Intravascular ultrasonic imaging catheter capable of performing shock wave treatment, medical equipment and control method

Abstract

The invention provides an intravascular ultrasonic imaging catheter capable of performing shock wave therapy, medical equipment and a control method, the intravascular ultrasonic imaging catheter comprises an imaging assembly, an outer sheath tube and a shock wave generating assembly, and the imaging assembly comprises an ultrasonic transducer, a transducer seat, a driving shaft and a coaxial cable; the imaging assembly is arranged in the outer sheath tube, and a catheter seat is arranged at the near end of the outer sheath tube; the shock wave generating assembly comprises a shock wave electrode and an electrode wire. The ultrasonic transducer and the shock wave electrode are mounted on the transducer seat; the far end of the coaxial cable is electrically connected with the ultrasonic transducer, and the near end of the coaxial cable extends to the catheter seat; the far end of the electrode wire is electrically connected with the shock wave electrode, and the near end of the electrode wire extends to the catheter base. The intravascular ultrasonic system is combined with the shock wave generating device, and two operations of intravascular ultrasonic imaging diagnosis and shock wave treatment can be completed by only one catheter, so that the surgical operation process is simplified, the surgical time is shortened, and the surgical cost is reduced.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an intravascular ultrasonic imaging catheter capable of performing shock wave therapy, a medical device and a control method. Background Art

[0002] When calcification occurs in blood vessels, the current main conventional practice is to first use an intravascular ultrasound catheter to diagnose intravascular calcification lesions. Intravascular ultrasound (IVUS) uses catheter technology to send a miniature ultrasound probe into the blood vessel cavity, and through sound wave scanning and reflection, it provides images of the blood vessel cavity in the body. It can clearly show the thickness of the vessel wall structure, the size and shape of the lumen, etc., accurately measure the blood vessel cavity diameter and cross-sectional area, and can even identify calcification, fibrosis and other lesions.

[0003] In the treatment of intravascular calcification, the shock wave balloon catheter using the hydro-electric effect can achieve good treatment results. The hydro-electric effect is that under the action of a high-voltage strong electric field, the electrons in the liquid between the electrodes are accelerated and ionize the liquid molecules near the electrodes. The ionized electrons in the liquid will be accelerated by the strong electric field between the electrodes to ionize more electrons, forming an electron avalanche. A plasma channel is formed in the area where the liquid molecules are ionized. As the ionization area expands, the liquid is broken down, forming a discharge channel between the electrodes. After the discharge channel is generated, a large discharge current will be generated due to the small discharge resistance. The discharge current heats the liquid around the discharge channel, causing the liquid to cavitate and produce bubbles, which collapse instantly to produce shock waves. This achieves the purpose of breaking up calcified lesions without causing damage to the vascular endothelium.

[0004] However, the current diagnosis and treatment of intravascular occlusive lesions are performed separately. The diagnosis of intravascular calcification lesions is performed first, and then the shock wave balloon catheter is used for treatment. The IVUS catheter needs to be pushed to the lesion site for intravascular ultrasound imaging, and then the IVUS catheter is withdrawn from the blood vessel. The shock wave balloon catheter is then inserted into the blood vessel and pushed to the lesion site for dilation treatment. The IVUS catheter needs to be inserted into the blood vessel to evaluate the treatment effect. The entire surgical process is relatively complicated, the operation time is long, and a variety of different instruments are required, and the cost of the operation is high.

[0005] In view of this, this application is filed. Summary of the invention

[0006] The present invention provides an intravascular ultrasonic imaging catheter, medical equipment and control method capable of performing shock wave therapy, so as to solve at least one of the above technical problems.

[0007] An intravascular ultrasonic imaging catheter capable of performing shock wave therapy comprises an imaging component, an outer sheath tube and a shock wave generating component.

[0008] The imaging component comprises an ultrasonic transducer, a transducer seat, a driving shaft and a coaxial cable; the imaging component is arranged in the outer sheath tube, and the proximal end of the outer sheath tube is provided with a catheter seat; the shock wave generating component comprises a shock wave electrode and an electrode wire.

