WO2022166611A1

WO2022166611A1 - Warm-blooded organ transfer platform and air exhaust method

Info

Publication number: WO2022166611A1
Application number: PCT/CN2022/073083
Authority: WO
Inventors: 李平; 颜翊凡; 汪茂林; 胡华恩
Original assignee: 苏州心擎医疗技术有限公司
Priority date: 2021-02-08
Filing date: 2022-01-21
Publication date: 2022-08-11
Also published as: CN116369305A; CN114342918A; CN114342918B

Abstract

A warm-blooded organ transfer platform and an air exhaust method. The warm-blooded organ transfer platform comprises a carrying apparatus (100) and a circulation loop (200) disposed on the carrying apparatus. The circulation loop (200) comprises: an organ box (210), and a pipe assembly provided with an inlet end and an outlet end, the inlet end being configured to be connected to a donor organ. A connecting member (240) is disposed on the organ box and has a first terminal (2411) located outside the organ box and a second terminal (2422) located inside the organ box; the first terminal (2411) is used for being connected to the outlet end, and the second terminal (2422) is used for being connected to the donor organ. A power device (230) is connected to the pipe assembly and used for providing power for liquid to flow between the circulation loop (200) and the donor organ. The first terminal (2411) is provided with an air exhaust port (243) located at the position, having the highest gravitational potential energy, of the circulation loop (200).

Description

Warm-blooded organ transport platform and exhaust method

Cross-reference related references

This application requires that the patent application number is 202110182283.6, and the application date is February 8, 2021; the patent application number is 202111437435.9, and the application date is November 30, 2021; the patent application number is 202210031671.9, and the application date is January 12, 2022 The priority of the Chinese invention patent of the above-mentioned application is incorporated herein by reference.

technical field

The invention belongs to the field of medical devices, and in particular relates to a warm-blooded organ transport platform and an exhaust method.

Background technique

With the development of the extracorporeal circulation system, the transport platform technology of isolated organs in vitro has become more and more mature, and the in vitro maintenance and transport requirements for different organs have also increased. In order to maintain the activity of the donor organ, the donor organ is maintained in a normal state. The normal state means that the donor organ can maintain an independent physiological function. Take the heart, for example, which is able to keep beating. Even if the heart is located outside the donor during storage or transport, the donor organ can be maintained in the same or similar physiology as the body.

Traditional organ transport is mostly carried out by means of refrigeration, that is, cold storage, which prolongs the survival time of organs by reducing or delaying the metabolic rate of organs. However, the lack of nutrients such as blood and oxygen caused by low temperature and in vitro state, the damage to organs is sometimes irreversible.

Gradually replace the above-mentioned traditional organ transport platform in an attempt to improve a more suitable living environment for isolated organs. Indispensable among them is to provide blood perfusion to the organ during its transport. However, in the process of work, how to discharge the gas in the perfusion pipeline has always been a pain point plaguing the industry.

SUMMARY OF THE INVENTION

Therefore, the technical problem to be solved by the present invention is to provide a warm-blooded organ transport platform and an exhaust method that restores the living environment of the isolated organ in vivo as much as possible and has a good exhaust effect.

In order to solve the above-mentioned technical problems, the warm-blooded organ transport platform of the present invention comprises: a carrying device and a circulation loop arranged on the carrying device. The circulation circuit includes: an organ box for accommodating the donor organ, a pipeline assembly with an inlet end and an outlet end, a connector provided on the organ box, a blood bag, a power unit, an oxygenator, and a blood bag located on the pipeline component. Thermostat.

The inlet end of the tubing assembly is used to connect with the donor organ. The connector has a first terminal located outside the organ box and a second terminal located inside the organ box, the first terminal is used for connecting with the outlet end of the tubing assembly, and the second terminal is used for connecting with the donor organ. The blood bag has an inlet connector and an outlet connector, and the pipeline assembly includes a first flow channel connecting the outlet connector and the first terminal, and a second flow channel for connecting the inlet connector and the donor organ; the end of the first flow channel facing away from the blood bag is formed The outlet end, the end of the second flow channel facing away from the blood bag constitutes the inlet end. The power device is used to provide power for the flow of fluid between the circulatory circuit and the donor organ, the oxygenator is used to oxygenate the blood passing through, and the temperature regulating device is used to regulate the temperature of the blood passing through. The first terminal is provided with an exhaust port, and the exhaust port is located at the highest point of the gravitational potential energy of the circulation loop.

Preferably, the power unit includes a motor, a pump head removably engageable with the motor. The pump head includes a pump housing, an impeller received in the pump housing and rotatable by a motor to power the flow of the liquid. The pump casing has an inlet fitting and an outlet fitting, and the outlet fitting is higher than the inlet fitting.

Preferably, the point of intersection of the outlet joint and the pump casing is at the highest point of the gravitational potential energy of the pump casing.

Preferably, the impeller can be driven to rotate around a central axis passing through the inlet joint, the power device is inclined on the bearing device, the inlet joint is inclined upward, and the included angle between the central axis and the horizontal plane is between 5° and 85°.

Preferably, the connector includes first and second joints. The first connector is arranged on the organ box and includes a first terminal and a third terminal. The second connector is detachably engaged with the first connector, and includes a second terminal and a fourth terminal. The fourth terminal is operably plug-fitted with the third terminal, the third terminal is a female head, and the fourth terminal is a male head.

Preferably, the connector further comprises a lock nut provided on one of the third and fourth terminals for threaded connection with the other of the third and fourth terminals when the third and fourth terminals are attached together, to keep the third and fourth terminals fixed.

Preferably, the connector further includes a sealing member disposed on the inner wall of the third terminal and/or the outer wall of the fourth terminal. More preferably, the first joint penetrates through the wall of the organ box and is sealed with the wall of the organ box.

Preferably, the outer side wall of the second joint is provided with a first stopper located between the second terminal and the fourth terminal, and the first stopper is used to stop the blood vessel when the blood vessel of the donor organ is sheathed on the second terminal. Perform stop limit.

Preferably, the first stopper is provided with at least two notches, and the part of the first stopper located between the two notches forms a hooking portion for the wire to bypass.

Preferably, the hook portion is provided with a second stopper extending substantially toward the direction of the fourth terminal, and the second stopper is spaced from the outer wall of the second connector.

Preferably, the blood bag is further provided with a perfusion interface at the top and a recovery joint at the bottom, a recovery tube is arranged in the blood bag, the lower end of the recovery tube is connected to the recovery joint, and the upper end is penetrated in the perfusion interface. A drainage channel is formed between the upper end of the recovery tube and the perfusion port.

Preferably, the temperature adjustment device at least comprises a first temperature adjustment sleeve wrapped around the outer wall of the first connecting pipe part where the first flow channel is located between the oxygenator and the power unit, and a first temperature adjustment sleeve wrapped around the first flow channel between the oxygenator and the connecting piece The second temperature adjusting sleeve connected to the outer wall of the second temperature adjusting sleeve, the first temperature adjusting element arranged in the first temperature adjusting sleeve, and the second temperature adjusting element arranged in the second temperature adjusting sleeve. Preferably, the length of the first temperature adjusting sleeve is between 0.3 and 1 m, and the length of the second temperature adjusting sleeve is between 0.3 and 1 m.

Preferably, the circulation loop further includes a first detection unit, which is arranged on the pipeline assembly and located between the oxygenator and the first terminal, for detecting the flow rate and/or pressure value of the blood before entering the donor organ. The second detection unit, which is arranged on the pipeline assembly, is located between the organ box and the inlet connector, and is used to detect the flow rate and/or pressure value of the blood flowing out of the donor organ.

Further, the circulation loop further includes a first sampling unit, which is arranged on the pipeline assembly and is used for acquiring blood samples in the pipeline assembly before entering the donor organ and/or injecting medicinal liquid into the pipeline assembly. The second sampling unit, which is arranged on the pipeline assembly, is used for acquiring blood samples in the pipeline assembly after flowing out of the donor organ and/or injecting medicinal liquid into the pipeline assembly.

Preferably, the first sampling unit includes a first sampling port provided on the first flow channel and located between the oxygenator and the first terminal, a first sampling tube connecting the first sampling port and the second flow channel, The first sampling device on the sampling tube. The first sampling device at least includes a first sampling interface for sampling, and further includes a first injection interface for injecting medicinal liquid into the first sampling tube.

Preferably, the second sampling unit includes a second sampling port provided on the second flow channel and located between the organ box and the inlet joint, a second sampling pipe connecting the second sampling port and the first sampling pipe, and a second sampling port provided in the second sampling port. A second sampling device on the tube. The second sampling device includes at least one second sampling interface for sampling, and further includes a second injection interface for injecting medicinal liquid into the second sampling tube.

Preferably, the organ box includes a casing for containing the organ of the donor, and a cover assembly detachably connected to the casing. The cover assembly includes a detachable cover that covers the open end of the casing, and a wrapping member located between the cover and the casing. The package includes a hollow frame and a film provided on the frame. The frame is operatively embedded in the open end of the casing, and the membrane is operatively wrapped around the donor organ and at least partially fills the vacant space between the donor organ and the casing.

Preferably, the bottom of the inner side of the casing is provided with a flexible buffer layer.

