Hyperbaric oxygen in-vitro visceral organ perfusion preservation device and preservation method

Abstract

The invention discloses a hyperbaric oxygen isolated visceral organ perfusion preservation device and a preservation method, and relates to the technical field of isolated visceral organ preservation. Comprising a shell, a viscera storage container, an oxygen disperser, a bubble removing and filtering device and a perfusion device, an interlayer space is arranged between the shell and the viscera storage container, a cooling medium is arranged in the interlayer space, isolated viscera and viscera storage liquid are contained in the viscera storage container, the oxygen disperser is arranged on the lower portion of the viscera storage container, and the bubble removing and filtering device is arranged on the lower portion of the oxygen disperser. A bubble removing and filtering device is arranged below the oxygen disperser to filter bubbles and tissue fragments, the bottom and the upper portion of the visceral organ storage container are connected with an inlet and an outlet of the perfusion device respectively, and the oxygen disperser fills oxygen into the visceral organ storage container and enables the internal pressure of the visceral organ storage container to reach 2-3 barometric pressures. Static storage of organs at a low temperature is achieved, nutrient substances are continuously provided for organ perfusion, oxygen supply is sufficient, equipment is simple, small and exquisite, operation is convenient, blood is not needed, and the device is more suitable for long-distance transfer.

Description

Technical Field

[0001] The present invention relates to the technical field of ex vivo organ preservation, and particularly relates to a hyperbaric oxygen ex vivo organ perfusion preservation device and a preservation method. Background Art

[0002] As one of the main effective treatment means for patients with end-stage organ failure, organ transplantation surgeries are increasing year by year along with the growth of patients. How to properly preserve ex vivo organs and maintain the good functions of donor organs is the key to the success of transplantation surgeries. Since the development of transplantation surgeries until now, most of the ex vivo organ preservations in China are still low-temperature static preservations. That is, after the ex vivo organ is taken out from the donor, perfused with a preservation solution, and then put into a plastic bag and placed in ice until it is put into the recipient's body. Although low temperature can reduce the oxygen consumption of the organ, too low a temperature may cause frostbite of the organ tissue, and long-term ischemia will still cause irreversible damage. After being put into the recipient's body, during the period when the surgeon anastomoses the blood vessels, there will still be a period of warm ischemia time. The longer the ischemia time, the more unfavorable it is for functional recovery, and the higher the incidence of post-transplant organ dysfunction.

[0003] This traditional preservation method of low-temperature static preservation mainly reduces the oxygen consumption of the organ through low temperature to reduce ischemia-hypoxia damage, but the safe preservation time that can be tolerated is very short. The preservation time of the heart generally should not exceed 4 - 6 hours, and the preservation time of the lungs should not exceed 8 hours, otherwise the incidence of graft dysfunction is extremely high. The disadvantages of low-temperature static preservation are: 1. It cannot continuously provide nutrients for ex vivo organs; 2. It cannot provide oxygen; 3. It cannot remove metabolic products, and the accumulation of acidic metabolic substances causes irreversible damage; 4. It cannot monitor the metabolic state of donor organs; 5. Too low a temperature causes frostbite of the organ.

[0004] Currently, the reported ex vivo organ preservation devices abroad mainly include two types. One is mechanical perfusion at normal temperature. Under simulated physiological conditions (37 degrees Celsius), continuous oxygenated blood perfusion is used. For example, the TansMedics organcare system (OCS) device in the United States maintains the heart beating at normal temperature and uses continuous blood perfusion. The other is mechanical perfusion at low temperature. For example, the XVIVO assist Tansport device in Sweden uses blood or organ protection fluid containing nutrients to continuously perfuse ex vivo organs such as the liver and heart at low temperature. Although these two preservation devices solve the perfusion problem of ex vivo organs, they have the following disadvantages: 1. Fresh or stored blood perfusion is required, increasing the risk of blood-borne disease transmission and blood contamination; 2. A membrane lung device is required to oxygenate the blood to provide oxygen. Its device is large in size and not suitable for portable transportation, and the cost is high; 3. The low-temperature perfusion organ protection fluid can only provide nutrients and cannot provide oxygen; 4. The TansMedics organ care system (OCS) device preserves at a relatively high temperature and needs to maintain the heart beating. The myocardial oxygen consumption is in the normal physiological state, and more precise regulation of perfusion pressure and flow is required. The intubation procedure is cumbersome, and arrhythmias such as ventricular fibrillation need to be dealt with, greatly increasing the labor and equipment costs.

