An intravascular ultrasound imaging catheter, medical device and control method for performing shockwave therapy

Abstract

The application provides an intravascular ultrasound imaging catheter, medical equipment and control method capable of shock wave treatment, which comprises an imaging assembly, an outer sheath and a shock wave generating assembly, the imaging assembly comprises an ultrasound transducer, a transducer seat, a driving shaft and a coaxial cable; the imaging assembly is arranged in the outer sheath, the proximal end of the outer sheath is provided with a catheter seat; the shock wave generating assembly comprises a shock wave electrode and an electrode lead wire; the ultrasound transducer and the shock wave electrode are mounted on the transducer seat; the distal end of the coaxial cable is electrically connected with the ultrasound transducer, and the proximal end extends to the catheter seat; the distal end of the electrode lead wire is electrically connected with the shock wave electrode, and the proximal end extends to the catheter seat. The intravascular ultrasound system is combined with the shock wave generating device, so that the intravascular ultrasound imaging diagnosis and the shock wave treatment can be completed by using only one catheter, the operation process is simplified, the operation time is shortened, and the operation cost is reduced.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to an intravascular ultrasound imaging catheter, medical device, and control method for shockwave therapy. Background Technology

[0002] When calcification occurs in blood vessels, the current main routine practice is to first use an intravascular ultrasound catheter to diagnose the calcified lesions. Intravascular ultrasound (IVUS) uses catheter technology to insert a miniature ultrasound probe into the lumen of the blood vessel. Through sound wave scanning and reflection, it provides in vivo images of the blood vessel lumen, which can clearly show the thickness of the vessel wall structure, the size and shape of the lumen, accurately measure the diameter and cross-sectional area of ​​the blood vessel, and even identify lesions such as calcification and fibrosis.

[0003] In the treatment of endovascular calcification, shockwave balloon catheters utilizing the electrohydraulic effect can achieve good therapeutic results. The electrohydraulic effect occurs when electrons in the liquid between electrodes are accelerated under a high-voltage, strong electric field, ionizing liquid molecules near the electrodes. The ionized electrons in the liquid are further accelerated by the strong electric field between the electrodes, creating an electron avalanche. A plasma channel is formed in the ionized liquid region. As the ionization region expands, the liquid is broken down, forming a discharge channel between the electrodes. Once the discharge channel is formed, due to the very low discharge resistance, a large discharge current is generated. This current heats the liquid surrounding the discharge channel, causing cavitation and the formation of bubbles. The instantaneous collapse of these bubbles generates a shock wave. This achieves the goal of breaking up calcified lesions without damaging the vascular intima.

[0004] However, the diagnosis and treatment of endovascular occlusive lesions are currently performed separately. First, the calcified lesions are diagnosed, and then treatment with a shockwave balloon catheter is initiated. This requires first advancing the IVUS catheter to the lesion site for intravascular ultrasound imaging, then withdrawing the IVUS catheter from the blood vessel. Next, the shockwave balloon catheter is inserted and advanced to the lesion site for dilation treatment. Finally, the IVUS catheter is reinserted to evaluate the treatment effect. The entire procedure is complex, time-consuming, requires the use of various instruments, and is costly.

[0005] In view of the above, this application is hereby submitted. Summary of the Invention

[0006] The present invention provides an intravascular ultrasound imaging catheter, medical device and control method for shock wave therapy, to solve at least one of the above-mentioned technical problems.

[0007] An intravascular ultrasound imaging catheter for shock wave therapy includes an imaging component, an outer sheath, and a shock wave generating component.

[0008] The imaging assembly includes an ultrasonic transducer, a transducer mount, a drive shaft, and a coaxial cable; the imaging assembly is disposed inside the outer sheath, and the proximal end of the outer sheath has a catheter mount; the shock wave generating assembly includes a shock wave electrode and an electrode wire.

[0009] The ultrasonic transducer and the shock wave electrode are mounted on the transducer base; the distal end of the coaxial cable is electrically connected to the ultrasonic transducer, and the proximal end extends to the conduit base; the distal end of the electrode wire is electrically connected to the shock wave electrode, and the proximal end extends to the conduit base.

