CN218979093U - Shock wave electrode assembly and balloon catheter device - Google Patents

Abstract

The present disclosure proposes a shock wave electrode assembly including an inner electrode, an outer electrode, and an insulating layer between the inner electrode and the outer electrode. The inner electrode is provided with a first hole, the insulating layer is provided with a second hole, the outer electrode is provided with a third hole, the aperture of the second hole is not smaller than that of the first hole, the aperture of the third hole is not smaller than that of the second hole, and the first hole, the second hole and the third hole are sequentially communicated to form a cavity. In addition, the present disclosure also proposes a balloon catheter device including the above shock wave electrode assembly.

Description

Shock wave electrode assembly and balloon catheter device

Technical Field

The present disclosure relates to electrode assemblies, and more particularly to shock wave electrode assemblies and balloon catheter devices.

Background

Atherosclerosis is a stenotic and sclerotic disease of the artery caused by plaque build-up. The plaque consists of fibrous tissue, fat, and calcium. The accumulated calcified plaque blocks the normal flow of blood, reducing the supply of oxygen and nutrients to the body. Causing diseases associated with arteries supplying blood to critical parts of the body, including the brain, heart and extremities.

The method of the electrohydraulic effect is used for destroying calcified lesion structures attached to the wall of a lesion vessel, i.e. electrodes are placed in an angioplasty balloon and can be used for the operation of calcified lesions in the wall of an artery by acting together with a high voltage generator. In this type of procedure, a balloon catheter is advanced along a guidewire into the occlusion region, and then the balloon is pressurized with a conductive fluid to bring the balloon into close proximity with the vessel. A series of high voltage pulses are applied to electrodes in the balloon by a high voltage generator, each pulse passing through the electrodes to create microscopic bubbles in the conductive fluid which undergo growth and momentary rupture, create a shock wave, and then pass through the balloon wall to the occlusion region.

Disclosure of Invention

The present disclosure proposes a shock wave electrode assembly including an inner electrode, an outer electrode, and an insulating layer between the inner electrode and the outer electrode. The inner electrode is provided with a first hole, the insulating layer is provided with a second hole, the outer electrode is provided with a third hole, the aperture of the second hole is not smaller than that of the first hole, the aperture of the third hole is not smaller than that of the second hole, and the first hole, the second hole and the third hole are sequentially communicated to form a cavity.

In one embodiment, the second and/or third apertures have a larger aperture than the first aperture.

In one embodiment, the apertures of the first, second and third holes increase in sequence, and the cavity is in the shape of a bell mouth.

In one embodiment, the axis of the cavity is perpendicular to the outer surface of the outer electrode.

In one embodiment, the axis of the cavity intersects the outer surface of the outer electrode and is not perpendicular.

In one embodiment, the inner electrode, the insulating layer and the outer electrode are all annular and coaxially arranged, the outer electrode is sleeved outside the insulating layer, the insulating layer is sleeved outside the inner electrode, and the first hole, the second hole and the third hole are coaxially arranged.

In one embodiment, the ratio of the thickness of the inner electrode to the thickness of the outer electrode is in the range of 1:2-2:1, and the ratio of the thickness of the insulating layer to the thickness of the inner electrode is in the range of 1:2-2:1.

In one embodiment, the ratio of the aperture of the first aperture to the aperture of the second aperture is in the range of 1:1-1:5, and the ratio of the aperture of the second aperture to the aperture of the third aperture is in the range of 1:1-1:5.

In one embodiment, the ratio of the length of the inner electrode to the length of the insulating layer ranges from 1:2 to 1:10, and the ratio of the length of the outer electrode to the length of the insulating layer ranges from 1:1 to 1:10.

In one embodiment, the first, second and/or third holes are cylindrical, frustoconical or conical in shape in radial cross section.

The present disclosure proposes a balloon catheter device comprising a balloon, an inner tube, an outer tube and at least one shock wave electrode assembly as described above. The distal end of the inner tube extends through the balloon and is connected with the distal end of the balloon, and the shock wave electrode assembly is arranged on the outer surface of the inner tube in the balloon; the outer tube is sleeved outside the inner tube, and the distal end of the outer tube is connected with the proximal end of the balloon.

