Catheter assembly of shock-wave balloon catheter system, and shock-wave generation system

Abstract

A catheter assembly of a shock-wave balloon catheter system, and a shock-wave generation system. The catheter assembly comprises: an outer tube; an inner tube, which is arranged in and runs through the outer tube, and forms a contraction portion at the distal end thereof; a balloon, which is sleeved outside the contraction portion, and has one end connected to the outer tube and the other end connected to the inner tube; and an electrode assembly, which is arranged between the contraction portion and the balloon. In the embodiments of the present application, the inner tube is provided with the contraction portion for accommodating the balloon, which can reduce the outer diameter of the balloon in a fully contracted state and in turn improve the capability of the catheter assembly passing through a blood vessel with vascular calcification and stenosis.

Description

Catheter assembly and shock wave generating system of shock wave balloon catheter system Technical Field

[0001] The present application generally relates to the technical field of minimally invasive interventional therapy and more specifically to a catheter assembly and a shock wave generating system of a shock wave balloon catheter system. Background Art

[0002] Vascular stenosis is primarily caused by atherosclerosis, a condition characterized by lipid deposition in the vascular lining, forming plaques that narrow the vascular lumen. This stenosis impedes normal blood flow, reducing oxygen and nutrient delivery to tissues and organs, leading to tissue ischemia and hypoxia. In severe cases, severe vascular stenosis can lead to life-threatening consequences such as angina, stroke, and limb ischemia and necrosis. Therefore, timely treatment of vascular stenosis and restoration of vascular patency are crucial.

[0003] The shock wave balloon catheter system is used to treat vascular stenosis. The shock wave balloon catheter system includes a catheter assembly and a shock wave generator. The catheter assembly includes an outer tube and an inner tube inserted into the outer tube. The distal end of the inner tube is connected to an inflatable balloon, and an electrode assembly is embedded in the balloon. The electrode assembly is connected to the shock wave generator to generate high-intensity shock waves. During operation, the catheter assembly is inserted into the human body so that the balloon is placed in the calcified blood vessel. Liquid is then injected into the balloon to expand the balloon until the outer wall of the balloon is in close contact with the inner wall of the calcified blood vessel. The shock wave generator is then activated to release shock waves to the inner wall of the calcified blood vessel. The mechanical energy of this shock wave directly acts on the calcified plaque on the inner wall of the blood vessel to fragment it.

[0004] The balloon is fixed to the end of the inner tube. When the balloon is folded, the outer contour of the balloon is larger than the outer contour of the catheter outer tube, which increases the difficulty of the catheter assembly passing through the calcified and narrowed blood vessels.

[0005] Application Contents

[0006] In order to at least solve one or more of the technical problems mentioned above, the present application proposes a catheter assembly and a shock wave generating system solution for a shock wave balloon catheter system in multiple aspects.

[0007] In a first aspect, the present application provides a catheter assembly of a shock wave balloon catheter system, comprising: an outer tube; an inner tube, which is inserted into the outer tube, and the distal end of the inner tube forms a contraction portion; a balloon, which is sleeved outside the contraction portion, and one end of the balloon is connected to the outer tube and the other end is connected to the inner tube; and an electrode assembly, which is arranged between the contraction portion and the balloon.

[0008] In some embodiments, a side of the constricted portion close to the proximal end of the inner tube has a slope.

[0009] In some embodiments, when the balloon is in a fully deflated state, the maximum outer diameter of the balloon is no greater than the maximum outer diameter of the outer tube.

[0010] In some embodiments, the outer diameter of the contraction portion is 0.3 mm to 0.4 mm, the maximum outer diameter of the inner tube is 0.42 mm to 0.52 mm, and the outer diameter of the outer tube is 1.06 mm to 1.15 mm.

[0011] In some embodiments, the balloon is made of thermoplastic elastomer or nylon, and the wall thickness of the balloon is 0.025 mm to 0.1 mm.

[0012] In some embodiments, the electrode assembly includes an inner electrode, an insulating ring, and an outer electrode connected in sequence from the inside to the outside, the inner electrode being conductively connected to a shock wave generator of a shock wave balloon catheter system via a first wire, the outer electrode being conductively connected to the shock wave generator via a second wire, the outer electrode being provided with a first discharge port, and the insulating ring being provided with a second discharge port at a position opposite to the first discharge port, exposing the inner electrode.

