CN104686502B - Safety protection enhanced organ low-temperature machine perfusion preservation device and method - Google Patents
Safety protection enhanced organ low-temperature machine perfusion preservation device and method Download PDFInfo
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- CN104686502B CN104686502B CN201510085562.5A CN201510085562A CN104686502B CN 104686502 B CN104686502 B CN 104686502B CN 201510085562 A CN201510085562 A CN 201510085562A CN 104686502 B CN104686502 B CN 104686502B
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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
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Abstract
The invention discloses a safety protection enhanced organ low-temperature machine perfusion preservation device and a method. The device comprises an organ box for holding an organ to be transplanted, a low-temperature incubator, a perfusion power source, a perfusion loop, a perfusion preparation loop, a flushing loop, and sensor assemblies arranged on various pipeline loops. The perfusion loop is composed of the perfusion power source, a filter, a buffer, a bubble trap, a first perfusion pipeline, a main channel pipeline and a second branch channel pipeline of a Y-shaped pipeline, an organ arteriovenous blood vessel and a second perfusion pipeline. The perfusion preparation loop is composed of the perfusion power source, a filter, a buffer, a bubble trap, a first perfusion pipeline, and a main channel pipeline and a first branch channel pipeline of a Y-shaped pipeline. The flushing loop is a flushing pipeline. According to the safety protection enhanced organ low-temperature machine perfusion preservation device, the design of the perfusion loop is optimized, the bubble trap and the bubble detector are added in the perfusion loop, and the perfusion loop and the flushing loop are used for selectively removing perfusion bubbles in real time, and the safety of perfusion is improved.
Description
Technical field
The invention belongs to biomedical instrument field is and in particular to one kind is used for treating that the external security protection of transplant organ strengthens
The cryogenic machine Perfusion preservation apparatus and method of type.
Background technology
Organ transplantation has become one of effective measures giving treatment to multiple organ failure patient vitals.Organ hypothermia preserves
The appearance of technology, the organ dysfunction for solving during transplant organ donor lacks and maintains in vitro provides solution, greatly
Improve greatly the clinical practice of organ transplantation technique.
Simple stored refrigerated and the continuous perfusion of machinery are topmost isolated organ storage in vitro methods in the last thirty years.Single
The feature of pure refrigeration is to reduce organ metabolic rate and the preservation liquid using hyperosmosises by providing 04 DEG C of low temperature environment
Prevent organ edema, but this store method can not provide lasting nutrient substance and oxygen supply for treating transplant organ, therefore
Stored refrigerated method is only capable of the forfeiture limitedly extending and can not stoping completely organ dysfunction.Consecutive low temperature machine perfusion preserves
（CHP）, it is to be pumped into infusion liquid in organ with low discharge low pressure, make infusion liquid and treat that the temperature of transplant organ maintains relatively low shape
State, supplies the basic nutrition needed for organ metabolism and removes the purpose about waste to reaching under low temperature.The mechanisms such as FDA, NHS
Clinical data prove transplant organ hypothermia perfusion technology can effectively reduce delayed renal graft function recover（DGF）Deng concurrent
Disease, improves the success rate of organ transplantation.Transplant organ hypothermia perfusion has become as the authoritative institutions such as FDA, NHS to organ transplantation
Proposed standard.
But, the preservation effective time limit using these method organs is shorter, and clinically the Dispersing Monkey Kidney Cell in Tissue Culture holding time is very difficult super
Cross 24-30h.The security protection of perfusion device itself among these, the timely process of possible breakdown, the physiology mould of organ Conservation environment
The factors such as plan all may affect effect and the preservation effective time limit that organ preserves.The present invention is directed to this, discloses a kind of safety
The hypothermic machine perfusion save set of protection enhancement mode and method.This save set designs to buffer filling by optimizing perfusion loop
Stream instantaneous high pressure, exclusion perfusion bubble in real time, in perfusion loop, reasonable placement sensor monitors perfusion organ viability and perfusion
Parameter, and provide fault alarm and good man-machine interaction for perfusing course adjustment, thus improving the safety of perfusion
And stability, to extend effective conserving time limit of organ as far as possible.
Content of the invention
In order to make up the deficiency in existing transplant organ storage in vitro technology, improve the safety of cryogenic mechanical perfusion and steady
Qualitative, the present invention proposes a kind of cryogenic machine Perfusion preservation apparatus and method of security protection enhancement mode.
It is an object of the present invention to provide a kind of cryogenic machine Perfusion preservation device of security protection enhancement mode.
Cryogenic machine Perfusion preservation device of the present invention, is mainly included for placing the organ box treating transplant organ, low temperature perseverance
Incubator, perfusion power source, perfusion loop, perfusion preparation loop, flush loop, sensor cluster, wherein sensor cluster includes
Temperature sensor, liquid level sensor, biochemical sensor, pressure transducer；
Treat that the organ box of transplant organ is placed in cryostat so that organ box temperature maintains 0～4 DEG C for placing
In low temperature environment；Described organ box top has gas exchange mouth, for filter bacteria, exchanging gas, maintains perfusion air pressure
Stable；The side of organ box is provided with contact type temperature sensor, for measuring the temperature of perfusate in organ box；Outside organ box
Wall is provided with liquid level sensor, for monitoring perfusate liquid level；
Described organ box adopts medical transparent material, monitors organ morphology change in box to facilitate, answers profile little simultaneously
Ingeniously facilitate organ easily and safely for perfusion, store, analyze, transporting and move between the equipment that this treats transplant organ.