In one embodiment, the balloon catheter device includes a plurality of shock wave electrode assemblies spaced apart along the axial direction of the inner tube; the plurality of shock wave electrode assemblies are arranged in the same circumferential direction of the inner tube or are arranged at an angle in the circumferential direction.

In one embodiment, the axial directions of the cavities of the plurality of shock wave electrode assemblies are substantially uniform.

In one embodiment, a plurality of cavities are provided on the shock wave electrode assembly.

According to the shock wave electrode assembly provided by the embodiment of the disclosure, the cavity with the horn mouth structure can reduce the diffusion of shock waves, focus the shock waves and increase the strength of the shock waves. Meanwhile, the propagation direction of the shock wave can be changed by changing the opening direction of the horn mouth, so that the directionality of the shock wave is improved, and the targeted treatment of calcification lesions and intravascular calcification lesions is facilitated. According to the shock wave electrode assembly, the inner electrodes are of the annular structure, a plurality of discharge cavities can be realized without increasing the number of the inner electrodes, the annular inner electrodes can also keep good mechanical strength, and the shock wave electrode assembly is not easy to deviate in the discharge process.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present disclosure, the drawings of the embodiments will be briefly described below, and it is apparent that the drawings in the following description relate only to some embodiments of the present disclosure, not to limit the present disclosure.

Fig. 1A-1D are schematic cross-sectional views of shock wave electrode assemblies according to some embodiments of the present disclosure.

Fig. 2 is a schematic perspective view of a shock wave electrode assembly according to one embodiment of the present disclosure.

Fig. 3 is an exploded view of the shock wave electrode assembly of fig. 2.

Fig. 4 is a schematic diagram of the horn effect of the cavity of the shock wave electrode assembly of one embodiment of the present disclosure.

Fig. 5 is a schematic view of a balloon catheter device according to one embodiment of the present disclosure.

Fig. 6A-6C are schematic cross-sectional views of balloon catheter devices according to some embodiments of the present disclosure.

Fig. 7 is a schematic view of a balloon catheter device having multiple shock wave electrode assemblies according to some embodiments of the present disclosure.

Detailed Description

The following description of the technical solutions in the embodiments of the present disclosure will be made clearly and completely with reference to the accompanying drawings in the embodiments of the present disclosure, and it is apparent that the described embodiments are only some embodiments of the present disclosure, not all embodiments. All other embodiments, which can be made by one of ordinary skill in the art without inventive effort, based on the embodiments in this disclosure are intended to be within the scope of this disclosure.

Unless defined otherwise, all terms (including technical and scientific terms) used in the embodiments of the disclosure have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and will not be interpreted in an idealized or overly formal sense unless expressly so defined by the presently disclosed embodiments.

The terms "first," "second," and the like, as used in embodiments of the present disclosure, do not denote any order, quantity, or importance, but rather are used to distinguish one element from another. Nor does the terms "a," "an," or "the" or similar terms mean a limitation of quantity, but rather that at least one is present. Likewise, the word "comprising" or "comprises", and the like, means that elements or items preceding the word are included in the element or item listed after the word and equivalents thereof, but does not exclude other elements or items. The terms "connected" or "connected," and the like, are not limited to physical or mechanical connections, but may include electrical or communication connections, whether direct or indirect. The "outer surface of the outer electrode" as defined in the present disclosure refers to the surface of the outer electrode that is remote from the inner electrode. "thickness" as defined in this disclosure refers to the distance between opposite sides of an object. The "distal" and "proximal" defined in this disclosure are described below, and the balloon device is inserted through the skin of the human body, then enters the human body vessel, and enters the lesion along the direction of the human body vessel. The entrance of human skin penetration is used as a datum point, one end far away from the datum point is a far end, and one end close to the datum point is a near end along the advancing direction of the saccule.

Traditional angioplasty procedures often employ balloon catheters to physically dilate lesions (e.g., calcified lesions) and reopen the vessel. But is prone to adventitial tear injury upon balloon dilation.

