Extracorporeal circuit, extracorporeal membrane oxygenation system and methods of use

Abstract

This invention provides an extracorporeal circulation kit, an extracorporeal membrane oxygenation (ECMO) system, and a method of use. The extracorporeal circulation kit includes a main tubing and a secondary tubing. One end of the main tubing is connected to a drain vessel, and the other end is connected to a return vessel. A blood pump and an oxygenator are connected in series on the main tubing, and both ends of the oxygenator are connected to the main tubing via quick-connect couplings. One end of the secondary tubing is connected to the input end of the oxygenator via a second three-way valve, and the other end is connected to the output end of the oxygenator via a third three-way valve. The secondary tubing is equipped with a fourth quick-connect coupling for connecting to both ends of a spare oxygenator. This structure ensures uninterrupted blood circulation and avoids drastic flow fluctuations during oxygenator replacement, thus reducing thrombus formation and impact on the patient. Furthermore, no blood is exposed or lost during replacement, reducing the risk of infection and air ingress. This improves the safety and continuity of treatment.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, and specifically relates to an extracorporeal circulation kit, an extracorporeal membrane oxygenation system, and a method of using it. Background Technology

[0002] Extracorporeal membrane oxygenation (ECMO) is a core life support technology in the field of critical care medicine for treating patients with severe cardiopulmonary failure.

[0003] The principle of ECMO is to draw blood from the patient's body, oxygenate the blood with oxygen outside the body, and then return the oxygenated blood to the body. The ECMO extracorporeal circulation kit (including a blood pump and an oxygenator) is the key component for achieving blood oxygenation.

[0004] Typically, an ECMO (extracorporeal membrane oxygenation) kit is an integrated, closed system. During prolonged operation, core components such as the oxygenator may require replacement due to plasma leakage or decreased gas exchange efficiency. In related technologies, replacing the ECMO kit or its core components involves a series of complex steps, including tubing disconnection, component replacement, venting, and circulatory reconstruction. These procedures inevitably lead to interruptions in extracorporeal circulation support. This interruption causes cessation of blood perfusion in the patient, significantly increasing the probability of serious complications such as circulatory collapse, gas embolism, massive blood loss, and infection.

[0005] Therefore, how to provide an extracorporeal circulation kit that can safely and smoothly replace the oxygenator without interrupting extracorporeal circulation, thereby effectively improving the safety and continuity of treatment, is a technical problem that urgently needs to be solved by those skilled in the art. Summary of the Invention

[0006] In view of this, the purpose of this invention is to provide an extracorporeal circulation kit that enables safe and stable replacement of the oxygenator without interrupting extracorporeal circulation or exposing blood to the external environment, thereby effectively improving the safety and continuity of treatment. Another objective of this invention is to provide an extracorporeal membrane oxygenation system incorporating the aforementioned extracorporeal circulation kit and a method for using the extracorporeal circulation kit.

[0007] To achieve the above objectives, the present invention provides the following technical solution:

[0008] An extracorporeal circulation kit includes: a main pipeline, one end of which is connected to a draining vessel and the other end of which is connected to a return vessel. A blood pump and an oxygenator are connected in series on the main pipeline, and both ends of the oxygenator are connected to the main pipeline via quick-connect fittings. The quick-connect fittings on the main pipeline for connecting to the oxygenator can be inserted into and connected to the main pipeline.

[0009] A secondary pipeline, one end of which is connected to the input end of the oxygenator via a second three-way valve, and the other end of which is connected to the output end of the oxygenator via a third three-way valve;

[0010] The secondary pipeline is equipped with a fourth quick-connect fitting, the male and female ends of which are used to connect with the two ends of the backup oxygenator, so that the backup oxygenator is connected in series with the secondary pipeline.

[0011] Optionally, in the above-mentioned extracorporeal circulation kit, a second side port connector and a third side port connector are provided on the main pipeline; the second side port connector and the third side port connector are distributed on the pipelines on both sides of the oxygenator, and one of the second side port connector and the third side port connector is used to connect to the pre-filled liquid container or both are connected to the pressure sensor.

[0012] And / or,

[0013] The secondary pipeline is provided with a fourth side hole connector and a fifth side hole connector; the fourth side hole connector and the fifth side hole connector are distributed on both sides of the fourth quick-connect connector, and one of the fourth side hole connector and the fifth side hole connector is used to connect to the pre-filled liquid container or both are used to connect to the pressure sensor.

[0014] Optionally, in the above-described extracorporeal circulation kit, the quick-connect fittings at both ends of the oxygenator are located on the pipeline between the second side-hole fitting and the third side-hole fitting.

[0015] Optionally, the above-mentioned extracorporeal circulation kit also includes a pre-filled fluid container, which is capable of being connected to and disconnected from the fourth side port connector and / or the second side port connector.

[0016] Optionally, in the above-mentioned extracorporeal circulation kit, a first drain valve is provided on the main pipeline, which is used to discharge backwash waste liquid generated by backwashing the main pipeline;

[0017] And / or,

[0018] A second drain valve is installed on the secondary pipeline, which is used to discharge backwash waste liquid generated by backwashing the secondary pipeline.

[0019] Optionally, in the above-mentioned extracorporeal circulation kit, the first drain valve and / or the second drain valve are equipped with a check valve;

[0020] The first drain valve's check valve is open from the main pipeline to the outside; the second drain valve's check valve is open from the secondary pipeline to the outside.

[0021] Optionally, in the above-mentioned extracorporeal circulation kit, a spare oxygenator is provided on the secondary pipeline, and one end of the spare oxygenator is connected to the female end of the fourth quick-connect fitting, and the other end is connected to the male end of the fourth quick-connect fitting.

[0022] Optionally, the above-mentioned extracorporeal circulation kit also includes a bridging pipeline, one end of which is connected to the main pipeline and the draining vessel via a first three-way valve;

[0023] The other end of the bridge pipe is connected to the main pipe and the return pipe via a fourth three-way valve.

[0024] Optionally, in the above-mentioned extracorporeal circulation kit, a seventh quick-connect connector is provided on the bridge pipe;

[0025] An eighth quick-connector is provided on the pipeline between the first three-way valve and the blood pump, and a sixth quick-connector is provided on the pipeline between the third three-way valve and the fourth three-way valve; the eighth quick-connector and the sixth quick-connector are components to be replaced.

[0026] A replacement component can be connected between the male and female ends of the seventh quick-connect connector, and the structure of the replacement component is the same as that of the component to be replaced.

[0027] Furthermore, the male connector of the sixth quick-connector can be connected to the female connector of the eighth quick-connector, or the female connector of the sixth quick-connector can be connected to the male connector of the eighth quick-connector.

[0028] Optionally, in the above-mentioned extracorporeal circulation kit, the bridge pipe is further provided with a sixth side hole connector and a seventh side hole connector, which are distributed on both sides of the seventh quick-connect connector;

[0029] Furthermore, one of the sixth side hole connectors and the seventh side hole connector is used to connect to the pre-filled liquid container, and the other is used for venting.

[0030] Optionally, the above-mentioned extracorporeal circulation kit also includes a pre-filled fluid container, which can be connected to or disconnected from the seventh side port connector or the sixth side port connector.

[0031] Optionally, the above-mentioned extracorporeal circulation kit also includes a first side hole connector and an eighth side hole connector;

[0032] The first side-hole connector is disposed on the pipeline between the eighth quick-connect connector and the first three-way valve; the eighth side-hole connector is disposed on the pipeline between the sixth quick-connect connector and the fourth three-way valve;

[0033] Furthermore, one of the first side-hole connector and the eighth side-hole connector is used to connect to the pre-filled liquid container, and the other is used to vent air; or, the first side-hole connector is used to connect to the pressure sensor.

[0034] Optionally, the above-mentioned extracorporeal circulation kit further includes a filter assembly, one end of which is connected to the male end of the eighth quick-connect connector, and the other end of which is connected to the female end of the eighth quick-connect connector.

[0035] Optionally, the above-mentioned extracorporeal circulation kit may further include at least one of a first pressure sensor, a second pressure sensor, and a third pressure sensor;

[0036] The first pressure sensor is installed on the pipeline at the input end of the blood pump;

[0037] The second pressure sensor is installed in the pipeline between the blood pump and the oxygenator;

[0038] The third pressure sensor is installed on the pipeline at the output end of the oxygenator.

[0039] Optionally, in the above-mentioned extracorporeal circulation kit, the third pressure sensor is disposed on the pipeline between the third three-way valve and the fourth three-way valve.

[0040] Optionally, the above-mentioned extracorporeal circulation kit also includes a hemolysis detection device, which is used to monitor the degree of hemolysis of blood in the main tubing and / or the secondary tubing.

[0041] Optionally, in the above-mentioned extracorporeal circulation kit, the hemolysis detection device is an electrochemical sensor or an optical detection sensor.

[0042] Optionally, the above-mentioned extracorporeal circulation kit may further include at least one of a first flow sensor, a second flow sensor, and a third flow sensor;

[0043] The first flow sensor is installed on the pipeline at the output end of the blood pump;

[0044] The second flow sensor is installed on the bridge pipe;

[0045] The third flow sensor is installed on the main pipeline.

[0046] Optionally, in the above-mentioned extracorporeal circulation kit, the first flow sensor is disposed on the pipeline between the blood pump and the second three-way valve;

[0047] The third flow sensor is located on the main pipeline or the secondary pipeline between the second three-way valve and the third three-way valve.

[0048] Optionally, the above-mentioned extracorporeal circulation kit may further include at least one of a first blood monitoring system and a second blood monitoring system;

[0049] The first blood monitoring system is installed on the pipeline between the blood pump and the second three-way valve. The first blood monitoring system is used to monitor the oxygenation status of the blood before it enters the oxygenator and / or before it enters the backup oxygenator installed on the auxiliary pipeline.

[0050] The second blood monitoring system is installed on the pipeline between the third three-way valve and the fourth three-way valve. The second blood monitoring system is used to monitor the oxygenation status of the blood after the output of the oxygenator and / or after the output of the standby oxygenator installed on the auxiliary pipeline.

[0051] Optionally, in the above-mentioned extracorporeal circulation kit, at least one of the first blood monitoring system and the second blood monitoring system is also used to monitor at least one of blood oxygen saturation, blood hemoglobin concentration, blood temperature, blood oxygen partial pressure and blood carbon dioxide partial pressure.

[0052] Optionally, in the above-mentioned extracorporeal circulation kit, both the first blood monitoring system and the second blood monitoring system may include a main control unit and a detection device, and the detection device is used to obtain the oxygenation status of the blood, and the detection device is communicatively connected to the main control unit.

[0053] Optionally, the above-mentioned extracorporeal circulation kit also includes a clamping device for controlling the opening and closing of the pipeline, the clamping device being capable of clamping the pipeline.

[0054] Optionally, in the above-mentioned extracorporeal circulation kit, the clamping device is disposed on the pipeline between the third three-way valve and the fourth three-way valve.

[0055] Optionally, the above-mentioned extracorporeal circulation kit also includes a pre-filling component;

[0056] The end of the drain tube away from the main pipeline is connected to the outlet of the pre-charge component via a first quick-connect connector;

[0057] The end of the reflux vessel away from the main pipeline is used to connect to the inlet of the pre-charge assembly via a fifth quick-connect fitting;

[0058] Furthermore, one end of the first quick-connect connector on the draining blood vessel can be inserted into one end of the fifth quick-connect connector on the reflux blood vessel.

