Device to keep organs alive from non-heart-beating donors

Abstract

The present invention relates to the technical field of organ transplantation equipment, and in particular to a device for maintaining the activity of a heart-free donor organ. The device comprises a first circulation pipeline, an input tube and an output tube, wherein the first circulation pipeline comprises a first connection end and a second connection end, a blood reservoir, a blood pump and an oxygenator are arranged between the first connection end and the second connection end, one end of the input tube is connected to the first connection end, the end of the input tube away from the first connection end is connected to the donor, one end of the output tube is connected to the second connection end, and the end of the output tube away from the second connection end is connected to the donor, wherein the first circulation pipeline, the input tube, the donor and the output tube form a closed blood circulation loop. The device is used to perfuse blood into the donor after the heart stops beating and the donor dies physiologically, so as to maintain the activity of the donor's internal organs, thereby reducing the warm ischemic shock of the organ during the period from the donor's heart stopping to the removal.

Description

Technical Field

[0001] The invention relates to the technical field of organ transplantation equipment, and in particular to a device for maintaining the activity of a non-heartbeat donor organ. Background Art

[0002] Organ transplantation is the gold standard for treating end-stage organ diseases. In the commonly used organ transplantation schemes, organs need to undergo long-term ischemic damage from the time they are obtained to the time they are transplanted to patients. Organ ischemic damage is the most important factor affecting the prognosis of transplantation, which can lead to a variety of complications and reduce the survival rate of patients.

[0003] Ischemia damage to organs includes warm ischemia damage and cold ischemia damage. Warm ischemia damage to organs refers to damage caused by ischemia or interruption of blood flow when the temperature is not lowered. Usually, the damage to the organ is the most serious at this stage, because although the blood flow is interrupted during warm ischemia, the organ tissue continues to metabolize. At this time, due to the lack of oxygen and various metabolic substrates, the metabolic level of the organ is still high, so the warm ischemia damage to the organ occurs faster and is more severe. After the oxygen is consumed, anaerobic metabolism can still be carried out, but the metabolic products cannot be cleared, which can cause acidosis, and the nutrients and enzyme systems necessary for metabolism are also consumed. Cold ischemia damage to organs refers to damage caused by ischemia of organs at low temperatures (0℃~4℃). Because the metabolism of the organ is significantly reduced and the oxygen consumption is reduced at low temperatures, the tolerance of the organ to ischemia can be increased, so usually the damage to the organ is the least at this stage, and the process of organ preservation is basically a cold ischemia process.

[0004] Currently, in traditional organ transplantation, the organs have very poor tolerance to warm ischemia and any slight negligence can easily lead to the loss of transplantation conditions. Therefore, the organs need to be quickly cleaned and cooled after removal to reduce the warm ischemia time. However, the warm ischemia during the period from the physiological death of the donor to the removal of the organ from the donor has not been well improved or resolved. Summary of the invention

[0005] The main purpose of the present invention is to provide a device for maintaining the activity of a heart-free donor organ, aiming to solve the technical problem of organ damage caused by warm ischemia during the period of time when the organ is removed from the donor after the donor's physiological death.

[0006] To achieve the above-mentioned purpose, the present invention proposes a device for maintaining the activity of organs in a non-heartbeat donor, which is used to perfuse blood into the donor after the donor's physiological death to maintain the activity of the organs in the donor. The device for maintaining the activity of organs in a non-heartbeat donor comprises:

[0007] a first circulation pipeline, the first circulation pipeline comprising a first connection end and a second connection end, a blood reservoir, a blood pump and an oxygenator being arranged between the first connection end and the second connection end, the blood reservoir being used to store blood, the blood pump being used to provide power for the flow of blood, and the oxygenator being used to achieve gas-blood exchange of blood;

[0008] an input tube, one end of which is connected to the first connection end, and one end of which is away from the first connection end and is connected to the donor;

[0009] an output tube, one end of which is connected to the second connection end, and one end of which is away from the second connection end and is connected to the donor;

[0010] Wherein, the first circulation pipeline, the input tube, the donor and the output tube form a closed blood circulation loop.

[0011] In some embodiments, the first circulation pipeline further includes:

[0012] a first pinch-off valve, the first pinch-off valve being disposed at one end of the first circulation pipeline close to the first connecting end;

[0013] a second pinch-off valve, the second pinch-off valve being disposed at one end of the first circulation pipeline close to the second connecting end;

[0014] a second circulation pipeline, the second circulation pipeline being arranged between the first pinch-off valve and the second pinch-off valve, and the second circulation pipeline comprising the blood reservoir, the blood pump and the oxygenator, and the second circulation pipeline being provided with a third pinch-off valve;

[0015] Among them, when the first pinch-off valve and the second pinch-off valve are in an open state and the third pinch-off valve is in a closed state, blood circulation is achieved in the first circulation pipeline, and blood flows through the blood reservoir, the blood pump, the oxygenator and the donor; when the first pinch-off valve and the second pinch-off valve are in a closed state and the third pinch-off valve is in an open state, blood circulation is achieved in the second circulation pipeline, and blood flows through the blood reservoir, the blood pump and the oxygenator.

[0016] In some embodiments, the second circulation pipeline is also provided with a heat exchanger, and the heat exchanger is connected to a hot water tank. The hot water tank includes a liquid inlet and a liquid outlet. The liquid inlet and the liquid outlet are connected to the heat exchanger through a pipeline, so that the solution in the hot water tank flows from the liquid outlet through the pipeline into the heat exchanger, and flows from the heat exchanger through the pipeline and back to the hot water tank from the liquid inlet, thereby realizing heat exchange of blood in the first circulation pipeline or the second circulation pipeline.

[0017] In some embodiments, the pipeline is provided with a water pump for increasing the flow rate of the solution in the hot water tank.

