Circulating suction apparatus and system

Abstract

The present disclosure relates to the field of medical device technology, and in particular, to a circulating suction apparatus and system. The circulating suction apparatus comprises: a perfusion mechanism, a first pressure sensor, and an on-off control mechanism. The on-off control mechanism is separately connected to the perfusion mechanism, a suction catheter, and a thrombus collection apparatus via pipelines, and the first pressure sensor is arranged between the on-off control mechanism and the suction catheter. The on-off control mechanism is configured to control the on-off state of the pipelines. The perfusion mechanism is configured to provide perfusion liquid to the pipeline between the suction catheter and the on-off control mechanism. The first pressure sensor is configured to measure a pressure value in the pipeline between the suction catheter and the on-off control mechanism. The present disclosure has a thrombus breaking capability, a thrombus motion control capability, and a suction catheter recanalization capability.

Description

Circulating suction device and system

[0001] Cross-references to related applications

[0002] This disclosure claims priority to Chinese Patent Application No. 2025103618998, filed on March 26, 2025, entitled "Circulating Suction Device and System", the entire contents of which are incorporated herein by reference. Technical Field

[0003] This disclosure relates to the field of medical device technology, and more specifically, to a circulating suction device and system. Background Technology

[0004] Deep vein thrombosis (DVT) refers to the formation of a blood clot within a vein. It can occur in any deep vein, and is most commonly found in the lower extremities or pelvis. However, it can also occur in the upper extremities, abdominal veins, or even the brain. Current treatment methods for DVT typically include anticoagulation therapy, catheter-directed thrombolysis (CDT), and mechanical thrombectomy.

[0005] For mechanical thrombectomy, existing mechanical thrombectomy equipment has the following problems: it lacks the ability to break up thrombi, has insufficient ability to aspirate subacute thrombi, lacks the ability to control thrombus movement within the catheter, and cannot solve the problem of catheter blockage and unblocking.

[0006] Public content

[0007] The embodiments of this disclosure provide a cyclic aspiration device and system, which has the ability to break up thrombi, control thrombus movement, and clear blockages in the aspiration catheter.

[0008] The embodiments of this disclosure can be implemented as follows:

[0009] Embodiments of this disclosure provide a cyclic suction device, including: an infusion mechanism, a first pressure sensor, and an on / off control mechanism;

[0010] The on / off control mechanism is connected to the perfusion mechanism, the aspiration catheter, and the thrombus collection device via pipelines, and the first pressure sensor is located between the on / off control mechanism and the aspiration catheter.

[0011] The on / off control mechanism is configured to control the on / off state of the pipeline; the infusion mechanism is configured to provide infusion liquid to the pipeline between the suction conduit and the on / off control mechanism; and the first pressure sensor is configured to measure the pressure value of the pipeline between the suction conduit and the on / off control mechanism.

[0012] Optionally, the pipeline includes a main pipeline and branch pipelines, and the on / off control mechanism includes a suction on / off control mechanism and an injection on / off control mechanism.

[0013] The aspiration on / off control mechanism is located on the main pipeline and is configured to control the on / off state of the main pipeline between the aspiration catheter and the thrombus collection device; the first pressure sensor is located between the aspiration on / off control mechanism and the aspiration catheter.

[0014] The injection on / off control mechanism is located on the branch pipeline to connect the injection mechanism to the main pipeline between the suction conduit and the suction on / off control mechanism via the branch pipeline. The injection on / off control mechanism is configured to control the on / off state between the injection mechanism and the main pipeline.

[0015] Optionally, the working mode of the cyclic aspiration device includes a thrombus fragmentation mode, in which the perfusion on / off control mechanism and the aspiration on / off control mechanism are interlocked.

[0016] The injection on / off control mechanism controls the branch pipeline to disconnect, while the suction on / off control mechanism controls the main pipeline to open; or, the injection on / off control mechanism controls the branch pipeline to open, while the suction on / off control mechanism controls the main pipeline to disconnect.

[0017] Optionally, the working mode of the circulatory aspiration device includes a thrombus movement control mode, in which the perfusion on / off control mechanism and the aspiration on / off control mechanism are linked.

[0018] The injection on / off control mechanism controls the flow of the branch pipeline, and the suction on / off control mechanism controls the flow of the main pipeline.

[0019] The time for the injection on / off control mechanism to control the branch pipeline to open is less than the time for the suction on / off control mechanism to control the main pipeline to open.

[0020] Optionally, the injection mechanism operates continuously, the injection on / off control mechanism controls the branch pipeline to remain open, and the suction on / off control mechanism controls the main pipeline to be indirectly open.

[0021] The amount of perfusion fluid provided by the perfusion mechanism during the period when the perfusion on / off control mechanism controls the opening of the branch pipeline is less than the amount of fluid aspirated by the thrombus collection device during the period when the aspiration on / off control mechanism controls the opening of the main pipeline.

[0022] Optionally, the injection mechanism operates continuously, and the injection mechanism and the injection on / off control mechanism are in a pressurized state;

[0023] The perfusion volume of the perfusion mechanism is related to the time it takes for the perfusion on / off control mechanism to control the conduction of the branch pipeline. The perfusion fluid volume of the perfusion mechanism is less than the single aspiration volume of the thrombus collection device.

[0024] Optionally, the circulating suction device further includes a second pressure sensor, which is disposed on the branch pipe and configured to measure the pressure value on the branch pipe.

[0025] Optionally, the thrombus collection device includes a thrombus collection tank and a vacuum pump, which are connected by a main pipeline;

[0026] The circulating aspiration device also includes a third pressure sensor, which is located on the main pipeline and configured to measure the pressure value of the main pipeline between the thrombus collection tank and the vacuum pump.

