Intelligent thrombus suction and thrombus cutting system

Abstract

The invention discloses an intelligent thrombus suction and cutting system, and belongs to the field of medical instruments. According to the system, the design of double pressure sensors and the intelligent pressure feedback control technology are adopted, and the suction state (blood suction, thrombus suction or complete blockage) is accurately recognized by monitoring pressure changes in a negative pressure pump pipeline and a suction catheter in real time and combining historical data analysis. The system automatically adjusts parameters of a pipeline control valve, a negative pressure pump, a peristaltic pump and the like according to the parameters, and intelligent optimization control over the suction process is achieved. The innovative integrated design of the double-cavity catheter integrates the functions of suction and thrombus breaking, when the complete blockage state is judged, the thrombus breaking program can be automatically or manually started, thrombus is quickly broken through high-speed liquid impact or thrombolysis medicine injection, and long-time suction catheter blockage is effectively prevented. The system obviously improves the thrombus aspiration efficiency, reduces the blood loss amount of a patient, optimizes the operation process, and has a good clinical application prospect.

Description

Technical Field

[0001] The present application relates to the field of medical devices, and in particular to the technical field of thrombus aspiration and thrombus cutting for vascular interventional surgery. Background Art

[0002] Thrombus refers to the abnormal coagulation of blood in blood vessels, which can lead to blood vessel obstruction and cause serious ischemic and hypoxic diseases. The rapid and safe removal of thrombus has always been the focus and difficulty of clinical treatment. At present, mechanical thrombus aspiration is one of the commonly used thrombus removal methods in clinical practice. It uses a catheter to connect the suction device to extract the thrombus from the blood vessel under the action of negative pressure.

[0003] However, traditional thrombus aspiration devices still have many limitations in practical applications, such as:

[0004] Difficulty in identifying the suction status: Existing devices are unable to accurately determine the suction status of the catheter end in real time, such as whether it is normal suction of blood, suction of thrombus, or blockage. This leads to blindness in the suction operation, which not only affects the suction efficiency, but also increases the risk of vascular damage.

[0005] The suction force and frequency control are not intelligent: Traditional equipment is difficult to automatically adjust the suction force and frequency according to the suction status. When suctioning blood, excessive suction force will cause unnecessary blood loss; when suctioning thrombus, insufficient force will affect the suction effect.

[0006] Lack of thrombus fragmentation function: For larger or dense thrombi, simple aspiration is often difficult to remove them quickly and effectively, but most existing devices lack the function of auxiliary thrombus fragmentation and cannot further improve the efficiency of thrombus removal.

[0007] High risk of catheter blockage: During the aspiration process, large blood clots may block the catheter lumen, resulting in interruption of aspiration. However, existing equipment lacks effective catheter blockage monitoring and treatment measures. Once blockage occurs, reintubation is required, which increases the operation time and patient trauma.

[0008] The structural design needs to be optimized: In order to achieve functions such as thrombus fragmentation and intra-catheter pressure monitoring, the structure of the thrombus aspiration catheter needs to be further optimized to improve surgical efficiency and safety.

[0009] The above problems limit the safety and effectiveness of traditional thrombus aspiration devices. Doctors face many challenges during surgery, and patients' treatment benefits are affected. Therefore, there is an urgent need for an intelligent, efficient, and integrated thrombus aspiration device to break through the existing technical bottleneck and improve the level of thrombus removal treatment. Summary of the invention

[0010] The purpose of the present application is to provide a system for intelligently aspirating and cutting thrombi to solve the problems raised in the above-mentioned background technology.

[0011] The present application discloses a system for intelligently aspirating and cutting thrombi, which is characterized by comprising:

[0012] Negative pressure pump;

[0013] A suction catheter comprising a suction lumen and an injection lumen

[0014] A suction pipeline, one end of which is connected to the negative pressure pump and the other end of which is connected to the suction lumen;

[0015] A pipeline control valve, arranged on the suction pipeline, for adjusting the suction flow;

[0016] a first pressure sensor, disposed between the negative pressure pump and the suction pipeline, for monitoring the pressure of the negative pressure pump;

[0017] A second pressure sensor is disposed on the suction lumen of the suction catheter and is used to monitor pressure changes under the suction state;

[0018] a peristaltic pump connected to the proximal end of the injection lumen and used to deliver a specified type of liquid to the injection lumen;

[0019] A main control circuit board is electrically connected to the first pressure sensor, the second pressure sensor, the negative pressure pump, and the peristaltic pump, respectively, and is used to: based on a preset pressure threshold and pressure change pattern, identify the suction state according to the pressure data of the first pressure sensor and the second pressure sensor, and the suction state includes suctioning blood, suctioning thrombus and complete blockage; based on the identified suction state, control the pressure of the negative pressure pump and the working parameters of the peristaltic pump; when a complete blockage state is identified, control the peristaltic pump to spray liquid into the suction lumen through the injection lumen to break up the thrombus.

[0020] In a preferred example, the suction lumen and the injection lumen of the suction catheter are coaxially arranged, the distal end of the injection lumen is provided with at least two openings and located in the suction lumen, and the openings are distributed along the circumference of the suction catheter.

[0021] In a preferred example, the system further includes a pipeline control valve, which is arranged on the suction pipeline and is used to adjust the suction flow; the main control circuit board is also electrically connected to the pipeline control valve and is used to control the opening and closing state and opening degree of the pipeline control valve.

[0022] In a preferred embodiment, the system further comprises:

[0023] A display device, electrically connected to the main control circuit board;

[0024] Wherein, the main control circuit board is also used for:

[0025] Control the display device to display system working status information in real time, and the system working status information includes one of the following or any combination thereof: current suction status; real-time pressure data of the first pressure sensor and the second pressure sensor; current pressure setting of the negative pressure pump; current opening degree of the pipeline control valve; current working parameters of the peristaltic pump; and system running time.

[0026] In a preferred example, the display device is designed with a touch screen and is also used to receive system parameter settings input by a user, wherein the system parameter settings include a pressure threshold, a liquid type selection, and a peristaltic pump operating parameter.

[0027] In a preferred embodiment, it is characterized in that:

[0028] The first pressure sensor is an electronic pressure sensor, which is installed between the negative pressure pump and the suction pipeline in one of the following ways: three-way joint installation, embedded installation, and adhesive fixation; the second pressure sensor adopts one of the following forms: a micro pressure sensor, the pressure sensing area is directly embedded in the wall opening and connected to the suction lumen by bonding or a three-way joint; a thin film pressure sensor, which is installed around the inner wall of the suction lumen at the distal end of the suction tube of the suction catheter; a guide wire pressure sensor, which is arranged along the length direction of the suction catheter;

[0029] Among them, the signal transmission line of the second pressure sensor adopts one of the following methods: buried along the inner wall of the suction catheter; led out through a tiny channel on the wall of the suction catheter; led out through an external cable; a wireless transmission module wirelessly transmits the pressure data to the main control circuit board.

[0030] In a preferred embodiment, the structure of the suction catheter includes:

[0031] An inner metal tube, constituting the suction lumen, wherein the inner metal tube is made of one of the following materials: stainless steel, nickel-titanium alloy, cobalt-chromium alloy;

[0032] An outer polymer tube is coated on the outer side of the inner metal tube and together with the inner metal tube, forms the suction lumen. The outer polymer tube is made of one of the following materials or a combination thereof: polyethylene, polyurethane, polytetrafluoroethylene;

[0033] Wherein, the hardness of the outer polymer tube gradually increases from the distal end to the proximal end to improve the pushing performance of the catheter;

[0034] The suction catheter further comprises:

[0035] A coating, coated on the outer surface of the outer polymer tube, for reducing friction with the blood vessel wall, wherein the coating is selected from one of the following materials: a hydrophilic coating, a drug coating, and an anticoagulant coating;

[0036] A positioning ring, arranged at the distal end of the suction catheter, for visual positioning under X-ray;

[0037] Wherein, the distance between the distal opening of the injection lumen and the distal end of the suction catheter is 5-20 mm;

[0038] The ratio of the cross-sectional area of ​​the suction lumen to the cross-sectional area of ​​the injection lumen is 5:1 to 25:1.

