CN115051691A - High-voltage pulse generating device and shock wave generating system - Google Patents

Abstract

The present disclosure provides a high voltage pulse generating device, which includes a high voltage pulse generator and a processor. The high-voltage pulse generator comprises a high-voltage direct-current power supply, an energy storage capacitor and a discharge capacitor, wherein the high-voltage direct-current power supply is electrically connected with the discharge capacitor, the energy storage capacitor is configured to charge the discharge capacitor, and at least one protection switch is arranged on the positive pole and/or the negative pole of the high-voltage pulse generator. The processor is electrically connected with the high-voltage pulse generator and is used for controlling and processing data of the high-voltage pulse generator. The present disclosure also proposes a shock wave generating system comprising a shock wave balloon catheter device comprising a balloon, an inner tube, a guide wire and at least one shock wave electrode assembly and an outer tube, and a high voltage pulse generating device as described above.

Description

High-voltage pulse generating device and shock wave generating system

Technical Field

The present disclosure relates to a high voltage pulse generator and a shock wave generating system, and more particularly, to a shock wave generating system having an energy storage capacitor and a discharge capacitor.

Background

For a common hydroelectric shock wave generating system, for example, most of hydroelectric extracorporeal lithotripsy systems use a high-voltage direct-current power supply to fully charge a pulse capacitor, and then trigger an extracorporeal lithotripsy electrode filled with conductive liquid through a spark gap switch to generate shock waves.

In such a system, there are some problems as follows. Firstly, the shock wave energy is difficult to control because the pulse capacitor is directly discharged, the discharge time of the pulse capacitor cannot be controlled, the discharge time depends on the factors such as the capacity of the pulse capacitor, the electrode distance and the like, and secondly, the reliability requirements on the trigger switch and the electrode are higher. Spark gap switches and electrodes of the extracorporeal shock wave lithotripsy system need to be replaced after being used for a period of time, because the discharge energy is uncontrollable each time, the excessive energy release can accelerate ablation and carbonization of the spark gap switches and the electrodes to change the breakdown threshold voltage, the energy of the generated shock waves is unstable, the lithotripsy effect is influenced, and although the spark gap switches and the electrodes of the extracorporeal shock wave lithotripsy system are designed in a strengthening way.

When the conventional design is used for a shock wave generation system for angioplasty, the technical problems still exist, the energy is difficult to control, and the output is unstable. In addition, the electrode design of the angioplasty shock wave generation system is small, if the energy of the pulse capacitor is not limited in a reasonable range, the service life of the electrode is seriously shortened, and if the same trigger switch is used, the integration level of the system is low, the equipment is heavy, the trigger switch needs to be replaced periodically, and the reliability is poor.

Disclosure of Invention

The present disclosure provides a high voltage pulse generating device including a high voltage pulse generator and a processor. The high-voltage pulse generator comprises a high-voltage direct-current power supply, an energy storage capacitor and a discharge capacitor, wherein the high-voltage direct-current power supply is electrically connected with the discharge capacitor, the energy storage capacitor is configured to charge the discharge capacitor, and at least one protection switch is arranged on the positive pole and/or the negative pole of the high-voltage pulse generator. The processor is electrically connected with the high-voltage pulse generator and is used for controlling and processing data of the high-voltage pulse generator.

In one embodiment, the high voltage pulse generator further comprises at least one diode, at least one trigger switch and at least one resistor, and the positive pole and the negative pole of the high voltage pulse generator are respectively connected with a protection switch. The high-voltage direct-current power supply, the diode and the energy storage capacitor are connected in series to form a charging circuit. The positive pole of the energy storage capacitor is connected to the positive pole of the high-voltage pulse generator through a protection switch to form a positive pole passage of the discharge circuit, the negative pole of the energy storage capacitor is connected to the negative pole of the high-voltage pulse generator through a trigger switch, a resistor, the discharge capacitor and another protection switch which are connected in series to form a negative pole passage of the discharge circuit, the processor is connected with and controls the trigger switch and the two protection switches, the trigger switch is used for switching on or off the negative pole passage of the discharge circuit, and the protection switches are used for controlling whether the high-voltage pulse electric energy is output outwards through the positive pole and the negative pole of the high-voltage pulse generator.

In one embodiment, the high voltage pulse generator comprises at least two discharge capacitors, which are connected in parallel.

In one embodiment, the capacity of the energy storage capacitor is greater than the capacity of the discharge capacitor; the capacity range of the energy storage capacitor is as follows: 0.0001uF-10 uF; the capacity range of the discharge capacitor is 0.0001uF-1uF, the range of the output pulse voltage of the high-voltage pulse generating device is 500V-10000V, and the pulse width is 0.1 mus-10 mus; the range of the output pulse current of the high-voltage pulse generating device is 20A-500A, and the pulse width is 0.1-3 mus.

In one embodiment, the high voltage pulse generator further comprises a display screen and an interactive control module, the display screen and the interactive control module are electrically connected with the processor, and the display screen and the interactive control module are configured to set an activation button to prevent accidental discharge of the high voltage pulse generator.

In one embodiment, the high voltage pulse generator further comprises a voltage and current sampling circuit, the voltage and current sampling circuit is respectively electrically connected with the processor and the high voltage pulse generator, the voltage and current sampling circuit is configured to collect the output voltage of the high voltage pulse generator and/or the current between the positive pole and the negative pole of the high voltage pulse generator in real time, and the processor is configured to judge whether the output voltage is within an expected range and/or whether the current is zero and turn on or off the trigger switch and/or the protection switch.

The present disclosure also provides a shock wave generating system comprising a shock wave balloon catheter device and a high voltage pulse generating device as described in any of the preceding embodiments. The shock wave balloon catheter device includes a balloon, an inner tube, a guide wire, at least one shock wave electrode assembly, and an outer tube. The inner tube runs through the sacculus, and the distal end of inner tube is connected with the distal end of sacculus. The wire extends in the axial direction of the shock wave balloon catheter device. The shock wave electrode assembly is disposed outside the inner tube, and the shock wave electrode assembly is connected to the high voltage pulse generator via a lead to apply high voltage pulse electric energy to the shock wave electrode assembly. The outer sleeve is arranged outside the inner tube and is connected with the near end of the saccule.

In one embodiment, the interior of the shockwave balloon catheter device is for being filled with an electrically conductive fluid, the shockwave electrode assembly comprises a positive electrode and a negative electrode, and the shockwave electrode assembly is configured to generate a high voltage pulse between the positive electrode and the negative electrode when connected to the high voltage pulse generating device and the high voltage pulse generating device discharges, thereby generating a shockwave in the balloon.

In one embodiment, a shock wave balloon catheter device includes a plurality of shock wave electrode assemblies arranged at intervals along an axial direction of an inner tube; a plurality of shock wave electrode assemblies arranged in series; the plurality of shock wave electrode assemblies are arranged in the same circumferential direction of the inner tube, or are arranged at an angle in the circumferential direction.

In one embodiment, the output sound pressure of the shock wave generating system is in a range of 0.1MPa to 20MPa and a width of 0.1 μ s to 3 μ s.

In one embodiment, when the processor determines that the output voltage and the current collected by the voltage and current sampling circuit are within a preset range and the shock wave balloon catheter device is normally connected with the high-voltage pulse generating device, the protection switch is closed, and further, the processor controls the trigger switch to be instantly closed and opened to control the output of the high-voltage pulse electric energy.