[0027] Optionally, the cyclic suction device further includes a processor, which is electrically connected to the first pressure sensor, the second pressure sensor, and the third pressure sensor;

[0028] The processor is configured to identify whether the aspiration catheter has aspirated a thrombus based on one or more of the pressure values ​​collected by the first pressure sensor, the second pressure sensor, and the third pressure sensor, and / or to identify the diameter value of the main pipeline, wherein the diameter value is negatively correlated with the on / off frequency corresponding to the aspiration on / off control mechanism.

[0029] Optionally, the on / off control mechanism is an integrated on / off control structure. The integrated on / off control structure adopts a two-position three-way valve. The two-position three-way valve is configured to control the on / off state of the pipeline between the aspiration catheter and the thrombus collection device, and is also configured to control the on / off state of the pipeline between the perfusion mechanism and the aspiration catheter.

[0030] Optionally, the circulatory aspiration device further includes a housing configured to provide protection for the perfusion mechanism, the first pressure sensor, and the on / off control mechanism; or, configured to provide protection for the perfusion mechanism, the first pressure sensor, the on / off control mechanism, and the thrombus collection device.

[0031] Embodiments of this disclosure also provide a circulating suction system, which includes the aforementioned circulating suction device and has all the functions of the circulating suction device.

[0032] Compared with existing technologies, the beneficial effects of the embodiments of this disclosure include, for example:

[0033] The circulating aspiration device and system provided in this disclosure include: an infusion mechanism, a first pressure sensor, and an on / off control mechanism. The on / off control mechanism is connected to the infusion mechanism, the aspiration catheter, and a thrombus collection device via pipelines. The first pressure sensor is disposed between the on / off control mechanism and the aspiration catheter. The on / off control mechanism is configured to control the on / off state of the pipeline. The infusion mechanism is configured to provide infusion fluid to the pipeline between the aspiration catheter and the on / off control mechanism. The first pressure sensor is configured to measure the pressure value of the pipeline between the aspiration catheter and the on / off control mechanism. The device can use the pressure value to identify the pipeline diameter and whether the aspiration catheter has aspirated a thrombus. If a thrombus is aspirated, the infusion mechanism can provide infusion fluid to the pipeline. Combined with the on / off control mechanism changing the on / off state of the pipeline, the infusion fluid can cause the thrombus in the pipeline to move, thereby achieving the functions of thrombus fragmentation and thrombus movement control. Furthermore, when the aspiration catheter becomes blocked due to a thrombus aspirated, the infusion fluid can be used to clear the blockage. Attached Figure Description

[0034] To more clearly illustrate the technical solutions of the embodiments of this disclosure, the accompanying drawings used in the embodiments will be briefly described below. It should be understood that the following drawings only show some embodiments of this disclosure 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.

[0035] Figure 1 is a schematic diagram of a circulating suction device provided in an embodiment of this disclosure;

[0036] Figure 2 is a schematic diagram of the specific structure of a circulating suction device provided in an embodiment of this disclosure;

[0037] Figure 3 is a connection diagram of a circulating suction device provided in an embodiment of this disclosure;

[0038] Figure 4 is a schematic diagram of a shutter structure provided in an embodiment of this disclosure;

[0039] Figure 5 is a partial structural schematic diagram of a circulatory aspiration device in a thrombus fragmentation mode provided in an embodiment of this disclosure;

[0040] Figure 6 is a partial structural schematic diagram of a circulatory aspiration device in a thrombus movement control mode provided in an embodiment of this disclosure;

[0041] Figure 7 is a partial structural schematic diagram of a circulatory aspiration device under another thrombus movement control mode provided in an embodiment of this disclosure;

[0042] Figure 8 is a partial structural schematic diagram of a circulating suction device in a dredging suction duct mode provided in an embodiment of the present disclosure;

[0043] Figure 9 is a partial structural schematic diagram of a circulating suction device in another unblocking suction duct mode provided in an embodiment of this disclosure;

[0044] Figure 10 is a schematic diagram of the specific structure of the circulating suction device provided in an embodiment of this disclosure.

[0045] Icons: 1-First pressure sensor; 2-Second pressure sensor; 3-Third pressure sensor; 4-Suction on / off control mechanism; 5-Injection on / off control mechanism; 6-Injection mechanism; 7-Main pipeline; 8-Branch pipeline; 9-First port; 10-Second port; 11-Third port; 12-Overall on / off control structure. Detailed Implementation

[0046] To make the objectives, technical solutions, and advantages of the embodiments of this disclosure clearer, the technical solutions of the embodiments of this disclosure will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this disclosure, and not all embodiments. The components of the embodiments of this disclosure described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0047] Therefore, the following detailed description of the embodiments of this disclosure provided in the accompanying drawings is not intended to limit the scope of the claimed disclosure, but merely to illustrate selected embodiments of the disclosure. All other embodiments obtained by those skilled in the art based on the embodiments of this disclosure without inventive effort are within the scope of protection of this disclosure.

[0048] It should be noted that similar labels and letters in the following figures indicate similar items. Therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures.

[0049] In the description of this disclosure, it should be noted that if terms such as "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," or "outer" appear to indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship commonly used when the product of the invention is in use, they are only for the convenience of describing this disclosure 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 this disclosure.

[0050] Furthermore, the use of terms such as "horizontal," "vertical," and "suspended" does not imply that the component must be absolutely horizontal or suspended, but rather that it can be slightly tilted. For example, "horizontal" simply means that its direction is more horizontal relative to "vertical," and does not mean that the structure must be completely horizontal, but can be slightly tilted.

