Electrode components and electrode balloon catheters

Abstract

The present invention provides an electrode component and an electrode balloon catheter, the electrode component comprising: a first electrode, a second electrode and a receiving structure; the receiving structure is arranged on the first electrode, at least part of the second electrode is arranged in the receiving structure, the first electrode and the second electrode are arranged at intervals; one of the first electrode and the second electrode is a positive electrode, and the other is a negative electrode; the first electrode and the second electrode are used to be electrically connected to a high-voltage generating and processing device. With such an arrangement, the electrode component is arranged in a single layer, which reduces the passing size of the electrode balloon catheter, makes the passing size of the electrode balloon catheter thinner, and is closer to the size of the pre-expansion balloon, and prevents the phenomenon that the electrode balloon catheter is difficult to pass or even the component is broken when the electrode balloon catheter is intervened.

Description

Technical Field

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

[0002] Angioplasty is a surgical method that uses mechanical methods to restore the narrowed blood vessel lumen to its original size. Traditional angioplasty often uses a balloon catheter to physically expand the narrow lesion to make the blood vessel unobstructed again. However, it is easy to cause tearing and damage to the adventitia of the blood vessel during balloon expansion. The method of indirectly crushing calcified deposits or "stones" in the urinary tract or bile duct using the hydrostatic effect can be used to destroy the calcified focus structure attached to the wall of the diseased blood vessel, that is, the hydrostatic lithotripsy technology can be applied in angioplasty. The principle of hydrostatic lithotripsy technology is that the liquid quickly vaporizes under a high-voltage strong electric field to form steam bubbles and expand outward. The bubble ruptures to generate a strong shock wave and acts on the surrounding environment of the liquid. Based on the principle of hydrostatic effect to destroy the structure of the calcified focus, an electrode component is placed in the balloon, and the electrode component is connected to an external pulse power supply through wires laid inside the catheter. When the balloon is placed near the calcified area of ​​the blood vessel, a high-voltage pulse is applied to the electrode component to form a shock wave. The shock wave propagates through the conductive liquid inside the balloon and impacts the balloon wall and the calcified area. Repeated pulses can destroy the structure of calcification and dilate narrowed blood vessels without damaging the surrounding soft tissues, thus avoiding the problem of vascular wall damage caused by balloon expansion in traditional angioplasty.

[0003] At present, the electrodes of the electrode balloon catheter are arranged in multiple layers, which increases the outer diameter of the catheter and makes it difficult to pass through. When the electrode balloon catheter is inserted into the human body, it is easy to have difficulty passing through the narrow blood vessel area. If the insertion is attempted multiple times, the hypotube at the connection between the proximal and distal ends may break.

[0004] Therefore, an electrode component has been developed, which is arranged on an electrode balloon catheter so that the passing dimension of the electrode balloon catheter is thinner and closer to the dimension of the pre-expanded balloon, thereby preventing the electrode balloon catheter from being difficult to pass or even breaking the component during intervention. This has become an urgent problem to be solved by electrode component or electrode balloon catheter manufacturers. Summary of the invention

[0005] The object of the present invention is to provide an electrode component and an electrode balloon catheter, so that the passing size of the electrode balloon catheter is thinner and closer to the size of the pre-expansion balloon, so as to solve the problem that the electrode balloon catheter is difficult to pass or even the component is broken during intervention.

[0006] In order to solve the above technical problems, the present invention provides an electrode component for an electrode balloon catheter, comprising: a first electrode, a second electrode and a receiving structure; the receiving structure is arranged on the first electrode, at least a part of the second electrode is arranged in the receiving structure, and the first electrode and the second electrode are arranged at intervals; one of the first electrode and the second electrode is a positive electrode, and the other is a negative electrode; the first electrode and the second electrode are used to be electrically connected to a high voltage generating and processing device.

[0007] Optionally, the shape of at least a portion of the second electrode matches the shape of the receiving structure.

[0008] Optionally, the first electrode is in an annular structure and is arranged around the circumference of the electrode balloon catheter, and the second electrode is arranged in a sheet shape.

[0009] Optionally, at least two receiving structures are provided on each of the first electrodes, and each of the receiving structures is matched with one of the second electrodes.

[0010] Optionally, the first electrode and / or the second electrode are arranged on the electrode balloon catheter by pasting, printing, electroplating, 3D printing or vapor deposition.

[0011] Optionally, the electrode component further includes an insulating connector, which is respectively connected to the first electrode and the second electrode to fix the relative position of the first electrode and the second electrode.

[0012] Optionally, the second electrode is fixedly connected to the insulating connector, the insulating connector is clamped to the first electrode, and the insulating connector, the first electrode and the second electrode are all arranged in the same layer on the electrode balloon catheter.

[0013] Optionally, the insulating connector is laid on the receiving structure, and the second electrode is arranged on the insulating connector.

[0014] Optionally, the receiving structure is disposed through the first electrode, or the receiving structure is disposed on a surface of the first electrode.

[0015] Optionally, the surface of the first electrode and / or the second electrode has micrometer-scale tips, and the tips are in the shape of a group of peaks.

[0016] In order to solve the above technical problems, the present invention also provides an electrode component for an electrode balloon catheter, comprising: a first electrode and a plurality of second electrodes; the first electrode has a plurality of receiving spaces, the receiving spaces are used to respectively embed at least a portion of each of the plurality of second electrodes, the first electrode and the second electrode are spaced apart, and the area of ​​the first electrode is greater than the area of ​​the second electrode; one of the first electrode and the second electrode is a positive electrode, and the other is a negative electrode; the first electrode and the second electrode are used to be electrically connected to a high voltage generating and processing device.

[0017] Optionally, the first electrode is an annular structure and is sleeved on the electrode balloon catheter, the second electrode is a circular sheet, and the plurality of second electrodes are evenly arranged along the circumference of the first electrode.

[0018] Optionally, the first electrode and the second electrode are fixed in position relative to each other by an insulating connector.

[0019] Optionally, the insulating connector is laid in the receiving space, and the second electrode is arranged on the insulating connector.

[0020] In order to solve the above technical problems, the present embodiment also provides an electrode balloon catheter, comprising: a balloon, an inner catheter and the electrode component as described above; the balloon is sleeved outside the inner catheter, and the balloon expands or contracts radially under the filling and extraction of filling fluid; the electrode component is arranged on the inner catheter and is located inside the balloon, and is used to be connected to a high-voltage generating and processing device.

[0021] Optionally, the electrode balloon catheter also includes a flexible circuit layer, which is disposed on the inner catheter; the flexible circuit layer is connected to the first electrode and the second electrode respectively, and the first electrode and the second electrode are connected to the high voltage generating and processing device through the flexible circuit layer.

[0022] In an electrode component and an electrode balloon catheter provided by the present invention, the electrode component includes: a first electrode, a second electrode and a receiving structure; the receiving structure is arranged on the first electrode, at least part of the second electrode is arranged in the receiving structure, and the first electrode and the second electrode are arranged at intervals; one of the first electrode and the second electrode is a positive electrode, and the other is a negative electrode; the first electrode and the second electrode are used to be electrically connected to a high-voltage generating and processing device. Such an arrangement makes the electrode component arranged in a single layer, reduces the passing size of the electrode balloon catheter, makes the passing size of the electrode balloon catheter thinner, and is closer to the size of the pre-expansion balloon, and prevents the phenomenon that the electrode balloon catheter is difficult to pass or even the component is broken when the electrode balloon catheter is intervened. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Those skilled in the art will appreciate that the accompanying drawings are provided for a better understanding of the present invention and do not constitute any limitation on the scope of the present invention.

