Organ perfusion device

Abstract

The invention belongs to the field of medical equipment, and provides an organ perfusion device, which comprises a liquid storage bin, a perfusion device and a control device, the organ bin is used for storing isolated organs; the pump is used for driving perfusate; the perfusion pipeline is used for perfusion of an isolated organ, is provided with two or more flow division pipelines and is used for perfusion and flow division; the temperature maintaining system is used for maintaining the perfusate and the isolated organ at different temperatures; the oxygenator is used for oxygenating the perfusate; the central control system is used for system control; the perfusion pipeline is driven by the pump to extract perfusion liquid from the liquid storage bin to perfuse the isolated organ in the organ bin. Metabolic waste can be prevented from entering circulation again through one-way perfusion, low-temperature and normal-temperature double-phase automatic switching is achieved, one-way tidal perfusion is achieved, the device structure is obviously simplified, and the overall performance such as safety, stability and portability is improved.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, specifically relating to an organ perfusion device. Background Technology

[0002] Organ mechanical perfusion devices are mainly used for low-flow organs such as the kidneys, severed limbs, vascular tissue complexes, uterus, and pancreas, and can also be used for perfusion of other organs such as the liver.

[0003] Normothermic Machine Perfusion (NMP), a novel organ preservation technology, fully simulates the in vivo physiological environment by controlling perfusion parameters such as temperature, pressure, flow rate, and oxygen flow rate, and using a perfusion fluid that mimics blood components, thus maintaining good metabolic activity and structural integrity of ex vivo organs. Normothermic machine perfusion can maintain organ viability for extended periods, reduce ischemic damage, prolong organ preservation time, accurately assess organ viability, and facilitate treatments such as thrombolysis, gene editing, and stem cell therapy on ex vivo organs. It can also be rapidly transported using drones.

[0004] In recent years, organ mechanical perfusion technology has developed rapidly, and related patents mainly focus on the following aspects: 1) Perfusion device design, with most patents focusing on the design of ambient temperature mechanical perfusion devices, including pumps, piping systems, and perfusion fluid temperature and flow control. 2) Intelligent control systems, which dynamically adjust the flow rate, pressure, and temperature of the perfusion fluid based on real-time data. Intelligent monitoring and regulation systems utilize sensors and feedback mechanisms to adjust the flow rate, temperature, and oxygen concentration of the perfusion fluid in real time to ensure organ survival under optimal conditions. 3) Organ protection and repair mechanisms. 4) Improvements in perfusion fluid formulations, etc.

[0005] Compared to large organs like the liver and lungs, small organs such as kidneys and severed limbs have lower flow rates and lower heating and oxygenation efficiency, especially in cases of organ damage caused by factors such as heart failure or donor death. Therefore, shunt tubing is essential to improve circulation efficiency and perfusion outcomes. Taking mechanical perfusion preservation of severed limbs as an example, this technique is primarily used to preserve limbs. Limb replantation is a crucial field in trauma surgery and microsurgery, and also an important technique in battlefield rescue. Traditional limb preservation relies on low-temperature static cryopreservation (e.g., ice at 4°C), which only delays metabolism but cannot repair tissue damage. If the ischemic time of a severed limb exceeds 6 hours, it will lead to irreversible muscle necrosis, nerve degeneration, and vascular endothelial damage, resulting in a replantation failure rate as high as 30%-50%. Mechanical limb perfusion can be used in battlefield trauma and disaster relief, significantly extending the preservation time of severed limbs to several days, improving preservation outcomes, especially maintaining nerve viability, and increasing the success rate of replantation. It can also be used for isolated perfusion chemotherapy in limb melanoma. Summary of the Invention

[0006] To address the problems in the background art, this invention proposes an organ perfusion device, comprising: a reservoir for storing perfusion fluid; an organ reservoir for storing isolated organs; a pump for driving the perfusion fluid; perfusion tubing for perfusing isolated organs, having two or more branch lines for perfusion and branching; a temperature maintenance system for maintaining the perfusion fluid and isolated organs at different temperatures; an oxygenator for oxygenating the perfusion fluid; and a central control system for system control. Driven by the pump, the perfusion tubing draws perfusion fluid from the reservoir to perfuse the isolated organs in the organ reservoir.

[0007] In one embodiment, the temperature maintenance system has a heating device and a cooling device. Under the control of the central control system, the temperature maintenance system is linked with the pump to perform normal perfusion of the isolated organ at normal temperature and to stop or slowly perfuse at low temperature.

[0008] In one embodiment, the perfusion tubing is used to perfuse isolated organs and has a unidirectional perfusion structure. Driven by a pump, liquid is drawn from the reservoir, oxygenated by an oxygenator, and then used to perfuse the isolated organ in the organ compartment in a unidirectional manner. The liquid flowing out through the organ vein does not flow back to the reservoir.

[0009] In one embodiment, the perfusion line has a pressure-protected shunt line, a proportional valve, or a shut-off valve to control the degree of shunt and regulate the perfusion pressure and flow rate to avoid organ damage due to excessive perfusion pressure.

[0010] In one embodiment, the temperature maintenance system includes a heating device, which includes an oxygenator temperature-controlled tube or an infrared device. The circulating fluid is heated by the oxygenator temperature-controlled tube and the oxygenator, or the organ is directly heated by the infrared device to maintain the temperature of the organ and the perfusion fluid under normal flow conditions.