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

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

[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 seat, the insulating tube is connected to the distal end of the transducer seat, the inner electrode is located on the inner side of the insulating tube, and the tube wall of the insulating tube corresponds to the inner electrode and is provided with an electrode hole near the transducer seat, and the end of the transducer seat near the shock wave electrode 41 is made of conductive material.

[0012] Preferably, the imaging assembly also includes a drive shaft seat, the drive shaft seat is located in the catheter 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 wire and the coaxial cable pass through the inner cavity of the transducer seat and the inner cavity of the drive shaft and are connected to the drive shaft seat.

[0013] Preferably, the outer sheath tube further comprises a sound-transmitting window tube and a telescopic assembly, the sound-transmitting window tube is connected to the distal end of the telescopic assembly, and the transducer seat works in the sound-transmitting window tube.

[0014] Preferably, the sound-transmitting 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 tube has an injection cavity connected to the injection port, the distal end of the outer sheath tube has a liquid outlet connected to the injection cavity, and the liquid outlet is provided with a barrier membrane for gas discharge.

[0016] Preferably, the transducer seat is provided with an electrode groove, 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, the intermediate insulating layer is provided with an electrode hole corresponding to the inner electrode, and the electrode hole is arranged close to the outer electrode ring, and 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 distal end and the proximal end of the transducer seat.

[0018] The present application also provides a medical device, comprising the intravascular ultrasound imaging catheter, catheter retraction device and console as described above; a high-voltage pulse power supply module is provided in the console; 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] The present application also provides a control method for controlling the medical device as described above, comprising:

[0020] S1, control the outer sheath to pass into the blood vessel, extend the ultrasonic transducer to the lesion, and perform ultrasonic imaging detection.

[0021] S2, according to the ultrasonic imaging detection results, adjust the position of the shock wave electrode to send shock waves to the vascular occlusion lesion for treatment.

[0022] S3, the position of the shock wave electrode and ultrasound transducer is switched by controlling the catheter retraction device to evaluate the treatment results.

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

[0024] The intravascular ultrasound imaging catheter of the present invention combines the intravascular ultrasound system with the shock wave generating device by installing a shock wave electrode on the transducer seat. Both intravascular ultrasound imaging diagnosis and shock wave therapy can be completed with only one catheter, thereby simplifying the surgical operation process, shortening the operation time, and reducing the surgical cost.

[0025] Furthermore, by connecting an insulating tube whose outer diameter is smaller than that of the transducer seat at the distal end of the transducer seat or providing an electrode groove at the transducer seat, the outer diameter of the shock wave electrode after installation is smaller than or equal to the outer diameter of the transducer seat, thereby eliminating the need to increase the diameter of the outer sheath tube and increasing the difficulty of the outer sheath tube entering the blood vessel and working in the blood vessel.

[0026] Furthermore, by providing multiple pairs of shock wave electrodes and distributing them at the distal and proximal ends of the ultrasonic transducer, more shock waves with mechanical properties can be emitted to the location of the occluded lesion in the blood vessel, thereby enhancing the effect of shock wave therapy.

[0027] Furthermore, the efficiency of diagnosis and treatment of intravascular occlusive lesions is further improved through medical equipment and corresponding control methods. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1It is a schematic structural diagram of an intravascular ultrasound imaging catheter capable of performing shock wave therapy according to a first embodiment of the present invention;

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

[0030] Figure 3 yes Figure 2 A schematic diagram of the structure of the second perspective;

[0031] Figure 4 yes Figure 2 A schematic diagram of a portion of the structure of a shock wave generating assembly;

[0032] Figure 5 is a schematic structural diagram of an intravascular ultrasound imaging catheter capable of performing shock wave therapy according to a second embodiment of the present invention;

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

[0034] Figure 7 yes Figure 6 A schematic cross-sectional view of a part of the structure;

[0035] Figure 8 yes Figure 6 A schematic diagram of the structure of the second perspective;

[0036] Fig. 9 yes Figure 6 A schematic diagram of a portion of the structure of a shock wave generating assembly;

[0037] Fig.10 It is a schematic structural diagram of the distal end of the imaging component and the shock wave generating component of a preferred embodiment of the present invention.

