exemplary embodiments will now be described more fully with reference to the accompanying drawings. However, these exemplary embodiments can be implemented in many forms and should not be construed as limited to the embodiments set forth herein; rather, they are provided so that this application will be thorough and complete, and will fully convey the concept of the exemplary embodiments to those skilled in the art. The same reference numerals in the drawings denote the same or similar parts, and therefore repeated descriptions of them will be omitted.

[0025] The described features, structures, or characteristics can be combined in any suitable manner in one or more embodiments. Numerous specific details are provided in the following description to give a full understanding of embodiments of this application. However, those skilled in the art will recognize that the technical solutions of this application can be practiced without one or more of these specific details, or other methods, components, materials, devices, etc. In these cases, well-known structures, methods, devices, implementations, materials, or operations will not be shown or described in detail.

[0026] The flowcharts shown in the accompanying drawings are merely illustrative and do not necessarily include all content and operations / steps, nor do they necessarily have to be performed in the described order. For example, some operations / steps can be broken down, while others can be combined or partially combined; therefore, the actual execution order may change depending on the specific circumstances.

[0027] The terms "first," "second," etc., in the specification, claims, and accompanying drawings of this application are used to distinguish different objects, not to describe a specific order. Furthermore, the terms "comprising" and "having," and any variations thereof, are intended to cover non-exclusive inclusion. For example, a process, method, system, product, or apparatus that includes a series of steps or units is not limited to the listed steps or units, but may optionally include steps or units not listed, or may optionally include other steps or units inherent to these processes, methods, products, or apparatuses.

[0028] Intravascular balloon lithotripsy (IVL) devices can be divided into three key hardware components: the electrode assembly, the balloon, and the main unit. The electrode assembly consists of one or more electrodes inserted into a vasodilating balloon to generate shock waves. These electrodes are connected to the main unit via cables, which then controls the simultaneous or time-sharing release of shock waves from the electrodes. In IVL, the design of the electrode assembly affects parameters such as the energy of the released shock waves, electrode lifespan, balloon size, the number of connecting cables, and wiring complexity.

[0029] The electrode assembly according to embodiments of this application will now be described in detail with reference to the accompanying drawings.

[0030] Figure 1 A schematic diagram of the structure of an electrode assembly according to an example embodiment of this application is shown. Figure 2 A schematic diagram of the discharge position of an electrode assembly according to an example embodiment of this application is shown.

[0031] See Figure 1 and Figure 2 The electrode assembly 100 in the example embodiment includes a first electrode 110, an insulating layer 120, and a second electrode 130.

[0032] The first electrode 110 is disposed on the outer surface of the inner tube 200 of the balloon catheter.

[0033] An insulating layer 120 is disposed on the outer surface of the first electrode 110, and the side end of the insulating layer 120 has a first opening 121.

[0034] The second electrode 130 is disposed on the outer surface of the insulating layer 120. The side end of the second electrode 130 has a second opening 131 corresponding to the first opening 121. The relative position of the first opening 121 and the second opening 131 along the circumferential direction can be adjusted. The first opening 121 and the second opening 131 are used to precisely control the discharge position of the electrode assembly 100. The discharge position of the electrode assembly 100 is located in the region adjacent to the second opening 131 of the second electrode 130 and the bottom of the groove of the first electrode 110. Precisely controlling the arc discharge position is beneficial for acoustic field energy control.

[0035] The electrode assembly 100 of this application mainly includes an inner electrode (first electrode 110), an outer electrode (second electrode 130), a non-conductive intermediate insulating layer (insulating layer 120) that isolates the inner and outer electrodes, and cables that connect the electrodes.

[0036] When the electrode assembly 100 is in a liquid (such as physiological saline or contrast agent), a high-voltage pulse (generally greater than 1500V) is applied to the inner and outer electrodes via the main unit. This creates an electric arc discharge on the electrodes, resulting in the rapid generation and bursting of tiny bubbles in the liquid. The generation and bursting of these bubbles then generate a short-duration but extremely strong shock wave. The design of the electrode assembly 100 affects the intensity, direction, and size of the effective area of ​​the shock wave.

[0037] According to an embodiment of this application, the first electrode 110 is a metal sheet. Optionally, the first electrode 110 can be made of stainless steel, platinum-iridium alloy, or other metal materials. The inner tube 200 of the balloon can be fitted inside the first electrode 110 or closely attached to the inner tube 200 of the balloon. A cable is welded or bonded to the outer side of the first electrode 110.

