Extracorporeal Circulation Dialysis Tubing Anticoagulation Test System and Test Method

Abstract

The present invention relates to an anticoagulation test system and test method for an extracorporeal circulation dialysis pipeline. The anticoagulation test system includes: a dialysis test pipeline device, including a dialysis circulation pipeline component and a sampling pipeline component, and the sampling pipeline component is used to collect the fluid flowing in the dialysis circulation pipeline component; a blood circulation simulation device, including a pump pressure component, a heat exchanger device and an oxygenator device; a blood reservoir device, including a first input port, a second input port and a shunt member, the dialysis circulation pipeline component is connected to the first input port and the shunt member, the oxygenator device is connected to the second input port, and the pump pressure component is connected to the shunt member, wherein the fluid flowing in the dialysis circulation pipeline component and the fluid flowing in the blood circulation simulation device are mixed in the blood reservoir device. The blood circulation simulation device can simulate the internal circulation of human blood to keep the test conditions of the extracorporeal circulation dialysis pipeline anticoagulation test system in line with the clinical use state.

Description

Technical Field

[0001] The present invention relates to the technical field of testing, and particularly to an anticoagulation testing system and method for an extracorporeal circulation dialysis pipeline. Background Art

[0002] The extracorporeal circulation dialysis pipeline is used to filter and purify blood, remove or reduce metabolites and harmful substances carried in the blood, maintain the balance of electrolytes and acid-base, so that the various indicators of the blood meet the normal human demand parameters, and the purified blood is transfused back into the human body to meet the normal circulation requirements of the human body.

[0003] Chinese Patent CN109498874A relates to an extracorporeal circulation pipeline for venous hemodialysis, including a dialysis connector, a pressure sensor, a venous drip chamber, a second hemostatic clip, a puncture needle pipeline connection joint, a third hose, a fifth hose, and a mother needle base pipeline. The liquid outlet of the dialysis connector is connected to the liquid inlet of the pressure sensor, the liquid outlet of the pressure sensor is connected to the liquid inlet of the venous drip chamber through the third hose, the liquid outlet of the venous drip chamber is connected to the puncture needle pipeline connection joint through the fifth hose, a first branch pipe interface is provided at the upper end of the venous drip chamber, the liquid outlet end of the mother needle base pipeline is connected to the first branch pipe interface, and the second hemostatic clip is arranged on the fifth hose.

[0004] During the R & D process of the extracorporeal circulation dialysis pipeline, various indicators need to be tested. For example, the extracorporeal circulation dialysis pipeline needs to be tested for anticoagulation. The existing test blood circulates multiple times along the extracorporeal circulation dialysis pipeline to complete the anticoagulation test. However, even when the extracorporeal circulation dialysis pipeline is tested under the set temperature conditions, the storage mechanism of the test blood is a static structure, which cannot simulate the in-vivo circulation of the human body and the actual clinical use state of the extracorporeal circulation dialysis pipeline. There are technical problems such as inconsistent index parameters after the test blood circulates and inaccurate anticoagulation detection of the extracorporeal circulation dialysis pipeline, so improvement is needed. Summary of the Invention

[0005] To overcome the problems existing in the related art, an embodiment of the present invention provides an anticoagulation testing system and method for an extracorporeal circulation dialysis pipeline.

[0006] An anticoagulation testing system for an extracorporeal circulation dialysis pipeline according to an embodiment of the present invention includes:

[0007] A dialysis test pipeline device, including a dialysis circulation pipeline assembly and a sampling pipeline assembly connected to the dialysis circulation pipeline assembly, where the sampling pipeline assembly is used to collect the fluid flowing in the dialysis circulation pipeline assembly;

[0008] A blood circulation simulation device, comprising a pump pressure assembly, a heat exchanger device and an oxygenator device connected by a catheter, wherein the heat exchanger device is used to adjust the temperature of the fluid flowing in the blood circulation simulation device, and the oxygenator device is used to adjust the oxygen content of the fluid flowing in the blood circulation simulation device;

[0009] A blood reservoir device, comprising a first input port, a second input port and a shunt member, wherein the dialysis circulation pipeline assembly is connected to the first input port and the shunt member, the oxygenator device is connected to the second input port, and the pump pressure assembly is connected to the shunt member. Wherein, the fluid flowing in the dialysis circulation pipeline assembly and the fluid flowing in the blood circulation simulation device are mixed in the blood reservoir device.

[0010] In one embodiment, the blood reservoir device comprises a housing and a filtering assembly installed in the housing. A blood storage cavity is formed between the housing and the filtering assembly. The first input port and the second input port communicate with the filtering assembly, and the shunt member communicates with the blood storage cavity.

[0011] In one embodiment, the filtering assembly comprises at least one filtering membrane bag, and the filtering membrane bag filters the fluid input from the first input port or the second input port correspondingly.

[0012] In one embodiment, the dialysis test pipeline assembly comprises a joint pipe assembly, a dialysis pump pressure assembly, an exhaust assembly and a test pipe group connected in sequence by pipelines. The joint pipe assembly communicates with the blood reservoir device, the sampling pipeline assembly is connected to the joint pipe assembly, the dialysis pump pressure assembly drives the fluid in the dialysis test pipeline device to flow according to a preset pump pressure value, and the exhaust assembly discharges the gas in the process of the fluid circulating in the dialysis test pipeline device.