[0024] Figure 1 Schematic diagram of the electrode balloon catheter according to the first embodiment of the present invention.

[0025] Figure 2 This is a schematic diagram of the inner catheter according to the first embodiment of the present invention.

[0026] Figure 3 This is a circuit diagram of a high voltage generating and processing device according to Embodiment 1 of the present invention.

[0027] Figure 4 It is a simplified equivalent circuit diagram of the high voltage generating unit according to the first embodiment of the present invention.

[0028] Figure 5 This is a flow chart of the electrode balloon catheter and high voltage generating device according to the first embodiment of the present invention.

[0029] Figure 6 This is a safe operation flow chart of the electrode balloon catheter and high voltage generating and processing device according to the first embodiment of the present invention.

[0030] Figure 7a Schematic diagram of electrode components according to Embodiment 1 and Embodiment 3 of the present invention.

[0031] Figure 7b Another schematic diagram of the electrode components of the first and third embodiments of the present invention.

[0032] Figure 8a Schematic diagram of electrode components of Embodiment 2 and Embodiment 3 of the present invention.

[0033] Figure 8b Another schematic diagram of the electrode components of the second and third embodiments of the present invention.

[0034] Fig. 9 This is a schematic diagram of the tip of the first electrode of the electrode component according to the first embodiment of the present invention.

[0035] In the attached figure:

[0036] 100-balloon, 110-filling fluid;

[0037] 200-internal catheter;

[0038] 300-shock wave generating assembly, 310-flexible circuit layer, 311-positive electrode line, 312-negative electrode line, 320-electrode component, 3201-first electrode, 3202-second electrode, 3203-housing structure, 3204-insulating connector, 3205-tip, A-first connector, B-second connector, C-third connector, D-fourth connector, E-electrode line, 321-positive electrode, 322-negative electrode, 340-catheter connector, 341-external positive electrode line, 342-external negative electrode line;

[0039] 400 - external catheter;

[0040] 500-high voltage generating and processing device, 510-logic processing unit, 511-logic processor, 520-high voltage generating unit, 521-high voltage generator, 522-high voltage resistor, 523-high voltage capacitor, 530-amplifying circuit, 540-display unit, 541-display, 550-trigger unit, 550a-trigger device, 551-first switch, 552-second switch, 560-sampling circuit, 570-connector, 580-operating handle;

[0041] 600-temperature sensor;

[0042] 700-Hydraulic sensor;

[0043] 800 - Pressure sensor. DETAILED DESCRIPTION

[0044] In order to make the purpose, advantages and features of the present invention clearer, the present invention is further described in detail below in conjunction with the accompanying drawings and specific embodiments. It should be noted that the drawings are all in a very simplified form and are not drawn to scale, and are only used to conveniently and clearly assist in explaining the purpose of the embodiments of the present invention. In addition, the structure shown in the drawings is often a part of the actual structure. In particular, the emphasis of each drawing is different, and sometimes different scales are used.

[0045] As used in this specification, the singular forms "one", "an" and "the" include plural objects, unless the content clearly indicates otherwise. As used in this specification, the term "or" is generally used in a sense including "and / or", unless the content clearly indicates otherwise. In addition, in the following description, for ease of description, "distal end" and "proximal end" are used, and "proximal end" refers to the end close to the patient away from the operator, and "proximal end" refers to the end away from the patient and close to the operator. In addition, in the description below, a large number of specific details are given in order to provide a more thorough understanding of the present invention. However, it is obvious to those skilled in the art that the present invention can be implemented without one or more of these details. In other examples, in order to avoid confusion with the present invention, some technical features known in the art are not described.

[0046] An embodiment of the present invention provides an electrode component and an electrode balloon catheter, the electrode component comprising: a first electrode, a second electrode and a receiving structure; the receiving structure is arranged on the first electrode, at least part of the second electrode is arranged in the receiving structure, the first electrode and the second electrode are arranged at intervals; one of the first electrode and the second electrode is a positive electrode, and the other is a negative electrode; the first electrode and the second electrode are used to be electrically connected to a high-voltage generating and processing device. An embodiment of the present invention also provides an electrode component, the electrode component comprising: a first electrode and a plurality of second electrodes; the first electrode has a plurality of receiving spaces, the receiving spaces are used to respectively embed at least part of each of the plurality of second electrodes, the first electrode and the second electrode are arranged at intervals, and the area of ​​the first electrode is greater than the area of ​​the second electrode; one of the first electrode and the second electrode is a positive electrode, and the other is a negative electrode; the first electrode and the second electrode are used to be electrically connected to a high-voltage generating and processing device. Such a configuration allows the electrode components to be arranged in a single layer, reducing the passage size of the electrode balloon catheter, making the passage size of the electrode balloon catheter thinner and closer to the size of the pre-expansion balloon, thereby preventing the electrode balloon catheter from being difficult to pass through or even breaking the component during intervention.

[0047] The following description is given with reference to the accompanying drawings.

[0048] [Example 1]

[0049] Please refer to Figures 1 to 7b , Figure 1 is a schematic diagram of an electrode balloon catheter according to Embodiment 1 of the present invention; Figure 2 is a schematic diagram of an inner catheter according to Embodiment 1 of the present invention; Figure 3 A circuit diagram of a high voltage generating and processing device according to a first embodiment of the present invention; Figure 4 is a simplified equivalent circuit diagram of a high voltage generating unit according to the first embodiment of the present invention; Figure 5 This is a flow chart of an electrode balloon catheter and a high voltage generating and processing device according to Embodiment 1 of the present invention; Figure 6 This is a safety operation flow chart of the electrode balloon catheter and the high voltage generating and processing device according to the first embodiment of the present invention; Figure 7a Schematic diagram of electrode components according to Embodiment 1 and Embodiment 3 of the present invention; Figure 7b Another schematic diagram of the electrode components of the first and third embodiments of the present invention. Fig. 9 This is a schematic diagram of the tip of the first electrode of the electrode component according to the first embodiment of the present invention.

[0050] The electrode component 320 provided in this embodiment can be used in an electrode balloon catheter. This article first introduces the electrode balloon catheter. Figure 1 As shown, the electrode balloon catheter comprises a balloon 100, an inner catheter 200 and a shock wave generating assembly 300. The electrode balloon catheter 100 preferably further comprises an outer catheter 400, which is sleeved on the outside of the inner catheter 200 and connected to the balloon 100.

[0051] The balloon 100 is, for example, a balloon of a shuttle structure, and the balloon 100 is sleeved outside the inner catheter 200, for example, it can be sleeved on the distal end of the inner catheter 200. Of course, the balloon 100 can also be a cylindrical structure, and can also be sleeved on the position between the proximal end and the distal end of the inner catheter 200. The inner catheter 200 is, for example, a cylinder. The balloon 100 is preferably arranged to extend along the axial direction of the inner catheter 200. Preferably, the distal end of the balloon 100 is connected to the distal end of the inner catheter 200, and the proximal end of the balloon 100 is connected to the distal end of the outer catheter 400. The balloon 100 expands or contracts along the radial direction of the balloon 100 under the filling and extraction of the filling liquid 110. The filling liquid 110 can be a conductive liquid, and the conductive liquid can be filled in the interior of the balloon 100, so that the balloon 100 can expand or contract. The filling amount of the filling liquid 110 is preferably the natural inner cavity volume of the balloon 100 in a non-deformed state. The filling liquid 110 can be saline, contrast solution, or a mixture of saline and contrast solution. In other embodiments, the filling liquid 110 can also be a non-conductive liquid, or other filling liquid that can be used in the human body.

