Ex vivo organ perfusion apparatus

Abstract

This application discloses an ex vivo organ perfusion device, comprising: a main body with an installation chamber and a temperature control chamber; a consumable module detachably mounted in the installation chamber via a quick-release structure, the consumable module including an installation frame, an organ chamber, an oxygenator, a filter plug, a detection sensor, a perfusion pump, and perfusion tubing; an organ chamber mounting slot is provided on the upper part of the installation frame, and the organ chamber is placed in the organ chamber mounting slot; the oxygenator and filter plug are fixed to the installation frame and located below the organ chamber; the detection sensor is fixed to the upper end face of the installation frame for detecting data of the perfusion fluid in the perfusion tubing; the perfusion pump, oxygenator, organ chamber, and filter plug form a perfusion fluid circulation loop through the perfusion tubing; and a temperature control mechanism located in the temperature control chamber, the temperature control mechanism including a heat exchange water tank and a temperature control component. This application achieves improved integration of the perfusion device, reduces the assembly difficulty of various components, especially the consumable module, simplifies the operation process, and improves ease of use.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and more specifically, to an ex vivo organ perfusion device. Background Technology

[0002] With the continuous growth of organ transplant surgeries worldwide, ex vivo organ perfusion equipment, as a key medical device for maintaining the physiological activity of ex vivo organs, extending the transplantable time window, and improving the success rate of transplantation, has become a core piece of equipment in the field of organ transplantation and related medical research. It is widely used in the in vitro preservation, functional evaluation, and repair of solid organs such as liver, kidney, lung, and heart.

[0003] Traditional perfusion equipment typically employs a decentralized design for its functional components, such as organ placement structures, oxygenators, embolic filters, perfusion pumps, sensors, and perfusion tubing. Each component is independently installed and fixed. This decentralized layout not only results in a large overall equipment size and space occupation, hindering efficient use of clinical space, but also leads to disorganized and chaotic connecting tubing, increasing the complexity of connections and operational difficulty.

[0004] Because the components are scattered and fixed, each time before use, the organ compartment, oxygenator, embolization filter, perfusion pump and other components need to be installed in place one by one, and then the perfusion tubing between the components needs to be connected one by one. The operation is complicated and time-consuming, which not only increases the workload of medical staff, but may also lead to tubing connection errors due to the complexity of the operation process, affecting the perfusion effect, or even causing damage to the excised organs. Summary of the Invention

[0005] The main objective of this application is to provide an ex vivo organ perfusion device to solve the problems of low integration, cumbersome assembly of components, inconvenient replacement of consumables, and complex operation procedures in related technologies.

[0006] Additional aspects and advantages of this application will be set forth in part in the description which follows, and in part will be obvious from the description or may be learned by practice of this application.

[0007] According to a first aspect of this application, an ex vivo organ perfusion device is provided, comprising: a device body, internally divided into an upper installation chamber and a lower temperature control chamber; a consumable module, vertically detachably mounted in the installation chamber via a quick-release structure and supported by the upper end face of the device body, and locked by a rotatable locking structure after installation; the consumable module includes a mounting frame, an organ chamber, an oxygenator, a filter plug, a detection sensor, a perfusion pump, and perfusion tubing; the upper part of the mounting frame has an organ chamber mounting groove adapted to the shape of the organ chamber, and the organ chamber is placed in the organ chamber mounting groove; the oxygenator is supported by the bottom of the mounting frame. The support is fixed to the side wall of the mounting frame, and the filter plug is fixed to the side wall of the mounting frame; both the oxygenator and the filter plug are located in the lower part of the organ compartment; the detection sensor is fixed to the upper end face of the mounting frame and is used to detect the data of the perfusion fluid in the perfusion pipeline; the perfusion pump, oxygenator, organ compartment and filter plug form a perfusion fluid circulation loop through the perfusion pipeline; the temperature control mechanism is located in the temperature control compartment, and the temperature control mechanism includes a heat exchange water tank and a temperature control component. The temperature control component is used to control the water temperature in the heat exchange water tank. The heat exchange water tank and the water bath heating chamber of the oxygenator are connected by a quick-release connector so as to be quickly disassembled synchronously with the consumable module.

[0008] In one exemplary embodiment of this application, the perfusion tubing includes an arterial perfusion tubing, a venous perfusion tubing, a first branch connected to the outlet of the perfusion pump, and a second branch connected to the outlet of the oxygenator. The first branch includes two branches, one of which is connected to the inlet of the oxygenator. The second branch includes two branches, one of which is connected to the arterial perfusion tubing, which is connected to the arterial perfusion end of the organ compartment. The other branch of the first and second branches is connected in parallel to the venous perfusion tubing, which is connected to the venous perfusion end of the organ compartment.

[0009] In one exemplary embodiment of this application, the side plate is further provided with an perfusion device fixing clip and a measuring cylinder fixing clip. The perfusion device fixing clip is used to fix the perfusion device, and the measuring cylinder fixing clip is used to fix the measuring cylinder. The consumable module also includes a dialyzer. The first side edge of the top plate is provided with a dialyzer fixing clip and an injection tube fixing clip. The dialyzer is fixed to the dialyzer fixing clip, and the injection tube is fixed to the injection tube fixing clip. The second side edge of the top plate is provided with a pressure sensor fixing clip. Two pressure sensors are fixed inside the pressure sensor fixing clip. The two pressure sensors are respectively connected to the venous perfusion tube and the arterial perfusion tube through pipelines to detect the perfusion fluid pressure.

[0010] In one exemplary embodiment of this application, the temperature control mechanism includes: a water pump; a water tank with an inlet and an outlet; a thermoelectric cooler disposed on the outer wall of the water tank; a heat dissipation module connected to the thermoelectric cooler for dissipating heat from the thermoelectric cooler; and a circulation pipeline for connecting the inlet, the water pump, the oxygenator, and the outlet, and for constructing a water circulation system for the water bath heating chamber of the water tank, the water pump, and the oxygenator.

[0011] In one exemplary embodiment of this application, the circulation pipeline includes a first return water path and a first pipeline, a monitoring component, and a second pipeline connected in sequence. The first pipeline is connected to the outlet of the water pump, and the first return water path is connected to the return water inlet. The monitoring component includes a tee connector, an integrated flow and temperature sensor, and a first pressure sensor. One end of the tee connector is connected to the first pipeline, one end is connected to the integrated flow and temperature sensor, and the other end is connected to the first pressure sensor. The integrated flow and temperature sensor is connected to the second pipeline. The inlet and outlet of the water bath heating chamber in the oxygenator are respectively connected to a third pipeline and a second return water path. The first return water path and the second pipeline are connected to a first quick-release connector, and the third pipeline and the second return water path are connected to a second quick-release connector. The first quick-release connector and the second quick-release connector are quickly disassembled by plugging in.

[0012] In one exemplary embodiment of this application, the temperature control mechanism further includes: a water tank level gauge for electrically connecting to the control module and configured to transmit the detected water tank level to the control module in the form of an electrical signal; a transparent level tube vertically disposed on one side of the water tank, with the upper and lower ends of the transparent level tube connected to the bottom and top of the water tank respectively via connectors; and an internal water tank temperature sensor for detecting the temperature of the circulating water in the water tank.

[0013] In one exemplary embodiment of this application, the organ compartment includes: a compartment body having a receiving cavity for accommodating an isolated organ, and an infusion inlet and an infusion outlet for connecting an infusion pipeline; a tray body disposed within the compartment body, the upper surface of which has a recessed support surface for contacting the surface of the isolated organ to support the isolated organ, the area of ​​the support surface in contact with the surface of the isolated organ being a solid support surface without openings, and the portion of the tray body outside the area of ​​the support surface in contact with the isolated organ having openings for the flow of infusion fluid and blood.

[0014] In an exemplary embodiment of this application, the tray body divides the receiving cavity into an upper chamber and a lower chamber. The upper chamber is used to receive the excised organ. The upper chamber and the lower chamber are connected. The infusion inlet is located in the upper chamber, and the infusion outlet is located in the lower chamber. A first surge protector is provided in the lower chamber. The two ends of the first surge protector are connected to the two side walls of the lower chamber, respectively. The first surge protector is provided with a plurality of liquid flow holes for liquid flow in the lower chamber. The lower surface of the tray body protrudes towards the bottom of the lower chamber and is close to the upper end face of the first surge protector.

[0015] In one exemplary embodiment of this application, the edge of the tray body is provided with a first injection pipeline constraint member. The first injection pipeline constraint member includes a first part extending along a first direction and a second part extending along a second direction. The first direction is vertical, and the second direction is set at an angle to the first direction. A first constraint hole is provided on the second part. The first constraint hole is configured to allow the injection pipeline to pass through or to allow the suspension member for suspending the injection pipeline to pass through.

[0016] In an exemplary embodiment of this application, a fixing part is provided on the first side and the second side of the tray body. The first side and the second side are opposite sides of the tray body. The fixing part on one side is used to detachably connect to the first end of the flexible organ fixation member, and the fixing part on the other side is used to detachably connect to the second end of the flexible organ fixation member. The flexible organ fixation member passes through the upper surface of the detached organ and fixes the detached organ.

[0017] The exemplary embodiments of this application may have some or all of the following beneficial effects: The ex vivo organ perfusion device provided in the exemplary embodiments of this application firstly integrates functional components such as the organ compartment, oxygenator, thimble filter, detection sensor, perfusion pump, and perfusion tubing into a unified consumable module mounting frame, significantly improving the device's integration level. The organ compartment is installed in a dedicated mounting slot on the upper part of the mounting frame. The oxygenator is supported by the bottom of the mounting frame and fixed to the side wall. The thimble filter is fixed to the side wall of the mounting frame and is located below the organ compartment along with the oxygenator. The detection sensor is fixed to the upper surface of the mounting frame. The components are rationally arranged and precisely positioned, effectively solving the problems of scattered components and messy tubing in existing equipment, reducing the overall size of the equipment, improving space utilization, and ensuring the stability of the perfusion fluid circulation loop.

[0018] Secondly, it significantly improves ease of use. The consumable module is detachably mounted in the installation compartment of the main body of the device through a quick-release structure, enabling the overall quick assembly and disassembly of the consumable module without the need to install or disassemble each functional component individually. This greatly simplifies the equipment assembly process and shortens operation time, making it particularly suitable for the high-efficiency operation requirements in emergency transplant scenarios and reducing the workload of medical staff. At the same time, the heat exchange water tank and the oxygenator are connected by a circulation pipeline with quick-release connectors. Combined with the quick-release design of the consumable module, it makes consumable replacement and maintenance more convenient, without the need for special tools. This effectively avoids damage to the main body of the device or consumables during replacement, reduces maintenance costs, and improves operational safety.

[0019] Furthermore, to ensure the stability of perfusion effects and the ease of testing, all functional components are uniformly positioned via a mounting bracket, improving assembly accuracy, ensuring the sealing of perfusion tubing connections, preventing perfusion fluid leakage, and guaranteeing the smooth flow of the perfusion fluid circulation loop. The detection sensor is fixed to the upper surface of the mounting bracket, facilitating the reading of perfusion fluid data within the tubing, simplifying the data recording process, and improving operational convenience. In addition, the temperature control mechanism is located within the temperature control chamber of the main body of the device, complementing the integrated layout of the consumables module, further enhancing the overall integration of the equipment. This achieves an organic combination of integrated functional components and convenient disassembly and assembly, perfectly balancing the dual requirements of integration and ease of use, effectively improving the clinical adaptability and operational efficiency of the equipment.

[0020] It should be understood that the above general description and the following detailed description are exemplary and explanatory only, and do not limit this application. Attached Figure Description

[0021] The accompanying drawings, which form part of this application, are used to provide a further understanding of the application and to make other features, objects, and advantages of the application more apparent. The illustrative embodiments and descriptions of this application are used to explain the application and do not constitute an undue limitation of the application. In the drawings: Figure 1 This is a schematic diagram of the structure of the ex vivo organ perfusion device according to the embodiments of this application; Figure 2 yes Figure 1 A magnified structural diagram of part B in the middle; Figure 3 This is an exploded structural diagram of the locking structure according to the embodiments of this application; Figure 4 This is a side view of the consumable module according to an embodiment of this application; Figure 5 This is a schematic diagram of another side view of the consumable module according to an embodiment of this application; Figure 6 This is a top view of the consumable module according to an embodiment of this application; Figure 7 This is a schematic diagram of another side view of the consumable module according to an embodiment of this application; Figure 8 This is a schematic diagram of the installation structure of the consumable module and the main body of the device according to the embodiments of this application; Figure 9 yes Figure 8 A magnified structural diagram of part A in the middle; Figure 10 This is a schematic diagram of the installation structure of the detection sensor according to an embodiment of this application; Figure 11 This is a schematic diagram of another installation structure of the detection sensor according to an embodiment of this application; Figure 12 This is a schematic diagram of the pipeline connection structure of the consumable module according to the embodiments of this application; Figure 13 This is a schematic diagram of the organ compartment after it has been opened, according to an embodiment of this application; Figure 14 This is a side view of the organ compartment after it has been opened, according to an embodiment of this application. Figure 15 This is a schematic diagram of the organ compartment after it is closed, based on an embodiment of this application. Figure 16 This is a side view of the organ compartment after it has been closed, according to an embodiment of this application. Figure 17 This is a schematic diagram of the organ compartment after it has been closed, according to an embodiment of this application; Figure 18 This is a schematic diagram of the exploded structure of the sealing component according to the embodiments of this application; Figure 19 This is a cross-sectional structural diagram of the sealing component according to the embodiments of this application; Figure 20 This is a schematic diagram of the organ tray structure according to an embodiment of this application; Figure 21 This is a cross-sectional view of the organ tray after it has been assembled into the organ compartment according to an embodiment of this application. Figure 22 This is another cross-sectional view of the organ tray after it has been assembled into the organ compartment according to an embodiment of this application; Figure 23 This is an exploded structural diagram of the temperature control mechanism according to the embodiments of this application; Figure 24 This is a schematic diagram of the overall structure of the temperature control mechanism according to the embodiments of this application. Detailed Implementation

[0022] Exemplary embodiments will now be described more fully with reference to the accompanying drawings. However, these exemplary embodiments can be implemented in many forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this application will be thorough and complete, and will fully convey the concept of the exemplary embodiments to those skilled in the art. The same reference numerals in the drawings denote the same or similar structures, and therefore their detailed descriptions will be omitted. Furthermore, the drawings are merely illustrative of this application and are not necessarily drawn to scale.

