Extracorporeal control device, control method and thrombus suction device for thrombus suction

Abstract

The application provides an extracorporeal control device, a control method and a thrombus suction device for thrombus suction. The extracorporeal control device comprises a main pipeline, a main valve, a pressure display device, a main static negative pressure source and at least one secondary negative pressure control unit. The distal end of the main pipeline is used for detachable connection with the proximal end of a suction catheter, the main valve is arranged at the distal end of the main pipeline, the pressure display device is in communication with the main pipeline and is close to the proximal end of the main valve, the main static negative pressure source is used for generating a static suction negative pressure, and the main static negative pressure source is in communication with the main pipeline and is located at the proximal end of the main valve. Each secondary negative pressure control unit comprises a secondary valve and a secondary static negative pressure source, and the secondary valve is used for enabling the secondary static negative pressure source to be in communication with or disconnected from the main pipeline. The technical scheme of the application can detect and display the suction negative pressure change condition in the thrombus suction process, is beneficial to quickly judging the reason why the thrombus cannot be sucked out, timely and correctly taking corresponding measures, improving the treatment efficiency and reducing the treatment risk.

Description

Technical Field

[0001] This application relates to the technical field of medical devices, and more specifically, to an external control device, control method, and thrombus aspiration apparatus for thrombus aspiration. Background Technology

[0002] A thrombus is a small piece of blood that forms on the surface of a blood vessel at a point where it has broken off or been repaired. Thrombi can cause blockages in blood vessels, restricting blood flow and significantly reducing the delivery of oxygen and nutrients to surrounding tissues. The presence of a thrombus can also cause necrosis (i.e., cell death) in tissues distal to the thrombus, potentially leading to brain damage or death.

[0003] Currently, in clinical practice, aspiration catheters can be used to remove thrombi and other obstructions that affect the patency of blood vessels. Under the guidance of equipment such as digital subtraction angiography (DSA), the distal end of the aspiration catheter is placed close to the thrombus in the blood vessel. A pressure source such as a large-volume syringe or a negative pressure suction pump connected to the proximal end of the aspiration catheter provides negative pressure to aspirate the thrombus and remove it from the body.

[0004] In existing technologies, most suction devices used by operators cannot detect the negative pressure within the suction catheter, leaving the operator in a state of blind waiting during thrombus aspiration. If the thrombus cannot be removed due to insufficient negative pressure within the suction catheter, and the operator continues to wait blindly, it is highly likely to increase treatment time and risks. Summary of the Invention

[0005] The purpose of this application is to provide an external control device, control method, and thrombus aspiration device for thrombus aspiration, which can at least solve the problems pointed out in the background art.

[0006] In a first aspect, an external control device for thrombus aspiration is provided, comprising a main negative pressure control unit and at least one secondary negative pressure control unit. The main negative pressure control unit includes a main pipeline, a main valve, a pressure display device, and a main static negative pressure source. The distal end of the main pipeline is detachably connected to the proximal end of an aspiration catheter for thrombus aspiration. The main valve is located on the main pipeline and near its distal end. The pressure display device is connected to the main pipeline and near the proximal end of the main valve. The main static negative pressure source generates a preset static aspiration negative pressure and is connected to the main pipeline and located proximal to the main valve. Each secondary negative pressure control unit includes a secondary valve and a secondary static negative pressure source. The secondary static negative pressure source generates a preset static aspiration negative pressure, and the secondary valve connects or disconnects the secondary static negative pressure source from the main pipeline.

[0007] In one feasible solution, a master controller is also included, which is connected to the pressure display device, the main valve, and the secondary valves for receiving pressure signals from the pressure display device and sending valve opening or closing signals to the main valve and the secondary valves.

[0008] In one feasible scheme, the secondary valves of all secondary negative pressure control units are sequentially arranged on the main pipeline and connected in series between the main valve and the proximal end of the main pipeline; a secondary static negative pressure source is provided on the proximal side of each secondary valve, which is connected to the cavity of the main pipeline on the proximal side of the secondary valve; the main static negative pressure source is connected to the cavity of the main pipeline between the main valve and the first secondary valve; and the pressure display device is connected to the cavity of the main pipeline between the main valve and the secondary valve.

[0009] In one feasible embodiment, each secondary negative pressure module further includes a secondary pressure display device, which is located on the proximal side of the corresponding secondary valve and connected to the pipeline connected to the corresponding secondary static negative pressure source. The secondary pressure display device is also signal-connected to the main controller.

[0010] In one feasible embodiment, the secondary negative pressure control unit includes branch pipes, all of which are connected in parallel to the cavity between the main valve and the distal end of the main pipe, with the proximal ends of all branch pipes closed; a secondary valve for each secondary negative pressure control unit is located on the branch pipe; and a secondary static negative pressure source for each secondary negative pressure control unit is connected to the branch pipe and located on the proximal side of the secondary valve.

[0011] In one feasible embodiment, each secondary negative pressure control unit further includes a secondary pressure display device, which is connected to the corresponding branch pipeline and located near the secondary valve. The secondary pressure display device is signal-connected to the main controller.

