Electrode balloon catheter and high-pressure generating treatment device

Abstract

This invention provides an electrode balloon catheter and a high-pressure generating and processing device. The electrode balloon catheter includes a balloon, an inner catheter, and a shock wave generating assembly. The balloon is fitted over the inner catheter and expands or contracts radially under the inflation and desorption of inflation fluid. The shock wave generating assembly includes a flexible circuit layer and electrode components. The flexible circuit layer is disposed on the inner catheter. The electrode components are disposed on the inner catheter and located inside the balloon. The electrode components are connected to the flexible circuit layer for connection to a high-pressure generating and processing device via the flexible circuit layer. This configuration allows the electrode balloon catheter to pass through a narrower diameter, closer to the size of a pre-inflated balloon, improving its permeability when inserted into the human body and preventing breakage of components within the electrode balloon catheter.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to an electrode balloon catheter and a high-voltage generation and processing device. Background Technology

[0002] Angioplasty is a surgical procedure that uses mechanical methods to restore narrowed blood vessels to their original size. Traditional angioplasty often uses balloon catheters to physically dilate the narrowed lesion, restoring patency. However, balloon dilation can easily cause tearing damage to the adventitia of the blood vessel. The method of indirectly fragmenting calcified deposits or "stones" in the urinary tract or biliary tract using the electrohydraulic effect can be used to destroy the calcified structures attached to the diseased blood vessel wall; that is, electrohydraulic lithotripsy can be applied to angioplasty. The principle of electrohydraulic lithotripsy is that a liquid rapidly vaporizes under a high-voltage, strong electric field to form vapor bubbles that expand outwards. The bursting of these bubbles generates a powerful shock wave that acts on the surrounding environment. Based on the principle of destroying the calcified structure through the electrohydraulic effect, electrode components are placed inside the balloon. These electrodes are connected to an external pulse power source via 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 components to generate a shock wave. The shock wave propagates through the conductive liquid inside the balloon, impacting the balloon wall and the calcified area. Repeated pulses can disrupt the structure of calcifications and dilate narrowed blood vessels without damaging surrounding soft tissues, thus avoiding the problem of blood vessel wall damage caused by balloon dilation in traditional angioplasty.

[0003] The currently used electrode balloon catheters still have the following problems:

[0004] 1) Due to the arrangement of the positive and negative electrodes, the outer diameter of the catheter increases after the electrodes are combined with the catheter, resulting in poor passage. When the electrode balloon catheter is inserted into the human body, it is prone to difficulty in passing through narrow areas of blood vessels. If multiple attempts are made, the hypotube at the proximal-distal connection may break.

[0005] 2) Because the electrode structure of the electrode balloon catheter is arranged in multiple layers, the outer diameter of the catheter increases, which affects the catheter's passage in blood vessels and can cause the hypotube to break.

[0006] 3) During the release of the shock wave, the balloon is prone to rupture. Without a suitable hydraulic feedback system in the catheter, once the balloon ruptures, the high voltage will directly act on the human body, causing a safety accident.

[0007] 4) When this treatment method is used, the outer surface of the balloon will completely adhere to the blood vessel wall. Prolonged balloon expansion will cause blockage of the blood vessel at that location, leading to transient ventricular capture or shock.

[0008] Therefore, developing an electrode balloon catheter with a smaller passage size that is closer to the size of a pre-dilated balloon, in order to prevent difficulties in passage or even component breakage during intervention, has become an urgent problem for electrode balloon catheter manufacturers. Summary of the Invention

[0009] The purpose of this invention is to provide an electrode balloon catheter and a high-pressure generating and processing device, so that the electrode balloon catheter has a smaller passage size and a passage size closer to that of a pre-dilated balloon, thereby solving the problem that the electrode balloon catheter is difficult to pass through or even breaks during intervention.

[0010] To address the aforementioned technical problems, the present invention provides an electrode balloon catheter, comprising: a balloon, an inner catheter, and a shock wave generating assembly; the balloon is sleeved outside the inner catheter, and the balloon expands or contracts radially under the inflation and desorption of filling fluid; the shock wave generating assembly includes a flexible circuit layer and an electrode component, the flexible circuit layer being disposed on the inner catheter; the electrode component is disposed on the inner catheter and located inside the balloon, the electrode component being connected to the flexible circuit layer for connection to a high-voltage generating and processing device via the flexible circuit layer.

[0011] Optionally, the radial thickness of the flexible circuit layer along the inner conduit does not exceed 0.2 mm.

[0012] Optionally, the flexible circuit layer is disposed on the inner conduit by means of pasting, printing, electroplating, 3D printing or vapor deposition.

[0013] Optionally, the electrode balloon catheter further includes a pressure sensor disposed at the distal end of the inner catheter, which is used to monitor the resistance experienced by the electrode balloon catheter and emit a resistance signal.

[0014] Optionally, the pressure sensor is a ring-shaped pressure sensor, which is sleeved on the distal end of the inner conduit.

[0015] Optionally, the electrode balloon catheter further includes a hydraulic sensor, which is disposed on the inner catheter and is used to monitor the inflation pressure inside the balloon in real time and send an inflation pressure signal.

[0016] Optionally, the electrode balloon catheter further includes an outer catheter, which is sleeved outside the inner catheter and communicates with the balloon. The hydraulic sensor is disposed on the outer surface of the inner catheter or the inner surface of the outer catheter.

[0017] Optionally, the electrode balloon catheter further includes a temperature sensor, which is disposed on the outer surface of the inner catheter or the inner surface of the outer catheter, for real-time monitoring of the temperature inside the balloon and emitting a temperature signal.

[0018] To address the aforementioned technical problems, the present invention also provides a high-pressure generation and processing device. This device is used for signal connection with the electrode balloon catheter as described above. The high-pressure generation and processing device includes a logic processing unit and a high-pressure generation unit. The logic processing unit is electrically connected to the high-pressure generation unit and is used to control the disconnection and connection of the high-pressure generation unit. The logic processing unit is also electrically connected to the hydraulic sensor of the electrode balloon catheter and is used to receive the filling pressure signal emitted by the hydraulic sensor. When the rate of decrease of the filling pressure or the absolute value of the filling pressure difference in the filling pressure signal received by the logic processing unit exceeds a set threshold, the logic processing unit disconnects the electrical connection with the high-pressure generation unit.

[0019] Optionally, the high-pressure generating and processing device further includes a display unit, which is connected to the logic processing unit; when the filling pressure value of the filling pressure signal is greater than the set working pressure value, the logic processing unit sends a filling pressure signal to the display unit, and the display unit receives the filling pressure signal and issues a prompt signal.

[0020] Optionally, the logic processing unit is further configured to receive a resistance signal emitted by the pressure sensor of the electrode balloon catheter. When the resistance value of the resistance signal is greater than a set threshold, the logic processing unit sends the resistance signal to the display unit, and the display unit receives the resistance signal and issues an alarm signal.