[0023] It should be noted that, unless otherwise specified, the embodiments and features described in this application can be combined with each other. This application will now be described in detail with reference to the accompanying drawings and embodiments.

[0024] To solve related technical problems, such as Figure 1 As shown, this embodiment provides an ex vivo organ perfusion device, including a device body 1, and is provided with an installation chamber 2 and a temperature control chamber 16; Consumable module 3 is detachably mounted in installation compartment 2 via a quick-release structure, such as... Figure 4 As shown, the consumable module 3 includes a mounting bracket 44, an organ compartment 30, an oxygenator 31, a filter plug 32, a detection sensor 35, an infusion pump 34, and an infusion pipeline 33; The upper part of the mounting frame 44 is provided with an organ compartment mounting groove 40, and the organ compartment 30 is placed in the organ compartment mounting groove 40; the oxygenator 31 is supported by the bottom of the mounting frame 44 and fixed by the side wall of the mounting frame 44, and the filter plug 32 is fixed to the side wall of the mounting frame 44; both the oxygenator 31 and the filter plug 32 are located at the lower part of the organ compartment 30; the detection sensor 35 is fixed to the upper end face of the mounting frame 44 and is used to detect the data of the perfusion fluid in the perfusion pipeline; the perfusion pump 34, the oxygenator 31, the organ compartment 30 and the filter plug 32 form a perfusion fluid circulation loop through the perfusion pipeline; The temperature control mechanism is located inside the temperature control chamber 16. The temperature control mechanism includes a heat exchange water tank and a temperature control component. The temperature control component is used to control the water temperature in the heat exchange water tank. The heat exchange water tank and the oxygenator 31 are connected by a circulation pipeline 330 with a quick-release connector 331.

[0025] In this embodiment, the main body 1 of the device adopts an integrated box structure. The box is divided into an independent installation compartment 2 and a temperature control compartment 16. The installation compartment 2 is located in the upper part of the box, and the temperature control compartment 16 is located in the lower part of the box. The two are isolated from each other to prevent the heat or condensation of the temperature control mechanism from affecting the normal operation of the consumable module 3. The consumable module 3 is detachably installed in the installation compartment 2 through a quick-release structure.

[0026] like Figures 4 to 7 As shown, the mounting frame 44 of the consumable module 3 includes a top plate 41, a bottom plate 43, and a side plate 42, which enhances the structural strength and stability of the mounting frame 44. The top plate 41 has an organ compartment mounting groove 40 in the middle that matches the shape of the organ compartment 30. The organ compartment 30 is placed directly in the organ compartment mounting groove 40. The bottom wall of the organ compartment mounting groove 40 has a flexible support pad to dampen slight vibrations to the organ compartment 30 and prevent damage to the excised organ. The bottom plate 43 has a raised support seat 402 on which the oxygenator 31 is placed. The side plate 42 has an adjustable oxygenator fixing clamp 403 at a corresponding position. The inner wall of the clamp has an anti-slip rubber pad, and the oxygenator 31 can be firmly fixed by tightening the clamp bolts. The side plate 42 is also provided with a filter plug fixing plate 420. The filter plug fixing plate 420 is provided with two arc-shaped fixing grooves. The lower end of the filter plug 32 is provided with two fixing pins that are adapted to the arc-shaped fixing grooves. After inserting the fixing pins vertically into the arc-shaped fixing grooves, the filter plug 32 is rotated circumferentially to the end of the arc-shaped fixing groove. Under the action of friction, the filter plug 32 can be quickly fixed. When disassembling, it can be removed by rotating in the opposite direction. The operation is convenient.

[0027] In this embodiment, the perfusion fluid flows as follows: the perfusion pump 34 delivers the perfusion fluid to the oxygenator 31 through the perfusion pipeline 33. The oxygenated perfusion fluid then enters the organ chamber 30 through the perfusion pipeline 33 to perform ex vivo perfusion of the isolated organ. After perfusion, the perfusion fluid enters the filter plug 32 for filtration and then flows back to the perfusion pump 34, thereby achieving cyclic perfusion of the isolated organ.

[0028] The detection sensor 35 is fixed to the upper surface of the top plate 41 of the mounting bracket 44 and located outside the organ compartment mounting slot 40 for easy connection to the perfusion pipeline. The perfusion pump 34, oxygenator 31, organ compartment 30, and filter plug 32 form a complete perfusion fluid circulation loop through the perfusion pipeline. The detection sensor 35 is connected to the perfusion pipeline through the detection pipeline to detect data such as the flow rate, pressure, and blood gas of the perfusion fluid in the perfusion pipeline. The temperature control mechanism is located in the temperature control chamber 16. The heat exchange water tank is made of stainless steel, and the temperature control component can stabilize the water temperature in the heat exchange water tank within a preset range. Both ends of the circulation pipeline 330 between the heat exchange water tank and the oxygenator 31 are equipped with quick-release connectors 331. The quick-release connectors 331 adopt a plug-in structure, and quick connection or disconnection can be achieved by pressing the connector buckle.

[0029] In this embodiment, on the one hand, the core functional components are integrated into a unified whole. The mounting frame 44 integrates components such as the organ compartment 30, oxygenator 31, and embolus filter 32, solving the problems of scattered components and messy pipelines in existing equipment, reducing equipment size, and improving space utilization. On the other hand, through the synergistic effect of quick-release structures (quick release between consumable module 3 and equipment body 1, and quick release of circulation pipeline 330 between oxygenator 31 and heat exchange water tank), the consumable module 3 as a whole and its key components can be quickly disassembled and assembled without special tools, greatly simplifying the assembly and maintenance process, reducing the workload of medical staff, and adapting to emergency transplant scenarios. Furthermore, the integrated design of the mounting frame 44 and the precise positioning of each component improve assembly accuracy, ensure the sealing of perfusion pipeline connections, avoid perfusion fluid leakage, and ensure the stability of perfusion circulation. In addition, the temperature control chamber 16 is isolated from the mounting chamber 2, and with the precise temperature control of the temperature control components, the temperature of the perfusion fluid is kept stable, providing a suitable physiological environment for the excised organ and ensuring the perfusion effect.

[0030] like Figure 8 and Figure 9 As shown, in the quick-release part of the consumable module 3, in this embodiment, the installation compartment 2 on the main body 1 has an open top. The mounting frame 44 is provided with a number of first hook parts 5, and the installation compartment 2 of the main body 1 is provided with a number of second hook parts 6. The first hook parts 5 and the second hook parts 6 form a hook-fitting engagement along the vertical direction, thereby realizing the vertical positioning of the mounting frame 44 in the installation compartment 2 and avoiding horizontal displacement after installation.

[0031] In one exemplary embodiment of this application, such as Figure 9As shown, the first mounting part 5 includes at least two mounting holes 50, and the second mounting part 6 includes at least two mounting hooks 60. The mounting holes 50 and the mounting hooks 60 are arranged in a one-to-one correspondence and are symmetrically distributed on both sides of the mounting frame 44 to ensure uniform force and more accurate positioning during mounting. Furthermore, the distance between the two sides of the mounting holes 50 gradually increases from top to bottom, that is, the mounting holes 50 have a "narrow at the top and wide at the bottom" trumpet-shaped structure. This design allows the mounting hooks 60 to slide quickly into the mounting holes 50 to form a mounting fit without precise alignment, thanks to the trumpet-shaped guiding effect, further improving the ease of installation. At the same time, after mounting, the mounting hooks 60 fit tightly against the inner wall of the mounting holes 50, which can reduce the shaking of the mounting frame 44 and improve positioning stability.

[0032] To further improve the vertical support stability of the consumable module 3 after installation, the edge of the mounting frame 44 is provided with an abutment part 44, and the upper end of the main body 1 is provided with a support part 200. The support part 200 is located below the abutment part 44. After the mounting frame 44 is vertically positioned by the hanging structure, the abutment part 44 and the support part 200 abut against each other to form a stable vertical support. This, together with the hanging structure, forms a double support positioning to prevent the mounting frame 44 from becoming vertically loose.

[0033] In one exemplary embodiment of this application, such as Figure 8 As shown, the abutment portions 44 are provided on both sides of the mounting bracket 44 to ensure that the mounting bracket 44 is subjected to balanced forces on both sides. The structures of the abutment portions 44 on both sides of the mounting bracket 44 may be different, but they shall at least include a surface that can abut against the support portion 200. Meanwhile, as... Figure 5 As shown, a lifting part 440 is provided above the abutment part 44. There is a gap between the lifting part 440 and the abutment part 44 for the operator's hand to reach in. The lifting part 440 is used for the operator to lift the mounting frame 44, which facilitates the disassembly and handling of the consumable module 3. Specifically, the lifting part 440 can be set as a protruding structure, integrally formed with the mounting frame 44, with a gap of 3-5cm, which is suitable for the size of an adult's finger. The operator can insert their fingers into the gap, hold the lifting part 440 and exert upward force to quickly remove the consumable module 3 from the mounting compartment 2 without the need for other tools, further improving the ease of disassembly.

[0034] The locking structure is used to stably lock the installed consumable module 3 within the installation chamber 2, preventing it from detaching vertically, while also enabling convenient unlocking, such as... Figures 1 to 3 As shown, the locking structure includes a locking component 7 and a locking mating hole 405, which cooperate with each other. One of them is located on the mounting bracket 44, and the other is located on the main body of the device 1. The locking and unlocking are switched by rotating the locking component 7.

[0035] In one exemplary embodiment of this application, a locking engagement hole 405 is provided on at least one side of the abutment portion 44 of the mounting bracket 44, and a locking component 7 is provided on at least one side of the support portion 200 of the device body 1. With this arrangement, the locking component 7, after passing through the locking engagement hole 405, is located within the gap between the abutment portion 44 and the lifting portion 440. This gap is large enough for an operator's hand to fit through, thus facilitating the operator to rotate the locking component 7 to adjust the locking and unlocking positions.

[0036] The locking hole 405 is a strip-shaped hole. The locking assembly 7 includes a locking seat 70 and a locking part 71. The locking seat 70 is fixedly mounted on the support part 200 of the main body 1. The locking part 71 is rotatably mounted on the locking seat 70 via a rotating shaft. The locking part 71 is a strip-shaped structure adapted to the strip-shaped hole and can pass through the strip-shaped hole vertically. When the locking assembly 7 is in the locked position, the locking part 71 rotates to a direction perpendicular to the strip-shaped hole. At this time, the lower end of the locking part 71 abuts against the upper end face of the abutment part 44. The vertical pressure of the locking part 71 restricts the mounting frame 44 from moving vertically upward, thereby restricting the mounting frame 44 from leaving the mounting chamber 2. When the locking assembly 7 is in the unlocked position, the locking part 71 rotates to a direction parallel to the strip-shaped hole. At this time, the size of the locking part 71 matches the strip-shaped hole and can pass through the strip-shaped hole vertically, releasing the restriction on the mounting frame 44 and allowing the mounting frame 44 to leave the mounting chamber 2 vertically.

[0037] To improve the stability and reliability of the locking mechanism, in one exemplary embodiment of this application, such as Figure 3 As shown, the locking assembly 7 also includes an elastic preload member 720, which is disposed between the locking part 71 and the rotating shaft. Preferably, it is a spring, used to apply a downward elastic preload force to the locking part 71. When the locking part 71 is in the locked position, the preload force of the elastic preload member 720 ensures that the locking part 71 remains tightly abutted against the upper surface of the abutment part 44, preventing the locking part 71 from loosening or rotating due to equipment vibration, thus further ensuring locking reliability.

[0038] Meanwhile, the locking assembly 7 also includes a flexible pad 72, which is located at the lower end of the locking part 71 and is made of a flexible material such as rubber. The flexible pad 72 is used to flexibly contact the upper surface of the abutment part 44 at the locking position. This design avoids hard contact between the locking part 71 and the abutment part 44 during rotation, reducing wear on both parts and extending their service life. Furthermore, the flexible pad 72 increases contact friction, further improving locking stability and preventing deformation of the abutment part 44 due to excessive locking pressure.

[0039] To prevent the locking part 71 from rotating excessively during unlocking and to ensure accurate unlocking position, the locking assembly 7 also includes a limiting member 700. The limiting member 700 is disposed on the locking seat 70 and located in the direction in which the locking part 71 rotates from the locked position to the unlocked position, and is used to abut against the locking part 71 to position it in the unlocked position. Specifically, the limiting member 700 can be configured as a protruding stop, integrally formed with the locking seat 70. When the locking part 71 rotates to the unlocked position, the side of the locking part 71 abuts against the limiting member 700 and cannot continue to rotate, ensuring that the locking part 71 is always parallel to the slot, facilitating the smooth passage of the locking part 71 through the slot during subsequent disassembly.

[0040] Further optimization involves providing a limiting groove 710 on the side of the locking part 71. The limiting groove 710 is used to accommodate the limiting member 700. When the locking part 71 is rotated to the unlock position, the limiting member 700 is embedded in the limiting groove 710 to form a limiting fit. This not only accurately positions the unlock position but also restricts the locking part 71 from shaking in the unlocked state, preventing accidental contact that could cause the locking part 71 to rotate to the locked position and affect the disassembly operation of the consumable module 3.

[0041] Based on the implementation details of the above structures, the assembly and disassembly process of consumable module 3 of the ex vivo organ perfusion device of this application is as follows, further demonstrating its advantage of rapid assembly and disassembly: 1. Installation Process: The operator holds the lifting parts 440 on both sides of the mounting bracket 44 and aligns the mounting bracket 44 with the mounting chamber 2 of the equipment body 1, so that the hooking hole 50 (first hooking part 5) on the mounting bracket 44 is aligned with the hooking hook 60 (second hooking part 6) in the mounting chamber 2. The mounting bracket 44 is placed downwards, and the hooking hook 60 slides into the hooking hole 50 along the guide of the trumpet-shaped hooking hole 50 to form a vertical hooking fit. Continue to place it downwards until the abutment part 44 of the mounting bracket 44 is fully abutted against the support part 200 of the equipment body 1, completing the precise positioning and vertical support. Then, rotate the locking part 71 of the locking component 7 from the unlocked position (parallel to the strip hole) to the locked position (perpendicular to the strip hole). The elastic pre-tightening member 720 applies a downward pre-tightening force, so that the locking part 71 is tightly abutted against the upper surface of the abutment part 44 through the flexible pad 72, completing the locking. The entire installation process does not require tools, is time-saving, and easy to operate.

