CN112244007A - Intelligent isolated organ long-term maintenance device - Google Patents
Intelligent isolated organ long-term maintenance device Download PDFInfo
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- CN112244007A CN112244007A CN202011032489.2A CN202011032489A CN112244007A CN 112244007 A CN112244007 A CN 112244007A CN 202011032489 A CN202011032489 A CN 202011032489A CN 112244007 A CN112244007 A CN 112244007A
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Images
Classifications
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- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N1/00—Preservation of bodies of humans or animals, or parts thereof
- A01N1/02—Preservation of living parts
- A01N1/0236—Mechanical aspects
- A01N1/0242—Apparatuses, i.e. devices used in the process of preservation of living parts, such as pumps, refrigeration devices or any other devices featuring moving parts and/or temperature controlling components
- A01N1/0247—Apparatuses, i.e. devices used in the process of preservation of living parts, such as pumps, refrigeration devices or any other devices featuring moving parts and/or temperature controlling components for perfusion, i.e. for circulating fluid through organs, blood vessels or other living parts
Abstract
The invention aims to provide an intelligent isolated organ long-term maintenance device, which solves the problem of isolated organ long-term preservation and is characterized by comprising the following components in parts by weight: the device comprises a perfusion module, a dialysis module, an oxygenation and blood gas regulation module, an automatic blood flow control module and a temperature control module, wherein the perfusion module is sequentially connected with the dialysis module, the oxygenation and blood gas regulation module, the automatic blood flow control module and the temperature control module to form a closed loop.
Description
Technical Field
The invention relates to the technical field of organ transplantation, in particular to an intelligent isolated organ long-term maintenance device.
Background
Clinically, more and more patients are waiting for organ transplantation, but the number of donated organs is far from meeting the demand, and the shortage of organs becomes a big problem facing the development of organ transplantation. One of the major reasons for organ shortage is that donor organs are inevitably in a non-physiological environment during harvesting and storage. After an organ is removed from a donor, it is subjected to non-physiological conditions such as ischemia and metabolic waste accumulation, and the ischemic organ in vitro dies in a short time (few minutes and more than 1 hour), but it is impractical to complete the transplantation operation in such a short time, which results in many donor organs being discarded or poor in quality. Therefore, it is sought to preserve the isolated organ by simulating the physiological environment of the human body, to maintain the activity of the isolated organ as much as possible, and to improve the utilization rate and quality of the donor organ.
At present, the common isolated organ preservation method in clinic is low-temperature preservation, and aims to reduce the metabolism of organs through low temperature, reduce the energy consumption of cells and the accumulation of metabolic waste so as to prolong the preservation time of the organs. However, hypothermia is typically only prolonged for hours and does not prevent cell death, and hypothermic conditions can also cause damage to tissue cells.
In addition, patent CN201410384703.9 discloses a cryo-or sub-normothermic preservation device for ex vivo kidney, which has started to consider organ preservation at sub-normothermia to improve the preservation quality of kidney. Patent No. cn201310723787.x discloses a transplant organ protection bag which is simple in structure, but which can only perform organ preservation at low temperature and cannot provide oxygen and circulating blood. Patent CN201280066672.1 discloses an oxygen supply device for an organ perfusion system, the design of which has been started to supply oxygen to perfused organs. Patent CN201710086860.5 discloses an in vitro perfusion preservation device for isolated organs, which is designed to perfuse isolated organs with perfusate, and has the functions of oxygen supply, blood flow regulation, etc., but it has not yet been able to fully simulate the environment in human body, and lacks the functions of metabolic waste removal, blood gas regulation, automatic blood flow control, liquid flow control, etc.
All the patents try to improve the in vitro preservation time of isolated organs, but the setting of simulating the internal environment of a human body is not sufficient and comprehensive.
Disclosure of Invention
The invention aims to provide an intelligent isolated organ long-term maintenance device, which solves the problem of isolated organ long-term preservation.