[0013] In one embodiment, the exhaust assembly comprises a drip funnel and an exhaust pipe member connected to the drip funnel. The pipeline of the dialysis pump pressure assembly is connected to the drip funnel, and the exhaust pipe member controls the liquid level in the drip funnel based on discharging the gas above the liquid level of the drip funnel.

[0014] In one embodiment, the blood circulation simulation device further comprises a blood oxygen detection branch, and the blood oxygen detection branch is arranged on the output pipeline of the oxygenator device.

[0015] In one embodiment, an oxygen content regulator connected to the oxygenator device is further included, and the oxygen content regulator adjusts the oxygen concentration based on the detection value of the blood oxygen detection branch.

[0016] The present invention also discloses a test method for anticoagulation of an extracorporeal circulation dialysis pipeline. Using the extracorporeal circulation dialysis pipeline anticoagulation test system as described above, the test method comprises the following steps:

[0017] Guide the fluid to circulate through the dialysis circuit assembly, and collect the fluid flowing in the dialysis circuit assembly through the sampling line assembly;

[0018] Deliver the fluid with a preset pressure value to the heat exchanger device and the oxygenator device through the pump pressure assembly;

[0019] Send the fluid flowing in the dialysis circuit assembly and the blood circulation simulation device into the blood reservoir device for filtration and mixing;

[0020] Let the filtered and mixed fluid flow into the dialysis circuit assembly and the blood circulation simulation device respectively;

[0021] Loop through the above steps in sequence.

[0022] In one embodiment, it includes:

[0023] Regularly collect the fluid flowing in the dialysis circuit assembly through the sampling line assembly;

[0024] Perform coagulation index detection.

[0025] In one embodiment, it includes: pre-clean the dialysis test line device with heparin fluid before the operation of the extracorporeal circulation dialysis line anticoagulation test system.

[0026] The technical solutions provided by the embodiments of the present invention may include the following beneficial effects: The blood circulation simulation device can simulate the internal circulation of human blood to keep the test conditions of the extracorporeal circulation dialysis line anticoagulation test system in line with the clinical use state, can accurately obtain the anticoagulation test parameters of the dialysis test line device, and has a good simulation effect. The extracorporeal circulation dialysis line anticoagulation test system collects the fluid circulating in the system through the sampling line assembly, and then detects various parameters in the fluid sample through the detection instrument, so as to obtain various coagulation index parameters, and the detection accuracy is high. The fluid flowing in the dialysis test line device and the blood circulation simulation device is mixed in the blood reservoir device to form a mixed fluid, simulating the human dialysis process, and the simulation effect is good.

[0027] It should be understood that the above general description and the following detailed description are only exemplary and explanatory, and cannot limit the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] The accompanying drawings here are incorporated into the specification and constitute a part of this specification, showing the embodiments in line with the present invention, and are used together with the specification to explain the principles of the present invention.

[0029] Figure 1 It is a schematic diagram of an anticoagulation test system shown according to an exemplary embodiment.

[0030] Figure 2 It is a schematic diagram of the fluid flow direction of an anticoagulation test system shown according to an exemplary embodiment.

[0031] Figure 3 It is a schematic cross-sectional structure diagram of a blood reservoir device shown according to an exemplary embodiment.

[0032] Figure 4 It is a schematic cross-sectional structure diagram of a blood reservoir device provided with a flow guide frame shown according to an exemplary embodiment.

[0033] Figure 5 It is a schematic transverse cross-sectional diagram of a blood reservoir device shown according to an exemplary embodiment.

[0034] Figure 6 It is a schematic cross-sectional structure diagram of another blood reservoir device shown according to an exemplary embodiment.

[0035] Figure 7 It is a schematic cross-sectional view of a heat exchanger device shown according to an exemplary embodiment.

[0036] In the figure, there are a dialysis test pipeline device 10; a dialysis circulation pipeline assembly 11; a joint pipe assembly 111; a multi-way joint 1111; a dialysis pump pressure assembly 112; an exhaust assembly 113; a test pipe group 114; a sampling pipeline assembly 12; a lead-out pipe 121; a sampling sealing assembly 122; a blood reservoir device 20; a first input port 21; a second input port 22; a shunt member 23; a main channel 231; a filtering assembly 24; a first filter bag 241; a second filter bag 242; a housing 25; a blood storage cavity 251; a spiral guide groove 252; a flow guide frame 26; a flow guide curved surface 261; a cylindrical extension surface 262; a flow guide gap 263; a flow guide pipe 264; a spiral groove 265; a filter membrane 27; a blood circulation simulation device 30; a pump pressure assembly 31; a heat exchanger device 32; a flow guide assembly 321; a fluid input channel 3211; a fluid output channel 3212; a flow guide hole 3213; a baffle 3214; a heat conduction assembly 322; a heat conduction pipe 3221; a heat exchange housing 323; an oxygenator device 33; an oxygen content regulator 34; a blood oxygen detection branch 35. Detailed implementation manners

[0037] Among them, the attached drawings are only for illustrative purposes, showing only schematic diagrams rather than actual pictures, and should not be construed as a limitation to this patent; in order to better illustrate the embodiments of the present invention, some components in the attached drawings will be omitted, enlarged or reduced, which do not represent the dimensions of the actual product; for those skilled in the art, it is understandable that some well-known structures and their descriptions in the attached drawings may be omitted.