[0018] In some embodiments, the hot water tank is provided with a first liquid level sensor and a first temperature sensor, the first liquid level sensor is used to monitor the liquid level of the solution in the hot water tank, and the first temperature sensor is used to monitor the temperature of the solution in the hot water tank.

[0019] In some embodiments, the second circulation pipeline is further provided with a flow meter and a blood oxygen monitor, the flow meter is used to monitor the flow of blood in the first circulation pipeline or the second circulation pipeline, and the blood oxygen monitor is used to monitor the oxygen content of the blood in the first circulation pipeline and the second circulation pipeline.

[0020] In some embodiments, the second circulation pipeline is also provided with a bubble removal device and a thrombus filtering device, the bubble removal device is used to remove bubbles when blood circulates in the first circulation pipeline or the second circulation pipeline, and the thrombus filtering device is used to filter out thrombi when blood circulates in the first circulation pipeline or the second circulation pipeline.

[0021] In some embodiments, the blood reservoir is provided with a second liquid level sensor and a second temperature sensor, wherein the second liquid level sensor is used to monitor the liquid level of the blood in the blood reservoir, and the second temperature sensor is used to monitor the temperature of the blood in the blood reservoir.

[0022] In some embodiments, the blood reservoir is provided with a liquid filling port for replenishing blood into the blood reservoir.

[0023] In some embodiments, a pressure sensor is provided at one end of the first circulation pipeline close to the first connection end for monitoring the blood pressure of the blood flowing into the donor through the first circulation pipeline.

[0024] Compared with the prior art, the present invention has the following beneficial effects:

[0025] In the technical solution of the present invention, a device for maintaining the activity of the organs of a non-heart-beating donor is provided. The device is used to perfuse blood into the donor after the heart stops beating and the donor dies physiologically, so as to maintain the activity of the organs in the donor, thereby reducing the warm ischemic shock of the organs during the period from the heart stopping beating of the donor to the removal. The device includes a first circulation pipeline, an input tube and an output tube, wherein the first circulation pipeline includes a first connecting end and a second connecting end, and a blood reservoir, a blood pump and an oxygenator are arranged between the first connecting end and the second connecting end of the first circulation pipeline. One end of the input tube is connected to the first connecting end, and the other end of the input tube is connected to the donor, for example, the input tube can be inserted into the femoral artery of the donor. One end of the output tube is connected to the second connecting end, and the other end of the output tube is connected to the donor, for example, the output tube can be inserted into the femoral vein of the donor. The first circulation pipeline, the input tube, the donor and the output tube form a closed blood circulation loop. Specifically, the blood in the blood reservoir flows along the first circulation pipeline driven by the blood pump, first flows through the oxygenator to realize the blood gas and blood exchange, and then enters the donor from the input tube to provide oxygen and other nutrients to the organs in the donor to maintain the normal metabolic activities of the organs. The blood can also carry away metabolic waste produced by the organs. After the blood circulates in the donor, it flows out of the donor through the output tube and performs the next round of blood circulation along the first circulation pipeline.

[0026] The device for maintaining the activity of the organs of a heartless donor provided by the present invention is equivalent to establishing an artificial heart and artificial lungs outside the donor. When the donor's heart stops beating and physiological death is confirmed, the device can continue to ensure the blood circulation of the donor's internal organs (mainly relying on the blood pump in the device to drive blood flow, thereby achieving blood circulation) and oxygen delivery (mainly relying on the oxygenator in the device to achieve oxygen delivery in the blood), and transport the carbon dioxide generated by the metabolism of the organs inside the donor to the outside of the donor, and achieve the exchange of oxygen and carbon dioxide in the blood outside the donor, thereby achieving the normal physiological activities of the donor's internal organs after the donor's heart stops beating, and continuing to ensure the physiological activity of the donor's internal organs, effectively avoiding the warm ischemic attack of the donor's internal organs during the period from the donor's heart stopping to the removal, thereby avoiding warm ischemic damage to the donor's internal organs, and creating a good transplantation condition for subsequent organ transplantation. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on the structures shown in these drawings without paying creative work.

[0028] Figure 1 This is a schematic diagram of the overall connection of a device for maintaining the activity of a non-heartbeat donor organ provided by an embodiment of the present invention;

[0029] Figure 2 A schematic diagram of a monitoring system for a device for maintaining the activity of a non-heartbeat donor organ provided by an embodiment of the present invention;

[0030] Figure 3 A flowchart of the steps of a method for using a device for maintaining the activity of a non-heartbeating donor organ provided by another embodiment of the present invention.

[0031] Description of Figure Numbers:

[0032] 100-first circulation pipeline;

[0033] 110 - first connection end; 120 - second connection end; 130 - first pinch-off valve; 140 - second pinch-off valve; 150 - pressure sensor;

[0034] 200-second circulation pipeline;

[0035] 210-third pinch-off valve; 220-blood reservoir; 230-blood pump; 240-oxygenator; 250-heat exchanger; 260-hot water tank; 270-flow meter; 280-blood oxygen monitor; 290-bubble removal device; 291-thrombus filtration device;

[0036] 221 - second liquid level sensor; 222 - second temperature sensor; 261 - water pump; 262 - first liquid level sensor; 263 - first temperature sensor;

[0037] 300-input pipe;

[0038] 400- output pipe;

[0039] 500-donor;

[0040] 600-control circuit board;

[0041] 700-touch display;

[0042] 800-Alarm.

[0043] The realization of the purpose, functional features and advantages of the present invention will be further explained in conjunction with embodiments and with reference to the accompanying drawings. DETAILED DESCRIPTION

[0044] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0045] It should be noted that if the embodiments of the present invention involve directional indications (such as up, down, left, right, front, back, etc.), the directional indications are only used to explain the relative position relationship, movement status, etc. between the components in a certain specific posture. If the specific posture changes, the directional indication will also change accordingly.

