Intravascular shockwave therapy system

Abstract

The application provides an intravascular shock wave treatment system, comprising a pulse treatment device and a shock wave balloon catheter, the pulse treatment device comprising a first pulse discharge circuit and a second pulse discharge circuit; the shock wave balloon catheter comprising a first electrode assembly and a second electrode assembly; the first pulse discharge circuit is electrically connected with the first electrode assembly and can deliver a first pulse voltage to the first electrode assembly in a first pulse sequence; the second pulse discharge circuit is electrically connected with the second electrode assembly and can deliver a second pulse voltage to the second electrode assembly in a second pulse sequence. The application can control the discharge of different electrode assemblies independently, can select the discharge of the electrode assemblies alone or in combination according to the treatment requirements, and makes the discharge form flexible and controllable; meanwhile, under the premise of ensuring the shock wave treatment effect, the requirements for the voltage peak value and the pulse current are reduced, so that the heat generated on the electrode assembly can be effectively reduced, and the service life of the electrode assembly is prolonged.

Description

Technical Field

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

[0002] Cardiovascular disease has long been a leading cause of death worldwide. Balloon angioplasty plays a crucial role in reducing the incidence and mortality of obstructive coronary artery disease and has become the most common treatment for coronary heart disease globally. Simultaneously, balloon angioplasty is also a primary method for revascularization in patients with peripheral artery disease. Currently, balloon angioplasty for calcified lesions typically requires high pressure, which, while treating the calcified lesions, often damages the vessel wall due to the high pressure.

[0003] Intravascular shockwave therapy is a technique that applies traditional electrohydraulic lithotripsy to treat vascular calcification. It consists of two parts: a shockwave balloon catheter and a pulse therapy device. The shockwave balloon catheter places one or more pairs of discharge electrode assemblies within a conventional angioplasty balloon. These electrode assemblies are electrically connected to the shockwave therapy device. The pulse therapy device applies high-voltage pulses to the electrode assemblies, causing them to release shockwaves. These shockwaves propagate through the liquid medium within the balloon, selectively destroying calcified lesions in the blood vessel without damaging the normal vessel wall.

[0004] Existing shockwave therapy systems typically connect different electrode components in series, then deliver pulsed voltages to each component via a single discharge channel. While this method offers the advantage of simple discharge control, it suffers from a single discharge mode and mutual interference between electrode components. A failure in one component can affect the operation of all others, failing to meet diverse clinical needs. Furthermore, the more electrode components connected in the same discharge circuit, the higher the required breakdown voltage, impacting discharge stability. Summary of the Invention

[0005] Based on this, the present invention provides an intravascular shockwave therapy system that independently controls the discharge of different electrode components according to independent pulse sequences.

[0006] The purpose of this invention is to provide an intravascular shockwave therapy system, comprising a pulse therapy device and a shockwave balloon catheter, wherein the pulse therapy device includes a first pulse discharge circuit and a second pulse discharge circuit; and the shockwave balloon catheter includes a first electrode assembly and a second electrode assembly.

[0007] 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 via a first pulse sequence. 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 via a second pulse sequence.

[0008] Furthermore, the first pulse sequence includes multiple first discharge waveforms, and the second pulse sequence includes multiple second discharge waveforms;

[0009] 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.

[0010] Furthermore, the intravascular shockwave 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 multiple pulse cycles;

[0011] The pulse cycle includes a discharge cycle and a pause cycle. In each discharge cycle, the first pulse discharge circuit delivers a first pulse voltage to the first electrode assembly with the parameters of the first discharge waveform, and the second pulse discharge circuit delivers 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. The pause cycle lasts for 0.5-2s.

[0012] 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.

[0013] 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; the magnitude of the voltage amplitude decrease is 10-50V.

[0014] Furthermore, within the same discharge cycle, the first discharge waveform and the second discharge waveform have a time interval of 50-1ms.

[0015] Furthermore, the number of pulse cycles is 5-20.

[0016] 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.

[0017] The pulse therapy device also includes a high-voltage pulse power supply, which is connected to the first pulse discharge circuit and the second pulse discharge circuit respectively. The high-voltage pulse power supply is used to charge the first energy storage capacitor C1 and the second energy storage capacitor C2.

[0018] 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.

[0019] Furthermore, the pulse therapy device also includes a processor connected to the first switch K1 and the second switch K2, and the processor is used to control the on and off states of the first switch K1 and the second switch K2.

[0020] Furthermore, the shockwave balloon catheter also includes a catheter assembly and a balloon. The catheter assembly includes an outer tube and an inner tube that passes through the inner lumen of the outer tube, with the distal end of the inner tube extending out from the distal end of the outer tube.

[0021] The balloon is wrapped around the outside of the inner tube that extends from the outer tube, and the proximal end of the balloon contracts to communicate with the annular channel formed between the outer tube and the inner tube;

[0022] The first electrode assembly and the second electrode assembly are disposed inside the balloon, which 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.