[0042] 2. Disassembly process: The operator rotates the locking part 71 of the locking component 7 in the opposite direction until the locking part 71 abuts against the limiting member 700 (the limiting member 700 is embedded in the limiting groove 710), and is in the unlocked position; then, the operator holds the lifting part 440 and applies upward force to move the mounting bracket 44 upward, the hook 60 disengages from the hook hole 50, the locking part 71 passes through the strip hole, and the consumable module 3 can be taken out from the installation compartment 2 to complete the disassembly. Again, no tools are required, and the operation is simple and efficient.

[0043] In one embodiment, the detection sensor 35 and the mounting bracket 44 are quick-release engaged, specifically, as shown below. Figure 7 and Figure 10 As shown, the mounting bracket 44 includes a frame 406 and a sensor mounting base 12. The frame 406 is provided with an organ compartment mounting groove 40, and the organ compartment 30 is detachably installed in the organ compartment mounting groove 40. The sensor mounting base 12 is fixedly mounted on the frame 406, and forms a sensor mounting groove 120 extending horizontally between the sensor mounting base 12 and the upper end surface of the frame 406.

[0044] The detection sensor 35 includes a flow sensor 350, which can accurately monitor changes in the perfusion fluid flow rate, promptly detect perfusion abnormalities, and ensure the safety of excised organs. For example... Figure 10 As shown, the side of the detection sensor 35 is provided with a horizontally extending sensor mounting part 352 (dashed line part). The sensor mounting part 352 is inserted into the sensor mounting groove 120 in the horizontal direction, that is, the detection sensor can be directly inserted into the sensor mounting groove 120 in the horizontal direction, or pulled out from the sensor mounting groove 120 in the horizontal direction, without the need for complicated multi-directional alignment operations.

[0045] The first fixing part 13 is located at the bottom of the detection sensor 35, specifically including a mating groove 130 located at the bottom of the detection sensor 35. The extending direction of the mating groove 130 is parallel to the extending direction of the sensor mounting groove 120, ensuring that the first fixing part 13 can precisely mate with the second fixing part 14 during the horizontal insertion process of the detection sensor 35.

[0046] Furthermore, such as Figure 11 As shown, the mating groove 130 includes a first groove segment 1301 and a second groove segment 1302 arranged sequentially along the insertion direction. Both the first groove segment 1301 and the second groove segment 1302 are arc-shaped. The arc-shaped structure can reduce contact friction with the second fixing part 14, avoid jamming during insertion, and at the same time provide a guiding effect for the second fixing part 14. The depth of the first groove segment 1301 is greater than the depth of the second groove segment 1302. The first groove segment 1301 is configured to engage with the second fixing part 14 to guide the detection sensor to move smoothly along a preset direction and apply a vertical first pressure to the detection sensor. The second groove segment 1302 is configured to engage with the second fixing part 14 to accurately position the detection sensor in a preset installation position and apply a vertical second pressure to the detection sensor 35. The second pressure is greater than the first pressure, realizing a smooth transition of the detection sensor 35 from guided movement to precise positioning, improving the accuracy and stability of assembly.

[0047] like Figure 10As shown, the second fixing part 14 is disposed on the mounting bracket 44 and cooperates with the first fixing part 13 to realize the vertical fixation of the detection sensor. It includes a fixing sleeve 142, an elastic element 140 and a top ball 141. The fixing sleeve 142 is detachably connected to the mounting bracket 44, which facilitates the maintenance and replacement of the elastic element 140 and the top ball 141 and reduces the later maintenance cost. The elastic element 140 is disposed inside the fixing sleeve 142, and the top ball 141 is constrained at the upper end of the fixing sleeve 142. The upper part of the top ball 141 extends out of the upper end surface of the mounting bracket 44 to ensure that it can form effective contact with the mating groove 130 of the first fixing part 13. When the sensor mounting part 350 is inserted into the sensor mounting groove 120 in the horizontal direction, the bottom of the detection sensor 35 contacts the top bead 141, and the top bead 141 is compressed. As the insertion is pushed forward, the top bead 141 enters the mating groove 130. At this time, the elastic element 140 is in a further compressed state. Under the elastic force of the elastic element 140, the top bead 141 applies upward pressure to the mating groove 130, thereby driving the detection sensor to move upward, so that the sensor mounting part 350 and the upper end of the sensor mounting groove 120 are tightly abutted in the vertical direction, thereby realizing the vertical fixation of the detection sensor 35.

[0048] Specifically, when the top bead 141 is inserted into the first groove 1301, the compression of the elastic element 140 is small due to the depth of the first groove 1301. The applied first pressure is used to guide the detection sensor 35 to move along the preset direction to avoid insertion misalignment, while also reducing the initial insertion resistance. When the top bead 141 is inserted into the second groove 1302, the compression of the elastic element 140 increases due to the shallower second groove 1302. The applied second pressure is greater than the first pressure, firmly positioning the detection sensor 35 in the preset installation position. The greater pressure ensures the stability after assembly. At the same time, since the second groove 1302 has a depth change relative to the first groove 1301, a clear snap-in feel is provided after the top bead 141 is inserted into the second groove 1302, further facilitating installation.

[0049] The infusion assembly provided in this application, firstly, because the sensor mounting part 350 of the detection sensor 35 and the sensor mounting groove 120 of the mounting bracket 44 adopt a horizontal plug-in fit, the arc-shaped structure of the mating groove 130 and the top ball 141 reduces the plug-in friction, and the first groove section 1301 of the mating groove 130 plays a guiding role, so that the detection sensor 35 can be smoothly inserted or removed in a single horizontal direction without complicated alignment and multi-directional adjustment. At the same time, the fixing sleeve 142 of the second fixing part 14 is detachably connected to the mounting bracket 44, which facilitates the maintenance and replacement of the elastic element 140 and the top ball 141, further improving the overall ease of disassembly and assembly. It can be seen that the horizontal plug-in fit simplifies the assembly path, the arc-shaped groove section and the guiding role avoid assembly jamming, and the detachable fixing sleeve 142 reduces the maintenance difficulty. Together, they realize the rapid disassembly and assembly of the detection sensor and related components, saving assembly and maintenance time, and adapting to the use needs of emergency medical scenarios.

[0050] Secondly, the first fixing part 13 and the second fixing part 14 cooperate, and the elastic force of the elastic element 140 causes the top ball 141 to apply upward pressure to the mating groove 130, forcing the sensor mounting part 350 to tightly abut against the upper end of the sensor mounting groove 120, effectively eliminating the vertical assembly gap; at the same time, the second groove section 1302 of the mating groove 130 is shallower, making the top ball 141 more firmly engaged, and the applied second pressure is greater than the first pressure, which can accurately position the detection sensor in the preset position, effectively resisting vibration or external impact during equipment operation, and preventing the detection sensor from shaking or displacing; thus, the vertical pre-tightening force eliminates the assembly gap, and the dual pressure design improves the positioning stability, thereby ensuring the stable contact between the detection sensor and the perfusion pipeline, ensuring the continuity and accuracy of perfusion fluid data monitoring, and providing a reliable basis for judging the state of ex vivo organs.

[0051] In one embodiment, the infusion line 33 and the detection sensor 35 are optimized to further improve the infusion effect and ease of operation, such as... Figure 12As shown, the specific setup is as follows: The perfusion line 33 includes an arterial perfusion line 332, a venous perfusion line 333, a first branch line 334, and a second branch line 335. The first branch line 334 is connected to the outlet of the perfusion pump 34 and is divided into two branches. One branch is connected to the inlet of the oxygenator 31 to deliver the perfusion fluid output from the perfusion pump 34 into the oxygenator 31 for oxygenation treatment. The other branch is connected in parallel to the venous perfusion line 333. The second branch line 335 is connected to the outlet of the oxygenator 31 and is also divided into two branches. One branch is connected to the arterial perfusion line 332. The end of the arterial perfusion line 332 away from the second branch line 335 is connected to the arterial perfusion end of the organ compartment 30 to deliver the oxygenated perfusion fluid to the isolated organ. The other branch is also connected in parallel to the venous perfusion line 333. The end of the venous perfusion line 333 away from the branch is connected to the venous perfusion end of the organ compartment 30 to perfuse the perfusion fluid into the vein of the isolated organ. When applied to the liver organ for ex vivo perfusion, the arterial perfusion tube 332 is used to connect to the hepatic artery, and the venous perfusion tube 333 is used to connect to the portal vein.

[0052] Therefore, in this embodiment, the perfusion fluid infused into the portal vein via the intravenous perfusion tube 333 includes two sources: one is the perfusion fluid directly delivered by the perfusion pump 34, and the other is the perfusion fluid oxygenated by the oxygenator 31. Since the perfusion fluid directly delivered by the perfusion pump 34 has a lower oxygen content, the oxygen content of the perfusion fluid in the intravenous perfusion tube 333 can be reduced after the two are combined, making it more suitable for the perfusion needs of the portal vein and improving the perfusion effect.

[0053] like Figure 6 As shown, the detection sensor 35 includes two flow sensors 350 and two blood gas sensors 351, all fixed to the upper surface of the top plate 41 of the mounting frame 44, achieving a centralized layout of the detection components. The two flow sensors 350 are connected to the arterial perfusion tube 332 and the venous perfusion tube 333 respectively via branch lines, real-time detecting the perfusion fluid flow rate at the arterial and venous ends, facilitating precise control of the perfusion rate and timely adjustment of the perfusion pump 34 parameters. Similarly, the two blood gas sensors 351 are connected to the arterial perfusion tube 332 and the venous perfusion tube 333 respectively, real-time detecting blood gas parameters such as blood oxygen saturation, pH value, and carbon dioxide partial pressure in the perfusion fluid, accurately reflecting the physiological state of the isolated organ. Simultaneously, a pressure sensor fixing clip is added to the second side edge of the top plate 41 of the mounting frame 44, fixing two perfusion fluid pressure sensors 39 within the clip, connected to the arterial perfusion tube 332 and the venous perfusion tube 333 respectively, real-time detecting the perfusion fluid pressure at both ends, preventing excessive pressure from damaging the organ or excessive pressure from affecting the perfusion effect.

[0054] In this embodiment, the coordinated arrangement of the flow sensor 350, blood gas sensor 351, and perfusion fluid pressure sensor 39 enables comprehensive and centralized detection of perfusion fluid flow, pressure, and blood gas parameters, solving the problems of scattered detection and inconvenient data reading in existing equipment. Furthermore, in conjunction with the basic integrated structure of the above embodiment, while maintaining the advantages of integration and convenient disassembly and assembly, it further improves the stability and controllability of the perfusion effect. Through real-time monitoring and parameter adjustment, it provides a more suitable perfusion environment for ex vivo organs and extends organ survival time.

[0055] In one embodiment, functional components are added and the structure of the mounting bracket 44 is optimized to expand the device's functionality and improve its versatility. The specific settings are as follows: Figure 5 As shown, an irrigation device fixing clip 404 and a measuring cylinder fixing clip 400 are added to the side plate 42 of the mounting bracket 44. The irrigation device fixing clip 404 is an adjustable clamp used to fix the irrigation device, which can be adapted to irrigation devices of different specifications to meet the additional needs of irrigation fluid filtration and adsorption during organ perfusion. The measuring cylinder fixing clip 400 is used to fix the measuring cylinder, which makes it convenient for medical staff to measure the products of organ metabolism or secretion to judge the organ status.

[0056] In one implementation, such as Figure 5 and Figure 6 As shown, a new dialyzer is added to consumable module 3. A dialyzer fixing clip 401 and an injection tube fixing clip are added to the first side edge of the top plate 41 of the mounting bracket 44. The dialyzer is fixed to the dialyzer fixing clip 401, and the injection tube 38 is fixed to the injection tube fixing clip. The injection tube 38 is connected to the filter plug 32 and has three injection ports, allowing simultaneous injection of various perfusion drugs (such as anticoagulants, nutrients, electrolytes, etc.) without repeated disassembly of the tubing, thus avoiding contamination of the perfusion fluid and tubing leakage. The dialyzer is connected to the perfusion circulation loop through tubing, enabling dialysis treatment of the perfusion fluid to remove metabolic waste, maintain stable physiological indicators of the perfusion fluid, and adapt to long-term perfusion requirements.

[0057] In this embodiment, on the one hand, new components such as perfusion devices, dialyzers, and measuring cylinders are added to achieve multi-functional integration of perfusion, filtration, dialysis, drug injection, and metering, solving the problem of existing equipment having limited functionality and difficulty in adapting to complex clinical scenarios, thus improving the equipment's versatility. On the other hand, the multi-injection port design of the injection tube 38 enables the simultaneous injection of multiple drugs, simplifying the operation process, reducing the risk of perfusion fluid contamination, and working in conjunction with the detection components in Embodiment 2 to accurately adjust the drug injection volume based on data such as blood gas and flow rate, improving the accuracy of perfusion. Furthermore, all new components are integrated into the mounting frame 44, maintaining the integrated advantages of the equipment, ensuring ease of operation, and expanding the applicability of the equipment to adapt to the perfusion needs of different organs such as the liver, kidneys, and lungs, as well as perfusion scenarios with different durations and operating conditions. In addition, the modular component design allows for flexible addition or removal according to clinical needs, reducing equipment maintenance costs, while being compatible with existing quick-release structures and perfusion circuits, achieving synergistic superposition of the technical effects of various implementation methods, further enhancing the clinical adaptability and usability of the equipment.

[0058] In one embodiment, such as Figure 4 As shown, the consumable module 3 also includes an oxygen pipeline connected to the oxygenator 31, with a quick-connect fitting at its end for connecting to an oxygen supply device, and an oxygen filter 36 installed on the oxygen pipeline. A pressure balancing pipe 37 is installed on the organ compartment 30, and an oxygen filter 36 is installed on the pressure balancing pipe 37 to filter the oxygen entering the organ compartment 30 while balancing the pressure inside and outside the organ compartment 30.

