An integrated coronary shockwave therapy catheter and control system thereof

Abstract

The application relates to the technical field of medical devices, and discloses an integrated coronary shock wave treatment catheter and a control system thereof, which comprises a catheter seat, a catheter shaft, a distal end pipe body, a capsule and a wire, the catheter seat is provided with a liquid filling port and an electrical connector, the proximal end of the catheter shaft is connected with the catheter seat, the proximal end of the distal end pipe body is connected with the distal end of the catheter shaft, the capsule is connected at the distal end of the distal end pipe body, an impulse generator / developing ring is arranged in the capsule, and the liquid filling port is communicated with the inside of the capsule via the catheter shaft and the distal end pipe body. The control part and the catheter part are directly combined into an integral whole through the electrical connector, a large main machine device required in the traditional scheme is omitted, the hardware procurement threshold and the subsequent equipment maintenance cost of a hospital are reduced, the overall volume of the product is reduced, and the operation of controlling the equipment and operating is independently completed by a surgeon in a space-limited operating room.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to an integrated coronary pulse shockwave therapy catheter and its control system. Background Technology

[0002] Coronary artery calcification is a common and complex anatomical condition in percutaneous coronary intervention (PCI). Severe vascular calcification can obstruct the passage of interventional devices and limit the adequate expansion of balloons and stents. Intravascular shockwave therapy (IWT) utilizes the electrohydraulic effect to generate a mechanical shock wave by producing a high-voltage electric arc discharge within the balloon, which can break up calcified plaques and restore vascular compliance.

[0003] Traditional endovascular shockwave therapy systems typically employ a separate architecture, consisting of a disposable interventional catheter and a large, reusable external high-pressure generator. During clinical procedures, the large size of the high-pressure generator, located in a non-sterile area, contrasts sharply with the sterile environment of the interventional catheter and the operator. Long-distance cables must connect the two, disrupting the routine workflow of the catheterization lab and increasing the risk of contamination in the sterile area. Furthermore, the surgeon cannot directly control the equipment from the operating table, requiring assistants to set parameters and operate the generator, thus reducing the continuity and independence of the surgical procedure.

[0004] As a large fixed asset, the external high-voltage generator is bulky and heavy, making it extremely inconvenient to move between multiple operating rooms and taking up space in the already crowded operating rooms. More importantly, the high-voltage power transmission between the generator and the catheters relies on external connectors. Repeated plugging and unplugging of the connectors can easily cause poor contact and also constitute a potential route for cross-infection of instruments.

[0005] Regarding the mechanical structure and vascular delivery performance of catheters, the anatomical path of coronary arteries is usually quite tortuous, and calcified lesions are often accompanied by rigidity of the vessel wall. Some existing shockwave catheters have deficiencies in the transition design of the tube material and structure. If the tube body is too soft, the axial pushing force applied to the proximal end cannot be effectively transmitted, and the catheter is prone to twisting in the blood vessel. If the tube body is too hard or the rigidity is too abrupt, it is difficult to conform to the tortuous shape of the blood vessel. When passing through complex bends, it not only faces great frictional resistance, but may even cause mechanical damage to the fragile vascular intima, thus making it difficult for the catheter to reach and be positioned in the distal target calcified area. Summary of the Invention

[0006] To address the shortcomings of existing technologies, this invention provides an integrated coronary pulse shockwave therapy catheter and its control system. This solves the problems of existing separate coronary pulse shockwave therapy systems, which rely on large main units, resulting in limited operation and high maintenance costs; the difficulty in balancing the transmission of pushing force and the smooth passage of distal blood vessels in the catheter's mechanical structure; and the slow response of traditional high-voltage discharge circuits, leading to poor lithotripsy efficiency and bulky power modules.

[0007] To achieve the above objectives, the present invention provides the following technical solution: The first aspect of the present invention provides an integrated coronary pulse shockwave therapy catheter, comprising a catheter seat, a catheter shaft, a distal tube body, a capsule, and a lead wire. The catheter seat is provided with an filling port and an electrical connector. The proximal end of the catheter shaft is connected to the catheter seat. The proximal end of the distal tube body is connected to the distal end of the catheter shaft. The capsule body is connected to the distal end of the distal tube body. The capsule body is provided with a pulse generator / contrast ring. The filling port communicates with the interior of the capsule via the catheter shaft and the distal tube, and the electrical connector is electrically connected to the pulse generator / radiation ring via a wire extending through the catheter shaft and the distal tube.

[0008] Preferably, it further includes a tip and a guidewire lumen, the tip being disposed at the distal end of the capsule; the distal tube is provided with a guidewire exchange port, the proximal end of the guidewire lumen is connected to the guidewire exchange port, and the distal end of the guidewire lumen extends through the distal tube and the capsule and is connected to the tip, thereby forming a rapid exchange structure for external guidewires to pass through.