In one embodiment, the high voltage pulse generator is configured to be connected with the shock wave electrode assembly and apply high voltage pulse electric energy to the shock wave electrode assembly to generate shock waves, and the high voltage pulse generator further comprises a safety storage chip circuit connected with the processor, wherein the safety storage chip circuit is configured to store specification information of the shock wave electrode assembly and/or access state signals of the shock wave electrode assembly.

In the shock wave generation system of the embodiment of the disclosure, the pulse generation circuit of the high-voltage pulse generation device is additionally provided with the discharge capacitor circuit, after the energy storage capacitor fully charges the discharge capacitor, the voltage difference between two ends of the shock wave electrode assembly stops discharging because the voltage difference is lower than the breakdown threshold voltage, so that the shock wave electrode assembly is prevented from being applied with excessive shock wave energy under the condition that the electrodes generate the shock wave energy, and the service life is shortened. Furthermore, the discharge time of the energy storage capacitor is controlled by setting the charging time of the discharge capacitor, namely, the time required for stopping the discharge of the energy storage capacitor is set until the voltage difference between the positive electrode and the negative electrode is lower than the breakdown threshold voltage, so that the discharge time of the energy storage capacitor is controlled, the discharge energy of the energy storage capacitor is controlled, namely, the shock wave energy output by the shock wave electrode assembly is controlled, and meanwhile, the phenomenon that the trigger switch of the discharge circuit and the shock wave electrode assembly are impacted by too much shock wave energy to cause the reduction of the service life is avoided. The invention can improve the pulse current when the shock wave electrode component discharges by increasing the capacity of the discharge capacitor, thereby improving the output shock wave energy, and the system has higher safety without improving the voltage.

Drawings

To more clearly illustrate the technical solutions of the embodiments of the present disclosure, the drawings of the embodiments will be briefly introduced below, and it is apparent that the drawings in the following description relate only to some embodiments of the present disclosure and are not limiting to the present disclosure.

FIG. 1 is a schematic view of a shockwave generating system according to one embodiment of the present disclosure.

Fig. 2 is a schematic view of a balloon catheter device according to one embodiment of the present disclosure.

FIG. 3 is a perspective schematic view of a shockwave electrode assembly according to one embodiment of the present disclosure.

FIG. 4 is an exploded view of a shockwave electrode assembly according to one embodiment of the present disclosure.

Fig. 5A-5C are cross-sectional schematic views of shock wave balloon catheter devices according to some embodiments of the present disclosure.

Fig. 6 is a schematic diagram of a shock wave balloon catheter device having multiple shock wave electrode assemblies according to one embodiment of the present disclosure.

FIG. 7 is a schematic diagram of a connection of a shockwave electrode assembly to a high voltage pulse generator according to one embodiment of the present disclosure.

Fig. 8 shows the composition of the high voltage pulse generating device 110 of one embodiment of the present disclosure.

Fig. 9 shows a circuit schematic of the high voltage pulse generator 111 of one embodiment of the present disclosure.

Fig. 10 shows a circuit schematic of a high voltage pulse generator 111 of yet another embodiment of the present disclosure.

Fig. 11 is a schematic wire connection diagram of a shock wave balloon catheter device having multiple shock wave electrode assemblies according to one embodiment of the present disclosure.

Fig. 12 is a diagram of a connection of a shock wave balloon catheter device having multiple shock wave electrode assemblies and a high voltage pulse generator 111 according to one embodiment of the present disclosure.

FIG. 13 is a flow chart of safe operation of a shock wave generation system according to one embodiment of the present disclosure.

Detailed Description

The technical solutions in the embodiments of the present disclosure will be clearly and completely described below with reference to the drawings in the embodiments of the present disclosure, and it is obvious that the described embodiments are only a part of the embodiments of the present disclosure, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments disclosed herein without making any creative effort, shall fall within the protection scope of the present disclosure.

Unless otherwise defined, all terms (including technical and scientific terms) used in the embodiments of the present disclosure have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein.

The use of "first," "second," and similar terms in the embodiments of the disclosure is not intended to indicate any order, quantity, or importance, but rather to distinguish one element from another. The use of the terms "a" and "an" or "the" and similar referents do not denote a limitation of quantity, but rather denote the presence of at least one. Likewise, the word "comprising" or "comprises", and the like, means that the element or item listed before the word covers the element or item listed after the word and its equivalents, but does not exclude other elements or items. In the following description, spatial and orientational terms such as "upper", "lower", "front", "rear", "top", "bottom", "vertical" and "horizontal" may be used to describe embodiments of the present disclosure, but it should be understood that these terms are merely for convenience in describing the embodiments shown in the drawings, and do not require that the actual device be constructed or operated in a particular orientation. In the following description, the use of terms such as "connected," "coupled," "secured," and "attached" may refer to two elements or structures being directly connected without other elements or structures therebetween, or indirectly connected through intervening elements or structures, unless expressly stated otherwise herein.

For a common hydroelectric shock wave generating system, such as a hydroelectric extracorporeal lithotripsy system, most of the system adopts a high-voltage direct-current power supply to charge a high-voltage pulse capacitor, and the method has high requirements on the reliability of a trigger switch device. Although a spark gap switch is often used in a high-voltage pulse capacitor circuit, the problems that the energy is difficult to control and the output is unstable still exist after the spark gap switch is used are found, and the integration level is low, the equipment is heavy and the reliability is poor.

The inventors of the present disclosure found that when conventional techniques are improved, such as triggering with a transistor switch, although the switching time is controllable, the transistor switch is easily broken down and has a short life in the process of directly applying electric energy of a large-capacity pulse capacitor to a shock wave balloon catheter apparatus. In addition, in the case of the angioplasty shockwave balloon catheter device, in order to satisfy good passability, the electrode pair is usually designed to be very small. Thus, when the shock wave balloon catheter device is discharged, the electrode pair is easily damaged. This solution is far from meeting the expected life of the electrode. In addition, in order to improve the reliability of the transistor trigger switch, a certain resistance is connected in series with the transistor circuit to reduce the impact of strong pulse current on the trigger switch. However, if the resistance value of the resistor is set to be too small, a large amount of pulse current is consumed, so that the shock wave energy output by the electrode is reduced, and the expected shock wave energy cannot be achieved. The inventor also found that when the electrode saccule used for different electrode pair spacing discharges, the consistency of output energy also deteriorates, and the more obvious the difference of the electrode spacing is, the more obvious the difference of the output energy is.

The inventor of the present disclosure also finds that in the existing design, stronger pulse current is obtained by increasing pulse voltage, but the method has high requirement on the insulation property of the material, and in order to ensure the passability of the shock wave balloon catheter device, the thickness of the insulation material and the like are generally limited, so that increasing the voltage brings risk of electric shock hazard. The inventor finds that increasing the capacity of the discharge capacitor can increase the pulse current intensity at the moment of discharge, thereby generating stronger shock wave energy.

Embodiments of the present disclosure provide a shock wave generation system for angioplasty, which solves some of the above-mentioned problems, and the embodiments of the present disclosure and examples thereof will be described in detail below with reference to the accompanying drawings.

