Intravascular shock wave treatment system

Abstract

The invention provides an intravascular shock wave treatment system which comprises pulse treatment equipment and a shock wave balloon catheter, and the pulse treatment equipment comprises a first pulse discharge circuit and a second pulse discharge circuit; the shock wave balloon catheter comprises a first electrode assembly and a second electrode assembly. The first pulse discharge circuit is electrically connected with the first electrode assembly and can transmit a first pulse voltage to the first electrode assembly through a first pulse sequence, and the second pulse discharge circuit is electrically connected with the second electrode assembly and can transmit a second pulse voltage to the second electrode assembly through a second pulse sequence. According to the invention, independent discharge control is carried out on different electrode assemblies, and independent discharge or combined discharge of the electrode assemblies can be selected according to treatment requirements, so that the discharge form is flexible and controllable; and meanwhile, on the premise that the shock wave treatment effect is guaranteed, the requirements for the voltage peak value and the pulse current are reduced, so that heat generated on the electrode assembly can be effectively reduced, and the service life of the electrode assembly is prolonged.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an intravascular shock wave therapy system. Background Art

[0002] Cardiovascular disease has always been one of the major causes of death in the world. Balloon angioplasty has played an important role in reducing the incidence and mortality of obstructive coronary artery disease and has become the most commonly used method for treating coronary heart disease in countries around the world. At the same time, balloon angioplasty is also the main method for revascularization in patients with peripheral arterial disease. At present, the use of balloon angioplasty to treat calcified lesions usually requires high pressure, which often damages the blood vessel wall while treating the calcified lesions.

[0003] The intravascular shock wave therapy system is a technology that applies traditional electrohydraulic lithotripsy to the treatment of vascular calcification. It consists of two parts: a shock wave balloon catheter and a pulse therapy device. The shock wave balloon catheter places one or more pairs of discharge electrode assemblies in the traditional angioplasty balloon. The electrode assemblies are electrically connected to the shock wave therapy device. The pulse therapy device applies high-voltage pulses to the electrode assemblies, causing the electrode assemblies to release shock waves. After the shock waves propagate through the liquid medium in the balloon, they can selectively destroy the calcified lesions in the blood vessels without causing damage to the normal blood vessel walls.

[0004] In the shock wave therapy system provided by the prior art, different electrode assemblies are usually connected in series, and then pulse voltage is transmitted to each electrode assembly through the same discharge channel. The advantage of this discharge method is that the discharge control is simple, but the discharge method is single, and multiple electrode assemblies affect each other. If one electrode assembly fails, it will affect the use of all electrode assemblies, thus failing to meet different clinical needs; and the more electrode assemblies are connected in the same discharge circuit, the higher the required breakdown voltage, which will affect the stability of the discharge. Summary of the invention

[0005] Based on this, the present invention provides an intravascular shock wave therapy system, which performs independent discharge control on different electrode assemblies according to independent pulse sequences.

[0006] The object of the present invention is to provide an intravascular shock wave therapy system, comprising a pulse therapy device and a shock wave balloon catheter, wherein the pulse therapy device comprises a first pulse discharge circuit and a second pulse discharge circuit; the shock wave balloon catheter comprises a first electrode assembly and a second electrode assembly; The first pulse discharge circuit is electrically connected to the first electrode assembly and can deliver a first pulse voltage to the first electrode assembly in a first pulse sequence, and the second pulse discharge circuit is electrically connected to the second electrode assembly and can deliver a second pulse voltage to the second electrode assembly in a second pulse sequence.

[0007] Further, the first pulse sequence includes a plurality of first discharge waveforms, and the second pulse sequence includes a plurality of second discharge waveforms; The voltage amplitude of the first discharge waveform and the second discharge waveform is 900-5000V, the pulse voltage width is 1-50μs, and the rising edge of the voltage amplitude is 200-500ns.

[0008] Further, the intravascular shock wave therapy system delivers a first pulse voltage and a second pulse voltage to the first electrode assembly and the second electrode assembly respectively with parameters of a plurality of pulse cycles; The pulse cycle includes a discharge cycle and a pause cycle. In each of the discharge cycles, the first pulse discharge circuit transmits a first pulse voltage to the first electrode assembly with the parameters of the first discharge waveform, and the second pulse discharge circuit transmits a second pulse voltage to the second electrode assembly with the parameters of the second discharge waveform. The first discharge waveform and the second discharge waveform have a time interval of 50μs-10ms; in the pause cycle, the first pulse discharge circuit and the second pulse discharge circuit stop discharging, and the pause cycle duration is 0.5-2s.

