Balloon catheter and shock wave device

By introducing parameter sensors into the balloon catheter, the voltage difference value during electrode discharge is detected, real-time monitoring of the degree of blood vessel dredging is achieved, the problem of insufficient blood vessel dredging monitoring in the prior art is solved, and the safety and accuracy of treatment are improved sex.

CN222426957UActive Publication Date: 2025-02-07SHENZHEN MICRO MEDICAL TECH CO LTD
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Patent Information

Application Number
CN202420579713.7
Authority / Receiving Office
CN · China
Patent Type
Utility models(China)
Current Assignee / Owner
Filing Date
2024-03-21
Publication Date
2025-02-07
Estimated Expiration
2034-03-21

AI Technical Summary

Technical Problem

In the prior art, shock wave catheter lacks vascular clearance monitoring devices, resulting in damage to the blood vessels being continuously treated, or problems with insufficient treatment time or degree, and depends on the experience of a doctor or X-ray examination, which has certain injuries.

Method used

A balloon catheter is designed, including a catheter body, a balloon assembly, an electrode and a parameter sensor. The parameter sensor is used to detect the difference in the instantaneous maximum voltage value when the electrodes in the first balloon and the second balloon are discharged, and this is used to determine the degree of current blood vessel dredging.

Benefits of technology

It effectively solves the problem of damage caused by continuous treatment of blood vessels, or insufficient treatment time or degree, reduces dependence on X-rays, and improves the safety and accuracy of treatment.

✦ Generated by Eureka AI based on patent content.

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Abstract

The utility model discloses a balloon catheter and a shock wave device, and relates to the technical field of medical instruments. The balloon catheter comprises a catheter body, a balloon assembly, an electrode and a parameter sensor. The near end of the catheter body is suitable for injecting liquid; the balloon assembly at least comprises a first balloon and a second balloon, and the first balloon and the second balloon are both arranged at the far end of the catheter body; the first balloon and the second balloon are each provided with a plurality of electrodes, and the electrodes are suitable for being electrically connected with a control system of the shock wave device. The parameter sensor is arranged in the catheter body and used for detecting the instantaneous maximum pressure difference value generated during discharging in the first balloon and the second balloon, and the parameter sensor is suitable for being electrically connected with a control system. According to the balloon catheter, the structure of the balloon catheter is improved, serious complications such as vascular perforation and even myocardial necrosis can be effectively avoided, and the safety of operation is greatly improved.
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Description

Technical Field

[0001] The utility model relates to the technical field of medical equipment, in particular to a balloon catheter and a shock wave device. Background Art

[0002] Interventional medicine is a discipline that relies on the guidance of medical imaging equipment, uses puncture and catheter technology to diagnose and treat diseases, and is mainly based on treatment. It has the characteristics of accurate positioning, less trauma, fewer complications, high efficacy, rapid effect, and strong repeatability. Interventional treatment has become the third largest clinical treatment method alongside internal medicine and surgical treatment.

[0003] The interventional surgeries currently used in clinical practice include: Percutaneous Transluminal Coronary Angioplasty (PTCA), stenting, mitral valve surgery, radiofrequency ablation, interventional treatment of congenital heart disease, intracoronary thrombolysis, etc. Among them, Percutaneous Transluminal Coronary Angioplasty (PTCA) is the most commonly used method for treating coronary heart disease. When the balloon catheter is inflated to expand the calcified lesions in the blood vessel wall, the balloon will gradually apply pressure until the calcified lesions rupture.

[0004] Studies have shown that by placing one or more pairs of discharge electrodes in an angioplasty balloon to form a shock wave generator device, and applying high voltage pulses to the shock wave generator device to generate shock waves in the balloon, the shock waves can selectively destroy the calcified lesions in the blood vessel wall while effectively avoiding damage to the blood vessel wall. Based on this, a balloon catheter that can generate shock waves and treat calcified lesions has been developed on the market, namely a shock wave balloon catheter, in which electrodes are generally single or multiple electrodes.