[0023] The intravascular shockwave therapy system provided by this invention allows for independent discharge control of different electrode components. It enables the selection of individual or combined discharge of electrode components based on treatment needs, resulting in flexible and controllable discharge patterns. Compared to technical solutions that connect multiple electrode components in series within the same pulse discharge circuit, this system reduces the requirement for breakdown voltage while achieving ideal therapeutic effects. It also lowers the peak discharge voltage and pulse current, effectively reducing heat generation on the electrode components, thereby minimizing ablation and extending their lifespan. Attached Figure Description

[0024] 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.

[0025] Figure 1 This is a schematic diagram of the intravascular shockwave therapy system in the first embodiment of the present invention.

[0026] Figure 2 This is a schematic diagram of the circuit connection of the intravascular shockwave therapy system in the first embodiment of the present invention.

[0027] Figure 3 This is an example waveform of multiple pulse cycles of the intravascular shockwave therapy system in the first embodiment of the present invention. Detailed Implementation

[0028] The technical solution of the present invention will be clearly and completely described below with reference to the embodiments. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. 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.

[0029] In this instruction manual, the proximal end refers to the end closer to the operator during the procedure, and the distal end refers to the end further away from the operator during the procedure.

[0030] refer to Figure 1 , Figure 2 The first embodiment of the present invention provides an intravascular shockwave therapy system, comprising:

[0031] The pulse therapy device 100 includes a high-voltage pulse power supply 110, a first pulse discharge circuit 120, and a second pulse discharge circuit 130. 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.

[0032] The shockwave balloon catheter 200 includes a catheter assembly 210, a balloon 220, a first electrode assembly 230, and a second electrode assembly 240. The catheter assembly 210 includes an outer tube 211 and an inner tube 212 that passes through the inner lumen of the outer tube 211. The distal end of the inner tube 212 extends from the distal end of the outer tube 211. The balloon 220 surrounds the outer tube 212 that extends from the outer tube 211, and its proximal end is sealed and connected to the 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 inside the balloon 220 and are fixed to the inner tube 212.

[0033] The first pulse discharge circuit 120 is electrically connected to the first electrode assembly 230 via a wire and can deliver 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 deliver a second pulse voltage to the second electrode assembly 230 in a second pulse sequence.

[0034] The intravascular shockwave therapy system provided by this invention allows a high-voltage pulse power supply 110 to charge a first energy storage capacitor C1 and / or a 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; 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 this invention enables individual control of the first electrode assembly 230 and the second electrode assembly 240, ensuring that the discharges between different electrode assemblies do not interfere with each other, thus allowing for flexible control according to clinical needs.

[0035] The previous method of discharging different electrode components using the same energy storage capacitor required waiting for the energy storage capacitor to be recharged after discharging one electrode component before discharging the next electrode component. The present invention, by setting a first energy storage capacitor C1 and a second energy storage capacitor C2, can discharge the first electrode component and the second electrode component simultaneously without waiting for the energy storage capacitor to be recharged, thereby improving the flexibility of discharge.

[0036] Furthermore, the shockwave therapy device also 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 / off state of the first switch K1 and the second switch K2.

[0037] Further, refer to Figure 3The first pulse sequence includes multiple first discharge waveforms V1, and the second pulse sequence includes multiple second discharge waveforms V2. The voltage amplitude of the first and second discharge waveforms is 900-5000V, the pulse voltage width is 1-50μs, and the rise time of the voltage amplitude is 200-500ns. The pulse sequence parameters provided by this invention enable the voltage to rise rapidly, thereby achieving better therapeutic effects under lower voltage conditions. The rise time of the voltage amplitude is set within this range, resulting in a large gradient in the generation of the shock wave, which allows for sufficient reflection when passing through the surfaces of media with different acoustic impedances, thus better fracturing of calcified plaques.

[0038] It should be noted that the intravascular shockwave therapy system provided by the present invention can perform combined discharges on the first electrode assembly 230 and the second electrode assembly 240 during use. In this embodiment, the intravascular shockwave therapy system delivers a first pulse voltage and a second pulse voltage to the first electrode assembly 230 and the second electrode assembly 240 respectively with parameters of multiple pulse cycles.

[0039] 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 supplies 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 supplies 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 lasts for 0.5-2s.

[0040] During the time corresponding to the first discharge waveform in 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 cycle 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.

[0041] During the second discharge waveform time corresponding to 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 cycle 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.

[0042] This solution sets the pulse discharge sequence of the first electrode assembly 230 and the second electrode assembly 240 within the aforementioned range, enabling the first electrode assembly 230 and the second electrode assembly 240 to rapidly release shock wave energy during the discharge phase, achieving a better calcification fragmentation effect. Setting the pulse period within the aforementioned parameter range allows for combined discharge of the first electrode assembly 230 and the second electrode assembly 240, enabling continuous discharge of both. This achieves a good therapeutic effect without mutual interference during the discharge process. A 50μm interval is set between the first discharge waveform V1 and the second discharge waveform V2. The s-10ms time interval can avoid simultaneously discharging the first electrode assembly 230 and the second electrode assembly 240 without affecting the operation time, thus avoiding the burden on the circuit. After completing one discharge of the first electrode assembly 230 and the second electrode assembly 240, a discharge pause time of 0.5-2s can be set to quickly charge the first energy storage capacitor C1 and the second energy storage capacitor C2, thereby ensuring the effect of the next discharge. At the same time, during the pause period after the electrode assembly discharge, the electrode assembly and the liquid medium inside the balloon can be cooled down, thereby avoiding damage to tissue cells and the electrodes themselves due to excessive temperature.

