A hand-held intravascular shockwave system

Abstract

The application discloses a handheld intravascular shock wave system which comprises a disposable shock wave catheter, a control handle and a high-voltage generating circuit, the disposable shock wave catheter comprises a connecting plug, a cable sheath, a luer seat, a connecting tube, a balloon assembly, an inner tube and an electrode assembly, the control handle is provided with a connecting socket, a switch button and a display screen, the disposable shock wave catheter is fixedly connected and electrically connected with the control handle through plug-in connection of the connecting plug and the connecting socket, a disposable battery is arranged in the connecting plug, an MCU controller, two-way drive bridge arms, a push-pull step-up transformer T1 and a Marx step-up circuit are arranged in the control handle, and the output end of the Marx step-up circuit is electrically connected with the electrode assembly through the connecting socket, the connecting plug and positive and negative electrode wires. The scheme has the advantages of compact structure, small size and convenient operation.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, and in particular relates to a handheld intravascular shockwave system. Background Technology

[0002] Electrohydraulic lithotripsy (EDL) technology has been widely used to treat calcifications in the urethra and bile ducts, and in recent years it has also been increasingly applied to the treatment of calcifications in the coronary arteries and peripheral blood vessels. An EDL shockwave device typically includes at least one pair of electrodes forming a shockwave generator, an energy storage device, and a pulse generator. The energy storage device usually uses a high-voltage capacitor, and the pulse generator produces narrow, high-voltage pulses in the nS to μS range. Under the drive of the high-voltage pulse, an electric arc is formed between the metal electrodes in the saline solution. This arc instantaneously ionizes the saline solution, generating plasma and gas, and simultaneously producing a shockwave. The calcifications inside the blood vessel absorb the shockwave, causing them to fragment into tiny fragments.

[0003] Currently, intravascular shockwave therapy systems mainly consist of three parts: the intravascular shockwave therapy device, the handpiece connection cable, and the intravascular shockwave catheter. The operation is relatively complex. Furthermore, since the surgeon performs the operation in a sterile area while the main unit is in a non-sterile area, the power supply, standby, and treatment preparation buttons are traditionally integrated into the main unit. This necessitates additional personnel operating in a non-sterile area of ​​the operating room to operate the main unit, causing significant inconvenience in surgical coordination. Additionally, pulse therapy information is displayed on the main unit, which is typically located in a non-sterile area, far from the surgeon, making information viewing very inconvenient.

[0004] Traditional shockwave systems primarily rely on rechargeable lithium batteries integrated within the main unit for energy. The equipment cannot be used while charging, and the rechargeable lithium battery system itself will also experience energy loss when not in use. Therefore, it is important to frequently check the battery level before surgery, as it is easy to delay the operation due to neglecting the battery level.

[0005] Traditional main units are relatively bulky, and the handle connection cable is relatively long. During surgery, the main unit takes up a lot of space, and the connection cable is prone to getting tangled with other equipment cables, causing some interference.

[0006] Therefore, handheld intravascular shockwave therapy devices with handles have gradually become the mainstream product form in the industry, characterized by their small size and ease of handling and use. Mainstream handheld products use small, rechargeable lithium battery modules. These modules are plugged into the handle and are replaceable; one module can meet the treatment needs of at least one case, and multiple modules can be kept in reserve, fully charged for standby use. When the handle runs out of power, the battery module can be replaced for continued use. However, during use, medical staff need to charge the lithium battery module to ensure it is fully charged, making maintenance inconvenient.

[0007] If the handheld device uses a disposable battery pack instead of a reusable rechargeable battery, the disposable battery pack can be integrated into the disposable consumable, forming a single unit. When the consumable and the handle are plugged in, the battery inside the consumable powers the handle. Both the consumable and the battery are discarded after use, completely solving the problem of needing to recharge the product. Due to the portability requirements of the device, the battery pack cannot be too large. The battery pack voltage is generally 6-12V and can be composed of several single batteries connected in series and parallel. The battery's main energy is used to power the high-voltage circuitry inside the device. The battery capacity is sufficient for one case, generally 2000mAh is enough. Furthermore, since the battery and balloon consumable are integrated and disposable, they need to meet a 3-5 year shelf life. Therefore, disposable lithium-manganese batteries are the best choice. The advantage of disposable lithium-manganese batteries is low leakage current, making them suitable for long-term storage. The disadvantage is high internal resistance. For the same volume, the internal resistance of a disposable lithium-manganese battery pack (hundreds of milliohms) is much greater than that of a rechargeable lithium battery pack (tens of milliohms), with a difference of more than 10 times. Due to the relatively high internal resistance of disposable lithium-manganese batteries, the large high-frequency switching current during high-voltage module operation can pull down the output voltage of the disposable lithium-manganese batteries, causing equipment malfunction or restart. This problem is even more pronounced in low-temperature environments, as the battery's internal resistance increases with decreasing temperature.

[0008] For example, patent document CN111956936A discloses a treatment device for angioplasty, including a high-voltage pulse power supply host and a pressure wave balloon catheter that communicate with each other. The high-voltage pulse power supply host includes a main control module, a display module, and a pulse power module for releasing high-voltage pulse signals. The pulse power module includes a power supply, a Max generator, and a drive circuit for driving the Max generator.

[0009] The power supply is a digital switching power supply, such as its... Figure 13As shown, the circuit includes a main control module, a drive module, an inverter circuit, a boost circuit, and a rectifier circuit. Its push-pull drive principle is as follows: The microcontroller (MCU) outputs two sub-pulse control signals (PWM) TF_A and TF_B. Due to the low voltage and drive capability of the PWM signals, they are amplified by transistors Q3 and Q4 respectively, and then drive MOSFETs Q1 and Q2. MOSFETs Q1 and Q2 alternately conduct, driving transformer T3. Since the MOSFETs lack current limiting, during circuit startup, the voltage across capacitor C1 is initially 0, effectively creating a short circuit. The MOSFETs' operating current is very large, and the battery's output current is also very large. A disposable lithium-manganese battery pack cannot withstand this level of surge current. The rectification principle is as follows: Transformer T3 outputs positive and negative AC square wave waveforms Vpulse+ and Vpulse-, which are rectified and converted into DC voltage through rectifier bridge BD1. The voltage across capacitor C1 is V. With a fixed battery voltage Vbat, the output voltage V depends only on the transformer turns ratio N, V ​​= N * Vbat. The rectifier bridge function only converts AC square waves into DC, without boosting the voltage. Boosting is achieved only through the transformer. For example, with a transformer turns ratio of 100, this circuit can boost the battery voltage from 12V to about 1200V.

[0010] The Marx generator comprises multiple transistors and multiple capacitors. Under the control of a drive circuit, the transistors control the capacitors to charge in parallel and discharge in series to release a high-voltage pulse signal. Figure 4 As shown, its working principle is as follows: When the four Insulated Gate Bipolar Transistors (IGBTs) are turned off, the voltage V rectified by the push-pull transformer charges the four capacitors in parallel, with each capacitor charged to the same voltage V as the input voltage. When the four IGBTs are turned on, the four capacitors, fully charged with voltage V, are connected in series to form a 4*V voltage, which is output to the load. In other words, the Max generator further boosts the voltage V rectified by the push-pull transformer by four times before supplying it to the load, for example, boosting 1200V to 4800V.

[0011] As can be seen from the above, the high-voltage pulse generating circuit in the prior art has the following disadvantages: 1. The overall implementation circuit is complex, requiring two-stage boost circuits to reach the target voltage.

[0012] 2. The first-stage push-pull drive circuit uses MOSFETs to drive each bridge arm. Since MOSFETs have no current limit, each bridge arm experiences a large operating current during circuit startup, which can easily drain the battery output voltage and cause a malfunction. The battery output current is also very large; a disposable lithium-manganese battery pack cannot withstand this level of surge current, leading to a low supply voltage that could cause the device to restart or fail to operate.

[0013] 3. The second-stage Max boost circuit requires four isolated optocouplers to drive the IGBTs separately. The control circuit is complex, with many components, resulting in high cost and low reliability.

[0014] Furthermore, traditional electrode assembly designs employ a structure with a rod-shaped inner electrode and an annular outer common electrode, separated by an intermediate insulating layer. Both the outer common electrode and the insulating layer have small holes. Because the two parts are separate, manual assembly is required, making automation extremely difficult. This leads to eccentricity of the two small holes in the assembly, causing unstable output energy. For example, patent documents such as CN104582621A and CN114366240A disclose a shock wave device with polarity switching, including an axially extending elongated member (i.e., a conduit), an airbag surrounding a portion of the elongated member, the airbag being able to be filled with a conductive fluid; the elongated member is provided with an electrode assembly consisting of two electrode pairs, each including a first electrode and a second electrode, located within the conductive fluid. The electrode assembly includes two inner electrodes positioned circumferentially opposite each other, an insulating sheath having two openings aligned on the two inner electrodes, and an outer common electrode having two openings coaxially aligned with the two openings of the insulating sheath. The insulating sheath is a ring-shaped structure that fits over the conduit and inner electrode. The inner electrode is a conductive metal sheet, which is fixed to the inner wall of the insulating sheath or the outer wall of the conduit by adhesive bonding. The outer common electrode is a circular conductive metal sheet, which is fitted onto the insulating sheath. The two openings on the independent insulating sheath are small holes, which are usually aligned with the centers of the two inner electrodes. The openings on the annular outer common electrode are also small holes, but the holes on the annular outer common electrode are larger than those on the insulating sheath. Furthermore, the holes on the outer common electrode must be aligned and concentric with the holes on the insulating sheath. The portion of the inner electrode exposed at the small hole position on the insulating sheath forms an electrical gap with the edge of the small hole on the outer common electrode. Multiple inner electrodes are connected in series or in parallel to a high-voltage controller via wires to achieve the effect of applying high voltage while the liquid medium fills the electrical gap, thereby generating a breakdown electrical gap discharge and producing a shock wave.