[0046] In addition, if there are descriptions involving "first", "second", etc. in the embodiments of the present invention, the descriptions of "first", "second", etc. are only used for descriptive purposes and cannot be understood as indicating or implying their relative importance or implicitly indicating the number of technical features indicated. Therefore, the features limited to "first" and "second" may explicitly or implicitly include at least one of the features. In addition, if "and / or", "and / or" or "and / or" appears in the full text, its meaning includes three parallel schemes. Taking "A and / or B" as an example, it includes scheme A, or scheme B, or a scheme that satisfies both A and B. In addition, the technical solutions between the various embodiments can be combined with each other, but it must be based on the ability of ordinary technicians in the field to implement. When the combination of technical solutions is contradictory or cannot be implemented, it should be deemed that such a combination of technical solutions does not exist and is not within the scope of protection required by the present invention.

[0047] Organ transplantation is the gold standard for treating end-stage organ diseases. In the commonly used organ transplantation schemes, organs need to undergo long-term ischemic damage from the time they are obtained to the time they are transplanted to patients. Organ ischemic damage is the most important factor affecting the prognosis of transplantation, which can lead to a variety of complications and reduce the survival rate of patients.

[0048] Ischemia damage to organs includes warm ischemia damage and cold ischemia damage. Warm ischemia damage to organs refers to damage caused by ischemia or blood flow interruption when the temperature is not lowered. Usually, this stage causes the most serious damage to the organ, because although blood flow is interrupted during warm ischemia, organ tissues continue to metabolize. At this time, due to the lack of oxygen and various metabolic substrates, the metabolic level of the organ is still high, so warm ischemia damage to the organ occurs faster and is more severe. After oxygen is consumed, anaerobic metabolism can still be carried out, but the metabolic products cannot be cleared, which can cause acidosis, and the nutrients and enzyme systems necessary for metabolism are also consumed. Cold ischemia damage to organs refers to damage caused by ischemia of organs at low temperatures (0℃~4℃). Because the metabolism of organs is significantly reduced and oxygen consumption is reduced at low temperatures, the tolerance of organs to ischemia can be increased, so usually this stage causes the least damage to the organ, and the process of organ preservation is basically a cold ischemia process.

[0049] Currently, in traditional organ transplantation, the organs have very poor tolerance to warm ischemia and any slight negligence can easily lead to the loss of transplantation conditions. Therefore, the organs need to be quickly cleaned and cooled after removal to reduce the warm ischemia time. However, the warm ischemia during the period from the physiological death of the donor to the removal of the organ from the donor has not been well improved or resolved.

[0050] In order to solve the technical problem that the organs are damaged by warm ischemia during the period of time when the organs are removed from the donor 500 after the donor 500 dies physiologically, referring to Figure 1 to Figure 2 An embodiment of the present invention provides a device for maintaining the activity of organs of a non-heartbeat donor 500, which is used to perfuse blood into the donor 500 after the donor 500 dies physiologically, so as to maintain the activity of the organs in the donor 500. The device for maintaining the activity of organs of a non-heartbeat donor 500 provided in this embodiment includes a first circulation pipeline 100, an input tube 300 and an output tube 400. The first circulation pipeline 100 includes a first connecting end 110 and a second connecting end 120. A blood reservoir 220, a blood pump 230 and an oxygenator 240 are arranged between the first connecting end 110 and the second connecting end 120. The blood reservoir 220 is used to store blood, the blood pump 230 is used to provide power for the flow of blood, the oxygenator 240 is used to achieve blood gas exchange, one end of the input tube 300 is connected to the first connecting end 110, the end of the input tube 300 away from the first connecting end 110 is connected to the donor 500, one end of the output tube 400 is connected to the second connecting end 120, and the end of the output tube 400 away from the second connecting end 120 is connected to the donor 500, wherein the first circulation pipeline 100, the input tube 300, the donor 500 and the output tube 400 form a closed blood circulation loop.

[0051] Specifically, in the technical solution of this embodiment, a device for maintaining the activity of the organs of a non-heart-beating donor 500 is provided. The device is used to perfuse blood into the donor 500 after the heart stops beating and the donor 500 dies physiologically, so as to maintain the activity of the organs of the donor 500, thereby reducing the warm ischemic shock of the organs during the period from the heart of the donor 500 to the removal. The device includes a first circulation pipeline 100, an input tube 300 and an output tube 400, wherein the first circulation pipeline 100 includes a first connection end 110 and a second connection end 120, and a blood reservoir 220, a blood pump 230 and an oxygenator 240 are arranged between the first connection end 110 and the second connection end 120 of the first circulation pipeline 100. One end of the input tube 300 is connected to the first connection end 110, and the other end of the input tube 300 is connected to the donor 500. One end of the output tube 400 is connected to the second connection end 120, and the other end of the output tube 400 is connected to the donor 500. The first circulation pipeline 100, the input tube 300, the donor 500 and the output tube 400 form a closed blood circulation loop. Specifically, the blood in the blood reservoir 220 flows along the first circulation pipeline 100 driven by the blood pump 230, first flows through the oxygenator 240 to achieve blood gas exchange, and then enters the donor 500 from the input tube 300 to provide oxygen and other nutrients to the organs in the donor 500 to maintain the normal metabolic activities of the organs, and the blood can also take away metabolic wastes produced by the organs. After the blood circulates in the donor 500, it flows out of the donor 500 through the output tube 400 and performs the next round of blood circulation along the first circulation pipeline 100.