[0012] In one feasible scheme, the main controller is signal-connected to the main static negative pressure source and the secondary static negative pressure source. The main controller is used to send negative pressure supply signals to the main static negative pressure source and the secondary static negative pressure source so that the main static negative pressure source and the secondary static negative pressure source generate a preset static negative pressure.

[0013] In one feasible embodiment, the pressure display device is a digital pressure gauge with a real-time pressure value display.

[0014] Secondly, a control method for the aforementioned external control device for thrombus aspiration is also provided. The distal end of the aspiration catheter, connected to the distal end of the main pipeline, is brought close to the thrombus within the blood vessel, with the main valve and secondary valves kept closed, and the main static negative pressure source and secondary static negative pressure source maintaining a predetermined static negative pressure. The control method includes the following steps:

[0015] S10. The main controller sends an opening signal to the main valve to open the main valve and connect the main static negative pressure source with the main pipeline and the aspiration catheter for aspirating thrombi.

[0016] S20. The main controller receives the pressure value signal from the pressure display device and calculates the pressure change rate.

[0017] S30. Determine the pressure change rate of S20 against the built-in standard negative pressure change rate range:

[0018] If the pressure change rate falls within the preset standard negative pressure change rate range, the main valve and secondary valve will remain open or closed.

[0019] If the pressure change rate is higher than the standard negative pressure change rate range, the main controller will warn of an airtightness problem and send a valve-closing signal to the main valve.

[0020] If the pressure change rate is less than the standard negative pressure change rate range, the main controller will warn of thrombus blockage of the aspiration catheter. The main controller will send an opening signal to at least one secondary valve to open the corresponding secondary valve to connect the corresponding secondary static negative pressure source with the main pipeline and the aspiration catheter for thrombus aspiration.

[0021] Continue with steps S40, S20-S30 until the thrombus is removed, then close the main valve and secondary valve.

[0022] In one feasible embodiment, prior to step S10, the following steps are also included:

[0023] S010, The main controller sends a main negative pressure supply signal to the main static negative pressure source, causing the main static negative pressure source to generate and maintain the first static negative pressure.

[0024] S020. The main controller receives the value of the first static negative pressure detected by the pressure display device and compares it with the built-in main negative pressure standard range:

[0025] If the first static negative pressure falls within the preset main negative pressure standard range, then proceed to step S10;

[0026] If the first static negative pressure does not fall within the preset main negative pressure standard value range, the main valve will remain closed.

[0027] In one feasible embodiment, before the master controller sends an opening signal to at least one secondary valve, the following steps are also included:

[0028] The main controller sends a secondary negative pressure supply signal to at least one secondary static negative pressure source, causing the secondary static negative pressure source to generate and maintain a second static negative pressure.

[0029] The main controller receives the value of the second static negative pressure detected by the corresponding secondary pressure display device;

[0030] If the second static negative pressure falls within the preset secondary negative pressure standard range, the main controller sends an opening signal to the corresponding secondary valve.

[0031] If the second static negative pressure does not fall within the preset secondary negative pressure standard value range, the secondary valve remains open or closed.

[0032] Thirdly, a thrombus aspiration device is provided, including an aspiration catheter and the aforementioned external control device for thrombus aspiration, wherein the distal end of the aspiration catheter is used to extend into and approach the thrombus in the blood vessel, and the distal end of the main pipeline of the external control device is detachably connected to the proximal end of the aspiration catheter.

[0033] Compared with the prior art, the beneficial effects of this application include at least the following:

[0034] 1. The external control device for thrombus aspiration of this application improves the operator's accuracy in judging the pressure during thrombus aspiration by setting a pressure display device, reduces the probability of the operator blindly opening or closing the valve, and improves the accuracy of operation.

[0035] 2. In the preferred embodiment of the external control device for thrombus aspiration of this application, by setting a main controller and connecting it with the pressure display device, the main valve and the secondary valve signals, the corresponding components can respond to the aspiration negative pressure status in the first time, shorten the response time of valve opening and closing, and allow the operator to deal with the problems more easily, thereby improving the response efficiency, controllability and ease of operation of the external control device.

[0036] 3. In the preferred embodiment of the external control device for thrombus aspiration of this application, the pressure display device is a digital pressure gauge with a real-time pressure value display. The operator can obtain the rate of pressure change by observing the fluctuations in the pressure value displayed on the digital screen, thereby judging the pressure status within the tubing connected to the aspiration catheter. When the thrombus cannot be aspirated, the operator can promptly determine whether the failure is due to insufficient negative pressure or an airtightness problem, thus taking timely and correct measures, which helps improve treatment efficiency and reduce treatment risks.