[0052] The shock wave generating assembly 300 includes an electrode component 320. Preferably, the shock wave generating assembly 300 further includes a flexible circuit layer 310.

[0053] Combination Figure 2As shown, the flexible circuit layer 310 is arranged on the inner catheter 200. The flexible circuit layer 310 preferably has certain flexibility and thin thickness. The flexible circuit layer 310 is, for example, a flexible circuit patch, which can be attached to the outer surface of the inner catheter 200, so that the radial dimension of the electrode balloon catheter can be the sum of the diameter of the inner catheter 200 and the radial dimension of the flexible circuit layer 310, thereby making the electrode balloon catheter and the current balloon catheter in which multiple positive and negative wires are bundled together and then combined with the inner catheter. Compared with the arrangement mode, the electrode balloon catheter can become smaller and closer to the diameter of the pre-expansion balloon, thereby improving the passability of the electrode balloon catheter to intervene in the human body, avoiding the situation that the components in the electrode balloon catheter are broken, and can also enable the electrode balloon catheter to pass through the narrower area in the blood vessel to reach the lesion. It can be understood that the pass size of the electrode balloon catheter can represent the radial dimension through the blood vessel; the diameter of the pre-expansion balloon represents the diameter size of the balloon 100 when it is not expanded. The flexible circuit layer 310 preferably includes a positive line 311 and a negative line 312. More preferably, the flexible circuit layer 310 also includes an insulating protective film, on which the positive line 311 and the negative line 312 are arranged, and the insulating protective film is attached to the inner catheter 200. The positive line 311 or the negative line 312 is, for example, made of conductive copper foil. Of course, the material of the positive and negative lines can also be other materials with high conductivity, such as metal materials such as gold, silver, and platinum. Of course, the flexible circuit layer 310 can also be arranged on the inner surface or the middle interlayer of the inner catheter 200, thereby preventing the flexible circuit layer 310 from contacting the filling fluid 110 on the outer surface of the inner catheter 200, thereby reducing safety hazards. It should be understood that, under the condition that the circuit conditions allow, the radial dimension of the flexible circuit layer 310 is as small as possible, so that the passage dimension of the electrode balloon catheter is minimized, thereby making the passage dimension closer to the diameter of the pre-expansion balloon. The proximal end of the flexible circuit layer 310 is connected to a high voltage generating device 500, and the distal end of the flexible circuit layer 310 is respectively connected to the electrode components 320. The high voltage generating device 500 includes, for example, a high voltage generating unit 520, which can emit a high voltage pulse so that the flexible circuit layer 310 can transmit the high voltage pulse, and the electrode component 320 receives the high voltage pulse and generates a shock wave.

[0054] Please continue to refer to Figure 1 and Figure 2The electrode component 320 is disposed on the inner catheter 200 and is located inside the balloon 100, so that the electrode component 320 can contact the filling fluid 110 inside the balloon 100. The electrode component 320 is connected to the flexible circuit layer 310, and is used to be connected to a high voltage generating device 500 through the flexible circuit layer 310. Specifically, the electrode component 320 includes a positive electrode 321 and a negative electrode 322, the positive electrode 321 is connected to the positive line 311, and the negative electrode 322 is connected to the negative line 312. The shock wave generating principle of the shock wave generating assembly 300 is as follows: the electrode balloon catheter is inserted into the narrow blood vessel with a calcified focus structure, and the electrode component 320 breaks through the filling liquid 110 at the discharge gap through positive and negative electrode discharge or arc discharge. The filling liquid 110 generates a large number of bubbles, and the stress of the bubble expansion and disappearance releases the shock wave. The shock wave is transmitted to the lesion site, softens and ruptures the calcified plaque, destroys the calcified focus structure of the targeted blood vessel, and thus achieves the purpose of unblocking the blood vessel. Treating patients in this way makes up for the shortcomings of traditional balloon dilatation, improves the success rate of the operation, and reduces postoperative complications.

[0055] Preferably, the flexible circuit layer 310 has a radial thickness of no more than 0.2 mm along the inner catheter 200, provided that high voltage and high current can pass therethrough, thereby making the passing dimension of the electrode balloon catheter close to the dimension of the pre-expansion balloon. In addition, the flexible circuit layer 310 has excellent bending performance. Furthermore, the radial thickness of the flexible circuit layer 310 can be less than 0.1 mm, further reducing the passing dimension. Of course, those skilled in the art can also set the radial thickness of the flexible circuit layer 310 along the inner catheter 200 according to actual needs.

[0056] Furthermore, in order to enable the flexible circuit layer 310 to be better connected to the inner catheter 200, the flexible circuit layer 310 is preferably arranged on the inner catheter 200 by pasting, printing, electroplating, 3D printing or vapor deposition, so that the overall outer diameter of the electrode balloon catheter is reduced and the passing performance is improved. Specifically, the flexible circuit layer 310 can be arranged with positive and negative lines in the form of a flexible printed circuit (FPC), and the flexible circuit layer 310 is pasted on the inner catheter 200. The flexible circuit layer 310 can also be arranged by printing the positive and negative lines directly on the inner catheter 200. The flexible circuit layer 310 can also be arranged by electroplating, 3D printing or vapor deposition. Of course, the flexible circuit layer 310 can also adopt a combination of these methods, for example, the positive line 311 of the flexible circuit layer 310 is 3D printed, and the negative line 312 is vapor deposited, or the positive line 311 is electroplated, and the negative line 312 is 3D printed. In this way, the positive line 311 and the negative line 312 can be attached to the outer surface of the inner conduit 200 respectively, so that the positive line 311 or the negative line 312 can be completely attached to the inner conduit 200 to ensure the safety of the circuit. Preferably, the electrode line of the flexible circuit layer 310 can be connected to the electrode component 320 by laser welding, soldering or pressing. In the first embodiment, the negative line 312 is connected to the negative electrode 322 by laser welding, and the positive line 311 is connected to the positive electrode 321 by pressing. Of course, those skilled in the art can also select the connection method of the positive line 311 and the negative line 312 according to actual needs. For example, the positive line 311 and the positive electrode 321 are connected by laser welding, and the negative line 312 and the negative electrode 322 are connected by pressing.

[0057] Further, such as Figure 2As shown, the electrode balloon catheter also includes a temperature sensor 600, which is arranged on the outer surface of the inner catheter 200 or the inner surface of the outer catheter 400. The temperature sensor 600 is used to measure the temperature inside the balloon 100 and send the temperature signal, so that the electrode balloon catheter can monitor the temperature inside the balloon at any time when releasing the shock wave, thereby reducing the risk in the operation. When the filling fluid has a hydroelectric effect, the filling fluid increases in temperature due to the increase of steam bubbles, but the filling fluid temperature does not exceed 2°C of the normal human body temperature. Therefore, the temperature sensor 600 is required to monitor the filling fluid to prevent the filling fluid temperature from being too high, affecting the treatment effect, and even affecting human health. The electrode balloon catheter can monitor the temperature state inside the balloon at any time when releasing the shock wave, thereby reducing the risk in the operation. More preferably, the temperature sensor 600 includes a flexible temperature sensor, which can be attached to the outer surface of the inner catheter 200, thereby reducing the radial size of the electrode balloon catheter. The configuration of the flexible temperature sensor may refer to the configuration of the flexible circuit layer 310 , which will not be described in detail here.