[0051] In the description of this disclosure, it should also be noted that, unless otherwise expressly specified and limited, the terms "set up," "install," "connect," and "link" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this disclosure based on the specific circumstances.

[0052] It should be noted that, where there is no conflict, the features in the embodiments of this disclosure can be combined with each other.

[0053] Deep vein thrombosis (DVT) refers to the formation of a blood clot within a vein. It can occur in any deep vein, typically in the lower extremities or pelvis, but can also occur in the upper extremities, abdominal veins, or even the brain. DVT is a common clinical complication in trauma and emergency patients, with an annual incidence of approximately 1 in 1000. Due to the unique characteristics of DVT: 1) DVT often lacks specific clinical symptoms, and its diagnosis often relies on routine screening, requiring significant manpower and medical resources. 2) Lower extremity thrombosis can lead to pulmonary embolism (PE), causing hemodynamic instability and endangering life. 3) Veins contain venous valves; treatments suitable for arteries, such as thrombectomy, can damage venous valve function, resulting in loss of venous transfusion function. Currently, treatment methods for DVT typically include anticoagulation therapy, catheter-directed thrombolysis (CDT), and mechanical thrombectomy.

[0054] Anticoagulation therapy: The role of anticoagulation therapy is to prevent the thrombus from spreading or forming new thrombi, thus creating conditions for collateral circulation to open and relieve symptoms. The most serious complications during anticoagulation therapy are bleeding and the dislodgement of old thrombi. Bleeding and thrombus dislodgement can cause serious harm to the patient.

[0055] Catheter-directed thrombolysis (CDT): CDT has become a commonly used treatment for acute deep vein thrombosis (DVT). Compared with traditional systemic anticoagulation therapy, it effectively reduces bleeding complications while accelerating thrombus dissolution. The degree of improvement in patients' quality of life from thrombolytic therapy is positively correlated with the degree of thrombus dissolution. Although CDT is an effective treatment that can relieve patients' pain, it increases the risk of bleeding complications, especially in patients with a recent history of major surgery. The clinical application of CDT is therefore limited, and its effectiveness in dissolving old thrombi is poor, which seriously restricts its overall efficacy.

[0056] Mechanical thrombectomy: Mechanical thrombectomy can rapidly remove thrombi, improve clinical symptoms, and reduce the use of urokinase, increasing treatment safety. Improving thrombectomy efficiency, shortening the treatment cycle, expanding the scope of treatment indications, and reducing bleeding risk are current directions of clinical research. A typical product is the AngioJet (Boston Scientific) mechanical thrombectomy system. This system is a minimally invasive treatment technology widely used in clinical practice in China in recent years. It is a percutaneous mechanical thrombectomy (PMT) system that combines drug and mechanical action. It mainly uses the principle of hydrodynamics to break up and aspirate thrombi, thereby achieving rapid thrombectomy and relieving venous obstruction. Literature reports that the AngioJet mechanical thrombectomy system is safe and effective, and that its use in combination with CDT can reduce the dosage of thrombolytic drugs and shorten hospital stays. However, the product has the following problems: 1) During thrombus aspiration, red blood cells are broken up by the high-speed jet of liquid, leading to hemoglobinuria, kidney damage, and even kidney failure; 2) The jet speed of the saline solution used for flushing is uncontrollable during thrombus aspiration, making it impossible to accurately and effectively flush out the thrombus; 3) Its complex structure, numerous disposable consumables, and high manufacturing costs result in a high selling price.

[0057] Currently, traditional mechanical thrombus aspiration devices have the following drawbacks: viscous thrombi (thrombi with a certain degree of toughness) can clog the aspiration catheter, preventing further aspiration; their complex structure, high cost of disposable consumables, and high manufacturing costs result in a higher selling price; they offer only one control mode, unable to freely switch between automatic and manual functions; they can only handle a limited range of thrombi, intelligently aspirating acute thrombi but lacking the ability to aspirate subacute thrombi (thrombi with a certain degree of toughness); they lack the function of breaking up thrombi before aspiration; the flow rate of thrombi in the catheter drops sharply with the entry of the thrombus, leading to a decrease in aspiration efficiency; and after aspirating a large amount of thrombi, the aspiration catheter becomes completely blocked, lacking the ability to clear or unblock the catheter.

[0058] To address some technical issues, related technologies provide an apparatus and method for controlled agglomerate suction (patent application publication number CN 112533550 A). The vacuum suction control system, configured for use with a vacuum source and a suction conduit, includes a connecting tube configured to connect the vacuum source to the lumen of the suction conduit. An on-off valve is operatively coupled to the connecting tube, and a sensing unit is configured to detect flow within the connecting tube and provide a signal representing the flow. A controller receives this signal to determine whether to open or close the valve. The controller can automatically close the valve to stop the flow when the flow through the connecting tube is unrestricted or according to a predetermined timing sequence. The controller can also periodically open the closed valve to determine whether the flow has entered an acceptable range. The controller can also perform pulsed suction using a pressure-operated component when the flow is restricted or blocked. An intermittent thrombus aspiration pump system and its method of use are also provided (patent application publication number CN 112316232 A), including an aspiration device and a control device. The control device includes a pressure sensor, a gas path control valve, a control circuit board, an aspiration connector, and a catheter connector. One end of the catheter connector is connected to an aspiration catheter, and the other end of the catheter connector is sequentially connected to the gas path control valve and the aspiration connector. The pressure sensor is connected to the airway between the catheter connector and the gas path control valve. The pressure sensor and the gas path control valve are electrically connected to the control circuit board. Through the cooperation between the control device and the aspiration device, the aspiration action only begins when the aspiration negative pressure reaches a certain value, realizing intermittent aspiration, improving the aspiration force of the aspiration pump system, reducing the aspiration time, thereby reducing the patient's bleeding and facilitating the patient's subsequent recovery.