[0013] In some embodiments, the inner electrode has a rectangular cross-section.

[0014] In some embodiments, a catheter joint is further included on the outer tube, wherein the catheter joint includes a curved channel connected to the annular channel between the outer tube and the inner tube, and the catheter joint has an end for connecting to the shock wave generator.

[0015] In some embodiments, the inner tube is provided with a guidewire lumen communicating with the outside.

[0016] In some embodiments, a developing ring is fixedly provided between the inner tube and the balloon.

[0017] In a second aspect, the present application provides a shock wave generating system, comprising the catheter assembly of the shock wave balloon catheter system as described in the first aspect above, and a shock wave generator connected to the catheter assembly of the shock wave balloon catheter system.

[0018] In some embodiments, the shock wave generator includes: a main control module, which is used to receive user instructions and output control signals for controlling the discharge process; an isolated boost module, which is electrically connected to the main control module for receiving the control signal of the main control module and converting the low-voltage DC voltage into a high-voltage DC output; a detection module, one end of which is connected to the isolated boost module and the other end is electrically connected to the main control module for detecting the status information of the isolated boost module and feeding back the detection results to the main control module, which then adjusts the control signal according to the detection results and outputs it.

[0019] Through the catheter assembly of the shock wave balloon catheter system provided above, embodiments of the present application, by providing a constricted portion on the inner tube for accommodating the balloon, can reduce the outer diameter of the balloon in a fully contracted state, thereby improving the catheter assembly's ability to pass through calcified and stenotic blood vessels. Furthermore, in some embodiments, by providing a slope on the side of the constricted portion near the proximal end of the inner tube, a smooth transition of the catheter assembly to the lesion can be achieved. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The above and other objects, features and advantages of the exemplary embodiments of the present application will become readily understood by reading the detailed description below with reference to the accompanying drawings. In the accompanying drawings, several embodiments of the present application are shown in an exemplary and non-limiting manner, and the same or corresponding reference numerals represent the same or corresponding parts, wherein:

[0021] FIG1 is a schematic structural diagram of a catheter assembly of a shock wave balloon catheter system provided in an embodiment of the present application;

[0022] FIG2 is a schematic structural diagram of the distal end of the inner tube in FIG1 ;

[0023] FIG3 is a schematic structural diagram of a shock wave balloon catheter system provided in an embodiment of the present application;

[0024] FIG4 is a schematic structural diagram of the electrode assembly in FIG1 ;

[0025] FIG5 is a schematic structural diagram of FIG4 with the inner tube hidden and the arrangement of the electrode assembly highlighted;

[0026] FIG6 is a proximal cross-sectional view of the electrode assembly in FIG5 ;

[0027] FIG7 is a cross-sectional view of the distal end of the electrode assembly in FIG5 ;

[0028] FIG8 is an exemplary structural block diagram of a shock wave generator provided in an embodiment of the present application;

[0029] FIG9 is a detailed exemplary structural block diagram of a shock wave generator provided in an embodiment of the present application.

[0030] Description of the drawings: 1. Outer tube; 2. Inner tube; 21. Contraction part; 22. Slope; 23. Guidewire cavity; 3. Balloon; 4. Electrode assembly; 41. Inner electrode; 42. Insulating ring; 421. Second discharge port; 43. Outer electrode; 431. First discharge port; 5. Development ring; 6. Catheter joint; 61. Liquid injection interface; 7. Hypotube; 8. Shock wave generator; 101. Main control module; 1011. Human-computer interaction unit; 1012. Microcontroller unit; 1013. Power management unit; 102. Isolated boost module; 1021. High-voltage isolation unit; 1022. Pulse isolation unit; 1023. Isolation drive unit; 1024. Power switch unit; 103. Detection module; 1031. Abnormality detection unit; 1032. Discharge current detection unit; 1033. Isolated current detection unit. DETAILED DESCRIPTION

[0031] The following will be combined with the drawings in the embodiments of this application to clearly and completely describe the technical solutions in the embodiments of this application. Obviously, the embodiments described are part of the embodiments of this application, not all of them. Based on the embodiments in this application, all other embodiments obtained by those skilled in the art without making creative efforts are within the scope of protection of this application.

