Warming organ transport platform and method of venting
Patent Information
- Application Number
- CN202211724522.7
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2021-11-30
- Filing Date
- 2022-01-12
- Publication Date
- 2026-09-04
- Estimated Expiration
- 2042-01-12
AI Technical Summary
然而,在工作过程中,如何排出灌注管路中的气体,一直是困扰行业的痛点
[0039]1、排气口设于循环回路的重力势能最高处有利于排气的原理如下:气体的密度小于液体的密度,气体在液体中会自动上浮,将排气口设在循环回路重力势能的最高处,气体可在最高点溢出,从而有利于气体排出循环回路。
Smart Images

Figure CN116369305B_ABST
Abstract
Description
[0001] This application is a divisional application of application number 202210031671.9, filed on January 12, 2022, entitled "Warm Blood Organ Transport Platform and Exhaust Method". Technical Field
[0002] This invention belongs to the field of medical devices, specifically relating to a warm-blood organ transport platform and a method for venting exhaust. Background Technology
[0003] With the development of extracorporeal circulation systems, the technology for transporting ex vivo organs has become increasingly mature, leading to a growing demand for the in vitro maintenance and transport of various organs. This is to maintain the viability of donor organs and ensure they remain in a normal state. A normal state refers to the ability of the donor organ to maintain independent physiological functions. Taking the heart as an example, the heart can remain beating. Even if the heart is located outside the donor body during preservation or transport, it is possible to maintain the same or similar physiological functions as when the organ is inside the body.
[0004] Traditional organ transport often relies on cryopreservation, or cold storage, which extends organ lifespan by lowering or slowing down the organ's metabolic rate. However, the lack of blood, oxygen, and other nutrients caused by low temperatures and being outside the body can sometimes cause irreversible damage to the organ.
[0005] Organ transport platforms, gradually replacing traditional methods, aim to provide a more suitable living environment for ex vivo organs. An indispensable element of this is providing blood perfusion during organ transport. However, how to remove gas from the perfusion tubing during operation has always been a major challenge for the industry. Summary of the Invention
[0006] Therefore, the technical problem to be solved by the present invention is to provide a warm-blooded organ transport platform and exhaust method that can restore the living environment of isolated organs as much as possible in vivo and have good exhaust effect.
[0007] To solve the above-mentioned technical problems, the warm blood organ transport platform of the present invention includes: a carrying device and a circulation loop disposed on the carrying device. The circulation loop includes: an organ box for receiving donor organs, a pipeline assembly having an inlet end and an outlet end, a connector disposed on the organ box, a blood bag disposed on the pipeline assembly, a power unit, an oxygenator, and a temperature control device.
[0008] The inlet end of the tubing assembly is used to connect to the donor organ. The connector has a first terminal located outside the organ container and a second terminal located inside the organ container. The first terminal is used to connect to the outlet end of the tubing assembly, and the second terminal is used to connect to the donor organ. The blood bag has an inlet connector and an outlet connector. The tubing assembly includes a first flow channel connecting the outlet connector to the first terminal and a second flow channel connecting the inlet connector to 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 unit provides power for the flow of liquid between the circulation loop and the donor organ, an oxygenator oxygenates the flowing blood, and a temperature control device regulates the temperature of the flowing blood. An exhaust port is provided on the first terminal, located at the highest point of gravitational potential energy in the circulation loop.
[0009] Preferably, the power unit includes a motor and a pump head detachably coupled to the motor. The pump head includes a pump housing and an impeller housed within the pump housing and driven to rotate by the motor to power the flow of liquid. The pump housing has an inlet connector and an outlet connector, with the outlet connector higher than the inlet connector.
[0010] Preferably, the intersection of the outlet connector and the pump casing is located at the point where the pump casing has the highest gravitational potential energy.
[0011] Preferably, the impeller can be driven to rotate around a central axis passing through the inlet joint, the power unit is inclined on the bearing device, the inlet joint is inclined upward, and the angle between the central axis and the horizontal plane is between 5° and 85°.
[0012] Preferably, the connector includes first and second connectors. The first connector is disposed 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 plugged into the third terminal, wherein the third terminal is a female connector and the fourth terminal is a male connector.
[0013] Preferably, the connector further includes a locking nut disposed 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, so as to keep the third and fourth terminals fixed.
[0014] Preferably, the connector further includes a seal disposed on the inner wall of the third terminal and / or the outer wall of the fourth terminal. More preferably, the first connector penetrates the wall of the organ box and is sealed to the wall of the organ box.
[0015] Preferably, the outer wall of the second connector is provided with a first stop located between the second terminal and the fourth terminal. The first stop is used to stop and limit the blood vessel when the blood vessel of the donor organ is sleeved onto the second terminal.
[0016] Preferably, the first stop has at least two notches, and the portion of the first stop located between the two notches forms a hook-on portion for the wire to pass through.
[0017] Preferably, the hook portion is provided with a second stop extending generally toward the fourth terminal, and the second stop is spaced apart from the outer wall of the second connector.
[0018] Preferably, the blood bag also has an exhaust port at the top and a retrieval connector at the bottom. A retrieval tube is located inside the blood bag, with its lower end connected to the retrieval connector and its upper end passing through the exhaust port. A drainage channel is formed between the upper end of the retrieval tube and the exhaust port.
[0019] Preferably, the temperature control device includes at least a first temperature control sleeve wrapped around the outer wall of the first connecting pipe portion of the first flow channel located between the oxygenator and the power unit, a second temperature control sleeve wrapped around the outer wall of the second connecting pipe portion of the first flow channel located between the oxygenator and the connector, a first temperature control element disposed in the first temperature control sleeve, and a second temperature control element disposed in the second temperature control sleeve. Preferably, the length of the first temperature control sleeve is between 0.3 and 1 m, and the length of the second temperature control sleeve is between 0.3 and 1 m.
[0020] Preferably, the circulation loop further includes a first detection unit, disposed on the tubing assembly between the oxygenator and the first terminal, for detecting the flow rate and / or pressure value of blood before it enters the donor organ. A second detection unit, disposed on the tubing assembly between the organ box and the inlet connector, for detecting the flow rate and / or pressure value of blood after it exits the donor organ.
[0021] Furthermore, the circulation loop also includes a first sampling unit, disposed on the tubing assembly, for acquiring blood samples from within the tubing assembly before entering the donor organ and / or injecting medication into the tubing assembly. A second sampling unit, disposed on the tubing assembly, is used for acquiring blood samples from within the tubing assembly after exiting the donor organ and / or injecting medication into the tubing assembly.
[0022] Preferably, the first sampling unit includes a first sampling port disposed 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, and a first sampling device disposed on the first sampling tube. The first sampling device includes at least a first sampling interface for sampling, and further includes a first injection interface for injecting a drug solution into the first sampling tube.
[0023] Preferably, the second sampling unit includes a second sampling port disposed on the second flow channel and located between the organ box and the inlet connector, a second sampling tube connecting the second sampling port and the first sampling tube, and a second sampling device disposed on the second sampling tube. The second sampling device includes at least one second sampling interface for sampling, and further includes a second injection interface for injecting a drug solution into the second sampling tube.
[0024] Preferably, the organ cassette includes a housing for holding a donor organ and a cover assembly detachably connected to the housing. The cover assembly includes a cover that detachably closes the open end of the housing and a wrapping member located between the cover and the housing. The wrapping member includes a hollow frame and a membrane disposed on the frame. The frame is operably fitted into the open end of the housing, and the membrane operably wraps the donor organ and at least partially fills the empty space between the donor organ and the housing.
[0025] Preferably, a flexible buffer layer is provided at the bottom of the inner side of the housing.
