Perfusion equipment and method for organ transfer

Abstract

The invention provides perfusion equipment and method for organ transfer, and relates to the technical field of medical instruments.The perfusion equipment comprises an organ bin, a perfusion tank, a driving pump, an oxygenator, a first-stage bubble discharging assembly, a bubble detection part, a second-stage bubble discharging assembly, a pipeline assembly and a valve device; the bubble detection part detects whether the perfusate contains bubbles or not in real time; the first-stage bubble discharging assembly and the second-stage bubble discharging assembly form two-stage gradient bubble removal; the pipeline assembly comprises a main pipeline and branch pipelines, and the main pipeline forms a main filling circulation path; the secondary bubble discharging assembly is connected to the main pipeline in parallel through the branch pipeline. The valve device switches the conveying pipeline to ensure that no bubble enters the organ bin. According to the invention, through two-stage gradient bubble removal, the ability to deal with sudden bubbles is improved; the storage tank continuously supplies liquid to guarantee continuous filling of the organ bin; the organ hypoxia injury caused by shut-down bubble removal is avoided; the purpose of improving the safety, continuity and stability of the filling equipment is achieved.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a perfusion device and method for organ transport. Background Technology

[0002] In the field of organ transplantation, the preservation and transport of ex vivo organs are crucial factors determining transplant success rates. Normative mechanical perfusion (NMP) technology, by continuously delivering oxygenated perfusion fluid in a manner that mimics the in vivo environment, can maintain organ metabolic activity and is significantly superior to traditional static cold preservation. However, the issue of air bubbles in the perfusion fluid remains a critical bottleneck restricting the safety of the technique: even a small amount of air bubbles entering the organ's microvessels can cause air embolism, leading to local ischemia or tissue necrosis, which is particularly harmful to highly metabolic organs (such as the heart and liver). Therefore, ensuring that the perfusion fluid is delivered to the organ without air bubbles and with high purity throughout the entire process is a core requirement for guaranteeing organ viability and safe transport.

[0003] Existing perfusion equipment for organ transport is usually equipped with a basic venting structure. A single degassing mechanism is insufficient to cope with sudden bubbles under complex operating conditions such as pump start-up transients, loose interfaces, and fluid replenishment. On the other hand, most systems lack real-time monitoring and dynamic response capabilities. Once bubbles intrude into the main circuit, the conventional practice is to stop the machine to drain the bubbles, which will interrupt the continuous fluid supply to the organ, causing hypoxic stress and seriously affecting organ function.

[0004] More importantly, most current transfusion equipment still falls short in terms of system integration, safety redundancy design, and pressure stability control. Especially during long-term transportation, external vibrations and changes in posture can easily cause disturbances in the liquid path and gas-liquid mixing, further increasing the probability of bubble formation. At the same time, if the defoaming process itself introduces flow fluctuations or pressure instability, it can also cause mechanical damage to the delicate organ microcirculation.

[0005] Therefore, in order to solve the above problems, this invention proposes a perfusion device for organ transport that integrates real-time bubble detection, multi-level collaborative defoaming, intelligent switching control, and stable output assurance, aiming to improve the safety, continuity, and stability of the perfusion device. Summary of the Invention

[0006] The purpose of this invention is to provide a perfusion device and method for organ transport, which aims to solve the problems of interrupted and unstable fluid supply to the organ chamber during air bubble removal.

[0007] To achieve the above objectives, the present invention adopts the following technical solution: a perfusion device for organ transport, comprising an organ compartment, a perfusion tank, a drive pump, and an oxygenator, and further comprising: The primary air bubble removal assembly is equipped with an inlet, a main outlet, and a secondary outlet; the main outlet delivers the de-aerated injection fluid, and the secondary outlet discharges the injection fluid containing air bubbles. A bubble detection device is installed at the main output port of the first-stage bubble removal assembly to detect in real time whether there are residual bubbles in the perfusion fluid. The secondary defoaming component is used to perform a second, efficient defoaming treatment on the injection fluid containing air bubbles; The piping assembly includes a main pipeline and branch pipelines. The main pipeline connects the organ compartment, infusion tank, drive pump, oxygenator, primary bubble removal assembly, bubble detection device and organ compartment in sequence, forming the main infusion circulation path. The branch pipelines connect the secondary bubble removal assembly in parallel between the primary bubble removal assembly and the organ compartment. The valve device switches between two operating states based on the signal from the bubble detection element: When no bubbles are detected, the system is in the first state: the perfusion fluid from the main output port is directly delivered to the organ compartment; at the same time, the perfusion fluid containing bubbles discharged from the auxiliary output port is sent to the secondary bubble removal assembly. When air bubbles are detected, the system switches to the second state: the perfusion fluid from the main output port is diverted to the secondary air bubble removal assembly, and then returns to the organ compartment from the branch line, ensuring that no air bubbles enter the organ compartment.

[0008] Preferably, the branch pipeline is also equipped with a storage tank, which is located between the secondary degassing assembly and the organ chamber, for temporarily storing the perfusion fluid of the secondary degassing treatment and for stably supplying fluid to the organ chamber.