[0021] Optionally, the logic processing unit is further configured to receive a temperature signal emitted by the temperature sensor of the electrode balloon catheter, and when the temperature value of the temperature signal is greater than a set threshold, the logic processing unit cuts off the high-voltage generating unit.

[0022] Optionally, the high-voltage generating and processing device further includes an amplification circuit, one end of which is connected to the logic processing unit, and the other end of which is connected to the hydraulic sensor, touch sensor, or temperature sensor of the electrode balloon catheter.

[0023] Optionally, the high-pressure generating and processing device further includes a timer connected to the logic processing unit; when the filling pressure of the filling pressure signal received by the logic processing unit reaches the set filling pressure, the timer starts timing; when the timer reaches the set time, it sends a time signal to the logic processing unit; the logic processing unit receives the time signal and sends the time signal to the display unit; the display unit receives the time signal and issues a prompt signal.

[0024] Optionally, the high-voltage generation and processing device further includes a sampling circuit, which is used to detect whether the voltage signal of the high-voltage generation unit, the electrode components of the electrode balloon catheter, or the flexible circuit layer are short-circuited.

[0025] In an electrode balloon catheter and high-pressure generating and processing device provided by the present invention, the electrode balloon catheter includes: a balloon, an inner catheter, and a shock wave generating assembly; the balloon is sleeved outside the inner catheter, and the balloon expands or contracts radially under the inflation and desorption of filling fluid; the shock wave generating assembly includes a flexible circuit layer and electrode components, the flexible circuit layer being disposed on the inner catheter; the electrode components are disposed on the inner catheter and located inside the balloon, the electrode components being connected to the flexible circuit layer for connection to a high-pressure generating and processing device through the flexible circuit layer. This configuration allows the electrode balloon catheter to have a narrower passage size, closer to the size of a pre-inflated balloon, improving the passageability of the electrode balloon catheter into the human body and preventing breakage of components within the electrode balloon catheter. Attached Figure Description

[0026] Those skilled in the art will understand that the accompanying drawings are provided to better understand the invention and do not constitute any limitation on the scope of the invention. Wherein:

[0027] Figure 1 This is a schematic diagram of the electrode balloon catheter according to Embodiment 1 of the present invention.

[0028] Figure 2 This is a schematic diagram of the internal catheter according to Embodiment 1 of the present invention.

[0029] Figure 3 This is a circuit diagram of the high-voltage generation and processing device according to Embodiment 1 of the present invention.

[0030] Figure 4 This is a simplified equivalent circuit diagram of the high-voltage generating unit in Embodiment 1 of the present invention.

[0031] Figure 5 This is a flowchart of the electrode balloon catheter and high-pressure generation and processing device according to Embodiment 1 of the present invention.

[0032] Figure 6 This is a flowchart illustrating the safe operation of the electrode balloon catheter and high-pressure generation and processing device according to Embodiment 1 of the present invention.

[0033] Figure 7a This is a schematic diagram of the electrode components in Embodiments 1 and 3 of the present invention.

[0034] Figure 7b This is another schematic diagram of the electrode components of Embodiment 1 and Embodiment 3 of the present invention.

[0035] Figure 8a This is a schematic diagram of the electrode components in Embodiments 2 and 3 of the present invention.

[0036] Figure 8b This is another schematic diagram of the electrode components of Embodiments 2 and 3 of the present invention.

[0037] Figure 9 This is a schematic diagram of the tip of the first electrode of the electrode component according to Embodiment 1 of the present invention.

[0038] In the attached image:

[0039] 100 - balloon, 110 - filling fluid;

[0040] 200-Inner catheter;

[0041] 300-Shock wave generating component, 310-Flexible circuit layer, 311-Positive electrode wire, 312-Negative electrode wire, 320-Electrode component, 3201-First electrode, 3202-Second electrode, 3203-Receiving structure, 3204-Insulating connector, 3205-Tip, A-First connection port, B-Second connection port, C-Third connection port, D-Fourth connection port, E-Electrode wire, 321-Positive electrode, 322-Negative electrode, 340-Conduit connector, 341-Outer positive electrode wire, 342-Outer negative electrode wire;

[0042] 400 - External catheter;

[0043] 500-High voltage generation and processing device, 510-Logic processing unit, 511-Logic processor, 520-High voltage generation unit, 521-High voltage generator, 522-High voltage resistor, 523-High voltage capacitor, 530-Amplifier 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;

[0044] 600 - Temperature sensor;

[0045] 700-Hydraulic sensor;

[0046] 800 - Pressure sensor. Detailed Implementation

[0047] To make the objectives, advantages, and features of this invention clearer, the invention will be further described in detail below with reference to 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 facilitate and clarify the explanation of the embodiments of this invention. Furthermore, the structures shown in the drawings are often part of the actual structures. In particular, different figures may emphasize different aspects and may sometimes use different scales.

[0048] As used herein, the singular forms “a,” “an,” and “the” include plural objects unless otherwise expressly indicated. As used herein, the term “or” is generally used to include the meaning of “and / or” unless otherwise expressly indicated. Furthermore, in the following description, for ease of description, “distal” and “proximal” are used, where “proximal” refers to the end closer to the patient and farther from the operator, and “proximal” refers to the end farther from the patient and closer to the operator. In addition, numerous specific details are set forth in the following description to provide a more thorough understanding of the invention. However, it will be apparent to those skilled in the art that the invention can be practiced without one or more of these details. In other instances, certain technical features well-known in the art have not been described to avoid obscuring the invention.

[0049] This invention provides an electrode balloon catheter and a high-pressure generating and processing device. The electrode balloon catheter includes a balloon, an inner catheter, and a shock wave generating assembly. The balloon is fitted over the inner catheter and expands or contracts radially under the inflation and desorption of inflation fluid. The shock wave generating assembly includes a flexible circuit layer and electrode components. The flexible circuit layer is disposed on the inner catheter. The electrode components are disposed on the inner catheter and located inside the balloon. The electrode components are connected to the flexible circuit layer for connection to a high-pressure generating and processing device via the flexible circuit layer. This configuration allows the electrode balloon catheter to pass through a narrower diameter, closer to the size of a pre-inflated balloon, improving its permeability and preventing breakage of components within the electrode balloon catheter. Furthermore, the high-pressure generation and processing device is used to connect with the electrode balloon catheter as described above. The high-pressure generation and processing device includes a logic processing unit and a high-pressure generation unit. The logic processing unit is also used to receive the filling pressure signal emitted by the hydraulic sensor of the electrode balloon catheter. When the rate of decrease of the filling pressure or the absolute value of the filling pressure difference in the filling pressure signal received by the logic processing unit exceeds a set threshold, the logic processing unit cuts off the high-pressure generation unit, thereby enabling the high-pressure generation and processing device to ensure the stability of the filling pressure inside the balloon in real time, avoiding potential hazards and safety accidents. Furthermore, the high-pressure generation and processing device also includes a timer logic operation mechanism to prevent the outer surface of the balloon from being in contact with blood vessels for a long time, causing ventricular capture or shock due to vascular blockage.