[0059] Optionally, in the above-mentioned extracorporeal circulation kit, each pipeline, each connector, and each component of the extracorporeal circulation kit is coated with an anticoagulant coating.

[0060] An extracorporeal membrane oxygenation system includes an extracorporeal circulation kit and a main unit, wherein the extracorporeal circulation kit is any of the extracorporeal circulation kits described above.

[0061] At least one of the first pressure sensor, second pressure sensor, third pressure sensor, hemolysis detection device, first flow sensor, second flow sensor, third flow sensor, first blood monitoring system, and second blood monitoring system of the extracorporeal circulation kit is electrically connected to the host.

[0062] A method of using an extracorporeal circulation kit, applied to any of the extracorporeal circulation kits described above, comprising:

[0063] Both the inlet and outlet blood vessels are connected to the pre-filled assembly, so that the extracorporeal circulation kit forms a closed loop;

[0064] Inject pre-filling fluid into the closed loop and start the blood pump to fill the main pipeline and auxiliary pipeline with the pre-filling fluid and remove the gas in the closed loop;

[0065] Remove the pre-filled components and connect the inlet and outlet vessels to the patient's blood vessels to establish extracorporeal circulation support;

[0066] If the oxygenator is found to be underperforming or malfunctioning: the operator opens the fourth quick-connect fitting on the auxiliary line and inserts the spare oxygenator, fills the spare oxygenator and the auxiliary line with pre-filling fluid, and vents the air; the operator first connects the return blood vessel to the outlet end of the auxiliary line, and then connects the blood pump to the auxiliary line to replace the oxygenator with the spare oxygenator.

[0067] Optionally, in the above-described method of using the extracorporeal circulation kit, after connecting the blood pump to the auxiliary tubing, the method further includes:

[0068] Close the port connecting the second three-way valve to the main pipeline, and fill the main pipeline with pre-filling fluid so that blood in the main pipeline and the oxygenator flows into the return vessel.

[0069] The connection between the main pipeline and the reflux vessel is closed.

[0070] Optionally, in the above-described method of using the extracorporeal circulation kit, after closing the connection between the main inlet and the reflux vessel, the method further includes:

[0071] Backwash fluid is introduced into the main pipeline and oxygenator, and the backwash waste liquid after rinsing the main pipeline and oxygenator is discharged from the main pipeline;

[0072] If the oxygenator's performance is not restored, open the quick-connect fittings on both sides of the oxygenator, disassemble the oxygenator, and connect the fittings on the main pipeline that connect to both sides of the oxygenator to connect the main pipeline.

[0073] Optionally, in the above-described method of using the extracorporeal circulation kit, after establishing extracorporeal circulation support, a weaning bridging test is further included, the weaning bridging test comprising:

[0074] First, connect the draining vessel and the bridging pipe, then connect the return vessel and the bridging pipe, so that the draining vessel, the bridging pipe and the return vessel are connected.

[0075] The operator reduces the port connecting the fourth three-way valve to the return blood vessel until the port connecting the fourth three-way valve to the return blood vessel is closed, and closes the port connecting the first three-way valve to the drain blood vessel, so that the extracorporeal circulation kit can form a closed blood flow channel.

[0076] Obtain the patient's tolerance level. If the patient can tolerate the weaning process, the operator connects the sixth side port connector to the pre-filled fluid container, opens the port connecting the fourth three-way valve to the return vessel, and simultaneously closes the port connecting the fourth three-way valve to the bridge pipeline. The blood pump is then turned off. The operator uses the sixth side port connector to fill the pipeline with pre-filled fluid and infuses the blood from the extracorporeal circulation kit into the patient's body through the return vessel. Then, the ECMO system is weaned off.

[0077] If the patient cannot tolerate weaning, open the port connecting the first three-way valve to the draining blood vessel, open the port connecting the fourth three-way valve to the return blood vessel, reduce the port connecting the first three-way valve to the bridged tube until the port connecting the first three-way valve to the bridged tube is closed, and the extracorporeal circulation is re-established; pre-filling fluid is injected into the bridged tube to allow the blood in the bridged tube to flow into the return blood vessel; close the port connecting the fourth three-way valve to the bridged tube.

[0078] The extracorporeal circulation kit disclosed in this invention features a secondary tubing connected in parallel to the main oxygenator. A fourth quick-connect fitting on this secondary tubing connects to a backup oxygenator. This allows for the installation of a backup oxygenator on the secondary tubing when the oxygenator's performance deteriorates or fails. Switching between the main and secondary tubing is controlled by opening and closing the ports of the second and third three-way valves, allowing the operator to select either the main or secondary tubing to form a blood circuit with the return and drain vessels. During replacement, the operator can disconnect the fourth quick-connect fitting and connect the backup oxygenator. The connection between the third and second three-way valves is then opened, followed by opening the second three-way valve and closing the main tubing. At this point, the blood flow in the circulation system completely switches from the main tubing to the secondary tubing.

[0079] Throughout the entire replacement process, blood circulation remains uninterrupted, and there are no drastic fluctuations in flow. Therefore, this helps reduce thrombus formation and minimizes the impact on the patient. Furthermore, there is no blood exposure or loss during the replacement process, which helps reduce the risk of infection and air ingress. This contributes to improved safety and continuity of treatment. Attached Figure Description

[0080] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on the provided drawings without creative effort.

[0081] Figure 1 This is a schematic diagram of the extracorporeal circulation kit disclosed in Embodiment 1 of the present invention;

[0082] Figure 2 This is a schematic diagram of the replacement process of the extracorporeal circulation oxygenator disclosed in Embodiment 1 of the present invention;

[0083] Figure 3 This is a schematic diagram of the structure after the replacement of the extracorporeal circulation oxygenator disclosed in Embodiment 1 of the present invention;

[0084] Figure 4 This is a schematic diagram of the extracorporeal circulation kit disclosed in Embodiment 2 of the present invention;

[0085] Figure 5 This is a schematic diagram of the extracorporeal circulation kit disclosed in Embodiment 3 of the present invention;

[0086] Figure 6 This is a schematic diagram of the extracorporeal circulation kit disclosed in Embodiment 4 of the present invention.

[0087] Explanation of reference numerals in the attached figures:

[0088] 100-Pre-fill component; 101-Bag body; 102-Bottle insertion needle; 103-One-way valve; 104-Tube clamp; 105-Discharge tube; 106-Inlet tube;

[0089] 201-First three-way valve, 202-Second three-way valve, 203-Third three-way valve, 204-Fourth three-way valve;

[0090] 300 - Blood pump, 400 - Oxygenator, 401 - Backup oxygenator;

[0091] 501 - Main inlet tube, 502 - Main tube, 503 - Bridging tube, 504 - Secondary tube, 505 - Return tube;

[0092] 601-First quick-connect connector, 602-Second quick-connect connector, 603-Third quick-connect connector, 604-Fourth quick-connect connector, 6041-First branch quick-connect connector, 6042-Second branch quick-connect connector, 605-Fifth quick-connect connector, 606-Sixth quick-connect connector, 607-Seventh quick-connect connector, 608-Eighth quick-connect connector, 6081-Eighth quick-connect connector first branch, 6082-Fifth quick-connect connector second branch;

[0093] 701-First side hole connector, 702-Second side hole connector, 703-Third side hole connector, 704-Fourth side hole connector, 705-Fifth side hole connector, 706-Sixth side hole connector, 707-Seventh side hole connector, 708-Eighth side hole connector;

[0094] 801-First pressure sensor, 802-Second pressure sensor, 803-Third pressure sensor, 804-Hemolysis detection device, 805-Filter assembly, 806-First flow sensor, 807-Second flow sensor, 808-Third flow sensor, 809-First blood monitoring system, 810-Second blood monitoring system;

[0095] 901 - First drain valve, 902 - Second drain valve;

[0096] 1000 - Clamping device; 0100 - Pre-filled liquid container. Detailed Implementation

[0097] Extracorporeal membrane oxygenation (ECMO) is a core life support technology in the field of critical care medicine for treating patients with severe cardiopulmonary failure.

[0098] The principle of ECMO is to draw blood from the patient's body, oxygenate the blood with oxygen outside the body, and then return the oxygenated blood to the body. The ECMO extracorporeal circulation kit (including a blood pump and an oxygenator) is the key component for achieving blood oxygenation.

[0099] Typically, an ECMO (extracorporeal membrane oxygenation) kit is an integrated, closed system. During prolonged operation, core components such as the oxygenator may require replacement due to plasma leakage or decreased gas exchange efficiency. In related technologies, replacing the ECMO kit or its core components involves a series of complex steps, including tubing disconnection, component replacement, venting, and circulatory reconstruction. These procedures inevitably lead to interruptions in extracorporeal circulation support. This interruption causes cessation of blood perfusion in the patient, significantly increasing the probability of serious complications such as circulatory collapse, gas embolism, massive blood loss, and infection.

[0100] In view of this, the core of the present invention is to provide an extracorporeal circulation kit that enables safe and stable replacement of the oxygenator without interrupting extracorporeal circulation, thereby effectively improving the safety and continuity of treatment.

[0101] The technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings of the embodiments of the present invention. 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 of ordinary skill in the art without creative effort are within the scope of protection of the present invention. This document describes the technical solutions of this application with different embodiments, wherein... Figures 1 to 3 This is a structural description of Example 1. Figure 4 This is a structural description of Example 2. Figure 5 This is a structural description of Example 3. Figure 6 This is a structural description of Example 4.

[0102] Example 1

[0103] like Figure 1 As shown, the extracorporeal circulation kit of the ECMO system in this embodiment may include: a pre-filling assembly 100, a valve assembly, a blood pump 300, an oxygenator 400, circulation tubing, a quick-connect fitting assembly, and a side-hole fitting assembly.

[0104] The valve assembly includes a first three-way valve 201, a second three-way valve 202, a third three-way valve 203, and a fourth three-way valve 204. The circulation pipeline includes a lead pipe 501, a main pipe 502, a bridging pipe 503, a secondary pipe 504, and a return pipe 505. The quick-connect fitting assembly includes a first quick-connect fitting 601, a second quick-connect fitting 602, a third quick-connect fitting 603, a fourth quick-connect fitting 604, and a fifth quick-connect fitting 605. The side-hole fitting assembly includes a first side-hole fitting 701, a second side-hole fitting 702, a third side-hole fitting 703, a fourth side-hole fitting 704, and a fifth side-hole fitting 705.

[0105] The blood pump 300, also known as a blood pump head, works by mechanically driving blood to flow within the circulatory system. This allows the blood to overcome the resistance of the circulatory system, continuously delivering venous blood to the oxygenator 400 and then pumping the oxygenated blood back into the arterial or venous system. In some embodiments, the speed of the blood pump 300 is adjustable, allowing for the regulation of blood flow rate as needed. This ensures that the patient's tissues and organs receive sufficient oxygen and that metabolic waste is steadily cleared from them.

[0106] In some embodiments, the blood pump 300 can be a centrifugal pump head or a roller pump head (also known as a peristaltic pump). Of course, the blood pump 300 in this embodiment is not limited to these. The principle of the centrifugal pump head is to use a high-speed rotating impeller to generate centrifugal force to drive blood flow; the principle of the roller pump head is to achieve peristaltic blood transfusion by squeezing the tubing with rollers, thereby driving blood flow.

