Intravascular shock wave treatment system

Abstract

The invention provides an intravascular shock wave treatment system which comprises a shock wave balloon catheter and a pulse treatment device, the shock wave balloon catheter comprises a catheter assembly, a balloon and N electrode assemblies, the catheter assembly is wrapped with the balloon, the N electrode assemblies are arranged in the balloon, and when the balloon is in a full state, the N electrode assemblies are arranged in the balloon. The maximum radial size of the balloon ranges from 2.5 mm to 12 mm, and the length of the balloon ranges from 40 mm to 150 mm. The pulse treatment equipment comprises M pulse discharge circuits, M > = N, and 3 < = N < = 10; each electrode assembly is independently connected with one pulse discharging circuit, and the pulse discharging circuits transmit pulse voltage to the corresponding electrode assemblies in a pulse sequence mode. According to the shock wave treatment system provided by the invention, independent control on different electrode assemblies can be realized, and the flexibility of discharge is improved.

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] The intravascular shock wave therapy system used to treat peripheral vascular calcification lesions has a shock wave balloon catheter with a larger balloon axial size compared to the balloon catheter used to treat coronary artery calcification lesions. More than three electrode assemblies are usually evenly arranged in the balloon along the axial direction of the catheter, thereby obtaining a better treatment effect.

[0005] However, when there are a large number of electrode assemblies in the balloon, the discharges between different electrode assemblies may affect each other. Summary of the invention

[0006] 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, thereby extending the service life of each electrode assembly while achieving an ideal treatment effect.

[0007] The object of the present invention is to provide an intravascular shock wave therapy system, comprising: A shock wave balloon catheter, comprising a catheter assembly, a balloon and N electrode assemblies, wherein the balloon is wrapped outside the catheter assembly, and the N electrode assemblies are arranged inside the balloon. When the balloon is in a filled state, the maximum radial dimension of the balloon is 2.5-12 mm, and the length is 40-150 mm; A pulse therapy device, the pulse therapy device comprising M pulse discharge circuits, wherein M≥N, and 3≤N≤10; Each of the electrode assemblies is individually connected to a pulse discharge circuit, and the pulse discharge circuit delivers a pulse voltage to the corresponding electrode assembly in a pulse sequence.

[0008] Furthermore, when the balloon is in a filled state, the maximum radial dimension of the balloon is 2.5-4.0 mm, the length is 60-80 mm, and N=4 or 5.

[0009] Furthermore, the pulse sequence of each pulse discharge circuit includes 4-20 discharge waveforms; the voltage amplitude of the 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 pulse sequence of each pulse discharge circuit includes 4-20 discharge waveforms; the voltage amplitude of the discharge waveform is 900-5000V, the pulse voltage width is 1-50μs, and the rising edge of the voltage amplitude is 200-500ns.

[0011] Furthermore, the voltage amplitude of the discharge waveform of each pulse sequence is 2000-2300V, and the pulse voltage width is 5-20μs.

[0012] Furthermore, the voltage amplitudes of the multiple discharge waveforms of the same pulse sequence decrease in sequence; the voltage amplitude decreases by 10-50V.

[0013] Furthermore, when the pulse discharge circuit transmits pulse voltages to the corresponding electrode assemblies respectively, the discharge waveforms of the electrode assemblies are spaced at least 50 μs apart.

[0014] Furthermore, the system includes multiple discharge circuit groups, each of which includes 1-4 pulse discharge circuits, and the interval between discharge waveforms of each pulse discharge circuit in the same discharge circuit group is 50μs-10ms; the interval between two adjacent discharge waveforms in different discharge circuit groups is 0.5-2s.

[0015] Furthermore, there are 2 to 4 electrode assemblies in each discharge circuit group.

[0016] Furthermore, each of the pulse discharge circuits includes an energy storage capacitor and a switch; the pulse treatment device also includes a high-voltage pulse power supply, which is respectively connected to each of the pulse discharge circuits and is used to charge the energy storage capacitor in each of the pulse discharge circuits; When the switch in each of the pulse discharge circuits is turned on, the energy storage capacitor in the pulse discharge circuit discharges to the corresponding electrode assembly.

[0017] Further, 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 passes through 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 N electrode assemblies are arranged inside the balloon, and the balloon can be filled with a liquid medium. When a pulse voltage is applied to the N electrode assemblies respectively, the N electrode assemblies can respectively generate a liquid-electric effect, and release shock wave energy that can be transmitted through the liquid medium into the balloon.

