Electrode balloon catheter

By designing a separate electrode balloon catheter, using a series-side combined electrode assembly and a high-voltage pulse generator, the problem that the electrode cannot adjust the energy direction in the prior art is solved, and effective treatment of different types of vascular calcification lesions is achieved.

WO2025050474A1PCT designated stage expired Publication Date: 2025-03-13NAT INST OF ADVANCED MEDICAL DEVICES SHENZHEN
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Patent Information

Application Number
PCT/CN2023/126476
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-09-06
Filing Date
2023-10-25
Publication Date
2025-03-13

AI Technical Summary

Technical Problem

The electrode assembly of the existing shock wave balloon catheter is an integral structure and cannot adjust the direction of the emission energy, resulting in poor treatment effect in areas with thick blood vessel walls.

Method used

A separate electrode balloon catheter is designed, including multiple sets of inner and outer electrodes, connected in series and parallel combination, and the output energy distribution of each electrode assembly is independently controlled by a high-voltage pulse generator.

Benefits of technology

Effective treatment of different types of vascular calcification lesions is achieved, especially at the thick end of the eccentric calcification ring, which can generate higher frequency and energy lateral shock waves, fragment calcified plaques.

✦ Generated by Eureka AI based on patent content.

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Abstract

The present application relates to the technical field of medical instruments, and relates to an electrode balloon catheter, comprising a balloon structure, a connecting tube assembly and electrode assemblies. The electrode assemblies are arranged in a ballon accommodating cavity, and each comprise an inner electrode, an outer electrode, and an insulating layer, the inner electrode is arranged on the inner side of the insulating layer and is connected in series to the outer electrode, and the electrode assemblies are connected to an external high-voltage pulse generator by means of wires penetrating through the connecting tube assembly; there are multiple electrode assemblies, the multiple electrode assemblies are connected in series or in parallel on the basis of treatment modes, and the electrode assemblies are arranged at intervals in the direction of extension of the balloon structure. In the electrode balloon catheter of embodiments, by using inner electrodes and outer electrodes connected in pairs in a serial-parallel combined form, and independently controlling by means of a multi-channel, parameter-configurable high-voltage pulse generator, the output energy distribution of the multiple electrode assemblies in different directions can be adjusted, and thus different types of vascular calcification lesions can be effectively treated.
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Description

Electrode balloon catheter Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to an electrode balloon catheter. Background Art

[0002] In shock wave balloon catheter applications, the electrode is a key component used to generate shock wave energy to treat calcified lesions. Current electrode assemblies are typically monolithic, connected in series, and driven at the same voltage. This results in essentially uniform shock wave energy in all directions within the vessel, offering advantages in treating centripetal calcifications. However, there are limitations in treating lesions such as eccentric calcifications and calcified nodules. Technical issues

[0003] Lesions such as eccentric calcifications and calcified nodules are often located in specific locations on the vessel wall, which are thicker and more difficult to treat. Current electrode assemblies distribute energy evenly around the circumference, making it difficult to deliver sufficient energy to thicker areas, thus impacting treatment effectiveness.

[0004] Therefore, it is necessary to make improvements to the above problems in order to change the current situation. Technical Solutions

[0005] The present application provides an electrode balloon catheter for solving the problem that the electrode in the existing shock wave balloon catheter is an integral structure and cannot adjust the direction of the emitted energy, resulting in poor treatment effectiveness when applied to areas with different lesion core thicknesses.

[0006] The present application proposes an electrode balloon catheter, comprising:

[0007] The balloon structure has a receiving cavity for receiving liquid;

[0008] a connecting tube assembly, sealed and connected to the proximal end of the balloon structure, the connecting tube assembly being in communication with the accommodating cavity and being used for transporting the liquid; and

[0009] An electrode assembly is disposed in the accommodating cavity, and the electrode assembly includes an inner electrode, an outer electrode and an insulating layer. The inner electrode is disposed on the inner side of the insulating layer and is connected in series with the outer electrode, and the electrode assembly is connected to an external high-voltage pulse generator via a wire passing through the connecting tube assembly; wherein, the electrode assembly is a separate structure, and the number of the electrode assemblies is multiple groups. The series or parallel connection mode of the electrode assemblies can be switched according to the treatment mode selection, and the electrode assemblies are arranged at intervals along the extension direction of the balloon structure.