[0038] In the drawings of the embodiments of the present invention, the same or similar reference numerals correspond to the same or similar components; in the description of the present invention, it should be understood that if terms such as "upper", "lower", "left", "right", "inner", "outer", etc. are used to indicate the orientation or positional relationship, it is based on the orientation or positional relationship shown in the drawings. This is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation. Therefore, the terms describing the positional relationship in the drawings are only for illustrative purposes and cannot be construed as a limitation of this patent. For those of ordinary skill in the art, the specific meanings of the above terms can be understood according to specific circumstances.

[0039] In the description of the present invention, unless otherwise clearly specified and limited, if terms such as "connection" are used to indicate the connection relationship between components, this term should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or integrated; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, and it can be the communication inside two components or the interaction relationship between two components. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0040] As Figures 1 to 5 shown, the present invention provides an anticoagulation test system for extracorporeal circulation dialysis tubing, which is used to simulate the anticoagulation parameter test of extracorporeal circulation dialysis tubing under clinical conditions to obtain accurate anticoagulation indicators for extracorporeal circulation dialysis tubing.

[0041] The anticoagulation test system includes a dialysis test tubing device 10, a blood circulation simulation device 30, and a reservoir device 20 connecting the dialysis test tubing device 10 and the blood circulation simulation device 30. Among them, the dialysis test tubing device 10 is used to simulate the extracorporeal circulation dialysis tubing of blood, the blood circulation simulation device 30 is used to simulate the in vivo blood circulation, and the reservoir device 20 constitutes the function of a blood mixing hub connecting the extracorporeal circulation and the in vivo circulation.

[0042] The reservoir device 20 is a container structure and has the functions of filtration and mixing. Among them, the reservoir device 20 includes a first input port 21, a second input port 22, and a shunt member 23. The first input port 21 is used to connect the dialysis test tubing device 10 to guide the fluid flowing in the dialysis test tubing device 10 into the reservoir device 20, and the second input port 22 is used to connect the blood circulation simulation device 30 to guide the fluid flowing in the blood circulation simulation device 30 into the reservoir device 20. The fluids are mixed in the reservoir device 20 to form a fluid with balanced parameters. The shunt member is used to guide the output of the fluid with balanced mixing in the reservoir device 20 to output to the dialysis test tubing device 10 and the blood circulation simulation device 30 respectively.

[0043] The dialysis test pipeline device 10 includes a dialysis circulation pipeline assembly 11 and a sampling pipeline assembly 12 connected to the dialysis circulation pipeline assembly 11. The sampling pipeline assembly 12 is used to collect the fluid flowing in the dialysis circulation pipeline assembly 11. One end of the dialysis circulation pipeline assembly 11 is connected to a branch of the fluid distributor, and the other end is connected to the first input port 21. The blood reservoir device 20 and the dialysis circulation pipeline assembly 11 form the first circulation pipeline. The sampling pipeline assembly 12 is connected to the dialysis circulation pipeline assembly 11 and can extract fluid samples flowing in the dialysis circulation pipeline assembly 11 at a preset frequency for detection, so as to obtain the anticoagulation parameters of the fluid flowing in the dialysis circulation pipeline assembly 11. For example, the fluid is a prepared test fluid, and the preparation method of the test fluid is to retrieve whole blood and add a certain unit of glucose, sodium heparin, and sodium bicarbonate to the whole blood for blood adjustment. The adjusted test fluid is used to determine indicators such as the counts of platelets, WBC, and RBC through a cell analyzer. If the indicators meet the requirements, it is injected into the blood reservoir device 20. If the indicators do not meet the requirements, the counts of platelets, WBC, and RBC are adjusted to the range of the indicators with normal saline.

[0044] The blood circulation simulation device 30 and the blood reservoir device 20 form the second circulation pipeline of the anticoagulation test system. Among them, the blood circulation simulation device 30 includes a pump pressure assembly 31, a heat exchanger device 32, and an oxygenator device 33 connected by a catheter. The heat exchanger device 32 is used to adjust the temperature of the fluid flowing in the blood circulation simulation device 30, and the oxygenator device 33 is used to adjust the oxygen content of the fluid flowing in the blood circulation simulation device 30. The oxygenator device 33 is connected to the second input port 22, and the pump pressure assembly 31 is connected to the shunt member 23. Among them, the fluid flowing in the dialysis circulation pipeline assembly 11 and the fluid flowing in the blood circulation simulation device 30 are mixed in the blood reservoir device 20.