[0005] In the prior art, the shock wave catheter includes a catheter body and a balloon arranged on the catheter body, and a plurality of electrodes are arranged in the balloon. The shock wave catheter lacks a vascular dredging monitoring device and purely relies on the doctor's experience or X-rays to judge the current degree of vascular dredging. It relies on pure human experience to judge whether the blood vessels are damaged due to continuous treatment, or whether the treatment time or degree is insufficient, and X-rays are harmful to the human body to a certain extent. Utility Model Content

[0006] The main purpose of the utility model is to provide a balloon catheter and shock wave device, aiming to realize the function of judging the current degree of blood vessel dredging, avoiding damage to the blood vessels due to continuous treatment, or insufficient treatment time or degree, and also minimizing the number of X-ray checks.

[0007] To achieve the above object, the utility model provides a balloon catheter, comprising:

[0008] a catheter body, wherein the proximal end of the catheter body is suitable for injecting liquid;

[0009] A balloon assembly, comprising at least a first balloon and a second balloon, wherein the first balloon and the second balloon are both arranged on the distal end of the catheter body;

[0010] Electrodes, the first balloon and the second balloon are each provided with a plurality of the electrodes, the electrodes being suitable for being electrically connected to a control system of a shock wave device for generating shock waves; and

[0011] A parameter sensor is disposed in the catheter body and is used to detect the difference in instantaneous maximum voltage values ​​when the electrodes in the first balloon and the second balloon discharge. The parameter sensor is suitable for being electrically connected to the control system.

[0012] Optionally, the parameter sensor is a pressure sensor or a differential pressure sensor, the pressure sensor includes a circuit board and a sensor body arranged on the circuit board, the sensor body is used to form a pressure signal, and the circuit board is used to transmit the pressure signal to the control system and receive the control signal of the control system.

[0013] Optionally, the catheter body includes a catheter, the first balloon and the second balloon are connected in series on the catheter, the proximal end of the catheter is connected to a catheter seat provided with an injection port, the catheter seat is connected to an extension tube assembly for allowing the electrode wire to pass through, and the extension tube assembly is suitable for connecting to the control system.

[0014] Optionally, the catheter body includes a first catheter and a second catheter, the first balloon is disposed on the distal end of the first catheter, and the second balloon is disposed on the distal end of the second catheter;

[0015] Among them, the first catheter and the second catheter are of split structure or integrated structure, the proximal ends of the first catheter and the second catheter are connected to the same catheter seat with an injection port, and the catheter seat is connected to two extension tube assemblies respectively used to allow the wires corresponding to the electrodes to pass through, and the two extension tube assemblies are suitable for connecting to the control system.

[0016] Optionally, the distance between the first balloon and the catheter seat is greater than the distance between the second balloon and the catheter seat.

[0017] Optionally, the catheter body includes an inner tube and an outer tube sleeved on the outer circumference of the inner tube, the inner tube is used to allow a guide wire to pass through, and a fluid channel is formed between the inner tube and the outer tube.

[0018] Optionally, the distance between the outer wall of the inner tube and the inner wall of the outer tube is 0.2 mm-0.6 mm.

[0019] Optionally, a wiring channel is provided in the catheter body for the wires of the electrodes to pass through.

[0020] To achieve the above object, the utility model also provides a shock wave device, comprising:

[0021] A control system for sending out a pulse signal; and

[0022] The balloon catheter as described above, wherein the electrodes of the balloon catheter are electrically connected to the control system, and the control system is used to control the electrodes to discharge or not discharge, and the balloon catheter comprises:

[0023] a catheter body, wherein the proximal end of the catheter body is suitable for injecting liquid;

[0024] A balloon assembly, comprising at least a first balloon and a second balloon, wherein the first balloon and the second balloon are both arranged on the distal end of the catheter body;

[0025] Electrodes, the first balloon and the second balloon are each provided with a plurality of the electrodes, the electrodes being suitable for being electrically connected to a control system of a shock wave device for generating shock waves; and

[0026] A parameter sensor is disposed in the catheter body and is used to detect the difference in instantaneous maximum voltage values ​​when the electrodes in the first balloon and the second balloon discharge. The parameter sensor is suitable for being electrically connected to the control system.

[0027] Optionally, the control system is further used to stop the electrode discharge when the pressure difference detected by the parameter sensor is less than a preset pressure difference, and to stop the corresponding electrode discharge when the pressure value of the second balloon detected by the parameter sensor is lower than a target pressure value.