[0009] Preferably, the main body of the conduit shaft is made of thiourea tube; the distal tube body is made of different hardness materials spliced ​​or woven in segments from the proximal end to the distal end, and the hardness of the distal tube body decreases in a stepwise manner towards the tip.

[0010] Preferably, the guide tube seat is also provided with an exhaust port; It also includes a liner wire and a balloon protective sleeve, wherein the liner wire is inserted inside the catheter shaft and the distal tube body, and the balloon protective sleeve is fitted over the outside of the folded balloon body.

[0011] A second aspect of the present invention provides an integrated coronary pulse shockwave therapy catheter and its control system, including a control part and an integrated coronary pulse shockwave therapy catheter; The control unit and the catheter seat of the integrated coronary pulse shockwave therapy catheter are combined into an independent integrated unit, and the internal circuit of the control unit is connected to the electrical connector. The control section is equipped with a power supply and a high-voltage discharge circuit. The high-voltage discharge circuit is electrically connected to the electrical connector, and a voltage-sensitive component is connected in series on the high-voltage discharge circuit. The voltage-sensitive component has a breakdown voltage threshold, which is the minimum critical voltage required for the voltage-sensitive component to switch from a high-resistance state to a conducting state. The voltage-sensitive component is configured to switch from a high-resistance state to a conducting state when the voltage across its terminals reaches the breakdown voltage threshold, thereby closing the high-voltage discharge circuit and outputting high-voltage pulse energy to the pulse generator / developer ring.

[0012] Preferably, the control section further includes a boost circuit module, a voltage multiplier circuit, and an energy storage capacitor. The voltage output by the power supply is converted into high-voltage electrical energy by the boost circuit module and the voltage multiplier circuit in sequence and stored in the energy storage capacitor. The energy storage capacitor is used to release the high-voltage electrical energy as the high-voltage pulse energy to the pulse generator / developing ring instantaneously when the voltage-sensitive component is turned on.

[0013] Preferably, the control section further includes a trigger circuit, which is isolated and decoupled from the high-voltage discharge circuit. The trigger circuit is used to output a trigger voltage to the voltage-sensitive component after receiving a discharge command, and the peak value of the trigger voltage is greater than the breakdown voltage threshold.

[0014] Preferably, the voltage-sensitive component is selected from at least one of transient voltage suppression diodes, gas discharge tubes, or glass discharge tubes.

[0015] Preferably, the control unit has a microprocessor internally configured to execute a running mode and a standby mode; In the standby mode, the microprocessor reduces the system operating frequency and disables peripheral functions to enter a low-power state; In the operating mode, the microprocessor performs task scheduling management, which specifically includes display update tasks, data acquisition tasks for voltage and conduit status of each module, and key processing tasks.

[0016] Preferably, the control unit's housing surface is provided with buttons and a display area. The buttons are used to receive operation commands and switch between the operating mode and the standby mode, and to trigger the release of the high-voltage pulse energy. The display area is used to output discharge status indication, discharge count prompt, and discharge energy level display in the operating mode.

[0017] This invention provides an integrated coronary pulsed shockwave therapy catheter and its control system. It has the following beneficial effects: 1. This invention directly integrates the control unit and the catheter unit into a single unit via electrical connectors, eliminating the need for a separate large host device as in traditional solutions. This achieves a high degree of miniaturization of the equipment, not only saving the cumbersome handling of traditional large chassis and improving ease of use, but also saving space in the operating room. Meanwhile, the catheter unit is used as a disposable consumable, while the control unit is covered with a transparent medical sterile plastic bag during actual use, physically isolating potential cross-infection pathways from the instruments. This results in extremely low costs for subsequent equipment maintenance and sterilization, thereby optimizing the overall operational efficiency of the catheterization lab.

[0018] 2. The catheter part of the present invention adopts a rapid exchange structure and combines a multi-segment mechanical design. The proximal end of the catheter uses a hypotube to provide reliable pressure resistance and pushing force during external operation. The distal end of the catheter to the tip adopts a multi-segment gradual transition design of materials with different hardness, which not only ensures the effective transmission of operating force, but also improves the passage and flexibility of the distal end of the catheter in tortuous and narrow coronary arteries, and reduces the risk of mechanical damage to the vascular intima during delivery.