The inventors of the present disclosure have found that in some prior art approaches, methods of using the electrohydraulic effect are used to disrupt calcified lesion structures attached to the wall of a diseased vessel, i.e., electrodes are placed in an angioplasty balloon and, by acting in conjunction with a high voltage generator, can be used for the operation of calcified lesions in the arterial wall. However, the direction of the generated shock wave is changeable due to the randomness of the discharge position of the common electrode assembly, the intensity is relatively dispersed, and the focusing is difficult. Thus, in response to these problems, a shock wave electrode assembly and a balloon catheter device are provided.

Embodiments of the present disclosure and examples thereof are described in detail below with reference to the attached drawing figures.

Fig. 1A-1D are schematic cross-sectional views of shock wave electrode assemblies according to some embodiments of the present disclosure. Fig. 2 is a schematic perspective view of a shock wave electrode assembly according to one embodiment of the present disclosure. Fig. 3 is an exploded view of the shock wave electrode assembly of fig. 2.

As shown in fig. 1A to 1D, the shock wave electrode assembly 100 includes an inner electrode 110, an outer electrode 130, and an insulating layer 120 between the inner electrode 110 and the outer electrode 130. The inner electrode 110 is provided with a first hole 112, the insulating layer 120 is provided with a second hole 122, and the outer electrode 130 is provided with a third hole 132. The aperture of the second hole 122 is not smaller than the aperture of the first hole 112, and the aperture of the third hole 132 is not smaller than the aperture of the second hole 122. The first hole 112, the second hole 122 and the third hole 132 are sequentially communicated to form a cavity 140. In one embodiment, the second and/or third apertures have a larger aperture than the first aperture, where the first aperture has a minimum aperture. In another embodiment, the apertures of the first, second and third holes increase in sequence, and the cavity 140 is in the shape of a flare, as shown. So that a certain gap is formed between the inner electrode 110 and the outer electrode 130, which gap makes a discharge loop between the outer electrode 130 and the inner electrode 110. When the shock wave electrode assembly is placed in a liquid, a proper pulse voltage is applied to break down the liquid between the inner electrode and the outer electrode, and an electric spark is generated to generate shock waves. According to embodiments of the present disclosure, the first, second, and third holes 112, 122, 132 may be formed using any suitable physical, chemical, or physicochemical process, such as mechanical drilling, laser drilling, or masking and etching processes. The term "sequentially increasing pore size" as used in the present disclosure includes a case where the pore size varies linearly (as shown in fig. 1C) and a case where the pore size varies non-linearly.

The direction of the shock wave can be adjusted by changing the angle of the opening according to the actual need. In one embodiment, the axis of the cavity 140 is perpendicular to the outer surface of the outer electrode 130, as shown in fig. 1A, 1B, and 1C. At this time, the shock wave emitted from the cavity 140 mainly propagates in a direction perpendicular to the outer surface of the external electrode 130. In one embodiment, the axis of the cavity 140 intersects the outer surface of the outer electrode 130 and is not perpendicular. In actual surgery, some calcified lesions require a shock wave for directional treatment. At this time, the cavity can be designed so that the axis of the cavity intersects with the outer surface of the external electrode and is not vertical, the cavity is changed into an inclined horn mouth shape, as shown in fig. 1D, and therefore the shock wave generated along the axis of the cavity can directionally propagate the calcified lesion to be treated. A shockwave electrode assembly according to the present disclosure provides the possibility of targeted treatment of calcified lesions. According to actual conditions, the cavity angle can be adjusted adaptively.

In one embodiment, the inner electrode 110, the insulating layer 120, and the outer electrode 130 are all ring-shaped, as shown in fig. 2 and 3. The inner electrode 110, the outer electrode 130 and the insulating layer 120 are coaxially arranged, the outer electrode 130 is sleeved outside the insulating layer 120, and the inner diameter of the outer electrode 130 is matched with the outer diameter of the insulating layer 120, so that the possibility of relative movement between the outer electrode 130 and the insulating layer 120 is reduced. Likewise, the insulating layer 120 is also provided to be sleeved outside the inner electrode 110, and the inner diameter of the insulating layer 120 is matched with the outer diameter of the inner electrode 110, thereby ensuring the stability of the discharge process. In this embodiment, the axes of the inner electrode 110, the insulating layer 120, and the outer electrode 130 are perpendicular to the axes of the first, second, and third holes 112, 122, and 132.