[0052] In some embodiments, the device for maintaining the activity of the organs of the non-heartbeating donor 500 provided in this embodiment can be used to maintain the normal physiological activities of the abdominal organs of the donor 500. At the same time, in order to ensure that the removal of the thoracic organs is not affected (in the actual operation, the priority of the removal of the thoracic organs is higher than the priority of the removal of the abdominal organs, so it is necessary to use the device provided by this embodiment to maintain the physiological activity of the abdominal organs and avoid the abdominal organs from suffering from warm ischemia and causing damage to the abdominal organs), a blocking balloon can be placed into the descending aorta of the donor 500 before inserting the inlet tube 300 into the donor 500. The blocking balloon can be used to completely isolate the blood circulation of the thoracic cavity and the abdominal cavity, so that the organs in the thoracic cavity will not be perfused, thereby ensuring the normal surgical treatment of the thoracic organs. When the input tube 300 and the output tube 400 are formally inserted into the donor 500, the input tube 300 can be inserted into the femoral artery of the donor 500, and the output tube 400 can be inserted into the femoral vein of the donor 500, so as to ensure that the blood flow from the first circulation pipeline 100 into the donor 500 is large enough, and then oxygen and other nutrients are promptly transported to the abdominal viscera through the blood, and the metabolic waste of the abdominal viscera is promptly taken out of the donor 500. In addition, since the donor 500 is only brain dead but not heart dead when the input tube 300 and the output tube 400 are inserted into the donor 500, it is easiest to insert the output tube 400 from the femoral vein, and the impact on the donor 500 is minimal. Alternatively, the output tube 400 can also be inserted into the neck vein, shoulder vein, etc. of the donor 500. Since the vein of the donor 500 is not actually blocked, the output tube 400 can be inserted into the main thoracic and abdominal veins.

[0053] The device for maintaining the activity of organs of a non-heartbeating donor 500 provided in this embodiment is equivalent to establishing an artificial heart and artificial lungs outside the donor 500, wherein the blood pump 230 is equivalent to the artificial heart, and the oxygenator 240 is equivalent to the artificial lungs. When the heart of donor 500 stops beating and physiological death is confirmed, the device can continue to ensure blood circulation of the internal organs of donor 500 (mainly relying on the blood pump 230 in the device to drive blood flow, thereby achieving blood circulation) and oxygen delivery (mainly relying on the oxygenator 240 in the device to achieve oxygen delivery in the blood), and transport the carbon dioxide produced by the metabolism of the internal organs of donor 500 to the outside of donor 500, and achieve the exchange of oxygen and carbon dioxide in the blood outside donor 500, so as to achieve the normal physiological activities of the internal organs of donor 500 after the heart of donor 500 stops beating, continue to ensure the physiological activity of the internal organs of donor 500, effectively avoid the internal organs of donor 500 from being hit by warm ischemia during the period from the heart of donor 500 to the removal, thereby avoiding warm ischemic damage to the internal organs of donor 500, and creating a good transplantation condition for subsequent organ transplantation.

[0054] In some embodiments, the perfusion fluid flowing from the first circulation pipeline 100 into the donor 500 may be a mixture of blood expander and blood in addition to blood. Perfusion fluids with other components may also be used as long as the physiological activity of the internal organs of the non-heartbeat donor 500 can be ensured.

[0055] It should be noted that the blood reservoir 220, blood pump 230, oxygenator 240 and blocking balloon in this embodiment are all common devices in the art, so the structure and use method of the blood reservoir 220, blood pump 230, oxygenator 240 and blocking balloon will not be described in detail.

[0056] In some embodiments, reference Figure 1 The first circulation pipeline 100 also includes a first pinch-off valve 130, a second pinch-off valve 140 and a second circulation pipeline 200. The first pinch-off valve 130 is arranged at one end of the first circulation pipeline 100 close to the first connecting end 110, and is used for opening and closing the blood at the input tube 300. The second pinch-off valve 140 is arranged at one end of the first circulation pipeline 100 close to the second connecting end 120, and is used for opening and closing the blood at the output tube 400. The second circulation pipeline 200 is arranged between the first pinch-off valve 130 and the second pinch-off valve 140, and the second circulation pipeline 200 includes the above-mentioned blood reservoir 220, blood pump 230 and oxygenator 240. The second circulation pipeline 200 is provided with a third pinch-off valve 210, which is used for opening and closing the blood on the second circulation pipeline 200. Among them, when the first pinch-off valve 130 and the second pinch-off valve 140 are in an open state and the third pinch-off valve 210 is in a closed state, blood circulation is achieved in the first circulation pipeline 100, and blood flows through the blood reservoir 220, the blood pump 230, the oxygenator 240 and the donor 500. When the first pinch-off valve 130 and the second pinch-off valve 140 are in a closed state and the third pinch-off valve 210 is in an open state, blood circulation is achieved in the second circulation pipeline 200, and blood flows through the blood reservoir 220, the blood pump 230 and the oxygenator 240.

[0057] Specifically, in order to ensure that various indicators of blood meet the state of normal human life activities when blood is perfused into the donor 500, such as blood pressure, temperature, oxygen content, flow rate, etc., and to improve the safety of perfusing blood into the donor 500, pre-perfusion will be performed in the second circulation pipeline 200 before blood is formally perfused into the donor 500 through the first circulation pipeline 100. During pre-perfusion, the first pinch-off valve 130 and the second pinch-off valve 140 are closed, and the third pinch-off valve 210 is opened, so that blood circulates only in the second circulation pipeline 200. The blood in the second circulation pipeline 200 flows through the blood reservoir 220 and the oxygenator 240 under the pumping action of the blood pump 230. While testing whether the blood reservoir 220, the blood pump 230 and the oxygenator 240 can work normally, the bubbles in the second circulation pipeline 200 are removed and the second circulation pipeline 200 is fully infiltrated, thereby minimizing the probability of thrombosis in the circulation pipeline during formal blood perfusion and minimizing the damage of the circulation pipeline to blood cells and platelets. After the blood circulates several times in the second circulation circuit 200 and the blood index (e.g., oxygen content) meets the blood state in a human body with normal physiological activities, the first pinch-off valve 130 and the second pinch-off valve 140 are opened, and the third pinch-off valve 210 is closed, so that the blood circulates only in the first circulation circuit 100, and the blood stored in the blood reservoir 220 flows from the input tube 300 to the donor 500 through the blood pump 230, while receiving the blood flowing out of the donor 500 from the output tube 400. During this period, the oxygenator 240 continuously provides oxygen to the blood and realizes gas exchange in the blood to ensure that the oxygen content in the blood is at the level of a human body with normal physiological activities and reduce the carbon dioxide content in the blood.