[0037] 4. The control method of the external control device for thrombus aspiration in this application eliminates the need for the operator to rely on subjective experience to judge the reason why the thrombus cannot be aspirated. Instead, it uses a quantified standard of pressure change rate to achieve automatic and objective judgment of the negative pressure during aspiration, automatically monitors the negative pressure changes during the thrombus aspiration process, and can automatically identify the reason why the thrombus was not aspirated and take corresponding measures. This provides the operator with more time to improve treatment efficiency and reduce treatment risks. Attached Figure Description

[0038] To more clearly illustrate the technical solutions of the embodiments of this application, the accompanying drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of this application and should not be regarded as a limitation of the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0039] Figure 1 This is a schematic diagram of an external control device for thrombus aspiration according to Embodiment 1 of this application;

[0040] Figure 2 This is a schematic diagram of an external control device with an added master controller, according to Embodiment 1 of this application;

[0041] Figure 3 This is a schematic diagram of an external control device having three secondary negative pressure control units, according to Embodiment 1 of this application;

[0042] Figure 4 This is a schematic diagram of an external control device with a secondary pressure display device according to Embodiment 1 of this application;

[0043] Figure 5 This is a schematic diagram of an external control device for thrombus aspiration shown in Embodiment 2 of this application;

[0044] Figure 6 This is a schematic diagram of an external control device with an added master controller, as shown in Embodiment 2 of this application;

[0045] Figure 7 This is a schematic diagram of an external control device having three secondary negative pressure control units, according to Embodiment 2 of this application;

[0046] Figure 8 This is a schematic flowchart illustrating a control method for an external control device for thrombus aspiration according to Embodiment 3 of this application.

[0047] In the diagram: 10. Main negative pressure control unit; 11. Main pipeline; 12. Main valve; 13. Pressure display device; 14. Main static negative pressure source; 20. Secondary negative pressure control unit; 21. Secondary valve; 22. Secondary static negative pressure source; 23. Secondary pressure display device; 24. Branch pipeline; 30. Main controller; 100. Suction conduit. Detailed Implementation

[0048] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. The components of the embodiments of this application described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0049] Therefore, the following detailed description of the embodiments of this application provided in the accompanying drawings is not intended to limit the scope of the claimed application, but merely to illustrate selected embodiments of the application. All other embodiments obtained by those skilled in the art based on the embodiments of this application without inventive effort are within the scope of protection of this application.

[0050] In the description of this application, it should be noted that the terms "upper," "lower," "inner," and "outer," etc., indicating orientation or positional relationships, are only for the convenience of describing the present 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, and therefore should not be construed as a limitation of the present invention. Furthermore, the terms "first," "second," and "third," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0051] In the description of this application, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," "linking," 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. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0052] In the description of this application, it should be noted that, unless otherwise specified, the embodiments and features in the embodiments of this application can be combined with each other.

[0053] It should be noted that the terms "distal" and "proximal" are used in the description of this application. "Proximal" refers to the end that is closer to the operator of the medical device, while "distal" refers to the end that is farther away from the operator of the medical device.

[0054] The inventors of this application, based on their clinical experience, have found that the main reasons why thrombi cannot be extracted are: 1) Insufficient suction force (or vacuum) in the aspiration catheter, which may cause the thrombus to block the inlet of the aspiration catheter or somewhere in the tube; 2) Problems with the airtightness of the aspiration device or aspiration catheter, which makes it impossible to maintain the vacuum in the aspiration catheter, resulting in a continuous decrease in the negative pressure of aspiration, which makes it impossible to extract the thrombus.

[0055] If the thrombus cannot be successfully aspirated, the treatment time and risk will increase accordingly. When the thrombus cannot be aspirated, the clinical practice is usually to increase the suction force in the hope of aspirating the thrombus by increasing the vacuum inside the aspiration catheter. However, if there is a problem with the airtightness of the aspiration device or aspiration catheter, even increasing the vacuum inside the aspiration catheter will not be able to aspirate the thrombus.

[0056] As described above, existing aspiration devices and methods cannot readily and quickly identify the problem if the thrombus cannot be aspirated during the thrombus aspiration process. This may lead to misjudgment by the operator, potentially increasing treatment time and the risk of thrombus treatment.

[0057] This application provides the following implementation, which at least solves the aforementioned technical problems.

[0058] Example 1:

[0059] like Figure 1 As shown, this embodiment provides an external control device for thrombus aspiration, including a main negative pressure control unit 10 and at least one secondary negative pressure control unit 20. The main negative pressure control unit 10 includes a main pipeline 11, a main valve 12, a pressure display device 13, and a main static negative pressure source 14. The distal end of the main pipeline 11 is detachably connected to the proximal end of an aspiration catheter 100 for thrombus aspiration. The main valve 12 is located on the main pipeline 11 and near its distal end. The pressure display device 13 is connected to the main pipeline 11 and located near the proximal end of the main valve 12. The main static negative pressure source 14 generates a preset static aspiration negative pressure and is connected to the main pipeline 11 and located proximal to the main valve 12. Each secondary negative pressure control unit 20 includes a secondary valve 21 and a secondary static negative pressure source 22. The secondary static negative pressure source 22 generates a preset static aspiration negative pressure, and the secondary valve 21 connects or disconnects the secondary static negative pressure source 22 from the main pipeline 11.