[0050] The following description refers to the accompanying drawings.

[0051] Example 1

[0052] Please refer to Figures 1 to 7b , Figure 1 This is a schematic diagram of the electrode balloon catheter according to Embodiment 1 of the present invention; Figure 2 This is a schematic diagram of the internal catheter according to Embodiment 1 of the present invention; Figure 3 This is a circuit diagram of the high-voltage generation and processing device according to Embodiment 1 of the present invention; Figure 4 This is a simplified equivalent circuit diagram of the high-voltage generating unit in Embodiment 1 of the present invention; Figure 5 This is a flowchart of the electrode balloon catheter and high-pressure generating and processing device according to Embodiment 1 of the present invention; Figure 6 This is a safety operation flowchart of the electrode balloon catheter and high-voltage generation and processing device according to Embodiment 1 of the present invention; Figure 7a This is a schematic diagram of the electrode components in Embodiments 1 and 3 of the present invention; Figure 7b This is another schematic diagram of the electrode components of Embodiment 1 and Embodiment 3 of the present invention. Figure 9This is a schematic diagram of the tip of the first electrode of the electrode component according to Embodiment 1 of the present invention.

[0053] like Figure 1 As shown, the electrode balloon catheter includes a balloon 100, an inner catheter 200, and a shock wave generating component 300. Preferably, the electrode balloon catheter 100 also includes an outer catheter 400, which is sleeved outside the inner catheter 200 and connected to the balloon 100.

[0054] The balloon 100 is, for example, a spindle-shaped balloon, which is fitted over the inner catheter 200, for example, at the distal end of the inner catheter 200. Alternatively, the balloon 100 can be cylindrical and fitted between the proximal and distal ends of the inner catheter 200. The inner catheter 200 is, for example, a cylinder. Preferably, the balloon 100 extends axially along the inner catheter 200. More 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 radially under the inflation and deflation of the inflation fluid 110. The inflation fluid 110 can be a conductive liquid, which can fill the interior of the balloon 100, allowing it to expand or contract. The filling volume of the filling fluid 110 is preferably the natural internal volume of the balloon 100 in its unaltered state. The filling fluid 110 can be physiological saline, contrast fluid, or a mixture of physiological saline and contrast fluid. In other embodiments, the filling fluid 110 can also be a non-conductive liquid, or other filling fluids suitable for human use.

[0055] The shock wave generating component 300 includes a flexible circuit layer 310 and an electrode component 320.

[0056] Combination Figure 2As shown, the flexible circuit layer 310 is disposed on the inner catheter 200. The flexible circuit layer 310 preferably has a certain degree of flexibility and a relatively thin thickness. The flexible circuit layer 310 is, for example, a flexible circuit patch that 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. This allows the electrode balloon catheter to have a smaller throughput dimension compared to current balloon catheter arrangements that bundle multiple positive and negative electrodes together before combining them with the inner catheter. This is closer to the diameter of the pre-inflated balloon, thereby improving the throughput of the electrode balloon catheter during human intervention, preventing breakage of components within the electrode balloon catheter, and enabling the electrode balloon catheter to reach the lesion site through narrower areas of the blood vessel. It is understood that the throughput dimension of the electrode balloon catheter can represent the radial dimension through the blood vessel; the diameter of the pre-inflated balloon represents the diameter of the balloon 100 when it is not inflated. The flexible circuit layer 310 preferably includes a positive electrode 311 and a negative electrode 312. More preferably, the flexible circuit layer 310 also includes an insulating protective film, on which the positive electrode 311 and the negative electrode 312 are disposed. The insulating protective film is attached to the inner conduit 200. The positive electrode 311 or the negative electrode 312 may be made of conductive copper foil, for example. Of course, the materials of the positive and negative electrodes can also be other materials with high conductivity, such as gold, silver, platinum, and other metals. The flexible circuit layer 310 may also be disposed on the inner surface or in the middle layer of the inner conduit 200 to prevent the flexible circuit layer 310 from contacting the filling fluid 110 on the outer surface of the inner conduit 200, thereby reducing safety hazards. It should be understood that, under the condition that the circuit allows, the radial dimension of the flexible circuit layer 310 should be as small as possible. This arrangement minimizes the passage size of the electrode balloon conduit, making the passage size closer to the diameter of the pre-expanded balloon. The proximal end of the flexible circuit layer 310 is connected to a high-voltage generating and processing device 500, and the distal end of the flexible circuit layer 310 is connected to the electrode component 320. The high-voltage generating and processing device 500 includes, for example, a high-voltage generating unit 520, which is capable of emitting high-voltage pulses, enabling the flexible circuit layer 310 to transmit the high-voltage pulses, and the electrode component 320 to receive the high-voltage pulses and thereby generate shock waves.

[0057] Please continue to refer to this. Figure 1 and Figure 2The electrode component 320 is disposed on the inner conduit 200 and 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 for connection to a high-voltage generating and processing device 500 via the flexible circuit layer 310. Specifically, the electrode component 320 includes a positive electrode 321 and a negative electrode 322, the positive electrode 321 being connected to the positive electrode line 311, and the negative electrode 322 being connected to the negative electrode line 312. The shock wave generating component 300 operates on the following principle: An electrode balloon catheter is inserted into a narrowed blood vessel with calcified structures. The electrode component 320, through positive and negative electrode discharge or arc discharge, breaks down the filling fluid 110 at the discharge gap. The filling fluid 110 generates a large number of bubbles. The stress from the expansion and collapse of these bubbles releases shock waves. These shock waves are transmitted to the lesion site, softening and rupturing the calcified plaques, destroying the calcified structures of the targeted blood vessel, thereby achieving the goal of unblocking the blood vessel. This method of treating patients overcomes the shortcomings of traditional balloon dilation, improves the success rate of the procedure, and reduces postoperative complications.

[0058] Preferably, the flexible circuit layer 310, while ensuring high voltage and high current transmission, has a radial thickness of no more than 0.2 mm along the inner conduit 200, thereby making the passage size of the electrode balloon conduit close to the size of the pre-dilated balloon. Furthermore, the flexible circuit layer 310 exhibits excellent bending performance. Even further, the radial thickness of the flexible circuit layer 310 can be less than 0.1 mm, further reducing the passage size. Of course, those skilled in the art can also set the radial thickness of the flexible circuit layer 310 along the inner conduit 200 according to actual needs.