[0032] It should be understood that the terms "include" and "comprising" used in the description and claims of this application indicate the presence of described features, wholes, steps, operations, elements and / or components, but do not exclude the presence or addition of one or more other features, wholes, steps, operations, elements, components and / or collections thereof.

[0033] It should also be understood that the terms used in this specification are for the purpose of describing specific embodiments only and are not intended to limit this application. As used in this specification and claims, the singular forms "a," "an," and "the" are intended to include the plural forms unless the context clearly indicates otherwise. It should also be further understood that the term "and / or" as used in this specification and claims refers to any and all possible combinations of one or more of the associated listed items, including and including these combinations.

[0034] The specific implementation of the present application will be described in detail below with reference to the accompanying drawings.

[0035] FIG1 is a schematic structural diagram of a catheter assembly for a shock wave balloon catheter system provided in an embodiment of the present application. In conjunction with FIG1 , this embodiment provides a catheter assembly for a shock wave balloon catheter system, comprising an outer tube 1, an inner tube 2, a balloon 3, and an electrode assembly 4. The inner tube 2 is inserted into the outer tube 1, and a constriction 21 is formed at the distal end of the inner tube 2. The balloon 3 is sheathed outside the constriction 21, with one end of the balloon 3 joined to the outer tube 1 and the other end of the balloon 3 joined to the inner tube 2, so that the inner tube 2 and the outer tube 1 form a double catheter, enabling the injection and discharge of liquid within the balloon 3. The liquid within the balloon 3 is typically physiological saline and / or a contrast agent. The electrode assembly 4 is disposed between the constriction 21 and the balloon 3 and is a key component of the catheter assembly for generating shock waves. The electrode assembly 4 rapidly releases electrical pulses within the balloon 3, forming pressure waves in the liquid, which in turn generates shock waves against the inner wall of the blood vessel.

[0036] By providing a contraction portion 21 on the inner tube 2 and placing the balloon 3 outside the contraction portion 21, the outer diameter of the balloon 3 in the contracted state can be reduced, thereby reducing the maximum outer diameter of the catheter assembly intervening in the blood vessel, effectively reducing the difficulty of the catheter assembly passing through the calcified and narrowed blood vessel.

[0037] It should be noted that the distal end and proximal end mentioned in this application are based on the operator. The distal end refers to the end of the guiding tube assembly farther from the operator, while the proximal end refers to the end of the guiding tube assembly closer to the operator.

[0038] In some preferred embodiments, as shown in Figures 1 and 2, the side of the contraction portion 21 close to the proximal end of the inner tube 2 has a slope 22. The provision of the slope 22 ensures a smooth transition of the inner tube 2 in the calcified and narrowed blood vessels, and the provision of the slope 22 reduces the possibility of kinking of the inner tube 2, ensuring its smooth passage. When the balloon 3 is in a fully contracted state, the maximum outer diameter of the balloon 3 is not greater than the maximum outer diameter of the outer tube 1, so as to reduce the influence of the volume of the balloon 3 itself on the passability of the catheter assembly. Furthermore, the outer diameter of the contraction portion 21 is 0.3mm to 0.4mm, while the outer diameter of the inner tube 2 is 0.42mm to 0.52mm. Experiments have shown that this design reduces the outer contour of the balloon 3 in a contracted state while ensuring the performance of the catheter assembly, effectively improving the passability of the balloon 3 through severely calcified lesions. Furthermore, a truncated cone-shaped end is fixedly connected to one side of the contraction portion 21 close to the distal end of the inner tube 2, and the maximum outer diameter of the above end is not greater than the minimum outer diameter of the contraction portion 21, so that the process of the catheter assembly intervening in the blood vessel is smoother.

[0039] In some preferred embodiments, balloon 3 can be a compliant balloon or a non-compliant balloon, preferably a non-compliant balloon. The wall of a non-compliant balloon is harder and has a higher acoustic impedance, which can reduce shock wave reflection and attenuation at the balloon interface, resulting in better shock wave transmission efficiency. Furthermore, the shape and size of the non-compliant balloon remain unchanged during treatment, facilitating the focusing of shock waves on the precise target tissue. Furthermore, balloon 3 has at least three flaps, which are wrapped tightly around the outside of the contraction portion 21 of the inner tube 2, so that balloon 3 is in a folded and deflated state before expansion. Accordingly, the wall thickness of balloon 3 is typically 0.025 mm to 0.1 mm. Balloon 3 can be made of a thermoplastic elastomer or nylon. Pebax, a plasticizer-free thermoplastic elastomer, can be used as the thermoplastic elastomer. Pebax has excellent biocompatibility and flexibility, which facilitates smooth passage of the catheter through tortuous blood vessels to the lesion site. Nylon material has high mechanical strength and can withstand higher pressure. Nylon also has a smaller sound wave attenuation coefficient, which is beneficial to the conduction of shock waves and reduces losses.