[0026] Preferably, the supporting device includes a movable trolley and a support panel mounted on the trolley. The organ box is disposed on the support panel, and the trolley forms an accommodating space below the support panel. The trolley is provided with a surrounding panel and a top cover rotatably mounted on the surrounding panel to operably close the organ box. The edge of the support panel is provided with a blood-blocking flange extending towards the surrounding panel. The distance between the upper end of the blood-blocking flange and the lower end of the surrounding panel is no more than 5 mm.
[0027] Preferably, the organ box is mounted on a support panel via a bracket. The upper surface of the bracket is inclined and has a high end and a low end. The organ box is positioned on the upper surface of the bracket. The lower surface of the organ box is provided with a hook and a limiting protrusion. The upper surface of the bracket is provided with a hook-and-loop portion near the high end for engaging with the hook and a mating portion near the low end for engaging with the limiting protrusion. The cross-section of the hook and the hook-and-loop portion is partially arc-shaped. The hook has the freedom to rotate around the hook-and-loop portion, and the mating portion and the limiting protrusion form a friction pair.
[0028] 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 plugs into and mates with the first plug-in structure. One of the first and second plug-in structures is configured as a locking block, and the other includes a slot for receiving the locking block. The slot opens horizontally, and the bracket moves on the support panel after being placed thereon, causing the locking block to enter or exit the slot.
[0029] Preferably, the support panel has a threaded hole, and the bracket has a notch that opens in the installation and insertion direction, which is the direction in which the bracket moves during the insertion of the locking block into the slot. The bracket is fixed to the support panel by fasteners, which include: a screw that engages in the threaded hole and a knob located on the top of the screw.
[0030] More preferably, the lower surface of the bracket is provided with a downwardly extending limiting post at the edge of the notch, and the upper surface of the support panel is recessed downward to form a limiting groove for cooperating with the limiting post. The limiting groove is approximately coaxial with the threaded hole and the hole diameter is larger than the threaded hole diameter.
[0031] The present invention provides a method for venting gas using the aforementioned warm-blood organ transport platform, comprising: connecting the inlet and outlet ends of a tubing assembly via a replacement tubing before the donor organ is connected to the circulatory loop; injecting flushing fluid into an infusion port located on the blood bag, the flushing fluid displaces gas in the tubing assembly and flows forward, causing at least a portion of the gas to be discharged from the gas outlet of the oxygenator; controlling the activation of the power unit when the flushing fluid has been injected to at least the required level; continuing to inject flushing fluid into the infusion port until the circulatory loop and replacement tubing are filled with the flushing fluid.
[0032] Preferably, the blood bag also has a venting port. Before the step of injecting flushing fluid into the filling port, the method further includes: opening the venting port. Then, as the flushing fluid flows forward, displacing gas in the tubing assembly, at least some of the gas is discharged from the venting port.
[0033] Preferably, during the process of the flushing fluid displacing the gas in the pipeline assembly, the flow rate of the gas discharged from the exhaust port is greater than the flow rate of the gas discharged from the oxygenator's gas outlet.
[0034] Preferably, the step of controlling the start of the power unit includes: when flushing fluid is detected to have reached the pump head, controlling the start of the motor and making the motor run intermittently.
[0035] Preferably, after the perfusion fluid fills the circulation loop and replacement tubing to purge the gas, the method further includes: perfusing blood into the perfusion port to mix the perfusion fluid with the blood until the blood fills the circulation loop and replacement tubing.
[0036] Preferably, before perfusing blood, the method further includes: opening the inlet and / or outlet connectors of the blood bag to drain a portion of the perfusing fluid from the blood bag.
[0037] Preferably, after the steps of filling the blood circulation loop and replacing the tubing, the method further includes: adjusting the position of the connector on the organ box so that the position of the vent is adjusted to the highest point of the gravitational potential energy of the circulation loop; sealing the inlet and outlet ends of the tubing assembly; removing the replacement tubing; with the second connector separated from the first connector, connecting the donor organ to the second terminal and the inlet end of the tubing assembly, and then connecting the third and fourth terminals, with air mixed into the first connector during the replacement process being discharged through the vent.
[0038] The technical solution provided by this invention has the following advantages:
[0039] 1. The principle that placing the exhaust port at the point of highest gravitational potential energy in the circulation loop is beneficial for exhaust is as follows: The density of gas is less than that of liquid, and gas will automatically float in liquid. By placing the exhaust port at the point of highest gravitational potential energy in the circulation loop, the gas can overflow at the highest point, which is beneficial for the gas to be discharged from the circulation loop.
[0040] 2. The outlet connector is higher than the inlet connector, and the intersection of the outlet connector and the pump casing is located at the highest point of the pump casing's gravitational potential energy. Therefore, gas mixed in through the inlet connector inside the pump casing will automatically rise to the outlet connector, thus facilitating the discharge of gas from the pump casing.
[0041] 3. By using oxygenators, temperature control devices, power devices, etc., installed on the circulation loop, along with the pipeline components that connect these functional components, warm blood perfusion can be achieved during organ transport. This creates a living environment for the ex vivo organ that is as close as possible to its in vivo state, reducing or even avoiding damage to the organ caused by low temperature and lack of nutrients, and increasing the survival time of the organ in the ex vivo state. This makes it possible for organ transport and transplantation over long periods of time. Attached Figure Description
[0042] Figure 1 A three-dimensional structural schematic diagram of the warm-blood organ transport platform provided by the present invention;
[0043] Figure 2 for Figure 1 Schematic diagram of the structure of the medium-loop circuit;
[0044] Figure 3 for Figure 1 Schematic diagram of the middle connector;
[0045] Figure 4 for Figure 3 A schematic diagram of the decomposed structure;
[0046] Figure 5 This is a schematic diagram of the sealing element in this invention when a side seal is used;
[0047] Figure 6 This is a schematic diagram of the sealing element in this invention when an end face seal is used;
[0048] Figure 7 This is a schematic diagram of the power unit being installed on the mobile trolley in this invention;
[0049] Figure 8 for Figure 1 A structural schematic diagram of the central support panel, bracket, and organ box from a first-view perspective;
[0050] Figure 9 for Figure 8 Exploded structural diagram of the central support panel, bracket, and organ box;
[0051] Figure 10 for Figure 8 Another exploded structural diagram of the central support panel, bracket, and organ box;
[0052] Figure 11 for Figure 10A magnified structural diagram of detail D;
[0053] Figure 12 for Figure 8 Another exploded structural diagram of the central support panel, bracket, and organ box;
[0054] Figure 13 for Figure 12 A magnified structural diagram of detail E in the middle;
[0055] Figure 14 for Figure 1 A structural schematic diagram of the central support panel, bracket, and organ box from a second-view perspective;
[0056] Figure 15 for Figure 1 A structural schematic diagram of the central support panel, bracket, and organ box from a third-person perspective;
[0057] Figure 16 This is a schematic cross-sectional view of the organ box and bracket in this invention;
[0058] Figure 17 for Figure 15 A magnified structural diagram of detail A in the middle;
[0059] Figure 18 for Figure 16 Enlarged structural diagram of detail B;
[0060] Figure 19 This is a schematic cross-sectional view of the blood bag in this invention;
[0061] Figure 20 for Figure 1 A schematic diagram of the structure of the organ box described in the text;
[0062] Figure 21 This is a schematic diagram of the structure of the vehicle in this invention;
[0063] Figure 22 This is a schematic diagram showing the aortic incision site with a line in this invention;
[0064] Figure 23 This is a schematic diagram of the fastener structure in this invention;
[0065] Figure 24 This is a flowchart of the exhaust method according to an embodiment of the present invention. Detailed Implementation
[0066] This invention provides a warm-blooded organ transport platform for preserving and transporting donor organs. The donor organs are parts of the human body or other animals that perform a specific physiological function, such as the heart, lungs, liver, and kidneys, and can be used in organ transplantation technology.