[0009] Preferably, the storage tank includes a constant pressure chamber, a liquid storage bladder is provided inside the constant pressure chamber, the constant pressure chamber forms a sealed cavity, the liquid storage bladder is provided with an inlet pipe and an outlet pipe, and a constant pressure component is provided on the constant pressure chamber for adjusting and maintaining a constant internal air pressure.

[0010] Preferably, the constant pressure chamber includes an upper shell and a lower shell, and mounting components are provided on the outside of the upper shell and the lower shell. The mounting components can seal the upper shell and the lower shell. Check valves are provided in both the inlet pipe and the outlet pipe to prevent liquid backflow.

[0011] Preferably, the feed pipe and the discharge pipe penetrate the bottom surface of the lower shell, and the portion located inside the constant pressure chamber is provided with a limiting ring, while the portion located outside the constant pressure chamber is provided with a fixing member. The bottom surface of the lower shell is provided with a fixing ring, and the fixing member and the fixing ring cooperate with the mounting component to ensure the sealing of the constant pressure chamber.

[0012] Preferably, the constant pressure component includes an air intake pipe, one end of which is connected to the inside of the constant pressure chamber, and the other end is provided with an air source. The constant pressure chamber is provided with a pressure relief pipe, and the air intake pipe and the pressure relief pipe are provided with a linkage valve, which can automatically control the air intake and exhaust volume according to the pressure inside the constant pressure chamber.

[0013] Preferably, the primary bubble removal assembly includes a housing, the housing is provided with an expansion pipe, and the expansion pipe is provided with a flow divider membrane to prevent bubbles from entering the main output port.

[0014] Preferably, the secondary degassing assembly includes a housing and a diaphragm, the diaphragm being integrated inside the housing, a stirring element being provided inside the housing, and a drive element being detachably connected to the stirring element being provided below the housing.

[0015] Preferably, the branch pipeline includes a first branch pipe, a second branch pipe, and a third branch pipe. The first branch pipe connects the outlet of the bubble detection device to the inlet of the secondary bubble removal assembly. The second branch pipe connects the secondary output port of the primary bubble removal assembly to the inlet of the secondary bubble removal assembly. The third branch pipe connects the secondary bubble removal assembly, the storage tank, and the organ compartment in sequence.

[0016] A perfusion method for organ transport includes the following steps: S01: The injection fluid flows out of the injection tank, is pressurized by the drive pump, and then enters the oxygenator; S02: The perfusion fluid output from the oxygenator enters the first-stage degassing assembly to separate the bubbles from the perfusion fluid; S03: The bubble detection device detects whether there are bubbles in the injection liquid at the main output port of the primary bubble degassing assembly. If no bubbles are detected, it enters S04; if bubbles are detected, it enters S05. S04: The perfusion fluid that has been tested is delivered to the organ compartment; the secondary output port of the primary bubble removal component sends the perfusion fluid containing bubbles to the secondary bubble removal component, and after the bubbles are removed, it is sent to the storage tank, and finally sent to the organ compartment from the storage tank, entering S06; S05: The perfusion fluid containing air bubbles after detection is transported to the secondary air bubble removal component, and after air bubbles are removed, it enters the storage tank; the perfusion fluid stored in the storage tank is continuously and stably supplied to the organ compartment, and then enters S06; S06: The perfusion fluid enters the organ chamber to supply oxygen and energy to the organ, and then exits the organ chamber into the perfusion tank, returning to S01.

[0017] Compared with the prior art, the beneficial effects of the present invention are as follows: This invention achieves efficient separation of bubbles and perfusion fluid through a primary bubble removal component and a secondary bubble removal component for deep purification of residual bubbles. This dual-gradient defoaming enhances the ability to handle sudden bubble formation. A bubble detection device monitors the main flow fluid in real time. Under normal conditions, the main flow directly supplies the organ compartment, while the branch flow simultaneously purifies the bubble-containing fluid at the secondary output. In emergencies, the entire main flow is diverted to the secondary component for processing, and the storage tank continuously supplies fluid to ensure uninterrupted perfusion of the organ compartment. This avoids organ hypoxia damage caused by bubble removal during downtime. The constant pressure chamber and reservoir in the storage tank dynamically adjust the chamber pressure, maintaining a constant external pressure in the reservoir to ensure the output perfusion fluid pressure and prevent organ damage due to unstable perfusion pressure. This achieves the goal of improving the safety, continuity, and stability of the perfusion equipment. Attached Figure Description

[0018] Figure 1 This is a schematic diagram of the overall structure of the present invention.

[0019] Figure 2 This is a schematic diagram showing the positions of the various structures in this invention.

[0020] Figure 3 This is a schematic diagram of the pipeline connection of the present invention.

[0021] Figure 4 This is a schematic diagram of the structure of the primary air bubble removal component in this invention.

[0022] Figure 5 This is a schematic diagram of the structure of the two-stage bubble removal component in this invention.

[0023] Figure 6 This is a perspective view of the storage tank in this invention.