[0040] As shown in Figures 2, 3, and 4, a high-voltage pulse voltage is applied to the electrode assembly 4 by an operator through a shock wave generator 8. Specifically, the shock wave generator 8 has a high-voltage pulse generating circuit inside. The electrode assembly 4 is connected to the high-voltage pulse generating circuit inside the shock wave generator 8 to form a strong electric field. As an example, the electrode assembly 4 of this embodiment includes an inner electrode 41, an insulating ring 42, and an outer electrode 43, which are connected in sequence from the inside to the outside. The inner electrode 41 is electrically connected to the high-voltage pulse generating circuit via a first conductor. The insulating ring 42 is sleeved on the outside of the inner electrode 41. The outer electrode 43 is annular and sleeved on the outside of the inner electrode 41 and the inner tube 21. The outer electrode 43 is electrically connected to the high-voltage pulse generating circuit via a second conductor. The insulating ring 42 is positioned between the inner electrode 41 and the outer electrode 43 for electrical isolation. The outer electrode 43 is provided with a first discharge port 431. The insulating ring 42 has a second discharge port 421 formed at a position corresponding to the first discharge port 431. The second discharge port 421 is used to expose the inner electrode 41. When the shock wave generator 8 is operating, it generates a high-voltage pulse, which is applied between the first and second wires. The high-voltage pulse is then transmitted sequentially through the first wire, the inner electrode 41, the fluid in the balloon 3, the outer electrode 43, and the second wire, ultimately forming a shock wave at the balloon 3.

[0041] During vascular calcification treatment, balloon 3 is inserted into a blood vessel and filled with liquid (such as saline and / or contrast agent), causing it to expand and adhere to the vessel's inner wall. When a high voltage is applied between inner electrode 41 and outer electrode 43, a high-voltage discharge is generated between them, generating a shock wave. The shock wave is transmitted through the liquid within balloon 3 to the balloon's wall, where it then acts on any calcified plaques it contacts, breaking them up. When the shock wave strikes a severely calcified, narrowed or occluded area of ​​the vessel, the instantaneous high voltage creates a mechanical fragmentation effect, breaking up the calcified plaques.

[0042] It is understandable that rapid discharge is required to generate shock waves. The greater the number of external electrodes 43, the larger the electrode area can be, which is conducive to the accumulation and storage of charge. Therefore, in a preferred embodiment, the number of internal electrodes 41 and external electrodes 43 in the balloon 3 is set to multiple. Specifically, multiple internal electrodes 41 are connected in parallel by wires to form an internal electrode group, and multiple external electrodes 43 are connected in parallel by wires to form an external electrode group. The internal electrode group and the external electrode group are then connected in series to the high-voltage pulse generating circuit of the shock wave generator 8. The series connection between different types of electrodes can form a potential difference, and the parallel connection of electrodes of the same type can form a uniform voltage distribution between the electrodes, which is conducive to improving the discharge effect of the balloon 3 catheter.

[0043] As shown in Figures 5, 6, and 7, as a specific example, the electrode assembly 4 within the catheter assembly includes two outer electrodes 43 and four inner electrodes 41. Each outer electrode 43 corresponds to two inner electrodes 41, and the two inner electrodes 41 corresponding to each outer electrode 43 are positioned within the outer electrode 43 and arranged opposite each other, such that the two first discharge ports 431 of each outer electrode 43 are opposite the second discharge ports 421 of the corresponding inner electrode 41 and are concentrically arranged. Furthermore, the axis of the first discharge port 431 of one outer electrode 43 is perpendicular to the axis of the first discharge port 431 of another outer electrode 43. It will be appreciated that the second discharge port 421 of each inner electrode 41 is located on the insulating ring 42 outside the corresponding inner electrode 41, and the second discharge port 421 can be circular, square, or elliptical in shape. A circular shape is preferred to produce a more uniform electric field distribution.