Described perfusion loop is by perfusion power source, filter, buffer, bubble trap and the first perfusion pipeline, Y type
The main channel pipeline of pipeline, the second branched bottom pipeline in Y-piece road, organ artery and vein vascular, the second perfusion pipeline are constituted, its
Middle bubble trap is triple channel structure；One end of the first perfusion pipeline and perfusion power source is passed through in the perfusion liquid inlet of organ box
Connect, the other end of perfusion power source is connected by the liquid-inlet of the first perfusion pipe-and-filter, the first liquid of filter
Body outlet is connected with buffer, and buffer is used for relaxing the instantaneous high pressure of perfusion power source perfusion, the second liquid of filter herein
The first passage orifice by the first perfusion pipeline and bubble trap for the body outlet；The second channel interface of bubble trap meets Y
The main channel pipeline of type pipeline, the second branched bottom pipeline in Y-piece road with treat transplant organ tremulous pulse and connect, treat that transplant organ is quiet
Arteries and veins is connected with one end of the second perfusion pipeline, and the other end of the second perfusion pipeline stretches into below the perfusate liquid level of organ box, shape
Become a perfusion loop；
Described perfusion preparation loop is by perfusion power source, filter, buffer, bubble trap and the first perfusion tube
Road, the main channel pipeline in Y-piece road, the first branched bottom pipeline in Y-piece road are constituted；Perfusion preparation loop and perfusion loop exist
The entrance of the first perfusion pipeline common-use tunnel and functional unit to the main channel pipeline in Y-piece road, and perfusion preparation loop
Outlet stretched into below the perfusate liquid level of organ box by the first branched bottom pipeline in Y-piece road, formed one preparation fill
Flow back to road；
Described flush loop is flushing pipe, and one end of flushing pipe third channel interface through bubble trap stretches into gas
Bubble trap, the other end stretches into below the perfusate liquid level of organ box；
In perfusion loop, perfusion preparation loop, flush loop, the first perfusion pipeline, flushing pipe, the of Y-piece road
The pipeline that one branched bottom pipeline stretches in organ box is not all directly connected with the blood vessel treating transplant organ to reduce filling as far as possible
Gas bubble affects on organ.
The perfusion power source and filter-portion pipeline of the first perfusion pipeline are provided with pressure transducer, in order to monitor filling
The injection pressure of flowing power source；The filter and bubble trap section of tubing of the first perfusion pipeline have dosing/sample tap,
Facilitate perfusing course to do biological immune to modify and organ physiological parameter analysis；
First valve is provided with the main channel pipeline in Y-piece road, controls the open and close in this loop；In Y-piece road
The first branched bottom pipeline be provided with the second valve, for control preparation perfusion loop open and close；In Y-piece road
Second branched bottom pipeline is provided with biochemical sensor, pressure transducer, is respectively used to monitor the perfusion of organ viability and organ
Pressure；
It is provided with biochemical sensor in the second perfusion pipeline, for monitoring organ viability after perfusion.
The third channel interface of bubble trap connects one end of flushing pipe, and the other end of flushing pipe stretches into the filling of organ box
Below flow liquid liquid level, constitute a flush loop；3rd valve is provided with flushing pipe, for controlling the unlatching rinsed and pass
Close；
The first passage interface of bubble trap, second channel seam are equipped with gas bubble detection, in order to detect that perfusion opens
Whether there is bubble in beginning front loop, and whether perfusing course produces bubble.
The duct length phase of bubble trap in bubble trap, is stretched into respectively from first passage interface and second channel interface
With, and it is longer than the duct length stretching into bubble trap from third channel interface, to facilitate the bubble in capture perfusate.
Filter membrane in described filter must be placed at the ullage of buffer, is easy to buffer and houses filter
The harmful substance leaching.
By two pressure transducers in the first perfusion channel with Y-piece road the second branched bottom pipeline respectively
Whether pressure comparative analysiss, can be pipeline blockage in monitoring system.
By two biochemical sensor associations being located on Y-piece road the second branched bottom pipeline and the second perfusion pipeline respectively
With work, can monitor perfusion start before, the organ viability in perfusing course and after perfusion.
The outside of described bubble trap is provided with non-contact temperature sensor, liquid level sensor, respectively in order to monitor
The temperature of its internal perfusate and liquid level.
The work process of whole device, perfusion parameter control and data analysiss can be monitored by a central control module,
Once break down Realtime Alerts, and provide user operation and presentation of information by human-computer interaction module.Described central authorities control mould
Block is connected by I/O with analysis module, sensor acquisition module with human-computer interaction module, data storage, passes through with perfusion module
Driver element connects, and is connected by serial ports with power management module, is connected by network interface with 3G communication module.Power management
Module is responsible for completing the on-off control to system power supply, the acquisition of battery electric quantity with display, the control of battery charging and discharging, electricity not
Foot report to the police and power reset restart wait operate.Human-computer interaction module provides user operation and presentation of information, and perfusing course occurs
Fault alarm can be shown with human-computer interaction module and report to the police.3G communication module realizes transportation organ perfusion to be saved ginseng
The remote monitoring of the information such as number, biochemical parameter, GPS, positioning and analysis, it is every that data storage and analysis module are used for storage system
Data, the letter such as the time showing including sensor cluster acquisition parameter and peripheral output display unit, voice, image, video
Breath, and above-mentioned data is analyzed, provide organ diastolic pressure, systolic pressure, perfusion flow, organ swelling degree, oxygen concentration change
The analysis results such as change, comprehensive assessment organ viability.
Another object of the present invention is that the organ based on said apparatus preserves and monitoring method, and the method includes following step
Suddenly：
Step（1）. organ to be transferred is placed in organ box, and by the tremulous pulse of organ to be transferred and Y-piece road second
Branched bottom pipeline connects, and the vein of organ to be transferred is connected with the second perfusion pipeline；
Step（2）. after system boot, boot up self-inspection first, whether the consumptive material such as detecting system interior conduit is installed in place
And the functional unit such as sensor, perfusion power source whether can with normal work, to be confirmed after initialized and started sensing
Device assembly and human-computer interaction module；Organ viability is evaluated by the storage of central control module log-on data and analysis module, comprehensive
Compare the perfusion parameter that organ activity data and human-computer interaction module set, produce the perfusion parameter setting optimizing, according to optimization
Setting starts hypothermic perfusion；Run come detecting system by central control module during perfusion, adjusted based on testing result
Whole perfusion execution or prompting operator；Perfusion parameter in perfusing course and organ parameter can preserve in real time, also can be led to by 3G
Letter module carries out remote monitoring.
