An ultrasonic-shockwave therapy system

Abstract

The application provides an ultrasonic-shock wave treatment system, which comprises an interventional catheter, a liquid supply assembly and a control assembly, the interventional catheter is internally provided with a shock wave excitation source and a micro ultrasonic transducer, the shock wave excitation source and the micro ultrasonic transducer are adapted to be connected with an external power supply; the liquid supply assembly is communicated with the interventional catheter to deliver liquid into the interventional catheter; the control assembly is connected with the liquid supply assembly, the shock wave excitation source and the micro ultrasonic transducer; wherein the control assembly controls the working time sequence of the liquid supply assembly, the shock wave excitation source and the micro ultrasonic transducer, so as to control the liquid supply assembly to replace the liquid in the interventional catheter after the shock wave excitation source completes single excitation, and the liquid in the interventional catheter is updated after the shock wave excitation source completes single excitation, so that a large number of microbubbles generated due to liquid-electric effect can be removed, and the strength of subsequent shock waves can be prevented from being reduced by the large number of microbubbles; meanwhile, the transducer is excited to emit ultrasonic waves after the shock wave completes single excitation, so that the related treatment effect can be further improved.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more specifically to an ultrasound-shockwave therapy system. Background Technology

[0002] Currently, the main difficulties in removing stones such as urinary tract stones, kidney stones, and gallstones through natural cavities are that larger stones are difficult to pass through natural cavities, large stones are difficult to break up using interventional catheters, tissues are easily damaged, and the breaking up of calcifications inside and outside blood vessels can damage the blood vessel walls, resulting in poor treatment effects on heart valve calcification.

[0003] Currently, ballistic lithotripsy and holmium laser lithotripsy are commonly used to break up stones. Ballistic lithotripsy catheters are large and have low stone-breaking efficiency, and have a greater impact on patients. Holmium laser lithotripsy uses high-energy lasers to break up stones, but it can easily cause tissue damage. However, by taking advantage of the fact that shock waves have little impact on soft tissues and can break up hard plaques, an interventional catheter can be delivered to the lesion through natural cavities, and shock waves can be generated from inside the body to break up stones efficiently and safely.

[0004] However, since the excitation of the electrohydraulic effect is always accompanied by the generation of a large number of microbubbles, and the microbubbles will always exist in the propagation path of the shock wave, when the next shock wave arrives, the microbubbles will have significant scattering and reflection phenomena on the shock wave, which will reduce the intensity of the shock wave reaching the lesion. At the same time, the microbubbles will also absorb the energy of the shock wave, causing them to oscillate and break down continuously, which will also reduce the intensity of the shock wave. Summary of the Invention

[0005] Therefore, the technical problem to be solved by the present invention is that in the prior art, the excitation of the electrohydraulic effect is always accompanied by the generation of a large number of microbubbles, and the microbubbles will always exist in the propagation path of the shock wave. When the next shock wave arrives, the microbubbles will have significant scattering and reflection phenomena on the shock wave, which reduces the intensity of the shock wave reaching the lesion. At the same time, the microbubbles will also absorb the energy of the shock wave, causing them to oscillate and break down continuously, which will also reduce the intensity of the shock wave.

[0006] Therefore, the present invention provides an ultrasound-shockwave therapy system, comprising:

[0007] An interventional catheter is provided with a shock wave excitation source, which is adapted to be connected to an external power source.

[0008] A fluid supply assembly, connected to the interventional catheter, for delivering fluid into the interventional catheter;

[0009] The control component is connected to the liquid supply component and the shock wave excitation source;

[0010] The control component controls the working sequence of the liquid supply component and the shock wave excitation source, so that after the shock wave excitation source has completed a single excitation, the liquid supply component is controlled to replace the liquid in the interventional catheter.

[0011] Optionally, the interventional catheter is further provided with a transducer, which is connected to the control component, and the transducer operates after the shock wave excitation source is activated, and the liquid supply component replaces the liquid in the interventional catheter after the transducer is activated.

[0012] Optionally, the intensity of the ultrasonic waves excited by the transducer is less than the intensity of the shock waves excited by the shock wave excitation source, so as to treat hard plaques and improve the efficiency of cellular drug absorption.

[0013] Optionally, the intensity of the ultrasonic waves excited by the transducer is greater than the intensity of the shock waves excited by the shock wave excitation source, so as to treat soft plaques and promote cell and tissue regeneration.