[0107] The oxygenator 400 in this embodiment can be a hollow fiber membrane oxygenator. The oxygenator 400 includes a gas exchange component and a heat exchanger. The oxygenator 400 uses the gas exchange component to controllably oxygenate the blood and remove carbon dioxide, thus completing the oxygenation of the blood and converting venous blood into arterial blood. The heat exchanger can be used to adjust the blood temperature. This embodiment does not describe the specific structure of the oxygenator 400; please refer to existing known oxygenators 400.

[0108] The pre-filling component 100 in this embodiment is used to contain pre-filling solution, which can be physiological saline or physiological saline with added drugs. In some embodiments, the pre-filling component 100 may include a bag body 101, a vial insertion needle 102, a one-way valve 103, a tube clamp 104, an outlet tube 105, and an inlet tube 106.

[0109] The bag body 101 contains pre-filled liquid, and the bottle insertion needle 102 is connected to the bag body 101, allowing the pre-filled liquid to be injected into the bag body 101. Optionally, the bottle insertion needle 102 may be positioned higher than the bag body 101. The bag body 101 has an outlet pipe 105 and an inlet pipe 106, both of which are connected to the interior of the bag body 101.

[0110] Both the outlet pipe 105 and the inlet pipe 106 are equipped with pipe clamps 104, which can be used to control the opening and closing of the outlet pipe 105 and the inlet pipe 106. The inlet pipe 106 is equipped with a one-way valve 103, and the one-way valve 103 is unidirectionally directed from the return tube 505 to the bag body 101 to prevent the pre-filled liquid in the bag body 101 from flowing back to the return tube 505.

[0111] The outlet tube 105 of the pre-filling component 100 is connected to the first port of the first three-way valve 201 via the inlet tube 501. The second port of the first three-way valve 201 is connected to the inlet of the blood pump 300. The outlet of the blood pump 300 is connected to the first port of the second three-way valve 202. The second port of the second three-way valve 202 is connected to the inlet of the oxygenator 400. The outlet of the oxygenator 400 is connected to the first port of the third three-way valve 203. The second port of the third three-way valve 203 is connected to the first port of the fourth three-way valve 204. The second port of the fourth three-way valve 204 is connected to the inlet tube 106 of the pre-filling component 100 via the return tube 505, thus forming the main structure of the extracorporeal circulation kit.

[0112] The outlet pipe 105 of the pre-charge component 100 and the first port of the first three-way valve 201 form a guide pipe 501; the second port of the fourth three-way valve 204 and the inlet pipe 106 of the pre-charge component 100 form a return pipe 505; the second port of the first three-way valve 201 and the first port of the fourth three-way valve 204 form a main pipeline.

[0113] Furthermore, the third port of the first three-way valve 201 is connected to the third port of the fourth three-way valve 204 through the bridge pipe 503. This can also be understood as the bridge pipe 503 being formed between the third port of the first three-way valve 201 and the third port of the fourth three-way valve 204.

[0114] Furthermore, the third port of the second three-way valve 202 and the third port of the third three-way valve 203 are connected through a secondary pipeline 504. This can also be understood as the secondary pipeline 504 forming a connection between the third ports of the second three-way valve 202 and the third three-way valve 203. It should be understood that in this embodiment, the secondary pipeline 504 and the main pipeline 502 are connected in parallel.

[0115] In the extracorporeal circulation kit disclosed in this embodiment, the first three-way valve 201 can control the opening and closing of the passage between the blood inlet tube 501 and the blood pump 300, and can control the opening and closing of one end of the bridging pipe 503; the second three-way valve 202 can control the opening and closing of the passage between the blood pump 300 and the oxygenator 400, and can control the opening and closing of one end of the auxiliary pipe 504; the third three-way valve 203 can control the opening and closing of the passage between the oxygenator 400 and the fourth three-way valve 204, and can control the opening and closing of the other end of the auxiliary pipe 504; the fourth three-way valve 204 can control the opening and closing of the passage between the third three-way valve 203 and the pre-filling component 100, and can control the opening and closing of the other end of the bridging pipe.

[0116] It is understandable that by changing the internal connection relationships of the first three-way valve 201, the second three-way valve 202, the third three-way valve 203, and the fourth three-way valve 204, the on / off control of the main pipeline 502, the bridge pipeline 503, and the secondary pipeline 504 can be achieved to adapt to different application scenarios.

[0117] In this embodiment, a first quick-connect fitting 601 is provided on the drain tube 501, that is, a first quick-connect fitting 601 is provided between the outlet pipe 105 of the pre-charge component 100 and the first three-way valve 201. In this example, the first quick-connect fitting 601 can be obtained by connecting the outlet pipe 105 of the pre-charge component 100 to the drain tube 501. A second quick-connect fitting 602 is provided between the second three-way valve 202 and the oxygenator 400. In this example, the second quick-connect fitting 602 can be obtained by connecting the main pipe 502 to one side of the oxygenator 400. A third quick-connect fitting 603 is provided between the oxygenator 400 and the third three-way valve 203. In this example, the third quick-connect fitting 603 can be obtained by connecting the main pipe 502 to the other side of the oxygenator 400. It can be understood that the oxygenator 400 is connected in series to the main pipe 502 via quick-connect fittings. A fourth quick-connector 604 is provided on the secondary pipeline 504, that is, a fourth quick-connector 604 is provided between the third port of the second three-way valve 202 and the third port of the third three-way valve 203. A fifth quick-connector 605 is provided on the return tube 505, that is, a fifth quick-connector 605 is provided between the inlet pipe 106 of the pre-filling component 100 and the fourth three-way valve 204.

[0118] In some embodiments, the first quick-connect connector 601, the second quick-connect connector 602, the third quick-connect connector 603, the fourth quick-connect connector 604, and the fifth quick-connect connector 605 have the same structure and all include a male and a female connector. One of the male and female connectors may be provided with a snap-fit, and the other with a slot. The snap-fit ​​and slot engage to achieve quick connection between the male and female connectors; pressing the snap-fit ​​allows for quick disassembly of the connection between the male and female connectors, facilitating quick connection and switching between circulation pipelines and components. It should be noted that the structure of the quick-connect connectors in other embodiments of this document may also be the same as that of the quick-connect connector in this embodiment.

[0119] It should be noted that before use, the extracorporeal circulation kit in this embodiment is pre-filled with pre-filling fluid using the pre-filling component 100 to pre-fill the entire circulation tubing and its structures. After pre-filling, the pre-filling component 100 needs to be removed. Therefore, in this embodiment, the first quick-connect connector 601 and the fifth quick-connect connector 605 are inserted into the extracorporeal circulation kit after the pre-filling component 100 has been removed and before the kit is used on a patient.

[0120] It should be understood that the first quick-connect connector 601 in this embodiment enables quick assembly and disassembly of the outlet tube 105 and the drain tube 501 of the pre-charge component 100, and the fifth quick-connect connector 605 enables quick assembly and disassembly of the inlet tube 106 and the return tube 505 of the pre-charge component 100. Optionally, a male head of the first quick-connect connector 601 can be provided at the outlet tube 105 of the pre-charge component 100, and a female head of the first quick-connect connector 601 can be provided at the drain tube 501, with the two interlocking to form the first quick-connect connector 601; a female head of the fifth quick-connect connector 605 can be provided at the inlet tube 106 of the pre-charge component 100, and a male head of the fifth quick-connect connector 605 can be provided at the return tube 505, with the two interlocking to form the fifth quick-connect connector 605. After the pre-filling component 100 is removed, the female head of the first quick-connect connector 601 of the drain tube 501 can be inserted into the male head of the fifth quick-connect connector 605 of the return tube 505, ensuring that the circulation tubing of the extracorporeal circulation kit is a closed tubing.

[0121] In this embodiment, a first side-hole connector 701 is provided on the main pipeline 502 between the first three-way valve 201 and the blood pump 300; a second side-hole connector 702 is provided on the main pipeline 502 between the second three-way valve 202 and the second quick-connect connector 602; and a third side-hole connector 703 is provided on the main pipeline 502 between the third quick-connect connector 603 and the third three-way valve 203. A fourth side-hole connector 704 is provided on the secondary pipeline 504 between the second three-way valve 202 and the fourth quick-connect connector 604, and a fifth side-hole connector 705 is provided between the fourth quick-connect connector 604 and the third three-way valve 203.

[0122] Optionally, the structures of the first side-hole connector 701, the second side-hole connector 702, the third side-hole connector 703, the fourth side-hole connector 704, and the fifth side-hole connector 705 can all be identical. In this example, when the side-hole connectors are not in use, a Luer cap is screwed on to seal the side-hole structure; when in use, they can be connected to a three-way valve or a side branch pipeline. It should be noted that the structures of the side-hole connectors in other embodiments of this article can also be identical.

[0123] The first side-hole connector 701, the second side-hole connector 702, and the third side-hole connector 703 can all be used to connect medical pressure sensors to monitor the pressure in the tubing before the blood pump 300, the tubing between the blood pump 300 and the oxygenator 400, and the tubing after the oxygenator 400, respectively. They can also be used to connect tubing for continuous renal replacement therapy (CRRT).

[0124] The above content describes the structure of the extracorporeal circulation kit. The following describes the flow relationship of the extracorporeal circulation kit under different operating conditions in this embodiment.

[0125] Combination Figure 1As shown, the circulation relationship of the extracorporeal circulation kit in normal working condition in this embodiment is as follows.

[0126] Before use, the pre-filling component 100 is used to pre-fill the entire extracorporeal circulation kit's circulation tubing and its structures with pre-filling fluid. After pre-filling, the pre-filling component 100 needs to be removed. It should be noted that during the pre-filling process of the pre-filling component 100 to pre-fill the extracorporeal circulation kit with the set pre-filling fluid, all circulation tubing is open, meaning that all circulation tubing is pre-filled with pre-filling fluid. After pre-filling is completed, the auxiliary tubing 504 and the bridging tubing 503 are shut off.

[0127] When applying the pre-filled extracorporeal circulation kit to a patient, the first quick-connect fitting 601 of the drain tube 501 is connected to the patient's intravascular cannula, allowing venous blood to be drained from the body. The return tube 505 is then connected to the patient's intravascular cannula, establishing extracorporeal circulation. Specifically, the first three-way valve 201 connects the drain tube 501 to the blood pump 300, and one end of the bridging line 503 is disconnected; the second three-way valve 202 connects the blood pump 300 to the oxygenator 400, and one end of the secondary line 504 is disconnected; the third three-way valve 203 connects the oxygenator 400 to the fourth three-way valve 204, and the other end of the secondary line 504 is disconnected; the fourth three-way valve 204 connects the main line 502 to the return tube 505, and the other end of the bridging line 503 is disconnected. Based on these connections, it is clear that in this state, neither the secondary line 504 nor the bridging line 503 is conductive, meaning they do not participate in blood circulation.

[0128] During operation, the patient's venous blood enters the extracorporeal circulation kit through the inlet tube 501. After gas exchange by the blood pump 300 and oxygenator 400, the oxygenated blood is returned to the patient's venous or arterial system through the return tube 505, thereby achieving partial or complete replacement of cardiopulmonary function.

[0129] Continue reading Figure 2 The circulation relationship of the extracorporeal circulation kit in the replacement state in this embodiment is as follows.

