WO2020192513A1 - Mechanical perfusion preservation device for living body's organs - Google Patents

Mechanical perfusion preservation device for living body's organs Download PDF

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Publication number
WO2020192513A1
WO2020192513A1 PCT/CN2020/079874 CN2020079874W WO2020192513A1 WO 2020192513 A1 WO2020192513 A1 WO 2020192513A1 CN 2020079874 W CN2020079874 W CN 2020079874W WO 2020192513 A1 WO2020192513 A1 WO 2020192513A1
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Prior art keywords
perfusion
organ
organs
preservation device
temperature
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PCT/CN2020/079874
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French (fr)
Chinese (zh)
Inventor
何椰
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天一阁医疗科技(广州)有限公司
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Publication of WO2020192513A1 publication Critical patent/WO2020192513A1/en

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    • AHUMAN NECESSITIES
    • A01AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01NPRESERVATION 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
    • A01N1/00Preservation of bodies of humans or animals, or parts thereof
    • A01N1/02Preservation of living parts
    • A01N1/0236Mechanical aspects
    • A01N1/0242Apparatuses, 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
    • A01N1/0247Apparatuses, 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

Definitions

  • the present invention relates to a medical device, and more specifically, to a mechanical perfusion preservation device for biological organs.
  • the best mechanical perfusion preservation device should meet the following characteristics: 1) The device is portable and easy to transport during the preservation process; 2) Real-time and dynamic assessment of organ vitality is performed simultaneously during preservation; 3) The damaged organ is repaired; 4) During the preservation process, treatments such as drugs, gene editing or stem cell infusion are carried out simultaneously; 5) simultaneous preservation of multiple organs; 6) creation of an in vitro environment closest to human physiology.
  • the current mechanical perfusion preservation technology can only save a single organ.
  • Organ-OX and Liver-assist can only save the liver
  • Kidney-assist and Life-Port can only save the kidney
  • TransMedics can only save the heart.
  • each donor needs to obtain 1 liver, 2 kidneys, 1 pancreas, 1 heart, 2 lungs, and 1 small intestine at the same time, a total of 8 organs.
  • Many different organ preservation devices are not only complicated and large, but also difficult to operate, maintain, and transport at the same time. Therefore, a universal preservation device that can store these organs at the same time is required.
  • human organs complement each other, and the simultaneous preservation of multiple organs helps to play the role of mutual protection between organs.
  • Ciim 1 of the invention mentions: a method for perfusing an organ or tissue, the method comprising: connecting a catheter to the organ or tissue, the catheter including multiple Root canal, and at least the first end of each of the two tubes is connected to the organ or tissue; fluid motive force is applied to the perfusion fluid in the two tubes to force the fluid through the The two tubes enter the organ or tissue to perfuse the organ or tissue; allowing the fluid motive force and the back pressure generated by the perfused organ or tissue to establish a flow balance between the two tubes; And then change the flow balance between the two tubes without changing the fluid motive force applied.
  • This invention patent is obviously different from the basic structure of the present invention.
  • the invention patent is a multi-tube structure, excluding the oxygenator and the plug filter, and the main components are different.
  • Chinese invention patent application 201580002264.3 discloses a device that simulates the human body, including: an animal-derived organ, which has biological tissue and blood vessels extending from the biological tissue; and a blood reservoir, which stores blood delivered to the blood vessel A tube that connects the blood vessel and the blood reservoir; a pump portion that is provided in the middle of the tube and transports blood from the blood reservoir to the blood vessel; and a storage portion that accommodates the organ,
  • the steam at a temperature higher than room temperature is delivered to the organ to humidify the organ, and the organ is set to a temperature of 20-50°C.
  • the basic structure of the invention does not include an oxygenator and a thrombus filter, and uses a single organ, which cannot achieve simultaneous perfusion of multiple organs.
  • the prior art realizes unidirectional perfusion, and human organs need blood to return and circulate. It can be seen that the prior art mechanical perfusion device for organs is complex, heavy, and does not realize multi-organ preservation, nor can it realize multi-organ preservation.
  • the device of the present invention uses a single pump and a perfusion line to simultaneously perfuse multiple organs or a single organ through the abdominal aorta or thoracic aorta system.
  • the liver and portal vein do not need to be intubated, and rely on the intestinal artery system and splenic artery.
  • the circulatory perfusate is used for reflux perfusion; multiple thoracic organs can be perfused at the same time through the thoracic aortic system, in which the pulmonary artery does not need to be intubated, and the circulatory perfusate of the right heart is used for perfusion.
  • multiple thoracic organs can be perfused at the same time through the thoracic aortic system, in which the pulmonary artery does not need to be intubated, and the circulatory perfusate of the right heart is used for perfusion.
  • a single cannula is required, which is significantly simplified, which is a fundamental principle completely different from the prior art.
  • the invention discloses a mechanical perfusion preservation device for biological organs, including:
  • Organ warehouse used to contain the organs and accessory blood vessels of the organism
  • Liquid storage bin located below the organ bin for storing circulating perfusion fluid
  • Temperature maintenance device used to maintain the temperature of biological organs and circulating fluid
  • Oxygenator used to continuously oxygenate the circulating perfusate
  • Plug filter used to filter circulating perfusate
  • Perfusion pipeline connect the reservoir, the thrombus filter and the oxygenator in sequence, and pressurize and circulate the organs under the drive of the pump;
  • the mechanical perfusion preservation device can pressurize and circulate the aortic system of an organism, and can perfuse a single or multiple organism organs at the same time.
  • the mechanical perfusion preservation device can simultaneously perfuse multiple abdominal organs through the abdominal aortic system, wherein the liver portal vein does not need to be cannulated, and the perfusion is performed through the circulating perfusate returned from the portal vein system.
  • the mechanical perfusion preservation device can simultaneously perfuse multiple thoracic organs through the thoracic aortic system, wherein the pulmonary artery does not need to be intubated and is perfused with the circulating perfusion fluid of the right heart.
  • the perfusion preservation device further includes: a blood vessel cannula, the blood vessel cannula is located at the end of the perfusion pipeline, and is used to connect the accessory blood vessels of the biological organs for perfusion.
  • the blood vessel cannula has a corresponding side hole, and the inner diameter of the side hole matches the corresponding positions and inner diameters of the different branches of the blood vessel cannula in the aortic system.
  • the temperature maintaining device is a water bath box, and the organ bin and the liquid storage bin are placed in the water bath box.
  • the perfusion preservation device further includes: an oxygenator heating circulation pump, which is used to pump out warm water from the water bath to heat the oxygenator in circulation.
  • the perfusion preservation device further includes: the temperature maintaining device includes a temperature controller, and the temperature controller can control the temperature of the water bath.
  • the perfusion preservation device further includes: the temperature maintaining device is a compressor, ice cubes or ultra-low temperature agent, which is used to maintain the low temperature of the liquid storage tank, the organ tank, and the biological organs.
  • the temperature maintaining device is a compressor, ice cubes or ultra-low temperature agent, which is used to maintain the low temperature of the liquid storage tank, the organ tank, and the biological organs.
  • the perfusion preservation device further includes a temperature sensor for monitoring the temperature of the circulating perfusion fluid and the biological organs in the liquid storage tank;
  • Flow sensor used to monitor the flow of circulating perfusion fluid in the perfusion pipeline
  • Pressure sensor used to monitor the pressure of the circulating perfusion fluid in the perfusion pipeline
  • the bubble sensor is used to monitor whether there are bubbles in the perfusion pipeline.
  • the perfusion preservation device further includes a controller, which collects the signal of the temperature sensor and controls the temperature maintenance device based on the signal.
  • the perfusion preservation device further includes a controller, which collects signals from the flow sensor and the pressure sensor, and controls the pump based on the signals.
  • the perfusion preservation device further includes: a controller that collects the signals of the flow sensor, the pressure sensor and the air bubble sensor, and controls the perfusion pipeline clamp valve based on the signals, and the perfusion pipeline clamp valve can stop the perfusion pipe Road perfusion.
  • the bottom of the organ bin has an organ bin shelf, and the organ bin shelf has a through hole that communicates with the liquid storage bin.
  • the perfusion preservation device further includes: a bile collecting and measuring device for collecting bile and a urine collecting and measuring device for collecting urine, so as to dynamically observe the vitality of biological organs.
  • the present invention Compared with the prior art of Chinese patent application 201580002264.3, the present invention has the following differences: 1) The basic structure is different.
  • the device of the present invention not only includes: organs and their connecting blood vessels, pumps, tubes, heating devices, organ bins ; It also includes oxygenators, thrombus filters, etc.; 2)
  • the pipeline structure of the device of the present invention is different from Chinese patent application 201580002264.3.
  • the present invention is based on a single pump and a single vessel cannula through the abdominal aorta or thoracic aortic system , Perfuse multiple organs in the abdominal or thoracic cavity at the same time.
  • the portal vein of the liver does not need to be intubated and relies on the intestinal and splenic return perfusate for perfusion; this device can simultaneously perfuse multiple thoracic organs through the thoracic aortic system.
  • the circulatory perfusion solution of the heart is perfused; 3)
  • the present invention realizes the blood return circulation, and the Chinese patent application 201580002264.3 is only one-way perfusion without mentioning circulatory perfusion;
  • beneficial effects of the present invention also include:
  • the device of the present invention is suitable for clinical organ preservation, repair and vitality assessment.
  • a single tube is inserted into the abdominal aorta or thoracic aorta and its branches, and multiple organs are perfused at the same time.
  • the liver portal vein does not need to be intubated and depends on passing through the intestine
  • the arterial system and the splenic artery are perfused by the backflow of blood; the pulmonary artery does not need to be cannulated and is perfused through the right heart.