[0005] Based on this, the present invention provides a high-pressure oxygen ex vivo organ perfusion preservation device and a preservation method to solve the above problems. Summary of the Invention

[0006] The present invention is to solve the deficiencies of the existing ex vivo organ preservation devices and methods, and provides a high-pressure oxygen ex vivo organ perfusion preservation device and a preservation method, which can achieve the preservation of ex vivo organs at a lower temperature, can provide sufficient oxygen, can continuously or intermittently provide nutrients for organ perfusion, the device is simple and compact, the operation is convenient, does not require the use of blood, and is more suitable for long-distance transportation.

[0007] The present invention is realized through the following technical solutions.

[0008] The first object of the present invention is to provide a high-pressure oxygen ex vivo organ perfusion preservation device, including a housing, an organ preservation container, an oxygen diffuser, a defoaming and filtering device, and a perfusion device; There is a sandwich space between the housing and the organ preservation container. A cooling medium is provided in the sandwich space. The organ preservation container is filled with an ex vivo organ and an organ preservation solution. An oxygen diffuser is provided at the lower part of the organ preservation container. A defoaming and filtering device is provided below the oxygen diffuser to filter bubbles and tissue fragments. The organ preservation container is communicated with the perfusion device, and the perfusion device perfuses the organ preservation solution filtered by the defoaming and filtering device into the inlet of the ex vivo organ; Among them, the oxygen diffuser fills oxygen into the organ preservation container and increases the atmospheric pressure in the organ preservation container to 2 - 3 atmospheres, so that the oxygen concentration in the organ preservation container is close to pure oxygen.

[0009] Furthermore, the defoaming and filtering device is composed of a filter screen coated with a defoaming agent.

[0010] Furthermore, the perfusion device includes an organ perfusion tube and a roller pump. The inlet of the organ perfusion tube is connected to the bottom of the organ preservation container, and the outlet of the organ perfusion tube is connected to the upper part of the organ preservation container and extends into the organ preservation container to be connected to the inlet of the excised organ.

[0011] Furthermore, a sampling tube and a perfusion pressure and temperature detection device are connected to the outlet section of the organ perfusion tube, and the perfusion pressure and temperature detection device is used to monitor the perfusion pressure and temperature.

[0012] Furthermore, a sealing cover is arranged on the top of the organ preservation container, and a pressure relief valve, an atmospheric pressure and oxygen concentration detection device are arranged on the sealing cover. The atmospheric pressure and oxygen concentration detection device is used to monitor the atmospheric pressure and oxygen concentration in the organ preservation container.

[0013] Furthermore, the oxygen diffuser is externally connected to an oxygen cylinder through an oxygen tube.

[0014] Furthermore, the inner bottom surface of the organ preservation container is an inclined surface.

[0015] Furthermore, a sterile plastic film cover is also sleeved on the sealing cover.

[0016] The second object of the present invention is to provide a method for preserving an excised organ, which is preserved by using the aforementioned device, including: Placing the excised organ in the organ preservation solution in the organ preservation container, keeping the temperature in the organ preservation container at 4 - 20 °C through the cooling medium arranged in the interlayer space, filling oxygen into the organ preservation container through the oxygen diffuser and increasing the atmospheric pressure in the organ preservation container to 2 - 3 atmospheres, so that the oxygen concentration in the organ preservation container is close to pure oxygen, and increasing the dissolved oxygen in the organ preservation solution; The perfusion device continuously perfuses the filtered organ preservation solution in the organ preservation container into the inlet of the excised organ to provide nutrients.