[0010] Preferably, the shock wave electrode is coaxially arranged with the transducer base, and the outer diameter of the shock wave electrode is not greater than the outer diameter of the transducer base.

[0011] Preferably, the shock wave electrode includes an insulating tube and an inner electrode. The outer diameter of the insulating tube is smaller than the outer diameter of the transducer base. The insulating tube is connected to the far end of the transducer base. The inner electrode is located inside the insulating tube. The wall of the insulating tube is provided with an electrode hole corresponding to the inner electrode and close to the transducer base. The end of the transducer base near the shock wave electrode 41 is made of conductive material.

[0012] Preferably, the imaging assembly further includes a drive shaft seat located within the conduit seat, with the distal end of the drive shaft connected to the transducer seat and the proximal end of the drive shaft connected to the drive shaft seat; the electrode wires and the coaxial cable pass through the transducer seat cavity and the drive shaft cavity, and are connected to the drive shaft seat.

[0013] Preferably, the outer sheath further includes a sound-permeable window tube and a telescopic assembly, the sound-permeable window tube being connected to the distal end of the telescopic assembly, and the transducer seat operating within the sound-permeable window tube.

[0014] Preferably, the acoustic window tube is made of polyethylene, block polyetheramide resin, polyurethane, or polytetrafluoroethylene.

[0015] Preferably, the catheter seat is provided with an injection port, the outer sheath has an injection cavity communicating with the injection port, the distal end of the outer sheath has an outlet hole communicating with the injection cavity, and the outlet hole is provided with a barrier membrane for gas discharge.

[0016] Preferably, the transducer seat is provided with an electrode groove, and the shock wave electrode is installed in the electrode groove. The shock wave electrode includes an inner electrode, an intermediate insulating layer and an outer electrode ring. An electrode hole corresponding to the inner electrode is opened on the intermediate insulating layer, and the electrode hole is located close to the outer electrode ring. The outer electrode ring is a conductive metal ring or a conductive end wall of the electrode groove.

[0017] Preferably, there are multiple pairs of shock wave electrodes, which are respectively installed at the far end and near end of the transducer base.

[0018] This application also provides a medical device, including the intravascular ultrasound imaging catheter, catheter retraction device, and console as described above; the console is equipped with a high-voltage pulse power module; the catheter retraction device is connected to the catheter seat, the console is electrically connected to the catheter retraction device, and the coaxial cable and the electrode wire are connected to the console through the catheter retraction device.

[0019] This application also provides a control method for controlling the medical device described above, comprising:

[0020] S1 controls the insertion of the outer sheath into the blood vessel, and the ultrasound transducer extends to the lesion site for ultrasound imaging detection.

[0021] S2, based on the ultrasound imaging results, adjust the position of the shock wave electrode to send shock waves to the vascular occlusion lesion for treatment.

[0022] S3 uses a catheter retraction device to control the switching of the positions of the shock wave electrode and the ultrasound transducer to evaluate the treatment results.

[0023] S3, if the treatment is not completed, continue to step S2; if the treatment is completed, withdraw the outer sheath.

[0024] The intravascular ultrasound imaging catheter of the present invention combines an intravascular ultrasound system with a shock wave generator by installing a shock wave electrode on the transducer seat. It can perform both intravascular ultrasound imaging diagnosis and shock wave therapy with only one catheter, simplifying the surgical procedure, shortening the operation time, and reducing the surgical cost.

[0025] Furthermore, by connecting an insulating tube with an outer diameter smaller than that of the transducer seat to the distal end of the transducer seat, or by setting an electrode groove in the transducer seat, the outer diameter of the shock wave electrode after installation is made smaller than or equal to the outer diameter of the transducer seat, thus eliminating the need to increase the diameter of the outer sheath tube and not increasing the difficulty of the outer sheath tube entering the blood vessel and working inside the blood vessel.

[0026] Furthermore, by setting multiple pairs of shock wave electrodes and distributing them at the distal and proximal ends of the ultrasound transducer, more shock waves with mechanical properties can be emitted towards the occluded lesion site within the blood vessel, thereby enhancing the effect of shock wave therapy.