[0058] Preferably, Figure 1 and Figure 2 As shown, the electrode balloon catheter also includes a hydraulic sensor 700, which is arranged on the inner catheter 200. The hydraulic sensor 700 is used to monitor the hydraulic pressure inside the balloon in real time and send the filling pressure signal, so that the electrode balloon catheter can monitor the pressure state inside the balloon at any time when releasing the shock wave, thereby reducing the risks in the operation. It should be understood that the gap between the inner catheter 200 and the outer catheter 400 is connected to the internal cavity of the balloon 100, so that when the hydraulic sensor 700 is arranged on the inner catheter 200 or the outer catheter 400, the filling fluid pressure inside the balloon can be measured. Preferably, the hydraulic sensor 700 is arranged on the outer surface of the inner catheter 200 or the inner surface of the outer catheter 400, so that the hydraulic sensor 700 can better measure the pressure of the filling fluid. More preferably, the hydraulic sensor 700 can be arranged at a position close to the proximal end of the inner catheter 200, so that the hydraulic sensor 700 can not increase the passing size of the electrode balloon catheter. Preferably, the hydraulic sensor 700 comprises a flexible hydraulic sensor, which can be attached to the outer surface of the inner catheter 200, thereby further reducing the radial dimension of the electrode balloon catheter.

[0059] Further, such as Figure 1 and Figure 2As shown, the electrode balloon catheter also includes a pressure sensor 800, which is arranged at the distal end of the inner catheter 200, and is used to monitor the pressure, resistance or pushing force of the electrode balloon catheter and send a resistance signal, so that the electrode balloon catheter can monitor the resistance or pushing force of the pressure sensor 800 at any time when releasing the shock wave, thereby reducing the risks in the operation. Preferably, the pressure sensor 800 is an annular pressure sensor, which is sleeved at the distal end of the inner catheter 200, so as to be able to more comprehensively detect the pressure, resistance or pushing force.

[0060] Better, such as Figure 1 As shown, the electrode balloon catheter further includes a catheter connector 340, and the catheter connector 340 is used to connect to an external high-voltage generating and processing device 500, and is used to communicate high-voltage signals and detection signals with the high-voltage generating and processing device 500. It should be understood that those skilled in the art can set the size of the electrode balloon catheter according to the needs of the operation or the patient, such as the radial size of the balloon 100 after filling, the axial size of the balloon 100, and the radial size of the inner catheter 200.

[0061] like Figure 3 As shown, this embodiment 1 further provides a high voltage generation processing device 500, which is used to connect the electrode balloon catheter signal as described above. The high voltage generation processing device 500 includes a logic processing unit 510 and a high voltage generation unit 520.

[0062] like Figure 3 As shown, the logic processing unit 510 is connected to the high voltage generating unit 520 by electrical signals, and is used to control the disconnection and connection of the high voltage generating unit 520. For example, the logic processing unit 510 is a logic processor 511, and the logic processor 511 has a logic circuit. If the logic processing unit 510 receives a certain electrical signal, the logic processing unit 510 determines the disconnection and connection of the high voltage generating unit 520 according to the electrical signal. The logic processor 511 can adopt STMicroelectronics 32-bit series microcontroller chip (STM32), field programmable gate array (Field Programmable Gate Array, FPGA), etc., to replace a microprocessor.

[0063] The logic processing unit 510 is connected to the hydraulic sensor 700 of the electrode balloon catheter by electrical signals, and is used to receive the filling pressure signal sent by the hydraulic sensor 700; when the filling pressure drop rate or the absolute value of the filling pressure difference in the filling pressure signal received by the logic processing unit 510 exceeds the set threshold, the logic processing unit 510 cuts off the electrical signal connection with the high-voltage generating unit 520. If the filling pressure value detected by the hydraulic sensor 700 drops sharply, the filling pressure drop rate or the absolute value of the filling pressure difference exceeds the set threshold, indicating that the balloon 100 is ruptured or other conditions that cause the filling pressure value to drop sharply, the logic processing unit 510 controls the high-voltage generating unit 520 to cut off the voltage applied to the two poles, thereby ensuring the safety of the operation. Preferably, the high-voltage generating processing device 500 also includes an amplifier circuit 530, one end of which is connected to the logic processing unit 510, and the other end of which is connected to the hydraulic sensor 700. The connection method may be a communication connection, that is, an electrical connection, etc., so that the signal of the hydraulic sensor 700 can be transmitted to the logic processing unit 510 .

[0064] Furthermore, in fact, since the released shock wave can destroy the structure of the calcified focus at the vascular lesion, compress the volume of the calcified focus, and expand the blood vessel cavity, the filling pressure of the balloon 100 is reduced, and the outer diameter is correspondingly reduced, so that the balloon 100 does not completely fit the target blood vessel, so the high-pressure generating and processing device 500 also includes a display unit 540, and the display unit 540 is, for example, a display 541. The display unit 540 is connected to the logic processing unit 510; when the filling pressure value deviates from the filling pressure range when the filling pressure is working, that is, when the filling pressure value of the filling pressure signal is greater than the set working pressure value, the hydraulic sensor 700 is connected to the logic processing unit 510 signal, and the logic processing unit 510 sends a filling pressure signal to the display unit 540, and the display unit 540 receives the filling pressure signal and sends a prompt signal. Preferably, the display unit 540 has an acoustic and optical generator, and the prompt signal can be an acoustic and optical prompt. Of course, those skilled in the art can set other prompt signals according to actual needs.

[0065] Preferably, the logic processing unit 510 is also used to receive the resistance signal emitted by the pressure sensor 800 of the electrode balloon catheter. The pressure sensor 800 can provide protection for the intervention of the electrode balloon catheter. When the resistance value of the resistance signal is greater than the set threshold, the logic processing unit 510 sends the resistance signal to the display unit 540, and the display unit 540 receives the resistance signal and sends an alarm signal. Similarly, the alarm signal can be an audible and visual alarm of the sound and light generator of the display unit 540, or other alarm forms. It should be understood that due to the interaction of forces, the resistance can also be understood as the pushing force of the pressure sensor 800. Preferably, one end of the amplifier circuit 530 is connected to the logic processing unit 510, and the other end of the amplifier circuit 530 is connected to the pressure sensor 800, so that the pressure sensor 800 signal can be transmitted to the logic processing unit 510.

[0066] More preferably, the logic processing unit 510 is also used to receive the temperature signal sent by the temperature sensor 600 of the electrode balloon catheter. When the temperature value of the temperature signal is greater than the set threshold, the logic processing unit 510 cuts off the high voltage generating unit 520. The logic processing unit 510 controls the high voltage generating unit 520 to cut off the voltage applied to the two electrodes, thereby ensuring the safety of the operation. Preferably, one end of the amplifier circuit 530 is connected to the logic processing unit 510, and the other end of the amplifier circuit 530 is connected to the temperature sensor 600, so that the temperature sensor 600 signal can be transmitted to the logic processing unit 510.