In said method, key technology mainly includes security protection and fault alarm, the regulation and control of perfusion Intelligence Feedback, network number
According to shared and remote monitoring, specific as follows：
Security protection and fault alarm need to consider that the accumulative bubble of line clogging, perfusate, temperature over-range and liquid level transfinite
Situation：
For line clogging it is proposed that detecting pipeline using the pressure reduction acute variation of perfusion line clogging rear and front end
Stopping state, and accurately determine its blocking position, by arranging pressure respectively after perfusion power source and before organ arterial inlet
Sensor is realizing.When line clogging, system automatic alarm, send a pulse barotropic wave in head end, barotropic wave is along pipeline
Propagation runs into and reflects during tamper, can obtain barotropic wave information twice in pipeline head end, and extracts pressure using wavelet transformation
Power abrupt information, obtains the time difference that barotropic wave passes twice through pressure transducer before organ venous inlet, finally comprehensive barotropic wave
Spread speed can determine the position of pipeline blockage.
For the bubble protection in perfusing course, can be realized to bubble using gas bubble detection and multiple-way duct system
Remove.The present invention enters front end setting gas bubble detection and the two-way pipeline of organ in perfusate（I.e. Y-piece road and flush pipe
Road）System, if perfusate is directly entered organ during bubble-free, otherwise pipeline is switched to flush loop or preparation perfusion loop row
Bubble removing.
For the monitoring of the temperature in perfusing course and liquid level, temperature is installed respectively outside organ box and bubble trap and passes
Sensor and liquid level sensor, the temperature of real-time monitoring transplant organ storage temperature and perfusate, liquid level, when temperature sensor detection
Temperature exceed setting scope（0～4 DEG C）, system alarm, automatically take the safety measure of shutdown, pass through man-machine interaction mould simultaneously
Block notifies user's request manual intervention, and liquid level sensor detects liquid level and transfinites in the same manner, and such as transportation strenuous vibration leads to device
Official's box is turned on one's side, and causes perfusate to leak and also stopping alarm is asked manual intervention.
The fault that can not automatically exclude for other, as too low in battery electric quantity, machine also will take the safeguard protections such as shutdown
Measure, and user is notified by human-computer interaction module and safety protection module, ask manual intervention.
Perfusion Intelligence Feedback regulates and controls：According to organ viability's parameter of biochemical sensor collection, in conjunction with other sensors collection
Perfusion parameter, and and human-computer interaction module set perfusion mode and parameter be compared, according to system store perfusion experience
Data-optimized perfusion parameter, controls according to optimum results central control module and drives perfusion power source execution perfusion or flushing；Its
The feedback regulation of middle perfusion parameter mainly includes perfusion channel control, pressure controlling and flow detection and control；
For perfusion channel control, the unlatching to realize multiple perfusion channel for the valve placed is relied primarily on perfusion pipeline
With closing；
For the pressure controlling in filling process, by the way of simulative heartbeat Rhythm Curve, simulated organ is won in vivo
Dynamic pressure curve can adopt closed loop feedback regulating system, such as by the use of pressure transducer as feed back input, peristaltic pump conduct
Targeting control targe realizes the closed loop control to pressure, adopts pid algorithm using time shafts as parameter Solid rocket engine amplitude；
Flow detection for perfusing course and control, can be according to perfusion power source per minute（As peristaltic pump）Rotate secondary
Number to calculate perfusion flow with rotating the perfusate volume squeezing out every time, thus realizing the automatic detection to perfusion flow.
Network data is shared and remote monitoring：Organ perfusion, preservation, various types of data and information can in transportation
To be grouped record, and doctor, scientist or other mechanisms are supplied to for research by 3G network module, realize waiting to transplant
The remote monitoring of the information such as organ physiological parameter, GPS location.
Compared with background technology, the invention has the advantages that：
（1）Improve the safety and stability of perfusion
The design of installation optimization perfusion loop, perfusate entrance is not directly connected with transplant organ angioaccess；In perfusion
Buffer is set after power source and filter, for collecting the harmful substance of perfusion perfusing course generation and to buffer perfusion instantaneously high
Pressure；Increase bubble trap and gas bubble detection in perfusion loop, and select to exclude in real time by perfusion loop and flush loop
Perfusion bubble, a series of behaves can improve the safety of perfusion, and in perfusion loop, reasonable placement sensor monitors perfusion device
Official's activity and perfusion parameter, and provide fault alarm and good human-computer interaction module for perfusing course adjustment, permissible
Improve the stability of perfusion, the raising of perfusion safety and stability has for the effective conserving time limit extending organ as far as possible
Significance.
（2）Perfusion save set employs fully simulated pulsating wave perfusion and dynamic simulation feedback control technology, perfusion pressure
Can be closer to human body with perfusion waveform.
（3）Reserved dosing/sample tap can facilitate perfusing course to do biological immune modification and organ physiological parameter analysis,
Drug therapy can be carried out according to organ viability.
Brief description
Fig. 1 is perfusion device principle schematic of the present invention；
Fig. 2 is perfusion device system control principle schematic diagram of the present invention；
Fig. 3 is rinse mode, the drive waveforms of perfusion power source and perfusion pressure under Constant pressure perfusion pattern, pulsation perfusion mode
Power waveform diagram；
Wherein 1. organs, 2. organ box, 2-1 gas exchange mouth, 3. perfusion power source, 4. filter, 5. bubble trap, 5-
1. first passage interface, 5-2. second channel interface, 5-3. third channel interface, 6. the first perfusion pipeline, 7. flushing pipe, 8.