[0045] The first circulation pipeline and the second circulation pipeline operate independently and mix fluids at the blood reservoir device 20, thereby simulating the clinical process of human dialysis and effectively obtaining the anticoagulation test parameters of the dialysis circulation pipeline assembly 11. The blood circulation simulation device 30 can simulate the internal circulation of human blood to keep the test conditions of the extracorporeal circulation dialysis pipeline anticoagulation test system in line with the clinical use state, accurately obtain the anticoagulation test parameters of the dialysis test pipeline device 10, and has a good simulation effect. The extracorporeal circulation dialysis pipeline anticoagulation test system collects the fluid circulating in the system through the sampling pipeline assembly 12, and then detects various parameters in the fluid sample through a detection instrument, thereby obtaining various coagulation index parameters, and the detection accuracy is high. The fluids flowing in the dialysis test pipeline device 10 and the blood circulation simulation device 30 are mixed in the blood reservoir device 20 to form a mixed fluid, simulating the human dialysis process with a good simulation effect.

[0046] In one embodiment, the blood reservoir device 20 is a component for realizing the mixing of fluids in the first and second circulation pipelines of the anticoagulation test system. It can not only guide and mix the two fluids, but also filter and purify the fluids.

[0047] The blood reservoir device 20 includes a housing 25 and a filter assembly 24 installed in the housing 25. A blood storage cavity 251 is formed between the housing 25 and the filter assembly 24. The first input port 21 and the second input port 22 are communicated with the filter assembly 24, and the shunt member 23 is communicated with the blood storage cavity 251. The housing 25 is a hollow container structure, and fluids are introduced only through the first input port 21 and the second input port 22. The shunt member 23 is provided with a main channel 231 and two or more branch channels communicated with the main channel 231. The fluid in the blood storage cavity 251 enters through the main channel 231 and then enters the first and second circulation pipelines through the branch channels respectively, realizing the unified distribution of the fluid. The fluid parameters of the fluids in the first and second circulation pipelines are basically the same. Preferably, the first input port 21 and the second input port 22 are arranged at the top of the housing 25, and the shunt member 23 is arranged at the bottom of the housing 25 to form a self-weight circulation and improve the smoothness of the fluid. Preferably, the bottom of the housing 25 is set as a conical or arc-shaped curved surface, so that the shunt member 23 is located at the lowest position of the liquid level at the bottom of the housing 25, and the liquid pressure at the inlet of the shunt member 23 is the largest and can guide the fluid to flow out completely.

[0048] Embodiment 1

[0049] As Figures 1 to 5 shown, the filter assembly 24 filters the fluids input by the dialysis circulation pipeline assembly 11 and the blood circulation simulation device 30 to remove blood clots, coagulated particles and other large particle substances generated during the fluid circulation process, and maintain the smoothness of the fluid circulation and meet the clinical requirements.

[0050] In an alternative embodiment, the filter assembly 24 includes at least one filter membrane bag, and the filter membrane bag filters the fluid input from the first input port 21 or the second input port 22 correspondingly. The filter membrane bag is provided with numerous mesh holes or membrane holes and other filter holes. The filter holes can pass the particles in the fluid that are less than or equal to the size of the filter holes, while the large particles exceeding the size of the filter holes are blocked inside the filter membrane bag.

[0051] Preferably, two filter membrane bags are provided, which are respectively set as the first filter bag 241 and the second filter bag 242. The first filter bag 241 and the second filter bag 242 are located in the housing 25. The first input port 21 communicates with the first filter bag 241, and the second input port 22 communicates with the second filter bag 242. Preferably, the filtering component 24 includes a flow guiding member introduced into the filter membrane bag. The flow guiding member includes a flow guiding pipe 264 and a flow guiding frame 26 extending from the flow guiding pipe 264 to the periphery. The flow guiding frame 26 is provided with a flow guiding curved surface 261. The flow guiding curved surface 261 extends from the flow guiding frame 26 towards the edge of the filter membrane bag to smoothly guide the fluid into the filter membrane bag and avoid phenomena such as excessive bubble formation. Optionally, the flow guiding curved surface 261 is set as a convex spherical surface, and the flow guiding pipe 264 is connected to the first input port 21 or the second input port 22 to guide the fluid to uniformly diffuse to the flow guiding curved surface 261. Preferably, a flow guiding gap 263 is formed between the end of the flow guiding curved surface 261 and the edge of the filter membrane bag for the fluid to flow through. Preferably, a cylindrical extension surface 262 is provided at the end of the flow guiding curved surface 261, and a plurality of concave spiral grooves 265 are distributed on the surface of the cylindrical extension surface 262. The spiral grooves 265 and the inner wall surface of the filter membrane bag form a guiding groove to disperse the flow direction and flow rate of the fluid and form a uniform filtering structure. Moreover, the guiding groove and the flow guiding gap 263 are communicated to jointly construct a flow guiding space for the fluid.

[0052] Embodiment 2

[0053] As Figure 1 、 Figure 2 and Figure 6 shown, different from the independent filter membrane bag structure of the bag-shaped or column-shaped filter screen in Embodiment 1, in this embodiment, the filtering component 24 is fixed to the housing 25 and divides the housing 25 into different filtering spaces for corresponding filtering and mixing.

[0054] Optionally, the filtering component 24 is at least one layer of filter membrane 27 running across the housing 25. The filter membrane 27 divides the housing 25 into at least two cavities. Among them, the cavity communicating with the shunt member 23 constitutes a blood storage cavity 251, and the cavity communicating with the first input port 21 or the second input port 22 is a filtering cavity. The filter membrane 27 divides the space in the housing 25 in a flattened posture, not only making the filtering area clearly divided, but also the first input port 21 or the second input port 22 can communicate with the same filtering cavity to achieve mixed filtering in the filtering cavity and then flow into the blood storage cavity 251 for secondary mixing to achieve an even mixing effect.