  • the device of the present invention is also suitable for medical minimally invasive training (laparoscopy, natural cavity endoscopy, surgical robots, digestive endoscopy, etc.), using a simple structure of single-intubation aortic system to infuse multiple organs, and using pig farms Obtained discarded large animal organ clusters are perfused and preserved in vitro, using blood or cell-free circulating perfusion fluid to circulate perfusion to supplement energy substrates and carry oxygen to maintain organ vitality without destroying the anatomical structure of abdominal or thoracic organs, helping doctors Master the basic operations of conventional surgery or minimally invasive techniques. While it is close to the effect of large animal experiments to the greatest extent, it has obvious advantages such as cost reduction, ethical problems avoided, anatomical variation, maintenance of the anatomical structure in the body, vitality of organs, and bleeding after injury.
  • Fig. 1 is a schematic plan view of the basic structure of the first embodiment of the device of the present invention.
  • Fig. 2 is a three-dimensional schematic diagram of the basic structure of the first embodiment of the device of the present invention.
  • Fig. 3 is a schematic diagram of the basic principle of the first embodiment of the device of the present invention.
  • Figure 4 is a top view of the organ compartment of the second embodiment of the device of the present invention.
  • Fig. 5 is a top view of the core components of the second embodiment of the device of the present invention.
  • Fig. 6 is a side view of the core components of the second embodiment of the device of the present invention.
  • Figure 7 is an exploded view of the core components of the second embodiment of the device of the present invention.
  • Figure 8 is the overall appearance of the oxygenator and plug filter assembly of the second embodiment of the device of the present invention.
  • Figure 9 is a cross-sectional view of the oxygenator and plug filter assembly of the second embodiment of the device of the present invention.
  • Fig. 10 is a schematic diagram of the electronic control system of the second embodiment of the device of the present invention.
  • Fig. 11 is a schematic diagram of a bile and urine collection device of the second embodiment of the device of the present invention.
  • the device of the present invention is used in a biological organ 1.
  • the biological organ 1 includes a biological organ and blood vessels attached to the biological organ.
  • the biological organ 1 can be an organ cluster or a single organ .
  • the device of the present invention is used for mechanical perfusion and preservation of biological organs 1, and includes: organ bin 2, liquid storage bin 3, temperature maintaining device 4, oxygenator 5, plug filter 6, pump 7 and perfusion pipeline 8.
  • organ bin 2 liquid storage bin 3
  • temperature maintaining device 4 oxygenator 5, plug filter 6, pump 7
  • perfusion pipeline 8 perfusion pipeline 8.
  • a blood vessel cannula 9 at the end of the perfusion line 8 is included.
  • the organ bin 2 is used to contain the biological organ 1 and the blood vessels attached to the biological organ;
  • the liquid storage bin 3 is located at the lower part of the organ bin 2 and is used to collect the circulating perfusion fluid returning from the venous end of the biological organ;
  • the temperature maintaining device 4 It is used to maintain the temperature of the body organ 1, the organ compartment 2, the liquid storage compartment 3 and the overall device;
  • the oxygenator 5 is used to oxygenate the circulating perfusion liquid, the oxygenator 5 is connected with an oxygen cylinder 46;
  • the plug filter 6 is used for Filters impurities such as thrombus and bubbles in the circulating perfusion solution;
  • pump 7 is used for device perfusion power maintenance, pressurized perfusion and circulating perfusion;
  • perfusion pipeline 8 is used to connect key components;
  • blood vessel cannula 9 is located at the end of perfusion pipeline 8 , Connect the aortic system of the organ 1 for pressurized perfusion and circulatory perfusion.
  • the blood vessel cannula 9 has corresponding side holes at corresponding positions of different branches in the aortic system, and the inner diameter is matched with it, so that the corresponding organs can be perfused more accurately.
  • the vascular cannula 9 may also have multiple branches.
  • the portal vein 76 does not need to be cannulated, and relies on the reflux perfusate perfused from the splenic artery 25 to the spleen 72, and the reflux perfusate perfused from the superior mesenteric artery 26 to the intestine 74.
  • the perfusion is performed after the confluence of the splenic vein, superior mesenteric vein and portal vein 32 .
  • the basic working principle of the device is as follows: the biological organ 1 is placed in the organ compartment 2, and the temperature is maintained by the temperature maintenance device 4 outside the organ compartment 2 (the organ compartment 2 is placed in the temperature maintenance device 4), and the cycle
  • the perfusion fluid (including blood or non-cellular circulating fluid, etc.) is refluxed and stored in the liquid storage tank 3, which is located below the organ tank 2.
  • the organ bin shelf 58 of the organ bin 2 has through holes, so that the organ bin 2 and the liquid storage bin 3 are physically connected, so that the perfusion fluid flows out from the biological organ 1 and flows back to the liquid storage bin 3 in the lower layer of the organ bin.
  • the temperature maintaining device 4 is in the form of a water bath box 10, which can not only directly heat the organ compartment 2 immersed in the water bath box 10, but also has an oxygenator heating cycle
  • the pump 71 (installed inside or outside the water bath tank 10) pumps out the warm water in the water bath tank 10, and circulates heating of the oxygenator 5, thereby improving the heating efficiency.
  • the temperature maintaining device 4 uses compressors, ice cubes or ultra-low temperature agents to maintain the low temperature of the liquid storage tank 3, the organ tank 2 and the biological organs 1 therein.
  • the circulating perfusate in the liquid storage tank 3 enters the thrombus filter 6 to filter out impurities and bubbles; then it passes through the oxygenator 5 for oxygenation; and then passes through the circulation line 8, the vascular cannula 9.
  • the aortic system of the organ 1 in the organ warehouse 2 and then use different branches of the aorta to simultaneously perfuse multiple organs; finally, the circulating perfusion fluid flows out through the venous end of the organ 1 and is collected The backflow is concentrated in the liquid storage tank 3, so that cyclic perfusion is formed.
  • the sequence of circulation is: Organ 1 in organ compartment 2—liquid storage compartment 3—thrombus filter 6—pump 7—oxygenator 5—perfusion line 8 (vascular cannula 9)—organism in organ compartment 2 Organ 1.
  • the perfusion pipeline 8 connects the main components.
  • the organ preservation device of the present invention simultaneously perfuses multiple organs through the abdominal aorta or thoracic aorta system, in which the liver portal vein 76 does not need to be cannulated, and is perfused with the circulating perfusate returned from the portal vein system.
  • the pulmonary artery does not need to be cannulated and is perfused with the circulating perfusion fluid of the right heart.
  • the vascular cannula 9 is located at the end of the perfusion pipeline 8 and is connected to the accessory blood vessels of the organ 1 for perfusion.
  • the blood vessel cannula 9 has corresponding side holes at corresponding positions of different branches in the aortic system, and the inner diameter is matched with it, so that the corresponding organs can be perfused more accurately.
  • the biological organ 1 and its accessory blood vessels are placed in the organ compartment 2, and all organs are arranged in accordance with the normal anatomical structure.
  • both ends of the abdominal aorta 28 are ligated by the proximal abdominal aorta blocking ligature 23 and the distal abdominal aortic blocking ligature 27, respectively, and the circulation line 8 (optionally, the end is connected to a blood vessel cannula 9)
  • the circulation line 8 (optionally, the end is connected to a blood vessel cannula 9)
  • the circulating perfusate is driven and pressurized by the pump 7, and is injected into the abdominal aorta 28 through the circulation line 8 (optionally connected to the vascular cannula 9 at the end), and then perfusion of various organs through the branches of the abdominal aorta.
  • the bilateral kidney 75 is perfused through the renal arteries 33; the liver 30 is perfused through the 24 branches of the abdominal trunk proper hepatic artery 31; the spleen 72 is perfused through the 24 branches of the abdominal trunk splenic artery 25; and the spleen 72 is perfused through the superior mesenteric artery 26
  • the inferior mesenteric artery 81 is arterially perfused into the intestine 74;
  • the venous return of the intestine 74 is the superior mesenteric vein 78 and the inferior mesenteric vein 79, the venous return of the spleen 72 is the splenic vein 77, and the venous return of the stomach 73 is the right gastromental vein 80
  • the splenic vein, superior mesenteric vein, and portal vein converge together at the confluence 32, and the liver is perfused through the portal vein 76, so the portal vein 76 can be perfused without intubation.
  • the device can perfuse the abdominal aorta 28 and its branches only through a single tube to complete the perfusion of the entire abdominal organs. All the circulating perfusate flows back to the organ compartment 2 and the reservoir 3 through the superior and inferior hepatic vena cava 29 and the inferior inferior vena cava 34 of the inferior vena cava system, and then the circulating perfusion solution in the reservoir 3 is driven by the pump 7 Enter the thrombus filter 6 to filter out impurities and bubbles; then pass through the oxygenator 5 for oxygenation; and then pass through the circulation line 8 (optionally connected to the vascular cannula 9 at the end) to enter the organism in the organ compartment 2
  • the aortic system of body organ 1 then uses different branches of the aorta to simultaneously perfuse multiple organs, and so on;
  • the device can simultaneously perfuse multiple thoracic organs through the thoracic aortic system, wherein the pulmonary artery does not need to be intubated, and is perfused through the circulating perfusion fluid of the right heart.
  • the vascular cannula 9 is located at the end of the perfusion pipeline 8 and is connected to the accessory blood vessels of the organ 1 for perfusion.
  • the blood vessel cannula 9 has corresponding side holes at corresponding positions of different branches in the aortic system, and the inner diameter is matched with it, so that the corresponding organs can be perfused more accurately.
  • the device of the present invention can be used for extracorporeal mechanical perfusion to preserve human organs, for multi-organ preservation, to play its key mutual protective effect, to preserve and to repair and evaluate organ vitality.
  • the device of the present invention uses animal organs such as pigs or sheep to be mechanically perfused outside of the body to restore organ vitality, simulate human organs to the greatest extent, and conduct medical training.
  • animal organs such as pigs or sheep to be mechanically perfused outside of the body to restore organ vitality, simulate human organs to the greatest extent, and conduct medical training.
  • the second embodiment of the present invention will be described below with reference to FIGS. 4-10 to further detail the structure and principle of the organ bin 2, the liquid storage bin 3, the temperature maintaining device 4, the oxygenator 5, and the plug filter 6.