[0130] If the oxygenator 400 deteriorates or malfunctions during extracorporeal circulation and needs replacement, the operator can disconnect it. Figure 1 The fourth quick-connector 604 on the secondary pipeline 504, i.e., the male and female ends of the fourth quick-connector 604, is disconnected and connected to the spare oxygenator 401. In this example, the male end of the spare oxygenator 401 is connected to the female end of the fourth quick-connector 604, forming a first branch quick-connector 6041; the female end of the spare oxygenator 401 is connected to the male end of the fourth quick-connector 604, forming a second branch quick-connector 6042. This allows the spare oxygenator 401 to be connected in series on the secondary pipeline 504.

[0131] One of the fourth side hole connectors 704 and the fifth side hole connector 705 on the secondary pipeline 504 is connected to the pre-fill liquid container, and the other serves as an exhaust port, thereby pre-filling and venting the newly connected standby oxygenator 401.

[0132] After the newly connected standby oxygenator 401 is pre-charged, the operator first connects the third port of the third three-way valve 203 to the auxiliary pipeline 504, and then connects the third port of the second three-way valve 202 to the auxiliary pipeline 504. At the same time, the connection between the second port of the second three-way valve 202 and the main pipeline 502 is closed. At this time, the blood flow in the circulation pipeline is completely switched from the main pipeline 502 to the auxiliary pipeline 504. During this process, the newly connected standby oxygenator 401 on the auxiliary pipeline 504 replaces the oxygenator 400 in the main pipeline 502, that is, the oxygenator 400 in the main pipeline 502 does not work.

[0133] A pre-filled fluid container is connected to the second side port connector 702 on the main pipe 502. The pre-filled fluid is used to slowly push the blood in the main pipe 502 and the oxygenator 400 on the main pipe 502 into the third three-way valve 203 to avoid wasting blood. Then the first port connecting the third three-way valve 203 to the main pipe 502 is closed. After that, the main pipe 502 and the oxygenator 400 on the main pipe 502 are filled with pre-filled fluid and no longer participate in the circulation.

[0134] The operator disconnects the second quick-connect connector 602 and the third quick-connect connector 603, thereby removing the oxygenator 400 from the main pipeline 502. The operator then connects the ends of the second quick-connect connector 602 and the third quick-connect connector 603 that are used to connect to the oxygenator 400, thus making the main pipeline 502 connected and completing a full replacement process for the oxygenator 400.

[0135] The replaced extracorporeal circulation kit is formed as follows Figure 3 The structure, Figure 3 The secondary pipeline 504 is... Figure 2 The main pipeline 502 was formed after the oxygenator 400 was removed. Figure 2 The secondary pipeline 504 of the newly connected backup oxygenator 401 becomes the new main pipeline 502.

[0136] As can be seen from the above process of replacing the oxygenator 400, the entire replacement process not only completed the replacement of the oxygenator 400, but also the switching of the auxiliary pipeline 504 and the main pipeline 502. Throughout the entire replacement process, blood circulation was not interrupted, and there were no drastic fluctuations in flow rate. Therefore, this helps reduce thrombus formation and minimizes the impact on the patient. Furthermore, there was no blood exposure or loss during the replacement process, which helps reduce the risk of infection and air ingress, thus improving the safety and continuity of treatment.

[0137] In addition, after replacing the oxygenator 400 using the above replacement method, maintenance personnel can repair the oxygenator 400 that needs repair or treatment. Since the entire blood circulation is not interrupted and there is no drastic flow fluctuation during the repair process, maintenance personnel can repair the oxygenator 400 for a long time. It can be understood that the repair of the oxygenator 400 is not limited by time.

[0138] In some embodiments, see Figure 1 In the structure, the operator can connect the third side port connector 703 of the main pipeline 502 to a pre-filled liquid container with a certain pressure and flow rate, and open the second side port connector 702 to backflush the oxygenator 400.

[0139] In some embodiments, the repaired or replaced oxygenator 400 can be re-pre-charged using the third side port connector 703 and the second side port connector 702, connected to the pre-filled liquid container, and used as a new spare oxygenator 401. Figure 3 On the secondary pipeline 504.

[0140] During blood circulation, if the performance of the newly connected backup oxygenator 401 deteriorates or needs to be replaced, the circulation tubing of the repaired oxygenator 400 can be switched to following the steps described above. This allows for repeated, uninterrupted circulation and component replacement without damaging the blood, potentially ensuring uninterrupted and long-term operation of the ECMO system.

[0141] Continue reading Figure 1 As shown, the extracorporeal circulation kit of the ECMO system in this embodiment requires an ECMO system weaning bridging test. The weaning bridging test process is as follows:

[0142] The operator first opens the third port connecting the first three-way valve 201 to the bridge pipe 503, and then opens the third port connecting the fourth three-way valve 204 to the bridge pipe 503, so that the bridge pipe 503 is open, thus realizing the bridging of the circulation pipeline of the extracorporeal circulation package.

[0143] Then, the operator can gradually reduce the opening of the second port connecting the fourth three-way valve 204 and the return vessel 505 until the second port connecting the fourth three-way valve 204 and the return vessel 505 is closed, and the first port connecting the first three-way valve 201 and the drain vessel 501 is closed. That is, the extracorporeal circulation kit no longer delivers blood to the patient, and the patient's blood no longer enters the extracorporeal circulation kit. In this way, the main pipeline 502 and the bridging pipeline 503 of the extracorporeal circulation kit, as well as the blood pump 300 and oxygenator 400 on the main pipeline 502, form a closed blood flow channel. This flow channel contains the blood pump 300 and the oxygenator 400. Under the action of the blood pump 300 and the oxygenator 400, the circulation pipeline of the extracorporeal circulation kit achieves self-circulation, preventing blood flow stagnation in the blood flow channel.

[0144] During the weaning bridging test, the blood in the circulation tubing can circulate without interruption, and the bridging of the ECMO system's circulation tubing can be achieved non-invasively and without damaging the blood.

[0145] Gradually reduce the blood flow in the extracorporeal circulation kit's draining vessels until it reaches zero, and obtain patient tolerance data.

[0146] If the patient experiences intolerance during weaning, cardiopulmonary bypass needs to be restored. The operator opens the first port connecting the first three-way valve 201 to the drain line 501, opens the second port connecting the fourth three-way valve 204 to the return line 505, and gradually closes the third port connecting the first three-way valve 201 to the bridging line 503, thus re-establishing cardiopulmonary bypass. Then, pre-filling fluid is introduced into the bridging line 503 to allow blood in the bridging line 503 to flow back into the return line 505, and finally, the third port connecting the fourth three-way valve 204 to the bridging line 503 is closed.

[0147] If the patient tolerates the weaning process, the blood pump 300 can be stopped, and then the ECMO can be weaned off.

[0148] It should be noted that, based on the operational characteristics of the extracorporeal circulation (ECMO) kit, the inlet tube 501 is at low pressure, while the return tube 505 is at high pressure. This can be understood as: inlet tube 501 is at negative pressure, and return tube 505 is at positive pressure. Therefore, during the restoration of ECMO system support, the operator first closes the connection between the first three-way valve 201 and the bridging pipe 503, then fills the bridging pipe with pre-filling fluid to allow blood in the bridging pipe to return to the inlet tube. Then, the operator closes the connection between the fourth three-way valve 204 and the bridging pipe 503.

[0149] In this embodiment, the extracorporeal circulation kit does not have any open operation steps during the weaning and bridging process, and the extracorporeal circulation kit forms a stable closed self-circulating system, reducing the risk of air intake and infection. In addition, it can prevent blood flow stagnation within the self-circulating system of the extracorporeal circulation kit, thus reducing the formation of thrombi, making the entire weaning and bridging test process non-invasive and blood-free.

[0150] In some embodiments, a sixth side hole connector and / or a seventh side hole connector are provided on the bridge pipe 503. Optionally, the sixth side hole connector is located near the fourth three-way valve 204, and the seventh side hole connector is located near the first three-way valve 201. The seventh side hole connector is connected to the pre-filled liquid container.

[0151] By using a seventh side port connector, in the event of patient intolerance during weaning, the operator can restore ECMO support by closing the bridging line 503: first, close the third port connecting the first three-way valve 201 to the bridging line 503; then, using the pre-filled fluid container connected to the seventh side port connector, gradually push the blood in the bridging line 503 into the return vessel 505; finally, close the third port connecting the fourth three-way valve 204 to the bridging line 503. This prevents residual blood in the bridging line 503, which could lead to thrombosis.

[0152] If the patient tolerates weaning, the operator connects the sixth side port connector to the pre-filled fluid container, opens the second port connecting the fourth three-way valve 204 to the return tube 505, and simultaneously closes the third port connecting the fourth three-way valve 204 to the bridging tube 503. After the blood pump 300 stops, the operator can use the pressure of the pre-filled fluid in the container connected to the sixth side port connector to gradually and slowly infuse blood from the extracorporeal circulation kit into the patient through the main tube 502, and then wean the ECMO system off.

[0153] The extracorporeal circulation kit in this embodiment can avoid thrombosis caused by residual blood through the sixth and seventh side hole connectors, which helps to ensure the normal use of the extracorporeal circulation kit.

[0154] Example 2

[0155] like Figure 4 As shown, the extracorporeal circulation kit of the ECMO system in this embodiment has been structurally optimized based on the structure of Embodiment 1.

[0156] In the example, an eighth quick-connect fitting 608 is provided in the pipeline between the first side-hole connector 701 and the blood pump 300; a sixth quick-connect fitting 606 is installed in the pipeline between the third three-way valve 203 and the fourth three-way valve 204; a seventh side-hole connector 707 is installed on the bridge pipeline 503 near the first three-way valve 201; a sixth side-hole connector 706 is installed on the bridge pipeline 503 near the fourth three-way valve 204; a seventh quick-connect fitting 607 is provided in the bridge pipeline 503 between the sixth side-hole connector 706 and the seventh side-hole connector 707; and an eighth side-hole connector 708 is provided in the pipeline between the sixth quick-connect fitting 606 and the fourth three-way valve 204.

[0157] Other structures of the extracorporeal circulation kit in this embodiment are described in the extracorporeal circulation kit description of Embodiment 1, and will not be repeated here. That is, when the oxygenator 400 needs to be replaced, the replacement method of the extracorporeal circulation kit in this embodiment is the same as described in Embodiment 1, and will not be repeated here.

[0158] With the added structure in this embodiment, if the blood pump 300, oxygenator 400, main tubing 502, auxiliary tubing 504, and other structures on the main tubing 502 and auxiliary tubing 504 of the extracorporeal circulation kit in this embodiment need to be completely replaced or repaired, the entire replacement of the component to be replaced can be completed through the bridging tubing 503. The specific replacement steps for the component to be replaced are as follows:

[0159] The operator opens the seventh quick-connect connector 607, separating the male and female ends of the seventh quick-connect connector 607, and connects the replacement component to the seventh quick-connect connector 607. The structure of the replacement component is similar to... Figure 4 The structure of the eighth quick-connect connector 608, blood pump 300, oxygenator 400, up to the sixth quick-connect connector 606, and the auxiliary tubing 504 is the same as that of the component to be replaced. The male (or female) connector of the eighth quick-connect connector 608 of the replacement component and the female (or male) connector of the sixth quick-connect connector 606 are respectively connected to the male and female connectors of the seventh quick-connect connector 607, thus forming a series structure. In this way, the replacement component is connected to the original extracorporeal circulation kit.