[0039] In a preferred embodiment, the main control circuit board adopts the following control algorithm:

[0040] The puff state recognition algorithm based on machine learning includes the following steps:

[0041] a) Collect and store historical suction data, including pressure data under different suction states, negative pressure pump parameters and pipeline control valve status;

[0042] b) using the support vector machine (SVM) algorithm to train the puff state classification model;

[0043] c) collecting pressure data of the first pressure sensor and the second pressure sensor in real time;

[0044] d) inputting the real-time pressure data into the trained classification model to obtain the current suction state;

[0045] The adaptive PID control algorithm is used to dynamically adjust system parameters and includes the following steps:

[0046] e) Automatically adjust the proportional, integral and differential parameters of the PID controller according to the identified suction state;

[0047] f) using the adjusted PID parameters to control in real time the pressure of the negative pressure pump, the opening degree of the pipeline control valve and the working parameters of the peristaltic pump;

[0048] g) Monitor system response and continuously optimize PID parameters based on the response results;

[0049] The intelligent throttle control algorithm is activated when a complete blockage state is identified, and includes the following steps:

[0050] h) Automatically select appropriate clog-breaking strategies based on the degree of blockage, including high-pressure pulse jetting, low-pressure continuous flushing, or alternating use of the two;

[0051] i) controlling the peristaltic pump to deliver liquid according to a selected strategy;

[0052] j) Real-time monitoring of the pressure change of the second pressure sensor to evaluate the plug breaking effect;

[0053] k) Dynamically adjust the plug breaking strategy according to the pressure change trend until the blockage is relieved or the preset time threshold is reached;

[0054] Wherein, the main control circuit board also includes a data recording and analysis module, which is used to:

[0055] 1) Record the entire data of each operation, including pressure changes, equipment parameters and operation time;

[0056] m) Analyze historical data and optimize control parameters and strategies;

[0057] n) Generate operation reports, including suction effect evaluation and equipment usage statistics.

[0058] In a preferred embodiment, the system further comprises:

[0059] a liquid supply device, connected to the peristaltic pump, for supplying liquid to the injection lumen;

[0060] Wherein, the liquid supply device comprises:

[0061] a) a plurality of liquid storage containers, each used to store different types of liquids, including physiological saline, thrombolytic drugs and contrast agents;

[0062] b) a multi-way valve connected to the plurality of liquid storage containers and used for selecting the type of liquid to be output;

[0063] c) a heating element for heating the selected liquid to a preset temperature;

[0064] The main control circuit board is also used for:

[0065] d) automatically controlling the multi-way valve to select an appropriate liquid type according to the identified suction state and the preset treatment plan;

[0066] e) controlling the operation of the heating element to ensure a constant temperature of the transported liquid;

[0067] f) Monitor liquid usage and sound an alarm when liquid storage containers are running low.

[0068] In a preferred embodiment, the main control circuit board is also used for:

[0069] According to the selected liquid type, the speed and flow parameters of the peristaltic pump are automatically matched, including:

[0070] a) when physiological saline is selected, the peristaltic pump is controlled to provide a large flow rate of 200-500 mL / min for mechanically breaking up the thrombus;

[0071] b) when an anticoagulant is selected, controlling the peristaltic pump to provide a micro-volume continuous infusion of 0.1-20 mL / min to prevent further thrombus formation;

[0072] c) when a thrombolytic agent is selected, controlling the peristaltic pump to deliver the thrombolytic agent to the thrombus site at a flow rate of 1-100 mL / min by pulse injection, for chemically dissolving the thrombus;

[0073] d) when contrast agent is selected, controlling the peristaltic pump to provide a flow rate of 20-150 mL / min for pumping and infusion;

[0074] Wherein, the main control circuit board is also used for:

[0075] d) dynamically adjusting the rotation speed and operation mode of the peristaltic pump according to the identified suction state and thrombus characteristics;

[0076] e) When delivering thrombolytic agents, monitor the cumulative delivery volume and automatically stop or switch to saline delivery when the preset safety threshold is reached;

[0077] f) Record the usage of different types of liquids, including usage time, dosage and corresponding suction effect, for optimization of subsequent treatment plans.

[0078] In a preferred embodiment, the system has a switching function between automatic mode and manual mode, including:

[0079] A mode switching switch, electrically connected to the main control circuit board, for switching between an automatic mode and a manual mode;

[0080] A foot controller, electrically connected to the main control circuit board, used to control key functions of the system in manual mode;

[0081] Wherein, the main control circuit board is also used for:

[0082] In automatic mode:

[0083] a) Automatically perform suction state recognition, parameter adjustment and plug breaking operations according to the preset algorithm;

[0084] b) When an abnormal situation is detected, it automatically switches to manual mode and sounds an alarm;

[0085] In manual mode:

[0086] c) responding to the input of the foot controller to control the start and stop of the negative pressure pump, the opening degree of the pipeline control valve and the working parameters of the peristaltic pump;

[0087] d) displaying system parameters in real time through the display device and allowing the operator to make manual adjustments;

[0088] When switching modes:

[0089] e) Ensure smooth transition of system parameters and maintain continuity and safety of operation;

[0090] f) Record the time and reason of mode switching;

[0091] In any mode:

[0092] g) Monitor the system operating status and automatically execute the safety shutdown procedure when an abnormal situation that may endanger patient safety is detected.

[0093] The embodiments of the present application have the following technical effects:

[0094] Intelligent identification of suction status: The first pressure sensor and the second pressure sensor respectively detect the pressure in the negative pressure pump pipeline and the suction catheter. Combined with the preset pressure threshold and pressure change pattern, the system can accurately identify the current suction status, including blood suction, thrombus suction and complete blockage.

[0095] Intelligent control of suction parameters: Based on the identified suction status, the main control circuit board automatically adjusts the pressure of the negative pressure pump and the working parameters of the peristaltic pump to achieve intelligent control of the suction force and frequency and improve the suction efficiency.

[0096] Automatic thrombus breaking function: When it is identified as a completely blocked state, the system automatically controls the peristaltic pump to spray liquid into the suction lumen through the injection lumen to break up the thrombus, effectively preventing the suction catheter from being blocked for a long time.

[0097] Structural design optimization: The suction catheter adopts a dual-lumen design in which the suction lumen and the injection lumen are coaxially arranged. The distal end of the injection lumen is provided with at least two openings and is located inside the suction lumen, thereby achieving efficient liquid injection and thrombus fragmentation, while improving the coverage and efficiency of thrombus fragmentation.

[0098] Diversified pressure sensing methods: The second pressure sensor can be installed in a variety of ways, such as micro pressure sensor, thin film pressure sensor or optical fiber pressure sensor, which improves the accuracy and adaptability of pressure detection.

[0099] Intelligent control algorithm: The machine learning-based suction state recognition algorithm, adaptive PID control algorithm and intelligent plug-breaking control algorithm are adopted to achieve dynamic optimization and automatic adjustment of system parameters.

[0100] Intelligent liquid supply: Based on the identified suction status and preset treatment plan, the system can automatically select the appropriate liquid type and intelligently match the speed and flow parameters of the peristaltic pump according to the liquid type.

[0101] Flexible operation mode: The system has the function of switching between automatic mode and manual mode, which provides doctors with more operation options while ensuring intelligence.

[0102] In summary, the intelligent thrombus aspiration and thrombus cutting system of the present invention significantly improves the efficiency of thrombus aspiration, reduces the patient's blood loss, effectively prevents catheter blockage, and optimizes the surgical process through technical means such as intelligent identification of aspiration status, automatic control of system parameters, and integrated thrombus fragmentation function, and has good clinical application prospects.

[0103] A large number of technical features are recorded in the specification of this application, which are distributed in various technical solutions. If all possible combinations of technical features of this application (i.e., technical solutions) are to be listed, the specification will be too long. In order to avoid this problem, the various technical features disclosed in the above-mentioned invention content of this application, the various technical features disclosed in the various embodiments and examples below, and the various technical features disclosed in the accompanying drawings can be freely combined with each other to form various new technical solutions (these technical solutions are all considered to have been recorded in this specification), unless the combination of such technical features is technically infeasible. For example, in one example, feature A+B+C is disclosed, and in another example, feature A+B+D+E is disclosed, and features C and D are equivalent technical means that play the same role. Technically, only one can be used, and it is impossible to use them at the same time. Feature E can be combined with feature C technically. Then, the solution of A+B+C+D should not be regarded as having been recorded because it is technically infeasible, and the solution of A+B+C+E should be regarded as having been recorded. BRIEF DESCRIPTION OF THE DRAWINGS

[0104] Figure 1 It is a schematic diagram of the pressure involved in the intelligent thrombus aspiration and thrombus cutting system according to the first embodiment of the present application.

[0105] Figure 2 It is a logical judgment diagram of the system for intelligently aspirating and cutting thrombi according to the first embodiment of the present application.

[0106] Figure 3 It is a schematic diagram of the system configuration of the intelligent thrombus aspiration and thrombus cutting system according to the first embodiment of the present application.