  • the bottom of the organ warehouse 2 is provided with an organ warehouse shelf 58 with a number of holes that communicate with the lower liquid storage warehouse 3 (see FIG. 2) to facilitate the perfusion circulation fluid to flow back to the liquid storage warehouse 3.
  • a return line 60 is provided inside the organ bin 2, one end of the return line 60 leads to the liquid storage bin 3, and the other end is connected to the circulation line 8.
  • the bottom surface of the liquid storage tank 3 is inclined toward the inlet of the return line 60 to facilitate maintaining a high liquid level, which not only facilitates the collection of circulating fluid, but also prevents the return line 60 from inhaling air.
  • the outer wall of the organ bin 2 is provided with an oxygenator heating circulation interface 63 for sucking warm water in the liquid storage bin 3 below the circulating organ bin 2 and heating the circulating perfusate through the oxygenator 5.
  • the oxygenator heating circulation interface 63 is not connected to the organ compartment 2 but is connected to the water bath box 10 (detailed below).
  • the side wall of the organ compartment 2 is provided with a diaphragm suspension 14 for suspending the diaphragm 22 (see FIG. 1).
  • the diaphragm suspension 14 is a protrusion protruding inward from the inner wall of the organ compartment 2, and multiple diaphragm suspensions 14 can be provided.
  • the diaphragm hook 14 is used to fix and hang the diaphragm part of the biological organ 1 to maximize the anatomical position of the liver in the abdominal cavity.
  • the device of the present invention includes: organ compartment 2, water bath box 10 (as an optional method of temperature maintaining device 4), pump 7, oxygenator 5, filter plug 6, return line 60 , The vascular cannula connecting portion 64 and the vascular cannula 9.
  • the return end of the perfusion line 8 is connected to the return line 60
  • the perfusion end is connected to the vascular cannula connecting portion 64 and the vascular cannula 9
  • the middle of the perfusion line 8 is connected to components such as pump 7, oxygenator 5, and thrombus filter 6.
  • the biological organ 1 is placed on the organ compartment shelf 58 in the organ compartment 2 and immersed in the water bath 10 to maintain the body temperature environment.
  • the diaphragm hook 14 is used to fix and hang the diaphragm of the biological organ 1 to maximize the restoration of the abdominal anatomy position.
  • the organ shelf 58 of the organ compartment 2 may be made of metal, which serves as the negative plate of the high-frequency electrosurgical knife 15 in order to use the high-frequency electrosurgical knife 15.
  • the circulating perfusate is driven by the pressure of the pump 7 and enters the abdominal aorta or thoracic aorta system of the organism 1 through the vascular cannula 9, and perfuses multiple organs in the abdominal or thoracic cavity at the same time.
  • the portal vein 76 does not need to be intubated and depends on the spleen
  • the arterial 25 is infused into the reflux perfusion fluid of the spleen 72, and the superior mesenteric artery 26 is perfused into the intestinal intestinal 74.
  • the perfusion is performed after the confluence of the splenic vein, superior mesenteric vein and portal vein 32.
  • the pulmonary artery does not need to be cannulated and is perfused with the circulating perfusion fluid of the right heart.
  • the circulating perfusate flows out through the inferior vena cava of the biological organ 1, and flows back to the reservoir 3 in the lower part of the organ bin 2 through the porous structure of the organ bin shelf 58; then, driven by the pump 7, the reservoir
  • the circulating fluid in 3 is drawn out through the return line 60 to flow to the plug filter 6 to filter out the thrombus and air clots mixed in the circulating fluid; then through the outlet of the plug filter 6 through the perfusion line 8 through the pump 7, and then through the perfusion
  • the pipeline 8 enters the oxygenator 5 to oxygenate the circulating fluid; then enters the vascular cannula connection portion 64 from the outlet of the oxygenator 5, and then enters the vascular cannula 9 through the vascular cannula connection portion 64, thus completing the cycle reciprocally Perfusion process.
  • the organ bin 2 and the liquid storage bin 3 are placed in a temperature maintaining device 4, and the temperature maintaining device 4 includes a water bath box 10 and a temperature controller 42.
  • the temperature maintaining device 4 includes a water bath box 10 and a temperature controller 42.
  • the second way is to set the oxygenator heating circulation pump 71 to suck the warm water in the water bath tank 10 through the oxygenator heating circulation interface 63 into the oxygenator heater 65, which is located in the oxygenator. Below the device 5 to heat the circulating fluid in the oxygenator 5.
  • the temperature controller 42 can control the temperature of the water bath box 10, and the temperature controller 42 can control the electric heating device to heat the water in the water bath box 10.
  • the oxygenator 5 and the plug filter 6 are centrally placed in the housing 54 of the oxygenator and plug filter, and the corresponding circulation pipelines 8 are regularly distributed in the housing 54 for quick installation and replacement; optionally, except for the pump 7 ,
  • the organ warehouse 2, the liquid storage warehouse 3, the oxygenator 5, the thrombus filter 6, the perfusion pipeline 8, the vascular cannula 9, the return pipeline 60 and other components can be used for one time, which is convenient for quick replacement.
  • the temperature sensor 68 is arranged inside the organ compartment 2 for monitoring the temperature of the biological organ 1 in the organ compartment 2.
  • the flow sensor 66 is arranged on the return line 60 and the vascular cannula connection portion 64 for monitoring the flow of the perfusion fluid circulating through the return line 60 and the vascular cannula connection portion 64.
  • the pressure sensor 69 is arranged on the blood vessel cannula connection portion 64, wherein the blood vessel cannula 9 is connected to the end of the blood vessel cannula connection portion 64.
  • the pressure sensor 69 is used to monitor the pressure at the vascular cannula connection portion 64, that is, to monitor the pressure of the circulating perfusate to be delivered to the vascular cannula 9.
  • the air bubble sensor 85 is used to monitor air bubbles in the perfusion line 8.
  • the organ perfusion preservation device of the present invention also includes a perfusion line clamp valve 70, which is arranged on the perfusion line 8.
  • the figure shows that it is arranged near the input end of the pump 7.
  • the perfusion line clamp valve 70 can be closed. The circulatory perfusion of the perfusion line 8 is quickly stopped to avoid damage to the biological organ 1 when abnormalities occur.
  • the organ perfusion preservation device of the present invention further includes an electronic control system, and the electronic control system is powered by a low-voltage DC power supply 82.
  • the electronic control system includes a controller 67, a control panel and a display screen 83.
  • Figure 10 shows the schematic circuit diagram of the electronic control system.
  • the device of the present invention may be equipped with a lifting column 43, which is installed under the liquid storage bin 3, and can raise the height of the liquid storage bin 3 (together with the organ bin 2).
  • the device of the present invention also includes a temperature sensor 68, a flow sensor 66, a pressure sensor 69, and a bubble sensor 85.
  • the controller 67 controls the temperature of the temperature maintaining device 4 and controls the pump 7. To prevent abnormal perfusion pressure or flow rate, control the opening and closing state of the perfusion pipeline clamp valve 70, and provide timely alarm through the alarm device 84 when an abnormal situation occurs in the device.
  • the alarm can be displayed on the control panel and the display 83.
  • the system of the present invention also has a bile collection and measurement device 16 and a urine collection and measurement device 17 for collecting bile and urine and dynamically observing organ vitality.

Abstract

The present invention relates to a piece of medical equipment. Provided is a mechanical perfusion preservation device for a living body's organ. The device comprises: an organ bin (2) for accommodating the living body's organ and accessory vessels thereof; a liquid storage bin (3) located below the organ bin (2) and used for storing circulation perfusate; a temperature maintaining device (4) for maintaining the temperatures of the living body's organ and the circulation perfusate; an oxygenator (5) for continuously oxygenating the circulation perfusate; a thrombus filter (6) for filtering the circulation perfusate; a pump (7) for pressurizing the circulation perfusate; and a perfusion pipeline (8) for sequentially connecting the liquid storage bin (3), the thrombus filter (6) and the oxygenator (5) and pressurizing and circularly perfusing the living body's organ under the drive of the pump (7). The mechanical perfusion preservation device may pressurize and circularly perfuse an aorta system of a living body and may perfuse one or more living body organs simultaneously. On the basis of the principles for the mechanical perfusion of organs, the device of the present invention may simultaneously perfuse a plurality of organs by using oxygenated blood or a cell component-free circulation perfusate.

Description

一种生物体器官的机械灌注保存装置Mechanical perfusion preservation device for biological organs 技术领域Technical field
本发明涉及一种医疗设备,更具体地,涉及一种生物体器官的机械灌注保存装置。The present invention relates to a medical device, and more specifically, to a mechanical perfusion preservation device for biological organs.
背景技术Background technique
随着器官移植技术的快速发展,对器官保存技术的要求越来越高,传统的UW液低温保存已经无法满足临床需要,因此新型的机械灌注保存技术已经逐渐被世界范围内的器官移植中心接受。最佳的机械灌注保存装置应满足以下特点:1)装置便携式,便于保存过程中进行运输;2)在保存同时,同步进行器官活力实时、动态评估;3)对受损器官进行修复;4)在保存过程中,同步进行药物、基因编辑或干细胞输注等治疗;5)多器官同时保存;6)创造最接近人体生理的体外环境。With the rapid development of organ transplantation technology, the requirements for organ preservation technology are getting higher and higher. The traditional UW liquid cryopreservation can no longer meet the clinical needs, so the new mechanical perfusion preservation technology has gradually been accepted by organ transplant centers worldwide. . The best mechanical perfusion preservation device should meet the following characteristics: 1) The device is portable and easy to transport during the preservation process; 2) Real-time and dynamic assessment of organ vitality is performed simultaneously during preservation; 3) The damaged organ is repaired; 4) During the preservation process, treatments such as drugs, gene editing or stem cell infusion are carried out simultaneously; 5) simultaneous preservation of multiple organs; 6) creation of an in vitro environment closest to human physiology.