[0011] In one embodiment, the temperature maintenance system includes a refrigeration device, which includes an oxygenator temperature-controlled tube or an air cooler. The circulating fluid is cooled by the oxygenator temperature-controlled tube and the oxygenator, or the organ is cooled by direct airflow through the air cooler, in order to maintain the temperature of the organ and the perfusion fluid under low flow conditions.

[0012] In one embodiment, the perfusion tubing is equipped with a pressure sensor to monitor the pressure of the perfusion tubing and the shunt tubing; the perfusion tubing is equipped with a flow and bubble sensor to monitor the flow rate and bubbles in the perfusion tubing and the shunt tubing; a temperature sensor is installed in the perfusion tubing and the organ compartment to monitor the temperature of the perfusion fluid and the organ; the perfusion tubing is equipped with a circulating fluid oxygen saturation or oxygen partial pressure sensor to monitor the oxygenation status of the circulating fluid, and the oxygen flow rate supplied to the oxygenator is controlled by the central control system to maintain a reasonable level of circulating oxygen partial pressure; the perfusion tubing is equipped with a glomerular filtration rate monitoring sensor to measure the glomerular filtration rate by detecting the signal of the fluorescent tracer added to the circulating fluid, thereby assessing the function of the isolated kidney online; the perfusion tubing is equipped with a tissue oxygen saturation sensor, and a pulse oxygen saturation sensor is used to monitor the oxygenation status of the organ or amputated limb tissue, and the oxygen flow rate supplied to the oxygenator is controlled by the central control system to maintain the tissue oxygen partial pressure at a reasonable level.

[0013] In one embodiment, the infusion device further includes: an oxygen supply device for supplying oxygen to the oxygenator, the oxygen supply device being an oxygen cylinder or an oxygen generator; a filter plug disposed on the infusion pipeline; and a micro-pump connected to the infusion pipeline.

[0014] In one implementation, the central control system controls the temperature maintenance system to work in conjunction with the pump to perform normal perfusion of the isolated organ at room temperature and to stop or slow down perfusion at low temperature. The central control system adjusts the perfusion parameters based on sensor parameters to ensure that the isolated organ is in optimal condition.

[0015] In one embodiment, the perfusion tubing or organ compartment is equipped with an ultraviolet device for sterilization and infection control; the perfusion tubing is equipped with a dialyzer to maintain electrolyte stability in the perfusion fluid, remove excess water, and maintain internal environmental stability; the perfusion tubing is equipped with a perfusion device to continuously remove inflammatory mediators and endotoxins from the circulating fluid; and a surge-proof porous baffle is installed in the reservoir to prevent the circulating fluid from overflowing or air from entering the perfusion tubing.

[0016] The device of this invention not only features a shunt tubing to improve the heating and oxygenation circulation efficiency of small organs such as kidneys and severed limbs, thus enhancing perfusion efficacy, but also allows for perfusion of multiple arteries with variations. This unidirectional tidal organ perfusion device, unlike existing circulating perfusion devices, enables unidirectional tidal perfusion of isolated organs, preventing metabolic waste from re-entering the circulation and effectively conserving perfusion fluid.

[0017] The perfusion device of this invention, under the control of a central control system, links the temperature maintenance system with the pump to perform normal perfusion of isolated organs at room temperature and to stop or slow down perfusion at low temperature. The central control system controls the alternating tidal temperature control perfusion between room temperature and low temperature, automatically switching modes, which is different from existing standalone low-temperature mechanical perfusion devices or standalone room temperature systems.

[0018] The infusion device of the present invention is an oxygenator-free room temperature infusion device, which uses pre-oxygenated artificial oxygen-carrying agent for infusion, thus avoiding the use of an oxygenator.

[0019] The perfusion device of this invention has the following technical advantages: 1) Unique unidirectional perfusion, unlike existing circulating perfusion devices, avoids metabolic waste re-entering the circulation; 2) The temperature maintenance system has both heating and cooling devices. Under the control of the central control system, the temperature maintenance system is linked with the pump to perform normal perfusion of isolated organs at room temperature and to stop or slow down perfusion at low temperature. The unique dual-mode system of low temperature and room temperature automatically switches between the two modes, unlike existing standalone low-temperature mechanical perfusion devices or standalone room temperature systems; 3) Intermittent tidal perfusion under the control of the central control system effectively saves perfusion fluid. These features make it more suitable for use in battlefield rescue, emergency rescue, and disaster relief environments.

[0020] The infusion device of the present invention avoids metabolic waste from re-entering the cycle through unidirectional infusion, automatically switches between low temperature and normal temperature modes, and provides intermittent tidal infusion, which significantly simplifies the device structure and improves overall performance such as safety, stability and portability. Attached Figure Description

[0021] To facilitate understanding of the invention, it will be described in more detail with reference to the specific embodiments shown in the accompanying drawings. These drawings depict only typical embodiments of the invention and should not be considered as limiting the scope of protection of the invention.

[0022] Figure 1 This is a simplified structural diagram of the device of the present invention.

[0023] Figure 2 This is a top view of the device of the present invention.

[0024] Figure 3 This is a rear view and internal structural diagram of the device of the present invention.

[0025] Figure 4 This is a left-side view of the device of the present invention.

[0026] Figure 5 This is a diagram of the consumable materials for the kidney perfusion tubing of the device of the present invention.

[0027] Figure 6 This is a top view of the kidney perfusion tubing consumables of the device of the present invention.

[0028] Figure 7 This is a diagram of the consumable materials for the severed limb tubing of the device of the present invention.

[0029] Figure 8 This is a basic structural diagram of the unidirectional tidal injection device of the present invention.