[0067] In summary, the temperature sensor 600, hydraulic sensor 700 and pressure sensor 800 used in the first embodiment can monitor the temperature, pressure and thrust inside the balloon, and the high-pressure generating and processing device 500 responds accordingly based on the feedback signals, thereby improving the efficiency of crushing calcified lesions, reducing risks and reducing harm to patients.

[0068] Preferably, in the process of releasing the shock wave, in order to avoid causing transient ventricular capture or shock, the high-pressure generating and processing device 500 will monitor the release frequency and the time of filling the balloon 100 in real time. Therefore, the high-pressure generating and processing device 500 also includes a timer (not shown), which is connected to the logic processing unit 510; when the filling pressure of the filling pressure signal received by the logic processing unit 510 reaches the set filling pressure, it should be understood that when the filling pressure reaches the set filling pressure, it means that the shock wave starts to be released. At this time, the timer starts timing, and the timing of the timer reaches the set time, for example, the set time is 10 seconds, the timer sends a time signal to the logic processing unit 510, the logic processing unit 510 receives the time signal, and sends the time signal to the display unit 540, the display unit 540 receives the time signal and sends a prompt signal, prompting the operator to withdraw the filling fluid 110 in the balloon 100, and after waiting for a certain period of time, the operator uses the filling fluid 110 to fill the balloon 100 again to release the shock wave. The setting of the timer enables the high-voltage generating and treating device 500 to control the time of releasing the shock wave, thereby further reducing the risks existing in the operation.

[0069] Need to understand, please refer to Figure 4As shown, the high voltage generating unit 520 includes a high voltage generator 521, a high voltage capacitor 523 and a trigger unit 550, and the trigger unit 550 is connected to the logic processing unit 510. The trigger unit 550 is, for example, a trigger device 550a, and the trigger device 550a includes, for example, a high voltage relay, an insulated gate bipolar transistor (IGBT), etc. Of course, those skilled in the art may also use other forms. The trigger unit 550 includes a first switch 551 and a second switch 552, the first switch 551 is arranged between the high voltage generator 521 and the high voltage capacitor 523, and the second switch 552 is arranged between the high voltage capacitor 523 and the electrode component 320. The logic processing unit 510 controls the switching of the first switch 551 and the second switch 552. When the high-voltage generator 521 charges the high-voltage capacitor 523, the first switch 551 of the trigger unit 550 is in a closed state and the second switch 552 is in an open state; when the electrode balloon catheter reaches the treatment position, the logic processing unit 510 controls the trigger unit 550 to change the states of the first switch 551 and the second switch 552, so that the first switch 551 is disconnected and the second switch 552 is closed. At this time, the high-voltage capacitor 523 applies voltage to the positive electrode 321 and the negative electrode 322 of the electrode component 320 to form a relatively large current, thereby generating an arc between the positive electrode 321 and the negative electrode 322 immersed in the filling fluid 110, and the arc generates a shock wave in the filling fluid 110.

[0070] Furthermore, in order to ensure the safety of operation, Figure 3 As shown, the high voltage generation processing device 500 further includes a sampling circuit 560, and the sampling circuit 560 is used to detect the voltage of the high voltage generation unit 520, the electrode component 320 of the electrode balloon catheter, or whether the flexible circuit layer 310 is short-circuited. Taking the detection of the high voltage generation unit 520 as an example, the operator performs voltage detection on the electrode balloon catheter before the operation, and the logic processing unit 510 sends a signal to the high voltage generator 521, and the high voltage generator 521 generates a high voltage to charge the high voltage capacitor 523 through a high voltage resistor 522, and at the same time, the sampling circuit 560 collects the voltage, feeds it back to the logic processing unit 510, and displays it on the display. Taking the detection of the electrode component 320 or the flexible circuit layer 310 as an example, the high voltage generator 521 generates an electrical signal, and the sampling circuit 560 collects the electrical signal of the electrode component 320 or the flexible circuit layer 310. After confirming that there is no short circuit prompt, the operator can perform the conventional minimally invasive interventional surgery.

[0071] Preferably, combined Figure 1 and Figure 3As shown, the high voltage generating and processing device 500 also includes a connector 570 and an operating handle 580. The connector 570 is used as a connection port between the high voltage generating and processing device 500 and the outside world, and is used to connect to the electrode balloon catheter. The connector 570 is connected to the catheter connector 340 of the electrode balloon catheter, so that the high voltage signal and detection signal of the high voltage generating and processing device 500 can be communicated with the electrode balloon catheter. Furthermore, the connector 570 is electrically connected to the electrode balloon catheter. The catheter connector 340 includes an external positive line 341 and an external negative line 342, the external positive line 341 is connected to the positive line 311, and the external negative line 342 is connected to the negative line 312. The operating handle 580 is used to control the opening and closing of the logic processing unit 510.

[0072] The following will be combined Figures 1 to 6 The working process of the electrode balloon catheter and the high voltage generating and processing device 500 and the circuit connection of the high voltage generating and processing device 500 are introduced.

[0073] First, please focus on Figure 3 As shown, the operator adjusts the mode of the logic processing unit 510 of the high-voltage generating and processing device 500 according to the patient's condition, such as coronary, peripheral or valvular lesions, to select the voltage value required for the electrode component 320 to release the shock wave in different modes, the filling pressure value range when the balloon 100 is expanded, and the resistance value range accepted by the pressure sensor 800. After the mode is selected, that is, after the interface selection is determined, the connector 570 is connected to the electrode balloon catheter of the size corresponding to the condition. After that, the operator performs preoperative testing. The high-voltage generator 521 generates high voltage to charge the high-voltage capacitor 523 through the high-voltage resistor 522, and at the same time, the sampling circuit 560 performs voltage and short-circuit detection and other information, which is fed back to the logic processing unit 510 and displayed on the display 541. After determining that the voltage value meets the set requirements and there is no short-circuit prompt, the interventional surgery operation is performed.

[0074] Then, the operator delivers the electrode balloon catheter to the vascular lesion. During the delivery of the electrode balloon catheter, the pressure sensor 800 feeds back the push force detection to the logic processing unit 510 through the amplifier circuit 530. When the push force value is greater than the threshold, the display 541 emits an audible and visual alarm. When reaching the vascular lesion, the filling fluid 110 fills the balloon 100, and the hydraulic sensor 700 monitors the filling pressure inside the balloon 100 in real time. When the shock wave is released, the hydraulic sensor 700 and the temperature sensor 600 communicate with the logic processing unit 510 in real time through the amplifier circuit 530 to perform pressure detection and temperature detection. If the internal temperature received by the temperature sensor 600 is higher than the warning threshold, the logic processing unit 510 controls the high voltage generator 521 to cut off the voltage applied to the two electrodes; if the filling pressure value received by the hydraulic sensor 700 drops sharply, the logic processing unit 510 controls the high voltage generator 521 to cut off the voltage applied to the two electrodes; if the filling pressure of the balloon 100 deviates from the set working filling pressure range, the display 541 sends a prompt signal. During the process of releasing the shock wave, if the shock wave release time exceeds 10 seconds, the logic processing unit 510 communicates with the display 541 to prompt the operator to withdraw the filling fluid 110 in the balloon 100. After waiting for a certain period of time, the operator uses the filling fluid 310 to refill the balloon 100 to release the shock wave.