Preferably, the carrying device includes a movable trolley and a support panel provided on the trolley. The organ box is arranged on the support panel, and the trolley forms an accommodating space under the support panel. The trolley is provided with a shroud and a top cover that is rotatably arranged on the shroud to cover the organ box operably. The edge of the support panel is provided with a blood-shielding flange extending toward the shroud. The distance between the upper end of the blood-separating flange and the lower end of the hoarding plate is not more than 5mm.

Preferably, the organ box is arranged on the support panel through a bracket, the upper surface of the bracket is inclined and has a high end and a lower end, and the organ box is arranged on the upper surface of the bracket. The lower surface of the organ box is provided with a hook and a limit bump, and the upper surface of the bracket is provided with a hook portion close to the high end and used for matching with the hook, and a hook close to the low end and used for matching with the limit bump. Matching Department. The cross section of the hook and the hook portion is in the shape of a partial arc, the hook has a degree of freedom to rotate around the hook portion, and the matching portion and the limiting projection form a friction pair.

Preferably, the upper surface of the support panel is provided with a first plug-in structure, and the lower surface of the bracket is provided with a second plug-in structure that is plug-fitted with the first plug-in structure. One of the first and second plug-in structures is configured as a card block, and the other of the two includes a slot for receiving the card block. The slot is open horizontally, and the bracket moves on the support panel after being placed on the support panel to allow the blocks to enter or move out of the slot.

Preferably, the support panel is provided with threaded holes, the bracket is provided with a notch, and the notch opens toward the installation and insertion direction, and the installation and insertion direction is the moving direction of the bracket during the process of making the card block enter the slot. The bracket is fixed to the support panel through fasteners, and the fasteners include: a screw screwed into the threaded hole and a knob arranged on the top of the screw.

Further preferably, a limit post extending downward is provided on the lower surface of the bracket at the edge of the notch, the upper surface of the support panel is recessed downward to form a limit slot for cooperating with the limit post, and the limit slot is approximately the same as the threaded hole. It is coaxially arranged and the diameter of the hole is larger than that of the threaded hole.

The venting method using the aforementioned warm-blooded organ transport platform provided by the present invention includes: before the donor organ is connected to the circulation circuit, a replacement pipeline is used to connect the inlet end and the outlet end of the pipeline assembly. The flushing fluid is perfused into the perfusion port provided on the blood bag, and the flushing fluid drives the gas in the pipeline assembly to flow forward, so that at least part of the gas is discharged from the gas outlet of the oxygenator. When the flushing fluid is at least poured into the power unit, the power unit is controlled to be turned on. Continue to prime the irrigation port with irrigation fluid until the perfusion fluid fills the circuit and replacement line.

Preferably, the blood bag also has a vent port. Before the step of filling the irrigation fluid into the filling interface, the method further includes opening the venting interface. Then, when the flushing liquid displaces the gas in the pipeline assembly and flows forward, at least part of the gas is discharged from the exhaust port.

Preferably, in the process that the flushing liquid displaces the gas in the pipeline assembly and flows forward, the flow rate of the gas discharged from the exhaust port is greater than the flow rate of the gas discharged from the gas outlet of the oxygenator.

Preferably, the step of controlling the activation of the power device includes: when it is detected that the flushing liquid reaches the pump head, controlling the activation of the motor and making the motor run intermittently.

Preferably, after the perfusate fills the circulation circuit and the replacement line to empty the gas, the method further comprises: perfusing the perfusion interface with blood to fuse the perfusate with the blood to fill the circulation circuit and the replacement line with blood.

Preferably, prior to perfusing the blood, the method further comprises: opening the inlet and/or outlet connections of the blood bag to drain part of the perfusate in the blood bag.

Preferably, after the steps of filling the circulation circuit and replacing the pipeline with blood, the method further includes: adjusting the position of the connecting piece on the organ box, so that the position of the exhaust port is adjusted to the highest position of the gravitational potential energy of the circulation circuit. Plug the inlet and outlet ends of the tubing assembly. Remove the replacement line. With the second joint separated from the first joint, the donor organ is inserted into the second terminal and the inlet end of the tubing assembly, and then the third and fourth terminals are joined, and the air mixed into the first joint during the replacement process Exhaust through the exhaust port.

The technical scheme provided by the present invention has the following advantages:

1. The principle of setting the exhaust port at the highest gravitational potential energy of the circulation loop is as follows: the density of the gas is less than that of the liquid, and the gas will automatically float up in the liquid, and the exhaust port is set at the highest gravity potential energy of the circulation loop. At this point, the gas can escape at the highest point, which facilitates the gas discharge from the circulation loop.

2. The outlet joint is higher than the inlet joint, and the intersection of the outlet joint and the pump casing is at the highest point of the gravitational potential energy of the pump casing. As a result, the gas mixed in the pump casing through the inlet joint will automatically float to the outlet joint, thereby facilitating the discharge of the gas in the pump casing.

3. Through the oxygenator, temperature adjustment device, power device, etc. set on the circulation circuit, and the pipeline components connected in series with these functional components, warm blood perfusion can be realized in organ transport, and then the isolated organ can be created as close as possible. Its living environment in vivo can reduce or even avoid the damage to organs caused by low temperature and lack of nutrients, improve the survival time of organs in vitro, and provide the possibility for long-span and long-term organ transfer and transplantation.

Description of drawings

Fig. 1 is the three-dimensional structure schematic diagram of the warm-blooded organ transport platform provided by the present invention;

Fig. 2 is the structural representation of the circulation loop in Fig. 1;

Fig. 3 is the structural representation of the connector in Fig. 1;

Fig. 4 is the exploded structure schematic diagram of Fig. 3;

Fig. 5 is the schematic diagram when the sealing member adopts side sealing in the present invention;

Fig. 6 is the schematic diagram when the sealing element adopts end face sealing in the present invention;

Fig. 7 is the schematic diagram when the power device is installed on the mobile trolley in the present invention;

FIG. 8 is a schematic structural diagram of the support panel, the bracket and the organ box in FIG. 1 from a first perspective;

FIG. 9 is a schematic diagram of the exploded structure of the support panel, the bracket and the organ box in FIG. 8;

Fig. 10 is another exploded structural diagram of the support panel, bracket and organ box in Fig. 8;

Fig. 11 is the enlarged structural schematic diagram of detail D in Fig. 10;

Fig. 12 is another exploded schematic diagram of the support panel, bracket and organ box in Fig. 8;

Fig. 13 is the enlarged structural schematic diagram of detail E in Fig. 12;

14 is a schematic structural diagram of the support panel, bracket and organ box in FIG. 1 from a second perspective;

15 is a schematic structural diagram of the support panel, bracket and organ box in FIG. 1 from a third perspective;

16 is a schematic cross-sectional structural diagram of an organ box and a bracket in the present invention;

Fig. 17 is the enlarged structural schematic diagram of detail A in Fig. 15;

FIG. 18 is an enlarged schematic view of detail B in FIG. 16;

Figure 19 is a schematic diagram of the cross-sectional structure of the blood bag in the present invention;

Fig. 20 is the structural representation of the organ box described in Fig. 1;

Figure 21 is a schematic structural diagram of a small car in the present invention;

Figure 22 is a schematic diagram when the incision of the aorta is provided with a line in the present invention;

Figure 23 is a schematic structural diagram of a fastener in the present invention;

FIG. 24 is a flowchart of an exhaust method according to an embodiment of the present invention.

Detailed ways

Embodiments of the present invention provide a warm-blooded organ transport platform for preserving and transporting donor organs. The above-mentioned donor organs are parts of the human body or other animals that can perform a certain independent physiological function, such as heart, lung, liver, kidney, etc., and can be used in organ transplantation technology.

As shown in FIG. 1 and FIG. 2 , the warm-blooded organ transport platform includes: a carrying device 100 and a circulation loop 200 arranged on the carrying device 100 . The circulation circuit 200 includes: an organ box 210 for accommodating a donor organ, a connector 240 provided on the organ box 210 , a pipeline assembly, and a power device 230 connected to the pipeline assembly. The pipeline assembly has an inlet end and an outlet end, the inlet end extends into the organ box 210 for connecting with the donor organ, and the outlet end is connected with the donor organ through the connector 240 .

The donor organ has an organ inlet for connection with the connector 240 and an organ outlet for connection with the inlet end of the tubing assembly. Driven by the power device 230, the blood flows into the donor organ through the pipeline assembly and the connecting piece 240, and then returns from the donor organ to the pipeline assembly. Thus, the blood is continuously circulated to provide nutrients for the donor organ, thereby maintaining the normal life characteristics of the donor organ.

In a schematic scenario, the above-mentioned donor organ is the heart, and the warm-blooded organ transport platform enables the heart to maintain its physiological function during the transport process away from the donor, thereby maximizing the activity of the heart.

It is worth noting that in the above example, the donor organ is the heart, which is only a feasible applicable scenario of the warm-blooded organ transport platform of this embodiment. In other scenarios that are feasible and cannot be explicitly excluded, the warm-blooded organ transport platform can also be used for the transport of organs such as lungs, livers, and kidneys.

The following description mainly focuses on the case of cardiac transport. However, based on the above description, it can be seen that the protection scope of the embodiments of the present invention is not limited accordingly.

