An active refrigerated perfusion system for isolated organs

Abstract

The application discloses an ex vivo organ perfusion system with active refrigeration, and belongs to the field of organ preservation, which comprises a preservation box, a preservation device, a refrigeration device and a perfusion device; the preservation device comprises a cold cavity and a liquid storage cavity arranged in the cold cavity; the cold cavity is internally stored with a cold accumulator and is connected with a cold release end of the refrigeration device, and the liquid storage cavity is filled with a perfusion liquid; the perfusion device comprises a perfusion pump and a bubble chamber, the liquid storage cavity and the bubble chamber are connected through an injection pipe, a flushing pipe and a perfusion pipe, the perfusion pump is connected in series on the injection pipe, and the end of the perfusion pipe is connected with an ex vivo organ; a temperature sensor and a controller are further arranged in the preservation box, a bubble sensor is arranged on the injection pipe and the perfusion pipe, a control valve is arranged on the flushing pipe and the perfusion pipe, and the controller is electrically connected with the temperature sensor, the refrigeration device, the perfusion pump, the control valve and the bubble sensor. The application can maintain the temperature stability of the ex vivo organ and avoid air damage, thereby realizing long-distance and long-time transportation.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of organ transportation technology, in particular to an active refrigeration ex vivo organ perfusion system. BACKGROUND

[0002] Organ transplantation is the most effective means for treating end-stage organ failure, and the so-called "organ transplantation" refers to the process of transplanting the still functional organs such as kidney, heart, liver and lung of a donor into a recipient by surgery to replace the damaged organs and work again. The emergence of organ transplantation gave birth to organ preservation technology. The success of any organ transplantation surgery cannot be achieved without high-quality donor organs, and organ preservation technology is to maximize the activity of organs during acquisition, transportation and surgery, and high-quality donor organs are the prerequisite for the success of organ transplantation surgery. At present, there are three types of organ preservation technology: static low-temperature preservation, low-temperature mechanical perfusion preservation and deep low-temperature preservation.

[0003] Low-temperature mechanical perfusion is a new type of organ preservation and transportation method, which has advantages in maintaining organ quality and reducing the incidence of postoperative primary non-function and delayed recovery of function. Low-temperature mechanical perfusion preservation refers to connecting the organ vessels to the perfusion system during organ preservation, and the peristaltic pump relies on external power to continuously circulate low-temperature preservation solution for the organ. Its advantages are that the continuous circulation of low-temperature preservation solution by the peristaltic pump can maintain low temperature and low metabolic activity of the organ, supplement nutrients and remove metabolic products generated during the preservation process in time, and can also flush the organ to reduce the formation of microthrombi and unblock the microcirculation, thereby playing a role in preserving and repairing the organ. Meanwhile, the biochemical indicators in the perfusion solution can also objectively evaluate the quality of the organ.

[0004] However, during long-distance transportation, the current organ low-temperature mechanical perfusion preservation equipment has limited cold storage capacity, and the internal temperature may rise, thereby affecting the quality of organ preservation. If the cold capacity is replenished, the external environment may cause internal contamination. Therefore, it is necessary to provide an active refrigeration ex vivo organ perfusion system to solve the above problems. SUMMARY

[0005] In view of the problem that the existing organ preservation and transportation equipment cannot maintain the internal temperature stable for a long time during transportation, the purpose of the present application is to provide an active refrigeration ex vivo organ perfusion system.

[0006] To achieve the above-mentioned purpose, the technical scheme of the present application is as follows:

[0007] An active refrigeration ex vivo organ perfusion system, comprising a preservation box, a preservation device installed in the interior of the preservation box and used for preserving an ex vivo organ, a refrigeration device used for providing cold capacity for the preservation device, and a perfusion device used for providing perfusion solution for the preservation device.