[0160] Optionally, the eighth quick connector 608 of the replacement component is connected to the seventh quick connector 607 on the side near the first three-way valve 201, and the sixth quick connector 606 of the replacement component is connected to the seventh quick connector 607 on the side near the fourth three-way valve 204.

[0161] The replacement component can be quickly plugged into the seventh quick-connect connector 607, which helps to improve the efficiency of the replacement component's assembly and disassembly.

[0162] After the replacement component is connected to the seventh quick-connect connector 607, the operator pre-charges and vents the replacement component using the seventh side connector 707 and the sixth side connector 706. Optionally, one of the seventh side connector 707 and the sixth side connector 706 can be connected to the pre-charge fluid container, while the other can serve as a vent. In this example, the sixth side connector 706 can be connected to the pre-charge fluid container, and the seventh side connector 707 can be opened to serve as a vent.

[0163] After the replacement component is pre-charged, the operator adjusts the direction of the fourth three-way valve 204 so that the fourth three-way valve 204 is connected to the bridge pipe 503. Then, the operator adjusts the direction of the first three-way valve 201 so that the first three-way valve 201 is connected to the bridge pipe 503, and starts the blood pump on the replacement component, that is, the bridge pipe 503 circulates blood.

[0164] At the same time, close the second port connecting the first three-way valve 201 to the main pipeline 502, and close the blood pump 300 on the component to be replaced (i.e., the blood pump on the main pipeline 502). Then, the operator connects the pre-filled fluid container at the first side port connector 701 and uses the pre-filled fluid in the pre-filled fluid container to slowly push the blood in the component to be replaced into the return blood vessel 505 through the fourth three-way valve 204.

[0165] Then, the operator closes the first port connecting the fourth three-way valve 204 on the component to be replaced to the main pipeline 502. In this way, the shutdown operation of the component to be replaced is completed, and the replacement operation of the replacement component is completed, that is, the replacement and switching operation of the replacement component of the extracorporeal circulation kit is completed.

[0166] Based on the above procedures, it is clear that blood circulation remains uninterrupted and blood flow does not fluctuate throughout the entire replacement process. Therefore, this helps reduce thrombus formation and minimizes the impact on the patient. Furthermore, the replacement process avoids blood exposure and loss, reducing the risk of infection and air ingress. This contributes to improved safety and continuity of treatment.

[0167] In addition, after replacing the replacement component using the above replacement method, maintenance personnel can repair the replacement component that needs repair or processing. Since the entire blood circulation is not interrupted and there is no drastic flow fluctuation during the repair process, maintenance personnel can repair the replacement component for a long time. It can be understood that the repair of the replacement component is not limited by time.

[0168] After the replacement component is working properly, the operator can disconnect the sixth quick connector 606 and the eighth quick connector 608, thereby removing the entire replacement component from the extracorporeal circulation kit. The remaining connector of the sixth quick connector 606 on the extracorporeal circulation kit is then connected to the remaining connector of the eighth quick connector 608, thus forming a new bridging pipeline 503 between the remaining connector of the sixth quick connector 606 and the remaining connector of the eighth quick connector 608.

[0169] If the circulation pipeline and components need to be replaced again, the above steps can be followed, and the replacement components can be pre-charged and vented using the first side hole connector 701 and the eighth side hole connector 708, so as to achieve uninterrupted replacement.

[0170] The steps for the bridging test of the extracorporeal circulation kit in this embodiment are described in Example 1 and will not be repeated here.

[0171] Example 3

[0172] like Figure 5 As shown, the extracorporeal circulation kit of the ECMO system in this embodiment has been structurally optimized based on the structures of Embodiment 1 and Embodiment 2.

[0173] In this example, an oxygenator 400 is provided on the main pipeline 502 of the extracorporeal circulation kit, and a spare oxygenator 401 is provided on the secondary pipeline 504.

[0174] The two ends of the oxygenator 400 can be connected in series with the main pipeline 502 through the second quick connector 602 and the third quick connector 603. This can be understood as follows: one end of the oxygenator 400 is plugged into the main pipeline 502 to form the second quick connector 602, and the other end of the oxygenator 400 is plugged into the main pipeline 502 to form the third quick connector 603.

[0175] The two ends of the standby oxygenator 401 can be connected in series to the secondary pipeline 504 via the first branch quick connector 6041 and the second branch quick connector 6042.

[0176] It is understood that the connection of the structure on the secondary pipeline 504 in this embodiment can be the same as the structure in the process of replacing the oxygenator 400 in Embodiment 1. It should be understood that... Figure 1 To reduce costs, the extracorporeal circulation kit in the system can be configured with only one oxygenator. Figure 5 The extracorporeal circulation kit can be directly equipped with two oxygenators to facilitate oxygenator replacement.

[0177] In some application scenarios, the operator can open both the second and third ports of the second three-way valve 202, meaning that blood driven by the blood pump 300 can simultaneously enter the main pipeline 502 and the auxiliary pipeline 504. The operator can also open both the first and third ports of the third three-way valve 203, thus allowing the main pipeline 502 and the auxiliary pipeline 504 to be connected in parallel. Blood can then enter the oxygenator 400 and the standby oxygenator 401 respectively, enabling the parallel use of the oxygenator 400 and the standby oxygenator 401. This significantly improves the gas exchange capacity of the ECMO system equipped with this extracorporeal circulation kit.

[0178] The simultaneous use of the oxygenator 400 and the backup oxygenator 401 in this embodiment is suitable for scenarios with high flow requirements or decreased oxygenator function. Furthermore, in scenarios where both the oxygenator 400 and the backup oxygenator 401 are used simultaneously, if one oxygenator fails, the other oxygenator can continue to maintain life support, thereby reducing the risk of emergency replacement.

[0179] As can be seen from the above description, the secondary pipeline 504 in this embodiment is not limited to the single example shown in the figure. Those skilled in the art can set up multiple parallel secondary pipelines 504 according to the oxygenation and flow requirements, and each secondary pipeline 504 can be provided with a fourth quick-connect fitting 604 so that an oxygenator can be connected in series on each secondary pipeline 504. Of course, an oxygenator can also be directly installed on each secondary pipeline 504.

[0180] Furthermore, in this embodiment, the extracorporeal circulation kit also includes a first pressure sensor 801 installed on the pipeline between the blood pump 300 and the first three-way valve 201, a second pressure sensor 802 installed on the pipeline between the blood pump 300 and the second three-way valve 202, and a third pressure sensor 803 installed on the pipeline between the third three-way valve 203 and the fourth three-way valve 204. It can also be understood that the first pressure sensor 801 is installed upstream of the blood pump 300, i.e., at the input end of the blood pump 300; the second pressure sensor 802 is installed between the blood pump 300 and the oxygenator 400; and the third pressure sensor 803 is installed downstream of the oxygenator 400, i.e., at the output end of the oxygenator 400.

[0181] In this embodiment, the first pressure sensor 801 is used to detect the pressure of the blood before it enters the blood pump 300, the second pressure sensor 802 is used to detect the pressure of the blood output from the blood pump 300, and the third pressure sensor 803 is used to detect the pressure after passing through the oxygenator 400 or the standby oxygenator 401.

[0182] The first pressure sensor 801, the second pressure sensor 802, and the third pressure sensor 803 can be used to monitor the pressure of key parts in the circulation pipeline in real time. The transmembrane pressure difference (the pressure difference before and after the oxygenator) can be obtained based on the pressure values ​​obtained by the second pressure sensor 802 and the third pressure sensor 803 to assess the status of the oxygenator in use.

[0183] In some embodiments, a first drain valve 901 is installed on the pipeline between the second three-way valve 202 and the oxygenator 400, and a second drain valve 902 is installed on the pipeline between the second three-way valve 202 and the standby oxygenator 401.

[0184] The first drain valve 901 can discharge backwash waste liquid in the main pipeline 502, and the second drain valve 902 can discharge backwash waste liquid in the secondary pipeline 504.

[0185] Taking the replacement of oxygenator 400 as an example, if the performance of oxygenator 400 deteriorates or malfunctions, after replacing the spare oxygenator 401 and its pipeline, oxygenator 400 can be flushed to remove particulate matter. Specifically, backflushing fluid can be introduced into the first oxygenator 400 through the third side port connector 703. After flushing the first oxygenator 400, the backflushing fluid is discharged through the first drain valve 901. Optionally, the backflushing fluid can be physiological saline, and the liquid discharged from the first drain valve 901 is backflushing waste liquid containing particulate matter and other impurities.

[0186] Optionally, both the first drain valve 901 and the second drain valve 902 are equipped with check valves, and the conduction direction of the check valves is one-way from the pipeline to the external environment, so as to ensure the one-way flow of waste liquid and prevent outside air from entering the circulation pipeline during the discharge process.

[0187] Example 4

[0188] like Figure 6 As shown, the extracorporeal circulation kit of the ECMO system in this embodiment has been structurally optimized compared to the structure in Embodiment 3.

[0189] In this example, the eighth quick-connect fitting 608 includes a male and a female connector. In this embodiment, a filter assembly 805 is provided between the male and female connectors of the eighth quick-connect fitting 608 in the circulation tubing of the extracorporeal circulation kit. It is understood that one end of the filter assembly 805 is inserted into the male connector of the eighth quick-connect fitting 608 to form a first branch 6081 of the eighth quick-connect fitting, and the other end of the filter assembly 805 is inserted into the female connector of the eighth quick-connect fitting 608 to form a second branch 6082 of the eighth quick-connect fitting. It should be understood that the filter assembly 805 is connected in series in the tubing between the first three-way valve 201 and the blood pump 300 via the quick-connect fitting.

[0190] By installing a filter assembly 805 in the pipeline between the first three-way valve 201 and the blood pump 300, particulate matter such as fat particles, thrombi, and human tissue detached from the human body can be filtered and removed from the circulation pipeline, preventing these particles from entering the blood pump 300 and oxygenator 400 and affecting their performance. These detached particles may be released into the bloodstream during vascular cannulation surgery to apply the ECMO system, or they may directly detach from the patient's body after the ECMO system establishes a blood circulation pathway.

[0191] In some embodiments, the extracorporeal circulation kit further includes a pre-fill solution container 0100, wherein the pre-fill solution container 0100 is used to contain the pre-fill solution. Optionally, the pre-fill solution container 0100 includes: a container, an insertion needle, and a clamp. The container contains the pre-fill solution, the insertion needle is connected to the container and can be used to fill the container with the pre-fill solution.

[0192] One outlet of the pre-filled liquid container 0100 is connected to the fourth side port connector 704 on the secondary pipeline 504, and the other outlet of the pre-filled liquid container 0100 is connected to the seventh side port connector 707 on the bridging pipeline 503. When the pre-filled liquid container 0100 is connected to the fourth side port connector 704 on the secondary pipeline 504, the pre-filled liquid container 0100 can pre-fill the spare oxygenator 401 of the secondary pipeline 504 before it is connected to the circulation pipeline. When the pre-filled liquid container 0100 is connected to the seventh side port connector 707 on the bridging pipeline 503, the pre-filled liquid container 0100 can pre-fill the replacement components connected to the bridging pipeline 503.

[0193] By directly integrating the pre-fill fluid container 0100 into the extracorporeal circulation kit, the operator does not need to pre-fill the oxygenator and the component to be replaced before replacing them, thereby reducing the number of replacement steps and effectively improving the replacement efficiency during the replacement of the oxygenator and the component to be replaced.