[0017] Furthermore, during the preservation process: Monitoring the atmospheric pressure and oxygen concentration in the organ preservation container through the atmospheric pressure and oxygen concentration detection device. When the atmospheric pressure in the organ preservation container exceeds 3 atmospheres, relieving the pressure through the pressure relief valve on the sealing cover; Extracting the organ preservation solution through the sampling tube to measure the blood gas index to monitor the metabolic state of the excised organ; The perfusion pressure and temperature are monitored by a perfusion pressure and temperature detection device, and the perfusion pressure is maintained between 60 - 120 mmHg by adjusting the perfusion flow rate.

[0018] Compared with the prior art, the present invention has the following advantages and beneficial effects.

[0019] 1. The device of the present invention can preserve excised organs at a lower temperature, and can continuously or intermittently perfuse and provide nutrients for the excised organs. It uses high-pressure pure oxygen to provide sufficient oxygen supply for the excised organs. At the same time, it avoids the use of cumbersome equipment, avoids the use of blood and membrane oxygenators, is more portable and simple, and has a small volume. It is an excised organ preservation device suitable for long-distance transportation.

[0020] 2. The excised organ preservation device of the present invention provides a moderately low-temperature environment for the preservation of excised organs by setting ice packs in the sandwich space as a cooling medium, reduces the oxygen consumption of the organs, and avoids direct contact between the organs and the ice cubes, thus avoiding organ tissue frostbite.

[0021] 3. The present invention continuously perfuses an organ preservation solution for the excised organs through a perfusion device to provide nutrients and remove acidic substances and carbon dioxide generated by the basic metabolism of the organs. These metabolic wastes are diluted and buffered by the organ preservation solution in the organ preservation container.

[0022] 4. The organ preservation solution filters out air bubbles and tissue debris through a defoaming and filtering device, avoiding the entry of air bubbles and tissue debris into the coronary artery during perfusion and avoiding arterial embolism.

[0023] 5. The present invention fills oxygen into the organ preservation container through an oxygen diffuser and increases the atmospheric pressure in the organ preservation container to 2 - 3 atmospheres, making the oxygen concentration in the organ preservation container close to pure oxygen. As a result, the dissolved oxygen in the organ preservation solution increases by more than 10 times compared to the normal physiological state. The high-pressure pure oxygen is used to increase the dissolved oxygen in the liquid, providing sufficient oxygen supply for the excised organs with low oxygen consumption. It avoids the use of blood oxygen supply, avoids the risks of blood-borne diseases, blood pressure pollution, and the cumbersome blood collection process, and does not require the cumbersome use of membrane lung oxygenated blood perfusion, being more convenient for carrying and transportation.

[0024] 6. The present invention monitors the atmospheric pressure and oxygen concentration in the organ preservation container through an atmospheric pressure and oxygen concentration detection device, monitors the metabolic state of the excised organs by sampling the organ preservation solution to measure blood gas indexes such as pH, lactate, and electrolytes, and monitors the perfusion pressure and temperature through a perfusion pressure and temperature detection device, providing a more complete monitoring system, and ensuring the safety during perfusion through the perfect monitoring system.

[0025] 7. By setting the inner bottom surface of the organ preservation container as an inclined surface, the bottom of the organ preservation container is a flat surface to ensure stable placement, but the inner bottom surface is an inclined surface to ensure that the liquid in the container can flow to the bottommost part, thus facilitating the inflow into the organ perfusion tube.

[0026] 8. By sleeving a layer of sterile plastic film cover above the sealing cover, an isolation effect can be achieved to prevent the inner cover from being contaminated, and the organ preservation container, oxygen diffuser, defoaming and filtering device, and perfusion tube are an integral sterile consumable, which can be separated from the outer shell. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] In order to more clearly illustrate the technical solutions of the exemplary embodiments of the present invention, the drawings required for use in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of the present invention, and therefore should not be regarded as a limitation of the scope. For those of ordinary skill in the art, without creative efforts, other related drawings can also be obtained based on these drawings. In the drawings: Figure 1 is a schematic structural diagram of the in vitro organ preservation device of the present invention; Reference numerals in the drawings and corresponding component names: 1 - Outer shell, 2 - Organ preservation container, 3 - Sealing cover, 4 - Pressure relief valve, 5 - Atmospheric pressure and oxygen concentration detection device, 6 - Control panel and display device, 7 - Sterile plastic film cover, 8 - Oxygen diffuser, 9 - Oxygen tube, 10 - Oxygen cylinder, 11 - Defoaming and filtering device, 12 - Filter screen, 13 - Organ perfusion tube, 14 - Roller pump, 15 - Sampling tube, 16 - Perfusion pressure and temperature detection device. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0028] To make the objectives, technical solutions, and advantages of the present invention clearer and more understandable, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the embodiments and the drawings. Obviously, the illustrative embodiments and their descriptions of the present invention are only used to explain the present invention and are not intended to limit the present invention.