[0028] In the technical solution of the utility model, the balloon catheter includes a catheter body, a balloon assembly, an electrode and a parameter sensor; the proximal end of the catheter body is suitable for injecting liquid; the balloon assembly includes at least a first balloon and a second balloon, and the first balloon and the second balloon are both arranged on the distal end of the catheter body; the first balloon and the second balloon are both provided with a plurality of electrodes, and the electrodes are suitable for being electrically connected to the control system of the shock wave device for generating shock waves; the parameter sensor is arranged in the catheter body, and is used to detect the difference in the instantaneous maximum voltage value when the electrodes in the first balloon and the second balloon discharge, and the parameter sensor is suitable for being electrically connected to the control system. It can be understood that the balloon catheter of the utility model detects the maximum instantaneous pressure value or the pressure difference between the electrodes in the first balloon and the second balloon when the electrodes discharge, so as to judge the degree of current blood vessel dredging, thereby effectively solving the problem of blood vessels being damaged by continuous treatment, or insufficient treatment time or degree.

[0029] In addition, the balloon catheter of the utility model includes at least two balloons. Even if a relatively sharp lesion such as a calcified nodule causes damage to one balloon during the operation, the other balloon can still block the blood and prevent the electrothermal effect generated by the discharge from directly acting on the blood vessels. This can effectively avoid serious complications such as vascular perforation and even myocardial necrosis, greatly improving the safety of the operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] In order to more clearly illustrate the embodiments of the utility model or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the utility model. For ordinary technicians in this field, other drawings can be obtained based on the structures shown in these drawings without paying creative work.

[0031] Figure 1 It is a structural schematic diagram of an embodiment of the balloon catheter of the utility model;

[0032] Figure 2 It is a structural schematic diagram of another embodiment of the balloon catheter of the utility model;

[0033] Figure 3 It is a structural schematic diagram of another embodiment of the balloon catheter of the utility model;

[0034] Figure 4 This is a structural schematic diagram of an extension tube assembly and its connector in an embodiment of a balloon catheter of the utility model;

[0035] Figure 5 This is a schematic diagram of the structure of a pressure sensor in an embodiment of a balloon catheter of the utility model;

[0036] Figure 6This is a control system block diagram of an embodiment of the shock wave device of the utility model;

[0037] Figure 7 It is a flow chart of a control method in one embodiment of the shock wave device of the utility model;

[0038] Figure 8 It is a flow chart of a control method in another embodiment of the shock wave device of the present invention.

[0039] Description of Figure Numbers:

[0040] 10. Catheter body; 20. Balloon assembly; 30. Electrode; 21. First balloon; 22. Second balloon; 121. First catheter; 122. Second catheter; 40. Catheter seat; 50. Extension tube assembly; 60. Connector; 70. Parameter sensor; 80. Control system; 71. Circuit board; 72. Sensor body.

[0041] The realization of the purpose, functional features and advantages of the utility model will be further explained in conjunction with embodiments and with reference to the accompanying drawings. DETAILED DESCRIPTION

[0042] The following will be combined with the drawings in the embodiments of the utility model to clearly and completely describe the technical solutions in the embodiments of the utility model. Obviously, the described embodiments are only part of the embodiments of the utility model, not all of the embodiments. Based on the embodiments of the utility model, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the utility model.

[0043] It should be noted that all directional indications in the embodiments of the present invention (such as up, down, left, right, front, back...) are only used to explain the relative position relationship, movement status, etc. between the components under a certain specific posture (as shown in the accompanying drawings). If the specific posture changes, the directional indication will also change accordingly.

[0044] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installation", "connection" and "connection" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0045] In addition, the descriptions of "first", "second", etc. in the present utility model are only used for descriptive purposes and cannot be understood as indicating or implying their relative importance or implicitly indicating the number of technical features indicated. Therefore, the features defined as "first" and "second" may explicitly or implicitly include at least one of the features. In addition, the meaning of "and / or" appearing in the full text is to include three parallel solutions. Taking "A and / or B" as an example, it includes solution A, or solution B, or a solution that satisfies both A and B. In addition, the technical solutions between the various embodiments can be combined with each other, but it must be based on the ability of ordinary technicians in this field to implement. When the combination of technical solutions is contradictory or cannot be implemented, it should be deemed that such a combination of technical solutions does not exist and is not within the scope of protection required by the present utility model.