[0059] In one embodiment, such as Figures 13 to 16 The structure of the organ compartment is described in detail below: The organ compartment includes a compartment body 300, within which a receiving cavity 301 of a certain depth is provided. The upper end of the compartment body 300 is open, allowing the excised organ to be placed into or removed from the receiving cavity 301 through the upper opening. The lower end of the compartment body 300 is provided with an infusion outlet 311, and an infusion inlet 302 is provided on the circumferential side. The infusion inlet 302 is connected to an infusion fluid inlet pipe, and the infusion outlet 311 is connected to an infusion fluid outlet pipe, thereby enabling the flow of the infusion fluid.

[0060] The upper end of the compartment 300 is provided with an openable inner cover 303, which can be used to open and close the receiving cavity 301. Specifically, when the inner cover 303 is closed on the compartment 300, the inner cover 303 closes the opening at the upper end of the compartment 300, making the receiving cavity 301 a closed environment. When the inner cover 303 is opened, the receiving cavity 301 is an open environment.

[0061] A first sealing element 307 is provided between the inner cover 303 and the chamber body 300. When the inner cover 303 is closed on the chamber body 300, the first sealing element 307 seals the receiving cavity 301, ensuring that the excised organ located in the receiving cavity 301 is not contaminated by the external environment. The first sealing element 307 can be preset on the upper end face of the chamber body 300 or the lower end face of the inner cover 303.

[0062] The upper end of the compartment 300 is also provided with a first fixing member 305. The first fixing member 305 is used to fix the inner cover 303 after it is closed in the compartment 300, and to apply downward pressure to the inner cover 303. The downward pressure is transmitted to the first sealing member 307 through the inner cover 303 to improve the sealing performance. In addition, the inner cover 303, after being fixed by the first fixing member 305, is not easy to loosen during the transportation of the organ compartment, thus ensuring the sealing performance of the receiving cavity 301.

[0063] An outer cover 304 is provided in addition to the inner cover 303, and the overall size of the outer cover 304 is larger than that of the inner cover 303. The outer cover 304 is also connected to the compartment body 300 in an opening and closing manner. After the outer cover 304 is closed on the compartment body 300, the inner cover 303 is located between the outer cover 304 and the compartment body 300, and the outer cover 304 completely covers the inner cover 303. A second sealing element 308 is provided between the outer cover 304 and the compartment body 300. When the outer cover 304 is closed on the compartment body 300, the second sealing element 308 keeps the outer cover 304 and the inner cover 303 in a sealed state.

[0064] The upper end of the compartment 300 is also provided with a second fixing member 306. The second fixing member 306 is located outside the first fixing member 305. The second fixing member 306 is used to fix the outer shell after the outer cover 304 is closed in the compartment 300, and to apply downward pressure to the outer cover 304. The downward pressure is transmitted to the second sealing member 308 through the outer cover 304 to improve the sealing performance. Furthermore, the outer cover 304, after being fixed by the second fixing member 306, is less likely to loosen during the transportation of the organ compartment, thus ensuring the sealing performance between the outer cover 304 and the inner cover 303.

[0065] As described above, in this embodiment, a first seal is formed between the inner cover 303 and the chamber 300, and a second seal is formed between the outer cover 304 and the inner cover 303. Firstly, the outer cover 304 provides additional protection for the inner cover 303, the first seal 307, and the detached organ within the receiving cavity 301, reducing the impact of external collisions and dust on the internal structure and the detached organ. Secondly, the double seal further enhances the overall sealing performance of the filling chamber, ensuring the stability of the filling environment.

[0066] In this embodiment, the ex vivo organ chamber, through the cooperation of various structures, not only achieves convenient placement and stable containment of ex vivo organs, but also significantly improves the sealing reliability and structural stability of the perfusion chamber through the double sealing and double fixing structural design. It can provide a long-term and stable perfusion environment for ex vivo organs, ensure the activity and functional integrity of ex vivo organs in vitro, and meet the needs of ex vivo organ preservation, research and related experiments.

[0067] In an exemplary embodiment of this application, the storage body 300 is provided with a rotating shaft on one side corresponding to the inner cover 303 and the outer cover 304 respectively. One end of the inner cover 303 is rotatably connected to the rotating shaft of the storage body 300, and one end of the outer cover 304 is rotatably connected to the other rotating shaft of the storage body 300. The rotating shafts of the inner cover 303 and the outer cover 304 are arranged in parallel. When it is necessary to insert or remove an excised organ, first release the second fixing member 306 from the constraint of the outer cover 304, then rotate the outer cover 304 to release it from the closed state of the chamber 300 and put it in the open position. Then release the first fixing member 305 from the constraint of the inner cover 303, and then rotate the inner cover 303 in the same direction to open the receiving cavity 301, thus completing the placement or removal of the excised organ. After the operation is completed, rotate the inner cover 303 in the opposite direction to close the receiving cavity 301. Fix the inner cover 303 to the chamber 300 with the first fixing member 305. Then rotate the outer cover 304 in the same opposite direction to close the outer side of the inner cover 303. Fix the outer cover 304 to the chamber 300 with the second fixing member 306 to complete the overall sealing and fixation.

[0068] The technical effects of the above-described implementation are as follows: Since both the inner cover 303 and the outer cover 304 rotate and open in the same direction, synchronous and unidirectional operation of the inner cover 303 and the outer cover 304 can be achieved, simplifying the operation process, improving the convenience of inserting and removing excised organs, and avoiding problems such as cumbersome operation and mutual interference caused by the different rotation directions of the inner cover 303 and the outer cover 304; the parallel arrangement of the rotation axes of the inner cover 303 and the outer cover 304 ensures the stability of the rotation process, reduces wear on the chamber 300 and seals during rotation, and extends the service life of the equipment; simultaneously… The design of rotating in the same direction ensures that the outer cover 304 does not obstruct the rotation space of the inner cover 303 when it is opened, and the inner cover 303 does not affect the reset of the outer cover 304 when it is opened, ensuring a smooth and efficient operation. In addition, the double sealing and double fixing structure improves the convenience of operation while taking into account the sealing reliability and structural stability of the perfusion chamber, ensuring that the perfusion process proceeds smoothly, providing a long-term and stable perfusion environment for ex vivo organs, ensuring the activity and functional integrity of ex vivo organs in vitro, and meeting the needs of ex vivo organ preservation, research and related experiments.

[0069] In one exemplary embodiment of this application, the ex vivo organ perfusion chamber further includes a first angle limiting member 309 and a second angle limiting member 310. The first angle limiting member 309 is configured to limit the maximum opening angle of the inner cover 303 to θ1, and the second angle limiting member 310 is configured to limit the maximum opening angle of the outer cover 304 to θ2, wherein θ2≥θ1.

[0070] Specifically, the first angle limiting member 309 is fixedly installed at the rotational connection between the compartment body 300 and the inner cover 303. It can be a limiting block, a limiting pin, or an elastic limiting structure. When the inner cover 303 rotates to angle θ1, the first angle limiting member 309 abuts against the inner cover 303, preventing the inner cover 303 from continuing to rotate, thereby limiting the maximum opening angle of the inner cover 303 to θ1. The second angle limiting member 310 is fixedly installed at the rotational connection between the compartment body 300 and the outer cover 304. It adopts the same shape as the first angle limiting member. With the same or compatible structure as 309, when the outer cover 304 is rotated to angle θ2, the second angle limiting member 310 abuts against the outer cover 304, limiting the maximum opening angle of the outer cover 304 to θ2, and ensuring that θ2≥θ1. θ1 can be set to 100-110° according to the rotation space of the inner cover 303 and the requirements for taking and placing off-body organs, and θ2 can be set to 100°-120° to match the opening angle of the inner cover 303, so as to avoid the outer cover 304 not opening too wide and obstructing the operating space of the inner cover 303.

[0071] Corresponding to the above implementation method, its technical effects are as follows: On the one hand, the first angle limiting member 309 can effectively limit the maximum opening angle of the inner cover 303, and avoid the inner cover 303 from colliding or wearing with the chamber body 300, the rotating shaft or other structures due to excessive rotation angle; the second angle limiting member 310 limits the maximum opening angle of the outer cover 304, which can prevent the outer cover 304 from occupying too much operating space due to excessive rotation angle, and can also prevent the outer cover 304 from rotating excessively, causing damage to the second sealing member 308 or loosening of the connection between the outer cover 304 and the chamber body 300; and the setting of θ2≥θ1 can ensure that there is enough space after the outer cover 304 is opened, and will not block the rotation trajectory and operating area of ​​the inner cover 303, ensuring that the inner cover 303 can be opened smoothly to the maximum angle, which is convenient for the removal and placement of excised organs, while avoiding mutual interference when the inner and outer covers 304 are opened.

[0072] On the other hand, by limiting θ2 to 100°-120°, it is possible to avoid the outer cover 304 and inner cover 303 opening too wide, which would create a large lever arm between the ends of the outer cover 304 and inner cover 303 and the chamber body 300. This would prevent the overall center of gravity of the detached organ chamber from being too close to the far end of the inner cover 303 and outer cover 304, thereby preventing the chamber body 300 from tilting under accidental pressure.

[0073] In one exemplary embodiment of this application, such as Figure 14 As shown, the first angle limiting member 309 includes a first connecting seat 3090 disposed on the first side of the compartment body 300, and the first connecting seat 3090 is provided with a first abutting slope; the first side of the inner cover 303 is hinged to the first connecting seat 3090, and the first abutting slope is used to abut against the edge of the inner cover 303 after it is opened. The second angle limiting member 310 includes a second connecting seat 3100 disposed on the first side of the compartment body 300, and the second connecting seat 3100 is provided with a second abutting slope 3101. The first side of the outer cover 304 is hinged to the second connecting seat 3100, and the second abutting slope 3101 is used to abut against the edge of the outer cover 304 after it is opened.

[0074] Specifically, on the first side of the compartment 300, corresponding to the rotational positions of the inner cover 303 and the outer cover 304, a first connecting seat 3090 and a second connecting seat 3100 are fixedly installed, respectively. The first connecting seat 3090 and the second connecting seat 3100 are spaced apart and both are fixedly connected to the compartment 300, and both protrude from the surface of the compartment 300. The first connecting seat 3090 has a first abutting slope machined on the side facing the rotational trajectory of the inner cover 303. The first side of the inner cover 303 is rotatably connected to the first connecting seat 3090 through a hinge shaft (i.e., the rotational shaft of the inner cover 303 is integrated into the first connecting seat 3090). When the inner cover 303 rotates to the maximum opening angle θ1, the edge of the inner cover 303 abuts against the first connecting seat 3090. The inclined surfaces are tightly abutted, and the inclination angle of the first abutting inclined surface is adapted to θ1, preventing the inner cover 303 from continuing to rotate, thereby limiting the maximum opening angle of the inner cover 303 to θ1; the second connecting seat 3100 has a second abutting inclined surface 3101 machined on the side facing the outward rotation trajectory, and the first side of the outer cover 304 is rotatably connected to the second connecting seat 3100 through a hinge shaft (that is, the rotation shaft of the outer cover 304 is integrated into the second connecting seat 3100). When the outer cover 304 rotates to the maximum opening angle θ2, the edge of the outer cover 304 is tightly abutted with the second abutting inclined surface 3101 of the second connecting seat 3100, and the inclination angle of the second abutting inclined surface 3101 is adapted to θ2, limiting the maximum opening angle of the outer cover 304 to θ2.

[0075] In this embodiment, the first angle limiting member 309 adopts a structure combining the first connecting seat 3090 and the first abutting slope. It not only realizes the hinged installation of the inner cover 303, but also achieves angle limiting through the abutting slope and the edge of the inner cover 303. It serves two purposes in one piece, simplifies the structural design, reduces the number of parts, and reduces the assembly difficulty. The abutting method between the first abutting slope and the edge of the inner cover 303 has a moderate contact area, which can disperse the impact force when the inner cover 303 rotates to the maximum angle, avoid excessive local force that could damage the inner cover 303 or the connecting seat, and at the same time stably limit the angle of the inner cover 303, preventing the inner cover 303 from rotating excessively and colliding with the compartment 300 and other components. The effect of the second angle limiting member 310 is the same.

[0076] In one exemplary embodiment of this application, such as Figure 13 As shown, the inner cover 303 has a first annular groove 3030 on its edge, and the first sealing element 307 includes a first sealing ring, which is embedded in the first annular groove 3030. The upper end face of the chamber 300 has a first annular protrusion 3031. When the inner cover 303 is closed, the first annular protrusion 3031 is partially located in the first annular groove 3030 and abuts against the first sealing ring.

[0077] Specifically, the first annular groove 3030 on the edge of the inner cover 303 forms an embedded positioning structure with the first sealing ring. The primary technical effect of this design is to achieve precise installation and reliable positioning of the first sealing ring, effectively avoiding the problems of displacement, detachment, or misalignment of the sealing ring during opening, closing, and compression, ensuring that the first sealing ring is always on the preset sealing path, laying the foundation for stable sealing. At the same time, the first annular protrusion 3031 provided on the upper surface of the chamber 300 partially extends into the first annular groove 3030 in the closed state and tightly abuts against the first sealing ring, forming a multi-level surface sealing structure. This structure, through the interference fit or surface contact between the annular protrusion and the sealing ring, can effectively seal the connection gap between the inner cover 303 and the chamber 300, physically eliminating the risk of leakage of the filling fluid from this connection point, and ensuring the sealing and stability of the filling environment inside the filling chamber.

[0078] Furthermore, the insertion of the first annular groove 3030 and the first annular protrusion 3031 can absorb part of the impact force through the elastic deformation of the sealing ring when the equipment is subjected to slight vibration or collision, thereby avoiding rigid contact between the inner cover 303 and the chamber body 300, reducing structural wear, extending the service life of the inner cover 303, the chamber body 300 and the first seal 307, and thus improving the structural durability and long-term operational reliability of the entire filling chamber.

[0079] The outer cover 304 has a second annular groove 3040 on its edge. The second seal 308 includes a second sealing ring, which is embedded in the second annular groove 3040. The upper end face of the chamber 300 has a second annular protrusion 3041. When the outer cover 304 is closed, the second annular protrusion 3041 is partially located in the second annular groove 3040 and abuts against the second sealing ring.

