CN114766470A - Low-temperature mechanical perfusion storage device and method - Google Patents
Low-temperature mechanical perfusion storage device and method Download PDFInfo
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- CN114766470A CN114766470A CN202210471250.8A CN202210471250A CN114766470A CN 114766470 A CN114766470 A CN 114766470A CN 202210471250 A CN202210471250 A CN 202210471250A CN 114766470 A CN114766470 A CN 114766470A
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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 provides a low-temperature mechanical perfusion preservation device and a low-temperature mechanical perfusion preservation method, wherein the device comprises an organ box for placing an organ to be transplanted, a coolant container, a filter, a bubble catcher, a semiconductor refrigerating element, a pump, a perfusion circuit, a circulation circuit, a sensor assembly, a solenoid valve assembly and a control display unit, wherein the sensor assembly comprises a bubble sensor, a pressure sensor, a flow sensor and a temperature sensor; the bubble catcher comprises three ports which are respectively a liquid inlet, a perfusion outlet and a circulating outlet, a partition board is vertically arranged at the bottom of the bubble catcher, and the partition board divides the bubble catcher into a plurality of communicated chambers; the semiconductor refrigeration element is mounted outside the bubble trap. The low-temperature mechanical perfusion storage device can directly detect the temperature of the perfusion fluid, can cool the perfusion fluid with the temperature exceeding the standard to the set temperature range as soon as possible, can prevent air bubbles from entering a perfusion pipeline as far as possible, and improves the accuracy of perfusion data and perfusion safety.
Description
Technical Field
The invention belongs to the field of biomedical instruments, and particularly relates to a low-temperature mechanical perfusion preservation device and method for organ transplantation.
Background
Organ transplantation refers to the surgical transfer of a viable isolated organ into a patient. The temperature must be controlled in a low-temperature environment of 2-8 ℃ during organ storage, and the traditional organ preservation method is static cold preservation. The longer the static cold storage time, the higher the incidence of delayed recovery of graft function after surgery, and in addition, the difficulty in objective assessment of isolated organs by static cold storage. Compared with static cold preservation, the low-temperature mechanical perfusion of the isolated organ can obviously reduce the incidence of delayed recovery of the function of the transplanted organ, is beneficial to improving the long-term survival rate of the transplanted organ, and meanwhile, the mechanical perfusion parameters can assist in evaluating the quality of the transplanted organ and are beneficial to the full utilization of the isolated organ. The organ perfusion transfer box is equipment for transferring, preserving and low-temperature mechanical perfusion of the isolated organ for transplantation, can prolong the storage time of the isolated organ, evaluate the quality of the isolated organ and reduce the incidence rate of postoperative DGF (delayed recovery of the function of the transplanted organ), and is widely applied at present. For example, the LifePort renal perfusion transport box introduced by the LSI corporation is the most widely used low-temperature mechanical perfusion product in clinical practice, and has been registered and sold in three markets of china, the united states and europe.
Typically, the perfusate needs to be cooled to a suitably low temperature before perfusion. Taking a LifePort kidney perfusion operation box as an example, the temperature safety of the perfusion liquid is mainly realized by controlling the temperature of an ice box. The ice box is provided with a thermal resistance type sensor for detecting the temperature of the ice box, a control system generally sets the temperature range of 0-8 ℃ for the temperature of the ice box, and when the temperature of the ice box is lower than 0 ℃ or higher than 8 ℃, the equipment cannot normally run. However, the above-mentioned perfusate temperature control method has a certain risk, and because the temperature of the ice box is detected instead of directly detecting the temperature of the perfusate, if the perfusate which is not cooled in place is filled into the perfusion equipment with the ice box, the isolated organ can be perfused for about half an hour or more under the state of higher than the ideal temperature, and the perfusate can be cooled to the proper temperature by the ice box, which can cause irreversible damage to the isolated organ.
The insufficient precooling of the perfusate may be related to the limited preservation conditions after the refrigerator is taken out, when the temperature of the perfusate in the operation box equipment is too high, the efficiency of the equipment for cooling the perfusate by depending on the physical ice box is too low, because the physical ice box mainly plays a role in maintaining the temperature of the perfusate, a doctor is required to wait for the temperature of the perfusate to be lower than 8 ℃ before installing the isolated organ and perfusing the isolated organ, the waiting time may exceed 1 hour, obviously, the waiting time is not so long in the operation process, and the existing operation box equipment lacks a mechanism for quickly cooling.