[0044] It should be noted that each first discharge port 431 is concentric with the corresponding second discharge port 421 to create a potential difference, generating a strong electric field, and further generating shock waves that act on the inner wall of the blood vessel in close proximity to the balloon 3. Furthermore, the size of the first discharge port 431 is larger than that of the second discharge port 421. As an example, the size of the second discharge port 421 can be 0.8 times that of the first discharge port 431. The small aperture of the second discharge port 421 allows the inner electrodes 41 to be closer together, resulting in a more concentrated electric field.

[0045] In some embodiments, the outer electrode 43 and the inner electrode 41 are both fixed to the contraction portion 21 of the inner tube 2 by UV glue or quick-drying glue. Specifically, the insulating ring 42 outside the inner electrode 41 is bonded to the contraction portion 21 of the inner tube 2, and the outer electrode 43 is bonded to the insulating ring 42 outside the inner electrode 41. Directly applying glue to fix the electrodes is simple and fast, and can eliminate additional fixing components or processes, thereby reducing costs. In addition, the glue can firmly adhere the inner electrode 41 and the outer electrode 43 to the wall of the inner tube 2, effectively reducing the possibility of the outer electrode 43 and the inner electrode 41 moving or falling off. Furthermore, in order to increase the stability and convenience of the bonding of the inner electrode 41, the inner electrode 41 is constructed as an electrode with a rectangular cross-section, and the insulating ring 42 is coated on the outer surface of the inner electrode 41. Adaptively, the cross-section of the insulating ring 42 is square. As an example, the cross-sectional size of the inner electrode 41 is between (0.2-0.4 mm)*(0.08-0.15 mm), preferably 0.21*0.13 mm.

[0046] In some embodiments, the inner electrode 41 is made of copper wire with a rectangular cross-section. The outer electrode 43 may be nickel-titanium alloy, platinum-iridium alloy, stainless steel, etc., preferably stainless steel. Stainless steel has high strength, high hardness and excellent corrosion resistance, can withstand the mechanical stress of high-voltage pulses, is not easy to corrode, and has a long service life. The insulating ring 42 is preferably a polyimide with a thickness of 0.023mm to 0.027mm. Experimental data verify that polyimide of this thickness can withstand high voltages of 2000V to 5000V under the premise of having sufficient mechanical support, and effectively insulate and electrically isolate the inner electrode 41 and the outer electrode 43, thereby reducing the possibility of electrical breakdown due to direct contact between the inner electrode 41 and the outer electrode 43.

[0047] In some embodiments, as shown in FIG1 , a developing ring 5 is fixedly disposed between the balloon 3 and the contraction portion 21 of the inner tube 2. The developing ring 5 is a marking ring used for X-ray development of the distal working area during interventional therapy. The material of the developing ring 5 needs to have sufficient mechanical strength and good biosafety. Polytetrafluoroethylene, polyimide, platinum-iridium alloy, nickel-titanium alloy, gold-plated stainless steel, or other metal or alloy materials can be selected. In this embodiment, there are two developing rings 5 ​​to identify the distance between the electrode assembly 4 and the target lesion. It is understood that the number of developing rings 5 ​​can be multiple to improve recognition accuracy.

[0048] In some embodiments, as shown in Figures 1 and 3, the outer tube 1 is further provided with a catheter connector 6 having a curved channel. The curved channel is connected to the annular channel formed by the outer tube 1 and the inner tube 2, and the catheter connector 6 also has an end for connecting to the shock wave generator 8 and an injection port 61 that is connected to the curved channel. Specifically, the injection port 61, the curved channel, and the annular channel formed by the outer tube 1 and the inner tube 2 form a liquid channel. The annular channel formed by the outer tube 1 and the inner tube 2 is filled with a liquid medium such as physiological saline and / or contrast agent through the injection port 61, allowing the liquid medium to flow into the balloon 3 and expand the balloon 3. Correspondingly, the liquid medium in the balloon 3 is sucked outward through the injection port 61, causing the balloon 3 to deflate. The expansion and contraction of the balloon 3 can achieve expansion of stenotic blood vessels or calcified lesions in the blood vessels. Furthermore, the catheter connector 6 is connected to the handle of the shock wave generator 8 via a TPU hose, wherein the length of the TPU hose is 100 to 150 mm. TPU material has good flexibility and can bend and deform, making it easier for operators to operate and adjust the catheter assembly. It also has a certain elasticity and can absorb pulsation and vibration caused by shock waves.