[0038] Reference numerals:

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

[0040] In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, rather than all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work 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 drawings is not intended to limit the scope of the invention claimed for protection, but merely represents the selected embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present invention.

[0041] In the description of the present invention, it should be understood that the terms "center", "longitudinal", "lateral", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside" and the like indicating orientations or positional relationships are based on the orientations or positional relationships shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. In the description of the present invention, unless otherwise specified, "plurality" means two or more.

[0042] The specific embodiments of the present invention are 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 performing shock wave therapy comprises an imaging component 1, an outer sheath tube 2 and a shock wave generating component 4.

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

[0046] The ultrasonic transducer 11 and the shock wave electrode 41 are installed on the transducer seat 12, and the transducer seat 12 can move axially and rotate circumferentially under the drive of the driving 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 catheter seat 3, thereby providing a pulse voltage and transmitting an electrical signal; the distal end of the electrode wire 42 is electrically connected to the shock wave electrode 41, and the proximal end extends to the catheter seat 3, thereby providing a pulse high voltage to the shock wave electrode 41.

[0047] The intravascular ultrasound imaging catheter of the present invention combines the intravascular ultrasound system with the shock wave generating device by installing the shock wave electrode 41 on the transducer seat 12. Both intravascular ultrasound imaging diagnosis and shock wave therapy can be completed with only one catheter, thereby simplifying the surgical operation process, shortening the operation time, and reducing the surgical cost.

[0048] The shock wave electrodes 41 may be provided in a pair, which are installed at the proximal or distal end of the ultrasonic transducer seat 12. In the present embodiment, the shock wave electrodes 41 are provided in two pairs, which are installed at the distal end and the proximal end of the ultrasonic transducer seat 12. By providing multiple pairs of shock wave electrodes 41 and distributing them at the distal end and the proximal end of the ultrasonic transducer seat 12, more shock waves with mechanical properties can be emitted to the occluded lesions in the blood vessels over a wider area, thereby enhancing the effect of shock wave therapy.

[0049] In other embodiments, there may be more than two 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 treatment.

[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, rectangular, etc. 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 produce a liquid-electric 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. Fig.10In a preferred embodiment, the outer electrode ring is a conductive end wall 122 of the electrode groove. The conductive end wall 122 is a side wall of the electrode groove and is in a ring shape, which can play a role equivalent to a conductive metal ring, thereby simplifying the structure and facilitating the control of the overall outer diameter of the transducer seat 12 on which the shock wave electrode 41 is installed. Further, in other preferred embodiments, there is only one pair of shock wave electrodes 41, and the transducer seat 12 is made of a conductive material as a whole, which is easy to manufacture.

[0052] Please refer to Figure 4 In this embodiment, the shock wave electrode 41 has two inner electrodes 411, and the electrode wire 42 includes a positive wire, a negative wire and an intermediate wire 421. The positive wire is connected to an inner electrode 411 of the first pair of shock wave electrodes 41, and the negative wire is connected to an 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; thus, a series circuit of positive wire-inner electrode-outer electrode ring-inner electrode-wire-inner electrode-outer electrode-inner electrode-negative wire is formed, which simplifies the circuit structure and increases the shock wave generating site through the setting of the double inner electrodes 411, thereby increasing the time for shock wave treatment at the same time and saving operation time.