FIG. 1 is a schematic view of a shockwave generating system according to one embodiment of the present disclosure. Fig. 2 is a schematic view of a balloon catheter device according to one embodiment of the present disclosure. As shown in fig. 1, the shock wave generating system 100 includes a high voltage pulse generating device 110, a shock wave balloon catheter device 130, and a control switch 140. The shock wave balloon catheter device 130 is connected to the high voltage pulse generating device 110 by a lead 120. The control switch 140 is a switch that is controlled interactively from outside, and in one embodiment, the control switch 140 may be a foot switch. The details of the high voltage pulse generating device 110 and the lead 120 will be described later in detail. As shown in fig. 1 and 2, the shock wave balloon catheter device 130 includes an inner tube 131, a balloon 132, an outer tube 133, a guide wire 120, and a shock wave electrode assembly 200. The wire 120 extends in the axial direction of the shock wave balloon catheter device 130. The shock wave electrode assembly 200 is disposed on the inner tube 131, the details of which will be described later. In one embodiment, the number of shockwave electrode assemblies is multiple, as desired. The inner tube 131 extends through the balloon 132, and the distal end of the inner tube 131 is connected to the distal end of the balloon 132. In one embodiment, the distal end of balloon 132 is welded to inner tube 131. Outer tube 133 fits over the exterior of inner tube 131 and is connected to the proximal end of balloon 132. In one embodiment, a proximal portion of balloon 132 is welded to outer tube 133. The gap between the inner tube 131 and the outer tube 133 forms a channel for receiving the conductive fluid. Inside the balloon 132 is a liquid passage chamber 133.

FIG. 3 is a perspective schematic view of a shockwave electrode assembly according to one embodiment of the present disclosure. FIG. 4 is an exploded view of a shockwave electrode assembly according to one embodiment of the present disclosure. Fig. 5 is a cross-sectional schematic view of a shock wave balloon catheter device according to some embodiments of the present disclosure. As shown, the shockwave electrode assembly 200 includes an inner electrode 210, an outer electrode 230, and an insulating layer 220 positioned between the inner electrode 210 and the outer electrode 230. The inner electrode 210 has a protruding pin 212 formed on a surface thereof, and the insulating layer 220 has a first hole 222 formed therein. The outer electrode 230 is provided with a second hole 232, and the diameter of the second hole 232 is larger than that of the first hole 122. The protruding pin 212 extends through the first aperture 222 and into the second aperture 232. So that the inner electrode 210 and the outer electrode 230 constitute a discharge circuit. In one embodiment, the inner electrode 210 is a sheet, the outer electrode 230 and the insulating layer 220 are ring-shaped, and as shown in fig. 3 and 5A, the outer electrode 230 and the insulating layer 220 are coaxially arranged, and the outer electrode 230 is sleeved outside the insulating layer 220. The inner diameter of the outer electrode 230 matches the outer diameter of the insulating layer 120, thereby reducing the likelihood of relative movement.

According to the embodiment of the present disclosure, the protruding pin 212 is disposed on the surface of the inner electrode 210, and the protruding pin 212 extends through the first hole 222 and into the second hole 232, such that an annular gap is formed between the outer electrode 230 and the protruding pin 212, and the gap makes a discharge loop between the outer electrode 230 and the inner electrode 210. When the shockwave electrode assembly 200 is placed in a liquid, a suitable pulse voltage is applied to break down the filling liquid and generate an electrical spark to generate a shockwave. The shock wave travels through the liquid inside the balloon, striking the balloon wall and calcified areas. Repeated pulse can destroy the structure of a calcified focus, expand a narrow blood vessel without damaging surrounding soft tissues, and can avoid the problem of blood vessel wall injury caused by balloon expansion in the traditional angioplasty.

In the actual operation process, there may be a plurality of calcified lesions to be treated, so that a structure with a plurality of shock wave electrode assemblies may be adopted, thereby constructing a plurality of discharge regions on the shock wave balloon catheter device 130, on one hand, improving the capability of the shock wave balloon catheter device 130 to treat a plurality of calcified lesions simultaneously, and on the other hand, possibly improving the uniformity of the distribution of the shock waves in the circumferential space of the inner tube, thereby being beneficial to the treatment of calcified lesions. Fig. 5B and 5C show schematic cross-sectional views of balloon catheter devices provided with two or three shock wave electrode assemblies.

FIG. 6 is a schematic diagram of a connection of a shockwave electrode assembly to a high voltage pulse generator according to one embodiment of the present disclosure. In one embodiment, a plurality of shock wave electrode assemblies are arranged in series. A plurality of shock wave electrode assemblies 200 may be arranged within the shock wave balloon catheter device 130, the shock wave electrode assemblies 200 being connected in series to produce a shock wave in the axial direction of the first bore of each shock wave electrode assembly 200. The interior of balloon 132 may be inflated with a conductive fluid through the access lumen. The shockwave electrode assemblies 200 are disposed at intervals on the outer surface of the inner tube 131, and transmit electric current by connecting a plurality of wires. Series arrangement of two shockwave electrode assemblies as shown in fig. 6, a first wire 121 is connected to the protruding pin of the inner electrode of the shockwave electrode assembly 200A, and forms a loop with the outer electrode of the shockwave electrode assembly 200A through a conductive fluid, and a first shockwave is generated in the axial direction of the first hole of the shockwave electrode assembly 200A. A third wire 123 connects the outer electrode of the shock wave electrode assembly 200A with the inner electrode of the shock wave electrode assembly 200B, which forms a loop with the outer electrode of the shock wave electrode assembly 200B through the conductive fluid. A second shock wave is generated in the axial direction of the first hole of the shock wave electrode assembly 200B. A second wire 122 connected to the outer electrode of the shock wave electrode assembly 200B extends axially along the shock wave balloon catheter device 130 and is connected to the high voltage pulse generating device 110. A plurality of shock wave electrode assemblies may be arranged inside the balloon in a similar manner to generate shock waves in the axial direction of the first holes of the shock wave electrode assemblies 200.

FIG. 7 is a schematic diagram of a connection of a shockwave electrode assembly to a high voltage pulse generator according to one embodiment of the present disclosure. As shown in the figure, the shockwave electrode assembly 200 is connected to the high-voltage output positive and negative electrodes of the high-voltage pulse generator 111 of the high-voltage pulse generator 110 through the positive electrode wire 121 and the negative electrode wire 122, respectively. As described above, when the interior of the shockwave electrode assembly 200 is filled with the conductive fluid, the inner electrode 210 and the outer electrode 220 form a discharge circuit, and when high voltage pulse power is applied between the inner electrode 210 and the outer electrode 220 of the shockwave electrode assembly 200, the high voltage breaks down the conductive fluid between the inner electrode 210 and the outer electrode 220, thereby generating a shockwave. In one embodiment, the conductive fluid is physiological saline, contrast agent, or the like, or a mixture thereof.