[0038] The first electrode 110 is fitted with a non-conductive insulating layer 120. The insulating layer 120 can be made of PI material of appropriate size or polymer materials such as polyurethane and polyimide. The insulating layer 120 can cover one end of the inner electrode connecting cable or completely cover the first electrode 110, thereby isolating the inner and outer electrodes.

[0039] The second electrode 130 is a metal tube or sheet, which can be made of stainless steel or other metals, such as gold, silver, copper, platinum, tungsten, or other metals or alloys with good conductivity. The second electrode 130 is fitted onto the outside of the insulating layer 120, and the second electrode 130 is welded or bonded to the cable.

[0040] The insulating layer 120 separates the inner and outer electrodes, forming a small gap between them, such as 0.05-0.1 mm, at the second opening 131. The total radial thickness of the first electrode 110, the insulating layer 120, and the second electrode 130 is no greater than 0.5 mm. By controlling the gap between the inner and outer electrodes, the voltage required for breakdown discharge of the inner and outer electrodes can be adjusted, thereby controlling the energy of the released shock wave.

[0041] According to an embodiment of this application, the first opening 121 has a first central axis 1211 along the axial direction of the electrode assembly 100, and the first opening 121 is symmetrical about the first central axis 1211. The second opening 131 has a second central axis 1311 along the axial direction of the electrode assembly 100, and the second opening 131 is symmetrical about the second central axis 1311. The first central axis 1211 and the second central axis 1311 are located in the same plane AA. This arrangement allows the electrode assembly 100 to stably and reliably control the discharge position during discharge, without interference to the discharge position due to the misalignment of the first opening 121 and the second opening 131.

[0042] The first opening 121 is one of the conventional left-right symmetrical openings, such as a semi-circular hole, a semi-elliptical hole, a semi-rhomboid hole, and a triangular hole. The second opening 131 is also one of the conventional left-right symmetrical openings, such as a semi-circular hole, a semi-elliptical hole, a semi-rhomboid hole, and a triangular hole.

[0043] In actual configuration, the outer contour shape and opening size of the first opening 121 and the second opening 131 can be adaptively adjusted according to the discharge effect requirements of the balloon catheter on the electrode assembly 100. For example, the shape of the second opening 131 is a semi-circular arc, and the shape of the first opening 121 is a semi-ellipse. The outer contour shapes of the first opening 121 and the second opening 131 can be configured to be similar or dissimilar according to the discharge performance requirements.

[0044] During the forming process of the electrode assembly 100, the first electrode 110 can be prepared on the outer surface of the inner tube 200 of the balloon by any one of the following methods: weaving, spraying, chemical vapor deposition, electroplating, or ion sputtering. The insulating layer 120 can be prepared on the outer surface of the first electrode 110 by any one of the following methods: printing, electroplating, CVD (Chemical Vapor Deposition), PVD (Physical Vapor Deposition), or ion sputtering. The second electrode 130 can be prepared on the outer surface of the insulating layer 120 by any one of the following methods: printing, electroplating, or magnetron sputtering.

[0045] Figure 3 A schematic diagram of the structure of an electrode assembly according to some embodiments of this application is shown.

[0046] See Figure 3 In some embodiments, the electrode assembly 100 includes a first electrode 110, an insulating layer 120, and a second electrode 130.

[0047] A first electrode 110 is disposed on the outer surface of the inner tube 200 of the balloon catheter. An insulating layer 120 is disposed on the outer surface of the first electrode 110, and a first opening 121 is provided at a side end of the insulating layer 120. A second electrode 130 is disposed on the outer surface of the insulating layer 120, and a second opening 131 is provided at a side end of the second electrode 130 corresponding to the first opening 121. The first opening 121 and the second opening 131 are used to precisely control the discharge position of the electrode assembly 100.

[0048] The first electrode 110 includes a first discharge portion 111 and a first structural portion 112, with the first discharge portion 111 fixed to the first structural portion 112. The first discharge portion 111 is exposed to the second electrode 130 through a first opening 121. The insulating layer 120 partially or completely covers the first structural portion 112.

[0049] In this configuration, the insulating layer 120 may undergo a certain degree of deformation and expansion. The insulating layer 120 covers part or all of the first electrode 110. The covered portion helps protect the parts of the first electrode 110 that do not require discharge from shock wave damage and also helps to fix the first electrode 110.