[0015] However, the above electrode assembly scheme, due to its structure of inner electrode, intermediate insulating sheath, and outer common electrode, has the following problems because the three layers are separated: 1. The inner electrodes are fixed to the inner wall of the insulating sheath or the outer wall of the conduit by adhesive bonding. The two inner electrodes need to be arranged at the same angle as the small holes on the insulating sheath. This makes assembly difficult, inefficient, and difficult to control the bonding quality.

[0016] 2. The insulating sleeve is independent of the inner electrode and the outer common electrode, and it has a ring structure. During manufacturing, it is difficult to cut the small holes with precise positioning and angle. This can lead to misalignment with the center of the inner electrode during assembly. Consequently, the inner electrode may not be exposed at the small holes in the insulating layer, resulting in complete insulation between the inner and outer electrodes and preventing the generation of a shock wave. Even with accurate hole cutting, assembly errors can easily cause the holes to deviate from the inner electrode, leading to unstable shock wave output energy.

[0017] 3. The external common electrode structure needs to be fitted onto the insulating sheath, and the holes on the external common electrode must be aligned with the centers of the holes on the insulating sheath. Due to the small size of the parts, most operations require manual handling, making automated manufacturing impossible. Assembly accuracy, product consistency, and reliability are difficult to guarantee, resulting in low production efficiency. However, if the centers of the holes on the external common electrode and the holes on the insulating sheath are misaligned, it will cause: poor consistency in the distance between the edges of the holes of the internal electrode and the external common electrode, i.e., the discharge gap. This discharge gap will lead to a large difference in shock wave energy, resulting in energy instability. High energy may damage blood vessels, while low energy will lead to poor or no therapeutic effect in treating calcification. In severe cases, the small holes on the insulating sheath may be completely blocked by the external common electrode, resulting in complete insulation between the internal and external electrodes, making it impossible to discharge and generate shock waves. Summary of the Invention

[0018] To address the aforementioned technical problems, the present invention aims to provide a handheld intravascular shockwave system. A disposable battery is placed inside the shockwave catheter, and the shockwave catheter and control handle are plugged and detached. The control handle integrates control buttons, an information display screen, and a high-voltage pulse generation module. The system is compact in structure and small in size, making it convenient for surgical operation.

[0019] To achieve the above objectives, the present invention adopts the following technical solution: A handheld intravascular shockwave system includes a disposable shockwave catheter, a control handle, and a high-voltage generating circuit. The disposable shockwave catheter includes a connector, cable sheath, Luer seat, connecting tube, balloon assembly, inner tube, and electrode assembly. The control handle is equipped with a connector socket, a switch button, and a display screen. The disposable shockwave catheter and the control handle are fixedly and electrically connected by plugging in the connector socket. The high-voltage generating circuit includes a disposable battery, an MCU controller, two drive arms, a push-pull boost transformer T1, and a Max-type boost circuit. The disposable battery is housed in the connector socket, while the MCU controller, two drive arms, push-pull boost transformer T1, and Max-type boost circuit are housed in the control handle. The output of the Max-type boost circuit is electrically connected to the electrode assembly via the connector socket, connector plug, and positive and negative wires.

[0020] Preferably, the control handle is housed inside a sterile protective shield.

[0021] Preferably, the electrode assembly includes at least one inner common electrode and an outer electrode; the inner common electrode is fixed to the outer wall of the inner tube, and the outer electrode covers the outside of the inner common electrode; the outer electrode is a planar flexible circuit board wound structure, including an outer insulating layer, an electrode circuit, and an inner insulating layer; the electrode circuit is sandwiched between the outer insulating layer and the inner insulating layer, and the electrode circuit includes at least two electrode plates, one electrode plate being conductively connected to the positive electrode wire, and the other electrode plate being conductively connected to the negative electrode wire; a first hole, a second hole, and a third hole are provided through the corresponding positions of the outer insulating layer, the electrode circuit, and the inner insulating layer, with the hole diameters satisfying: first hole > second hole > third hole; the inner common electrode is partially exposed through the third hole, and the electrode circuit is partially exposed through the second hole; a discharge gap that can be filled with conductive fluid is formed between the inner and outer electrodes through the channel, and each electrode plate and the inner common electrode form a set of discharge electrode pairs.

[0022] Preferably, the inner common electrode has a ring structure and is sleeved on the inner tube.

[0023] Preferably, the gap between the inner common electrode and the inner tube and outer electrode is filled with insulating glue, leaving only the third hole position to allow the inner common electrode to be exposed for discharge.

[0024] Preferably, the internal common electrode is made of stainless steel or platinum-iridium alloy.

[0025] Preferably, the inner common electrode includes a first inner common electrode and a second inner common electrode, which are spaced apart along the axial direction of the inner tube; the electrode circuit of the outer electrode includes a first electrode plate, a second electrode plate, a third electrode plate, a fourth electrode plate, a first electrical connection line, a second electrical connection line, and a third electrical connection line; the first electrode plate and the fourth electrode plate are arranged opposite each other and correspond to the first inner common electrode, and the second electrode plate and the third electrode plate are arranged opposite each other and correspond to the second inner common electrode; the first electrical connection line connects the third electrode plate and the fourth electrode plate, the second electrical connection line connects the second electrode plate and leads out a negative electrode wire solder joint, and the third electrical connection line connects the first electrode plate and leads out a positive electrode wire solder joint; the positive electrode wire solder joint is welded to the positive electrode wire, and the negative electrode wire solder joint is welded to the negative electrode wire.

[0026] Preferably, the first electrode plate and the first inner common electrode form a first electrode pair, the fourth electrode plate and the first inner common electrode form a fourth electrode pair, the second electrode plate and the second inner common electrode form a second electrode pair, and the third electrode plate and the second inner common electrode form a third electrode pair; the four sets of electrode pairs are dispersed along the circumference and axial direction of the inner tube to synchronously generate multi-directional shock waves.

[0027] Preferably, heat shrink tubing is fitted over the positive and negative electrode solder joints, and insulating adhesive is filled inside the heat shrink tubing to achieve insulation and sealing of the solder joints.

[0028] Preferably, the outer and inner insulating layers are made of polyimide, the electrode circuit is attached to the surface of the inner insulating layer by etching or electroplating, and the outer and inner insulating layers are sealed by hot pressing or adhesive bonding.

[0029] Preferably, the planar outer electrode is formed by laser or mechanical drilling to create the first, second, and third holes, and then heat-set by winding to form a ring structure. This ensures that the three layers of holes are coaxial and concentric.

[0030] Preferably, the output of the disposable battery is connected to the push-pull boost transformer T1, the MCU controller drives the two drive bridge arms, the output of the two drive bridge arms is connected to the two independent windings of the primary winding of the push-pull boost transformer T1, the secondary winding of the push-pull boost transformer T1 is connected to the Max boost circuit, and the Max boost circuit outputs high-voltage pulses.

[0031] Preferably, the first drive arm includes a switching transistor Q1, a sensing transistor Q2, a current sampling resistor R5, and a current limiting resistor R3. The PWM1 signal output of the MCU controller is connected to the base of the switching transistor Q1 and the collector of the sensing transistor Q2 via the current limiting resistor R3. The emitter of the switching transistor Q1 is connected to the common ground GND after being connected in series with the current sampling resistor R5. The emitter of the sensing transistor Q2 is connected to the common ground GND, and the base of the sensing transistor Q2 is connected to the emitter of the switching transistor Q1. The collector of the switching transistor Q1 is connected to the primary winding pin of the push-pull transformer T1. The second drive arm includes a switching transistor Q3. The circuit consists of a detection transistor Q4, a current sampling resistor R7, and a current-limiting resistor R6. The PWM2 signal output of the MCU controller is connected to the base of the switching transistor Q3 and the collector of the detection transistor Q4 via the current-limiting resistor R6. The emitter of the switching transistor Q3 is connected to the common ground GND after being connected in series with the current sampling resistor R7. The emitter of the detection transistor Q4 is connected to the common ground GND, and the base of the detection transistor Q4 is connected to the emitter of the switching transistor Q3. The collector of the switching transistor Q3 is connected to the pin of the second winding of the primary winding of the push-pull transformer T1. The positive terminal of the battery is connected to the center tap pin of the primary winding of the push-pull transformer T1, and the negative terminal of the battery is connected to the common ground GND.