Fig. 8 shows the composition of the high voltage pulse generating device 110 of one embodiment of the present disclosure. As shown, the high voltage pulse generator 110 includes a high voltage pulse generator 111, a processor 112, a display screen and interaction control module 113, a voltage and current sampling circuit 114, and a secure memory chip circuit 115. The high voltage pulse generator 111 provides high voltage pulse electrical energy to the shock wave balloon catheter device 130 for generating shock waves. The details of the high voltage pulse generator 111 will be described later. The processor 112 is a central control unit of the high voltage pulse generator 110, and is electrically connected to the high voltage pulse generator 111. The processor 112 is used for controlling and processing data of the high-voltage pulse generator 111, the display screen and interaction control module 113, the voltage and current sampling circuit 114 and the secure memory chip circuit 115. In some embodiments, the processor 112 may use a combination of one or more of a Microcontroller (MCU), a Digital Signal Processor (DSP), and a programmable gate array (FPGA). The display screen and interaction control module 113 is a data display and control input part of the high voltage pulse generator 110, and the display screen and interaction control module 113 is electrically connected with the processor 112 and receives data information processed by the processor 112 for control and information output. The display screen and the interactive control module 113 are provided with activation buttons to prevent the catheter from being damaged due to accidental high-voltage discharge in an inactivated state, for example, if the display screen and the interactive control module 113 are started by misoperation under the condition that the balloon is not filled with conductive liquid, the balloon can be burnt by discharge sparks, and for example, if the display screen and the interactive control module 113 are started by misoperation in the interventional therapy process, shock waves are not generated at the position of a lesion, and the like. The voltage current sampling circuit 114 is electrically connected to the processor 112 and the high voltage pulse generator 110, respectively. The voltage and current sampling circuit 114 is used for collecting the output voltage and current of the high-voltage pulse generator 110 in real time, and after being processed by the processor 112, is used for controlling the output state of the high-voltage pulse generator 110, so that the safety and reliability of the system are improved. The voltage acquisition can detect whether the output voltage is in an expected range, for example, if the acquired voltage is too small, the voltage acquisition cannot play a role in treatment, if the acquired voltage is too large, the risk of electric shock is caused, under the above condition, the voltage acquired and detected by the circuit is too large or too small, and after the voltage is processed by the processor 112, the display screen and the interactive control module 113 give a prompt and do not output high voltage. The current collection is used to detect whether the shockwave balloon catheter device 130 is open-circuited, and if not protected in an open-circuit state, multiple discharges at the open-circuit point may be formed, which may cause electric shock injury or damage to human tissues due to temperature rise. The safety memory chip circuit 115 is used for providing specification information storage, life counting, output protection of the high voltage pulse generating device 110 and the like for the shock wave balloon catheter device 130. The safety memory chip circuit 115 is connected to the processor 112, and the safety memory chip circuit 115 is configured to store the specification information of the shockwave balloon catheter device 130 and also configured to set an access status signal of the shockwave balloon catheter device 130. In some embodiments, the secure memory chip circuit 115 may use a memory, a counter, a Microcontroller (MCU), or the like.

Fig. 9 shows a circuit schematic of the high voltage pulse generator 111 of one embodiment of the present disclosure. As shown in FIG. 9, the high voltage pulse generator 111 includes a high voltage DC power supply 111-0, an energy storage capacitor C1, a discharge capacitor C2, a diode D1-D2, a resistor R1-R5, a protection switch K1-K3, and a trigger switch Q1-Q2. The high-voltage direct current power supply 111-0 is a charging power supply of the energy storage capacitor C1, and may be a high-voltage DC-DC power supply, or a high-voltage direct current power supply that is rectified by a transformer through step-up rectification or multi-stage voltage doubling rectification, and in a preferred embodiment, the high-voltage direct current power supply 111-0 is selected from the high-voltage DC-DC power supply. The high voltage direct current power supply 111-0 can set an output voltage, for example, the charging voltage of the energy storage capacitor C1 can be adjusted to 0-10KV DC by setting the output voltage, and the energy storage capacitor charging circuit 111-1 is formed by the diode D1. In some embodiments, the energy storage capacitor C1 may use a high voltage film capacitor or a high voltage ceramic capacitor or a combination thereof. The diode D1 is used to protect the high voltage dc power supply 111-0 from reverse current surge, and the diode D2 is a freewheeling diode. In the embodiments K1, K2, and K3, relays are used, so D2 and R2 absorb the electromotive force generated by the coil when the relay K3 is turned off, and protect the circuit. K3 and R1 are used for releasing the internal residual voltage of energy storage capacitor C1, K3 disconnection when energy storage capacitor C1 discharges normally, close K3 after the discharge is finished, and the residual voltage at two ends of energy storage capacitor C1 is consumed through R1, thereby ensuring the safety of the system. The protection switches K1 and K2 are used for controlling whether the high-voltage pulse electric energy is output outwards through the positive electrode HV + of the high-voltage pulse generator 111 and the negative electrode HV-of the high-voltage pulse generator 111, the normally open relay is used in the embodiment, when the discharge circuit 111-2 is formed, the K1 and the K2 are in an off state, the high-voltage pulse generator 111 cannot convey the high-voltage pulse electric energy outwards, and the system safety can be improved. Here, for example, in a state where the shockwave balloon catheter device 130 of fig. 1 is not connected to the high-voltage pulse generator 111, the processor 112 recognizes whether the two are connected by providing the safety memory chip circuit 115 shown in fig. 8 to the shockwave balloon catheter device 130. If connected, the high voltage pulse generator 111 delivers high voltage pulse power to the shockwave balloon catheter device 130 by pre-closing the guard switches K1 and K2 by the processor 112 upon activation of the control switch 140 shown in FIG. 1. If the control switch 140 shown in fig. 1 is not connected, the high-voltage pulse power cannot be output to the outside even if the control switch K1 and the control switch K2 are in the off state, thereby ensuring the safety of the system. The resistor R3 is a residual voltage bleeder resistor of the discharge capacitor C2, and is connected in parallel with the discharge capacitor C2. R3 is set to megaohm (M omega) level, and ensures that the discharge circuit does not pass through the R3 path during discharge. After the discharge is finished, the residual voltage of the discharge capacitor is absorbed by the resistor R3, so that the voltage of the negative electrode HV-of the high-voltage pulse generator 111 is close to 0 potential, the voltage difference loaded on the positive electrode pair and the negative electrode pair is ensured to be in accordance with the expected voltage during the next discharge, and the output is more stable. In another embodiment, the R3 path may be added with a normally closed switch that opens during discharge and closes after discharge is complete. The R3 can also be set to a low resistance value, as shown in fig. 10 (the content of the figure will be described in detail later), a trigger switch Q4 is added to control the on/off of R3, and R3 can use a low resistance resistor to quickly consume the residual voltage of the discharge capacitor C2. Due to the arrangement, the device can cope with a high-frequency discharge scene (for example, 3 times of electricity discharge in 1 s), and can ensure that the residual voltage of the discharge capacitor C2 can be absorbed each time, so that the voltage difference between the positive electrode and the negative electrode is expected voltage during next discharge, and the output shock wave energy is more stable.