[0075] For further information, please refer to Figure 5 As shown, in order to more clearly illustrate the working process of the electrode balloon catheter and the high voltage generating and processing device 500, this embodiment 1 provides the working steps of the electrode balloon catheter and the high voltage generating and processing device 500.

[0076] S1: Start.

[0077] S2: Initialization test. The high voltage generation and processing device 500 detects whether all parameters of the electrode balloon catheter and the high voltage generation and processing device 500 are normal, such as whether there is a short circuit, whether there is a loss of pressure, etc. If all parameters meet the standards, proceed to the next step; if one parameter of all parameters does not meet the standards, it means that the initialization test fails.

[0078] S3: Activate the high voltage power supply to charge the capacitor.

[0079] S4: Determine whether the voltage reaches the set value. Specifically, the capacitor voltage can be detected. When the capacitor voltage reaches the threshold, the condition for entering the next step is met, that is, the electrode balloon catheter is inserted into the human body; if the capacitor voltage does not reach the threshold, the operation of the previous step is repeated.

[0080] S5: Determine whether the resistance encountered during intervention is greater than a set value. If the resistance is greater than the set value, an audible and visual alarm is used to remind the operator. If the resistance is not greater than the set value during intervention and the targeted lesion is successfully reached, the filling fluid 110 is used to fill and expand the balloon 100.

[0081] S6: Press the handle button of the operating handle 580.

[0082] S7: Determine whether there is a short circuit. The high voltage generation and processing device 500 detects whether the circuit is short-circuited. If a short circuit is detected, the discharge is terminated immediately. If no short circuit is detected, the next step is entered.

[0083] S8: Discharge.

[0084] S9: Determine whether the hydraulic pressure and temperature are greater than the set value. The hydraulic pressure represents the filling pressure. The step S9 of determining whether the hydraulic pressure and temperature are greater than the set value can be performed simultaneously with the step S8 of discharging. If the hydraulic pressure and temperature are greater than the set value, the discharging is terminated; if the hydraulic pressure and temperature are not greater than the set value, the previous step is performed.

[0085] For further information, please refer to Figure 6 As shown, in order to reduce the surgical risks of transient ventricular capture or shock in patients, the high-voltage generating and processing device 500 also includes a safe operation process step.

[0086] S10: Start. A signal to inflate the balloon 100 is issued.

[0087] S11: Balloon inflation.

[0088] S12: Determine whether the specified hydraulic pressure is reached. If the pressure inside the balloon 100 reaches the set threshold, such as 4 standard atmospheres (4atm), proceed to the next step; if the balloon 100 does not reach the set threshold, proceed to the previous step.

[0089] S13: Activate the timer to start timing.

[0090] S14: Determine whether the time limit has been reached. If the time limit has reached the set value, for example, 10 seconds, proceed to the next step; if the time limit has not reached the set value, proceed to the previous step.

[0091] S15: Sound and light warning: The operator can withdraw the filling liquid 110 in the balloon 100 according to the sound and light warning, thereby improving the safety of the operation.

[0092] This embodiment 1 also provides an electrode component 320. Figure 1 , Figure 7a as well as Figure 7bThe electrode component 320 of the first embodiment is described in detail. The electrode component 320 is used for an electrode balloon catheter. It should be understood that the electrode component 320 can be applied to the electrode balloon catheter described above, and can also be used for other electrode balloon catheters, such as electrode balloon catheters using non-flexible positive and negative electrode wires. The electrode component 320 includes: a first electrode 3201, a second electrode 3202, and a receiving structure 3203.

[0093] like Figure 7a As shown, the first electrode 3201 is preferably an annular structure, which is circumferentially arranged around an electrode balloon catheter, for example, it can be around the inner catheter 200 of the electrode balloon catheter as described above. Of course, the first electrode 3201 can also be arranged around other electrode balloon catheters. The first electrode 3201 can also be in other shapes, such as a rectangular sheet structure, or in the shape of a thin sheet such as a patch, etc., which is arranged on the inner catheter 200.

[0094] Please continue to refer to Figure 7a The receiving structure 3203 may be, for example, a circular structure. The receiving structure 3203 is disposed on the first electrode 3201, preferably through the receiving structure 3203 disposed on the first electrode 3201. In other embodiments, the receiving structure 3203 may also be disposed on the surface of the first electrode 3201. The receiving structure 3203 may be disposed at the side end of the first electrode 3201, or may be disposed at the middle of the first electrode 3201. Of course, the receiving structure 3203 may also be in the shape of a rectangle, square, diamond or triangle. The shape, size and position of the receiving structure 3203 may be determined according to the position, direction and size of the required shock wave. Those skilled in the art may set it according to actual needs. The shape of the receiving structure 3203 is not limited in this embodiment.

[0095] Please continue to refer to Figure 7a, at least part of the second electrode 3202 is arranged in the receiving structure 3203, ensuring that the electrode discharge between the second electrode 3202 and the first electrode 3201 can be discharged between the same layers, so that the electrode component 320 is arranged in a single layer, reducing the passing size of the electrode balloon catheter, making the passing size closer to the size of the pre-expansion balloon, avoiding the use of a stacked electrode structure with discharge between stacks, and preventing the electrode balloon catheter from being difficult to pass or even breaking when the electrode balloon catheter is intervened. The first electrode 3201 and the second electrode 3202 are arranged at intervals, ensuring that the interval between the two can be used for filling with filling fluid, so that the first electrode 3201 and the second electrode 3202 are parallel and separated single-layer electrode structures, reducing the passing size of the electrode balloon catheter. The second electrode 3202 is preferably arranged in a sheet shape, one of the first electrode 3201 and the second electrode 3202 is a positive electrode 321, and the other is a negative electrode 322, and the first electrode 3201 and the second electrode 3202 are used to be electrically connected to a high voltage generation and processing device 500. In the first embodiment, the first electrode 3201 is a positive electrode 321 , and the second electrode 3202 is a negative electrode 322 . In other embodiments, the first electrode 3201 may also be a negative electrode 322 , and the second electrode 3202 may also be a positive electrode 321 .

[0096] Further, such as Figure 7a As shown, the shape of at least part of the second electrode 3202 matches the shape of the receiving structure 3203. For example, if the receiving structure 3203 is a circular structure, the at least part of the second electrode 3202 is also a circular structure; if the receiving structure 3203 is a square structure, the at least part of the second electrode 3202 is also a square structure. Of course, the second electrode 3202 may be at least partially disposed in the receiving structure 3203, or may be entirely disposed in the receiving structure 3203.

[0097] Preferably, Figure 7a As shown, at least two containing structures 3203 are arranged on each of the first electrodes 3201, and each of the containing structures 3203 is respectively matched with one of the second electrodes 3202. By setting it in this way, one of the first electrodes 3201 can satisfy at least two shock wave generation points, thereby reducing the number of first electrodes 3201 installed and improving the efficiency of shock wave generation.

[0098] Preferably, the first electrode 3201 and / or the second electrode 3202 are arranged on an electrode balloon catheter by pasting, printing, electroplating, 3D printing or vapor deposition, for example, preferably arranged on the inner catheter 200 of the electrode balloon catheter as described above, and of course, can also be arranged on other electrode balloon catheters. The carrier is, for example, the inner catheter 200, and can also be an insulating connector 3204. More preferably, the first electrode 3201 and / or the second electrode 3202 are directly formed and arranged with the flexible circuit layer 310 respectively. In this embodiment, the second electrode 3202 is directly formed and arranged with the flexible circuit layer 310, so that the second electrode 3202 has a beneficial effect with the flexible circuit layer 310, which will not be repeated herein.

