An intravascular shockwave pulse generation system

Abstract

The utility model relates to a kind of intravascular shock wave pulse generation system, including handle and catheter consumables, microprocessor control module, high-voltage pulse generation module and power management module are equipped in handle, catheter consumables include catheter, luer joint and catheter joint, one-time battery is also set in catheter joint, the other end of catheter is equipped with balloon, electrode is equipped in balloon, catheter joint is inserted with handle, and make one-time battery and power management module intercommunication, electrode and high-voltage pulse generation module intercommunication;Power management module, high-voltage pulse generation module are all connected with microprocessor control module, power management module converts the voltage of one-time battery into the operating voltage required by microprocessor control module and high-voltage pulse generation module.The utility model places one-time battery in catheter consumables, catheter consumables is overall for disposable use, without medical staff charging maintenance operation to equipment, overall volume is small, and storage is convenient to take.

Description

Technical Field

[0001] This utility model relates to a medical device, and more particularly to an intravascular shock wave pulse generation system. Background Technology

[0002] Currently, intravascular shockwave therapy equipment is typically a desktop system with consumable catheters. The device generates controllable high-voltage pulses, and the catheters, as disposable consumables, convert these pulses into shockwave energy. Especially for coronary shockwave therapy equipment, due to the extremely high requirements for low leakage current in cardiac treatment, using grid power transformers to supply power cannot achieve such low leakage current. Therefore, these devices are powered by built-in rechargeable lithium batteries. The device is fully charged before treatment, and the lithium battery is used to discharge during treatment. Often, a single full charge is sufficient to support the treatment of more than five cases. As shockwave therapy equipment is managed by the hospital, it requires regular charging and maintenance to prevent battery depletion. The easy mixing and loss of chargers is also a common problem. Furthermore, medical staff need to ensure the device is fully charged before surgery to guarantee a smooth procedure. However, the device's internal battery capacity is finite, and the duration and power consumption of each surgery vary, making it uncertain how many surgeries a single full charge can support, thus impacting surgical planning.

[0003] Shockwave therapy equipment requires batteries that can power multiple surgical procedures on a single charge, necessitating large capacities and volumes, typically exceeding 20Wh. Furthermore, the equipment requires specialized charging and discharging circuitry for management, resulting in its bulky size and necessitating a desktop design. Desktop devices, placed on a tabletop or mobile platform, are extremely space-consuming to move and use, which is particularly problematic given the limited space in operating rooms. This design also hinders the operation of medical staff. After surgery, the storage and retrieval of the trolley and equipment also require considerable space.

[0004] Furthermore, currently, manual infusion pumps are used to inflate shockwave balloons with contrast agents and saline. While the balloon operates at a certain pressure, balloon rupture is foreseeable during treatment. However, in the event of balloon rupture, the electrodes are exposed to the bloodstream, and continuous high-voltage pulses are extremely detrimental to the patient. Therefore, medical staff must constantly monitor the pressure gauge of the infusion pump during treatment, and if balloon rupture occurs, the high-voltage pulse excitation must be stopped immediately. However, in the use of some shockwave generators with higher pulse frequencies (e.g., 2Hz), the 500ms pulse period is clearly shorter than a human reaction time. Therefore, even after a person notices an abnormal drop in the pressure gauge and manually stops the pulses, one or two pulses may still leak out, which can be life-threatening for the patient. Utility Model Content

[0005] To address the aforementioned technical problems, the present invention aims to provide an intravascular shockwave pulse generation system. This system eliminates the need for a charger, eliminating the need for medical staff to charge and maintain traditional shockwave devices. It also reduces the size of the device by allowing it to be handheld, thus solving the problems of inconvenience in moving and handling the device and the space-consuming storage required during use.

[0006] To achieve the above-mentioned objectives, this utility model adopts the following technical solution:

[0007] An intravascular shockwave pulse generation system includes a handle and catheter consumables. The handle houses a microprocessor control module, a high-voltage pulse generation module, and a power management module. The catheter consumables include a catheter, a Luer connector mounted on the catheter, and a catheter connector at one end of the catheter. A disposable battery is also housed in the catheter connector. A balloon with an electrode is located at the other end of the catheter. The catheter connector is inserted into the handle, connecting the disposable battery to the power management module and the electrode to the high-voltage pulse generation module. Both the power management module and the high-voltage pulse generation module are connected to the microprocessor control module. The power management module converts the voltage of the disposable battery into the operating voltage required by the microprocessor control module and the high-voltage pulse generation module.