In one embodiment, the ratio of the thickness of the inner electrode 110 to the thickness of the outer electrode 130 is in the range of 1:2-2:1. In one embodiment, the ratio of the thickness of the insulating layer 120 to the thickness of the inner electrode 110 is in the range of 1:2-2:1. According to an embodiment of the present disclosure, the insulating layer 120 mainly serves to block the inner electrode 110 and the outer electrode 130. If the thickness of the insulating layer 120 is small, i.e., the distance between the inner electrode 110 and the outer electrode 130 is too short, the conductive medium between the inner electrode and the outer electrode is easily broken down, the generated shock wave energy is small and even the inner electrode and the outer electrode are directly conducted without generating shock waves. If the thickness of the insulating layer 120 is large (e.g., the ratio of the thickness of the insulating layer to the thickness of the inner electrode is greater than 5:1), i.e., the distance between the inner electrode 110 and the outer electrode 130 is too far, the conductive medium is difficult to be effectively broken down, and it is difficult to effectively generate a shock wave. In the embodiment of the present disclosure, the thickness of the inner electrode 110, the outer electrode 130, or the insulating layer 120 refers to the distance between the radially opposite inner and outer sides of the shock wave electrode assembly 100. The insulating layer 120 is made of a nonconductive insulating material such as polyimide, polyamide, fluoropolymer (e.g., PTFE, FEP, etc.), polyamide-block polyether copolymer, polyethylene, polypropylene, etc. In addition, the thickness of the insulating layer 120 is related to the dielectric constant of the insulating material, and a high dielectric constant has better insulating properties, and in the same situation, the requirement, such as a polyamide material with a higher dielectric constant, can be satisfied by using a thinner insulating layer 120. Therefore, according to practical situations, the insulating layers may be made of insulating materials having different dielectric constants, so that the thickness ratio of the inner electrode 110, the insulating layer 120, and the outer electrode 130 may be changed accordingly. In addition, the materials of the outer electrode 130 and the inner electrode 110 may be conductive metals, such as stainless steel, copper, silver, gold, etc.

In some embodiments, the length of the inner electrode 110 and the length of the insulating layer 120 are 1:2-1:10. If the length of the inner electrode 110 is too short, the inner electrode 110 is easily moved in translation with respect to the insulating layer 120. If the length of the inner electrode 110 is too long, on the one hand, the delivery of the balloon catheter in the patient is affected and on the other hand the cost of materials is increased. Accordingly, the length of the external electrode 130 may be adjusted accordingly according to practical circumstances, which is not limited by the present disclosure. In some embodiments, the length of the outer electrode 130 and the length of the insulating layer 120 are 1:1-1:10. In accordance with embodiments of the present disclosure, once the length of the outer electrode 130 is too long, the trafficability of the balloon catheter may be affected. Accordingly, the length of the external electrode 130 may be adjusted accordingly according to practical circumstances, which is not limited by the present disclosure. According to the embodiment of the present disclosure, the length of the external electrode 130 is smaller than that of the insulating layer 120, so that it can be better fixed on the insulating layer 120. In the embodiment of the present disclosure, the length of the inner electrode 110, the outer electrode 130, or the insulating layer 120 refers to the distance between the opposite ends in the axial direction of the shock wave electrode assembly 100.

In one embodiment, the first, second and third holes 112, 122 and 132 are coaxially disposed, and since the insulating layer is located between the inner and outer electrodes 110 and 130, a certain gap is formed between the outer and inner electrodes 130 and 110, which is advantageous for uniform discharge. In one embodiment, the ratio of the aperture of the second aperture 122 to the aperture of the third aperture 132 is in the range of 1:1-1:5. In one embodiment, the ratio of the aperture of the first aperture 112 to the aperture of the second aperture 122 is in the range of 1:1-1:5. The direction of the generated shock wave is changeable and the intensity is relatively dispersed due to the randomness of the discharge position of the common electrode assembly. According to the shock wave electrode assembly of the embodiment of the present disclosure, since the apertures of the first hole 112 of the inner electrode 110, the first hole 122 of the insulating layer 120, and the third hole 132 to the outer electrode 130 are sequentially increased, it is possible to ensure that the cavity 140 has a horn structure having a narrow end and a wide end. The horn mouth structure can reflect partial diffused sound waves, so that energy is gathered, diffusion loss is reduced, the amplitudes of the waves are overlapped, and the impact wave strength is larger and can be transmitted to a farther place.