[0059] Furthermore, to better connect the flexible circuit layer 310 to the inner conduit 200, the flexible circuit layer 310 is preferably disposed on the inner conduit 200 by means of bonding, printing, electroplating, 3D printing, or vapor deposition, thereby reducing the overall outer diameter of the electrode balloon catheter and improving its throughput performance. Specifically, the flexible circuit layer 310 can be constructed using a flexible printed circuit (FPC) to house the positive and negative electrodes, and the flexible circuit layer 310 is bonded to the inner conduit 200. Alternatively, the flexible circuit layer 310 can be constructed using a printed circuit method, directly printing the positive and negative electrodes onto the inner conduit 200. The flexible circuit layer 310 can also be disposed using electroplating, 3D printing, or vapor deposition. Of course, the flexible circuit layer 310 can also be combined in several ways. For example, the positive electrode line 311 of the flexible circuit layer 310 can be 3D printed, and the negative electrode line 312 can be set by vapor deposition, or the positive electrode line 311 can be electroplated, and the negative electrode line 312 can be 3D printed. This allows the positive electrode line 311 and the negative electrode line 312 to be attached to the outer surface of the inner conduit 200, thereby ensuring complete adhesion between the positive electrode line 311 or the negative electrode line 312 and the inner conduit 200, guaranteeing the safety of the circuit. Preferably, the electrode lines of the flexible circuit layer 310 can be connected to the electrode component 320 by laser welding, soldering, or lamination. In this embodiment, the negative electrode line 312 is connected to the negative electrode 322 by laser welding, and the positive electrode line 311 is connected to the positive electrode 321 by lamination. Of course, those skilled in the art can also choose the connection method of the positive electrode 311 and the negative electrode 312 according to actual needs. For example, the positive electrode 311 is connected to the positive electrode 321 by laser welding, and the negative electrode 312 is connected to the negative electrode 322 by pressing.

[0060] Furthermore, such as Figure 2As shown, the electrode balloon catheter also includes a temperature sensor 600, which is disposed 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 emit the temperature signal, so that the electrode balloon catheter can monitor the temperature inside the balloon at any time when releasing the shock wave, reducing the risks during surgery. When the filling fluid undergoes a hydroelectric effect, the temperature of the filling fluid increases due to the increase of vapor bubbles, but the temperature of the filling fluid does not exceed 2°C of the normal human body temperature. Therefore, the temperature sensor 600 is needed to monitor the filling fluid to prevent the filling fluid temperature from becoming too high, affecting the treatment effect, or even affecting human health. The electrode balloon catheter can monitor the temperature state inside the balloon at any time when releasing the shock wave, reducing the risks during surgery. More preferably, the temperature sensor 600 includes a flexible temperature sensor that can be attached to the outer surface of the inner catheter 200, thereby reducing the radial dimension of the electrode balloon catheter. The configuration of the flexible temperature sensor can be referenced from the configuration of the flexible circuit layer 310, and will not be described again here.

[0061] Preferred, such as Figure 1 and Figure 2 As shown, the electrode balloon catheter also includes a hydraulic sensor 700, which is disposed on the inner catheter 200. The hydraulic sensor 700 is used to monitor the hydraulic pressure inside the balloon in real time and emit the inflation pressure signal, so that the electrode balloon catheter can monitor the pressure state inside the balloon at any time when releasing the shock wave, reducing the risks during surgery. It should be understood that the gap between the inner catheter 200 and the outer catheter 400 communicates with the internal cavity of the balloon 100, so that the hydraulic sensor 700 can measure the inflation fluid pressure inside the balloon whether it is disposed on the inner catheter 200 or the outer catheter 400. Preferably, the hydraulic sensor 700 is disposed 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 inflation fluid pressure. More preferably, the hydraulic sensor 700 can be disposed near the proximal end of the inner catheter 200, so that the hydraulic sensor 700 does not increase the passage size of the electrode balloon catheter. Preferably, the hydraulic sensor 700 includes a flexible hydraulic sensor that can be attached to the outer surface of the inner conduit 200, thereby further reducing the radial dimension of the electrode balloon conduit.

[0062] Furthermore, such as Figure 1 and Figure 2As shown, the electrode balloon catheter also includes a pressure sensor 800, which is disposed at the distal end of the inner catheter 200. The pressure sensor 800 monitors the pressure, resistance, or pushing force experienced by the electrode balloon catheter and sends a resistance signal. This allows the electrode balloon catheter to continuously monitor the resistance or pushing force of the pressure sensor 800 when releasing the shock wave, reducing the risks during surgery. Preferably, the pressure sensor 800 is a ring-shaped pressure sensor, which is sleeved on the distal end of the inner catheter 200, thereby enabling more comprehensive detection of the experienced pressure, resistance, or pushing force.

[0063] Better, such as Figure 1 As shown, the electrode balloon catheter also includes a catheter connector 340, which is used to connect to an external high-voltage generating and processing device 500, and 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 dimensions of the electrode balloon catheter according to the needs of the surgery or the patient, such as the radial dimension of the balloon 100 after inflation, the axial dimension of the balloon 100, and the radial dimension of the inner catheter 200.

[0064] like Figure 3 As shown, this embodiment also provides a high-voltage generation and processing device 500, which is used for signal connection with the electrode balloon catheter as described above. The high-voltage generation and processing device 500 includes a logic processing unit 510 and a high-voltage generation unit 520.

[0065] like Figure 3 As shown, the logic processing unit 510 is electrically connected to the high-voltage generating unit 520 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, which has logic circuits. If the logic processing unit 510 receives a certain electrical signal, it determines whether to disconnect or connect the high-voltage generating unit 520 based on the electrical signal. The logic processor 511 can be an STMicroelectronics 32-bit microcontroller chip (STM32), a Field Programmable Gate Array (FPGA), etc., thus replacing a microprocessor.

[0066] The logic processing unit 510 is electrically connected to the hydraulic sensor 700 of the electrode balloon catheter, and is used to receive the inflation pressure signal emitted by the hydraulic sensor 700. When the rate of decrease of the inflation pressure or the absolute value of the inflation pressure difference in the inflation pressure signal received by the logic processing unit 510 exceeds a set threshold, the logic processing unit 510 disconnects the electrical connection with the high-pressure generating unit 520. If the inflation pressure value detected by the hydraulic sensor 700 drops sharply, and the rate of decrease of the inflation pressure or the absolute value of the inflation pressure difference exceeds the set threshold, it indicates that the balloon 100 has ruptured or other conditions have caused a sharp drop in the inflation pressure value. The logic processing unit 510 controls the high-pressure generating unit 520 to cut off the voltage applied to the two poles, ensuring operational safety. Preferably, the high-pressure generating and processing device 500 further 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 can be a communication connection, i.e., an electrical connection, etc., so that the signal of the hydraulic sensor 700 can be transmitted to the logic processing unit 510.