[0055] Optionally, the filtering component 24 includes a columnar hollow mounting frame detachably mounted on the housing 25, and the filtering membrane 27 is tensioned on the outer peripheral wall of the mounting frame to form a container structure. The first input port 21 or the second input port 22 communicates with the inside of the mounting frame, and the outer shell surrounds the outside to form an inner and outer ring structure. Optionally, a spiral guide groove 252 is provided tangentially on the mounting frame. The spiral guide groove 252 extends beyond the inner side wall of the mounting frame or is opened on the inner side wall. The first input port 21 or the second input port 22 flows into the corresponding spiral guide groove 252 tangentially along the mounting frame to form a smooth flow.

[0056] The shunt component 23 has a multi-branch structure from the total to the sub to form a multi-channel output. Preferably, the main channel 231 and the branch channels in the shunt component 23 form a channel structure approximately in the shape of a "Y". Among them, the ratio of the cross-sectional area of the main channel 231 to the cross-sectional area of one branch channel is 1-3. Specifically, the ratio of the cross-sectional area of the main channel 231 to the cross-sectional area of one branch channel is set to proportional values such as 1, 1.5, 2, 2.5, 3, etc. There is a difference between the main flow channel and the branch channels to form a pressure difference and improve the fluid flow rate.

[0057] Embodiment III

[0058] As Figures 1 to 7 shown, the dialysis test pipeline assembly includes a connector pipe assembly 111, a dialysis pump pressure assembly 112, an exhaust assembly 113 and a test pipe group 114 connected in sequence through pipelines. The connector pipe assembly 111 communicates with the blood reservoir device 20, and the sampling pipeline assembly 12 is connected to the connector pipe assembly 111. The dialysis pump pressure assembly 112 drives the fluid in the dialysis test pipeline device 10 to flow according to a preset pump pressure value, and the exhaust assembly 113 discharges the gas in the process of the fluid circulating in the dialysis test pipeline device 10.

[0059] The connector pipe assembly 111 is a pipeline structure connecting the dialysis pump pressure assembly 112 and the blood reservoir device 20, and auxiliary structures such as a stop clamp are provided on the connector pipe assembly 111. The sampling pipeline assembly 12 is connected to the connector pipe assembly 111, and the connection part is located between the dialysis pump pressure assembly 112 and the blood reservoir device 20, so that the fluid sample input from the blood reservoir device 20 into the dialysis test pipeline device 10 can be accurately collected. By regularly or randomly extracting the fluid sample of the sampling pipeline assembly 12, the coagulation indexes can be measured by a coagulation analyzer, such as the coagulation analyzer detecting 4 coagulation items: prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT), fibrinogen (FIB).

[0060] Optionally, the adapter tube assembly 111 is provided with a multi-pass adapter 1111. For example, the multi-pass adapter 1111 can be set as a three-way adapter, a four-way adapter, etc. The sampling pipeline assembly 12 includes a lead-out tube 121 connected to the multi-pass adapter 1111, a sampling seal assembly 122 located at the end of the lead-out tube 121, and a hemostatic clip installed on the lead-out tube 121. The sampling seal assembly 122 is used for puncturing and leading out or discharging the fluid sample, and putting the fluid sample into a coagulation analyzer to realize the detection of coagulation items.

[0061] Optionally, the dialysis pump pressure assembly 112 is set as a roller pump or a blood pump in other pump pressure forms. The dialysis test pipeline device 10 uses the dialysis pump pressure assembly 112 as a driving source to drive the fluid in the dialysis test pipeline device 10 to flow.

[0062] The exhaust assembly 113 is arranged at the output end of the dialysis pump pressure assembly 112. Among them, the exhaust assembly 113 includes a drip chamber and an exhaust pipe component connected to the drip chamber. The pipeline of the dialysis pump pressure assembly 112 is connected to the drip chamber. The exhaust pipe component controls the liquid level in the drip chamber based on discharging the gas above the liquid level of the drip chamber. The cross-sectional shape of the drip chamber is much larger than the size of the conduit in the pipeline. The fluid entering the drip chamber from the conduit accumulates in the drip chamber. There is an air space between the liquid level in the drip chamber and the input port of the conduit. The exhaust pipe component is connected to the drip chamber and communicates with the air space, so as to control the gas volume in the air space. Preferably, the exhaust pipe component is a unidirectional conduction component to keep the gas content in the drip chamber stable. Preferably, the exhaust pipe component is a one-way valve.

[0063] The test tube group 114 is connected to the drip chamber and the blood storage device 20. Optionally, the ratio of the conduction length for fluid flow in the test tube group 114 to the conduction length for fluid flow in the adapter tube assembly 111 is 2 to 8, so that the test pipeline group has good fluidity, can also fully reflect the anticoagulant performance of the test pipeline, and improve the accuracy of the anticoagulant performance detection of the pipeline. For example, the ratio of the conduction lengths is 2, 3, 4, 5, 6, 8 and other length ratios.