目前的机械灌注保存技术只能保存单个器官,例如Organ-OX和Liver-assist只能单独保存肝脏,Kidney-assist和Life-Port只能单独保存肾脏,Trans Medics只能单独保存心脏。而器官捐献供体器官获取过程时,每个供体需要同时完整获取1个肝脏、2个肾脏、1个胰腺、1个心脏、2个肺脏、1个小肠,共计8个器官,那就需要多个不同器官保存设备,不仅复杂、庞大而且难以同时操作、同时维护和运输,需要能够同时保存这些器官或者通用型的保存装置。而且,人体器官间相辅相成,多器官的同时保存有助于发挥器官间的相互保护作用。The current mechanical perfusion preservation technology can only save a single organ. For example, Organ-OX and Liver-assist can only save the liver, Kidney-assist and Life-Port can only save the kidney, and TransMedics can only save the heart. In the process of organ donation from a donor organ, each donor needs to obtain 1 liver, 2 kidneys, 1 pancreas, 1 heart, 2 lungs, and 1 small intestine at the same time, a total of 8 organs. Many different organ preservation devices are not only complicated and large, but also difficult to operate, maintain, and transport at the same time. Therefore, a universal preservation device that can store these organs at the same time is required. Moreover, human organs complement each other, and the simultaneous preservation of multiple organs helps to play the role of mutual protection between organs.
另外在医学培训过程中,为了让外科腹腔镜、自然腔道内镜、手术机器人、内科消化内镜等训练效果更真实,需要利用大动物进行手术操作训练。但是随着社会文明的进步、医学伦理的发展,加之建立大动物手术室的昂贵成本、单次大动物实验的昂贵费用等因素,均限制了利用大动物进行手术训练。目前医学培训大多使用市场上买来的,可食用大动物器官供培训使用,但是这些器官往往是没有活力的离体死亡器官,而且是单个器官,不仅缺乏活力,器官与在体存活状态差别较大,并且无法准确模拟出血,肠子无法蠕动,肝脏无法产生胆汁,肾脏无法产生尿,心脏无法跳动,因此模拟效果较差;而且单个器官的整体解剖结构已经被破坏,无法进行系统解剖训练,培训效果较差。近年来出现的虚拟现实培训装置,也存在很多缺陷,例如缺乏解剖变异,手术操作缺乏真实性,售价高昂等缺陷。In addition, in the process of medical training, in order to make the training effect of surgical laparoscopy, natural cavity endoscopy, surgical robot, and internal digestive endoscopy more realistic, it is necessary to use large animals for surgical operation training. However, with the progress of social civilization and the development of medical ethics, coupled with the high cost of establishing a large animal operating room, and the high cost of a single large animal experiment, all factors have restricted the use of large animals for surgical training. At present, most medical training uses the large edible animal organs bought on the market for training. However, these organs are often dead organs in vitro without vitality, and are single organs. Not only are they lacking vitality, but the organs are different from in vivo survival. It is too large and cannot accurately simulate bleeding, the intestines cannot move, the liver cannot produce bile, the kidneys cannot produce urine, and the heart cannot beat, so the simulation effect is poor; and the overall anatomy of a single organ has been destroyed, and systematic anatomy training and training cannot be performed. The effect is poor. Virtual reality training devices that have emerged in recent years also have many defects, such as lack of anatomical variation, lack of authenticity in surgical operations, and high prices.
中国发明专利201380046850.9公开了具有下游流动控制的器官灌注设备,该发明权利要求1提及:一种灌注器官或组织的方法,所述方法包括:将导管连接到器官或组织,所述导管包括多根管,并且至少两根所述管中的每一根的第一端部连接到所述器官或组织;将流体原动力施加到所述两根管中的灌注流体,以迫使所述流体通过所述两根管进入所述器官或组织以灌注所述器官或组织;允许由所述流体原动力和由被灌注的所述器官或组织生成的背压在所述两根管之间建立流动平衡;以及然后改变所述两根管之间的所述流动平衡,而不改变所施加的所述流体原动力。该发明专利与本发明基本结构差异明显,该发明专利为多管结构,不包括氧合器及滤栓器,主要部件均不相同。Chinese invention patent 201380046850.9 discloses an organ perfusion device with downstream flow control. Claim 1 of the invention mentions: a method for perfusing an organ or tissue, the method comprising: connecting a catheter to the organ or tissue, the catheter including multiple Root canal, and at least the first end of each of the two tubes is connected to the organ or tissue; fluid motive force is applied to the perfusion fluid in the two tubes to force the fluid through the The two tubes enter the organ or tissue to perfuse the organ or tissue; allowing the fluid motive force and the back pressure generated by the perfused organ or tissue to establish a flow balance between the two tubes; And then change the flow balance between the two tubes without changing the fluid motive force applied. This invention patent is obviously different from the basic structure of the present invention. The invention patent is a multi-tube structure, excluding the oxygenator and the plug filter, and the main components are different.
中国发明专利申请201580002264.3公开了一种模拟人体装置,包括:来自动物的器官,其具有生物体组织和自所述生物体组织延伸的血管;血液积存部,其积存有向所述血管输送的血液;管,其连接所述血管与所述血液积存部;泵部,其设于所述管的中途并从所述血液积存部向所述血管输送血液;以及收纳部,其收纳所述器官,向所述器官输送比室温高的温度的蒸气对所述器官加湿,并且将所述器官设为20-50℃的温度。该发明的基本结构不包括氧合器及滤栓器,而且使用的是单个器官,无法实现多器官同时灌注。而且该现有技术实现的是单向灌注,而人体器官是需要血液回流循环的。可见,现有技术的器官机械灌注装置复杂、笨重、而且没有实现多器官保存,也无法实现多器官保存。Chinese invention patent application 201580002264.3 discloses a device that simulates the human body, including: an animal-derived organ, which has biological tissue and blood vessels extending from the biological tissue; and a blood reservoir, which stores blood delivered to the blood vessel A tube that connects the blood vessel and the blood reservoir; a pump portion that is provided in the middle of the tube and transports blood from the blood reservoir to the blood vessel; and a storage portion that accommodates the organ, The steam at a temperature higher than room temperature is delivered to the organ to humidify the organ, and the organ is set to a temperature of 20-50°C. The basic structure of the invention does not include an oxygenator and a thrombus filter, and uses a single organ, which cannot achieve simultaneous perfusion of multiple organs. Moreover, the prior art realizes unidirectional perfusion, and human organs need blood to return and circulate. It can be seen that the prior art mechanical perfusion device for organs is complex, heavy, and does not realize multi-organ preservation, nor can it realize multi-organ preservation.
发明内容Summary of the invention
为了实现临床多器官同时离体保存,必须建立以腹主动脉或胸主动脉为核心的多器官灌注系统。为简化操作,本发明的装置通过单泵及灌注管路,通过腹部主动脉或胸主动脉系统同时灌注多个器官或单个器官,其中肝脏门静脉无需插管,依赖通过肠道动脉系统及脾动脉的循环灌注液进行回流灌注;可通过胸主动脉系统同时灌注多个胸部器官,其中肺动脉无需插管,通过右心的循环灌注液进行灌注。在保存多器官的情况下,仅需单根插管,明显简化,这与现有技术是完全不同的基本原理。In order to achieve clinical preservation of multiple organs simultaneously in vitro, a multi-organ perfusion system with abdominal aorta or thoracic aorta as the core must be established. In order to simplify the operation, the device of the present invention uses a single pump and a perfusion line to simultaneously perfuse multiple organs or a single organ through the abdominal aorta or thoracic aorta system. The liver and portal vein do not need to be intubated, and rely on the intestinal artery system and splenic artery. The circulatory perfusate is used for reflux perfusion; multiple thoracic organs can be perfused at the same time through the thoracic aortic system, in which the pulmonary artery does not need to be intubated, and the circulatory perfusate of the right heart is used for perfusion. In the case of preserving multiple organs, only a single cannula is required, which is significantly simplified, which is a fundamental principle completely different from the prior art.
本发明公开一种生物体器官的机械灌注保存装置,包括:The invention discloses a mechanical perfusion preservation device for biological organs, including:
器官仓:用于容纳生物体器官及附属血管;Organ warehouse: used to contain the organs and accessory blood vessels of the organism;
储液仓:位于所述器官仓下方,用于存储循环灌注液;Liquid storage bin: located below the organ bin for storing circulating perfusion fluid;
温度维持装置:用于维持生物体器官及循环液的温度;Temperature maintenance device: used to maintain the temperature of biological organs and circulating fluid;
氧合器:用于将循环灌注液持续氧合;Oxygenator: used to continuously oxygenate the circulating perfusate;
滤栓器:用于过滤循环灌注液;Plug filter: used to filter circulating perfusate;
泵:对循环灌注液进行加压;Pump: pressurize the circulating perfusate;
灌注管路:依次连接储液仓、滤栓器及氧合器,并在泵的驱动下,对所述生物体器官进行加压、循环灌注;Perfusion pipeline: connect the reservoir, the thrombus filter and the oxygenator in sequence, and pressurize and circulate the organs under the drive of the pump;
所述机械灌注保存装置能够对生物体的主动脉系统进行加压、循环灌注,能够同时灌注单个或多个生物体器官。The mechanical perfusion preservation device can pressurize and circulate the aortic system of an organism, and can perfuse a single or multiple organism organs at the same time.
进一步,所述机械灌注保存装置能够通过腹主动脉系统同时灌注多个腹部器官,其中肝脏门静脉无需插管,通过门静脉系统回流的循环灌注液进行灌注。Further, the mechanical perfusion preservation device can simultaneously perfuse multiple abdominal organs through the abdominal aortic system, wherein the liver portal vein does not need to be cannulated, and the perfusion is performed through the circulating perfusate returned from the portal vein system.
进一步,所述机械灌注保存装置能够通过胸主动脉系统同时灌注多个胸部器官,其中肺动脉无需插管,通过右心的循环灌注液进行灌注。Further, the mechanical perfusion preservation device can simultaneously perfuse multiple thoracic organs through the thoracic aortic system, wherein the pulmonary artery does not need to be intubated and is perfused with the circulating perfusion fluid of the right heart.