The organ perfusion transfer box maintains the low-temperature environment of the perfusate by means of the physical ice box filled with 5.5kg of ice-water mixture, so at least 4.5kg of crushed ice and 1kg of ice water must be prepared for filling the physical ice box before use, and when several kidneys are perfused at the same time, a lot of time is needed for preparing enough crushed ice and ice water and the filling is needed to be carried out one by one before the perfusion, and the process is complicated.
The organ perfusion transfer box has the function of evaluating the quality of an isolated organ, and the quality of an isolated kidney is evaluated through perfusion resistance, the change of flow parameters and a final result, so the accuracy of perfusion flow and resistance generally influences clinical evaluation. The organ perfusion transfer box obtains flow parameters by calculating the rotation speed of the peristaltic pump per minute, and the resistance is obtained by calculating the detection pressure and the flow of the pressure sensor. When the peristaltic pump is abnormal, if a fixer is loosened and a pump pipe falls off, the fixed flow pumped by the peristaltic pump in a single cycle changes (if the fixed flow is reduced), in order to reach a set pressure, the rotational speed of the peristaltic pump must be increased, a pseudo-high flow can be formed under the same set pressure, the pseudo-high flow is substituted into the calculation to form a pseudo-low resistance, because the flow is calculated by the existing operation box equipment only depending on the rotational speed of the peristaltic pump, the accuracy of the flow cannot be identified, inaccurate flow prompt cannot be sent, and the false flow and the resistance usually mislead clinical judgment.
When the perfusate enters the isolated organ, bubbles are prevented from being entrained into the organ, so that the perfusate usually needs to pass through a bubble catcher in advance to remove the bubbles. The bubble trap can discharge bubbles in the pipeline through a circulation port at the top end. . During circulation, the circulation port is opened to purge air or other gases from the perfusate path. From the current practice of various cryogenic mechanical infusion-type products, there is still a risk that bubbles in the bubble trap continue to flow downstream and enter the organ.
In general, there is still room for improvement in the existing organ perfusion transfer boxes in terms of convenience of use, perfusion safety, data accuracy, and the like.
Disclosure of Invention
The invention provides a low-temperature mechanical perfusion storage device, which improves the accuracy of perfusion temperature detection and perfusion safety.
The technical scheme adopted by the invention is as follows:
a low-temperature mechanical perfusion preservation device comprises an organ box for placing an organ to be transplanted, a coolant container, a pump, a filter, a bubble catcher, a sensor assembly, a solenoid valve assembly and a control display unit, wherein the sensor assembly comprises a bubble sensor, a pressure sensor, a flow sensor and a temperature sensor;
the coolant container is arranged around the periphery of the organ box, the side edge of the coolant container is provided with an opening, and the outer side surface of the opening is provided with a temperature sensor for detecting perfusate in the organ box;
the bubble catcher comprises three ports which are respectively a liquid inlet, a perfusion outlet and a circulating outlet, a partition board is vertically arranged at the bottom of the bubble catcher, and the partition board divides the bubble catcher into a plurality of communicated chambers;
a semiconductor refrigerating element is arranged outside the bubble catcher;
the filling loop comprises a pump, a filter, a bubble catcher, a main pipeline and a filling pipeline, the pump, the filter and the bubble catcher are sequentially connected through the main pipeline, a filling outlet of the bubble catcher is connected with the filling pipeline, and the filling pipeline is provided with a bubble sensor, a pressure sensor and a flow sensor;
the circulating loop comprises a pump, a filter, a bubble catcher, a main pipeline and a circulating pipeline, the pump, the filter and the bubble catcher are connected through the main pipeline in sequence, and a circulating outlet of the bubble catcher is connected with the circulating pipeline.
Furthermore, the filling pipeline is a Y-shaped pipeline and comprises a main filling pipeline, a filling branch and a circulating branch, and the circulating branch is communicated with the circulating pipeline through a connector.
Further, the temperature sensor is an infrared temperature sensor, the bubble sensor is an ultrasonic sensor, and the pressure sensor is a gas pressure sensor.
Further, the height of the partition wall accounts for 1/3-1/2 of the total height of the bubble trap.
Further, the semiconductor refrigeration element is a peltier refrigeration plate and is arranged on one side surface of the bubble trap.