[0064] Example 4

[0065] As Figure 1 、 Figure 2 and Figure 7 As shown, the blood circulation simulation device 30 includes a pump pressure assembly 31, a heat exchanger device 32 and an oxygenator device 33 connected by a conduit. The heat exchanger device 32 is used to adjust the temperature of the fluid flowing in the blood circulation simulation device 30, and the oxygenator device 33 is used to adjust the oxygen content of the fluid flowing in the blood circulation simulation device 30. The pump pressure assembly 31 is set as a roller pump or a blood pump in other pump pressure forms. The blood circulation simulation device 30 uses the pump pressure assembly 31 as a driving source to drive the fluid in the blood circulation simulation device 30 to flow.

[0066] The heat exchanger device 32 achieves the stabilization of the fluid temperature through heat exchange with a high-temperature medium during the fluid flow process. Optionally, the heat exchanger device 32 includes a heat exchange shell 323, a flow guiding assembly 321 located within the heat exchange shell 323, and a heat conducting assembly 322. The flow guiding assembly 321 is provided with a fluid input channel 3211 and a fluid output channel 3212, and the heat conducting assembly 322 is provided with a medium input channel and a medium output channel. Among them, the heat conducting assembly 322 is made of a material with a high heat conductivity to improve the heat exchange efficiency. For example, the heat conducting assembly 322 is made of a material with a high heat conductivity such as a metal tube or a hollow fiber tube. The heat conducting medium flows along the heat conducting assembly 322, and heat exchange is achieved through the contact surface between the heat conducting assembly 322 and the fluid. Preferably, the heat conducting assembly 322 is provided as a tubular multi-root heat conducting tube 3221, and the heat conducting tube 3221 is distributed in a shuttle manner within the flow guiding assembly 321 to expand the contact area between the fluid in the flow guiding assembly 321 and the heat conducting tube 3221 and improve the heat conduction efficiency. Preferably, the heat conducting tube 3221 has a parallel tube structure. Preferably, the heat conducting assembly 322 is woven into a mesh structure. Among them, the heat conducting medium can be set as a water fluid or a gas.

[0067] Preferably, the flow guiding assembly 321 is provided as a hollow tubular structure, and the fluid input channel 3211 and the fluid output channel 3212 are respectively connected to both ends of the flow guiding assembly 321. Flow guiding holes 3213 are provided on the tube wall of the flow guiding assembly 321, and the flow guiding holes 3213 communicate the inside and outside of the flow guiding assembly 321. The heat conducting assembly 322 is arranged around the flow guiding assembly 321 and exchanges heat with the fluid flowing out of the flow guiding holes 3213. Optionally, an inclined baffle 3214 is provided within the flow guiding assembly 321, and the baffle 3214 faces the side of the flow guiding holes 3213 to enable the fluid to flow out of the flow guiding holes 3213 smoothly. Further, the hole wall of the flow guiding holes 3213 is provided with an inclined surface, and this inclined surface guides the fluid to flow out of the flow guiding assembly 321 tangentially to reduce the impact of the fluid and can extend the flow path of the fluid within the flow guiding assembly 321 within a smaller heat exchange shell 323 to improve the heat exchange effect.

[0068] The fluid output from the flow guiding assembly 321 enters the oxygenator device 33, and the oxygen content of the blood-like fluid is adjusted at the oxygenator device 33 to avoid problems such as blood hemolysis and deterioration caused by a high carbon dioxide content in the blood.

[0069] Further, the blood circulation simulation device 30 further includes a blood oxygen detection branch 35, and the blood oxygen detection branch 35 is arranged on the output pipeline of the oxygenator device 33. By arranging the blood oxygen detection branch 35 on the output pipeline of the oxygenator device 33, the blood oxygen detection branch 35 is used to detect the oxygen content in the blood output from the oxygenator device 33 to ensure that the output blood meets the blood oxygen parameter index of normal blood. Optionally, a blood oxygen detection sensor is arranged on the blood oxygen detection branch 35 to output the blood oxygen content in real time, and the oxygenator device can adjust the blood oxygen content in real time. For example, when the blood oxygen content detected by the blood oxygen detection branch 35 meets the set range, the oxygenator device operates normally. When the blood oxygen content detected by the blood oxygen detection branch 35 is less than the normal value, the oxygenator device increases the blood oxygen content.

[0070] Further, the anticoagulation test system further includes an oxygen content regulator 34 connected to the oxygenator device 33, and the oxygen content regulator 34 adjusts the oxygen concentration based on the detection value of the blood oxygen detection branch 35. The oxygen content regulator 34 is used to supply high-concentration oxygen to the oxygenator device 33, and the oxygen can be set as pure oxygen or a gas with different concentrations formed by mixing according to different gas ratios. When the blood oxygen content detected by the blood oxygen detection branch 35 in the blood is lower than the preset value, the oxygen content regulator 34 increases the oxygen concentration or the gas supply amount to increase the blood oxygen concentration.