[0027] Furthermore, medical equipment and corresponding control methods can be used to further improve the efficiency of diagnosis and treatment of intravascular occlusive lesions. Attached Figure Description

[0028] Figure 1This is a schematic diagram of the structure of the intravascular ultrasound imaging catheter capable of shockwave therapy according to the first embodiment of the present invention;

[0029] Figure 2 yes Figure 1 A schematic diagram of the structure at the distal end of the imaging component and the shock wave generating component;

[0030] Figure 3 yes Figure 2 A structural diagram from a second perspective;

[0031] Figure 4 yes Figure 2 A partial structural diagram of the shock wave generating component;

[0032] Figure 5 This is a schematic diagram of the structure of the intravascular ultrasound imaging catheter capable of shockwave therapy according to the second embodiment of the present invention;

[0033] Figure 6 yes Figure 5 A schematic diagram of the structure at the distal end of the imaging component and the shock wave generating component;

[0034] Figure 7 yes Figure 6 Partial structural cross-sectional diagram;

[0035] Figure 8 yes Figure 6 A structural diagram from a second perspective;

[0036] Figure 9 yes Figure 6 A partial structural diagram of the shock wave generating component;

[0037] Figure 10 This is a schematic diagram of the structure at the distal end of the imaging component and the shock wave generating component according to a preferred embodiment of the present invention.

[0038] Figure label:

[0039] 1. Imaging assembly; 11. Ultrasonic transducer; 12. Transducer mount; 121. Electrode groove; 122. Conductive end wall; 13. Drive shaft; 14. Coaxial cable; 15. Drive shaft mount; 2. Outer sheath; 21. Telescopic assembly; 211. Support tube; 212. Moving tube; 213. Outer tube; 214. Stress relief tube; 22. Acoustic window tube; 23. Tip tube; 24. Injection chamber; 25. Outlet; 26. Imaging ring; 3. Catheter mount; 31. Injection port; 4. Shock wave generating assembly; 41. Shock wave electrode; 411. Inner electrode; 412. Intermediate insulating layer; 413. Outer electrode ring; 414. Electrode hole; 415. Insulating tube; 42. Electrode wire; 421. Intermediate wire; 5. One-way valve; 7. Glue. Detailed Implementation

[0040] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention. Therefore, the following detailed description of the embodiments of the present invention provided in the accompanying drawings is not intended to limit the scope of the claimed invention, but merely to represent selected embodiments of the invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0041] In the description of this invention, it should be understood that the terms "center," "longitudinal," "lateral," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," and "outer," etc., indicating orientation or positional relationships, are based on the orientation or positional relationships shown in the accompanying drawings and are only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this invention. In the description of this invention, unless otherwise stated, "a plurality of" means two or more.

[0042] The specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings.

[0043] Example 1

[0044] Please refer to Figures 1 to 4 An intravascular ultrasound imaging catheter capable of shockwave therapy includes an imaging component 1, an outer sheath 2, and a shockwave generating component 4.

[0045] The imaging assembly 1 includes an ultrasonic transducer 11, a transducer seat 12, a drive shaft 13, and a coaxial cable 14; the imaging assembly 1 is disposed inside the outer sheath 2, and the proximal end of the outer sheath 2 has a catheter seat 3; the shock wave generating assembly 4 includes a shock wave electrode 41 and an electrode wire 42.

[0046] The ultrasonic transducer 11 and the shock wave electrode 41 are mounted on the transducer base 12, which can move axially and rotate circumferentially under the drive of the drive shaft 13. The distal end of the coaxial cable 14 is electrically connected to the ultrasonic transducer 11, and the proximal end extends to the conduit base 3, thereby providing pulse voltage and transmitting electrical signals. The distal end of the electrode wire 42 is electrically connected to the shock wave electrode 41, and the proximal end extends to the conduit base 3, thereby providing pulsed high voltage to the shock wave electrode 41.

[0047] The intravascular ultrasound imaging catheter of the present invention combines an intravascular ultrasound system with a shock wave generator by installing a shock wave electrode 41 on the transducer seat 12. It can perform both intravascular ultrasound imaging diagnosis and shock wave therapy with only one catheter, which simplifies the surgical procedure, shortens the operation time, and reduces the surgical cost.