[0107] Figure 4 It is a schematic diagram of the structure of the pressure sensor in the aspiration catheter and the injection chamber in the intelligent thrombus aspiration and thrombus cutting system according to the first embodiment of the present application.

[0108] Figure 5 This is another system configuration diagram of the system for intelligently aspirating and cutting thrombi according to the first embodiment of the present application.

[0109] Throughout the drawings, the same reference numerals are used to denote the same elements or structures, wherein:

[0110] 10: Display device

[0111] 20: Switch

[0112] 30: External liquid

[0113] 40: First pressure sensor

[0114] 50: Gas pipeline

[0115] 60: Suction pipe

[0116] 70: Blood collection tank

[0117] 80: Guidewire

[0118] 90: Suction line

[0119] 100: Second pressure sensor

[0120] 110: Suction catheter

[0121] 120: Peristaltic pump

[0122] 130: Negative pressure pump

[0123] 140: Pipeline control valve

[0124] 150: Main control circuit board DETAILED DESCRIPTION

[0125] In the following description, many technical details are provided to help readers better understand the present application. However, those skilled in the art can understand that the technical solution claimed in the present application can be implemented even without these technical details and various changes and modifications based on the following embodiments.

[0126] Description of some concepts:

[0127] A thrombus is a lump of blood formed by abnormal coagulation of blood in a blood vessel, which can lead to blood vessel blockage and cause ischemic diseases.

[0128] A negative pressure pump is a power device that generates and maintains negative pressure, providing suction force for thrombus aspiration.

[0129] A collection can is a container connected to a negative pressure pump and a suction catheter, used to collect the aspirated thrombus and blood.

[0130] A pressure sensor is a sensitive element used to detect pressure changes in pipelines in real time, converting pressure signals into electrical signals to provide a basis for intelligent control.

[0131] The pipeline control valve refers to an actuator that adjusts the opening and closing state and channel size of the suction pipeline according to control instructions. It can be in the form of a solenoid valve, a pinch valve, etc.

[0132] The suction pipeline refers to the pipe connecting the suction duct and the collection tank, which is used to transmit the suction force and transport the suctioned material.

[0133] A suction catheter refers to a slender tubular device inserted into a blood vessel. The front end opening is used to aspirate thrombus, and the rear end is connected to the suction pipeline.

[0134] The jet lumen tube is a thin tube arranged parallel to the suction lumen and is used to deliver high-speed liquid or thrombolytic drugs to break up the thrombus.

[0135] Peristaltic pump tube is an infusion device that produces quantitative flow by squeezing a soft tube. It is used to accurately control the flow rate and infusion volume of the liquid in the injection tube cavity.

[0136] Thrombolysis refers to the process of breaking up larger blood clots, which can be achieved through high-speed liquid impact or the action of thrombolytic drugs.

[0137] The Luer interface refers to a quick connector that is used to reliably connect catheters and pipelines for easy loading and unloading.

[0138] The injection lumen refers to a lumen in the aspiration catheter that is specifically used to inject liquid. It is used to inject high-pressure liquid to break up thrombi or apply thrombolytic agents to assist the aspiration process.

[0139] The following is a brief description of some of the innovative features of this application:

[0140] In view of the above technical problems, the inventor of this application, after in-depth research, proposed an intelligent thrombus aspiration and thrombus cutting system, which aims to improve surgical efficiency, reduce patient blood loss, and optimize the automated control of the aspiration process. The main innovations include:

[0141] 1) Dual pressure sensor intelligent feedback control: The system uses two high-precision pressure sensors to monitor the pressure changes in the negative pressure pump pipeline and the suction catheter respectively. Combined with the preset pressure threshold and pressure change pattern, the suction state (suction of blood, suction of thrombus or complete blockage) is accurately identified. The main control circuit board 150 automatically adjusts the negative pressure pump pressure and peristaltic pump operating parameters according to the identified suction state to achieve intelligent optimization control of the suction process.

[0142] 2) Integrated design of dual-lumen catheter: The suction catheter adopts an innovative design in which the suction lumen and the injection lumen are coaxially arranged. The distal end of the injection lumen is provided with at least two openings located in the suction lumen, which improves the efficiency and coverage of thrombus fragmentation. This integrated design integrates the suction and thrombus fragmentation functions, simplifies the operation steps, and improves the treatment efficiency and safety.

[0143] 3) Intelligent thrombus breaking function: When the system identifies a completely blocked state, the peristaltic pump is automatically controlled to spray liquid from the injection lumen to the suction lumen to break up the thrombus. Through high-speed liquid impact or thrombolytic drug injection, the blocked thrombus is quickly broken up, effectively preventing long-term catheter blockage.

[0144] 4) Advanced control algorithm: Adopt the suction state recognition algorithm based on machine learning to improve the accuracy of state judgment. Use the adaptive PID control algorithm to achieve dynamic optimization of system parameters. The intelligent plug breaking control algorithm automatically selects the appropriate plug breaking strategy according to the degree of blockage.

[0145] 5) Intelligent liquid management: The system automatically selects the appropriate liquid type based on the identified suction status and preset treatment plan. According to different liquid types, the speed and flow parameters of the peristaltic pump are intelligently matched to optimize the thrombus breaking effect.

[0146] 6) Flexible operation mode: The system has the function of switching between automatic mode and manual mode, which provides doctors with more operation options while ensuring intelligence.

[0147] In order to make the objectives, technical solutions and advantages of the present application clearer, the implementation methods of the present application will be further described in detail below in conjunction with the accompanying drawings.

[0148] The first embodiment of the present application relates to a system for intelligently aspirating and cutting thrombi, the structure of which is as follows: Figure 3 and Figure 5 As shown, including:

[0149] Negative pressure pump 130;

[0150] A suction catheter 110, the suction catheter 110 includes a suction lumen and an injection lumen

[0151] A suction pipeline 90, one end of which is connected to the negative pressure pump 130, and the other end of which is connected to the suction lumen;

[0152] A pipeline control valve 140, provided on the suction pipeline 90, for adjusting the suction flow rate;

[0153] A first pressure sensor 40 is disposed between the negative pressure pump 130 and the suction pipeline 90 and is used to monitor the pressure of the negative pressure pump 130;

[0154] A second pressure sensor 100 is disposed on the suction lumen of the suction catheter 110 and is used to monitor pressure changes under the suction state;

[0155] a peristaltic pump 120 connected to the proximal end of the injection lumen and used to deliver a specified type of liquid to the injection lumen;

[0156] The main control circuit board 150 is electrically connected to the first pressure sensor 40, the second pressure sensor 100, the negative pressure pump 130, and the peristaltic pump 120, respectively. The main control circuit board 150 is used to: based on a preset pressure threshold and pressure change pattern, identify the suction state according to the pressure data of the first pressure sensor 40 and the second pressure sensor 100, and the suction state includes suctioning blood, suctioning thrombus and complete blockage; based on the identified suction state, control the pressure of the negative pressure pump 130 and the working parameters of the peristaltic pump 120; when a complete blockage state is identified, control the peristaltic pump 120 to spray liquid into the suction lumen through the injection lumen to break up the thrombus.

[0157] Optionally, the suction lumen and the injection lumen of the suction catheter 110 are coaxially arranged, and the distal end of the injection lumen is provided with at least two openings and is located in the suction lumen, and the openings are distributed along the circumference of the suction catheter 110 .

[0158] Optionally, the system also includes a pipeline control valve 140, which is arranged on the suction pipeline 90 and is used to adjust the suction flow; the main control circuit board 150 is also electrically connected to the pipeline control valve 140 to control the opening and closing state and opening degree of the pipeline control valve 140.

[0159] Optionally, the system further includes:

[0160] The display device 10 is electrically connected to the main control circuit board 150;

[0161] The main control circuit board 150 is also used for:

[0162] The display device 10 is controlled to display the system working status information in real time, and the system working status information includes one of the following or any combination thereof: current suction status; real-time pressure data of the first pressure sensor 40 and the second pressure sensor 100; current pressure setting of the negative pressure pump 130; current opening degree of the pipeline control valve 140; current working parameters of the peristaltic pump 120; and system running time.

[0163] Optionally, the display device 10 is designed with a touch screen and is also used to receive system parameter settings input by a user, where the system parameter settings include a pressure threshold, a liquid type selection, and a peristaltic pump 120 operating parameter.

[0164] Main control circuit board 150

[0165] Optionally, the first pressure sensor 40 is an electronic pressure sensor, which is installed between the negative pressure pump 130 and the suction pipeline 90 in one of the following ways: three-way joint installation, embedded installation or adhesive fixation. Three-way joint installation is to connect the pressure sensor to the pipeline through a three-way joint; embedded installation is to embed the pressure sensor into a groove on the pipeline wall; adhesive fixation is to directly stick the pressure sensor on the outer wall of the pipeline.