[0029] The following will appropriately refer to the drawings to detail the embodiments of a hyperbaric oxygen in vitro organ perfusion preservation device and preservation method of the present invention. However, there may be cases where unnecessary details are omitted. For example, there are cases where the detailed descriptions of well-known matters and repeated descriptions are omitted. This is to avoid the following description from becoming unnecessarily lengthy and to facilitate the understanding of those skilled in the art.

[0030] The "range" disclosed in this application is defined in the form of a lower limit and an upper limit. A given range is defined by selecting a lower limit and an upper limit, and the selected lower limit and upper limit define the boundary of a specific range. The range defined in this way can include or exclude the end values, and can be combined arbitrarily, that is, any lower limit can be combined with any upper limit to form a range.

[0031] If there is no special instruction, all embodiments and optional embodiments of this application can be combined with each other to form a new technical solution.

[0032] If there is no special instruction, all technical features and optional technical features of this application can be combined with each other to form a new technical solution.

[0033] If there is no special instruction, the "including" and "comprising" mentioned in this application mean open type, and can also be closed type.

[0034] If there is no special instruction, all steps of this application can be carried out in sequence or randomly, and preferably in sequence.

[0035] The technical solution of the present invention will be further described in detail below in conjunction with embodiments.

[0036] It should be noted that the methods used in the embodiments are all conventional methods without special instructions. The materials, reagents, methods and instruments used are all conventional materials, reagents, methods and instruments in this field, and those skilled in the art can obtain them through commercial channels.

[0037] Embodiment 1

[0038] A high-pressure oxygen ex vivo organ perfusion preservation device, as Figure 1 shown, includes a housing 1, an organ preservation container 2, an oxygen diffuser 8, a defoaming and filtering device 11 and a perfusion device; There is a sandwich space between the housing 1 and the organ preservation container 2, a cooling medium is provided in the sandwich space, the organ preservation container 2 contains an organ and an organ preservation solution, an oxygen diffuser 8 is provided at the lower part of the organ preservation container 2, and a defoaming and filtering device 11 is provided below the oxygen diffuser 8 to filter bubbles and tissue fragments. The bottom of the organ preservation container 2 is connected to the outlet of the perfusion device, and the upper part of the organ preservation container 2 is connected to the inlet of the perfusion device. The filtered organ preservation solution is perfused into the inlet of the organ through the perfusion device; Among them, the oxygen diffuser 8 fills oxygen into the organ preservation container 2 and increases the atmospheric pressure in the organ preservation container 2 to 2-3 atmospheres. At this time, the oxygen concentration in the container is pure oxygen.

[0039] In the present invention, the organ preservation container 2 is a disposable sterile consumable, which is a cylindrical / cubic storage tank. The bottom of the organ preservation container 2 is flat to ensure stable placement. The cooling medium is selected as an ice pack, which can be taken out and frozen again after melting, with a high reuse rate. Moreover, using an ice pack as the cooling medium is more convenient for carrying and transporting the entire device.

[0040] Under normal atmospheric pressure and an oxygen concentration of 21%, about 5 ml / L of oxygen dissolves in the organ preservation solution. However, under the low-temperature conditions and the high-pressure pure oxygen environment of 2 - 3 atmospheres in the present invention, about 50 - 80 ml / L of oxygen dissolves in the crystal, greatly increasing the dissolved oxygen in the liquid and providing sufficient oxygen supply for organs with low oxygen consumption.