[0067] like Figure 1 and Figure 2 As shown, the warm-blood organ transport platform includes: a carrying device 100 and a circulation loop 200 disposed on the carrying device 100. The circulation loop 200 includes: an organ box 210 for receiving a donor organ, a connector 240 disposed on the organ box 210, a tubing assembly, and a power unit 230 connected to the tubing assembly. The tubing assembly has an inlet end and an outlet end, the inlet end extending into the organ box 210 for connection with the donor organ, and the outlet end connected to the donor organ via the connector 240.
[0068] The donor organ has an organ inlet for connection with connector 240 and an organ outlet for connection with the inlet end of the tubing assembly. Driven by power unit 230, blood flows into the donor organ through the tubing assembly and connector 240, and then flows back from the donor organ to the tubing assembly. This continuous blood circulation provides nutrients to the donor organ, thereby maintaining its normal vital functions.
[0069] In an illustrative scenario, the donor organ is the heart. The warm-blood organ transport platform enables the heart to maintain its physiological functions during transport away from the donor, thereby maximizing the preservation of the heart's activity.
[0070] It is worth noting that the donor organ in the above example is the heart, which is only one feasible application scenario for the warm-blood organ transport platform in this embodiment. In other feasible scenarios that cannot be explicitly ruled out, the warm-blood organ transport platform can also be used for the transport of organs such as the lungs, liver, and kidneys.
[0071] The following description primarily focuses on cardiac transport. However, as can be seen from the above description, the scope of protection of the embodiments of the present invention is not limited thereto.
[0072] When the donor organ is the heart, the organ inlet is the aorta, the organ outlet is the pulmonary artery, the connector 240 is the aortic connector, and the connection inlet between the heart and the connector 240 is the aorta.
[0073] like Figures 3 to 6 As shown, the connector 240 includes a detachable first connector 241 and a second connector 242. The first connector 241 is disposed on the organ box 210, and the second connector 242 is housed within the organ box 210. The connector 240's separate design facilitates the installation of the first connector 241 onto the organ box 210, and the second connector 242 can be connected to the aorta of the heart while detached from the first connector 241, thus simplifying the connection operation with the heart.
[0074] The first connector 241 includes a first terminal 2411 located outside the organ box 210 and connected to the outlet end of the tubing assembly, and a third terminal 2412 located inside the organ box 210 and inserted into the second connector 242. The first terminal 2411 is provided with an exhaust port 243 for exhausting air, and the exhaust port 243 is located at the highest point of gravitational potential energy in the circulation loop 200.
[0075] The principle behind placing the exhaust port 243 at the point of highest gravitational potential energy in the circulation loop 200 to facilitate exhaust is as follows: the density of gas is less than that of blood, and gas will automatically float in blood. By placing the exhaust port 243 at the point of highest gravitational potential energy in the circulation loop 200, gas can overflow at the highest point, thus facilitating the exhaust of gas from the circulation loop 200.
[0076] If the exhaust port 243 is at the same horizontal position as other parts of the circulation loop 200, the gas will float up under the action of buoyancy, but it will be blocked by the inner wall of the first connector 241. The gas bubbles can only stay in place and cannot be discharged.
[0077] The second connector 242 includes a second terminal 2422 for connection to the aorta of the heart, and a fourth terminal 2421 operably engaged with the third terminal 2412. In this embodiment, the third terminal 2412 is a female connector, and the fourth terminal 2421 is a male connector. The third terminal 2412 is fixed relative to the organ housing 210, and the fourth terminal 2421, as the male connector, can be easily inserted into the third terminal 2412. Thus, after the connection to the aorta of the heart is completed, the second connector 242 can quickly and easily engage with the first connector 241.
[0078] During the process of connecting the aorta of the heart to the second connector 242, considering the softness of the aorta and its self-lubricating inner and outer surfaces, it is difficult to fit the aorta onto the second terminal 2422 of the second connector 242. In actual operation, such as Figure 22 As shown, a wire 500 is installed at the incision site of the aorta. Medical staff pull the wire 500, which, with the assistance of the wire 500, opens the aorta, and then places the aorta onto the second terminal 2422.
[0079] Multiple lines 500 can be provided and arranged circumferentially. The function of multiple lines 500 is to expand the aortic incision. For example, medical staff can pull the lines 500 outward along the radial direction of the aortic incision, which forces the aortic incision to expand, thereby facilitating the aortic sleeve onto the second terminal 2422.
[0080] The outer wall of the second connector 242 is provided with a first stop 2423 located between the second terminal 2422 and the fourth terminal 2421. This stop is used to limit the aorta when it is connected to the second terminal 2422, so as to prevent the second terminal 2422 from being inserted too deeply and damaging the internal structure of the heart, thereby minimizing or even avoiding trauma to the heart.
[0081] The first stop 2423 has at least two notches 2424, and the portion of the first stop 2423 between the two notches 2424 forms a hook-on portion for the wire 500 to pass through. After the aorta is fitted onto the second terminal 2422, the wire 500 can be wrapped and tightened around the hook-on portion to temporarily hold the aorta on the second terminal 2422, thereby preventing the aorta from falling off the second terminal 2422 during the subsequent process of securing the aorta to the second terminal 2422 with cable ties.
[0082] The hook-on portion is provided with a second stop 2425 extending generally toward the fourth terminal 2421, and the second stop 2425 is spaced apart from the outer wall of the second connector 242. Thus, the second stop 2425 can prevent the wire 500 from coming loose from the hook-on portion in the radial direction of the second connector 242.
[0083] The connector 240 also includes a locking nut 244 for connecting the first connector 241 and the second connector 242. The locking nut 244 is disposed on one of the third terminal 2412 and the fourth terminal 2421 and is used for threaded connection with the other of the third terminal 2412 and the fourth terminal 2421 when the third terminal 2412 and the fourth terminal 2421 are attached together, so as to keep the third terminal 2412 and the fourth terminal 2421 fixed.
[0084] like Figure 5 and Figure 6 As shown, the locking nut 244 is engaged with the fourth terminal 2421 and can rotate 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 that mates with the first thread.
[0085] The locking nut 244 is located on the fourth terminal 2421, which serves as the male connector, to facilitate its connection 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, being located on the fourth terminal 2421, is close to the hand of the medical staff. Furthermore, the locking nut 244 moves from bottom to top during tightening, conforming to user habits and allowing for convenient tightening. In addition, the second connector 242 is essentially free before engaging with the first connector 241. The locking nut 244 on it provides greater operational flexibility, allowing the user to align and engage the second connector 242 with the first connector 241 before performing the fixing operation, avoiding unnecessary steps.
[0086] The connector 240 also includes a seal 400 for sealing between the first connector 241 and the second connector 242. The first connector 241 has a first liquid flow channel communicating with the vent 243, and the second connector 242 has a second liquid flow channel. After the first connector 241 and the second connector 242 are connected, the first liquid flow channel and the second liquid flow channel are connected. The seal 400 is used to prevent liquid (including flushing or infusion fluid used during the venting stage and blood during the transfer process) from leaking from the connection between the first liquid flow channel and the second liquid flow channel when flowing through the connector 240.
[0087] The sealing element 400 can be positioned in several ways: First, the sealing element 400 is located on the inner wall of the third terminal 2412. Second, the sealing element 400 is located on the outer wall of the fourth terminal 2421. Third, the sealing element 400 is located on both the inner wall of the third terminal 2412 and the outer wall of the fourth terminal 2421.