[0014] Optionally, the interventional catheter further includes a guidewire sheath, which has a through hole along its length, and the through hole is adapted to insert a guidewire; a liquid outlet pipe and a liquid inlet pipe are provided between the surface of the guidewire sheath and the sidewall of the through hole, and the liquid outlet pipe and the liquid inlet pipe are both connected to the liquid supply assembly.

[0015] Optionally, the guidewire sheath surface is provided with an inlet and an outlet, the inlet is connected to the inlet pipe, the outlet is connected to the outlet pipe, and the inlet and outlet are located on opposite sides of the guidewire sheath surface.

[0016] Optionally, the interventional catheter further includes a wrapping and fixing layer, which is sleeved on the surface of the guidewire sheath. The transducer and the shock wave excitation source are disposed between the surface of the guidewire sheath and the wrapping and fixing layer, and are insulated from each other.

[0017] Optionally, the wrapping and fixing layer is provided with a through groove, the through groove is located at the liquid inlet and the area of ​​the through groove is larger than the area of ​​the liquid inlet, and the shock wave excitation source is located at the liquid inlet.

[0018] Optionally, the liquid supply assembly includes:

[0019] Hydraulic pump;

[0020] Liquid supply pump;

[0021] A three-position three-way solenoid valve, with its two inlet ends connected to the hydraulic pump and the supply pump respectively, and its outlet end connected to the inlet of the interventional catheter.

[0022] The solenoid valve is connected to the fluid outlet of the interventional catheter;

[0023] The hydraulic pump is connected to the interventional catheter via the three-position three-way solenoid valve to ensure the pressure inside the interventional catheter; the fluid supply pump is connected to the interventional catheter via the three-position three-way solenoid valve to deliver fluid into the interventional catheter.

[0024] Optionally, the control component includes a timing controller to control the operating timing of the transducer, the shock wave excitation source, and the liquid supply component.

[0025] The ultrasonic-shockwave therapy system provided by this invention has the following advantages:

[0026] 1. This invention provides an ultrasound-shockwave therapy system, comprising an interventional catheter, a fluid supply component, and a control component. The interventional catheter contains a shockwave excitation source adapted to be connected to an external power source. The fluid supply component is connected to the interventional catheter to deliver fluid into the interventional catheter. The control component is connected to the fluid supply component and the shockwave excitation source. The control component controls the operating sequence of the fluid supply component and the shockwave excitation source, so that after the shockwave excitation source completes a single excitation, it controls the fluid supply component to replace the fluid in the interventional catheter.

[0027] This ultrasound-shockwave therapy system, through the connection of a liquid supply component to the interventional catheter and a control component to the liquid supply component and the shockwave excitation source, controls the working sequence of the liquid supply component and the shockwave excitation source. After the shockwave excitation source completes a single excitation, the control component controls the liquid supply component to replace the fluid in the interventional catheter. By updating the fluid in the interventional catheter after the shockwave excitation source completes a single excitation, a large number of microbubbles generated by the electrohydraulic effect can be cleared, thus preventing a large number of microbubbles from reducing the intensity of subsequent shockwaves.

[0028] 2. The present invention provides an ultrasound-shockwave therapy system, wherein the interventional catheter is further provided with a transducer, the transducer is connected to the control component, and the transducer operates after the shockwave excitation source is excited, and the liquid supply component replaces the liquid in the interventional catheter after the transducer is excited.

[0029] Although the microbubbles in this ultrasound-shockwave therapy system significantly affect the intensity of the next shockwave, they can also lower the cavitation threshold of the area where the microbubbles are located. Cavitation activity can significantly promote the further fragmentation of hard and soft plaques. Therefore, the cavitation threshold can be lowered using microbubbles before they are removed, and then low-intensity ultrasound can be used to induce the cavitation effect, further improving the efficiency of lesion destruction.

[0030] 3. The present invention provides an ultrasound-shockwave therapy system, wherein the intensity of the ultrasound waves excited by the transducer is less than the intensity of the shock waves excited by the shockwave excitation source, so as to treat hard plaques and improve the efficiency of cell absorption of drugs.

[0031] This ultrasound-shockwave therapy system, when treating hard plaques such as mid-to-late stage vascular calcification and various stones, uses shockwaves as the primary physical agent, requiring high-intensity shockwaves (>0.25 mJ / mm²). 2 The timing controller prioritizes triggering the Marx boost circuit, followed by a 1-100ms delay before triggering the power amplifier, ensuring that the ultrasound always lags behind the shock wave excitation. At this point, the ultrasound interacts with the microbubbles generated by the electrohydraulic effect, inducing cavitation and enhancing the therapeutic effect of the shock wave.