The above object of the present invention is achieved by the following technical solutions:
an intelligent isolated organ long-term maintenance device, comprising: the device comprises a perfusion module, a dialysis module, an oxygenation and blood gas regulation module, an automatic blood flow control module and a temperature control module, wherein the perfusion module is sequentially connected with the dialysis module, the oxygenation and blood gas regulation module, the automatic blood flow control module and the temperature control module to form a closed loop.
Further, the dialysis device comprises a liquid quantity estimation module, wherein the liquid quantity estimation module is connected with the dialysis module.
Further, the perfusion module comprises: the organ containing cover comprises a cover organ cabin and pipelines, wherein an isolated organ is placed in the cover organ cabin, and the pipelines comprise a blood backflow pipeline, a product collecting pipeline and an isolated organ blood supply pipeline.
Furthermore, the blood reflux pipeline and the product collecting pipeline penetrate through the bottom of the covered organ cabin to be connected with the isolated organ, the isolated organ blood supply pipeline penetrates through the side wall of the covered organ cabin to be connected with the isolated organ, a sponge rubber mat attached with a non-water-absorbing film is placed at the bottom of the covered organ cabin, scales are arranged on the side wall of the covered organ cabin, the blood reflux pipeline is connected with a peristaltic pump, the product collecting pipeline is connected with a measuring cylinder, and two sets of isolated organ blood supply pipelines are arranged.
Furthermore, the dialysis module comprises a filter, a dialysate bag, a dialysis pipeline passage and a waste liquid bag, wherein the blood backflow pipeline is connected with the filter through a peristaltic pump, the dialysate bag is connected with the filter, and the waste liquid bag is connected with the filter through the peristaltic pump.
Further, the oxygenation and blood gas regulation module comprises a membrane lung, an air bag, a CD1500 continuous blood gas monitoring system, an oxygen gas storage tank, a nitrogen gas storage tank, a carbon dioxide gas storage tank, a gas supply and control device and a total gas flow control valve, wherein the membrane lung is positioned behind the blood bank and connected in series on the blood backflow pipeline, the oxygen gas storage tank, the nitrogen gas storage tank and the carbon dioxide gas storage tank are connected with the air bag and are respectively controlled by valves, the CD150 continuous blood gas monitoring system transmits signals to a signal transducer, the signal transducer is connected with the oxygen gas storage tank, the nitrogen gas storage tank and the carbon dioxide gas storage tank through the valves, and the signal transducer is connected with the air bag through the total gas flow control valve.
Further, the automated blood flow control module comprises: the blood enters the isolated organ blood supply pipeline through the peristaltic pump, the pressure sensor and the flow rate sensor are installed on the isolated organ blood supply pipeline, the pressure sensor and the flow rate sensor are connected with the signal transduction device, and the signal transduction device is connected with the peristaltic pump.
Further, the temperature control module comprises: the temperature control assembly is connected with the water heat exchange system.
Furthermore, the blood reflux pipeline, the blood supply pipeline of the isolated organ and the dialysis pipeline are heparin coating pipelines.
Furthermore, a leukocyte filter is arranged on the blood return pipeline behind the dialysis module.