[0041] The ex vivo organ preservation device of the present invention provides a moderate low-temperature environment for organ preservation by setting an ice pack as the cooling medium in the sandwich space, reducing organ oxygen consumption, and avoiding direct contact between the organ and the ice, thus avoiding tissue frostbite; through the perfusion device, the preservation solution is continuously perfused into the organ to provide nutrients and remove acidic substances and carbon dioxide generated by the basic metabolism of the organ. These metabolic wastes are diluted and buffered by the organ preservation solution in the organ preservation container 2, and then the defoaming and filtering device 11 filters out air bubbles and tissue fragments, avoiding the entry of air bubbles and tissue fragments into the artery during perfusion and avoiding the risk of arterial air embolism; through the oxygen diffuser 8, oxygen is filled into the organ preservation container 2 and the atmospheric pressure in the organ preservation container 2 is increased to 2 - 3 atmospheres, making the oxygen concentration in the organ preservation container 2 close to pure oxygen. As a result, the dissolved oxygen in the organ preservation solution increases by more than 10 times compared with the normal physiological state. Using high-pressure pure oxygen increases the dissolved oxygen in the liquid, provides sufficient oxygen supply for organs with low oxygen consumption, avoids using blood for oxygen supply, avoids the risks of blood-borne diseases, blood pollution, and the cumbersome blood collection process, and does not require the cumbersome and complex use of membrane lung oxygenation blood perfusion, being more convenient for carrying and transporting.

[0042] In summary, the device of the present invention can preserve ex vivo organs at a relatively low temperature, continuously perfuse the organs to provide nutrients, use high-pressure pure oxygen to provide sufficient oxygen supply for the organs, while avoiding the use of cumbersome equipment and avoiding the use of blood, being more portable, simple, and small in size, and is an ex vivo organ preservation device suitable for long-distance transportation.

[0043] Example 2

[0044] This example further illustrates the device of the present invention on the basis of Example 1.

[0045] The defoaming and filtering device 11 is composed of a filter screen 12 coated with a defoaming agent, and the defoaming agent uses dimethyl silicone oil.

[0046] The shape of the defoaming and filtering device 11 conforms to the inner wall shape of the organ preservation container 2. The defoaming and filtering device 11 is composed of a filter screen 12 coated with a defoaming agent, which is convenient for filtering air bubbles and tissue fragments, and can effectively prevent air bubbles and tissue fragments from entering the coronary artery during perfusion, avoiding the risk of arterial embolism.

[0047] Embodiment 3

[0048] This embodiment further illustrates the device of the present invention on the basis of Embodiment 1.

[0049] The perfusion device includes an organ perfusion tube 13 and a roller pump 14. The bottom of the organ preservation container 2 is connected to the outlet of the perfusion device, and the upper part of the organ preservation container 2 is connected to the inlet of the perfusion device. The filtered organ preservation solution is perfused into the inlet of the organ through the perfusion device.

[0050] Among them, the inlet of the organ perfusion tube 13 is connected to the bottom of the organ preservation container 2, and the outlet of the organ perfusion tube 13 is connected to the upper part of the organ preservation container 2 and extends into the organ preservation container 2 to be connected to the organ inlet.

[0051] Specifically, the organ perfusion tube 13 includes an inlet end and an outlet end. The inlet end is connected to the bottom of the organ preservation container 2; the outlet end is connected to the top of the organ preservation container 2 and then extends into the organ preservation container 2 to be connected to the perfusion tube of the blood supply artery. The middle part of the organ perfusion tube is installed on the roller pump 14. The rotation of the roller pump 14 drives the flow of the organ preservation solution, and the antegrade perfusion of the organ provides nutrients for it.

[0052] It should be noted that the organ preservation container 2 and the organ perfusion tube 13 are integrated, and the roller pump 14 and the organ perfusion tube 13 are separable and are installed during use.

[0053] Embodiment 4

[0054] This embodiment further illustrates the device of the present invention on the basis of Embodiment 3.

[0055] A sampling tube 15 and a perfusion pressure and temperature detection device 16 are connected to the outlet section of the organ perfusion tube 13. The perfusion pressure and temperature detection device 16 is used to monitor the perfusion pressure and temperature.