[0008] The storage device comprises a cold cavity arranged in the storage box and a liquid storage cavity arranged in the cold cavity; the cold cavity has a cold storage agent stored therein, the cold cavity is connected with a cold energy releasing end of the refrigeration device, and the liquid storage cavity is filled with perfusion liquid;

[0009] The perfusion device comprises a perfusion pump and a bubble chamber, the liquid storage cavity and the bubble chamber are connected through an injection pipe, the perfusion pump is connected in series on the injection pipe, the liquid storage cavity and the bubble chamber are further connected with a flushing pipe and a perfusion pipe, and an end of the perfusion pipe extending into the liquid storage cavity is connected with the isolated organ;

[0010] The storage box is further provided with a temperature sensor for detecting the temperature of the perfusion liquid or the cold storage agent and a controller for control, bubble sensors for detecting air are arranged on the injection pipe and the perfusion pipe, control valves are arranged on the flushing pipe and the perfusion pipe, and the controller is electrically connected with the temperature sensor, the refrigeration device, the perfusion pump, the control valves and the bubble sensors.

[0011] Further, a placing groove for placing the cold cavity is arranged in the storage box, and an outer wall of the placing groove is connected with the cold energy releasing end of the refrigeration device.

[0012] Preferably, a sandwich space for storing the cold storage agent is arranged in the cold cavity, and a filling opening is arranged on a side wall of the cold cavity and communicated with the sandwich space.

[0013] Further, a filter is further arranged on the injection pipe.

[0014] Preferably, the refrigeration device comprises an evaporating coil, a condenser, a compressor and a capillary tube connected in sequence, wherein the evaporating coil is the cold energy releasing end.

[0015] Further, the refrigeration device further comprises a fan and a drying filter, the drying filter is arranged on a pipeline connecting the condenser and the compressor, the fan is fixedly arranged in the storage box, an air current generated by the fan is directed to the condensing pipe, and a heat dissipation air hole is arranged on a side wall of the storage box.

[0016] Further, a display screen electrically connected with the controller is arranged on a side wall of the storage box.

[0017] Preferably, the preservation box comprises a box body and a box cover, the box body is divided into a left preservation area and a right equipment area by a vertical partition plate, the equipment area is divided into a lower refrigeration area and an upper control area by a horizontal partition plate, and a perfusion plate is fixedly installed on the top of the control area; wherein, the preservation equipment is installed in the preservation area, the refrigeration equipment is installed in the refrigeration area, a control panel carrying the controller and a power supply for power supply are installed in the control area, and the perfusion equipment is fixedly installed on the perfusion plate.

[0018] Preferably, the box cover is divided into a left cover and a right cover, the right cover is fixedly connected to the right side of the box body, the left side of the left cover is detachably connected to the box body through a lock buckle, and the left cover and the right cover are detachably connected through a safety lock.

[0019] Further, a handle is arranged on the side wall of the box body.

[0020] By adopting the above technical scheme, the application has the following beneficial effects:

[0021] 1. Due to the arrangement of the refrigeration equipment in the preservation box, when the temperature is detected to be too high, the cold quantity can be released to the preservation equipment by controlling the refrigeration equipment to work, so that the isolated organs are always in a suitable temperature range, thereby facilitating long-time transportation and preservation;

[0022] 2. The arrangement of the injection pipe and the perfusion pipe connected between the bubble chamber and the liquid storage cavity and the bubble sensor thereon makes the bubble sensor detect air bubbles, and then air is discharged from the pipeline by opening the flushing pipe and closing the perfusion pipe, and then the flushing pipe is closed and the perfusion pipe is opened, so that the perfusion liquid can continue to be continuously delivered to the isolated organs, thereby preventing air from entering the isolated organs and reducing damage;

[0023] 3. The arrangement of the cold cavity in the preservation box and the cold storage agent in the cold cavity makes it possible to pre-cool the cold cavity before use, so that the cold cavity can be quickly put into use when the organ needs to be transported, and the process of refrigerating the cold cavity is saved. BRIEF DESCRIPTION OF DRAWINGS

[0024] Figure 1 It is an external schematic view of the application;

[0025] Figure 2 It is a main view of the internal structure of the application after removing the front side wall of the box body;

[0026] Figure 3 It is a plan view of the internal structure of the application after removing the left cover;

[0027] Figure 4 It is a right view of the internal structure of the application after removing the right side wall of the box body;

[0028] Figure 5 Connection diagram of perfusion device in the present application;

[0029] Figure 6 Control principle diagram of the present application.

