Shock wave lithotripsy catheter and shock wave lithotripsy catheter system having the same

Abstract

A shock wave lithotripsy catheter comprises a sheath and a first balloon connected to the distal end of the sheath, the first balloon having a contractible and expandable accommodating cavity, the sheath having a liquid injection port connected to the accommodating cavity, the shock wave lithotripsy catheter further comprising an electrode group disposed in the accommodating cavity, a mounting structure connected to the electrode group and at least partially located in the sheath, and an ultrasonic imaging component disposed in the mounting structure, the mounting structure having a mounting cavity for accommodating the ultrasonic imaging component, and the mounting structure having a liquid guide hole connecting the accommodating cavity and the mounting cavity; by providing the liquid guide hole connecting the accommodating cavity and the mounting cavity on the mounting structure, it is only necessary to perform a liquid injection operation on the accommodating cavity to achieve expansion of the first balloon and place the ultrasonic imaging component in an ultrasonic coupling agent, thereby simplifying the operation process of the shock wave lithotripsy catheter.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a shock wave lithotripsy catheter and a shock wave lithotripsy catheter system having the same. Background Art

[0002] Shockwave lithotripsy catheters use electrohydraulic lithotripsy during angioplasty or valvular calcification. The basic principle is to use a certain voltage to generate bubbles within a fluid-filled balloon. These bubbles collapse in a very short time, generating shock waves that fragment calcified tissue. Because intravascular shockwave lithotripsy is an independent treatment, other methods are required to pre-diagnose calcified lesions and evaluate the efficacy of shockwave lithotripsy after surgery. Common diagnostic methods include intravascular ultrasound imaging.

[0003] Conventional shock wave lithotripsy catheters often incorporate an electrode assembly within a balloon and an ultrasound imaging component within a separate mounting cavity. The balloon housing the electrode assembly and the mounting cavity housing the ultrasound imaging component are then separately injected with fluid to inflate the balloon and immerse the ultrasound imaging component in an ultrasonic coupling agent. However, this separate injection process complicates the operation of the shock wave lithotripsy catheter. Summary of the Invention

[0004] The object of the present invention is to provide a shock wave lithotripsy catheter that is easy to operate and a shock wave lithotripsy catheter system having the same.

[0005] To achieve one of the above-mentioned objects of the invention, one embodiment of the present invention provides a shock wave lithotripsy catheter, comprising a sheath and a first balloon connected to the distal end of the sheath, the first balloon having a contractible and expandable accommodating cavity, the sheath having a liquid injection port connected to the accommodating cavity, the shock wave lithotripsy catheter also comprising an electrode group disposed in the accommodating cavity, a mounting structure connected to the electrode group and at least partially located in the sheath, and an ultrasonic imaging device disposed in the mounting structure, the mounting structure having a mounting cavity for accommodating the ultrasonic imaging device, and the mounting structure having a liquid guide hole connecting the accommodating cavity and the mounting cavity.

[0006] As a further improvement of one embodiment of the present invention, the mounting structure includes a first mounting portion located in the sheath, a second mounting portion connected to the first mounting portion and located in the accommodating cavity, the ultrasonic imaging component is arranged in the second mounting portion, and the liquid guide hole is arranged on the first mounting portion and / or the second mounting portion.

[0007] As a further improvement of one embodiment of the present invention, the first mounting part includes a first mounting tube matching the sheath tube, the second mounting part includes a second mounting tube matching the ultrasonic imaging device, the first mounting tube and the second mounting tube have the same inner diameter, and the liquid guide hole is arranged on the second mounting tube.

[0008] As a further improvement of one embodiment of the present invention, the first mounting part includes a first mounting tube matching the sheath tube, the second mounting part includes a second balloon matching the ultrasonic imaging device, and the inner diameter of the second balloon is larger than the inner diameter of the first mounting tube.

[0009] As a further improvement of one embodiment of the present invention, the second mounting portion further includes a first tube connecting the first mounting tube and the second balloon, and a second tube connected to the end of the second balloon away from the first tube, and the liquid guide hole is provided on the second tube.

[0010] As a further improvement of one embodiment of the present invention, the first mounting portion extends along the axial direction of the sheath tube, and a liquid conduction channel connecting the accommodating cavity and the liquid injection port is formed between the first mounting portion and the sheath tube. The sheath tube also has a liquid discharge port and a pressure measuring port connected to the liquid conduction channel, and the liquid injection port, liquid discharge port and pressure measuring port are all located at the proximal end of the sheath tube.

