Overall femoral artery cannula plugging device after ECMO machine removal

Abstract

The invention provides an integral femoral artery cannula plugging device after ECMO machine removal, which comprises a main tube, a connecting mechanism, a drainage tube, a drainage tube, a drainage tube and a drainage tube, and is characterized in that the main tube is movably mounted in a femoral artery cannula through the connecting mechanism; the connecting mechanism comprises a bag body and a connecting hose, and the bag body is installed outside the main pipe; one end of the connecting hose is connected with the bag body, a valve is arranged at the other end of the connecting hose, expansion or contraction of the bag body is controlled by injecting or releasing a medium into the bag body, and plugging or opening of the femoral artery cannula is achieved. Blocking and opening of the cannula are achieved through expansion / contraction of the bag body, complexity of cannula treatment after traditional machine removal is avoided, the cannula can be directly used when the cannula is used on a machine again, and key treatment time is saved; the double-cavity structure can achieve tube washing and tube sealing respectively, and the risk of thrombus formation is effectively reduced; the probability that external pollutants enter can be reduced through bag body plugging and cock auxiliary sealing, and the infection risk is reduced.

Description

Technical Field

[0001] This invention relates to the field of femoral artery cannulation technology, specifically to a complete femoral artery cannulation occlusion device after ECMO weaning. Background Technology

[0002] Extracorporeal membrane oxygenation (ECMO), as a vital life support technology, plays a crucial role in the treatment of severe cardiopulmonary failure and other diseases. However, during ECMO treatment, patients' conditions are complex and changeable, and they may need to be readmitted shortly after weaning due to relapses. Currently, traditional weaning procedures have many shortcomings and cannot meet the need for rapid readmission. For example, the methods used to handle the tubing after weaning cannot guarantee its patency and cleanliness in a short period, requiring significant time for reprocessing and preparation before readmission, which may delay the patient's optimal treatment time and even endanger their life. Furthermore, traditional methods carry a high risk of complications such as thrombosis and infection, which are extremely detrimental to patient recovery. Therefore, developing an occluder that addresses these issues, integrates flushing and sealing functions, and provides support for readmission has significant clinical importance and practical application value. Summary of the Invention

[0003] To address the aforementioned technical problems, this invention provides an integrated femoral artery cannula occlusion device for ECMO weaning. This device solves the problems of low efficiency and high risk associated with traditional cannulation methods when patients require reintegration after ECMO weaning due to recurring conditions. It achieves integrated management of femoral artery cannula flushing and sealing, providing support for rapid reintegration.

[0004] The technical solution adopted in this invention is as follows:

[0005] An integrated femoral artery cannula occlusion device for ECMO weaning includes: a main tube, which is movably installed inside the femoral artery cannula via a connecting mechanism, and the main tube has an infusion port; the connecting mechanism includes: a balloon body, which is installed outside the main tube; a connecting hose, one end of which is connected to the balloon body, and the other end of which is provided with a valve, which controls the expansion or contraction of the balloon body by injecting or releasing a medium into the balloon body to achieve occlusion or opening of the femoral artery cannula; a thrombosis monitoring module, integrated on the main tube, for obtaining thrombosis monitoring data inside the femoral artery cannula through impedance monitoring, the thrombosis monitoring data including impedance change data; a pressure monitoring module, integrated on the surface of the balloon body, for obtaining blood flow pressure data; a processor, communicatively connected to the thrombosis monitoring sensor and the pressure monitoring module, for processing the thrombosis monitoring data and blood flow pressure data to generate control signals; and a controller, connected to the processor and the valve, for operating the valve according to the control signals to adjust the medium inside the balloon body to achieve adaptive occlusion.

[0006] Furthermore, the main tube includes a conical part and a straight part, which are integrally formed. One end of the conical part of the main tube is inserted into the femoral artery cannula. Infusion ports are symmetrically arranged on the conical part. The thrombosis monitoring module is located at the conical part and is used to obtain thrombosis monitoring data near the end of the femoral artery cannula.

[0007] Furthermore, it also includes an inner tube, which is installed inside the main tube. One end of the inner tube is fixedly connected to the end of the conical part. An infusion chamber one is formed between the outer wall of the inner tube and the inner wall of the main tube, and the inside of the inner tube is an infusion chamber two.