[0058] In some embodiments, a use case of the device for maintaining the activity of organs of a heart-beating donor 500 is provided. For example, after the donor 500 is brain dead and the family agrees to donate the organs, the device provided in this embodiment is used to intubate the input tube 300 and the output tube 400 of the donor 500, and the blocking balloon is placed into the descending aorta of the donor 500 through the input tube 300. After the pipeline is connected, the device is started, and first the device is made to reach the pre-perfusion state, and then the ventilator of the donor 500 is removed. After the doctor announces that the patient's heart has stopped beating and there are no signs of life activities, the first pinch-off valve 130 and the second pinch-off valve 140 are quickly opened, and the third pinch-off valve 210 is closed at the same time, and the preset blocking balloon is inflated with air or liquid, so that the blocking balloon expands to block the arterial connection between the chest cavity and the abdominal cavity, and the device is switched to the formal perfusion state to perfuse blood for the heart-beating donor 500 to maintain the activity of the donor 500's organs.

[0059] The device for maintaining the activity of the organs of the non-heart-beating donor 500 provided in this embodiment adopts a pre-perfusion design, which can pre-heat the device so that the device can reach a stable working state in advance, and detect whether the device can work normally, so as to prevent the donor 500 organs from losing the conditions for transplantation due to the device not working normally, causing medical losses. In addition, through pre-perfusion, the blood can reach the normal material content requirements in advance, and after the donor 500 dies physiologically, the blood that meets the requirements can be perfused into the donor 500 as soon as possible, thereby shortening or even eliminating the warm ischemia time of the internal organs of the donor 500.

[0060] In some embodiments, reference Figure 1 The second circulation pipeline 200 is also provided with a heat exchanger 250, and the heat exchanger 250 is connected to a hot water tank 260. The hot water tank 260 includes a liquid inlet and a liquid outlet. The liquid inlet and the liquid outlet are connected to the heat exchanger 250 through a pipeline, so that the solution in the hot water tank 260 flows into the heat exchanger 250 from the liquid outlet through the pipeline, and flows back to the hot water tank 260 from the heat exchanger 250 through the pipeline from the liquid inlet, thereby realizing heat exchange of blood in the first circulation pipeline 100 or the second circulation pipeline 200.

[0061] Specifically, in order to ensure that the organs in the non-heartbeat donor 500 have normal physiological activity, it is necessary to perfuse blood with a temperature close to the normal body temperature of the human body (generally around 37°C) into the donor 500. In the present embodiment, a heat exchanger 250 is provided on the second circulation pipeline 200. The blood in the circulation pipeline can exchange heat in the heat exchanger 250 to increase or decrease the temperature of the blood to the normal body temperature of the human body (generally around 37°C), thereby maintaining the perfusion temperature of the internal organs of the donor 500 and maintaining the normal physiological activity of the internal organs of the donor 500.

[0062] It should be noted that, since the second circulation pipeline 200 is a part of the first circulation pipeline 100, when the flow direction of blood is switched from the second circulation pipeline 200 to the first circulation pipeline 100, the heat exchanger 250 can still conduct heat to the blood in the device, so that the temperature of the blood in the device is always maintained at a specified temperature (generally around 37°C, which is close to the normal body temperature of the human body).

[0063] In some embodiments, the hot water tank 260 is built with an electric heating device and a cooling device. The electric heating device can heat the solution inside the hot water tank 260, and the cooling device can cool the solution inside the hot water tank 260 to achieve temperature regulation of the solution inside the hot water tank 260. The solution inside the hot water tank 260 can be, for example, water. The hot water tank 260 can also be provided with a water inlet. When the solution is continuously consumed, liquid can be added to the hot water tank 260 through the water inlet to ensure that there is sufficient solution in the hot water tank 260 to conduct heat to the blood in the heat exchanger 250, so that the temperature of the blood in the device is maintained at a specified temperature (generally about 37°C, which is close to the normal body temperature of the human body).

[0064] In some embodiments, reference Figure 1 , the pipeline is provided with a water pump 261, which is used to increase the flow rate of the solution in the hot water tank 260. Specifically, the solution in the hot water tank 260 can be quickly pumped to the heat exchanger 250 through the water pump 261, and the solution in the heat exchanger 250 can be quickly pumped back to the hot water tank 260, so as to achieve rapid circulation of the solution between the heat exchanger 250 and the hot water tank 260, maintain the temperature of the heat exchanger 250 at a specified temperature (generally about 37°C, which is close to the normal body temperature of the human body), thereby improving the heat exchange efficiency of the blood in the device in the heat exchanger 250.

[0065] In some embodiments, reference Figure 1 The hot water tank 260 is provided with a first liquid level sensor 262 and a first temperature sensor 263 . The first liquid level sensor 262 is used to monitor the liquid level of the solution in the hot water tank 260 , and the first temperature sensor 263 is used to monitor the temperature of the solution in the hot water tank 260 .