[0030] In the figure: 1-box, 101-left cover, 102-right cover, 103-lock, 104-safety lock, 2-vertical partition, 3-horizontal partition, 4-perfusion plate, 5-control plate, 6-power supply, 7-cold cavity, 8-liquid storage cavity, 9-putting groove, 10-evaporation coil, 11-condenser, 12-compressor, 13-capillary tube, 14-fan, 15-radiating air hole, 16-dry filter, 17-perfusion pump, 18-bubble chamber, 19-injection tube, 20-flushing tube, 21-perfusion tube, 22-control valve, 23-bubble sensor, 24-master switch, 25-display screen, 26-handles, 27-adaptor, 28-charging plate. DETAILED DESCRIPTION

[0031] The specific embodiments of the present application will be further described below with reference to the accompanying drawings. It should be noted that the description of these embodiments is used to help understand the present application, but does not constitute a limitation on the present application. In addition, the technical features involved in the various embodiments of the present application described below can be combined with each other as long as they do not conflict with each other.

[0032] It should be noted that in the description of the present application, the terms "upper", "lower", "left", "right", "front", "back" and the like indicate the orientation or positional relationship of the structure of the present application shown in the drawings, and are only for the convenience of describing the present application simply, and do not indicate or imply that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, therefore cannot be understood as a limitation on the present application.

[0033] For "first" and "second" in the present technical solution, it is only a distinction of the same or similar structure, or the corresponding structure with similar function, not the arrangement of the importance of these structures, nor the order, or comparison of size, or other meanings.

[0034] In addition, unless otherwise explicitly specified and limited, the terms "mounting", "connection" should be understood broadly, for example, the connection can be fixed connection, or detachable connection, or integrally connected; can be mechanical connection, or electrical connection; can be directly connected, or indirectly connected through intermediate medium, can be the communication inside two structures. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the overall idea of the present application and the specific circumstances of the present solution.

[0035] Example 1

[0036] An active cooling ex vivo organ perfusion system, such as Figures 1-4 As shown, the device includes a preservation box and preservation equipment, refrigeration equipment, and perfusion equipment installed inside the preservation box. The preservation equipment is used to preserve the excised organ, the refrigeration equipment provides cooling to the preservation equipment, and the perfusion equipment provides circulating perfusion fluid to the preservation equipment.

[0037] In this embodiment, the storage box includes a box body 1 and a lid covering the top of the box body 1. A handle 26 is provided on the side wall of the box body 1. The interior of the box body 1 is divided into a storage area on the left and an equipment area on the right by a vertical partition 2. The equipment area is further divided into a lower refrigeration area and an upper control area by a horizontal partition 3. A filling plate 4 is fixedly installed on the top of the control area. In this embodiment, the storage equipment is installed in the storage area, and the refrigeration equipment, except for the evaporator coil 10, is installed in the refrigeration area. A control board 5, installed on the top surface of the horizontal partition 3 and used for control purposes, is arranged in the control area. The filling equipment is fixedly installed on the filling plate 4. A power supply 6 for supplying power to the filling equipment and the refrigeration equipment is also installed in the refrigeration area.

[0038] In this embodiment, the storage device includes a cold chamber 7, a liquid storage chamber 8, and a placement tank 9.

[0039] The top surface of the cold cavity 7 is recessed inward to facilitate the placement of the liquid storage cavity 8. A space exists between the side wall of the recessed portion of the cold cavity 7 and the outer wall of the cold cavity 7 to store refrigerant. A filling port, communicating with this space, is provided on the top wall of the cold cavity 7. Two filling ports are symmetrically distributed for faster filling. After filling, the filling port is sealed with a cap or plug. The liquid storage cavity 8 is configured as a container-shaped structure adapted to the recessed portion of the cold cavity 7. The liquid storage cavity 8 is used to store excised organs and is filled with perfusion fluid. The side wall of the liquid storage cavity 8 has holes for the inflow and outflow of perfusion fluid to facilitate circulation of the perfusion fluid through the perfusion device. The top of the liquid storage cavity 8 has an opening for the excised organ to enter or exit, or the top is open, and it is usually equipped with a sealing cap.