[0053] Please refer to Figure 2 and Figure 3 , the ultrasonic transducer 11 is installed in the inner cavity in the middle of the transducer seat 12 by glue 7, and the outer diameter of the ultrasonic transducer 11 after installation does not exceed the outer diameter of the transducer seat 12. The transducer seat 12 is provided with 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 seat 12. In other embodiments, the outer diameter of the installed shock wave electrode 41 may also be equal to the outer diameter of the transducer seat 12; in other embodiments, the ultrasonic transducer 11 may also be installed in the inner cavity in the middle of the transducer seat 12 by welding, clamping, etc.

[0054] Therefore, by setting the electrode groove 121 in the transducer seat 12, the outer diameter of the shock wave electrode 41 after installation is less than or equal to the outer diameter of the transducer seat 12, so that there is no need to increase the diameter of the outer sheath 2, that is, the intravascular ultrasound imaging catheter, thereby increasing the difficulty of the outer sheath 2 entering the blood vessel and working in the blood vessel.

[0055] The outer sheath tube 2 also includes a sound-transmitting window tube 22 and a telescopic assembly 21 . The sound-transmitting window tube 22 is connected to the distal end of the telescopic assembly 21 . The transducer seat 12 works in the sound-transmitting window tube 22 . Therefore, the ultrasonic transducer 11 and the shock wave electrode 41 both work in the sound-transmitting window tube 22 .

[0056] The material of the sound-transmitting window tube 22 is a material with good sound permeability and biocompatibility, preferably polyethylene (PE) and block polyetheramide resin (PEBAX), which have good flexibility and biocompatibility and can meet certain sound permeability requirements. It can also be polytetrafluoroethylene (PTFE), which is a material with extremely low friction coefficient and good chemical stability. Its excellent sound permeability makes it the material of the sound-transmitting window tube 22. In other embodiments, it can also be other materials with good sound permeability and biocompatibility, such as special composite materials.

[0057] Please refer to Figure 1 The imaging assembly 1 also includes a drive shaft seat 15, which is located in the catheter 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 relief tube 214. The movable tube 212 is slidably sleeved on the outer side of the support tube 211, and the outer tube 213 is slidably sleeved on the outer side 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 a liquid injection port 31, and the outer sheath 2 has a liquid injection cavity 24 connected to the liquid injection port 31, so that physiological saline or other conductive liquids that can cooperate 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 provided with a one-way valve 5.

[0060] The distal end of the outer sheath tube 2 has a liquid outlet 25 connected to the injection cavity 24. The liquid outlet 25 is provided with a barrier film for gas discharge. The main function of the liquid outlet 25 is to discharge the air in the outer sheath tube 2. This barrier film is made of special materials and can be tightly covered on the liquid outlet 25 by welding, bonding or welding. The design of the barrier film enables it to discharge air while isolating liquid and solid particles. In this way, while discharging the air in the outer sheath tube 2, it can effectively prevent the blood in the blood vessel from entering the outer sheath tube 2 through the liquid outlet 25, and prevent the physiological saline in the outer sheath tube 2 and the solid particles generated by the electrode ablation when the electrode is fired from entering the blood vessel.

[0061] For further information, please refer to Figure 1The distal end of the outer sheath tube 2 also has a tip tube 23, on which a developing ring 26 is sleeved, and the tip tube 23 has a guide wire traction cavity, which has a traction inlet at the distal end of the tip tube 23 and a traction outlet at the side of the tip tube 23, thereby eliminating the need to set an inner tube for traction of the guide wire at the working position of the shock wave electrode 41, thereby increasing the complexity of the transducer seat 12.

[0062] The present invention also provides a medical device, comprising the intravascular ultrasound imaging catheter, catheter retraction device and console as described above; a high-voltage pulse power supply module is provided in the console; the catheter retraction device is connected to the catheter seat 3, the 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 then are electrically connected to the console through the catheter retraction device.

[0063] Thus, when working, the ultrasonic transducer 11 located in the sound-transmitting window tube 22 receives electrical signals from the console, and through electrical stimulation, the piezoelectric crystals in the ultrasonic transducer 11 expand and contract to generate high-frequency ultrasonic waves, which are then scattered and reflected at the tissue interface. Part of the reflected ultrasonic waves are converted back into electrical signals by the ultrasonic transducer 11, transmitted to the console through the coaxial cable 14, and finally analyzed and processed by the imaging engine in the console and converted into a grayscale cross-sectional image.