Further, the system comprises an internet of things module and is used for uploading the perfusion real-time data to a cloud end or a mobile terminal.
Further, the device comprises an oxygenator which is arranged between the filter and the bubble catcher and provides oxygen for the liquid path.
The invention also provides a method of operating a cryogenic mechanical perfusion preservation apparatus, characterised by the steps of:
step one, installing a perfusion loop and a circulation loop, filling perfusion liquid, and starting a machine;
setting perfusion parameters, starting a circulation mode, and operating a peristaltic pump to enable perfusion liquid to circulate in the main pipeline, the filter, the bubble catcher and the circulation pipeline;
after the circulation mode is finished, connecting the isolated organ into the organ box by using a T-shaped connecting sleeve, opening a cap at the tail end which is not connected with the T-shaped connecting sleeve, starting an exhaust mode, operating a peristaltic pump to enable perfusate to flow out from the tail end which is not connected with the connecting sleeve through a main pipeline, a filter, a bubble catcher, a perfusion main pipeline and a perfusion branch pipeline, and discharging bubbles in the perfusion pipeline;
after the exhaust mode is finished, covering a cap at the tail end of the connecting sleeve which is not connected with the tail end, and detecting the tightness of the liquid path;
and step five, starting a perfusion mode, operating a peristaltic pump to enable perfusion liquid to enter an artery of the isolated organ through the main pipeline, the filter, the bubble catcher, the perfusion main pipeline and the perfusion branch.
Further, in the fifth step, the bubble sensor on the main perfusion pipeline detects that bubbles exist in the perfusion liquid, the perfusion mode is stopped, the perfusion liquid is discharged through the circulating branch pipeline and the circulating pipeline until the bubble sensor does not detect the bubbles any more, and the perfusion mode is restarted.
Further, in step five, when the difference between the flow rate monitored by the flow rate sensor on the perfusion branch and the pumping flow rate of the peristaltic pump exceeds a set value, the perfusion mode is stopped, and meanwhile, a warning is given out.
Further, in step five, the controller controls the peristaltic pump to decrease the flow supply when the pressure monitored by the fluid line pressure sensor on the perfusion branch exceeds a predetermined threshold.
Further, the perfusion parameters include pressure, flow, temperature, and perfusion time.
Compared with the prior art, the invention has the following advantages:
1. the infrared temperature sensor is arranged on the ice box close to the perfusate, so that the temperature of the perfusate is directly detected, and the perfusate with proper temperature is ensured to enter the organ; meanwhile, the semiconductor refrigerating element is arranged on the side surface of the bubble catcher, so that the perfusate with the temperature exceeding the standard is cooled to a set temperature range as soon as possible, and the temperature safety of the perfusate is also ensured;
2. the baffle plate is arranged in the bubble catcher, so that bubbles can be prevented from entering a filling pipeline as far as possible, and the filling safety is ensured; meanwhile, only one bubble sensor needs to be arranged on the whole filling pipeline, so that parts are reduced;
3. a pressure sensor and a flow sensor are arranged on the perfusion pipeline, so that the perfusion stability can be monitored in real time, and equipment faults can be found in time;
4. has the function of the Internet of things.
Drawings
FIG. 1 is a schematic view of a first embodiment of the perfusion apparatus of the present invention;
FIG. 2 is a cross-sectional perspective view of a bubble trap of the priming device of the first embodiment of the present invention;
FIG. 3 is a schematic view of a second embodiment of the perfusion apparatus according to the present invention;
FIG. 4 is a cross-sectional view of an oxygenator of a perfusion apparatus of a second embodiment of the present invention;
in the figure, 1-ice box; 2-a pump; 3. 4, 5-electromagnetic valve; 6-controlling the display unit; 8-1, 8-2 and 8-3 main pipelines; 9-semiconductor refrigeration element; 10-20 μm filter; 11-a bubble trap; 12-a circulation line; 13-perfusion of the main pipeline; 14-perfusion branch; 15-circulation branch; 16-a bubble sensor; 17-a pressure sensor; 18-a flow sensor; 19-an oxygenator; 19-1-oxygenator air inlet, 19-2-oxygenator liquid inlet, 19-3-oxygenator liquid outlet, 19-4-oxygenator sampling port and 20-oxygen cylinder.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, however, the embodiments described below are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be obtained by a person skilled in the art without making any creative effort based on the embodiments in the present invention, belong to the protection scope of the present invention.