[0060] In this embodiment, the external control device for thrombus aspiration, before the main valve 12 is opened, allows the pressure display device 13 to detect and display the magnitude of the static aspiration negative pressure generated by the main static negative pressure source 14. This provides the operator with a direct numerical display, facilitating their judgment of whether the aspiration negative pressure generated by the main static negative pressure source 14 meets the required aspiration negative pressure, reducing the probability of the operator blindly opening or closing the main valve 12, and improving operational accuracy. After the main valve 12 is opened, the pressure display device 13 detects and displays the magnitude of the aspiration negative pressure inside the aspiration catheter 100, allowing the operator to directly perceive the magnitude of the negative pressure inside the aspiration catheter 100 during the aspiration process, thus improving the accuracy of the operator's judgment of the aspiration negative pressure magnitude during thrombus aspiration.

[0061] In this embodiment, the pressure display device 13 can be a pointer-type pressure gauge, a pressure gauge with a digital display, etc., which can detect both positive and negative pressure. Preferably, a digital pressure gauge that can display pressure values ​​in real time is used. The operator can obtain the rate of pressure change by observing the fluctuations in the pressure values ​​displayed on the screen, thereby determining the pressure status within the tubing connected to the aspiration catheter. When a thrombus cannot be aspirated, the operator can promptly determine whether the inability to aspirate is due to insufficient negative pressure or an airtightness issue, allowing for timely and correct interventions, which helps improve treatment efficiency and reduce treatment risks.

[0062] It should be noted that the pressure gauges mentioned above may be integrated or separate units. For example, an analog pressure gauge can be an integrated unit. Similarly, a pressure gauge with a digital display can include a pressure sensor and a display module. The pressure sensor can be connected to the display module circuitry via a conductive cable, or both can be integrated onto the same circuit board. The pressure sensor detects negative or positive pressure values ​​and sends an electrical signal to the display module, which then processes the signal and displays the numerical value.

[0063] Furthermore, in this embodiment, the pressure display device 13 preferably uses a digital pressure gauge that can display real-time pressure values ​​and the rate of pressure change per unit time. In this way, the operator can know the real-time value of the suction negative pressure through the pressure display device 13, and can also intuitively know the change of the suction negative pressure. This allows the operator to make a more accurate judgment on the suction negative pressure during the suction process based on the real-time pressure value and the pressure change per unit time, which helps to analyze the reasons why the blood clot cannot be suctioned and facilitates timely and correct treatment measures.

[0064] In this embodiment, the static negative pressure generated by the primary static negative pressure source 14 and the secondary static negative pressure source 22 refers to the static value that the primary static negative pressure source 14 and the secondary static negative pressure source 22 maintain after generating their own suction negative pressure, such as -13.9 psi (Pounds per square inch), -15 psi, -17 psi, etc. This static value can be pre-set according to the suction negative pressure required for thrombus aspiration. Connecting the suction negative pressure value to the main pipeline 11 as a static value ensures that the suction force for thrombus aspiration is neither too large nor too small. Excessive thrombus suction force may damage the patient's blood vessels or cause excessive bleeding, posing a life-threatening risk. Insufficient thrombus suction force may result in the thrombus not being aspirated, increasing treatment time. Fluctuating suction force may also cause the blood vessels at the thrombus site to undergo repeated changes in different contraction sizes, further increasing the possibility of vascular damage.

[0065] In this embodiment, the main static negative pressure source 14 and the secondary static negative pressure source 22 can both be syringes with self-locking, electric booster syringes, or negative pressure suction pumps that can generate the desired negative pressure. It is preferred to use syringes with self-locking, which have a simple structure, are easier to operate, have low cost, and are safer and more reliable.

[0066] Both self-locking syringes and electrically propelled syringes have a fixed-capacity injection chamber and a piston that can move within the chamber. If the injection chamber is 50 ml, the suction negative pressure generated within the injection chamber when the piston of the syringe or booster is pulled to its maximum capacity is approximately -13.9 psi. For negative pressure suction pumps, the desired and fixed suction negative pressure value can be generated through pre-setting.

[0067] In this embodiment, as Figure 2 As shown, the main controller 30 can be connected to the pressure display device 13, the main valve 12, and the secondary valve 21 to receive the negative pressure signal sent by the pressure display device 13, determine whether the suction negative pressure has reached the predetermined requirements, and send the valve opening or closing signal to the main valve 12 and the secondary valve 21 according to the judgment result. It can respond to the suction negative pressure status in the first time, shorten the response time of the suction negative pressure switch, and allow the operator to deal with the problem more calmly.

[0068] It should be noted that, Figure 2 The pressure display device 13 can be a pressure display device capable of outputting pressure signals as electrical signals, and the electrical signals are connected to the main controller 30. Both the main valve 12 and the secondary valve 21 can be solenoid valves, electric valves, etc., with solenoid valves being preferred, and they form a signal connection with the main controller 30. The main controller 30 can be a PLC, a microcontroller, an industrial computer, etc.