With continued reference to fig. 9, 111-2 is a discharge circuit having a positive path from the positive pole of the energy storage capacitor C1 through the protection switch K1 to the positive pole HV + of the high voltage pulse generator 111, and then through a positive electrode line at the shock wave balloon catheter device 130 to the positive pole. The negative pole path of the circuit is connected to the negative pole through the trigger switch Q1, the resistor R5, the current sensor 111-4, the discharge capacitor C2, the protection switch K2-HV-, and then the negative pole line of the shock wave balloon catheter device 130. The positive electrode path and the negative electrode path form a discharge circuit. The trigger switch Q1 is used to turn on or off the negative electrode path of the discharge circuit 111-2 (K1, K2 are already closed), and the resistor R5 is a charging resistor of the discharge capacitor C2. The discharge capacitor C2 is connected in series with the storage capacitor C1 during discharge, and the storage capacitor C1 charges the discharge capacitor C2 during discharge. When the discharge capacitor C2 is charged, the potential of the negative electrode is the same as the potential of the energy storage capacitor. When the voltage difference between the positive electrode and the negative electrode is lower than the breakdown voltage, the discharge is finished, so that the discharge of the energy storage capacitor C1 is stopped. The discharge time of the energy storage capacitor C1 is the time for charging the voltage of the discharge capacitor C2 until the voltage difference between the positive electrode and the negative electrode is lower than the breakdown voltage, and then the energy of the energy storage capacitor C1 can be effectively controlled. In another embodiment, the trigger switch Q1 controls the circuit to be turned on and off for 1 μ s through a logic device, so as to control the discharge time of the energy storage capacitor C1 to be 1 μ s. Even if the control precision deviates, the improved scheme can limit the energy of the energy storage capacitor C1, and avoid the phenomenon that the excessive energy is discharged to reduce the service life of the electrode and damage the trigger switch. And V0 is a voltage sampling point for collecting the positive voltage of the capacitor in real time. 111-4 is a current sensor, which may be a sampling resistor, an ac transformer, etc., for monitoring the current of the discharge circuit during discharge. After the voltage and current are collected by the voltage and current sampling circuit 114 shown in fig. 8, the collected voltage and current are processed by the processor 112, threshold parameters are set by programming of the processor, a voltage value is used for overvoltage protection or component self-inspection, and a current value is used for detecting whether an electrode line is broken or not. In one embodiment, an ionization circuit is also provided. As shown in fig. 9, the positive path of the ionization circuit coincides with the positive path of the discharge circuit from the positive pole of the energy storage capacitor C1 through the switch K1 to HV +, and then through the positive electrode line passing through the shockwave balloon catheter device 130 to the positive electrode. The negative electrode path of the ionization circuit is from the negative electrode of the energy storage capacitor to HV & lt- & gt through a trigger switch Q2, a resistor R4 and a protection switch K2, and is connected to the negative electrode through a negative electrode wire of the shock wave balloon catheter device 130, and the positive electrode and the negative electrode are connected through conductive liquid. The circuit formed by the positive and negative vias described above is referred to herein as an ionization circuit. The ionization circuit may provide a pretreatment for the conductive liquid, as will be described in detail below. It should be noted that the ionization circuit or the discharge circuit can be selectively used by triggering the closing of the switches Q1 and Q2.

In some embodiments, the energy storage capacitor C1 and the discharge capacitor C2 may use high voltage film capacitors or high voltage ceramic capacitors or a combination thereof. The protection switches K1-K3 and the trigger switches Q1-Q2 can be switched on and off by logic devices through relays, Insulated Gate Bipolar Transistors (IGBTs) or metal-oxide semiconductor field effect transistors (MOSFETs) and the like. In one embodiment, the capacity range of the energy storage capacitor C1 is: 0.0001uF-10 uF; the capacity range of the discharge capacitor C2 is 0.0001uF-1 uF. The output pulse voltage of the high voltage pulse generating device 110 is set to: 500V-10000V, the pulse width is 0.1 mus-10 mus; the output pulse current of the high-voltage pulse generator 110 is 20A-500A, and the pulse width is 0.1 mus-3 mus. In one embodiment, the output sound pressure of the shock wave generation system 100 is 0.1MPa to 20MPa and the width is 0.1 μ s to 3 μ s.

The high voltage pulse generator 111 according to the embodiment of the present disclosure, the specific operation thereof is explained as follows: when the high voltage pulse generator 111 is activated, the high voltage dc power supply 111-0 charges the energy storage capacitor C1 to a desired voltage. At this time, the processor 112 performs a system check on the high voltage pulse generator 110, and the processor 112 detects the voltage value of V0 to determine whether the voltage value meets the expected voltage. If the connection is met (no voltage output or output voltage exceeding the expected voltage appears), whether the electrode saccule is normally connected or not is judged. If the electrode saccule is determined to be normally connected, the protection switches K1 and K2 shown in fig. 9 are pre-closed, and the potential from the positive electrode to the positive electrode of the circuit (including the ionization circuit and the discharge circuit 111-2) is the same as the potential of the energy storage capacitor. The switch Q2 is controlled to be conductive by the start-up logic control device, and the conduction time is set to be 1ms in the embodiment, namely, the ionization time of the start-up ionization circuit is 1 ms. It is contemplated that the voltage across resistor R4 will be divided to apply a non-disruptive low voltage across the positive and negative electrodes, causing ionization of the conductor fluid around the positive and negative electrodes for 1ms, followed by the disconnection of Q2. At the moment, the ion content of the conductive fluid between the positive electrode and the negative electrode is increased, and higher pulse current can be obtained during breakdown. The Q1 is then turned on by the logic device to start the discharge circuit. At this time, a desired voltage is applied between the positive and negative electrodes, and breakdown occurs between the positive and negative electrodes, thereby forming a discharge circuit. Meanwhile, the energy storage capacitor C1 charges the energy storage capacitor C2. When the energy storage capacitor C2 is charged to a certain voltage, the voltage is the same as the potential of the negative electrode. When the voltage difference between the positive and negative electrodes is lower than the breakdown voltage, the discharge ends. The discharge time of the energy storage capacitor C1 is described as an example, for example, the initial expected voltage is 3000V for the positive electrode, 0V for the negative electrode, and 3000V for the initial potential difference between the positive and negative electrodes. Assuming that the lowest breakdown voltage is 500V, when a discharge circuit is formed, starting to discharge until a discharge capacitor is charged to 2500V, namely the potential of a negative electrode is 2500V, the potential difference of the positive electrode and the negative electrode is 500V, and just reaching the lowest breakdown voltage; if the discharge is continued and the potential difference between the positive electrode and the negative electrode is lower than the breakdown voltage, the discharge is ended. Therefore, the discharging time of the energy storage capacitor C1 is the time for charging the discharging capacitor C2 from 0V to 2500V, and the time is set by configuring the capacitance value of the discharging capacitor C2 and the resistance value of the resistor R5. After the discharge is finished, Q1 is switched off, and the residual voltage of the discharge capacitor C2 is consumed through the resistor R3, so that the potential of the negative electrode is 0V and the potential difference of the positive electrode and the negative electrode is expected voltage at the next discharge. During the discharging process, the current sensor 111-4 collects the pulse current to detect the condition of the electrode, if the current is lower than a preset value, for example, 50A, the electrode performance is reduced or the electrode is disconnected, and the processor 112 shown in fig. 8 prompts an operator through the processor 112, so that the reliability of the system is improved. After the discharge is completed, the logic control unit turns off the switches K1 and K2. The residual voltage of the energy storage capacitor C1 is consumed through R1 when the K3 is closed, and the system safety is improved. This disclosure is through carrying out circuit improvement to high-voltage pulse generating device 110, discharge capacitance circuit has been designed, time through setting up for discharging the electric capacity charge is in order to realize controlling energy storage capacitance discharge time, switching device and electrode have been avoided to stand uncontrollable energy and influence the life-span, damaged even, the reliability of system has been improved, meanwhile, through the capacity that increases discharge capacitance and set up ionization circuit can improve impulse current when shock wave sacculus pipe device 130 discharges, and then improve the shock wave energy of shock wave sacculus pipe device 130 output, need not to improve voltage, make the security of system higher.

In addition, the capacity of the energy storage capacitor C1 is set to be much larger than that of the discharge capacitor C2. This ensures that the energy storage capacitor C1 can fully charge the discharge capacitor C2 during the instant on/off of the trigger switch, and at the instant when the trigger switch Q1 is turned on, the energy storage capacitor C1 immediately charges the discharge capacitor C2, and the two ends of the discharge capacitor C2 are connected to the positive and negative electrodes of the shock wave electrode assembly 200, respectively. One end of the energy storage capacitor C1 reaches the positive electrode potential of the energy storage capacitor after being charged, and the other end of the energy storage capacitor C1 is 0 potential. The pressure difference between the two ends is applied between the positive electrode and the negative electrode, and the conductive fluid between the positive electrode and the negative electrode moves directionally by the strong electric field to form a discharge channel to generate shock waves. By controlling the charging time of the discharging capacitor C2, namely charging the discharging capacitor C2, until the voltage difference between the positive electrode and the negative electrode is lower than the breakdown voltage, the energy of the energy storage capacitor C1 is controllable, excessive energy is prevented from being applied to the electrode and the trigger device, the electrode and the trigger device work under the controllable energy, and the reliability is improved.