[0011] As a further improvement of one embodiment of the present invention, the shock wave lithotripsy catheter also includes a mounting seat connected to the end of the first mounting portion facing away from the second mounting portion, a rotating member rotatably connected to the mounting seat and arranged in the first mounting portion, the mounting seat is sealingly connected to the proximal end of the sheath tube, and the ultrasonic imaging component is fixed to the end of the rotating member facing away from the mounting seat.

[0012] As a further improvement of an embodiment of the present invention, the ultrasonic imaging component includes a rotating seat connected to the rotating member and a transducer arranged on the rotating seat, and the normal of the transducer sensing surface is arranged at a certain angle to the axis of the rotating member.

[0013] As a further improvement of one embodiment of the present invention, the electrode group includes a first electrode and a second electrode arranged relatively on both sides of the ultrasonic imaging element, the first electrode and the second electrode each include a first pole sleeve fixed on the mounting structure, an insulating sleeve fixed on the first pole sleeve, and a second pole sleeve fixed on the insulating sleeve, the second pole sleeve is provided with a discharge hole, the insulating sleeve is provided with a conductive hole corresponding to the discharge hole, and at least part of the outer wall surface of the first pole sleeve is exposed in the conductive hole.

[0014] As a further improvement of one embodiment of the present invention, the shock wave lithotripsy catheter also includes a positioning assembly arranged on the mounting structure and a guide assembly connected to the end of the mounting structure facing away from the sheath. The positioning assembly is arranged in the accommodating cavity and includes a first positioning member and a second positioning member relatively arranged on both sides of the ultrasonic imaging member. The guide assembly includes a guide tube connected to the mounting structure and a guide wire cooperating with the guide tube.

[0015] To achieve the above-mentioned purpose, the present invention also provides a shock wave lithotripsy catheter system, comprising a host, the shock wave lithotripsy catheter system comprising the shock wave lithotripsy catheter as described above, a connecting line electrically connecting the host and the shock wave lithotripsy catheter, the host comprising an ultrasonic imaging module connected to an ultrasonic imaging device, a pulse current module connected to an electrode group, and a display module reflecting the ultrasonic imaging module and the pulse current module, the connecting line being detachably connected to the shock wave lithotripsy catheter

[0016] Compared with the prior art, in the embodiment of the present invention, a liquid guide hole connecting the accommodating cavity and the mounting cavity is provided on the mounting structure. Therefore, it is only necessary to inject liquid into the accommodating cavity to achieve the expansion of the first balloon and place the ultrasonic imaging component in the ultrasonic coupling agent, thereby simplifying the operation process of the shock wave lithotripsy catheter. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 is a schematic diagram of a shock wave lithotripsy catheter system according to a preferred embodiment of the present invention;

[0018] Figure 2 yes Figure 1 A cross-sectional view at AA in the middle portion is provided, and a preferred embodiment of a shock wave lithotripsy catheter is provided;

[0019] Figure 3 Schematic diagrams of three preferred embodiments of ultrasonic imaging devices of the present invention;

[0020] Figure 4 is a schematic diagram of a first electrode and a second electrode in a preferred embodiment of the present invention;

[0021] Figure 5 yes Figure 1 A cross-sectional view at AA in the figure is provided, and another preferred embodiment of a shock wave lithotripsy catheter is provided. DETAILED DESCRIPTION

[0022] The present invention will be described in detail below with reference to the specific embodiments shown in the accompanying drawings. However, these embodiments do not limit the present invention, and any structural, methodological, or functional changes made by those skilled in the art based on these embodiments are all within the scope of protection of the present invention.

[0023] In the present invention, for the convenience of description, when the shock wave lithotripsy catheter is normally used, the side close to the user is the proximal end, and the side away from the user is the distal end.

[0024] It should also be noted that, in the description of the present invention, unless otherwise expressly specified or limited, the terms "mounted," "connected," and "connected" should be understood broadly. For example, they may refer to fixed, detachable, or integral connections; mechanical or electrical connections; and direct or indirect connections through an intermediary. Those skilled in the art will understand the specific meanings of the above terms in the present invention depending on the specific circumstances.

[0025] In the various drawings of the present invention, for the sake of convenience, some sizes of structures or parts are exaggerated relative to other structures or parts, and thus, only the basic structure of the subject matter of the present invention is illustrated.

[0026] like Figure 1 A shock wave lithotripsy catheter includes a sheath 10 and a first balloon 20 connected to the distal end of the sheath 10. In this embodiment, the first balloon 20 is sealed to the sheath 10 by means of crimping, gluing, thermoforming, or the like.

[0027] Coordinate Reference Figure 2 As shown, the first balloon 20 has a contractible and expandable accommodating cavity 20a, and the sheath 10 has an injection port 11 connected to the accommodating cavity 20a. In this embodiment, the first balloon 20 can be a semi-compliant or compliant balloon and should be able to withstand a pressure of at least 10 atm. The injection port 11 is connected to a pump or syringe to inject liquid into the accommodating cavity 20a to expand the first balloon 20.