[0008] As a preferred embodiment, the catheter connector also includes a pressure monitoring circuit. When the catheter connector is inserted into the handle, the pressure monitoring circuit is connected to the microprocessor control module. A hydraulic sensor is also installed inside the catheter and is connected to the pressure monitoring circuit. This structure monitors the fluid pressure inside the catheter and balloon via sensors. In the event of a rapid loss of pressure in the balloon, the pulse generation is quickly stopped, ensuring that no residual high-pressure pulse enters the body after balloon rupture, thus minimizing patient harm.

[0009] As a preferred embodiment, the hydraulic sensor is placed at the Luer connector, and the portion of the conduit connecting the hydraulic sensor and the conduit connector forms a sealed section. Placing the hydraulic sensor 25 at the Luer connector, compared to placing the hydraulic sensor 25 at the balloon, keeps the sensor away from the discharge electrode, resulting in less interference and a simpler, more stable, and reliable design.

[0010] As a preferred embodiment, the handle also includes an audible and visual alarm module connected to the microprocessor control module. The microprocessor control module controls the interruption of the high-pressure pulse generation module via a signal from the pressure monitoring circuit, and controls the audible and visual alarm module to issue an alarm signal. This structure, upon detecting balloon rupture, not only promptly stops the high-pressure pulse but also provides an audible and visual alarm signal to remind the user to take timely action.

[0011] As a preferred embodiment, the catheter connector is further provided with a catheter identification circuit, which is connected to the microprocessor control module when the catheter connector is inserted into the handle.

[0012] As a preferred embodiment, the handle also includes buttons and a display module connected to the microprocessor control module. These buttons and the display module control the start and stop of the high-voltage pulse generation module, and simultaneously display the pulse count and conduit model information. This structure allows for direct operation of the system via the handle; the generation of the shock wave can be controlled simply by pressing the buttons; and information such as the pulse count, conduit model, and battery level can also be displayed.

[0013] As a preferred embodiment, the handle and the conduit are connected by an electrical connector, and the connection length is less than 10cm, eliminating the need for a connection cable and facilitating storage and management.

[0014] As a preferred embodiment, the high-voltage pulse generating module generates a 300-20000V high-voltage pulse with a maximum frequency of 2Hz, and the internal pressure of the balloon is 2-10MPa.

[0015] As a preferred embodiment, the disposable battery is a single or two disposable lithium primary batteries with a capacity of 4–6 Wh. This satisfies the need for treating individual cases while maintaining a small overall size. Furthermore, the disposable lithium primary batteries have low self-discharge characteristics, allowing for long-term storage.

[0016] As a preferred embodiment, the disposable battery is placed inside the catheter connector and is non-removable, and the entire catheter consumable is sterilized by irradiation or ethylene oxide.

[0017] Compared with the prior art, the beneficial effects of this utility model are as follows:

[0018] This invention places a disposable battery in the catheter consumable, which is used only once. Therefore, the battery only needs to provide power for a single surgical procedure, and the battery volume is 75% smaller than that of traditional devices. Because a disposable battery is used, there is no need to charge the battery, no need for an external charger, and no need for an internal charging management circuit. Therefore, the system is simpler and the overall system size is smaller. The handheld system does not require a trolley or desktop.

[0019] For medical staff, the system is small in size and easy to hold. It can be used directly in the hand or placed on the hospital bed, and the operation is intuitive and convenient. Since there is no rechargeable battery inside the handle, there is no need to charge and maintain the handle regularly. There is no need to confirm charging before treatment. After the surgery for a single case, the catheter consumables can be discarded directly, and a new catheter consumable can be replaced for the next case. There is no need to worry about whether the device has enough power. Attached Figure Description

[0020] 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.

[0021] Figure 1 This is a schematic diagram of the overall structure of this utility model.

[0022] The attached figures are labeled as follows: 1. Handle; 11. Microprocessor control module; 12. Button and display module; 13. High-voltage pulse generation module; 14. Power management module; 15. Audible and visual alarm module; 2. Catheter connector; 21. Pressure monitoring circuit; 22. Catheter identification circuit; 23. Disposable battery; 24. Sealing section; 25. Hydraulic sensor; 26. Luer connector; 27. Catheter; 28. Electrode; 30. Liquid; 31. Balloon; 120. Electrical connector. Detailed Implementation

[0023] 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.

[0024] It should be noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the exemplary embodiments according to this application. As used herein, the singular form is intended to include the plural form as well, unless the context clearly indicates otherwise. 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.