[0059] However, the applicant's research revealed that existing technologies still have the following problems: they lack the ability to break up thrombi and are insufficient for aspirating subacute thrombi; they lack the ability to control the movement of thrombi within the catheter; due to structural limitations, all aspiration modes of thrombus aspiration devices with circulation control on the market require operation under the control of the control device, and there is no manual aspiration mode, resulting in a single control mode, which deprives operators of an important option under special conditions; they cannot solve the problem of catheter blockage and unblocking; and they cannot intelligently distinguish the diameter and length of the catheter.

[0060] Based on this, the present disclosure provides a circulating aspiration device and system to improve the above-mentioned problems. The embodiments of the present disclosure have at least the ability to break up thrombi, the ability to control the movement of thrombi, and the ability to clear blockages in the aspiration catheter.

[0061] To facilitate understanding of this embodiment, a detailed description of a circulating suction device disclosed in this disclosure will be provided first. Referring to Figure 1, a schematic diagram of the structure of a circulating suction device is shown, which includes: an injection mechanism, a first pressure sensor, and an on / off control mechanism.

[0062] In one embodiment, the on / off control mechanism is connected via pipelines to the perfusion mechanism, the aspiration catheter, and the thrombus collection device, respectively, and a first pressure sensor is disposed between the on / off control mechanism and the aspiration catheter. The perfusion mechanism can be a perfusion pump.

[0063] In one example, the tubing consists of a main line and branch lines. The on / off control mechanism includes an aspiration on / off control mechanism, which connects to a first pressure sensor via the main line. One end of the main line is connected to an aspiration catheter, and the other end is connected to a thrombus collection device. A perfusion mechanism is connected via branch lines, with one end connected to a perfusion fluid storage device and the other end connected to the main line between the aspiration catheter and the aspiration on / off control mechanism. The perfusion location is on the side of the on / off control mechanism closer to the thrombus.

[0064] In another example, the tubing consists of a main line and branch lines. The on / off control mechanism includes an aspiration on / off control mechanism and an infusion on / off control mechanism. The main line connects a first pressure sensor and the aspiration on / off control mechanism. One end of the main line is connected to an aspiration catheter, and the other end is connected to a thrombus collection device. The branch lines connect an infusion mechanism and an infusion on / off mechanism. The end of the branch line closer to the infusion mechanism is connected to an infusion fluid storage device, and the end closer to the infusion on / off mechanism is connected to the main line between the aspiration catheter and the aspiration on / off control mechanism. The infusion location is on the side of the on / off control mechanism closer to the thrombus.

[0065] In another example, the pipeline is divided into a main pipeline and branch pipelines. The on / off control mechanism is an integrated on / off control mechanism. The main pipeline connects the first pressure sensor and the integrated on / off control mechanism. One end of the main pipeline is connected to the aspiration catheter, and the other end is connected to the thrombus collection device. The branch pipeline connects to the perfusion mechanism. One end of the branch pipeline is connected to the perfusion fluid storage device, and the other end is connected to the integrated on / off control mechanism.

[0066] The on / off control mechanism is configured to control the on / off state of the tubing. Specifically, the aforementioned aspiration on / off control mechanism is configured to control the on / off state of the main pipeline between the aspiration catheter and the thrombus collection device; the aforementioned perfusion on / off control mechanism is configured to control the on / off state of the branch pipeline between the perfusion device and the main pipeline; and the aforementioned overall on / off control mechanism is configured to control the on / off state of the main pipeline between the aspiration catheter and the thrombus collection device, and to control the on / off state of the branch pipeline between the perfusion device and the main pipeline.

[0067] The infusion mechanism is configured to provide infusion fluid to the pipeline between the aspiration catheter and the on / off control mechanism. By controlling the on / off state of the pipeline through the on / off control mechanism, the infusion mechanism can drive the movement of the thrombus in the main pipeline, thereby realizing the functions of thrombus fragmentation, thrombus movement control, and unblocking the aspiration catheter.

[0068] The first pressure sensor is configured to measure the pressure value of the tubing between the aspiration catheter and the on / off control mechanism. This pressure value can be configured to identify the diameter of the main tubing and to identify whether the aspiration catheter has aspirated a thrombus.

[0069] The circulating aspiration device provided in this embodiment can use pressure values ​​to identify whether a thrombus has been aspirated from the pipeline diameter and aspiration catheter. If a thrombus is aspirated, the perfusion mechanism can provide perfusion fluid to the pipeline. Combined with the on / off control mechanism to change the on / off state of the pipeline, the perfusion fluid can drive the movement of the thrombus in the pipeline, thereby realizing the thrombus fragmentation function and the thrombus movement control function. In addition, when the aspiration catheter is blocked due to a thrombus aspirated, the perfusion fluid can be used to clear the aspiration catheter.

[0070] The purpose of this disclosure is to provide a thrombus extraction instrument with cyclic aspiration (hereinafter referred to as a cyclic aspiration device). This cyclic aspiration device integrates a cyclic control system and an aspiration system into one unit, and features small size, portability, and low cost. The cyclic aspiration device consists of an aspiration on / off control mechanism, a perfusion on / off control mechanism, and a pressure sensor. It is used in conjunction with a vacuum pump and is connected to the thrombus collection tank of the vacuum pump.