[0028] Furthermore, the shock wave lithotripsy catheter also includes an electrode group 30 disposed within the accommodating cavity 20a, a mounting structure 40 connected to the electrode group 30 and at least partially located within the sheath 10, and an ultrasonic imaging component 50 disposed within the mounting structure 40. In this embodiment, after the electrode group 30 is connected to a high-voltage pulse power supply, bubbles are generated within the first liquid-filled balloon 20. These bubbles collapse in a very short time, generating shock waves that are then transmitted to the vascular lesions, thereby achieving the purpose of fragmenting calcified diseased tissue. The mounting structure 40 is confined within the sheath 10. When the shock wave is generated, the position of the electrode group 30 on the mounting structure 40 is ensured not to shift, thereby ensuring the normal operation of the electrode group 30. The ultrasonic imaging component 50 is disposed within the mounting structure 40 to avoid being affected by the shock wave generated in the first balloon 20, thereby ensuring the normal operation of the ultrasonic imaging component 50.

[0029] Furthermore, the mounting structure 40 has a mounting cavity 40a for accommodating the ultrasonic imaging device 50, and a liquid guide hole 40b connecting the accommodating cavity 20a and the mounting cavity 40a. In this embodiment, at least a portion of the outer wall of the mounting structure 40 forming the mounting cavity 40a is made of an acoustically transparent material, such as polyolefin, polyimide, polyester, or other low-ultrasonic impedance materials, so that ultrasonic waves transmitted or received by the ultrasonic imaging device 50 can smoothly pass through the mounting structure 40. The liquid guide hole 40b can guide the liquid in the accommodating cavity 20a into the mounting cavity 40a, immersing the ultrasonic imaging device 50 in the liquid. The shock wave lithotripsy catheter can fill the accommodating cavity 20a and the mounting cavity 40a with liquid through a single liquid inlet 11, eliminating the need for an additional liquid inlet to separately fill the mounting cavity 40a, thereby simplifying the structure of the shock wave lithotripsy catheter.

[0030] Specifically, physiological saline is preferably injected into the accommodating chamber 20a through the injection port 11. The saline then enters the mounting chamber 40a through the liquid guide hole 40b. The injected saline serves as both an inflation fluid for the accommodating chamber 20a and an ultrasonic coupling agent and coolant for the ultrasonic imaging element 50, ensuring that the first balloon 20 is fully inflated and that sufficient acoustic transmittance exists between the ultrasonic imaging element 50 and the blood vessel being measured.

[0031] When there is sufficient liquid in both the mounting cavity 40a and the accommodating cavity 20a, the shock wave generated by the electrode group 30 is transmitted to the first balloon 20 through the physiological saline in the accommodating cavity 20a, and acts on the lesion of the blood vessel through the first balloon 20; the ultrasonic wave emitted by the ultrasonic imaging element 50 passes through the physiological saline in the mounting cavity 40a and the mounting structure 40, and is transmitted to the vascular tissue through the physiological saline in the accommodating cavity 20a and the first balloon 20 or the sheath 10. After being reflected on the vascular tissue, it returns along the original route and is received by the ultrasonic imaging element 50, thereby obtaining the pathological condition of the vascular lesion.

[0032] By providing a liquid guide hole 40b connecting the accommodating cavity 20a and the mounting cavity 40a on the mounting structure 40, it is only necessary to inject liquid into the accommodating cavity 20a to achieve the expansion of the first balloon 20 and place the ultrasonic imaging element 50 in the ultrasonic coupling agent, thereby simplifying the operation process of the shock wave lithotripsy catheter.

[0033] Moreover, since the ultrasonic imaging component 50 and the electrode group 30 are integrated into the first balloon 20 in this embodiment, the shock wave lithotripsy catheter has an ultrasonic imaging function. Ultrasonic imaging and vascular plaque lithotripsy can be completed by inserting the shock wave lithotripsy catheter into the human tissue only once, thereby eliminating the need for multiple insertions of the electrode group catheter and the ultrasonic imaging component catheter, further simplifying the vascular plaque lithotripsy.

[0034] In some embodiments, the ultrasonic imaging element 50 may also be an optical coherence tomography imaging element, or other elements with imaging function, as long as the shock wave lithotripsy catheter has the imaging function.

[0035] Furthermore, the mounting structure 40 includes a first mounting portion 41 located in the sheath 10, a second mounting portion 43 connected to the first mounting portion 41 and located in the accommodating cavity 20a, the ultrasonic imaging component 50 is arranged in the second mounting portion 43, and the liquid guide hole 40b is arranged on the first mounting portion 41 and / or the second mounting portion 43.