[0010] According to one embodiment of the present application, the connecting tube assembly includes a connecting tube structure, a cable connection seat and a catheter assembly, the connecting tube structure is sealed and connected to the proximal end of the balloon structure, the catheter assembly is respectively connected to the connecting tube structure and the cable connection seat, the conductive wires are respectively connected to the electrode assembly and the cable connection seat, and the cable connection seat is used to connect to the high-voltage pulse generator; the catheter assembly is connected to the accommodating cavity and is used to transport the liquid.

[0011] According to one embodiment of the present application, the inner electrode is a sheet-like structure, the outer electrode is a tubular structure, and the inner electrode is attached to the connecting tube assembly, and the outer electrode is sleeved on the outside of the inner electrode; the electrode assembly also includes an insulating layer, the insulating layer is sleeved on the outside of the inner electrode, and the insulating layer is located between the inner electrode and the outer electrode.

[0012] According to one embodiment of the present application, the external electrode is provided with a first through hole, and the insulating layer is provided with a second through hole.

[0013] According to one embodiment of the present application, the connecting tube structure includes an inner tube and an outer tube, the inner tube is used to accommodate the guide wire, the inner tube is arranged on the inner side of the outer electrode, the inner electrode is attached to the inner tube, and the inner tube is sealed and connected to the balloon structure, and the outer electrode is arranged inside the outer tube; an infusion cavity and a wire cavity are provided inside the outer tube, the infusion cavity is respectively connected to the accommodating cavity and the catheter assembly, and the wire cavity is respectively connected to the cable connection seat and the electrode assembly.

[0014] According to one embodiment of the present application, a supporting steel wire is provided inside the outer tube.

[0015] According to one embodiment of the present application, the catheter assembly includes a catheter seat and an extension tube, the catheter seat is respectively connected to the extension tube and the cable connection seat, and the end of the extension tube away from the catheter seat is connected to the connecting tube structure; the catheter seat is provided with an infusion connector and a wire connector, the infusion connector is connected to the accommodating cavity, and the wire connector is respectively connected to the cable connection seat and the electrode assembly.

[0016] According to one embodiment of the present application, the extension tube is a hypotube or a polymer tube.

[0017] According to one embodiment of the present application, the balloon structure includes a balloon body, a tip and a developing ring, the tip is connected to the distal end of the balloon body, and the connecting tube assembly is connected to the proximal end of the balloon body; the balloon body and the connecting tube assembly are sealed and connected to enclose and form the accommodating cavity, and the developing ring is sleeved on the connecting tube structure and located on the inner tube.

[0018] According to one embodiment of the present application, the electrode balloon catheter also includes a temperature sensor and / or a pressure sensor, wherein the temperature sensor is arranged inside the connecting tube assembly and is used to obtain the temperature signal inside the balloon structure, and the pressure sensor is arranged inside the connecting tube assembly and is used to obtain the pressure signal inside the balloon structure. Beneficial effects

[0019] The implementation of the embodiments of the present application has the following beneficial effects:

[0020] In the electrode balloon catheter of this embodiment, by adopting a series-parallel combination of inner and outer electrodes and independently controlling a multi-channel, parameter-configurable high-voltage pulse generator, the output energy distribution of multiple groups of electrode assemblies can be adjusted. This not only treats centripetal calcification lesions, but also generates lateral shock waves of higher frequency and energy at the thick end of the eccentric calcification ring to fragment it, thereby achieving effective treatment of different types of vascular calcification lesions. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without any creative work.