In conclusion, the beneficial technical effects of the invention are as follows:
(1) the double-circulation design of the device enables the device to be used for quickly connecting and storing various organs such as liver, kidney, pancreas and the like, and the device is a universal organ storage device;
(2) the device utilizes the perfusate based on the red blood cells for perfusion, the state of the perfusate is close to that of blood, so that the red blood cells still carry oxygen to supply tissue cells in the process of in vitro preservation of the organ, thereby greatly lacking the ischemia reperfusion injury generated after organ transplantation, and being beneficial to the rapid development of the ischemic organ transplantation technology in the future;
(3) the automatic control technology has high intelligent degree, can fully save manpower and material resources used by a machine, can accurately and quickly maintain the stability of the isolated organ preservation environment, and is beneficial to preserving the isolated organ for a long time;
(4) the dialysis module is helpful for clearing the metabolic waste in the circulation and reducing the damage of the metabolic waste to the isolated organ, and can also maintain the ion concentration of the perfused blood to be stable at a certain reference level and simulate the environment in the human body, thereby being helpful for maintaining the activity of the isolated organ for a long time;
(5) the oxygenation and blood gas regulation module not only provides oxygenation for perfused blood, but also can continuously monitor the blood gas of the perfused blood in real time and make automatic feedback regulation;
(6) the automatic blood flow control module realizes automatic maintenance of proper flow rate and pressure for perfusing isolated organs, reduces manpower and simplifies the operation process of a machine; meanwhile, the two indexes are monitored simultaneously, and the matching relation of the two indexes is set, so that the method is beneficial to quickly and accurately judging the possible problems of the machine in clinical operation, reducing the adverse effect of system faults on the perfusion process and prolonging the in vitro perfusion preservation time of the isolated organ;
(7) the liquid quantity estimation module is helpful for judging the liquid quantity circulating in the system and the change condition of the liquid quantity in the perfusion process; the estimation value of the liquid volume is helpful for estimating whether the perfusion volume of the isolated organ is sufficient or not, so as to prevent the insufficient perfusion of the isolated organ; the operation condition of the filling equipment can be judged beneficially according to the change condition of the liquid amount in the filling process;
(8) the temperature control module enables the blood of the perfused organ to be kept at a constant temperature of about 37 ℃, so that the problem that the tissue cells of the isolated organ are damaged due to too low temperature in a low-temperature static preservation method is solved;
(9) the cover-containing organ cabin is used for containing isolated organs, the bottom of the cover-containing organ cabin is padded with a sponge rubber pad covered with a non-absorbent film, so that the long-term ischemic necrosis of the organs can be prevented, the rubber pad is arranged at the joint of the cover and the organ cabin, so that the cabin body can form a relatively closed space to simulate a closed abdominal cavity or a closed thoracic cavity, the relatively sterile state can be favorably kept, and the evaporation loss of liquid in a circulation path can be favorably prevented; the inner wall of the organ cabin is also provided with scales which can be used for predicting the liquid amount in the organ cabin;
(10) the heparin coating can effectively prevent the formation of thrombus in the pipeline, maintains the stability of machine operation, and this device design has the leucocyte filter, can effectively filter out leucocyte etc. helps alleviateing the immunoreaction of transplantation postoperative, improves the success rate of transplantation.
Drawings
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention will be further described in detail with reference to the accompanying drawings, in which:
FIG. 1 is a schematic view of an intelligent isolated organ long-term maintenance device according to the present invention;
FIG. 2 is hepatic arterial pressure;
FIG. 3 is hepatic artery blood flow;
FIG. 4 is a hepatic artery resistance index;
FIG. 5 is portal venous blood flow;
FIG. 6 is portal vein pressure;
FIG. 7 is a portal vein resistance index;
FIG. 8 is the arterial carbon dioxide partial pressure (PCO2) of four cases of the liver;
FIG. 9 is the oxygen partial pressure (PO2) for four cases of liver;
FIG. 10 is perfusate glucose levels for four cases of liver;
FIG. 11 is the pH of four cases of liver;
FIG. 12 is perfusate lactate levels for four cases of liver.
The specific symbols are:
1-covered organ cabin; 2-sponge cushion covered by non-absorbent film; 3-dialysis tubing access; 4-a filter; 5-dialysate bag; 6-waste liquid bag; 7-blood bank; 8-membrane lung; 9-gas supply and control means; 10-a signal transduction device; 11-micro pump connection port; 12-a thrombus filter; 13-a product collection conduit; 14-the organ supplies blood vessel one; 15-the organ supplies blood vessel II; 16-a blood return line; 17-a water heat exchange system; 18-a cannula; 19-air bag; 20-measuring cylinder; 21-total gas flow control valve; 22-leukocyte filter; an F-flow sensor; a P-pressure sensor; t-signal conversion means; a-a perfusion module; b-a dialysis module; a C-oxygenation and blood gas regulation device; d-an automated blood flow control module; and E-a temperature control module.
Detailed Description
In order to more clearly illustrate the embodiments or technical solutions in the prior art of the present invention, the drawings and technical solutions required to be used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only some embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to the drawings without creative efforts.
The invention is further described below with reference to the accompanying drawings.