[0069] In this embodiment, as Figure 1 As shown, preferably, the main controller 30 is signal-connected to the main static negative pressure source 14 and the secondary static negative pressure source 22. The main controller 30 is used to send negative pressure supply signals to the main static negative pressure source 14 and the secondary static negative pressure source 22, so that the main static negative pressure source 14 and the secondary static negative pressure source 22 generate a preset static negative pressure. The main static negative pressure source 14 and the secondary static negative pressure source 22 can be electric booster injectors, negative pressure suction pumps, etc., thereby realizing automatic control of the entire thrombus aspiration process and improving the controllability and aspiration efficiency of the thrombus aspiration process.

[0070] In this embodiment, as Figure 1 and 2As shown, the main pipeline 11 extends from the proximal end to the distal end in a single-chamber configuration, with the proximal end closed. The secondary valves 21 of all secondary negative pressure control units 20 are sequentially arranged on the main pipeline 11 and located between the main valve 12 and the proximal end of the main pipeline 11, forming a series connection. A secondary static negative pressure source 22 is provided on the proximal side of each secondary valve 21, communicating with the cavity of the main pipeline 11 on the proximal side of the secondary valve 21. The main static negative pressure source 14 communicates with the cavity of the main pipeline 11 between the main valve 12 and the first secondary valve 21. The pressure display device 13 is connected to the cavity of the main pipeline 11 between the main valve 12 and the secondary valve 21.

[0071] When the secondary valve 21 of the secondary negative pressure control unit 20 is opened, the suction negative pressure generated by the secondary static negative pressure source 22 will be connected to the main pipeline 11 and the suction conduit 100. At this time, the pressure display device 13 detects the suction negative pressure value in the overall pipeline after the secondary static negative pressure source 22 is added, which can also provide the operator with corresponding surgical operation reference.

[0072] like Figure 3 As shown, if there are two secondary negative pressure control units 20, and the secondary valve 21 of the secondary negative pressure control unit 20 near the far end is already open, and the secondary static negative pressure source 22 of the secondary negative pressure control unit 20 near the far end is already connected to the main pipeline 11, if it is clear that the suction negative pressure is still insufficient, the secondary negative pressure control unit 20 near the near end may need to participate to further increase the suction negative pressure. In this case, the secondary valve 21 of the secondary negative pressure control unit 20 near the near end needs to be opened again, and the secondary static negative pressure source 22 near the near end needs to be connected to the main pipeline 11. At this time, the main valve 12 and both secondary valves 21 are open. When there are more than two secondary negative pressure control units 20, their working principle and operation method are basically the same as described above.

[0073] In this embodiment, as Figure 4 As shown, each secondary negative pressure control unit 20 may also include a secondary pressure display device 23. The secondary pressure display device 23 is located on the proximal side of the corresponding secondary valve 21 and is connected to the pipeline to which the corresponding secondary static negative pressure source 22 is connected. Before the secondary static negative pressure source 22 of the secondary negative pressure control unit 20 is connected to the main pipeline 11, the corresponding secondary valve 21 is in the closed state. At this time, the suction negative pressure generated by the secondary static negative pressure source 22 can be clearly detected by the secondary pressure display device 23, and it can be intuitively judged whether the suction negative pressure generated by the secondary static negative pressure source 22 meets the predetermined requirements. If the predetermined requirements are not met, it can be checked whether the secondary static negative pressure source 22 is malfunctioning or whether there is an airtightness problem in the pipeline.

[0074] Preferably, such as Figure 4As shown, the secondary pressure display device 23 is signal-connected to the main controller 30. The secondary pressure display device 23 sends the detected suction negative pressure signal to the main controller 30. The main controller 30 receives the suction negative pressure signal and analyzes whether the predetermined suction negative pressure range has been reached. For example, if the suction negative pressure generated by the main static negative pressure source 14 is insufficient to remove the thrombus, and the operator determines that the secondary static negative pressure source 22 needs to increase the suction negative pressure by -4 psi to -6 psi, then when the suction negative pressure value of the secondary pressure display device 23 reaches the suction negative pressure range of -4 psi to -6 psi, the main controller 30 sends an opening signal to the corresponding secondary valve 21. If the suction negative pressure value of the secondary pressure display device 23 does not reach -4 psi or exceeds -6 psi, the main controller 30 keeps the secondary valve 21 closed, thereby realizing automatic control of the suction negative pressure access of the secondary pressure display device 23, improving treatment efficiency, and effectively reducing the occurrence of misjudgment and misoperation. In addition, if the suction negative pressure value of the secondary pressure display device 23 does not reach -4psi or exceeds -6psi, it can be checked whether the secondary static negative pressure source 22 is malfunctioning or whether there is an airtightness problem in the pipeline. It is necessary to readjust the suction negative pressure generated by the secondary static negative pressure source 22 to fall into the suction negative pressure range of -4psi to -6psi, and then open the corresponding secondary valve 21 to connect the secondary static negative pressure source 22 to the main pipeline 11.

[0075] Example 2:

[0076] like Figure 5 As shown, the main difference between this embodiment and embodiment 1 is that the secondary valve 21 of the secondary negative pressure control unit 20 in embodiment 1 is connected to the main pipeline 11 in series, while the secondary valve 21 of the secondary negative pressure control unit 20 in this embodiment is connected to the main pipeline 11 in parallel.