[0066] Specifically, since the survival conditions of the organs in the non-heart-beating donor 500 are very harsh, the slightest carelessness will cause the organs to be damaged and lose the conditions for transplantation, resulting in major medical errors. Therefore, in order to more accurately monitor the content and temperature of the solution in the hot water tank 260, avoid accidents caused by negligence of medical staff, and ensure that the blood in the device can smoothly achieve heat exchange, the hot water tank 260 is provided with a first liquid level sensor 262 and a first temperature sensor 263. When the solution content in the hot water tank 260 is too low or too high, the first liquid level sensor 262 will trigger an alarm to remind the medical staff to add water to the hot water tank 260 or drain water from the hot water tank 260 in time, to prevent the blood from being unable to be effectively heat-transferred due to too low solution content, or to prevent the solution from overflowing due to too high solution content, thereby spilling the solution on the floor or on medical equipment, causing accidents, such as medical staff slipping or medical equipment being electrically connected. Similarly, when the temperature of the solution in the hot water tank 260 is too low or too high, the first temperature sensor 263 will trigger an alarm to remind medical staff to promptly heat up or cool down the solution in the hot water tank 260 to prevent the blood from failing to reach the specified temperature (generally around 37°C, close to the normal body temperature of the human body) due to the solution temperature being too low, or to prevent the active substances in the blood from being inactivated due to the solution temperature being too high, thereby avoiding damage to the internal organs of the donor 500.

[0067] In some embodiments, reference Figure 1 The second circulation pipeline 200 is also provided with a flow meter 270 and a blood oxygen monitor 280. The flow meter 270 is used to monitor the flow rate of blood in the first circulation pipeline 100 or the second circulation pipeline 200, and the blood oxygen monitor 280 is used to monitor the oxygen content of blood in the first circulation pipeline 100 and the second circulation pipeline 200. It should be noted that since the second circulation pipeline 200 is a part of the first circulation pipeline 100, the flow meter 270 can monitor the blood flow rate (blood flow rate refers to the amount of blood flowing per unit time (such as per minute)) on the second circulation pipeline 200 and the blood flow rate on the first circulation pipeline 100, and the blood oxygen monitor 280 can monitor the oxygen content of blood in the second circulation pipeline 200 and the oxygen content of blood in the first circulation pipeline 100.

[0068] Specifically, the upper and lower thresholds of the flow meter 270 and the blood oxygen monitor 280 can be preset to allow the blood flow and blood oxygen content to fluctuate within a certain normal range. If the fluctuations in the blood flow and blood oxygen content exceed the upper and lower thresholds of the flow meter 270 and the blood oxygen monitor 280, the flow meter 270 and the blood oxygen monitor 280 will trigger an alarm to remind medical staff to adjust and correct the blood flow and blood oxygen content in the circulation circuit to restore them to normal levels. For example, the blood flow in the circulation circuit can be adjusted by the blood pump 230, and the oxygen supply to the blood in the circulation circuit can be adjusted by the oxygenator 240. The blood flow on the first circulation pipeline 100 and the second circulation pipeline 200 can be accurately monitored by the flow meter 270, and the blood flow to the internal organs of the donor 500 can be accurately controlled to avoid the blood flow from the first circulation pipeline 100 to the internal organs of the donor 500 being too large to cause impact on the organs, and to avoid the blood flow from the first circulation pipeline 100 to the internal organs of the donor 500 being too small to maintain the normal physiological activities of the organs. The blood oxygen monitor 280 can accurately monitor the oxygen content of the blood in the first circulation pipeline 100 and the second circulation pipeline 200, to avoid the blood from the first circulation pipeline 100 to the internal organs of the donor 500 being too high to cause oxygen poisoning of the organs, and to avoid the blood from the first circulation pipeline 100 to the internal organs of the donor 500 being too low to enable the organs to complete normal metabolic activities.

[0069] In some embodiments, reference Figure 1 The second circulation pipeline 200 is also provided with a bubble removal device 290 and a thrombus filter device 291. The bubble removal device 290 is used to remove bubbles when blood circulates in the first circulation pipeline 100 or the second circulation pipeline 200, and the thrombus filter device 291 is used to filter thrombi when blood circulates in the first circulation pipeline 100 or the second circulation pipeline 200. It should be noted that since the second circulation pipeline 200 is a part of the first circulation pipeline 100, the bubble removal device 290 can remove both bubbles generated when blood circulates in the second circulation pipeline 200 and the first circulation pipeline 100, and the thrombus filter device 291 can filter both thrombi generated when blood circulates in the second circulation pipeline 200 and the first circulation pipeline 100.

[0070] Specifically, by setting a bubble removal device 290 and a thrombus filtering device 291 on the blood circulation pipeline, bubbles and thrombi in the blood can be filtered out to prevent bubbles and thrombi from entering the internal organs of the donor 500 and causing blockage of the organs, hindering the normal flow of blood, thereby ensuring that the organs can maintain normal physiological activities.

[0071] In some embodiments, reference Figure 1The blood reservoir 220 is provided with a second liquid level sensor 221 and a second temperature sensor 222 . The second liquid level sensor 221 is used to monitor the liquid level of the blood in the blood reservoir 220 , and the second temperature sensor 222 is used to monitor the temperature of the blood in the blood reservoir 220 .