[0030] Figure 9 This is a flowchart of the tidal injection control process of the device of the present invention.

[0031] Figure 10 This is a flowchart of the temperature control process of the device of the present invention.

[0032] Figure Labels

[0033] 101 Infusion Pipeline, 101-1 Diverter Pipeline, 101-2 Pressure Protection Diverter Pipeline, 101-3 Proportional Valve, 102 Pump, 103 Storage Tank, 104 Central Control System, 105 Organ Compartment, 105-1 Organ Compartment Cover, 105-2 Organ Compartment Cover Fixing Clip, 106 Temperature Maintenance System, 107 Heating Device, 107-1 Heating Device Cooling Fan, 108 Refrigeration Device, 109 Oxygenator, 1010 Filter, 1011 Oxygen Supply Device, 1012 Ultraviolet Device, 1013 Display Screen, 1014 Shut-off Valve, 1015 Flow and Bubble Sensor, 1016 Micro Pump, 1017 Casters, 1018 Handle, 1019 Pump Speed Adjustment knob, 1020 sensor socket, 1021 main unit housing, 1024 oxygenator temperature-changing tube, 1024-1 oxygenator temperature-changing tube interface, 1029 pressure sensor, 1030 water inlet, 1032 oxygen connection tube, 1033 fixing plate, 1034 drug dosing port, 1035 temperature sensor, 1036 pulse oxygen saturation sensor, 1037 circulating fluid oxygen saturation or oxygen partial pressure sensor, 1038 tissue oxygen saturation sensor, 1039 glomerular filtration rate monitoring sensor, 1040 dialyzer, 1041 perfusion device, 1042 infrared device, 1043 air cooler, 1044 surge-proof porous partition, 1045 organ compartment reflux connector. Detailed Implementation

[0034] The following is a reference to the appendix. Figure 1-10 The embodiments of the present invention are described in order to enable those skilled in the art to better understand and implement the present invention. However, the listed embodiments are not intended to limit the present invention. In the absence of conflict, the following embodiments and the technical features in the embodiments can be combined with each other, wherein the same components are represented by the same reference numerals.

[0035] First Implementation Method (Circulating Infusion Mode)

[0036] like Figures 1-7As shown, the perfusion device of the present invention includes: a perfusion line 101 for perfusing isolated organs, having two or more branch lines 101-1 for perfusion and branching; a pump 102 for driving perfusion; a reservoir 103 for storing perfusion fluid; a central control system 104 for system control; an organ chamber 105 for storing isolated organs; a temperature maintenance system 106 for maintaining the temperature of the perfusion fluid and isolated organs; and an oxygenator 109 for oxygenating the perfusion fluid. Driven by the pump 102, the perfusion line 101 draws perfusion fluid from the reservoir 103 to perfuse the isolated organs in the organ chamber 105.

[0037] like Figure 1 and 2 The diagram shown is a simplified overall structural diagram of the device of the present invention. The perfusion line 101 includes two or more shunt lines 101-1 for organ perfusion and shunt, improving the oxygenation, heating, and circulation efficiency of low-flow organs. It can also be used to perfuse different vascular branches of a single organ or multiple organs. The proportional valve 101-3 is used to control the opening and closing of the shunt lines 101-1. Preferably, the perfusion line 101 has a pressure-protected shunt line 101-2 and a proportional valve 101-3, which are used to quickly shunt the perfusion line 101 after the pump 102 (taking a peristaltic pump as an example) drives the perfusion line 101 to exceed the limited pressure, thereby adjusting the perfusion pressure and flow rate and preventing organ damage due to excessively high perfusion pressure.

[0038] Driven by pump 102, the perfusion line 101, after oxygenation by oxygenator 109, perfuses the isolated organ in organ compartment 105. A flow and bubble sensor 1015 monitors the flow rate and bubbles in the perfusion shunt line 101-1. A micro-pump 1016 is connected to the perfusion line 101 for continuous anticoagulation, thrombolysis, anti-infection, and vasodilatory treatment of the isolated organ. Pump 102 drives the perfusion; preferably, pump 102 is a roller pump. A reservoir 103 stores the perfusion fluid. A central control system 104 controls the system. Organ compartment 105 stores the isolated organ. A temperature maintenance system 106 maintains the temperature of the perfusion fluid and the isolated organ. Oxygenator 109 oxygenates the perfusion fluid. Driven by pump 102, the perfusion line 101 draws perfusion fluid from reservoir 103 to perfuse the isolated organ in organ compartment 105.

[0039] The perfusion line 101 is equipped with a dialyzer 1040 to maintain electrolyte stability in the perfusion fluid, remove excess water, and maintain internal environmental stability. The perfusion line 101 is also equipped with a perfusion device 1041 to continuously remove inflammatory mediators and endotoxins from the circulating fluid. Due to the functions of the dialyzer 1040 and perfusion device 1041, the perfusion fluid is continuously renewed, metabolic waste is promptly removed, and the internal environment remains stable.

[0040] Preferably, the infusion device of the present invention includes an organ compartment 105 for storing excised limbs or organs. The organ compartment 105 has an organ compartment cover 105-1 and an organ compartment cover fixing buckle 105-2.