[0048] The shock wave electrodes 41 may be a single pair, installed on the proximal or distal side of the ultrasound transducer base 12; in this embodiment, there are two pairs of shock wave electrodes 41, respectively installed on the distal and proximal ends of the ultrasound transducer base 12. By providing multiple pairs of shock wave electrodes 41 and distributing them at the distal and proximal ends of the ultrasound transducer base 12, more and wider-ranging shock waves with mechanical properties can be emitted towards the occluded lesion site within the blood vessel, thereby enhancing the effect of shock wave therapy.

[0049] In other embodiments, there may be two or more pairs of shock wave electrodes 41, preferably distributed at the distal and proximal ends of the ultrasonic transducer seat 12, which can further expand the axial treatment area during shock wave therapy.

[0050] In this embodiment, the shock wave electrode 41 includes an inner electrode 411, an intermediate insulating layer 412, and an outer electrode ring 413. The outer electrode ring 413 and the intermediate insulating layer 412 are provided with electrode holes 414 corresponding to the inner electrode 411. The electrode holes 414 can be any shape such as circular, triangular, or rectangular. When the intravascular ultrasound imaging catheter is working, the area where the shock wave electrode 41 is located will be filled with conductive liquid. When the electrode wire 42 transmits a pulsed high voltage to the shock wave electrode 41, the inner electrode 411 will undergo a hydroelectric effect through the electrode hole 414 and the outer electrode ring 413, thereby generating a shock wave.

[0051] In this embodiment, the outer electrode ring 413 is an independent conductive metal ring. Please refer to... Figure 10In a preferred embodiment, the outer electrode ring is the conductive end wall 122 of the electrode groove. This conductive end wall 122 is located on one side wall of the electrode groove and is ring-shaped, functioning as a conductive metal ring. This simplifies the structure and facilitates control of the overall outer diameter of the transducer base 12 on which the shock wave electrodes 41 are mounted. Furthermore, in other preferred embodiments, there is only one pair of shock wave electrodes 41, and the transducer base 12 is entirely made of conductive material, which facilitates manufacturing.

[0052] Please refer to Figure 4 In this embodiment, the shock wave electrode 41 has two inner electrodes 411. The electrode wire 42 includes a positive wire, a negative wire, and an intermediate wire 421. The positive wire is connected to one inner electrode 411 of the first pair of shock wave electrodes 41, and the negative wire is connected to one inner electrode 411 of the first pair of shock wave electrodes 41. The intermediate wire 421 is connected to the other inner electrode 411 of the first pair of shock wave electrodes 41, and the negative wire is connected to the other inner electrode 411 of the first pair of shock wave electrodes 41. This forms a series circuit of positive wire-inner electrode-outer electrode ring-inner electrode-wire-inner electrode-outer electrode-inner electrode-negative wire, which simplifies the circuit structure and increases the shock wave generation location by setting up two inner electrodes 411, thereby increasing the time for simultaneous shock wave treatment and saving surgical time.

[0053] Please refer to Figure 2 and Figure 3 The ultrasonic transducer 11 is installed in the inner cavity of the transducer base 12 using adhesive 7, and the outer diameter of the installed ultrasonic transducer 11 does not exceed the outer diameter of the transducer base 12. The transducer base 12 has an electrode groove 121 for installing the shock wave electrode 41, and the outer diameter of the shock wave electrode 41 is smaller than the outer diameter of the transducer base 12. In other embodiments, the outer diameter of the installed shock wave electrode 41 can also be equal to the outer diameter of the transducer base 12; in other embodiments, the ultrasonic transducer 11 can also be installed in the inner cavity of the transducer base 12 by welding, snap-fitting, or other methods.

[0054] By providing an electrode groove 121 in the transducer seat 12, the outer diameter of the shock wave electrode 41 after installation is made smaller than or equal to the outer diameter of the transducer seat 12, thus eliminating the need to increase the diameter of the outer sheath 2, i.e., the intravascular ultrasound imaging catheter, and thus not increasing the difficulty of the outer sheath 2 entering the blood vessel and working inside the blood vessel.