[0056] Among them, the sampling tube 15 can extract the organ preservation solution to measure blood gas indexes such as pH, lactic acid, and electrolytes to monitor the metabolic state of the organ. When sampling is not required, the sampling tube 15 is sealed and opened when needed to extract samples for measurement. When extracting samples, the sampling volume is about 0.5 ml, which will not affect the internal pressure and oxygen concentration, realizing the monitoring of the organ metabolic state.

[0057] The perfusion pressure and temperature detection device 16 can use a pressure sensor and a temperature sensor to achieve its functions. By monitoring the perfusion pressure and temperature, a more complete monitoring system is provided, which can monitor the organ perfusion pressure and temperature and ensure safety during perfusion.

[0058] Example 5

[0059] This example further illustrates the device of the present invention on the basis of any one of Examples 1-4.

[0060] A sealable cover 3 that can be opened is provided at the top of the organ preservation container 2. A pressure relief valve 4 and an atmospheric pressure and oxygen concentration detection device 5 are provided on the sealable cover 3. The atmospheric pressure and oxygen concentration detection device 5 is used to monitor the atmospheric pressure and oxygen concentration in the organ preservation container 2.

[0061] Among them, the atmospheric pressure and oxygen concentration detection device 5 can use an atmospheric pressure sensor and an oxygen sensor to achieve its functions. By monitoring the atmospheric pressure and oxygen concentration in the organ preservation container 2, a more complete monitoring system is provided, which can monitor the atmospheric pressure and oxygen concentration in the organ preservation container 2 during the organ perfusion process and ensure safety during perfusion.

[0062] In addition, a control panel and a display device 6 are integrated on the top of the sealable cover 3. Relevant parameters are set and the operation of the roller pump 14 is controlled through the control panel and the display device 6, and at the same time, various monitoring data are displayed for easy real-time adjustment.

[0063] Example 6

[0064] This example further illustrates the device of the present invention on the basis of Example 5.

[0065] The oxygen diffuser 8 is externally connected to an oxygen cylinder 10 through an oxygen pipe 9; the top of the organ preservation container 2 is sealed through the sealable cover 3, and oxygen is connected to the oxygen diffuser 8 through the outer oxygen pipe 9. By continuously flowing in oxygen, the atmospheric pressure in the container is increased to reach a level of 2-3 atmospheres. At this time, the oxygen concentration in the container is close to pure oxygen, and the dissolved oxygen in the organ preservation solution can increase by more than 10 times compared with the normal physiological state.

[0066] The present invention increases the dissolved oxygen in the organ preservation solution by high-pressure pure oxygen, provides sufficient oxygen supply for organs with low oxygen consumption, avoids using blood for oxygen supply, thereby avoiding the risks of blood-borne diseases, blood pressure pollution, and the cumbersome blood collection process, simplifies the operation, and has higher safety.

[0067] Example 7

[0068] This example further illustrates the device of the present invention on the basis of Example 6.

[0069] The inner bottom surface of the organ preservation container 2 is an inclined surface, and the bottom of the organ preservation container 2 is a flat surface to ensure its stable placement, but the inner bottom surface is an inclined surface to ensure that the liquid in the container can flow to the bottommost part, thus facilitating the inflow into the organ perfusion tube 13.

[0070] Example 8

[0071] This example further illustrates the device of the present invention on the basis of Example 6.

[0072] Furthermore, a sterile plastic film cover 7 is also sleeved on the sealing cover 3. By sleeving a layer of sterile plastic film cover 7 above the sealing cover 3, an isolation effect can be achieved to prevent the inner cover from being contaminated.

[0073] Regarding the above description of the device of the present invention, it should also be noted that the organ preservation container 2, the oxygen diffuser 8, the defoaming and filtering device 11, and the organ perfusion tube 13 are an integral disposable sterile consumable and can be separated from the outer shell 1.

[0074] It should be understood that all detection devices such as the perfusion pressure and temperature detection device 16, the atmospheric pressure and oxygen concentration detection device 5, etc. are all connected to the control panel and display device 6 on the outer shell by sensing wires, and relevant monitoring data can be displayed thereon, and the roller pump 14 and the oxygen flow are controlled through the control panel, thereby adjusting the perfusion pressure.