[0080] Specifically, the embedding design of the second annular groove 3040 on the edge of the outer cover 304 and the second sealing ring is consistent with the sealing structure principle of the inner cover 303. First, it achieves the fixed positioning of the second sealing ring, preventing it from shifting during opening, closing or use, and ensuring the stability of the sealing structure of the outer cover 304.

[0081] The second annular protrusion 3041 on the upper surface of the chamber 300 abuts against the second sealing ring, forming a second sealing barrier between the outer cover 304 and the chamber 300. This structure, together with the first sealing structure of the inner cover 303, forms a dual-sealing protection system. Even if there is a minor risk of leakage in the first seal (the inner cover 303 seal), the second seal further prevents leakage, completely solving the technical defect of easy failure of a single sealing structure in existing technologies, and providing a high level of environmental protection for the long-term stable preservation of ex vivo organs.

[0082] In one exemplary embodiment of this application, the first fastener 305 includes a first fastening member, which is fixedly disposed on at least one opposite side of the compartment body 300, and the edge of the inner cover 303 is provided with a first fastening groove that engages with the first fastening member. The second fastener 306 includes a second fastening member, which is fixedly disposed on at least one opposite side of the compartment body 300, and the edge of the outer cover 304 is provided with a second fastening groove that engages with the second fastening member.

[0083] Specifically, the first fastening component adopts a manually rotating structure, which can be in the form of a rotating snap fastener, a rotary snap fastener, etc., and is symmetrically fixed on opposite sides of the compartment body 300 (i.e., at least one opposite side of the compartment body 300). The first fastening component is hinged to the compartment body 300 through a rotating shaft, and can be manually rotated around the hinge shaft. The fastening end of the first fastening component corresponds one-to-one with the first fastening groove on the edge of the inner cover 303 and fits snugly.

[0084] When the inner cover 303 is rotated in the opposite direction to the position of closing the receiving cavity 301, the first fastening groove on the edge of the inner cover 303 is aligned with the first fastening member on the compartment body 300. The first fastening member is manually rotated towards the inner cover 303 so that the fastening end of the first fastening member rotates and engages in the first fastening groove. The clamping force of the first fastening member achieves the fastening and fixing of the inner cover 303 and the compartment body 300. The first fastening member is manually rotated in the opposite direction so that the fastening end disengages from the first fastening groove, thereby releasing the fastening and opening the inner cover 303.

[0085] The second fastening component has the same structure and assembly method as the first fastening component. Both are manually rotating structures and are symmetrically fixed on at least one opposite side of the compartment body 300 (they can be set on the same side as the first fastening component or staggered to ensure that they do not interfere with each other during rotation). The outer cover 304 has a second fastening groove at the position corresponding to the second fastening component.

[0086] When the outer cover 304 is rotated in the opposite direction to the position outside the inner cover 303, the second fastening groove on the edge of the outer cover 304 aligns with the second fastening member on the compartment body 300. The second fastening member is manually rotated towards the outer cover 304, causing its fastening end to engage with the second fastening groove. The outer cover 304 and compartment body 300 are then fastened and fixed by the clamping force. The fastening is released by manually rotating the second fastening member in the opposite direction, allowing the outer cover 304 to be opened. Preferably, both the first and second fastening members are provided in two sets, symmetrically arranged on two opposite sides of the compartment body 300, improving the stability of the fixation. Furthermore, each set of fastening members rotates synchronously, ensuring uniform force on the cover.

[0087] In this embodiment, the first fixing member 305 adopts a fastening structure of the first fastening member and the first fastening groove. The structure is simple and easy to assemble. Without the need for additional tools, the inner cover 303 and the chamber 300 can be quickly fixed and unlocked, which greatly improves the operation efficiency and facilitates the rapid placement and removal of excised organs and the rapid sealing of the infusion chamber. The first fastening member is fixed on at least one opposite side of the chamber 300 and precisely matches the first fastening groove of the inner cover 303. This ensures that the inner cover 303 is evenly stressed when closing the receiving cavity 301, preventing the inner cover 303 from shifting or loosening. This further ensures the sealing effect of the first sealing member 307 and prevents leakage of infusion fluid due to the inner cover 303 not being securely fixed.

[0088] like Figure 16 As shown, after the inner cover 303 is closed and fixed by the manual rotation fastening structure of the first fastening member and the first fastening groove, a preset gap is reserved between the upper end face of the inner cover 303 (the side away from the receiving cavity 301) and the lower end face of the outer cover 304 (the side close to the inner cover 303) to ensure that the two do not contact each other. After the outer cover 304 is closed and fixed by the manual rotation fastening structure of the second fastening member and the second fastening groove, the outer cover 304 is only fixed to the compartment body 300 by the second fastening member and sealed by the second sealing member 308. Its inner side does not contact any part of the inner cover 303. Moreover, the size of the preset gap can be reasonably set according to the structural dimensions of the inner cover 303 and the outer cover 304, so as not to affect the protective function of the outer cover 304 for the inner cover 303, and to ensure that the inner and outer covers 304 are fixed independently and do not interfere with each other. Meanwhile, in conjunction with the aforementioned manual rotating fastener fixing method, the inner cover 303 and the outer cover 304 are respectively fixed to the chamber body 300 through their respective fasteners. The fixing force of both acts directly on the chamber body 300, further avoiding contact pressure between the outer cover 304 and the inner cover 303.

[0089] With this configuration, the outer cover 304 and the inner cover 303 do not contact each other when closed. This prevents the fixing pressure, weight, and external forces that may be transmitted to the outer cover 304 from being transmitted to the inner cover 303. This completely avoids the outer cover 304 applying any form of pressure to the inner cover 303, thus effectively preventing the inner cover 303 from deforming or shifting due to the additional pressure from the outer cover 304. Consequently, it prevents the first annular groove 3030 on the edge of the inner cover 303 and the first sealing ring embedded therein from becoming loose, misaligned, or subjected to uneven force. This ensures that the first sealing ring is always in close contact with the first annular protrusion 3031 of the chamber body 300, guaranteeing the sealing reliability of the first sealing element 307 and eliminating the problem of injection fluid leakage caused by pressure on the inner cover 303 and loosening of the sealing ring.

[0090] Meanwhile, the inner and outer covers 304 do not contact each other and are fixed independently, so that their fixing operations do not interfere with each other. The fixing stability of the inner cover 303 is not affected by the assembly and fixing of the outer cover 304, and the fixing of the outer cover 304 will not interfere with the sealing effect of the inner cover 303, further improving the independence and stability of the entire filling chamber sealing and fixing system.

[0091] In addition, the reserved gap can provide a buffer space for the thermal expansion and contraction of the inner cover 303 and the outer cover 304, avoiding the two from being squeezed and damaged due to expansion caused by temperature changes, and extending the service life of the cover and the seal. At the same time, the non-contact design can also reduce friction and wear between the inner and outer covers 304, reduce maintenance costs, and, together with the double cover, double seal and double manual fastening structure, comprehensively ensure the long-term stable operation of the filling chamber.

[0092] In one embodiment, such as Figures 17 to 19 As shown, a biopsy port 313 is provided on one side wall of the chamber 300, and the biopsy port 313 communicates with the receiving cavity 301. A sealing member 312 is provided inside the biopsy port 313 to keep the biopsy port 313 in a sealed state. The sealing member 312 includes a biopsy puncture part 3120. Before the biopsy needle punctures, the biopsy puncture part 3120 is a completely closed structure, thereby ensuring the sealing performance of the receiving cavity 301 inside the chamber 300. At the same time, the biopsy puncture part 3120 is configured to allow the biopsy needle to pass through, so that the biopsy needle can enter the receiving cavity 301 to perform biopsy operations on the excised organs preserved in the receiving cavity 301. Furthermore, during the puncture process, the biopsy puncture part 3120 can wrap around the outer peripheral surface of the biopsy needle, so that the biopsy puncture part 3120 and the biopsy needle have good sealing performance and prevent the external environment from contaminating the receiving cavity 301.

[0093] The ex vivo organ perfusion chamber of this application achieves significant technical advantages by providing a biopsy port 313 on at least one side wall of the chamber body 300 and configuring a sealing member 312 to seal the biopsy port 313. The sealing member 312 includes a biopsy puncture part 3120 for the biopsy needle to pass through and to seal and enclose the biopsy needle. Firstly, the specially designed biopsy port 313 provides a dedicated channel for biopsy operations during the preservation and transportation of ex vivo organs, eliminating the need to pause perfusion and fully open the chamber body 300 as in traditional methods. This effectively avoids damage to the physiological preservation environment inside the chamber body 300 and prevents organ damage caused by sudden changes in organ temperature and perfusion pressure. Firstly, the structure ensures the preservation of organ viability. Secondly, the biopsy puncture section 3120 of the sealing component 312 can achieve a sealed enclosure when the biopsy needle passes through, which not only avoids the problem of leakage of preservation fluid and the entry of outside air, but also maintains the sealed environment and stable perfusion pressure inside the chamber 300, reducing the risk of organ contamination. Thirdly, the structure takes into account both the sealing of the chamber 300 and the convenience of biopsy operation, realizing the compatibility of ex vivo organ preservation, transportation and biopsy operation. Biopsy sampling can be completed without interrupting the preservation process, meeting the clinical needs for real-time and accurate quality assessment of ex vivo organs, and providing a guarantee for the smooth performance of subsequent transplantation surgery.

[0094] In one exemplary embodiment of this application, the biopsy puncture part 3120 is made of a flexible material, such as medical-grade silicone, rubber or flexible polyurethane, which is biocompatible and has a thickness of 0.5-3mm. This ensures the flexibility of the structure and avoids insufficient sealing performance due to the material being too thin, or affecting the puncture operation of the biopsy needle due to the material being too thick.

[0095] The diameter of the biopsy puncture section 3120 is larger than the diameter of the biopsy needle, and the biopsy puncture section 3120 is configured to allow the biopsy needle to puncture into it at different positions and pass through it in different puncture directions, and the biopsy needle can be deflected within the receiving cavity 301 after passing through the biopsy puncture section 3120. Specifically, since the biopsy puncture section 3120 is made of a flexible material, it has a certain degree of deformability. When the biopsy needle punctures any area of ​​the biopsy puncture section 3120, the flexible material can adapt to the insertion of the biopsy needle and quickly rebound after puncture, tightly wrapping around the outer wall of the biopsy needle to maintain a sealed state. At the same time, the deformation characteristics of the flexible material allow the biopsy needle to be inserted at different angles of 0-90° with the surface of the biopsy puncture section 3120, achieving puncture operations in different directions without adjusting the position of the chamber 300. In addition, after the biopsy needle passes through the biopsy puncture section 3120 and enters the receiving cavity 301, it can freely deflect within a certain range with the help of the elastic support of the flexible material. This allows medical staff to flexibly adjust the puncture angle and depth of the biopsy needle according to the placement of the excised organ in the receiving cavity 301 and the target biopsy site, so as to accurately obtain the target tissue sample.

[0096] Therefore, it can be seen that by using the flexible material of the biopsy puncture section 3120 in this embodiment, the biopsy needle can be punctured at different positions and in different directions in the biopsy puncture section 3120, and can deflect within the receiving cavity 301 after puncture. This breaks the limitations of the traditional rigid puncture structure on the puncture position and direction. Medical staff can flexibly adjust the biopsy operation method according to the actual placement of the excised organ and the position of the target biopsy site. The target tissue sample can be accurately obtained without disassembling or adjusting the chamber 300 or interrupting the perfusion process, which greatly improves the convenience and accuracy of the biopsy operation.

[0097] Furthermore, the flexible biopsy puncture section 3120 can adapt to the biopsy needle during puncture, and quickly rebounds after puncture to tightly wrap around the outer wall of the biopsy needle, effectively avoiding problems such as leakage of preservation fluid and entry of outside air caused by excessive gaps in traditional puncture structures. At the same time, regardless of the position or direction of the biopsy needle puncture, the flexible material can achieve a tight fit with the biopsy needle, maintaining a sealed environment and stable perfusion pressure within the chamber 300 throughout the process, avoiding damage to the excised organ due to environmental changes, and ensuring organ viability.

[0098] In one exemplary embodiment of this application, such as Figure 18 and Figure 19 As shown, the sealing component 312 also includes an annular base 3121 and an annular clamping part 3122. The biopsy puncture part 3120 is located between the clamping part 3122 and the base 3121. The clamping part 3122 is fixedly connected to the base 3121 and applies axial pressure to the biopsy puncture part 3120. The three form a stacked assembly structure of "base 3121-biopsy puncture part 3120-clamping part 3122". The biopsy puncture part 3120 is sandwiched between the clamping part 3122 and the base 3121, and together they achieve the sealing of the biopsy port 313 and the biopsy operation.

[0099] The base 3121 is made of annular rigid biocompatible material (such as medical-grade rigid plastic or stainless steel). Its outer peripheral surface is provided with a first step 31210, and the inner peripheral surface of the biopsy port 313 is provided with a second step. The first step 31210 and the second step are axially abutted together. At the same time, the outer peripheral surface of the base 3121 is sealed with the inner peripheral surface of the biopsy port 313 by means of sealing ring, interference fit, sealant, etc. The inner peripheral surface is provided with a third step 31211. The biopsy puncture part 3120 is located inside the base 3121, and its inner end face abuts against the end face of the third step 31211, thereby preventing the biopsy puncture part 3120 from shifting. The clamping part 3122 is a ring-shaped structure, made of the same material as the base 3121. It is connected to the base 3121 by means of detachable means such as threads and snaps. After assembly, part of it is located inside the base 3121 and abuts against the outer end face of the biopsy puncture part 3120, thereby applying uniform axial pressure to the biopsy puncture part 3120 to ensure that it is firmly fixed and reliably sealed.

[0100] In this embodiment, the first stepped portion 31210 of the base 3121 and the second stepped portion of the biopsy port 313 are axially abutted and positioned. This, combined with the sealing between the base 3121 and the biopsy port 313, the secondary seal formed by the pressing portion 3122 pressing the biopsy puncture portion 3120, and the rebound of the biopsy puncture portion 3120 after puncture to wrap around the needle body, prevents leakage of the preservation fluid and maintains environmental stability in the chamber 300. Furthermore, the biopsy puncture portion 3120 is firmly positioned to prevent displacement during puncture, and its flexible characteristics enhance the stability and accuracy of the biopsy operation.