[0022] in:

[0023] FIG1 is a schematic structural diagram of an electrode balloon catheter in an embodiment of the present application;

[0024] FIG2 is a schematic diagram of the cross-sectional structure of the electrode assembly 300 in an embodiment of the present application;

[0025] FIG3 is a schematic diagram of a partial structure of an electrode balloon catheter in an embodiment of the present application;

[0026] FIG4 is a schematic structural diagram of an external electrode in one embodiment of the present application;

[0027] FIG5 is a schematic cross-sectional view of an outer electrode in another embodiment of the present application;

[0028] FIG6 is a schematic diagram of the circuit layout of the electrode balloon catheter in an embodiment of the present application;

[0029] FIG7 is a schematic diagram of a partial structure of a balloon structure in an electrode balloon catheter in an embodiment of the present application;

[0030] Reference numerals:

[0031] 10. Electrode balloon catheter; 100. Balloon structure; 110. Balloon body; 111. Accommodating cavity; 120. Tip; 130. Development ring; 200. Connecting tube assembly; 210. Connecting tube structure; 211. Inner tube; 212. Outer tube; 220. Cable connector; 230. Catheter assembly; 231. Catheter connector; 2311. Infusion connector; 2312. Wire connector; 232. Extension tube; 300. Electrode assembly 300; 310. Inner electrode; 320. Outer electrode; 321. First through hole; 330. Insulating layer; 331. Second through hole. Modes for Carrying Out the Invention

[0032] To make the objectives, technical solutions, and advantages of this application more clear, the technical solutions of this application will be clearly and completely described below in conjunction with the accompanying drawings. Obviously, the embodiments described are only part of the embodiments of this application, not all of them. Based on the embodiments of this application, all other embodiments obtained by ordinary technicians in this field without making any creative efforts are within the scope of protection of this application.

[0033] 1 to 7 , an embodiment of the present application provides an electrode balloon catheter 10, which includes a balloon structure 100, a connecting tube assembly 200, and an electrode assembly 300; a accommodating cavity 111 for accommodating liquid is provided inside the balloon structure 100; the connecting tube assembly 200 is sealed and connected to the proximal end of the balloon structure 100, and the connecting tube assembly 200 is in communication with the accommodating cavity 111 and is used to transport liquid; the electrode assembly 300 is disposed in the accommodating cavity 111, and includes an inner electrode 310, an outer electrode 320, and an insulating layer 330, wherein the inner electrode 310 is disposed on the inner side of the insulating layer 330 and is connected in series with the outer electrode 320, and the electrode assembly 300 is connected to an external high-voltage pulse generator via a wire passing through the connecting tube assembly 200; wherein the electrode assembly 300 is a separate structure, and the number of the electrode assemblies 300 is multiple, and the multiple groups of electrode assemblies 300 are connected in series or in parallel according to the mode selection, and the electrode assemblies 300 are arranged at intervals along the extension direction of the balloon structure 100.

[0034] In the electrode balloon catheter 10 of this embodiment, by adopting the inner electrode 310 and the outer electrode 320 in a series-parallel combination, and independently controlling the multi-channel, parameter-configurable high-voltage pulse generator, the output energy distribution of the multiple groups of electrode assemblies 300 can be adjusted. This not only can treat centripetal calcification lesions, but also can generate lateral shock waves of higher frequency and energy at the thick end of the eccentric calcification ring to fragment it, thereby achieving effective treatment of different types of vascular calcification lesions.

[0035] When using the electrode balloon catheter 10 of this embodiment, the inner electrode 310 and the outer electrode 320 arranged in the same direction are connected in series through a wire, and the electrode assemblies 300 arranged in different directions are connected in parallel. Each electrode assembly 300 can be independently controlled, and a uniform circumferential shock wave and / or a non-uniform lateral shock wave can be generated as needed; this can achieve the treatment of centripetal calcification lesions, and generate a higher frequency and energy lateral shock wave for the thick end of the eccentric calcification ring to fragment it, thereby achieving effective treatment of different types of vascular calcification lesions.

[0036] During use, electrode assembly 300 is a piezoelectric energy converter that receives a high-voltage pulse excitation signal from a high-voltage pulse generator and converts it into a shock wave. Specifically, inner electrode 310 is disposed within connecting tube structure 210 and is preferably a sheet-like structure with a length ranging from 0.2 to 3.0 mm and a width ranging from 0.1 to 3.0 mm. Inner electrode 310 can be made of a metal material such as gold, silver, copper, stainless steel, platinum, molybdenum, tungsten, or a platinum-iridium alloy. The connection between inner electrode 310 and the conductor can be achieved by conductive adhesive bonding, thermal welding, or laser welding. In this embodiment, the excitation pulse high-voltage signal for shock waves generated by electrode assembly 300 has an amplitude range of 200 to 5000 V, a repetition frequency range of 0.5 to 10 Hz, a pulse duration range of 0.5 to 20 μs, and a shock wave pressure of less than 20 MPa.