[0194] In some embodiments, a hemolysis detection device 804 is installed on the pipeline between the third three-way valve 203 and the fourth three-way valve 204. The hemolysis detection device 804 is used to monitor the degree of hemolysis in the circulating pipeline, thereby achieving real-time and continuous dynamic monitoring of the hemolysis status of the blood in the circulating pipeline. Furthermore, if the hemolysis detection device 804 detects hemolysis in the pipeline or that the degree of hemolysis exceeds a preset range, it will alert the operator.

[0195] The hemolysis detection device 804 can be a hemolysis monitoring sensor, which can monitor the hemoglobin content in plasma. If hemolysis occurs, the red blood cell membranes rupture, and hemoglobin inside the red blood cells is released into the plasma, increasing the hemoglobin content in the plasma. The hemolysis monitoring sensor determines whether a hemolytic reaction has occurred by monitoring the hemoglobin content in the plasma.

[0196] In this embodiment, the extracorporeal circulation kit is equipped with a hemolysis detection device 804 to monitor in real time whether hemolysis occurs in the blood in the circulation tubing, thereby improving the safety of patients using the ECMO system.

[0197] In some embodiments, the hemolysis monitoring sensor can be an electrochemical sensor. Since hemoglobin in blood is electrochemically active (it can undergo oxidation at an electrode), if hemoglobin is placed on a working electrode (such as a platinum electrode), the electrode will cause the hemoglobin to oxidize. This oxidation reaction generates an electric current. The electrochemical sensor determines the hemoglobin concentration by monitoring the magnitude of this current. Typically, the current magnitude is directly proportional to the hemoglobin concentration; that is, a larger current indicates a higher hemoglobin content in the plasma, i.e., a higher concentration, and a smaller current indicates a lower hemoglobin content in the plasma, i.e., a lower concentration.

[0198] In some alternative embodiments, the hemolysis monitoring sensor can also be an optical detection sensor. Hemoglobin is sensitive to light of specific wavelengths, especially 540nm and 576nm, which it readily absorbs. Therefore, when blood is irradiated with a beam of a specific color, the intensity of the light detected by the optical detection sensor reflects the concentration of hemoglobin in the plasma; the weaker the light, the higher the hemoglobin content, i.e., the higher the concentration. It should be noted that when using an optical detection sensor as a hemolysis monitoring sensor, a miniature spectral sensor can be integrated on the outside of the circulation tubing, thus avoiding contact with the blood and reducing the risk of infection.

[0199] In some embodiments, a hemolysis detection device 804 may be installed at the inlet blood vessel 501, the return blood vessel 505, and the blood pump 300 to comprehensively and accurately assess the blood status in the circulation tubing and components, ensuring patient safety.

[0200] In some embodiments, a clamping device 1000 is provided on the pipeline between the third three-way valve 203 and the fourth three-way valve 204. The clamping device 1000 can clamp the pipeline to achieve the opening and closing of the pipeline.

[0201] When air bubbles are detected in the circulation tubing or a sudden malfunction occurs (e.g., tubing components detach or rupture), the clamping device 1000 can be used to clamp the tubing, thereby stopping blood circulation in an emergency.

[0202] Optionally, the clamping device 1000 is installed in the pipeline between the third three-way valve 203 and the fourth three-way valve 204. That is, the clamping device 1000 is located close to the reflux vessel 505, which can quickly allow blood in the circulation pipeline to enter the patient's body, thus improving the safety of using the extracorporeal circulation kit.

[0203] like Figure 6 The extracorporeal circulation kit shown has a first flow sensor 806 installed on the pipeline between the blood pump 300 and the second three-way valve 202. A second flow sensor 807 is installed on the bridging pipeline 503 between the first three-way valve 201 and the fourth three-way valve 204. A third flow sensor 808 is installed on the pipeline between the oxygenator 400 and the third three-way valve 203.

[0204] The first flow sensor 806 is used to monitor the blood flow output by the blood pump 300 in real time, so as to adjust the speed of the blood pump 300 and ensure the stability of the blood flow in the system.

[0205] The second flow sensor 807 is used to monitor the real-time blood flow of the bridging tubing 503. During the ECMO system weaning bridging test, the operator can use devices such as Hoffman clips to precisely and controllably adjust the blood flow drawn out of the patient's body in combination with the flow values ​​obtained by the first flow sensor 806 and the second flow sensor 807 to meet the different needs of the patient.

[0206] The third flow sensor 808 is used to monitor the blood flow in the main pipeline 502 where the oxygenator 400 is located. When the oxygenator 400 and the standby oxygenator 401 are used in parallel, the blood flow through the oxygenator 400 and the blood flow through the standby oxygenator 401 can be monitored separately and in real time by monitoring the first flow sensor 806 and the third flow sensor 808.

[0207] By separately monitoring the blood flowing through oxygenator 400 and standby oxygenator 401, operators can easily and precisely allocate the flow rate of oxygenator 400 and standby oxygenator 401 using devices such as Hoffman clips.

[0208] Figure 6 In the illustrated embodiment, the extracorporeal circulation kit further includes a first blood monitoring system 809 and a second blood monitoring system 810. It should be noted that the first pressure sensor 801, second pressure sensor 802, third pressure sensor 803, hemolysis detection device 804, first flow sensor 806, second flow sensor 807, third flow sensor 808, first blood monitoring system 809, and second blood monitoring system 810 involved in this embodiment can all be assembled during the use of the extracorporeal circulation kit.

[0209] The first blood monitoring system 809 is located at the output end of the blood pump 300 and is used to monitor the oxygenation status of blood entering the oxygenator 400 and / or the standby oxygenator 401. Optionally, the first blood monitoring system 809 is located in the pipeline between the blood pump 300 and the second three-way valve 202, so that the oxygenation status of blood entering both the oxygenator 400 and the standby oxygenator 401 can be monitored.

[0210] The second blood monitoring system 810 is installed on the pipeline at the output end of the oxygenator 400 to monitor the oxygenation status of the blood output from the oxygenator. Optionally, the second blood monitoring system 810 is installed on the pipeline between the third three-way valve 203 and the fourth three-way valve 204. In this way, the oxygenation status of blood passing through both the oxygenator 400 and the standby oxygenator 401 can be monitored.

[0211] Optionally, both the first blood monitoring system 809 and the second blood monitoring system 810 are also capable of real-time monitoring of blood oxygen saturation (SpO2 / SvO2).

[0212] The first blood monitoring system 809 monitors the blood oxygen saturation before the oxygenator, that is, monitors the blood oxygen saturation at the inlet blood vessel 501, which can determine the oxygen consumption of the patient's tissues and organs and the remaining oxygen content in the blood.

[0213] The second blood monitoring system 810 monitors the blood oxygen saturation after the oxygenator, specifically the blood oxygen saturation at the return blood vessel 505. This reflects the gas exchange function of the oxygenator, thereby determining the oxygenation efficiency of the oxygenator to ensure stable oxygen supply to the patient's tissues and organs and avoid hypoxemia or oxygen toxicity.

[0214] In other optional embodiments, both the first blood monitoring system 809 and the second blood monitoring system 810 have the function of real-time monitoring of blood hemoglobin concentration (Hb). A low hemoglobin concentration (Hb) in the blood reduces the blood's oxygen delivery capacity, and hematocrit (HCT) is used to assess blood dilution or transfusion needs.

[0215] In other alternative embodiments, both the first blood monitoring system 809 and the second blood monitoring system 810 have real-time monitoring functions for blood temperature, blood oxygen partial pressure (PO2), and blood carbon dioxide partial pressure (PCO2).

[0216] Both the first blood monitoring system 809 and the second blood monitoring system 810 in this embodiment include a main control unit and a detection device.

[0217] The detection device is used to acquire blood parameters, including but not limited to oxygenation status, blood oxygen saturation, temperature, blood oxygen partial pressure, and carbon dioxide partial pressure. Optionally, the detection device may include a photodetector and an infrared temperature sensor.

[0218] The detection device and the main control unit can be electrically connected via a signal amplification circuit. The main control unit communicates with the ECMO system host via a communication module. Therefore, the detection device can transmit the acquired blood parameter information to the main control unit.

[0219] The detection unit in this embodiment includes multiple light sources, multiple photodetectors, and an infrared temperature sensor. The light sources and photodetectors can be used to acquire parameters such as blood oxygenation status, blood oxygen saturation, blood hemoglobin concentration, blood oxygen partial pressure, and blood carbon dioxide partial pressure. The infrared temperature sensor is used to acquire blood temperature.

[0220] Optionally, the first blood monitoring system 809 and the second blood monitoring system 810 can be blood gas analyzers.

[0221] Based on the positions of the first blood monitoring system 809 and the second blood monitoring system 810, it can be seen that in this embodiment, the first blood monitoring system 809 focuses on pre-oxygenation monitoring, while the second blood monitoring system 810 focuses on monitoring the post-oxygenation effect. Both the first blood monitoring system 809 and the second blood monitoring system 810 are connected to the host of the ECMO system, thus forming a closed-loop system for monitoring oxygen metabolism during ECMO treatment, which is the core tool for the ECMO system to achieve precise life support.

[0222] The first pressure sensor 801, the second pressure sensor 802, the third pressure sensor 803, the hemolysis detection device 804, the first flow sensor 806, the second flow sensor 807, and the third flow sensor 808 in this embodiment are all communicatively connected to the host of the ECMO system.

[0223] This enables the integration of multimodal data from real-time online monitoring of the ECMO system, improving clinical decision-making efficiency and patient safety.

[0224] It should be noted that the oxygenator 400 and blood pump 300 in this article can be an integrated design. When their performance deteriorates or malfunctions, the integrated component of oxygenator 400 and blood pump 300 can be replaced without interruption through a pre-installed bridge pipeline.

[0225] The oxygenator 400 and blood pump 300 integrated component described in this paper incorporates a flow sensor, pressure sensor, temperature sensor, bubble sensor, and carbon dioxide gas concentration sensor. This reduces the number of sensors and blood contact points, lowering the risk of coagulation and infection, while also simplifying the installation process of the ECMO system's extracorporeal circulation kit.

[0226] In other embodiments of this document, the circulation tubing, connectors, and internal blood flow areas of the ECMO system's extracorporeal circulation kit are coated with an anticoagulant coating. Preferably, the anticoagulant coating is a choline phosphate coating.

[0227] It should be noted that this article is not limited to the four embodiments described above. That is, the structures in the four embodiments can be combined with each other to form different embodiments, and all of them are included within the scope of this article.

[0228] Furthermore, this application also discloses an ECMO system, including an extracorporeal circulation kit and a main unit. The extracorporeal circulation kit is the same as the one disclosed in the above embodiments. Therefore, the ECMO system with this extracorporeal circulation kit also has all the above-mentioned technical effects, which will not be repeated here.

[0229] Furthermore, this application also discloses a method for using the extracorporeal circulation kit, applied to the extracorporeal circulation kit disclosed in the above embodiments, which includes the following steps:

[0230] S100: Pre-fill fluid for the extracorporeal circulation kit.

[0231] Both the inlet blood vessel 501 and the return blood vessel 505 are connected to the pre-filled component 100 to form a closed loop in the extracorporeal circulation kit.