[0032] Preferably, the first pin of the secondary winding of the push-pull transformer T1 is connected in series with a buffer resistor R2, which serves as the intermediate common node of the Max boost circuit, and the second pin of the secondary winding of the push-pull transformer T1 serves as the other pole of the AC input of the Max boost circuit.

[0033] Preferably, the Max boost circuit includes an upper voltage doubler unit, a lower voltage doubler unit, and a high-voltage energy storage capacitor C2. The high-voltage energy storage capacitor C2 has its terminals connected to the high-voltage output positive terminal HV+ and the high-voltage output negative terminal HV-. The upper voltage doubler unit includes diodes D1 and D2, capacitors C1 and C3, and a voltage equalization resistor R1. Capacitors C3, D1, and C1 are connected in series. Capacitor C3 is connected to the first pin of the secondary winding of the push-pull transformer T1 via a buffer resistor R2. Capacitor C1 is connected to the second pin of the secondary winding of the push-pull transformer T1. The anode of diode D1 is connected to capacitor C3, and the cathode of diode D1 is connected to both capacitor C1 and the high-voltage output positive terminal HV+. The voltage equalization resistor R1 is connected in parallel across capacitor C1. Diode D2 is connected in parallel with diode D1 and capacitor C1. The anode of diode D2 is connected to the push-pull transformer... The second pin of the secondary winding of transformer T1 is connected, and the negative terminal of diode D2 is connected to the positive terminal of diode D1. The lower voltage multiplier unit includes diode D3, diode D4, capacitor C4, capacitor C5 and voltage equalizing resistor R4. Capacitor C5, diode D4 and capacitor C4 are connected in series. Capacitor C4 is connected to the second pin of the secondary winding of push-pull transformer T1. Capacitor C5 is connected to the first pin of the secondary winding of push-pull transformer T1 through buffer resistor R2. The positive terminal of diode D4 is connected to capacitor C4 and the negative terminal of high voltage output HV-. The negative terminal of diode D4 is connected to capacitor C5. Voltage equalizing resistor R4 is connected in parallel across capacitor C4. Diode D3 is connected in parallel with diode D4 and capacitor C4. The negative terminal of diode D3 is connected to the second pin of the secondary winding of push-pull transformer T1. The positive terminal of diode D3 is connected to the negative terminal of diode D4.

[0034] Because the present invention adopts the above technical solution, it has the following advantages: 1. A disposable battery is placed inside the shockwave catheter. The shockwave catheter and control handle are plugged in and plugged in. The control handle integrates control buttons, an information display screen, and a high-voltage pulse generation module. Its compact structure and small size facilitate surgical operation. During use, a sterile protective cover is first placed over the control handle for sterile protection. Then, the catheter plug is connected to the main unit plug. After connection, the battery inside the catheter directly powers the control handle. After the catheter is inserted into the pre-treated calcified lesion vessel, the operator can directly operate the buttons on the control handle to perform treatment and observe the required information through the information display screen. After use, simply remove the catheter, and the system automatically shuts off. In this way, the battery is integrated into the disposable catheter; the system is powered on immediately after the plug and socket are connected, requiring no complicated operation. The control handle is not disposable; since the battery is inside the catheter, the control handle does not require charging management. The control handle integrates treatment pause / start, pulse trigger buttons, and an information display. Combined with the use of the sterile protective cover, this allows the operator to operate the system and view treatment information independently in a sterile area, without the need for multiple people to assist.

[0035] 2. The electrode assembly uses a common electrode as the inner electrode, while the electrode circuit connecting the positive and negative leads is fabricated on the outer electrode. The outer electrode is made of a flexible printed circuit board (FPC). This design places the three channels requiring coaxial alignment on the outer electrode FPC, ensuring electrode alignment accuracy and reducing assembly difficulty. Furthermore, the ring-shaped inner common electrode can be automatically assembled onto the inner tube using forging, pressing, and other automated methods, resulting in good assembly accuracy and reliability, and high production efficiency. The outer electrode is manufactured using a flexible printed circuit board with an initial planar structure. The outer electrode and insulating layer are integrated, and shape cutting and drilling can be performed using high-precision laser or mechanical processing, resulting in high production efficiency, low manufacturing cost, and avoiding errors caused by manual assembly and inspection. This leads to more accurate alignment and more stable output energy.

[0036] 3. The high-voltage generation circuit uses the simplest circuitry and lowest cost to limit the operating current of the high-voltage module, ensuring the total operating current of the battery remains within a controllable range. This solves the problem of excessive internal resistance in disposable lithium-manganese batteries causing the output voltage to be lower than expected during operation. The overall circuit is simple and reliable, eliminating the need for complex IGBT drive circuits, simplifying components, reducing costs, and improving reliability and lifespan. With the same transformer turns ratio, a boost ratio of 4*N*Vbat can be directly achieved, resulting in a smaller overall size and a simpler transformer design. Using transistors Q1 and Q3 to drive the bridge arms, it can be directly driven by the MCU without the need for driver conversion and amplification. Transistors Q2 and Q4, along with resistors R5 and R7, are used to limit the operating current of each bridge arm, keeping the maximum current of each bridge arm within a reasonable range (I=0.7V / R5). The current limiting point is accurate, the battery output current is controllable, and it prevents the battery output voltage from being pulled down, causing a system restart. In this way, it adopts hardware-independent closed-loop input current limiting, hardware backup does not rely on the main control software for current limiting, microsecond-level response, avoids power-on surge impact, and is well adapted to disposable lithium manganese batteries. Attached Figure Description

[0037] The accompanying drawings, which form part of this application, are used to provide a further understanding of this application. The illustrative embodiments of this application and their descriptions are used to explain this application and do not constitute a limitation thereof.

[0038] Figure 1 This is a schematic diagram of the handheld intravascular shockwave system of the present invention.

[0039] Figure 2 This is a perspective view of the control handle of the present invention.

[0040] Figure 3 This is an exploded view of the control handle of the present invention.

[0041] Figure 4A schematic diagram of the main circuit board assembled in the inner shell of the control handle.

[0042] Figure 5 This is a diagram showing the control handle after the lower casing has been removed.

[0043] Figure 6 This is a schematic diagram of the structure of a sterile protective shield.

[0044] Figure 7 This is a schematic diagram of the structure of the disposable shock wave duct of the present invention.

[0045] Figure 8 This is an exploded view of the connector plug of the present invention.

[0046] Figure 9 This is an exploded view of the connector socket of the present invention.

[0047] Figure 10 This is a structural diagram of the socket casing.

[0048] Figure 11 and Figure 12 These are structural diagrams from two different angles showing the socket housing assembled with the socket circuit board and magnetic connector A.

[0049] Figure 13 This is a schematic diagram of the plug housing.

[0050] Figure 14 and Figure 15 These are schematic diagrams of the plug housing assembled with magnetic connector B, a disposable battery, and the plug circuit board from two different angles.

[0051] Figure 16 This is a schematic diagram of the plug sleeve structure.

[0052] Figure 17 This is a schematic diagram of the connector plug.

[0053] Figure 18 and Figure 19 These are schematic diagrams of the cross-sectional structure of the connector at two different angles.

[0054] Figure 20 This is a circuit diagram of the high-voltage generating circuit of the present invention.

[0055] Figure 21 This is a schematic diagram of the electrode assembly of the present invention.

[0056] Figure 22 This is an exploded view of the electrode assembly of the present invention.

[0057] Figure 23 This is a schematic diagram of the winding of the outer electrode of the present invention.

[0058] Figure 24 This is a schematic diagram showing the unfolded external electrode of the present invention.

[0059] Figure 25 This is a schematic diagram of the layering of the external electrode of the present invention.

[0060] The components include: 1. Control handle; 2. Connecting plug; 201. Plug circuit board; 202. Electrical connector B; 203. Magnetic connector B; 204. Plug housing; 2041. Socket B; 2042. Annular rib; 2043. Annular mounting cavity; 2044. Mounting hole B; 2045. Annular water-retaining rib; 2046. Battery compartment; 2047. Battery lead wire groove; 205. Disposable battery; 2051. Battery lead wire; 206. Plug sleeve; 2061. 1. Installation guide groove; 2062. Battery compartment enclosure; 3. Sterile protective cover; 31. Socket cover; 311. Hot melt welding area; 32. PE bag; 33. Pull cord; 4. Cable conduit; 5. Luer seat; 6. Connecting tube; 7. Balloon assembly; 8. Inner tube; 9. Electrode assembly; 91. First inner common electrode; 92. Second inner common electrode; 93. Outer electrode; 931. First electrode plate; 932. Second electrode plate; 933. Third electrode plate; 9331. First hole; 9 332, Second hole; 9333, Third hole; 934, Fourth electrode plate; 935, Outer insulation layer; 936, Inner insulation layer; 937, First electrical connection wire; 938, Second electrical connection wire; 939, Third electrical connection wire; 9314, First center wire; 9323, Second center wire; 94, Positive conductor; 941, Positive conductor solder joint; 95, Negative conductor; 951, Negative conductor solder joint; 96, Heat shrink tubing; 10, Connecting socket; 101, Socket circuit board; 1 02. Electrical connector A; 103. Magnetic connector A; 104. Socket housing; 1041. Socket A; 1042. Front recess; 1043. Mounting cavity; 1044. Mounting hole A; 11. Lower shell; 12. Middle shell; 13. Main circuit board; 14. Display circuit board; 141. Electronic switch A; 142. Electronic switch B; 143. Display screen; 15. Plastic button; 151. Treatment preparation / pause button; 152. Pulse trigger button; 16. Upper shell. Detailed Implementation

[0061] The present invention will be further described below with reference to the accompanying drawings and embodiments.