[0024] Figure 7 This is a schematic diagram of the storage tank in this invention.

[0025] Figure label: 1. Organ compartment; 2. Infusion tank; 3. Drive pump; 4. Oxygenator; 5. Primary degassing assembly; 51. Inlet; 52. Main outlet; 53. Secondary outlet; 54. Housing; 55. Expander pipe; 56. Diverter membrane; 6. Bubble detection device; 7. Secondary degassing assembly; 71. Shell; 72. Diaphragm; 73. Stirring device; 74. Drive device; 8. Piping assembly; 81. Main pipe; 82. Branch pipe; 821. First branch pipe; 822. Second branch pipe; 823. 83. Third branch pipe; 83. Valve device; 831. First valve; 832. Second valve; 833. Third valve; 9. Storage tank; 91. Constant pressure box; 911. Upper shell; 912. Lower shell; 913. Mounting component; 914. Fixing ring; 92. Liquid storage bladder; 921. Feed pipe; 922. Discharge pipe; 923. Check valve; 924. Limiting ring; 925. Fixing component; 93. Constant pressure assembly; 931. Air inlet pipe; 932. Pressure relief pipe; 933. Linkage valve. Detailed Implementation

[0026] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention. Example 1

[0027] To improve the safety, continuity, and stability of the grouting equipment, such as Figures 1 to 5 As shown, the present invention proposes a perfusion device for organ transport, including an organ compartment 1, a perfusion tank 2, a drive pump 3 and an oxygenator 4, a primary degassing assembly 5, a bubble detection element 6, a secondary degassing assembly 7, a pipeline assembly 8 and a valve device 83.

[0028] The primary degassing assembly 5 has an inlet 51, a main outlet 52, and a secondary outlet 53. The inlet 51 is connected to the output end of the oxygenator 4. The main outlet 52 is used to deliver the pre-degassed injection fluid, and the secondary outlet 53 is used to discharge a portion of the injection fluid carrying air bubbles. The primary degassing assembly 5 includes a housing 54, inside which is an expansion pipe 55. The expansion pipe 55 increases the cross-sectional area of ​​the liquid flow and reduces the flow velocity. A flow divider 56 is installed inside the expansion pipe 55 to prevent air bubbles from entering the main outlet 52.

[0029] The expansion tube 55 suddenly increases the cross-sectional area of ​​the liquid flow channel, causing the flow rate of the injection fluid to drop sharply. After the flow rate decreases, the buoyancy of the bubbles is greater than the fluid shear force, and the tiny bubbles can aggregate and float. The surface of the diversion membrane 56 can be a hydrophilic and gas-repellent material such as polyethersulfone coating. When the liquid permeates through the membrane pores, the bubbles are blocked on the membrane surface and tilted and guided to the auxiliary outlet 53 along the direction of liquid flow. A guide plate can be provided on the side of the diversion membrane 56 near the inlet 51 to prevent the injection fluid from directly impacting the diversion membrane 56 and to prevent the impact force from squeezing the bubbles into the main outlet 52 side.

[0030] The main output port 52 is located at the bottom of the housing 54 and outputs bubble-free injection liquid; the auxiliary output port 53 is located at the top of the housing 54 and continuously discharges liquid containing bubbles to avoid the risk of sudden embolism caused by gas accumulation; the combination of deceleration and bubble collection and membrane separation mechanisms improves the bubble removal rate.

[0031] The bubble detection element 6 is located at the main output port 52 of the first-stage bubble removal assembly 5 and is used to detect whether there are residual bubbles in the injection fluid in real time. The bubble detection element 6 uses an ultrasonic bubble sensor to detect bubbles. The principle is to use the reflection and attenuation characteristics of ultrasonic waves at the gas-liquid interface: the transmitting end generates high-frequency ultrasonic waves, which penetrate the pipe wall and enter the liquid.

[0032] In the absence of bubbles, ultrasonic waves propagate stably in a homogeneous liquid, resulting in high signal strength at the receiving end. With bubbles present, the significant difference in acoustic impedance between the bubbles and the liquid creates a strong reflection interface; the ultrasonic waves are scattered or blocked by the bubbles, leading to a significant attenuation of the signal strength at the receiving end. The ultrasonic bubble detector 6 offers high accuracy in bubble detection, is non-contact, reusable, and unaffected by liquid color.

[0033] The secondary defoaming component 7 is used to perform secondary efficient defoaming treatment on the gas-containing injection fluid. The gas-containing injection fluid includes the gas-containing injection fluid separated from the primary defoaming component 5 and the injection fluid with residual bubbles detected by the bubble detection component 6.

[0034] The secondary degassing assembly 7 includes a housing 71 and a diaphragm 72. The diaphragm 72 is integrated inside the housing 71 and has hydrophilic and gas-repellent properties, allowing liquid to pass through while blocking gas. The housing 71 also has a stirring element 73 and a driving element 74 below the housing 71, which can drive the stirring element 73 to rotate. The stirring element 73 and the driving element 74 are detachably connected.