[0019] 3. The control system of the present invention uses voltage-sensitive components as switch control components in the high-voltage discharge circuit, and works in conjunction with voltage multiplier circuits and energy storage capacitors. When the trigger pulse reaches the threshold, the voltage-sensitive components are quickly broken down and the high-voltage energy in the energy storage capacitor is released. Compared with conventional electronic switches, the circuit structure has a shorter conduction response time, which makes the rising edge of the shock wave generated by electrode discharge steeper, improving the fragmentation efficiency of coronary calcified plaques. At the same time, the instantaneous discharge of energy stored in the capacitor also effectively reduces the size and manufacturing cost of the high-voltage power supply module inside the system. Attached Figure Description

[0020] Figure 1 This is a schematic diagram of the distal tube structure of the present invention; Figure 2 This is a schematic diagram of the hysteresis tube structure of the present invention; Figure 3 This is a schematic diagram of the catheter seat structure of the present invention; Figure 4 This is a schematic diagram of the conduit shaft structure of the present invention; Figure 5 This is a schematic diagram of the guidewire exchange port structure of the present invention; Figure 6 This is a schematic diagram of the integrated coronary pulse shockwave therapy catheter control system of the present invention; Figure 7 This is a schematic diagram of the high-voltage control circuit of the present invention.

[0021] The components are as follows: 1. Liner wire; 2. Balloon protective sheath; 3. Tip; 4. Balloon body; 5. Pulse generator / contrast ring; 6. Distal tube body; 7. Guidewire lumen; 8. Guidewire exchange port; 9. Hypocap tube; 10. Catheter shaft; 11. Catheter seat; 12. Exhaust port; 13. Fluid filling port; 14. Electrical connectors. Detailed Implementation

[0022] The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0023] See attached document Figure 1 -Appendix Figure 3 An integrated coronary pulse shockwave therapy catheter includes a catheter seat 11, a catheter shaft 10, a distal tube body 6, a capsule 4, and a lead wire. The catheter seat 11 is provided with an filling port 13 and an electrical connector 14. The proximal end of the catheter shaft 10 is connected to the catheter seat 11, the proximal end of the distal tube body 6 is connected to the distal end of the catheter shaft 10, and the capsule 4 is connected to the distal end of the distal tube body 6. A pulse generator / contrast ring 5 is provided inside the capsule 4. The filling port 13 is connected to the interior of the capsule 4 via the catheter shaft 10 and the distal tube 6, and the electrical connector 14 is electrically connected to the pulse generator / contrast ring 5 via a wire extending through the catheter shaft 10 and the distal tube 6. It also includes a tip 3 and a guidewire lumen 7. The tip 3 is located at the distal end of the capsule 4. The distal tube 6 is provided with a guidewire exchange port 8. The proximal end of the guidewire lumen 7 is connected to the guidewire exchange port 8. The distal end of the guidewire lumen 7 extends through the distal tube 6 and the capsule 4 and is connected to the tip 3 to form a rapid exchange structure for external guidewires to pass through.

[0024] Specifically, unlike traditional equipment that relies on external large-scale mainframes, the system integrates a micro power supply to provide the power required for operation. Its control unit and the catheter body are physically and electrically fixed in place through electrical connectors on the catheter hub, avoiding long-distance cable laying across the sterile area of ​​the operating table and the surrounding non-sterile area. This allows the surgeon to independently control all equipment operations within the sterile area. During actual vascular intervention, the operator holds the proximal end of the system and can directly use the buttons on the surface of the housing to issue commands such as system start / stop, energy level setting, and pulse triggering in real time. The corresponding equipment operating voltage and remaining discharge count are simultaneously mapped to the display area to provide real-time clinical visual feedback.

[0025] The high-voltage pulse energy generated by the button trigger does not need to be transferred through external connectors. Instead, it is directly introduced into the extension circuit inside the catheter along the electrical connector and precisely acts on the distal lesion target. After a single interventional lithotripsy procedure is completed, the catheter part will be discarded as a standard disposable medical consumable, while the control part will be retained for reuse. In actual clinical use, the operator will put a transparent medical sterile plastic bag over the control part. This design not only takes advantage of miniaturization to eliminate the space occupation and transportation troubles of large high-voltage main unit equipment for the hospital, but also uses the sterile bag to physically isolate cross-infection, making the subsequent equipment maintenance and sterilization costs relatively low, thereby effectively optimizing the overall operating efficiency of the catheterization room.

[0026] See attached document Figure 1 -Appendix Figure 5 The main body of the conduit shaft 10 is made of thiopanthen tube 9; the distal tube body 6 is made of different hardness materials spliced ​​or woven in sections from the proximal end to the distal end, and the hardness of the tube body 6 decreases in a stepwise manner towards the tip 3. The conduit seat 11 is also provided with an exhaust port 12. It also includes a liner wire 1 and a balloon protective sleeve 2. The liner wire 1 is inserted inside the catheter shaft 10 and the distal tube body 6, and the balloon protective sleeve 2 is fitted over the outside of the folded balloon body 4.