[0036] In this embodiment, the mounting structure 40 is constrained within the sheath 10 by the first mounting portion 41, thereby ensuring the stability of the mounting structure 40 when the electrode assembly 30 generates shock waves. Because the ultrasonic imaging component 50 is located within the second mounting portion 43, and the second mounting portion 43 is located within the accommodating cavity 20a, the ultrasonic imaging component 50 is also located within the accommodating cavity 20a. In this way, both the electrode assembly 30 and the ultrasonic imaging component 50 are located within the accommodating cavity 20a. When the shock waves generated by the electrode assembly 30 act on the vascular lesion through the first balloon 20, the ultrasonic imaging component 50 can more intuitively obtain the vascular lesion condition at the first balloon 20.

[0037] Moreover, the second mounting portion 43 is communicated with the interior of the first mounting portion 41 . No matter whether the liquid guide hole 40 b is arranged on the first mounting portion 41 or the second mounting portion 43 , it is ensured that the liquid guide hole 40 b is communicated with the mounting cavity 40 a .

[0038] In addition, the mounting structure 40 may be provided with a plurality of liquid guide holes 40b to accelerate the flow of liquid between the accommodating cavity 20a and the mounting cavity 40a, thereby increasing the inflation rate of the first balloon 20. The plurality of liquid guide holes 40b are evenly arranged circumferentially along the central axis of the sheath 10 or the mounting structure to ensure the stability of the liquid flow between the accommodating cavity 20a and the mounting cavity 40a.

[0039] Furthermore, the first mounting portion 41 extends along the axis of the sheath tube 10 and defines a liquid-conducting passage 13 between the first mounting portion 41 and the sheath tube 10, connecting the accommodating cavity 20a with the liquid injection port 11. In this embodiment, the liquid-conducting passage 13 is formed between the first mounting portion 41 and the sheath tube 10, thereby eliminating the need for a separate injection conduit to inject liquid into the accommodating cavity 20a and conserving radial space within the shock wave lithotripsy catheter.

[0040] Furthermore, the sheath tube 10 also has a liquid discharge port 15 and a pressure measuring port 17 connected to the liquid guide channel 13. The liquid injection port 11, the liquid discharge port 15, and the pressure measuring port 17 are all located at the proximal end of the sheath tube 10. In this embodiment, after the liquid discharge port 15 is connected to a pump or a syringe, the liquid and air in the accommodating cavity 20a can be extracted through the liquid guide channel 13, thereby shrinking the first balloon 20 and removing the shock wave lithotripsy catheter from the blood vessel. The pressure measuring port 17 is connected to a pressure gauge and can obtain the pressure in the accommodating cavity 20a in real time, thereby accurately obtaining and adjusting the degree of expansion of the first balloon 20. Moreover, the liquid injection port 11, the liquid discharge port 15, and the pressure measuring port 17 are all arranged at the proximal end of the sheath tube 10, close to the user's operating end, which facilitates the installation of external components on the liquid injection port 11, the liquid discharge port 15, and the pressure measuring port 17.

[0041] Furthermore, the shock wave lithotripsy catheter also includes a mounting seat 60 connected to the end of the first mounting portion 41 facing away from the second mounting portion 43, and a rotating member 70 rotatably connected to the mounting seat 60 and arranged in the first mounting portion 41. The mounting seat 60 is sealed and connected to the proximal end of the sheath tube 10, and the ultrasonic imaging component 50 is fixed to the end of the rotating member 70 facing away from the mounting seat 60.

[0042] In this embodiment, the first mounting portion 41 is fixedly connected to the mounting base 60, ensuring that the mounting structure 40 does not deviate within the sheath 10 and the first balloon 20 when the electrode assembly 30 generates a shock wave. The mounting base 60 and the sheath 10 can be sealed and fixed by means of crimping or gluing to prevent leakage of liquid in the liquid-conducting channel 13 between the mounting base 60 and the sheath 10.

[0043] Moreover, since the ultrasonic imaging element 50 can rotate around the axis of the sheath 10 along with the rotating element 70, the ultrasonic imaging element 50 can scan the blood vessel circumferentially to obtain a tissue structure diagram of a circle at the diseased blood vessel, thereby obtaining the radial structure of the blood vessel.

[0044] Coordinate Reference Figure 3 As shown, specifically, the ultrasonic imaging component 50 includes a rotating base 51 connected to the rotating component 70 and a transducer 53 provided on the rotating base 51 , and the normal of the sensing surface of the transducer 53 is provided at a certain angle to the axis of the rotating component 70 .