[0041] Furthermore, the perfusion device of the present invention includes a temperature maintenance system 106, located at the lower part of the device, comprising: a heating device 107, which includes heating the circulating fluid through the oxygenator temperature-changing tube 1024 and the oxygenator 109, and directly irradiating the organ with an infrared device 1042 to maintain the temperature of the organ and perfusion fluid under normal flow conditions; and a cooling device 108, which includes cooling the circulating fluid through the oxygenator temperature-changing tube 1024 and the oxygenator 109, and directly blowing air onto the organ to cool it, to maintain the temperature of the organ and perfusion fluid under low flow conditions. The temperature maintenance system 106 is used to maintain the temperature of the perfusion fluid and the excised organ. The temperature maintenance system 106 has a dual-phase state of low temperature and normal temperature to maintain the temperature of the perfusion fluid and the organ. Based on this, the perfusion device of the present invention can realize an alternating cycle of normal temperature perfusion and low temperature cessation perfusion. The temperature maintenance system 106 has a heating device 107 and a cooling device 108. Under the control of the central control system 104, the temperature maintenance system 106 is linked with the pump 102. Under normal temperature conditions, the pump 102 perfuses the isolated organ at a normal speed, and under low temperature conditions, the perfusion is stopped or the perfusion is slowed down.

[0042] The principle is described below.

[0043] Mode 1: In the ambient temperature perfusion stage, the temperature of the perfusion fluid and organ is maintained within the range of 20-37°C. Pump 102 maintains a normal perfusion rate, and oxygen supply device 1011 maintains a normal oxygen supply flow rate. When the central control system 104 selects the ambient temperature perfusion mode, the temperature maintenance system 106 heats the isolated limb or organ to maintain basic organ functions and normal metabolism. In one embodiment, the temperature maintenance system 106 includes a heating device 107, which heats the isolated limb or organ. The heating method of the heating device 107 includes: an infrared device 1042, an oxygenator temperature-controlled tube 1024, etc. In one embodiment, the heating device 107 includes a heating device cooling fan 107-1, a heating device circulating water tank, and a heating device circulating water pump. The heating device circulating water tank is used for storing and heating the circulating water in the heating system, and the heating device circulating water pump is used to drive the circulating water to heat the oxygenator 109.

[0044] Mode 2: Low-temperature perfusion stage, characterized by maintaining the temperature of the perfusion fluid and organ within the range of 4-20°C, pump 102 maintaining a low perfusion rate or stopping perfusion, and oxygen supply device 1011 reducing the oxygen supply flow rate or stopping oxygen supply. When the central control system 104 selects the low-temperature perfusion mode, the temperature maintenance system 106 performs low-temperature perfusion on the isolated limb or organ, or even stops perfusion, relying on residual energy and oxygen carriers to maintain metabolism, using ice or a refrigeration system preferably based on the urea refrigeration principle. In one embodiment, the temperature maintenance system 106 includes a refrigeration device 108, which cools the isolated limb or organ. In one embodiment, the refrigeration device 108 includes an oxygenator temperature-controlled tube 1024 and an air cooler 1043, used to maintain the temperature of the organ and perfusion fluid under low flow conditions.

[0045] Under the control of the central control system 104, the temperature maintenance system 106 is linked with the pump 102. According to the predetermined time stage, the pump 102 perfuses the isolated organ at a normal speed under normal temperature conditions, and stops perfusion or perfuses slowly under low temperature conditions.

[0046] The device of this invention not only features a shunt tubing system to improve the heating and oxygenation efficiency of small organs such as kidneys and severed limbs, thus enhancing perfusion efficacy, but also allows for the perfusion of multiple variant blood vessels using the shunt tubing system. This device is a unique dual-mode system in the world, automatically switching between low-temperature and ambient-temperature modes, unlike existing standalone low-temperature mechanical perfusion devices or standalone ambient-temperature systems. It significantly simplifies the device structure and improves overall performance, including safety, stability, and portability.

[0047] The apparatus of the present invention will now be described in detail with reference to the accompanying drawings.

[0048] Figure 1 This is a simplified structural diagram of the device of the present invention. The perfusion line 101 includes two or more shunt lines 101-1 for organ perfusion and shunt, improving oxygenation and circulation efficiency, and can also be used for perfusion of different arterial shunts. A proportional valve 101-3 is used to control the opening and closing degree of the shunt lines 101-1. Preferably, the perfusion line 101 has a pressure-protected shunt line 101-2 and a proportional valve 101-3 to shunt when the pressure exceeds a certain limit, preventing excessive organ perfusion pressure from damaging the organ. Driven by the pump 102, the perfusion line 101, after oxygenation by the oxygenator 109, perfuses the isolated organ in the organ chamber 105. A flow and bubble sensor 1015 is used to monitor the flow rate and bubbles in the perfusion shunt line 101-1. A micro-pump 1016 is used for continuous anticoagulation, thrombolysis, anti-infection, and vasodilator treatments on the isolated organ.

[0049] Pump 102 drives the perfusion process, reservoir 103 stores the perfusion fluid, and central control system 104 controls the system. Organ compartment 105 stores the isolated organ. Temperature maintenance system 106 maintains the temperature of the perfusion fluid and the isolated organ. Oxygenator 109 oxygenates the perfusion fluid. Driven by pump 102, perfusion line 101 draws perfusion fluid from reservoir 103 to perfuse the isolated organ in organ compartment 105. Temperature maintenance system 106 includes heating device 107 and cooling device 108. Under the control of central control system 104, temperature maintenance system 106 is linked with pump 102 to perform normal perfusion of the isolated organ at room temperature and to stop or slow perfusion at low temperature. The room temperature range is 20-37 degrees Celsius. The low-temperature state refers to a temperature range of 4-20 degrees Celsius.