[0064] When the medical device is in use, physiological saline is first injected into the gap between the inner wall of the lumen of the outer sheath tube 2 and the outer wall of the imaging component 1 through the injection port 31 on the catheter seat 3 to flush and exhaust the gas, and the gas is discharged from the liquid outlet 25 at the distal end of the outer sheath tube 2. Then, under the guidance of a guide wire or other instrument, the distal end of the outer sheath tube 2 is inserted into the blood vessel. When the transducer seat 12 reaches the lesion location, the catheter seat 3 is then connected to the catheter withdrawal device, and the other end of the catheter withdrawal device is connected to the console.

[0065] While the catheter retraction device serves as a relay station for the transmission of electrical signals between the 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 in the inner cavity of the outer sheath 2 through the motor in the catheter retraction device.

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

[0067] S1, control the outer sheath 2 to pass into the blood vessel, extend the ultrasonic transducer 11 to the lesion, and perform ultrasonic imaging detection.

[0068] S2, according to the ultrasonic imaging detection result, adjusting the position of the shock wave electrode 41 to send shock waves to the vascular occlusion lesion for treatment.

[0069] S3, controlling the switching of the positions of the shock wave electrode 41 and the ultrasonic transducer 11 through the catheter withdrawal device to evaluate the treatment results.

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

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

[0072] Example 2

[0073] Please refer to Figures 5 to 8 , which is different from Example 1 in the structure and installation method of the shock wave electrode 41 of the shock wave generating assembly 4.

[0074] In this embodiment, the shock wave electrode 41 of the shock wave generating assembly 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 seat 12 . The insulating tube 415 is connected to the distal end of the transducer seat 12 .

[0075] In this embodiment, the insulating tube 415 is a tube made of insulating material with two axial cavities, and the inner electrode 411 is located in the cavity of the insulating tube 415; the material of the insulating tube 415 can be PEEK, PI, ABS or other insulating materials. The structure of the inner electrode 411 can be various. In this embodiment, the inner electrode 411 is the electrode wire 42. In other embodiments, the inner electrode 411 can be a metal tube such as stainless steel sleeved on the electrode wire 42, and the inner electrode 411 can also be a stainless steel tube sleeved on the wire and then flattened to form a sheet-shaped inner electrode 411.

[0076] The tube wall of the insulating tube 415 corresponds to the inner electrode 411 and is provided with an electrode hole 414 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, and at least one end of the transducer seat 12 close to the shock wave electrode 41 is made of conductive material, so that at least one end of the transducer seat 12 close to the shock wave electrode 41 plays the function of an external electrode and generates a liquid-electric effect with the inner electrode 411.

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

[0078] Further preferably, the transducer seat 12 is made of conductive material as a whole. Thus, the wall of the insulating tube 415 serves as the intermediate insulating layer 412, the transducer seat 12 serves as the outer electrode ring, and 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 seat-inner electrode 411-negative electrode wire.

[0079] In other embodiments, the insulating tube 415 may also be a multi-cavity structure or a simple tubular structure, and the inner electrode 411 is connected to the inner side of the insulating tube 415 by bonding, welding or injection molding, or an insulating rod dedicated to connecting the inner electrode 411 is provided in the insulating tube 415, and further, the insulating rod is provided with a groove for placing the inner electrode 411. The structure of the insulating tube 415 is not limited here, and it only needs to realize the shock wave electrode function of the inner electrode 411-insulating tube 415-transducer seat 12.

[0080] The above are only preferred implementations of the present invention. The protection scope of the present invention is not limited to the above embodiments. All technical solutions under the concept of the present invention belong to the protection scope of the present invention.