[0166] The second pressure sensor 100 adopts one of the following forms: a miniature pressure sensor, whose pressure sensing area is directly exposed and fixed in the lumen through an opening in the tube wall, and the main body of the second pressure sensor 100 is located on the outer wall of the catheter; a thin film pressure sensor, which is installed in a surrounding manner on the inner wall of the distal end of the suction lumen of the suction catheter 110; a guidewire pressure sensor, which is integrated on the guidewire and arranged along the length direction of the catheter.

[0167] Among them, the sensing area of ​​the micro pressure sensor is directly exposed to the lumen by opening a hole on the wall of the suction catheter 110, and is fixed by bonding or clamping, and the other parts of the sensor are located outside the catheter. The thin film pressure sensor adopts a ring design, which is attached to the inner wall of the distal end of the suction catheter 110, and measures pressure through principles such as piezoresistance and piezoelectricity. The guidewire pressure sensor is integrated on the guidewire and can be arranged in the lumen along the length of the catheter, combining the functions of guidewire and pressure measurement.

[0168] The signal transmission line of the second pressure sensor 100 adopts one of the following methods: spirally wound or straightly buried along the inner wall of the suction catheter 110; led out through a tiny wire groove set on the wall of the suction catheter 110; led out through an external cable connected to the proximal sensor of the suction catheter 110; and integrated with a wireless transmission module to wirelessly transmit the pressure data to the main control circuit board 150.

[0169] Optionally, the structure of the suction catheter 110 includes:

[0170] An inner metal tube, constituting the suction lumen, wherein the inner metal tube is made of one of the following materials: stainless steel, nickel-titanium alloy, cobalt-chromium alloy;

[0171] An outer polymer tube is coated on the outer side of the inner metal tube and together with the inner metal tube, forms the suction lumen. The outer polymer tube is made of one of the following materials or a combination thereof: polyethylene, polyurethane, polytetrafluoroethylene;

[0172] Wherein, the hardness of the outer polymer tube gradually increases from the distal end to the proximal end to improve the pushing performance of the catheter;

[0173] The suction catheter 110 further includes:

[0174] A coating, coated on the outer surface of the outer polymer tube, for reducing friction with the blood vessel wall, wherein the coating is selected from one of the following materials: a hydrophilic coating, a drug coating, and an anticoagulant coating;

[0175] A positioning ring, disposed at the distal end of the suction catheter 110, for visual positioning under X-ray;

[0176] Wherein, the distance between the distal opening of the injection lumen and the distal end of the suction catheter 110 is 5-20 mm;

[0177] The ratio of the cross-sectional area of ​​the suction lumen to the cross-sectional area of ​​the injection lumen is 5:1 to 25:1.

[0178] Optionally, the main control circuit board 150 adopts the following control algorithm:

[0179] The puff state recognition algorithm based on machine learning includes the following steps:

[0180] a) collecting and storing historical suction data, including pressure data under different suction states, parameters of the negative pressure pump 130 and states of the pipeline control valve 140;

[0181] b) using the support vector machine (SVM) algorithm to train the puff state classification model;

[0182] c) collecting pressure data of the first pressure sensor 40 and the second pressure sensor 100 in real time;

[0183] d) inputting the real-time pressure data into the trained classification model to obtain the current suction state;

[0184] The adaptive PID control algorithm is used to dynamically adjust the system parameters. The adaptive PID control algorithm is an intelligent control method that can automatically adjust the parameters of the PID controller according to the changes in the suction state to achieve optimal control of the system. The basic principle is: first, identify the current suction state based on the pressure data detected by the pressure sensor, and then automatically adjust the proportional coefficient (P), integral coefficient (I) and differential coefficient (D) of the PID controller according to the suction state, and use the adjusted PID parameters to control the negative pressure pump pressure, pipeline control valve opening and peristaltic pump working parameters in real time to achieve the best match. At the same time, the algorithm also continuously monitors the system's response to the PID parameters, and continuously optimizes the PID coefficients according to the response results to achieve adaptive optimization of the control effect. In this way, the system can quickly and accurately adjust the control parameters for different suction states, always maintain the optimal working state, and thus improve the efficiency of thrombus suction. Specifically, it includes the following steps:

[0185] e) Automatically adjust the proportional, integral and differential parameters of the PID controller according to the identified suction state;

[0186] f) using the adjusted PID parameters to control in real time the pressure of the negative pressure pump 130, the opening degree of the pipeline control valve 140 and the working parameters of the peristaltic pump 120;

[0187] g) Monitor system response and continuously optimize PID parameters based on the response results;

[0188] The intelligent throttle control algorithm is activated when a complete blockage state is identified, and includes the following steps:

[0189] h) Automatically select appropriate clog-breaking strategies based on the degree of blockage, including high-pressure pulse jetting, low-pressure continuous flushing, or alternating use of the two;

[0190] i) controlling the peristaltic pump 120 to deliver liquid according to a selected strategy;

[0191] j) monitoring the pressure change of the second pressure sensor 100 in real time to evaluate the plug breaking effect;

[0192] k) Dynamically adjust the plug breaking strategy according to the pressure change trend until the blockage is relieved or the preset time threshold is reached;

[0193] The main control circuit board 150 further includes a data recording and analysis module for:

[0194] 1) Record the entire data of each operation, including pressure changes, equipment parameters and operation time;

[0195] m) Analyze historical data and optimize control parameters and strategies;

[0196] n) Generate operation reports, including suction effect evaluation and equipment usage statistics.

[0197] Optionally, the system further includes:

[0198] a liquid supply device, connected to the peristaltic pump 120, for supplying liquid to the injection lumen;

[0199] Wherein, the liquid supply device comprises:

[0200] a) a plurality of liquid storage containers, each used to store different types of liquids, including physiological saline, thrombolytic drugs and contrast agents;

[0201] b) a multi-way valve connected to the plurality of liquid storage containers and used for selecting the type of liquid to be output;

[0202] c) a heating element for heating the selected liquid to a preset temperature;

[0203] The main control circuit board 150 is also used for:

[0204] d) automatically controlling the multi-way valve to select an appropriate liquid type according to the identified suction state and the preset treatment plan;

[0205] e) controlling the operation of the heating element to ensure a constant temperature of the transported liquid;

[0206] f) Monitor liquid usage and sound an alarm when liquid storage containers are running low.

[0207] Optionally, the main control circuit board 150 is also used for:

[0208] According to the selected liquid type, the rotation speed and flow rate parameters of the peristaltic pump 120 are automatically matched, specifically including:

[0209] a) when physiological saline is selected, the peristaltic pump is controlled to provide a large flow rate of 200-500 mL / min for mechanically breaking up the thrombus;

[0210] b) when an anticoagulant is selected, controlling the peristaltic pump to provide a micro-volume continuous infusion of 0.1-20 mL / min to prevent further thrombus formation;

[0211] c) when a thrombolytic agent is selected, controlling the peristaltic pump to deliver the thrombolytic agent to the thrombus site at a flow rate of 1-100 mL / min by pulse injection, for chemically dissolving the thrombus;

[0212] d) when contrast agent is selected, controlling the peristaltic pump to provide a flow rate of 20-150 mL / min for pumping and infusion;

[0213] The main control circuit board 150 is also used for:

[0214] d) dynamically adjusting the rotation speed and operation mode of the peristaltic pump 120 according to the identified suction state and thrombus characteristics;

[0215] e) When delivering thrombolytic agents, monitor the cumulative delivery volume and automatically stop or switch to saline delivery when the preset safety threshold is reached;

[0216] f) Record the usage of different types of liquids, including usage time, dosage and corresponding suction effect, for optimization of subsequent treatment plans.

[0217] 11. The intelligent thrombus aspiration and thrombus cutting system according to claim 5, characterized in that the system has a switching function between automatic mode and manual mode, including:

[0218] A mode switching switch, electrically connected to the main control circuit board 150, for switching between an automatic mode and a manual mode;

[0219] A foot controller, electrically connected to the main control circuit board 150, used to control key functions of the system in manual mode;

[0220] The main control circuit board 150 is also used for:

[0221] In automatic mode:

[0222] a) Automatically perform suction state recognition, parameter adjustment and plug breaking operations according to the preset algorithm;

[0223] b) When an abnormal situation is detected, it automatically switches to manual mode and sounds an alarm;

[0224] In manual mode:

[0225] c) responding to the input of the foot controller to control the start and stop of the negative pressure pump 130, the opening degree of the pipeline control valve 140 and the working parameters of the peristaltic pump 120;

[0226] d) displaying system parameters in real time through the display device 10 and allowing the operator to adjust them manually;

[0227] When switching modes:

[0228] e) Ensure smooth transition of system parameters and maintain continuity and safety of operation;

[0229] f) Record the time and reason of mode switching;

[0230] In any mode:

[0231] g) Monitor the system operating status and automatically execute the safety shutdown procedure when an abnormal situation that may endanger patient safety is detected.