In one embodiment, the cross-sectional shapes of the first, second and third apertures 112, 122, 132 may be elliptical or the like in addition to the circular configuration of the illustrated embodiment. In addition, other shapes may be used for the structures of the inner electrode 110, the outer electrode 130, and the holes in the insulating layer 120, and in one embodiment, the first hole 112, the second hole 122, and the third hole 132 have a cylindrical shape, a frustum shape, and a cone shape in a radial cross section, where the radial cross section is any cross section where the cavity axis is located. The first hole 112, the second hole 122, and the third hole 132 are each cylindrical in shape in radial cross section, as shown in fig. 1A. Preferably, in one embodiment, the inner electrode 110 first hole 112, the insulating layer second hole 122, and the outer electrode 130 third hole 132 are tapered holes in radial cross-section, as shown in fig. 1C. The structure has a more regular horn mouth shape, so that the horn concentration effect of the shock wave can be promoted, and the directivity and strength of the shock wave are improved. In principle, the length of the horn mouth and the width of the opening of the horn mouth can greatly influence the aggregation effect of the horn, and the longer the length of the horn mouth is, the narrower the opening is, so that the aggregation effect can be better exerted. In some embodiments of the present disclosure, increasing the thickness of the inner electrode 110, the insulating layer, the outer electrode 130, or decreasing the aperture of the third hole 132 of the outer electrode 130 can reduce the diffusion propagation of the shock wave, increase the focusing effect on the shock wave, and increase the shock wave strength.

According to an embodiment of the present disclosure, a discharge circuit is formed between the outer electrode 130 and the inner electrode 110. When the shock wave electrode assembly 100 is placed in a liquid, a proper pulse voltage is applied to break down the filling liquid, and an electric spark is generated, thereby generating a shock wave. The shock wave propagates through the liquid inside the balloon, striking the balloon wall and calcified areas. Repeated pulses can destroy the structure of calcification foci, dilate stenosed vessels, and not damage surrounding soft tissues. Since the first hole 112 of the inner electrode 110, the second hole 122 of the insulating layer, and the third hole 132 of the outer electrode 130 constitute the cavity 140 having a horn structure with a narrow end and a wide end, as shown in fig. 4, the structure can reflect the partially diffused sound wave, collect energy, reduce diffusion loss, and the amplitudes of the waves are superimposed, so that the intensity of the shock wave becomes greater and can propagate to a farther place, and in addition, the horn shape can change the structure to adjust the direction of the shock wave.

Fig. 5 is a schematic view of a balloon catheter device according to one embodiment of the present disclosure. As shown in fig. 5, balloon catheter device 300 includes tip 310, inner tube 320, balloon 330, outer tube 350, and shock wave electrode assembly 200. As described above, the shock wave electrode assembly 200 includes the inner electrode 210, the outer electrode 230, and the insulating layer 220 between the inner electrode 210 and the outer electrode 230. The first, second and third holes 112, 122 and 132 are disposed on the inner electrode 210, the insulating layer 220 and the outer electrode 230, respectively. Since the details of the shock wave electrode assembly have been described above, a detailed description thereof will be omitted. The distal end of the inner tube 320 extends through the balloon 330 and is connected to the distal end of the balloon 330 at the tip 310, the shock wave electrode assembly 200 being disposed on the outer surface of the inner tube 320 located in the balloon 330; the outer tube 350 is sleeved outside the inner tube 320, and the distal end of the outer tube 350 is connected to the proximal end of the balloon 330. Inside the inner tube 320 is a guide wire cavity for the passage of a guide wire during operation, and the gap between the inner tube 320 and the outer tube 350 forms a liquid passing cavity. The interior of balloon 330 may be filled with a conductive fluid through the fluid lumen. In one embodiment, as shown in fig. 5, balloon catheter device 300 further includes a guidewire 340 extending axially of balloon catheter device 300, guidewire 340 comprising a first guidewire 340A and a second guidewire 340B. The first wire 340A is connected to the inner electrode 210, and the second wire 340B is connected to the outer electrode 230. The two wires extend axially along the balloon catheter device 300 and are connected to a high voltage generator (not shown) and current is transferred through the first wire 340A to the inner electrode 210, the inner electrode 210 forming a loop with the outer electrode 230 through the filled conductive fluid, the high voltage pulse breaking down the conductive fluid and generating a shock wave in the axial direction of the lumen 140. The current is then transferred to the outer electrode 230 and back to the high voltage generator along the second wire 340B. The shock wave electrode assembly is arranged in the balloon of the balloon catheter device according to the embodiment of the disclosure, so that shock waves can be generated efficiently, the calcified lesions in the blood vessel are broken, and the treatment effect of blocking the lesions is effectively improved. Meanwhile, the direction of the horn mouth opening can be adjusted to change the direction of the shock wave, so that the calcified focus can be treated in a targeted manner.