[0027] Specifically, during the clinical interventional delivery phase of the system, the operator needs to pre-establish a guidewire track, that is, pass the distal end of the external interventional guidewire through the stenosis of the target vessel. Then, the operator inserts the proximal end of the guidewire remaining outside the body into the tip 3 of the catheter of this system, allowing it to pass posteriorly along the internal guidewire lumen 7, and exit from the guidewire exchange port 8 on the side wall of the distal tube body 6, thereby nesting the entire catheter on the guidewire track and advancing it deeper into the blood vessel. During the sliding along the guidewire, the axial pushing force applied by the operator at the external end is mainly borne by the high structural strength and anti-kink capacity of the hypotube 9 and the catheter shaft 10.

[0028] These proximal rigid components form a reliable mechanical transmission framework, effectively and with low loss transmitting external physical pushing force to the distal end of the catheter. As the distal end of the catheter gradually penetrates into the complex and meandering coronary artery branches, the multi-segment stiffness-step reduction design of the distal catheter 6 plays a structural compliance role. This part of the catheter can adapt and bend compliantly with the natural anatomical curvature of the human blood vessel, reducing the frictional resistance of the catheter wall while avoiding mechanical cutting of the vascular intima. Through the effective torque transmission of the proximal rigid tubing and the morphological fit of the distal flexible structure, the distal cyst 4 can safely cross the tortuous section of the blood vessel and is finally smoothly delivered and anchored in the predetermined calcified lesion area, creating the necessary working position for subsequent fluid filling and pressure treatment and shock wave lithotripsy.

[0029] See attached document Figure 6 and attached Figure 7 An integrated coronary pulse shockwave therapy catheter and its control system, comprising a control unit and an integrated coronary pulse shockwave therapy catheter; The control unit is integrated with the catheter seat 11 of the integrated coronary pulse shockwave therapy catheter as an independent integrated unit, and the internal circuit of the control unit is connected to the electrical connector 14. The control section is equipped with a power supply and a high-voltage discharge circuit. The high-voltage discharge circuit is electrically connected to the electrical connector 14, and a voltage-sensitive component is connected in series on the high-voltage discharge circuit. The voltage-sensitive component has a breakdown voltage threshold, which is the minimum critical voltage required for the voltage-sensitive component to switch from a high-resistance state to a conducting state. The voltage-sensitive component is configured to switch from a high-resistance state to a conducting state when the voltage across its terminals reaches the breakdown voltage threshold, thereby closing the high-voltage discharge circuit and outputting high-voltage pulse energy to the pulse generator / developer ring 5. The control section also includes a boost circuit module, a voltage multiplier circuit, and an energy storage capacitor. The voltage output from the power supply is converted into high-voltage electrical energy by the boost circuit module and the voltage multiplier circuit and stored in the energy storage capacitor. The energy storage capacitor is used to release high-voltage electrical energy as high-voltage pulse energy to the pulse generator / development ring 5 instantaneously when the voltage-sensitive components are turned on. The control section also includes a trigger circuit. The trigger circuit is isolated and decoupled from the high-voltage discharge circuit. The trigger circuit is used to output a trigger voltage to the voltage-sensitive components after receiving the discharge command, and the peak value of the trigger voltage is greater than the breakdown voltage threshold. The voltage-sensitive component is selected from at least one of transient voltage suppression diode, gas discharge tube or glass discharge tube. The control section is equipped with a microprocessor, which is configured to execute operating mode and standby mode. In standby mode, the microprocessor reduces the system operating frequency and disables peripheral functions to enter a low-power state; In operation mode, the microprocessor performs task scheduling management, which specifically includes display update tasks, data acquisition tasks for voltage and conduit status of each module, and key processing tasks. The control unit's housing surface is equipped with buttons and a display area. The buttons are used to receive operation commands and switch between operating mode and standby mode, as well as to trigger the release of high-voltage pulse energy. The display area is used to output discharge status indication, discharge count prompt, and discharge energy level display in operating mode.

[0030] Specifically, in this embodiment, the control unit and the catheter seat 11 of the integrated coronary pulse shockwave therapy catheter are combined into an independent integrated unit. The outer shell of the control unit can be non-detachably connected to the proximal end of the catheter seat 11 through ultrasonic welding, snap-fit, or adhesive bonding. Inside the above structure, the internal circuitry of the control unit can be electrically connected to the electrical connectors 14 provided on the catheter seat 11 through metal springs, probes, or direct welding to establish a power supply and signal transmission link.

[0031] The control unit internally houses a power supply and a high-voltage discharge circuit. The power supply can utilize miniature high-rate lithium polymer batteries or disposable lithium manganese batteries to meet the system's energy requirements. Since the low-voltage DC output from the power supply is generally unsuitable for directly generating shock waves, the control unit is equipped with a boost circuit module, a voltage multiplier circuit, and an energy storage capacitor.