When the donor organ is the heart, the entrance of the organ is the aorta, the outlet of the organ is the pulmonary artery, the connecting piece 240 is aortic joint, and the connecting entrance connecting the heart and the connecting piece 240 is the aorta.

As shown in FIGS. 3 to 6 , the connector 240 includes a first joint 241 and a second joint 242 that are releasably engaged. The first connector 241 is provided on the organ box 210 , and the second connector 242 is accommodated in the organ box 210 . The connector 240 adopts a separate arrangement to facilitate the installation of the first connector 241 on the organ box 210 , and the second connector 242 can be connected to the aorta of the heart in a state of being separated from the first connector 241 , and then to the heart. Easy to operate.

The first connector 241 includes a first terminal 2411 located outside the organ box 210 and connected to the outlet end of the pipeline assembly, and a third terminal 2412 located inside the organ box 210 and plugged with the second connector 242 . The first terminal 2411 is provided with an exhaust port 243 for exhaust, and the exhaust port 243 is located at the highest point of the gravitational potential energy of the circulation loop 200 .

The principle that the exhaust port 243 is located at the highest gravitational potential energy of the circulation circuit 200 is beneficial to exhaust as follows: the density of the gas is lower than that of the blood, and the gas will automatically float up in the blood. The exhaust port 243 is set at the highest point of the gravitational potential energy of the circulation loop 200 , and the gas can overflow at the highest point, thereby facilitating the gas to be discharged from the circulation loop 200 .

If the exhaust port 243 and other parts of the circulation loop 200 are located at the same horizontal position, although the gas floats up under the action of buoyancy, it will be blocked by the inner wall of the first joint 241, and the bubbles formed by the gas can only stay in place, and the gas will not move. Unable to discharge.

The second connector 242 includes a second terminal 2422 for connection with the aorta of the heart, and a fourth terminal 2421 operatively plug-fitted with the third terminal 2412 . In this embodiment, the third terminal 2412 is a female head, and the fourth terminal 2421 is a male head. The third terminal 2412 is fixed relative to the organ box 210 , and the fourth terminal 2421 as a male head can be easily inserted into the third terminal 2412 . Therefore, after the connection with the aorta of the heart is completed, the second connector 242 can be quickly and conveniently connected with the first connector 241 .

In the process of connecting the aorta of the heart to the second connector 242, considering that the body of the aorta of the heart is soft and the inner and outer surfaces are self-lubricating, it is difficult to sheath the aorta onto the second terminal 2422 of the second connector 242 . In actual operation, as shown in FIG. 22 , a line 500 is provided at the incision of the aorta. The medical staff pulls the wire 500 to open the aorta with the help of the wire 500 , and then sets the aorta on the second terminal 2422 .

A plurality of wires 500 may be provided and arranged in the circumferential direction. The function of the plurality of wires 500 is to dilate the aortic incision. For example, the medical staff pulls the wires 500 outward along the radial direction of the aortic incision, so that the aortic incision is forced to dilate, thereby facilitating the aorta to be sheathed on the second terminal 2422. superior.

A first stop 2423 located between the second terminal 2422 and the fourth terminal 2421 is provided on the outer side wall of the second connector 242 for stopping the aorta when the aorta of the heart is sleeved on the second terminal 2422 It can prevent the second terminal 2422 from being inserted too deeply and damage the internal structure of the heart, so as to minimize or even avoid the trauma to the heart.

The first stopper 2423 is provided with at least two notches 2424 , and the part of the first stopper 2423 located between the two notches 2424 forms a hooking portion for the wire 500 to bypass. After the aorta is sheathed on the second terminal 2422, the wire 500 can be wound and fastened on the hooking part, so that the aorta is temporarily held on the second terminal 2422, so as to prevent the aorta from being tied with a wire tie in the future During the process of being fixed on the second terminal 2422, the aorta falls off from the second terminal 2422.

The hook portion is provided with a second stopper 2425 extending substantially toward the fourth terminal 2421 , and the second stopper 2425 is spaced from the outer wall of the second connector 242 . Thereby, the second stopper 2425 can prevent the wire 500 from being released from the hook portion in the radial direction of the second joint 242.

The connector 240 further includes a locking nut 244 for connecting the first joint 241 and the second joint 242, the locking nut 244 is provided on one of the third terminal 2412 and the fourth terminal 2421, and is used for connecting the third terminal 2412 and the fourth terminal 2421. The fourth terminal 2421 is threaded with the other of the third terminal 2412 and the fourth terminal 2421 when attached together to keep the third terminal 2412 and the fourth terminal 2421 fixed.

As shown in FIGS. 5 and 6 , the locking nut 244 is clamped on the fourth terminal 2421 and can be rotated relative to the second connector 242 . The inner ring of the locking nut 244 is provided with a first thread, and the third terminal 2412 is provided with a second thread matched with the first thread.

The locking nut 244 provided on the fourth terminal 2421 as a male head can facilitate the screwing of the locking nut 244 with the third terminal 2412. The reasons are as follows: after inserting the fourth terminal 2421 into the third terminal 2412, the locking nut 244 Set on the fourth terminal 2421, the locking nut 244 is close to the hands of the medical staff, and the locking nut 244 moves from bottom to top during the tightening process, which is in line with the usage habits and can be easily screwed by the medical staff Lock nut 244. In addition, the second joint 242 is basically in a free state before engaging with the first joint 241 , and the lock nut 244 provided on it has greater operational flexibility, which is convenient for the user to complete the connection between the second joint 242 and the first joint 241 The fixing operation of the two should be carried out only after the alignment and bonding, so as to avoid useless operations.

The connector 240 also includes a seal 400 for sealing between the first joint 241 and the second joint 242 . The first joint 241 is provided with a first liquid flow channel communicating with the exhaust port 243 , and the second joint 242 is provided with a second liquid flow channel. After the first joint 241 and the second joint 242 are connected, the first liquid flow channel communicates with the second liquid flow channel. Seal 400 is used to prevent leakage of fluids (including flushing or perfusate used during the venting phase and blood during transport) from the junction of the first fluid flow path and the second fluid flow path when flowing through connection 240 .

There are several options for the location of the sealing member 400 : In the first solution, the sealing member 400 is arranged on the inner wall of the third terminal 2412 . In the second solution, the sealing member 400 is provided on the outer wall of the fourth terminal 2421 . In the third solution, a sealing member 400 is provided on the inner wall of the third terminal 2412 and the outer wall of the fourth terminal 2421 .

The sealing method of the sealing member 400 may be side sealing or end sealing. As shown in FIG. 5 , when the side sealing is adopted, the sealing member 400 is sleeved on the outer side wall of the fourth terminal 2421 , and the outer side wall of the fourth terminal 2421 is provided with an annular groove for embedding the sealing member 400 . For example, the sealing member 400 is an O-ring, and the sealing member 400 is squeezed between the outer side wall of the fourth terminal 2421 and the inner side wall of the third terminal 2412 . As shown in FIG. 6 , when the end face sealing is adopted, the cross section of the sealing member 400 in the insertion direction is trapezoidal or rectangular, and the sealing member 400 is provided on the end face of the fourth terminal 2421 .

The first joint 241 penetrates through the wall of the organ box 210 and is sealed with the wall of the organ box 210 . The wall of the organ box 210 is provided with a connecting hole for the first connector 241 to pass through, and the first connector 241 and the connecting hole are sealed, so as to prevent bacteria in the external environment from entering the organ box 210, so that in the subsequent cardiac transport During the process, a sterile environment is maintained within the organ cassette 210 .

The outer wall of the first connector 241 is provided with a locking edge 2413 located outside the organ box 210 . After the first joint 241 and the second joint 242 are tightly connected by the locking nut 244 , the locking flange 2413 and the end face of the locking nut 244 close to the first joint 241 clamp the wall of the organ box 210 . Therefore, the connecting member 240 has the advantages of stable and reliable connection. In addition, by virtue of the fitting arrangement of the snap edge 2413 and the wall of the organ box 210 , the connection hole on the organ box 210 can also be sealed.

In this embodiment, the power device 230 is a magnetic levitation blood pump, which is used to provide power for the flow of the liquid (blood, irrigation fluid or perfusate) in the circulation circuit 200 . As shown in FIG. 7 , the power unit 230 includes a motor 231 and a pump head detachably engaged with the motor 231 . The pump head includes: a pump casing 232, an impeller that is accommodated in the pump casing 232 and can be driven to rotate by the motor 231 to provide power for blood flow.

The magnetic suspension blood pump can adopt the existing structure represented by CN111561519B, CN110711275B, CN305927879S, or conform to or be similar to the description of the above-mentioned representative patent features, and use magnetic suspension bearings, so that the impeller is suspended in the pump casing 232, reducing or even avoiding conventional mechanical bearing pairs. Damage to blood cells and avoid hemolysis.

The pump casing 232 has an inlet joint 233 in the axial direction of the pump casing 232 and an outlet joint 234 in the tangential direction of the pump casing 232 . The inlet joint 233 is used for the liquid to flow into the pump casing 232 , and the outlet joint 234 is used for the liquid to flow out of the pump casing 232 . The pump casing 232 accommodates an impeller, and the motor 231 drives the impeller to rotate, thereby sucking blood into the pump casing 232 .