[0062] It should be noted that the following detailed descriptions are illustrative and intended to provide further explanation of this application. Unless otherwise specified, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application pertains.

[0063] Embodiments of the present invention are described in detail below, examples of which are illustrated in the accompanying drawings, wherein the same or similar reference numerals denote the same or similar elements or elements having the same or similar functions throughout. The embodiments described below with reference to the accompanying drawings are exemplary and intended to explain the present invention, and should not be construed as limiting the present invention.

[0064] In the description of this invention, unless the context clearly indicates otherwise, the singular form is also intended to include the plural form. Furthermore, it should be understood that when the terms "comprising" and / or "including" are used in this specification, they indicate the presence of features, steps, operations, devices, components, and / or combinations thereof.

[0065] In the description of this invention, it should be understood that the terms "center," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "clockwise," and "counterclockwise," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention.

[0066] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of this invention, unless otherwise stated, "a plurality of" means two or more, unless explicitly defined otherwise.

[0067] In this invention, unless otherwise explicitly specified and limited, the terms "installation," "connection," "linking," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0068] In this invention, unless otherwise explicitly specified and limited, "above" or "below" the second feature can include direct contact between the first and second features, or contact between the first and second features through another feature between them. Furthermore, "above," "over," and "on top" of the second feature includes the first feature directly above or diagonally above the second feature, or simply indicates that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature includes the first feature directly below or diagonally below the second feature, or simply indicates that the first feature is at a lower horizontal level than the second feature. Example

[0069] like Figure 1 The handheld intravascular shockwave system shown includes a disposable shockwave catheter, a control handle 1, and a sterile protective shield 3.

[0070] like Figure 2 and Figure 3 As shown, the control handle 1 includes a connection socket 10, an upper shell 16, a lower shell 11, a middle shell 12, plastic buttons 15, a main circuit board 13, and a display circuit board 14. The display circuit board 14 has electronic switches A141 and B142, and a display screen 143. The upper shell 16 has a transparent display area and button mounting holes. During installation, the protruding treatment preparation / pause button 151 and pulse trigger button 152 on the plastic buttons 15 are respectively installed in the corresponding holes of the upper shell 16. Then, the display circuit board 14 is installed in the corresponding area of ​​the upper shell 16, and the electronic switch A141 is installed in the treatment preparation area. Below the pause button 151, the electronic switch B142 is installed below the pulse trigger button 152, and the display screen 143 is installed below the transparent area of ​​the upper shell 16. The display circuit board 14 and the upper shell 16 sandwich the plastic button 15 in the middle, fitting tightly together. The plastic button 15 is made of elastic plastic material (silicone, rubber, TPU, TPR, TPE, etc.) and has sealing properties. The display circuit board 14 is tightly fixed to the plastic button 15 and the upper shell 16 by screws to form the upper shell assembly, so that its assembly has waterproof performance and water cannot enter the control handle 1 through the gap between the button and the button hole.

[0071] like Figure 4 and Figure 5 As shown, the main circuit board 13 is assembled inside the middle shell 12 to form a middle shell assembly. It can be connected by screws or waterproofed by sealant. The display circuit board 14, the socket circuit board 101 and the main circuit board 13 are electrically connected by wires. Then the upper shell assembly, the connecting socket 10 and the middle shell assembly are assembled and fixed by screws. Then the lower shell 11 is assembled by bayonet connection. After assembly, there is no external appearance and no screw structure, which makes the appearance more beautiful and has a certain degree of anti-disassembly performance.

[0072] like Figure 6 As shown, the sterile protective cover 3 includes a socket cover 31, a PE bag 32, and a pull rope 33. The opening at the head of the PE bag 32 is connected to the socket cover 311 by a heat-sealing connection 311. The pull rope 33 at the tail of the PE bag 32 is used to tighten the seal to achieve the effect of isolating the control handle 1. The socket cover 31 is made of transparent plastic, which makes it easy to observe the LED light.

[0073] like Figure 7 The disposable shock wave catheter shown includes a connector 2, a cable sheath 4, a Luer seat 5, a connecting tube 6, a balloon assembly 7, an inner tube 8, and an electrode assembly 9.

[0074] like Figure 8 , Figures 13 to 19 As shown, the connector 2 includes a connector circuit board 201, a connector housing 204, a disposable battery 205, and a connector sleeve 206. The connector housing 204 has a battery compartment 2046, and the disposable battery 205 is fixed inside the battery compartment 2046. The connector circuit board 201 is fixed inside the connector housing 204, and the disposable battery 205 is electrically connected to the connector circuit board 201. The connector housing 204 and the connector sleeve 206 are interlocked and secured, covering the battery compartment 2046 and the connector circuit board 201. Multiple electrical connectors B202 are soldered onto the connector circuit board 201, and the electrical connectors B202 penetrate the connector housing 204. The connector socket 10 has multiple electrical connectors A102. When the connector socket 10 and the connector 2 are connected, the corresponding electrical connectors A102 and B202 are plugged in to achieve conductive connection.

[0075] like Figures 9 to 12 As shown, the connection socket 10 includes a socket housing 104 and a socket circuit board 101. A mounting cavity 1043 is provided on one side of the socket housing 104. The socket circuit board 101 is disposed in the mounting cavity 1043. A socket hole A1041 is also provided on the mounting cavity 1043. One end of the electrical connector A102 is soldered to the socket circuit board 101, and the other end passes through the socket hole A1041.

[0076] like Figures 13 to 15 As shown, an annular mounting cavity 2043 is provided on one side of the plug housing 204, the battery compartment 2046 is fixed in the annular mounting cavity 2043, the plug circuit board 201 is sleeved around the battery compartment 2046, and the annular mounting cavity 2043 is also provided with a socket B2041, and the electrical connector B202 passes through the socket B2041.

[0077] The socket housing 104 is also provided with a front recess 1042 on the other side, and the electrical connector A102 is located in the front recess 1042. The plug housing 204 is also provided with an annular rib 2042 on the other side, and the electrical connector B202 is located in the area enclosed by the annular rib 2042. The connector socket 10 and the connector plug 2 are plugged in, so that the annular rib 2042 is inserted into the front recess 1042, and the electrical connector B202 and the electrical connector A102 are plugged in and connected to each other.

[0078] The socket housing 104 is also provided with an annular water-blocking groove 1045 on the other side, and the plug housing 204 is also provided with an annular water-blocking rib 2045 on the other side. The connecting socket 10 and the connecting plug 2 are plugged in, so that the annular water-blocking rib 2045 is inserted into the annular water-blocking groove 1045.

[0079] The socket housing 104 also has a mounting hole A1044; a magnetic connector A103 is embedded in the mounting hole A1044. The plug housing 204 also has a mounting hole B2044, and a magnetic connector B203 is embedded in the mounting hole B2044. The connector socket 10 and the connector plug 2 are inserted into each other, so that the magnetic connector A103 and the magnetic connector B203 attract each other. Both the magnetic connector A103 and the magnetic connector B203 are made of magnetically conductive material, and at least one of them is made of a magnetic material.

[0080] The socket housing is made of transparent or semi-transparent light-guiding material. The socket circuit board 101 is also equipped with an LED indicator for indicating the working status. When the LED indicator is lit, it can be observed through the socket housing.

[0081] The battery compartment 2046 has a battery lead groove 2047 on at least one side for placing battery leads 2051. The battery leads 2051 are placed in the battery lead groove 2047 until they are connected to two of the metal electrical connectors B202 on the plug circuit board (PCBA) 201 (i.e., the positive and negative terminals of the battery).

[0082] The plug sleeve 206 contains a battery compartment cavity 2062, and the inner wall of the battery compartment cavity 2062 is also provided with an installation guide groove 2061 that mates with the battery lead wire groove 2047. The plug shell 204 and the plug sleeve 206 are inserted and secured, so that the battery compartment 2046 and the battery compartment cavity 2062 are also tightly fitted. The plug sleeve 206 is made of plastic elastomer (including silicone, TPE, TPR, PVC, rubber and other elastic plastics). Due to its tight fit with the battery compartment 2046, it can ensure a certain degree of waterproofness. The fit between the battery lead wire groove 2047 and the installation guide groove 2061 also serves as an anti-reverse installation and guide structure when assembling the plug sleeve 206 and the plug shell 204, ensuring that the plug shell is easily and correctly installed.