[0032] 4. The present invention provides an ultrasound-shockwave therapy system, wherein the intensity of the ultrasound excited by the transducer is greater than the intensity of the shockwave excited by the shockwave excitation source, for the treatment of soft plaques.

[0033] This ultrasound-shockwave therapy system, when treating soft plaques such as early vascular calcification and thrombosis, uses ultrasound as the primary physical agent, requiring a high-intensity ultrasound output (MI>0.5) and a reduced intensity (<0.25 mJ / mm²). 2 The shock wave is applied, and the timing controller needs to prioritize triggering the power amplifier. Based on actual needs, a low-intensity shock wave is selected to enhance the treatment of soft plaques, and the Marx boost circuit needs to provide a low voltage (<1.5kV) and a low duty cycle (<50%). In this case, the shock wave serves as an adjunct therapy, capable of disrupting the hemoglobin fibrillary network and calcification deposits within the soft plaque, thereby increasing the ablation rate of the ultrasound.

[0034] 5. This invention provides an ultrasound-shockwave therapy system that uses low-intensity shockwaves (<0.11 mJ / mm²) when it is necessary to promote the recovery of damaged tissue. 2 The primary method involves continuously stimulating the damaged tissue with high PRF (>1Hz). In some cases, high-intensity, short-pulse ultrasound can also be used to promote tissue absorption of the drug. Attached Figure Description

[0035] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0036] Figure 1 This is a structural diagram of the ultrasound-shockwave therapy system provided in an embodiment of the present invention;

[0037] Figure 2 This is a schematic diagram of the guidewire sheath in the ultrasonic-shockwave therapy system provided in an embodiment of the present invention;

[0038] Figure 3 This is a schematic diagram of the guidewire sheath in another direction provided in an embodiment of the present invention;

[0039] Figure 4 This is a cross-sectional view of the guidewire sheath in the ultrasonic-shockwave therapy system provided in an embodiment of the present invention;

[0040] Figure 5 This is a front view of the encapsulation and fixation layer in the ultrasound-shockwave therapy system provided in an embodiment of the present invention;

[0041] Figure 6 This is a rear view of the encapsulated fixation layer in the ultrasound-shockwave therapy system provided in an embodiment of the present invention;

[0042] Figure 7 This is a side view of the encapsulated fixation layer in the ultrasound-shockwave therapy system provided in an embodiment of the present invention;

[0043] Figure 8 This is a cross-sectional view of the encapsulation and fixation layer in the ultrasound-shockwave therapy system provided in an embodiment of the present invention;

[0044] Figure 9 This is a schematic diagram of the structure of the interventional catheter in the ultrasound-shockwave therapy system provided in an embodiment of the present invention;

[0045] Figure 10 This is a schematic diagram of the back structure of the interventional catheter in the ultrasound-shockwave therapy system provided in an embodiment of the present invention;

[0046] Figure 11 This is a schematic diagram of the lateral structure of the interventional catheter in the ultrasound-shockwave therapy system provided in an embodiment of the present invention;

[0047] Figure 12 This is a schematic diagram of the liquid supply component in the ultrasound-shockwave therapy system provided in an embodiment of the present invention;

[0048] Figure 13 This is a flowchart illustrating the operation of the ultrasound-shockwave therapy system provided in an embodiment of the present invention.

[0049] Explanation of reference numerals in the attached figures:

[0050] 11-Guide wire sheath; 12-Outlet pipe; 13-Inlet pipe; 14-Inlet; 15-Outlet; 16-Wrapping and fixing layer; 17-Through groove; 18-Outlet adapter port;

[0051] 2-Transducer;

[0052] 3-Shock wave excitation source; 31-Discharge point;

[0053] 41-Hydraulic pump; 42-Supply pump; 43-Three-position three-way solenoid valve; 44-Solenoid valve. Detailed Implementation

[0054] The technical solution of the present invention will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present 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.

[0055] In the description of this invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicating orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, are only for the convenience of describing the 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 the invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance. In addition, the technical features involved in the different embodiments of the invention described below can be combined with each other as long as they do not conflict with each other.

[0056] Example

[0057] Currently, treating lesions through natural cavities or blood vessels is a highly efficient, safe, low-cost, and time-saving treatment method. Compared to ballistic lithotripsy and holmium laser lithotripsy, it utilizes the characteristics of shock waves that have little impact on soft tissues and can break up hard plaques. An interventional catheter can be delivered to the lesion through natural cavities, and shock waves can be generated from within the body to efficiently and safely break up stones.