As shown in fig. 1, a long-term isolated organ maintenance device aims to provide an isolated organ with a physiological environment similar to the normal human body (suitable oxygen and nutrient supply, timely waste metabolite removal, stable hemodynamics and blood gas regulation), and intelligently maintains the long-term stability of the environment of the isolated organ, and is suitable for long-term preservation of isolated organs such as isolated liver under normal temperature conditions. The device mainly comprises a perfusion module A, a dialysis module B, an oxygenation and blood gas regulation module C, an automatic blood flow control module D, a temperature control module E and a circulating liquid amount estimation module F.
The perfusion module A comprises a covered organ cabin 1 and various pipelines. The organ cabin 1 containing the cover contains isolated organs, the bottom of the organ cabin is padded with a sponge rubber pad 2 covered with a non-water-absorbing film to prevent the organs from being subjected to ischemia and necrosis for a long time, and the contact part of the cover and the organ cabin is attached with a layer of rubber pad to form a relatively closed space for the cabin body and simulate a closed abdominal cavity or a chest cavity, so that the relatively sterile state can be maintained, and the evaporation loss of liquid in a circulation path can be prevented; the inner wall of the organ-containing cabin 1 is also provided with scales which can be used for pre-estimating the liquid amount in the organ cabin. The isolated organ blood backflow pipeline 16 (in the isolated liver perfusion, the isolated organ blood backflow pipeline 16 is connected with the inferior vena cava through a hose), and the isolated organ product collection pipeline 13 (in the isolated liver perfusion, the isolated organ product collection pipeline 13 is connected with the biliary tract through a hose to collect bile) are all sent out from the bottom of the organ cabin 1 with the cover, venous blood backflow in the blood backflow pipeline 16 is powered by a peristaltic pump, and the tail end of the isolated organ product collection pipeline 13 is connected with a graduated burette 20. Two sets of isolated organ blood supply pipelines 14 and 15 enter the organ cabin from the side opening of the organ cabin 1 with the cover and are connected with the blood supply vessels of the corresponding isolated organs through hose connectors; the double blood supply organs start 14 and 15 channels simultaneously, for example, in the process of perfusing an isolated liver, a blood supply pipeline I14 of the isolated organ is connected with a hepatic artery of the isolated liver through a hose connector, and a blood supply pipeline II 15 of the isolated organ is connected with a portal vein through the hose connector; for example, a single blood supply isolated organ, only one blood supply channel can be reserved by clamping one valve). When the device is operated, the isolated organ blood supply pipelines 14 and 15 are connected with corresponding blood supply arteries of the isolated organ to perfuse the isolated organ in the covered organ cabin 1, and the blood flows back to the device through the blood return pipeline 16. The device mainly uses perfusate prepared by simulating blood to preserve isolated organs, the perfusate is prepared by taking red blood cells as a base, the red blood cells have strong oxygen carrying capacity, the perfusion by utilizing the red blood cells is beneficial to providing sufficient oxygen for the isolated organs, other components mainly comprise colloid fluid (simulating the action of albumin and the like and maintaining the colloid osmotic pressure of the perfusate), so that the balance of the osmotic pressure inside and outside blood vessels of the isolated organs is realized, the edema of isolated organ tissues is prevented, sodium, calcium, magnesium and the like (maintaining the crystal osmotic pressure of the perfusate and preventing the edema of the isolated organ cells, the hemolysis of the red blood cells and the like), antibiotics, hormones, trace elements, amino acids, alkali, heparin and the like. In the preparation process, the concentrated red blood cells of the same blood type with the isolated organ are diluted to a proper proportion.