[0009] Furthermore, the voltage amplitude of the first discharge waveform and the second discharge waveform is 2000-2300V, and the pulse voltage width is 5-20μs.

[0010] Furthermore, the voltage amplitudes of the multiple first discharge waveforms in the first pulse sequence decrease sequentially; the voltage amplitudes of the multiple second discharge waveforms in the second pulse sequence decrease sequentially; and the voltage amplitude decreases by 10-50V.

[0011] Furthermore, in the same discharge cycle, the first discharge waveform and the second discharge waveform have a time interval of 50-1 ms.

[0012] Furthermore, the number of the pulse cycles is 5-20.

[0013] Furthermore, the first pulse discharge circuit includes a first energy storage capacitor C1 and a first switch K1; the second pulse discharge circuit includes a second energy storage capacitor C2 and a second switch K2; The pulse treatment device further comprises a high-voltage pulse power supply, which is connected to the first pulse discharge circuit and the second pulse discharge circuit respectively, and is used to charge the first energy storage capacitor C1 and the second energy storage capacitor C2; When the first switch K1 is turned on, the first energy storage capacitor C1 discharges to the first electrode assembly; when the second switch K2 is turned on, the second energy storage capacitor C2 discharges to the second electrode assembly.

[0014] Furthermore, the pulse treatment device further includes a processor, wherein the processor is connected to the first switch K1 and the second switch K2, and the processor is used to control the on and off of the first switch K1 and the second switch K2.

[0015] Furthermore, the shock wave balloon catheter further comprises a catheter assembly and a balloon, wherein the catheter assembly comprises an outer tube and an inner tube inserted into the inner cavity of the outer tube, and the distal end of the inner tube extends out from the distal end of the outer tube; The balloon is wrapped around the outside of the inner tube passing through the outer tube, and the proximal end of the balloon is contracted to communicate with the annular channel formed between the outer tube and the inner tube; The first electrode assembly and the second electrode assembly are arranged inside the balloon, and the balloon can be filled with a liquid medium. When a first pulse voltage and a second pulse voltage are applied to the first electrode assembly and the second electrode assembly respectively, the first electrode assembly can release a first shock wave energy transmitted outward through the liquid medium, and the second electrode assembly can release a second shock wave energy transmitted outward through the liquid medium.

[0016] The intravascular shock wave therapy system provided by the present invention can select the electrode assemblies for individual discharge or combined discharge according to the treatment needs by independently controlling the discharge of different electrode assemblies, so that the discharge form is flexible and controllable; compared with the technical solution of connecting multiple electrode assemblies in series in the same pulse discharge circuit, the requirements for the breakdown voltage are reduced while obtaining the ideal treatment effect, and the discharge voltage peak and pulse current can be reduced, thereby effectively reducing the heat generated on the electrode assembly, thereby reducing the ablation of the electrode assembly and extending the service life of the electrode assembly. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] In order to more clearly illustrate the specific implementation methods of the present invention or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0018] Figure 1 It is a schematic diagram of the structure of the intravascular shock wave therapy system in the first embodiment of the present invention.

[0019] Figure 2 Schematic diagram of circuit connection of the intravascular shock wave therapy system in the first embodiment of the present invention.

[0020] Figure 3 1 is an example waveform of multiple pulse cycles of the intravascular shock wave therapy system in the first embodiment of the present invention. DETAILED DESCRIPTION

[0021] The technical solution of the present invention will be clearly and completely described below in conjunction with the embodiments. 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 creative work are within the scope of protection of the present invention.

[0022] In this specification, the proximal end refers to the end closer to the operator during surgery, and the distal end refers to the end farther from the operator during surgery.