[0045] In this embodiment, three implementations of the ultrasonic imaging element 50 are provided. Figure 3 In embodiment (a), the rotating seat 51 adopts a cylindrical structure. The rotating seat 51 has the advantages of simple structure and low manufacturing cost. Moreover, the normal of the sensing surface of the transducer 53 is perpendicular to the axis of the rotating part 70, and the inner wall of the blood vessel can be observed along the radial direction of the sheath 10.

[0046] Figure 3In the embodiment (b), the rotating seat 51 adopts a polygonal structure with a cross-section of a regular polygon, so that the transducer 53 is installed on the plane of the rotating seat 51, which is convenient for the installation of the transducer 53. Moreover, the normal of the sensing surface of the transducer 53 is perpendicular to the axis of the rotating part 70, so that the inner wall of the blood vessel can be observed along the radial direction of the sheath 10.

[0047] Figure 3 In embodiment (c), the rotating base 51 adopts a polygonal structure with a right-angled trapezoidal longitudinal cross-section, so that the normal line of the sensing surface of the transducer 53 is inclined relative to the axis of the rotating member 70. Furthermore, the sensing surface of the transducer 53 in this embodiment faces away from the rotating member 70, that is, toward the distal end of the sheath 10. This allows the transducer 53 and the first balloon 20 to first observe the location of the lesion when the shock wave catheter moves within the blood vessel, facilitating the operator's accurate delivery of the first balloon 20 to the lesion.

[0048] Specifically, the transducer 53 can not only convert electrical energy into acoustic energy, but also convert acoustic energy into electrical energy. The wires electrically connected to the ultrasonic imaging element 50 can be provided on the rotating element 70, or the current and control signals can be directly transmitted through the rotating element 70.

[0049] Furthermore, the electrode assembly 30 includes a first electrode 31 and a second electrode 33 disposed on opposite sides of the ultrasonic imaging element 50. In this embodiment, the electrode assembly 30 preferably comprises two electrodes, namely the first electrode 31 and the second electrode 33, to amplify the shock wave while rationally utilizing the internal space of the shock wave lithotripsy catheter. The first electrode 31 and the second electrode 33 are arranged along the axis of the sheath 10. By adjusting the distance between the first electrode 31 and the second electrode 33, the expansion shape of the first balloon 20 can be controlled. The ultrasonic imaging element 50 is disposed between the first electrode 31 and the second electrode 33, enabling accurate imaging of blood vessels simultaneously affected by the shock waves generated by the first electrode 31 and the second electrode 33.

[0050] Coordinate Reference Figure 4 As shown, specifically, the first electrode 31 and the second electrode 33 each include a first pole sleeve 30a fixed on the mounting structure 40, an insulating sleeve 30b fixed on the first pole sleeve 30a, and a second pole sleeve 30c fixed on the insulating sleeve 30b, the second pole sleeve 30c is provided with a discharge hole 30d, the insulating sleeve 30b is provided with a conductive hole 30e corresponding to the discharge hole 30d, and at least part of the outer wall surface of the first pole sleeve 30a is exposed in the conductive hole 30e.

[0051] In this embodiment, the first electrode 31 and the second electrode 33 employ the same structure, thereby reducing the manufacturing cost of the electrode assembly 30. The same electrode has multiple discharge holes 30d, which are evenly arranged circumferentially along the axis of the sheath 10. This allows the shock waves generated by the first and second electrodes 31 and 33 to circumscribe the first balloon 20, enhancing the lithotripsy effect of the shock wave lithotripsy catheter. The aperture size of the discharge hole 30d is larger than the aperture size of the conductive hole 30e. The first and second electrode sleeves 30a and 30c are respectively connected to the positive and negative poles of a high-voltage pulse power supply. The wires connecting the first and second electrode sleeves 30a and 30c can pass through the mounting structure 40 or the fluid conduit 13.

[0052] The first pole sleeve 30a and the second pole sleeve 30c are made of conductive materials, such as steel, nickel, copper, etc. The insulating sleeve 30b is made of insulating materials, such as PEEK, PE, etc.

[0053] When the conductive liquid in the accommodating chamber 20a submerges the first and second electrodes 31, 33, the first and second electrode sleeves 30a, 30c, become electrically connected through the conductive liquid. Because the discharge aperture 30d of the second electrode sleeve 30c is sufficiently close to, but not in contact with, the first electrode sleeve 30a exposed within the conductive aperture 30e, a spark gap forms. Consequently, when a high-voltage pulse voltage is applied to the first and second electrode sleeves 30a, 30c, an arc discharge is generated across the spark gap. Water near the spark gap is vaporized in a very short period of time, forming a rapidly expanding and collapsing water vapor bubble. This expansion and collapse generates a mechanical shock wave that propagates around the vessel. The mechanical shock wave is transmitted through the conductive liquid in the accommodating chamber 20a and the first balloon 20 to the calcified plaque in the blood vessel wall, causing cracks and fractures in the calcified plaque.