[0018] The intravascular shock wave therapy system provided by the present invention can realize independent control of different electrode assemblies by discharging to corresponding electrode assemblies through different energy storage capacitors, and can realize discharge of each electrode assembly without waiting for the energy storage capacitor to be charged again, so that the shock wave therapy device provided by the present invention can discharge by combining different electrode assemblies according to treatment needs, thereby improving the flexibility of discharge. Dividing multiple pulse discharge circuits into different discharge circuit groups and discharging them in combination can carry out targeted discharge treatment according to clinical needs, while avoiding mutual influence between electrode assemblies; setting a time interval of 0.5-2s after the discharge is completed can cool down the electrode assembly and the liquid medium in the balloon while quickly charging the energy storage capacitor, thereby effectively reducing electrode loss and reducing damage to blood vessels. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] 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.

[0020] 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.

[0021] Figure 2 Schematic diagram of circuit connection of the intravascular shock wave therapy system in the first embodiment of the present invention.

[0022] Figure 3 FIG. 1 is a waveform diagram of a discharge sequence when five electrode assemblies are discharged in combination in the first embodiment of the present invention. DETAILED DESCRIPTION

[0023] 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.

[0024] 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.

[0025] refer to Figure 1 , Figure 2 The first embodiment of the present invention provides an intravascular shock wave therapy system, including a shock wave balloon catheter 100 and a pulse therapy device 200. The shock wave balloon catheter 100 includes a catheter assembly 110, a balloon 120 and five electrode assemblies 130. The balloon 120 is wrapped around the outside of the catheter assembly 110, and the five electrode assemblies 130 are arranged inside the balloon at intervals along the axial direction of the catheter assembly 110. When the balloon 120 is in a filled state, the maximum radial dimension of the balloon is 2.5-7.0 mm, and the length is 40-150 mm. The pulse treatment device 200 includes a pulse high voltage power supply 210 and five pulse discharge circuits 220; The five electrode assemblies are respectively connected to a pulse discharge circuit 220 , and the pulse discharge circuit 220 transmits a pulse voltage to the corresponding electrode assembly 130 in a pulse sequence.

[0026] It should be noted that, in the present invention, the number of electrode assemblies 130 can be 3, 4, 5, 6, 7, 8, 9, or 10. The intravascular shock wave therapy system provided by the present invention is particularly suitable for the treatment of peripheral vascular calcification lesions.

[0027] The number of pulse discharge circuits 220 can be the same as the number of electrode assemblies 130, or can be greater than the number of electrode assemblies 130. When the number of pulse discharge circuits is the same as the number of electrode assemblies, each pulse discharge circuit 220 is connected to an electrode assembly 130 to transmit a pulse voltage to the electrode assembly 130; when the number of pulse discharge circuits is greater than the number of electrode assemblies, each electrode assembly 130 is connected to a corresponding pulse discharge circuit 220, and the extra pulse discharge circuits can be used as reserved circuits for adapting to different shock wave balloon catheters.

[0028] Preferably, when the balloon provided by the present invention is in a filled state, the maximum radial dimension of the balloon is 2.0-4.0 mm, the length is 60-80 mm, and the number of electrode assemblies is 4 or 5. The shock wave therapy system provided by this solution can meet the treatment needs of most types of peripheral vascular calcification lesions.

[0029] refer to Figure 1 In this embodiment, the catheter assembly 110 includes an outer tube 111 and an inner tube 112 inserted into the inner cavity of the outer tube 111, and the distal end of the inner tube 112 passes through the distal end of the outer tube 111; the balloon 120 is wrapped around the outside of the inner tube 112 passing through the outer tube 111, and the proximal end of the balloon 120 is contracted to communicate with the annular channel formed between the outer tube 111 and the inner tube 112; the interior of the balloon 120 is provided with a first electrode assembly 131, a second electrode assembly 132, a third electrode assembly 133, a fourth electrode assembly 134 and a fifth electrode assembly 135, and the above five electrode assemblies 131, 132, 133, 134 and 135 are axially spaced on the outer wall of the inner tube 112, and the balloon 120 can be filled with a liquid medium. When a pulse voltage is applied to the five electrode assemblies respectively, the five electrode assemblies can respectively generate a liquid-electric effect, and release shock wave energy that can be transmitted through the liquid medium into the balloon 120.

[0030] refer to Figure 2 The pulse treatment device 200 includes a first pulse discharge circuit 221, a second pulse discharge circuit 222, a third pulse discharge circuit 223, a fourth pulse discharge circuit 224 and a fifth pulse discharge circuit 225. The first pulse discharge circuit 221 includes a first energy storage capacitor C1 and a first switch K1; the second pulse discharge circuit 222 includes a second energy storage capacitor C2 and a second switch K2; the third pulse discharge circuit 223 includes a third energy storage capacitor C3 and a third switch K3; the fourth pulse discharge circuit 224 includes a fourth energy storage capacitor C4 and a fourth switch K4; the fifth pulse discharge circuit 225 includes a fifth energy storage capacitor C5 and a fifth switch K5. The high-voltage pulse power supply 210 is respectively connected to the first pulse discharge circuit 221, the second pulse discharge circuit 222, the third pulse discharge circuit 223, the fourth pulse discharge circuit 224 and the fifth pulse discharge circuit 225, for charging the first energy storage capacitor C1, the second energy storage capacitor C2, the third energy storage capacitor C3, the fourth energy storage capacitor C4 and the fifth energy storage capacitor C5.