Dialysis module B includes dialysis tubing path 3, filter 4, dialysate 5, waste bag 6, and peristaltic pump 2 that drives the flow of dialysate. The ions in the dialysate 5 mainly include sodium ions, potassium ions, calcium ions, magnesium ions, chloride ions, bicarbonate ions, glucose, and the like, at concentrations similar to normal concentrations in blood. Venous blood in the blood return line 16 flows into the filter 4 under the drive of the peristaltic pump, and dialysate also enters the dialysis line path 3 of the filter 4 under the drive of the peristaltic pump. In the filter 4, the dialysate and the return venous blood are separated by a semipermeable membrane, ion and metabolic waste exchange is carried out by the driving force of ion concentration difference and the suction force of a peristaltic pump, and when the concentration of certain ions in the blood is higher than the normal level, the ions are separated out from the blood side of the semipermeable membrane into the dialysate side; when the concentration of certain ions in the blood is lower than the normal level, the ions on one side of the semipermeable membrane dialysate can enter one side of the semipermeable membrane blood; for metabolic waste, the concentration of one side of the dialysate is zero, and the metabolic waste can continuously penetrate through the dialysis membrane from the blood side and enter one side of the dialysate; by the above exchange, dialysis module B can function to maintain the ion concentration in the blood at a certain baseline level, while the source does not carry away metabolic waste. After that, the dialysate 5 is exchanged and then enters the waste liquid bag 6 along the dialysis tube path 3, and the venous blood in the blood return tube 16 is dialyzed and then flows into the blood reservoir 7.
The oxygenation and blood gas regulation module C consists of a membrane lung 8, a CDI500 continuous blood gas monitoring system, an air bag 19, an oxygen gas storage tank 9A, a nitrogen gas storage tank 9B, a carbon dioxide gas storage tank 9C, respective gas flow control valves A \ B \ C and a total gas flow control valve 21. The membrane lung 8 is positioned behind the blood reservoir and is connected in series to the blood return pipeline 16, and the blood in the blood reservoir 7 flows through the membrane lung 8 and enters the blood supply pipelines 14 and 15 of the isolated organs after being fully oxygenated. The three-atmosphere gas storage tank 9A \ B \ C enters the air bag 19 through the respective gas flow control valve A \ B \ C, the oxygen partial pressure in the air bag 19 is changed by different flow proportions, and the gas in the air bag 19 enters the membrane lung through the total gas flow control valve. The CDI500 type continuous blood gas monitoring system monitors the blood gas of blood oxygenated by a membrane lung, the CDI500 type continuous blood gas monitoring system monitors the oxygen partial pressure, the carbon dioxide partial pressure and the pH value of the blood oxygenated by the membrane lung, the collected oxygen partial pressure information is processed by the signal transducer and then fed back to the gas flow control valve A \ B \ C, the size and the proportion of various gas flows are adjusted through the gas flow control valve to reach a certain oxygen partial pressure level, and if the CDI500 type continuous blood gas monitoring system monitors that the oxygen partial pressure of the blood oxygenated by the membrane lung is too low, the oxygen partial pressure is fed back to the gas flow control valve A \ B \ C to increase the flow of oxygen and reduce the flow of other gases, so that the blood oxygen partial pressure is increased; similarly, the partial pressure of carbon dioxide and the pH value of the blood after oxygenation by the membrane lung, which are monitored by the CDI500 type continuous blood gas monitoring system, are fed back to the total gas flow control valve to adjust the speed of the gas entering the membrane lung 8, for example, when the CDI500 type continuous blood gas monitoring system monitors that the partial pressure of carbon dioxide of the blood after oxygenation by the membrane lung rises and the pH value drops, the information is processed by the signal transducer and fed back to the total gas flow control valve to increase the flow rate of the gas entering the membrane lung 8, so that excessive carbon dioxide in the blood is washed out. Through the feedback regulation, the blood perfused with the isolated organ is maintained to have proper oxygen partial pressure, carbon dioxide partial pressure and pH value. In addition, the carbon dioxide gas storage tank only supplies carbon dioxide gas in the early stage of perfusion to maintain proper pH value and partial pressure of carbon dioxide in blood, and after the isolated organ can be metabolized by itself to form carbon dioxide, the carbon dioxide gas is gradually reduced to stop supplying the carbon dioxide gas.