[0032] The voltage output from the power supply is sequentially converted into high-voltage electrical energy by a boost circuit module and a voltage multiplier circuit, and then stored in an energy storage capacitor. Specifically, the boost circuit module can adopt a Boost DC-DC boost topology to initially boost the base voltage provided by the battery, for example, to about 50V to 200V. The voltage multiplier circuit is connected to the output of the boost circuit module and can adopt a Cockcroft-Walton multi-stage diode-capacitor voltage multiplier rectifier network to further accumulate and amplify the initially boosted voltage to the required high voltage state, for example, between 1000V and 3500V, and continuously inject high-voltage electrical energy into and store it in the energy storage capacitor. The specific component selection and wiring design of the DC-DC boost converter and the multi-stage diode-capacitor voltage multiplier network can be conventionally configured by those skilled in the art according to the voltage requirements of the application scenario; these are well-known technologies in the field and will not be elaborated further here.

[0033] The theoretical value of the high-voltage pulse energy stored in the energy storage capacitor follows the calculation model below: ; in, This represents the high-voltage pulse energy accumulated within the energy storage capacitor, measured in joules (J). This represents the capacitance of the energy storage capacitor, measured in farads (F). This represents the charging voltage output of the voltage multiplier circuit and applied across the energy storage capacitor, measured in volts (V). In specific applications of coronary pulsed wave therapy, to ensure effective lithotripsy without damaging blood vessels, the energy of a single high-voltage pulse... Typically, the energy level is set within a specific range, such as 1J to 5J. Based on this energy requirement, those skilled in the art can calculate the corresponding hardware parameters, such as the energy storage capacitor. The capacitance can be selected from 10nF to 100nF, with corresponding charging voltages. The voltage can be controlled between 1000V and 3500V. The system monitors and adjusts the charging voltage. It can precisely control the energy level of the high-voltage pulse energy output.

[0034] One end of the high-voltage discharge circuit is connected to the energy storage capacitor, and the other end is electrically connected to the electrical connector 14. A voltage-sensitive component is connected in series in the high-voltage discharge circuit. This voltage-sensitive component has a breakdown voltage threshold, which is the minimum critical voltage required for the voltage-sensitive component to transition from a high-resistance state to a conducting state. Its value is typically set slightly lower than the maximum design output voltage of the voltage multiplier circuit to ensure effective triggering. The voltage-sensitive component can be selected from at least one of a transient voltage suppression diode, a gas discharge tube, or a glass discharge tube. When the breakdown voltage threshold is not reached, the component presents a high-resistance state, blocking the high-voltage discharge circuit and limiting the leakage of high-voltage energy from the energy storage capacitor.

[0035] The control section also includes a trigger circuit to control the timing of high-voltage energy discharge. The trigger circuit and the high-voltage discharge circuit are isolated and decoupled. In one embodiment, the trigger circuit and the high-voltage discharge circuit are isolated by a high-voltage optocoupler or a miniature isolation transformer to suppress the reverse breakdown of the low-voltage trigger circuit and the front-end control chip caused by the surge generated by the high-voltage discharge circuit at the moment of conduction.

[0036] The high-voltage pulse release logic of the integrated control system includes the following specific operation steps: Energy storage phase: The system controls the boost circuit module and voltage multiplier circuit to charge the energy storage capacitor. During this phase, the voltage across the voltage-sensitive components is below the breakdown voltage threshold, and the high-voltage discharge circuit remains open. Triggering phase: After receiving a discharge command from the microprocessor, the trigger circuit outputs a trigger voltage. The peak value of this trigger voltage is greater than the breakdown voltage threshold of the voltage-sensitive component, and the trigger voltage is applied to the high-voltage discharge circuit via an isolation decoupling device; Breakdown and release phase: When the trigger voltage reaches the breakdown voltage threshold, the voltage-sensitive component switches from a high-resistance state to a conducting state, closing the high-voltage discharge circuit. The closed high-voltage discharge circuit provides a release channel for the energy storage capacitor, which instantaneously releases the aforementioned high-voltage electrical energy to the pulse generator / developing ring 5, forming high-voltage pulse energy; Reset Phase: After the energy stored in the capacitor is completely released, the voltage across the high-voltage discharge circuit drops rapidly. When this voltage falls below the holding voltage of the voltage-sensitive component, the component automatically returns to a high-resistance state, thereby cutting off the high-voltage discharge circuit. The system then re-enters standby mode or waits to execute the next energy storage command, thus forming a complete pulse release closed-loop logic.