[0077] Specifically, in this embodiment, such as Figure 5 As shown, each secondary negative pressure control unit 20 includes a branch pipe 24. All branch pipes 24 of the secondary negative pressure control units 20 are connected in parallel to the cavity between the main valve 12 and the distal end of the main pipe 11. The proximal ends of all branch pipes 24 are closed. The secondary valve 21 of each secondary negative pressure control unit 20 is installed on the branch pipe 24. The secondary static negative pressure source 22 of each secondary negative pressure control unit 20 is connected to the branch pipe 24 and is located on the proximal side of the secondary valve 21.

[0078] In addition to possessing the advantages of Embodiment 1, this embodiment also includes the following: In this embodiment, as long as the secondary valve 21 of the corresponding secondary negative pressure control unit 20 is opened, the corresponding secondary static negative pressure source 22 can be directly connected to the main pipeline 11. This is equivalent to all secondary negative pressure control units 20 and main negative pressure control units 10 being of the same level. The secondary negative pressure control unit 20 can be used as the main negative pressure control unit 10, and the main negative pressure control unit 10 can be used as the secondary negative pressure control unit 20. Therefore, the use of the secondary negative pressure control unit 20 and the main negative pressure control unit 10 does not need to distinguish the order of use, thus improving the usability of the entire external control device.

[0079] It should be noted that if the primary static negative pressure source 14 and the secondary static negative pressure source 22 produce different static suction negative pressures, the operator needs to determine whether the corresponding primary negative pressure control unit 10 and secondary negative pressure control unit 20 can be used interchangeably or in any order based on the clinical situation. Similarly, if multiple secondary static negative pressure sources 22 produce different static suction negative pressures, the operator also needs to determine whether multiple secondary negative pressure control units 20 can be used interchangeably or in any order based on the clinical situation.

[0080] In this embodiment, as Figure 6 and Figure 7 As shown, Figure 6 This is a schematic diagram of a system with two secondary negative pressure control units 20. Figure 7 This is a schematic diagram of a system with three secondary negative pressure control units 20. Each secondary negative pressure control unit 20 may also include a secondary pressure display device 23, which is connected to a corresponding branch pipe 24 and located near the secondary valve 21. The secondary pressure display device 23 is signal-connected to the main controller 30. Correspondingly, before the secondary static negative pressure source 22 of the secondary negative pressure control unit 20 is connected to the main pipeline 11, the corresponding secondary valve 21 is in the closed state. At this time, the suction negative pressure generated by the corresponding secondary static negative pressure source 22 can be clearly detected by the secondary pressure display device 23, and it can be intuitively judged whether the suction negative pressure generated by the secondary static negative pressure source 22 reaches the required increase in suction negative pressure range. If it does not reach the required increase in suction negative pressure range, it can be checked whether the secondary static negative pressure source 22 is faulty or whether there is an airtightness problem in the pipeline. The suction negative pressure generated by the secondary static negative pressure source 22 needs to be readjusted to fall into the required increase in suction negative pressure range. Then, the corresponding secondary valve 21 is opened to connect the secondary static negative pressure source 22 to the main pipeline 11.

[0081] Example 3:

[0082] This embodiment provides a control method for the external control device for thrombus aspiration as described in Embodiments 1 and 2. Before the control method is operated, the distal end of the aspiration catheter 100 connected to the distal end of the main pipeline 11 is brought close to the thrombus in the blood vessel, and the main valve 12 and the secondary valve 21 are kept closed. The main static negative pressure source 14 and the secondary static negative pressure source 22 maintain a predetermined static negative pressure.

[0083] Furthermore, combined Figure 4 and Figure 6 The schematic diagram of the external control device shown illustrates the steps in detail.

[0084] like Figure 8 As shown, the control method for the external control device used for thrombus aspiration includes the following steps:

[0085] S10, the main controller 30 sends an opening signal to the main valve 12 to open the main valve 12 and connect the main static negative pressure source 14 with the main pipeline 11 and the aspiration catheter 100 for aspirating thrombi.

[0086] S20, the main controller 30 receives the pressure value signal sent by the pressure display device 13 and calculates the pressure change rate;

[0087] S30. Determine the pressure change rate of S20 against the built-in standard negative pressure change rate range:

[0088] S31. If the pressure change rate falls within the preset standard negative pressure change rate range, the main valve 12 and the secondary valve 21 are maintained in their open / closed states. S32. If the pressure change rate is higher than the standard negative pressure change rate range, the main controller 30 warns of an airtightness problem and sends a valve-closing signal to the main valve 12. S33. If the pressure change rate is less than the standard negative pressure change rate range, the main controller 30 warns of thrombus blockage of the aspiration catheter 100, and the main controller 30 sends an opening signal to at least one secondary valve 21 to open the secondary valve 21 to connect the secondary static negative pressure source 22 with the main pipeline 11 and the aspiration catheter 100 for thrombus aspiration.