[0049] As shown in FIG1 , a common method for controlling the entry of the shock wave balloon 3 catheter into a blood vessel is through a guidewire. Accordingly, in some embodiments, a guidewire lumen 23 communicating with the outside is formed from the sidewall of the outer tube 1 to the distal end of the inner tube 2. Before the shock wave is controlled, a suitable guidewire is first selected based on the vascular path and the location of the lesion. The guidewire is inserted from the puncture point on the patient's body surface and, under X-ray guidance, is delivered to the lesion site through the vascular path. The shock wave balloon 3 catheter is then slid along the guidewire and fixed in the guidewire lumen 23, allowing the catheter assembly to follow the guidewire until the balloon 3 reaches the predetermined lesion site.

[0050] In some embodiments, as shown in FIG1 , the catheter assembly further includes a hypotube 7, which is connected between the outer tube 1 and the catheter connector 6, and the proximal end of the inner tube 2 sequentially passes through the outer tube 1 and the hypotube 7. The hypotube 7 can be made of stainless steel, titanium alloy, fiberglass, or the like.

[0051] The present application also provides a shock wave generating system, comprising a catheter assembly according to any of the above embodiments and a shock wave generator 8 connected to the catheter assembly. It is understood that the catheter assembly and shock wave generator 8 are integrated and disposable, effectively reducing the risk of cross-infection.

[0052] The working principle of the shock wave generator 8 will be further explained below in conjunction with specific modules of the shock wave generator 8.

[0053] As shown in Figure 8, the shock wave generator 8 includes a main control module 101, an isolated boost module 102, and a detection module 103. The main control module 101 is used to receive user instructions and output a control signal for controlling the discharge process. The isolated boost module 102 is electrically connected to the main control module 101 for receiving the control signal of the main control module 101 and converting the low-voltage DC voltage into a high-voltage DC output. The detection module 103 is connected to the isolated boost module 102 and the main control module 101 for detecting the status information of the isolated boost module 102 and feeding the detection result back to the main control module 101. The main control module 101 then adjusts the control signal according to the detection result and outputs it.

[0054] As shown in Figure 9, in some embodiments, the main control module 101 includes a human-computer interaction unit 1011, a microcontroller unit 1012, and a power management unit 1013. The human-computer interaction unit 1011 is equipped with a touch screen and physical buttons, supporting multiple human-computer interaction methods. The touch screen can display treatment parameter settings and treatment progress information. The physical buttons can perform basic operations such as starting and pausing treatment. The operator can use the touch screen and physical buttons to start discharge, adjust the energy level, and perform other operations. The microcontroller unit 1012 responds to control signals from the human-computer interaction unit 1011 to adjust and control the entire discharge process. Specifically, the microcontroller unit 1012 has preset treatment modes and can control parameters such as discharge pulse width, waveform, and frequency. During treatment, these parameters can be adjusted according to human-computer interaction instructions. The power management unit 1013 is powered by four to eight 3V disposable batteries, providing multiple independent power modules to ensure stable power supply for the system.

[0055] As shown in Figure 9, in some embodiments, the isolated boost module 102 includes a high-voltage isolation unit 1021, a pulse isolation unit 1022, an isolation drive unit 1023 and a power switch unit 1024. The high-voltage isolation unit 1021 is used to achieve electrical isolation protection between the main control module 101 and the high-voltage output end. Specifically, an isolated high-voltage DC power supply can be used. The pulse isolation unit 1022 is used to receive the pulse control signal output by the main control module 101, and drive the boost conversion after isolation. The isolation drive unit 1023 is used to convert the isolated pulse signal into a signal suitable for driving the power switch tube. Specifically, an optocoupler or similar device can be used to achieve isolated transmission. The power switch unit 1024 is connected to the pulse isolation unit 1022 for achieving high-voltage switching and completing the conversion from DC to pulse voltage.