[0088] The sealing method of seal 400 can be either side sealing or end face sealing. For example... Figure 5 As shown, when a side seal is used, the seal 400 is fitted onto the outer wall of the fourth terminal 2421, and the outer wall of the fourth terminal 2421 has an annular groove for embedding the seal 400. For example, the seal 400 is an O-ring, and the seal 400 is pressed between the outer wall of the fourth terminal 2421 and the inner wall of the third terminal 2412. Figure 6 As shown, when end face sealing is used, the cross section of the seal 400 in the insertion direction is trapezoidal or rectangular, and the seal 400 is disposed on the end face of the fourth terminal 2421.
[0089] The first connector 241 penetrates the wall of the organ box 210 and is sealed to the wall of the organ box 210. The wall of the organ box 210 is provided with a connection hole for the first connector 241 to pass through. The first connector 241 is sealed to the connection hole, thereby preventing bacteria from the external environment from entering the organ box 210, so as to maintain a sterile environment inside the organ box 210 during subsequent cardiac transport.
[0090] The outer wall of the first connector 241 is provided with a retaining protrusion 2413 located outside the organ box 210. The retaining protrusion 2413 extends perpendicular to the insertion direction of the first connector 241 and the second connector 242. After the first connector 241 and the second connector 242 are fastened together by the locking nut 244, the retaining protrusion 2413 and the end face of the locking nut 244 near the first connector 241 clamp the wall of the organ box 210. This gives the connector 240 the advantages of stable and reliable connection. Furthermore, the close fit between the retaining protrusion 2413 and the wall of the organ box 210 also seals the connection hole on the organ box 210.
[0091] In this embodiment, the power unit 230 is a magnetically levitated blood pump, used to provide power for the flow of liquid (blood, flushing fluid, or perfusion fluid) in the circulation loop 200. Figure 7 As shown, the power unit 230 includes a motor 231 and a pump head detachably coupled to the motor 231. The pump head includes a pump housing 232 and an impeller housed in the pump housing 232 and driven to rotate by the motor 231 to power blood flow.
[0092] The magnetic levitation blood pump can adopt the existing structure represented by CN111561519B, CN110711275B, CN305927879S, or conform to or approximate the features described in the above representative patents. It uses a magnetic levitation bearing, so that the impeller is suspended in the pump housing 232, which reduces or even avoids the damage to blood cells caused by conventional mechanical bearings and avoids hemolysis.
[0093] The pump housing 232 has an inlet connector 233 located in the axial direction of the pump housing 232 and an outlet connector 234 located in the tangential direction of the pump housing 232. The inlet connector 233 is used to allow liquid to flow into the pump housing 232, and the outlet connector 234 is used to allow liquid to flow out of the pump housing 232. An impeller is housed inside the pump housing 232, and the motor 231 drives the impeller to rotate, thereby drawing blood into the pump housing 232.
[0094] The outlet connector 234 is higher than the inlet connector 233, and the intersection of the outlet connector 234 and the pump casing 232 is located at the highest point of the gravitational potential energy of the pump casing 232. As a result, the gas mixed in through the inlet connector 233 in the pump casing will automatically float to the outlet connector 234, which facilitates the discharge of gas from the pump casing 232 and the pipeline connected to the pump casing 232.
[0095] In this embodiment, the motor 231 operates intermittently. During exhaust, the motor 231 is stopped, and air bubbles inside the pump housing 232 rise to the outlet connector 234 of the pump housing 232. When the motor 231 restarts, the air bubbles are expelled from the pump housing 232. Conversely, if the motor 231 operates continuously instead of intermittently, a vortex will form in the middle of the pump housing 232, and air bubbles mixed in with the blood will participate in the vortex, without time to rise, thus hindering the expulsion of gas from the pump housing 232.
[0096] The impeller has a central axis M, which rotates around the central axis M under the drive of the motor 231. The central axis M passes through the inlet connector 233 along the axial direction of the inlet connector 233. The impeller is driven to rotate by the motor 231 through magnetic coupling technology.
[0097] Considering that the impeller is suspended within the pump casing 232, to reduce the influence of gravity on the impeller's suspension, the power unit 230 is inclined on the bearing device 100 so that the inlet connector 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 even further between 30° and 55°. The above-mentioned angles can be integer values such as 5°, 10°, 15°, 20°, 25°, 30°, 35°, 40°, 45°, 50°, 55°, 60°, 65°, 70°, 75°, 80°, and 85°, or they can be angles increasing in increments of 1°, 2°, 3°, 4°, 6°, 7°, 8°, and 9° between 5° and 85°.
[0098] like Figure 2 As shown, the circulation loop 200 also includes a blood bag 220, an oxygenator 290, a temperature control device 292, a first detection unit 250, a second detection unit 260, a first sampling unit 270, and a second sampling unit 280, all mounted on the piping assembly. The organ box 210, power unit 230, blood bag 220, oxygenator 290, temperature control device 292, first detection unit 250, second detection unit 260, first sampling unit 270, and second sampling unit 280 mounted on the piping assembly are collectively referred to as functional components. These functional components are connected through the piping assembly to form a circulation loop.
[0099] The arrangement of the above-mentioned functional components on the piping assembly is as follows: organ box 210, second detection unit 260, blood bag 220, power unit 230, temperature control 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 piping assembly. The arrangement of the above-mentioned functional components can be adjusted according to actual conditions, and the scope of protection of this invention is not limited thereto.
[0100] The blood bag 220 is located between the organ box 210 and the power unit 230. Driven by the power unit 230, the blood bag 220 continuously supplies blood to the heart through the tubing assembly, so that the heart maintains the same or similar blood environment as the body during transport, thus avoiding damage to the heart due to ischemia during transport.
[0101] Combination Figure 19 As shown, the blood bag 220 has an internal cavity for storing blood. The blood bag 220 is equipped with an inlet connector 221 and an outlet connector 222 that communicate with the cavity. The inlet connector 221 and outlet connector 222 are respectively connected to a tubing assembly. The outlet connector 222 is located at the bottom of the blood bag 220, allowing blood to flow out naturally under gravity. The inlet connector 221 can be located at the bottom, top, or side of the blood bag 220, depending on the specific application.
[0102] The tubing assembly includes a first flow channel connecting the outlet connector 222 of the blood bag 220 to the first terminal 2411, and a second flow channel connecting the inlet connector 221 of the blood bag 220 to the heart. The end of the first flow channel away from the blood bag 220 constitutes the outlet end of the tubing assembly, and the end of the second flow channel away from the blood bag 220 constitutes the inlet end of the tubing assembly.
[0103] The second flow channel includes a third connecting tube 293 located inside the organ box 210 for connection to the heart, a connector 295 located on the wall of the organ box 210 and connected to the third connecting tube 293, and a fourth connecting tube 294 located outside the organ box 210 and connected to the connector 295. One end of the third connecting tube 293 is the inlet end of the tubing assembly, and the other end is used to connect to the connector 295. The connector 295 is used to connect the third connecting tube 293 and the fourth connecting tube 294, and the fourth connecting tube 294 is used to connect the connector 295 and the blood bag 220.
[0104] Since the external temperature is variable, in order to simulate the internal temperature environment of the human body as much as possible, the temperature control device 292 is used to keep the blood in the pipeline assembly warm or cool it down so that the blood temperature is maintained between 32℃ and 42℃, so as to avoid the impact of temperature changes on the heart.
[0105] In practice, the temperature control device 292 is more commonly used for heat preservation than for cooling.
[0106] The power unit 230, temperature control device 292, oxygenator 290, and first detection unit 250 are sequentially arranged on the first flow channel. The oxygenator 290 and temperature control device 292 are located between the power unit 230 and the connector 240. The temperature control device 292 can be positioned in several ways: First, it is positioned between the oxygenator 290 and the power unit 230 to increase the temperature of the deoxygenated blood entering the oxygenator 290, thereby improving oxygenation efficiency (oxygenation efficiency is positively correlated with temperature). Second, it is positioned between the oxygenator 290 and the connector 240 to increase the temperature of the oxygenated blood entering the heart (generally ensuring a minimum of 34°C), achieving warm blood transport. Third, temperature control devices 292 are installed both between the oxygenator 290 and the power unit 230, and between the oxygenator 290 and the connector 240.