[0025] Furthermore, in the description of this utility model, 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 utility model 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 utility model.

[0026] 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 technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of this utility model, unless otherwise stated, "a plurality of" means two or more, unless otherwise expressly defined.

[0027] In this utility model, 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 utility model according to the specific circumstances.

[0028] 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.

[0029] The present invention will be further described below with reference to the accompanying drawings and embodiments:

[0030] like Figure 1As shown, an intravascular shockwave pulse generation system includes a handle 1 and a catheter consumable. The handle 1 and the catheter consumable are directly connected by an electrical connector 120, and the connection length is less than 10cm, without any connecting cable. The handle 1 contains a microprocessor control module 11, a high-voltage pulse generation module 13, and a power management module 14. The high-voltage pulse generation module 13 generates a 300-20000V high-voltage pulse. The conduit consumables include a conduit 27, a Luer connector 26 disposed on the conduit 27, and a conduit connector 2 disposed at one end of the conduit 27. The conduit connector 2 also contains a disposable battery 23. The other end of the conduit 27 is provided with a balloon 31, and the balloon 31 contains an electrode 28. The conduit connector 2 is inserted into the handle 1, so that the disposable battery 23 is connected to the power management module 14, and the electrode 28 is connected to the high-voltage pulse generation module 13. The power management module 14 and the high-voltage pulse generation module 13 are both connected to the microprocessor control module 11. The power management module 14 converts the voltage of the disposable battery 23 into the working voltage required by the microprocessor control module 11 and the high-voltage pulse generation module 13.

[0031] To improve system portability and enable handheld use, the disposable battery capacity should be sufficient for treating a single case, approximately 5Wh. One or two disposable lithium primary batteries are sufficient for each treatment session. These batteries have low self-discharge and can be stored for extended periods. The lithium primary batteries are housed internally within the catheter connector and are not removable. All catheter consumables are sterilized by irradiation or ethylene oxide to meet aseptic requirements.

[0032] The conduit connector 2 is also equipped with a pressure monitoring circuit 21. When the conduit connector 2 is inserted into the handle 1, the pressure monitoring circuit 21 is connected to the microprocessor control module 11. The conduit 27 is equipped with a hydraulic sensor 25, which is connected to the pressure monitoring circuit 21. The hydraulic sensor 25 is located at the Luer connector 26, and the portion of the conduit 27 where the hydraulic sensor 25 connects to the conduit connector 2 is sealed with glue to form a sealing section 24.

[0033] Placing the hydraulic sensor 25 at the Luer connector is a simpler, more stable, and reliable method than placing it at the balloon. This is because the sensor is further away from the discharge electrode, resulting in less interference. Combined with the pressure monitoring mechanism, it can prevent the emission of extra pulses at the moment of balloon rupture, thus minimizing the harm to the patient caused by balloon rupture.

[0034] The handle 1 is also equipped with an audible and visual alarm module 15 connected to the microprocessor control module 11. The microprocessor control module 11 controls the interruption of the high-pressure pulse generation module 13 through the signal of the pressure monitoring circuit 21, and controls the audible and visual alarm module 15 to issue an alarm signal.

[0035] The aforementioned structure monitors the fluid pressure inside the catheter and balloon using sensors. When the pressure in the balloon is about to be lost, the pulse generation is quickly stopped to ensure that no residual high-pressure pulse enters the body after the balloon ruptures, reducing harm to the patient. At the same time, it provides audible and visual alarm signals to remind the user to take timely action.

[0036] The catheter connector 2 is also equipped with a catheter identification circuit 22. When the catheter connector 2 is inserted into the handle 1, the catheter identification circuit 22 is connected to the microprocessor control module 11. The handle 1 is also equipped with a button and display module 12 connected to the microprocessor control module 11. The button and display module 12 control the start and stop of the high-voltage pulse generation module 13, and simultaneously display the pulse count and catheter model information. The above structure allows the system to be operated directly on the handle. The generation of the shock wave can be controlled by button operation; at the same time, information such as the pulse count, catheter model, and power level can be displayed.