进一步,所述的灌注保存装置还包括:血管插管,所述血管插管位于灌注管路末端,用于连接生物体器官附属血管进行灌注。Further, the perfusion preservation device further includes: a blood vessel cannula, the blood vessel cannula is located at the end of the perfusion pipeline, and is used to connect the accessory blood vessels of the biological organs for perfusion.
进一步,血管插管具有相应侧孔,所述侧孔的内径与血管插管在主动脉系统内的不同分支对应的位置及内径相匹配。Further, the blood vessel cannula has a corresponding side hole, and the inner diameter of the side hole matches the corresponding positions and inner diameters of the different branches of the blood vessel cannula in the aortic system.
进一步,所述温度维持装置为水浴箱,所述器官仓和所述储液仓放置在所述水浴箱内。Further, the temperature maintaining device is a water bath box, and the organ bin and the liquid storage bin are placed in the water bath box.
进一步,所述的灌注保存装置还包括:氧合器加热循环泵,其用于将水浴箱内温水抽出,来对氧合器进行循环加热。Further, the perfusion preservation device further includes: an oxygenator heating circulation pump, which is used to pump out warm water from the water bath to heat the oxygenator in circulation.
进一步,所述的灌注保存装置还包括:温度维持装置包括温度控制器,温度控制器能够控制所述水浴箱的温度。Further, the perfusion preservation device further includes: the temperature maintaining device includes a temperature controller, and the temperature controller can control the temperature of the water bath.
进一步,所述的灌注保存装置还包括:温度维持装置为压缩机、冰块或者超低温剂,用于维持储液仓、器官仓及生物体器官的低温。Further, the perfusion preservation device further includes: the temperature maintaining device is a compressor, ice cubes or ultra-low temperature agent, which is used to maintain the low temperature of the liquid storage tank, the organ tank, and the biological organs.
进一步,所述的灌注保存装置还包括:温度传感器,用于监测储液仓内的循环灌注液及生物体器官的温度;Further, the perfusion preservation device further includes a temperature sensor for monitoring the temperature of the circulating perfusion fluid and the biological organs in the liquid storage tank;
流量传感器,用于监测灌注管路内的循环灌注液的流量;Flow sensor, used to monitor the flow of circulating perfusion fluid in the perfusion pipeline;
压力传感器,用于监测灌注管路内的循环灌注液的压力;Pressure sensor, used to monitor the pressure of the circulating perfusion fluid in the perfusion pipeline;
气泡传感器,用于监测灌注管路内是否有气泡。The bubble sensor is used to monitor whether there are bubbles in the perfusion pipeline.
进一步,所述的灌注保存装置还包括:控制器,其收集温度传感器的信号,并基于所述信号控制温度维持装置。Further, the perfusion preservation device further includes a controller, which collects the signal of the temperature sensor and controls the temperature maintenance device based on the signal.
进一步,所述的灌注保存装置还包括:控制器,其收集流量传感器和压力传感器的信号,并基于所述信号控制泵。Further, the perfusion preservation device further includes a controller, which collects signals from the flow sensor and the pressure sensor, and controls the pump based on the signals.
进一步,所述的灌注保存装置还包括:控制器,其收集流量传感器、压力 传感器和气泡传感器的信号,并基于所述信号控制灌注管路钳制阀,所述灌注管路钳制阀能够停止灌注管路的灌注。Further, the perfusion preservation device further includes: a controller that collects the signals of the flow sensor, the pressure sensor and the air bubble sensor, and controls the perfusion pipeline clamp valve based on the signals, and the perfusion pipeline clamp valve can stop the perfusion pipe Road perfusion.
进一步,所述器官仓底部具有器官仓搁板,器官仓搁板具有通孔与所述储液仓相通。Further, the bottom of the organ bin has an organ bin shelf, and the organ bin shelf has a through hole that communicates with the liquid storage bin.
进一步,所述的灌注保存装置还包括:收集胆汁的胆汁收集计量装置和收集尿液的尿液收集计量装置,以动态观察生物体器官的活力。Further, the perfusion preservation device further includes: a bile collecting and measuring device for collecting bile and a urine collecting and measuring device for collecting urine, so as to dynamically observe the vitality of biological organs.
与中国专利申请201580002264.3的现有技术相比,本发明与有如下不同点:1)基本结构不同,本发明的装置不仅包括:器官及其连接血管、泵部、管、加温装置、器官仓;还包括氧合器、滤栓器等;2)本发明的装置的管路结构与中国专利申请201580002264.3不同,本发明依据单泵及单根血管插管,通过腹主动脉或胸主动脉系统,同时灌注腹腔或者胸腔多个器官,肝脏门静脉无需插管,依赖肠道及脾脏回流灌注液进行灌注;本装置可通过胸主动脉系统同时灌注多个胸部器官,其中肺动脉无需插管,通过右心的循环灌注液进行灌注;3)本发明实现了血液回流循环,中国专利申请201580002264.3仅为单向灌注,没有提及循环灌注;Compared with the prior art of Chinese patent application 201580002264.3, the present invention has the following differences: 1) The basic structure is different. The device of the present invention not only includes: organs and their connecting blood vessels, pumps, tubes, heating devices, organ bins ; It also includes oxygenators, thrombus filters, etc.; 2) The pipeline structure of the device of the present invention is different from Chinese patent application 201580002264.3. The present invention is based on a single pump and a single vessel cannula through the abdominal aorta or thoracic aortic system , Perfuse multiple organs in the abdominal or thoracic cavity at the same time. The portal vein of the liver does not need to be intubated and relies on the intestinal and splenic return perfusate for perfusion; this device can simultaneously perfuse multiple thoracic organs through the thoracic aortic system. The circulatory perfusion solution of the heart is perfused; 3) The present invention realizes the blood return circulation, and the Chinese patent application 201580002264.3 is only one-way perfusion without mentioning circulatory perfusion;
另外,本发明的有益效果还包括:In addition, the beneficial effects of the present invention also include:
1)本发明的装置适用于临床器官保存、修复及活力评估,通过单管插入腹主动脉或者胸主动脉及其分支,同时灌注保存多个器官,其中肝脏门静脉无需插管,依赖通过肠道动脉系统及脾动脉灌注的血液回流灌注;其中肺动脉无需插管,通过右心的血液灌注。可以充分发挥多器官的相互保护作用,例如肾脏排出多余水分及维持酸碱平衡,肝脏代谢功能及免疫功能等,肠道吸收水分、营养物质及促进肝脏修复等功能,胰腺调节血糖及促进消化等功能。多器官相辅相成,共同降低器官移植术后移植物功能不良或者失功的风险。1) The device of the present invention is suitable for clinical organ preservation, repair and vitality assessment. A single tube is inserted into the abdominal aorta or thoracic aorta and its branches, and multiple organs are perfused at the same time. Among them, the liver portal vein does not need to be intubated and depends on passing through the intestine The arterial system and the splenic artery are perfused by the backflow of blood; the pulmonary artery does not need to be cannulated and is perfused through the right heart. Can give full play to the mutual protection of multiple organs, such as the kidneys excrete excess water and maintain acid-base balance, liver metabolism and immune function, etc., the intestine absorbs water and nutrients and promotes liver repair functions, and the pancreas regulates blood sugar and promotes digestion. Features. Multiple organs complement each other and jointly reduce the risk of graft dysfunction or loss of function after organ transplantation.
2)本发明的装置还适用于医学微创训练(腹腔镜、自然腔道内镜、手术机器人、消化内镜等),利用单插管主动脉系统灌注多器官的简便结构,利用养猪场获取的废弃大动物器官簇,在体外灌注保存,利用血液或无细胞型循环灌注液,循环灌注补充能量底物及携氧,维持器官活力,而且不破坏腹腔或者胸腔器官的解剖结构,帮助医生掌握常规手术或微创技术基本操作。在最大程度上接近大动物实验的效果的同时,具有成本明显降低,避免伦理问题,而且存在解剖变异,保持在体解剖结构,器官保持活力,损伤后有出血等明显优势。2) The device of the present invention is also suitable for medical minimally invasive training (laparoscopy, natural cavity endoscopy, surgical robots, digestive endoscopy, etc.), using a simple structure of single-intubation aortic system to infuse multiple organs, and using pig farms Obtained discarded large animal organ clusters are perfused and preserved in vitro, using blood or cell-free circulating perfusion fluid to circulate perfusion to supplement energy substrates and carry oxygen to maintain organ vitality without destroying the anatomical structure of abdominal or thoracic organs, helping doctors Master the basic operations of conventional surgery or minimally invasive techniques. While it is close to the effect of large animal experiments to the greatest extent, it has obvious advantages such as cost reduction, ethical problems avoided, anatomical variation, maintenance of the anatomical structure in the body, vitality of organs, and bleeding after injury.
附图说明Description of the drawings
图1是本发明装置的第一实施方式基本结构平面示意图。Fig. 1 is a schematic plan view of the basic structure of the first embodiment of the device of the present invention.
图2是本发明装置的第一实施方式基本结构立体示意图。Fig. 2 is a three-dimensional schematic diagram of the basic structure of the first embodiment of the device of the present invention.
图3是本发明装置的第一实施方式基本原理示意图。Fig. 3 is a schematic diagram of the basic principle of the first embodiment of the device of the present invention.
图4是本发明装置的第二实施方式器官仓俯视图。Figure 4 is a top view of the organ compartment of the second embodiment of the device of the present invention.
图5是本发明装置的第二实施方式核心部件俯视图。Fig. 5 is a top view of the core components of the second embodiment of the device of the present invention.
图6是本发明装置的第二实施方式核心部件侧视图。Fig. 6 is a side view of the core components of the second embodiment of the device of the present invention.
图7是本发明装置的第二实施方式核心部件爆炸图。Figure 7 is an exploded view of the core components of the second embodiment of the device of the present invention.