[0071] In one embodiment, the present disclosure provides a schematic diagram of the specific structure of a circulating suction device as shown in FIG2, including a first pressure sensor 1, a second pressure sensor 2, a third pressure sensor 3, a suction on / off control mechanism 4, an injection on / off control mechanism 5, an injection mechanism 6, a main pipeline 7, a branch pipeline 8, a first port 9, a second port 10, and a third port 11.

[0072] The pipelines include the main pipeline 7 and the branch pipelines 8, and the on / off control mechanisms include the suction on / off control mechanism 4 and the injection on / off control mechanism 5.

[0073] For ease of understanding, please refer to Figure 3, which shows a connection diagram of a circulating suction device.

[0074] In one example, Figures 2 and 3 show that the suction on / off control mechanism 4 is installed on the main pipeline 7.

[0075] Optionally, the first port 9 on the main pipeline 7 is connected to a thrombus collection device, which includes a thrombus collection tank and a vacuum pump. The thrombus collection tank and the vacuum pump are connected through the main pipeline. The vacuum pump is also known as a negative pressure pump. Specifically, the first port 9 on the main pipeline 7 is connected to the thrombus collection tank in the thrombus collection device. The second port 10 on the main pipeline 7 is provided with a suction pipeline interface, which is configured to connect to a suction conduit.

[0076] Optionally, the aspiration on / off control mechanism 4 is configured to control the on / off state of the main pipeline 7 between the aspiration catheter and the thrombus collection device. Optionally, the aspiration on / off control mechanism 4 can be a solenoid valve, a servo push-pull rod, a shutter structure, etc. Among them, the servo push-pull rod achieves the on / off effect by squeezing the pipeline; referring to the schematic diagram of a shutter structure shown in Figure 4, the on / off effect can also be achieved by opening and closing the blades in the shutter structure.

[0077] Optionally, the first pressure sensor 1 is disposed between the suction on / off control mechanism 4 and the suction catheter, and is configured to measure the pressure value of the main pipeline 7 between the suction catheter and the thrombus collection device.

[0078] Optionally, a third pressure sensor 3 is disposed on the main pipeline 7 and configured to measure the pressure value of the main pipeline 7 between the thrombus collection tank and the vacuum pump.

[0079] Optionally, both the first pressure sensor 1 and the third pressure sensor 3 are negative pressure sensors.

[0080] In one example, Figures 2 and 3 also illustrate that the injection on / off control mechanism 5 is disposed on the branch pipe 8, so as to connect the injection mechanism 6 to the main pipe 7 between the suction conduit and the suction on / off control mechanism through the branch pipe 8. The injection on / off control mechanism 5 is configured to control the on / off state between the injection mechanism 6 and the main pipe 7. Optionally, the injection on / off control mechanism 5 can be a solenoid valve, a servo push-pull rod, a shutter structure, etc.

[0081] Optionally, the third port 11 of the branch pipe 8 is configured to connect to the injection liquid storage device, which stores the injection liquid, and the injection mechanism 6 is configured to transmit the injection liquid to the main pipe 7 via the branch pipe 8.

[0082] Optionally, the second pressure sensor 2 is disposed on the branch pipe 8 and configured to measure the pressure value on the branch pipe 8. In one example, the second pressure sensor 2 is a liquid pressure sensor.

[0083] In one example, Figure 3 also illustrates a processor electrically connected to a first pressure sensor 1, a second pressure sensor 2, and a third pressure sensor 3. The processor is configured to identify whether a thrombus has been aspirated by the aspiration catheter, and / or identify the diameter of the main pipeline, based on one or more pressure values ​​collected by each of the first pressure sensor 1, the second pressure sensor 2, and the third pressure sensor 3. The diameter value is negatively correlated with the on / off frequency of the aspiration on / off control mechanism. Specifically, the identification of whether a thrombus has been aspirated by the aspiration catheter and / or the diameter of the main pipeline can be based on the pressure difference between the first pressure sensor 1 and the third pressure sensor 3. Alternatively, the identification of whether a thrombus has been aspirated by the aspiration catheter and / or the diameter of the main pipeline can be based on the pressure value detected by any one of the first pressure sensor 1, the second pressure sensor 2, and the third pressure sensor 3.

[0084] In addition, the processor is electrically connected to the suction on / off control mechanism 4, the injection on / off control mechanism 5, the injection mechanism 6 and the vacuum pump to control the suction on / off control mechanism 4, the injection on / off control mechanism 5, the injection mechanism 6 and the vacuum pump.

[0085] Optionally, the processor can be an MCU (Microcontroller Unit) processor.

[0086] Based on the above structure, the embodiments of this disclosure provide the functions achievable by the circulating suction device. Specifically:

[0087] (1) Intelligent identification of pipeline diameter.

[0088] After the first port 9 on the main pipe 7 is connected to the thrombus collection tank, with the suction on / off control mechanism 4 fully open, the pressure difference between the first pressure sensor 1 and the third pressure sensor 3 is detected. This difference is equal to the pressure drop during the vacuum suction process. The pressure drop is related to the cross-sectional area and length of the main pipe 7. Given a specified length of the main pipe 7, the pressure drop caused by the change in the cross-sectional area of ​​the main pipe 7 decreases as the cross-sectional area of ​​the main pipe 7 increases, and the difference between the two pressure sensors also decreases.

[0089] By determining the pipe diameter, the no-load (reference value for air suction) value of the product can be effectively calibrated, and the switching frequency of the suction on / off control mechanism 4 during the thrombus suction process can be determined.