As shown in fig. 6 and 9 in conjunction, when the shock wave balloon catheter device 130 is arranged with a plurality of shock wave electrode assemblies as shown in fig. 6, the output shock wave energy may be weakened as the number of shock wave electrode assemblies increases. To solve this problem, the inventors of the present disclosure performed various capacity setting verification experiments on the discharge capacitor C2 of fig. 9. In one embodiment, the energy storage capacitor C1 is set to a capacity much larger than that of the discharge capacitor C2, which is set to 0.15 μ F in this embodiment, the capacity of the discharge capacitor C2 is fixed, which is set to 20nF in this embodiment, and the voltage is set to 2500V, and the average value of the pulse current of the pick-and-place circuit 111-2 is obtained through each set of 10 experiments. The results show that when the number of the shock wave electrode assemblies is 1, the average pulse current peak value is 190A, and the average sound pressure energy is 10.2 MPa; when the number of the shock wave electrode assemblies is 2, the average pulse current peak value is 148A, and the average sound pressure energy is 6 Mpa; when the number of the shock wave electrode assemblies is 4, the average pulse current peak value is 80A, and the average sound pressure energy is 2.3 MPa. It can be seen that as the number of the shock wave electrode assemblies increases, the pulse current of the discharge circuit 111-2 is significantly attenuated, but the output is still stable, and the shock wave energy is also attenuated. In another embodiment, the capacity of the storage capacitor C1 is kept constant and is set to 0.15 μ F. The capacity of the discharge capacitor C2 was increased, and 60nF was set in this embodiment. At the same voltage, 10 discharges were averaged for each shock wave balloon catheter device 130 having different numbers of shock wave electrode assemblies disposed. The results showed that when the number of the shock wave electrode assemblies was 1, the average pulse current peak was 270A, and the average sound pressure energy was 15.1 MPa; when the number of the shock wave electrode assemblies is 2, the average pulse current peak value is 178A, and the average sound pressure energy is 8.9 Mpa; when the number of the shock wave electrode assemblies is 4, the average pulse current peak value is 149A, and the average sound pressure energy is 6.3 MPa. It can be seen from the results of the above two embodiments that the output energy can be improved by keeping the capacity of the energy storage capacitor C1 unchanged and increasing the capacity of the discharge capacitor C2.

Thus, the high voltage pulse generator 111 according to the present disclosure provides a solution to the situation where energy is attenuated as the number of shockwave electrode assemblies 200 increases. When a certain number of shock wave electrode assemblies 200 are arranged on the shock wave balloon catheter device 130, under the condition of not increasing the output voltage, the capacity of the discharge capacitor C2 is increased, so that the output energy of the certain number of shock wave electrode assemblies 200 arranged on the shock wave balloon catheter device 130 is still stable, calcified plaques in blood vessels can be effectively broken, and the stability and the effectiveness are improved. Specifically, in adapting the shockwave balloon catheter device 130 for multiple shockwave electrode assemblies 200, rather than increasing the output voltage, only one suitable storage capacitor C1 capacity and discharge capacitor C2 capacity need be matched based on the shockwave electrode assemblies 200, greatly enhancing safety.

The aspects of the other embodiments may also be applied to the case where the energy is attenuated as the number of the shockwave electrode assemblies 200 increases. Fig. 10 shows a circuit schematic of a high voltage pulse generator 111 of yet another embodiment of the present disclosure. As can be seen from the figure, fig. 10 adds a discharge capacitor C3 on the basis of fig. 9, and the discharge capacitors C3 and C2 are connected in parallel. A trigger switch Q3 is also added to select whether the discharge capacitor C3 is connected to the discharge circuit. In one embodiment, discharge capacitor C2 is set to 20nF and discharge capacitor C3 is set to 30 nF. The shock wave balloon catheter device 130 uses an arrangement of 2 shock wave electrode assemblies 200 and 4 shock wave electrode assemblies 200, respectively. When only the energy storage capacitor C1 is selected to charge the discharge capacitor C2, and the output high-voltage pulse electric energy acts on the shock wave balloon catheter device 130 with 2 shock wave electrode assemblies 200, the generated shock wave energy can be stabilized within an expected range, namely about 6 MPa. When the high-voltage pulse electric energy generated by the discharge circuit 111-2 is applied to the shock wave balloon catheter device 130 configured with 4 shock wave electrode assemblies 200, the output pulse current is greatly attenuated, and the output shock wave energy is also attenuated to be lower than 3 Mpa. And when the Q1 is switched on, the Q3 is also switched on, and the discharge capacitors C2 and C3 are in a parallel connection state, namely the total capacity of the discharge capacitors is increased to 50 nF. When the high-voltage pulse electric energy generated by charging the discharge capacitor through the energy storage capacitor C1 is applied to the shock wave balloon catheter device 130 configured with 4 shock wave electrode assemblies 200, the output pulse current is increased, and the shock wave energy is further increased and stabilized at about 6 MPa.

In a preferred embodiment, the secure memory chip circuit 115 shown in FIG. 8 may be utilized and integrated into the shockwave balloon catheter device 130. When the shock wave balloon catheter device 130 is connected to the high voltage pulse generating device 110, the processor 112 of the high voltage pulse generating device 110 establishes communication with the secure memory chip circuit 115 of the shock wave balloon catheter device 130. The processor 112 reads information such as the specification of the connected shockwave balloon catheter device 130. When the trigger is started, the processor 112 automatically selects whether the trigger switch Q3 is turned on according to a preset program, so that the capacitance of the discharge circuit can be selected. For example, when the connected shockwave balloon catheter device 130 is configured as 2 shockwave electrode assemblies 200 and shockwave therapy is to be initiated, the processor 112 sets the trigger switch Q3 to the off state according to the read specification of the shockwave balloon catheter device 130, the energy storage capacitor C1 charges only the discharge capacitor C2, and the generated high-voltage pulse electric energy is transmitted to the shockwave balloon catheter device 130 to generate the shockwave energy at the desired setting. Similarly, when the shockwave balloon catheter device 130 arranged with 4 shockwave electrode assemblies 200 is switched on, the processor 112 drives the trigger switch Q3 to be switched on during discharging, so that the discharging capacitor C3 and the discharging capacitor C2 are in parallel, and the high-voltage pulse electric energy generated when the trigger switch Q1 is switched on is applied to the shockwave balloon catheter device 130 arranged with 4 shockwave electrode assemblies 200, so as to generate the shockwave energy according with the expected setting. In general, a plurality of trigger switches Q may be provided, and the switches may be connected to a discharge capacitor, and may be selectively connected to or disconnected from a reference capacitor of the discharge circuit. An appropriate discharge capacitance is selected to select a desired shock wave energy to accommodate shock wave balloon catheter devices of different number of shock wave electrode assembly configurations. By adding multiple sets of trigger switches, the information of the configured shockwave electrode assembly 200 is written into the secure memory chip. After identifying that the shock wave balloon catheter device 130 with different numbers of shock wave electrode assemblies is connected, the processor 112 controls the discharge capacitor to select different capacities so as to deal with calcified lesions with different distribution ranges. When the shock wave balloon catheter devices 130 with different numbers of shock wave electrode assemblies 200 are selected, stable and powerful shock wave energy can be output, the operation time is greatly shortened, and the lithotripsy efficiency is improved.