[0083] Figure 18 and Figure 19 As shown, when connecting, the connector 2 is inserted into the connector socket 10. After being fully inserted, the metal electrical connectors A102 and B202 make contact to form a conductive connection. There can be many pairs of metal electrical connectors A102 and B202, but at least two pairs are connected to the positive and negative terminals of the disposable battery 205. These two pairs are also connected to the power input port of the device to ensure that the battery can supply power to the device normally.

[0084] After the connector plug 2 is fully inserted into the connector socket 10, the annular convex rib 2042 is fully inserted into the recess 1042, and the annular water-blocking rib 2045 is inserted into the annular water-blocking groove 1045. Since the metal electrical connector A102 and the metal electrical connector B202 are completely wrapped in these concave and convex structures, the creepage distance from the live parts to the surface of the shell is increased after insertion, and a certain degree of waterproofing is also increased.

[0085] After the connector plug 2 is fully inserted into the connector socket 10, the magnetic connector A103 and the magnetic connector B203 come into contact and attract each other through magnetic force, ensuring a more reliable connection between the connector plug 2 and the connector socket 10.

[0086] like Figure 7As shown, one end of the cable sheath 4 is fitted to the tail of the plug sleeve 206, and the other end of the cable sheath 4 is connected to the Luer seat 5. The front end of the Luer seat 5 is sealed to the proximal end of the connecting tube 6, and the distal end of the connecting tube 6 is sealed to the balloon assembly 7. The Luer seat 5 is provided with a Luer connector, which can be connected to a syringe. The shock wave liquid medium enters the balloon from the inlet of the Luer connector and forms a certain pressure. The balloon assembly 7 contains an inner tube 8 and an electrode assembly 9. The electrode assembly 9 is fitted on the surface of the inner tube 8. The electrode assembly 9 passes through the connecting tube 6 and the Luer seat 5 via wires (positive wire 94 and negative wire 95) and enters the interior of the connecting plug 2 through the cable sheath 4, forming an electrical connection with two electrical connectors B202 on the plug circuit board 201.

[0087] In use, first, put the control handle 1 into the sterile protective sleeve 3, and tighten the socket cover 31 to the front end of the control handle 1 to prevent it from falling off. Tighten the pull rope 33 at the tail to seal it. Insert the connector 2 of the disposable shockwave catheter into the connector socket 10 on the control handle 1 to form an electrical connection. After insertion, the disposable battery 205 supplies power to the control handle 1, and the magnetic connectors in the connector 2 and connector socket 10 attract each other to prevent them from falling off. At least one of the two magnetic connectors is a magnet, and the other is a magnetically conductive material. At this time, the LED indicator in the connector socket 10 lights up, indicating that the system is powered on and the system starts self-testing. After the self-test is completed, the display screen 143 displays the required information. At this time, the shockwave liquid medium is injected into the balloon through the inlet hole on the Luer connector to cover the electrode assembly 9. Then, press the treatment preparation / pause button 151 on the control handle 1. The LED indicator changes color to indicate that the pulse is ready to be triggered. Then, press and hold the pulse trigger button 152 on the control handle 1. The control handle 1 delivers energy to the electrode assembly 9 to trigger the shockwave.

[0088] like Figure 21 and Figure 22 An electrode assembly for a shock wave system is shown, including a first inner common electrode 91, a second inner common electrode 92 and an outer electrode 93. The first inner common electrode 91 and the second inner common electrode 92 are ring-shaped and sleeved on the inner tube 8, and the outer electrode 93 is sleeved outside the first inner common electrode 91 and the second inner common electrode 92.

[0089] In this embodiment, as Figures 23 to 25As shown, the outer electrode 93 is made of a planar flexible circuit. The planar flexible circuit is composed of an outer insulating layer 935, an electrode circuit, and an inner insulating layer 936. The electrode circuit is disposed between the outer insulating layer 935 and the inner insulating layer 936. The electrode circuit includes a first electrode plate 931, a second electrode plate 932, a third electrode plate 933, a fourth electrode plate 934, a first electrical connection line 937, a second electrical connection line 938, and a third electrical connection line 939. The first electrode plate 931 is electrically connected to the positive electrode wire 94 through the third electrical connection line 939. The second electrode plate 932 is electrically connected to the negative electrode wire 95 through the second electrical connection line 938. The third electrode plate 933 and the fourth electrode plate 934 are electrically connected through the first electrical connection line 937. The first electrode plate 931 and the fourth electrode plate 934 are arranged opposite each other outside the first inner common electrode 91 with a first center line 9314. The second electrode plate 932 and the third electrode plate 933 are arranged opposite each other outside the second inner common electrode 92 with a second center line 9323. A second hole 9332 is formed at the center of each of the four electrode plates. A first hole 9331 is formed at the concentric position of the outer insulating layer with the second hole 9332. A third hole 9333 is formed at the concentric position of the inner insulating layer with the second hole 9332. The diameters of the three holes are as follows: first hole 9331 > second hole 9332 > third hole 9333. After the three layers are laminated, a portion of each of the four electrode plates is exposed through the first hole 9331. After the outer electrode 93 is fitted over the first inner common electrode 91 and the second inner common electrode 92, a portion of both the first inner common electrode 91 and the second inner common electrode 92 is exposed through the third hole 9333. In this way, the outer electrode is fitted onto the inner common electrode. The four electrode plates on the outer electrode are insulated from the two inner common electrodes through an inner insulating layer. However, since the inner and outer electrodes form a certain gap between the first hole 9331 and the third hole 9333, after the shock wave conductive liquid is filled into the balloon, the liquid fills the gap between the inner and outer electrodes, forming an unstable conductive connection. After being broken down by the pulsed high voltage, it forms a shock wave source. A first electrode pair is formed between the first electrode plate 931 and the first inner common electrode 91, a second electrode pair is formed between the second electrode plate 932 and the second inner common electrode 92, a third electrode pair is formed between the third electrode plate 933 and the second inner common electrode 92, and a fourth electrode pair is formed between the fourth electrode plate 934 and the first inner common electrode 91, thus forming four shock wave sources.

[0090] During operation, the high-voltage generating circuit that generates high-voltage pulses applies high-voltage electrical energy to the positive electrode wire 94. The electrical energy is then transmitted to the first electrode plate 931 through the third electrical connection wire 939. Since the gap between the first electrode plate 931 and the first inner common electrode 91 is filled with shock wave conductive liquid, which is an unstable connection, the high-voltage electrical energy can break down this gap, thereby generating a high-voltage discharge. Subsequently, a shock wave is formed in the liquid. Similarly, the electrical energy will sequentially break down the gap between the first inner common electrode 91 and the fourth electrode plate 934, the gap between the second electrode plate 932 and the second inner common electrode 92, and the gap between the third electrode plate 933 and the second inner common electrode 92, generating shock waves around the four holes. Then, a conductive circuit is formed through the negative electrode wire 95.

[0091] In other embodiments, one or more electrode pairs may be provided, which are arranged in series or in parallel between the positive electrode wire 94 and the negative electrode wire 95.

[0092] Existing technologies, such as the electrode designs disclosed in patent documents with publication numbers CN104582621A and CN114366240A, employ an electrode assembly structure consisting of an inner electrode, an intermediate insulating sheath, and an outer common electrode. These three layers are separated, and both the outer electrode and the insulating sheath have small holes, with corresponding holes requiring coaxial alignment. However, because these two parts are separate, manual assembly is required, which is extremely difficult to automate, resulting in low production efficiency, high manufacturing costs, and the potential for misalignment of the two holes during assembly, leading to unstable output energy. Specifically, the following problems exist: 1. The inner electrodes are fixed to the inner wall of the insulating sheath or the outer wall of the conduit by adhesive bonding. The two inner electrodes need to be arranged at the same angle as the small holes on the insulating sheath. This makes assembly difficult, inefficient, and difficult to control the bonding quality.

[0093] In comparison, the present invention uses an inner common electrode with a ring structure, which can be assembled onto the inner tube through automated methods such as forging and pressing. The assembly accuracy and reliability are better, and the production efficiency is higher.

[0094] 2. The insulating sleeve is independent of the inner electrode and the outer common electrode, and it has a ring structure. During manufacturing, it is difficult to cut the small holes precisely at the correct angles. This can lead to misalignment with the center of the inner electrode during assembly, potentially resulting in the inner electrode not being exposed at the holes in the insulating layer, causing complete insulation between the inner and outer electrodes and preventing the generation of a shock wave. Even with accurate hole cutting, assembly errors can easily cause the holes to deviate from the inner electrode, leading to unstable shock wave output energy. Similarly, the outer common electrode structure needs to be fitted onto the insulating sleeve, and the holes on the outer common electrode must be aligned with the centers of the holes on the insulating sleeve. Due to the small size of the parts, most of this requires manual operation, making automated manufacturing impossible. Assembly accuracy, product consistency, and reliability are difficult to guarantee, resulting in low production efficiency. However, if the holes on the outer common electrode and the holes on the insulating sheath are not centered, it will cause the following problems: the distance between the edges of the holes of the inner electrode and the outer common electrode, i.e., the discharge gap, will be inconsistent. The discharge gap will lead to a large difference in shock wave energy, resulting in unstable energy. If the energy is too high, it will damage blood vessels, and if the energy is too low, it will lead to poor treatment effect or no treatment effect. In severe cases, the small holes on the insulating sheath may be completely blocked by the outer common electrode, and the inner and outer electrodes will be completely insulated, making it impossible to discharge and generate shock waves.