[0090] (2) Thrombus fragmentation mode. In the thrombus fragmentation mode, the perfusion on / off control mechanism 5 and the aspiration on / off control mechanism 4 are interlocked. The interlocking relationship is that the perfusion on / off control mechanism 5 controls the branch pipeline to be disconnected, and the aspiration on / off control mechanism 4 controls the main pipeline to be open; or, the perfusion on / off control mechanism 5 controls the branch pipeline to be open, and the aspiration on / off control mechanism 4 controls the main pipeline to be disconnected.

[0091] Referring to Figure 5, a partial structural diagram of a circulatory aspiration device in thrombus fragmentation mode is shown. In the aspiration state, the aspiration on / off control mechanism 4 is opened to start aspiration. When the pressure difference between the first pressure sensor 1 and the third pressure sensor 3 is detected to be a thrombus (including three types: acute, mixed, and subacute thrombus; basic data can be obtained in the laboratory), the perfusion mechanism 6 and the perfusion on / off control mechanism 5 are activated. At the same time, the aspiration on / off control mechanism 4 is closed, and liquid is perfused into the aspiration catheter. The volume of the perfusion liquid is determined by the opening time of the perfusion mechanism 6 and the aspiration on / off control mechanism 4. The volume is much smaller than the volume of the lumen inside the catheter. The perfusion liquid does not enter the human body but only stays in the catheter, pushing the thrombus forward so that the thrombus leaves the aspiration catheter opening by 1-3 mm.

[0092] Next, the perfusion mechanism 6 and the perfusion on / off control mechanism 5 are closed, while the suction on / off control mechanism 4 is opened. A small amount of perfusion fluid, blood, and thrombus near the suction catheter opening are drawn into the suction catheter. Since the thrombus is 1-3 mm away from the catheter opening, it can be broken up by the inertia of the negative pressure suction when it comes into contact with the catheter opening.

[0093] In this embodiment, the perfusion mechanism 6 and the perfusion on / off control mechanism 5 serve to: use the small amount of perfused liquid to push the thrombus away from the aspiration catheter opening, providing the initial distance for momentum conversion.

[0094] It should be noted that the infused fluid does not enter the human body during the aspiration process.

[0095] (3) Thrombus movement control mode. In the thrombus movement control mode, the perfusion on / off control mechanism and the aspiration on / off control mechanism are linked. The linkage means that the perfusion on / off control mechanism controls the branch tubing to be open, and the aspiration on / off control mechanism controls the main tubing to be open. The time for the perfusion on / off control mechanism to control the branch tubing to be open is less than the time for the aspiration on / off control mechanism to control the main tubing to be open.

[0096] In practical applications, the thrombus moves along the negative pressure direction in the main pipeline towards the thrombus collection tank. As the number of blood rings increases, the negative pressure attraction on the thrombus is greater near the vacuum pump and less far away from the vacuum pump.

[0097] Based on this, referring to the partial structural diagram of a circulatory aspiration device in a thrombus movement control mode shown in Figure 6, when the perfusion mechanism 6 and the perfusion on / off control mechanism 5 are opened, as shown in Figure 6, a portion of the liquid will be diverted towards the thrombus in the body to push away the thrombus, and a portion will approach the aspiration on / off control mechanism 4, configured to squeeze the thrombus through the aspiration on / off control mechanism 4.

[0098] Optionally, see Figure 7, which shows a partial structural diagram of the circulatory aspiration device under another thrombus movement control mode. Figure 7 indicates the direction of movement of the perfusion fluid and also marks the area where the perfusion fluid and thrombus mix. It can be seen that the perfusion fluid can move the thrombus in two directions, with part of it being pushed back into the aspiration catheter and part of it being squeezed into the thrombus collection tank.

[0099] Optionally, the infusion fluid can be physiological saline, etc. The flow inertia of the fluid is greater than that of the thrombus, which can better accelerate the flow of the thrombus to the thrombus collection vessel.

[0100] Because thrombi are viscous, if they remain stationary within the catheter, they can cause blockage of the aspiration catheter, directly prolonging or terminating the procedure, or requiring replacement of instruments and increasing treatment costs. Therefore, by controlling the opening time of the perfusion mechanism 6 and the perfusion on / off control mechanism 5, and ensuring that the opening time of the aspiration on / off control mechanism 4 is longer than that of the perfusion mechanism 6 and the perfusion on / off control mechanism 5, the thrombus can be controlled to maintain a constant unidirectional reciprocating motion within the catheter. This reduces friction, maintaining sliding friction between the thrombus and the aspiration tubing, reducing the need for negative pressure suction, or increasing the aspiration efficiency at the same negative pressure.

[0101] (4) The perfusion mechanism operates continuously, the perfusion on / off control mechanism controls the branch pipeline to remain continuously open, and the suction on / off control mechanism controls the main pipeline to remain indirectly open; the amount of perfusion fluid provided by the perfusion mechanism during the period when the branch pipeline is open under the control of the perfusion on / off control mechanism is less than the amount of suction by the thrombus collection device during the period when the main pipeline is open under the control of the suction on / off control mechanism. In one example, by controlling the branch pipeline to remain continuously open under the control of the perfusion on / off control mechanism, the perfusion mechanism can continuously provide perfusion fluid to the branch pipeline. By controlling the operating efficiency of the perfusion mechanism, the amount of perfusion fluid continuously provided to the branch pipeline by the perfusion mechanism can be changed, so that the amount of perfusion fluid is less than the amount of suction by the thrombus collection device during the period when the main pipeline is open under the control of the suction on / off control mechanism. This can also reduce friction and keep the thrombus and suction pipeline in a sliding friction state, reducing the need for negative pressure suction, or increasing the suction efficiency of negative pressure suction at the same pressure.