[0037] This invention uses a medical manual infusion pump to inject saline and contrast agent into the Luer connector, filling the catheter and balloon with liquid 30 and maintaining the balloon pressure within the range of 2-10 MPa. A hydraulic sensor 25 is placed in the Luer connector tee. The connection between the hydraulic sensor and the catheter connector is sealed with glue. The hydraulic sensor senses the liquid pressure inside the catheter and balloon. It is generally assumed that the liquid pressure inside the balloon and catheter is uniform; therefore, sensing the pressure at the Luer connector is equivalent to sensing the pressure at the balloon. During normal pulse activation, the maximum high-pressure pulse frequency is 2Hz, meaning a pulse is triggered once every 500ms. At this time, the balloon pressure remains within the range of 2-10 MPa. If the balloon ruptures at a certain pulse activation point and the pressure drops below 1 MPa within 100ms, the microprocessor control module 11 receives the excessively low liquid pressure value and controls the high-pressure pulse generation module 13 to stop triggering pulses. The user is alerted to a balloon malfunction via the audible and visual alarm module 15. The time from balloon rupture to pulse interruption does not exceed 200ms, and the next pulse cycle cannot be activated.

[0038] In the description of this specification, the references to terms such as "one embodiment," "some embodiments," "example," "specific example," or "some examples," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment 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 may be combined in any suitable manner in one or more embodiments or examples.

[0039] 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 and variations 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 modifications made to the above embodiments based on the technical essence of the present invention shall still fall within the scope of the technical solution of the present invention.

Claims

1. An intravascular shockwave pulse generation system, comprising a handle (1) and catheter consumables, characterized in that: The handle (1) is equipped with a microprocessor control module (11), a high-voltage pulse generation module (13), and a power management module (14). The conduit consumables include a conduit (27), a Luer connector (26) on the conduit (27), and a conduit connector (2) at one end of the conduit (27). A disposable battery (23) is also provided in the conduit connector (2). A balloon (31) is provided at the other end of the conduit (27). An electrode (28) is provided in the balloon (31). The conduit connector (2) is inserted into the handle (1), and the disposable battery (23) is connected to the power management module (14), and the electrode (28) is connected to the high-voltage pulse generation module (13). The power management module (14) and the high-voltage pulse generation module (13) are both connected to the microprocessor control module (11). The power management module (14) converts the voltage of the disposable battery (23) into the working voltage required by the microprocessor control module (11) and the high-voltage pulse generation module (13).

2. The intravascular shock wave pulse generation system according to claim 1, characterized in that, The catheter connector (2) is also equipped with a pressure monitoring circuit (21). When the catheter connector (2) is inserted into the handle (1), the pressure monitoring circuit (21) is connected to the microprocessor control module (11). The catheter (27) is equipped with a hydraulic sensor (25), which is connected to the pressure monitoring circuit (21).

3. The intravascular shock wave pulse generation system according to claim 2, characterized in that, The hydraulic sensor (25) is placed at the Luer connector (26), and the hydraulic sensor (25) and the conduit (27) of the conduit connector (2) form a sealed section (24).

4. The intravascular shock wave pulse generation system according to claim 2, characterized in that, The handle (1) is also equipped with an audible and visual alarm module (15) connected to the microprocessor control module (11). The microprocessor control module (11) controls the interruption of the high-pressure pulse generation module (13) through the signal of the pressure monitoring circuit (21) and controls the audible and visual alarm module (15) to issue an alarm signal.

5. The intravascular shock wave pulse generation system according to claim 1, characterized in that, The catheter connector (2) is also provided with a catheter identification circuit (22). When the catheter connector (2) is inserted into the handle (1), the catheter identification circuit (22) is connected to the microprocessor control module (11).

6. The intravascular shock wave pulse generation system according to claim 5, characterized in that, The handle (1) is also equipped with a button and display module (12) connected to the microprocessor control module (11). The button and display module (12) controls the start and stop of the high voltage pulse generation module (13) and displays the pulse number and catheter model information.

7. The intravascular shock wave pulse generation system according to claim 1, characterized in that, The handle (1) is connected to the conduit consumable via an electrical connector (120), and the connection length is less than 10cm.

8. The intravascular shock wave pulse generation system according to claim 1, characterized in that, The high-voltage pulse generation module (13) generates a high-voltage pulse of 300 to 20000V with a maximum frequency of 2Hz, and the internal pressure of the balloon (31) is 2 to 10MPa.

9. The intravascular shock wave pulse generation system according to claim 1, characterized in that, The disposable battery (23) is a single or two disposable lithium primary batteries with a capacity of 4 to 6 Wh.

10. The intravascular shock wave pulse generation system according to claim 1, characterized in that, The disposable battery (23) is placed inside the conduit connector (2) and cannot be removed. The conduit consumables are irradiated or sterilized with ethylene oxide.

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