It should be noted that the solution of the above embodiment can also be used to cope with the case where the difference in the electrode pitch arrangement of the shockwave electrode assembly 200 is too large. This situation also results in a large and unstable difference in the energy output by shockwave electrode assembly 200. By matching an optimal discharge capacitance circuit to the shockwave electrode assemblies 200 so that the output energy of the shockwave balloon catheter device 130 is not attenuated, such as for calcified lesions with long distribution, when a plurality of shockwave electrode assemblies 200 are arranged, each shockwave electrode assembly 200 can generate stable and powerful shockwave energy, the treatment effectiveness can be improved, and the operation time can be saved.

In addition, there are alternatives to adjust the shock wave energy. In one embodiment, as shown in FIG. 10, an ionization circuit is provided to provide pretreatment for the conductive liquid. The positive electrode path of the ionization circuit is consistent with the positive electrode path of the discharge circuit, the negative electrode path of the ionization circuit is from the negative electrode of the energy storage capacitor to HV & lt- & gt through a trigger switch Q2, a resistor R4 and a switch K2, and is connected to the negative electrode through a negative electrode line of the shock wave balloon catheter device 130, and the positive electrode and the negative electrode are connected through conductive liquid. The Q2 switch is triggered to turn on the control circuit (under the condition that the switches K1 and K2 are pre-closed), and the resistor R4 is a voltage dividing resistor. A voltage dividing resistor is provided here to divide the desired voltage to a low voltage. When the low voltage acts on the positive and negative electrodes, breakdown does not occur, but the conductive liquid is ionized between the positive and negative electrodes, so that ions between the positive and negative electrodes are increased. When a desired voltage is subsequently applied between the positive and negative electrodes, a higher breakdown current will be obtained, resulting in a higher intensity of shock wave energy.

In one embodiment, the shock wave energy can be adjusted by adjusting the output voltage of the high voltage dc power supply 111-0, but increasing the voltage to a certain level may cause a certain shock risk problem. When the voltage reaches the risk edge of the breakdown of the insulating material, for example, the voltage of 5000V, the insulation of the shock wave balloon catheter device 130 is reduced, so that the shock wave balloon catheter device cannot play a role in preventing electric shock, and the shock wave energy cannot be increased by increasing the voltage. However, when the voltage is low, for example 2500V, the magnitude of the pulse current at the time of discharge can be increased by increasing the output voltage and thus increasing the capacity of the discharge capacitor, thereby increasing the shock wave energy.

In practice, the shock wave balloon catheter device 130 with multiple shock wave electrode assemblies 200 disposed thereon may apply shock wave energy to normal tissue while applying shock wave therapy at calcified plaque of a blood vessel. To avoid the occurrence of such a situation, the present disclosure provides a solution of the following embodiment. Fig. 11 is a schematic wire connection diagram of a shock wave balloon catheter device having multiple shock wave electrode assemblies according to one embodiment of the present disclosure. Fig. 12 is a diagram of a connection of a shock wave balloon catheter device having multiple shock wave electrode assemblies and a high voltage pulse generator 111 according to one embodiment of the present disclosure. The shock wave balloon catheter device 130 may be arranged as 1 or more shock wave electrode assemblies 200, and the shock wave electrode assemblies 200 and the lead may be connected as follows: one shockwave electrode assembly 200 is connected to a wire alone, two shockwave electrode assemblies 200 are connected to a wire, four shockwave electrode assemblies 200 are connected to a wire, etc. In one embodiment, three shock wave electrode assemblies 200 are arranged for one shock wave balloon catheter device 130, as shown in fig. 11. First shockwave electrode assembly 200A is connected by first lead 120A, and second shockwave electrode assembly 200B and third shockwave electrode assembly 200C are connected by second lead 120B. The inner electrode of the second shockwave electrode assembly 200B and the inner electrode of the third shockwave electrode assembly 200C are connected by wires to form a series configuration. The first and second wires are connected to the high voltage pulse generator 110 according to the connection method shown in fig. 12. Wherein the positive electrode wire and the negative electrode wire in the first lead are respectively connected with the first positive electrode HV1+ and the first negative electrode HV 1-of the high-voltage pulse generator 111. And the positive electrode line and the negative electrode line in the second lead are respectively connected with a second positive electrode HV2+ and a second negative electrode HV 2-of the high-voltage pulse generator 111. When the shock wave balloon catheter device 130 is inserted into a calcified plaque of a blood vessel, the calcified plaque is only distributed at the position opposite to the first shock wave electrode assembly 200A through radiography, and the second shock wave electrode assembly 200B and the third shock wave electrode assembly 200C correspond to normal tissues, so that shock wave energy does not need to be applied. The arrangement of the shockwave electrode assembly 200 and electrode leads has been pre-programmed with a safety memory chip circuit 115 as shown in fig. 8. When the shock wave balloon catheter device 130 so arranged is connected to the high voltage pulse generating device 110, the processor 112 recognizes the specification and jumps to the corresponding parameter control interface. It may be arranged to discharge first shockwave electrode assembly 200A or second and third shockwave electrode assemblies 200B and 200C, or to discharge three shockwave electrode assemblies 200. Specifically, when the first shockwave electrode assembly 200 is selected to discharge, the processor 112 of the high-voltage pulse generator 110 controls the switches K1 and K2 to be turned on in advance, and K3 and K4 are turned off, and after the trigger switch Q1 shown in fig. 9 is turned on, the high-voltage pulse power only applies the high-voltage pulse power to the first shockwave electrode assembly 200 through the first positive and negative electrode lines, so as to generate shockwaves and break calcified plaques opposite to the first shockwave electrode assembly 200. Similarly, the second shockwave electrode assembly 200B and the third shockwave electrode assembly 200C can be selected to apply pulse energy while the first shockwave electrode assembly 200A is not applied with pulse energy or the three shockwave electrode assemblies are all simultaneously applied with pulse energy to generate shockwaves, which is only illustrated by way of example, and in addition, the shockwave treatment can be determined to be applied only to the calcified vascular plaque after the imaging by the combination of the shockwave electrode assembly 200 and the conducting wire.

FIG. 13 is a flow chart of safe operation of a shock wave generation system according to one embodiment of the present disclosure. As shown in the figure, before starting to use the shock wave generating system 100, it is determined one by one whether to connect the shock wave balloon catheter device, activate the system, output voltage is expected, and start, if the answer to the above-mentioned problem is yes, the next operation is performed: and the protection switches K1 and K2 are switched on, Q1 is switched on, and high-voltage pulse electric energy is output. If the answer to the above-mentioned problem is no, the protection switches K1 and K2 are turned off so that the high voltage pulse power is not outputted. After the high-voltage pulse power is output, it is also necessary to determine whether the output current is greater than an output current threshold, for example, 60A, where the output current threshold may be set according to the actual application. If the answer is "yes", the process will return to the beginning and make the decision again. If the answer is 'no', the system prompts the shock wave balloon catheter device to fail, and then the protective switches K1 and K2 are disconnected, so that high-voltage pulse power is not output. The above-described safe operational flow design further enhances the safety and reliability of the shock wave generation system 100 of the disclosed embodiments.