[0046] The utility model provides a balloon catheter, which can be applicable to a shock wave generating device or an ablation device, etc., but is not limited here.

[0047] Reference Figure 1 , Figure 2 and Figure 6 In some embodiments of the utility model, the balloon catheter includes a catheter body 10, a balloon assembly 20 and electrodes 30; the proximal end of the catheter body 10 is suitable for injecting liquid; the balloon assembly 20 includes at least a first balloon 21 and a second balloon 22, and the first balloon 21 and the second balloon 22 are both arranged on the distal end of the catheter body 10; the first balloon 21 and the second balloon 22 are both provided with a plurality of electrodes 30, and the electrodes 30 are suitable for being electrically connected to the control system 80 of the shock wave device for generating shock waves.

[0048] The first balloon 21 and the second balloon 22 have the same size. The first balloon 21 and the second balloon 22 have the same maximum filling pressure. The first balloon 21 and the second balloon 22 are connected in series so as to be filled at the same time.

[0049] In this embodiment, the catheter body 10 can be made of insulating material, specifically polymer material, and a catheter seat 40 can be provided at the proximal end of the catheter body. The catheter seat 40 can be provided with two openings, and the extension tube assembly 50 can be connected to one of the openings, and the other opening can be connected to a liquid supply device for injecting liquid, and the liquid is used to fill the first balloon 21 and the second balloon 22. The liquid can be physiological saline or contrast agent, etc., which is not limited here.

[0050] The catheter body 10 is a flexible catheter with an inner cavity channel, which may include an inner tube and an outer tube, wherein a fluid channel is formed between the inner tube and the outer tube, and the gap between the inner tube and the outer tube may be set to 0.2mm-0.6mm, wherein the inner cavity channel is used to pass a guide wire; more than two balloons are arranged at the distal end of the catheter body 10, and the balloons are sealed and connected to the catheter body 10, and a plurality of pairs of electrodes 30 are arranged in the balloons, and the form of the electrodes 30 is not limited.

[0051] During the treatment process, the first balloon 21 and the second balloon 22 are filled, and under the control of the vibration wave, a high voltage is applied to the electrode 30 to generate an arc, which in turn generates bubbles. When the bubbles expand and split, shock waves are generated, which are transmitted to the blood vessel wall through the balloon, thereby rupturing or shattering the calcified part.

[0052] It should be noted that each high voltage pulse applied to the electrode 30 forms an arc between the electrodes 30. The voltage pulse may have an amplitude as low as 500 volts, with a voltage amplitude in the range of 1000 volts to 10,000 volts. The balloon may be filled with water or saline or contrast agent, etc., so as to gently install the balloon in the wall of the artery or vein, for example, directly close to the calcified lesion. The liquid may also contain an X-ray contrast agent to allow fluoroscopic viewing of the catheter during use. Once the catheter is positioned on the guidewire, the operating physician or surgeon may begin to apply high voltage pulses to the electrode 30 to form a shock wave that lyses the calcified plaque. The shock wave will be guided sequentially through the fluid, balloon, blood and blood vessel wall to the calcified lesion, where the energy will break up the hardened plaque without the balloon applying too much pressure on the arterial wall.

[0053] It can be understood that the balloon catheter of the present invention includes at least two balloons. Even if a relatively sharp lesion such as a calcified nodule causes damage to one balloon during the operation, the other balloon can still block the blood and maintain normal operation. This can avoid the electrothermal effect generated by the discharge directly acting on the blood vessels, and can effectively avoid serious complications such as vascular perforation and even myocardial necrosis, thereby greatly improving the safety of the operation.

[0054] The utility model has at least two technical solutions: First, the first balloon 21 and the second balloon 22 are connected in series on the same catheter, such as Figure 1 As shown, this solution has the advantages of high strength, high toughness, good fatigue resistance, corrosion resistance, etc. Second, the first balloon 21 and the second balloon 22 are connected to two catheters, wherein the two catheters are formed into an integrated structure by injection molding or binding, and share the same catheter seat 40, such as Figure 2 and Figure 3 shown.

[0055] In the first solution, specifically, Figure 1 and Figure 4 As shown, the catheter body 10 may include a catheter, the first balloon 21 and the second balloon 22 are connected in series on the catheter, the proximal end of the catheter is connected to a catheter seat 40 provided with an injection port, the catheter seat 40 is connected to an extension tube assembly 50 for allowing the wire of the electrode 30 to pass through, and the extension tube assembly 50 is suitable for being electrically connected to the control system 80 through a connector 60.