[0040] In order to prevent the cold energy from being directly released to the outside through the box 1, the cold cavity 7 needs to be insulated. In this embodiment, a placing groove 9 is arranged in the storage area of the box 1. The placing groove 9 has an open top and is in a shell-shaped structure. The top of the placing groove 9 has an outwardly folded connecting piece which is fixed to the top surface or the upper side wall of the box 1 by screws. The circumferential side wall and the bottom wall of the placing groove 9 are spaced apart from the inner wall of the box 1. The existence of the gap can effectively reduce the heat transfer area between the placing groove 9 and the box 1, thereby reducing the loss of cold energy. Alternatively, the gap can be filled with a heat insulation material such as polyurethane foam. Since the placing groove 9 is arranged, the cold energy release end of the refrigeration device is directly connected to the placing groove 9, and then the cold energy is released to the cold cavity 7 and the liquid storage cavity 8 through the placing groove 9. Therefore, it can be understood that the materials of the cold cavity 7, the liquid storage cavity 8 and the placing groove 9 are all good heat-conducting materials such as stainless steel. In other preferred embodiments, the placing groove 9 can be omitted, and the heat insulation material can be directly filled between the outer wall of the cold cavity 7 and the inner wall of the box 1.

[0041] In this embodiment, the refrigeration device comprises an evaporating coil 10, a condenser 11, a compressor 12 and a capillary tube 13 which are connected in sequence and arranged in a loop. The evaporating coil 10 is the cold energy release end and is arranged in the storage area and surrounds the circumferential side wall and the bottom wall of the placing groove 9. The other components of the refrigeration device are arranged in the refrigeration area and only need to pass through the perforations in the vertical partition 2. During operation, the compressor 12 processes the refrigerant to a high-temperature and high-pressure state. The refrigerant then passes through the capillary tube 13 to be throttled and depressurized. Then, the refrigerant absorbs heat and evaporates in the evaporating coil 10 to provide cold energy for the storage device. Then, the low-pressure gaseous refrigerant enters the condenser 11 to be condensed into low-pressure refrigerant liquid and then enters the compressor 12 again to form a refrigeration cycle.

[0042] In order to prevent the heat dissipation of the compressor 12 and the heat release of the condenser 11 from affecting the use of the storage box, a fan 14 is installed in the refrigeration area and is close to the condenser 11. Meanwhile, the heat dissipation air holes 15 are arranged on the side wall of the box 1. In order to improve the heat dissipation efficiency, the fan 14, the condenser 11, the compressor 12 and the heat dissipation air holes 15 are arranged in a straight line. The airflow blown by the fan 14 passes through the condenser 11 and the compressor 12 in sequence and is then quickly discharged through the heat dissipation air holes 15. In addition, in order to prevent the water vapor in the refrigerant from affecting the use of the storage box, the refrigeration device further comprises a drying filter 16 which is installed on the pipeline (copper pipe) connecting the condenser 11 and the compressor 12.

[0043] In the embodiment, the perfusion device is configured to include a perfusion pump 17 and a bubble chamber 18. The bubble chamber 18 is configured as a housing with a certain volume, and three interfaces are arranged on the side wall of the bubble chamber 18. One of the interfaces is connected to the liquid outlet on the side wall of the liquid storage cavity 8 through the injection pipe 19, and the other two interfaces on the side wall of the bubble chamber 18 are respectively connected to the flushing pipe 20 and the perfusion pipe 21. The flushing pipe 20 is connected to the liquid inlet on the side wall of the liquid storage cavity 8, and the perfusion pipe 21 extends into the interior of the liquid storage cavity 8 and is connected to the isolated organ at the end thereof. In addition, a transparent observation window is arranged on the bubble chamber 18 to facilitate observation of whether there is air in the bubble chamber 18 and the volume of the air. The perfusion pump 17 is configured as a peristaltic pump, and the perfusion pump 17 is connected in series to the injection pipe 19. In addition, the control valves 22 for controlling the state of the fluid passage are arranged on the flushing pipe 20 and the perfusion pipe 21, as shown in FIG. 2. The control valve 22 on the flushing pipe 20 is referred to as a flushing valve, and the control valve 22 on the perfusion pipe 21 is referred to as a perfusion valve. Figure 5

[0044] When the perfusion device is in operation, the perfusion pump 17 draws the perfusion liquid in the liquid storage cavity 8 into the bubble chamber 18 through the injection pipe 19. When the perfusion liquid does not contain air, the flushing valve is closed and the perfusion valve is opened, and then the perfusion liquid continuously flows to the isolated organ. When the perfusion liquid contains air, the flushing valve is opened and the perfusion valve is closed, and then the perfusion liquid flows from the flushing pipe 20 to the liquid storage cavity 8, and after the air is discharged, the flushing valve is closed and the perfusion valve is opened, and then the circulation of the perfusion liquid can be continued. In addition, a filter (not shown in the figure) is arranged on the injection pipe 19 to filter out metabolic residues.