[0232] The accompanying drawings are further explained below.

[0233] like Figure 1 As shown, the horizontal axis represents time and the vertical axis represents pressure.

[0234] P b Indicates the pressure value detected at the negative pressure pump 130

[0235] ΔP1 represents the pressure difference between the pressure of the drawn blood after the device is started and the pressure detected at the negative pressure pump 130. The upper limit of the pressure difference is the lower limit of the standard error range of the standard value of the drawn blood pressure, which is classified according to the catheter and application scenario and is a fixed value in the database.

[0236] P represents the pressure value at the catheter during thrombus aspiration.

[0237] ΔP2 represents the pressure difference between the pressure at the catheter when the catheter is blocked by thrombus or the catheter is closed and the pressure detected by the negative pressure pump 130. The upper limit of the pressure difference is the upper limit of the standard error of the pressure standard value at the catheter when the catheter is blocked by thrombus or the catheter is closed. This value is classified according to the catheter and application scenario and is a fixed value in the database.

[0238] ΔP represents the pressure difference between the pressure value at the catheter during thrombus aspiration and the pressure detected at the negative pressure pump 130 .

[0239] like Figure 2 As shown, Figure 2 The system's logical judgment process is demonstrated, explaining how to identify the suction state through pressure monitoring and analysis and regulate the suction process accordingly.

[0240] The whole process can be divided into the following steps:

[0241] 1) Input the specifications of the suction catheter 110 and start the device to begin pressure monitoring and data collection.

[0242] 2) Compare and analyze the real-time pressure monitoring value with the historical pressure data:

[0243] If ΔP ≥ ΔP1, it means that the device is aspirating blood and has not come into contact with the thrombus.

[0244] If ΔP2<ΔP<ΔP1, and Pb reaches the set value of the negative pressure pump 130, it means that the device is aspirating thrombus. If Pb does not reach the set value, the pressure P should be tested by continuous aspiration.

[0245] If ΔP≤ΔP2, and the pressure at the negative pressure pump 130 has reached the preset value, it means that the catheter is blocked by thrombus and the thrombus breaking procedure needs to be started.

[0246] Select the catheter category and application scenario in the device. The catheter is classified according to specifications, including length and diameter, and the application scenario is classified according to blood vessels. After turning on the device, intermittent suction will automatically begin.

[0247] Detect P pressure value, according to Figure 1 Perform a numerical judgment. If ΔP2<ΔP<ΔP1, and the pressure Pb of the negative pressure pump 130 has reached the set value, the thrombus is being aspirated. At this time, the program instructs the valve to fully open and stop intermittent aspiration. If Pb has not reached the set value, compare the P downward trend with the Pb downward trend. If the P downward rate is greater than the Pb downward rate, the valve is fully opened, otherwise continue intermittent aspiration.

[0248] If ΔP ≥ ΔP1, it means that blood is being aspirated at this time and the aspiration continues intermittently.

[0249] If ΔP≤ΔP2, and Pb has reached the preset value, it means that the catheter is blocked by thrombus. At this time, the valve is fully opened and the thrombus breaking program is started. At this time, it is determined whether P has an upward trend. If so, it means that there is no thrombus blocking the catheter. It is necessary to continue to determine whether ΔP2<ΔP<ΔP1 is satisfied, so as to continue to aspirate small pieces of thrombus. If P has no upward trend, it means that there is still thrombus blocking the catheter, and the program remains unchanged.

[0250] If Pb does not reach the preset value, continue to compare the downward trends of P and Pb.

[0251] 4) Execute corresponding suction control operations according to the judgment results, and perform pressure monitoring and state judgment in a cycle to achieve real-time intelligent regulation of the suction process.

[0252] 5) When the pressure drops to the shutdown and pressure relief stage, that is, ΔP≤ΔP2, the system executes the shutdown procedure to complete the suction operation.

[0253] The flowchart clearly demonstrates the working logic and intelligent control strategy of the system. Through real-time pressure monitoring and comparative analysis, the system can automatically identify three suction states, and optimize the suction force and frequency according to the state characteristics, thereby improving the suction efficiency while minimizing the patient's blood loss, reflecting the significant intelligent features. At the same time, the integrated thrombus breaking program can effectively deal with the risk of blockage of the suction catheter 110, further enhancing the application value of the system.

[0254] like Figure 3 As shown, Figure 3 The overall structural composition of the intelligent thrombus aspiration and thrombus cutting system and the connection relationship between its components are demonstrated.

[0255] The system mainly consists of the following parts:

[0256] Suction catheter 110: inserted into the patient's blood vessel, used to aspirate thrombus and deliver thrombus-breaking liquid. Suction catheter 110 is divided into two parts: a suction lumen and an injection lumen.

[0257] Suction pipeline 90: connects the suction catheter 110 and the negative pressure pump 130, transmits negative pressure to the suction catheter 110, and delivers the suctioned material to the blood collection tank 70. A pressure sensor is provided on the pipeline to monitor the pressure in the suction catheter 110.

[0258] Negative pressure pump 130: provides suction negative pressure, and is connected to the suction pipeline 90 and the blood collection tank 70. The working parameters of the negative pressure pump 130 can be automatically adjusted according to pressure feedback.

[0259] Blood collection tank 70: connected to the suction pipeline 90, used to collect the sucked thrombus and blood. The tank body is detachable and has a filter screen inside for easy cleaning and replacement.

[0260] Peristaltic pump 120: connected to the injection lumen of the suction catheter 110, used to deliver high-pressure liquid or thrombolytic drugs required for thrombus fragmentation. The flow rate and time of the peristaltic pump 120 are controllable to ensure accurate delivery of the drug solution.

[0261] Pressure sensor: respectively arranged on the pipeline of the negative pressure pump 130 and the suction catheter 110, detects the pressure change in the system in real time, and transmits the pressure signal to the main control circuit board 150.

[0262] Main control circuit board 150: receives and analyzes the data of the pressure sensor, and controls the working status of each execution component (such as the negative pressure pump 130, the peristaltic pump 120 and the pipeline valve), and is the control and decision-making center of the system.

[0263] Pipeline valve: It is arranged on the suction pipeline 90 and is used to adjust the opening and closing and size of the suction channel. The opening frequency and amplitude of the valve can be automatically controlled by the main control circuit board 150.

[0264] Operation panel and display device 10: a human-machine interaction interface, used to set system parameters, start / stop the system, and display key information such as pressure curve and suction status in real time.

[0265] The interconnection between the components in the figure is shown by connecting lines. The pressure sensor, peristaltic pump 120 and pipeline valve are all electrically connected to the main control circuit board 150 to receive its control instructions. At the same time, the suction catheter 110, the suction pipeline 90, the negative pressure pump 130 and the blood collection tank 70 are connected through the suction catheter 110 or the pipeline to form a complete suction circuit.

[0266] The structural diagram clearly shows the system's composition and internal logical relationship, providing an intuitive reference for understanding the system's working principle and integrated design. The modular and integrated design approach is conducive to the realization of system functions and subsequent maintenance optimization.

[0267] like Figure 4 As shown, according to the description in the technical disclosure book, Figure 4 Schematic diagram showing the pressure sensor and the injection chamber in the suction catheter 110. The specific description is as follows

[0268] The suction catheter 110 is composed of an inner metal tube and an outer polymer tube. The metal tube can be a spring tube, a snake tube or other tube with good bending performance. The outer polymer tube can be made of materials such as PE / PTU / PTFE or a combination of materials, and the hardness of the material gradually decreases from the proximal end to the distal end so that the distal end can better adapt to the blood vessel. The surface of the outer polymer tube can be coated to reduce the friction passing through the blood vessel. The outer polymer tube and the metal tube are assembled by heat shrinking, bonding, etc. The injection cavity pipeline is a polymer pipeline, which is connected to the inner wall of the suction tube cavity by bonding, heat connection or welding. The distal end of the injection cavity pipeline is at a certain distance from the distal end of the suction tube 60, which is convenient for placing a positioning ring and a pressure sensor (some types of catheters). The distal end of the injection cavity has two openings for spraying external liquids, such as saline, thrombolytic drugs, etc.

[0269] The structure of the suction catheter 110 can be referred to Figure 4 .