[0102] (5) The perfusion mechanism operates continuously, and the perfusion mechanism and the perfusion on / off control mechanism are under pressure. The perfusion volume of the perfusion mechanism is related to the time the perfusion on / off control mechanism controls the opening of the branch tubing. The perfusion fluid volume of the perfusion mechanism is less than the single aspiration volume of the thrombus collection device. In one example, by changing the time the perfusion on / off control mechanism controls the opening of the branch tubing, the perfusion fluid volume provided by the perfusion mechanism to the branch tubing can be adjusted so that the perfusion fluid volume of the perfusion mechanism is less than the single aspiration volume of the thrombus collection device. This can also reduce friction and maintain sliding friction between the thrombus and the aspiration tubing, reducing the need for negative pressure suction, or increasing the aspiration efficiency of negative pressure suction at the same pressure.

[0103] (6) Increase the flow rate of thrombi in the tubing.

[0104] Due to the increased perfusion fluid within the main infusion line 7, the relative flow velocity of the mixture of thrombus and perfusion fluid is significantly increased, changing from a viscous state to a mixed state, which can substantially reduce the operation time.

[0105] (7) Unblock the suction tube.

[0106] Referring to Figure 8, a partial structural diagram of a circulating aspiration device in a catheter unblocking mode is shown. After the aspiration catheter is blocked by a thrombus, the aspiration on / off control mechanism 4 is closed, and the perfusion mechanism 6 and perfusion on / off control mechanism 5 are activated. The perfusion fluid can flush the thrombus blocking the blood vessel back into the body, achieving catheter unblocking. When the first pressure sensor 1 detects a low positive pressure value, it is determined that the aspiration catheter has been unblocked. Referring to Figure 9, a partial structural diagram of a circulating aspiration device in another catheter unblocking mode is shown. Figure 9 illustrates the unblocked state where the tubing is filled with perfusion fluid, and the thrombus is removed from the catheter.

[0107] (8) Perfusion mode. The increased perfusion function allows perfusion fluid to be directly infused into the body, reducing blood loss.

[0108] In one embodiment, this disclosure also provides a schematic diagram of another cyclic aspiration device as shown in FIG10. The aforementioned on / off control mechanism is an integrated on / off control structure 12. The integrated on / off control structure 12 adopts a two-position three-way valve. The two-position three-way valve is configured to control the on / off state of the pipeline between the aspiration catheter and the thrombus collection device, and is configured to control the on / off state of the pipeline between the perfusion mechanism 6 and the aspiration catheter. The working principle of the cyclic aspiration device shown in FIG10 can be referred to the aforementioned embodiments, and will not be described again in this disclosure.

[0109] In addition, the circulating suction device also includes a housing.

[0110] In one example, the housing is configured to provide protection for the perfusion mechanism, the first pressure sensor, and the on / off control mechanism. This also means the circulatory aspiration device is configured as a separate unit connected to an external aspiration catheter and an external thrombus collection device. In one embodiment, the circulatory aspiration device includes at least the perfusion mechanism, the first pressure sensor, and the on / off control mechanism. Optionally, the circulatory aspiration device includes the components shown in Figure 2 or Figure 10.

[0111] In another example, the housing is configured to provide protection for the perfusion mechanism 6, the first pressure sensor 1, the on / off control mechanism, and the thrombus collection device, that is, the circulatory aspiration device and the thrombus collection device are integrated into one unit.

[0112] In summary, the circulating aspiration device provided in this embodiment has at least the following features: ① intelligent identification of catheter diameter, which can automatically call the optimal parameters according to the catheter; ② thrombus fragmentation mode, which increases the fragmentation mode of thrombus by utilizing the kinetic inertia of thrombus and the negative water hammer effect; ③ thrombus movement control in the catheter: adjusting the opening of the perfusion mechanism 6 and the perfusion valve to control the mixing ratio of blood and thrombus in the aspiration catheter; ④ increasing the flow velocity of thrombus in the pipeline; ⑤ unblocking the aspiration catheter after it is blocked by thrombus.

[0113] The above description is merely a specific embodiment of this disclosure, but the scope of protection of this disclosure is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the scope of the technology disclosed in this disclosure should be included within the scope of protection of this disclosure. Therefore, the scope of protection of this disclosure should be determined by the scope of the claims. Industrial applicability

[0114] In summary, this disclosure provides a circulating aspiration device and system, comprising: an infusion mechanism, a first pressure sensor, and an on / off control mechanism. The on / off control mechanism is connected to the infusion mechanism, the aspiration catheter, and a thrombus collection device via pipelines. The first pressure sensor is disposed between the on / off control mechanism and the aspiration catheter. The on / off control mechanism is configured to control the on / off state of the pipeline. The infusion mechanism is configured to provide infusion fluid to the pipeline between the aspiration catheter and the on / off control mechanism. The first pressure sensor is configured to measure the pressure value of the pipeline between the aspiration catheter and the on / off control mechanism. This device can use the pressure value to identify the pipeline diameter and whether the aspiration catheter has aspirated a thrombus. In the case of a thrombus aspirated, the infusion mechanism can provide infusion fluid to the pipeline. Combined with the on / off control mechanism changing the on / off state of the pipeline, the infusion fluid can cause the thrombus within the pipeline to move, thereby achieving thrombus fragmentation and thrombus movement control functions. Furthermore, when the aspiration catheter becomes blocked due to a thrombus aspirated, the infusion fluid can be used to clear the blockage.