[0037] Specifically, the connecting tube assembly 200 includes a connecting tube structure 210, a cable connecting seat 220 and a catheter assembly 230. The connecting tube structure 210 is sealed and connected to the proximal end of the balloon structure 100. The catheter assembly 230 is respectively connected to the connecting tube structure 210 and the cable connecting seat 220. The wires are respectively connected to the electrode assembly 300 and the cable connecting seat 220. The cable connecting seat 220 is used to connect to the high-voltage pulse generator lead; the catheter assembly 230 is connected to the accommodating cavity 111 and is used to transport liquid.

[0038] In this embodiment, the cable connector 220 is used to connect to an external high-voltage pulse generator. The two can be connected via a quick-release interface and provide a high-voltage pulse excitation signal to the electrode assembly 300. The catheter assembly 230 can be used to deliver liquid into the accommodating cavity 111 and use the liquid to drive the balloon structure 100 to expand or contract. The catheter assembly 230 can be used to pass a guidewire to drive the balloon structure 100 to the affected area.

[0039] In one embodiment, the inner electrode 310 is a sheet-like structure, and the outer electrode 320 is a tubular structure. The inner electrode 310 is attached to the connecting tube assembly 200 , and the outer electrode 320 is sleeved on the outer side of the inner electrode 310 .

[0040] In this embodiment, the insulating layer 330 is disposed above the inner electrode 310 and is a tubular structure with an outer diameter of 0.4-2.0 mm and a thickness of 0.01-0.1 mm. The outer electrode 320 is disposed above the insulating layer 330 and is either an annular or sheet-like structure. The annular structure has an outer diameter of 0.4-2.0 mm and a thickness of 0.01-0.5 mm, and is secured to the insulating layer 330 via an annular arm. The sheet-like structure has a length of 0.5-3.0 mm and a width of 0.1-3.0 mm, and is secured to the insulating layer 330 via hook-shaped structures at both ends. The wires are led out from the external electrode 320 and are connected in a series-parallel combination. The electrode assemblies 300 in the same direction are connected in series with wires, and the electrode assemblies 300 in different directions are connected in parallel with wires. They are independently controlled by a multi-channel, parameter-configurable high-voltage pulse generator, which can generate both uniform circumferential shock waves and non-uniform lateral shock waves. It can not only treat centripetal calcification lesions, but also generate higher frequency and energy lateral shock waves at the thick end of the eccentric calcification ring to fragment it, thereby meeting the needs of treating different types of vascular calcification lesions.

[0041] Specifically, the electrode assembly 300 is disposed at the distal end of the connecting tube assembly 200. The electrode assembly 300 comprises an inner electrode 310, an insulating layer 330, and an outer electrode 320. The inner electrode 310 is a sheet-like structure, while the insulating layer 330 is a tubular structure positioned above the inner electrode 310. The outer electrode 320 is positioned above the insulating layer 330 and is a separate ring-shaped or sheet-like structure. The insulating layer 330 and the outer electrode 320 each have an opening coaxially aligned with the inner electrode 310. Lead wires extend from the electrode assembly 300 and are connected in series or in parallel using a series-parallel combination. Electrode assemblies 300 in the same direction are connected in series, while electrode assemblies 300 in different directions are connected in parallel. These are independently controlled by a multi-channel, parameter-configurable high-voltage pulse generator, generating both uniform circumferential shock waves and non-uniform lateral shock waves. This allows for the treatment of not only centripetal calcified lesions but also higher-frequency and higher-energy lateral shock waves at the thick end of eccentric calcified lesions, causing fragmentation, thus meeting the treatment needs of different types of vascular calcification. The signal amplitude range of the shock wave is 200-5000V, the repetition frequency range is 0.5-10Hz, the pulse duration range is 0.5-20μs, and the shock wave pressure is less than 20MPa.