[0008] Furthermore, the ends of the main tube and the inner tube are respectively provided with connectors that communicate with infusion chamber one and infusion chamber two. The connectors are used to connect to the pressurized infusion device, and the processor controls the pressurized infusion device according to the thrombosis monitoring data.

[0009] Furthermore, there is a gap between the outer wall of the main tube and the inner wall of the femoral artery cannula, and a detachable stopcock is provided between the main tube and the femoral artery cannula.

[0010] Furthermore, the stopcock includes a stopcock body and a connecting ring, the connecting ring being fixedly connected to the stopcock body, the stopcock body having a through hole adapted to the outer diameter of the main tube, the main tube passing through the through hole; the connecting ring connecting the main tube and the femoral artery cannula.

[0011] Furthermore, the surfaces of the tube and capsule are coated with a nanoscale antibacterial coating.

[0012] Furthermore, the processor's processing steps include:

[0013] Acquire thrombosis monitoring data and blood flow pressure data;

[0014] The thrombosis risk index is calculated based on thrombosis monitoring data, and the ideal cyst pressure value is calculated based on blood flow pressure data.

[0015] Compare the current cyst pressure with the ideal cyst pressure value to determine whether the deviation exceeds the preset pressure threshold;

[0016] Based on the judgment result, a control signal is generated, and the controller increases or decreases the amount of medium injected according to the control signal.

[0017] The beneficial effects of this invention are:

[0018] This invention relates to a comprehensive femoral artery cannulation occluder for ECMO weaning. The occlusion and opening of the cannula are achieved through the expansion and contraction of the bladder, avoiding the complexity of traditional post-weaning cannulation procedures. It can be used directly upon reinsertion, saving critical treatment time. Furthermore, the dual-lumen structure allows for separate flushing and sealing of the cannula, effectively reducing the risk of thrombosis. Bladder occlusion and stopcock-assisted sealing reduce the probability of external contaminants entering, minimizing infection risk. In addition, an integrated thrombosis and pressure monitoring module, along with a processor and controller, enables adaptive occlusion, eliminating the need for frequent manual intervention and comprehensively improving the safety, convenience, and efficiency of ECMO weaning cannulation management. Attached Figure Description

[0019] Figure 1 This is a schematic diagram of the connection between the integral femoral artery cannula occluder and the femoral artery cannula after ECMO weaning according to an embodiment of the present invention;

[0020] Figure 2 This is a schematic diagram of the overall femoral artery cannulation occluder structure after ECMO weaning according to an embodiment of the present invention;

[0021] Figure 3 for Figure 1 Enlarged structural diagram at point A in the middle;

[0022] Figure 4 This is a schematic diagram of the planar structure of the valve according to an embodiment of the present invention.

[0023] Explanation of reference numerals in the attached figures:

[0024] 10-Main pipe; 11-Conical section; 12-Straight section; 13-Infusion port;

[0025] 20 - Capsule body; 30 - Connecting hose; 40 - Valve;

[0026] 50 - Inner tube, 51 - Infusion chamber one, 52 - Infusion chamber two;

[0027] 60-Plug, 61-Plug body, 62-Connecting ring, 63-Through hole. Detailed Implementation

[0028] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0029] like Figures 1-4As shown in the figure, an integrated femoral artery cannula occlusion device for ECMO weaning according to an embodiment of the present invention includes a main tube 10; the main tube 10 is movably installed inside the femoral artery cannula through a connecting mechanism, and the main tube 10 is provided with an infusion port 13; the connecting mechanism includes a balloon 20 and a connecting hose 30, wherein the balloon 20 is installed outside the main tube 10; one end of the connecting hose 30 is connected to the balloon 20, and the other end of the connecting hose 30 is provided with a valve 40, which controls the expansion or contraction of the balloon 20 by injecting or releasing a medium into the balloon 20, thereby achieving the occlusion or opening of the femoral artery cannula.

[0030] In this invention, the main tube is the main supporting frame of the occluder. It is a slender tubular structure made of medical-grade polymer materials, such as polytetrafluoroethylene and medical polyurethane, which meet the requirements of biocompatibility (non-sensitizing and non-cytotoxic), mechanical stability (not easily deformed after insertion into the femoral artery cannula), and corrosion resistance (resistant to immersion in blood, anticoagulants, and flushing solutions). The tube diameter is matched with commonly used femoral artery cannulas in clinical practice, such as the 12-16Fr specification. It should be noted that the outer diameter of the main tube is smaller than the inner diameter of the cannula to reserve space for the expansion of the cyst.