[0023] refer to Figure 1 , Figure 2 The first embodiment of the present invention provides an intravascular shock wave therapy system, comprising: The pulse treatment device 100 includes a high-voltage pulse power supply 110, a first pulse discharge circuit 120 and a second pulse discharge circuit 130, wherein the first pulse discharge circuit 120 includes a first energy storage capacitor C1 and a first switch K1; the second pulse discharge circuit 130 includes a second energy storage capacitor C2 and a second switch K2; the high-voltage pulse power supply 110 is connected to the first pulse discharge circuit 120 and the second pulse circuit 130, and is used to charge the first energy storage capacitor C1 and the second energy storage capacitor C2; A shock wave balloon catheter 200, comprising a catheter assembly 210, a balloon 220, a first electrode assembly 230 and a second electrode assembly 240. The catheter assembly 210 comprises an outer tube 211 and an inner tube 212 passing through an inner cavity of the outer tube 211, the distal end of the inner tube 212 passing through the distal end of the outer tube 211, the balloon 220 is wrapped around the outside of the inner tube 212 passing through the outer tube 211, and the proximal end of the balloon 220 is sealed and connected to an annular channel formed between the outer tube 211 and the inner tube 212; the first electrode assembly 230 and the second electrode assembly 240 are located in the balloon 220 and fixed on the inner tube 212; The first pulse discharge circuit 120 is electrically connected to the first electrode assembly 230 through a wire, and can transmit a first pulse voltage to the first electrode assembly 230 in a first pulse sequence; the second pulse discharge circuit 130 is electrically connected to the second electrode assembly 240, and can transmit a second pulse voltage to the second electrode assembly 230 in a second pulse sequence.

[0024] In the intravascular shock wave therapy system provided by the present invention, the high-voltage pulse power supply 110 can charge the first energy storage capacitor C1 and / or the second energy storage capacitor C2; when the first switch K1 is turned on, the first energy storage capacitor C1 discharges to the first electrode assembly 230, and when the second switch K2 is turned on, the second energy storage capacitor C2 discharges to the second electrode assembly 240. The pulse therapy device provided by the present invention can realize the separate control of the first electrode assembly 230 and the second electrode assembly 240, so that the discharges between different electrode assemblies will not interfere with each other, so that it can be flexibly controlled according to clinical needs.

[0025] The solution of discharging different electrode assemblies with the same energy storage capacitor requires waiting for the energy storage capacitor to be recharged after discharging one electrode assembly before discharging the next electrode assembly. The present invention provides a first energy storage capacitor C1 and a second energy storage capacitor C2, so that the first electrode assembly and the second electrode assembly can be discharged at the same time without waiting for the energy storage capacitor to be recharged, thereby improving the flexibility of discharge.

[0026] Furthermore, the shock wave therapy device further includes a processor 140, which is connected to the first switch K1 and the second switch K2 respectively, and is used to control the on and off of the first switch K1 and the second switch K2.

[0027] Further, refer to Figure 3 , the first pulse sequence includes a plurality of first discharge waveforms V1, and the second pulse sequence includes a plurality of second discharge waveforms V2; the voltage amplitude of the first discharge waveform and the second discharge waveform is 900-5000V, the pulse voltage width is 1-50μs, and the rising edge of the voltage amplitude is 200-500ns. The pulse sequence parameters provided by the present invention can make the voltage rise quickly, so that a better treatment effect can be achieved under lower voltage conditions. The rising edge of the voltage amplitude is set within this range, so that the generation of the shock wave has a larger gradient, so that when passing through the surface of the medium with different acoustic impedances, it can be fully reflected and the calcified plaque can be better fractured.

[0028] It should be noted that the intravascular shock wave therapy system provided by the present invention can perform combined discharge on the first electrode assembly 230 and the second electrode assembly 240 during use. In this embodiment, the intravascular shock wave therapy system delivers the first pulse voltage and the second pulse voltage to the first electrode assembly 230 and the second electrode assembly 240 respectively with parameters of multiple pulse cycles.

[0029] Specifically, the pulse period T includes a discharge period t1 and a pause period t2. In each discharge period, the first pulse discharge circuit 120 transmits a first pulse voltage to the first electrode assembly 230 with the parameters of the first discharge waveform V1, and the second pulse discharge circuit 130 transmits a second pulse voltage to the second electrode assembly 240 with the parameters of the second discharge waveform V2. The first discharge waveform V1 and the second discharge waveform V2 have a time interval of 50μs-10ms; in the pause period, the first pulse discharge circuit 120 and the second pulse discharge circuit 130 stop discharging, and the pause period duration is 0.5-2s.

[0030] During the time corresponding to the first discharge waveform of each discharge cycle t1, the first switch K1 is turned on, and the first energy storage capacitor C1 discharges to the first electrode assembly 230; during the pause period t2, the first switch K1 is turned off, the first energy storage capacitor C1 stops discharging to the first electrode assembly 230, and the high-voltage pulse power supply 110 charges the first energy storage capacitor C1.