[0042] Furthermore, the outer electrode 320 defines a first through hole 321 , and the insulating layer 330 defines a second through hole 331 .

[0043] In this embodiment, the outer electrode 320 has a first through hole 321 coaxially aligned with the inner electrode 310, the diameter of the first through hole 321 is between 0.01-0.5 mm, each direction corresponds to an outer electrode 320, and the second through holes 321 thereon are not connected, and the insulating layer 330 has a second through hole 331 aligned with the inner electrode 310, and the diameter of the second through hole 331 is between 0.01-0.5 mm;.

[0044] Specifically, the connecting tube structure 210 includes an inner tube 211 and an outer tube 212. The inner tube 211 is used to accommodate the guide wire. The inner tube 211 is arranged on the inner side of the outer electrode 320. The inner electrode 310 is attached to the inner tube 211, and the inner tube 211 is sealed and connected to the balloon structure 100. The outer electrode 320 is arranged inside the outer tube 212; an infusion cavity and a wire cavity are provided inside the outer tube 212. The infusion cavity is respectively connected to the accommodating cavity 111 and the catheter assembly 230, and the wire cavity is respectively connected to the cable connection seat 220 and the electrode assembly 300.

[0045] In this embodiment, the inner tube 211 is arranged at the distal end of the balloon structure 100, and can be a slender tube structure with a cavity, with an outer diameter between 0.3-1.0 mm and an inner diameter between 0.2-0.9 mm. The outer surface extends axially, and a guide wire port is provided on the inner tube 211. A guide wire is inserted into the inner tube 211 so that the distal end of the balloon structure 100 can enter the calcified lesion area in the human blood vessel. The material of the inner tube 211 can be polyurethane (PU), polytetrafluoroethylene (PTFE), low-density polyethylene (LDPE), high-density polyethylene (HDPE), polyvinyl chloride (PVC), nylon (PA), segmented polyetheramide (Pebax), polyethylene terephthalate (PET) or a composite material. The outer tube 212 is arranged at the proximal end of the balloon structure 100. It can be a slender tube structure with a cavity. The outer diameter is between 0.3-2.0 mm and the inner diameter is between 0.2-1.8 mm. The outer surface extends axially. The outer tube 212 is used to insert the inner tube 211 and the guide wire. The outer tube 212 is also used to transport liquid into the accommodating cavity 111 of the balloon structure 100 at the distal end of the tube body. The material of the outer tube 212 can be polyimide, polyetheretherketone, polyethylene, PEBA, PET, FEP, PTFE, PA and other materials.

[0046] A wire extends from outer electrode 320 and axially along inner tube 211. Outer tube 212 encases the wire. The wire extends to the proximal end of connecting tube assembly 200 and connects to wire connector 2312 of catheter assembly 230. The wire has an outer diameter of 0.08-0.5 mm and can be made of any conductive material, such as enameled wire, gold, silver, platinum, or copper.

[0047] Furthermore, a supporting steel wire is provided inside the outer tube 212 .

[0048] In this embodiment, the outer tube 212 may also be a slender tube structure with a cavity, the outer surface of which extends axially. The outer tube 212 is used to house the inner tube 211 and the guide wire, and a central steel wire is added to enhance the support force, thereby improving the pushability and anti-bending ability of the balloon structure 100. By adding a central steel wire to the outer tube 212 to enhance the support force, the pushability and anti-bending ability of the electrode balloon catheter 10 are improved.

[0049] In one embodiment, the balloon structure 100 component 230 includes a catheter seat 231 and an extension tube 232, the catheter seat 231 is respectively connected to the extension tube 232 and the cable connection seat 220, and the end of the extension tube 232 away from the catheter seat 231 is connected to the connecting tube structure 210; the catheter seat 231 is provided with an infusion connector 2311 and a wire connector 2312, the infusion connector 2311 is connected to the accommodating cavity 111, and the wire connector 2312 is respectively connected to the cable connection seat 220 and the electrode assembly 300.

[0050] In this arrangement, the wire is connected to the electrode assembly 300 and is installed in the outer tube 212 to extend axially. The proximal end of the balloon structure 100 is provided with an extension tube 232 connected to the catheter seat 231, and is connected to an external infusion device through the catheter seat 231 to transport liquid into the accommodating cavity 111 to control the expansion or contraction of the balloon structure 100. At the same time, the catheter assembly 230 can be used to connect to the cable connection seat 220 to accommodate the wire.