The fluid volume estimation module F is mainly used for estimating and monitoring the total volume of fluid in the system and maintaining the stability of the hematocrit, the scale of the inner wall of the organ chamber 1 containing the cover can be used for roughly estimating the volume of fluid in the chamber, the volume of fluid in the blood reservoir 7 can be roughly estimated by the scale on the fluid bag, and the estimated volume of fluid in each pipeline is equivalent to the approximate volume of fluid in the whole system. The liquid quantity estimation module F is helpful for judging the liquid quantity circulating in the system and the change condition of the liquid quantity in the perfusion process; the estimation value of the liquid volume is helpful for estimating whether the perfusion volume of the isolated organ is sufficient or not, so as to prevent the insufficient perfusion of the isolated organ; the method is helpful for judging the operation condition of the perfusion equipment according to the change condition of the liquid amount in the perfusion process, for example, whether blood leakage exists in the circulation loop is considered when the change of the total liquid amount is large in a short time, the rotating speed of each peristaltic pump in the coordination loop is considered when the difference of the blood amount in the blood reservoir 7 and the blood amount in the organ cabin is large, and the like. The combination of the liquid estimation module F and the dialysis module B can be used for maintaining the stability of the hematocrit, after the estimation of the module F, if the liquid volume is too much, no dialysate is injected into the dialysis pipeline passage 3, the dialysis function is converted into the ultrafiltration function by the driving of the peristaltic pump, and the redundant liquid volume in the circulation is filtered; when the amount of the liquid is too small, the micro-pump connection port 11 is replenished with the liquid, thereby stabilizing the hematocrit in the maintenance cycle.
The automatic blood flow control module D is a feedback channel consisting of a pressure sensor P, a flow velocity sensor F, a signal transduction and control system C and a peristaltic pump and is externally connected with a display screen 17. Blood in the blood bank 7 is perfused the isolated organ through isolated organ blood supply pipeline 14, 15 respectively under the effect of peristaltic pump, and pressure sensor P and velocity of flow sensor F's monitoring point all are located blood supply pipeline entering isolated organ department, and pressure and velocity of flow information that it collected feed back to the peristaltic pump after signal transduction, and the rotational speed of peristaltic pump is adjusted in the instruction, and pressure and velocity of flow information are shown through the display screen simultaneously. The logic is as follows: the flow rate and the pressure of the blood flow at the inlet of the perfused isolated organ are both set in a certain proper range, and when the pressure and the flow rate monitored by the sensor are both in the respective set ranges, the rotating speed of the peristaltic pump is not adjusted; when the sensor monitors that any one of the pressure or the flow rate exceeds the upper limit of the respective set range, the rotation speed of the peristaltic pump is fed back and reduced, so that the pressure and the flow rate are reduced to the respective set range; when the pressure or the flow rate monitored by the sensor is lower than the lower limit of the respective set range, the rotation speed of the peristaltic pump is fed back and increased, so that the pressure and the flow rate are increased to be within the respective set range. The flow rate and the pressure are in a pair of correlation relations, the degree of flow rate change and the degree of pressure change present a certain proportional relation, and the matched parameter range of the flow rate change and the pressure change can be set by combining with the clinical actual perfused organ under normal conditions; if the two can not be simultaneously in respective setting range after a plurality of times of adjustment (the adjustment times are set in combination with specific clinical conditions), namely the two are uncoordinated in change, the uncoordinated information is fed back to the display screen and gives an alarm to remind the operator to perform manual intervention treatment. Flow rate to pressure mismatches are typically found in: when the ratio of the flow rate to the pressure change is too large, the system is prompted to have too low internal resistance, which is seen in the falling of a pipeline at a certain position of the system or the excessive expansion of a perfused organ blood vessel; when the ratio of the flow rate to the pressure is too small, the increase of the internal resistance of the system is prompted, and the situation that embolism occurs in the system, such as thromboembolism, vascular embolism or thrombosis in an isolated organ, vasoconstriction in the isolated organ, and the like is found.
The temperature control module E consists of a water heat exchange system 17 and a sleeve 18 with a groove, wherein the length of the sleeve 18 is about 10cm, warm water from the water heat exchange system flows in the sleeve, and a part of blood supply pipelines 14 and 15 of the isolated organs are embedded in the groove. Blood flowing in the blood supply pipelines 14 and 15 of the isolated organs is heated by the temperature control module and then perfused to the isolated organs, so that the temperature of the perfused blood of the isolated organs is kept within a set range.