[0056] As shown in FIG9 , in some embodiments, the detection module 103 includes an abnormality detection unit 1031, a discharge current detection unit 1032, and an isolated current detection unit 1033. The abnormality detection unit 1031 is used to detect various faults and abnormal conditions during system operation, such as overtemperature, overvoltage, overcurrent, short circuit, etc., and feed them back to the microcontroller unit 1012. The microcontroller unit 1012 uses this information to adjust the corresponding control logic. The discharge current detection unit 1032 converts the current of the power switch unit 1024 detected by the isolated current detection unit 1033 into a voltage signal that can be collected by the microcontroller unit 1012, allowing the microcontroller unit 1012 to monitor the status of the electrode in real time and make corresponding adjustment strategies based on the corresponding status.

[0057] Although multiple embodiments of the present application have been shown and described herein, it will be apparent to those skilled in the art that such embodiments are provided by way of example only. Those skilled in the art can conceive of many changes, modifications, and alternatives without departing from the thought and spirit of the present application. It should be understood that in the process of practicing the present application, various alternatives to the embodiments of the present application described herein can be adopted. The accompanying claims are intended to define the scope of protection of the present application and therefore cover equivalents or alternatives within the scope of these claims.

Claims

1. A catheter assembly for a shock wave balloon catheter system, characterized in that: include: External pipe; An inner tube, which is inserted into the outer tube, and a contraction portion is formed at the distal end of the inner tube; A balloon, which is sleeved outside the contraction portion, and one end of the balloon is connected to the outer tube, and the other end of the balloon is connected to the inner tube; An electrode assembly is disposed between the contraction portion and the balloon.

2. The catheter assembly of the shock wave balloon catheter system according to claim 1, characterized in that: The side of the contraction portion close to the proximal end of the inner tube has a slope.

3. The catheter assembly of the shock wave balloon catheter system according to claim 1, characterized in that: When the balloon is in a fully contracted state, the maximum outer diameter of the balloon is not greater than the maximum outer diameter of the outer tube.

4. The catheter assembly of the shock wave balloon catheter system according to claim 2, characterized in that: The outer diameter of the contraction portion is 0.3 mm to 0.4 mm, the maximum outer diameter of the inner tube is 0.42 mm to 0.52 mm, and the outer diameter of the outer tube is 1.06 mm to 1.15 mm.

5. The catheter assembly of the shock wave balloon catheter system according to claim 1, characterized in that: The material of the balloon is thermoplastic elastomer material or nylon, and the wall thickness of the balloon is 0.025mm-0.1mm.

6. The catheter assembly of the shock wave balloon catheter system according to any one of claims 1 to 5, characterized in that: The electrode assembly comprises an inner electrode, an insulating ring and an outer electrode which are sequentially connected from the inside to the outside, the inner electrode being conductively connected to a shock wave generator of a shock wave balloon catheter system via a first wire, the outer electrode being conductively connected to the shock wave generator via a second wire, the outer electrode being provided with a first discharge port, and the insulating ring being provided with a second discharge port which exposes the inner electrode at a position directly opposite to the first discharge port.

7. The catheter assembly of the shock wave balloon catheter system according to claim 6, characterized in that: The cross section of the inner electrode is rectangular.

8. The catheter assembly of the shock wave balloon catheter system according to claim 1, characterized in that: It also includes a conduit joint arranged on the outer tube, the conduit joint includes a curved channel connected to the annular channel between the outer tube and the inner tube, and the conduit joint has an end for connecting the shock wave generator.

9. The catheter assembly of the shock wave balloon catheter system according to claim 1, characterized in that: The inner tube is provided with a guide wire cavity communicated with the outside.

10. The catheter assembly of the shock wave balloon catheter system according to claim 1, characterized in that: A developing ring is fixedly arranged between the inner tube and the balloon.

11. A shock wave generating system, characterized in that: The invention comprises a catheter component of the shock wave balloon catheter system according to any one of claims 1 to 10 and a shock wave generator connected to the catheter component of the shock wave balloon catheter system.

12. The shock wave generating system according to claim 11, characterized in that: The shock wave generator comprises: A main control module, which is used to receive user instructions and output control signals to control the discharge process; An isolated boost module, which is electrically connected to the main control module to receive a control signal from the main control module and convert a low-voltage DC voltage into a high-voltage DC output; A detection module, one end of which is connected to the isolated boost module and the other end of which is electrically connected to the main control module, is used to detect the status information of the isolated boost module and feed back the detection result to the main control module, which then adjusts the control signal according to the detection result and outputs it.

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