The outlet joint 234 is higher than the inlet joint 233 , and the intersection of the outlet joint 234 and the pump casing 232 is located at the highest point of the gravitational potential energy of the pump casing 232 . Therefore, the gas mixed in the pump casing through the inlet joint 233 will automatically float up to the outlet joint 234 , thereby facilitating the discharge of the gas in the pump casing 232 and the pipeline connected to the pump casing 232 .

In this embodiment, the motor 231 operates intermittently. When exhausting, the motor 231 is in a stopped state, and the air bubbles in the pump casing 232 will float to the outlet joint 234 of the pump casing 232 . When the motor 231 runs again, the air bubbles can be discharged from the pump casing 232 . Counter-evidence: if the motor 231 runs continuously instead of intermittently, a vortex will be formed in the middle of the pump casing 232 , and the air bubbles mixed in the blood will participate in the vortex, and there will be no time to float up, which is unfavorable for the gas to be discharged from the pump casing 232 .

The impeller has a central axis M, the impeller rotates around the central axis M driven by the motor 231 , and the central axis M passes through the inlet joint 233 along the axial direction of the inlet joint 233 . The impeller is driven to rotate by the motor 231 through magnetic coupling technology.

Considering that the impeller is suspended in the pump casing 232 , in order to reduce the influence of gravity on the suspension of the impeller, the power device 230 is disposed on the bearing device 100 obliquely, so that the inlet joint 233 is inclined upward. The angle between the central axis M and the horizontal plane is between 5° and 85°, further between 10° and 75°, further between 20° and 65°, and further between 30° and 55°. . The included angle can be 5°, 10°, 15°, 20°, 25°, 30°, 35°, 40°, 45°, 50°, 55°, 60°, 65°, 70°, 75°, Integer values such as 80°, 85°, etc., or the included angle is between 5° and 85° at intervals of 1°, 2°, 3°, 4°, 6°, 7°, 8°, 9° unit growth.

As shown in FIG. 2 , the circulation loop 200 further includes a blood bag 220 , an oxygenator 290 , a temperature adjusting device 292 , a first detection unit 250 , a second detection unit 260 , a first sampling unit 270 and The second sampling unit 280 . The organ box 210, the power unit 230, the blood bag 220, the oxygenator 290, the temperature adjusting device 292, the first detection unit 250, the second detection unit 260, the first sampling unit 270 and the second The sampling units 280 are collectively referred to as functional elements. The above-mentioned various functional parts are connected by pipeline components to form a circulation loop.

The arrangement sequence of the above functional components on the pipeline assembly is as follows: organ box 210 , second detection unit 260 , blood bag 220 , power device 230 , temperature adjustment device 292 , oxygenator 290 , and first detection unit 250 . The first sampling unit 270 and the second sampling unit 280 are connected in parallel with the pipeline assembly. The arrangement order of the above functional components can be adjusted according to the actual situation, and the protection scope of the present invention is not limited thereby.

The blood bag 220 is located between the organ cassette 210 and the power unit 230 . Driven by the power device 230, the blood bag 220 continuously supplies blood to the heart through the pipeline assembly, so that the heart maintains the same or close blood environment as the body during the transfer process, and avoids damage to the heart due to ischemia during the transfer process .

As shown in FIG. 19 , a accommodating cavity for storing blood is formed inside the blood bag 220 , and an inlet joint 221 and an outlet joint 222 communicating with the accommodating cavity are provided on the blood bag 220 . The inlet joint 221 and the outlet joint 222 are respectively connected with the tube Road component connection. The outlet connector 222 is provided at the bottom end of the blood bag 220, so that the blood can be naturally output under the action of gravity. The inlet connector 221 can be provided at the bottom end, the upper end or the side of the blood bag 220, which can be determined according to the actual usage.

The tubing assembly includes a first flow channel for connecting the outlet connector 222 of the blood bag 220 and the first terminal 2411, and a second flow channel for connecting the inlet connector 221 of the blood bag 220 and the heart. The end of the first flow channel facing away from the blood bag 220 constitutes the outlet end of the tubing assembly, and the end of the second flow channel facing away from the blood bag 220 constitutes the inlet end of the tubing assembly.

The second flow channel includes a third connecting pipe 293 located in the organ box 210 for connecting with the heart, a joint 295 provided on the wall of the organ box 210 and connected to the third connecting pipe 293, and a joint 295 disposed outside the organ box 210 and connected to the third connecting pipe 293. The fourth connecting pipe 294 to which the joint 295 is connected. One end of the third connecting pipe 293 is the inlet end of the pipeline assembly, and the other end is used for connecting the joint 295 . The joint 295 is used for connecting the third connecting pipe 293 and the fourth connecting pipe 294 , and the fourth connecting pipe 294 is used for connecting the joint 295 and the blood bag 220 .

Since the temperature of the external environment is changeable, in order to simulate the internal temperature environment of the human body to the greatest extent, the blood in the pipeline assembly is kept warm or cooled by the temperature regulating device 292, so that the blood temperature is maintained at 32°C to 42°C In between, avoid the impact of temperature changes on the heart.

In practice, it is more common for the temperature adjusting device 292 to be used for heat preservation than for cooling.

The power device 230 , the temperature adjustment device 292 , the oxygenator 290 , and the first detection unit 250 are sequentially arranged on the first flow channel, and the oxygenator 290 and the temperature adjustment device 292 are located between the power device 230 and the connector 240 . The setting positions of the temperature regulating device 292 are as follows: In the first case, the temperature regulating device 292 is arranged between the oxygenator 290 and the power device 230 to increase the temperature of the hypoxic blood to be entered into the oxygenator 290 , improve oxygenation efficiency (oxygenation efficiency is positively related to temperature). In the second case, the temperature adjusting device 292 is provided between the oxygenator 290 and the connector 240 to increase the temperature of the oxygen-enriched blood to be entered into the heart (generally a minimum of 34° C.) to achieve warm blood transport. In the third case, a temperature adjusting device 292 is provided between the oxygenator 290 and the power device 230 and between the oxygenator 290 and the connecting member 240 .

It is worth noting that the warm blood transport of the organ is not only achieved by the thermoregulation device 292, but the oxygenator 290 also provides assistance or contribution to the realization of this purpose. It is known that, in order to improve the oxygenation efficiency, the oxygenator 290 generally has a heat preservation or heating function, and the self-contained function can increase the temperature of the blood to a certain extent, as described later for details.

The temperature adjustment device 292 at least includes a first temperature adjustment sleeve 2921 wrapped around the outer wall of the first connecting pipe 297 where the first flow channel is located between the oxygenator 290 and the power unit 230 , and a first temperature adjustment sleeve 2921 wrapped around the first flow channel between the oxygenator 290 and the oxygenator 290 . The second temperature adjusting sleeve 2922 on the outer wall of the second connecting pipe 298 between the connecting pieces 240, the first temperature adjusting element (not shown) arranged in the first temperature adjusting sleeve 2921, and the second temperature adjusting sleeve 2921 A second temperature regulating element (not shown) in the casing 2922.

In an optional embodiment, the temperature regulating element is an electric heating wire, which is respectively embedded or pre-embedded in the temperature regulating sleeve. The temperature-adjusting sleeve is provided with a side incision running through its length direction, so that the temperature-adjusting sleeve can be easily opened, so that the temperature-adjusting sleeve can be conveniently sleeved on the connecting pipe.

In another feasible embodiment, the temperature adjustment element may be a channel formed in the temperature adjustment sleeve for the circulation of a heating fluid such as water, oil, and heat medium. The channel communicates with an external heat source, such as a water tank, to realize the circulating flow of the hot fluid.

By setting the temperature adjusting device 292, the temperature of the oxygen-enriched blood to be entered into the heart is increased while the temperature of the oxygen-deficient blood to be entered into the oxygenator 290 is increased, thereby maintaining the activity of the heart to the maximum extent.

The reaching or maintaining of the temperature regulating sleeve and the temperature regulating element is controlled by its length. In this embodiment, the length of the temperature-adjusting sleeve is 0.3-1 m, more preferably 0.4-0.8 m, and still more preferably 0.5-0.7 m. For example, it can be a value of 0.3m, 0.5m, 1m, etc., or it can be an increase of the value between 0.3m and 1m at 0.1m intervals.

Both the first flow channel and the second flow channel include several connecting pipes for connecting adjacent functional parts. Preferably, the above-mentioned connecting pipe is a hose, so as to provide space for the position adjustment of the functional part.

The oxygenator 290 is used to perform gas replacement on the blood, specifically oxygenate the blood, and remove carbon dioxide from the blood. The oxygenator 290 is in communication with an external oxygen supply device 291 for supplying oxygen to the oxygenator 290 . 1 and 2, the oxygen supply device 291 is an oxygen cylinder, the carrier device 100 is provided with a recessed portion for at least partially embedding the oxygen supply cylinder, and a holding assembly for fixing the oxygen cylinder is provided next to the recessed portion, For example, turning the set hoop.

Oxygenator 290 includes a housing having a blood inlet, a blood outlet, a gas inlet, and a gas outlet, and a heating module disposed within the housing between the blood inlet and the blood outlet to control the temperature of circulating blood. The gas inlet is connected to the oxygen supply device 291 .

The heating module can be a heating wire or a heating liquid having a certain temperature and communicating with an external container such as a water tank. The following description will be given by taking water with a certain temperature to heat the blood entering the oxygenator 290 as an example.