[0055] The outer sheath tube 2 also includes an acoustic window tube 22 and a telescopic component 21. The acoustic window tube 22 is connected to the distal end of the telescopic component 21. The transducer seat 12 operates inside the acoustic window tube 22. Therefore, the ultrasonic transducer 11 and the shock wave electrode 41 both operate inside the acoustic window tube 22.

[0056] The sound-permeable window tube 22 is made of a material with good sound transmission and biocompatibility, preferably polyethylene (PE) or block polyetheramide resin (PEBAX). These two materials possess good flexibility and biocompatibility while meeting certain sound transmission requirements. Polytetrafluoroethylene (PTFE) can also be used. PTFE is a material with an extremely low coefficient of friction and good chemical stability, and its excellent sound transmission properties make it a suitable material for the sound-permeable window tube 22. In other embodiments, other materials with good sound transmission and biocompatibility, such as special composite materials, can also be used.

[0057] Please refer to Figure 1 The imaging assembly 1 further includes a drive shaft seat 15, which is located inside the conduit seat 3. The distal end of the drive shaft 13 is connected to the transducer seat 12, and the proximal end of the drive shaft 13 is connected to the drive shaft seat 15. The electrode wire 42 and the coaxial cable 14 pass through the inner cavity of the transducer seat 12 and the inner cavity of the drive shaft 13, and are connected to the drive shaft seat 15.

[0058] The telescopic assembly 21 includes a support tube 211, a movable tube 212, an outer tube 213, and a stress-relieving tube 214. The movable tube 212 is slidably sleeved on the outside of the support tube 211, and the outer tube 213 is slidably sleeved on the outside of the movable tube 212. The outer tube 213 is connected to the support tube 211, and the proximal end of the movable tube 212 is connected to the catheter seat 3 to move with the catheter seat 3.

[0059] The catheter seat 3 is provided with an injection port 31, and the outer sheath 2 has an injection chamber 24 that communicates with the injection port 31, so that physiological saline or other conductive liquids that can work in conjunction with the ultrasonic transducer 11 and the shock wave electrode 41 can be injected from the catheter seat 3. In this embodiment, the catheter seat 3 is also equipped with a one-way valve 5.

[0060] The distal end of the outer sheath 2 has an outlet 25 communicating with the injection chamber 24. The outlet 25 is equipped with a barrier membrane for gas discharge. The main function of the outlet 25 is to discharge air from the outer sheath 2. This barrier membrane is made of a special material and can be tightly covered on the outlet 25 by welding, bonding, or welding. The design of the barrier membrane allows air to be discharged while isolating liquid and solid particles. In this way, while discharging air from the outer sheath 2, it can effectively prevent blood from entering the outer sheath 2 through the outlet 25, and prevent physiological saline and solid particles generated by electrode ablation during electrode firing from entering the blood vessel.

[0061] For further details, please refer to... Figure 1The distal end of the outer sheath tube 2 also has a tip tube 23, on which a imaging ring 26 is fitted. The tip tube 23 has a guide wire traction cavity. The guide wire traction cavity has a traction inlet at the distal end of the tip tube 23 and a traction outlet on the side of the tip tube 23. Therefore, it is not necessary to set an inner tube for traction guide wire at the working position of the shock wave electrode 41, which would increase the complexity of the transducer seat 12.

[0062] The present invention also provides a medical device, including an intravascular ultrasound imaging catheter, a catheter retraction device, and a control console as described above; the control console is provided with a high-voltage pulse power supply module; the catheter retraction device is connected to the catheter seat 3, the control console is electrically connected to the catheter retraction device, and the electrode wire 42 and the coaxial cable 14 pass through the inner cavity of the transducer seat 12 and the inner cavity of the drive shaft 13, are connected to the drive shaft seat 15, and are then electrically connected to the control console through the catheter retraction device.