[0058] However, how to increase or maintain the intensity of the shock wave is the key issue for achieving effective treatment. Since the excitation of the electrohydraulic effect is always accompanied by the generation of a large number of microbubbles, and microbubbles will always exist in the propagation path of the shock wave, when the next shock wave arrives, the microbubbles will have significant scattering and reflection phenomena on the shock wave, which will reduce the intensity of the shock wave reaching the lesion. At the same time, the microbubbles will also absorb the energy of the shock wave, causing themselves to oscillate and rupture continuously, which will also reduce the intensity of the shock wave. Moreover, as the shock wave is continuously excited, the liquid environment of its discharge will also change continuously, which will affect the stability of the entire catheter.

[0059] To address the aforementioned issues, this embodiment provides an ultrasound-shockwave therapy system that enables controlled excitation of ultrasound and shockwaves to treat various lesions and promote tissue self-repair.

[0060] like Figures 1 to 11 As shown, the ultrasound-shockwave therapy system includes an interventional catheter, a fluid supply component, and a control component. The interventional catheter contains a transducer 2 and a shockwave excitation source 3. The transducer 2 and shockwave excitation source 3 are suitable for connection to an external power supply, which is an existing high-voltage power supply system. The high-voltage power supply in this system is a Marx boost circuit, capable of providing a rectangular pulse voltage with a variable pulse width of 1kV-5kV. Higher voltage values ​​and pulse widths can excite higher intensity and wider-range shockwaves. The specific voltage amplitude can be adjusted reasonably according to the actual condition of the lesion. The control component includes a timing controller to control the working sequence of the transducer 2 and shockwave excitation source 3, and, after both the transducer 2 and shockwave excitation source 3 have completed excitation, the control component controls the fluid supply component to replace the fluid within the interventional catheter.

[0061] Figure 1 The ultrasound system includes a transducer 2 encapsulated within an interventional catheter and an external power amplifier; a fluid supply assembly is connected to the interventional catheter to deliver fluid into the interventional catheter; and a control assembly is connected to the fluid supply assembly, the transducer 2, and the shock wave excitation source 3.

[0062] In this embodiment, the interventional catheter includes a guidewire sheath 11 and a wrapping and fixation layer 16. For example... Figures 2 to 4As shown, the guidewire sheath 11 is cylindrical and has a through hole along its length, through which a guidewire is inserted. A fluid outlet channel 12 and a fluid inlet channel 13 are interconnected between the surface of the guidewire sheath 11 and the sidewall of the through hole. The guidewire sheath 11 has a fluid inlet port 14 communicating with the fluid inlet channel 13, and a fluid outlet port 15 communicating with the fluid outlet channel 12. The fluid inlet port 14 and the fluid outlet port 15 are located on opposite sides of the surface of the guidewire sheath 11. During installation, the fluid outlet channel 12 and the fluid inlet channel 13 can be connected to the fluid supply assembly through the fluid inlet port 14 to deliver fluid into the interventional catheter, or to discharge waste fluid from the interventional catheter through the fluid outlet port 15. In this embodiment, the fluid delivered into the interventional catheter is physiological saline.

[0063] like Figures 5 to 8 As shown, Figure 8 The diagram shows a cross-section of the wrapping and fixing layer 16. The middle portion of the wrapping and fixing layer 16 has a ring-shaped cross-section, and each of its two outer cross-sections also has a ring structure. Figure 5 This is a front view of the wrapping and fixing layer 16. It can be seen that the wrapping and fixing layer 16 consists of three interconnected columnar structures. Each of the three columnar structures has through holes and is interconnected. The diameter of the cross-section of the middle columnar structure is larger than that of the columns on either side. During installation, the middle columnar structure of the wrapping and fixing layer 16 is fitted onto the outer surface of the guide wire sheath 11, as shown below. Figure 5 As shown, a through groove 17 is formed on the surface of the wrapping and fixing layer 16, and the through groove 17 penetrates the surfaces of three interconnected columnar structures, such as... Figure 6 and Figure 7 As shown, the surface of the columnar structure in the middle of the wrapping and fixing layer 16 is also provided with a liquid outlet adapter 18, and the liquid outlet adapter 18 and the through groove 17 are provided on opposite sides of the wrapping and fixing layer 16.