[0045] In the embodiment, in order to realize automatic control of the refrigeration device and the perfusion device and reduce the labor input, a temperature sensor (not shown in the figure) for detecting the temperature of the placement groove 9 is arranged in the box body 1. For example, the temperature sensor is an infrared sensor, which is fixedly arranged on the inner wall of the box body 1 or the vertical partition 2 and is directed to the side wall of the placement groove 9. In addition, the bubble sensor 23 for detecting air is arranged on the injection pipe 19 and the perfusion pipe 21. In addition, the controller, such as a single-chip microcomputer, is arranged on the control board 5 in the control area in the box body 1. The temperature sensor, the control valves 22 (the flushing valve and the perfusion valve), and the bubble sensor 23 are electrically connected to the control board 5 through cables, and the two control valves 22 are preferably electromagnetic shut-off valves. Correspondingly, the compressor 12 in the refrigeration device and the perfusion pump 17 in the perfusion device are respectively electrically connected to the control board 5 through cables. In addition, the master control switch 24 is arranged on the side wall of the control area and is connected to the power supply 6 and the control board 5 through wires. In addition, the adapter 27 matched with the power supply 6 is arranged in the refrigeration area, and the charging board 28 matched with the power supply 6 is fixedly arranged on the top surface of the horizontal partition 3.​

[0046] As shown in Figure 6 The working principle of the present application is as follows:

[0047] (1) Before the ex-vivo organ (for example, ex-vivo kidney, of course, also applicable to ex-vivo heart or other ex-vivo organs) is put into the storage cavity 8, the cold cavity 7 is usually removed, 2.2 kg of water is injected through the filling port, and is stored in a 0℃ refrigerator for 24 hours. Then the cold cavity 7 is removed and placed in the placing groove 9 in the storage box, and the storage cavity 8 is placed in the cold cavity 7, so that the precooling time can be shortened.

[0048] (2) The main switch 26 is turned on, at this time the perfusion pump 17 starts to work, the flushing valve is opened and the perfusion valve is closed. The perfusion solution in the storage cavity 8 flows into the bubble chamber 18 through the filling pipe 19, and then reflows into the storage cavity 8 through the flushing pipe 19, so as to discharge the air that may exist in the perfusion device. After the flushing step is completed, the flushing valve is closed and the perfusion valve is opened, the perfusion solution flows into the perfusion pipe 21 through the bubble chamber 18, and the ex-vivo kidney can be installed in the storage cavity 8. After the ex-vivo kidney is installed (in the process of circulating perfusion), if the air bubble sensor 23 detects that there is air, the perfusion valve is closed and the flushing valve is opened. After the perfusion pump 17 works for a certain time (for example, 5 seconds), the air can be discharged, and then the perfusion valve is opened and the flushing valve is closed. This is repeated, so as to avoid the air from entering the ex-vivo kidney and causing damage.

[0049] (3) During the circulation of the perfusion solution, if the temperature sensor detects that the temperature of the placing groove 9 is higher than 6℃ (the temperature of the perfusion solution is 0-8℃), the compressor 12 and the fan 14 are powered on, and the refrigeration device starts to work, so as to provide cold energy for the placing groove 9. When the temperature of the placing groove 9 is lower than 0℃, the refrigeration device stops working, and this is repeated, so as to solve the problem that the ex-vivo kidney is damaged due to the insufficient cold energy of the cold storage material and the high temperature of the system during long-distance and long-time transportation of the ex-vivo kidney preservation device.