[0107] It is worth noting that the warm blood transport of organs relies not only on the temperature control device 292, but also on the oxygenator 290, which provides assistance or contribution to this purpose. It is known that, to improve oxygenation efficiency, the oxygenator 290 generally has built-in heat preservation or heating functions, which can achieve a certain degree of temperature rise in the blood, as described later.
[0108] The temperature control device 292 includes at least a first temperature control sleeve 2921 wrapped around the outer wall of the first connecting pipe 297 portion located between the oxygenator 290 and the power unit 230 in the first flow channel, a second temperature control sleeve 2922 wrapped around the outer wall of the second connecting pipe 298 portion located between the oxygenator 290 and the connector 240 in the first flow channel, a first temperature control element (not shown) disposed in the first temperature control sleeve 2921, and a second temperature control element (not shown) disposed in the second temperature control sleeve 2922.
[0109] In one optional embodiment, the temperature regulating element is a heating wire, which is embedded or pre-embedded in the temperature regulating sleeve. The temperature regulating sleeve has a side cut that runs through its length, making it easy to pry open the temperature regulating sleeve and thus conveniently fit it onto the connecting pipe.
[0110] In another feasible embodiment, the temperature regulating element can be a channel formed in the temperature regulating sleeve for the flow of heating fluids such as water, oil, or heat transfer medium. The channel connects to an external heat source, such as a water tank, to achieve the circulation of the heating fluid.
[0111] By setting a temperature control device 292, the temperature of the deoxygenated blood to be introduced into the oxygenator 290 is increased, while the temperature of the oxygenated blood to be introduced into the heart is also increased, thereby maximizing the preservation of the heart's activity.
[0112] The temperature control achieved or maintained by the temperature regulating sleeve and temperature regulating element is controlled by their length. In this embodiment, the length of the temperature regulating sleeve is between 0.3 and 1 m, more preferably between 0.4 and 0.8 m, and even more preferably between 0.5 and 0.7 m. For example, it can be 0.3 m, 0.5 m, 1 m, etc., or the value can increase in increments of 0.1 m between 0.3 m and 1 m.
[0113] Both the first and second flow channels include several connecting pipes for connecting adjacent functional components. Preferably, these connecting pipes are flexible hoses to provide space for adjusting the position of the functional components.
[0114] The oxygenator 290 is used for gas replacement of blood, specifically oxygenating the blood and removing carbon dioxide. The oxygenator 290 is connected to an external oxygen supply device 291, which supplies oxygen to the oxygenator 290. Figure 1 and Figure 2 As shown, the oxygen supply device 291 is an oxygen cylinder, and the support device 100 is provided with a recessed portion for at least partially embedding the oxygen cylinder. Next to the recessed portion is a retaining component for fixing the oxygen cylinder, such as a rotating clamp.
[0115] The oxygenator 290 includes a housing and a heating module. The housing has a blood inlet, a blood outlet, a gas inlet, and a gas outlet. The heating module is arranged inside the housing between the blood inlet and the blood outlet to control the temperature of the flowing blood. The gas inlet is connected to the oxygen supply device 291.
[0116] The heating module can be a heating wire or a heated liquid that has a certain temperature and is connected to an external container such as a water tank. The following explanation uses the heating of blood entering the oxygenator 290 with water at a certain temperature as an example.
[0117] The oxygenation membrane is a hollow fiber membrane with internal fluid channels. The channel walls of the oxygenation membrane have small molecular pores, allowing gas to pass through while isolating liquids. The shell also has an inlet and an outlet. Warm water is introduced into the oxygenation membrane to heat the blood before it is discharged through the outlet.
[0118] The first sampling unit 270 is used to obtain blood samples from the tubing assembly before it enters the heart and / or to inject medication into the tubing assembly. The second sampling unit 280 is used to obtain blood samples from the tubing assembly after it exits the heart and / or to inject medication into the tubing assembly.
[0119] By comparing changes in blood parameters before and after flowing into and out of the heart, the quality of the blood can be fully assessed. When blood parameters do not meet preset requirements, medication can be injected into the tubing assembly through the first sampling unit 270 and the second sampling unit 280 to adjust the blood parameters and ensure that the blood meets the usage requirements, thereby guaranteeing the physiological function of the heart outside the body.
[0120] like Figure 2 As shown, the first sampling unit 270 includes a first sampling port disposed on a first flow channel and located between the oxygenator 290 and the first terminal 2411, a first sampling tube 271 connecting the first sampling port and the second flow channel, and a first sampling device 272 disposed on the first sampling tube 271. The first sampling device 272 includes at least a first sampling interface 2721 for sampling and a first injection interface 2722 for injecting a drug solution into the first sampling tube 271. The junction of the first sampling tube 271 and the second flow channel is located on the fourth connecting pipe 294 of the second flow channel. The injection interface 2722 is connected to an injection pump via a pipeline.
[0121] The first sampling device 272 has three interfaces: a first sampling interface 2721, a first injection interface 2722, and a first spare interface. The first spare interface can be set as either a sampling interface or an injection interface as needed. Of course, the number of interfaces of the first sampling device 272 can also be four, five, or other numbers, which will not be elaborated here.
[0122] Similarly, the second sampling unit 280 includes a second sampling port located on the second flow channel between the organ box 210 and the inlet connector 221, a second sampling tube 281 connecting the second sampling port to the aforementioned first sampling tube 271, and a second sampling device 282 provided on the second sampling tube 281. The second sampling device 282 includes at least one second sampling interface 2821 for sampling and one second injection interface 2822 for injecting a drug solution into the second sampling tube 281. The second sampling device 282 also has three interfaces: the second sampling interface 2821, the second injection interface 2822, and a second spare interface.
[0123] The first sampling port of the first sampling unit 270 is located on the first flow channel via a tee P, and the second sampling port of the second sampling unit 280 is located on the second flow channel via a tee Q. The sampling devices 272 and 282 can be N-ports, where N is greater than or equal to 4, such as a five-port, where two ports are connected to the pipeline, and the remaining three ports form the sampling interface, the injection interface, and the spare interface.
[0124] When sampling is not required, simply seal the sampling port. When sampling is needed, open the sampling port. Alternatively, the sampling port may have a flexible hemostatic valve. When sampling is required, insert the appropriate device, such as a sampling tube, to perform the sampling. After removing the device, the hemostatic valve automatically closes, achieving a seal.
[0125] The first detection unit 250 and the second detection unit 260 are used to detect the flow rate and / or pressure of blood entering and exiting the heart within the tubing assembly. The first detection unit 250 is located in the first flow channel of the tubing assembly, between the oxygenator 290 and the first terminal 2411, and is used to detect the flow rate and / or pressure of blood before it enters the heart. The second detection unit 260 is located in the second flow channel of the tubing assembly, between the organ box 210 and the inlet connector 221, and is used to detect the flow rate and / or pressure of blood after it exits the heart. The first detection unit 250 includes a first pressure sensor 251 and a first flow rate sensor 252. The second detection unit 260 differs from the first detection unit 250 in its location; therefore, the second detection unit 260 will not be described in detail here.
[0126] like Figure 1 and Figure 20 As shown, the organ box 210 includes a housing 2101 with an open end and a cover assembly 2102 detachably connected to the housing 2101. The housing 2101 is used to hold the heart, and the cover assembly 2102 is used to seal the open end of the housing 2101 to prevent bacteria, air and other external impurities from entering the organ box 210 and to create a sterile environment.