[0270] In structure A, the pressure sensing device is composed of a traditional electronic pressure sensor and a circuit board, and the sensing area of ​​the pressure sensor enters the catheter cavity through the proximal opening of the catheter. The circuit board collects and processes the pressure sensor signal and is connected to the main control circuit board 150 through a cable. A Bluetooth module can also be added to the circuit board to communicate with the main control board via Bluetooth.

[0271] In structure B, the pressure sensor is a guidewire type pressure sensor, which can be fixed at the distal opening of the inner wall of the suction cavity, facing the middle position of the two openings of the injection cavity, and can also be directly used as a guidewire. The catheter has a separate guidewire cavity, which is made of polymer material and is fixed to the inner wall of the suction lumen by bonding, thermal bonding or welding.

[0272] In structure C, the catheter is a thin-film pressure sensor, located at the inner wall of the distal end of the suction lumen, surrounding the lumen and bonded to the inner wall with medical glue. The flexible film circuit adheres to the tube wall and extends to the proximal connection port of the catheter, and the cable is transferred to the main control circuit board 150 outside the catheter.

[0273] In structure D, the catheter places the sensing area of ​​the thin film sensor at the proximal end of the catheter, and is connected to the main control circuit board 150 through the catheter opening and an external cable.

[0274] Each type of catheter is connected to the extension tube through the Luer interface, and the injection chamber is connected to the external liquid circuit through the adapter.

[0275] Figure 4 The sensor sensing area, the pressure sensing guide wire 80, the liquid injection port and the injection cavity are shown from top to bottom.

[0276] The sensor sensing area is located at the front end or the distal end of the suction catheter 110 according to different catheter types, and is used to sense the pressure change in the suction catheter 110 and transmit the pressure signal to the main control board.

[0277] Behind the sensing area is the injection chamber inside the suction conduit 110. The proximal end of the injection chamber is connected to the peristaltic pump 120 pipeline, and the distal end has liquid injection ports on both sides with the center line of the suction conduit 110 as the symmetry axis.

[0278] When the system determines that the suction catheter 110 is blocked, the peristaltic pump 120 will pump pressurized liquid into the front end of the suction catheter 110 through the injection chamber, and spray it out from the liquid injection port at high speed to impact and break up the blocked thrombus to clear the suction catheter 110.

[0279] The pressure sensing area detects the changes in the pressure in the suction catheter 110 in real time, and feeds back the pressure signal to the system, intelligently judging the suction state of the suction catheter 110, thereby automatically adjusting the negative pressure pump 130 and the thrombus breaking device to achieve efficient suction and removal of blood clots.

[0280] In summary, the structure of the suction catheter 110 skillfully integrates the pressure sensing and directional liquid injection functions, realizes the intelligent thrombus suction and thrombus fragmentation functions, and well solves the problems existing in the prior art.

[0281] Working principle:

[0282] The working principle of this intelligent thrombus aspiration and thrombus cutting system is as follows:

[0283] Suction state identification: The system monitors the pressure changes in the negative pressure pump 130 pipeline and the suction catheter 110 in real time through the first pressure sensor 40 and the second pressure sensor 100. The main control circuit board 150 identifies the current suction state (suctioning blood, suctioning thrombus or complete blockage) based on the preset pressure threshold and pressure change pattern combined with the real-time pressure data.

[0284] Intelligent parameter control: According to the identified suction state, the main control circuit board 150 automatically adjusts the system parameters: When suctioning blood: reduce the pressure of the negative pressure pump 130, adjust the parameters of the peristaltic pump 120 to reduce the amount of blood suction. When suctioning thrombus: increase the pressure of the negative pressure pump 130, adjust the parameters of the peristaltic pump 120 to improve the suction efficiency. When completely blocked: adjust the pressure of the negative pressure pump 130 to the maximum, and start the thrombus breaking program.

[0285] Thrombolysis function: When the system identifies a completely blocked state, the main control circuit board 150 controls the peristaltic pump 120 to spray liquid into the suction lumen through the injection lumen. Multiple openings at the far end of the injection lumen ensure that the liquid impacts the thrombus from different angles, thereby improving the efficiency of thrombolysis. The system can select a thrombolysis strategy of high-pressure pulse injection, low-pressure continuous flushing, or alternating the two.

[0286] Intelligent liquid management: The system automatically selects the appropriate liquid type (such as saline, thrombolytic drugs or contrast agents) according to the identified suction state and the preset treatment plan. According to the selected liquid type, the rotation speed and flow parameters of the peristaltic pump 120 are automatically matched.

[0287] Adaptive control: The system uses an adaptive PID control algorithm to dynamically adjust control parameters according to the suction state. Real-time monitoring of system response, continuous optimization of negative pressure pump 130 pressure, peristaltic pump 120 working parameters, etc.

[0288] Operation mode: The system has automatic mode and manual mode. In automatic mode, the system executes the whole process according to the preset algorithm. In manual mode, the operator can adjust key parameters through the foot controller.

[0289] Data recording and analysis: The system records the entire process data of each operation, including pressure changes, equipment parameters and operation time. Analyze historical data and continuously optimize control parameters and strategies.

[0290] Through this intelligent working principle, the system can automatically identify the suction status, dynamically adjust the suction parameters, accurately control the thrombus fragmentation process, significantly improve the thrombus suction efficiency, reduce the patient's blood loss, effectively prevent the suction catheter 110 from being blocked, and optimize the entire surgical process.

[0291] It should be further pointed out that in this embodiment, the structure of at least two openings at the distal end of the injection lumen and located in the suction lumen has several specific functions:

[0292] Increased spray coverage: Multiple openings allow the liquid to be sprayed from different directions, increasing the spray coverage. This can more effectively break up thrombi, especially when the thrombi are large or irregular in shape.

[0293] Improve the efficiency of thrombus fragmentation: Multiple openings can generate multiple streams of liquid to impact the thrombus from different angles. This multi-directional impact force can break up the thrombus faster and more thoroughly, improving the efficiency of thrombus fragmentation.

[0294] Reduced risk of blockage: If there is only one opening, it may be completely blocked by a large piece of blood clot. Having multiple openings reduces the risk of all openings being blocked at the same time, ensuring that at least some of the fluid can be ejected to continue the clot breakup.

[0295] Evenly distribute the liquid: Multiple openings can make the liquid more evenly distributed in the aspiration tube lumen, which helps to clean the lumen more completely and prevent the deposition of thrombus fragments on the tube wall.

[0296] Increase the adaptability of the system: Different openings can be designed into different sizes or shapes as needed to accommodate different types of thrombi or different treatment needs. For example, some openings can be used for high-pressure injection and some for low-pressure flushing.

[0297] Improved operational flexibility: In some cases, doctors may need to fragment thrombi in specific directions. The design of multiple openings makes this possible.

[0298] Technical effects:

[0299] The intelligent thrombus aspiration and thrombus cutting system of the above embodiment has the following technical effects:

[0300] Intelligent identification of suction status: The first pressure sensor 40 and the second pressure sensor 100 respectively detect the pressure in the negative pressure pump 130 pipeline and the suction catheter 110. Combined with the preset pressure threshold and pressure change pattern, the system can accurately identify the current suction status, including suction of blood, suction of thrombus and complete blockage.

[0301] Intelligent regulation of suction parameters: Based on the identified suction state, the main control circuit board 150 automatically adjusts the pressure of the negative pressure pump 130 and the working parameters of the peristaltic pump 120 to achieve intelligent regulation of the suction force and frequency and improve the suction efficiency.

[0302] Automatic thrombus breaking function: When a state of complete blockage is identified, the system automatically controls the peristaltic pump 120 to spray liquid into the suction lumen through the injection lumen to break up the thrombus, effectively preventing the suction catheter 110 from being blocked for a long time.

[0303] Structural design optimization: The suction catheter 110 adopts a dual-lumen design in which the suction lumen and the injection lumen are coaxially arranged. The distal end of the injection lumen is provided with at least two openings and is located inside the suction lumen, thereby achieving efficient liquid injection and thrombus fragmentation, while improving the coverage and efficiency of thrombus fragmentation.

[0304] Diversified pressure sensing methods: The second pressure sensor 100 can be installed in a variety of ways, such as a micro pressure sensor, a thin film pressure sensor or an optical fiber pressure sensor, which improves the accuracy and adaptability of pressure detection.

[0305] Intelligent control algorithm: The machine learning-based suction state recognition algorithm, adaptive PID control algorithm and intelligent plug-breaking control algorithm are adopted to achieve dynamic optimization and automatic adjustment of system parameters.