[0035] The diaphragm 72 is made of polytetrafluoroethylene microporous membrane, which allows liquid to permeate while blocking gas; the agitator 73 is made of axial flow impeller or honeycomb porous rotor, and the surface is hydrophobic to prevent air bubbles from adhering; the drive unit 74 is made of brushless DC motor, which achieves sterile isolation transmission with the agitator 73 through magnetic coupler; the drive unit 74 and the agitator 73 are connected by snap-fit ​​detachable connection for easy maintenance and replacement; the secondary degassing assembly 7 can be equipped with a pressure sensor to monitor the pressure fluctuations in the shell 71 in real time.

[0036] The shell 71 is divided into upper and lower sections, both of which are cylindrical structures. The diameter of the upper shell 71 is smaller than that of the lower shell 71. The diaphragm 72 is integrated into the lower section of the shell 71. The inner wall of the diaphragm 72 has the same diameter as the inner wall of the upper shell 71, forming a chamber for the coexistence of the injection fluid and air bubbles. The diaphragm 72 and the side wall of the lower shell 71 form a chamber containing only the injection fluid. The top of the upper section of the shell 71 is provided with a negative pressure exhaust port, which can extract the gas accumulated inside the shell 71. The negative pressure environment inside the shell 71 allows air bubbles to be better discharged from the injection fluid.

[0037] The inlet of the secondary degassing component 7 is located in the upper section of the housing 71. The injection liquid entering the secondary degassing component 7 directly enters the gas-liquid coexistence chamber. After the agitator 73 rotates, the injection liquid is formed into a vortex state, which gathers the bubbles in the injection liquid towards the center of the vortex, making it easier for the bubbles to be discharged. Furthermore, the diaphragm 72 ensures that only the injection liquid exists on the periphery of the lower section of the housing 71. The outlet of the secondary degassing component 7 is connected to the chamber in the lower section of the housing 71 where only the injection liquid exists, outputting injection liquid that does not contain bubbles.

[0038] Piping assembly 8 connects the above components into a closed loop; piping assembly 8 includes: main pipe 81 and branch pipe 82; under normal operation, the bubble detector 6 does not detect bubbles, the main pipe 81 circulates the infusion fluid, and the branch pipe 82 removes bubbles and stores and circulates a small portion of the infusion fluid; in case of an abnormal situation, the bubble detector 6 detects bubbles, the portion of the main pipe supplying fluid to the organ chamber 1 is interrupted, and the branch pipe supplies fluid to the organ chamber 1 to ensure that the fluid supply to the organ chamber 1 is uninterrupted.

[0039] The main perfusion path 81 connects the organ compartment 1, the perfusion tank 2, the drive pump 3, the oxygenator 4, the primary bubble removal assembly 5, the bubble detection device 6, and the organ compartment 1 in sequence, forming the main perfusion circulation path; the organ compartment 1 is provided with at least one multi-functional detection port for connecting sensors or extracting liquid samples; the drive pump 3 can be a magnetic levitation pump, with its pump head and pump body detachably set, and the pump body and pump head magnetically coupled for transmission.

[0040] Branch pipe 82 is connected in parallel between the primary bubble degassing assembly 5 and the organ compartment 1. The branch pipe connects the input end of the secondary bubble degassing assembly 7 to the bubble detection element 6 and the secondary output port 53 of the primary bubble degassing assembly 5, respectively. The output end of the secondary bubble degassing assembly 7 is connected to the organ compartment 1.

[0041] The branch pipe 82 includes a first branch pipe 821, a second branch pipe 822 and a third branch pipe 823. The first branch pipe 821 connects the outlet of the bubble detection device 6 to the inlet of the secondary bubble removal assembly 7. The second branch pipe 822 connects the auxiliary output port 53 of the primary bubble removal assembly 5 to the inlet of the secondary bubble removal assembly 7. The third branch pipe 823 connects the outlet of the secondary bubble removal assembly 7 and the inlet of the organ compartment 1.

[0042] Valve device 83 switches between two operating states based on the detection signal from bubble detector 6: When the bubble detector 6 does not detect any bubbles, it is in the first state, and the perfusion fluid from the main output port 52 is directly delivered to the organ compartment 1 via the bubble sensor; at the same time, the perfusion fluid containing bubbles discharged from the auxiliary output port 53 is sent to the secondary bubble removal assembly 7 via the branch pipeline 82 for pretreatment.

[0043] When the bubble detector 6 detects a bubble, it switches to the second state, and all the perfusion fluid from the main output port 52 is diverted and introduced into the secondary bubble removal component 7 through the branch pipe 82 for secondary bubble removal treatment. The treated fluid is then returned to the organ compartment 1 through the subsequent path to ensure that no bubbles enter the organ compartment 1.

[0044] The valve device 83 includes a first valve 831, a second valve 832, and a third valve 833. The first valve 831 is located on the first branch pipe 821, the second valve 832 is located on the second branch pipe 822, and the third valve 833 is located on the main pipeline 81 connecting the bubble detection element 6 to the organ compartment 1. The first valve 831, the second valve 832, and the third valve 833 are all electromagnetic shut-off valves. A manual valve can be installed on the third branch pipe 823 to ensure the system's fault tolerance capability.