Second perfusion pipeline, 9.Y type pipeline, 9-1. the first branched bottom pipeline, 9-2. the second branched bottom pipeline, 9-3. main channel
Pipeline, 10. buffer, 11. liquid level sensors, 12. gas bubble detections, 13-1. first valve, 13-2. second valve, 13-3.
3rd valve, 14. biochemical sensors, 15. pressure transducers, 16. dosings/sample tap, 17. cryostats, 18. contact temperature
Degree sensor, 19. non-contact temperature sensors.
Specific embodiment
Below in conjunction with the accompanying drawings the present invention is further analyzed.
Fig. 1 provides perfusion device principle schematic of the present invention.
As shown in figure 1, cryogenic machine Perfusion preservation device of the present invention, mainly include for placing the organ treating transplant organ
Box (2), cryostat (17), perfusion power source (3), perfusion loop, perfusion preparation loop, flush loop, sensor cluster,
Wherein sensor cluster includes temperature sensor, liquid level sensor, biochemical sensor, pressure transducer；
For placing the organ box treating transplant organ（2）It is placed in cryostat (17) so that organ box (2) temperature is tieed up
Hold in 0～4 DEG C of low temperature environment；Described organ box (2) 11 top has gas exchange mouth (2-1), for filter bacteria, hands over
Ventilation body, maintains perfusion stable gas pressure；The side of organ box (2) is provided with contact type temperature sensor (18), for measuring organ
The temperature of the interior perfusate of box (2)；The outer wall of organ box (2) is provided with liquid level sensor (11), for monitoring perfusate liquid level；
Described organ box (2) adopts medical transparent material, monitors organ morphology change in box to facilitate, answers profile simultaneously
Compact volume and convenience organ organ easily and safely for perfusion, store, analyze, transporting and move between the equipment that this treats transplant organ
Dynamic.
Described perfusion loop is by perfusion power source (3), filter (4), buffer (10), bubble trap（5）And the
One perfusion pipeline（6）, Y-piece road（9）Main channel pipeline 9-3, Y-piece road（9）The second branched bottom pipeline 9-2, organ
Blood vessel, the second perfusion pipeline（8）Constitute；Organ box（2）Perfusion liquid inlet pass through the first perfusion pipeline（6）With perfusion power
Source（3）One end connect, perfusion power source（3）The other end pass through the first perfusion pipeline（6）With filter（4）Liquid-inlet
Connection, filter（4）First liquid outlet and buffer（10）Connection, buffer herein（10）For relaxing perfusion power source
（3）The instantaneous high pressure of perfusion, filter（4）Second liquid outlet pass through the first perfusion pipeline（6）With bubble trap（5）?
One channel interface（5-1）Connection；Bubble trap（5）Second channel interface（5-2）Connect Y-piece road（9）Main channel pipeline（9-
3）, Y-piece road（9）The second branched bottom pipeline (9-2) with treat transplant organ tremulous pulse and connect, treat transplant organ vein and second
Perfusion pipeline（8）One end connection, the second perfusion pipeline（8）The other end stretch into organ box（2）Perfusate liquid level below, shape
Become a perfusion loop；
Described perfusion preparation loop is by perfusion power source (3), filter (4), buffer (10), bubble trap（5）And
First perfusion pipeline（6）, Y-piece road（9）Main channel pipeline（9-3）, Y-piece road（9）The first branched bottom pipeline（9-1）
Constitute；Perfusion preparation loop and perfusion loop are in the first perfusion pipeline（6）Entrance to Y-piece road（9）Main channel pipeline（9-
3）Between common-use tunnel and functional unit, and the outlet in perfusion preparation loop pass through Y-piece road（9）The first branched bottom pipeline
(9-1) stretch into organ box（2）Perfusate liquid level below, formed one preparation perfusion loop；
In perfusion loop, perfusion preparation loop, flush loop, the first perfusion pipeline（6）, flushing pipe（7）, Y-piece
Road（9）The first branched bottom pipeline（9-1）Stretch into organ box（2）Interior pipeline is all direct and treats transplant organ（1）'s
Blood vessel is connected to be affected on organ with reducing perfusion bubble as far as possible.
In the first perfusion pipeline（6）Perfusion power source (3) and filter (4) section of tubing be provided with pressure transducer
（15）, in order to monitor the injection pressure of perfusion power source (3)；In the first perfusion pipeline（6）Filter (4) and bubble trap
（5）Dosing/sample tap is had on section of tubing（16）, biological immune is modified and organ physiological parameter is divided to facilitate perfusing course to do
Analysis；
In Y-piece road（9）Main channel pipeline（9-3）It is provided with the first valve (13-1), control the unlatching in perfusion loop
With closing；In Y-piece road（9）The first branched bottom pipeline (9-1) be provided with the second valve (13-2), pre- for controlling perfusion
The open and close in standby loop；In Y-piece road（9）The second branched bottom pipeline (9-2) be provided with biochemical sensor（14）, pressure
Force transducer（15）, it is respectively used to monitor the injection pressure of organ viability and organ；
In the second perfusion pipeline（8）It is provided with biochemical sensor（14）, for monitoring organ viability.
Bubble trap（5）Third channel interface（5-3）Connect flushing pipe（7）One end, flushing pipe（7）The other end
Stretch into organ box（2）Perfusate liquid level below, constitute a flush loop；In flushing pipe（7）It is provided with the 3rd valve
(13-3), for controlling the opening and closing rinsed；
The first passage interface of bubble trap (5)（5-1）, second channel interface（5-1）Place is equipped with gas bubble detection
（12）, in order to detect that perfusion starts to whether there is bubble in front loop, and whether perfusing course produce bubble.
In bubble trap (5), respectively from first passage interface（5-1）With second channel interface（5-2）Stretch into bubble to fall into
The duct length of trap (5) is identical, and is longer than from third channel interface（5-3）Stretch into the duct length of bubble trap (5), with convenient
Bubble in capture perfusate.