[0031] During the time corresponding to the second discharge waveform of the discharge cycle t1, the second switch K2 is turned on, and the second energy storage capacitor C2 discharges to the second electrode assembly 240; during the pause period t2, the second switch K2 is turned off, the second energy storage capacitor C2 stops discharging to the second electrode assembly 240, and the high-voltage pulse power supply 110 charges the second energy storage capacitor C2.

[0032] In this solution, by setting the pulse discharge sequence of the first electrode assembly 230 and the second electrode assembly 240 within the above range, the first electrode assembly 230 and the second electrode assembly 240 can quickly release shock wave energy during the discharge stage to achieve a better calcification crushing effect; by setting the pulse period within the above parameter range, the first electrode assembly 230 and the second electrode assembly 240 can be combined and discharged, so that the first electrode assembly 230 and the second electrode assembly 240 can be continuously discharged, and while obtaining a better treatment effect, the discharge process will not interfere with each other; 50μ is set between the first discharge waveform V1 and the second discharge waveform V2 The time interval of s-10ms can avoid discharging the first electrode assembly 230 and the second electrode assembly 240 at the same time without affecting the operation time, thereby avoiding burdening the circuit; after completing the discharge of the first electrode assembly 230 and the second electrode assembly 240, a discharge pause time of 0.5-2s is set, and the first energy storage capacitor C1 and the second energy storage capacitor C2 can be quickly charged, thereby ensuring the next discharge effect. At the same time, during the pause period after the electrode assembly is discharged, the electrode assembly and the liquid medium in the balloon can be cooled down, thereby avoiding damage to tissue cells and the electrode itself due to excessive temperature.

[0033] Furthermore, the voltage amplitude of the first discharge waveform V1 and the second discharge waveform V2 is 2000-2300V, and the pulse voltage width is 5-20μs. Compared with the technical solution of connecting the electrode assemblies in series, this solution can reduce the voltage amplitude and pulse current of the discharge of a single electrode assembly while achieving the same calcification crushing effect in one pulse cycle of the first electrode assembly 230 and the second electrode assembly 240, thereby reducing the loss of the electrode assembly.

[0034] Furthermore, in the same discharge cycle, the first discharge waveform V1 and the second discharge waveform V2 have a time interval of 50 μs-1 ms.

[0035] This is because after the first pulse discharge circuit discharges, there is residual voltage in the circuit. Setting the second electrode assembly to discharge after 50μs can fully release the residual voltage in the circuit, thereby not affecting the voltage amplitude and pulse current output by the second discharge circuit; setting the interval time to less than 1ms can make the shock wave energy more concentrated, reduce damage to blood vessels, and achieve better treatment effects.

[0036] Furthermore, the duration of each pause cycle is 0.8-1.2 seconds. This solution can achieve a good cooling effect on the electrode assembly and the liquid environment in the balloon while minimizing the surgical operation time.

[0037] It should be noted that, in the present invention, the first discharge waveform and the second discharge waveform may be the same or different.

[0038] In a preferred embodiment of the present invention, the voltage amplitudes of the multiple first discharge waveforms in the first pulse sequence decrease in sequence; the voltage amplitudes of the multiple second discharge waveforms in the second pulse sequence decrease in sequence; the voltage amplitude decreases by 10-50 V. As the treatment process proceeds, the calcified plaques in the blood vessels gradually loosen, and the required shock wave energy gradually decreases. This solution sets the voltage amplitude of the discharge waveform in each pulse sequence to gradually decrease, which can better match the treatment process of calcified lesions and make the treatment more precise.

[0039] Furthermore, the number of pulse cycles is 5 to 20. Within this parameter range, a better therapeutic effect can be achieved on calcified lesions.

[0040] Furthermore, the shock wave balloon catheter provided by the present invention has a balloon length of 6-20 mm and a radial dimension of 2.0-5.0 mm after the balloon is filled. The shock wave balloon catheter provided by the present solution is provided with two independently controlled electrode assemblies, and is particularly suitable for the treatment of calcified lesions in coronary arteries.