[0050] The perfusion tubing 101 is equipped with a dialyzer 1040 to maintain electrolyte stability in the perfusion fluid, remove excess water, and maintain internal environmental stability. The perfusion tubing 101 is also equipped with a perfusion device 1041 to continuously remove inflammatory mediators and endotoxins from the circulating fluid. Due to the functions of the dialyzer 1040 and perfusion device 1041, the perfusion fluid is continuously renewed, metabolic waste is promptly removed, and the internal environment remains stable, which is crucial for long-term mechanical perfusion of isolated organs.

[0051] The temperature maintenance system 106 is located at the lower part of the device and includes: a heating device 107, which includes heating the circulating fluid through the oxygenator temperature-changing tube 1024 and the oxygenator 109, and directly irradiating the organ with an infrared device 1042 to maintain the temperature of the organ and perfusion fluid under low flow conditions; and a cooling device 108, which includes cooling the circulating fluid through the oxygenator temperature-changing tube 1024 and the oxygenator 109, and directly blowing air onto the organ to cool it, and maintaining the temperature of the organ and perfusion fluid under low flow conditions.

[0052] The infusion line 101 is equipped with a pressure sensor 1029 for monitoring the pressure of the infusion line 101 and the diversion line 101-1; the infusion line 101 is equipped with a flow and bubble sensor 1015 for monitoring the flow and bubbles of the infusion line 101 and the diversion line 101-1; a temperature sensor 1035 is installed in the infusion line 101 and the organ compartment 105 for monitoring the infusion temperature; and an ultraviolet device 1012 is installed in the infusion line 101 or the organ compartment 105 for sterilization and infection control.

[0053] Figure 2This is a top view of the invention. The main unit housing 1021 serves as a protective shell. A display screen 1013, which can be a touchscreen or an LCD screen, is located at the front of the device to display perfusion status, sensor values, power levels, etc. Multiple sensor jacks 1020 are used to connect sensors, and sensor data can be displayed on the display screen 1013. The sensors include a flow and bubble sensor 1015, a pressure sensor 1029, a temperature sensor 1035, a pulse oxygen saturation sensor 1036, a circulating fluid oxygen saturation or oxygen partial pressure sensor 1037, a tissue oxygen saturation sensor 1038, and a glomerular filtration rate monitoring sensor 1039.

[0054] The perfusion line 101 includes two or more shunt lines 101-1 for organ perfusion and shunt, improving oxygenation and circulation efficiency, and can also be used for perfusion of different arterial shunts. Preferably, the shunt line 101-1 is equipped with a proportional valve 101-3 to control the degree of shunt and adjust the perfusion pressure and flow rate. Preferably, the shunt line 101-1 is equipped with a shut-off valve 1014 to control the opening or closing of the shunt line 101-1. Preferably, the perfusion line 101 has a pressure-protected shunt line 101-2 and a proportional valve 101-3 to shunt when the pressure exceeds a certain limit, preventing organ damage due to excessive perfusion pressure. Driven by the pump 102, the perfusion line 101, after oxygenation by the oxygenator 109, perfuses the excised organ in the organ compartment 105. A flow and bubble sensor 1015 is used to monitor the flow rate and air bubbles in the perfusion shunt line 101-1. The micro-infusion pump 1016 is used for continuous anticoagulation, thrombolysis, anti-infection, and vasodilation treatment of isolated organs. The pump speed adjustment knob 1019 controls the pump speed. The organ compartment 105 has a surge-proof porous baffle 1044 to prevent overflow of the perfusion fluid during movement. Casters 1017 are used for moving the device. The handle 1018 is used for traction and movement of the device.

[0055] Figure 3 This is a rear view and internal structural diagram of the device of the present invention. A display screen 1013 is provided at the front of the device, which can be a touch screen or an LCD screen, for displaying the infusion status, sensor values, power level, etc.

[0056] Sensor jacks 1020 include jacks for a flow and bubble sensor 1015, a pressure sensor 1029, a temperature sensor 1035, a pulse oxygen saturation sensor 1036, a circulating fluid oxygen saturation or oxygen partial pressure sensor 1037, a tissue oxygen saturation sensor 1038, and a glomerular filtration rate monitoring sensor 1039. Specifically: the temperature sensor 1035 monitors temperature; the circulating fluid oxygen saturation or oxygen partial pressure sensor 1037 monitors the oxygenation status of the circulating fluid and controls the oxygen flow rate supplied to the oxygenator 109 via the central control system 104 to maintain a reasonable circulating oxygen partial pressure level; the glomerular filtration rate monitoring sensor 1039 measures the glomerular filtration rate by detecting the signal of the fluorescent tracer added to the circulating fluid, thereby assessing the function of the isolated kidney online; the tissue oxygen saturation sensor 1038 and the pulse oxygen saturation sensor 1036 are used to monitor the oxygenation status of organ or severed limb tissues and control the oxygen flow rate supplied to the oxygenator 109 via the central control system 104 to maintain the tissue oxygen partial pressure at a reasonable level.

[0057] Pump 102 drives perfusion, pressure sensor 1029 continuously monitors perfusion pressure, and organ compartment cover 105-1 seals the organ compartment 105 to prevent infection. Perfusion tubing 101 includes two or more shunt lines 101-1 for organ perfusion and shunt, improving oxygenation and circulation efficiency, and can also be used for perfusion of different vascular variants. A thrombectomy filter 1010 filters impurities and air bubbles from the perfusion fluid. A micro-pump 1016 is located at the rear of the device for precise thrombolysis, anticoagulation, anti-infection, and blood glucose regulation treatments. Oxygenator temperature control tube 1024 heats or cools the oxygenator 109. Oxygenator temperature control tube interface 1024-1 connects to the temperature maintenance system 106. Oxygenator 109 oxygenates the perfusion fluid; oxygen connection tube 1032 serves as the oxygen supply channel for oxygenator 109.