[0031] The main tube and the femoral artery cannula are connected via a mechanism to achieve a detachable and adjustable installation. When occlusion is required after weaning, the main tube is inserted into the cannula, and the balloon expands to fix its position and seal the gap. When re-insertion is required, the balloon contracts, and the main tube can be directly removed or left in the cannula as a guiding channel without damaging the original structure of the cannula. This solves the complexity of traditional cannula removal or repeated insertion and removal after weaning.

[0032] The connecting mechanism is the core actuator for achieving cannula closure / opening. It replaces traditional mechanical seals (such as heparin caps and threaded plugs) by physically deforming the capsule through the medium, achieving non-destructive closure and rapid switching.

[0033] The bladder is a ring / cylindrical elastic bladder made of medical-grade silicone or natural rubber with a Shore hardness of 30-50 HA, balancing elasticity and tear resistance. It is fixedly fitted onto the outer wall of the main tube (near the rear end of the infusion port to avoid obstructing the infusion port). When the bladder is not inflated, its outer diameter is smaller than the inner diameter of the femoral artery cannula, ensuring that the main tube can be inserted smoothly. After inflating, its outer diameter matches the inner diameter of the cannula, filling the gap to achieve a seal.

[0034] Specifically, the capsule is a hollow, sealed structure that can hold liquid media, such as physiological saline. It has good biocompatibility, is easy to sterilize, and is low in cost. When the media is injected into the capsule, it expands radially, adhering tightly to the inner wall of the femoral artery cannula and the outer wall of the main tube, forming a ring-shaped seal that blocks the exchange of substances between the inside and outside of the cannula, preventing external contaminants from entering the blood vessel and preventing blood leakage. When the media is released, the capsule contracts and resets, releasing the seal and restoring patency of the cannula. Compared to traditional mechanical seals, such as stopcocks and threaded caps, the capsule seal has self-adaptive fitting characteristics, adapting to slight deviations in the inner diameter of different cannulas. For example, clinical cannulas may have an inner diameter fluctuation of ±0.5mm due to manufacturing errors, without causing mechanical wear on the inner wall of the cannula, reducing the risk of vascular injury.

[0035] The connecting tubing is a slender medical tube made of the same material as the capsule or medical-grade PVC, with an inner diameter of 1-2 mm and a length of 30-50 cm. One end is sealed and connected to the hollow chamber of the capsule, while the other end extends outside the body for easy access by medical personnel. The connecting tubing serves as a channel for media delivery, connecting the external valve to the internal capsule, preventing cannula displacement caused by direct manipulation of the capsule. The connecting tubing must possess a certain degree of flexibility, allowing for slight movement with the patient's position, such as when the patient turns over, to avoid vascular irritation caused by traction on the main tube.

[0036] The valve can be a medical check valve (solenoid valve) or a gate valve (such as a Luer connector gate valve that meets medical standards), with anti-backflow function to prevent the medium in the capsule from flowing back and contaminating it, and the injection / release speed of the medium can be adjusted manually or automatically.

[0037] When occluding, open the valve and inject physiological saline into the cyst using a syringe or pressurizing device. After filling, close the valve to maintain the pressure in the cyst. When opening, open the valve, and the medium in the cyst will flow out naturally under the action of the pressure difference between the blood vessel and the external atmospheric pressure, or be released with the assistance of a negative pressure device. After the cyst contracts, close the valve.

[0038] The present invention also includes a thrombosis monitoring module, a pressure monitoring module, a processor, and a controller. The thrombosis monitoring module is integrated on the main tube and is used to obtain thrombosis monitoring data within the femoral artery cannula through impedance monitoring. The thrombosis monitoring data includes impedance change data. The pressure monitoring module is integrated and installed on the surface of the balloon body and is used to obtain blood flow pressure data. The processor is communicatively connected to the thrombosis monitoring sensor and the pressure sensor and is used to process the thrombosis monitoring data and blood flow pressure data to generate control signals.

[0039] The controller connects to the processor and valve, and is used to operate the valve according to the control signal to regulate the medium in the bladder and achieve adaptive sealing.