The oxygenation membrane is a hollow fiber membrane with fluid channels formed inside. Oxygenated membranes have small molecular pores on the channel walls that allow gas to pass through while blocking liquids. The shell is also provided with a water inlet and a water outlet. Warm water is passed through the oxygenation membrane, and the blood is kept warm and discharged through the water outlet.

The first sampling unit 270 is used for obtaining blood samples in the tubing assembly before entering the heart and/or injecting medical fluid into the tubing assembly. The second sampling unit 280 is used for obtaining blood samples in the tubing assembly after flowing out of the heart and/or injecting medical fluid into the tubing assembly.

By comparing the changes of blood parameters before flowing into the heart and after flowing out of the heart, the quality of blood can be fully grasped. When the parameters of the blood do not meet the preset requirements, the first sampling unit 270 and the second sampling unit 280 can be used to inject medicinal liquid into the pipeline assembly to adjust the parameter values of the blood so that the blood meets the requirements for use, thereby ensuring that the heart is outside the body physiology.

As shown in FIG. 2 , the first sampling unit 270 includes a first sampling port disposed on the first flow channel and located between the oxygenator 290 and the first terminal 2411, and a first sampling port that communicates with the first sampling port and the second flow channel The tube 271 and the first sampling device 272 provided on the first sampling tube 271. The first sampling device 272 at least includes a first sampling interface 2721 for sampling and a first injection interface 2722 for injecting medicinal liquid into the first sampling tube 271 . The intersection of the first sampling tube 271 and the second flow channel is located on the fourth connecting tube 294 of the second flow channel. The syringe interface 2722 is connected to the syringe pump through tubing.

The first sampling device 272 is provided with three interfaces, namely a first sampling interface 2721 , a first injection interface 2722 and a first spare interface. The first spare interface can be set as a sampling interface or an injection interface as required. Of course, the number of the interfaces of the first sampling device 272 may also be four, five or other numbers, which will not be repeated here.

Similarly, the second sampling unit 280 includes a second sampling port disposed on the second flow channel and located between the organ box 210 and the inlet connector 221, and a second sampling pipe 281 connecting the second sampling port and the first sampling pipe 271. and a second sampling device 282 provided on the second sampling tube 281 . The second sampling device 282 at least includes a second sampling interface 2821 for sampling and a second injection interface 2822 for injecting medicinal liquid into the second sampling tube 281 . The second sampling device 282 is also provided with three ports, which are a second sampling port 2821 , a second injection port 2822 and a second spare port, respectively.

The first sampling port of the first sampling unit 270 is set on the first flow channel through the tee P, and the second sampling port of the second sampling unit 280 is set on the second flow channel through the tee Q. The

sampling devices

272 and 282 can be N-ports, where N is greater than or equal to 4, such as five-ports, two of which are connected to pipelines, and the remaining three ports form a sampling port, an injection port and a backup port.

When sampling is not required, the sampling interface can be blocked. When sampling is required, open the sampling interface. Alternatively, a flexible hemostatic valve is provided in the sampling port. When sampling is required, sampling can be achieved by inserting a corresponding device such as a sampling tube. After the device is pulled out, the hemostatic valve is automatically closed to achieve sealing.

The first detection unit 250 and the second detection unit 260 are used to detect the flow rate and/or pressure value of the blood in the pipeline assembly before entering the heart and flowing out of the heart. The first detection unit 250 is disposed on the first flow channel of the pipeline assembly, between the oxygenator 290 and the first terminal 2411, and is used to detect the flow rate and/or pressure value of the blood before entering the heart. The second detection unit 260 is disposed on the second flow channel of the pipeline assembly, between the organ box 210 and the inlet connector 221, and is used to detect the flow rate and/or pressure value of the blood flowing out of the heart. The first detection unit 250 includes a first pressure sensor 251 and a first flow rate sensor 252 . The difference between the second detection unit 260 and the first detection unit 250 lies in the different installation positions, and the second detection unit 260 will not be described in detail here.

As shown in FIGS. 1 and 20 , the organ box 210 includes a casing 2101 having an open end, and a cover assembly 2102 detachably connected to the casing 2101 . The casing 2101 is used to hold the heart, and the cover assembly 2102 is used to seal the open end of the casing 2101 to prevent external impurities such as bacteria and air from entering the organ box 210 and create a sterile environment.

The casing 2101 is made of hard material, so that the casing 2101 has a fixed shape and protects the heart. A flexible buffer layer 2104 is provided on the bottom of the inner side of the casing 2101, for example, a buffer layer made of sponge, which plays a protective role of buffering and shock absorption to the heart and reduces damage to the heart.

The cover assembly 2102 includes a detachable cover 2105 for covering the open end of the casing 2101 , and a wrapping member 2106 between the cover 2105 and the casing 2101 . The package 2106 includes a hollow frame 2107 and a film 2103 provided on the frame 2107 . The frame 2107 is operatively embedded in the open end of the casing 2101 , and the membrane 2103 is operatively wrapped around the heart and at least partially fills the vacant space between the heart and the casing 2101 .

The wrapping member 2106 and the cover body 2105 can be a separate structure, or can be a conjoined structure, for example, the wrapping member 2106 is rotatably connected to the cover body 2105. The film 2103 is provided on the open end of the housing 2101 through the frame 2107 as a carrier. The cover film 2103 can be a plastic film, preferably, the cover film has three layers, which can better create a sealed environment.

The multi-layer film is attached to the heart and can also stabilize the position of the heart in the housing 2101, so as to reduce the shaking of the heart during transit, protect the heart to the greatest extent, and minimize or even avoid trauma to the heart. Further, when the covering component 2102 is covered on the open end, the heart is confined in the space surrounded by the buffer layer 2104 and the covering film 2103 , which has the advantage of a good limiting effect.

The lid body 2105 is provided with a visualization window. The visualization window has a convex spherical surface or a spherical-like structure, which plays the role of amplifying the real image, which is convenient for medical staff to observe the state of the heart in the process of transportation and preservation.

In some applicable scenarios, when the heart needs to be transported over a long distance, a large change in the external temperature difference may be involved. For example, the heart is transported from Hainan with a lower latitude to Beijing with a higher latitude, or vice versa. Then, during the transport process, the difference between the surface temperature of the heart and the outside temperature is large. If the above-mentioned film 2103 is not wrapped around the heart, the water vapor volatilized on the surface of the heart will condense on the visualization window of the cover body 2105, thereby forming water mist on the inner wall of the visualization window, affecting the observation effect.

The heart is wrapped by the film 2103, although the water vapor evaporated from the surface of the heart will still condense on the inner surface of the film 2103 to form water mist, but the water vapor is limited to a small range, which does not affect the visualization effect of the visualization window. In some preferred embodiments, the organ box 210 is provided with a suction part. When the air is exhausted through the suction part, the film 2103 can fit better with the heart.

The cover body 2105 and the wrapping member 2106 are disposed separately, and the cover body 2105 and the wrapping member 2106 are pivotally connected to the same lateral edge of the open end. The cover body 2105 and the wrapping member 2106 are pivotally connected. When the open end is open, the cover body 2105 and the wrapping member 2106 are still connected to the housing 2101, which can avoid the loss of the cover assembly 2102 or the loss of the cover assembly 2102. It has the advantage of being convenient to use.

When the heart is placed in the organ box 210 for transport, waste blood dripping from the heart will be accumulated in the organ box 210 . The above-mentioned waste blood has the following three sources: The first source is that the heart inevitably carries blood when it is taken out of the human body, and the above-mentioned blood will enter the organ box 210 along with the heart. The second source is that during the beating process of the heart in the organ box 210 , some blood will seep out and drop into the organ box 210 . For the third source, a pressure relief tube 296 is usually provided on the heart, one end of the pressure relief tube 296 is connected to the left ventricle of the heart, and the other end of the pressure relief tube 296 is a free end, so as to facilitate the heart's pressure relief. In this embodiment, an incision is made on the left ventricle, and then a pressure relief tube 296 is inserted. The blood flowing out after the left ventricle is compressed will flow into the organ box 210 through the pressure relief tube 296 .

A waste blood connector 2108 is also provided on the organ box 210 . Correspondingly, the blood bag 220 is provided with a recovery joint 223, and the waste blood joint 2108 and the recovery joint 223 are connected through a recovery pipe 2231. Thus, the waste blood in the organ cassette 210 can enter the blood bag 220 through the recovery tube 2231 for recovery.

The blood bag 220 is also provided with a perfusion interface 224 at the top of the blood bag 220. The perfusion interface 224 is communicated with the accommodating cavity of the blood bag 220. The perfusion interface 224 is used to perfuse liquid into the blood bag 220. fluid/perfusate, etc.

The recovery joint 223 is located below the perfusion interface 224 . Preferably, the recovery joint 223 is located at the bottom of the blood bag 220 . The blood bag 220 is provided with a recovery tube 226 , the lower end of the recovery tube 226 is connected to the recovery joint 223 , and the upper end is penetrated through the perfusion interface 224 . A drainage channel is formed between the upper end of the recovery tube 226 and the perfusion port 224 . The recovery tube 226 is generally vertical within the blood bag 220 and is inserted generally vertically into the perfusion port 224 . In practice, it is found that when the recovery tube 226 is penetrated in the perfusion interface 224 in a substantially vertical state, the waste blood in the organ box 210 can smoothly enter the accommodating cavity of the blood bag 220 to realize recovery. Moreover, when the waste blood contains a small amount of gas (such as air), gas-liquid separation can be achieved at the perfusion interface 224 , so that the gas mixed in the waste blood can be smoothly discharged through the perfusion interface 224 .