[0058] Figure 4 This is a left-side view of one embodiment of the device of the present invention.

[0059] A display screen 1013, which can be a touchscreen or LCD screen, is installed on the front of the device to display perfusion status, sensor values, and battery level. Sensor sockets 1020 include sockets for flow and bubble sensors 1015, pressure sensors 1029, temperature sensors 1035, pulse oxygen saturation sensors 1036, circulating fluid oxygen saturation or oxygen partial pressure sensors 1037, tissue oxygen saturation sensors 1038, and glomerular filtration rate monitoring sensors 1039. A pump speed adjustment knob 1019 controls the pump speed. Casters 1017 are used for moving the device. A water inlet 1030 is used to replenish the circulating water in the temperature maintenance system 106. Status indicator lights are located below the display screen 1013 to indicate whether the device is operating normally or abnormally, providing light warnings. A power module supplies power to the device. A power socket is used for inserting and securing the power cord. A switch controls the device's on / off state. A data interface is used to read data or upgrade the control system.

[0060] Pump 102 is used to drive perfusion, pressure sensor 1029 is used to continuously monitor perfusion pressure, and organ compartment cover 105-1 is used to seal organ compartment 105 to prevent infection. Heating device cooling fan 107-1 is used to dissipate heat from heating device 107 in a timely manner to facilitate precise temperature control.

[0061] The oxygenator 109 is used to oxygenate the perfusion fluid. The oxygen connection pipe 1032 serves as the oxygen supply channel for the oxygenator 109. The oxygenator temperature control pipe 1024 is used to heat or cool the oxygenator 109. A micro-pump 1016 is installed at the rear of the device to facilitate precise administration of treatments such as thrombolysis, anticoagulation, anti-infection, and blood glucose regulation.

[0062] The organ compartment reflux connector 1045 is located at the lowest point of the organ compartment 105, facilitating the aspiration and reflux of circulating fluid.

[0063] Figure 5 This is a diagram of the kidney perfusion tubing consumables for the device of the present invention, which relies on the fixed insert plate 1033 as a support structure.

[0064] The perfusion tubing 101 includes two or more shunt lines 101-1 for organ perfusion and shunt, improving oxygenation and circulation efficiency, and can also be used for perfusion of shunts in different variant vessels. A shut-off valve 1014 controls the opening or closing of the shunt lines 101-1. A pressure sensor 1029 monitors the perfusion pressure. An organ compartment cover 105-1 seals the organ compartment 105 to prevent infection. An organ compartment cover securing clip 105-2 secures the organ compartment cover 105-1.

[0065] Preferably, the perfusion line 101 has a pressure protection diversion line 101-2 and a proportional valve 101-3 for diverting the flow when the pressure exceeds the limit, so as to avoid organ damage caused by excessive organ perfusion pressure.

[0066] Driven by pump 102, the perfusion line 101, after oxygenation by oxygenator 109, perfuses the isolated organ in organ compartment 105. Filter plug 1010 is used to filter impurities and air bubbles in the perfusion fluid.

[0067] The oxygenator temperature control tube 1024 is used to heat or cool the oxygenator 109. The oxygenator temperature control tube interface 1024-1 is used to connect to the temperature maintenance system 106. The oxygenator 109 is used to oxygenate the injection fluid; the oxygen connection tube 1032 is used as the oxygen supply channel for the oxygenator 109.

[0068] Figure 6 This is a top view of the kidney perfusion tubing consumables of the device of the present invention.

[0069] The perfusion tubing 101 includes two or more shunt lines 101-1 for organ perfusion and shunt, improving oxygenation and circulation efficiency, and can also be used for perfusion of different arterial shunts. A pressure sensor 1029 is used to monitor perfusion pressure. An organ compartment cover 105-1 is used to seal the organ compartment 105 to prevent infection. An organ compartment cover fixing clip 105-2 is used to secure the organ compartment cover 105-1.

[0070] Preferably, the perfusion line 101 has a pressure protection diversion line 101-2 and a proportional valve 101-3 for diverting the flow when the pressure exceeds the limit, so as to avoid organ damage caused by excessive organ perfusion pressure.

[0071] Driven by pump 102, the perfusion line 101, after oxygenation by oxygenator 109, perfuses the isolated organ in organ compartment 105. Filter plug 1010 is used to filter impurities and air bubbles in the perfusion fluid.

[0072] The drug delivery port 1034 is used to add therapeutic drugs to the excised organs in the organ compartment 105.

[0073] Figure 7 This is a diagram of the consumable materials for the severed limb tubing of the device of the present invention.

[0074] The perfusion tubing 101 includes two or more shunt lines 101-1 for organ perfusion and shunt, improving oxygenation and circulation efficiency, and can also be used for perfusion of different arterial shunts. A shut-off valve 1014 controls the opening or closing of the shunt lines 101-1. A pressure sensor 1029 monitors the perfusion pressure. An organ compartment cover 105-1 seals the organ compartment 105 to prevent infection. An organ compartment cover fixing clip 105-2 secures the organ compartment cover 105-1.