[0054] Furthermore, the shock wave lithotripsy catheter also includes a positioning assembly 80 disposed on the mounting structure 40 and a guide assembly 90 connected to the end of the mounting structure 40 facing away from the sheath 10. In this embodiment, the positioning assembly 80 is made of a radiation-opaque material, enabling CT to detect the position of the positioning assembly 80 and, consequently, the location of the shock wave lithotripsy catheter when the shock wave lithotripsy catheter is inserted into human tissue. The provision of the guide assembly 90 enables the catheter to be guided to the location of the lesion.

[0055] Specifically, the positioning assembly 80 is disposed within the accommodating cavity 20a and includes a first positioning member 80a and a second positioning member 80b disposed oppositely to each other on either side of the ultrasonic imaging member 50. In this embodiment, the ultrasonic imaging member 50 is located between the first positioning member 80a and the second positioning member 80b, thereby facilitating the user's determination of the position of the ultrasonic imaging member 50.

[0056] Specifically, the guide assembly 90 includes a guide tube 91 connected to the mounting structure 40 and a guide wire 93 that cooperates with the guide tube 91. In this embodiment, the guide tube 91 is a hollow structure that is sealed with the connecting structure 40 to prevent leakage of liquid within the accommodating cavity 20a from the guide tube 91. The guide wire 93 is matched and disposed within the hollow structure. The guide tube 91 and the first balloon 20 are sealed by crimping, gluing, thermoforming, or other methods to prevent leakage of the accommodating cavity 20a from the connection between the guide tube 91 and the first balloon 20. During operation, the imaging catheter is first advanced to the proximal end of the target location (i.e., the lesion location). The guide wire 93 is then inserted and the tip of the guide wire 93 is passed over the target location to the distal end of the target location. The guide tube 91 of the shock wave lithotripsy catheter of this embodiment is then inserted into the proximal end of the guide wire 93, and the first balloon 20 is advanced along the guide wire 93 to the target location and stopped.

[0057] In order to realize the installation of the ultrasonic imaging component 50, the present invention provides a preferred implementation of the installation structure 40. The installation structure 40 in this embodiment has a simple structure and a low manufacturing cost.

[0058] Coordinate Reference Figure 2 As shown, specifically, the first mounting portion 41 includes a first mounting tube 41a that matches the sheath tube 10, and the second mounting portion 43 includes a second mounting tube 43a that matches the ultrasonic imaging device 50. The first mounting tube 41a and the second mounting tube 43a have the same inner diameter. In this embodiment, because the first mounting tube 41a and the second mounting tube 43a have the same inner diameter and the central axis of the first mounting tube 41a and the central axis of the second mounting tube 43a are collinear, the liquid flowing into the mounting structure 40 through the liquid guide hole 40b experiences little resistance when flowing between the first mounting tube 41a and the second mounting tube 43a.

[0059] Moreover, the first mounting tube 41a and the second mounting tube 43a are preferably made of tubes with the same inner and outer diameters, that is, the mounting structure 40 adopts an integrally formed tubular structure, which reduces manufacturing costs. At this time, the mounting structure 40 is made of sound-transmitting material.

[0060] Specifically, the liquid guide holes 40b are provided on the second mounting tube 43a. In this embodiment, since the mounting cavity 40a is formed within the second mounting tube 43a, the second mounting tube 43a is made of a sound-permeable material. Multiple liquid guide holes 40b are provided on the second mounting tube 43a, and the multiple liquid guide holes 40b are evenly distributed along the circumference of the axis of the second mounting tube 43a.

[0061] In order to realize the installation of the ultrasonic imaging component 50, the present invention provides another preferred embodiment of the mounting structure 40. The mounting structure 40 in this embodiment can meet the installation requirements of ultrasonic imaging components 50 of larger sizes and can also reduce the impact of shock waves on the ultrasonic imaging component 50.

[0062] Coordinate Reference Figure 5 As shown, specifically, the first mounting portion 41 includes a first mounting tube 41b matching the sheath 10, and the second mounting portion 43 includes a second balloon 43b matching the ultrasonic imaging component 50, and the inner diameter of the second balloon 43b is larger than the inner diameter of the first mounting tube 41b.