[0063] Thus, during operation, the ultrasonic transducer 11 located inside the acoustic window tube 22 receives electrical signals from the control console. Through electrical stimulation, the piezoelectric crystal in the ultrasonic transducer 11 expands and contracts to generate high-frequency ultrasonic waves. Subsequently, these ultrasonic waves are scattered and reflected at the tissue interface. Some of the reflected ultrasonic waves are converted back into electrical signals by the ultrasonic transducer 11 and transmitted to the control console via the coaxial cable 14. Finally, the imaging engine in the control console analyzes and processes the signals, converting them into grayscale cross-sectional images.

[0064] When using this medical device, first inject physiological saline into the gap between the inner wall of the outer sheath 2 and the outer wall of the imaging component 1 through the injection port 31 on the catheter seat 3 to flush and vent the air. The gas is discharged from the outlet 25 at the distal end of the outer sheath 2. Then, under the guidance of instruments such as guidewires, insert the distal tip of the outer sheath 2 into the blood vessel. When the transducer seat 12 reaches the lesion location, connect the catheter seat 3 to the catheter retraction device. The other end of the catheter retraction device is connected to the control console.

[0065] The catheter retraction device serves as a relay station for electrical signal transmission between the control console and the intravascular ultrasound imaging catheter. Its main function is to drive the imaging component 1 and the shock wave generating component 4 to move axially and rotate circumferentially within the outer sheath 2 via a motor inside the catheter retraction device.

[0066] The present invention also provides a control method for controlling the medical device described above, comprising:

[0067] S1, control the outer sheath 2 to enter the blood vessel, and extend the ultrasound transducer 11 to the lesion site for ultrasound imaging detection.

[0068] S2, based on the ultrasound imaging results, adjust the position of the shock wave electrode 41 to send shock waves to the vascular occlusion lesion for treatment.

[0069] S3, the positions of the shock wave electrode 41 and the ultrasound transducer 11 are controlled by the catheter retraction device to evaluate the treatment results.

[0070] S3, if the treatment is not completed, continue to step S2; if the treatment is completed, withdraw the outer sheath 2.

[0071] By using the control method corresponding to this medical device, the surgical procedure is simplified, the operation time is shortened, and the efficiency of diagnosis and treatment of endovascular occlusive lesions is further improved.

[0072] Example 2

[0073] Please refer to Figures 5 to 8 The difference from Embodiment 1 lies in the structure and installation method of the shock wave electrode 41 of the shock wave generating component 4.

[0074] In this embodiment, the shock wave electrode 41 of the shock wave generating component 4 includes an insulating tube 415 and an inner electrode 411. The outer diameter of the insulating tube 415 is smaller than the outer diameter of the transducer base 12, and the insulating tube 415 is connected to the far end of the transducer base 12.

[0075] In this embodiment, the insulating tube 415 is a tubular material with two axial cavities, and the inner electrode 411 is located within the cavity of the insulating tube 415. The insulating tube 415 can be made of PEEK, PI, ABS, or other insulating materials. The structure of the inner electrode 411 can be varied. In this embodiment, the inner electrode 411 is an electrode wire 42. In other embodiments, the inner electrode 411 can be a stainless steel or other metal tube sleeved on the electrode wire 42. Alternatively, the inner electrode 411 can be formed by flattening a stainless steel tube after it is sleeved on the wire, thus forming a sheet-like inner electrode 411.

[0076] The insulating tube 415 has an electrode hole 414 on its wall corresponding to the inner electrode 411 and near the transducer seat 12. Therefore, in this embodiment, the insulating layer of the electrode wire 42 corresponding to the electrode hole 414 is removed. The transducer seat 12 is made of conductive material at least at the end near the shock wave electrode 41, so that the transducer seat 12 at least at the end near the shock wave electrode 41 functions as an outer electrode and generates a hydroelectric effect with the inner electrode 411.

[0077] Furthermore, the electrode hole 414 can be any shape such as circular, triangular, or rectangular.

[0078] In a further preferred embodiment, the transducer base 12 is made entirely of conductive material. Thus, the wall of the insulating tube 415 serves as the intermediate insulating layer 412, and the transducer base 12 is used as the outer electrode ring. The insulating tube 415 has electrode holes 414 at positions corresponding to the inner electrode 411. The circuit is: positive electrode wire - inner electrode 411 - transducer base - inner electrode 411 - negative electrode wire.