In order to facilitate the discharge of the gas in the accommodating cavity when the blood bag 220 is filled with liquid, the blood bag 220 is further provided with an exhaust port 225 , and the exhaust port 225 is located on the top of the blood bag 220 . Both the perfusion port 224 and the exhaust port 225 are provided with valves that can be opened and closed.

The buffer layer 2104 is provided with a plurality of diversion channels 2109 for diversion, which are used to guide the blood leaking from the heart to the waste blood joint 2108, so that the waste blood in the organ box 210 can be concentrated in the waste blood joint 2108. The diversion channel 2109 is in the shape of a branch.

As shown in FIG. 1 , the carrying device 100 includes: a movable trolley 110 , a support panel 120 arranged on the trolley 110 , and the organ box 210 is arranged on the support panel 120 . As shown in FIG. 21 , the cart 110 is provided with a shroud 112 and a top cover 113 rotatably provided on the shroud 112 to operably cover the organ box 210 .

As shown in FIG. 9 and FIG. 10 , the edge of the support panel 120 is provided with a blood-shielding flange 126 extending toward the enclosure plate 112 . In this way, blood can be prevented from splattering outward during the heart transit process or when the heart is connected to the aortic joint, so as to collect and control the blood splatter within a limited range, and only the upper surface of the support panel 120 needs to be cleaned later. It can effectively prevent blood from being ejected into the external environment.

The trolley 110 is formed with an accommodating space under the support panel 120 , and the accommodating space is used for accommodating the power device 230 and the syringe pump. Both the power unit 230 and the syringe pump are located at the bottom of the trolley 110, and the blood-blocking flange 126 is to block the power unit 230 and the syringe pump below from contaminating blood.

The distance between the upper end of the blood-separating flange 126 and the lower end of the hoarding plate 112 can be 5mm, 4mm, 3mm, 2mm, 1mm, 0mm, etc., or it can be an increase in the interval of 0.1m between 0mm and 5mm .

The cart 110 is provided with wheels 114 and handrails 115 to facilitate the transportation of the organ box 210 . Considering that the support panel 120 is a non-consumable material and is not frequently replaced, the support panel 120 and the trolley 110 are tightly connected.

As shown in FIG. 14 , the support panel 120 is provided with a hook 127 , and the trolley 110 is provided with a beam 111 that cooperates with the hook 127 . The hook 127 is hung on the beam 111 and is fastened by screws or pins. The connection structure is simple , The advantages of stable and reliable connection.

After the organ box 210 is installed on the support panel 120 , the position of the circulation loop 200 relative to the carrying device 100 is predetermined. The above-mentioned "the position of the circulation loop 200 relative to the carrying device 100 is predetermined" means that each functional component on the circulating loop 200 has a predetermined installation position on the carrying device 100. After the installation of one functional component is completed, the installation of other functional components The location is set.

As shown in FIGS. 8 to 14 , the cart 110 is provided with a power unit 230 and an oxygen supply unit 291 , and the support panel 120 is provided with an oxygenator bracket 129 for installing the oxygenator 290 and a blood bag for installing the blood bag 220 . Bag mounting area 125 . The blood bag mounting area 125 is provided with a blood bag holder 1251, the blood bag holder 1251 is pivotally connected to the support panel 120, and the blood bag holder 1251 is configured to limit the blood bag 220 to the blood bag Mounting area 125.

As shown in FIGS. 8 to 10 , the organ box 210 is disposed on the support panel 120 through the bracket 300 , and the organ box 210 is disposed on the upper surface of the bracket 300 . The upper surface of the bracket 300 is disposed obliquely, and has a high end and a low end, so that the organ box 210 is disposed on the bracket 300 obliquely. The connector 240 is located on the high end side of the bracket 300, and the waste blood connector 2108 is located on the low end side of the bracket 300, so as to facilitate exhausting and discharging waste blood.

Regarding the installation of the organ box 210, considering that in different scenarios, for example, adults and children have different heart sizes, the organ box 210 needs to be replaced, and the organ box 210 and the bracket 300 are detachably connected. As shown in FIG. 12 and FIG. 16 , the lower surface of the official box 210 is provided with a hook 211 and a limiting protrusion 212 , and the upper surface of the bracket 300 is provided with a hook portion close to the high end and used for the hook 211 to match 320 and a matching portion close to the lower end for matching with the limiting bump 212 .

As shown in FIG. 12 to FIG. 18 , the upper surface of the bracket 300 is recessed downward to form a supporting groove 310 , the supporting groove 310 is inclined in the up-down direction, and the hooking part 320 and the matching part are located in the groove of the supporting groove 310 . end. After the organ box 210 is installed on the bracket 300 , the bottom of the casing 2101 of the organ box 210 is accommodated in the support groove 310 , and the cover component 2102 of the organ box 210 is completely located outside the support groove 310 .

The bottom of the bracket slot 310 is provided with an opening, the hook 211 is hung on the lower edge 321 of the opening, and the area on the lower edge 321 that matches the hook 211 is the hook portion 320 . After the hook 211 is hung on the hook portion 320, the cooperation between the hook 211 and the hook portion 320 can prevent the organ box 210 from sliding off the bracket 300 under the action of its own gravity, so that the organ box 210 can be kept on the bracket 300.

As shown in FIG. 18 , the cross-sections of the hook 211 and the hook portion 320 are partially arc-shaped. The above "section" refers to a section taken through a vertical plane. A circular arc contact is formed between the hook 211 and the hook portion 320. The hook 211 has a degree of freedom to rotate around the hook portion 320, which can facilitate the hook 211 to be hung on the hook portion 320, and has the advantages of convenient disassembly and assembly. advantage.

As shown in FIG. 17 , the lower edge 321 is further provided with a pair of protruding ribs 322 located outside the bracket groove 310 , and the protruding ribs 322 are located on opposite sides of the hooking portion 320 . After the hooks 211 are hung on the lower edge 321 , the protruding ribs 322 are located on opposite sides of the hooks 211 to limit the position of the organ box 210 in the left and right directions. Therefore, the organ box 210 is not easy to shake, which can make the placement of the heart in the organ box 210 more stable.

The hook opening of the hook 211 is inclined downward, and the hook 211 is approximately in an "L" shape or a "C" shape, which can be easily hung on the lower edge 321 of the hook portion 320 . The number of the hooks 211 can be provided in multiples, and the plurality of hooks 211 are distributed along the extending direction of the lower edge 321 to make the hanging more stable and reliable.

As shown in FIG. 16 , the matching portion is the lower edge of the support groove 310 , and the limiting protrusion 212 abuts and cooperates with the lower edge to form a friction pair. After the limiting protrusions 212 are in contact with the bottom edge of the second face, the limiting protrusions 212 are located below the matching portion, and the matching portion has the function of preventing the organ box 210 from moving upward, preventing the organ box 210 from moving upward, Therefore, the hook 211 is prevented from being separated from the hook portion 320 . In addition, since a friction pair is formed between the limiting protrusion 212 and the matching portion, the frictional force between the organ box 210 and the bracket 300 is increased, so that the organ box 210 is stably supported on the bracket 300 . Therefore, the organ box 210 has the advantage of stable and reliable connection.

It can be understood that the above-mentioned matching portion can also be a groove (not shown in the figure) provided at the bottom of the support groove 310, and the limiting protrusion 212 is inserted in the groove, thereby limiting the upward movement of the organ box 210. , to prevent the hook 211 from disengaging from the hook portion 320 .

The bracket 300 is inserted on the support panel 120 and is fastened to the support panel 120 through the fastener 122 . Therefore, the bracket 300 and the organ box 210 can be detached from the support panel 120 for sterilization or maintenance, which has the advantages of convenient assembly and disassembly and reliable connection.

For the installation of the bracket 300 , as shown in FIG. 10 and FIG. 12 , the upper surface of the support panel 120 is provided with a first plug-in structure 121 , and the lower surface of the bracket 300 is provided with a second plug-in structure 121 which is plugged and matched with the first plug-in structure 121 . Plug structure 330 . The bracket 300 is inserted on the support panel 120 through the cooperation between the first insertion structure 121 and the second insertion structure 330 .

One of the first plug-in structure 121 and the second plug-in structure 330 is configured as a card block, and the other of the two includes a slot for receiving the card block. Convenient and reliable. The first plug-in structure 121 and the second plug-in structure 330 are both block-shaped, the first plug-in structure 121 is symmetrically disposed on the support panel 120 , and the second plug-in structure 330 is symmetrically disposed on the bracket 300 .

As shown in FIG. 11 , the first plug structure 121 is provided with a slot 1211 for inserting the second plug structure 330 . The above-mentioned slot 1211 is opened in the horizontal direction, and the bracket 300 is configured to move on the support panel 120 after being placed on the support panel 120 so that the block enters or moves out of the slot 1211 . The above-mentioned “it” refers to the support panel 120 .