[0037] High-voltage pulse energy is transmitted through the catheter hub 11 and electrical connector 14, along a conductor extending through the catheter shaft 10 and distal tube 6, to the pulse generator / contrast ring 5 inside the capsule 4. Upon receiving the high-voltage pulse energy, the pulse generator / contrast ring 5 instantaneously generates an electric arc discharge in the surrounding conductive liquid medium, such as contrast agent or saline. Physically, the high temperature generated by the arc causes a very small amount of surrounding liquid to vaporize instantaneously, forming rapidly expanding cavitation bubbles. The rapid expansion of these bubbles compresses the surrounding liquid, generating a mechanical shock wave that radiates outwards. This mechanical shock wave penetrates the capsule 4 and acts on the calcified lesions on the vessel wall. Utilizing the difference in acoustic impedance between the calcified tissue and the soft vascular tissue, it creates micro-fractures in the hard calcified plaques, while the softer normal vascular tissue absorbs the shock wave energy without damage, thus achieving safe and effective interventional lithotripsy.

[0038] In this embodiment, a microprocessor serves as the control core within the control unit. The microprocessor is electrically connected to the aforementioned power supply, boost circuit module, trigger circuit, and other hardware entities, coordinating energy conversion timing and processing external signal inputs. The control unit's outer casing features buttons and a display area, which together form the interface between the operator and the integrated coronary pulse shockwave therapy catheter. To adapt to the needs of different surgical stages and manage equipment energy consumption, the microprocessor is configured to operate in both running and standby modes.

[0039] The buttons are configured to receive operation commands and switch between operating and standby modes. After the device is powered on or after a timeout period, the system enters standby mode. In standby mode, the microprocessor executes a hibernation command to reduce the system operating frequency and disable peripheral functions, thus entering a low-power state. Specifically, the microprocessor switches its system clock source from an external high-frequency crystal oscillator to an internal low-frequency oscillator, suspends the core computation of the central processing unit, and simultaneously disables the communication bus interface, cuts off the power supply to the display area, and disables the enable pin of the boost circuit module. Given the miniaturized and portable design of the control unit, its built-in battery capacity is limited; this low-power state helps maintain the device's power supply during transportation, storage, and pre-operative preparation. When the operator presses a button, an external interrupt signal is generated. The microprocessor captures this operation command, exits hibernation, resumes the high-frequency clock, and reinitializes all hardware modules, thereby switching to operating mode.

[0040] In runtime mode, the microprocessor runs a bare-metal polling framework or a real-time operating system based on its internal timer resources to perform task scheduling and management. This task scheduling and management specifically includes data acquisition tasks for module voltages and conduit status, key press processing tasks, and display update tasks. These tasks are executed alternately by the microprocessor within a set time period, and include the following operational steps: The microprocessor performs data acquisition tasks for the voltage and conduit status of each module: it drives the internal analog-to-digital converter to periodically acquire analog signals from the hardware circuitry. The acquired data range includes the remaining power voltage of the power supply and the charging feedback voltage across the energy storage capacitor. Simultaneously, the microprocessor acquires conduit status data by detecting the loop impedance value at the interface with the electrical connectors to determine the connection integrity of the pulse generator / disinfection ring and the circuit insulation condition. If the acquired loop impedance value deviates from the set normal operating range—for example, exhibiting high impedance for an open circuit or low impedance for a short circuit—the microprocessor sets its internal status flag to abnormal, thus blocking the subsequent discharge process.

[0041] Executing button processing tasks: The microprocessor scans the pin level changes of the buttons on the outer casing surface and performs debouncing processing with software delay to confirm valid operation commands. The button processing logic can parse the corresponding control intent based on the different press durations. The buttons are used not only to switch operating modes but also to trigger the release of high-voltage pulse energy. In a specific interactive embodiment, the microprocessor sets a time threshold to classify button actions. For example, actions lasting less than 1 second are identified as short press commands, used for switching between different energy levels or operating modes; actions lasting 2 seconds or more are identified as long press commands, which are parsed as operation commands to trigger the release of high-voltage pulse energy.

[0042] Perform the display update task: The microprocessor summarizes the data and operation instruction parsing results obtained in the previous steps, drives the external video memory, and maps the current logical state of the device to the display area on the surface of the casing.

[0043] The display area can be a liquid crystal display (LCD), an organic light-emitting diode (OLED) screen, or an OLED array. The display area is used to output discharge status indication, discharge count prompts, and discharge energy level displays in operating mode. The discharge status indication includes visual prompts for boost charging, ready to trigger, discharge execution, and fault alarms; the discharge count prompt displays the number of high-voltage pulses released or the remaining effective usage counts to remind operators to prevent exceeding the catheter's mechanical fatigue limits; the discharge energy level display shows the currently set high-voltage level for operators to adjust when dealing with vascular lesions of different calcification levels. For the porting of the display area's underlying driver code and the layout of the graphical interface, those skilled in the art can refer to the microprocessor development manual for conventional program writing; its underlying development is well-known technology in the field and will not be elaborated upon here.