[0064] like Figures 9 to 11 As shown, after the wrapping and fixing layer 16 is sleeved on the outer surface of the guide wire sheath 11, the liquid outlet adapter 18 on the wrapping and fixing layer 16 corresponds to the liquid outlet 15 on the guide wire sheath 11, and the through groove 17 on the wrapping and fixing layer 16 corresponds to the liquid inlet 14 on the guide wire sheath 11. This allows the liquid supply component to communicate with the liquid outlet pipe 12 and the liquid inlet pipe 13 inside the guide wire sheath 11 after passing through the wrapping and fixing layer 16.

[0065] In this embodiment, as Figure 9As shown, the transducer 2 is provided with two through slots 17 on the upper and lower sides of the wrapping and fixing layer 16. The shock wave excitation source 3 consists of two parallel wires, which are respectively located inside the columnar structures on both sides of the wrapping and fixing layer 16. The two parallel wires have exposed discharge points 31. The two parallel wires are connected to the high-voltage power supply system. The exposed discharge points 31 on the two parallel wires can generate a liquid-electric effect to excite the shock wave under the control of the high-voltage power supply system. At the same time, the liquid in the insertion conduit is the discharge medium. The method of exciting the shock wave is the existing technology, and its principle will not be elaborated here.

[0066] In this embodiment, the wrapping and fixing layer 16 is used to fix the wire and transducer 2 to the surface of the guide wire sheath 11 and ensure insulation between them. The wrapping and fixing layer 16 is made of a flexible, highly acoustically permeable insulating material.

[0067] Because the composition of calcification lesions varies significantly across its early, middle, and late stages, early and middle-stage calcification primarily consists of soft plaques such as lipids or thrombi. Shockwave therapy is less effective against soft plaques, while ultrasound is more effective at ablation. Late-stage calcification mainly involves phosphate deposition, while gallstones are primarily composed of calcium oxalate, both of which are hard plaques and more sensitive to shockwave therapy. Therefore, to effectively treat different lesions, high-intensity ultrasound combined with shockwave therapy can be used to ablate soft plaques.

[0068] However, since the excitation of the electrohydraulic effect is always accompanied by the generation of a large number of microbubbles, and the microbubbles will always exist in the propagation path of the shock wave, when the next shock wave arrives, the microbubbles will have significant scattering and reflection phenomena on the shock wave, which will reduce the intensity of the shock wave reaching the lesion. At the same time, the microbubbles will also absorb the energy of the shock wave, causing them to oscillate and break down continuously, which will also reduce the intensity of the shock wave.

[0069] To improve treatment efficiency and stability, increasing the shock wave intensity requires providing a higher voltage for the catheter's shock wave excitation. Higher voltage places greater demands on the downstream power supply equipment and also on the overall pressure resistance of the interventional catheter. Since the initial shock wave intensity is unaffected, maintaining a high level of intensity in subsequent shock waves necessitates increasing the intensity of subsequent shock waves, potentially damaging blood vessels and soft tissues. Furthermore, higher voltage can exacerbate burn-out of the shock wave excitation source 3 during discharge, accelerating catheter aging and reducing its lifespan. Because maintaining a high shock wave intensity through increased voltage to counteract the microbubble shielding effect is difficult and costly, addressing the adverse effects of microbubbles is an effective approach to improving treatment efficiency.

[0070] Although microbubbles significantly affect the intensity of the next shock wave, they can also lower the cavitation threshold of the area where the microbubbles are located. Cavitation activity can significantly promote the further fragmentation of hard and soft plaques. Therefore, microbubbles can be used to lower the cavitation threshold before they are removed, and then low-intensity ultrasound can be used to induce the cavitation effect, thereby further improving the treatment efficiency of the lesions.

[0071] Based on this, the ultrasound-shockwave therapy system in this embodiment is divided into the following two situations during treatment:

[0072] When treating hard plaques such as mid-to-late stage vascular calcification and various stones, shockwave therapy is used as the primary physical agent. This requires a high-intensity shockwave (>0.25 mJ / mm²) and a low-intensity ultrasound (MI<0.5). The timing controller must prioritize triggering the Marx boost circuit, followed by a 1-100 ms delay before triggering the power amplifier, ensuring the ultrasound always lags behind the shockwave excitation. The interaction between the ultrasound and the microbubbles generated by the electrohydraulic effect induces cavitation, enhancing the therapeutic effect of the shockwave.

[0073] When treating soft plaques such as early vascular calcification and thrombosis, ultrasound is used as the primary therapeutic physical agent. This requires outputting high-intensity ultrasound (MI>0.5) and low-intensity shock waves (<0.25mJ / mm2). In this case, the timing controller needs to prioritize triggering the power amplifier. The appropriate low-intensity shock wave is selected to enhance the treatment of soft plaques, and the Marx boost circuit needs to provide a low voltage (<1.5kV) and a low duty cycle (<50%). In this case, the shock wave serves as an adjunct therapy, disrupting the hemoglobin fibrous network and calcification deposits within the soft plaque, increasing the ablation rate of the ultrasound, and stimulating tissue self-repair.