The support panel 120 is provided with a threaded hole 123, and the bracket 300 is provided with a notch 340, and the notch 340 is opened toward the installation and insertion direction. The installation and insertion direction is the moving direction of the bracket 300 when the card block enters the slot 1211 .

The bracket 300 is fixed to the support panel 120 by a fastener 122 . As shown in FIG. 23 , the fastener 122 includes: a screw rod 1221 screwed into the threaded hole 123 , and a knob 1222 provided on the top of the screw rod 1221 . As shown in FIG. 9 and FIG. 10 , the moving direction of the fastener 122 is perpendicular to the installation and insertion direction of the bracket 300 on the support panel 120 . For example, if the installation and insertion direction is the horizontal direction, the moving direction of the fastener 122 is the vertical direction.

After the bracket 300 is inserted into the support panel 120, the screw 1221 of the fastener 122 is partially accommodated in the notch 340, and the knob 1222 is located just above the notch 340. At this time, the bracket 300 can be completed by rotating the knob 1222 The installation with the support panel 120 has the advantage of convenient installation.

Further, as shown in FIGS. 12 and 13 , the lower surface of the bracket 300 is located at the edge of the notch 340 and is provided with a limit post 341 extending downward, and the upper surface of the support panel 120 is recessed downward to form a limit post 341 for connecting with the limit post 341 . The matching limiting groove 124 is arranged approximately coaxially with the threaded hole 123 and the diameter of the limiting groove 124 is larger than that of the threaded hole 123 .

The limit post 341 is used to define the position of the notch 340 . After the bracket 300 is installed on the support panel 120 , the limit post 341 is inserted into the limit slot 124 and abuts against the circumferential wall of the limit slot 124 , thereby The relative positional relationship between the bracket 300 and the support panel 120 is made more precise, and the installation accuracy is high.

A sealing ring 128 is also provided between the fastener 122 and the threaded hole 123, and the sealing ring 128 is used to prevent the splashed blood accumulated in the blood-isolating flange 126 from leaking to the outside, so as to realize the collection and limited range of blood splashes. control.

The present invention also provides a method for degassing a warm-blooded organ transport platform. Although the present invention provides the method operation steps as described in the following embodiments or flowcharts, based on routine or no creative work, in the method There may be more or fewer steps involved. In addition, in the steps of the method that do not have a necessary causal relationship in logic, the execution order of these steps is not limited to the execution order provided in the embodiments of the present invention.

As shown in Figure 24, the illustrated venting method includes:

Step S10: before the donor organ is connected to the circulation loop 200, a replacement pipeline (not shown) is used to connect the inlet end and the outlet end of the pipeline assembly;

Step S20 : inject flushing liquid into the perfusion interface 224 provided on the blood bag 220 , and the flushing liquid displaces the gas in the pipeline assembly to flow forward, so that at least part of the gas is discharged from the gas outlet of the oxygenator 290 , wherein the above The gas outlet is in communication with the atmosphere;

Step S30: when the flushing liquid is at least poured into the power device 230, control to turn on the power device 230;

Step S40: Continue to perfuse the irrigation liquid into the perfusion interface 224 until the perfusion liquid fills the circulation circuit 200 and the replacement pipeline.

Before the heart is connected to the organ box 210, the pipeline assembly needs to be evacuated to avoid air in the pipeline assembly when the heart is subsequently connected to the heart and the circulation is established. The above-mentioned flushing fluid may be physiological saline.

The method further includes opening the vent port 225 of the blood bag 220 prior to the step of priming the irrigation fluid into the priming port 224 . Then, when the flushing liquid displaces the gas in the pipeline assembly and flows forward, at least part of the gas is discharged from the exhaust port 225 . Since the gas discharge flow rate is related to the resistance, in practice, the gas is discharged from the oxygenator 290, and there is a resistance of the oxygenation membrane. Therefore, the flow rate of the gas discharged from the exhaust port 225 is larger than the flow rate of the gas discharged from the gas outlet of the oxygenator 290 . That is, in the degassing stage before the heart is inserted, the degassing port 225 on the blood bag 220 is actually the main air outlet channel.

The step of controlling to turn on the power device 230 includes: when it is detected that the flushing liquid reaches the pump head, controlling to turn on the motor 231 and making the motor 231 run intermittently. Specifically, since the outlet joint 234 is higher than the inlet joint 233, the gas mixed in the pump casing through the inlet joint 233 will automatically float up to the outlet joint 234, thereby facilitating the connection between the pump casing 232 and the pipeline connected to the pump casing 232. Gas exhaust.

After the perfusate fills the circulatory circuit 200 and the replacement line to evacuate the gas, blood can be perfused into the perfusion port 224 of the blood bag 220 to make the perfusate (physiological saline) fused with the blood. In this way, the perfusion of blood is achieved without draining the perfusate. The blood perfused comes from the donor, and the blood collection kit provided by the application number 2021213153778 can be used to take out the required blood from the donor, and then perfuse the blood drawn from the kit to the blood bag 220, and gradually complete the entire circulation circuit 200 and replacement tubing for blood perfusion.

Further, before the blood is perfused after the gas depletion is completed, the inlet connector 222 and/or the outlet connector 221 of the blood bag 220 are opened, and a part of the perfusate in the blood bag 220 is discharged. In this way, space is provided in advance for blood perfusion. Meanwhile, since the circulation circuit 200 (especially the blood bag 220 ) is filled with perfusate, when the perfusion port 224 is opened to perfuse blood, if there is no reserved space in the blood bag 220 , the perfusate may overflow. The above problems can be avoided by releasing part of the perfusate in advance.

After the steps of filling the circulation circuit 200 with blood and replacing the pipeline, the method further includes: first, adjusting the position of the connector 240 on the organ box 210 so that the position of the exhaust port 243 is adjusted to the highest gravitational potential energy of the circulation circuit 200 place. Then, plug the inlet and outlet ends of the tubing assembly. Finally, remove the replacement line.

When the second connector 242 and the first connector 241 are in a separated state, the heart is connected to the second terminal 2422 and the inlet end of the tubing assembly, and then the third terminal 2412 and the fourth terminal 2421 are joined, and the first terminal 2421 is mixed in during the replacement process. The air in the joint 241 is exhausted through the exhaust port 243 .

In the above process, the exhaust port 243 is located at the highest point of the gravitational potential energy of the circulation loop 200 , and the air can overflow at the highest point, thereby facilitating the air to be discharged from the circulation loop 200 .

Obviously, the above-described embodiments are only a part of the embodiments of the present invention, but not all of the embodiments. Based on the embodiments of the present invention, those of ordinary skill in the art can make other changes or changes in different forms without creative work, which shall fall within the protection scope of the present invention.

Claims

A warm-blooded organ transport platform, characterized in that it comprises: a carrying device and a circulation loop arranged on the carrying device;

The circulation loop includes:

Organ boxes, for housing donor organs;

a tubing assembly having an inlet end and an outlet end, the inlet end being used to connect with the donor organ;

The connecting piece is arranged on the organ box, and has a first terminal located outside the organ box and a second terminal located inside the organ box; the first terminal is used for connecting with the outlet end, so the second terminal is used to connect with the donor organ;

The blood bag is arranged on the pipeline assembly and has an inlet joint and an outlet joint; the pipeline assembly includes: a first flow channel connecting the outlet joint and the first terminal, for connecting the inlet joint and the first terminal. a second flow channel of the donor organ; the end of the first flow channel facing away from the blood bag constitutes the outlet end, and the end of the second flow channel facing away from the blood bag constitutes the inlet end;

a power device, connected to the pipeline assembly, for providing power for the flow of liquid between the circulation loop and the donor organ;

an oxygenator, arranged on the pipeline assembly, for oxygenating the blood flowing through;

a temperature regulating device, arranged on the pipeline assembly, for regulating the temperature of the blood flowing through;

Wherein, an exhaust port is provided on the first terminal, and the exhaust port is located at the highest point of the gravitational potential energy of the circulation loop.
The warm-blooded organ transport platform according to claim 1, wherein the power device comprises: a motor and a pump head detachably engaged with the motor; the pump head comprises: a pump housing, received in the an impeller in the pump casing and rotatable by the motor to power the flow of the liquid; the pump casing has an inlet connection and an outlet connection, the outlet connection being higher than the inlet connection;

Preferably, the intersection of the outlet joint and the pump casing is located at the highest point of the gravitational potential energy of the pump casing;

Further preferably, the impeller can be driven to rotate around a central axis passing through the inlet joint, the power device is obliquely arranged on the bearing device, the inlet joint is inclined upward, and the central axis is between the horizontal plane. The included angle between them is between 5° and 85°.
The warm-blooded organ transport platform according to claim 1, wherein the connector comprises: a first connector and a second connector; the first connector is provided on the organ box and includes the first terminal , a third terminal; the second joint and the first joint can be detachably joined, including the second terminal and the fourth terminal;

the fourth terminal is operably inserted and matched with the third terminal, the third terminal is a female head, and the fourth terminal is a male head;

Preferably, the connector further comprises: a lock nut provided on one of the third and fourth terminals for engaging with the third and fourth terminals when the third and fourth terminals are attached together The other of the third terminal and the fourth terminal is screwed to keep the third terminal and the fourth terminal fixed;