[0067] Furthermore, in practice, because the released shockwave can destroy the calcification structure at the vascular lesion site, compress the volume of the calcification, and expand the vascular lumen, the inflation pressure of the balloon 100 is reduced, and the outer diameter is correspondingly reduced. This results in the balloon 100 not completely conforming to the target blood vessel. Therefore, the high-pressure generating and processing device 500 also includes a display unit 540, which is, for example, a display 541. The display unit 540 is connected to the logic processing unit 510. When the inflation pressure value deviates from the working inflation pressure range, i.e., when the inflation pressure value of the inflation pressure signal is greater than the set working pressure value, the hydraulic sensor 700 is signal-connected to the logic processing unit 510. The logic processing unit 510 sends an inflation pressure signal to the display unit 540, and the display unit 540 receives the inflation pressure signal and issues a prompt signal. Preferably, the display unit 540 has an audio-visual generator, and the prompt signal can be an audio-visual prompt. Of course, those skilled in the art can set other prompt signals according to actual needs.

[0068] Preferably, the logic processing unit 510 is further configured to receive a resistance signal from the pressure sensor 800 of the electrode balloon catheter. The pressure sensor 800 provides protection during the intervention of the electrode balloon catheter. When the resistance value of the resistance signal exceeds a set threshold, the logic processing unit 510 sends the resistance signal to the display unit 540, which receives the resistance signal and issues an alarm signal. Similarly, the alarm signal can be an audible and visual alarm from the display unit 540's audible and visual generator, 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 amplification circuit 530 is connected to the logic processing unit 510, and the other end of the amplification circuit 530 is connected to the pressure sensor 800, thereby enabling the signal from the pressure sensor 800 to be transmitted to the logic processing unit 510.

[0069] More preferably, the logic processing unit 510 is further configured to receive a temperature signal emitted by the temperature sensor 600 of the electrode balloon catheter. When the temperature value of the temperature signal exceeds a 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 poles, ensuring operational safety. Preferably, one end of the amplification circuit 530 is connected to the logic processing unit 510, and the other end of the amplification circuit 530 is connected to the temperature sensor 600, thereby enabling the signal from the temperature sensor 600 to be transmitted to the logic processing unit 510.

[0070] In summary, the temperature sensor 600, hydraulic sensor 700, and pressure sensor 800 used in this embodiment can monitor the temperature, pressure, and pushing force inside the balloon. The high-pressure generation and processing device 500 responds accordingly based on the feedback signals, which improves the efficiency of breaking up calcified lesions, reduces risks, and minimizes harm to patients.

[0071] Preferably, during the release of the shock wave, to avoid causing transient ventricular capture or shock, the high-pressure generating and processing device 500 will monitor the release frequency and the inflation time of 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 inflation pressure of the inflation pressure signal received by the logic processing unit 510 reaches the set inflation pressure, it should be understood that when the inflation pressure reaches the set inflation pressure, it indicates that the release of the shock wave has begun. At this time, the timer starts timing. When 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 issues a prompt signal, prompting the operator to withdraw the inflation fluid 110 from the balloon 100. After a certain period of time, the operator uses the inflation fluid 110 to re-inflate the balloon 100 and release the shock wave. The timer setting enables the high-voltage generation and processing device 500 to control the timing of the release of the shock wave, further reducing the risks present during surgery.

[0072] Please refer to the following for understanding. 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, which is connected to the logic processing unit 510. The trigger unit 550 is, for example, a triggering device 550a, which may include a high-voltage relay, an insulated-gate bipolar transistor (IGBT), etc. Of course, those skilled in the art can also use other forms. The trigger unit 550 includes a first switch 551 and a second switch 552. The first switch 551 is disposed between the high-voltage generator 521 and the high-voltage capacitor 523, and the second switch 552 is disposed 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 closed and the second switch 552 is open. When the electrode balloon catheter reaches the treatment position, the logic processing unit 510 controls the trigger unit 550 to change the state of the first switch 551 and the second switch 552, so that the first switch 551 is open 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 electric arc between the positive electrode 321 and the negative electrode 322 immersed in the filling liquid 110. The electric arc generates a shock wave in the filling liquid 110.

[0073] Furthermore, to ensure operational safety, such as Figure 3 As shown, the high-voltage generation and processing device 500 also includes a sampling circuit 560, which is used to detect whether the voltage of the high-voltage generation unit 520 and the electrode component 320 or flexible circuit layer 310 of the electrode balloon catheter are short-circuited. Taking the detection of the high-voltage generation unit 520 as an example, before the operation, the operator performs voltage detection on the electrode balloon catheter. The logic processing unit 510 sends a signal to the high-voltage generator 521. The high-voltage generator 521 generates high voltage, which charges the high-voltage capacitor 523 through a high-voltage resistor 522. 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 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 flexible circuit layer 310. After confirming that there is no short circuit, the operator can proceed with the conventional minimally invasive interventional surgery.

[0074] Preferred, 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 serves as the 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, thereby enabling the high-voltage signal and detection signal of the high-voltage generating and processing device 500 to communicate 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 wire 341 and an external negative wire 342. The external positive wire 341 is connected to the positive wire 311, and the external negative wire 342 is connected to the negative wire 312. The operating handle 580 is used to control the opening and closing of the logic processing unit 510.

[0075] The following will combine Figures 1 to 6 The working process of the electrode balloon catheter and the high-voltage generation and processing device 500, as well as the circuit connection of the high-voltage generation and processing device 500, are described.

[0076] First, please refer to the following: Figure 3 As shown, the operator adjusts the mode of the logic processing unit 510 of the high-voltage generator 500 according to the patient's condition, such as whether the patient has coronary artery, peripheral, or valvular lesions, to select the voltage value required for the electrode component 320 to release the shock wave, the range of inflation pressure values ​​when the balloon 100 is inflated, and the range of resistance values ​​accepted by the pressure sensor 800 in different modes. After selecting the mode, i.e., after the interface selection is confirmed, the connector 570 is connected to the electrode balloon catheter of the size corresponding to the condition. Afterwards, 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. At the same time, the sampling circuit 560 performs voltage and short-circuit detection, and feeds back the information to the logic processing unit 510 and displays it on the display 541. After confirming that the voltage value meets the set requirements and there is no short-circuit warning, the interventional surgery is performed.

[0077] The operator then delivers the electrode balloon catheter to the vascular lesion. During the delivery of the electrode balloon catheter, the pressure sensor 800, through the amplification circuit 530, feeds back the pushing force to the logic processing unit 510. When the pushing force value exceeds a threshold, the display 541 issues an audible and visual alarm. Upon reaching the vascular lesion, the filling fluid 110 inflates the balloon 100, and the hydraulic sensor 700 monitors the inflation pressure inside the balloon 100 in real time. When the shock wave is released, the hydraulic sensor 700 and the temperature sensor 600 communicate in real time with the logic processing unit 510 through the amplification circuit 530 to perform pressure 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-pressure generator 521 to cut off the voltage applied to the two electrodes; if the inflation pressure value received by the hydraulic sensor 700 drops sharply, the logic processing unit 510 controls the high-pressure generator 521 to cut off the voltage applied to the two electrodes; if the inflation pressure of the balloon 100 deviates from the set working inflation pressure range, the display 541 issues a warning signal. During the release of the shock wave, if the release time exceeds 10 seconds, the logic processing unit 510 communicates with the display 541 to prompt the operator to withdraw the inflation fluid 110 from the balloon 100. After a certain period of time, the operator uses the inflation fluid 310 to re-inflate the balloon 100 to release the shock wave.