[0095] In contrast, in this invention, the external electrode is manufactured using a flexible circuit board method, and the initial structure is a planar structure. The external electrode and the insulating layer are integrated. The shape cutting and machine drilling can be carried out using automated processing methods such as high-precision laser or mechanical processing, which can ensure that the three-layer channel is coaxial and concentric, resulting in high production efficiency, low manufacturing cost, avoiding errors caused by manual assembly and inspection, more accurate alignment, and more stable output energy.

[0096] In this embodiment, the first inner common electrode 91 and the second inner common electrode 92 are made of stainless steel, platinum-iridium alloy, or other conductive metals. This independently arranged inner common electrode in a ring structure not only conducts electricity but also possesses a certain degree of rigidity, providing good support and protection for the outer electrode FPC.

[0097] In this preferred embodiment, the gaps between the first inner common electrode 91, the second inner common electrode 92, the inner tube 8, and the outer electrode 93 are filled with insulating adhesive. This ensures that the inner common electrode, except for the exposed small hole, is completely insulated with insulating material, thereby guaranteeing energy utilization efficiency and safety.

[0098] In this preferred embodiment, the tail end of the third electrical connection wire 939 exposes the outer and inner insulation layers to form a positive electrode wire solder joint 941, and the tail end of the second electrical connection wire 938 exposes the outer and inner insulation layers to form a negative electrode wire solder joint 951. Both are welded or crimped to the positive electrode wire 94 and the negative electrode wire 95 respectively to form a conductive connection. In order to make the solder joint insulated, the solder joint is covered with a heat shrink tube 96, and the inside of the heat shrink tube 96 is filled with insulating glue to make it insulated.

[0099] In this preferred embodiment, the planar outer electrode is wound and then formed into a ring-shaped outer electrode through heat setting, bonding, or other methods. This method is convenient and cost-effective.

[0100] In this preferred embodiment, the outer insulating layer 935 and the inner insulating layer 936 of the outer electrode 93 are made of polyimide (PI material). The electrode circuit is attached to the inner insulating layer 936 by etching, electroplating or other methods. The outer insulating layer 936 is used to sandwich the electrode circuit between the inner and outer insulating layers by hot pressing, adhesive bonding or other methods to achieve waterproof and insulating purposes.

[0101] In the above technical solution, the common electrode is used as the inner electrode, and the electrode circuit connecting the positive and negative wires is fabricated on the outer electrode. The outer electrode is made of a flexible printed circuit board (FPC). This way, the three holes that need to be coaxially aligned are all located on the outer electrode FPC, ensuring electrode alignment accuracy and reducing assembly difficulty. In other embodiments, the inner common electrode and the outer electrode can also be fabricated on the same flexible printed circuit board (FPC), that is, a double-layer circuit FPC is used. After being wound into a ring structure, the electrode circuit of the outer electrode is still located between the outer insulating layer and the inner insulating layer. The inner common electrode is located inside the inner insulating layer. There is also an innermost insulating layer inside the inner common electrode. The innermost insulating layer and the inner insulating layer sandwich the inner common electrode in the middle and provide waterproof insulation. In this way, the assembly is simpler and more convenient, and the accuracy and reliability are better.

[0102] like Figure 20 The high-voltage generating circuit shown includes a disposable battery BAT1, an MCU controller, two drive bridge arms, a push-pull boost transformer T1, and a Max boost circuit.

[0103] The disposable battery BAT1 is the aforementioned disposable battery 205 installed in the connector plug 2. The positive terminal of the disposable battery BAT1 outputs the battery supply voltage Vbat and is connected to the primary center tap pin 7 of the push-pull transformer T1. The negative terminal of BAT1 is connected to the common ground GND. The MCU controller, two drive bridge arms, push-pull boost transformer T1, and Max boost circuit are set on the main circuit board 13. The high-voltage output terminals HV+ and HV- of the Max boost circuit are electrically connected to the positive wire 94 and negative wire 95 in the electrode assembly 9 through the socket circuit board 101 and the plug circuit board 201, respectively, providing a high voltage of 1kV to 3kV or higher to the downstream load. The circuit configuration is a push-pull transformer plus a Max boost circuit. The MCU outputs two PWM waves for driving, PWM1 and PWM2 are complementary square waves with a 50% duty cycle. Electronic switches A141 and B142 on the display circuit board 14, the display screen 143, and the LED indicator on the socket circuit board 101 are connected to the MCU controller.

[0104] In this preferred embodiment, the disposable battery 205 is a disposable lithium manganese battery.

[0105] In this preferred embodiment, the first drive bridge arm includes a switching transistor Q1, a sensing transistor Q2, a current sampling resistor R5, and a current limiting resistor R3. The PWM1 signal output terminal of the MCU is connected to the base B of the switching transistor Q1 and the collector C of the sensing transistor Q2 via the current limiting resistor R3. The emitter E of the switching transistor Q1 is connected to the common ground GND after being connected in series with the current sampling resistor R5. The emitter E of the sensing transistor Q2 is connected to the common ground GND, and the base B of the sensing transistor Q2 is connected to the emitter E of the switching transistor Q1. The collector C of the switching transistor Q1 is connected to the primary first winding pin 6 of the push-pull transformer T1.

[0106] The first drive arm operates as follows: When the MCU's PWM1 outputs a high level, the current is limited by the current-limiting resistor R3, and the current flows through the BE junction of the switching transistor Q1 and the current sampling resistor R5 to GND. Because the BE junction of the switching transistor Q1 receives current, the CE junction of the switching transistor Q1 conducts. After the switching transistor Q1 conducts, the battery-powered current flows sequentially through the primary winding of transformer T1, the switching transistor Q1, and the current sampling resistor R5 to ground, forming a continuous current path. This current generates a voltage across the current sampling resistor R5. Since the BE junction of the sensing transistor Q2 is connected in parallel with the current sampling resistor R5, when the voltage across the current sampling resistor R5 rises to the transistor's conduction threshold of 0.7V, the BE junction of the sensing transistor Q2 generates current. The impedance of the CE junction of the sensing transistor Q2 decreases, tending to conduct, which forces the base B voltage of the switching transistor Q1 to drop. The BE junction current of the switching transistor Q1 decreases, and the CE junction current flowing through the switching transistor Q1 also decreases accordingly (due to the transistor's amplification characteristics, the CE current is β times the BE current). In this way, a dynamic balance is maintained, and the circuit forms a negative feedback closed-loop regulation, ultimately limiting the maximum current flowing through the CE junction of the switching transistor Q1 to 0.7 / R5.

[0107] Similarly, the second drive bridge arm includes a switching transistor Q3, a sensing transistor Q4, a current sampling resistor R7, and a current limiting resistor R6. The PWM2 signal output of the MCU is connected to the base B of the switching transistor Q3 and the collector C of the sensing transistor Q4 via the current limiting resistor R6. The emitter E of the switching transistor Q3 is connected to the common ground GND after being connected in series with the current sampling resistor R7. The emitter E of the sensing transistor Q4 is connected to the common ground GND, and the base B of the sensing transistor Q4 is connected to the emitter E of the switching transistor Q3. The collector C of the switching transistor Q3 is connected to the pin 9 of the primary second winding of the push-pull transformer T1.

[0108] The second drive arm operates as follows: When the MCU's PWM2 output is high, the current is limited by the current-limiting resistor R6, and the current flows through the BE junction of the switching transistor Q3 and the current sampling resistor R7 to GND. Because the BE junction of the switching transistor Q3 receives current, the CE junction of the switching transistor Q3 conducts. After the switching transistor Q3 conducts, the battery-powered current flows sequentially through the second winding of the primary winding of transformer T1, the switching transistor Q3, and the current sampling resistor R7 to ground, forming a continuous current path. This current generates a voltage across the current sampling resistor R7. Since the BE junction of the sensing transistor Q4 is connected in parallel with the current sampling resistor R7, when the voltage across the current sampling resistor R7 rises to the transistor's conduction threshold of 0.7V, the BE junction of the sensing transistor Q4 generates current. The impedance of the CE junction of the sensing transistor Q4 decreases, tending to conduct, which forces the base B voltage of the switching transistor Q3 to drop. The BE junction current of the switching transistor Q3 decreases, and the CE junction current flowing through the switching transistor Q3 also decreases accordingly. In this way, a dynamic balance is maintained, and the circuit forms a negative feedback closed-loop regulation, ultimately limiting the maximum current flowing through the CE junction of the switching transistor Q3 to 0.7 / R5.