[0041] The above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit the same. Although the present invention has been described in detail with reference to the above embodiments, those skilled in the art should understand that the technical solutions described in the above embodiments may still be modified, or some or all of the technical features may be replaced by equivalents. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. An intravascular shock wave therapy system, characterized in that: It comprises a pulse treatment device and a shock wave balloon catheter, wherein the pulse treatment device comprises a first pulse discharge circuit and a second pulse discharge circuit; the shock wave balloon catheter comprises a first electrode assembly and a second electrode assembly; The first pulse discharge circuit is electrically connected to the first electrode assembly and can deliver a first pulse voltage to the first electrode assembly in a first pulse sequence, and the second pulse discharge circuit is electrically connected to the second electrode assembly and can deliver a second pulse voltage to the second electrode assembly in a second pulse sequence.

2. The intravascular shock wave therapy system according to claim 1, characterized in that: The first pulse sequence includes a plurality of first discharge waveforms, and the second pulse sequence includes a plurality of second discharge waveforms; The voltage amplitude of the first discharge waveform and the second discharge waveform is 900-5000V, the pulse voltage width is 1-50μs, and the rising edge of the voltage amplitude is 200-500ns.

3. The intravascular shock wave therapy system according to claim 2, wherein the intravascular shock wave therapy system delivers a first pulse voltage and a second pulse voltage to the first electrode assembly and the second electrode assembly respectively with parameters of a plurality of pulse cycles; The pulse cycle includes a discharge cycle and a pause cycle. In each of the discharge cycles, the first pulse discharge circuit transmits a first pulse voltage to the first electrode assembly with the parameters of the first discharge waveform, and the second pulse discharge circuit transmits a second pulse voltage to the second electrode assembly with the parameters of the second discharge waveform. The first discharge waveform and the second discharge waveform have a time interval of 50μs-10ms; in the pause cycle, the first pulse discharge circuit and the second pulse discharge circuit stop discharging, and the pause cycle duration is 0.5-2s.

4. The intravascular shock wave therapy system according to claim 2, characterized in that: The voltage amplitude of the first discharge waveform and the second discharge waveform is 2000-2300V, and the pulse voltage width is 5-20μs.

5. The intravascular shock wave therapy system according to claim 2, characterized in that: The voltage amplitudes of the multiple first discharge waveforms in the first pulse sequence decrease sequentially; the voltage amplitudes of the multiple second discharge waveforms in the second pulse sequence decrease sequentially; the voltage amplitude decreases by 10-50V.

6. The intravascular shock wave therapy system according to claim 3, characterized in that: In the same discharge cycle, the first discharge waveform and the second discharge waveform have a time interval of 50 μs-1 ms.

7. The intravascular shock wave therapy system according to claim 3, characterized in that: The number of the pulse cycles is 5-20.

8. The intravascular shock wave therapy system according to claim 1, characterized in that: The first pulse discharge circuit includes a first energy storage capacitor C1 and a first switch K1; the second pulse discharge circuit includes a second energy storage capacitor C2 and a second switch K2; The pulse treatment device further comprises a high-voltage pulse power supply, which is connected to the first pulse discharge circuit and the second pulse discharge circuit respectively, and is used to charge the first energy storage capacitor C1 and the second energy storage capacitor C2; When the first switch K1 is turned on, the first energy storage capacitor C1 discharges to the first electrode assembly; when the second switch K2 is turned on, the second energy storage capacitor C2 discharges to the second electrode assembly.

9. The intravascular shock wave therapy system according to any one of claims 1 to 8, characterized in that: The pulse treatment device further includes a processor, which is connected to the first switch K1 and the second switch K2, and is used to control the on and off of the first switch K1 and the second switch K2.

10. The intravascular shock wave therapy system according to any one of claims 9, characterized in that: The shock wave balloon catheter further comprises a catheter assembly and a balloon, wherein the catheter assembly comprises an outer tube and an inner tube inserted into the inner cavity of the outer tube, and the distal end of the inner tube extends out from the distal end of the outer tube; The balloon is wrapped around the outside of the inner tube passing through the outer tube, and the proximal end of the balloon is contracted to communicate with the annular channel formed between the outer tube and the inner tube; The first electrode assembly and the second electrode assembly are arranged inside the balloon, and the balloon can be filled with a liquid medium. When a first pulse voltage and a second pulse voltage are applied to the first electrode assembly and the second electrode assembly respectively, the first electrode assembly can release a first shock wave energy transmitted outward through the liquid medium, and the second electrode assembly can release a second shock wave energy transmitted outward through the liquid medium.

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