[0050] Figure 4 A schematic diagram of the structure of a balloon catheter according to an example embodiment of this application is shown. Figure 5 A schematic cross-sectional view of a balloon catheter according to an example embodiment of this application is shown.

[0051] See Figure 4 and Figure 5 The balloon catheter in the example embodiment includes an inner balloon tube 200 and an electrode assembly 100.

[0052] The electrode assembly 100 is disposed on the outer surface of the balloon inner tube 200.

[0053] The electrode assembly 100 can be configured as two non-connected electrodes, such as a first electrode assembly 300 and a second electrode assembly 400.

[0054] The first electrode assembly 300 includes a first inner electrode 310, a first insulating layer 320, and a first outer electrode 330. The first inner electrode 310 is disposed on the outer surface of the balloon inner tube 200. The first insulating layer 320 is disposed on the outer surface of the first inner electrode 310, and a first insulating layer opening 321 is provided at a side end of the first insulating layer 320. The first outer electrode 330 is disposed on the outer surface of the first insulating layer 320, and a first outer electrode opening 331 is provided at a side end of the first outer electrode 330 corresponding to the first insulating layer opening 321. The first insulating layer opening 321 and the first outer electrode opening 331 are used to control the discharge position of the first electrode assembly 300.

[0055] The second electrode assembly 400 includes a second inner electrode 410, a second insulating layer 420, and a second outer electrode 430. The second inner electrode 410 is disposed on the outer surface of the balloon inner tube 200 at a distance from the first inner electrode 310. The second insulating layer 420 is disposed on the outer surface of the second inner electrode 410, and a second insulating layer opening 421 is provided at a side end of the second insulating layer 420. The second outer electrode 430 is disposed on the outer surface of the second insulating layer 420, and a second outer electrode opening 431 is provided at a side end of the second outer electrode 430 corresponding to the second insulating layer opening 421. The second insulating layer opening 421 and the second outer electrode opening 431 are used to control the discharge position of the second electrode assembly 400.

[0056] In the example embodiment, the balloon catheter has two non-connected electrodes configured as electrode assemblies 300, with the first electrode assembly 300 and the second electrode assembly 400 positioned opposite each other on either side of the balloon inner tube 200. The first electrode assembly 300 and the second electrode assembly 400 each have independent structures; that is, the first inner electrode 310 and the second inner electrode 410 are not connected. A first insulating layer 320 and a first outer electrode 330 cover the outside of the first inner electrode 310, and a second insulating layer 420 and the second outer electrode 430 cover the outside of the second inner electrode 410.

[0057] In the electrode assembly 100, a semi-circular hole is made at the position where the outer electrode faces the inner electrode, and a semi-circular or semi-elliptical hole is made in the insulating layer to form a relatively fixed breakdown point, thereby enabling more precise control over the position and direction of the shock wave emission. This design can form two inner electrodes connected in series.

[0058] Current flows from the host through the cable from the first inner electrode 310 (e.g., the right inner electrode) through the outer electrode and then through the second inner electrode 410 (the left inner electrode) before flowing back to the host through the cable. Two breakdown points, i.e. two shock wave emission points, are formed at the junction of the first inner electrode 310 / first outer electrode 330 and the second inner electrode 410 / second outer electrode 430.

[0059] According to an embodiment of this application, the two shock wave emission points can be set 180° opposite each other so that shock waves can be emitted simultaneously in two opposite directions, thereby increasing the angle that the shock waves can cover (ideally 360°). Setting them 180° opposite each other is beneficial for dissolving calcified lesions with a large coverage angle in blood vessels.

[0060] Optionally, a groove can be made at the end of the inner electrode to form a welding groove for the cable, which facilitates the placement of the cable and can significantly reduce the overall outer contour size of the electrode.

[0061] Optionally, at the cable solder joints, the electrodes can be protected and their mechanical strength enhanced by applying a non-conductive adhesive (such as epoxy) to prevent breakdown at undesigned breakdown points.

[0062] According to some embodiments of this application, at another location on the balloon catheter at a certain distance apart, a similar combination of inner and outer electrode pairs, similar to the previous series electrode pair, can be set in series with the previous series electrode pair. In this case, the balloon catheter of this application includes four or more series electrode pairs, and these series electrode pairs can be simultaneously activated to release shock wave energy at different locations on the balloon, thereby expanding the range of shock wave effect. This arrangement is advantageous for the electrode pairs to release shock waves at different locations, which is beneficial for treating calcified lesions with larger angles.