[0074] In this embodiment, as Figure 9 As shown, the through groove 17 is located at the liquid inlet 14, and the area of ​​the through groove 17 is larger than the area of ​​the liquid inlet 14. The shock wave excitation source 3 is located at the liquid inlet 14. Because the shock wave generates a large number of microbubbles during excitation, these microbubbles generally linger near the discharge point 31. Therefore, the proximity of the liquid inlet 14 and the discharge point 31 is beneficial for the removal of microbubbles. At the same time, in order to address the problem that microbubbles cannot all enter the liquid outlet 15 under complex conditions such as catheter structure limitations and catheter bends, the proximity of the liquid inlet 14 and the discharge point 31 can preferentially remove microbubbles near the excitation source and avoid the microbubble shielding effect. Meanwhile, the wrapping and fixing layer 16 has a large through groove 17, which can accommodate the discharge point 31 of the shock wave excitation source 3 on the one hand, and the liquid inlet 14 of the interventional guidewire sheath 11 on the other hand, responsible for injecting liquid into the interventional catheter.

[0075] like Figure 12As shown, the liquid supply assembly includes a hydraulic pump 41, a liquid supply pump 42, a three-position three-way solenoid valve 43, and a solenoid valve 44. The two inlet ends of the three-position three-way solenoid valve 43 are connected to the hydraulic pump 41 and the liquid supply pump 42, respectively, and the outlet end of the three-position three-way solenoid valve 43 is connected to the inlet 14 of the interventional catheter. The solenoid valve 44 is connected to the outlet 15 of the interventional catheter.

[0076] In this embodiment, the hydraulic pump 41 can be electric or manual and is responsible for providing pressure to the inside of the interventional catheter. The fluid supply pump 42 is responsible for providing high-speed, high-flow-rate fluid to the interventional catheter. The three-position three-way solenoid valve 43 and the solenoid valve 44 cooperate with each other to achieve different working modes.

[0077] like Figure 12 As shown, specifically, since the interventional catheter is empty before use, a water injection operation is required. At this time, the coil below the three-position three-way solenoid valve 43 is energized under the control of the control component, and the fluid supply pump 42 is connected to the fluid inlet 14 of the interventional catheter. The solenoid valve 44 then opens, forming an open circuit. The fluid supply pump 42 then provides high-speed, high-flow-rate fluid into the interventional catheter until it is full; the readings of flow meters Q1 and Q2 are observed to determine if it is basically full. Then, the upper coil of the three-position three-way solenoid valve 43 is energized, and the hydraulic pump 41 is connected to the fluid inlet 14 of the interventional catheter. The solenoid valve 44 closes, forming a closed loop. The hydraulic pump 41 applies pressure, and the readings of pressure gauges P1 and P2 are observed. If they remain stable, it indicates that the pressure inside the interventional catheter is stable; if the readings are unstable, the above steps need to be repeated until the water injection operation is complete.

[0078] Since the transducer 2 and the shock wave excitation source need to maintain a certain pressure inside the interventional catheter during operation to ensure that the balloon on the interventional catheter is inflated and closely adheres to the blood vessel, and to achieve blood vessel dilation, the fluid inside the interventional catheter needs to be updated to remove microbubbles after the transducer 2 finishes working. Therefore, the fluid supply component needs two working modes: one to maintain balloon inflation, one to dilate blood vessels, and one to update the fluid inside the interventional catheter.

[0079] The first operating mode is when the fluid supply pump 42 is connected to the fluid circuit and the solenoid valve 44 is opened to create an open fluid circuit. In this mode, the fluid supply pump 42 provides high-flow-rate fluid to quickly replace the waste fluid in the interventional catheter. After each shock wave and ultrasound stimulation is completed, wait 10-100ms before entering the first operating mode to replace the fluid in the interventional catheter.

[0080] When the solenoid valve 44 is closed, the hydraulic pump 41 is connected to the hydraulic circuit, forming a closed-loop hydraulic circuit, which is the second working mode. The pressure of the entire hydraulic circuit is determined by the pressure input by the hydraulic pump 41. The pressure provided by the hydraulic pump 41 is determined by the force applied to the rear pressure rod. Therefore, the pressure inside the entire conduit can be changed by changing the force of the pressure rod, thereby achieving pressure stability inside the conduit and inflation and filling of the balloon.