图8是本发明装置的第二实施方式氧合器及滤栓器组件整体外观。Figure 8 is the overall appearance of the oxygenator and plug filter assembly of the second embodiment of the device of the present invention.
图9是本发明装置的第二实施方式氧合器及滤栓器组件剖面图。Figure 9 is a cross-sectional view of the oxygenator and plug filter assembly of the second embodiment of the device of the present invention.
图10是本发明的装置的第二实施方式的电子控制系统示意图。Fig. 10 is a schematic diagram of the electronic control system of the second embodiment of the device of the present invention.
图11是本发明的装置的第二实施方式的胆汁、尿液收集装置示意图。Fig. 11 is a schematic diagram of a bile and urine collection device of the second embodiment of the device of the present invention.
附图标记:Reference signs:
1-生物体器官,2-器官仓,3-储液仓,4-温度维持装置,5-氧合器,6-滤栓器,7-泵,8-灌注管路,9-血管插管,10-水浴箱,14-膈肌悬挂,16-胆汁收集计量装置,17-尿液收集计量装置,22-膈肌,23-近端腹主动脉阻断结扎线,24-腹腔干,25-脾动脉,26-肠系膜上动脉,27-远端腹主动脉插管结扎线,28-腹主动脉,29-肝上下腔静脉,30-肝脏,31-肝固有动脉,32-脾静脉、肠系膜上静脉与门静脉汇合处,33-肾动脉,34-肝下下腔静脉,42-温度控制器,43-升降柱,46-氧气瓶,54-氧合器及滤栓器外壳,58-器官仓搁板,60-回流管路,63-氧合器加热循环接口,64-血管插管连接部,65-氧合器加热器,66-流量传感器,67-控制器,68-温度传感器,69-压力传感器,70-灌注管路钳制阀,71-氧合器加热循环泵,72-脾脏,73-胃,74-肠道,75-肾脏,76-门静脉,77-脾静脉,78-肠系膜上静脉,79-肠系膜下静脉,80-胃网膜右静脉,81-肠系膜下动脉,82-低压直流电源,83-控制面板及显示屏,84-警报装置,85-气泡传感器。1-Organism, 2-Organ storage, 3-Reservoir, 4-Temperature maintenance device, 5-Oxygenator, 6-Thrombus filter, 7-Pump, 8-Perfusion line, 9-Vascular cannula , 10-water bath, 14-diaphragm suspension, 16-bile collection and measurement device, 17-urine collection and measurement device, 22-diaphragm, 23-proximal abdominal aorta blocking ligature, 24-abdominal trunk, 25-spleen Artery, 26-superior mesenteric artery, 27-distal abdominal aorta cannulation ligature, 28-abdominal aorta, 29-superior and superior hepatic vena cava, 30-liver, 31-proper hepatic artery, 32-splenic vein, supra mesenteric Confluence of vein and portal vein, 33-renal artery, 34-inferior vena cava, 42-temperature controller, 43-lifting column, 46-oxygen cylinder, 54-oxygenator and thrombus filter housing, 58-organ compartment Shelf, 60- return line, 63- oxygenator heating circulation interface, 64- vascular cannula connection, 65- oxygenator heater, 66- flow sensor, 67- controller, 68- temperature sensor, 69 -Pressure sensor, 70-perfusion pipeline clamp valve, 71-oxygenator heating circulation pump, 72-spleen, 73-stomach, 74-intestine, 75-kidney, 76-portal vein, 77-splenic vein, 78-mesentery Superior vein, 79-inferior mesenteric vein, 80-right gastroepiploic vein, 81-inferior mesenteric artery, 82-low voltage DC power supply, 83-control panel and display screen, 84-alarm device, 85-bubble sensor.
具体实施方式detailed description
下面参照附图描述本发明的实施方式,其中相同的部件用相同的附图标记表示。在不冲突的情况下,下述的实施例及实施例中的技术特征可以相互组合。The embodiments of the present invention are described below with reference to the drawings, in which the same components are denoted by the same reference numerals. In the case of no conflict, the following embodiments and technical features in the embodiments can be combined with each other.
第一实施方式The first embodiment
如图1-3所示,本发明的装置用于生物体器官1,生物体器官1包括生物体器官和自所述生物体器官附属的血管,生物体器官1可以是器官簇或者单独的器官。As shown in Figures 1-3, the device of the present invention is used in a biological organ 1. The biological organ 1 includes a biological organ and blood vessels attached to the biological organ. The biological organ 1 can be an organ cluster or a single organ .
本发明的装置用于机械灌注保存生物体器官1,包括:器官仓2、储液仓3、温度维持装置4、氧合器5、滤栓器6、泵7和灌注管路8。优选地,包括灌注管路8末端的血管插管9。The device of the present invention is used for mechanical perfusion and preservation of biological organs 1, and includes: organ bin 2, liquid storage bin 3, temperature maintaining device 4, oxygenator 5, plug filter 6, pump 7 and perfusion pipeline 8. Preferably, a blood vessel cannula 9 at the end of the perfusion line 8 is included.
器官仓2用于容纳生物体器官1和自所述生物体器官附属的血管;储液仓3位于器官仓2下部,用于收集从生物体器官静脉端回流的循环灌注液;温度维持装置4用于维持生物体器官1、器官仓2、储液仓3及装置整体温度;氧合器5用于将循环灌注液氧合,氧合器5连接有氧气瓶46;滤栓器6用于过滤循环灌注液中的血栓、气泡等杂质;泵7用于装置灌注动力维持,加压灌注及循环灌注;灌注管路8用于连接各关键部件;血管插管9位于灌注管路8的末端,连接生物体器官1的主动脉系统,进行加压灌注及循环灌注。优选地,血管插管9在主动脉系统内的不同分支对应位置,具有相应侧孔,内径与之匹配,可更加准确地灌注相应器官。血管插管9也可以具有多个分支。The organ bin 2 is used to contain the biological organ 1 and the blood vessels attached to the biological organ; the liquid storage bin 3 is located at the lower part of the organ bin 2 and is used to collect the circulating perfusion fluid returning from the venous end of the biological organ; the temperature maintaining device 4 It is used to maintain the temperature of the body organ 1, the organ compartment 2, the liquid storage compartment 3 and the overall device; the oxygenator 5 is used to oxygenate the circulating perfusion liquid, the oxygenator 5 is connected with an oxygen cylinder 46; the plug filter 6 is used for Filters impurities such as thrombus and bubbles in the circulating perfusion solution; pump 7 is used for device perfusion power maintenance, pressurized perfusion and circulating perfusion; perfusion pipeline 8 is used to connect key components; blood vessel cannula 9 is located at the end of perfusion pipeline 8 , Connect the aortic system of the organ 1 for pressurized perfusion and circulatory perfusion. Preferably, the blood vessel cannula 9 has corresponding side holes at corresponding positions of different branches in the aortic system, and the inner diameter is matched with it, so that the corresponding organs can be perfused more accurately. The vascular cannula 9 may also have multiple branches.
门静脉76无需插管,依赖从脾动脉25灌注至脾脏72的回流灌注液,肠系膜上动脉26灌注至肠道74的回流灌注液,在脾静脉、肠系膜上静脉与门静脉汇合处32汇合后进行灌注。The portal vein 76 does not need to be cannulated, and relies on the reflux perfusate perfused from the splenic artery 25 to the spleen 72, and the reflux perfusate perfused from the superior mesenteric artery 26 to the intestine 74. The perfusion is performed after the confluence of the splenic vein, superior mesenteric vein and portal vein 32 .
如图2所示,本装置基本工作原理如下:生物体器官1放置在器官仓2内,由器官仓2外侧的温度维持装置4维持温度(器官仓2放在温度维持装置4内),循环灌注液(包括血液或非细胞型循环液等)回流并储存在储液仓3内,储液仓3位于器官仓2下方。器官仓2的器官仓搁板58上具有通孔,使得器官仓2和储液仓3是物理相通的,便于灌注液从生物体器官1流出后,回流到器官仓下层的储液仓3。在一个实施方式中(如图6、图7所示),温度维持装置4选用水浴箱10的形式,不仅可以对浸泡在水浴箱10内的器官仓2直接加热,并且有氧合器加热循环泵71(设置在水浴箱10内部或者外部)将水浴箱10内温水抽出,对氧合器5进行循环加热,提高加热效率。在另一个实施方式中,温度维持装置4选用压缩机、冰块或者超低温剂等形式,维持储液仓3、器官仓2及其内的生物体器官1的低温。As shown in Figure 2, the basic working principle of the device is as follows: the biological organ 1 is placed in the organ compartment 2, and the temperature is maintained by the temperature maintenance device 4 outside the organ compartment 2 (the organ compartment 2 is placed in the temperature maintenance device 4), and the cycle The perfusion fluid (including blood or non-cellular circulating fluid, etc.) is refluxed and stored in the liquid storage tank 3, which is located below the organ tank 2. The organ bin shelf 58 of the organ bin 2 has through holes, so that the organ bin 2 and the liquid storage bin 3 are physically connected, so that the perfusion fluid flows out from the biological organ 1 and flows back to the liquid storage bin 3 in the lower layer of the organ bin. In one embodiment (as shown in Figures 6 and 7), the temperature maintaining device 4 is in the form of a water bath box 10, which can not only directly heat the organ compartment 2 immersed in the water bath box 10, but also has an oxygenator heating cycle The pump 71 (installed inside or outside the water bath tank 10) pumps out the warm water in the water bath tank 10, and circulates heating of the oxygenator 5, thereby improving the heating efficiency. In another embodiment, the temperature maintaining device 4 uses compressors, ice cubes or ultra-low temperature agents to maintain the low temperature of the liquid storage tank 3, the organ tank 2 and the biological organs 1 therein.