[0043] 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 electrode assemblies in series, this solution can reduce the voltage amplitude and pulse current of a single electrode assembly discharge while achieving the same calcification and fragmentation effect within one pulse cycle for the first electrode assembly 230 and the second electrode assembly 240, thereby reducing the wear on the electrode assembly.

[0044] Furthermore, within the same discharge cycle, the first discharge waveform V1 and the second discharge waveform V2 have a time interval of 50μs - 1ms.

[0045] This is because after the first pulse discharge circuit discharges, there is a residual voltage in the circuit. Discharging the second electrode assembly after 50μs can fully release the residual voltage in the circuit, so as not to affect 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 improve the treatment effect.

[0046] Furthermore, the duration of each pause cycle is 0.8-1.2 seconds. This approach achieves good cooling of the electrode assembly and the fluid environment within the balloon while minimizing surgical operation time.

[0047] It should be noted that in this invention, the first discharge waveform and the second discharge waveform can be the same or different.

[0048] In a preferred embodiment of the present invention, the voltage amplitudes of multiple first discharge waveforms in the first pulse sequence decrease sequentially; the voltage amplitudes of multiple second discharge waveforms in the second pulse sequence decrease sequentially; the decrease in voltage amplitude is 10-50V. As the treatment progresses, the calcified plaques in the blood vessels gradually loosen, and the required shock wave energy gradually decreases. This scheme, by setting the voltage amplitudes of the discharge waveforms in each pulse sequence to gradually decrease, can better match the treatment process of calcified lesions, making the treatment more precise.

[0049] Furthermore, the number of pulse cycles is 5-20. Within this parameter range, it can achieve good therapeutic effects on calcified lesions.

[0050] Furthermore, the shockwave balloon catheter provided by this invention has a balloon length of 6-20 mm and a radial dimension of 2.0-5.0 mm after balloon inflation. The shockwave balloon catheter provided by this solution incorporates two independently controlled electrode assemblies, making it particularly suitable for the treatment of intravascular calcification lesions in the coronary arteries.

[0051] The above embodiments are only used to illustrate the technical solutions of the present invention, and are not intended to limit it. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features therein. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. An intravascular shockwave therapy system, characterized in that, The device includes a pulse therapy device and a shockwave balloon catheter. The pulse therapy device includes a first pulse discharge circuit and a second pulse discharge circuit. The shockwave balloon catheter includes 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 via a first pulse sequence; 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 via a second pulse sequence. The first pulse sequence includes multiple first discharge waveforms, and the second pulse sequence includes multiple second discharge waveforms; The voltage amplitude of the first discharge waveform and the second discharge waveform is 2000-2300V, the pulse voltage width is 5-20μs, and the rising edge of the voltage amplitude is 200-500ns. The intravascular shockwave 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 multiple pulse cycles; The pulse cycle includes a discharge cycle and a pause cycle. In each discharge cycle, the first pulse discharge circuit delivers a first pulse voltage to the first electrode assembly with the parameters of the first discharge waveform, and the second pulse discharge circuit delivers a second pulse voltage to the second electrode assembly with the parameters of the second discharge waveform. In the same discharge cycle, the first discharge waveform and the second discharge waveform have a time interval of 50μs-1ms. In the pause cycle, the first pulse discharge circuit and the second pulse discharge circuit stop discharging, and the pause cycle lasts for 0.5-2s.

2. The intravascular shockwave therapy system according to claim 1, 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 magnitude of the voltage amplitude decrease is 10-50V.

3. The intravascular shockwave therapy system according to claim 2, characterized in that, The number of pulse cycles is 5-20.

4. The intravascular shockwave 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 therapy device also includes a high-voltage pulse power supply, which is connected to the first pulse discharge circuit and the second pulse discharge circuit respectively. The high-voltage pulse power supply 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.

5. The intravascular shockwave therapy system according to claim 4, characterized in that, The pulse therapy device further includes a processor, which is connected to the first switch K1 and the second switch K2. The processor is used to control the on and off states of the first switch K1 and the second switch K2.

6. The intravascular shockwave therapy system according to claim 5, characterized in that, The shockwave balloon catheter also includes a catheter assembly and a balloon. The catheter assembly includes an outer tube and an inner tube that passes through the lumen of the outer tube, with the distal end of the inner tube extending out from the distal end of the outer tube. The balloon is wrapped around the outside of the inner tube that extends from the outer tube, and the proximal end of the balloon contracts 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 disposed inside the balloon, which 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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