And others: all pipeline systems are heparin-coated pipelines, and before blood perfuses isolated organs, the blood flows through the thrombus filter, so that thrombus is prevented from being formed by the two and anticoagulant drugs. A leukocyte filter 22 is provided on the blood return vein 16 after the dialysis module B.
The working process of the invention is as follows: the blood for perfusing the isolated organ is perfused into the isolated organ in the covered organ cabin 1 under the driving of the peristaltic pump, under the action of the peristaltic pump and gravity, the perfused blood in the covered organ cabin 1 flows out through a venous blood backflow pipeline 16 at the bottom of the covered organ cabin 1, most of the blood enters a dialysis module B under the action of the peristaltic pump, and a small part of the blood directly enters a blood bank through a loop; under the action of the peristaltic pump, the blood flows through the filter 4, under the action of the peristaltic pump, the dialysate enters the filter 4 in the opposite direction, and in the filter 4, the dialysate and the blood are subjected to ion and metabolic waste exchange through a semipermeable membrane; the blood which is cleared of metabolic waste and subjected to ion exchange by the dialysis module 4 flows into a blood bank 7; under the action of the peristaltic pump, the blood in the blood bank 7 flows through the membrane lung 8 in the oxygenation C to be fully oxygenated, and the fully oxygenated blood flows through the temperature control module E to be heated under the action of the peristaltic pump, so that the temperature of the perfused blood is kept at the set temperature, and then flows into the covered organ cabin 1 through the isolated organ perfusion pipeline.
The experimental method comprises the following steps: the performance of the device is preliminarily verified by taking perfused isolated liver as an example. We collected 4 tumor livers excised during liver transplantation for experimental study. The liver is a double blood supply organ, in the process of perfusing the isolated liver, the isolated organ blood supply pipeline I14 is connected with the hepatic main artery of the isolated liver through a hose connector, the isolated organ blood supply pipeline II 15 is connected with the portal vein through a hose connector, and perfusing is carried out by using perfusate prepared from the patient blood type concentrated red blood cells, so as to provide continuous oxygen and nutrition supply. The product collecting pipeline 13 is connected with the biliary tract through a hose to collect bile. Recording the flow and pressure of the perfusion liquid, carrying out blood gas analysis, and analyzing the function of the diseased liver. Liver tissue was taken for histological analysis after perfusion.
Experimental data and results:
the total perfusion time of the four livers is 10h, 11h, 18h and 47h respectively.
-hemodynamic changes: during the whole perfusion process, the average perfusion pressure is 52-60mmHg at the beginning, the average hepatic artery blood flow fluctuation is in the range of 100-230ml/min, and the blood flow is kept stable after 1h (figures 2 and 3). The hepatic artery resistance index gradually decreased from 0.6 to 0.3 (fig. 4). The portal blood flow was stabilized at 0.5-1.3L/min (FIG. 5) and the pressure at 8-13mmHg (FIG. 6) within 1 hour after perfusion. The portal vein resistance index decreased from 27 to nearly 8 (fig. 7). These results indicate that the microvasculature perfused ex vivo into the liver remains patent with both hepatic and portal blood flow maintained within physiological ranges under perfusion with the present device.
Liver function: the arterial carbon dioxide partial pressures (PCO2) of the four livers stabilized between 15mmHg and 75mmHg (fig. 8), while the oxygen partial pressure (PO2) fluctuated between 90-340mmHg (fig. 9), indicating that the oxygenation status of the device was normal. The average perfusion glucose fluctuated between 27.8-3.4 mmol/L (FIG. 10), indicating that there was significant glucose consumption during perfusion. In addition, the potential of the pH stabilized within the normal range (FIG. 11), while the mean perfusate lactate level remained below 5mmol/L (FIG. 12) for most of the time. Overall, these data indicate that the device can restore and maintain metabolism and bile production in vitro for up to 47 hours in vitro for the liver ex vivo.
③ pathological changes: HE staining analysis showed no change in liver parenchyma after perfusion, intact antral structure, and viable hepatocytes. Overall, the integrity of the liver tissue was preserved and no further damage was observed during perfusion of the device.