[0078] For further details, please refer to the following: Figure 5 As shown, in order to more clearly illustrate the working process of the electrode balloon catheter and high-pressure generating and processing device 500, this embodiment provides the working steps of the electrode balloon catheter and high-pressure generating and processing device 500.

[0079] S1: Begin.

[0080] S2: Initialization Test. The high-voltage generation and processing device 500 checks 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 or pressure loss. If all parameters meet the standards, proceed to the next step; if any parameter does not meet the standards, the initialization test is unqualified.

[0081] S3: Activate the high-voltage power supply to charge the capacitor.

[0082] S4: Determine if the voltage has reached the set value. Specifically, this can be done by detecting the capacitor voltage. When the capacitor voltage reaches the threshold, the conditions for proceeding to the next step are met, i.e., the electrode balloon catheter is inserted into the human body; if the capacitor voltage does not reach the threshold, repeat the operation of the previous step.

[0083] S5: Determine whether the resistance encountered during intervention is greater than the set value. If the resistance is greater than the set value, an audible and visual alarm will alert the operator. If the resistance is not greater than the set value and the target lesion is successfully reached, the balloon 100 will be inflated using the filling fluid 110.

[0084] S6: Press the handle button on the 580 operating handle.

[0085] S7: Determine if a short circuit is detected. The high-voltage generation and processing device 500 detects whether the circuit is short-circuited. If a short circuit is detected, the discharge is immediately terminated; if no short circuit is detected, proceed to the next step.

[0086] S8: Discharge.

[0087] S9: Determine if the hydraulic pressure and temperature are greater than the set values. Here, hydraulic pressure refers to the charging pressure. Step S9, determining if the hydraulic pressure and temperature are greater than the set values, can be performed simultaneously with step S8, the discharge step. If the hydraulic pressure and temperature are greater than the set values, the discharge ends; if the hydraulic pressure and temperature are not greater than the set values, proceed to the previous step.

[0088] For further details, please refer to... Figure 6 As shown, in order to reduce the surgical risks such as transient ventricular capture or shock in patients, the high-voltage generation and processing device 500 also includes safe operation procedures.

[0089] S10: Start. Signal to inflate the balloon to 100.

[0090] S11: Balloon inflation.

[0091] S12: Determine whether the specified hydraulic pressure has been reached. If the pressure inside the balloon 100 reaches the set threshold, for example, 4 standard atmospheres (4 atm), proceed to the next step; if the balloon 100 has not reached the set threshold, proceed to the previous step.

[0092] S13: Activate timer to start timing.

[0093] S14: Determine if the time limit has been reached. If the time limit has been reached, for example, 10 seconds, proceed to the next step; if the time limit has not been reached, proceed to the previous step.

[0094] S15: Audible and visual warning. Based on the audible and visual warning, the operator can withdraw the filling fluid 110 from the balloon 100, improving the safety of the procedure.

[0095] This embodiment also provides an electrode component 320, which will be described below in conjunction with... Figure 1 , Figure 7a as well as Figure 7bThe electrode component 320 of this embodiment is described in detail. The electrode component 320 is used in 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 in 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 housing structure 3203.

[0096] like Figure 7a As shown, the first electrode 3201 is preferably a ring-shaped structure, arranged circumferentially around an electrode balloon catheter, for example, it can be arranged 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 other shapes, such as a rectangular sheet structure, or a thin sheet shape such as a patch, etc., which are disposed on the inner catheter 200.

[0097] Please continue to refer to this. Figure 7a The receiving structure 3203 can be, for example, a circular structure. The receiving structure 3203 is disposed on the first electrode 3201, preferably penetrating the first electrode 3201. In other embodiments, the receiving structure 3203 can also be disposed on the surface of the first electrode 3201. The receiving structure 3203 can be disposed at the side end of the first electrode 3201 or at the middle of the first electrode 3201. Of course, the receiving structure 3203 can also be rectangular, square, rhomboid, or triangular, etc. The shape, size, and position of the receiving structure 3203 can be determined according to the required position, direction, and size of the shock wave. Those skilled in the art can set it according to actual needs. This embodiment does not limit the shape of the receiving structure 3203.

[0098] Please continue to refer to this. Figure 7aAt least a portion of the second electrode 3202 is disposed within the receiving structure 3203, ensuring that electrode discharge between the second electrode 3202 and the first electrode 3201 can be discharged within the same layer. This results in a single-layer arrangement of electrode components 320, reducing the passage size of the electrode balloon catheter and making it closer to the size of the pre-inflated balloon. This avoids the use of a stacked electrode structure with discharge between layers, preventing difficulties in passage or even component breakage during electrode balloon catheter intervention. The first electrode 3201 and the second electrode 3202 are spaced apart, ensuring that the gap between them can be used for filling with filling fluid. This results in a parallel and separate single-layer electrode structure for the first electrode 3201 and the second electrode 3202, further reducing the passage size of the electrode balloon catheter. The second electrode 3202 is preferably arranged in a sheet-like form, with one of the first electrode 3201 and the second electrode 3202 being a positive electrode 321 and the other a negative electrode 322. The first electrode 3201 and the second electrode 3202 are used for electrical connection with a high-voltage generating and processing device 500. In this 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.

[0099] Furthermore, such as Figure 7a As shown, the shape of at least a portion of the second electrode 3202 matches the shape of the receiving structure 3203. For example, if the receiving structure 3203 is circular, the at least a portion of the second electrode 3202 is also circular; if the receiving structure 3203 is square, the at least a portion of the second electrode 3202 is also square. Of course, the second electrode 3202 may be at least partially disposed within the receiving structure 3203, or it may be entirely disposed within the receiving structure 3203.

[0100] Preferred, such as Figure 7a As shown, each first electrode 3201 is provided with at least two of the receiving structures 3203, and each of the receiving structures 3203 is respectively matched with a second electrode 3202. This arrangement allows for the provision of one first electrode 3201 to satisfy at least two shock wave generation points, reducing the number of first electrodes 3201 installed and improving the efficiency of shock wave generation.

[0101] Preferably, the first electrode 3201 and / or the second electrode 3202 are disposed on an electrode balloon catheter by means of bonding, printing, electroplating, 3D printing, or vapor deposition. For example, they are preferably disposed on the inner catheter 200 of the electrode balloon catheter as described above. Of course, they can also be disposed on other electrode balloon catheters. The carrier is, for example, the inner catheter 200, and may also be an insulating connector 3204. More preferably, the first electrode 3201 and / or the second electrode 3202 are directly formed and disposed with the flexible circuit layer 310. In this embodiment, the second electrode 3202 is directly formed and disposed together with the flexible circuit layer 310, so that the second electrode 3202 has the beneficial effects of the flexible circuit layer 310, which will not be elaborated here.