[0109] In this way, the two PWM1 and PWM2 outputs are complementary and non-overlapping, Q1 and Q3 are turned on alternately, the two bridge arms are turned on alternately, the maximum on current of each bridge arm is locked at 0.7 / R5, each bridge arm is turned on at 50% and does not overlap, so the maximum output current of the battery is limited to 0.7 / R5.

[0110] In this preferred embodiment, the primary winding of the push-pull transformer T1 is divided into two independent windings. The center tap pin 7 of the primary winding of the push-pull transformer T1 is connected to the positive terminal Vbat of the disposable battery BAT1. Pins 7 to 6 form the first winding of the primary winding, and pins 7 to 9 form the second winding of the primary winding. Pin 6 of the first winding of the primary winding is connected to the collector C of the switching transistor Q1 in the first drive bridge arm. Pin 9 of the second winding of the primary winding is connected to the collector C of the switching transistor Q3 in the second drive bridge arm. The two ends of the secondary winding of the push-pull transformer T1 are the first pin (pin 3) and the second pin (pin 2), respectively, and output an AC square wave. The peak value of the square wave voltage is N*Vbat, where N is the turns ratio of the push-pull transformer T1.

[0111] In this preferred embodiment, pin 3 of the push-pull transformer T1 is connected in series with a buffer resistor R2, which serves as the intermediate common node of the Max boost circuit. Pin 2 is the other terminal of the AC input of the Max boost circuit. This series buffer resistor on the secondary winding of the transformer can suppress capacitor surges, improving the reliability and lifespan of the components.

[0112] In this preferred embodiment, the Max boost circuit includes an upper voltage doubler unit (D1, D2, C1, C3, R1), a lower voltage doubler unit (D3, D4, C4, C5, R4), and a high-voltage energy storage capacitor C2. The two ends of the high-voltage energy storage capacitor C2 are the high-voltage output positive terminal HV+ and the high-voltage output negative terminal HV-.

[0113] The upper side includes diode D1, diode D2, capacitor C1, capacitor C3, and voltage equalizing resistor R1. Capacitor C3, diode D1, and capacitor C1 are connected in series. Capacitor C1 is connected to pin 2 of the secondary winding of push-pull transformer T1. Capacitor C3 is connected to pin 3 of the secondary winding of push-pull transformer T1 via buffer resistor R2. The positive terminal of diode D1 is connected to capacitor C3, and the negative terminal of diode D1 is connected to capacitor C1 and the high voltage output positive terminal HV+. Voltage equalizing resistor R1 is connected in parallel across capacitor C1. Diode D2 is connected in parallel with diode D1 and capacitor C1. The positive terminal of diode D2 is connected to pin 2 of the secondary winding of push-pull transformer T1, and the negative terminal of diode D2 is connected to the positive terminal of diode D1.

[0114] The voltage boosting process of the upper voltage doubler unit circuit is as follows: When the push-pull transformer T1 outputs a positive half-wave, the voltage at pin 3 of the push-pull transformer T1 is 0, the voltage at pin 2 is V, and the current path is: secondary winding pin 2 of push-pull transformer T1 → diode D2 → capacitor C3 → buffer resistor R2 → secondary winding pin 3 of push-pull transformer T1, charging capacitor C3 so that capacitor C3 receives voltage V, and the voltage at the upper end of capacitor C3 is V, while the voltage at the lower end is 0.

[0115] When the push-pull transformer T1 outputs a negative half-wave, the voltage at pin 2 of the push-pull transformer T1 is 0, and the voltage at pin 3 is V. The current path is: secondary winding pin 3 of push-pull transformer T1 → buffer resistor R2 → capacitor C3 → diode D1 → capacitor C1 → secondary winding pin 2 of push-pull transformer T1. Since capacitor C3 has a voltage V in the first half-cycle, the output voltage at pin 3 of the secondary winding of push-pull transformer T1 is also V. The voltage on capacitor C3 and the voltage at pin 3 of the secondary winding of push-pull transformer T1 are connected in series and superimposed to obtain 2V. The series voltage charges capacitor C1. After several switching cycles, capacitor C1 will eventually receive a voltage of 2V, with the voltage at the upper end of capacitor C1 being 2V and the voltage at the lower end of capacitor C1 being 0.

[0116] Similarly, the lower voltage multiplier unit includes diode D3, diode D4, capacitor C4, capacitor C5, and voltage equalization resistor R4. Capacitor C5, diode D4, and capacitor C4 are connected in series. Capacitor C4 is connected to pin 2 of the secondary winding of push-pull transformer T1. Capacitor C5 is connected to pin 3 of the secondary winding of push-pull transformer T1 via buffer resistor R2. The positive terminal of diode D4 is connected to capacitor C4 and the negative terminal HV- of the high voltage output. The negative terminal of diode D4 is connected to capacitor C5. Voltage equalization resistor R4 is connected in parallel across capacitor C4. Diode D3 is connected in parallel with diode D4 and capacitor C4. The negative terminal of diode D3 is connected to pin 2 of the secondary winding of push-pull transformer T1. The positive terminal of diode D3 is connected to the negative terminal of diode D4.

[0117] The voltage boosting process of the lower-side voltage doubler unit circuit is as follows: When the push-pull transformer T1 outputs a negative half-wave, the voltage at pin 2 of the push-pull transformer T1 is 0, and the voltage at pin 3 is V. The current path is: secondary winding pin 3 of the push-pull transformer T1 → buffer resistor R2 → capacitor C5 → diode D3 → secondary winding pin 2 of the push-pull transformer T1, charging capacitor C5 so that capacitor C5 receives voltage V, and the voltage at the upper end of capacitor C5 is V, while the voltage at the lower end is 0.

[0118] When the push-pull transformer T1 outputs a positive half-wave, the voltage at pin 3 of the push-pull transformer T1 is 0, and the voltage at pin 2 is V. The current path is: secondary winding pin 2 of push-pull transformer T1 → capacitor C4 → diode D4 → capacitor C5 → buffer resistor R2 → secondary winding pin 3 of push-pull transformer T1. Since capacitor C5 has a voltage V in the first half-cycle, the output voltage at pin 2 of the secondary winding of push-pull transformer T1 is also V. The voltage on capacitor C5 and the voltage at pin 2 of the secondary winding of push-pull transformer T1 are connected in series and superimposed to obtain 2V. The series voltage charges capacitor C4. After several switching cycles, capacitor C4 will eventually obtain a voltage of 2V, and the voltage at the upper end of capacitor C4 is 2V, while the voltage at the lower end of capacitor C4 is 0.

[0119] In this way, a 2V voltage will be generated across capacitors C1 and C4. After capacitors C1 and C4 are connected in series, they charge the high-voltage energy storage capacitor C2, ultimately generating a 4V voltage across C2. That is, the fully charged voltage of the high-voltage energy storage capacitor C2 is 4*N*Vbat, where N is the turns ratio of the push-pull transformer T1, and Vbat is the voltage of the primary battery.

[0120] In this preferred embodiment, voltage equalizing resistors R1 and R4 are connected in parallel across capacitors C1 and C4, respectively, to balance the voltage division of the capacitors. Their resistance values ​​are equal, preferably 100MΩ. High-voltage energy storage capacitor C2 is connected in parallel between the positive terminal HV+ and the negative terminal HV- of the high-voltage output, providing energy storage for the subsequent high-voltage load. The capacitance of high-voltage energy storage capacitor C2 is preferably 100nF to 1μF; the capacitances of capacitors C1, C3, C4, and C5 are preferably 1nF to 10nF.

[0121] Compared with the prior art, this embodiment has the following advantages: 1. The overall circuit is simple and reliable, eliminating the need for complex IGBT drive circuits, simplifying components, reducing costs, and improving reliability.

[0122] 2. With the same transformer turns ratio, a step-up ratio of 4*N*Vbat can be directly achieved for the output voltage, resulting in a smaller overall size and a simpler transformer design.

[0123] 3. Utilizing transistors Q1 and Q3 to drive the bridge arms directly from the MCU without the need for driver conversion and amplification, transistors Q2 and Q4, along with resistors R5 and R7, limit the operating current of each bridge arm, keeping the maximum current within a reasonable range (I=0.7V / R5). This precise current limiting ensures controllable battery output current, preventing a drop in battery output voltage that could cause a system restart. This hardware-based independent closed-loop input current limiting provides hardware protection, eliminating reliance on main control software for current limiting, enabling microsecond-level response, avoiding power-on surge impacts, and providing excellent compatibility with disposable lithium-manganese batteries.

[0124] Other product details not disclosed in this embodiment are all prior art and do not constitute the innovative content of this invention. For example, the specific structure of the balloon catheter, the balloon pressure detection / identification circuit, the electrode condition detection circuit, and the electronic switch control circuit are all prior art. Please refer to the contents disclosed in patent documents with publication numbers CN119157600A, CN104582621A, CN114366240A, CN102271748A, CN104619272A, CN111956936A, etc.