[0063] In this embodiment, the ultrasonic imaging component 50 is disposed within the second balloon 43b. The dimensions of the second balloon 43b can be increased based on the dimensions of the ultrasonic imaging component 50, eliminating the need to increase the dimensions of the first mounting tube 41b, thereby meeting different usage requirements. Furthermore, the first mounting tube 41b is fixedly connected to the mounting base 60 and the second balloon 43b, respectively. When the shock wave generated by the electrode assembly 30 is transmitted to the second balloon 43b, the flexibility of the second balloon 43b reduces the impact of the shock wave on the first mounting tube 41b and the ultrasonic imaging component 50, ensuring the stability of the connection between the mounting structure 40 and the mounting base 60 and improving the imaging effect of the ultrasonic imaging component 50.

[0064] Since the mounting cavity 40a is formed in the second balloon 43b, the second balloon 43b is made of a sound-transmitting material.

[0065] Specifically, the second mounting portion 43 further includes a first tube 43c connecting the first mounting tube 41b and the second balloon 43b, and a second tube 43d connected to the end of the second balloon 43b away from the first tube 43c. The liquid guide hole 40b is provided on the second tube 43d.

[0066] In this embodiment, the first tube 43c and the first mounting tube 41b have the same inner diameter, and the central axis of the first tube 43c is collinear with the central axis of the first mounting tube 41b. This reduces resistance to the fluid as it flows through the first tube 43c and the first mounting tube 41b. Furthermore, the first tube 43c and the first mounting tube 41b are preferably manufactured with the same inner and outer diameters, that is, they are formed into an integral tubular structure, which reduces manufacturing costs.

[0067] Moreover, the central axis of the first tube 43 c and the central axis of the second balloon 43 b are collinear with each other, which facilitates the rotation of the rotating member 70 within the mounting structure 40 .

[0068] In this embodiment, the second tube 43d is preferably manufactured with the same inner and outer diameters as the first tube 43c to reduce manufacturing costs. Furthermore, the central axes of the second tube 43d, the first tube 43c, and the second balloon 43b are collinear, facilitating installation of the first electrode 31 and the second electrode 33. Multiple liquid-conducting holes 40b are provided in the second tube 43d, evenly spaced circumferentially along the axis of the second tube 43d.

[0069] refer to Figures 1 to 5 As shown, a preferred embodiment of the present invention provides a shock wave lithotripsy catheter system, in which an ultrasonic imaging device 50 is integrated in the shock wave lithotripsy catheter, which can obtain the radial structure of the blood vessel before or during angioplasty, facilitates the adjustment of shock wave parameters during treatment, and improves the safety of angioplasty.

[0070] Specifically, such as Figure 1 A shock wave lithotripsy catheter system includes a host 100, a shock wave lithotripsy catheter, and a connecting line 110 electrically connecting the host 100 and the shock wave lithotripsy catheter. The host 100 includes an ultrasonic imaging module connected to an ultrasonic imaging element 50, a pulse current module connected to an electrode group 30, and a display module 100a reflecting the ultrasonic imaging module and the pulse current module. The connecting line 110 is detachably connected to the shock wave lithotripsy catheter.

[0071] In this embodiment, the high-voltage pulses generated by the pulse current module and the excitation pulses generated by the ultrasonic imaging module of the host 100 can both be transmitted to the shock wave lithotripsy catheter via the connecting line 110. Furthermore, the ultrasonic echo signals received by the ultrasonic imaging element 50 can also be transmitted back to the host 100 via the connecting line 110.

[0072] The connecting cable 110 contains multiple wires. The distal end of the connecting cable 110 has a connector 110a, which is detachably connected to the mounting base 60. The connecting cable 110a contains a control chip. When connected to the mounting base 60, the memory chip in the mounting base 60 can be read. The memory chip in the mounting base 60 stores the parameters of the shock wave lithotripsy catheter, such as model, number of uses, etc. The connector 110a transmits the read parameters of the shock wave lithotripsy catheter to the host 100 through the connecting cable 110. The host 100 displays the parameters on the display module 100a and determines the life of the shock wave lithotripsy catheter based on parameters such as the number of uses of the shock wave lithotripsy catheter. When the host 100 determines that the service life of the shock wave lithotripsy catheter has exceeded the limit, it prohibits the emission of high-voltage pulses to the shock wave lithotripsy catheter and reminds the user to replace the shock wave lithotripsy catheter with a new one on the display module 100a.

[0073] The display module 100a can be touch-screen or non-touch-screen, and is used to interact with the user and display information, including parameters used in the lithotripsy process and intravascular images, such as the high-voltage pulse voltage amplitude, pulse width, and frequency during treatment. The host 100 also includes control buttons, which can be multiple, for interacting with the user and selecting and setting treatment parameters.

[0074] There is a start button on the mounting base 60, which can be one or two or more start buttons. The start button can be used to conveniently start or stop the high-voltage pulse emitted by the host 100 and start or stop the scanning of the ultrasonic imaging element 50, thereby conveniently controlling the start or stop of treatment and the start or stop of scanning images.