[0232] Inject pre-filling fluid into the closed loop and start blood pump 300 to fill the main pipeline 502 and the secondary pipeline 504 with pre-filling fluid and remove gas from the closed loop.

[0233] Remove the pre-filled components and connect the inlet vessel 501 and return vessel 505 to the patient's blood vessels to establish extracorporeal circulation support.

[0234] S200: Determine if the oxygenator 400 has deteriorated or malfunctioned, and replace the oxygenator 400.

[0235] S200 specifically includes S201: The operator can determine whether the oxygenator 400's performance has declined or whether the oxygenator 400 is malfunctioning by observing the blockage of the oxygenator 400 or by detecting the oxygenation level of the blood after passing through the oxygenator 400. The degree of performance decline of the oxygenator 400 can be set according to different needs; for example, the operator detects that the performance of the oxygenator 400 is less than 80% of its initial performance.

[0236] S202: The operator opens the fourth quick-connect fitting on the secondary pipeline, inserts the spare oxygenator, fills the spare oxygenator and secondary pipeline with pre-filling fluid, and vents the air.

[0237] The operator connects the spare oxygenator 401 in series to the secondary pipeline 504. Optionally, the male connector of the spare oxygenator 401 is connected to the female connector of the fourth quick-connect fitting 604, forming a first branch quick-connect fitting 6041; the female connector of the spare oxygenator 401 is connected to the male connector of the fourth quick-connect fitting 604, forming a second branch quick-connect fitting 6042. This allows the spare oxygenator 401 to be connected in series to the secondary pipeline 504.

[0238] In some embodiments, one of the fourth side port connector 704 and the fifth side port connector 705 on the secondary pipeline 504 can be connected to a pre-filled liquid container, while the other serves as an exhaust port. In the example, the pre-filled liquid container fills the fourth side port connector 704 with pre-filled liquid, thereby filling the secondary pipeline 504 and the standby oxygenator 401 with pre-filled liquid. During the pre-filling process, the gas in the secondary pipeline 504 can be discharged through the fifth side port connector 705.

[0239] S203: The operator first connects the return blood vessel to the outlet end of the auxiliary tubing, and then connects the blood pump to the auxiliary tubing.

[0240] First, open the third port connecting the third three-way valve 203 to the auxiliary line 504, so that the return line 505 can be connected to the auxiliary line 504; then open the third port connecting the second three-way valve 202 to the auxiliary line 504 and close the second port connecting the second three-way valve 202 to the main line 502, so that the outlet of the blood pump 300 can be connected to the auxiliary line 504, thereby forming a blood flow path through the inlet line 501, the auxiliary line 504 and the return line 505.

[0241] After the above operations are completed, the newly connected standby oxygenator 401 on the secondary pipeline 504 will replace the oxygenator 400 on the main pipeline 502, meaning that the oxygenator 400 on the main pipeline 502 will not work.

[0242] S204: Pre-fill the main pipeline with pre-filling fluid to allow blood in the main pipeline and the oxygenator to flow into the return vessel; close the connection between the oxygenator and the return vessel.

[0243] Pre-fill fluid is introduced into the main pipeline, allowing blood in the main pipeline 502 and the oxygenator 400 to flow into the third three-way valve 203; the first port connecting the third three-way valve 203 to the main pipeline 502 is closed.

[0244] A pre-filled fluid container is connected to the second side port connector 702 on the main pipe 502. The pre-filled fluid is used to slowly push the blood in the main pipe 502 and the oxygenator 400 on the main pipe 502 into the third three-way valve 203 to avoid wasting blood. Then the first port connecting the third three-way valve 203 to the main pipe 502 is closed. After that, the main pipe 502 and the oxygenator 400 on the main pipe 502 are filled with pre-filled fluid and no longer participate in the circulation.

[0245] S205: Flushing or repairing the oxygenator.

[0246] Fill the oxygenator 400 with backwash fluid and discharge the backwash waste liquid after rinsing the oxygenator 400 into the main pipeline 502.

[0247] If the oxygenator 400 does not recover its performance, open the quick-connect fittings on both sides of the oxygenator 400, remove the oxygenator 400, and connect the fittings on the main pipeline 502 that are used to connect to both sides of the oxygenator 400 to connect the main pipeline 502, thus completing a complete replacement process for the oxygenator 400.

[0248] Furthermore, the method of using the extracorporeal circulation kit disclosed in this application embodiment may also include S300: replacing the component to be replaced, the process of replacing the component to be replaced includes the following steps:

[0249] S301: Determine if the component to be replaced has experienced performance degradation or failure.

[0250] The components to be replaced include blood pump 300, oxygenator 400, main line 502 and auxiliary line 504, and other structures disposed on main line 502 and auxiliary line 504.

[0251] Operators can determine whether the performance of the component to be replaced has deteriorated or whether it is malfunctioning by observing the blockage of the component or by detecting the flow rate, pressure, hemolysis, or oxygenation level of the blood passing through the component. The degree of performance degradation of the component to be replaced can be set according to different needs; for example, if the operator detects that the performance of the oxygenator 400 is less than 80% of its initial performance.

[0252] S302: The operator opens the seventh quick-connect fitting on the bridge pipe, inserts the replacement assembly, fills the replacement assembly with pre-fill fluid, and vents the air.

[0253] The operator opens the seventh quick-connect connector 607, separating the male and female prongs, and connects the replacement component to the seventh quick-connect connector 607. The replacement component has the same structure as the component to be replaced. The male (or female) prong of the eighth quick-connect connector 608 of the replacement component and the female (or male) prong of the sixth quick-connect connector 606 are connected to the male and female prongs of the seventh quick-connect connector 607, respectively, forming a series structure. In this way, the replacement component is connected to the original extracorporeal circulation kit.

[0254] After the replacement component is connected to the seventh quick-connect connector 607, the operator pre-fills and vents the replacement component through the seventh side connector 707 and the sixth side connector 706. In the example, the pre-fill container fills the seventh side connector 707 with pre-fill fluid, so that the replacement component is filled with pre-fill fluid. During the pre-fill process, the gas in the replacement component is discharged through the sixth side connector 706.

[0255] S303: The operator first connects the reflux vessel to the outlet end of the bridging pipe, and then connects the drain vessel to the inlet end of the bridging pipe.

[0256] Specifically, switch the fourth three-way valve 204 to connect the return blood vessel 505 to the bridging pipe 503, switch the first three-way valve 201 to connect the lead blood vessel 501 to the bridging pipe 503, start the blood pump on the replacement component, close the first port connecting the first three-way valve 201 to the main pipe 502, and turn off the blood pump 300 on the component to be replaced.

[0257] Once the above steps are completed, the alternative component will be able to start.

[0258] S304: Inflate the component to be replaced with pre-filled fluid to allow blood in the component to flow back into the blood vessel; close the first port of the fourth three-way valve connected to the main pipeline.

[0259] The operator connects the pre-filled fluid container to the first side port connector 701 and uses the pre-filled fluid in the container to slowly push the blood in the component to be replaced into the return blood vessel 505 through the fourth three-way valve 204. In this way, the shutdown operation of the component to be replaced is completed, and the replacement operation of the replacement component is completed, that is, the replacement and switching operation of the component to be replaced in the extracorporeal circulation kit is completed.

[0260] Based on the above procedures, it is clear that blood circulation remains uninterrupted and blood flow does not fluctuate throughout the entire replacement process. Therefore, this helps reduce thrombus formation and minimizes the impact on the patient. Furthermore, the replacement process avoids blood exposure and loss, reducing the risk of infection and air ingress. This contributes to improved safety and continuity of treatment.

[0261] In addition, after replacing the replacement component using the above replacement method, the maintenance personnel can repair the component that needs repair or processing. Since the entire blood circulation is not interrupted and there is no drastic flow fluctuation during the repair process, the maintenance personnel can repair the component to be replaced for a long time. It can be understood that the repair of the component to be replaced is not limited by time.

[0262] S305: Disassemble the component to be replaced.

[0263] After the replacement component is working properly, the operator can disconnect the sixth quick connector 606 and the eighth quick connector 608, thereby removing the entire replacement component from the extracorporeal circulation kit. The remaining connector of the sixth quick connector 606 on the extracorporeal circulation kit is then connected to the remaining connector of the eighth quick connector 608, thus forming a new bridging pipeline 503 between the remaining connector of the sixth quick connector 606 and the remaining connector of the eighth quick connector 608.

[0264] In addition, the method of using the extracorporeal circulation kit disclosed in this embodiment, after establishing extracorporeal circulation support, also includes S400: withdrawal bridging test, and the withdrawal bridging test includes the following steps:

[0265] S401: First connect the inlet blood vessel 501 to the bridging tube 503, then connect the return blood vessel 505 to the bridging tube 503, so that the inlet blood vessel 501, the bridging tube 503 and the return blood vessel 505 are connected, thus realizing the bridging of the circulation tubing of the extracorporeal circulation kit.

[0266] Specifically, the operator first opens the third port connecting the first three-way valve 201 to the bridge pipe 503, and then opens the third port connecting the fourth three-way valve 204 to the bridge pipe 503, so that the bridge pipe 503 is open.

[0267] Then, the operator reduces the second port connecting the fourth three-way valve 204 and the return vessel 505 until the second port connecting the fourth three-way valve 204 and the return vessel 505 is closed, and closes the first port connecting the first three-way valve 201 and the drain vessel 501. This means the extracorporeal circulation kit no longer delivers blood to the patient, and the patient's blood no longer enters the extracorporeal circulation kit. This can also be understood as gradually reducing the blood flow in the drain vessel 501 of the extracorporeal circulation kit until it reaches zero. In this way, the main pipeline 502 and bridging pipeline 503 of the extracorporeal circulation kit, as well as the blood pump 300 and oxygenator 400 on the main pipeline 502, form a closed blood flow channel. This channel contains the blood pump 300 and oxygenator 400, enabling self-circulation of the extracorporeal circulation kit's circulation tubing under the action of the blood pump 300 and oxygenator 400, preventing blood flow stagnation within the circulation channel. During the weaning bridging test, blood circulation in the tubing can be uninterrupted, and the bridging of the ECMO system's circulation tubing can be achieved non-invasively and without damaging the blood.

[0268] S402: Obtain the patient's own tolerance level.

[0269] If the patient experiences intolerance during weaning, extracorporeal circulation needs to be restored. The operator closes the bridging tubing 503. Specifically, first, open the first port of the first three-way valve 201 and the first port of the drain tube 501, and open the second port of the fourth three-way valve 204 and the return tube 505. Then, gradually close the third port of the first three-way valve 201 and the bridging tubing 503, so that the main tubing 502 connects the drain tube 501 and the return tube 505. The blood pump 300 and oxygenator 400 provide support to the patient, and extracorporeal circulation is restored. Then, using the seventh side port connector, connect the priming fluid container and fill the bridging tubing with priming fluid, gradually pushing the blood in the bridging tubing 503 into the return tube 505.

[0270] If the operator obtains the patient's tolerance for weaning, the operator can connect the sixth side port connector to the pre-filled fluid container, open the second port connecting the fourth three-way valve 204 to the return vessel 505, and simultaneously close the third port connecting the fourth three-way valve 204 to the bridging pipe 503. The operator shuts down the blood pump 300, and uses the pressure of the pre-filled fluid in the pre-filled fluid container connected to the sixth side port connector to gradually and slowly infuse blood from the extracorporeal circulation kit into the patient's body, and then wean the ECMO system off.