[0089] Continue with steps S40, S20-S30 until the thrombus is removed, then close the main valve and secondary valve.

[0090] In the past, thrombus aspiration relied almost entirely on the operator's subjective experience to judge changes in the negative pressure. However, with the implementation of the solution in this embodiment, there is no need for a person to judge the reason why the thrombus could not be aspirated based on subjective experience. Instead, a quantified standard of pressure change rate is used to achieve automatic and objective judgment of the negative pressure situation during aspiration. This enables effective monitoring of negative pressure changes during thrombus aspiration, automatically identifying the reason why the thrombus could not be aspirated, and automatically taking corresponding measures. This provides the operator with more time for operation, thereby improving treatment efficiency and reducing treatment risks.

[0091] Specifically, for the pressure change rate in step S20, it is preferable to use the pressure change per unit time (negative pressure change).

[0092] If the thrombus is normally aspirated under the suction negative pressure of the main static negative pressure source 14, as the thrombus is gradually removed, the suction negative pressure in the main pipeline 11 and the suction catheter 100 will slowly decrease (a slow decrease in negative pressure means the pressure value gradually approaches the positive pressure value). The pressure value detected by the pressure display device 13 will then show a basically uniform change, and the corresponding pressure change rate will fluctuate slightly within a predictable and finite range. This predictable and finite range is the standard negative pressure change rate range defined in steps S31, S32, and S33. Since the vascular conditions of people of different ages and physical conditions are different, and the location of thrombus blockage may also differ, there can be multiple standard ranges for the standard negative pressure change rate to adapt to different situations. Those skilled in the art can obtain the standard negative pressure change rate range through statistics and research.

[0093] In step S31, if the pressure change rate falls within the preset standard negative pressure change rate range, it indicates that the thrombus aspiration process is normal. The main controller 30 continues to maintain the open / closed state of the main valve 12 and the secondary valve 21, and continues aspiration until the thrombus is removed.

[0094] In step S32, if the pressure change rate is higher than the standard negative pressure change rate range, it indicates that the aspiration negative pressure is decreasing relatively quickly. The main controller 30 will warn of an airtightness problem and send a valve-closing signal to the main valve 12. Then, it is necessary to check and eliminate the airtightness problem as soon as possible or replace the external control device for thrombus aspiration. Then, repeat steps S1 to S4.

[0095] In step S33, if the pressure change rate is less than the standard negative pressure change rate range, or even if the pressure change rate is 0, it indicates that the thrombus is blocked at a certain point in the aspiration catheter 100. At this time, the main controller 30 sends an opening signal to at least one secondary valve 21 to open the secondary valve 21 to connect the secondary static negative pressure source 22 with the main pipeline 11 and the aspiration catheter 100 for aspirating the thrombus, thereby increasing the aspiration negative pressure to aspirate the blocked thrombus.

[0096] In this embodiment, the following steps may be included before step S10:

[0097] S010, the main controller 30 sends a main negative pressure supply signal to the main static negative pressure source 14, causing the main static negative pressure source 14 to generate and maintain the first static negative pressure.

[0098] S020, the main controller 30 receives the value of the first static negative pressure detected by the pressure display device 13 and compares it with the built-in main negative pressure standard range: if the first static negative pressure falls within the preset main negative pressure standard range, then proceed to step S10; if the first static negative pressure does not fall within the preset main negative pressure standard value range, then maintain the open / closed state of the main valve 12.

[0099] The aforementioned steps effectively ensure that the main static negative pressure source 14 is functioning properly and can generate the required suction negative pressure. The standard range of the main negative pressure can be determined based on clinical experience.

[0100] In this embodiment, before the main controller 30 sends an opening signal to at least one secondary valve 21, the following steps may also be included:

[0101] The main controller 30 sends a secondary negative pressure supply signal to at least one secondary static negative pressure source 22, causing the secondary static negative pressure source 22 to generate and maintain a second static negative pressure.

[0102] The main controller 30 receives the value of the second static negative pressure detected by the corresponding secondary pressure display device 23;

[0103] If the second static negative pressure falls within the preset secondary negative pressure standard range, the main controller 30 sends an opening signal to the corresponding secondary valve 21.

[0104] If the second static negative pressure does not fall within the preset secondary negative pressure standard value range, the secondary valve 21 remains in the open / closed state.

[0105] The aforementioned steps effectively ensure that the secondary static negative pressure source 22 is functioning properly and can generate the required suction negative pressure. The standard range of the secondary negative pressure can be the same as, less than, or greater than the standard range of the primary negative pressure. Since the secondary static negative pressure source 22 is a supplement to the primary static negative pressure source 14, the preferred solution is to make the standard range of the secondary negative pressure less than or equal to the standard range of the primary negative pressure.

[0106] The external control devices for thrombus aspiration in Examples 1 and 2, and the corresponding control method in Example 3, enable automatic and objective judgment of the negative pressure during aspiration without relying on subjective experience to determine the reason why the thrombus cannot be aspirated. Instead, they use a quantified standard of pressure change rate to achieve this. This allows for effective monitoring of negative pressure changes during thrombus aspiration, automatically identifying the reasons why the thrombus cannot be aspirated, and automatically taking corresponding measures. This provides the operator with more time to improve treatment efficiency and reduce treatment risks.