Fig. 1-3 show an embodiment of a cryomechanical perfusion preservation device, which mainly comprises an organ cassette (not shown) for placing an organ to be transplanted, an ice cassette 1, a pump 2, a filter 10, a bubble trap 11, a semiconductor refrigeration element 9, a perfusion circuit, a circulation circuit, a sensor assembly, a solenoid valve assembly 3, 4, 5, a control display unit 6, wherein the sensor assembly comprises a bubble sensor 16, a pressure sensor 17, a flow sensor 18, a temperature sensor (not shown). The entire apparatus is insulated from the external environment.
The control display unit 6 comprises an external instruction input module, a data storage and analysis module, a controller, a display module, a warning unit and an internet of things module.
The external command input module can provide input of a power switch, pressure adjustment, a perfusion mode, a circulation mode and the like. The display module can display perfusion parameters (including pressure, flow, temperature, perfusion time and the like), organ information, alarm information and the like. The external instruction input module and the display module can be integrated on a touch display screen.
The data storage and analysis module compares the detection value of the sensor with a preset value range and feeds back the comparison result to the controller. The controller can respond to the comparison result of the detection values of the temperature sensors to select the perfusion operation or the circulation operation or control the on and off of the semiconductor refrigerating element; the priming operation or the purging operation may be selected in response to a value of the bubble sensor; liquid leakage or pump abnormality can be prompted in the display unit based on the flow rate values of the flow rate sensor and the pump; the output flow of the pump may be controlled in response to the value of the fluid path pressure sensor.
The organ cassette may have a cradle on which the organ is disposed, the organ may be a kidney ex vivo of a human or animal. The organ cassette and/or cradle is configured to allow a perfusate bath to form around the organ. The organ cassette is configured to provide uninterrupted sterile conditions during transport, recovery, analysis and storage while maintaining thermal conduction with the ice cassette.
The organ cassette is arranged in an ice cassette 1 having a recess, which may contain a cooling medium such as ice, ice water, saline or the like, although any other suitable cooling medium may be used, for example a polymeric phase change gel material. In use, the organ is disposed within the cradle, the cradle is disposed within the organ cassette, and the organ cassette is disposed within the ice cassette such that the ice cassette surrounds the outer periphery of the organ cassette such that the organ cassette is maintained at a temperature in the range of 0 ℃ to 8 ℃ in a low temperature environment, the ice cassette providing cooling to the organ without directly contacting the organ.
A30 mm hole (not shown) is formed in the position 100mm above the side face of the ice box 1, an infrared temperature sensor is arranged on the outer side wall near the hole, and the temperature of perfusate in an organ box in the ice box can be directly detected through the hole, so that the practicability and the accuracy of the temperature sensor are improved. The detection temperature is denoted as T1, the temperature range of T1 is 0-7 ℃, and when the temperature of T1 is lower than 0 ℃ or higher than 7 ℃, the device can not perform perfusion operation and only performs circulation operation.
The filter 10 is used to filter particulate matter in the fluid path and prevent the particulate matter from entering and clogging the flow path of the device. The particulate matter may be, for example, fat particles or blood clots produced by the isolated organ. The filter may be a single filter or a combination of filters having different pore sizes, and an available filter of 1 20 μm is used.
The pump 2 may be any pump suitable in connection with perfusion of an organ. Examples of suitable pumps may include manually operated pumps, centrifugal pumps, and peristaltic pumps, where commercially available 75 rpm dc motor peristaltic pumps are used.
The bubble trap 11 preferably separates bubbles that may be entrained in the perfusate flow, preventing them from continuing downstream and into the isolated organ. The bubble trap can also be used as a heat exchange unit for rapid cooling of the perfusion fluid. The bubble trap is generally in the shape of a cube with a lower portion and a triangle with an upper portion, and includes a circulation outlet that allows for venting during circulation or priming. The circulation outlet may be connected to the perfusate flow path. After the circulation mode is initiated, the circulation line to which the circulation outlet is connected is opened in order to purge air or other gases. Once the gas is purged from the perfusate path, the recycle outlet may be closed. The circulation outlet can be closed by a controller in the control and display unit controlling the solenoid valve.