[0071] Embodiment Five

[0072] Use the extracorporeal circulation dialysis pipeline anticoagulation test system disclosed in the above embodiments to detect the anticoagulation performance of the extracorporeal circulation dialysis pipeline. In one embodiment, the test method includes the following steps:

[0073] Step S101, guide the fluid to circulate through the dialysis circulation pipeline assembly 11, and collect the fluid flowing in the dialysis circulation pipeline assembly 11 through the sampling pipeline assembly 12. The pump pressure assembly 31 in the dialysis circulation pipeline assembly 11 guides the fluid in the blood storage device 20 to circulate. The circulation of the dialysis circulation pipeline assembly 11 and the blood circulation simulation device 30 is carried out simultaneously. The blood in the first circulation pipeline and the second circulation pipeline is mixed at the blood storage device 20 to form a fluid with consistent parameters. The sampling pipeline assembly 12 collects blood samples from the first circulation pipeline regularly or at a preset frequency, and the anticoagulation parameters of the blood circulating in the entire anticoagulation test system can be obtained. For example, the sampling pipeline assembly 12 extracts blood samples at time periods such as 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 5.5h, 6h when the anticoagulation test system starts to run, and uses a coagulation analyzer to measure four coagulation items of the collected blood samples: prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT), and fibrinogen (FIB). Among them, in order to control the difference, the range of coagulation factor measurement results is controlled as follows:

[0074] Activated partial thromboplastin time (APTT): seconds: 25 - 60.

[0075] Prothrombin time (PT): seconds: 11 - 30.

[0076] Fibrinogen (FIB): 2 - 4 g / L.

[0077] Thrombin time (TT): seconds: 12 - 30.

[0078] Use t - test and F - test to determine whether the differences in the four coagulation items of the anticoagulant pipeline and the non - anticoagulant pipeline, namely prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT), and fibrinogen (FIB), are significant; if the differences are significant and the anticoagulant effect of the anticoagulant pipeline is better than that of the non - anticoagulant pipeline, then the pipeline is considered to have an anticoagulant effect.

[0079] Step S102, use the pump pressure assembly 31 to deliver fluid with a preset pressure value to the heat exchanger device 32 and the oxygenator device 33. The blood circulates in the blood circulation simulation device 30. Specifically, the blood circulation simulation device 30 uses the pump pressure assembly 31 as the driving source to drive the fluid circulation in the blood circulation simulation device 30. The heat exchanger device 32 realizes the stabilization of the fluid temperature through heat exchange with the medium with a high temperature during the fluid flow process. The fluid output from the heat exchanger device 32 enters the oxygenator device 33, and the oxygen content of the blood - like fluid is adjusted at the oxygenator device 33 to avoid problems such as hemolysis and deterioration caused by a high carbon dioxide content in the blood.

[0080] Step S103, send the fluid flowing in the dialysis circulation pipeline assembly 11 and the blood circulation simulation device 30 into the blood storage device 20 for filtration and mixing. The blood storage device 20 filters the fluid input from the dialysis circulation pipeline assembly 11 and the blood circulation simulation device 30 to remove blood clots, coagulated particles, and other large - particle substances generated during the fluid circulation process, maintaining the smoothness of the fluid circulation and meeting clinical requirements.

[0081] Step S104, make the filtered and mixed fluid flow into the dialysis circulation pipeline assembly 11 and the blood circulation simulation device 30 respectively.

[0082] Step S105, cycle the above steps in sequence.

[0083] The dialysis test pipeline device 10, the blood circulation simulation device 30, and the blood reservoir device 20 constitute the first and second circulation pipelines that operate synchronously and independently, thereby simulating the clinical process of human dialysis and being able to effectively obtain the anticoagulation test parameters of the dialysis circulation pipeline component 11. The blood circulation simulation device 30 can simulate the internal circulation of human blood to keep the test conditions of the extracorporeal circulation dialysis pipeline anticoagulation test system in line with the clinical use state, can accurately obtain the anticoagulation test parameters of the dialysis test pipeline device 10, and has a good simulation effect. The extracorporeal circulation dialysis pipeline anticoagulation test system collects the fluid circulating in the system through the sampling pipeline component 12, and then detects various parameters in the fluid sample through a detection instrument, thereby obtaining various coagulation index parameters, and has high detection accuracy. The fluids flowing in the dialysis test pipeline device 10 and the blood circulation simulation device 30 are mixed in the blood reservoir device 20 to form a mixed fluid, simulating the human dialysis process with a good simulation effect.

[0084] In step S101, the following steps are further included:

[0085] Step S201, regularly collect the fluid flowing in the dialysis circulation pipeline component 11 through the sampling pipeline component 12.

[0086] The sampling pipeline component 12 regularly collects the fluid flowing in the dialysis circulation pipeline component 11 to obtain the anticoagulation performance test of the blood at different time periods and after the dialysis circulation pipeline component 11 has been used for different times, thereby obtaining the blood sample of the dialysis circulation pipeline component 11.

[0087] Step S202, perform coagulation index detection. The blood sample collected by the sampling pipeline component 12 is subjected to T-test and F-test to determine whether the differences in the four coagulation items of the anticoagulation pipeline and the non-anticoagulation pipeline: prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT), and fibrinogen (FIB) are significant; if the differences are significant and the anticoagulation effect of the anticoagulation pipeline is better than that of the non-anticoagulation pipeline, it is considered that the pipeline has an anticoagulation effect.