[0101] In one exemplary embodiment of this application, such as Figure 19 As shown, the biopsy puncture section 3120 includes an axially protruding section 31200 extending inward along the axial direction. The inner end face of the axially protruding section 31200 is located outside the inner end face of the base 3121. The axially protruding section 31200 has a biopsy channel 31201 for the biopsy needle to pass through. The biopsy channel 31201 is flared from the outside to the inside, which facilitates the deflection of the biopsy needle after passing through the biopsy channel 31201. The diameter of the biopsy channel 31201 is larger than the diameter of the biopsy needle.

[0102] Specifically, the axial protrusion 31200 is integrally formed with the main body of the biopsy puncture section 3120 and uses the same flexible biocompatible material (such as medical-grade silicone or rubber) as the biopsy puncture section 3120. The axial protrusion 31200 extends axially inward along the inner end face of the base 3121, with its inner end face located outside the inner end face of the base 3121. The core function of this design is that when the biopsy needle deflects as it passes through the biopsy channel 31201, the axial protrusion 31200 can block the biopsy needle from making hard contact with the base 3121, preventing wear on the biopsy needle or scratches on the base 3121. Furthermore, the axial protrusion 31200 can mate with the inner circumferential surface of the base 3121, facilitating the positioning of the biopsy puncture section 3120 during installation.

[0103] In one exemplary embodiment of this application, such as Figure 18 and Figure 19As shown, the base 3121 has a screw-in groove 31212 on its circumferential side, and the outer circumferential surface of the clamping part 3122 has a screw-in protrusion 31220. The screw-in protrusion 31220 is configured to move axially and engage with the screw-in groove 31212, then rotate circumferentially and lock, thus completing the detachable and fixed connection between the base 3121 and the clamping part 3122, thereby clamping and fixing the biopsy puncture part 3120. Furthermore, the base 3121 and the biopsy puncture part 3120 are circumferentially interference-fitted, meaning the diameter of the biopsy puncture part 3120 is larger than the diameter of the mounting surface on the base 3121 used to install the biopsy puncture part 3120; specifically, the diameter difference can be 1-5 mm. This configuration increases the fit between the base 3121 and the biopsy puncture part 3120 circumferential wall to prevent leakage. Furthermore, after the rigid clamping part 3122 is assembled, the clamping part 3122 applies an inward squeezing force to the biopsy puncture part 3120. When the puncture needle is pulled out, this squeezing force enables the flexible biopsy puncture part 3120 to quickly close the puncture hole, preventing leakage after the puncture needle is pulled out.

[0104] In one exemplary embodiment of this application, the engagement groove 31212 is provided with a locking groove 31213 recessed towards the axially outer side of the base 3121 at its circumferential end. The engagement protrusion 31220 is configured to at least partially engage in the locking groove 31213 under the squeezing force of the biopsy puncture part 3120, thereby achieving a stable lock between the base 3121 and the clamping part 3122 and preventing circumferential loosening of the two.

[0105] Furthermore, in one exemplary embodiment of this application, such as Figure 18 As shown, the outer end face of the clamping part 3122 is provided with an operating protrusion 31221 for operation. The operating protrusion 31221 is integrally formed with the clamping part 3122 and is made of the same hard biocompatible material as the clamping part 3122. Its shape is designed to be easy to hold or operate with the help of tools, so that medical staff can rotate the clamping part 3122 to achieve screw-locking with the base 3121.

[0106] Specifically, after the engagement protrusion 31220 moves axially and engages with the engagement groove 31212, the clamping part 3122 is rotated, causing the engagement protrusion 31220 to move circumferentially along the engagement groove 31212 until the engagement protrusion 31220 reaches the locking groove 31213 at the end of the engagement groove 31212. At this time, the biopsy puncture part 3120 is clamped and generates a squeezing force. This squeezing force acts in the opposite direction on the clamping part 3122, pushing the engagement protrusion 31220 to at least partially engage with the locking groove 31213, forming a circumferential limit, preventing the clamping part 3122 from rotating relative to the base 3121, and ensuring that the two are firmly locked. During operation, by holding or rotating the protrusion 31221 with the help of a tool, the clamping part 3122 can be rotated to separate the engagement protrusion 31220 from the locking groove 31213, thus completing the disassembly.

[0107] This application achieves initial fixation through the engagement of the screw-in protrusion 31220 and the screw-in groove 31212, while the locking groove 31213 engages with the screw-in protrusion 31220. Combined with the compressive force of the biopsy puncture part 3120, this effectively prevents circumferential loosening of the base 3121 and the clamping part 3122, ensuring stable axial pressure on the biopsy puncture part 3120 and guaranteeing sealing performance. The operating protrusion 31221 allows medical personnel to quickly rotate the clamping part 3122, enabling rapid assembly and disassembly of the base 3121 and the clamping part 3122 without the need for complex tools, thus improving operational efficiency and meeting the needs of convenient clinical use.

[0108] In one embodiment, the organ compartment is provided with an organ tray 8, which includes, for example... Figure 20 The tray body 82 shown is made of a biocompatible, rigid, and non-deformable material, preferably medical-grade polytetrafluoroethylene or medical-grade stainless steel. This material is non-toxic and will not damage the isolated liver organoid, while possessing sufficient structural strength to stably support the weight of the organ and prevent tray deformation from affecting the support effect. The tray body 82 has a circular or square structure, and its size is adapted to the standard size of isolated liver organoids, ensuring both support stability and easy placement into the isolated organ perfusion device.

[0109] The upper surface of the tray body 82 is provided with a recessed support surface 80. The support surface 80 is an arc-shaped recessed structure adapted to the outline of the isolated liver organoid. Its curvature is precisely designed to fit the natural curvature of the isolated liver. The recess depth is 3-5cm, ensuring that the liver organoid can fully contact the support surface 80 after placement, achieving a close fit support. The surface of the support surface 80 is polished, with a roughness Ra≤0.8μm, ensuring a smooth and burr-free surface, further avoiding scratch damage to the soft organ surface.

[0110] The area of ​​the supporting surface 80 that contacts the surface of the isolated liver organoid is a solid supporting surface without openings 86. This solid supporting surface is the core area of ​​the supporting surface 80, and its coverage area matches the bottom contact area of ​​the isolated liver organoid, typically accounting for 60%-70% of the total area of ​​the supporting surface 80. This ensures that the organ receives sufficient support while avoiding uneven local stress. Because this area is a complete solid structure without any openings 86, the surface of the liver organoid only contacts the smooth solid surface, completely eliminating the local pressure concentration caused by the edges of openings 86 in the prior art, thus protecting the integrity of the organ's surface and internal tissue structure.

[0111] The tray body 82 has openings 86 outside the area where the supporting curved surface 80 contacts the excised organ. Specifically, the openings 86 are only located in the non-contact area of ​​the supporting curved surface 80 and the edge area of ​​the tray body 82. The openings 86 do not affect the supporting function of the solid support surface. The openings 86 are circular through holes with a diameter of 1-2 mm. The openings 86 are evenly distributed in an array with a spacing of 3-5 mm. This size design ensures smooth flow of perfusion fluid and blood, facilitating the exchange of substances between the excised liver organoid and the external environment, while also preventing the openings 86 from being too large, which would reduce the structural strength of the tray, and preventing excessively fast perfusion fluid flow from impacting the organ.

[0112] When using the organ tray of this embodiment, such as Figure 21 As shown, the tray body 82 is first placed in the designated position in the organ compartment, and then the isolated liver organoid is gently placed on the solid support surface of the support curved surface 80. Since the support curved surface 80 fits the contour of the liver, the organ can be placed stably with uniform force and without excessive deformation. During the perfusion process, the perfusion fluid and blood flow smoothly through the opening 86 on the tray body 82 to complete the perfusion of the organ. At the same time, since the organ only contacts the solid support surface and does not contact the edge of the opening 86, local pressure concentration is effectively avoided, reducing damage to the organ.

[0113] In one exemplary embodiment of this application, the location of the opening 86 can be flexibly adjusted to better adapt to the perfusion requirements: at least some of the openings 86 are located on the supporting curved surface 80 and close to the edge of the supporting curved surface 80, and the openings 86 are distributed circumferentially along the supporting curved surface 80. This arrangement allows the perfusion fluid to form a uniform circulation at the edge of the supporting curved surface 80, avoiding the accumulation of perfusion fluid in the supporting curved surface 80, which would cause the perfusion fluid to soak the organ for a long time and thus damage the organ; at the same time, at least some of the openings 86 are located in the part of the tray body 82 outside the supporting curved surface 80, further expanding the circulation range of the perfusion fluid and blood and improving the efficiency of material exchange.

[0114] In one implementation, such as Figure 20 As shown, the tray body 82 is square, the supporting curved surface 80 is circular, and the openings outside the supporting curved surface 80 are located in the four corner areas 821 of the tray body. The corner areas 821 have a downward tilt angle, for example, tilted downward by 1-3°, so that the injection fluid located in the corner areas 821 can flow outward along the tilt of the corner areas 821, and prevent the injection fluid from flowing back into the supporting curved surface 80.

[0115] In one exemplary embodiment of this application, the lower surface of the tray body 82 is provided with a protruding bottom curved surface, which corresponds to the support curved surface 80. This structural design can reduce the thickness of the tray body 82, while the bottom curved surface can guide the injection liquid to form an orderly backflow under the tray, thereby improving the injection circulation effect.

[0116] To achieve precise positioning of the pallet body 82 within the filling chamber and prevent pallet displacement during filling from affecting support and filling effect, in one exemplary embodiment of this application, such as Figure 22 As shown, the bottom surface of the tray body 82 is provided with a first positioning part 89, which is used to cooperate with a second positioning part inside the ex vivo organ perfusion chamber to position the tray body 82. Specifically, when the tray body 82 is square, the first positioning part 89 is located outside the bottom curved surface 81 to avoid interference between the bottom curved surface 81 and the positioning structure. Furthermore, the first positioning part 89 includes a positioning protrusion, and the second positioning part that cooperates with the positioning protrusion is a positioning groove. The cooperation between the protrusion and the groove provides precise positioning, convenient assembly, and effectively limits the horizontal displacement of the tray body 82.

[0117] In one exemplary embodiment of this application, such as Figure 20 As shown, a notch 820 is provided on one side of the tray body 82. The notch 820 is used to prevent interference between the tray body 82 and the perfusion interface when the tray body 82 is assembled into the organ perfusion chamber, ensuring that the size of the tray body 82 can be as close as possible to the size of the perfusion chamber, and ensuring smooth connection between the perfusion tubing and the organ, thus improving assembly convenience.

[0118] In one embodiment, such as Figure 21 As shown, the tray body 82 is horizontally positioned within the receiving cavity 301. The edge of the tray body 82 is close to the inner wall of the receiving cavity 301 of the storage body 300, dividing the receiving cavity 301 into two interconnected chambers—the upper chamber 3010 and the lower chamber 3011. The upper chamber 3010 is used to place excised organs (such as liver, kidney, etc.). Several connecting holes are provided on the tray body 82 to connect the upper chamber 3010 and the lower chamber 3011. The infusion inlet is provided corresponding to the upper chamber 3010, and the infusion outlet 311 is provided corresponding to the lower chamber 3011.

[0119] The first surge protector 9 is located in the lower chamber 3011. A connecting slot 10 is opened on the left and right side walls of the lower chamber 3011 along the vertical direction. The size of the connecting slot 10 matches the end size of the first surge protector 9. The slot depth is 5-8mm. The two ends of the first surge protector 9 are inserted into the corresponding connecting slot 10 to achieve a plug-in fit, which facilitates the installation and disassembly of the first surge protector 9.

[0120] Two first surge protectors 9 are arranged at intervals along the flow direction of the injection fluid (from the connecting hole of the upper chamber 3010 to the injection outlet 311). The two first surge protectors 9 divide the lower chamber 3011 into a first chamber 30110, a second chamber 30111, and a third chamber 30112 in sequence. The injection outlet 311 is located in the first chamber 30110, and the connecting hole of the upper chamber 3010 is set to correspond to the third chamber 30112, realizing multi-stage energy dissipation of surges. When the injection fluid in the lower chamber 3011 fluctuates, the injection fluid can be dissipated a second time under the double blocking effect of the first surge protectors 9, which can completely weaken the surge kinetic energy and prevent the injection fluid from forming liquid surface oscillations. Compared with a single baffle, the surge protection effect is significantly improved.

[0121] The first surge protector 9 is provided with a plurality of liquid flow holes 90 for liquid flow in the lower chamber 3011. The liquid flow holes 90 include open grooves 91 at the lower end of the first surge protector 9 and closed through holes 92 in the middle and upper parts of the first surge protector 9. The open grooves 91 are evenly distributed along the width of the baffle, with 3-5 grooves and a groove depth of 10-15mm. The openings face downwards and are separated from the bottom of the lower chamber 3011. The closed through holes 92 are circular with a diameter of 3-6mm and are evenly distributed on the baffle. The through holes and the open grooves 91 are staggered to ensure that the injection fluid can pass smoothly from different positions.

[0122] Specifically, the open groove 91 is located at the lower end of the partition, which can guide the injection fluid at the bottom of the lower chamber 3011 to pass slowly, avoiding the accumulation of flow at the bottom and the formation of local surges; the closed through hole 92 is located in the middle and upper part of the partition, which can disperse the high-speed injection fluid flowing in from the upper chamber 3010, and achieve the layered energy dissipation effect of "dispersing high-speed liquid flow in the upper layer and guiding low-speed accumulation in the lower layer", which can more comprehensively suppress surges at different positions and different flow velocities; at the same time, the open groove 91 is not easy to be blocked, and the closed through hole 92 is staggered with the groove to ensure smooth flow of injection fluid, avoid pressure increase and new surges caused by blockage, and adapt to different injection flow scenarios.

[0123] The lower surface of the tray body 82 protrudes towards the bottom of the lower chamber 3011 and is close to the upper surface of the first surge shield 9 on the side near the third chamber 30112, with a gap of 5-10mm between them. The lower surface of the tray body 82 is a protruding bottom curved surface 81, which is arc-shaped and gradually increases in height from the edge to the center. The center of the bottom curved surface 81 corresponds to the second chamber 30111. The material of the bottom curved surface 81 is the same as that of the tray body 82, and the surface is smooth. At the same time, the upper surface of the tray body 82 is provided with a recessed support curved surface 80, which is used to contact the surface of the excised organ. The support curved surface 80 corresponds vertically to the bottom curved surface 81, adapting to the shape of the excised organ and improving the stability of the organ placement.