The embodiment of the disclosure provides a shock wave generation system for angioplasty, in the system, a pulse generation circuit of a high-voltage pulse generation device is divided into an energy storage capacitor charging circuit and a discharging capacitor circuit through circuit improvement, and the energy of the energy storage capacitor is controllable through charging the discharging capacitor to the time when the voltage difference between a positive electrode and a negative electrode is lower than the breakdown voltage. This prevents excessive energy from being applied to the electrodes and the trigger device from operating at a controlled energy, improving reliability. Meanwhile, the capacity of the discharge capacitor is increased, so that the pulse current of the shock wave balloon catheter device during discharging can be improved, the shock wave energy output by the shock wave balloon catheter device is further improved, the voltage does not need to be increased, and the safety of the system is higher. The system enables the shock wave balloon catheter devices with different shock wave electrode assemblies 200 to be configured without attenuation of output energy by matching the shock wave balloon catheter devices with different arrangement numbers of shock wave electrode assemblies and larger difference of the distances between the shock wave electrode assemblies with an optimal discharge capacitance circuit. The system can also avoid the larger and unstable energy difference output by the shock wave sacculus conduit device with overlarge electrode distance arrangement difference by adding different discharge capacitor capacities and triggering switches and selecting circuits with different discharge capacitor capacities. In addition, the system can realize that different shock wave electrode assemblies 200 can be selected to discharge through the connection combination of the shock wave electrode assemblies 200, the system can realize the capability of targeted therapy on calcified plaques when being applied to calcified plaques with uneven distribution of calcification of blood vessels and output by selecting different lead groups, thereby avoiding normal calcified tissues from being applied with shock wave energy and improving the safety.

The following points need to be explained:

(1) the drawings of the embodiments of the disclosure only relate to the structures related to the embodiments of the disclosure, and other structures can refer to common designs.

(2) Without conflict, embodiments of the present disclosure and features of the embodiments may be combined with each other to arrive at new embodiments.

The above is only a specific embodiment of the present disclosure, but the scope of the present disclosure is not limited thereto, and the scope of the present disclosure should be determined by the scope of the claims.

Claims (12)

1. A high voltage pulse generating apparatus, comprising:

a high voltage pulse generator including an electrically connected high voltage DC power supply, an energy storage capacitor and a discharge capacitor, the high voltage DC power supply being a charging power supply for the energy storage capacitor, the energy storage capacitor being configured to charge the discharge capacitor, the positive and/or negative electrode of the high voltage pulse generator being provided with at least one protection switch, and

and the processor is electrically connected with the high-voltage pulse generator and is used for controlling and processing data of the high-voltage pulse generator.

2. The apparatus according to claim 1, wherein the high voltage pulse generator further comprises at least one diode, at least one trigger switch and at least one resistor, and a protection switch is connected to each of the positive and negative electrodes of the high voltage pulse generator;

the high-voltage direct-current power supply, the diode and the energy storage capacitor are connected in series to form a charging circuit;

the positive pole of energy storage capacitor is connected to through one the protection switch the positive pole of high voltage pulse generator is in order to form discharge circuit's positive pole route, the negative pole of energy storage capacitor is through series connection trigger switch, resistance, discharge capacitor and another the protection switch is connected to high voltage pulse generator's negative pole is in order to form discharge circuit's negative pole route, the treater is connected and is controlled trigger switch and two the protection switch, trigger switch is used for switching on or breaking discharge circuit's negative pole route, protection switch is used for controlling whether high-voltage pulse electric energy is through the positive pole and the negative pole of high voltage pulse generator outwards export.

3. The high voltage pulse generating apparatus according to claim 1, wherein said high voltage pulse generator comprises at least two of said discharge capacitors, at least two of said discharge capacitors being connected in parallel.

4. The high voltage pulse generating apparatus according to claim 1, wherein a capacity of said energy storage capacitor is larger than a capacity of said discharge capacitor; the capacity range of the energy storage capacitor is as follows: 0.0001uF-10 uF; the capacity range of the discharge capacitor is 0.0001uF-1uF, the range of the output pulse voltage of the high-voltage pulse generating device is 500V-10000V, and the pulse width is 0.1 mus-10 mus; the range of the output pulse current of the high-voltage pulse generating device is 20A-500A, and the pulse width is 0.1-3 mus.

5. The high voltage pulse generating device of claim 1, further comprising a display screen and an interactive control module, the display screen and interactive control module being electrically connected to the processor, the display screen and interactive control module configured to provide an activation button to prevent accidental discharge of the high voltage pulse generating device.

6. The high voltage pulse generator according to claim 1, further comprising a voltage-current sampling circuit electrically connected to the processor and the high voltage pulse generator, respectively, wherein the voltage-current sampling circuit is configured to collect an output voltage of the high voltage pulse generator and/or a current between a positive electrode and a negative electrode of the high voltage pulse generator in real time, and wherein the processor is configured to determine whether the output voltage is within a desired range and/or whether the current is zero and to turn on or off the trigger switch and/or the protection switch.

7. A shock wave generating system comprising a shock wave balloon catheter device and a high voltage pulse generating device according to any one of claims 1-6, the shock wave balloon catheter device comprising:

a balloon is arranged on the outer surface of the body,

an inner tube, the inner tube penetrates through the balloon, the distal end of the inner tube is connected with the distal end of the balloon,

a wire extending in an axial direction of the shockwave balloon catheter device,

at least one shock wave electrode assembly disposed outside the inner tube, the shock wave electrode assembly being connected with the high voltage pulse generator via the lead to apply high voltage pulse electric energy to the shock wave electrode assembly, and

the outer tube is sleeved outside the inner tube and connected with the near end of the balloon.

8. The shock wave generating system according to claim 7, wherein the interior of the shock wave balloon catheter device is for being filled with an electrically conductive fluid, the shock wave electrode assembly comprises a positive electrode and a negative electrode, and the shock wave electrode assembly is configured to generate a high voltage pulse between the positive electrode and the negative electrode when connected to the high voltage pulse generating device and the high voltage pulse generating device is discharged, thereby generating a shock wave in the balloon.

9. The shock wave generating system according to claim 7, wherein the shock wave balloon catheter device comprises a plurality of the shock wave electrode assemblies arranged at intervals along an axial direction of the inner tube; a plurality of said shockwave electrode assemblies arranged in series; the plurality of shock wave electrode assemblies are arranged in the same circumferential direction of the inner tube, or are arranged at an angle in the circumferential direction.

10. The shock wave generating system of claim 7, wherein the shock wave generating system has an output sound pressure in a range of 0.1MPa to 20MPa and a width in a range of 0.1 μ s to 3 μ s.

11. The shock wave generation system of claim 7, wherein when the processor determines that the output voltage and the current collected by the voltage and current sampling circuit are within a predetermined range and the shock wave balloon catheter device is normally connected to the high voltage pulse generator, the protection switch is closed, and further, the processor controls the trigger switch to be instantly closed and opened to control the output of the high voltage pulse power.

12. The shock wave generation system of claim 7, wherein the high voltage pulse generation device is configured to couple to the shock wave electrode assembly to apply high voltage pulse electrical energy to the shock wave electrode assembly to generate a shock wave, the high voltage pulse generation device further comprising a safety memory chip circuit coupled to the processor, the safety memory chip circuit configured to store specification information of the shock wave electrode assembly and/or access status signals of the shock wave electrode assembly.

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