Filter membrane in described filter (4) must be placed at the ullage of buffer (10), is easy to buffer
(10) house the harmful substance that filter (4) leaches.
By being located at the first perfusion channel respectively（6）With Y-piece road（9）On second branched bottom pipeline (9-2) two
Whether the pressure comparative analysiss of pressure transducer (15), can be pipeline blockage in monitoring system.
By being located at Y-piece road respectively（9）Second branched bottom pipeline (9-2) and the second perfusion pipeline（8）On two
Biochemical sensor (14) collaborative work, can monitor perfusion start before, the organ viability in perfusing course and after perfusion.
The outside of described bubble trap (5) is provided with non-contact temperature sensor (18), liquid level sensor (11), point
Not in order to monitor temperature and the liquid level of its internal perfusate.
Whole perfusion device has four kinds of perfusion mode available, respectively rinse mode, run-up mode, Constant pressure perfusion mould
Formula, pulsation perfusion mode.Its object is to guarantee the safety and stability of organ perfusion.Rinse mode and run-up mode are used for excluding whole
Bubble in individual perfusion fluid path, Constant pressure perfusion pattern and pulsation perfusion mode are the mode of operation of the normal perfusion of organ.
1. rinse mode
Perfusion device schematic diagram as shown in Figure 1, under rinse mode, the first valve (13-1) is closed, the 3rd valve (13-
3) open.Perfusion power source (3) operates, by liquid by flushing pipe（7）Discharge, thus excluding through perfusion power source (3), being located at
First perfusion channel（6）On pressure transducer (15), filter (4), dosing/sample tap (16), buffer (10), located at gas
The gas bubble detection of bubble trap (5) first passage interface, bubble trap (5), flushing pipe（7）In bubble.By observation or
Rinse mode can be stopped after treating the removal of bubbles in this perfusion loop by the way of gas bubble detection automatic detection.
2. run-up mode
Perfusion device schematic diagram as shown in Figure 1, under run-up mode, the first valve (13-1) is opened, the 3rd valve (13-
3) close, the second valve (13-2) is opened.Perfusion power source (3) operates, by perfusate by Y-piece road（9）First branched bottom
Pipeline (9-1) is discharged.Thus excluding perfusion power source (3), the pressure transducer (15) being located in the first perfusion channel, filter
(4), dosing/sample tap (16), buffer (10), be respectively arranged on bubble trap (5) first passage interface and second channel interface
Two gas bubble detections, bubble trap (5), Y-piece road（9）The first branched bottom pipeline (9-1) and main channel pipeline
（9-3）In bubble.By observation or using gas bubble detection automatic detection by way of detect in perfusion loop whether there is gas
Bubble, can stop rinse mode after treating removal of bubbles.
3. Constant pressure perfusion pattern
As shown in Figure 1 perfusion device principle schematic, under Constant pressure perfusion pattern, the arteries of organ and Y-piece road
（9）The second branched bottom pipeline (9-2) connect, the first valve (13-1) open, the 3rd valve (13-3) close, the second valve
(13-2) close.Perfusion power source (3) continuously runs, and perfusate is through perfusion power source (3), the pressure in the first perfusion channel
Force transducer (15), filter (4), dosing/sample tap (16), buffer (10), it is respectively arranged on bubble trap (5) first passage
Two gas bubble detections of interface and second channel interface, bubble trap (5), Y-piece road（9）The first branched bottom pipeline
(9-1) and main channel pipeline（9-3）Middle entrance organ.In this mode, by located at Y-piece road（9）Second branch lead to
Pressure transducer (15) on road pipeline (9-2) obtains current injection pressure in real time, thus carrying out feedback regulation, controls perfusion pressure
Power is under constant-mode.
4. pulsation perfusion mode
As shown in Figure 1 perfusion device principle schematic, under pulsation perfusion mode, the arteries of organ and Y-piece road
（9）The second branched bottom pipeline (9-2) connect, the first valve (13-1) open, the 3rd valve (13-3) close, the second valve
(13-2) close.Perfusion power source (3) operates in a pulsing mode, the perfusion in perfusate Constant pressure perfusion pattern as shown in above-mentioned 3
Loop enters organ, and pump is operated with accelerating-constant speed-periodic the mode of deceleration-constant speed.So that the infusion liquid of output produces pulsation
Effect, such that it is able to simulate human heartbeat's rhythm and pace of moving things.By located at Y-piece road（9）The second branched bottom pipeline (9-2) on pressure
Force transducer (15) obtains current injection pressure in real time, thus carrying out feedback regulation, controls fluctuation pressure to be in set point.
The work process of whole device, perfusion parameter control and data analysiss can have a central control module monitoring,
Once break down Realtime Alerts, and provide user operation and presentation of information by human-computer interaction module.Described central authorities control mould
Block is connected by I/O with analysis module, sensor acquisition module with human-computer interaction module, data storage, passes through with perfusion module
Driver element connects, and is connected by serial ports with power management module, is connected by network interface with 3G communication module.Power management
Module is responsible for completing the on-off control to system power supply, the acquisition of battery electric quantity with display, the control of battery charging and discharging, electricity not
Foot report to the police and power reset restart wait operate.Human-computer interaction module provides user operation and presentation of information, and perfusing course occurs
Fault alarm can be shown with human-computer interaction module and report to the police.3G communication module realizes transportation organ perfusion to be saved ginseng
The remote monitoring of the information such as number, biochemical parameter, GPS, positioning and analysis, it is every that data storage and analysis module are used for storage system
Data, the letter such as the time showing including sensor cluster acquisition parameter and peripheral output display unit, voice, image, video
Breath, and above-mentioned data is analyzed, provide organ diastolic pressure, systolic pressure, perfusion flow, organ swelling degree, oxygen concentration change
The analysis results such as change, comprehensive assessment organ viability.