[0072] Specifically, since the blood flowing into the donor 500 is provided by the blood reservoir 220, in order to more directly and accurately monitor the temperature of the blood flowing into the donor 500 and ensure that there is sufficient blood supply in the blood reservoir 220, a second liquid level sensor 221 and a second temperature sensor 222 are provided on the blood reservoir 220. When the blood content in the blood reservoir 220 is too low or too high, the second liquid level sensor 221 will trigger an alarm to remind medical staff to inject blood into the blood reservoir 220 in time or stop injecting blood, so as to prevent the delay of blood delivery to the internal organs of the donor 500 due to too low blood content, causing damage to the organs due to insufficient blood supply, or to prevent blood overflow due to too high blood content, resulting in a waste of precious medical resources. Similarly, when the temperature of the blood in the blood reservoir 220 is too low or too high, the second temperature sensor 222 will trigger an alarm to remind medical staff to promptly heat up or cool down the blood in the blood reservoir 220 to prevent the blood from failing to reach the specified temperature (generally around 37°C, which is close to the normal body temperature of the human body) due to the blood temperature being too low, or to prevent the active substances in the blood from being inactivated due to the blood temperature being too high, thereby avoiding damage to the internal organs of the donor 500.

[0073] In some embodiments, the blood reservoir 220 is provided with a liquid filling port for replenishing blood into the blood reservoir 220. Specifically, a sealing ring may be provided at the liquid filling port to ensure good sealing performance of the blood reservoir 220 when blood does not need to be replenished into the blood reservoir 220, thereby preventing impurities in the air from entering the blood reservoir 220 and causing blood contamination.

[0074] In some embodiments, reference Figure 1 A pressure sensor 150 is provided at one end of the first circulation pipeline 100 near the first connection end 110, which is used to monitor the blood pressure of the blood flowing from the first circulation pipeline 100 into the donor 500. When the blood pressure is too low or too high, the pressure sensor 150 will trigger an alarm to remind medical staff to adjust the blood pressure in time to prevent the blood from being unable to be normally supplied to the donor 500 due to too low blood pressure, or to prevent the internal organs of the donor 500 from being greatly impacted due to too high blood pressure, thereby ensuring normal blood supply to the donor 500.

[0075] In some embodiments, reference Figure 2The system mechanisms in the device, such as the blood pump 230, the oxygenator 240, the pinch valve, the heat exchanger 250, the hot water tank 260, the water pump 261, the sensor, the monitor, etc., are all connected to the same control circuit board 600. The control circuit board 600 is connected to a touch screen 700. After the device is powered on and before the circulation pipeline is started, the system parameters can be preset through the touch screen 700. The control circuit board 600 is also connected to an alarm 800. When any system mechanism in the device exceeds the preset system parameter threshold, an alarm will be triggered to ensure the safety of the device during operation.

[0076] Correspondingly, another embodiment of the present invention also provides a method for using the device for maintaining the activity of the organs of a non-heart-beating donor 500, referring to Figure 3 , the method of use comprises the following steps:

[0077] Step S100: inserting the input tube 300 and the output tube 400 into the donor 500, so that the first circulation pipeline 100, the input tube 300, the donor 500 and the output tube 400 form a closed blood circulation loop;

[0078] Specifically, the input tube 300 may be inserted into the femoral artery of the donor 500 , and the output tube 400 may be inserted into the femoral vein of the donor 500 .

[0079] Step S200: starting the device so that the device reaches a pre-filling state;

[0080] Specifically, the first pinch-off valve 130 and the second pinch-off valve 140 are closed, the third pinch-off valve 210 is opened, and the heat exchanger 250 is heated by the hot water tank 260. When the water temperature in the hot water tank 260 reaches the set temperature, the heating is stopped. When the water temperature in the hot water tank 260 is lower than the set temperature, the heating is started. The greater the difference from the lower limit of the set temperature, the higher the heating power of the hot water tank 260. The system flow is monitored by the flow meter 270. When the flow is lower than the set threshold, the speed of the blood pump 230 is increased, and when the flow is higher than the preset threshold, the speed of the blood pump 230 is reduced. The total gas flow and the air-oxygen ratio are set by the oxygenator 240, and the monitoring value of the blood oxygen monitor 280 is ignored in the pre-perfusion state and only displayed. Among them, the value of the second temperature sensor 222 reaches the specified temperature (generally about 37°C, which is close to the normal body temperature of the human body), the speed of the blood pump 230 is stable, and no bubbles appear in the circulation pipeline, that is, the pre-perfusion state is reached.

[0081] Step S300: After the donor 500 is physiologically dead, the device is quickly switched from the pre-perfusion state to the formal perfusion state.

[0082] Specifically, the first pinch valve 130 and the second pinch valve 140 are opened, the third pinch valve 210 is closed, and the liquid level of the blood in the blood reservoir 220 is monitored in real time through the second liquid level sensor 221. When the liquid level of the blood in the blood reservoir 220 is lower than the preset safety range, the medical staff is reminded to replenish the fluid. When the liquid level of the blood in the blood reservoir 220 is lower than the warning limit, an alarm is immediately sounded and the speed of the blood pump 230 is reduced until the liquid level returns to the normal range and then the speed of the blood pump 230 is automatically restored. When the liquid level of the blood in the blood reservoir 220 decreases too rapidly, the blood pump 230 is shut down and an alarm is sounded. The blood pressure and blood flow rate in the circulation pipeline are adjusted by the blood pump 230. When the blood pressure is within the set range, the rotation speed of the blood pump 230 is determined by the blood flow rate. When the blood flow rate is lower than the set range, the rotation speed of the blood pump 230 is increased. When the blood flow rate is higher than the set range, the rotation speed of the blood pump 230 is reduced. When the blood pressure is lower than the set range, the rotation speed of the blood pump 230 is increased. When the blood pressure is higher than the set range, the rotation speed of the blood pump 230 is reduced. The blood oxygen content in the circulation pipeline is monitored by the blood oxygen monitor 280. When the blood oxygen content is lower than the set value, the gas flow rate of the oxygenator 240 is gradually increased until the blood oxygen content meets the standard. If the blood oxygen content still does not meet the standard after the gas flow rate reaches the highest set value, the oxygen ratio in the oxygenator 240 is gradually increased until the blood oxygen content meets the standard. If the blood oxygen content still does not meet the standard, an alarm is issued to prompt the replacement of the oxygenator 240.