Fig. 6A is a schematic cross-sectional view of a balloon catheter device according to an embodiment of the present disclosure. To describe the assembly process of the shock wave electrode assembly 200 in the balloon catheter apparatus 300 with reference to fig. 3, 5 and 6A, in order to install the shock wave electrode assembly in the balloon catheter apparatus, the inner electrode 210 is first sleeved on the inner tube 320, the inner electrode 210 and the inner tube 320 are fixed by glue, then the insulating layer 220 having the second hole 222 is sleeved on the inner electrode 210, the insulating layer 220 is moved to align the first hole 222 with the first hole 212 of the inner electrode 210, the two holes are coaxial, and the inner tube 320 and the insulating layer 220 are fixed by glue. Then, the external electrode 230 is sleeved again, the second hole 232 is moved to be aligned with the first hole 222, so that the two holes are coaxial, the first hole 212, the second hole 222 and the third hole 232 are coaxial and form the cavity 140, and the external electrode 230 is fixed on the insulating layer 220 by glue. In this embodiment, the axes of the inner electrode 210, the insulating layer 220, and the outer electrode 230 are perpendicular to the axes of the first hole 212, the second hole 222, and the third hole 232. Because the inner tube, the inner electrode, the insulating layer and the outer electrode all have circular cross sections, the design reduces the assembly difficulty of the shock wave electrode assembly in the balloon catheter, simplifies the process and is easy to manufacture the balloon catheter device at low cost. In one embodiment, the shock wave electrode assembly is provided with a plurality of cavities, specifically, a plurality of first holes 212 disposed on the inner electrode, a plurality of second holes 222 disposed on the insulating layer 220, and a plurality of third holes 232 disposed on the outer electrode 230. Wherein the number of first holes 222, second holes 232, and third holes 232 are equal. In view of the fact that in practice, it may be necessary to treat a plurality of calcified lesions in the circumferential direction of a blood vessel, if a balloon catheter apparatus having one shock wave electrode assembly is used, it is necessary to treat a plurality of calcified lesions one by one. In this case, therefore, a structure having a plurality of shock wave electrode assemblies may be employed to construct a plurality of discharge regions on the balloon catheter apparatus, not only to provide the balloon catheter apparatus with the capability of simultaneously treating a plurality of calcified lesions, but also to improve the uniformity of the distribution of shock waves in the circumferential space of the inner tube, thereby facilitating the treatment of calcified lesions. Fig. 6A, 6B and 6C show schematic cross-sectional views of balloon catheter devices having 1, 2 or 4 lumens of a shock wave electrode assembly disposed thereon, respectively. In addition, the distribution of the shock wave electrode assembly in the circumferential direction of the inner tube 320 is adjusted accordingly to accommodate the actual location distribution of the calcified lesions to be treated, which is not limited by the present disclosure.