[0045] The first state of valve device 83 is: first valve 831 is closed, second valve 832 is open, and third valve 833 is open. The perfusion fluid is sent from the main pipeline 81 through the third valve 833 into the organ compartment 1. Air bubbles and a small portion of the perfusion fluid enter the secondary air bubble removal assembly 7 from the branch pipeline 82 through the second valve 832. The second state of valve device 83 is: first valve 831 is open, second valve 832 is closed, and third valve 833 is closed. The perfusion fluid can only enter the secondary air bubble removal assembly 7 from the branch pipeline 82 where the first valve 831 is located to remove air bubbles. Then, the secondary air bubble removal assembly 7 sends the perfusion fluid into the organ compartment 1 through the branch pipeline.

[0046] During normal operation, valve device 83 switches between a first state and a second state to change the delivery position of the perfusion fluid. When the bubble detector 6 does not detect bubbles, the valve is in the first state, and the perfusion fluid from the main output port 52 of the primary bubble removal assembly 5 is delivered to the organ compartment 1, while the perfusion fluid from the auxiliary output port 53 is delivered to the secondary bubble removal assembly 7. When the bubble detector 6 detects bubbles, the valve is in the second state, and all the perfusion fluid is delivered by the main output port 52 of the primary bubble removal assembly 5 to the secondary bubble removal assembly 7, and then sent to the organ compartment 1 after passing through the secondary bubble removal assembly 7.

[0047] In this embodiment, the primary bubble removal component 5 achieves efficient separation of bubbles from the perfusion fluid, while the secondary bubble removal component 7 deeply purifies residual bubbles. This dual-gradient defoaming enhances the ability to handle sudden bubble formations. The bubble detection component 6 monitors the main pipeline fluid in real time. Under normal conditions, the main pipeline directly supplies the organ chamber 1, while the branch pipeline simultaneously purifies the bubble-containing fluid at the auxiliary output port 53. In emergencies, the main pipeline introduces the secondary component for processing. This improves the safety and continuity of the perfusion equipment while avoiding organ hypoxia damage caused by shutdown for bubble removal. Example 2

[0048] In actual use, the process of switching to defoaming and the defoaming treatment process itself can introduce flow fluctuations or pressure instability, which can cause mechanical damage to the delicate microcirculation of organs.

[0049] To solve the above technical problems, such as Figures 1 to 7 As shown, in another embodiment of the present invention, a storage tank 9 is also provided on the branch pipe. The storage tank 9 is located between the secondary deaerator assembly 7 and the organ chamber 1. The input end of the storage tank 9 is connected to the output end of the secondary deaerator assembly 7, and the output end of the storage tank 9 is connected to the organ chamber 1. It is used to temporarily store the perfusion fluid treated by the secondary deaerator assembly and serves as a buffer storage unit to maintain a stable fluid supply to the organ chamber 1. The storage tank 9 is located on the third branch pipe 823, which is connected sequentially to the secondary deaerator assembly 7, the storage tank 9, and the organ chamber 1 along the perfusion fluid delivery direction.

[0050] The storage tank 9 includes a constant pressure tank 91, inside which is a liquid storage bladder 92. The constant pressure tank 91 forms a sealed cavity that surrounds the external space of the liquid storage bladder 92. The liquid storage bladder 92 is used to store the perfusion fluid. The liquid storage bladder 92 is provided with an inlet pipe 921 and an outlet pipe 922 for the inflow and outflow of the perfusion fluid. The constant pressure tank 91 is provided with a constant pressure component 93, which is used to regulate and maintain a constant internal air pressure in the constant pressure tank 91, maintain a stable external pressure in the liquid storage bladder 92, and ensure a stable pressure of the perfusion fluid output to the organ chamber 1.

[0051] Both the inlet pipe 921 and the outlet pipe 922 are equipped with check valves 923 to prevent liquid backflow and reduce the risk of contamination. The constant pressure box 91 includes an upper shell 911 and a lower shell 912. The upper shell 911 and the lower shell 912 are fitted with mounting parts 913. The mounting parts 913 can seal the upper shell 911 and the lower shell 912. The mounting parts 913 are annular clamps with sealing rubber rings on their inner sides. The axial seal between the upper shell 911 and the lower shell 912 is achieved by the bolt tightening force.

[0052] The feed pipe 921 and the discharge pipe 922 penetrate the bottom surface of the lower shell 912. The portions of the feed pipe 921 and the discharge pipe 922 located inside the constant pressure chamber 91 are fixedly connected to the limit ring 924. The ends of the feed pipe 921 and the discharge pipe 922 away from the liquid storage bladder 92 are each provided with a fixing member 925. The bottom surface of the lower shell 912 is provided with a fixing ring 914 fixed thereto. The fixing ring 914 can be sleeved on the outside of the feed pipe 921 and the discharge pipe 922. The fixing member 925 is threadedly connected to the fixing ring 914, and together with the mounting member 913, they ensure the sealing of the constant pressure chamber 91.