[0031] When the first switch K1 is turned on, the first energy storage capacitor C1 discharges to the first electrode assembly 131; when the second switch K2 is turned on, the second energy storage capacitor C2 discharges to the second electrode assembly 132; when the third switch K3 is turned on, the third energy storage capacitor C3 discharges to the third electrode assembly 133; when the fourth switch K4 is turned on, the fourth energy storage capacitor C4 discharges to the fourth electrode assembly 134; when the fifth switch K5 is turned on, the fifth energy storage capacitor C5 discharges to the fifth electrode assembly 135.

[0032] The present invention uses different energy storage capacitors to discharge to corresponding electrode assemblies, thereby realizing independent control of different electrode assemblies, and discharging of each electrode assembly can be realized without waiting for the energy storage capacitor to be charged again, so that the shock wave therapy device provided by the present invention can discharge by combining different electrode assemblies according to treatment needs, thereby improving the flexibility of discharge.

[0033] Furthermore, the shock wave therapy device also includes a processor 230, which is respectively connected to the first switch K1, the second switch K2, the third switch K3, the fourth switch K4 and the fifth switch K5, and is used to control the on and off of the first switch K1, the second switch K2, the third switch K3, the fourth switch K4 and the fifth switch K5.

[0034] Furthermore, the pulse sequence of each pulse discharge circuit discharging to the corresponding electrode assembly includes 4-20 discharge waveforms, the voltage amplitude of each discharge waveform is 1000-5000V, 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 shock waves has a larger gradient, so that when passing through the surface of the medium with different acoustic impedances, it can be fully reflected and better fracturing calcified plaques.

[0035] Furthermore, the voltage amplitude of the discharge waveform of each pulse sequence is 2000-2300V, and the pulse voltage width is 5-20μs. Compared with the prior art solutions, the intravascular shock wave therapy system provided by the present invention can reduce the requirements for the voltage peak during discharge, thereby effectively reducing the heat generated on the electrode assembly, reducing the loss of the electrode assembly, and extending the service life of the electrode assembly.

[0036] It should be noted that, in the present invention, the parameters of the discharge waveforms of different pulse sequences may be the same or different; the parameters of multiple discharge waveforms of the same pulse sequence may be the same or different.

[0037] Preferably, the voltage amplitudes of the multiple discharge waveforms of the same pulse sequence decrease in sequence; the voltage amplitude decreases by 10-50 V. As the treatment process progresses, 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, making the treatment more precise and avoiding unnecessary damage to the blood vessels caused by excessive energy.

[0038] Furthermore, when multiple pulse discharge circuits deliver pulse voltages to their corresponding electrode assemblies, the discharge waveforms of each pulse sequence are separated by at least 50 μs. The electrode assemblies provided by this solution will not discharge at the same time, thereby avoiding the burden on the circuit caused by simultaneous discharge.

[0039] Furthermore, the multiple pulse discharge circuits provided by the present invention can be formed into different discharge circuit groups for combined discharge. Specifically, each discharge circuit group includes 1-4 pulse discharge circuits, and the discharge waveforms of each pulse discharge circuit in the same discharge circuit group are spaced 50μs-10ms in sequence; the interval between two adjacent discharge waveforms of different discharge circuit groups is 0.5-2s. This scheme can combine the discharge of different electrode assemblies according to clinical treatment needs, thereby improving the flexibility of calcified lesion treatment; setting the discharge waveforms in the same discharge circuit group to be spaced 50μs-10ms in sequence can reduce the circuit burden without affecting the operation time; after completing the discharge of a discharge circuit group, setting a discharge pause time of 0.5-2s can quickly charge the energy storage capacitor that has completed the discharge, thereby ensuring the next discharge effect, and at the same time, the electrode assembly can be cooled down during this time, thereby avoiding damage to tissue cells and the electrode itself caused by excessive temperature.

[0040] Furthermore, the discharge waveforms in the same discharge circuit group are set to be spaced 50μs-1ms in sequence. This is because after the first pulse discharge circuit is discharged, 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 achieve better treatment effects.