[0051] Specifically, catheter adapter 231 is disposed at the proximal end of balloon structure 100 and is a branched Luer-shaped adapter. It has two connected ports: an infusion connector 2311 and a wire connector 2312. Infusion connector 2311 is used to deliver fluid to expand the accommodating cavity 111 of the distal balloon structure 100. Wire connector 2312 is used to accommodate the wires of electrode assembly 300. Catheter adapter 231 can be made of polycarbonate (PC), polyurethane, ABS plastic, or the like.

[0052] In one embodiment, the extension tube 232 is a hypotube or other polymer plastic tube.

[0053] It can be understood that the sea wave tube or other polymer plastic tube is arranged at the proximal end of the balloon structure 100, and has a main body with a tubular hollow structure. The main body has a proximal face, a distal face and a side surface located between the proximal face and the distal face. The side surface includes a non-cutting area and a cutting area. The laser cutting forms a spiral groove on the cutting area, and the surface of the non-cutting area is smooth. The distal end of the sea wave tube or other polymer plastic tube is connected to the outer tube 212, and the proximal end is connected to the catheter seat 231. The outer diameter is between 0.3-2.0 mm, and the tube body material can be stainless steel, nickel titanium and other metal materials.

[0054] Specifically, the balloon structure 100 includes a balloon body 110, a tip 120 and a developing ring 130, the tip 120 is connected to the distal end of the balloon body 110, and the connecting tube assembly 200 is connected to the proximal end of the balloon body 110; the balloon body 110 and the connecting tube assembly 200 are sealed and connected to enclose a accommodating cavity 111, and the developing ring 130 is sleeved on the connecting tube structure 210 and located on the inner side of the accommodating cavity.

[0055] In this embodiment, the balloon body 110 is disposed at the distal end of the inner tube 211, forming a sealed chamber 111 with the inner tube 211 to enclose the electrode assembly 300. The liquid filled within the balloon body 110 includes saline or a saline / contrast mixture. After the balloon body 110 is filled with liquid, the internal detachable electrode assembly 300 is excited by a high-voltage pulse signal, generating an arc. This can induce a hydroelectric effect in the liquid, generating a circumferential or lateral shock wave that is transmitted through the balloon body 110 to the calcified area, causing lysis of the calcified plaque. The balloon body 110 has a single-layer or double-layer structure design, requiring regular folding to reduce the outer diameter and make the outer surface more regular and smooth. The minimum outer diameter of the balloon body 110 after folding is 0.5-1.0 mm. Using a three-fold or five-fold structure makes it easier to pass through severe stenosis. When filled with liquid and expanded, the balloon body 110 has a diameter of 2-6 mm. The shock waves generated by the electrode assembly 300 inside the balloon body 110 can be transmitted through the balloon body 110 to the calcified lesion area. The liquid can be saline or a mixture of saline and contrast agent. The balloon body 110 can be made of nylon, polyethylene terephthalate, polyethylene, polyvinyl chloride, polyurethane, silicone rubber, or one or more combinations of other polymer materials. The connection to the tip 120 and the connecting tube structure 210 can be glue bonding, heat welding, or laser welding. The surface of the balloon is sprayed with a polymer coating, which makes the surface of the balloon body 110 smoother when exposed to water, making it easier to pass through narrow lesions.