[0056] In the second option, specifically, Figures 2 to 4 As shown, the catheter body 10 may include a first catheter 121 and a second catheter 122, the first balloon 21 is arranged on the distal end of the first catheter 121, and the second balloon 22 is arranged on the distal end of the second catheter 122; wherein the first catheter 121 and the second catheter 122 are split structures or form an integrated structure, the proximal ends of the first catheter 121 and the second catheter 122 are connected to the same catheter seat 40, two extension tube assemblies 50 are connected to the catheter seat 40, and the two extension tube assemblies 50 are electrically connected to the control system 80 through the connector 60 respectively.

[0057] In order to judge the treatment effect and further improve the safety of the operation, based on the above embodiment, further, mainly refer to Figure 1 and Figure 3 , the distance between the first balloon 21 and the catheter seat 40 may be greater than the distance between the second balloon 22 and the catheter seat 40 .

[0058] Combination Figure 1 , Figure 3 and Figure 6 In this embodiment, a parameter sensor 70 is provided in the catheter seat 40 for detecting the instantaneous maximum voltage value or the pressure difference between the electrodes 30 in the first balloon 21 and the second balloon 22 when they discharge, and the parameter sensor 70 is suitable for being electrically connected to the control system 80.

[0059] It can be understood that the balloon catheter of the present invention detects the respective liquid pressure values ​​in the first balloon 21 and the second balloon 22 or the pressure difference between the two by setting a parameter sensor 70 to determine the current degree of blood vessel dredging, thereby effectively solving the problem of blood vessels being damaged due to continuous treatment, or insufficient treatment time or degree.

[0060] The parameter sensor 70 may be a pressure sensor or a differential pressure sensor. That is, the parameter sensor 70 may be two pressure sensors, respectively used to measure the maximum instantaneous pressure value of the first balloon 21 and the second balloon 22 during discharge, or a differential pressure sensor, used to obtain the pressure difference between the maximum instantaneous pressure value of the first balloon 21 and the second balloon 22 during discharge. Figure 5 and Figure 6 As shown, the pressure sensor may include a circuit board 71 and a sensor body 72 disposed on the circuit board 71 , the sensor body 72 is used to form a pressure signal, and the circuit board 71 is used to transmit the pressure signal to the control system 80 and receive the control signal of the control system 80 .

[0061] The specific implementation process is as follows: fill the first balloon 21 and the second balloon 22. After filling, the pressure of the liquid in the balloon can be 4atm. Since the first balloon 21 is in the calcified or diseased area of ​​the blood vessel, the part of the first balloon 21 close to the blood vessel wall will be partially squeezed or slightly deformed. First, apply voltage to the shock wave electrode 30 in the second balloon 22 to generate arc discharge between the electrodes 30. When the arc generates bubble discharge, the pressure value in the balloon will increase instantly. At this time, the maximum instantaneous pressure value in the second balloon 22 is measured and fed back to the control system 80. Then apply voltage to the first balloon 21 (the balloon in the calcified or diseased area). Since the first balloon 21 is in the calcified area, when the voltage is applied, the pressure value generated instantly after the bubble bursts is greater than the instantaneous maximum pressure value in the second balloon 22. Therefore, the voltage will be continuously applied to the first balloon 21, and the instantaneous pressure value in the first balloon 21 will be continuously monitored until the difference between the instantaneous pressure value in the first balloon 21 and the maximum instantaneous pressure value in the second balloon is lower than the preset threshold.

[0062] Among them, a pressure sensor is used to monitor the instantaneous maximum pressure value generated when the electrode in the balloon discharges in real time. When the balloon ruptures and causes pressure decay, the pressure sensor can capture the signal and send it to the control system 80, thereby improving the safety of such products in clinical use. At the same time, compared with measuring pressure with one balloon, the operator does not know to what extent the impact is considered to be the end of treatment (end of vascular lithotripsy). In this embodiment, two balloons are used, and the other balloon can obtain the maximum instantaneous pressure value of the normal blood vessel during discharge. There is a reference comparison value, and the operator can judge the treatment effect and know whether the treatment is over. Finally, the dredging effect of the blood vessels can be determined by X-ray imaging. It is not necessary to apply voltage every time and start X-ray imaging once, which also reduces the number of X-ray effects, thereby reducing adverse effects on the human body.