Organ based on said apparatus preserves and monitoring method, and the method comprises the following steps：
Step（1）. by organ to be transferred（1）It is placed in organ box (2), and by organ to be transferred（1）Vein and Y type
Pipeline（9）Second branched bottom pipeline (9-2) connects, organ to be transferred（1）Tremulous pulse and the second perfusion pipeline（8）Connect；
Step（2）. as shown in Fig. 2 after system boot, booting up self-inspection first, the consumptive material such as detecting system interior conduit is
No be installed in place and the functional unit such as sensor, perfusion power source (3) whether can with normal work, to be confirmed after carry out initial
Change and start sensor cluster and human-computer interaction module；By the storage of central control module log-on data and analysis module evaluator
The perfusion parameter that official's activity, Integrated comparative organ viability's data and human-computer interaction module set, produces the perfusion parameter optimizing and sets
Put, hypothermic perfusion is started according to optimal design-aside；Run come detecting system by central control module during perfusion, be based on
Testing result adjustment perfusion execution or prompting operator；Perfusion parameter in perfusing course and organ parameter can preserve in real time,
Remote monitoring can be carried out by 3G communication module.
Fig. 3 be given rinse mode, Constant pressure perfusion pattern, pulsation perfusion mode under perfusion power source (3)（As pump）Driving
Waveform and perfusion pressure waveform diagram.
For line clogging it is proposed that detecting pipeline using the pressure reduction acute variation of perfusion line clogging rear and front end
Stopping state, and accurately determine its blocking position, by arranging two with before organ venous inlet afterwards in perfusion power source (3) respectively
Individual pressure transducer (15) is realizing.When line clogging, system automatic alarm, send a pulse barotropic wave in head end, just
Pressure ripple is propagated to run into along pipeline and is reflected during tamper, can obtain barotropic wave information twice in pipeline head end, and utilize small echo
Pressure jump information is extracted in conversion, obtains the time difference that barotropic wave passes twice through pressure transducer (15) before organ venous inlet,
Finally the spread speed of comprehensive barotropic wave can determine the position of pipeline blockage.
For the monitoring of the temperature in perfusing course and liquid level, install outside organ box (2) and bubble trap (5) respectively
Temperature sensor and liquid level sensor (11), the temperature of real-time monitoring transplant organ storage temperature and perfusate, liquid level, work as temperature
The temperature of sensor detection exceedes setting scope（0~4℃）, system alarm, automatically take the safety measure of shutdown, pass through simultaneously
Human-computer interaction module notifies user's request manual intervention, and liquid level sensor (11) detects liquid level in the same manner transfinites, such as transportation
Strenuous vibration leads to organ box (2) to be turned on one's side, and causes perfusate to leak and also stopping alarm is asked manual intervention.
The fault that can not automatically exclude for other, as too low in battery electric quantity, machine also will take the safeguard protections such as shutdown
Measure, and user is notified by human-computer interaction module and safety protection module, ask manual intervention.
Hypothermic perfusion device proposed by the present invention passes through to optimize perfusion loop, and reasonable arrangement sensing station is improving perfusion
Safety is it is ensured that the stability of perfusion.The entrance of perfusate is not directly connected with the blood vessel of transplant organ in the present invention, and adopts
It is that fluid path switching provides Untouched control with multiple valve arrangements, perfusion loop increases surge chamber, bubble trap (5) delaying
With perfusion instantaneous high pressure, exclude bubble in time, perfusion safety is improved with this；Break down and alarm, and can be according to fault
Rank and type arrange troubleshooting mode.The present invention can extend organ and preserve the effect time limit, and can do in perfusing course
Biological immune is modified and organ physiological parameter analysis, organ treatment.
Above-described embodiment is not the restriction for the present invention, and the present invention is not limited only to above-described embodiment, as long as meeting
Application claims, belong to protection scope of the present invention.
Claims (10)
1. organ hypothermia machine perfusion save set is it is characterised in that include for placing organ box, the low temperature treating transplant organ
Calorstat, perfusion power source, perfusion loop, perfusion preparation loop, flush loop, the sensor group on each pipeline loop
Part, wherein sensor cluster include temperature sensor, liquid level sensor, biochemical sensor, pressure transducer；
Described perfusion loop is by perfusion power source, filter, buffer, bubble trap and the first perfusion pipeline, Y-piece road
Main channel pipeline, the second branched bottom pipeline in Y-piece road, organ artery and vein vascular, second perfusion pipeline constitute, wherein gas
Bubble trap is triple channel structure；The perfusion liquid inlet of organ box is passed through the first perfusion pipeline and is connected with one end of perfusion power source
Connect, the other end of perfusion power source is connected by the liquid-inlet of the first perfusion pipe-and-filter, the first liquid of filter
Outlet is connected with buffer, and buffer is used for relaxing the instantaneous high pressure of perfusion power source perfusion, the second liquid of filter herein
Outlet is by the first passage orifice of the first perfusion pipeline and bubble trap；The second channel interface of bubble trap connects Y type
The main channel pipeline of pipeline, the second branched bottom pipeline in Y-piece road with treat transplant organ tremulous pulse and connect, treat transplant organ vein
Connect with one end of the second perfusion pipeline, the other end of the second perfusion pipeline stretches into below the perfusate liquid level of organ box, formed
One perfusion loop；
Treat that the organ box of transplant organ is placed in cryostat so that organ box temperature maintains 0～4 DEG C of low temperature for placing
In environment；
Described perfusion preparation loop is by perfusion power source, filter, buffer, bubble trap and the first perfusion pipeline, Y type
The main channel pipeline of pipeline, the first branched bottom pipeline in Y-piece road are constituted, and wherein bubble trap is triple channel structure；Perfusion
Preparation loop and perfusion loop common-use tunnel and function between the entrance of the first perfusion pipeline is to the main channel pipeline in Y-piece road
Assembly, and the outlet in perfusion preparation loop stretches into the perfusate liquid level of organ box by the first branched bottom pipeline in Y-piece road
Lower section, forms a preparation perfusion loop；
Described flush loop is flushing pipe, and one end of flushing pipe third channel interface through bubble trap stretches into bubble and falls into
Trap, the other end stretches into below the perfusate liquid level of organ box；
The work process of whole device, perfusion parameter control and data analysiss are monitored by central control module, once breaking down
Realtime Alerts, provide user operation and presentation of information by human-computer interaction module；Described central control module and man-machine interaction mould
Block, data storage are connected by I/O with analysis module, sensor acquisition module, are connected by driver element with perfusion module, with
Power management module is connected by serial ports, is connected by network interface with 3G communication module.