[0081] 10-100ms before each shock wave excitation, the hydraulic circuit switches to the second working mode, and the hydraulic pump 41 applies a certain pressure to maintain the pressure inside the interventional catheter and the inflation of the balloon until the shock wave and ultrasound excitation are completed and the first mode is switched back; or when it is necessary to dilate blood vessels through the balloon, a larger pressure is required, and the hydraulic pump 41 can apply a greater pressure to make the balloon further expand and dilate blood vessels.

[0082] In this embodiment, the balloon needs to be a semi-compliant or compliant balloon, such as polyvinyl chloride (PVC), polyethylene terephthalate, etc. In some embodiments, the balloon has high extensibility, which can also achieve the requirements of balloon inflation and close contact with the blood vessel wall at a high flow rate of the infusion pump 42. In this case, it is not necessary to switch to the second working mode, and the second working mode is only entered when blood vessel dilation is required.

[0083] Because balloon dilation of blood vessels is still required after breaking up calcified plaques, unavoidable strain can occur on the vessel walls and tissues during the dilation process, easily leading to excessive stretching of uncalcified tissues. Performing lithotripsy within natural cavities can also cause soft tissue damage due to stone removal. Therefore, the ultrasound-shockwave therapy system provided in this embodiment can utilize low-intensity shockwaves (<0.11 mJ / mm²). 2 It has the function of promoting the self-recovery of damaged tissues.

[0084] The ultrasound-shockwave therapy system provided in this embodiment, when in operation, such as Figure 13 As shown:

[0085] The pulse waveform signal is sent by the external host computer and analyzed by the pulse waveform controllers in the high-voltage power supply system and the ultrasonic system to determine the output waveforms of the Marx boost circuit and the power amplifier, which then drive the shock wave excitation source 3 and the transducer 2.

[0086] The host computer provides operating timing signals to the control components. The high-voltage power supply system, ultrasonic system, and liquid supply components are all controlled by timing controllers. Among them, the timing controllers control the three-position three-way solenoid valve 43 and the solenoid switching valve, controlling the different operating modes of the liquid supply components.

[0087] Each time the controller puts the fluid supply component into the second operating mode, it triggers the Marx boost circuit to generate a shock wave after a 10-100ms delay, subsequently triggering the power amplifier to generate ultrasound. After the shock wave and ultrasound have completed their generation, the timing controller puts the fluid supply component into the first operating mode, completing one full treatment cycle. The number of treatments is also controlled by the timing controller. The first operating mode is responsible for updating the fluid environment inside the interventional catheter during shock wave therapy intervals, while the second operating mode maintains the catheter pressure during shock wave therapy.

[0088] The triggering of the Marx boost circuit and power amplifier can also be directly controlled by the host computer, which has the highest control authority.

[0089] When treating hard plaques such as mid-to-late stage vascular calcification and various stones, shockwave therapy is used as the primary physical agent. This requires a high-intensity shockwave (>0.25 mJ / mm²) and a low-intensity ultrasound (MI<0.5). The timing controller must prioritize triggering the Marx boost circuit, followed by a 1-100 ms delay before triggering the power amplifier, ensuring the ultrasound always lags behind the shockwave excitation. The interaction between the ultrasound and the microbubbles generated by the electrohydraulic effect induces cavitation, enhancing the therapeutic effect of the shockwave.

[0090] When treating soft plaques such as early vascular calcification and thrombosis, ultrasound is used as the primary therapeutic physical agent. This requires outputting high-intensity ultrasound (MI>0.5) and low-intensity shock waves (<0.25mJ / mm2). In this case, the timing controller needs to prioritize triggering the power amplifier. The appropriate low-intensity shock wave is selected to enhance the treatment of soft plaques, and the Marx boost circuit needs to provide a low voltage (<1.5kV) and a low duty cycle (<50%). In this case, the shock wave serves as an adjunct therapy, disrupting the hemoglobin fibrillary network and calcification deposits within the soft plaque, thereby increasing the ablation rate of the ultrasound.

[0091] When it is necessary to promote the recovery of damaged tissue, low-intensity shock waves (<0.11 mJ / mm2) are used as the main source of stimulation, while higher pulse frequency (PRF) (>1 Hz) is continuously applied to the damaged tissue. In some cases, high-intensity, short-pulse ultrasound can also be used to promote the absorption of drugs by the tissue.