[0053] Dividing the constant pressure chamber 91 into an upper shell 911 and a lower shell 912 makes it easier to place the liquid storage bladder 92 inside the constant pressure chamber 91. The process of placing the liquid storage bladder 92 into the constant pressure chamber 91 is as follows: the upper shell 911 and the lower shell 912 are separated, the inlet pipe 921 and the outlet pipe 922 of the liquid storage bladder 92 are inserted into the reserved hole of the lower shell 912, the fixing member 925 is sleeved on the inlet pipe 921 and the outlet pipe 922 from the outside of the lower shell 912, and the fixing member 925 is fixed to the fixing ring 914 on the lower shell 912 by threaded connection. Then the upper shell 911 and the lower shell 912 are sealed and installed as one unit by the mounting member 913 to form a sealed environment inside the constant pressure chamber 91.

[0054] The constant pressure assembly 93 includes an air inlet pipe 931, one end of which is connected to the inside of the constant pressure chamber 91, and the other end is equipped with an air source. The constant pressure chamber 91 is equipped with a pressure relief pipe 932 for overpressure release. The air inlet pipe 931 and the pressure relief pipe 932 are equipped with a linkage valve 933, which can automatically control the air intake and exhaust volume according to the pressure inside the constant pressure chamber 91.

[0055] The constant pressure chamber 91 is also equipped with a pressure sensor. The linkage valve 933 can be a proportional valve, which dynamically adjusts the air intake and pressure relief based on the feedback from the pressure sensor inside the chamber to maintain the air pressure inside the constant pressure chamber 91. When the storage tank 9 is replenished with perfusion fluid through the branch pipe 82, the linkage valve 933 is controlled to reduce the air pressure inside the constant pressure chamber 91. When the storage bladder 92 is full, the constant pressure chamber 91 returns to the normal working air pressure. If the bubble detector 6 detects bubbles during the replenishment of perfusion fluid to the storage bladder 92, and the storage tank 9 needs to provide perfusion fluid to the organ compartment 1, the linkage valve 933 is controlled to quickly restore the air pressure inside the constant pressure chamber 91 to the working air pressure.

[0056] When determining the amount of infusion fluid in the reservoir 92, the shape and position of the reservoir 92 can be detected by setting up devices such as infrared sensors and distance sensors inside the constant pressure box 91, thereby determining the amount of infusion fluid; the amount of remaining infusion fluid in the reservoir 92 can also be determined by detecting the amount of infusion fluid entering and exiting the reservoir 92.

[0057] Alternatively, a movable plate can be installed on the top of the reservoir 92. The movable plate can slide within the constant pressure box 91 via a limit rod. The movable plate will press down on the reservoir 92 due to its own weight. Changes in the amount of liquid in the reservoir 92 will cause the movable plate to slide up and down. A limit switch is installed in the constant pressure box 91. The amount of liquid injected into the reservoir 92 can be determined by the state of the movable plate contacting the limit switch.

[0058] The reservoir 92 of the storage tank 9 adopts an external pressure constant pressure design. The external pressure of the reservoir 92 is actively adjusted by the air source to overcome the pressure decay problem of traditional gravity-fed fluid supply, ensure the hydraulic stability of organ perfusion, and is suitable for long-distance transportation. It avoids organ microvascular damage caused by pressure fluctuations and reduces the risk of thrombosis after transplantation.

[0059] When the bubble detector 6 detects a bubble, the third valve 833 closes, and the organ compartment 1 is supplied with perfusion fluid by the storage tank 9. The perfusion fluid in the reservoir 92 is stably delivered into the organ compartment 1 by the constant pressure environment outside it. The constant pressure component 93 ensures that the reservoir 92 can still maintain a constant pressure on the reservoir 92 when its volume decreases. The check valve 923 can ensure that the perfusion fluid is only delivered to the organ compartment 1.

[0060] When the bubble detector 6 does not detect any bubbles and the amount of filling fluid stored in the reservoir 92 decreases to the set amount, the air pressure in the constant pressure chamber 91 is reduced to ensure that the filling fluid after bubble removal can enter the reservoir 92 for storage. When the filling fluid in the reservoir 92 fills the reservoir 92, the pressure environment in the constant pressure chamber 91 returns to the normal air pressure state, and the filling fluid continues to enter the reservoir 92. The amount entering the reservoir 92 is the same as the amount exiting, ensuring that the bubble removal process proceeds smoothly under normal conditions.

[0061] When the bubble detector 6 does not detect any bubbles, the perfusion fluid is sent from the perfusion tank 2 to the drive pump 3, then to the oxygenator 4, and then to the primary bubble removal assembly 5 to separate the bubbles. The main output port 52 of the primary bubble removal assembly 5 outputs the perfusion fluid, which is then delivered to the organ compartment 1 after passing through the bubble detector 6. At the same time, the auxiliary output port 53 of the primary bubble removal assembly 5 sends part of the perfusion fluid carrying bubbles to the secondary bubble removal assembly 7, which removes the bubbles from the perfusion fluid in the secondary bubble removal assembly 7 and sends it to the storage tank 9.