[0056] Specifically, the tip 120 is disposed at the distal end of the balloon body 110 and is designed as a tapered, long, soft tip with an outer diameter that increases from the distal end to the proximal end. This enhances the tracking capability of the balloon structure 100, facilitates passage through tortuous lesions, and reduces damage to blood vessels caused by the balloon structure 100. When using the electrode balloon catheter 10 of this embodiment, the tip 120 first contacts the calcified lesion area. The outer diameter for introduction is between 0.3-1.0 mm, the outer diameter for passage is between 0.4-1.2 mm, the inner diameter is between 0.2-0.9 mm, and the inner diameter remains constant from the distal end to the proximal end. The length is between 5-15 mm, and the thickness is between 0.1-0.5 mm. This takes into account the transition from the tip 120 to the balloon body 110, enhances its pushing capability, facilitates passage through tortuous lesions, and reduces damage to blood vessels caused by the balloon structure 100. In some embodiments, the tip 120 can be made of a smooth, elastic polymer material; the polymer material can include polyurethane (PU), polytetrafluoroethylene (PTFE), low-density polyethylene (LDPE), high-density polyethylene (HDPE), polyvinyl chloride (PVC), nylon (PA), segmented polyetheramide (Pebax), polyethylene terephthalate (PET), or a composite material. The proximal end of the tip 120 undergoes a roughening surface treatment and can be connected to the balloon body 110 by gluing, thermal welding, or laser welding. This ensures a better connection between the tip 120 and the balloon body 110, enhances weld security, and prevents the tip 120 from becoming detached from the balloon body 110 during use.

[0057] Furthermore, the developing rings 130 are radiopaque metal rings mounted at both ends of the balloon body 110. They are used for X-ray imaging, marking the working section of the balloon body 110, and accurately positioning the balloon body 110 during surgery. Embedded markings are used to reduce the outer diameter of the working section of the balloon body 110 structure 100 to between 0.3 and 1.0 mm, with an inner diameter between 0.2 and 0.9 mm and a length between 1 mm and 3 mm. The developing rings 130 can be made of metal materials such as gold, platinum, molybdenum, tungsten, or a platinum-iridium alloy.

[0058] In a preferred embodiment, the electrode balloon catheter 10 also includes a temperature sensor and / or a pressure sensor. The temperature sensor is arranged inside the connecting tube assembly 200 and is used to obtain the temperature signal inside the balloon structure 100. The pressure sensor is arranged inside the connecting tube assembly 200 and is used to obtain the pressure signal inside the balloon structure 100.

[0059] In this embodiment, the temperature sensor, a thermistor, is disposed on the inner tube 211. It converts the received temperature into an output electrical signal, which is used to monitor the temperature inside the balloon structure 100 in real time. The pressure sensor, a fiber optic pressure sensor, is also disposed on the inner tube 211. It converts the received pressure into an output electrical signal, which is used to monitor the hydraulic pressure inside the balloon structure 100 in real time. In one embodiment, the temperature sensor and pressure sensor can be disposed within the accommodating cavity 111.

[0060] In the description of the embodiments of the present application, it should be noted that the terms "center", "longitudinal", "lateral", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing the embodiments of the present application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operate in a specific orientation, and therefore cannot be understood as limiting the embodiments of the present application. In addition, the terms "first", "second", and "third" are used for descriptive purposes only and cannot be understood as indicating or implying relative importance.

[0061] In the description of the embodiments of this application, it should be noted that, unless otherwise specified or limited, the terms "connected" and "connection" should be understood in a broad sense. For example, they can refer to fixed connections, detachable connections, or integral connections; they can refer to mechanical connections or electrical connections; they can refer to direct connections or indirect connections through an intermediate medium. Those skilled in the art will understand the specific meanings of the above terms in the embodiments of this application based on the specific circumstances.

[0062] In the embodiments of the present application, unless otherwise expressly specified or limited, a first feature being "above" or "below" a second feature may mean that the first and second features are in direct contact, or that the first and second features are in indirect contact through an intermediate medium. Furthermore, a first feature being "above," "above," and "above" a second feature may mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature is higher in level than the second feature. A first feature being "below," "below," and "below" a second feature may mean that the first feature is directly below or obliquely below the second feature, or simply means that the first feature is lower in level than the second feature.

[0063] In the description of this specification, the description with reference to the terms "one embodiment", "some embodiments", "example", "specific example", or "some examples" means that the specific features, structures, materials or characteristics described in conjunction with the embodiment or example are included in at least one embodiment or example of the embodiments of the present application. In this specification, the schematic representations of the above terms do not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials or characteristics described can be combined in any one or more embodiments or examples in a suitable manner. In addition, those skilled in the art can combine and combine different embodiments or examples described in this specification and the features of different embodiments or examples, unless they are contradictory.