In one embodiment, balloon catheter device 300 includes a plurality of shock wave electrode assemblies 200 arranged at intervals along the axial direction of inner tube 320. When a plurality of calcified lesions are required and spaced apart from each other in an actual operation, if the balloon catheter device of the single shock wave electrode assembly 200 is used, the balloon catheter device must be delivered to the site of different calcified lesions for treatment one by one, which causes inconvenience to the physician's operation. Thus, in response to the above, a balloon catheter device having a plurality of shock wave electrode assemblies 200 arranged at intervals along the axial direction of the inner tube may be employed, and fig. 7 shows a schematic view of a balloon catheter device having 3 shock wave electrode assemblies 200.

The balloon is wrapped around the axially extending catheter, and the interior of the balloon may be filled with an electrically conductive fluid through the fluid lumen. The 3 shock wave electrode assemblies 200 are arranged at the outer surface of the inner tube 320 at a certain interval, and transmit current by connecting two wires. Wherein the first wire 340A is connected to the inner electrode 210A, the inner electrode 210B and the inner electrode 210C, and the second wire is connected to the outer electrode 230A, the outer electrode 230B and the outer electrode 230C, thereby forming a discharge loop between the inner electrode and the outer electrode of each shock wave electrode assembly 200, thereby generating shock waves, specifically, first shock waves in the axial direction of the cavity 240A of the shock wave electrode assembly 200A. The first shock wave is generated in the axial direction of the cavity 240B of the shock wave electrode assembly 200B. The first shock wave is generated in the axial direction of the cavity 240C of the shock wave electrode assembly 200C. A plurality of shock wave electrode assemblies may be arranged inside the balloon in a similar connection manner, generating shock waves in the axial direction of the cavity of the shock wave electrode assembly 200. Meanwhile, according to the actual position distribution of the calcified lesion to be treated, the distribution of the different shock wave electrode assemblies 200 in the axial direction of the inner tube 320 is correspondingly adjusted, which is not limited by the present disclosure. In one embodiment, the axial directions of the cavities of the plurality of shock wave electrode assemblies are substantially uniform. For example, for a calcified lesion area on a blood vessel wall along an axial direction, at this time, the axial directions of the cavities of a plurality of shock wave electrode assemblies arranged at intervals along the axial direction of the inner tube can be substantially uniformly directed to the calcified lesion area, so that targeted shock wave treatment is performed on the calcified lesion area, and the treatment effect is greatly improved.

In one embodiment, the plurality of shock wave electrode assemblies 200 are arranged in the same circumferential direction of the inner tube 320, or are arranged at an angle in the circumferential direction. For the balloon catheter apparatus provided with a plurality of shock wave electrode assemblies 200, the relative arrangement direction between the shock wave electrode assemblies 200 may affect the intensity and distribution of shock waves generated by the entire balloon. The plurality of shock wave electrode assemblies 200 may be arranged in the same circumferential direction of the inner tube 320 or may be arranged at an angle in the circumferential direction according to the position of the calcified lesion to be treated in the operation, which is not limited in the present disclosure. Fig. 7 is a schematic view of a balloon catheter device in which three shock wave electrode assemblies 200 are arranged at 90 degree intervals along the circumference of the inner tube 320, i.e., the projections of the 3 shock wave electrode assemblies on a projection plane perpendicular to the central axis of the inner tube do not coincide. In the embodiment of the disclosure, the balloon catheter device is provided with the capability of simultaneously treating a plurality of calcified lesions by adopting a plurality of shock wave electrode assemblies, and in addition, the positions of the shock wave electrode assemblies 200 can be correspondingly arranged according to the positions of the plurality of calcified lesions to be treated, such as being arranged in the same circumferential direction or sequentially at a certain angle, so that the treatment effect on the blocked lesions is improved, the operation time is saved, and the efficiency is improved.

The discharge position of the common electrode assembly is generally high in randomness, the direction of the generated shock wave is changeable, the shock wave is difficult to focus and the strength is relatively dispersed, so that the shock wave is seriously dissipated in the propagation process, and the targeted treatment of lesions is not facilitated. According to the shock wave electrode assembly provided by the embodiment of the disclosure, the cavity with the horn mouth structure can reduce the diffusion of shock waves, focus the shock waves and increase the strength of the shock waves. Meanwhile, the direction of propagation of the shock wave generated from the cavity of the shock wave electrode assembly is changed by changing the structure of the horn mouth, specifically, by adjusting the opening direction of the horn mouth, and the design can improve the directionality of the shock wave, thereby being beneficial to targeted treatment of calcification lesions and intravascular calcification lesions. According to the shock wave electrode assembly, the inner electrodes are of the annular structure, a plurality of discharge cavities can be realized without increasing the number of the inner electrodes, the annular inner electrodes can also keep good mechanical strength, and the shock wave electrode assembly is not easy to deviate in the discharge process.