[0062] When the bubble detector 6 detects a bubble, the perfusion fluid delivered by the bubble detector 6 to the organ compartment 1 is cut off, and the perfusion fluid delivered from the secondary output port 53 of the primary bubble removal assembly 5 to the secondary bubble removal assembly 7 is also cut off. The perfusion fluid is then delivered by the bubble detector 6 to the secondary bubble removal assembly 7 to complete the secondary cleaning of the bubbles. The perfusion fluid with the secondary bubble cleaning is then sent to the storage tank 9. At the same time, the perfusion fluid stored in the storage tank 9 is delivered into the organ compartment 1 to ensure a continuous fluid supply to the organ compartment 1.

[0063] This invention, through the installation of the storage tank 9, ensures uninterrupted perfusion of the organ chamber 1 during emergencies by continuously supplying liquid to the storage tank 9; avoids organ hypoxia damage caused by degassing during shutdown; and dynamically adjusts the chamber pressure by using the constant pressure box 91 and the liquid storage bladder 92 in the storage tank 9 to maintain a constant external pressure of the liquid storage bladder 92, ensuring the output perfusion liquid pressure and preventing organ damage due to unstable perfusion pressure; thus improving the safety, continuity, and stability of the perfusion equipment; and solving the problems of liquid supply interruption and unstable liquid supply pressure during degassing of the perfusion equipment. Example 3

[0064] Based on the above embodiments, a perfusion method for organ transport includes the following steps: S01: The injection fluid flows out from the injection tank 2, is pressurized by the drive pump 3, and then enters the oxygenator 4 for gas exchange.

[0065] S02: The oxygenated injection fluid output from the oxygenator 4 enters the first-stage degassing assembly 5, where the bubbles are separated from the injection fluid by the expansion pipe 55 and the diversion membrane 56.

[0066] S03: The injection fluid from the main output port 52 of the first-stage bubble removal component 5 enters the bubble detection component 6 to detect whether there are bubbles in the injection fluid. If no bubbles are detected, it enters S04; if bubbles are detected, it enters S05.

[0067] S04: The tested perfusion fluid is transported to the organ compartment 1 through the main pipeline 81; a small amount of perfusion fluid carrying air bubbles is continuously discharged from the secondary outlet 53 of the primary de-bubbling assembly 5, sent to the secondary de-bubbling assembly 7 for purification, and then into the storage tank 9, and finally sent to the organ compartment 1 from the storage tank 9, entering S06.

[0068] S05: The perfusion fluid containing air bubbles is transported to the secondary degassing assembly 7 through the first branch pipe 821. Deep degassing is completed by stirring and diaphragm 72. The degassed perfusion fluid enters the storage tank 9. The perfusion fluid stored in the storage tank 9 is continuously and stably supplied to the organ compartment 1 to ensure uninterrupted perfusion. Then it enters S06.

[0069] S06: The perfusion fluid enters organ chamber 1 to supply oxygen and energy to the organ, and then exits organ chamber 1 into perfusion tank 2, returning to S01.

[0070] In step S04, valve device 83 is in the first state, third valve 833 is open, and main pipeline 81 supplies fluid to organ chamber 1; second valve 832 is open, and secondary outlet 53 of primary degassing assembly 5 continuously discharges a small amount of perfusion fluid carrying air bubbles to secondary degassing assembly 7 through second branch pipe 822; first valve 831 is closed, so that first branch pipe 821 is not connected, ensuring the amount of perfusion fluid entering organ chamber 1.

[0071] In step S04, after the perfusion fluid in the storage tank 9 is filled, the same amount of perfusion fluid is slowly delivered into the organ compartment 1 according to the amount of perfusion fluid subsequently entering the storage tank 9; in step S05, the perfusion fluid in the storage tank 9 is delivered into the organ compartment 1 quickly and stably.

[0072] In step S05, valve device 83 is in the second state, third valve 833 is closed, cutting off the fluid supply from main pipeline 81 to organ chamber 1; second valve 832 is closed, stopping the discharge of perfusion fluid from secondary outlet 53 of primary de-bubbling assembly 5 to secondary de-bubbling assembly 7; first valve 831 is opened, guiding the perfusion fluid originally leading to organ chamber 1 to first branch pipe 821, which then enters secondary de-bubbling assembly 7.

[0073] The above description is only a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any equivalent substitutions or modifications made by those skilled in the art within the scope of the technology disclosed in the present invention, based on the technical solution and inventive concept of the present invention, should be covered within the scope of protection of the present invention.