[0127] The shell 2101 is made of a rigid material to give it a fixed shape and protect the heart. The bottom inner side of the shell 2101 is provided with a flexible cushioning layer 2104, such as a foam cushioning layer, which cushions and absorbs shocks to protect the heart and reduce damage to the heart.
[0128] The covering assembly 2102 includes a cover 2105 that detachably covers the open end of the housing 2101, and a wrapping member 2106 located between the cover 2105 and the housing 2101. The wrapping member 2106 includes a hollow frame 2107 and a membrane 2103 disposed on the frame 2107. The frame 2107 is operatively fitted into the open end of the housing 2101, and the membrane 2103 operatively wraps around the heart and at least partially fills the empty space between the heart and the housing 2101.
[0129] The package 2106 and the cover 2105 can be separate or integrated structures; for example, the package 2106 can be rotatably connected to the cover 2105. The film 2103 is mounted on the open end of the shell 2101 via a frame 2107. The film 2103 can be a plastic film; preferably, the film has three layers to create a better sealing environment.
[0130] The multi-layered membrane, when closely fitted to the heart, stabilizes the heart's position within the housing 2101, reducing heart movement during transport and maximizing heart protection to minimize or even avoid trauma. Furthermore, when the covering assembly 2102 is applied to the open end, the heart is confined within the space enclosed by the buffer layer 2104 and the membrane 2103, offering excellent positioning effectiveness.
[0131] The cover 2105 is equipped with a visualization window, which has an outward convex spherical or near-spherical structure to magnify the real image, making it easier for medical staff to observe the state of the heart during transportation and preservation.
[0132] In certain applicable scenarios, when the heart needs to be transported over long distances, it may involve significant changes in external temperature. For example, a heart might be transported from a low-latitude Hainan to a high-latitude Beijing, or vice versa. During this transport, the temperature difference between the heart's surface and the external environment is substantial. If the aforementioned covering 2103 is not applied to the heart, water vapor evaporating from the heart's surface will condense on the visualization window of the cover 2105, forming water mist on the inner wall of the window and affecting the observation results.
[0133] By wrapping the heart with the membrane 2103, although water vapor evaporating from the heart's surface will still condense on the inner surface of the membrane 2103 to form water mist, the water vapor is confined to a small area and does not affect the visualization effect of the visualization window. In some preferred embodiments, the organ box 210 is provided with an air extraction section. When air is expelled through the air extraction section, the membrane 2103 can fit the heart better.
[0134] The cover 2105 and the package 2106 are separate components, and are pivotally connected to the same lateral edge of the open end. Because the cover 2105 and the package 2106 are pivotally connected, even when the open end is open, they remain attached to the housing 2101, preventing the cover component 2102 from being lost or falling off, thus offering the advantage of ease of use.
[0135] During the transport of the heart within the organ container 210, waste blood dripping from the heart will accumulate within the container. This waste blood has three sources: First, the heart inevitably carries blood when removed from the body, and this blood will enter the organ container 210 along with the heart. Second, some blood will seep out and drip into the organ container 210 during the heart's beating process. Third, the heart is typically equipped with a pressure relief tube 296, one end of which is connected to the left ventricle, and the other end is a free end to facilitate pressure relief from the heart. In this embodiment, an incision is made in the left ventricle, and then the pressure relief tube 296 is inserted. Blood flowing out of the left ventricle due to compression will flow into the organ container 210 through the pressure relief tube 296.
[0136] The organ box 210 is also equipped with a waste blood connector 2108. Correspondingly, the blood bag 220 is equipped with a recycling connector 223, and the waste blood connector 2108 and the recycling connector 223 are connected by a recycling pipe 2231. Thus, the waste blood in the organ box 210 can enter the blood bag 220 for recycling through the recycling pipe 2231.
[0137] The blood bag 220 is also equipped with a vent 224 located at the top of the blood bag 220, which communicates with the receiving cavity of the blood bag 220. To facilitate the expulsion of gas from the receiving cavity when liquid is injected into the blood bag 220, an injection port 225 is also provided on the top of the blood bag 220. Both the vent 224 and the injection port 225 are equipped with valves that can be opened and closed. The injection port 225 is used to inject liquid into the blood bag 220, which can be blood, flushing fluid / infusion fluid, etc.
[0138] The recovery connector 223 is located below the venting port 224; preferably, the recovery connector 223 is located at the bottom of the blood bag 220. A recovery tube 226 is provided inside the blood bag 220. The lower end of the recovery tube 226 is connected to the recovery connector 223, and the upper end passes through the venting port 224. A drainage channel is formed between the upper end of the recovery tube 226 and the venting port 224. The recovery tube 226 is approximately vertical inside the blood bag 220 and is inserted approximately vertically into the venting port 224. In actual operation, it has been found that when the recovery tube 226 is inserted approximately vertically into the venting port 224, waste blood in the organ box 210 can smoothly enter the receiving cavity of the blood bag 220 for recovery. Furthermore, when the waste blood contains a small amount of gas (such as air), gas-liquid separation can be achieved at the venting port 224, allowing the gas mixed in the waste blood to be smoothly discharged through the filling port 224.
[0139] The buffer layer 2104 is provided with multiple flow channels 2109 for guiding blood that seeps from the heart to the waste blood connector 2108, so that the waste blood in the organ box 210 is concentrated at the waste blood connector 2108. The flow channels 2109 are branched.
[0140] like Figure 1 As shown, the supporting device 100 includes: a movable trolley 110, a support panel 120 disposed on the trolley 110, and an organ box 210 disposed on the support panel 120. Figure 21 As shown, the trolley 110 is provided with a side panel 112 and a top cover 113 rotatably disposed on the side panel 112 to operably cover the organ box 210.
[0141] like Figure 9 and Figure 10 As shown, the support panel 120 has a blood-blocking flange 126 extending towards the enclosure 112 at its edge, and the distance between the upper end of the blood-blocking flange 126 and the lower end of the enclosure 112 is no more than 5mm. This prevents blood from splashing outwards during cardiac transport or when operating the aortic connector, thus collecting and controlling blood splashes within a limited range. Afterwards, only the upper surface of the support panel 120 needs to be cleaned, effectively preventing blood from spraying into the external environment.
[0142] The trolley 110 has a receiving space formed below the support panel 120, which is used to house the power unit 230 and the infusion pump. The power unit 230 and the infusion pump are both located at the bottom of the trolley 110, and the blood-proof flange 126 is used to prevent blood from contaminating the power unit 230 and the infusion pump below.
[0143] The distance between the upper end of the blood-blocking flange 126 and the lower end of the surrounding plate 112 can be 5mm, 4mm, 3mm, 2mm, 1mm, 0mm, etc., or it can be an increase of 0mm to 5mm in 0.1m increments.
[0144] The trolley 110 is equipped with wheels 114 and handles 115 to facilitate the transport of the organ box 210. Considering that the support panel 120 is not a consumable and is not frequently replaced, the support panel 120 is securely connected to the trolley 110.
[0145] like Figure 14 As shown, the support panel 120 is provided with a hook 127, and the trolley 110 is provided with a crossbeam 111 that cooperates with the hook 127. The hook 127 is hung on the crossbeam 111 and fastened by screws or pins, which has the advantages of simple connection structure and stable and reliable connection.
[0146] Once the organ box 210 is installed on the support panel 120, the position of the circulation loop 200 relative to the support device 100 is fixed. The above-mentioned "the position of the circulation loop 200 relative to the support device 100 is fixed" means that each functional component on the circulation loop 200 has a fixed installation position on the support device 100. Once one functional component is installed, the installation positions of the other functional components are fixed.