[0050] Example Two

[0051] In this embodiment, the box cover is divided into a left cover 101 and a right cover 102, wherein the right cover 102 is connected with the box body 1 as a whole, the left side of the left cover 101 is detachably connected with the box body 1 through a lock catch 103, and the abutting position of the left cover 101 and the right cover 102 is detachably connected through a safety lock 104. The safety lock 104 is installed on the right cover 102, and the lock tongue thereof extends out and abuts against the groove on the left cover 101, so as to realize the locking function.

[0052] The left cover 101 is used to cover the storage area and the infusion plate 4, and the top surface of the right cover 102 is provided with a display screen 25 electrically connected with the controller of the control panel 5. The display screen 25 displays the parameters of each electrical element, such as the temperature value measured by the temperature sensor, the air content measured by the air bubble sensor 23, the working state of the compressor 12, the working state of the fan 14, and the like.

[0053] The above detailed description of the embodiments of the present application is made in conjunction with the accompanying drawings, but the present application is not limited to the described embodiments. For those skilled in the art, various changes, modifications, replacements and variations of the embodiments can be made without departing from the principles and spirits of the present application, and still fall within the protection scope of the present application.

Claims

1. An active refrigerated isolated organ perfusion system, comprising: The application relates to a preservation box and a preservation device, a refrigeration device and a perfusion device. The preservation device comprises a cold cavity and a liquid storage cavity; the cold cavity is internally filled with a cold storage agent and is connected with a cold quantity releasing end of the refrigeration device; and the liquid storage cavity is filled with perfusion liquid. The perfusion device comprises a perfusion pump and a bubble chamber; the liquid storage cavity and the bubble chamber are connected through an injection pipe; the perfusion pump is connected in series with the injection pipe; the liquid storage cavity and the bubble chamber are further connected through a flushing pipe and a perfusion pipe; and the end of the perfusion pipe inserted into the liquid storage cavity is connected with an isolated organ. The preservation box is further provided with a temperature sensor for detecting the temperature of the perfusion liquid or the cold storage agent and a controller for control; the injection pipe and the perfusion pipe are provided with bubble sensors for detecting air; the flushing pipe and the perfusion pipe are provided with control valves; and the controller is electrically connected with the temperature sensor, the refrigeration device, the perfusion pump, the control valves and the bubble sensors. The preservation box is provided with a placing groove for placing the cold cavity; and the outer wall of the placing groove is connected with the cold quantity releasing end of the refrigeration device. The cold cavity is provided with a sandwich space for storing the cold storage agent; and the side wall of the cold cavity is provided with an injection opening connected with the sandwich space. The refrigeration device comprises an evaporation coil, a condenser, a compressor and a capillary tube which are connected in sequence; and the evaporation coil is the cold quantity releasing end. The preservation box comprises a box body and a box cover; the box body is divided into a preservation area on the left and a device area on the right through a vertical partition plate; the device area is divided into a refrigeration area on the lower part and a control area on the upper part through a horizontal partition plate; and the top of the control area is fixedly provided with a perfusion plate; the preservation device is arranged in the preservation area; the refrigeration device is arranged in the refrigeration area; the control area is provided with a control plate carrying the controller and a power supply for power supply; and the perfusion device is fixedly arranged on the perfusion plate.

2. The active refrigeration perfusion system for isolated organs of claim 1, wherein: The injection pipe is further provided with a filter.

3. The active refrigeration perfusion system for isolated organs of claim 1, wherein: The refrigeration device further comprises a fan and a drying filter; the drying filter is arranged on a pipeline connecting the condenser and the compressor; the fan is fixedly arranged in the preservation box; the air flow generated by the fan is directed to the condenser; and the side wall of the preservation box is provided with a heat dissipation air hole.

4. The active refrigeration perfusion system for isolated organs of claim 1, wherein: The side wall of the preservation box is provided with a display screen electrically connected with the controller.

5. The active refrigeration perfusion system for isolated organs of claim 1, wherein: The box cover is divided into a left cover and a right cover; the right cover is fixedly connected with the right side of the box body; the left side of the left cover is detachably connected with the box body through a lock buckle; and the left cover and the right cover are detachably connected through a safety lock.

6. The active refrigeration perfusion system for isolated organs of claim 1, wherein: The side wall of the box body is provided with a handle.

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