[0099] Preferably, the electrode component 320 further includes an insulating connector 3204, which is connected to the first electrode 3201 and the second electrode 3202 respectively, and is used to fix the relative position of the first electrode 3201 and the second electrode 3202. In the first embodiment, the insulating connector 3204 is used to fix the second electrode 3202 so that the second electrode 3202 is spaced apart from the first electrode 3201, so that discharge is achieved between the first electrode 3201 and the second electrode 3202 through the filling liquid 110. Further, as Figure 7bAs shown, the second electrode 3202 is fixedly connected to the insulating connector 3204, and the insulating connector 3204 is clamped on the first electrode 3201. The insulating connector 3204, the first electrode 3201 and the second electrode 3202 are all arranged in the same layer on an electrode balloon catheter, for example, preferably arranged on the inner catheter 200 of the electrode balloon catheter. Of course, they can also be arranged on other electrode balloon catheters, so that the first electrode 3201 and the second electrode 3202 are arranged in the same layer and separately along the inner catheter 200, thereby ensuring that the electrode component 320 is arranged in a single layer, reducing the passing size of the electrode balloon catheter. Specifically, the first electrode 3201 is provided with a first connection port A, for example, the first connection port A is a groove; the insulating connector 3204 is provided with a second connection port B and a third connection port C, and the second connection port B and the third connection port C are a protrusion; the second electrode 3202 is provided with a fourth connection port D. The second connection port B is snapped with the first connection port A to achieve connection and fixation of the insulating connector 3204 and the first electrode 3201. The third connection port C is connected with the fourth connection port D to achieve connection and fixation of the insulating connector 3204 and the second electrode 3202. More specifically, two first connection ports A are arranged on the same side of the first electrode 3201; the insulating connector 3204 is arranged in a mountain shape, and the protrusions on both sides of the mountain-shaped insulating connector are two second connection ports B, and the protrusion in the middle is a third connection port C; on the same side as the first electrode 3201, the second electrode 3202 is provided with a fourth connection port D. With this arrangement, a gap is formed between the first electrode 3201 and the second electrode 3202 to ensure that the two will not touch and short-circuit. In fact, when a shock wave occurs between the positive and negative electrodes, the shock wave is perpendicular to the plane where the negative electrode discharges to the positive electrode, that is, perpendicular to the plane where the negative electrode discharges to the positive electrode. Figure 7a In the plane shown, the first electrode 3201 and the second electrode 3202 are set to discharge in the same layer in this embodiment, which improves the release direction of the shock wave and enables the shock wave to reach the lesion more efficiently. Preferably, the material of the insulating connector 3204 is a material with good thermal insulation performance, strong insulation ability, and bendability, preferably polytetrafluoroethylene (PTFE), polyimide (PI) and the like.

[0100] like Fig. 9As shown, further, the surface of the first electrode 3201 and / or the second electrode 3202 has a micron-sized tip 3205, and the tip 3205 is in the shape of a group of peaks. The diameter and height of the tip 3205 are both in the micron-sized range. Preferably, the height of the tip 3205 is between 1 and 100 microns. It is understandable that the surface of the first electrode 3201 and / or the second electrode 3202 can be processed at the micron level to form a concave-convex structure. Preferably, please continue to refer to Fig. 9 , the surface of the negative electrode 322 has a micron-sized tip 3205. The tip 3205 is, for example, perpendicular to the surface of the electrode. During discharge, due to the hydro-electric effect, the energy density of the peak-shaped tip 3205 formed by micro-level treatment is greater, thereby improving the release intensity of the shock wave, thereby improving the efficiency of crushing calcified lesions. During discharge, the negative electrode generates an electric spark and discharges toward the positive electrode. The surface of the negative electrode is preferably treated at the micron level, and its energy density can be significantly increased. In other embodiments, the positive electrode can also be treated at the micron level. In this embodiment, the second electrode 3202 is the negative electrode 322, and the surface of the second electrode 3202 has a micron-sized tip 3205. Of course, the first electrode 3201 and / or the second electrode 3202 can also be treated at the nano level. The nano-level treatment can also cause the filling fluid 110 to produce a hydro-electric effect. The principle is the same as the principle of micro-level treatment, which will not be repeated here.

[0101] [Example 2]

[0102] Please refer to Figure 8a to Figure 8b , Figure 8a Schematic diagram of electrode components according to Embodiment 2 and Embodiment 3 of the present invention; Figure 8b Another schematic diagram of the electrode components of the second and third embodiments of the present invention.

[0103] The electrode components of the second embodiment are the same as those of the first embodiment and are not described again. Only the differences are described below.

[0104] like Figure 8a and Figure 8bAs shown, the insulating connector 3204 is laid on the receiving structure 3203, and the second electrode 3202 is arranged on the insulating connector 3204. In this way, the electrode component 320 is also a single-layer structure arranged on the inner catheter 200, thereby reducing the passing size of the electrode balloon catheter. Similarly, the discharge of the first electrode 3201 and the second electrode 3202 is the same layer discharge. Further, the receiving structure 3203 is directly arranged on the surface of the first electrode 3201. In the second embodiment, the receiving structure 3203 is arranged on the surface of the first electrode 3201 to form a structure similar to a groove. The insulating connector 3204 is laid on the receiving structure 3203, and the second electrode 3202 is embedded in the receiving structure 3203 and installed on the insulating connector 3204. Similarly, there is a certain gap between the first electrode 3201 and the second electrode 3202. In other embodiments, the receiving structure 3203 can be set through the first electrode 3201. For example, the first electrode 3201 is attached to the inner conduit 200, the insulating connector 3204 is directly set on the receiving structure 3203, and is also directly attached to the inner conduit 200, and the second electrode 3202 is set on the insulating connector 3204. Of course, the first electrode 3201 is directly attached to the inner conduit 200, and the second electrode 3202 is also directly attached to the inner conduit 200. The insulating connector 3204 is set in the gap between the first electrode 3201 and the second electrode 3202 to avoid short circuit. The first electrode 3201 and the second electrode 3202 are respectively connected to a high voltage generation and processing device through an electrode line E. It should be understood that the electrode line E includes a positive electrode line and a negative electrode line, the positive electrode is connected to the positive electrode line, and the negative electrode is connected to the negative electrode line.

[0105] The electrode balloon catheter in the first embodiment may include one or more electrode components 320. When multiple electrode components 320 are included, the electrode component 320 in the first embodiment may be used, or the electrode component 320 in the second embodiment may be used.

[0106] [Example 3]

[0107] Figure 7a Schematic diagram of electrode components according to Embodiment 1 and Embodiment 3 of the present invention. Figure 7b Another schematic diagram of the electrode components of the first and third embodiments of the present invention. Figure 8a Schematic diagram of electrode components of Embodiment 2 and Embodiment 3 of the present invention. Figure 8b Another schematic diagram of the electrode components of the second and third embodiments of the present invention.

[0108] The same parts of the electrode components of the third embodiment as those of the first and second embodiments will not be described again, and only the differences will be described below.

[0109] Please refer to Figures 7a to 8b The electrode component 320 provided in this embodiment is used for an electrode balloon catheter, and the electrode component 320 includes: a first electrode 3201 and a plurality of second electrodes 3202 .