Claims

1. An intravascular ultrasound imaging catheter capable of performing shock wave therapy, characterized in that: include, an imaging assembly, including an ultrasound transducer, a transducer mount, a drive shaft, and a coaxial cable; An outer sheath tube, wherein the imaging assembly is disposed inside the outer sheath tube, and a catheter seat is provided at the proximal end of the outer sheath tube; A shock wave generating assembly, including a shock wave electrode and an electrode wire; The ultrasonic transducer and the shock wave electrode are installed on the transducer seat; the distal end of the coaxial cable is electrically connected to the ultrasonic transducer, and the proximal end extends to the catheter seat; the distal end of the electrode wire is electrically connected to the shock wave electrode, and the proximal end extends to the catheter seat.

2. The intravascular ultrasound imaging catheter capable of shock wave therapy according to claim 1, characterized in that: The shock wave electrode is coaxially arranged with the transducer seat, and the outer diameter of the shock wave electrode is not greater than the outer diameter of the transducer seat.

3. The intravascular ultrasound imaging catheter capable of shock wave therapy according to claim 2, characterized in that: 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 seat. The insulating tube is connected to the distal end of the transducer seat. The inner electrode is located on the inner side of the insulating tube. The tube wall of the insulating tube corresponds to the inner electrode and is provided with an electrode hole near the transducer seat. One end of the transducer seat near the shock wave electrode is made of conductive material.

4. The intravascular ultrasound imaging catheter capable of shock wave therapy according to claim 3, characterized in that: The imaging assembly also includes a drive shaft seat, which is located in the catheter 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 wire and the coaxial cable pass through the inner cavity of the transducer seat and the inner cavity of the drive shaft and are connected to the drive shaft seat.

5. The intravascular ultrasound imaging catheter capable of shock wave therapy according to claim 1, characterized in that: The outer sheath tube also includes a sound-transmitting window tube and a telescopic component. The sound-transmitting window tube is connected to the distal end of the telescopic component, and the transducer seat works in the sound-transmitting window tube. The sound-transmitting window tube is made of polyethylene, block polyetheramide resin, polyurethane or polytetrafluoroethylene.

6. The intravascular ultrasound imaging catheter capable of shock wave therapy according to claim 1, characterized in that: The catheter seat is provided with a liquid injection port, the outer sheath tube has a liquid injection cavity connected to the liquid injection port, the distal end of the outer sheath tube has a liquid outlet connected to the liquid injection cavity, and the liquid outlet is provided with a barrier membrane for gas discharge.

7. The intravascular ultrasound imaging catheter capable of shock wave therapy according to claim 2, characterized in that: 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. The intermediate insulating layer is provided with an electrode hole corresponding to the inner electrode, and the electrode hole is arranged close to the outer electrode ring. The outer electrode ring is a conductive metal ring or a conductive end wall of the electrode groove.

8. The intravascular ultrasound imaging catheter capable of shock wave therapy according to claim 7, characterized in that: There are multiple pairs of shock wave electrodes, which are respectively installed at the distal end and the proximal end of the transducer seat.

9. A medical device, characterized in that: It comprises an intravascular ultrasound imaging catheter, a catheter withdrawal device and a console as described in any one of claims 1 to 8; a high-voltage pulse power supply module is provided in the console; the catheter withdrawal device is connected to the catheter seat, the console is electrically connected to the catheter withdrawal device, and the coaxial cable and the electrode wire are connected to the console through the catheter withdrawal device.

10. A control method, characterized in that: For controlling the medical device as claimed in claim 9, comprising: S1, control the outer sheath to pass into the blood vessel, extend the ultrasonic transducer to the lesion, and perform ultrasonic imaging detection; S2, according to the ultrasonic imaging detection results, adjusting the position of the shock wave electrode to send shock waves to the vascular occlusive lesion for treatment; S3, the position of the shock wave electrode and ultrasound transducer is switched by controlling the catheter withdrawal device to evaluate the treatment results; S3, if the treatment is not completed, continue with step S2, if the treatment is completed, withdraw the outer sheath.

Images