[0044] In the data acquisition tasks for the voltage and conduit status of each module, the microprocessor needs to obtain the actual high voltage value to monitor the energy supplied by the energy storage capacitor to the discharge circuit. As can be seen from basic circuit principles, this high voltage exceeds the conventional physical tolerance limit of the microprocessor pins. Therefore, a voltage divider resistor network is configured in the circuit to proportionally attenuate the high voltage before inputting it to the analog-to-digital converter. The microprocessor's operational logic for restoring the acquired digital signal to the actual voltage follows the following calculation model: ; in, This represents the estimated actual charging voltage across the energy storage capacitor obtained through conversion, in volts (V). It represents the quantized digital value obtained by the analog-to-digital converter within the microprocessor in a single sample, and is a dimensionless parameter. The number of bits representing the hardware resolution of the analog-to-digital converter, typically 12 or 16; The reference voltage representing the operation of the analog-to-digital converter is measured in volts (V). This value depends on the system supply voltage of the microprocessor and is typically selected as 3.3V or 2.5V. This represents the attenuation ratio set by the hardware voltage divider network. Its value is set according to the ratio of the highest design voltage to the reference voltage, and is usually set between 100 and 1000. For example, a value of 1000 means that the voltage of up to 3000V will be linearly attenuated to 3V for safe acquisition.

[0045] When the microprocessor receives an operation command to trigger the release of high-voltage pulse energy during the execution of the key processing task, it obtains the data based on the aforementioned calculation model. The voltage is compared with the target voltage corresponding to the preset discharge energy level. When the current system parameters meet the set conditions and the conduit is in normal condition, the microprocessor sends an action signal to the trigger circuit; otherwise, if... If the target threshold is not reached or the aforementioned conduit state is determined to be abnormal, the microprocessor will intercept the discharge command and output a corresponding fault alarm in the display area via the display update task driver. This logic structure provides fault tolerance and condition verification mechanisms for the safe release of pulse energy.

[0046] Working Principle: At the overall system operation level, this system requires no external control equipment. It is powered by its own battery, and the control unit and catheter unit are integrated at the hardware level via electrical connectors 14 on the catheter holder 11. In a sterile operating area, the operator covers the control device with a medical transparent sterile plastic bag and directly uses the buttons on the control unit panel to start / stop the system and set discharge parameters. The device's operating status is displayed, and the generated electrical signals and control commands are directly fed into the catheter's internal circuit via electrical connectors 14. After a single surgery, the operator only needs to discard the disposable catheter unit. Because the control unit is physically isolated by a sterile bag, subsequent low-cost basic maintenance and sterilization are all that's required before reuse. The overall miniaturized design greatly improves the ease of use in crowded operating rooms.

[0047] During the mechanical delivery phase of the catheter, the operator first passes the guidewire through the diseased blood vessel, then inserts the proximal end of the guidewire into the catheter tip 3, through the guidewire lumen 7, and out through the guidewire exchange port 8 on the distal tube body 6, advancing the system along the guidewire into the blood vessel. The axial pushing force applied externally is mainly borne by the high-strength hypotube 9 and the catheter shaft 10 and transmitted distally; when the distal end of the catheter enters a coronary artery branch, the distal tube body 6, with its multi-segment gradually varying stiffness design, adapts to the anatomical curvature of the blood vessel. Through the combination of rigid transmission at the proximal end and compliant deformation at the distal end, the capsule 4 is finally smoothly advanced and positioned in the calcified lesion area inside the blood vessel.

[0048] During the pulse energy release phase, the operator injects a mixture of contrast agent and saline solution into the capsule 4 through the filling port 13. During this process, internal air can be vented through the vent port 12. The boost module and voltage multiplier circuit within the control unit first convert the battery voltage to high voltage and pre-store electrical energy in the energy storage capacitor. When the operator presses the trigger button, the trigger circuit outputs a voltage signal, causing the voltage across the voltage-sensitive components in the high-voltage circuit to reach their nominal breakdown threshold. The voltage-sensitive components then instantly conduct, closing the high-voltage discharge circuit. The high-voltage electrical energy accumulated in the energy storage capacitor is rapidly released to the pulse generator / contrast ring 5 inside the capsule 4. The high-energy electrical pulse breaks down the liquid medium at the pulse generator / contrast ring 5, forming a high-temperature plasma channel. The surrounding liquid then vaporizes, generating expanding bubbles, which radiate outward mechanical pressure pulses to form shock waves that act on the blood vessel wall to shatter calcified plaques.