[0125] In the description of this specification, the terms "one embodiment," "some embodiments," "one implementation," "specific implementation," "other implementation," "example," "specific example," or "some examples," etc., refer to specific features, structures, materials, or characteristics described in connection with that embodiment or example, which are included in at least one embodiment, implementation, or example of the present invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described above can also be combined in any suitable manner in one or more embodiments, implementations, or examples. The technical solutions described in this invention also include technical solutions formed by any one or more specific features, structures, materials, or characteristics described above, either individually or in combination.

[0126] Although embodiments of the present invention have been shown and described above, it is understood that the above embodiments are exemplary and should not be construed as limiting the present invention. Those skilled in the art can make changes, modifications, substitutions, alterations, deletions of some features, additions of features, or recombinations of features to the above embodiments within the scope of the present invention without departing from the principles and spirit of the present invention. Any simple modifications, equivalent changes, and alterations made to the above embodiments based on the innovative principles of the present invention shall still fall within the scope of the technical solutions of the present invention.

Claims

1. A handheld intravascular shockwave system, characterized in that, The device includes a disposable shock waveguide, a control handle (1), and a high-voltage generating circuit. The disposable shock waveguide includes a connector (2), a cable sheath (4), a Luer seat (5), a connecting tube (6), a balloon assembly (7), an inner tube (8), and an electrode assembly (9). The control handle (1) is equipped with a connector socket (10), a switch button, and a display screen. The disposable shock waveguide and the control handle (1) are fixedly connected and electrically connected by plugging in the connector plug (2) and the connector socket (10). The high-voltage generating circuit includes a disposable battery (205), an MCU controller, two drive bridge arms, a push-pull boost transformer T1, and a Max boost circuit. The disposable battery (205) is located inside the connector plug (2). The MCU controller, two drive bridge arms, push-pull boost transformer T1, and Max boost circuit are located inside the control handle (1). The output end of the Max boost circuit is electrically connected to the electrode assembly (9) through the connector socket (10), the connector plug (2), and positive and negative wires.

2. The handheld intravascular shockwave system according to claim 1, characterized in that, The control handle (1) is located inside the sterile protective cover (3).

3. The handheld intravascular shockwave system according to claim 1, characterized in that, The electrode assembly (9) includes at least one inner common electrode and an outer electrode (93); the inner common electrode is fixed to the outer wall of the inner tube (8), and the outer electrode (93) covers the outside of the inner common electrode; the outer electrode (93) is a planar flexible circuit board wound structure, including an outer insulating layer (935), an electrode circuit and an inner insulating layer (936); the electrode circuit is sandwiched between the outer insulating layer (935) and the inner insulating layer (936), and the electrode circuit includes at least two electrode plates, one electrode plate is electrically connected to the positive electrode wire (94), and the other electrode plate is connected to the negative electrode wire (95). Conductive connection; the outer insulating layer (935), electrode circuit and inner insulating layer (936) are provided with a first hole (9331), a second hole (9332) and a third hole (9333) through the corresponding positions, and the hole diameters satisfy: first hole (9331) > second hole (9332) > third hole (9333); the inner common electrode is partially exposed through the third hole (9333), the electrode circuit is partially exposed through the second hole (9332), and a discharge gap that can be filled with conductive fluid is formed between the inner and outer electrodes through the channel. Each electrode plate and the inner common electrode form a set of discharge electrode pairs.

4. A handheld intravascular shockwave system according to claim 3, characterized in that, The inner common electrode is a ring structure and is sleeved on the inner tube (8).

5. A handheld intravascular shockwave system according to claim 3, characterized in that, The gap between the inner common electrode and the inner tube (8) and the outer electrode (93) is filled with insulating glue, leaving only the third hole (9333) to allow the inner common electrode to be exposed for discharge.

6. A handheld intravascular shockwave system according to claim 3, characterized in that, The inner common electrode includes a first inner common electrode (91) and a second inner common electrode (92), which are spaced apart along the axial direction of the inner tube (8); the electrode circuit of the outer electrode (93) includes a first electrode plate (931), a second electrode plate (932), a third electrode plate (933), a fourth electrode plate (934), a first electrical connection line (937), a second electrical connection line (938), and a third electrical connection line (939); the first electrode plate (931) and the fourth electrode plate (934) are arranged opposite to each other and correspond to the first inner common electrode (91), and the second electrode plate... (932) is arranged opposite to the third electrode plate (933) and corresponds to the second inner common electrode (92); the first electrical connection line (937) connects the third electrode plate (933) and the fourth electrode plate (934), the second electrical connection line (938) connects the second electrode plate (932) and leads out the negative electrode wire solder joint (951), the third electrical connection line (939) connects the first electrode plate (931) and leads out the positive electrode wire solder joint (941); the positive electrode wire solder joint (941) is welded to the positive electrode wire (94), and the negative electrode wire solder joint (951) is welded to the negative electrode wire (95).

7. A handheld intravascular shockwave system according to claim 1, characterized in that, The output of the disposable battery is connected to the push-pull step-up transformer T1. The MCU controller drives two drive bridge arms. The output of the two drive bridge arms is connected to the two independent windings of the primary winding of the push-pull step-up transformer T1. The secondary winding of the push-pull step-up transformer T1 is connected to the Max step-up circuit, which outputs a high-voltage pulse.

8. A handheld intravascular shockwave system according to claim 7, characterized in that, The first drive bridge arm includes a switching transistor Q1, a sensing transistor Q2, a current sampling resistor R5, and a current limiting resistor R3. The PWM1 signal output of the MCU controller is connected to the base of the switching transistor Q1 and the collector of the sensing transistor Q2 via the current limiting resistor R3. The emitter of the switching transistor Q1 is connected to the common ground GND after being connected in series with the current sampling resistor R5. The emitter of the sensing transistor Q2 is connected to the common ground GND, and the base of the sensing transistor Q2 is connected to the emitter of the switching transistor Q1. The collector of the switching transistor Q1 is connected to the primary winding pin of the push-pull transformer T1. The second drive arm includes a switching transistor Q3, a sensing transistor Q4, a current sampling resistor R7, and a current limiting resistor R6. The PWM2 signal output of the MCU controller is connected to the base of the switching transistor Q3 and the collector of the sensing transistor Q4 via the current limiting resistor R6. The emitter of the switching transistor Q3 is connected to the common ground GND after being connected in series with the current sampling resistor R7. The emitter of the sensing transistor Q4 is connected to the common ground GND, and the base of the sensing transistor Q4 is connected to the emitter of the switching transistor Q3. The collector of the switching transistor Q3 is connected to the pin of the primary second winding of the push-pull transformer T1. The positive terminal of the battery is connected to the center tap pin of the primary winding of the push-pull transformer T1, and the negative terminal of the battery is connected to the common ground GND.

9. A handheld intravascular shockwave system according to claim 7, characterized in that, After the first pin of the secondary winding of the push-pull transformer T1 is connected in series with the buffer resistor R2, it serves as the intermediate common node of the Max boost circuit. The second pin of the secondary winding of the push-pull transformer T1 serves as the other pole of the AC input of the Max boost circuit.

10. A handheld intravascular shockwave system according to claim 9, characterized in that, The Max boost circuit includes an upper voltage doubler unit, a lower voltage doubler unit, and a high-voltage energy storage capacitor C2. The two ends of the high-voltage energy storage capacitor C2 are the high-voltage output positive terminal HV+ and the high-voltage output negative terminal HV-. The upper voltage multiplier unit includes diode D1, diode D2, capacitor C1, capacitor C3, and voltage equalization resistor R1. Capacitor C3, diode D1, and capacitor C1 are connected in series. Capacitor C3 is connected to the first pin of the secondary winding of push-pull transformer T1 via buffer resistor R2. Capacitor C1 is connected to the second pin of the secondary winding of push-pull transformer T1. The positive terminal of diode D1 is connected to capacitor C3, and the negative terminal of diode D1 is connected to capacitor C1 and the high voltage output positive terminal HV+. Voltage equalization resistor R1 is connected in parallel across capacitor C1. Diode D2 is connected in parallel with diode D1 and capacitor C1. The positive terminal of diode D2 is connected to the second pin of the secondary winding of push-pull transformer T1, and the negative terminal of diode D2 is connected to the positive terminal of diode D1. The lower voltage multiplier unit includes diodes D3 and D4, capacitors C4 and C5, and voltage equalizing resistor R4. Capacitors C5, D4, and C4 are connected in series. Capacitor C4 is connected to the second pin of the secondary winding of push-pull transformer T1. Capacitor C5 is connected to the first pin of the secondary winding of push-pull transformer T1 via buffer resistor R2. The positive terminal of diode D4 is connected to capacitor C4 and the negative terminal of high voltage output HV-. The negative terminal of diode D4 is connected to capacitor C5. Voltage equalizing resistor R4 is connected in parallel across capacitor C4. Diode D3 is connected in parallel with diode D4 and capacitor C4. The negative terminal of diode D3 is connected to the second pin of the secondary winding of push-pull transformer T1. The positive terminal of diode D3 is connected to the negative terminal of diode D4.

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