[0107] Example 4:

[0108] This embodiment provides a thrombus aspiration device, including an aspiration catheter 100 and an external control device for thrombus aspiration as described in embodiments 1 and 2 above. The distal end of the aspiration catheter 100 is used to extend into and approach the thrombus in the blood vessel, and the distal end of the main pipeline 11 of the external control device is detachably connected to the proximal end of the aspiration catheter 100.

[0109] The above are merely preferred embodiments of this application and are not intended to limit this application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the protection scope of this application.

Claims

1. An extracorporeal control device for thrombus aspiration, characterized in that, The application relates to a negative pressure control system for a blood thrombus suction device, which comprises the following components: a main pipeline, the distal end of which is detachably connected to the proximal end of a blood thrombus suction pipeline; a main valve arranged on the main pipeline and close to the distal end of the main pipeline; a pressure display device in communication with the main pipeline and close to the proximal end of the main valve; a main static negative pressure source for generating a preset static suction negative pressure, which is in communication with the main pipeline and located on the proximal side of the main valve; at least one secondary negative pressure control unit, each of which comprises a secondary valve and a secondary static negative pressure source for generating a preset static suction negative pressure, and the secondary valve is used for connecting or disconnecting the secondary static negative pressure source and the main pipeline; a main controller in signal connection with the pressure display device, the main valve and the secondary valve, and the main controller is internally provided with a standard negative pressure change rate range; during use, the main controller receives the pressure value signal sent by the pressure display device and calculates the pressure change rate; the main controller judges the pressure change rate and the standard negative pressure change rate range, which comprises the following steps: if the pressure change rate falls within the preset standard negative pressure change rate range, the opening and closing states of the main valve and the secondary valve are maintained; if the pressure change rate is higher than the standard negative pressure change rate range, the main controller warns that there is an air tightness problem and sends a valve closing signal to the main valve; if the pressure change rate is lower than the standard negative pressure change rate range, the main controller warns that the blood thrombus blocks the blood thrombus suction pipeline, and the main controller sends an opening valve signal to at least one secondary valve to open the corresponding secondary valve to connect the corresponding secondary static negative pressure source, the main pipeline and the blood thrombus suction pipeline. The secondary valves of all the secondary negative pressure control units are arranged in series on the main pipeline and located between the main valve and the proximal end of the main pipeline to form a series connection; a secondary static negative pressure source is arranged on the proximal side of each secondary valve and in communication with the cavity of the main pipeline on the proximal side of the secondary valve; the main static negative pressure source is in communication with the cavity of the main pipeline between the main valve and the first secondary valve; the pressure display device is in communication with the cavity of the main pipeline between the main valve and the secondary valve. Each secondary negative pressure control unit further comprises a secondary pressure display device arranged on the proximal side of the corresponding secondary valve and in communication with the pipeline connected to the corresponding secondary static negative pressure source, and the secondary pressure display device is in signal connection with the main controller. The secondary negative pressure control unit comprises branch pipelines, all the branch pipelines of the secondary negative pressure control units are in parallel communication with the cavity between the main valve and the distal end of the main pipeline, and the proximal ends of all the branch pipelines are closed; the secondary valve of each secondary negative pressure control unit is arranged on the branch pipeline; the secondary static negative pressure source of each secondary negative pressure control unit is in communication with the branch pipeline and located on the proximal side of the secondary valve. ​ ​ ​ ​ ​ ​ ​ ​ 2. Extracorporeal control device for thrombus aspiration according to claim 1, characterized in that ​ ​ ​ ​ 3. Extracorporeal control device for thrombus aspiration according to claim 2, characterized in that ​ 4. The extracorporeal control device for thrombus aspiration according to claim 1, characterized in that, ​ ​ ​ 5. Extracorporeal control device for thrombus aspiration according to claim 4, characterized in that Each of the secondary negative pressure control units further comprises a secondary pressure display device, which is in signal connection with the main controller and is in communication with the branch pipeline and is on the proximal side of the secondary valve.

6. Extracorporeal control device for thrombus aspiration according to any one of claims 1 to 5, characterized in that, The main controller is in signal connection with the main static negative pressure source and the secondary static negative pressure source, and is used to send a negative pressure supply signal to the main static negative pressure source and the secondary static negative pressure source, so that the main static negative pressure source and the secondary static negative pressure source generate a preset static negative pressure.

7. The extracorporeal control device for thrombus aspiration according to any one of claims 1-5, wherein the pressure display device is a digital pressure gauge with real-time pressure value display.

8. A thrombus suction device, characterized by Comprising: a suction catheter, a distal end of which is used to extend into and close to a thrombus in a blood vessel; The extracorporeal control device for thrombus aspiration according to any one of claims 1-7, wherein a distal end of the main pipeline of the extracorporeal control device is detachably connected to a proximal end of the suction catheter.

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