Claims

1. A perfusion device for organ transport, comprising an organ compartment, a perfusion tank, a drive pump, and an oxygenator, characterized in that, Also includes: The primary bubble degassing assembly is equipped with an input port, a main output port, and a secondary output port; The main output port delivers the de-air-filled injection fluid, and the auxiliary output port discharges the injection fluid containing air bubbles. A bubble detection device is installed at the main output port of the first-stage bubble removal assembly to detect in real time whether there are residual bubbles in the perfusion fluid. The secondary defoaming component is used to perform a second, efficient defoaming treatment on the injection fluid containing air bubbles; The piping assembly includes a main pipeline and branch pipelines. The main pipeline connects the organ compartment, infusion tank, drive pump, oxygenator, primary bubble removal assembly, bubble detection device and organ compartment in sequence, forming the main infusion circulation path. The branch pipelines connect the secondary bubble removal assembly in parallel between the primary bubble removal assembly and the organ compartment. The valve device switches between two operating states based on the signal from the bubble detection element: When no bubbles are detected, the system is in the first state: the perfusion fluid from the main output port is directly delivered to the organ compartment; at the same time, the perfusion fluid containing bubbles discharged from the auxiliary output port is sent to the secondary bubble removal assembly. When air bubbles are detected, the system switches to the second state: the perfusion fluid from the main output port is diverted to the secondary air bubble removal assembly, and then returns to the organ compartment from the branch line, ensuring that no air bubbles enter the organ compartment.

2. The perfusion device for organ transport according to claim 1, characterized in that, The branch pipeline is also equipped with a storage tank, which is located between the secondary degassing assembly and the organ chamber. The storage tank is used to temporarily store the perfusion fluid of the secondary degassing treatment and to stably supply fluid to the organ chamber.

3. The perfusion device for organ transport according to claim 2, characterized in that, The storage tank includes a constant pressure chamber, which contains a liquid storage bladder. The constant pressure chamber forms a sealed cavity. The liquid storage bladder is equipped with an inlet pipe and an outlet pipe. The constant pressure chamber is equipped with a constant pressure component for adjusting and maintaining a constant internal air pressure.

4. The perfusion device for organ transport according to claim 3, characterized in that, The constant pressure chamber includes an upper shell and a lower shell. The upper shell and the lower shell are provided with mounting parts, which can seal the upper shell and the lower shell. The inlet pipe and the outlet pipe are both provided with check valves to prevent liquid backflow.

5. The perfusion device for organ transport according to claim 4, characterized in that, The feed pipe and discharge pipe penetrate the bottom surface of the lower shell, and the portion inside the constant pressure box is provided with a limiting ring, while the portion outside the constant pressure box is provided with a fixing member. The bottom surface of the lower shell is provided with a fixing ring. The fixing member and the fixing ring work together with the mounting component to ensure the sealing of the constant pressure box.

6. The perfusion device for organ transport according to claim 3, characterized in that, The constant pressure component includes an air inlet pipe, one end of which is connected to the inside of the constant pressure chamber, and the other end is equipped with an air source. The constant pressure chamber is equipped with a pressure relief pipe, and the air inlet pipe and the pressure relief pipe are equipped with a linkage valve, which can automatically control the air intake and exhaust volume according to the pressure inside the constant pressure chamber.

7. The perfusion device for organ transport according to claim 1, characterized in that, The primary air bubble removal assembly includes a housing, inside which is an expansion pipe, and inside the expansion pipe is a flow divider membrane, which prevents air bubbles from entering the main outlet.

8. The perfusion device for organ transport according to claim 1, characterized in that, The secondary degassing assembly includes a shell and a diaphragm. The diaphragm is integrated inside the shell. The shell also contains a stirring element. A drive element that is detachably connected to the stirring element is located below the shell.

9. The perfusion device for organ transport according to claim 1, characterized in that, The branch pipeline includes a first branch pipe, a second branch pipe, and a third branch pipe. The first branch pipe connects the outlet of the bubble detection device to the inlet of the secondary bubble removal component. The second branch pipe connects the secondary output port of the primary bubble removal component to the inlet of the secondary bubble removal component. The third branch pipe connects the secondary bubble removal component, the storage tank, and the organ compartment in sequence.

10. A perfusion method for organ transport based on the device according to any one of claims 2 to 9, characterized in that, Includes the following steps: S01: The injection fluid flows out of the injection tank, is pressurized by the drive pump, and then enters the oxygenator; S02: The perfusion fluid output from the oxygenator enters the first-stage degassing assembly to separate the bubbles from the perfusion fluid; S03: The bubble detection device detects whether there are bubbles in the injection liquid at the main output port of the primary bubble degassing assembly. If no bubbles are detected, it enters S04; if bubbles are detected, it enters S05. S04: The perfusion fluid that has been tested is delivered to the organ compartment; the secondary output port of the primary bubble removal component sends the perfusion fluid containing bubbles to the secondary bubble removal component, and after the bubbles are removed, it is sent to the storage tank, and finally sent to the organ compartment from the storage tank, entering S06; S05: The perfusion fluid containing air bubbles after detection is transported to the secondary air bubble removal component, and after air bubbles are removed, it enters the storage tank; the perfusion fluid stored in the storage tank is continuously and stably supplied to the organ compartment, and then enters S06; S06: The perfusion fluid enters the organ chamber to supply oxygen and energy to the organ, and then exits the organ chamber into the perfusion tank, returning to S01.

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