[0306] Intelligent liquid supply: Based on the identified suction status and preset treatment plan, the system can automatically select the appropriate liquid type and intelligently match the speed and flow parameters of the peristaltic pump 120 according to the liquid type.

[0307] Flexible operation mode: The system has the function of switching between automatic mode and manual mode, which provides doctors with more operation options while ensuring intelligence.

[0308] In summary, the intelligent thrombus aspiration and thrombus cutting system of the above-mentioned embodiment significantly improves the efficiency of thrombus aspiration, reduces the patient's blood loss, effectively prevents catheter blockage, optimizes the surgical process, and has good clinical application prospects through technical means such as intelligent identification of aspiration status, automatic control of system parameters, and integrated thrombus fragmentation function.

[0309] In order to better understand the technical solution of the present application, a specific example is provided below for illustration. The details listed in the example are mainly for ease of understanding and are not intended to limit the scope of protection of the present application.

[0310] This example proposes an intelligent system for aspirating and cutting thrombi, which identifies the state of thrombus aspiration through pressure detection, and controls the negative pressure, tube valve and thrombus breaking program in a linked manner, thereby reducing the time waste from the start of the equipment to stable operation, reducing the patient's blood loss, preventing the blockage of the suction catheter 110, and improving the suction efficiency. The system includes a negative pressure pump 130, a blood collection tank 70, a suction pipeline 90, a suction catheter 110 (including a catheter cavity and an injection cavity), a peristaltic pump 120, a main control circuit board 150, a pipeline control valve 140 (such as a solenoid valve, a clamp valve, etc.), and two sensing devices (such as a traditional electronic pressure sensor, a film pressure sensor, etc.) that respectively record the pressure in the air circuit of the negative pressure pump 130 and the suction catheter 110.

[0311] The sensing device and the pipeline control valve 140 are connected to the main control circuit board 150 through a line, and are connected to the negative pressure pump 130 and the blood collection tank 70 through a gas pipeline. The upper cover of the blood collection tank 70 is detachable, and a filter is provided inside to filter thrombus and blood. The negative pressure pump 130 is connected to the main control circuit board 150 through a line. The control parameters of the pipeline control valve 140 mainly include the opening frequency and the channel size.

[0312] The suction catheter 110 includes a suction lumen and an injection lumen. The proximal end of the injection lumen extends out of the suction catheter 110 and is connected to the peristaltic pump 120 pipeline through an interface (such as a Luer interface, a plug-in interface), and the distal end is opened on both sides with the center line of the suction catheter 110 as the symmetry axis, for injecting liquid into the suction lumen.

[0313] The suction pipeline 90 includes a liquid pipeline and a three-way connecting pipe. The two interfaces of the three-way pipe are respectively connected to the suction cavity of the suction catheter 110 and the suction pipeline 90 (or the extension catheter), the sensing part of the sensor device (such as the O-ring, the film sensing area, etc.) is fixed (such as bonding) through the opening on the interface wall of the suction catheter 110, and the other interface connects the output liquid path of the peristaltic pump 120 to the injection cavity of the suction catheter 110, and can be used for the guide wire to pass according to the specifications of the suction catheter 110.

[0314] The two sensor devices transmit data via a cable connection, and wireless Bluetooth communication can also be used. The display device 10 is used to display the pressure monitored by the sensor device and the current thrombus breaking state. The peristaltic pump 120 is connected to an external liquid (such as saline, diluted thrombolytic drugs, etc.), and transports the liquid to the injection chamber of the suction catheter 110 through a liquid pipeline. The peristaltic pump 120 is connected to the main control circuit board 150 and the foot control valve through a line, and can realize automatic control or manual control. The flow rate and start time of the peristaltic pump 120 can be set in the display device 10 according to the type of liquid.

[0315] The device database stores historical data of the sensor device, which is classified according to the diameter of the suction catheter 110, the length of the suction catheter 110, and the extension catheter length. The historical data includes the average pressure value with standard error, the calculated pressure range, the average value of the pressure difference range, and the pressure change trend. Before starting the device, the suction catheter 110 information is input on the display device 10, and the system automatically screens and matches the corresponding historical data group to determine the suction state. The suction state is divided into three types: complete blockage, suction thrombus, and suction blood.

[0316] This example can automatically identify the suction situation, jointly adjust the suction force and suction frequency, and automatically or manually start the thrombus fragmentation program, thereby reducing the patient's blood loss, preventing the suction catheter 110 from being blocked, and improving the efficiency of thrombus suction.

[0317] Specifically, the pipeline control valve 140 (such as a solenoid valve, a clamp valve, etc.) is controlled by the main control circuit board 150, and its opening frequency and channel size are adjusted according to the suction state. When the suction state is to suck blood, the pipeline control valve 140 opens and closes at a certain frequency, and adjusts the open channel to be incompletely open, and the pressure of the negative pressure pump 130 is reduced accordingly; when the suction state is to suck thrombus, the pipeline control valve 140 is continuously opened, the channel is adjusted to be fully open, and the pressure of the negative pressure pump 130 is correspondingly increased to reach the maximum value; when the suction state is completely blocked, the pipeline control valve 140 is continuously opened, the channel is adjusted to be fully open, the negative pressure pump 130 pressure opens the maximum negative pressure, and the peristaltic pump 120 starts to work, and the injection cavity in the suction catheter 110 uses high-speed liquid impact to break up the thrombus or release thrombolytic drugs at a certain flow rate. This action can be manually controlled by a foot switch.

[0318] The key points of this example include:

[0319] The system consists of a negative pressure pump 130, a blood collection tank 70, a suction pipeline 90, a suction catheter 110, a peristaltic pump 120, a pipeline control valve 140 and a sensor device.

[0320] Intelligent control: According to the identified suction state, the opening frequency and channel size of the pipeline control valve 140, the pressure of the negative pressure pump 130, the opening and closing and flow rate of the peristaltic pump 120 and other parameters are regulated in real time to realize the intelligent suction and cutting of thrombus.

[0321] Dual pressure sensing: Two pressure sensors are provided at the negative pressure pump 130 pipeline and the suction catheter 110 to identify the suction state by detecting a combination of the pressure value range and the pressure difference range.

[0322] Diversified forms of pressure sensors: The pressure sensor at the end of the suction catheter 110 can be in various forms, such as fixed through an opening in the wall of the suction catheter 110, a ring-shaped film pressure sensor adhered to the inner wall of the suction catheter 110, a miniature contact pressure sensor placed at the port of the suction catheter 110, etc.

[0323] Design of double-lumen suction catheter 110: The suction catheter 110 includes a suction lumen and an injection lumen. The proximal end of the injection lumen is connected to the peristaltic pump 120, and the distal end is opened on both sides of the center line of the suction catheter 110 for spraying liquid into the suction lumen to achieve thrombus cutting.

[0324] It should be noted that in the application documents of this patent, relational terms such as first and second are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Moreover, the terms "include", "comprise" or any other variants thereof are intended to cover non-exclusive inclusion, so that the process, method, article or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or device. In the absence of further restrictions, the elements defined by the sentence "including one" do not exclude the existence of other identical elements in the process, method, article or device including the elements. In the application documents of this patent, if it is mentioned that an action is performed according to an element, it means that the action is performed at least according to the element, which includes two situations: performing the action only according to the element, and performing the action according to the element and other elements. Expressions such as multiple, multiple, and multiple include 2, 2 times, 2 kinds, and more than 2, more than 2 times, and more than 2 kinds.

[0325] All documents mentioned in this application are considered to be included in the disclosure of this application as a whole, so that they can be used as the basis for modification when necessary. In addition, it should be understood that after reading the above disclosure of this application, those skilled in the art can make various changes or modifications to this application, and these equivalent forms also fall within the scope of protection claimed in this application.

Claims

1. An intelligent system for aspirating and cutting thrombi, characterized in that: include: Negative pressure pump; A suction catheter comprising a suction lumen and an injection lumen A suction pipeline, one end of which is connected to the negative pressure pump and the other end of which is connected to the suction lumen; A pipeline control valve, arranged on the suction pipeline, for adjusting the suction flow; a first pressure sensor, disposed between the negative pressure pump and the suction pipeline, for monitoring the pressure of the negative pressure pump; A second pressure sensor is disposed on the suction lumen of the suction catheter and is used to monitor pressure changes under the suction state; a peristaltic pump connected to the proximal end of the injection lumen and used to deliver a specified type of liquid to the injection lumen; A main control circuit board is electrically connected to the first pressure sensor, the second pressure sensor, the negative pressure pump, and the peristaltic pump, respectively, and is used to: based on a preset pressure threshold and pressure change pattern, identify the suction state according to the pressure data of the first pressure sensor and the second pressure sensor, and the suction state includes suctioning blood, suctioning thrombus and complete blockage; based on the identified suction state, control the pressure of the negative pressure pump and the working parameters of the peristaltic pump; when a complete blockage state is identified, control the peristaltic pump to spray liquid into the suction lumen through the injection lumen to break up the thrombus.