[0124] In addition, the bottom curved surface 81 is arc-shaped, which can evenly distribute the injection fluid along the curved surface, avoiding the concentrated impact of fluid flow on the baffle caused by the flat bulge, and reducing local surges; such as Figure 21 As shown, the center of the bottom curved surface 81 corresponds to the second chamber 30111, and the lower end is close to the first surge protector 9, thereby shortening the distance between the bottom surface of the tray body 82 and the first surge protector 9. This makes it easier for the injection fluid in the chamber formed by the separation of the first surge protector 9 to be blocked by the bottom surface of the tray body 82, making the flow of the injection fluid smoother.

[0125] The second surge protector 11 is located in the second chamber 30111 and the third chamber 30112, arranged in a crisscross pattern. The height of the second surge protector 11 in the second chamber 30111 is less than the height of the first surge protector 9. The height of the second surge protector 11 in the third chamber 30112 is less than or equal to the height of the first surge protector 9. Furthermore, the heights of the longitudinal and transverse second surge protectors 11 in the third chamber 30112 are different, which further optimizes the flow field in the lower chamber 3011 and enhances the surge protection effect.

[0126] Specifically, such as Figure 22 As shown, the crisscrossing second surge protection baffles 11 in the second chamber 30111 and the third chamber 30112 can further divide the liquid flow and dissipate surge kinetic energy. The height of the second surge protection baffle 11 in the second chamber 30111 is less than that of the first surge protection baffle 9, which can guide the liquid flow to transition smoothly and avoid sudden changes in the liquid flow. The height of the longitudinal and transverse second surge protection baffles 11 in the third chamber 30112 is different, which can break the regular flow of the liquid flow, further weaken the surge, make the flow field in the lower chamber 3011 more uniform, and thus ensure the stability of the injection environment in the upper chamber 3010.

[0127] In one embodiment, the second surge protection baffles 11 crisscrossing in the second chamber 30111 are cross-shaped and integrally formed with the chamber body 300. The second surge protection baffles 11 crisscrossing in the third chamber 30112 are T-shaped and are two sets symmetrically distributed.

[0128] In one embodiment, such as Figure 20As shown, the edge of the tray body 82 is provided with a first infusion pipeline constraint member 83, which is seamlessly connected to the tray body 82. It includes a first part 830 extending along a first direction (i.e., vertical) and a second part 831 extending along a second direction. The second direction is set at an angle to the first direction, and the angle is greater than 90°. This angle design can adapt to the extension path of the infusion pipeline from the top or side of the chamber to the organ, avoiding poor flow caused by the pipeline due to the small bending angle. The second part 831 is provided with a first constraint hole 832. The diameter of the first constraint hole 832 is adapted to the outer diameter of commonly used infusion pipelines, usually 2-8mm. It can be designed with different sizes according to the actual pipeline specifications, or set as an adjustable hole diameter structure. It is configured for two usage methods: one is to allow the infusion pipeline to pass through directly, and limit the pipeline through the hole wall; the other is to allow the suspension components (such as hooks, rings, hanging lines, etc.) of the infusion pipeline to pass through, realizing the suspension constraint of the pipeline. The usage method can be flexibly selected according to the arrangement height of the infusion pipeline.

[0129] Furthermore, the height of the first part 830 is close to the depth of the ex vivo organ perfusion chamber, with a difference of no more than 5mm. This ensures that the first part 830 can extend to near the top of the chamber 300, providing sufficient vertical support for the tubing. Simultaneously, it increases the distance between the second part 831 and the tray body 82, preventing the second part 831 from contacting the ex vivo organ placed on the tray body 82. Moreover, the second direction is set towards the inside of the tray body 82, allowing the constrained perfusion tubing to extend towards the organ at the center of the tray body 82. This shortens the distance between the tubing and the organ's vascular interface, facilitating precise docking and reducing redundant tubing length within the chamber, further preventing tubing entanglement. Additionally, with the second direction facing inwards towards the tray body 82, the second part 831 does not encroach on space outside the tray body 82, allowing the dimensions of the tray body 82 to be as close as possible to the dimensions of the organ chamber, thus providing a larger support surface.

[0130] To meet the biopsy requirements during organ perfusion, a first perfusion tubing constraint 83 is positioned near the biopsy port of the ex vivo organ perfusion chamber. The first part 830 of the first perfusion tubing constraint 83 has a channel 833 for the biopsy needle to pass through. The diameter of the channel 833 is much larger than the outer diameter of commonly used biopsy needles, ensuring that the biopsy needle can be directly inserted into the chamber through the channel 833 to perform biopsy operations on the ex vivo organ on the tray body 82 without having to avoid the tubing constraint or move the organ tray. This avoids interference with the perfusion tubing during biopsy operations and improves the convenience and accuracy of biopsy operations. At the same time, the wall of the channel 833 can limit the biopsy needle to prevent it from deviating and damaging the organ or tubing.

[0131] The tray body 82 is preferably square, but can also be round, elliptical, or other shapes depending on the shape of the perfusion chamber. Each side has at least one first perfusion pipeline constraint member 83 to ensure that perfusion pipelines extending in multiple directions are effectively constrained. For example, a first perfusion pipeline constraint member 83 can be provided on each of the four sides of a square tray body 82 to achieve classified constraint of the pipelines and further improve the orderly arrangement. Simultaneously, one side of the tray body 82 has a notch 820, the size of which is adapted to the perfusion interface of the organ perfusion chamber. This notch allows the perfusion interface to pass through when the tray body 82 is assembled into the organ perfusion chamber, preventing interference between the perfusion interface and the tray body 82 and ensuring smooth assembly. The tray body 82 also has two first perfusion pipeline constraint members 83 on the side with the notch 820, located on either side of the notch 820. These two first perfusion pipeline constraint members 83 constrain the perfusion pipelines connected to the perfusion interface, allowing the pipelines to extend orderly from both sides of the notch 820 to the organ, preventing the pipelines from tangling or piling up at the perfusion interface.

[0132] To achieve graded constraints on grouting pipelines at different heights and further optimize pipeline layout, such as... Figure 20 As shown, the organ tray may also include a second infusion line constraint 84, which is located at the edge of the tray body 82 and spaced apart from the first infusion line constraint 83. The specific spacing can be flexibly adjusted according to the tray size. It includes a third part 840 extending along the first direction (vertical) and a fourth part 841 extending along the third direction. The third direction is set at an angle to the first direction and preferably opposite to the second direction to accommodate low-level pipelines extending in different directions. The height of the third part 840 is less than that of the second part 831. The ratio of the height of the first part 830 to the height of the third part 840 is preferably 1:0.3-0.6. For example, when the height of the first part 830 is 10cm, the height of the third part 840 is 3-6cm. This height design allows the first infusion pipeline constraint member 83 to constrain high-level infusion pipelines, such as pipelines extending from the top of the chamber, and the second infusion pipeline constraint member 84 to constrain low-level infusion pipelines, such as pipelines near the tray surface and connected to the blood vessels at the bottom of the organ. This achieves a layered arrangement of high and low-level pipelines and completely eliminates entanglement and interference between pipelines of different heights. The fourth part 841 is provided with a second constraint hole. The structure and size of the second constraint hole are the same as those of the first constraint hole 832. It is configured to allow the low-level infusion pipelines to pass directly or to allow the suspension members that suspend the low-level infusion pipelines to pass through, ensuring the stable constraint of the low-level pipelines. At the same time, it cooperates with the first infusion pipeline constraint member 83 to achieve an orderly arrangement of all pipelines in the chamber.

[0133] In addition, since the height of the third part 840 is much lower than the height of the first part 830, the fourth part 841 will be closer to the tray body 82. Therefore, in order to avoid the fourth part 841 from contacting the excised organ placed on the tray body 82, the extension direction of the fourth part 841 (i.e., the third direction) is opposite to the extension direction of the second part 831 (i.e., the second direction), that is, the fourth part 841 extends outward.

[0134] In one embodiment, such as Figure 20 As shown, a fixing part 87 is provided on the first and second sides of the pallet body 82, and the first and second sides are opposite edges in the length direction of the pallet body 82. In this embodiment, the fixing part 87 includes four hanging posts 870 spaced apart along the first edge of the pallet body 82, and four hanging posts 870 are also spaced apart along the second edge, and the four hanging posts 870 on the first side correspond one-to-one with the four hanging posts 870 on the second side.

[0135] Specifically, the first and second edges of the tray body 82 are provided with hanging interfaces 88, which are vertically extending through-slot structures. Hanging posts 870 extend horizontally, with one end fixedly connected to the edge of the tray body 82 and the other end suspended. Each hanging post 870 corresponds to a hanging interface 88. The hanging post 870 is located directly above the hanging interface 88, and its lower surface is higher than the upper surface of the hanging interface 88, forming a gap for attaching flexible organ fixation components. This gap ensures the stability of the flexible organ fixation components after attachment and prevents them from falling off.

[0136] In this embodiment, the flexible organ fixation device uses sterile medical gauze. The two ends of the gauze naturally form hanging holes, which allow for detachable attachment to the hanging posts 870 on both sides. During use, the excised organ is placed on the solid support surface of the supporting curved surface 80, and then the two ends of the gauze are respectively hung on the first and second hanging posts 870. The gauze's pulling action binds and fixes the excised organ, effectively preventing shaking and displacement during transportation.

[0137] Because multiple hanging posts 870 are provided on the first and second sides of the tray body 82, the method of fixing the excised organs with gauze is relatively flexible. For example, gauze can be used to connect the hanging posts 870 on both sides in a horizontal manner, or in a diagonal manner, or in a combination of horizontal and diagonal methods.

[0138] The following is combined Figure 23 and Figure 24 The temperature control mechanism in the ex vivo organ perfusion equipment is described below: The temperature control mechanism comprises five core components: a water pump 17, a water tank 18, a thermoelectric cooler 19, a heat dissipation module 20, and a circulation pipeline 23. The specific configuration and connection relationships of each component are as follows: The water pump 17 serves as the power source for water circulation, providing stable power to the entire circulation system. The water tank 18, as the core carrier for temperature regulation, is equipped with an inlet 27 and an outlet for the inflow and outflow of circulating water, providing a stable storage space for subsequent temperature regulation. The semiconductor cooling chip 19 is fixedly installed on the outer wall of the water tank 18, directly contacting the wall of the water tank 18, and can quickly regulate the cooling or heating of the circulating water in the water tank 18. Compared with traditional cooling and heating methods, it has a faster response speed and more precise temperature control. The heat dissipation module 20 and the semiconductor... The thermoelectric cooler 19 is fixedly connected, and its core function is to dissipate heat from the thermoelectric cooler 19 in a timely manner during operation, preventing the thermoelectric cooler 19 from experiencing a decrease in cooling efficiency due to heat accumulation and ensuring the stability of temperature control. The circulation pipe 23 serves as the core connection, sequentially connecting the inlet 27, water pump 17, oxygenator, and return outlet, ultimately constructing a closed-loop water circulation system for the water tank 18, water pump 17, and the water bath heating chamber of the oxygenator. This ensures stable flow of circulating water between components, achieving uniform temperature transfer and compensation. The water circulation path is shown in [reference needed]. Figure 23 The arrow shown.

[0139] In one exemplary embodiment of this application, to further improve the monitoring accuracy and stability during the circulation process, the circulation pipeline 23 is optimized. The circulation pipeline 23 includes a first pipeline 230, a monitoring component, and a second pipeline 234 connected in sequence. The end of the first pipeline 230 away from the monitoring component is fixedly connected to the outlet of the water pump 17, used to transport the circulating water output by the water pump 17 to the monitoring component. The end of the second pipeline 234 away from the monitoring component is used to connect to the heat exchange water inlet of the oxygenator, transporting the monitored circulating water to the water bath heating chamber of the oxygenator. The monitoring component specifically includes a three-way connector 231, an integrated flow and temperature sensor 233, and a first pressure sensor 232. The connection relationship among the three is as follows: one end of the three-way connector 231 is fixedly connected to the end of the first pipeline 230 away from the water pump 17, one end is connected to one end of the integrated flow and temperature sensor 233, the other end is fixedly connected to the first pressure sensor 232, and the other end of the integrated flow and temperature sensor 233 is connected to the second pipeline 234.

[0140] With this setup, the circulation pipeline 23 is divided into a first pipeline 230, a monitoring component, and a second pipeline 234, achieving segmented coordination between water delivery and monitoring, and avoiding interference from the monitoring component with water flow stability. The tee connector 231 eliminates the need for additional pipelines to achieve synchronous monitoring of flow, temperature, and pressure, simplifying the pipeline structure. The integrated flow and temperature sensor 233 can capture the flow and temperature data of the circulating water in real time, while the first pressure sensor 232 monitors the pipeline pressure in real time. The combination of these two sensors can promptly detect abnormal flow (such as insufficient flow leading to untimely temperature compensation, or excessive flow leading to increased temperature loss), temperature deviation (such as deviation from the set physiological temperature), and abnormal pressure (such as pipeline blockage leading to excessive pressure). Based on the monitoring data, staff can quickly adjust parameters such as the speed of the water pump 17 and the working status of the semiconductor cooling chip 19 to avoid abnormal situations affecting the temperature control effect, thereby preventing damage to ex vivo organs due to abnormal temperature, flow, and pressure, and ultimately improving temperature control stability and organ perfusion safety.

[0141] In one exemplary embodiment of this application, the specific structure of the heat dissipation module 20 is optimized to improve heat dissipation efficiency. The heat dissipation module 20 includes heat dissipation fins 21 and a centrifugal cooling fan 22. One side of the heat dissipation fins 21 is tightly attached to the surface of the thermoelectric cooler 19, and the other side is tightly attached to the centrifugal cooling fan 22. The heat generated by the thermoelectric cooler 19 during operation can be quickly conducted to the heat dissipation fins 21. The heat dissipation fins 21 increase the contact area for heat dissipation. Combined with the forced heat dissipation effect of the centrifugal cooling fan 22, the heat can be quickly dissipated to the external environment, effectively preventing the thermoelectric cooler 19 from overheating, ensuring its cooling or heating efficiency is stable, and thus ensuring the temperature control stability of the entire temperature control mechanism.