Further preferably, the connecting member further comprises: a sealing member disposed on the inner wall of the third terminal and/or the outer wall of the fourth terminal;

Further preferably, the first joint penetrates through the wall of the organ box, and is sealed with the wall of the organ box.
The warm-blooded organ transport platform according to claim 3, wherein a first stopper located between the second terminal and the fourth terminal is provided on the outer side wall of the second joint, the first stop The stopper is used to stop and limit the blood vessel when the blood vessel of the donor organ is sheathed on the second terminal;

Preferably, at least two notches are provided on the first stopper, and a portion of the first stopper located between the two notches forms a hooking portion for the wire to bypass;

Further preferably, a second stopper extending substantially toward the fourth terminal is provided on the hooking portion, and the second stopper is spaced from the outer wall of the second connector.
The warm-blooded organ transport platform according to claim 1, wherein the blood bag is further provided with a perfusion port at the top and a recovery joint at the bottom, and a recovery tube is arranged in the blood bag, and the recovery tube is The lower end of the recovery pipe is connected to the recovery joint, and the upper end is penetrated in the perfusion interface; a drainage channel is formed between the upper end of the recovery pipe and the perfusion interface.
The warm-blooded organ transport platform according to claim 1, wherein the temperature regulation device at least comprises: a first connecting pipe wrapped in the first flow channel between the oxygenator and the power device Part of the first temperature adjustment sleeve on the outer wall, and a second temperature adjustment sleeve wrapped on the part of the outer wall of the second connecting pipe where the first flow channel is located between the oxygenator and the connecting piece, arranged in the first temperature adjustment sleeve The first temperature adjustment element in the temperature sleeve, and the second temperature adjustment element provided in the second temperature adjustment sleeve; preferably, the length of the first temperature adjustment sleeve is between 0.3 and 1 m, and the The length of the second temperature adjusting sleeve is between 0.3 and 1 m.
The warm-blooded organ transport platform according to claim 1, wherein,

The circulation loop also includes:

a first detection unit, provided on the pipeline assembly, located between the oxygenator and the first terminal, for detecting the flow rate and/or pressure value of the blood before entering the donor organ;

a second detection unit, provided on the pipeline assembly, located between the organ box and the inlet connector, for detecting the flow rate and/or pressure value of the blood flowing out of the donor organ;

Further, the circulation loop also includes:

a first sampling unit, arranged on the pipeline assembly, and used for acquiring blood samples in the pipeline assembly before entering the donor organ and/or injecting medicinal liquid into the pipeline assembly;

a second sampling unit, disposed on the pipeline assembly, and used for acquiring blood samples in the pipeline assembly after flowing out of the donor organ and/or injecting medicinal liquid into the pipeline assembly;

Preferably, the first sampling unit comprises: a first sampling port disposed on the first flow channel and located between the oxygenator and the first terminal, communicating between the first sampling port and the first sampling port The first sampling tube of the second flow channel, and the first sampling device provided on the first sampling tube; the first sampling device at least includes a first sampling interface for sampling, and further includes a the first injection interface for injecting medicinal liquid in the first sampling tube;

Preferably, the second sampling unit comprises: a second sampling port disposed on the second flow channel and located between the organ box and the inlet joint, communicating the second sampling port with the first sampling port The second sampling tube of the sampling tube, and the second sampling device provided on the second sampling tube; the second sampling device at least includes a second sampling interface for sampling, and further includes a second sampling interface for sampling to the second sampling tube. The second injection interface for injecting the medicinal liquid in the second sampling tube.
The warm-blooded organ transport platform according to claim 1, wherein the organ box comprises: a casing for containing the donor organ, and a covering component detachably connected to the casing; the covering The assembly includes: a detachable cover body that covers the open end of the casing, and a wrapping piece located between the cover body and the casing; the wrapping piece includes: a hollow frame, which is arranged on the frame the frame is operatively embedded in the open end of the shell, the membrane operatively wraps the donor organ and at least partially fills the vacant space between the donor organ and the shell ;

Preferably, the bottom of the inner side of the casing is provided with a flexible buffer layer.
The warm-blooded organ transport platform according to claim 1, wherein the carrying device comprises: a movable trolley, a support panel arranged on the trolley, and the organ box is arranged on the support panel, The trolley forms an accommodating space under the support panel; the trolley is provided with a shroud and a top cover rotatably provided on the shroud to cover the organ box operably, the edge of the support panel is A blood-separating flange extending toward the direction of the enclosure is provided, and the interval between the upper end of the blood-sparing flange and the lower end of the enclosure is not greater than 5 mm.
The warm-blooded organ transport platform according to claim 9, wherein the organ box is arranged on the support panel through a bracket, and the upper surface of the bracket is inclined and has a high end and a low end , the organ box is arranged on the upper surface of the bracket;

The lower surface of the organ box is provided with hooks and limiting projections, and the upper surface of the bracket is provided with a hooking part close to the high end and used for the hook to fit and a hook part close to the low end and a mating portion for mating with the limiting bump;

The cross section of the hook and the hook portion is in a partial arc shape, the hook has a degree of freedom to rotate around the hook portion, and the matching portion and the limiting protrusion form a friction pair.
The warm-blooded organ transport platform according to claim 10, wherein the upper surface of the support panel is provided with a first plug-in structure, and the lower surface of the bracket is provided with a plug-fit connection with the first plug-in structure The second plug-in structure, one of the first plug-in structure and the second plug-in structure is configured as a card block, and the other of the two includes a slot for receiving the card block; the The slot is open in a horizontal direction, and the bracket is configured to move thereon after being placed on the support panel to cause the block to enter or move out of the slot;

Preferably, the support panel is provided with a threaded hole, and the bracket is provided with a notch, and the notch opens toward the installation and insertion direction, and the installation and insertion direction is such that the block enters the slot. The moving direction of the bracket during the process; the bracket is fixed to the support panel by a fastener, and the fastener includes: a screw screwed into the threaded hole and a knob arranged on the top of the screw;

Further preferably, the lower surface of the bracket is provided with a limiting column extending downward at the edge of the gap, and the upper surface of the support panel is recessed downward to form a limiting groove for matching with the limiting column. , the limiting groove and the threaded hole are substantially coaxially arranged and have a diameter larger than that of the threaded hole.
A method for exhausting a warm-blooded organ transport platform according to any one of claims 1 to 11, characterized in that, comprising:

Before the donor organ is connected to the circulation circuit, a replacement tubing is used to connect the inlet end and the outlet end of the tubing assembly;

Filling flushing liquid into the perfusion interface provided on the blood bag, the flushing liquid drives the gas in the pipeline assembly to flow forward, so that at least part of the gas is discharged from the gas outlet of the oxygenator;

When the flushing liquid is at least poured into the power device, controlling the power device to be turned on;

Continue to perfuse the irrigation fluid into the perfusion port until the perfusion fluid fills the circulation circuit and replacement line.
The exhaust method of claim 12, wherein:

The blood bag also has an exhaust port;

Before the step of pouring flushing liquid into the perfusion port, the method further includes: opening the exhaust port; then, in the process of displacing the gas in the pipeline assembly to flow forward, the flushing liquid at least partially gas is discharged from the exhaust port;

Preferably, in the process of flushing liquid displacing the gas in the pipeline assembly to flow forward, the flow rate of the gas discharged from the exhaust port is greater than the flow rate of the gas discharged from the gas outlet of the oxygenator flow.
The exhaust method of claim 12, wherein the power device comprises: a motor and a pump head detachably engaged with the motor; the pump head comprises: a pump casing, a pump head accommodated in the pump casing an impeller in the middle and which can be driven to rotate by the motor to provide power for liquid flow; the pump casing has the inlet joint and the outlet joint; the outlet joint is higher than the inlet joint;

The step of controlling to turn on the power unit includes: when it is detected that the flushing fluid reaches the pump head, controlling to turn on the motor, and make the motor run intermittently.
The degassing method according to claim 12, characterized in that, after the perfusion fluid fills the circulation circuit and the replacement line to evacuate the gas, the method further comprises: perfusing blood into the perfusion interface to make The perfusate is fused with the blood until the blood fills the circulation circuit and the replacement line;

Preferably, prior to perfusing the blood, the method further comprises: opening the inlet and/or outlet connections of the blood bag to drain a portion of the perfusate in the blood bag.
The exhaust method according to claim 15, wherein the connecting member comprises: a first joint and a second joint; the first joint is provided on the organ box, and comprises the first terminal, the first joint and the second joint; Three terminals; the second terminal is detachably engaged with the first terminal, including the second terminal and the fourth terminal; the fourth terminal is operably plug-fitted with the third terminal, the The third terminal is a female head, and the fourth terminal is a male head;

After the steps of filling the circulation circuit and replacing the circuit with blood, the method further includes:

Adjust the position of the connector on the organ box, so that the position of the exhaust port is adjusted to the highest position of the gravitational potential energy of the circulation loop;

blocking the inlet and outlet ends of the pipeline assembly;

remove the replacement line;

With the second joint and the first joint in a separated state, the donor organ is connected to the second terminal and the inlet end of the tubing assembly, and then the third terminal and the fourth terminal are joined, and the replacement process is performed. The air mixed into the first joint is discharged through the exhaust port.