[0075] Driven by pump 102, the perfusion line 101, after oxygenation by oxygenator 109, perfuses the isolated organ in organ compartment 105. Filter plug 1010 is used to filter impurities and air bubbles in the perfusion fluid.

[0076] The oxygenator temperature control tube 1024 is used to heat or cool the oxygenator 109. The oxygenator temperature control tube interface 1024-1 is used to connect to the temperature maintenance system 106. The oxygenator 109 is used to oxygenate the injection fluid; the oxygen connection tube 1032 is used as the oxygen supply channel for the oxygenator 109.

[0077] The organ compartment reflux connector 1045 is located at the lowest point of the organ compartment 105, facilitating the aspiration and reflux of circulating fluid.

[0078] Second Implementation Method - Unidirectional Infusion Mode

[0079] like Figure 8 The diagram shows the unidirectional tidal perfusion mode of this device. Pump 102 drives the perfusion, reservoir 103 stores the perfusion fluid, and central control system 104 controls the system. Organ container 105 stores the excised organ. Temperature maintenance system 106 maintains the temperature of the perfusion fluid and the excised organ. Oxygenator 109 oxygenates the perfusion fluid. Oxygen supply device 1011 provides oxygen to oxygenator 109; the oxygen supply device can be an oxygen cylinder or an oxygen generator.

[0080] First, driven by pump 102, the perfusion line 101 draws liquid from the reservoir 103, oxygenates it through oxygenator 109, and then performs unidirectional perfusion on the isolated organ in organ compartment 105. The liquid flowing out through the organ vein does not flow back to the reservoir 103, thus performing unidirectional perfusion. However, because the perfusion rate is as high as 100 ml / min or more, 6 liters of perfusion fluid are needed in just 1 hour. Therefore, conventional perfusion techniques require tens or even hundreds of kilograms of perfusion fluid, which is difficult to achieve.

[0081] Secondly, under the control of the central control system 104, the temperature maintenance system 106 is linked with the pump 102. At normal temperature, the pump 102 perfuses the isolated organ at a normal rate; at low temperature, the pump 102 stops perfusing or perfuses slowly. The device operates at low temperature most of the time, requiring very little perfusate, while at normal temperature for a small portion of the time, it requires normal perfusate. Therefore, the demand for perfusate is significantly reduced, achieving not only the goal of unidirectional perfusation but also avoiding the risks of air embolism and thrombosis caused by backflow, and preventing metabolic waste from re-entering the circulation and damaging organs. This makes it more suitable for emergency rescue and battlefield applications. The normal temperature range is 20-37 degrees Celsius. The low temperature range is 4-20 degrees Celsius. Preferably, the oxygen supply device 1011 also participates in the linkage, supplying oxygen at a normal flow rate at normal temperature and stopping or slowly supplying oxygen at low temperature.

[0082] Furthermore, in order to maintain precise and rapid heating and cooling of the excised organ at low flow rates, the temperature maintenance system 106 has both a heating device 107 and a cooling device 108. The temperature maintenance system 106 is located at the lower part of the device and includes: the heating device 107, which includes heating the circulating fluid through the oxygenator temperature-changing tube 1024 and the oxygenator 109, and directly heating the organ by irradiation through the infrared device 1042, for maintaining the temperature of the organ and perfusion fluid under low flow rate conditions; and the cooling device 108, which includes cooling the circulating fluid through the oxygenator temperature-changing tube 1024 and the oxygenator 109, and directly cooling the organ by blowing air through the air cooler 1043, for maintaining the temperature of the organ and perfusion fluid under low flow rate conditions.

[0083] Finally, the perfusion line 101 includes two or more shunt lines 101-1 for organ perfusion and shunt, improving oxygenation and circulation efficiency, and can also be used for perfusion of different arterial shunts. A proportional valve 101-3 is used to control the opening and closing of the shunt lines 101-1. Preferably, the perfusion line 101 has a pressure-protected shunt line 101-2 and a proportional valve 101-3 to shunt when the pressure exceeds a certain limit, preventing organ damage from excessively high perfusion pressure. A flow and bubble sensor 1015 is used to monitor the flow rate and bubbles in the perfusion shunt lines 101-1. A micro-infusion pump 1016 is used for continuous anticoagulation, thrombolysis, anti-infection, and vasodilator treatments on isolated organs.

[0084] Due to the advantages of unidirectional tidal perfusion, perfusion waste fluid no longer enters the pipeline, so the dialyzer 1040 of the first embodiment of the circulating perfusion mode is no longer needed to maintain electrolyte stability of the perfusion fluid, remove excess water, and maintain internal environment stability; the perfusion pipeline 101 is also no longer needed to be equipped with a perfusion device 1041 to continuously remove inflammatory mediators and endotoxins from the circulating fluid.

[0085] Third Implementation Method

[0086] like Figures 9-10 The diagram illustrates the basic principle of temperature control in this device.

[0087] like Figure 9 The diagram shown is the tidal perfusion control flowchart for this device. Upon startup, system initialization and HMI data parsing are performed to determine if the tidal perfusion parameters have been set. If so, the heat exchange tank temperature is set, and tidal perfusion begins. During execution, the time for each stage is checked; if not completed, the process proceeds to the next stage. Upon completion of all stages, a message indicating the end of perfusion is displayed, and all outputs are shut down. Simultaneously, during heat exchange tank data parsing and the acquisition of organ temperature, blood temperature, and perfusion pressure, if the temperature or pressure exceeds a threshold, an HMI alarm is triggered, and the HMI sensor data is updated and parsed as needed to determine whether to terminate the perfusion.