[0040] It should be understood that thrombosis is a core risk in ECMO weaning and cannulation management. The thrombosis monitoring module identifies thrombosis formation trends in real time through impedance changes, providing data support for proactive prevention. Specifically, the thrombosis monitoring module can use a flexible MEMS impedance electrode sensor. A small-amplitude AC excitation current of 10-100kHz is applied to the blood / thrombosis area in the femoral artery cannula (avoiding stimulation of vascular endothelial cells) through the electrode pair, and the impedance signal between the electrodes is collected in real time. When a thrombus (impedance 500-1000Ω) forms, the mesoporous gold electrode can quickly capture the step increase and rate of change of the impedance value.

[0041] The pressure monitoring module can employ a miniature flexible pressure sensor, such as a piezoresistive pressure sensor, with an accuracy of ±1 mmHg and a size ≤2 mm × 2 mm. The sensor is integrated into the outer surface of the bladder, i.e., the side in contact with blood, ensuring direct sensing of blood flow pressure. The blood flow pressure data mainly includes femoral artery systolic pressure, diastolic pressure, and mean arterial pressure. Pressure monitoring helps prevent the bladder pressure from becoming too high or too low. If the bladder pressure exceeds the systolic blood flow pressure, it will compress the blood vessel wall, causing blood flow obstruction and leading to lower limb ischemia. By monitoring blood flow pressure, a safe upper limit for the bladder pressure can be set. If the bladder pressure is lower than the diastolic blood flow pressure, leakage may occur in the sealing gap, potentially allowing external contaminants to enter the blood vessel and cause infection. By monitoring blood flow pressure, the bladder pressure can be dynamically adjusted to ensure a tight seal.

[0042] The processor model can be MSP430FR5994. The processor communicates with the thrombosis monitoring module and the pressure monitoring module to receive thrombosis monitoring data and blood flow pressure data in real time. The controller is connected to the processor via wires (to receive control signals) and is also connected to the valve (automatic mode: solenoid valve) to control the valve opening and closing and adjust the speed.

[0043] For example, taking the case of increased blood flow pressure in a patient as an example, the adaptive occlusion logic is as follows:

[0044] The pressure monitoring module detected that the femoral artery systolic blood pressure rose from 120 mmHg to 140 mmHg and sent the data to the processor.

[0045] The processor calculates the ideal cyst pressure value: The ideal cyst pressure value is 0.7 × 120 = 84 mmHg. The current ideal cyst pressure value is 0.7 × 140 = 98 mmHg. The current cyst pressure is 84 mmHg, which is a deviation of 14 mmHg (exceeding the threshold of 5 mmHg).

[0046] The processor generates a control signal to inject 3 mL of physiological saline and sends it to the controller.

[0047] After receiving the signal, the controller drives the valve to open and injects 3mL of physiological saline into the capsule through the connecting tubing. The capsule expands and the pressure rises to 98mmHg.

[0048] The built-in pressure sensor in the bladder provides real-time feedback on the current pressure. Once the processor confirms that the deviation is less than the threshold, it generates a signal to close the valve. The controller then closes the valve, completing the adaptive adjustment to ensure the occlusion effect while avoiding vascular compression.

[0049] like Figure 2 As shown, in one embodiment of the present invention, the main tube 10 includes a conical portion 11 and a straight portion 12, wherein the conical portion 11 and the straight portion 12 are integrally formed, one end of the conical portion 11 of the main tube 10 is inserted into the femoral artery tube, the infusion port 13 is symmetrically arranged on the conical portion 11, and the thrombosis monitoring module is located at the conical portion for obtaining thrombosis monitoring data near the femoral artery cannulation end.

[0050] In this invention, the main tube 10 is integrally formed from a conical part and a straight cylindrical part. The main tube 10 serves as the main support structure of the occluder, acting as both a channel for fluid delivery and a mounting carrier for the bladder and inner tube. The diameter of the conical part gradually decreases along the insertion direction, for example, a proximal diameter of 3-5 mm, a distal diameter of 2-3 mm, and a length of 5-8 cm, ending in a smooth arc. The straight cylindrical part has a uniform diameter, consistent with the proximal diameter of the conical part, and a length of 10-15 cm. Its outer wall can be graduated for easy observation of the insertion depth. One end of the main tube is inserted into the femoral artery cannula, enhancing the fit with the inner wall of the cannula. The straight cylindrical part is located outside the conical part, protruding from the patient's body for ease of operation. Infusion ports 13 are located on the side wall of the main tube near the inserted femoral artery cannula end, communicating with the interior of the main tube 10. The number of infusion ports 13 can be set according to requirements, such as 2-4, with a diameter of 0.5-1 mm. Infusion port 1 serves as a channel for flushing, sealing, and administering medication. After weaning, normal saline (to flush out residual blood in the catheter and prevent thrombus adhesion), anticoagulants (such as heparin solution to inhibit thrombus formation), or emergency medications can be injected through the infusion port. This achieves both occlusion and treatment, overcoming the shortcomings of traditional occluders that can only block but cannot actively prevent thrombosis.