[0064] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present application, rather than to limit them. Although the present application has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or make equivalent replacements for some of the technical features therein. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the embodiments of the present application.

Claims

1. An electrode balloon catheter, characterized in that: include: The balloon structure has a receiving cavity for receiving liquid; a connecting tube assembly, which is sealingly connected to the proximal end of the balloon structure, and the connecting tube assembly is connected to the accommodating cavity and is used to transport the liquid; and An electrode assembly is arranged in the accommodating cavity, and the electrode assembly includes an inner electrode, an outer electrode and an insulating layer. The inner electrode is arranged on the inner side of the insulating layer and is connected in series with the outer electrode, and the electrode assembly is connected to an external high-voltage pulse generator through a wire passing through the connecting tube assembly; wherein the electrode assembly is a separate structure, and the number of the electrode assemblies is multiple groups. The series or parallel connection mode of the electrode assemblies can be switched according to the treatment mode selection, and the electrode assemblies are arranged at intervals along the extension direction of the balloon structure.

2. The electrode balloon catheter according to claim 1, characterized in that: The connecting tube assembly includes a connecting tube structure, a cable connecting seat and a catheter assembly. The connecting tube structure is sealingly connected to the proximal end of the balloon structure. The catheter assembly is respectively connected to the connecting tube structure and the cable connecting seat. The conducting wire is respectively connected to the electrode assembly and the cable connecting seat. The cable connecting seat is used to connect to the high-voltage pulse generator. The catheter assembly is connected to the accommodating cavity and is used to transport the liquid.

3. The electrode balloon catheter according to claim 2, characterized in that: The inner electrode is a sheet-like structure, the outer electrode is a tubular structure, and the inner electrode is attached to the connecting tube assembly, and the outer electrode is sleeved on the outside of the inner electrode; the electrode assembly also includes an insulating layer, the insulating layer is sleeved on the outside of the inner electrode, and the insulating layer is located between the inner electrode and the outer electrode.

4. The electrode balloon catheter according to claim 3, characterized in that: The outer electrode is provided with a first through hole, and the insulating layer is provided with a second through hole.

5. The electrode balloon catheter according to claim 2, characterized in that: The connecting tube structure includes an inner tube and an outer tube, the inner tube is used to accommodate the guide wire, the inner tube is arranged on the inner side of the outer electrode, the inner electrode is attached to the inner tube, and the inner tube is sealed and connected to the balloon structure, and the outer electrode is arranged inside the outer tube; an infusion cavity and a wire cavity are arranged inside the outer tube, the infusion cavity is respectively connected to the accommodating cavity and the catheter assembly, and the wire cavity is respectively connected to the cable connecting seat and the electrode assembly.

6. The electrode balloon catheter according to claim 5, characterized in that: A supporting steel wire is arranged inside the outer tube.

7. The electrode balloon catheter according to claim 5, characterized in that: The catheter assembly includes a catheter seat and an extension tube, the catheter seat is respectively connected to the extension tube and the cable connection seat, and one end of the extension tube away from the catheter seat is connected to the connecting tube structure; the catheter seat is provided with an infusion connector and a wire connector, the infusion connector is connected to the accommodating cavity, and the wire connector is respectively connected to the cable connection seat and the electrode assembly.

8. The electrode balloon catheter according to claim 7, characterized in that: The extension tube is a hypotube or a polymer tube.

9. The electrode balloon catheter according to claim 1, characterized in that: The balloon structure includes a balloon body, a tip and a developing ring, the tip is connected to the distal end of the balloon body, and the connecting tube assembly is connected to the proximal end of the balloon body; the balloon body and the connecting tube assembly are sealed and connected to enclose and form the accommodating cavity, and the developing ring is sleeved on the connecting tube structure and located on the inner tube.

10. The electrode balloon catheter according to claim 1, characterized in that: The electrode balloon catheter also includes a temperature sensor and / or a pressure sensor. The temperature sensor is arranged inside the connecting tube assembly and is used to obtain a temperature signal inside the balloon structure. The pressure sensor is arranged inside the connecting tube assembly and is used to obtain a pressure signal inside the balloon structure.

Citation Information

Patent Citations

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