[0063] The utility model further proposes a shock wave device, which includes a balloon catheter. The specific structure of the balloon catheter refers to the above embodiment. Since the shock wave device proposed by the utility model includes all schemes of all embodiments of the above balloon catheter, it has at least the same technical effects as the above balloon catheter, which will not be elaborated here one by one.

[0064] Reference Figure 6 In one embodiment of the utility model, the shock wave device also includes a control system 80 for sending pulse signals, and the electrodes 30 of the balloon catheter are electrically connected to the control system 80, and the control system 80 is used to control whether the electrodes 30 discharge or not discharge.

[0065] Please combine Figure 1 and Figure 7In one embodiment, when the balloon catheter is the first technical solution described above, that is, the first balloon 21 and the second balloon 22 are connected in series on the catheter, the control method of the shock wave device includes the following steps:

[0066] S11, filling the first balloon 21 and detecting a first pressure value of the first balloon 21;

[0067] S12, when the first pressure value is at a preset pressure value, filling the second balloon 22 and detecting a second pressure value of the second balloon 22;

[0068] S13, controlling the electrodes 30 of the first balloon 21 and the second balloon 22 to discharge to generate shock waves;

[0069] S14: When the second pressure value is lower than the target pressure value, the discharge of the electrode 30 is stopped.

[0070] During the control process of the electrode 30, the second balloon 22 can be made to reach the target position such as the vascular stenosis or blockage area first, and then the first balloon 21 is filled at the first time, and the pressure value of the first balloon 21 is obtained; then the second balloon 22 is filled at the second time, and the pressure value of the second balloon 22 is obtained. Because the second balloon 22 is in the vascular stenosis or blockage area, the pressure value of the second balloon 22 will be greater than the pressure value of the first balloon 21. The pressure difference between the first time and the second time can be set in advance, or the second balloon 22 can be filled when it is detected that the pressure value of the first balloon 21 reaches a preset value.

[0071] Then the electrode 30 is started, that is, by applying a high voltage pulse signal, the electrode 30 in the balloon discharges electricity, generates an arc, and then generates bubbles, which expand or split, generate shock waves, act on the balloon wall, and transmit to the blood vessel wall. Among them, since the blood vessel where the second balloon 22 is located is relatively narrow, its pressure value should be higher than the pressure value of the first balloon 21. When the pressure of the second balloon 22 gradually decreases, it means that the corresponding blood vessel position is gradually unblocked.

[0072] Please combine Figure 2 and Figure 8 In another embodiment, when the balloon catheter is the second technical solution described above, that is, the first balloon 21 and the second balloon 22 are respectively arranged on the first catheter 121 and the second catheter 122, and the first catheter 121 and the second catheter 122 share a catheter seat 40, the control method of the shock wave device includes the following steps:

[0073] S21, filling the first balloon 21 and the second balloon 22 simultaneously, detecting the maximum instantaneous pressure value of each electrode 30 in the first balloon 21 and the second balloon 22 when the electrodes 30 are discharged and calculating the pressure difference, or detecting the pressure difference between the maximum instantaneous pressure value of the electrodes 30 of the first balloon 21 and the second balloon 22 when the electrodes 30 are discharged;

[0074] S22, controlling the electrodes 30 of the first balloon 21 and the second balloon 22 to discharge to generate shock waves;

[0075] S23, when the pressure difference is less than the preset pressure difference, stop the discharge of the electrode 30.

[0076] In this embodiment, the first balloon 21 and the second balloon 22 are filled at the same time, and the maximum instantaneous pressure value when the inner electrodes of the first balloon 21 and the second balloon 22 are discharged is detected. When the second balloon 22 enters the blocked or narrow blood vessel area, the maximum instantaneous pressure value generated when the electrodes of the second balloon 22 are discharged will be greater than the maximum instantaneous pressure value of the first balloon 21; or the maximum instantaneous pressure difference value when the electrodes of the first balloon 21 and the second balloon 22 are discharged is detected; at the same time, high pressure is applied to the first balloon 21 and the second balloon 22 to generate shock waves, and the pressure or pressure difference between the two is continuously detected. When the difference between the second pressure value of the second balloon 22 and the first pressure value of the first balloon 21 is less than the preset pressure range, it indicates that the blood vessel at the first balloon 21 is unblocked or close to the unblocking degree of the first balloon 21, and the high voltage is stopped. The effect of this is that the effect of the current treatment can be judged intuitively and quantitatively through the pressure value, rather than relying purely on the doctor's experience to judge the degree of current blood vessel unblocking.