[0051] The core area of ​​thrombosis is near the end of the cannula when blood flow is slow and blood is prone to stagnation. By placing the module in the conical part, impedance data at the blood vessel inlet can be directly collected, allowing for early identification of thrombosis trends. If the impedance value rises slightly, it provides more accurate raw data for the processor to calculate the thrombosis risk index, avoiding delays in anticoagulation intervention.

[0052] like Figure 2 and Figure 3 As shown, in one embodiment of the present invention, the present invention further includes an inner tube 50, which is disposed inside the main tube 10. One end of the inner tube 50 is fixedly connected to the end of the tapered portion 11. An infusion chamber 1 51 is formed between the outer wall of the inner tube 50 and the inner wall of the main tube 10, and the interior of the inner tube 50 is an infusion chamber 2 52.

[0053] The inner tube is a slender tubular shape, made of the same material as the main tube, with a diameter of 1 / 2 to 2 / 3 of the inner diameter of the main tube, and a length matching the total length of the tapered and straight sections of the main tube. The inner tube 50 is coaxially mounted inside the main tube 10, with one end fixedly connected to the end of the tapered section (insertion end), forming a dual-cavity structure with the main tube 10. This allows for the independent delivery of two different liquids. Specifically, infusion chamber one is formed by an annular gap between the outer wall of the inner tube and the inner wall of the main tube, extending to the infusion port of the tapered section of the main tube (communicating with the infusion port); infusion chamber two is formed by the internal cavity of the inner tube, with a circular cross-section, extending to the fixed point where the inner tube is connected to the end of the tapered section. The inner tube is fixedly connected to the main tube without gaps, ensuring complete isolation between infusion chamber one and infusion chamber two. The two liquids do not mix or interfere with each other during delivery; for example, infusion chamber one delivers anticoagulants such as heparin, while infusion chamber two delivers saline flushing solution.

[0054] like Figure 3 As shown, in one embodiment of the present invention, the ends of the main tube 10 and the inner tube 50 are respectively provided with connectors that communicate with infusion chamber one 51 and infusion chamber two 52. The connectors are used to connect to the pressurized infusion device, and the processor controls the pressurized infusion device according to the thrombosis monitoring data.

[0055] The connectors are located on the exposed ends of the main tube and the inner tube, respectively. The connectors are standard interfaces, such as Luer connectors. The connectors connect to external pressurized infusion devices, such as medical infusion pumps (with pressure regulation function, pressure range 0.1-0.5MPa). By pressurizing, the fluid, such as flushing fluid or anticoagulant, is effectively delivered to the femoral artery cannula, ensuring effective flushing and sealing. For longer cannulas, pressurization can prevent fluid retention.

[0056] like Figure 3 and Figure 4 As shown, in one embodiment of the present invention, there is a gap between the outer wall of the main tube 10 and the inner wall of the femoral artery cannula, and a stopcock 60 is detachably provided between the main tube 10 and the femoral artery cannula. Specifically, the stopcock 60 includes a plug body 61 and a connecting ring 62. The connecting ring 62 is fixedly connected to the plug body 61, and the plug body 61 is provided with a through hole adapted to the outer diameter of the main tube 10, through which the main tube 10 passes; the connecting ring 62 connects the main tube 10 and the femoral artery cannula.

[0057] The plug 61 and the connecting ring 62 are integrally molded and can be made of rigid medical plastic. The connecting ring 62 is press-fitted with the outer wall of the main tube 10 and the femoral artery cannula to maintain a certain connection stability. The stopcock 60 restricts the shaking of the main tube 10, ensuring the relative position of the main tube 10 and the femoral artery cannula is stable and helping to reduce the risk of fluid leakage.