[0075] Example 9

[0076] This example provides a method for preserving an ex vivo organ, which is preserved by using the device described in any one of Examples 1-8, including: Filling the organ preservation container 2 with an organ preservation solution, placing the ex vivo organ in the organ preservation solution, connecting the outlet of the organ perfusion tube 13 to the perfusion tube of the blood supply artery, and driving the filtered organ preservation solution to flow through the roller pump 14 to perfuse the coronary artery of the organ in a retrograde manner; The preservation conditions are: keeping the temperature in the organ preservation container 2 between 4 - 20 °C through ice packs arranged in the sandwich space, filling the organ preservation container 2 with oxygen through the oxygen diffuser 8 and increasing the atmospheric pressure in the organ preservation container 2 to 2 - 3 atmospheres. At this time, the oxygen concentration in the container is close to pure oxygen, increasing the dissolved oxygen in the organ preservation solution.

[0077] The present invention increases the dissolved oxygen of the organ preservation solution by increasing the atmospheric pressure and oxygen concentration at a lower temperature. Under the preservation conditions of low temperature, 2 - 3 atmospheres and the oxygen concentration in the container being close to pure oxygen in the present invention, the dissolved oxygen in the organ preservation solution increases by more than 10 times compared with the normal physiological state, providing sufficient oxygen supply for low-oxygen-consumption organs, avoiding the use of blood oxygen supply, avoiding the risks of blood-borne diseases, blood pressure pollution, and the cumbersome blood sampling process, and not requiring the cumbersome and complex use of membrane lung oxygenation blood perfusion, being more suitable for preservation during long-distance transportation.

[0078] Example 10

[0079] This example further illustrates the ex vivo organ preservation method on the basis of Example 9.

[0080] During the preservation process: The atmospheric pressure and oxygen concentration inside the organ preservation container 2 are monitored by the atmospheric pressure and oxygen concentration detection device 5. When the atmospheric pressure inside the organ preservation container 2 exceeds 3 atmospheres, pressure relief is carried out through the pressure relief valve 4 on the sealing cover 3; The organ preservation solution is sampled through the sampling tube 15 to measure blood gas indexes such as pH, lactic acid, and electrolytes to monitor the organ metabolic state; The perfusion pressure and temperature are monitored by the perfusion pressure and temperature detection device 16, and the perfusion flow is adjusted to keep the perfusion pressure between 60 - 120 mmHg.

[0081] In the present invention, the control panel and display device 6 can display data such as perfusion pressure, atmospheric pressure, oxygen concentration, and temperature; the atmospheric pressure and oxygen concentration are monitored by the atmospheric pressure and oxygen concentration detection device 5 on the sealing cover 3. When the oxygen concentration and atmospheric pressure are inappropriate, they can be adjusted by adjusting the oxygen flow. When it exceeds 3 atmospheres, the pressure relief valve 4 at the top of the lid opens for automatic pressure relief; during the preservation process, samples are also taken through the sampling tube 15 for measurement to monitor the organ metabolic state; when the perfusion pressure is inappropriate, it can be adjusted by adjusting the perfusion flow. The present invention provides a more complete monitoring system, and the safety during perfusion is ensured through the perfect monitoring system.

[0082] Finally, it should be noted that: the above specific examples are only used to illustrate the purpose, technical solutions and beneficial effects of the present invention in detail. It should be understood that the above description is only the specific implementation manners of the present invention, and is not used to limit the protection scope of the present invention; although the present invention has been described in detail with reference to the above specific examples, those of ordinary skill in the art should understand that: they can still modify the technical solutions recorded in the above examples, or perform equivalent replacements or improvements on some or all of the technical features; and these modifications, equivalent replacements, and improvements do not make the essence of the corresponding technical solutions deviate from the scope of the technical solutions of the embodiments of the present invention, and they should all be covered by the scope of the claims and the description of the present invention.