Claims

1. An integrated coronary pulsed shockwave therapy catheter, characterized in that, It includes a catheter hub (11), a catheter shaft (10), a distal tube body (6), a capsule (4), and a lead wire. The catheter hub (11) is provided with an inlet (13) and an electrical connector (14). The proximal end of the catheter shaft (10) is connected to the catheter hub (11), the proximal end of the distal tube body (6) is connected to the distal end of the catheter shaft (10), and the capsule (4) is connected to the distal end of the distal tube body (6). A pulse generator / contrast ring (5) is provided inside the capsule (4). The filling port (13) is in communication with the interior of the capsule (4) via the catheter shaft (10) and the distal tube (6), and the electrical connector (14) is electrically connected to the pulse generator / illumination ring (5) via the wire extending through the catheter shaft (10) and the distal tube (6).

2. The integrated coronary pulsed shockwave therapy catheter according to claim 1, characterized in that, It also includes a tip (3) and a guidewire lumen (7), the tip (3) being disposed at the distal end of the capsule (4); the distal tube (6) is provided with a guidewire exchange port (8), the proximal end of the guidewire lumen (7) is connected to the guidewire exchange port (8), and the distal end of the guidewire lumen (7) extends through the distal tube (6) and the capsule (4) and is connected to the tip (3) to form a rapid exchange structure for external guidewires to pass through.

3. The integrated coronary pulsed shockwave therapy catheter according to claim 2, characterized in that, The main body of the conduit shaft (10) is made of a hyaluronic acid tube (9); the distal tube body (6) is made of different hardness materials spliced ​​or woven in sections from the proximal end to the distal end, and the hardness of the distal tube body (6) decreases in a stepwise manner towards the tip (3).

4. The integrated coronary pulsed shockwave therapy catheter according to claim 1, characterized in that, The guide tube seat (11) is also provided with an exhaust port (12); It also includes a liner (1) and a balloon protector (2), wherein the liner (1) is inserted inside the catheter shaft (10) and the distal tube body (6), and the balloon protector (2) is fitted over the outside of the folded balloon body (4).

5. An integrated coronary pulsed shockwave therapy catheter and its control system, characterized in that, For operating an integrated coronary pulse shockwave therapy catheter as described in any one of claims 1-4, comprising a control section and an integrated coronary pulse shockwave therapy catheter; The control unit is integrated with the catheter seat (11) of the integrated coronary pulse shockwave therapy catheter as an independent integrated unit, and the internal circuit of the control unit is connected to the electrical connector (14). The control section is equipped with a power supply and a high-voltage discharge circuit. The high-voltage discharge circuit is electrically connected to the electrical connector (14), and a voltage-sensitive component is connected in series on the high-voltage discharge circuit. The voltage-sensitive component has a breakdown voltage threshold, which is the minimum critical voltage required for the voltage-sensitive component to switch from a high-resistance state to a conducting state. The voltage-sensitive component is configured to switch from a high-resistance state to a conducting state when the voltage across its terminals reaches the breakdown voltage threshold, thereby closing the high-voltage discharge circuit and outputting high-voltage pulse energy to the pulse generator / development ring (5).

6. The integrated coronary pulsed shockwave therapy catheter and its control system according to claim 5, characterized in that, The control section is also equipped with a boost circuit module, a voltage multiplier circuit and an energy storage capacitor. The voltage output by the power supply is converted into high voltage energy by the boost circuit module and the voltage multiplier circuit in sequence and stored in the energy storage capacitor. The energy storage capacitor is used to release the high voltage energy as the high voltage pulse energy to the pulse generator / development ring (5) instantaneously when the voltage sensitive component is turned on.

7. The integrated coronary pulsed shockwave therapy catheter and its control system according to claim 6, characterized in that, The control section also includes a trigger circuit, which is isolated and decoupled from the high-voltage discharge circuit. The trigger circuit is used to output a trigger voltage to the voltage-sensitive component after receiving a discharge command, and the peak value of the trigger voltage is greater than the breakdown voltage threshold.

8. The integrated coronary pulsed shockwave therapy catheter and its control system according to claim 5, characterized in that, The voltage-sensitive component is selected from at least one of transient voltage suppression diodes, gas discharge tubes, or glass discharge tubes.

9. The integrated coronary pulse shockwave therapy catheter and its control system according to claim 5, characterized in that, The control unit is equipped with a microprocessor, which is configured to execute a running mode and a standby mode. In the standby mode, the microprocessor reduces the system operating frequency and disables peripheral functions to enter a low-power state; In the operating mode, the microprocessor performs task scheduling management, which specifically includes display update tasks, data acquisition tasks for voltage and conduit status of each module, and key processing tasks.

10. The integrated coronary pulsed shockwave therapy catheter and its control system according to claim 9, characterized in that, The control unit's housing surface is provided with buttons and a display area. The buttons are used to receive operation commands and switch between the operating mode and the standby mode, and to trigger the release of the high-voltage pulse energy. The display area is used to output discharge status indication, discharge count prompt, and discharge energy level display in the operating mode.

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