[0058] In one embodiment of the present invention, the surfaces of the tube and the capsule are coated with a nanoscale antibacterial coating. Here, nanoscale refers to a coating thickness of 10-100 nm (1 nm = 10⁻⁻⁴ nm). 9 The diameter of the tube is much smaller than that of the tube and the capsule (e.g., the diameter of the tube is 3-5 mm), so it will not affect the insertion of the tube or the elasticity of the capsule. Specifically, a nano-silver coating can be used. The nano-silver particles (5-20 nm in diameter) can release silver ions (Ag⁺). Ag⁺ can penetrate the bacterial cell membrane and bind to the proteins (such as enzyme proteins) and DNA in the bacteria, destroying the respiratory chain and genetic material of the bacteria, leading to bacterial death. At the same time, Ag⁺ can inhibit the formation of bacterial biofilm and prevent bacterial adhesion and aggregation.

[0059] In one embodiment of the present invention, the processor's processing steps include:

[0060] Acquire thrombosis monitoring data and blood flow pressure data. Thrombosis monitoring data includes instantaneous impedance values, impedance change rate, and impedance deviation, which reflect the dynamic trend of thrombus formation within the catheter. Blood flow pressure data includes femoral artery systolic pressure, femoral artery diastolic pressure, and mean arterial pressure, which reflect the pressure status within the patient's blood vessels.

[0061] The thrombosis risk index is calculated based on thrombosis monitoring data, and the ideal cyst pressure value is calculated based on blood flow pressure data.

[0062] Among them, the thrombosis risk index The core calculation formula is the logistic regression model, as follows:

[0063]

[0064] The model intercept; This is the coefficient of impedance change rate; This refers to the blood flow pressure coefficient; The blood flow pressure coefficient is denoted as , where , , and All parameters are obtained from machine learning (such as logistic regression) training; The femoral artery blood flow pressure at time t; Let t be the rate of change of impedance. Let t be the impedance deviation at time t.

[0065] Ideal capsule pressure value The calculation formula is:

[0066]

[0067] In the formula, Pressure safety factor; This refers to the systolic blood pressure of the femoral artery. This is the deformation correction factor; The elastic modulus of the blood vessel wall is estimated based on the patient's physiological parameters (age, weight) and reflects the elastic tolerance of the blood vessel wall. The better the elasticity, the greater the elasticity. The smaller; This represents the maximum allowable deformation of the cyst.

[0068] Compare current cyst pressure The pressure value is compared with the ideal pressure value to determine whether the deviation exceeds the preset pressure threshold. What is needed is the current cyst pressure. The pressure data is collected by a flexible pressure sensor installed inside the bladder cavity. The sensor is electrically connected to the processor, and the collected pressure data reflects the current actual pressure of the bladder.

[0069] Preset pressure threshold It can be set to ±5 mmHg, pressure deviation , representing Below Medium needs to be injected; negative values ​​represent Higher than A medium needs to be released.

[0070] like ,like , ,deviation This triggers pressure regulation; if If deviation No adjustment is triggered.

[0071] Based on the judgment result, a control signal is generated, and the controller increases or decreases the amount of medium injected according to the control signal.

[0072] For example, if ( (Low), generating a signal to "inject 3mL of physiological saline"; if ( (High level), generating a signal to "release 2 mL of physiological saline".

[0073] The control signal is transmitted to the controller, which drives the valve and the infusion pressurization device to perform media injection / release operations until... Approaching .

[0074] In this invention, during operation, after the machine is removed, the conical part of the main tube 10 is inserted into the femoral artery cannula, and the stopcock 60 is fixed to the femoral artery cannula by the connecting ring 62 to ensure the stability of the main tube 10. The medium is injected into the bladder 20 through the valve 40 to expand it and seal the gap between the femoral artery cannula and the main tube 10 to prevent external contamination. The pressurized infusion device is connected through the connector, and flushing fluid (such as normal saline) and anticoagulant (such as heparin) are respectively introduced through infusion chamber one and infusion chamber two to achieve flushing (removing residual blood in the tube) and sealing (preventing thrombosis) to keep the cannula unobstructed and clean.

[0075] When the patient needs to be put back on the machine, the valve 40 is opened to release the medium inside the capsule 20, causing it to contract and release the blockage of the femoral artery cannula. There is no need to re-process the cannula, which significantly shortens the preparation time.