2. organ hypothermia machine perfusion save set as claimed in claim 1 is it is characterised in that described organ box top is opened
There is gas exchange mouth, for filter bacteria, exchanging gas, maintain perfusion stable gas pressure；The side of organ box is provided with contact temperature
Degree sensor, for measuring the temperature of perfusate in organ box；The outer wall of organ box is provided with liquid level sensor, for monitoring perfusion
Liquid liquid level.
3. organ hypothermia machine perfusion save set as claimed in claim 1 is it is characterised in that in perfusion loop, perfusion preparation
In loop, flush loop, the first perfusion pipeline, flushing pipe, the first branched bottom pipeline in Y-piece road stretch in organ box
Pipeline is not all directly connected with the blood vessel treating transplant organ, with reducing perfusion bubble as far as possible, organ is affected.
4. organ hypothermia machine perfusion save set as claimed in claim 1 is it is characterised in that filling in the first perfusion pipeline
Flowing power source and filter-portion pipeline are provided with pressure transducer, in order to monitor the injection pressure of perfusion power source；First
Have dosing/sample tap on the filter of perfusion pipeline and bubble trap section of tubing, facilitate perfusing course to do biological immune and repair
Decorations and organ physiological parameter analysis；
First valve is provided with the main channel pipeline in Y-piece road, controls the open and close in this loop；In Y-piece road
One branched bottom pipeline is provided with the second valve, for controlling the open and close in preparation perfusion loop；In Y-piece road second
Branched bottom pipeline is provided with biochemical sensor, pressure transducer, is respectively used to monitor the injection pressure of organ viability and organ；
It is provided with biochemical sensor in the second perfusion pipeline, for monitoring organ viability after perfusion；
3rd valve is provided with flushing pipe, for controlling the opening and closing rinsed；
The first passage interface of bubble trap, second channel seam are equipped with gas bubble detection, before detecting that perfusion starts
Whether there is bubble in loop, and whether perfusing course produces bubble；
The outside of described bubble trap is provided with non-contact temperature sensor, liquid level sensor, respectively in order to monitor in it
The temperature of portion's perfusate and liquid level.
5. organ hypothermia machine perfusion save set as claimed in claim 1 is it is characterised in that in bubble trap, respectively from
The duct length that first passage interface stretches into bubble trap with second channel interface is identical, and is longer than and stretches into from third channel interface
The duct length of bubble trap, to facilitate the bubble in capture perfusate.
6. organ hypothermia machine perfusion save set as claimed in claim 1 is it is characterised in that mistake in described filter
Filter membrane must be placed at the ullage of buffer, is easy to buffer and houses the harmful substance that filter leaches.
7. the organ based on organ hypothermia machine perfusion save set as claimed in claim 1 preserves and monitoring method, and it is special
Levy and be that the method specifically includes following steps：
Step (1). organ to be transferred is placed in organ box, and by the tremulous pulse of organ to be transferred and Y-piece road second branch
Passage tube connects, and the vein of organ to be transferred is connected with the second perfusion pipeline；
Step (2). after system boot, boot up self-inspection first, the consumptive material such as detecting system interior conduit whether be installed in place and
The functional units such as sensor, perfusion power source whether can with normal work, to be confirmed after initialized and started sensor group
Part and human-computer interaction module；Organ viability, Integrated comparative are evaluated by the storage of central control module log-on data and analysis module
Organ viability's data and the perfusion parameter of human-computer interaction module setting, produce the perfusion parameter setting optimizing, according to optimal design-aside
Start hypothermic perfusion；Run come detecting system by central control module during perfusion, adjusted based on testing result and fill
Stream execution or prompting operator；Perfusion parameter in perfusing course and organ parameter can preserve in real time, also can be communicated mould by 3G
Block carries out remote monitoring；
Mainly include security protection in said method to share and long-range with fault alarm, the regulation and control of perfusion Intelligence Feedback, network data
Monitoring.
8. the organ based on organ hypothermia machine perfusion save set as claimed in claim 7 preserves and monitoring method, and it is special
Levy and be that described security protection and fault alarm mainly include following monitoring：Line clogging, perfusate add up bubble, temperature surpasses
Limit and liquid level transfinite：
For line clogging, detect the stopping state of pipeline using the pressure reduction acute variation of perfusion line clogging rear and front end,
And accurately determine its blocking position, by arranging pressure transducer real after perfusion power source and before organ arterial inlet respectively
Existing；When line clogging, system automatic alarm, send a pulse barotropic wave in head end, barotropic wave runs into stifled along pipeline propagation
Reflect during plug thing, barotropic wave information twice can be obtained in pipeline head end, and extract pressure jump information using wavelet transformation,
Obtain the time difference that barotropic wave passes twice through pressure transducer before organ venous inlet, finally the spread speed of comprehensive barotropic wave can
To determine the position of pipeline blockage；
For the bubble protection in perfusing course, can realize bubble is gone using gas bubble detection and multiple-way duct system
Remove；Enter front end setting gas bubble detection and the two-way tubing of organ in perfusate, if perfusate directly enters during bubble-free
Enter organ, otherwise pipeline is switched to flush loop or preparation perfusion loop exclusion bubble；
For the monitoring of the temperature in perfusing course and liquid level, mounting temperature sensor outside organ box and bubble trap respectively
And liquid level sensor, the temperature of real-time monitoring transplant organ storage temperature and perfusate, liquid level, when the temperature of temperature sensor detection
Degree exceedes setting scope, system alarm, automatically takes the safety measure of shutdown, notifies user to ask by human-computer interaction module simultaneously
Ask manual intervention, liquid level sensor detects liquid level and transfinites in the same manner, cause perfusate to leak and also stopping alarm request is manually done
In advance；
The fault that can not automatically exclude for other, machine also will take the safety precautions such as shutdown, and pass through man-machine interaction
Module and safety protection module notify user, ask manual intervention.