[0083] In this embodiment, thanks to the improvement of the above-mentioned device for maintaining the activity of organs of a non-heartbeating donor 500, the method of using the device for maintaining the activity of organs of a non-heartbeating donor 500 in this embodiment has the same technical effect as the above-mentioned device for maintaining the activity of organs of a non-heartbeating donor 500, and will not be repeated here.

[0084] It should be noted that other contents of the device for maintaining the activity of the organs of the non-heartbeat donor 500 and the method for using the same disclosed in the present invention can be found in the prior art and will not be described in detail here.

[0085] The above are only preferred embodiments of the present invention, and are not intended to limit the patent scope of the present invention. All equivalent structural changes made using the contents of the present invention's specification and drawings, or directly / indirectly applied in other related technical fields, are included in the patent protection scope of the present invention.

Claims

1. A device for maintaining the activity of organs in a non-heart-beating donor, used to perfuse blood into the donor after the donor's physiological death to maintain the activity of the organs in the donor's abdominal cavity, characterized in that: The device for maintaining the activity of a non-heart-beating donor organ comprises: a first circulation pipeline, the first circulation pipeline comprising a first connection end and a second connection end, a blood reservoir, a blood pump and an oxygenator being arranged between the first connection end and the second connection end, the blood reservoir being used to store blood, the blood pump being used to provide power for the flow of blood, and the oxygenator being used to achieve gas-blood exchange of blood; an inlet tube, one end of which is connected to the first connecting end, and one end of which is away from the first connecting end and is connected to the femoral artery of the donor; an output tube, one end of which is connected to the second connection end, and one end of which is away from the second connection end and is connected to the femoral vein of the donor; The descending aorta of the donor is preset with an occluding balloon, which completely isolates the blood circulation between the thoracic cavity and the abdominal cavity of the donor, so as to ensure that the blood perfused into the donor through the input tube circulates only in the abdominal cavity of the donor; The first circulation pipeline, the input tube, the donor and the output tube form a closed blood circulation loop; The first circulation pipeline also includes: a first pinch-off valve, the first pinch-off valve being disposed at one end of the first circulation pipeline close to the first connecting end; a second pinch-off valve, the second pinch-off valve being disposed at one end of the first circulation pipeline close to the second connecting end; a second circulation pipeline, the second circulation pipeline being arranged between the first pinch-off valve and the second pinch-off valve, and the second circulation pipeline comprising the blood reservoir, the blood pump and the oxygenator, and the second circulation pipeline being provided with a third pinch-off valve; Wherein, when the first pinch-off valve and the second pinch-off valve are in an open state, and the third pinch-off valve is in a closed state, blood circulation is achieved in the first circulation pipeline, and blood flows through the blood reservoir, the blood pump, the oxygenator and the donor; when the first pinch-off valve and the second pinch-off valve are in a closed state, and the third pinch-off valve is in an open state, blood circulation is achieved in the second circulation pipeline, and blood flows through the blood reservoir, the blood pump and the oxygenator; The second circulation pipeline is further provided with a heat exchanger, and the heat exchanger is connected to a hot water tank, and the hot water tank includes a liquid inlet and a liquid outlet, and the liquid inlet and the liquid outlet are connected to the heat exchanger through a pipeline, so that the solution in the hot water tank flows from the liquid outlet through the pipeline into the heat exchanger, and flows from the heat exchanger through the pipeline and back to the hot water tank from the liquid inlet, thereby realizing heat exchange of blood in the first circulation pipeline or the second circulation pipeline; The heat exchanger is used to adjust the temperature of the blood in the first circulation line or the second circulation line to 37°C.

2. The device for maintaining the activity of a non-heart-beating donor organ according to claim 1, characterized in that: The pipeline is provided with a water pump for increasing the flow rate of the solution in the hot water tank.

3. The device for maintaining the activity of a non-heart-beating donor organ according to claim 1, characterized in that: The hot water tank is provided with a first liquid level sensor and a first temperature sensor. The first liquid level sensor is used to monitor the liquid level of the solution in the hot water tank, and the first temperature sensor is used to monitor the temperature of the solution in the hot water tank.

4. The device for maintaining the activity of a non-heart-beating donor organ according to claim 1, characterized in that: The second circulation pipeline is also provided with a flow meter and a blood oxygen monitor, the flow meter is used to monitor the flow of blood in the first circulation pipeline or the second circulation pipeline, and the blood oxygen monitor is used to monitor the oxygen content of the blood in the first circulation pipeline and the second circulation pipeline.

5. The device for maintaining the activity of a non-heart-beating donor organ according to claim 1, characterized in that: The second circulation pipeline is also provided with a bubble removal device and a thrombus filtering device. The bubble removal device is used to remove bubbles when blood circulates in the first circulation pipeline or the second circulation pipeline, and the thrombus filtering device is used to filter out thrombi when blood circulates in the first circulation pipeline or the second circulation pipeline.

6. The device for maintaining the activity of a non-heart-beating donor organ according to claim 1, characterized in that: The blood reservoir is provided with a second liquid level sensor and a second temperature sensor, wherein the second liquid level sensor is used to monitor the liquid level of the blood in the blood reservoir, and the second temperature sensor is used to monitor the temperature of the blood in the blood reservoir.

7. The device for maintaining the activity of a non-heart-beating donor organ according to claim 1, characterized in that: The blood reservoir is provided with a liquid filling port for replenishing blood to the blood reservoir.

8. The device for maintaining the activity of a non-heart-beating donor organ according to any one of claims 1 to 7, characterized in that: A pressure sensor is provided at one end of the first circulation pipeline close to the first connection end, for monitoring the blood pressure of the blood flowing into the donor through the first circulation pipeline.

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