[0077] In the prior art, the degree of calcification in the blood vessels cannot be observed by human eyes, nor can it be judged by experience, and needs to be observed through X-ray images. However, the control method of the present application can provide the operator with a very intuitive indicator of blood vessel dredging, and can effectively protect the blood vessels from being damaged due to continuous treatment, and will not cause problems such as insufficient treatment time or degree.

[0078] The above description is only an optional embodiment of the present invention, and does not limit the patent scope of the present invention. All equivalent structural changes made by using the contents of the present invention specification and drawings under the inventive concept of the present invention, or directly / indirectly applied in other related technical fields are included in the patent protection scope of the present invention.

Claims

1. A balloon catheter, characterized in that: include: a catheter body, wherein the proximal end of the catheter body is suitable for injecting liquid; A balloon assembly, comprising at least a first balloon and a second balloon, wherein the first balloon and the second balloon are both arranged on the distal end of the catheter body; Electrodes, the first balloon and the second balloon are both provided with a plurality of the electrodes, the electrodes are suitable for being electrically connected to a control system of a shock wave device, and are used to generate shock waves; as well as A parameter sensor is disposed in the catheter body and is used to detect the difference in instantaneous maximum voltage values ​​when the electrodes in the first balloon and the second balloon discharge. The parameter sensor is suitable for being electrically connected to the control system.

2. The balloon catheter according to claim 1, characterized in that: The parameter sensor is a pressure sensor or a differential pressure sensor. The pressure sensor includes a circuit board and a sensor body arranged on the circuit board. The sensor body is used to form a pressure signal. The circuit board is used to transmit the pressure signal to the control system and receive the control signal of the control system.

3. The balloon catheter according to claim 1, characterized in that: The catheter body includes a catheter, the first balloon and the second balloon are connected in series on the catheter, the proximal end of the catheter is connected to a catheter seat provided with an injection port, the catheter seat is connected to an extension tube assembly for allowing the wire of the electrode to pass through, and the extension tube assembly is suitable for connecting to the control system.

4. The balloon catheter according to claim 1, characterized in that: The catheter body comprises a first catheter and a second catheter, the first balloon is arranged on the distal end of the first catheter, and the second balloon is arranged on the distal end of the second catheter; Among them, the first catheter and the second catheter are of split structure or integrated structure, the proximal ends of the first catheter and the second catheter are connected to the same catheter seat with an injection port, and the catheter seat is connected to two extension tube assemblies respectively used to allow the wires corresponding to the electrodes to pass through, and the two extension tube assemblies are suitable for connecting to the control system.

5. The balloon catheter according to claim 3 or 4, characterized in that: The distance between the first balloon and the catheter seat is greater than the distance between the second balloon and the catheter seat.

6. The balloon catheter according to claim 1, characterized in that: The catheter body comprises an inner tube and an outer tube sleeved on the outer circumference of the inner tube, the inner tube is used to allow a guide wire to pass through, and a fluid channel is formed between the inner tube and the outer tube.

7. The balloon catheter according to claim 6, characterized in that: The distance between the outer wall of the inner tube and the inner wall of the outer tube is 0.2 mm-0.6 mm.

8. The balloon catheter according to claim 1, characterized in that: The catheter body is provided with a wiring channel for the wires of the electrodes to pass through.

9. A shock wave device, characterized in that: include: A control system for sending out pulse signals; as well as The balloon catheter according to any one of claims 1 to 8, wherein the electrodes of the balloon catheter are electrically connected to the control system, and the control system is used to control the electrodes to discharge or not discharge.

10. The shock wave device according to claim 9, characterized in that The control system is also used to stop the electrode discharge when the pressure difference detected by the parameter sensor is less than a preset pressure difference, and to stop the corresponding electrode discharge when the pressure value of the second balloon detected by the parameter sensor is lower than a target pressure value.