[0079] In other embodiments, the insulating tube 415 can be a multi-cavity structure or a simple tubular structure. The inner electrode 411 is connected to the inner side of the insulating tube 415 by means of bonding, welding, or injection molding. Alternatively, the insulating tube 415 may also have an insulating rod specifically for connecting the inner electrode 411, and the insulating rod may have a groove for placing the inner electrode 411. The structure of the insulating tube 415 is not limited here, as long as it can realize the shock wave electrode function of the inner electrode 411-insulating tube 415-transducer seat 12.

[0080] The above are merely preferred embodiments of the present invention. The scope of protection of the present invention is not limited to the above embodiments. All technical solutions that fall within the scope of the present invention are within the scope of protection of the present invention.

Claims

1. An intravascular ultrasound imaging catheter capable of performing shockwave therapy, characterized in that, include, Imaging components include an ultrasonic transducer, a transducer mount, a drive shaft, and a coaxial cable; An outer sheath, wherein the imaging component is disposed within the outer sheath, and the proximal end of the outer sheath has a catheter seat; Shock wave generating assembly, including shock wave electrodes and electrode wires; The ultrasonic transducer and the shock wave electrode are mounted on the transducer base; the distal end of the coaxial cable is electrically connected to the ultrasonic transducer, and the proximal end extends to the conduit base; the distal end of the electrode wire is electrically connected to the shock wave electrode, and the proximal end extends to the conduit base. The shock wave electrode is coaxially arranged with the transducer base, and the outer diameter of the shock wave electrode is not greater than the outer diameter of the transducer base. The transducer base is provided with an electrode groove, and the shock wave electrode is installed in the electrode groove. The shock wave electrode includes an inner electrode, an intermediate insulating layer, and an outer electrode ring. An electrode hole corresponding to the inner electrode is opened on the intermediate insulating layer, and the electrode hole is located close to the outer electrode ring. The outer electrode ring is the conductive end wall of the electrode groove. Alternatively, the shock wave electrode includes an insulating tube and an inner electrode. The outer diameter of the insulating tube is smaller than the outer diameter of the transducer base. The insulating tube is connected to the far end of the transducer base. The inner electrode is located inside the insulating tube, and the tube wall of the insulating tube is provided with an electrode hole corresponding to the inner electrode and close to the transducer base. The end of the transducer base close to the shock wave electrode is made of conductive material.

2. The intravascular ultrasound imaging catheter capable of shockwave therapy according to claim 1, characterized in that, The imaging assembly further includes a drive shaft seat located within the conduit seat. The distal end of the drive shaft is connected to the transducer seat, and the proximal end of the drive shaft is connected to the drive shaft seat. The electrode wires and the coaxial cable pass through the transducer seat cavity and the drive shaft cavity, and are connected to the drive shaft seat.

3. The intravascular ultrasound imaging catheter capable of shockwave therapy according to claim 1, characterized in that, The outer sheath also includes a sound-permeable window tube and a telescopic assembly. The sound-permeable window tube is connected to the distal end of the telescopic assembly, and the transducer seat operates inside the sound-permeable window tube. The sound-permeable window tube is made of polyethylene, block polyether amide resin, polyurethane, or polytetrafluoroethylene.

4. The intravascular ultrasound imaging catheter capable of shockwave therapy according to claim 1, characterized in that, The catheter seat is provided with an injection port, the outer sheath has an injection cavity connected to the injection port, the distal end of the outer sheath has an outlet hole connected to the injection cavity, and the outlet hole is provided with a barrier membrane for gas discharge.

5. The intravascular ultrasound imaging catheter capable of shockwave therapy according to claim 1, characterized in that, The shock wave electrodes are in multiple pairs and are respectively installed at the far end and near end of the transducer base.

6. A medical device, characterized in that, The device includes an intravascular ultrasound imaging catheter, a catheter retraction device, and a control console as described in any one of claims 1 to 5; the control console is equipped with a high-voltage pulse power supply module; the catheter retraction device is connected to the catheter seat, the control console is electrically connected to the catheter retraction device, and the coaxial cable and the electrode wire are connected to the control console through the catheter retraction device.

Images