Claims

1. A hyperbaric oxygen in vitro organ perfusion preservation device, characterized in that: It comprises a housing (1), an organ storage container (2), an oxygen diffuser (8), a bubble removal and filtering device (11) and a perfusion device; An interlayer space is provided between the shell (1) and the organ storage container (2), a cooling medium is provided in the interlayer space, an isolated organ and an organ storage solution are contained in the organ storage container (2), an oxygen diffuser (8) is provided at the lower part of the organ storage container (2), a bubble removal filter device (11) is provided below the oxygen diffuser (8) to filter bubbles and tissue fragments, the organ storage container (2) is connected to a perfusion device, and the perfusion device perfuses the organ storage solution filtered by the bubble removal filter device (11) into the inlet of the isolated organ; The oxygen diffuser (8) fills the organ storage container (2) with oxygen and increases the atmospheric pressure in the organ storage container (2) to 2-3 atmospheres, so that the oxygen concentration in the organ storage container (2) reaches pure oxygen.

2. A hyperbaric oxygen in vitro organ perfusion preservation device according to claim 1, characterized in that: The defoaming filtering device (11) is composed of a filter screen (12) coated with a defoaming agent.

3. A hyperbaric oxygen in vitro organ perfusion preservation device according to claim 1, characterized in that: The perfusion device comprises an organ perfusion tube (13) and a roller pump (14); the inlet of the organ perfusion tube (13) is connected to the bottom of the organ storage container (2); the outlet of the organ perfusion tube (13) is connected to the upper part of the organ storage container (2) and extends into the organ storage container (2) to be connected to the inlet of the isolated organ.

4. A hyperbaric oxygen in vitro organ perfusion preservation device according to claim 3, characterized in that: The outlet section of the organ perfusion tube (13) is connected to a sampling tube (15) and a perfusion pressure and temperature detection device (16), and the perfusion pressure and temperature detection device (16) is used to monitor the perfusion pressure and temperature.

5. A hyperbaric oxygen in vitro organ perfusion preservation device according to any one of claims 1 to 4, characterized in that: A sealing cover (3) is provided on the top of the organ storage container (2), and a pressure relief valve (4) and an atmospheric pressure and oxygen concentration detection device (5) are provided on the sealing cover (3). The atmospheric pressure and oxygen concentration detection device (5) is used to monitor the atmospheric pressure and oxygen concentration in the organ storage container (2).

6. A hyperbaric oxygen in vitro organ perfusion preservation device according to claim 5, characterized in that: The oxygen diffuser (8) is externally connected to an oxygen cylinder (10) via an oxygen tube (9).

7. A hyperbaric oxygen in vitro organ perfusion preservation device according to claim 6, characterized in that: The inner bottom surface of the organ storage container (2) is an inclined surface.

8. The hyperbaric oxygen in vitro organ perfusion preservation device according to claim 6, characterized in that: The sealing cover (3) is also sleeved with a sterile plastic film cover (7).

9. A method for preserving an in vitro organ, characterized in that: The method comprises using the device according to any one of claims 1 to 8 for storage, comprising: The isolated organ is placed in an organ preservation solution in an organ preservation container (2), the temperature in the organ preservation container (2) is maintained between 4 and 20° C. by a cooling medium provided in the interlayer space, oxygen is introduced into the organ preservation container (2) through an oxygen diffuser (8) and the atmospheric pressure in the organ preservation container (2) is increased to 2 to 3 atmospheres, so that the oxygen concentration in the organ preservation container (2) reaches pure oxygen, thereby increasing the dissolved oxygen in the organ preservation solution; The perfusion device perfuses the filtered organ preservation fluid in the organ preservation container (2) into the inlet of the isolated organ to provide nutrients.

10. The method for preserving an in vitro organ according to claim 9, characterized in that: During the save process: The atmospheric pressure and oxygen concentration in the organ storage container (2) are monitored by an atmospheric pressure and oxygen concentration detection device (5); when the atmospheric pressure in the organ storage container (2) exceeds 3 atmospheres, the pressure is released through a pressure relief valve (4) on the sealing cover (3); The organ preservation fluid is extracted through a sampling tube (15) to measure blood gas indexes to monitor the metabolic state of the isolated organ; The perfusion pressure and temperature are monitored by a perfusion pressure and temperature detection device (16), and the perfusion pressure is maintained between 60-120 mmHg by adjusting the perfusion flow rate.

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