[0142] In one exemplary embodiment of this application, to improve the uniformity and efficiency of temperature regulation, semiconductor cooling chips 19 are disposed on opposite sides of the water tank 18. The semiconductor cooling chips 19 on both sides can work synchronously, cooling or heating the internal circulating water from both sides of the water tank 18 simultaneously, avoiding the problem of uneven temperature distribution in the water tank 18 caused by setting only one side, so that the circulating water temperature can quickly reach the set value and the temperature distribution is more uniform, further improving the accuracy of temperature control.

[0143] In one exemplary embodiment of this application, to enhance the heat transfer efficiency between the thermoelectric cooler 19 and the water tank 18, a thinning groove is provided on the outer wall of the water tank 18. The thermoelectric cooler 19 is embedded in the thinning groove, and the surface of the thermoelectric cooler 19 is in close contact with the inner wall of the thinning groove. The thinning groove reduces the thickness of the corresponding position of the water tank 18 wall, allowing the cooling or heating generated by the thermoelectric cooler 19 to be transferred to the circulating water inside the water tank 18 more quickly, reducing heat loss and improving the response speed and efficiency of temperature regulation.

[0144] In one exemplary embodiment of this application, to ensure the safe and stable operation of the water tank 18, the temperature control mechanism further includes a water tank level gauge 24. The water tank level gauge 24 is electrically connected to an external control module and is configured to detect the liquid level in the water tank 18 in real time and transmit the detected liquid level information to the control module in the form of an electrical signal. When the liquid level in the water tank 18 is lower than or higher than a set threshold, the control module can promptly issue a warning signal to remind staff to add circulating water or drain excess circulating water, thus preventing damage to the water pump 17 due to abnormal liquid level or damage to the equipment due to overflow of circulating water, thereby improving the safety and reliability of the equipment.

[0145] In one exemplary embodiment of this application, to facilitate workers' direct observation of the liquid level in the water tank 18, the temperature control mechanism further includes a transparent liquid level tube 28. The transparent liquid level tube 28 is vertically fixed to one side of the water tank 18, and its upper and lower ends are respectively sealed to the bottom and top of the water tank 18 via connectors. The transparent liquid level tube 28 and the water tank 18 form a communicating vessel structure, and the liquid level in the water tank 18 can be directly displayed through the transparent liquid level tube 28. Workers can quickly grasp the liquid level status without disassembling the equipment, making operation more convenient.

[0146] In an exemplary embodiment of this application, in order to achieve real-time monitoring and precise control of the circulating water temperature in the water tank 18, the temperature control mechanism further includes an internal water tank temperature sensor 29. The internal water tank temperature sensor 29 is embedded inside the water tank 18 and is used to detect the temperature of the circulating water in the water tank 18 in real time and transmit the temperature signal to the control module. The control module automatically adjusts the working state of the semiconductor cooling chip 19 according to the detected temperature signal to achieve precise control of the circulating water temperature and ensure that the circulating water temperature is stable within the physiological range required by the excised organ.

[0147] In one exemplary embodiment of this application, the structure of the water tank 18 is further optimized. The top of the water tank 18 is provided with a water inlet 25, through which the operator can add circulating water to the water tank 18. A balance valve 26 is sealed on the water inlet 25. The core function of the balance valve 26 is to balance the air pressure inside and outside the water tank 18, so as to avoid the air pressure difference caused by the temperature change of the circulating water in the water tank 18, which could lead to deformation of the water tank 18 or obstruction of the circulating water flow. At the same time, a baffle plate is fixedly provided inside the water tank 18. The baffle plate can effectively slow down the flow speed of the circulating water in the water tank 18, avoid uneven temperature caused by violent water flow fluctuations, and reduce the damage of water flow impact to the internal structure of the water tank 18, further ensuring the stability of temperature control.

[0148] Other embodiments of this application will readily conceive of by those skilled in the art upon consideration of the specification and practice of the embodiments thereof. This application is intended to cover any variations, uses, or adaptations of this application that follow the general principles of this application and include common knowledge or customary techniques in the art not claimed in this application. The specification and embodiments are to be considered exemplary only, and the true scope and spirit of this application are indicated by the appended claims.

Claims

1. An apparatus for perfusion of an organ ex vivo, characterized in that, include: The main body of the equipment is internally divided into an upper installation compartment and a lower temperature control compartment. The consumable module is detachably mounted vertically in the installation compartment via a quick-release structure and supported by the upper end face of the main body of the device. After installation, it is locked by a locking structure. The consumable module includes an installation frame, an organ compartment, an oxygenator, a filter plug, a detection sensor, an infusion pump, and an infusion pipeline. The upper part of the mounting frame is provided with an organ compartment mounting groove adapted to the shape of the organ compartment, and the organ compartment is placed in the organ compartment mounting groove; the oxygenator is supported by the bottom of the mounting frame and fixed by the side wall of the mounting frame, and the filter plug is fixed to the side wall of the mounting frame; both the oxygenator and the filter plug are located at the lower part of the organ compartment; the detection sensor is fixed to the upper end face of the mounting frame and is used to detect the data of the perfusion fluid in the perfusion pipeline; the perfusion pump, the oxygenator, the organ compartment, and the filter plug form a perfusion fluid circulation loop through the perfusion pipeline; A temperature control mechanism is located inside the temperature control chamber. The temperature control mechanism includes a heat exchange water tank and a temperature control component. The temperature control component is used to control the water temperature in the heat exchange water tank. The heat exchange water tank is connected to the water bath heating chamber of the oxygenator via a quick-release connector so that it can be quickly and synchronously disconnected with the consumable module.

2. The isolated organ perfusion apparatus according to claim 1, characterized in that, The infusion tubing includes an arterial infusion tubing, a venous infusion tubing, a first branch connected to the outlet of the infusion pump, and a second branch connected to the outlet of the oxygenator. The first branch includes two branches, one of which is connected to the inlet of the oxygenator. The second branch includes two branches, one of which is connected to the arterial perfusion tube, which is connected to the arterial perfusion end of the organ compartment. The other branch of the first and second branches is connected in parallel to the venous perfusion tube, which is connected to the venous perfusion end of the organ compartment.

3. The isolated organ perfusion apparatus according to claim 2, characterized in that, It also includes an injection tube connected to the filter plug, the injection tube having two or more injection ports configured for injecting the required medication.

4. The ex vivo organ perfusion device according to claim 3, characterized in that, The mounting frame includes a top plate, a bottom plate, and a side plate. The top plate is provided with the mounting groove, and the detection sensor is located on the top plate and outside the mounting groove. The base plate is provided with a support seat, the side plate is provided with an oxygenator fixing clamp, and the oxygenator is located on the support seat and fixed by the oxygenator fixing clamp; The side plate is also provided with a filter plug fixing plate. The filter plug fixing plate is provided with two arc-shaped fixing grooves. The lower end of the filter plug is provided with a fixing pin. The fixing pin is used to vertically insert and cooperate with the arc-shaped fixing grooves and slide circumferentially to a fixed position to fix the filter plug.

5. The ex vivo organ perfusion device according to claim 4, characterized in that, The side plate is also provided with an irrigation device fixing buckle and a measuring cylinder fixing buckle. The irrigation device fixing buckle is used to fix the irrigation device. The measuring cylinder fixing buckle is used to fix the measuring cylinder. The consumables module also includes a dialyzer. The first side edge of the top plate is provided with a dialyzer fixing buckle and a liquid injection tube fixing buckle. The dialyzer is fixed to the dialyzer fixing buckle, and the liquid injection tube is fixed to the liquid injection tube fixing buckle. The second side edge of the top plate is provided with a pressure sensor fixing buckle, and two pressure sensors are fixed in the pressure sensor fixing buckle. The two pressure sensors are respectively connected to the venous infusion tube and the arterial infusion tube through pipelines to detect the pressure of the infusion fluid.

6. The ex vivo organ perfusion device according to claim 1, characterized in that, The mounting bracket is provided with a sensor mounting slot in the horizontal direction, and the side of the detection sensor is provided with a horizontally extending sensor mounting part, which is inserted into the sensor mounting slot in the horizontal direction. The bottom of the detection sensor is provided with a first fixing part, and the mounting bracket is provided with a second fixing part. The first fixing part and the second fixing part are configured to cooperate with each other during the insertion of the sensor mounting part into the sensor mounting slot and apply an upward pressure to the detection sensor using elasticity, so that the sensor mounting part and the upper end of the sensor mounting slot abut against each other in the vertical direction.

7. The ex vivo organ perfusion device according to claim 6, characterized in that, The first fixing part includes a mating groove provided at the bottom of the detection sensor, and the extending direction of the mating groove is parallel to the extending direction of the sensor mounting groove; The second fixing part includes an elastic element and a top ball disposed in the mounting frame. The upper part of the top ball extends out of the upper end face of the mounting frame. When the sensor mounting part is inserted into the sensor mounting groove in the horizontal direction, the top ball compresses the elastic element and is stuck into the mating groove, and applies an upward pressure to the mating groove under the elastic force of the elastic element. The mating groove includes a first groove segment and a second groove segment arranged sequentially along the insertion direction, wherein the depth of the first groove segment is greater than the depth of the second groove segment. The first groove is configured to engage with the top bead to guide the detection sensor to move along a preset direction and apply a vertical first pressure to the detection sensor; The second groove is configured to engage with the top bead to position the detection sensor in a preset installation position and apply a vertical second pressure to the detection sensor, the second pressure being greater than the first pressure.

8. The ex vivo organ perfusion device according to claim 1, characterized in that, The temperature control mechanism includes: Water pump; The water tank is equipped with an inlet and an outlet. A semiconductor cooling chip is disposed on the outer wall of the water tank; A heat dissipation module is connected to the thermoelectric cooler and is used to dissipate heat from the thermoelectric cooler. A circulation pipeline is used to connect the water inlet, the water pump, the oxygenator, and the return water inlet, and to construct a water circulation system for the water tank, the water pump, and the water bath heating chamber of the oxygenator.

9. The ex vivo organ perfusion device according to claim 8, characterized in that, The circulation pipeline includes a first return water path and a first pipeline, a monitoring component, and a second pipeline connected in sequence. The first pipeline is connected to the outlet of the water pump, and the first return water path is connected to the return water inlet. The monitoring component includes a tee connector, an integrated flow and temperature sensor, and a first pressure sensor; one end of the tee connector is connected to the first pipeline, one end is connected to the integrated flow and temperature sensor, and the other end is connected to the first pressure sensor; the integrated flow and temperature sensor is connected to the second pipeline. The inlet and outlet of the water bath heating chamber in the oxygenator are respectively connected to the third pipeline and the second return water pipeline. The first return water pipeline and the second pipeline are connected to the first quick-release connector, and the third pipeline and the second return water pipeline are connected to the second quick-release connector. The first quick-release connector and the second quick-release connector are quickly disassembled by plugging in.

10. The ex vivo organ perfusion device according to claim 9, characterized in that, The temperature control mechanism also includes: The water tank level gauge is used to be electrically connected to the control module and is configured to transmit the detected water tank level to the control module as an electrical signal. A transparent liquid level tube is vertically installed on one side of the water tank, and the upper and lower ends of the transparent liquid level tube are respectively connected to the bottom and top of the water tank through connectors; An internal temperature sensor for the water tank is used to detect the temperature of the circulating water inside the tank.

11. The ex vivo organ perfusion device according to claim 1, characterized in that, The organ compartment includes: The chamber is equipped with a receiving cavity for accommodating excised organs, and an infusion inlet and an infusion outlet for connecting the infusion tubing; The tray body is located inside the chamber. The upper surface is provided with a recessed support surface. The support surface is used to contact the surface of the isolated organ to support the isolated organ. The area of ​​the support surface that contacts the surface of the isolated organ is a solid support surface without openings. The portion of the tray body outside the area of ​​the support surface that contacts the isolated organ is provided with openings for the flow of perfusion fluid and blood.

12. The ex vivo organ perfusion device according to claim 11, characterized in that, The tray body divides the receiving cavity into an upper chamber and a lower chamber. The upper chamber is used to receive the excised organ. The upper chamber and the lower chamber are connected. The infusion inlet is located in the upper chamber, and the infusion outlet is located in the lower chamber. The lower chamber is provided with a first surge protection baffle, the two ends of which are respectively connected to the two side walls of the lower chamber, and the first surge protection baffle is provided with a plurality of liquid flow holes for liquid flow in the lower chamber. The lower surface of the tray body protrudes toward the bottom of the lower chamber and is close to the upper surface of the first surge protector.

13. The ex vivo organ perfusion device according to claim 11, characterized in that, The edge of the tray body is provided with a first injection pipeline constraint member. The first injection pipeline constraint member includes a first part extending along a first direction and a second part extending along a second direction. The first direction is vertical, and the second direction is set at an angle to the first direction. The second part is provided with a first constraint hole. The first constraint hole is configured to allow the injection pipeline to pass through or to allow the suspension member of the injection pipeline to pass through.

14. The ex vivo organ perfusion device according to claim 13, characterized in that, The tray body has a fixing part on the first side and the second side, which are opposite sides of the tray body. The fixing part on one side is used to detachably connect to the first end of the flexible organ fixation member, and the fixing part on the other side is used to detachably connect to the second end of the flexible organ fixation member. The flexible organ fixation member passes through the upper surface of the excised organ and fixes the excised organ.

15. The ex vivo organ perfusion device according to claim 11, characterized in that, The organ compartment also includes: The inner cover is connected to the compartment body in an opening and closing manner to open and close the receiving cavity; A first sealing element is disposed between the inner cover and the chamber body; The first fastener is used to secure the inner cover and the compartment body; An outer cover is cladly connected to the compartment body, and the outer cover is located outside the inner cover; A second sealing element is disposed between the outer cover and the chamber body; The second fastener is used to secure the outer cover and the compartment body.

16. The ex vivo organ perfusion device according to claim 11, characterized in that, The chamber has a biopsy port on at least one side wall, and the biopsy port is provided with a sealing element. The sealing element includes a biopsy puncture part through which the biopsy needle passes and is sealed and wrapped around the biopsy needle. The biopsy puncture section is made of a flexible material and is configured to allow the biopsy needle to puncture at different positions and pass through in different puncture directions. After passing through the biopsy puncture section, the biopsy needle can deflect within the receiving cavity.

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