[0102] 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, for fixing the relative positions of the first electrode 3201 and the second electrode 3202. In this embodiment, the insulating connector 3204 is used to fix the second electrode 3202, so that the second electrode 3202 and the first electrode 3201 are kept apart, so that the first electrode 3201 and the second electrode 3202 can discharge through the filling liquid 110. Further, as... Figure 7bAs shown, the second electrode 3202 is fixedly connected to the insulating connector 3204, which is snapped onto 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, preferably on the inner conduit 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 conduit 200, thereby ensuring that the electrode components 320 are arranged in a single layer and reducing the passage size of the electrode balloon catheter. Specifically, the first electrode 3201 is provided with a first connection port A, which is, for example, a groove; the insulating connector 3204 is provided with a second connection port B and a third connection port C, which are, for example, protrusions; the second electrode 3202 is provided with a fourth connection port D. The second connection port B engages with the first connection port A, connecting and fixing the insulating connector 3204 to the first electrode 3201. The third connection port C connects with the fourth connection port D, connecting and fixing the insulating connector 3204 to the second electrode 3202. More specifically, two first connection ports A are provided on the same side of the first electrode 3201; the insulating connector 3204 is arranged in a mountain-shaped configuration, with two second connection ports B protruding on both sides and a third connection port C protruding in the middle; on the same side as the first electrode 3201, the second electrode 3202 is provided with a fourth connection port D. This arrangement creates a gap between the first electrode 3201 and the second electrode 3202 to prevent them from touching and short-circuiting. 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... Figure 7a As shown in the diagram, in this embodiment, the first electrode 3201 and the second electrode 3202 are configured to discharge in the same layer, which improves the release direction of the shock wave and allows the shock wave to reach the lesion site more efficiently. Preferably, the insulating connector 3204 is made of a material with good heat insulation performance, strong insulation ability, and bendability, preferably polytetrafluoroethylene (PTFE), polyimide (PI), or similar materials.

[0103] like Figure 9As shown, further, the surfaces of the first electrode 3201 and / or the second electrode 3202 have micron-sized tips 3205, which are peak-shaped. The diameter and height of the tips 3205 are both micron-sized; preferably, the height of the tips 3205 is between 1 and 100 micrometers. It is understood that micron-sized processing of the surfaces of the first electrode 3201 and / or the second electrode 3202 can create an uneven structure. Preferably, please refer to... Figure 9 The surface of the negative electrode 322 has micron-sized tips 3205. These tips 3205 are, for example, perpendicular to the electrode surface. During discharge, due to the electrohydraulic effect, the energy density of the peak-shaped tips 3205 formed by the micron-sized treatment is greater, thereby increasing the release intensity of the shock wave and improving the efficiency of breaking up calcified lesions. During discharge, the negative electrode generates an electric spark that discharges towards the positive electrode. The surface of the negative electrode preferably undergoes a micron-sized treatment, which can significantly increase its energy density. In other embodiments, the positive electrode can also undergo a micron-sized treatment. In this embodiment, the second electrode 3202 is the negative electrode 322, and the surface of the second electrode 3202 has micron-sized tips 3205. Of course, the first electrode 3201 and / or the second electrode 3202 can also undergo a nano-sized treatment. Nano-sized treatment can also cause the filling fluid 110 to produce an electrohydraulic effect, and its principle is the same as that of micron-sized treatment, which will not be elaborated here.

[0104]

Example 2

[0105] Please refer to Figures 8a to 8b , Figure 8a This is a schematic diagram of the electrode components in Embodiments 2 and 3 of the present invention; Figure 8b This is another schematic diagram of the electrode components of Embodiments 2 and 3 of the present invention.

[0106] The electrode components in this second embodiment are the same as those in the first embodiment, and will not be described again. The following description focuses only on the differences.

[0107] like Figure 8a and Figure 8bAs shown, the insulating connector 3204 is laid on the receiving structure 3203, and the second electrode 3202 is disposed on the insulating connector 3204. This arrangement ensures that the electrode component 320 is also a single-layer structure disposed on the inner conduit 200, thereby reducing the passage size of the electrode balloon conduit. Similarly, the discharge of the first electrode 3201 and the second electrode 3202 is a co-layer discharge. Further, the receiving structure 3203 is directly disposed on the surface of the first electrode 3201. In this second embodiment, the receiving structure 3203 is disposed on the surface of the first electrode 3201 to form a trench-like structure. The insulating connector 3204 is laid on the receiving structure 3203, and the second electrode 3202 is embedded within the receiving structure 3203 and mounted on the insulating connector 3204. Similarly, a certain gap exists between the first electrode 3201 and the second electrode 3202. In other embodiments, the receiving structure 3203 can pass through the first electrode 3201. For example, the first electrode 3201 is attached to the inner conduit 200, and the insulating connector 3204 is directly disposed in the receiving structure 3203 and also directly attached to the inner conduit 200. The second electrode 3202 is disposed on the insulating connector 3204. Of course, the first electrode 3201 and the second electrode 3202 are directly attached to the inner conduit 200, and the insulating connector 3204 is disposed in the gap between the first electrode 3201 and the second electrode 3202 to prevent short circuits. The first electrode 3201 and the second electrode 3202 are respectively connected to a high-voltage generating and processing device through electrode lines E. It should be understood that the electrode lines E include positive electrode lines and negative electrode lines, with positive electrodes connected to positive electrode lines and negative electrodes connected to negative electrode lines.

[0108] The electrode balloon catheter in this embodiment can include one or more electrode components 320. When multiple electrode components 320 are included, the electrode component 320 in embodiment one or the electrode component 320 in embodiment two can be used.

[0109]

Example 3

[0110] Figure 7a This is a schematic diagram of the electrode components in Embodiments 1 and 3 of the present invention. Figure 7b This is another schematic diagram of the electrode components of Embodiment 1 and Embodiment 3 of the present invention. Figure 8a This is a schematic diagram of the electrode components in Embodiments 2 and 3 of the present invention. Figure 8b This is another schematic diagram of the electrode components of Embodiments 2 and 3 of the present invention.

[0111] The electrode components in this embodiment three are the same as those in embodiments one and two, and will not be described again. The following description focuses only on the differences.

[0112] Please refer to Figures 7a to 8b The electrode component 320 provided in this embodiment is used for an electrode balloon catheter. The electrode component 320 includes a first electrode 3201 and a plurality of second electrodes 3202.

[0113] The first electrode 3201 has a plurality of receiving spaces 3203, each receiving space 3203 being used to embed at least a portion of each of the plurality of second electrodes 3202. The plurality of second electrodes 3202 may be, for example, two or three. The plurality of receiving spaces 3203 may be, for example, two, three, or four. Preferably, the number of second electrodes 3202 is equal to the number of 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. Those skilled in the art can configure the shape and area of ​​the second electrodes 3202 accommodated in the receiving spaces 3203 according to actual needs.