[0063] In actual setup, the location of the shock wave emission points of different electrode pairs on the circumference and the spacing between different electrode pairs can be flexibly adjusted according to the operator's needs and preferences when performing stone crushing operations, so as to meet the needs of directional and fixed-point stone crushing.

[0064] This application also discloses a balloon shockwave device, including the electrode assembly or balloon catheter in any of the above embodiments.

[0065] Exemplary embodiments of this application have been specifically shown and described above. It should be understood that this application is not limited to the detailed structures, arrangements, or implementation methods described herein; rather, this application is intended to cover various modifications and equivalent arrangements contained within the spirit and scope of the appended claims.

Claims

1. An electrode assembly for a balloon catheter, the balloon catheter including an inner balloon tube, the electrode assembly being characterized in that it comprises: The first electrode is disposed on the outer surface of the inner tube of the balloon. An insulating layer is disposed on the outer surface of the first electrode, and the side end of the insulating layer has a first opening; The second electrode is disposed on the outer surface of the insulating layer. The side end of the second electrode has a second opening corresponding to the first opening. The relative position of the first opening and the second opening in the circumferential direction can be adjusted. The first opening and the second opening are used to control the discharge position at a fixed point. The discharge position of the electrode assembly is located in the area adjacent to the second opening of the second electrode and the bottom of the first electrode. The first electrode includes: The first discharge section is exposed to the second electrode through the first opening; A first structural part, wherein the first discharge part is fixed to the first structural part, and the insulating layer partially or completely covers the first structural part.

2. The electrode assembly according to claim 1, characterized in that, The first opening has a first central axis along the axial direction of the electrode assembly, and the first opening is symmetrical about the first central axis. The second opening has a second central axis along the axial direction of the electrode assembly, and the second opening is symmetrical about the second central axis.

3. The electrode assembly according to claim 2, characterized in that, The first central axis and the second central axis are located in the same plane.

4. The electrode assembly according to claim 1, characterized in that, The first opening is one of a semi-circular hole, a semi-elliptical hole, a semi-rhomboid hole, and a triangular hole; The second opening is one of the following: a semi-circular hole, a semi-elliptical hole, a semi-rhomboid hole, and a triangular hole.

5. The electrode assembly according to claim 1, characterized in that, The first electrode is fabricated on the outer surface of the inner tube of the balloon by any one of the following methods: weaving, spraying, chemical vapor deposition, electroplating, or ion sputtering; and / or The insulating layer is prepared on the outer surface of the first electrode using any one of the following methods: printing, electroplating, CVD, PVD, or ion sputtering; and / or The second electrode is prepared on the outer surface of the insulating layer using any one of the following methods: printing, electroplating, or magnetron sputtering.

6. A balloon catheter, characterized in that, include: Intratubular tube; At least one electrode assembly as described in any one of claims 1-5, the electrode assembly being disposed on the outer surface of the inner tube of the balloon.

7. The balloon catheter according to claim 6, characterized in that, The balloon catheter includes: The first electrode assembly includes: The first inner electrode is disposed on the outer surface of the inner tube of the balloon. A first insulating layer is disposed on the outer surface of the first inner electrode, and the side end of the first insulating layer has a first insulating layer opening; A first external electrode is disposed on the outer surface of the first insulating layer. The side end of the first external electrode has a first external electrode opening corresponding to an opening in the first insulating layer. The first insulating layer opening and the first external electrode opening are used to control the discharge position of the first electrode assembly. The second electrode assembly includes: The second inner electrode is disposed on the outer surface of the balloon inner tube at a distance from the first inner electrode; A second insulating layer is disposed on the outer surface of the second inner electrode, and the side end of the second insulating layer has an opening. The second external electrode is disposed on the outer surface of the second insulating layer. The side end of the second external electrode has a second external electrode opening corresponding to the opening of the second insulating layer. The second insulating layer opening and the second external electrode opening are used to control the discharge position of the second electrode assembly.

8. The balloon catheter according to claim 7, characterized in that, Along the circumferential direction of the inner tube of the balloon, the discharge position of the first electrode assembly is oriented differently from that of the second electrode assembly.

9. A balloon shockwave device, characterized in that, Includes the balloon catheter as described in any one of claims 6-8.

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