[0041] It should be noted that the present invention can combine and discharge different pulse discharge circuits according to treatment needs. It is only necessary to set the number of pulse discharge circuits in each discharge circuit group to no more than 4, and the number of discharge waveforms of each pulse discharge circuit to 4-20, that is, the discharge times of each electrode assembly shall not exceed its predetermined discharge times.

[0042] Furthermore, in order to simplify the discharge control steps, the plurality of pulse discharge circuits may be divided into a plurality of discharge circuit groups for cyclic discharge.

[0043] Furthermore, the interval between two adjacent discharge waveforms of different discharge circuit groups is 0.5-1s. Since different discharge circuit groups are set to discharge cyclically, there are multiple intervals for the electrode assembly to stop discharging after discharge. This solution can shorten the operation time as much as possible.

[0044] In this embodiment, reference Figure 2 , Figure 3 , the five pulse discharge circuits are divided into a first discharge group and a second discharge group, wherein the first discharge group includes a first pulse discharge circuit 221 and a second pulse discharge circuit 222, and the second discharge group includes a third pulse discharge circuit 223, a fourth pulse discharge circuit 224 and a fifth pulse discharge circuit 225; the interval t1 between the discharge waveform V1 of the first pulse discharge circuit 221 and the discharge waveform V2 of the second pulse discharge circuit 222 is 50μs, and the intervals between the discharge waveforms of the third pulse discharge circuit 223, the fourth pulse discharge circuit 224 and the fifth pulse discharge circuit 225 are 10μs respectively; the interval t2 between the discharge waveform V2 of the second pulse discharge circuit 222 and the discharge waveform V3 of the third pulse discharge circuit 223 is 1s. 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: include: A shock wave balloon catheter, comprising a catheter assembly, a balloon and N electrode assemblies, wherein the balloon is wrapped outside the catheter assembly, and the N electrode assemblies are arranged inside the balloon. When the balloon is in a filled state, the maximum radial dimension of the balloon is 2.5-12 mm, and the length is 40-150 mm; A pulse therapy device, the pulse therapy device comprising M pulse discharge circuits, wherein M≥N, and 3≤N≤10; Each of the electrode assemblies is individually connected to a pulse discharge circuit, and the pulse discharge circuit delivers a pulse voltage to the corresponding electrode assembly in a pulse sequence.

2. The intravascular shock wave therapy system according to claim 2, characterized in that: When the balloon is in a filled state, the maximum radial dimension of the balloon is 2.5-4.0 mm, the length is 60-80 mm, and N=4 or 5.

3. The intravascular shock wave therapy system according to claim 1, characterized in that: The pulse sequence of each pulse discharge circuit includes 4-20 discharge waveforms; the voltage amplitude of the discharge waveform is 900-5000V, the pulse voltage width is 1-50μs, and the rising edge of the voltage amplitude is 200-500ns.

4. The intravascular shock wave therapy system according to claim 3, characterized in that: The voltage amplitude of the discharge waveform of each pulse sequence is 2000-2300V, and the pulse voltage width is 5-20μs.

5. The intravascular shock wave therapy system according to claim 4, characterized in that: The voltage amplitudes of the multiple discharge waveforms of the same pulse sequence decrease in sequence; the voltage amplitude decreases by 10-50V.

6. The intravascular shock wave therapy system according to claim 3, characterized in that: When the pulse discharge circuit delivers pulse voltages to the corresponding electrode assemblies, the discharge waveforms of the electrode assemblies are spaced at least 50 μs apart.

7. The intravascular shock wave therapy system according to claim 6, characterized in that: The system comprises a plurality of discharge circuit groups, each of which comprises 1-4 pulse discharge circuits, the discharge waveforms of the pulse discharge circuits in the same discharge circuit group are spaced 50 μs-10 ms in sequence, and the intervals between two adjacent discharge waveforms in different discharge circuit groups are 0.5-2 s.

8. The intravascular shock wave therapy system according to claim 7, characterized in that: There are 2 to 4 electrode assemblies in each discharge circuit group.

9. The intravascular shock wave therapy system according to claim 1, characterized in that: Each of the pulse discharge circuits includes an energy storage capacitor and a switch; the pulse treatment device also includes a high-voltage pulse power supply, which is connected to each of the pulse discharge circuits respectively and is used to charge the energy storage capacitor in each of the pulse discharge circuits; When the switch in each of the pulse discharge circuits is turned on, the energy storage capacitor in the pulse discharge circuit discharges to the corresponding electrode assembly.

10. The intravascular shock wave therapy system according to claim 1, characterized in that: 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 passes through 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 N electrode assemblies are arranged inside the balloon, and the balloon can be filled with a liquid medium. When a pulse voltage is applied to the N electrode assemblies respectively, the N electrode assemblies can respectively generate a liquid-electric effect, and release shock wave energy that can be transmitted through the liquid medium into the balloon.

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