在泵7的驱动下,储液仓3中的循环灌注液进入滤栓器6,过滤掉其中的杂质及气泡;然后经过氧合器5进行氧合;再通过循环管路8、血管插管9,进入器官仓2中的生物体器官1的主动脉系统,然后利用主动脉的不同分支对多个器官同时进行灌注;最后,循环灌注液等经过生物体器官1的静脉端流出,被收集回流集中在储液仓3,如此往复形成循环灌注。Driven by the pump 7, the circulating perfusate in the liquid storage tank 3 enters the thrombus filter 6 to filter out impurities and bubbles; then it passes through the oxygenator 5 for oxygenation; and then passes through the circulation line 8, the vascular cannula 9. Enter the aortic system of the organ 1 in the organ warehouse 2, and then use different branches of the aorta to simultaneously perfuse multiple organs; finally, the circulating perfusion fluid flows out through the venous end of the organ 1 and is collected The backflow is concentrated in the liquid storage tank 3, so that cyclic perfusion is formed.
循环顺序依次为器官仓2内的生物体器官1—储液仓3—滤栓器6—泵7—氧合器5—灌注管路8(血管插管9)—器官仓2内的生物体器官1。灌注管路8连接各主要部件。The sequence of circulation is: Organ 1 in organ compartment 2—liquid storage compartment 3—thrombus filter 6—pump 7—oxygenator 5—perfusion line 8 (vascular cannula 9)—organism in organ compartment 2 Organ 1. The perfusion pipeline 8 connects the main components.
本发明的器官保存装置通过腹部主动脉或胸主动脉系统同时灌注多个器官,其中肝脏门静脉76无需插管,通过门静脉系统回流的循环灌注液进行灌注。其中肺动脉无需插管,通过右心的循环灌注液进行灌注。The organ preservation device of the present invention simultaneously perfuses multiple organs through the abdominal aorta or thoracic aorta system, in which the liver portal vein 76 does not need to be cannulated, and is perfused with the circulating perfusate returned from the portal vein system. The pulmonary artery does not need to be cannulated and is perfused with the circulating perfusion fluid of the right heart.
可选地,血管插管9位于灌注管路8末端,连接生物体器官1的附属血管,进行灌注。Optionally, the vascular cannula 9 is located at the end of the perfusion pipeline 8 and is connected to the accessory blood vessels of the organ 1 for perfusion.
可选地,血管插管9在主动脉系统内的不同分支对应位置,具有相应侧孔,内径与之匹配,可更加准确地灌注相应器官。Optionally, the blood vessel cannula 9 has corresponding side holes at corresponding positions of different branches in the aortic system, and the inner diameter is matched with it, so that the corresponding organs can be perfused more accurately.
如图3所示,使用本装置时,首先,生物体器官1及其附属血管被放置在器官仓2内,所有器官按照正常解剖结构排列。然后,腹主动脉28的两端分别被近端腹主动脉阻断结扎线23、远端腹主动脉阻断结扎线27结扎,循环管路8(可选地,末端连接血管插管9)插入腹主动脉28后被结扎线固定。循环灌注液被泵7驱动加压,通过循环管路8(可选地,末端连接血管插管9)注入腹主动脉28,然后通过腹主动脉分支灌注各器官。其中,通过肾动脉33对双侧肾脏75进行灌注;通过腹腔干24分支肝固有动脉31对肝脏30进行动脉灌注;并通过腹腔干24分支脾动脉25对脾脏72进行灌注;通过肠系膜上动脉26、肠系膜下动脉81对肠道74进行动脉灌注;肠道74的静脉回流肠系膜上静脉78及肠系膜下静脉79,脾脏72的静脉回流脾静脉77,胃73的静脉回流胃网膜右静脉80,共同在脾静脉、肠系膜上静脉与门静脉汇合处32汇合,共同通过门静脉76对肝脏进行灌注,因此门静脉76无需插管即可实现灌注。本装置仅通过单根管对腹主动脉28及其分支灌注,即可完成对全腹腔脏器的灌注。所有循环灌注液通过下腔静脉系统的肝上下腔静脉29及肝下下腔静脉34回流到器官仓2及储液仓3,然后在泵7的驱动下,储液仓3中的循环灌注液进入滤栓器6,过滤掉其中的杂质及气泡;然后经过氧合器5进行氧合;再通过循环管路8(可选地,末端连接血管插管9),进入器官仓2中的生物体器官1的主动脉系统,然后利用主动脉的不同分支对多个器官同时进行灌注,如此循环往复;As shown in Figure 3, when using this device, first, the biological organ 1 and its accessory blood vessels are placed in the organ compartment 2, and all organs are arranged in accordance with the normal anatomical structure. Then, both ends of the abdominal aorta 28 are ligated by the proximal abdominal aorta blocking ligature 23 and the distal abdominal aortic blocking ligature 27, respectively, and the circulation line 8 (optionally, the end is connected to a blood vessel cannula 9) After insertion into the abdominal aorta 28, it is fixed by a ligature. The circulating perfusate is driven and pressurized by the pump 7, and is injected into the abdominal aorta 28 through the circulation line 8 (optionally connected to the vascular cannula 9 at the end), and then perfusion of various organs through the branches of the abdominal aorta. Among them, the bilateral kidney 75 is perfused through the renal arteries 33; the liver 30 is perfused through the 24 branches of the abdominal trunk proper hepatic artery 31; the spleen 72 is perfused through the 24 branches of the abdominal trunk splenic artery 25; and the spleen 72 is perfused through the superior mesenteric artery 26 The inferior mesenteric artery 81 is arterially perfused into the intestine 74; the venous return of the intestine 74 is the superior mesenteric vein 78 and the inferior mesenteric vein 79, the venous return of the spleen 72 is the splenic vein 77, and the venous return of the stomach 73 is the right gastromental vein 80, The splenic vein, superior mesenteric vein, and portal vein converge together at the confluence 32, and the liver is perfused through the portal vein 76, so the portal vein 76 can be perfused without intubation. The device can perfuse the abdominal aorta 28 and its branches only through a single tube to complete the perfusion of the entire abdominal organs. All the circulating perfusate flows back to the organ compartment 2 and the reservoir 3 through the superior and inferior hepatic vena cava 29 and the inferior inferior vena cava 34 of the inferior vena cava system, and then the circulating perfusion solution in the reservoir 3 is driven by the pump 7 Enter the thrombus filter 6 to filter out impurities and bubbles; then pass through the oxygenator 5 for oxygenation; and then pass through the circulation line 8 (optionally connected to the vascular cannula 9 at the end) to enter the organism in the organ compartment 2 The aortic system of body organ 1, then uses different branches of the aorta to simultaneously perfuse multiple organs, and so on;
本装置可通过胸主动脉系统同时灌注多个胸部器官,其中肺动脉无需插管,通过右心的循环灌注液进行灌注。The device can simultaneously perfuse multiple thoracic organs through the thoracic aortic system, wherein the pulmonary artery does not need to be intubated, and is perfused through the circulating perfusion fluid of the right heart.
可选地,血管插管9位于灌注管路8末端,连接生物体器官1的附属血管,进行灌注。Optionally, the vascular cannula 9 is located at the end of the perfusion pipeline 8 and is connected to the accessory blood vessels of the organ 1 for perfusion.
可选地,血管插管9在主动脉系统内的不同分支对应位置,具有相应侧孔,内径与之匹配,可更加准确地灌注相应器官。Optionally, the blood vessel cannula 9 has corresponding side holes at corresponding positions of different branches in the aortic system, and the inner diameter is matched with it, so that the corresponding organs can be perfused more accurately.
可选地,本发明的装置可用于体外机械灌注保存人体器官,用于多器官保存,发挥其关键互相保护作用,保存同时修复、评估器官活力。Optionally, the device of the present invention can be used for extracorporeal mechanical perfusion to preserve human organs, for multi-organ preservation, to play its key mutual protective effect, to preserve and to repair and evaluate organ vitality.
可选地,本发明的装置用猪或羊等动物器官,体外机械灌注,恢复器官活力,最大程度模拟人体器官,进行医学培训。Optionally, the device of the present invention uses animal organs such as pigs or sheep to be mechanically perfused outside of the body to restore organ vitality, simulate human organs to the greatest extent, and conduct medical training.
第二实施方式Second embodiment
下面参照图4-10描述本发明的第二实施方式,进一步细化器官仓2、储液仓3、温度维持装置4、氧合器5及滤栓器6组件的结构和原理。The second embodiment of the present invention will be described below with reference to FIGS. 4-10 to further detail the structure and principle of the organ bin 2, the liquid storage bin 3, the temperature maintaining device 4, the oxygenator 5, and the plug filter 6.
如图4所示,器官仓2底部具有器官仓搁板58,开有若干孔,与下部的储液仓3(见图2)相通,便于灌注循环液回流至储液仓3。器官仓2内侧设置有回流管路60,回流管路60一端通向储液仓3,另一端连接循环管路8。优选地,储液仓3的底面是倾斜的,朝着回流管路60接入处倾斜,便于维持较高液面高度,不仅便于收集循环液,而且可防止回流管路60吸入空气。器官仓2的外壁设置有氧合器加热循环接口63,用于抽吸循环器官仓2下方的储液仓3中的温水,通过氧合器5对循环灌注液进行加热。氧合器加热循环接口63与器官仓2不相通,与水浴箱10(下面详述)相通。As shown in FIG. 4, the bottom of the organ warehouse 2 is provided with an organ warehouse shelf 58 with a number of holes that communicate with the lower liquid storage warehouse 3 (see FIG. 2) to facilitate the perfusion circulation fluid to flow back to the liquid storage warehouse 3. A return line 60 is provided inside the organ bin 2, one end of the return line 60 leads to the liquid storage bin 3, and the other end is connected to the circulation line 8. Preferably, the bottom surface of the liquid storage tank 3 is inclined toward the inlet of the return line 60 to facilitate maintaining a high liquid level, which not only facilitates the collection of circulating fluid, but also prevents the return line 60 from inhaling air. The outer wall of the organ bin 2 is provided with an oxygenator heating circulation interface 63 for sucking warm water in the liquid storage bin 3 below the circulating organ bin 2 and heating the circulating perfusate through the oxygenator 5. The oxygenator heating circulation interface 63 is not connected to the organ compartment 2 but is connected to the water bath box 10 (detailed below).