In this embodiment, the design capacity of the bubble trap is 300ml, the A port of the bubble trap is a liquid inlet, the B port of the bubble trap is a perfusion outlet, and a partition board is vertically arranged at the middle position of the bottom of the bubble trap and has a height of 1/3-1/2 of the total height of the bubble trap. The perfusate gets into bubble trapper cavity left side, and the water level flows into the cavity right side after arriving the baffle top, because the setting of baffle, the bubble in the perfusate is followed the baffle upward movement and is converged to the cavity top, circulation export C promptly. Under the circulation mode, A mouth and C mouth are open state, and B mouth is closed state, and the perfusate gets into from A mouth, flows out from C mouth, takes away the bubble in the pipeline. Under the filling mode, C mouth is the closed condition, and A mouth and B mouth are the open mode, and the perfusate gets into from A mouth, flows out from B mouth, and the bubble assembles C mouth, and the device switches to the circulation mode from the filling mode every 10 minutes, and C mouth is opened, and the bubble is discharged from C mouth along with the perfusate. A bubble sensor 16 is also provided around the downstream perfusion line of the bubble trap to detect whether bubbles remain in the perfusate. If the presence of air bubbles is detected, the priming mode is stopped and switched to the venting mode. The bubble sensor may be an ultrasonic bubble sensor that may not contact the perfusate, and therefore need not be cleaned and is easily replaced.
The bubble trap is provided with a temperature sensor located on the narrow side (not shown) to detect the perfusate temperature in the bubble trap, which is designated as T2, T2 is in the temperature range of 0-8 deg.C, and the device cannot perform perfusion operation when T2 is lower than 0 deg.C or higher than 8 deg.C. The side of the bubble trap is equipped with a semiconductor refrigerating element 9, which can be a Peltier refrigerating sheet, and the semiconductor refrigerating element can improve the waiting time when the temperature of perfusate poured into the organ box is higher than 8 ℃. When the temperature sensor senses that the temperature of the perfusate is higher than 8 ℃ and is in a power supply mode of a power line, the device prompts the perfusate to enter a circulation mode, the liquid starts to circulate quickly, the controller controls the semiconductor refrigerating element to start, and the refrigerating piece is attached to the bubble catcher to output low temperature, so that the perfusate is reduced to below 8 ℃ as soon as possible.
The perfusion pipeline is provided with a flow sensor for detecting the flow of perfusion liquid flowing through the pipeline, and the flow sensor can be an ultrasonic flow sensor. The flow sensor is arranged in the pipeline, and the detection data of the flow sensor is compared with the flow data of the peristaltic pump, so that whether the peristaltic pump breaks down or not and whether a liquid leakage situation occurs in a filling system or not can be judged in time, the problem that the flow data of the peristaltic pump only is relied on to cause inaccurate flow display caused by deformation, aging or faults of a peristaltic pump component can be solved, and the accuracy of filling data is improved.
And a liquid path pressure sensor 17 is arranged on the filling pipeline. The fluid path pressure sensor detects the real-time pressure of the fluid path and provides overpressure monitoring. In the event that the perfusate pressure flowing through the tubing exceeds a predetermined threshold, the device can automatically stop and/or reduce the flow provided by the pump to prevent damage to the organ.
The perfusion circuit comprises a peristaltic pump 2, main lines 8-1, 8-2 and 8-3, a filter 10, a bubble trap 11, a Y-shaped perfusion line comprising a perfusion main line 13, a perfusion branch 14 and a circulation branch 15, which may be suitable flexible fluid conduits. The perfusate inlet of the organ box is connected with one end of a peristaltic pump through a main pipeline 8-1, the other end of the peristaltic pump is connected with the liquid inlet of a filter 10 through a main pipeline 8-2, the liquid outlet of the filter 10 is connected with the liquid inlet of a bubble catcher 11 through a main pipeline 8-3, the liquid outlet of the bubble catcher 11 is connected with a perfusion main pipeline 13 and a perfusion branch pipeline 14, and the liquid outlet end of the perfusion branch pipeline 14 extends into the lower part of the perfusate liquid level of the organ box to form a perfusion loop. Wherein, the main perfusion pipeline 13 is provided with a bubble sensor 16, the branch perfusion pipeline 14 is provided with a flow sensor 18 and a liquid pressure sensor 17, and the branch circulation pipeline 15 is communicated with the circulation pipeline 12. The isolated organ is soaked in the low-temperature perfusate in the organ box, and the peristaltic pump in the device can provide power to ensure that the low-temperature perfusate enters from the artery of the organ and flows out from the vein of the organ to form circulation, so that the low-temperature mechanical continuous perfusion of the isolated organ is realized.