[0088] In an embodiment, the test method includes: pre-cleaning the dialysis test pipeline device 10 with heparin fluid before the extracorporeal circulation dialysis pipeline anticoagulation test system runs. The heparin fluid pre-cleans the dialysis test pipeline device 10, which can not only clean the dialysis test pipeline device 10 once, check whether there are liquid leakage points and flush out particulate impurities in the dialysis test pipeline device 10, keep the dialysis test pipeline device 10 clean, but also set an anticoagulation layer on the dialysis test pipeline device 10 to improve the overall anticoagulation effect.

[0089] Further, the test method includes pre-cleaning the blood circulation simulation device 30 with heparin fluid before the operation of the extracorporeal circulation dialysis line anticoagulation test system to clean impurities in the line and form an anticoagulant layer.

[0090] Other embodiments of the present invention will be readily apparent to those skilled in the art upon consideration of the specification and practice of the disclosure herein. This application is intended to cover any variations, uses, or adaptations of the invention following the general principles of the invention and including known common general knowledge or conventional technical means in the technical field not disclosed herein. The specification and examples are only exemplary, and the true scope and spirit of the invention are pointed out by the following claims.

[0091] It should be understood that the present invention is not limited to the exact structures described above and shown in the drawings, and various modifications and changes can be made without departing from its scope. The scope of the present invention is only limited by the appended claims.

Claims

1. An extracorporeal circulation dialysis line anticoagulation test system, characterized in that, include: A dialysis test pipeline device, comprising a dialysis circulation pipeline assembly and a sampling pipeline assembly connected to the dialysis circulation pipeline assembly, wherein the sampling pipeline assembly is used to collect fluid flowing in the dialysis circulation pipeline assembly; A blood circulation simulation device, comprising a pump assembly, a heat exchanger device and an oxygenator device connected by a catheter, wherein the heat exchanger device is used to adjust the temperature of a fluid circulating in the blood circulation simulation device, and the oxygenator device is used to adjust the oxygen content of the fluid circulating in the blood circulation simulation device; A blood reservoir device, comprising a first input port, a second input port and a shunt, wherein the dialysis circulation pipeline assembly is connected to the first input port and the shunt, the oxygenator device is connected to the second input port, and the pump pressure assembly is connected to the shunt, wherein the fluid flowing in the dialysis circulation pipeline assembly and the fluid flowing in the blood circulation simulation device are mixed in the blood reservoir device; The dialysis test pipeline device comprises a joint pipe assembly, a dialysis pump pressure assembly, an exhaust assembly and a test tube set which are sequentially connected through pipelines, the joint pipe assembly is communicated with the blood reservoir device, the sampling pipeline assembly is connected to the joint pipe assembly, the dialysis pump pressure assembly drives the fluid in the dialysis test pipeline device to circulate according to a preset pump pressure value, and the exhaust assembly discharges the gas of the fluid in the circulation process of the dialysis test pipeline device; The exhaust assembly includes a drip bucket and an exhaust pipe connected to the drip bucket. The pipeline of the dialysis pump pressure assembly is connected to the drip bucket. The exhaust pipe controls the liquid level in the drip bucket based on discharging the gas above the liquid level in the drip bucket.

2. The extracorporeal circulation dialysis tubing anticoagulation test system according to claim 1, wherein The blood storage device includes a shell and a filter assembly installed in the shell. A blood storage chamber is formed between the shell and the filter assembly. The first input port and the second input port are connected to the filter assembly, and the diverter is connected to the blood storage chamber.

3. The extracorporeal circulation dialysis line anticoagulation test system according to claim 2, wherein, The filter assembly includes at least one filter membrane bag, and the filter membrane bag filters the fluid input from the first input port or the second input port accordingly.

4. The extracorporeal circulation dialysis line anticoagulation test system according to claim 1, wherein The blood circulation simulation device also includes a blood oxygen detection branch, which is arranged at the output end pipeline of the oxygenator device.

5. The extracorporeal circulation dialysis line anticoagulation test system according to claim 4, characterized in that, It also includes an oxygen content regulator connected to the oxygenator device, and the oxygen content regulator adjusts the oxygen concentration based on the detection value of the blood oxygen detection branch.

6. A test method for anticoagulation of an extracorporeal circulation dialysis pipeline, characterized in that, Using the extracorporeal circulation dialysis circuit anticoagulation test system according to any one of claims 1 to 5, the test method comprises the following steps: Guiding the fluid to circulate through the dialysis circulation pipeline assembly, and collecting the fluid circulating in the dialysis circulation pipeline assembly through the sampling pipeline assembly; Delivering fluid of a preset pressure value to the heat exchanger device and the oxygenator device through a pump pressure assembly; Sending the fluid flowing through the dialysis circulation pipeline assembly and the blood circulation simulation device into a blood reservoir device for filtering and mixing; The filtered and mixed fluids flow into the dialysis circulation pipeline assembly and the blood circulation simulation device respectively; Repeat the above steps in sequence.

7. The test method according to claim 6, wherein include: regularly collecting the fluid circulating in the dialysis circulation pipeline assembly through the sampling pipeline assembly; Perform coagulation index detection.

8. The testing method according to claim 6, wherein Including: Pre-clean the dialysis test line device with heparin fluid before the operation of the extracorporeal circulation dialysis line anticoagulation test system.

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