[0114] 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 within the first electrode 3201. With this arrangement, the beneficial effects of the motor component 320 can be referred to in Embodiment 1, and will not be repeated here.

[0115] 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 in Embodiment 1, and will not be repeated here.

[0116] like Figures 7a to 8b As shown, please refer to the details. Figure 7a Preferably, the first electrode 3201 is an annular structure, 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, thereby enabling uniform discharge between the positive and negative electrodes and allowing the balloon 100 to expand uniformly along the circumference of the first electrode 3201. In this third embodiment, there are two second electrodes 3202, which are evenly arranged along the circumference of the first electrode 3201.

[0117] Preferred, such as Figure 7a and Figure 8bAs shown, the first electrode 3201 and the second electrode 3202 are fixed in relative positions by an insulating connector 3204. The insulating connector 3204 serves two purposes: firstly, it ensures insulation between the first electrode 3201 and the second electrode 3202; secondly, it acts as a fixing support.

[0118] Preferred, such as Figure 8a As shown, the insulating connector 3204 is laid on the receiving space 3203, and the second electrode 3202 is disposed on the insulating connector 3204, thereby laying the foundation for the second electrode 3202 and the first electrode 3201 to be disposed in the same layer.

[0119] In summary, the electrode balloon catheter and high-pressure generating and processing device provided by this invention include: a balloon, an inner catheter, and a shock wave generating assembly; the balloon is sleeved outside the inner catheter, and expands or contracts radially under the inflation and desorption of filling fluid; the shock wave generating assembly includes a flexible circuit layer and electrode components, the flexible circuit layer being disposed on the inner catheter; the electrode components are disposed on the inner catheter and located inside the balloon, and the electrode components are connected to the flexible circuit layer for connection to a high-pressure generating and processing device via the flexible circuit layer. This configuration allows the electrode balloon catheter to have a narrower passage size, closer to the size of a pre-inflated balloon, improving the passageability of the electrode balloon catheter into the human body and preventing breakage of components within the electrode balloon catheter.

[0120] The above description is merely a description of preferred embodiments of the present invention and is not intended to limit the scope of the present invention in any way. Any changes or modifications made by those skilled in the art based on the above disclosure shall fall within the protection scope of the claims.

Claims

1. A high-voltage generation and processing device, characterized in that, The high-voltage generation and processing device is used for signal connection with the electrode balloon catheter; The electrode balloon catheter includes: a balloon, an inner catheter, a shock wave generating assembly, and a hydraulic sensor; The balloon is fitted outside the inner catheter, and the balloon expands or contracts radially when filled and withdrawn with filling fluid. The shock wave generating component includes a flexible circuit layer and electrode components, wherein the flexible circuit layer is disposed on the inner conduit; The electrode component is disposed on the inner catheter and located inside the balloon. The electrode component is connected to the flexible circuit layer and is used to connect to a high-voltage generating and processing device through the flexible circuit layer. The hydraulic sensor is mounted on the inner catheter and partially located inside the balloon, and is used to monitor the inflation pressure inside the balloon in real time and send an inflation pressure signal. The high-voltage generation and processing device includes a logic processing unit and a high-voltage generation unit; The logic processing unit is electrically connected to the high-voltage generating unit and is used to control the disconnection and connection of the high-voltage generating unit; The logic processing unit is electrically connected to the hydraulic sensor of the electrode balloon catheter and is used to receive the filling pressure signal emitted by the hydraulic sensor. When the rate of decrease of the filling pressure or the absolute value of the filling pressure difference in the filling pressure signal received by the logic processing unit exceeds a set threshold, the logic processing unit disconnects the electrical signal connection with the high pressure generating unit.

2. The high-voltage generation and processing device according to claim 1, characterized in that, The high-pressure generating and processing device also includes a display unit, which is connected to the logic processing unit. When the filling pressure value of the filling pressure signal is greater than the set working pressure value, the logic processing unit sends a filling pressure signal to the display unit, and the display unit receives the filling pressure signal and issues a prompt signal.

3. The high-voltage generation and processing device according to claim 2, characterized in that, The electrode balloon catheter also includes a pressure sensor located at the distal end of the inner catheter, used to monitor the resistance experienced by the electrode balloon catheter and emit a resistance signal; the logic processing unit is also used to receive the resistance signal emitted by the pressure sensor of the electrode balloon catheter, and when the resistance value of the resistance signal is greater than a set threshold, the logic processing unit sends the resistance signal to the display unit, and the display unit receives the resistance signal and emits an alarm signal.

4. The high-voltage generation and processing device according to claim 1, characterized in that, The high-voltage generating and processing device also includes an amplification circuit. One end of the amplification circuit is connected to the logic processing unit, and the other end of the amplification circuit is connected to the hydraulic sensor, touch sensor, or temperature sensor of the electrode balloon catheter, respectively.

5. The high-voltage generation and processing device according to claim 2, characterized in that, The high-pressure generating and processing device also includes a timer connected to the logic processing unit. When the filling pressure of the filling pressure signal received by the logic processing unit reaches the set filling pressure, the timer starts timing. When the timer reaches the set time, it sends a time signal to the logic processing unit. The logic processing unit receives the time signal and sends the time signal to the display unit. The display unit receives the time signal and issues a prompt signal.

6. The high-voltage generation and processing device according to claim 1, characterized in that, The high-voltage generation and processing device further includes a sampling circuit, which is used to detect whether the voltage signal of the high-voltage generation unit, the electrode components of the electrode balloon catheter, or the flexible circuit layer are short-circuited.

7. The high-voltage generation and processing device according to claim 1, characterized in that, The thickness of the flexible circuit layer along the radial direction of the inner conduit does not exceed 0.2 mm.

8. The high-voltage generation and processing device according to claim 1, characterized in that, The flexible circuit layer is applied to the inner conduit by means of bonding, printing, electroplating, 3D printing or vapor deposition.

9. The high-voltage generation and processing device according to claim 3, characterized in that, The pressure sensor is a ring-shaped pressure sensor, which is sleeved on the distal end of the inner conduit.

10. The high-voltage generation and processing device according to claim 9, characterized in that, The electrode balloon catheter also includes an outer catheter, which is sleeved outside the inner catheter and communicates with the balloon. The hydraulic sensor is disposed on the outer surface of the inner catheter or the inner surface of the outer catheter.

11. The high-voltage generation and processing device according to claim 10, characterized in that, The electrode balloon catheter also includes a temperature sensor, which is disposed on the outer surface of the inner catheter or the inner surface of the outer catheter, for real-time monitoring of the temperature inside the balloon and emitting a temperature signal; the logic processing unit is also used to receive the temperature signal emitted by the temperature sensor of the electrode balloon catheter, and when the temperature value of the temperature signal is greater than a set threshold, the logic processing unit cuts off the high-pressure generating unit.

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