The circulation circuit comprises a peristaltic pump 2, primary lines 8-1, 8-2 and 8-3, a filter 10, a bubble trap 11 and a circulation line 12. The perfusate inlet of the organ box is connected with one end of a peristaltic pump 2 through a main pipeline 8-1, the other end of the peristaltic pump is connected with the liquid inlet of a filter 10 through the main pipeline 8-2, the liquid outlet of the filter 10 is connected with the liquid inlet of a bubble catcher 11 through a main pipeline 8-3, the liquid outlet of the bubble catcher 11 is connected with one end of a circulating pipeline 12, and the other end of the circulating pipeline 12 extends into the lower part of the perfusate liquid level of the organ box to form a circulating loop. The circulation line 12 is provided with a port (not shown), and the circulation branch 15 is communicated with the circulation line 12 through the port.
1. Circulation mode
In the circulation mode, the controller controls the solenoid valve 3 to be open and the solenoid valves 4 and 5 to be closed. The peristaltic pump 2 operates to make the perfusate flow through the circulating main pipelines 8-1 and 8-2, the filter 10, the main pipeline 8-3, the bubble catcher 11 and the circulating pipeline 12 in sequence to remove bubbles.
2. Perfusion mode
In the perfusion mode, the controller controls the electromagnetic valve 5 to be opened, the electromagnetic valves 3 and 4 to be closed, and the peristaltic pump 2 to operate, so that perfusion liquid flows through the main pipelines 8-1 and 8-2, the filter 10, the main pipeline 8-3, the bubble catcher 11, the perfusion main pipeline 13 and the perfusion branch 14 in sequence.
When the bubble sensor 16 on the main perfusion pipeline 13 detects that bubbles exist in the perfusion fluid flowing through the main perfusion pipeline 13, the controller controls the electromagnetic valve 5 to be closed, the electromagnetic valve 4 to be opened, the perfusion fluid is discharged through the circulating branch 15 and the circulating pipeline 12, the exhaust mode is started until the bubble sensor does not detect the bubbles any more, the controller controls the electromagnetic valve 5 to be opened, the electromagnetic valve 4 is closed, and the perfusion mode is restarted.
The flow sensor 18 on the perfusion branch 14 monitors the flow B of the perfusion fluid flowing through the perfusion branch 14, meanwhile, the peristaltic pump 2 can monitor the pumping flow A of the pipeline, when the flow B is smaller than A for a certain value, the phenomenon that the leakage occurs in the middle section of the pipeline or the peristaltic pump is abnormal is inferred, the controller controls the perfusion stopping mode, and meanwhile, the equipment gives an alarm.
A fluid pressure sensor 17 on the infusion branch 14 monitors the pressure of the infusion fluid flowing through the infusion branch 14 and the controller controls the peristaltic pump to decrease the flow supply when the pressure exceeds a predetermined threshold.
A method of operating a cryogenic mechanical perfusion preservation apparatus is described, comprising the steps of:
step one, installing a perfusion loop and a circulation loop, filling perfusion liquid, and starting a machine;
setting perfusion parameters such as pressure, flow, temperature, perfusion time and the like through a control display unit on the equipment, starting a circulation mode, and operating a peristaltic pump to enable perfusion liquid to circulate in the main pipeline, the filter, the bubble catcher and the circulation pipeline;
thirdly, after the circulation mode is finished, connecting the isolated organ into the organ box by using a T-shaped connecting sleeve, respectively connecting an organ artery and a perfusion branch at two ends of the T-shaped connecting sleeve, opening the connecting sleeve which is not connected with a tail end cap, starting an exhaust mode, operating a peristaltic pump to enable perfusion liquid to flow out from the tail end which is not connected with the connecting sleeve through a main pipeline, a filter, a bubble catcher, a perfusion main pipeline and a perfusion branch and discharge bubbles of the perfusion pipeline;
after the exhaust mode is finished, covering a cap at the tail end of the connecting sleeve which is not connected with the tail end, and detecting the tightness of the liquid path;
step five, starting a perfusion mode, operating a peristaltic pump to enable perfusion liquid to enter an artery of the isolated organ through a main pipeline, a filter, a bubble catcher, a perfusion main pipeline and a perfusion branch; stopping the perfusion mode when the bubble sensor on the main perfusion pipeline detects that bubbles exist in the perfusion liquid, discharging the perfusion liquid through the circulating branch until the bubble sensor does not detect the bubbles any more, and restarting the perfusion mode; when the difference between the flow monitored by the flow sensor on the perfusion branch and the pumping flow of the peristaltic pump exceeds a set interval, stopping the perfusion mode and simultaneously sending out a warning; when the pressure monitored by the liquid path pressure sensor on the perfusion branch exceeds a preset threshold value, the controller controls the peristaltic pump to reduce the flow supply.