Arterial and portal venous blood flow was substantially stable 1h after perfusion and remained within physiological range. The results of blood gas analysis showed recovery and maintenance of metabolic function of the liver. In addition, in one example, the pathological liver is perfused for 47 hours, and the generation of bile shows the fresh and alive function in the whole perfusion process of 47 hours. Histological analysis showed little damage to the liver after perfusion. In conclusion, the device can well recover and maintain the functions of isolated organs after perfusing the isolated liver.
The above description is only an embodiment of the present invention, but the scope of the present invention is not limited thereto, and any changes or substitutions that are not thought of through the inventive work should be included in the scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope defined by the claims.
Claims (10)
1. An intelligent isolated organ long-term maintenance device, comprising: the device comprises a perfusion module, a dialysis module, an oxygenation and blood gas regulation module, an automatic blood flow control module and a temperature control module, wherein the perfusion module is sequentially connected with the dialysis module, the oxygenation and blood gas regulation module, the automatic blood flow control module and the temperature control module to form a closed loop.
2. The intelligent isolated organ long-term maintenance device according to claim 1, comprising a fluid volume estimation module, wherein the fluid volume estimation module is connected to the dialysis module.
3. The intelligent isolated organ long-term maintenance device according to claim 1 or 2, wherein the perfusion module comprises: the organ containing cover comprises a cover organ cabin and pipelines, wherein an isolated organ is placed in the cover organ cabin, and the pipelines comprise a blood backflow pipeline, a product collecting pipeline and an isolated organ blood supply pipeline.
4. The intelligent isolated organ long-term maintenance device according to claim 3, wherein the blood return line and the product collection line pass through the bottom of the covered organ chamber to be connected with the isolated organ, the isolated organ blood supply line passes through the side wall of the covered organ chamber to be connected with the isolated organ, a sponge rubber mat attached with a non-absorbent film is placed at the bottom of the covered organ chamber, scales are arranged on the side wall of the covered organ chamber, the blood return line is connected with a peristaltic pump, the product collection line is connected with a measuring cylinder, and two sets of the isolated organ blood supply lines are provided.
5. The intelligent isolated organ long-term maintenance device according to claim 3, wherein the dialysis module comprises a filter, a dialysate bag, a dialysis tubing path, and a waste bag, the blood return tubing is connected to the filter via a peristaltic pump, the dialysate bag is connected to the filter, and the waste bag is connected to the filter via a peristaltic pump.
6. The intelligent isolated organ long-term maintenance device according to claim 3, the oxygenation and blood gas regulation module comprises a membrane lung, an air bag, a CD1500 continuous blood gas monitoring system, an oxygen gas storage tank, a nitrogen gas storage tank, a carbon dioxide gas storage tank, a gas supply and control device and a total gas flow control valve, the membrane lung is positioned behind the blood reservoir and is connected in series with the blood return pipeline, the oxygen gas storage tank, the nitrogen gas storage tank and the carbon dioxide gas storage tank are connected with the air bag, and are respectively controlled by valves, the CD1500 continuous blood gas monitoring system transmits signals to the signal transducer, the signal transducer is connected with the oxygen gas storage tank, the nitrogen gas storage tank and the carbon dioxide gas storage tank through the valves, and the signal transducer is connected with the air bag through a total gas flow control valve.
7. The intelligent isolated organ long-term maintenance device of claim 3, wherein the automated blood flow control module comprises: the blood enters the isolated organ blood supply pipeline through the peristaltic pump, the pressure sensor and the flow rate sensor are installed on the isolated organ blood supply pipeline, the pressure sensor and the flow rate sensor are connected with the signal transduction device, and the signal transduction device is connected with the peristaltic pump.
8. The intelligent isolated organ long-term maintenance device according to claim 3, wherein the temperature control module comprises: the temperature control assembly is connected with the water heat exchange system.
9. The intelligent isolated organ long-term maintenance device according to claim 5, wherein the blood return line, the isolated organ blood supply line and the dialysis line path are heparin-coated lines.
10. The intelligent isolated organ long-term maintenance device according to claim 3, wherein a leukocyte filter is arranged on the blood return line after the dialysis module.
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