2. The system according to claim 1, characterized in that The suction lumen and the injection lumen of the suction catheter are coaxially arranged, and the distal end of the injection lumen is provided with at least two openings located in the suction lumen, and the openings are distributed along the circumference of the suction catheter.

3. The system according to claim 2, characterized in that The system also includes a pipeline control valve, which is arranged on the suction pipeline and is used to adjust the suction flow rate; the main control circuit board is also electrically connected to the pipeline control valve and is used to control the opening and closing state and opening degree of the pipeline control valve.

4. The intelligent thrombus aspiration and thrombus cutting system according to claim 3 is characterized in that: The system further comprises: A display device, electrically connected to the main control circuit board; Wherein, the main control circuit board is also used for: Control the display device to display system working status information in real time, and the system working status information includes one of the following or any combination thereof: current suction status; real-time pressure data of the first pressure sensor and the second pressure sensor; current pressure setting of the negative pressure pump; current opening degree of the pipeline control valve; current working parameters of the peristaltic pump; and system running time.

5. The intelligent thrombus aspiration and thrombus cutting system according to claim 4 is characterized in that: The display device adopts a touch screen design and is also used to receive system parameter settings input by a user. The system parameter settings include pressure threshold, liquid type selection and peristaltic pump operating parameters.

6. The intelligent thrombus aspiration and thrombus cutting system according to claim 1, characterized in that: The first pressure sensor is an electronic pressure sensor, which is installed between the negative pressure pump and the suction pipeline in one of the following ways: three-way joint installation, embedded installation, and adhesive fixation; the second pressure sensor adopts one of the following forms: a micro pressure sensor, the pressure sensing area is directly embedded in the wall opening and connected to the suction lumen by bonding or a three-way joint; a thin film pressure sensor, which is installed around the inner wall of the suction lumen at the distal end of the suction tube of the suction catheter; a guide wire pressure sensor, which is arranged along the length direction of the suction catheter; Among them, the signal transmission line of the second pressure sensor adopts one of the following methods: buried along the inner wall of the suction catheter; led out through a tiny channel on the wall of the suction catheter; led out through an external cable; a wireless transmission module wirelessly transmits the pressure data to the main control circuit board.

7. The intelligent thrombus aspiration and thrombus cutting system according to claim 1, characterized in that: The structure of the suction catheter comprises: An inner metal tube, constituting the suction lumen, wherein the inner metal tube is made of one of the following materials: stainless steel, nickel-titanium alloy, cobalt-chromium alloy; An outer polymer tube is coated on the outer side of the inner metal tube and together with the inner metal tube, forms the suction lumen. The outer polymer tube is made of one of the following materials or a combination thereof: polyethylene, polyurethane, polytetrafluoroethylene; Wherein, the hardness of the outer polymer tube gradually increases from the distal end to the proximal end to improve the pushing performance of the catheter; The suction catheter further comprises: A coating, coated on the outer surface of the outer polymer tube, for reducing friction with the blood vessel wall, wherein the coating is selected from one of the following materials: a hydrophilic coating, a drug coating, and an anticoagulant coating; A positioning ring, arranged at the distal end of the suction catheter, for visual positioning under X-ray; Wherein, the distance between the distal opening of the injection lumen and the distal end of the suction catheter is 5-20 mm; The ratio of the cross-sectional area of ​​the suction lumen to the cross-sectional area of ​​the injection lumen is 5:1 to 25:

1.

8. The intelligent thrombus aspiration and thrombus cutting system according to claim 1, characterized in that: The main control circuit board adopts the following control algorithm: The puff state recognition algorithm based on machine learning includes the following steps: a) Collect and store historical suction data, including pressure data under different suction states, negative pressure pump parameters and pipeline control valve status; b) using the support vector machine (SVM) algorithm to train the puff state classification model; c) collecting pressure data of the first pressure sensor and the second pressure sensor in real time; d) inputting the real-time pressure data into the trained classification model to obtain the current suction state; The adaptive PID control algorithm is used to dynamically adjust system parameters and includes the following steps: e) Automatically adjust the proportional, integral and differential parameters of the PID controller according to the identified suction state; f) using the adjusted PID parameters to control in real time the pressure of the negative pressure pump, the opening degree of the pipeline control valve and the working parameters of the peristaltic pump; g) Monitor system response and continuously optimize PID parameters based on the response results; The intelligent throttle control algorithm is activated when a complete blockage state is identified, and includes the following steps: h) Automatically select appropriate clog-breaking strategies based on the degree of blockage, including high-pressure pulse jetting, low-pressure continuous flushing, or alternating use of the two; i) controlling the peristaltic pump to deliver liquid according to a selected strategy; j) Real-time monitoring of the pressure change of the second pressure sensor to evaluate the plug breaking effect; k) Dynamically adjust the plug breaking strategy according to the pressure change trend until the blockage is relieved or the preset time threshold is reached; Wherein, the main control circuit board also includes a data recording and analysis module, which is used to: l) Record the entire data of each operation, including pressure changes, equipment parameters and operation time; m) Analyze historical data and optimize control parameters and strategies; n) Generate operation reports, including suction effect evaluation and equipment usage statistics.

9. The intelligent thrombus aspiration and thrombus cutting system according to claim 1, characterized in that: The system further comprises: a liquid supply device, connected to the peristaltic pump, for supplying liquid to the injection lumen; Wherein, the liquid supply device comprises: a) a plurality of liquid storage containers, each used to store different types of liquids, including physiological saline, thrombolytic drugs and contrast agents; b) a multi-way valve connected to the plurality of liquid storage containers and used for selecting the type of liquid to be output; c) a heating element for heating the selected liquid to a preset temperature; The main control circuit board is also used for: d) automatically controlling the multi-way valve to select an appropriate liquid type according to the identified suction state and the preset treatment plan; e) controlling the operation of the heating element to ensure a constant temperature of the transported liquid; f) Monitor liquid usage and sound an alarm when liquid storage containers are running low.

10. The intelligent thrombus aspiration and thrombus cutting system according to claim 9, characterized in that: The main control circuit board is also used for: According to the selected liquid type, the speed and flow parameters of the peristaltic pump are automatically matched, including: a) when physiological saline is selected, the peristaltic pump is controlled to provide a large flow rate of 200-500 mL / min for mechanically breaking up the thrombus; b) when an anticoagulant is selected, controlling the peristaltic pump to provide a micro-volume continuous infusion of 0.1-20 mL / min to prevent further thrombus formation; c) when a thrombolytic agent is selected, controlling the peristaltic pump to deliver the thrombolytic agent to the thrombus site at a flow rate of 1-100 mL / min by pulse injection, for chemically dissolving the thrombus; d) when contrast agent is selected, controlling the peristaltic pump to provide a flow rate of 20-150 mL / min for pumping and infusion; Wherein, the main control circuit board is also used for: d) dynamically adjusting the rotation speed and operation mode of the peristaltic pump according to the identified suction state and thrombus characteristics; e) When delivering thrombolytic agents, monitor the cumulative delivery volume and automatically stop or switch to saline delivery when the preset safety threshold is reached; f) Record the usage of different types of liquids, including usage time, dosage and corresponding suction effect, for optimization of subsequent treatment plans.

11. The intelligent thrombus aspiration and thrombus cutting system according to claim 5, characterized in that: The system has a switching function between automatic mode and manual mode, including: A mode switching switch, electrically connected to the main control circuit board, for switching between an automatic mode and a manual mode; A foot controller, electrically connected to the main control circuit board, used to control key functions of the system in manual mode; Wherein, the main control circuit board is also used for: In automatic mode: a) Automatically perform suction state recognition, parameter adjustment and plug breaking operations according to the preset algorithm; b) When an abnormal situation is detected, it automatically switches to manual mode and sounds an alarm; In manual mode: c) responding to the input of the foot controller to control the start and stop of the negative pressure pump, the opening degree of the pipeline control valve and the working parameters of the peristaltic pump; d) displaying system parameters in real time through the display device and allowing the operator to make manual adjustments; When switching modes: e) Ensure smooth transition of system parameters and maintain continuity and safety of operation; f) Record the time and reason of mode switching; In any mode: g) Monitor the system operating status and automatically execute the safety shutdown procedure when an abnormal situation that may endanger patient safety is detected.

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