Fig. 4 shows another embodiment of the cryogenic mechanical perfusion preservation device, differing from the first embodiment by the addition of an oxygenator 19 in the flow path, the oxygenator being disposed between the filter and the bubble trap. The oxygenator 19 is provided with an oxygen inlet 19-1, a perfusate liquid inlet 19-2, a perfusate liquid outlet 19-3 and a sampling port 19-4. The oxygen source can be hospital hyperbaric oxygen, a large oxygen bottle or a customized small oxygen bottle, and the oxygen bottle 20 is adopted here, and a gas flowmeter is arranged at the same time, so that the oxygen flow can be accurately controlled.
Oxygen enters the perfusate through the air inlet 19-1 of the oxygenator to improve the oxygen content of the perfusate. The perfusate can be periodically extracted from the sampling port 19-4 and the oxygen content in the perfusate can be detected, and when the oxygen content is too low, the controller controls the gas flowmeter to increase the oxygen flow.
Claims (12)
1. A low-temperature mechanical perfusion preservation device is characterized by comprising an organ box for placing an organ to be transplanted, a coolant container, a pump, a filter, a bubble catcher, a sensor assembly, a solenoid valve assembly and a control display unit, wherein the sensor assembly comprises a bubble sensor, a pressure sensor, a flow sensor and a temperature sensor;
the coolant container is arranged around the periphery of the organ box, an opening is formed in the side edge of the coolant container, and the outer side face of the opening is provided with the temperature sensor for detecting perfusate in the organ box;
the bubble catcher comprises three ports which are respectively a liquid inlet, a perfusion outlet and a circulating outlet, a partition board is vertically arranged at the bottom of the bubble catcher, and the partition board divides the bubble catcher into a plurality of communicated cavities;
a semiconductor refrigeration element is arranged outside the bubble catcher;
the perfusion circuit comprises the pump, the filter, the bubble catcher, a main pipeline and a perfusion pipeline, the pump, the filter and the bubble catcher are sequentially connected through the main pipeline, the perfusion outlet of the bubble catcher is connected with the perfusion pipeline, and the perfusion pipeline is provided with the bubble sensor, the pressure sensor and the flow sensor;
the circulating loop comprises the pump, the filter, the bubble catcher, the main pipeline and a circulating pipeline, the pump, the filter and the bubble catcher are sequentially connected through the main pipeline, and the circulating outlet of the bubble catcher is connected with the circulating pipeline.
2. The cryogenic mechanical perfusion preservation device of claim 1, wherein the perfusion line is a Y-shaped perfusion line and includes a main perfusion line, a perfusion branch and a circulation branch, and the circulation branch is communicated with the circulation line through an interface on the circulation line.
3. The cryogenic mechanical perfusion preservation device of claim 2, wherein the temperature sensor is an infrared temperature sensor, the bubble sensor is an ultrasonic sensor, and the pressure sensor is a gas pressure sensor.
4. The cryogenic mechanical perfusion preservation device of claim 2, wherein the height of the partition is 1/3-1/2 of the total height of the bubble trap.
5. A cryogenic mechanical perfusion preservation device according to claim 2, wherein the semiconductor refrigeration element is a peltier refrigeration plate, disposed on one side of the bubble trap.
6. The cryogenic mechanical perfusion preservation device of claim 2, further comprising an internet of things module configured to upload perfusion real-time data to a cloud or a mobile terminal.
7. The cryogenic mechanical perfusion preservation device of claim 2, further comprising an oxygenator disposed between the filter and the bubble trap.