[0076] The integrated femoral artery cannula occluder for ECMO weaning according to embodiments of the present invention achieves cannula occlusion and opening through the expansion / contraction of the bladder, avoiding the complexity of traditional post-weaning cannula management. It can be used directly upon reinsertion, saving critical treatment time. Furthermore, the dual-lumen structure allows for separate flushing and sealing of the cannula, effectively reducing the risk of thrombosis. Bladder occlusion and stopcock-assisted sealing reduce the probability of external contaminants entering, minimizing infection risk. In addition, the integrated thrombosis and pressure monitoring module, along with a processor and controller, enables adaptive occlusion, eliminating the need for frequent manual intervention and comprehensively improving the safety, convenience, and efficiency of ECMO post-weaning cannula management.

[0077] In the description of this specification, references to terms such as "one embodiment," "some embodiments," "example," "specific example," or "some examples," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of the invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples.

[0078] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are specific and detailed, they should not be construed as limiting the scope of the present invention. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this patent should be determined by the appended claims.

Claims

1. A total femoral artery cannulation occlusion device after ECMO weaning, characterized in that, include: The main tube, which is movably installed inside the femoral artery cannula via a connecting mechanism, has an infusion port on it; the connecting mechanism includes: The capsule is installed outside the main tube; A connecting hose is provided, with one end of the connecting hose connected to the balloon body and the other end of the connecting hose equipped with a valve. By injecting or releasing a medium into the balloon body, the expansion or contraction of the balloon body can be controlled to achieve the occlusion or opening of the femoral artery cannula. The thrombosis monitoring module, integrated into the main tube, is used to obtain thrombosis monitoring data within the femoral artery cannula through impedance monitoring. The thrombosis monitoring data includes impedance change data. A pressure monitoring module, integrated and installed on the surface of the capsule, is used to obtain blood flow pressure data; The processor is communicatively connected to the thrombosis monitoring sensor and the pressure monitoring module, and is used to process thrombosis monitoring data and blood flow pressure data to generate control signals; The controller, connected to the processor and valve, is used to operate the valve according to control signals, regulate the medium in the bladder, and achieve adaptive sealing.

2. The integral femoral artery cannulation occlusion device after ECMO weaning according to claim 1, characterized in that, The main tube consists of a conical section and a straight section, which are integrally formed. One end of the conical section is inserted into the femoral artery cannula. Infusion ports are symmetrically arranged on the conical section. The thrombosis monitoring module is located at the conical section and is used to obtain thrombosis monitoring data near the femoral artery cannula end.

3. The integral femoral artery cannulation occlusion device after ECMO weaning according to claim 2, characterized in that, It also includes an inner tube, which is installed inside the main tube. One end of the inner tube is fixedly connected to the end of the conical part. An infusion chamber one is formed between the outer wall of the inner tube and the inner wall of the main tube, and the inside of the inner tube is an infusion chamber two.

4. The integral femoral artery cannulation occlusion device after ECMO weaning according to claim 2, characterized in that, The ends of the main tube and the inner tube are respectively provided with connectors that communicate with infusion chamber one and infusion chamber two. The connectors are used to connect to the pressurized infusion device; the processor controls the pressurized infusion device according to the thrombosis monitoring data.

5. The integral femoral artery cannulation occlusion device after ECMO weaning according to claim 3, characterized in that, There is a gap between the outer wall of the main tube and the inner wall of the femoral artery cannula, and a detachable stopcock is provided between the main tube and the femoral artery cannula.

6. The integral femoral artery cannulation occlusion device after ECMO weaning according to claim 5, characterized in that, The stopcock includes a stopcock body and a connecting ring. The connecting ring is fixedly connected to the stopcock body. The stopcock body has a through hole that matches the outer diameter of the main tube, through which the main tube passes. The connecting ring connects the main tube and the femoral artery cannula.

7. The integral femoral artery cannulation occlusion device after ECMO weaning according to claim 6, characterized in that, The duct and capsule surfaces are coated with a nanoscale antibacterial coating.

8. The integral femoral artery cannulation occlusion device after ECMO weaning according to claim 7, characterized in that, The processor's processing steps include: Acquire thrombosis monitoring data and blood flow pressure data; The thrombosis risk index is calculated based on thrombosis monitoring data, and the ideal cyst pressure value is calculated based on blood flow pressure data. Compare the current cyst pressure with the ideal cyst pressure value to determine whether the deviation exceeds the preset pressure threshold; Based on the judgment result, a control signal is generated, and the controller increases or decreases the amount of medium injected according to the control signal.

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