[0092] In any related treatment, the timing controller controls the timing of ultrasound, shock wave excitation source 3, and is also responsible for the working mode of the fluid supply component. When the shock wave is activated, it enters the second working mode to maintain a certain pressure to ensure that the catheter is in close contact with the lesion; after each shock wave excitation, it needs to switch to the first working mode to refresh the fluid in the catheter and ensure that each shock wave excitation has the same discharge environment.

[0093] Obviously, the above embodiments are merely illustrative examples for clear explanation and are not intended to limit the implementation. Those skilled in the art will recognize that other variations or modifications can be made based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations here. However, obvious variations or modifications derived therefrom are still within the scope of protection of this invention.

Claims

1. An ultrasonic-shockwave therapy system, characterized in that, include: An interventional catheter is provided with a shock wave excitation source (3) inside, which is adapted to be connected to an external power source; A fluid supply assembly, connected to the interventional catheter, for delivering fluid into the interventional catheter; The control component is connected to the liquid supply component and the shock wave excitation source (3); The control component controls the working sequence of the liquid supply component and the shock wave excitation source (3) so that after the shock wave excitation source (3) completes a single excitation, the liquid supply component is controlled to replace the liquid in the interventional catheter. The interventional catheter is also provided with a transducer (2), which is connected to the control component and an external power supply. The working sequence of the transducer (2) is after the shock wave excitation source (3) is excited. The liquid supply component replaces the liquid in the interventional catheter after the transducer (2) is excited.

2. The ultrasound-shockwave therapy system according to claim 1, characterized in that, The intensity of the ultrasonic waves excited by the transducer (2) is less than the intensity of the shock waves excited by the shock wave excitation source (3), so that the transducer (2) can enhance the therapeutic effect of the microbubbles that accompany the shock waves excited by the shock wave excitation source (3) to treat hard plaques and improve the efficiency of cell drug absorption.

3. The ultrasound-shockwave therapy system according to claim 1, characterized in that, The intensity of the ultrasonic waves excited by the transducer (2) is greater than the intensity of the shock waves excited by the shock wave excitation source (3) in order to treat soft plaques and promote cell and tissue regeneration.

4. The ultrasound-shockwave therapy system according to any one of claims 1-3, characterized in that, The interventional catheter also includes a guidewire sheath (11), which has a through hole along its length, and the through hole is suitable for inserting a guidewire; the surface of the guidewire sheath (11) and the side wall of the through hole are provided with an outlet pipe (12) and an inlet pipe (13) that are interconnected, and the outlet pipe (12) and the inlet pipe (13) are both connected to the liquid supply assembly.

5. The ultrasonic-shockwave therapy system according to claim 4, characterized in that, The guide wire sheath (11) has an inlet (14) and an outlet (15) on its surface. The inlet (14) is connected to the inlet pipe (13), and the outlet (15) is connected to the outlet pipe (12). The inlet (14) and outlet (15) are located on opposite sides of the surface of the guide wire sheath (11).

6. The ultrasound-shockwave therapy system according to claim 5, characterized in that, The interventional catheter also includes a wrapping and fixing layer (16), which is sleeved on the surface of the guidewire sheath (11). The transducer (2) and the shock wave excitation source (3) are located between the surface of the guidewire sheath (11) and the wrapping and fixing layer (16), and are insulated from each other.

7. The ultrasound-shockwave therapy system according to claim 6, characterized in that, The wrapping and fixing layer (16) is provided with a through groove (17), the through groove (17) is located at the liquid inlet (14) and the area of ​​the through groove (17) is larger than the area of ​​the liquid inlet (14), and the shock wave excitation source (3) is located at the liquid inlet (14).

8. The ultrasound-shockwave therapy system according to claim 1, characterized in that, The liquid supply assembly includes: Hydraulic pump (41); Liquid supply pump (42); The three-position three-way solenoid valve (43) has two inlet ends connected to the hydraulic pump (41) and the liquid supply pump (42) respectively, and the outlet end of the three-position three-way solenoid valve (43) is connected to the inlet (14) of the interventional catheter. A solenoid valve (44) is connected to the outlet (15) of the interventional catheter; The hydraulic pump (41) is connected to the interventional catheter via the three-position three-way solenoid valve (43) to ensure the pressure inside the interventional catheter; the fluid supply pump (42) is connected to the interventional catheter via the three-position three-way solenoid valve (43) to deliver fluid into the interventional catheter.

9. The ultrasonic-shockwave therapy system according to claim 1, characterized in that, The control component includes a timing controller to control the working timing of the liquid supply component, the transducer (2) in the interventional catheter, and the shock wave excitation source (3).

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