8. The method of operating a cryogenic mechanical perfusion preservation device according to any one of claims 2 to 7, including the steps of:
step one, installing a perfusion loop and a circulation loop, filling perfusion liquid, and starting up the machine;
setting perfusion parameters, starting a circulation mode, and operating a peristaltic pump to enable perfusion liquid to circulate in the main pipeline, the filter, the bubble catcher and the circulation pipeline;
after the circulation mode is finished, connecting the isolated organ into the organ box by using a T-shaped connecting sleeve, opening a cap at the tail end which is not connected with the T-shaped connecting sleeve, starting an exhaust mode, operating a peristaltic pump to enable perfusate to flow out from the tail end which is not connected with the connecting sleeve through a main pipeline, a filter, a bubble catcher, a perfusion main pipeline and a perfusion branch pipeline, and discharging bubbles in the perfusion pipeline;
after the exhaust mode is finished, covering a cap at the tail end of the connecting sleeve which is not connected with the tail end, and detecting the tightness of the liquid path;
and step five, starting a perfusion mode, operating a peristaltic pump to enable perfusion liquid to enter an artery of the isolated organ through the main pipeline, the filter, the bubble catcher, the perfusion main pipeline and the perfusion branch.
9. The method of claim 8, wherein in step five, the bubble sensor of the main perfusion circuit detects the presence of bubbles in the perfusion fluid, the perfusion mode is stopped, and the perfusion fluid is drained through the circulation branch and the circulation circuit until the bubble sensor no longer detects bubbles, and the perfusion mode is restarted.
10. The method of claim 8, wherein in step five, when the difference between the flow rate monitored by the flow sensor in the perfusion branch and the pumping flow rate of the peristaltic pump exceeds a set value, the perfusion mode is stopped and a warning is issued.
11. The method of operating a cryogenic mechanical perfusion preservation device according to claim 8, wherein in step five, the controller controls the peristaltic pump to reduce the flow supply when the pressure monitored by the fluid circuit pressure sensor in the perfusion branch exceeds a predetermined threshold.
12. The method of operating a cryogenic mechanical perfusion preservation device according to claim 8, wherein the perfusion parameters include pressure, flow, temperature and perfusion time.
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| CN202210471250.8A CN114766470A (en) | 2022-04-28 | 2022-04-28 | Low-temperature mechanical perfusion storage device and method |
| CN202320512996.9U CN219593503U (en) | 2022-04-28 | 2023-03-16 | Low-temperature mechanical perfusion preservation device |
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| CN202210471250.8A CN114766470A (en) | 2022-04-28 | 2022-04-28 | Low-temperature mechanical perfusion storage device and method |
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| CN202320512996.9U Active CN219593503U (en) | 2022-04-28 | 2023-03-16 | Low-temperature mechanical perfusion preservation device |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115885972A (en) * | 2022-10-24 | 2023-04-04 | 中国科学院理化技术研究所 | Organ perfusion preservation equipment |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4186565A (en) * | 1978-05-19 | 1980-02-05 | Henry Ford Hospital | Perfusion system for organ preservation |
| CN104186459A (en) * | 2014-08-07 | 2014-12-10 | 中国人民解放军第三〇九医院 | Sub-normal-temperature or low-temperature isolated kidney storage device |
| CN204682348U (en) * | 2015-02-16 | 2015-10-07 | 湖州云恩生物科技有限公司 | Organ hypothermia machine perfusion save set |
| CN109717184A (en) * | 2019-03-14 | 2019-05-07 | 杭州莱普晟医疗科技有限公司 | A kind of machine perfusion system saved in vitro double kidneys |
-
2022
- 2022-04-28 CN CN202210471250.8A patent/CN114766470A/en not_active Withdrawn
-
2023
- 2023-03-16 CN CN202320512996.9U patent/CN219593503U/en active Active
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4186565A (en) * | 1978-05-19 | 1980-02-05 | Henry Ford Hospital | Perfusion system for organ preservation |
| CN104186459A (en) * | 2014-08-07 | 2014-12-10 | 中国人民解放军第三〇九医院 | Sub-normal-temperature or low-temperature isolated kidney storage device |
| CN204682348U (en) * | 2015-02-16 | 2015-10-07 | 湖州云恩生物科技有限公司 | Organ hypothermia machine perfusion save set |
| CN109717184A (en) * | 2019-03-14 | 2019-05-07 | 杭州莱普晟医疗科技有限公司 | A kind of machine perfusion system saved in vitro double kidneys |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115885972A (en) * | 2022-10-24 | 2023-04-04 | 中国科学院理化技术研究所 | Organ perfusion preservation equipment |
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| CN219593503U (en) | 2023-08-29 |
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