The following points need to be described:

(1) The drawings of the embodiments of the present disclosure relate only to the structures to which the embodiments of the present disclosure relate, and reference may be made to the general design for other structures.

(2) The embodiments of the present disclosure and features in the embodiments may be combined with each other to arrive at a new embodiment without conflict.

The foregoing is merely specific embodiments of the disclosure, but the scope of the disclosure is not limited thereto, and the scope of the disclosure should be determined by the claims.

Claims (14)

1. A shock wave electrode assembly, comprising:

an inner electrode, an outer electrode, and an insulating layer between the inner electrode and the outer electrode;

the inner electrode is provided with a first hole,

the insulating layer is provided with a second hole,

a third hole is arranged on the outer electrode,

the aperture of the second hole is not smaller than the aperture of the first hole,

the aperture of the third hole is not smaller than the aperture of the second hole,

the first hole, the second hole and the third hole are sequentially communicated to form a cavity.

2. The shock wave electrode assembly according to claim 1, wherein the aperture of the second and/or third holes is larger than the aperture of the first holes.

3. The shock wave electrode assembly of claim 1, wherein the apertures of the first, second and third holes are sequentially increased, and the cavity has a bell-mouth shape.

4. The shock wave electrode assembly of claim 1, wherein the axis of the cavity is perpendicular to the outer surface of the outer electrode.

5. The shock wave electrode assembly of claim 1, wherein the axis of the cavity intersects and is not perpendicular to the outer surface of the outer electrode.

6. The shock wave electrode assembly of claim 1, wherein the inner electrode, the insulating layer and the outer electrode are all annular and coaxially arranged, the outer electrode is sleeved outside the insulating layer, the insulating layer is sleeved outside the inner electrode, and the first hole, the second hole and the third hole are coaxially arranged.

7. The shock wave electrode assembly of claim 1, wherein the ratio of the thickness of the inner electrode to the thickness of the outer electrode is in the range of 1:2-2:1, and the ratio of the thickness of the insulating layer to the thickness of the inner electrode is in the range of 1:2-2:1.

8. The shock wave electrode assembly of claim 1, wherein the ratio of the aperture of the first aperture to the aperture of the second aperture is in the range of 1:1 to 1:5, and the ratio of the aperture of the second aperture to the aperture of the third aperture is in the range of 1:1 to 1:5.

9. The shock wave electrode assembly of claim 1, wherein the ratio of the length of the inner electrode to the length of the insulating layer ranges from 1:2 to 1:10, and the ratio of the length of the outer electrode to the length of the insulating layer ranges from 1:1 to 1:10.

10. The shock wave electrode assembly according to claim 1, wherein the shape of the first hole, the second hole and/or the third hole in a radial cross section is cylindrical, frustoconical or conical.

11. A balloon catheter device comprising a balloon, an inner tube, an outer tube, and at least one shock wave electrode assembly according to any one of claims 1 to 10; the distal end of the inner tube extends through the balloon and is connected with the distal end of the balloon, and the shock wave electrode assembly is arranged on the outer surface of the inner tube in the balloon; the outer tube is sleeved outside the inner tube, and the distal end of the outer tube is connected with the proximal end of the balloon.

12. The balloon catheter device of claim 11, wherein said balloon catheter device comprises a plurality of said shock wave electrode assemblies spaced apart along the axial direction of said inner tube; the plurality of shock wave electrode assemblies are arranged in the same circumferential direction of the inner tube or are arranged at an angle in the circumferential direction.

13. The balloon catheter device of claim 12, wherein the axial directions of the lumens of said plurality of shock wave electrode assemblies are substantially uniform.

14. The balloon catheter device of claim 11 wherein said shock wave electrode assembly has a plurality of said lumens disposed thereon.

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