[0147] like Figures 8 to 14 As shown, the trolley 110 is equipped with a power unit 230 and an oxygen supply device 291. The support panel 120 is equipped with an oxygenator bracket 129 for mounting the oxygenator 290 and a blood bag mounting area 125 for mounting the blood bag 220. A blood bag clamping member 1251 is provided at the blood bag mounting area 125. The blood bag clamping member 1251 is pivotally mounted on the support panel 120 and is configured to confine the blood bag 220 within the blood bag mounting area 125.
[0148] like Figures 8 to 10 As shown, the organ box 210 is mounted on the support panel 120 via a bracket 300, and the organ box 210 is located on the upper surface of the bracket 300. The upper surface of the bracket 300 is inclined, having a high end and a low end, so that the organ box 210 is inclined on the bracket 300. 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, thereby facilitating venting and waste blood discharge.
[0149] Regarding the installation of the organ box 210, considering the different heart sizes in different scenarios, such as adults and children, the organ box 210 may need to be replaced. Therefore, the organ box 210 and the bracket 300 are detachably connected. Figure 12 and Figure 16 As shown, the lower surface of the 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 hooking part 320 near the high end for engaging with the hook 211 and a mating part near the low end for engaging with the limiting protrusion 212.
[0150] like Figures 12 to 18 As shown, the upper surface of the bracket 300 is recessed downward to form a support groove 310. The support groove 310 is inclined in the vertical direction, and the hook part 320 and the mating part are located at the bottom of the support groove 310. When the organ box 210 is placed on the bracket 300, the bottom of the shell 2101 of the organ box 210 is received in the support groove 310, and the covering assembly 2102 of the organ box 210 is completely located outside the support groove 310.
[0151] The bottom of the support groove 310 has an opening, and the hook 211 is hooked onto the lower edge 321 of the opening. The area on the lower edge 321 that engages with the hook 211 is the hooking part 320. After the hook 211 is hooked onto the hooking part 320, the engagement between the hook 211 and the hooking part 320 prevents the organ box 210 from slipping off the bracket 300 under its own weight, thereby keeping the organ box 210 on the bracket 300.
[0152] like Figure 18 As shown, the cross-section of the hook 211 and the hook-attachment 320 is partially arc-shaped. The aforementioned "cross-section" refers to the cross-section obtained through a vertical plane. The hook 211 and the hook-attachment 320 form an arc-shaped contact, and the hook 211 has the freedom to rotate around the hook-attachment 320, which facilitates the hook 211 to be hung on the hook-attachment 320 and has the advantage of easy assembly and disassembly.
[0153] like Figure 17 As shown, a pair of protruding ribs 322 are also provided at the lower edge 321, located on the outside of the support groove 310. The protruding ribs 322 are located on opposite sides of the hook part 320. When the hook 211 is hooked on the lower edge 321, the protruding ribs 322 are located on opposite sides of the hook 211, which can limit the position of the organ box 210 in the left and right directions. As a result, the organ box 210 is not easy to shake, which can make the heart more stable when placed in the organ box 210.
[0154] The hook 211 is inclined downwards and is roughly "L" or "C" shaped, which can be easily hung on the lower edge 321 of the hook part 320. Multiple hooks 211 can be provided, and multiple hooks 211 are distributed along the extension direction of the lower edge 321 to make the hanging more stable and reliable.
[0155] like Figure 16 As shown, the mating part is the lower edge of the support groove 310, and the limiting protrusion 212 forms a friction pair after abutting against the lower edge. After the limiting protrusion 212 abuts against the bottom edge of the second surface, the limiting protrusion 212 is located below the mating part, and the mating part has the function of preventing the organ box 210 from moving upward, preventing the organ box 210 from having an upward movement, thereby preventing the hook 211 from disengaging from the hook part 320. In addition, since a friction pair is formed between the limiting protrusion 212 and the mating part, the friction between the organ box 210 and the bracket 300 is increased, thereby making the organ box 210 stably supported on the bracket 300. Therefore, the organ box 210 has the advantage of stable and reliable connection.
[0156] Understandably, the aforementioned mating part can also be a groove (not shown in the figure) provided at the bottom of the support groove 310, with the limiting protrusion 212 inserted into the groove, thereby restricting the upward movement of the organ box 210 and preventing the hook 211 from disengaging from the hook part 320.
[0157] The bracket 300 is inserted into the support panel 120 and is securely connected to the support panel 120 by fasteners 122. Thus, the bracket 300 and the organ box 210 can be removed from the support panel 120 for disinfection or maintenance, which has the advantages of convenient disassembly and assembly and reliable connection.
[0158] For the installation of bracket 300, such as Figure 10 and Figure 12 As shown, the upper surface of the support panel 120 is provided with a first insertion structure 121, and the lower surface of the bracket 300 is provided with a second insertion structure 330 that engages with the first insertion structure 121. The bracket 300 is inserted into the support panel 120 through the engagement between the first insertion structure 121 and the second insertion structure 330.
[0159] One of the first insertion structure 121 and the second insertion structure 330 is constructed as a locking block, and the other includes a slot for receiving the locking block. The locking block and the slot are engaged, making installation convenient and secure. Both the first insertion structure 121 and the second insertion structure 330 are block-shaped. The first insertion structure 121 is symmetrically arranged on the support panel 120, and the second insertion structure 330 is symmetrically arranged on the bracket 300.
[0160] like Figure 11 As shown, the first insertion structure 121 has a slot 1211 for insertion of the second insertion structure 330. The slot 1211 is open in a horizontal direction, and the bracket 300 is configured to move on the support panel 120 after being placed on it, so that the locking block enters or exits the slot 1211. The "it" refers to the support panel 120.
[0161] The support panel 120 has a threaded hole 123, and the bracket 300 has a notch 340, which opens in the installation and insertion direction. The installation and insertion direction is the direction in which the bracket 300 moves during the process of the card block entering the slot 1211.
[0162] The bracket 300 is fixed to the support panel 120 by fasteners 122, such as Figure 23 As shown, the fastener 122 includes: a screw 1221 screwed into a threaded hole 123, and a knob 1222 disposed on the top of the screw 1221. Figure 9 and Figure 10 As shown, the moving direction of the fastener 122 is perpendicular to the mounting and insertion direction of the bracket 300 on the support panel 120. For example, if the mounting and insertion direction is horizontal, then the moving direction of the fastener 122 is vertical.
[0163] After the bracket 300 is inserted into the support panel 120, the screw 1221 of the fastener 122 is housed in the notch 340, and the knob 1222 is located directly above the notch 340. At this time, by rotating the knob 1222, the installation of the bracket 300 and the support panel 120 can be completed, which has the advantage of convenient installation.
[0164] Furthermore, such as Figure 12 and Figure 13 As shown, the lower surface of the bracket 300 is provided with a downwardly extending limiting post 341 at the edge of the notch 340, and the upper surface of the support panel 120 is recessed downward to form a limiting groove 124 for cooperating with the limiting post 341. The limiting groove 124 is approximately coaxial with the threaded hole 123 and the hole diameter is larger than the hole diameter of the threaded hole 123.
[0165] The limiting post 341 is used to limit the position of the notch 340. After the bracket 300 is installed on the support panel 120, the limiting post 341 is inserted into the limiting groove 124 and abuts against the circumferential wall of the limiting groove 124, thereby making the relative positional relationship between the bracket 300 and the support panel 120 more accurate and having the advantage of high installation accuracy.
[0166] A sealing ring 128 is also provided between the fastener 122 and the threaded hole 123. The sealing ring 128 is used to prevent the splashed blood accumulated in the blood-blocking flange 126 from leaking outward, thereby realizing the collection and control of blood splash within a limited range.