9. the organ based on organ hypothermia machine perfusion save set as claimed in claim 7 preserves and monitoring method, and it is special
Levy and be that described perfusion Intelligence Feedback regulation and control are the organ viability's parameters according to biochemical sensor collection, in conjunction with other sensors
The perfusion parameter of collection, and the perfusion mode setting and parameter are compared with human-computer interaction module, store perfusion according to system
Empirical data optimizes perfusion parameter, controls according to optimum results central control module and drives perfusion power source execution perfusion or punching
Wash；The feedback regulation of wherein perfusion parameter mainly includes perfusion channel control, pressure controlling and flow detection and control；
For perfusion channel control, unlatching and pass to realize multiple perfusion channel for the valve placed are relied primarily on perfusion pipeline
Close；
For the pressure controlling in filling process, by the way of simulative heartbeat Rhythm Curve, simulated organ pollex in vivo
Pressure curve can adopt closed loop feedback regulating system；
Flow detection for perfusing course and control, can squeeze according to perfusion power source number of revolutions per minute and each rotation
The perfusate volume extruding is calculating perfusion flow, thus realizing the automatic detection to perfusion flow.
10. the organ based on organ hypothermia machine perfusion save set as claimed in claim 7 preserves and monitoring method, and it is special
Levy and be that described whole perfusion device has four kinds of perfusion mode available, respectively rinse mode, run-up mode, constant voltage fill
Stream mode, pulsation perfusion mode；Rinse mode and run-up mode are used for excluding the bubble in whole perfusion fluid path, Constant pressure perfusion mould
Formula and pulsation perfusion mode are the mode of operation of the normal perfusion of organ；
1. rinse mode
Under rinse mode, the first valve closing, the 3rd valve opening；Perfusion power source operates, and liquid is arranged by flushing pipe
Go out, thus excluding the pressure transducer through perfusion power source, being located in the first perfusion channel, filter, dosing/sample tap, delaying
Rush device, the gas bubble detection located at bubble trap first passage interface, bubble trap, the bubble in flushing pipe；By observation
Or rinse mode can be stopped after treating the removal of bubbles in this perfusion loop by the way of gas bubble detection automatic detection；
2. run-up mode
Under run-up mode, the first valve opening, the 3rd valve closing, the second valve opening；Perfusion power source operates, by perfusion
Liquid is discharged by Y-piece road the first branched bottom pipeline；Thus excluding perfusion power source, the pressure being located in the first perfusion channel passes
Sensor, filter, dosing/sample tap, buffer, it is respectively arranged on the two of bubble trap first passage interface and second channel interface
Bubble in individual gas bubble detection, bubble trap, the first branched bottom pipeline in Y-piece road and main channel pipeline；By seeing
Survey or whether there is bubble in perfusion loop using detecting by the way of gas bubble detection automatic detection, permissible after treating removal of bubbles
Stop rinse mode；
3. Constant pressure perfusion pattern
Under Constant pressure perfusion pattern, the arteries of organ are connected with the second branched bottom pipeline in Y-piece road, and the first valve is opened
Open, the 3rd valve closing, the second valve closing；Perfusion power source continuously runs, and perfusate is through perfusion power source, positioned at the first filling
Pressure transducer on circulation road, filter, dosing/sample tap, buffer, be respectively arranged on bubble trap first passage interface with
Two gas bubble detections of second channel interface, bubble trap, the first branched bottom pipeline in Y-piece road and main channel pipeline
Middle entrance organ；In this mode, obtained in real time by the pressure transducer on the second branched bottom pipeline in Y-piece road
Current injection pressure, thus carrying out feedback regulation, controls perfusion pressure to be under constant-mode；
4. pulsation perfusion mode
Under pulsation perfusion mode, the arteries of organ are connected with the second branched bottom pipeline in Y-piece road, and the first valve is opened
Open, the 3rd valve closing, the second valve closing；Perfusion power source operates in a pulsing mode, and perfusate is pressed in Constant pressure perfusion pattern
Perfusion loop enter organ, pump with accelerate-constant speed-periodic the mode of decelerations-constant speed to operate so that export infusion liquid product
Raw pulsation effect, such that it is able to simulate human heartbeat's rhythm and pace of moving things；By the pressure on the second branched bottom pipeline in Y-piece road
Sensor obtains current injection pressure in real time, thus carrying out feedback regulation, controls fluctuation pressure to be in set point.
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| JP6897763B2 (en) * | 2017-04-17 | 2021-07-07 | 株式会社島津製作所 | Emission spectrophotometer |
| CN110178835A (en) * | 2019-07-01 | 2019-08-30 | 胡行健 | A kind of acoustic control myocardial preservation perfusion system |
| CN110786317A (en) * | 2019-11-04 | 2020-02-14 | 广州市冠流生物医学科技有限公司 | Integrated organ perfusion apparatus |
| CN111911402B (en) * | 2020-06-19 | 2021-03-26 | 珠海维尔康生物科技有限公司 | Control method and equipment for automatic conversion between pressure control and pulse control of filling pump |
| CN114617119A (en) * | 2022-03-04 | 2022-06-14 | 杭州莱普晟医疗科技有限公司 | Systems and methods for pancreatic perfusion |
| CN115777688B (en) * | 2022-11-03 | 2023-05-12 | 河南中医药大学第一附属医院 | Isolated myocardial tissue perfusion experiment system |
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