[0271] The extracorporeal circulation kit in this embodiment can avoid thrombosis caused by blood residue through the sixth side hole connector and / or the seventh side hole connector, which helps to ensure the normal use of the extracorporeal circulation kit.

[0272] In this embodiment, the extracorporeal circulation kit has no open operation steps during the bridging operation, and the extracorporeal circulation kit forms a stable closed self-circulating system, reducing the risk of air intake and infection. In addition, it can prevent blood flow stagnation within the self-circulating system of the extracorporeal circulation kit, thus reducing the formation of thrombi, making the entire bridging process non-invasive and without damaging the blood.

[0273] Finally, it should be noted that in this document, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the term "comprising" or any other variation thereof is intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus.

[0274] The various embodiments in this specification are described in a progressive manner, with each embodiment focusing on the differences from other embodiments. The same or similar parts between the various embodiments can be referred to each other.

[0275] The above description of the disclosed embodiments enables those skilled in the art to make or use the invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the invention. Therefore, the invention is not to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. An extracorporeal circulation package, characterized by, include: A main pipeline (502) is connected at one end to a drain line (501) and at the other end to a return line (505). A blood pump (300) and an oxygenator (400) are connected in series on the main pipeline (502). Both ends of the oxygenator (400) are connected to the main pipeline (502) via quick-connect fittings. The quick-connect fittings on the main pipeline (502) for connecting to the oxygenator (400) can be inserted into and connected to the main pipeline (502). A secondary pipeline (504) is provided, one end of which is connected to the input end of the oxygenator (400) via a second three-way valve (202), and the other end of which is connected to the output end of the oxygenator (400) via a third three-way valve (203). The secondary pipeline (504) is provided with a fourth quick-connect fitting (604), the male and female ends of which are used to connect with the two ends of the spare oxygenator (401) so that the spare oxygenator (401) is connected in series with the secondary pipeline (504). The main pipeline (502) is provided with a second side port connector (702) and a third side port connector (703); the second side port connector (702) and the third side port connector (703) are distributed on the pipelines on both sides of the oxygenator (400), and one of the second side port connector (702) and the third side port connector (703) is used to connect to the pre-filled liquid container; the pre-filled liquid container is connected to the second side port connector (702) on the main pipeline (502), and the blood in the main pipeline (502) and the oxygenator (400) on the main pipeline (502) is slowly pushed into the third three-way valve (203) by the pre-filled liquid and returned to the return vessel (505).

2. The extracorporeal circulation kit according to claim 1, characterized in that, The secondary pipeline (504) is provided with a fourth side hole connector (704) and a fifth side hole connector (705); the fourth side hole connector (704) and the fifth side hole connector (705) are distributed on both sides of the fourth quick-connect connector (604), and one of the fourth side hole connector (704) and the fifth side hole connector (705) is used to connect to the pre-filled liquid container or both are used to connect to the pressure sensor.

3. The extracorporeal circuit package of claim 2, wherein, The quick-connect fittings at both ends of the oxygenator (400) are located on the pipeline between the second side hole fitting (702) and the third side hole fitting (703).

4. The extracorporeal circulation kit according to claim 2, characterized in that, It also includes a pre-filled liquid container (0100) which is capable of being connected to and disconnected from the fourth side hole connector (704) and / or the second side hole connector (702).

5. The extracorporeal circulation kit according to claim 2, characterized in that, A first drain valve (901) is provided on the main pipeline (502), and the first drain valve (901) is used to discharge the backwash waste liquid generated by backwashing the main pipeline (502); And / or, The secondary pipeline (504) is equipped with a second drain valve (902), which is used to discharge the backwash waste liquid generated by backwashing the secondary pipeline (504).

6. The extracorporeal circulation kit according to claim 5, characterized in that, The first drain valve (901) and / or the second drain valve (902) are equipped with check valves; The one-way valve of the first drain valve (901) is open from the main pipeline (502) to the outside in a one-way direction; the one-way valve of the second drain valve (902) is open from the auxiliary pipeline (504) to the outside in a one-way direction.

7. The extracorporeal circulation kit according to any one of claims 1 to 6, characterized in that, The secondary pipeline (504) is equipped with a spare oxygenator (401), and one end of the spare oxygenator (401) is connected to the female end of the fourth quick connector (604), and the other end is connected to the male end of the fourth quick connector (604).

8. The extracorporeal circulation kit according to any one of claims 1 to 6, characterized in that, It also includes a bridge pipe (503), one end of which is connected to the main pipe (502) and the drain pipe (501) through a first three-way valve (201); The other end of the bridge pipe (503) is connected to the main pipe (502) and the return pipe (505) through the fourth three-way valve (204).

9. The extracorporeal circulation kit according to claim 8, characterized in that, The bridge pipe (503) is equipped with a seventh quick-connect connector (607). An eighth quick-connector (608) is provided on the pipeline between the first three-way valve (201) and the blood pump (300), and a sixth quick-connector (606) is provided on the pipeline between the third three-way valve (203) and the fourth three-way valve (204); the eighth quick-connector (608) and the sixth quick-connector (606) are components to be replaced; The male and female ends of the seventh quick-connect connector (607) can be connected to a replacement component, the structure of which is the same as that of the component to be replaced; Furthermore, the male head of the sixth quick-connect connector (606) can be connected to the female head of the eighth quick-connect connector (608), or the female head of the sixth quick-connect connector (606) can be connected to the male head of the eighth quick-connect connector (608).

10. The extracorporeal circulation kit according to claim 9, characterized in that, The bridge pipe (503) is also provided with a sixth side hole connector (706) and a seventh side hole connector (707), which are distributed on both sides of the seventh quick connector (607); Furthermore, one of the sixth side hole connector (706) and the seventh side hole connector (707) is used to connect to the pre-filled liquid container, and the other is used to vent air.

11. The extracorporeal circulation kit according to claim 10, characterized in that, It also includes a pre-filled liquid container (0100) which is capable of being connected to or disconnected from the sixth side hole connector (706) or the seventh side hole connector (707).

12. The extracorporeal circulation kit according to claim 9, characterized in that, It also includes a first side hole connector (701) and an eighth side hole connector (708). The first side-hole connector (701) is disposed on the pipeline between the eighth quick-connect connector (608) and the first three-way valve (201); the eighth side-hole connector (708) is disposed on the pipeline between the sixth quick-connect connector (606) and the fourth three-way valve (204); Furthermore, one of the first side hole connector (701) and the eighth side hole connector (708) is used to connect to the pre-filled liquid container, and the other is used to vent; or, the first side hole connector (701) is used to connect to the pressure sensor.

13. The extracorporeal circulation kit according to claim 9, characterized in that, It also includes a filter assembly (805), one end of which is connected to the male end of the eighth quick connector (608), and the other end of which is connected to the female end of the eighth quick connector (608).

14. The extracorporeal circulation kit according to claim 8, characterized in that, It also includes at least one of a first pressure sensor (801), a second pressure sensor (802), and a third pressure sensor (803); The first pressure sensor (801) is disposed on the pipeline at the input end of the blood pump (300); The second pressure sensor (802) is disposed on the pipeline between the blood pump (300) and the oxygenator (400); The third pressure sensor (803) is installed on the pipeline at the output end of the oxygenator (400).

15. The extracorporeal circulation kit according to claim 14, characterized in that, The third pressure sensor (803) is installed on the pipeline between the third three-way valve (203) and the fourth three-way valve (204).

16. The extracorporeal circulation kit according to claim 8, characterized in that, It also includes a hemolysis detection device (804) for monitoring the degree of hemolysis of blood in the main pipeline (502) and / or the secondary pipeline (504).

17. The extracorporeal circulation kit according to claim 16, characterized in that, The hemolysis detection device (804) is an electrochemical sensor or an optical detection sensor.

18. The extracorporeal circulation kit according to claim 8, characterized in that, It also includes at least one of a first flow sensor (806), a second flow sensor (807), and a third flow sensor (808); The first flow sensor (806) is disposed on the pipeline at the output end of the blood pump (300); The second flow sensor (807) is disposed on the bridge pipe (503); The third flow sensor (808) is mounted on the main pipeline (502).

19. The extracorporeal circulation kit according to claim 18, characterized in that, The first flow sensor (806) is disposed on the pipeline between the blood pump (300) and the second three-way valve (202); The third flow sensor (808) is disposed on the main pipeline (502) or the secondary pipeline (504) between the second three-way valve (202) and the third three-way valve (203).

20. The extracorporeal circulation kit according to claim 8, characterized in that, It also includes at least one of the first blood monitoring system (809) and the second blood monitoring system (810); The first blood monitoring system (809) is installed on the pipeline between the blood pump (300) and the second three-way valve (202). The first blood monitoring system (809) is used to monitor the oxygenation status of the blood before entering the oxygenator (400) and / or before entering the backup oxygenator installed on the auxiliary pipeline (504). The second blood monitoring system (810) is installed on the pipeline between the third three-way valve (203) and the fourth three-way valve (204). The second blood monitoring system (810) is used to monitor the oxygenation status of the blood after the output of the oxygenator (400) and / or after the output of the standby oxygenator installed on the auxiliary pipeline (504).

21. The extracorporeal circulation kit according to claim 20, characterized in that, At least one of the first blood monitoring system (809) and the second blood monitoring system (810) is also used to monitor at least one of blood oxygen saturation, blood hemoglobin concentration, blood temperature, blood oxygen partial pressure and blood carbon dioxide partial pressure.

22. The extracorporeal circulation kit according to claim 20, characterized in that, The first blood monitoring system (809) and the second blood monitoring system (810) may each include a main control unit and a detection device, and the detection device is used to obtain the oxygenation status of the blood, and the detection device is communicatively connected to the main control unit.

23. The extracorporeal circulation kit according to claim 8, characterized in that, It also includes a clamping device (1000) for controlling the opening and closing of the pipeline, the clamping device (1000) being capable of clamping the pipeline.

24. The extracorporeal circulation kit according to claim 23, characterized in that, The clamping device (1000) is installed on the pipeline between the third three-way valve (203) and the fourth three-way valve (204).

25. The extracorporeal circulation kit according to any one of claims 1 to 6, characterized in that, It also includes a pre-charged component (100); The end of the drain tube (501) away from the main pipeline (502) is connected to the outlet of the pre-charge assembly (100) via a first quick-connect connector (601); The end of the return vessel (505) away from the main pipeline (502) is used to connect to the inlet of the pre-charge assembly (100) via a fifth quick-connect fitting (605); Furthermore, one end of the first quick-connect connector (601) on the drain vessel (501) can be connected to one end of the fifth quick-connect connector (605) on the return vessel (505).

26. The extracorporeal circulation kit according to any one of claims 1 to 6, characterized in that, All tubing, connectors, and blood flow points of the extracorporeal circulation kit are coated with an anticoagulant coating.

27. An extracorporeal membrane oxygenation system, characterized in that, It includes an extracorporeal circulation kit and a main unit, wherein the extracorporeal circulation kit is the extracorporeal circulation kit as described in any one of claims 1 to 26; At least one of the following components of the extracorporeal circulation kit—the first pressure sensor (801), the second pressure sensor (802), the third pressure sensor (803), the hemolysis detection device (804), the first flow sensor (806), the second flow sensor (807), the third flow sensor (808), the first blood monitoring system (809), and the second blood monitoring system (810)—is electrically connected to the host machine.

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