[0075] It should be understood that although this specification is described in terms of implementation methods, not every implementation method contains only one independent technical solution. This narrative method of the specification is only for the sake of clarity. Those skilled in the art should regard the specification as a whole. The technical solutions in each implementation method can also be appropriately combined to form other implementation methods that can be understood by those skilled in the art.

[0076] The series of detailed descriptions listed above are only specific descriptions of feasible implementation methods of the present invention. They are not intended to limit the scope of protection of the present invention. Any equivalent implementation methods or changes that do not deviate from the technical spirit of the present invention should be included in the scope of protection of the present invention.

Claims

1. A shock wave lithotripsy catheter comprising a sheath and a first balloon connected to the distal end of the sheath, wherein the first balloon has a shrinkable and expandable accommodating cavity, and the sheath has an injection port communicating with the accommodating cavity, characterized in that: The shock wave lithotripsy catheter further includes an electrode group disposed in the accommodating cavity, a mounting structure connected to the electrode group and at least partially located in the sheath, and an ultrasonic imaging component disposed in the mounting structure, the mounting structure having a mounting cavity for accommodating the ultrasonic imaging component, and a liquid guide hole connecting the accommodating cavity and the mounting cavity, so as to guide liquid in the accommodating cavity into the mounting cavity; The mounting structure includes a first mounting portion located in the sheath tube, a second mounting portion connected to the first mounting portion and located in the accommodating cavity, the first mounting portion includes a first mounting tube matching the sheath tube, the second mounting portion includes a second balloon matching the ultrasonic imaging component, the inner diameter of the second balloon is larger than the inner diameter of the first mounting tube, the second mounting portion also includes a first tube connecting the first mounting tube and the second balloon, and a second tube connected to the end of the second balloon away from the first tube, the liquid guide hole is arranged on the second tube; the first mounting portion extends along the axial direction of the sheath tube, and a liquid guide channel connecting the accommodating cavity and the liquid injection port is formed between the first mounting portion and the sheath tube, and the ultrasonic imaging component is arranged in the second balloon.

2. The shock wave lithotripsy catheter according to claim 1, wherein: The sheath tube also has a liquid discharge port and a pressure measuring port connected to the liquid guide channel, and the liquid injection port, the liquid discharge port and the pressure measuring port are all located at the proximal end of the sheath tube.

3. The shock wave lithotripsy catheter according to claim 2, wherein: The shock wave lithotripsy catheter also includes a mounting seat connected to the end of the first mounting part facing away from the second mounting part, a rotating member rotatably connected to the mounting seat and arranged in the first mounting part, the mounting seat is sealingly connected to the proximal end of the sheath tube, and the ultrasonic imaging member is fixed to the end of the rotating member facing away from the mounting seat.

4. The shock wave lithotripsy catheter according to claim 3, wherein: The ultrasonic imaging component includes a rotating seat connected to a rotating member and a transducer arranged on the rotating seat. The normal of the transducer sensing surface is arranged at a certain angle to the axis of the rotating member.

5. The shock wave lithotripsy catheter according to claim 1, wherein: The electrode group includes a first electrode and a second electrode arranged opposite to each other on both sides of the ultrasonic imaging element, the first electrode and the second electrode each include a first pole sleeve fixed on the mounting structure, an insulating sleeve fixed on the first pole sleeve, and a second pole sleeve fixed on the insulating sleeve, the second pole sleeve is provided with a discharge hole, the insulating sleeve is provided with a conductive hole corresponding to the discharge hole, and at least part of the outer wall surface of the first pole sleeve is exposed in the conductive hole.

6. The shock wave lithotripsy catheter according to claim 1, wherein: The shock wave lithotripsy catheter also includes a positioning assembly arranged on the mounting structure and a guide assembly connected to the end of the mounting structure facing away from the sheath. The positioning assembly is arranged in the accommodating cavity and includes a first positioning member and a second positioning member relatively arranged on both sides of the ultrasonic imaging member. The guide assembly includes a guide tube connected to the mounting structure and a guide wire matched with the guide tube.

7. A shock wave lithotripsy catheter system, comprising a main unit, characterized in that: The shock wave lithotripsy catheter system includes the shock wave lithotripsy catheter according to any one of claims 1 to 6, and a connecting line electrically connecting a host and the shock wave lithotripsy catheter, the host including an ultrasonic imaging module connected to an ultrasonic imaging device, a pulse current module connected to an electrode group, and a display module reflecting the ultrasonic imaging module and the pulse current module, and the connecting line is detachably connected to the shock wave lithotripsy catheter.

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