[0088] like Figure 10The diagram shows the temperature control flowchart of this device. First, it checks if the temperature has been set. If so, it acquires the water temperature and pipe pressure. Next, it checks if the pressure exceeds the threshold. If it does, the output stops and the alarm module is activated. If not, it checks if the temperature exceeds the threshold; if so, the output also stops and the alarm module is activated. If both pressure and temperature do not exceed the threshold, the water tank parameters are sent back to the central control unit, which sequentially controls the cooling fan and the thermoelectric cooler to output the corresponding power. The current direction and output power of the thermoelectric cooler are calculated using a cascaded PID controller.

[0089] The embodiments described above are merely preferred embodiments of the present invention. The terms "in one embodiment," "in another embodiment," "in yet another embodiment," or "in still another embodiment" used in this specification all refer to one or more of the same or different embodiments according to this disclosure. Ordinary variations and substitutions made by those skilled in the art within the scope of the present invention should be included within the protection scope of the present invention.

Claims

1. An organ perfusion device, characterized in that, include: Storage tank: Used to store the filling fluid; Organ storage compartment: Used for storing organs extracted from the body; Pump: Used to drive the injection fluid; Infusion tubing: Used for infusing ex vivo organs, with two or more shunt lines for infusion and shunt; Temperature maintenance system: used to maintain the perfusion fluid and isolated organs at different temperatures; Oxygenator: Used to oxygenate the perfusion fluid; Central control system: used for system control; Driven by a pump, the perfusion pipeline draws perfusion fluid from the storage tank to perfuse the isolated organs in the organ compartment.

2. The organ perfusion device according to claim 1, characterized in that, The temperature maintenance system has a heating device and a cooling device. Under the control of the central control system, the temperature maintenance system is linked with the pump to perform normal perfusion of isolated organs at normal temperature and to stop or slow down perfusion at low temperature.

3. The organ perfusion device according to claim 1, characterized in that, The perfusion tubing is used for unidirectional perfusion of isolated organs. Driven by a pump, liquid is drawn from the reservoir, oxygenated by the oxygenator, and then used to perfuse the isolated organ in the organ compartment. The liquid flows out through the organ vein and does not flow back to the reservoir.

4. The organ perfusion device according to claim 2, characterized in that, The perfusion line has a pressure-protected diversion line, a proportional valve or a shut-off valve, used to control the degree of diversion and regulate the perfusion pressure and flow rate to avoid organ damage due to excessive perfusion pressure.

5. The organ perfusion device according to claim 2, characterized in that, The temperature maintenance system includes a heating device, which includes an oxygenator temperature-controlled tube or an infrared device. The circulating fluid is heated by the oxygenator temperature-controlled tube and the oxygenator, or the organ is directly heated by the infrared device to maintain the temperature of the organ and the perfusion fluid under normal flow conditions.

6. The organ perfusion device according to claim 2, characterized in that, The temperature maintenance system includes a refrigeration device, which includes an oxygenator temperature-controlled tube or an air cooler. The circulating fluid is cooled by the oxygenator temperature-controlled tube and the oxygenator, or the organ is cooled by direct airflow through the air cooler, in order to maintain the temperature of the organ and perfusion fluid under low flow conditions.

7. The organ perfusion device according to claim 1, characterized in that, The injection pipeline is equipped with a pressure sensor to monitor the pressure of the injection pipeline and the diversion pipeline; The injection pipeline is equipped with flow and bubble sensors to monitor the flow and bubbles in the injection pipeline and the branch pipeline; Temperature sensors are installed in the perfusion tubing and organ compartment to monitor the temperature of the perfusion fluid and organs; The injection pipeline is equipped with a circulating liquid oxygen saturation or oxygen partial pressure sensor to monitor the oxygenation status of the circulating liquid. The oxygen flow rate supplied to the oxygenator is controlled by the central control system to maintain a reasonable level of circulating oxygen partial pressure. The perfusion line is equipped with a glomerular filtration rate monitoring sensor, which measures the glomerular filtration rate by detecting the signal of the fluorescent tracer added to the circulating fluid, and evaluates the function of the isolated kidney online. The perfusion line is equipped with a tissue oxygen saturation sensor and a pulse oxygen saturation sensor to monitor the oxygenation status of organs or severed limbs. The oxygen flow rate supplied to the oxygenator is controlled by a central control system to maintain the tissue oxygen partial pressure at a reasonable level.

8. The organ perfusion device according to claim 1, characterized in that, Also includes: An oxygen supply device is used to provide oxygen to an oxygenator. The oxygen supply device can be an oxygen cylinder or an oxygen generator. Filter plugs are installed on the injection pipeline; A micro-pump, which is connected to the infusion line.

9. The organ perfusion device according to claim 1, characterized in that, The central control system links the temperature maintenance system with the pump to perform normal perfusion of the excised organ at normal temperature and to stop or slow down perfusion at low temperature. The central control system adjusts the perfusion parameters based on sensor parameters to ensure that the excised organ is in the best condition.

10. The organ perfusion device according to claim 1, characterized in that, The infusion tubing or organ compartment is equipped with an ultraviolet light device for sterilization and infection control. A dialyzer is installed in the perfusion line to maintain electrolyte stability in the perfusion solution, remove excess water, and maintain internal environmental stability. The infusion line is equipped with an infusion device to continuously remove inflammatory mediators and endotoxins from the circulating fluid; The storage tank is equipped with a surge-proof porous baffle to prevent the circulating fluid from overflowing or air from entering the filling pipeline.

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