[0167] This invention also provides a method for venting air from a warm-blooded organ transport platform. Although this invention provides the method operation steps as described in the following embodiments or flowcharts, based on conventional or non-inventive methods, the method may include more or fewer operation steps. Furthermore, for steps in the method that do not logically have a necessary causal relationship, the execution order of these steps is not limited to the execution order provided in the embodiments of this invention.
[0168] like Figure 24 As shown, the exhaust method includes:
[0169] Step S10: Before the donor organ is connected to the circulatory loop 200, the inlet and outlet ends of the tubing assembly are connected using a replacement tubing (not shown in the figure);
[0170] Step S20: Flushing fluid is injected into the filling port 225 on the blood bag 220. The flushing fluid displaces the gas in the pipeline assembly and flows forward, causing at least a portion of the gas to be discharged from the gas outlet of the oxygenator 290, wherein the gas outlet is in communication with the atmosphere.
[0171] Step S30: When the flushing fluid has been filled to at least the power unit 230, control the power unit 230 to be turned on;
[0172] Step S40: Continue to inject flushing fluid into injection port 225 until the injection fluid fills the circulation loop 200 and the replacement pipeline.
[0173] Before connecting the heart to the organ box 210, the tubing assembly needs to be purged to prevent air from remaining inside during subsequent connection to the heart and establishment of circulation. The purging fluid can be physiological saline.
[0174] Before the step of infusing flushing fluid into the infusion port 225, the method further includes opening the vent port 224 of the blood bag 220. During the forward flow of flushing fluid displacing gas in the tubing assembly, at least some gas is discharged from the vent port 224. Since gas discharge flow rate is related to resistance, and in practice, gas is discharged from the oxygenator 290 due to the resistance of the oxygenation film, the flow rate of gas discharged from the vent port 224 is greater than the flow rate of gas discharged from the gas outlet of the oxygenator 290. That is, during the venting phase before cardiac access, the vent port 224 on the blood bag 220 is actually the primary gas discharge channel.
[0175] The steps for controlling the start of the power unit 230 include: when flushing fluid is detected to have reached the pump head, controlling the start of the motor 231 and causing the motor 231 to operate intermittently. Specifically, since the outlet connector 234 is higher than the inlet connector 233, the gas mixed in through the inlet connector 233 in the pump casing will automatically rise to the outlet connector 234, thereby facilitating the discharge of gas from the pump casing 232 and the pipeline connected to the pump casing 232.
[0176] After the perfusion fluid fills the circulation loop 200 and replacement tubing to purge the gas, blood can then be perfused into the perfusion port 225 of the blood bag 220, allowing the perfusion fluid (physiological saline) to mix with the blood. This achieves blood perfusion without draining the perfusion fluid. The perfused blood comes from the donor and can be obtained from the donor using the blood collection kit provided in application number 2021213153778. The extracted blood is then perfused from the kit into the blood bag 220, gradually completing the perfusion of the entire circulation loop 200 and replacement tubing.
[0177] Furthermore, after the gas has been purged and before blood is infused, the inlet connector 222 and / or outlet connector 221 of the blood bag 220 are opened to release a portion of the perfusion fluid from the blood bag 220. This provides space beforehand for blood perfusion. Simultaneously, since the circulation loop 200 (especially the blood bag 220) is filled with perfusion fluid, if there is no reserved space in the blood bag 220 when the perfusion port 224 is opened to infuse blood, the perfusion fluid may overflow. Releasing a portion of the perfusion fluid beforehand avoids this problem.
[0178] Following the steps of filling the blood-filled circulation loop 200 and replacing the tubing, 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 point of gravitational potential energy in the circulation loop 200. Then, sealing the inlet and outlet ends of the tubing assembly. Finally, removing the replacement tubing.
[0179] With the second connector 242 separated from the first connector 241, the heart is connected to the second terminal 2422 and the inlet of the tubing assembly, and then the third terminal 2412 and the fourth terminal 2421 are connected. Air mixed into the first connector 241 during the replacement process is discharged through the exhaust port 243.
[0180] During the above process, the exhaust port 243 is located at the highest point of the gravitational potential energy of the circulation loop 200, and air can overflow at the highest point, which is conducive to the exhaust of air from the circulation loop 200.
[0181] Obviously, the embodiments described above are merely some, not all, embodiments of the present invention. Based on the embodiments of the present invention, those skilled in the art can make other variations or modifications without creative effort, and all such variations or modifications should fall within the scope of protection of the present invention.
Claims
1. A warm-blooded organ transport platform, comprising a circulatory loop, said circulatory loop comprising: Organ boxes are used to hold donor organs; A tubing assembly having an inlet end and an outlet end, the inlet end being used for connection to a donor organ; A connector, disposed on the organ box, has a first terminal located outside the organ box and a second terminal located inside the organ box; the first terminal is used to connect to the outlet end, and the second terminal is used to connect to the donor organ; A blood bag, disposed on the tubing assembly, has an inlet connector and an outlet connector; the tubing assembly includes: a first flow channel connecting the outlet connector to the first terminal, and a second flow channel connecting the inlet connector to the donor organ; the end of the first flow channel away from the blood bag constitutes the outlet end, and the end of the second flow channel away from the blood bag constitutes the inlet end; A power unit, connected to the piping assembly, is used to power the flow of fluid between the circulation loop and the donor organ; An oxygenator is provided on the piping assembly and located between the power unit and the connector; The first sampling unit is located on the tubing assembly and is used to obtain a blood sample from the tubing assembly before it enters the donor organ. The blood bag is equipped with an exhaust port at the top and a recycling connector at the bottom. The recycling connector is connected to the organ box to recycle waste blood inside the organ box. The blood bag is equipped with a recycling tube, the lower end of which is connected to the recycling connector. The upper end of the recovery pipe passes through the exhaust port, and a drainage channel is formed between the upper end of the recovery pipe and the exhaust port.
2. The warm-blood organ transport platform as described in claim 1, The first sampling unit includes: A first sampling port is provided on the first flow channel, a first sampling tube connects the first sampling port and the second flow channel, and a first sampling device is provided on the first sampling tube; The first sampling port is located between the oxygenator and the first terminal, and the first sampling device includes at least one first sampling interface for sampling.
3. The warm-blood organ transport platform as described in claim 2, wherein the first sampling device further includes a first injection port, the first injection port being used to inject a drug solution into the first sampling tube.
4. The warm-blood organ transport platform as described in claim 2, The second flow channel includes: The third connecting pipe located inside the organ box, the connector located on the wall of the organ box, and the fourth connecting pipe located on the outside of the organ box; The connector is connected to the third connecting tube, and the fourth connecting tube is used to connect the connector to the blood bag; the intersection of the first sampling tube and the second flow channel is located on the fourth connecting tube.
5. The warm blood organ transport platform as described in claim 1, wherein the circulation loop further includes a second sampling unit, the second sampling unit being disposed on the tubing assembly, for obtaining a blood sample from the tubing assembly after the donor organ has flowed out.
6. The warm-blood organ transport platform as described in claim 5, The second sampling unit includes: A second sampling port is provided on the second flow channel, a second sampling tube is connected to the second sampling port and the first sampling tube, and a second sampling device is provided on the second sampling tube; The second sampling port is located between the organ box and the inlet connector, and the second sampling device includes at least one second sampling interface for sampling.
7. The warm-blood organ transport platform as described in claim 6, wherein the second sampling device further includes a second injection port for injecting a drug solution into the second sampling tube.
8. The warm-blood organ transport platform as described in claim 1, The power unit includes: Motor, and pump head detachably coupled to said motor; The pump head includes: a pump housing and an impeller housed in the pump housing; the impeller can be driven to rotate by the motor to provide power for liquid flow. The pump casing has an inlet connector and an outlet connector, with the outlet connector being higher than the inlet connector.
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