Claims

1. A cyclical suction device, characterized in that, include: Injection mechanism, first pressure sensor and on / off control mechanism; The on / off control mechanism is connected to the perfusion mechanism, the aspiration catheter, and the thrombus collection device via pipelines, and the first pressure sensor is disposed between the on / off control mechanism and the aspiration catheter. The on / off control mechanism is configured to control the on / off state of the pipeline; the infusion mechanism is configured to provide infusion liquid to the pipeline between the suction conduit and the on / off control mechanism; and the first pressure sensor is configured to measure the pressure value of the pipeline between the suction conduit and the on / off control mechanism.

2. The circulating suction device according to claim 1, characterized in that, The pipeline includes a main pipeline and branch pipelines, and the on / off control mechanism includes a suction on / off control mechanism and an injection on / off control mechanism. The suction on / off control mechanism is disposed on the main pipeline, and the suction on / off control mechanism is configured to control the on / off state of the main pipeline between the suction catheter and the thrombus collection device; the first pressure sensor is disposed between the suction on / off control mechanism and the suction catheter; The infusion on / off control mechanism is disposed on the branch pipeline to connect the infusion mechanism to the main pipeline between the suction conduit and the suction on / off control mechanism via the branch pipeline. The infusion on / off control mechanism is configured to control the on / off state between the infusion mechanism and the main pipeline.

3. The circulating suction device according to claim 2, characterized in that, The suction on / off control mechanism and / or the injection on / off control mechanism adopt a solenoid valve, servo push-pull rod or shutter structure.

4. The circulating suction device according to claim 2 or 3, characterized in that, The working modes of the cyclic aspiration device include a thrombus fragmentation mode, and the perfusion on / off control mechanism and the aspiration on / off control mechanism are interlocked in the thrombus fragmentation mode. The injection on / off control mechanism controls the branch pipeline to disconnect, and the suction on / off control mechanism controls the main pipeline to open; or, the injection on / off control mechanism controls the branch pipeline to open, and the suction on / off control mechanism controls the main pipeline to disconnect.

5. The circulating suction device according to any one of claims 2-4, characterized in that, The working modes of the circulatory aspiration device include a thrombus movement control mode, in which the perfusion on / off control mechanism and the aspiration on / off control mechanism are linked. The injection on / off control mechanism controls the branch pipeline to be open, and the suction on / off control mechanism controls the main pipeline to be open. The time for the injection on / off control mechanism to control the branch pipeline to be open is less than the time for the suction on / off control mechanism to control the main pipeline to be open.

6. The circulating suction device according to any one of claims 2-5, characterized in that, The injection mechanism operates continuously, the injection on / off control mechanism controls the branch pipeline to be continuously open, and the suction on / off control mechanism controls the main pipeline to be indirectly open. The amount of perfusion fluid provided by the perfusion mechanism during the period when the perfusion on / off control mechanism controls the opening of the branch pipeline is less than the amount of fluid aspirated by the thrombus collection device during the period when the aspiration on / off control mechanism controls the opening of the main pipeline.

7. The circulating suction device according to any one of claims 2-6, characterized in that, The injection mechanism operates continuously, and the injection mechanism and the injection on / off control mechanism are in a pressurized state; The perfusion volume of the perfusion mechanism is related to the time when the perfusion on / off control mechanism controls the conduction of the branch pipeline, and the perfusion fluid volume of the perfusion mechanism is less than the single aspiration volume of the thrombus collection device.

8. The circulating suction device according to any one of claims 2-7, characterized in that, The circulating suction device also includes a second pressure sensor, which is disposed on the side pipe and configured to measure the pressure value on the side pipe.

9. The circulating suction device according to any one of claims 2-8, characterized in that, The thrombus collection device includes a thrombus collection tank and a vacuum pump, and the thrombus collection tank and the vacuum pump are connected through the main pipeline; The circulating suction device also includes a third pressure sensor, which is disposed on the main pipeline and configured to measure the pressure value of the main pipeline between the thrombus collection tank and the vacuum pump.

10. The circulating suction device according to claim 7 or 8, characterized in that, The circulating suction device also includes a processor, which is electrically connected to a first pressure sensor, a second pressure sensor, and a third pressure sensor. The processor is configured to identify whether the aspiration catheter has aspirated a thrombus based on one or more of the pressure values ​​collected by the first pressure sensor, the second pressure sensor, and the third pressure sensor, and / or to identify the diameter value of the main pipeline, wherein the diameter value is negatively correlated with the on / off frequency corresponding to the aspiration on / off control mechanism.

11. The circulating suction device according to claim 10, characterized in that, The processor is configured to: identify whether the aspiration catheter has aspirated a thrombus based on the pressure difference between the first pressure sensor and the third pressure sensor, and / or identify the diameter of the main tubing.

12. The circulating suction device according to claim 10, characterized in that, The processor is configured to: identify whether the aspiration catheter has aspirated a thrombus based on the pressure value detected by any one of the first pressure sensor, the second pressure sensor, and the third pressure sensor, and / or identify the diameter value of the main pipeline.

13. The circulating suction device according to claim 1, characterized in that, The on / off control mechanism is an integrated on / off control structure. The integrated on / off control structure adopts a two-position three-way valve. The two-position three-way valve is configured to control the on / off state of the pipeline between the aspiration catheter and the thrombus collection device, and is also configured to control the on / off state of the pipeline between the perfusion mechanism and the aspiration catheter.

14. The circulating suction device according to any one of claims 1-13, characterized in that, The cyclic aspiration device further includes a housing, which is configured to provide protection for the perfusion mechanism, the first pressure sensor, and the on / off control mechanism; or, it is configured to provide protection for the perfusion mechanism, the first pressure sensor, the on / off control mechanism, and the thrombus collection device.

15. A circulating suction system, characterized in that, The circulating suction device includes any one of claims 1-14.

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