[0110] The first electrode 3201 has a plurality of receiving spaces 3203, and the receiving spaces 3203 are used to respectively embed at least a portion of each second electrode 3202 in the plurality of second electrodes 3202. The plurality of second electrodes 3202 are, for example, two or three. The plurality of receiving spaces 3203 are, for example, two, three or four. Preferably, the number of the second electrodes 3202 is equal to the number of the receiving spaces 3203. At least a portion of each second electrode 3202 can be accommodated in each receiving space 3203. Of course, the entirety of each second electrode 3202 can be accommodated in each receiving space 3203, and those skilled in the art can set the shape and area of ​​the second electrode 3202 accommodated in the receiving space 3203 according to actual needs.

[0111] The first electrode 3201 and the second electrode 3202 are spaced apart, and the area of ​​the first electrode 3201 is larger than the area of ​​the second electrode 3202, so that the second electrode 3202 can always be accommodated in the first electrode 3201. With such a configuration, the beneficial effects of the motor component 320 can be referred to in the first embodiment, which will not be described in detail herein.

[0112] One of the first electrode 3201 and the second electrode 3202 is a positive electrode, and the other is a negative electrode; the first electrode 3201 and the second electrode 3202 are used to be electrically connected to a high voltage generating and processing device. The contents of the first electrode 3201 and the second electrode 3202 are the same as those in Example 1 and will not be repeated herein.

[0113] like Figures 7a to 8b For details, please refer to Figure 7a Preferably, the first electrode 3201 is an annular structure, which is sleeved on the electrode balloon catheter, and the second electrode 3202 is a circular sheet. The plurality of second electrodes 3202 are evenly arranged along the circumference of the first electrode 3201, so that the discharge points between the positive and negative electrodes can be evenly discharged, so that the balloon 100 can be evenly expanded along the circumference of the first electrode 3201. In the third embodiment, the number of the second electrodes 3202 is two, and the two second electrodes 3202 are evenly arranged along the circumference of the first electrode 3201.

[0114] Preferably, Figure 7a and Figure 8bAs shown, the first electrode 3201 and the second electrode 3202 are fixed in relative position by an insulating connector 3204. The insulating connector 3204 not only enables the first electrode 3201 and the second electrode 3202 to be insulated, but also has the function of fixing the bracket.

[0115] Preferably, Figure 8a As shown, the insulating connector 3204 is laid in the receiving space 3203, and the second electrode 3202 is arranged on the insulating connector 3204, thereby laying a foundation for the second electrode 3202 and the first electrode 3201 to be arranged on the same layer.

[0116] In summary, in an electrode component and an electrode balloon catheter provided by the present invention, the electrode component includes: a first electrode, a second electrode and a receiving structure; the receiving structure is arranged on the first electrode, at least part of the second electrode is arranged in the receiving structure, and the first electrode and the second electrode are arranged at intervals; one of the first electrode and the second electrode is a positive electrode, and the other is a negative electrode; the first electrode and the second electrode are used to be electrically connected to a high-voltage generating and processing device. Such an arrangement makes the electrode component arranged in a single layer, reduces the passing size of the electrode balloon catheter, makes the passing size of the electrode balloon catheter thinner, and is closer to the size of the pre-expansion balloon, and prevents the phenomenon that the electrode balloon catheter is difficult to pass or even the component is broken when the electrode balloon catheter is intervened.

[0117] The above description is only a description of the preferred embodiments of the present invention, and is not intended to limit the scope of the present invention. Any changes or modifications made by a person skilled in the art in the field of the present invention based on the above disclosure shall fall within the scope of protection of the claims.

Claims

1. An electrode component for an electrode balloon catheter, characterized in that: include: A first electrode, a second electrode and a receiving structure; The receiving structure is disposed on the first electrode, at least a portion of the second electrode is disposed in the receiving structure, and the first electrode and the second electrode are disposed at intervals; One of the first electrode and the second electrode is a positive electrode, and the other is a negative electrode; the first electrode and the second electrode are used to be electrically connected to a high voltage generating and processing device; The electrode component further includes an insulating connector, which is connected to the first electrode and the second electrode respectively, and is used to fix the relative position of the first electrode and the second electrode; The second electrode is fixedly connected to the insulating connector, the insulating connector is clamped to the first electrode, and the insulating connector, the first electrode and the second electrode are all arranged on the electrode balloon catheter in the same layer.

2. The electrode component according to claim 1, characterized in that The shape of at least a portion of the second electrode matches the shape of the receiving structure.

3. The electrode component according to claim 1, characterized in that The first electrode is in an annular structure and is arranged around the circumference of the electrode balloon catheter, and the second electrode is arranged in a sheet shape.

4. The electrode component according to claim 1, characterized in that At least two receiving structures are arranged on each of the first electrodes, and each of the receiving structures is matched with one of the second electrodes.

5. The electrode component according to claim 1, characterized in that The first electrode and / or the second electrode are arranged on the electrode balloon catheter by means of pasting, printing, electroplating, 3D printing or vapor deposition.

6. The electrode component according to claim 1, characterized in that The insulating connector is laid on the receiving structure, and the second electrode is arranged on the insulating connector.

7. The electrode component according to claim 6, characterized in that The receiving structure is disposed through the first electrode, or the receiving structure is disposed on a surface of the first electrode.

8. The electrode component according to claim 1, characterized in that The surfaces of the first electrode and / or the second electrode have micrometer-scale tips, and the tips are in the shape of a group of peaks.

9. An electrode component for an electrode balloon catheter, characterized in that: The electrode component includes: a first electrode and a plurality of second electrodes; The first electrode has a plurality of receiving spaces, the receiving spaces are used to respectively embed at least a portion of each of the plurality of second electrodes, the first electrode is spaced apart from the second electrode, and an area of ​​the first electrode is larger than an area of ​​the second electrode; One of the first electrode and the second electrode is a positive electrode, and the other is a negative electrode; the first electrode and the second electrode are used to be electrically connected to a high voltage generating and processing device; The first electrode and the second electrode are fixed in relative position by an insulating connector; The second electrode is fixedly connected to the insulating connector, the insulating connector is clamped to the first electrode, and the insulating connector, the first electrode and the second electrode are all arranged on the electrode balloon catheter in the same layer.

10. The electrode component according to claim 9, characterized in that The first electrode is an annular structure and is sleeved on the electrode balloon catheter. The second electrode is a circular sheet. The plurality of second electrodes are evenly arranged along the circumference of the first electrode.

11. The electrode component according to claim 9, characterized in that The insulating connector is laid in the receiving space, and the second electrode is arranged on the insulating connector.

12. An electrode balloon catheter, characterized in that: include: A balloon, an inner catheter, and an electrode component according to any one of claims 1 to 11; The balloon is sheathed outside the inner catheter, and the balloon expands or contracts radially under the filling and extraction of filling fluid; The electrode component is arranged on the inner catheter and located inside the balloon, and is used to be connected to a high voltage generating device.

13. The electrode balloon catheter according to claim 12, characterized in that: The electrode balloon catheter also includes a flexible circuit layer, which is arranged on the inner catheter; the flexible circuit layer is connected to the first electrode and the second electrode respectively, and the first electrode and the second electrode are connected to the high voltage generating device through the flexible circuit layer.

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