器官仓2的侧壁上设置有膈肌悬挂14,用于悬挂膈肌22(见图1),膈肌悬挂14为从器官仓2的内壁向内突出的凸起,可以设置多个膈肌悬挂14。膈肌挂钩14用于将生物体器官1的膈肌部分固定并悬挂,最大程度还原肝脏在腹腔内解剖位置。The side wall of the organ compartment 2 is provided with a diaphragm suspension 14 for suspending the diaphragm 22 (see FIG. 1). The diaphragm suspension 14 is a protrusion protruding inward from the inner wall of the organ compartment 2, and multiple diaphragm suspensions 14 can be provided. The diaphragm hook 14 is used to fix and hang the diaphragm part of the biological organ 1 to maximize the anatomical position of the liver in the abdominal cavity.
如图5-图7所示,本发明的装置包括:器官仓2、水浴箱10(作为温度维持装置4可选方式)、泵7、氧合器5、滤栓器6、回流管路60、血管插管连接部64及血管插管9。其中,灌注管路8的回流端连接回流管路60,灌注端连接血管插管连接部64及血管插管9,灌注管路8中间连接泵7、氧合器5及滤栓器6等部件。生物体器官1放置在器官仓2内的器官仓搁板58上,一起浸入水浴箱10维持体温环境,膈肌挂钩14用于将生物体器官1的膈肌部分固定并悬挂,最大程度还原腹腔内解剖位置。可选地,器官仓2的器官搁板58可由金属制成,作为高频电刀15的负极板,以便使用高频电刀15。As shown in Figures 5-7, the device of the present invention includes: organ compartment 2, water bath box 10 (as an optional method of temperature maintaining device 4), pump 7, oxygenator 5, filter plug 6, return line 60 , The vascular cannula connecting portion 64 and the vascular cannula 9. Among them, the return end of the perfusion line 8 is connected to the return line 60, the perfusion end is connected to the vascular cannula connecting portion 64 and the vascular cannula 9, and the middle of the perfusion line 8 is connected to components such as pump 7, oxygenator 5, and thrombus filter 6. . The biological organ 1 is placed on the organ compartment shelf 58 in the organ compartment 2 and immersed in the water bath 10 to maintain the body temperature environment. The diaphragm hook 14 is used to fix and hang the diaphragm of the biological organ 1 to maximize the restoration of the abdominal anatomy position. Optionally, the organ shelf 58 of the organ compartment 2 may be made of metal, which serves as the negative plate of the high-frequency electrosurgical knife 15 in order to use the high-frequency electrosurgical knife 15.
循环灌注液在泵7的加压驱动下,通过血管插管9进入生物体器官1的腹主动脉或胸主动脉系统,同时灌注腹腔或者胸腔多个器官,门静脉76无需插管,依赖从脾动脉25灌注至脾脏72的回流灌注液,肠系膜上动脉26灌注至肠道74的回流灌注液,在脾静脉、肠系膜上静脉与门静脉汇合处32汇合后进行灌注。肺动脉无需插管,通过右心的循环灌注液进行灌注。其后循环灌注液通过生物体器官1的下腔静脉流出,通过器官仓搁板58的多孔结构集中回流至器官仓2下部的储液仓3;其后在泵7的驱动下,储液仓3内的循环液通过回流管路60被抽出流向滤栓器6,过滤掉循环液中混杂的血栓和气栓;然后经过滤栓器6的出口通过灌注管路8经过泵7,其后通过灌注管路8进入氧合器5,对循环液进行氧合;再由氧合器5的出口进入血管插管连接部64,再经过血管插管连接部64进入血管插管9,如此往复完成循环灌注过程。The circulating perfusate is driven by the pressure of the pump 7 and enters the abdominal aorta or thoracic aorta system of the organism 1 through the vascular cannula 9, and perfuses multiple organs in the abdominal or thoracic cavity at the same time. The portal vein 76 does not need to be intubated and depends on the spleen The arterial 25 is infused into the reflux perfusion fluid of the spleen 72, and the superior mesenteric artery 26 is perfused into the intestinal intestinal 74. The perfusion is performed after the confluence of the splenic vein, superior mesenteric vein and portal vein 32. The pulmonary artery does not need to be cannulated and is perfused with the circulating perfusion fluid of the right heart. Thereafter, the circulating perfusate flows out through the inferior vena cava of the biological organ 1, and flows back to the reservoir 3 in the lower part of the organ bin 2 through the porous structure of the organ bin shelf 58; then, driven by the pump 7, the reservoir The circulating fluid in 3 is drawn out through the return line 60 to flow to the plug filter 6 to filter out the thrombus and air clots mixed in the circulating fluid; then through the outlet of the plug filter 6 through the perfusion line 8 through the pump 7, and then through the perfusion The pipeline 8 enters the oxygenator 5 to oxygenate the circulating fluid; then enters the vascular cannula connection portion 64 from the outlet of the oxygenator 5, and then enters the vascular cannula 9 through the vascular cannula connection portion 64, thus completing the cycle reciprocally Perfusion process.
如图6-图9所示,器官仓2和储液仓3放置在温度维持装置4内,温度维持装置4包括水浴箱10和温度控制器42。温度维持通过两种途径,第一种途径,水浴箱10内承装的是温水直接将器官仓2、储液仓3及生物体器官1加热。第二种途径,通过设置氧合器加热循环泵71将水浴箱10内的温水通过氧合器加热循环接口63抽吸,进入氧合器加热器65内,氧合器加热器65位于氧合器5下方,以加热氧合器5内的循环液。As shown in FIGS. 6-9, the organ bin 2 and the liquid storage bin 3 are placed in a temperature maintaining device 4, and the temperature maintaining device 4 includes a water bath box 10 and a temperature controller 42. There are two ways to maintain the temperature. In the first way, warm water is contained in the water bath 10 to directly heat the organ compartment 2, the liquid storage compartment 3, and the biological organ 1. The second way is to set the oxygenator heating circulation pump 71 to suck the warm water in the water bath tank 10 through the oxygenator heating circulation interface 63 into the oxygenator heater 65, which is located in the oxygenator. Below the device 5 to heat the circulating fluid in the oxygenator 5.
温度控制器42可以控制水浴箱10的温度,温度控制器42可以控制电加热装置加热水浴箱10内的水。The temperature controller 42 can control the temperature of the water bath box 10, and the temperature controller 42 can control the electric heating device to heat the water in the water bath box 10.
氧合器5及滤栓器6被集中放置在氧合器及滤栓器外壳54内,相应循环管路8规则分布在外壳54中,便于快速安装及更换;可选地,除泵7以外,器官仓2、储液仓3、氧合器5、滤栓器6、灌注管路8及血管插管9、回流管路60等部件可为一次性使用,便于快速更换。The oxygenator 5 and the plug filter 6 are centrally placed in the housing 54 of the oxygenator and plug filter, and the corresponding circulation pipelines 8 are regularly distributed in the housing 54 for quick installation and replacement; optionally, except for the pump 7 , The organ warehouse 2, the liquid storage warehouse 3, the oxygenator 5, the thrombus filter 6, the perfusion pipeline 8, the vascular cannula 9, the return pipeline 60 and other components can be used for one time, which is convenient for quick replacement.
再次参考如图6,温度传感器68设置在器官仓2内部,用于监测器官仓2内的生物体器官1的温度。流量传感器66设置在回流管路60及血管插管连接部64上,用于监测流过回流管路60及血管插管连接部64循环灌注液的流量。压力传感器69设置在血管插管连接部64上,其中血管插管连接部64末端连接有血管插管9。压力传感器69用于监测血管插管连接部64处的压力,也就是监测要输送到血管插管9的循环灌注液的压力。气泡传感器85用于监测灌注管路8内气泡。Referring again to FIG. 6, the temperature sensor 68 is arranged inside the organ compartment 2 for monitoring the temperature of the biological organ 1 in the organ compartment 2. The flow sensor 66 is arranged on the return line 60 and the vascular cannula connection portion 64 for monitoring the flow of the perfusion fluid circulating through the return line 60 and the vascular cannula connection portion 64. The pressure sensor 69 is arranged on the blood vessel cannula connection portion 64, wherein the blood vessel cannula 9 is connected to the end of the blood vessel cannula connection portion 64. The pressure sensor 69 is used to monitor the pressure at the vascular cannula connection portion 64, that is, to monitor the pressure of the circulating perfusate to be delivered to the vascular cannula 9. The air bubble sensor 85 is used to monitor air bubbles in the perfusion line 8.
再次参考图6,本发明的器官灌注保存装置还包括灌注管路钳制阀70,其设置在灌注管路8上,图中显示为设置在泵7输入端附近,灌注管路钳制阀 70关闭能够快速停止灌注管路8的循环灌注,避免出现异常时损坏生物体器官1。6 again, the organ perfusion preservation device of the present invention also includes a perfusion line clamp valve 70, which is arranged on the perfusion line 8. The figure shows that it is arranged near the input end of the pump 7. The perfusion line clamp valve 70 can be closed. The circulatory perfusion of the perfusion line 8 is quickly stopped to avoid damage to the biological organ 1 when abnormalities occur.
如图10所示,本发明的器官灌注保存装置还包括电子控制系统,所述电子控制系统由低压直流电源82供电。所述电子控制系统包括控制器67和控制面板及显示屏83。图10显示了该电子控制系统的电路原理图。其中,本发明的装置可以配有升降柱43,升降柱43安装在储液仓3下方,可以抬升储液仓3(连同器官仓2)的高度。本发明的装置还包括温度传感器68、流量传感器66、压力传感器69及气泡传感器85,上述传感器的信号传入控制器67分析处理后,通过控制器67控制温度维持装置4的温度,控制泵7的转速以防止灌注压力或流量异常,控制灌注管路钳制阀70开合状态,在装置发生异常情况时通过警报装置84进行及时警报,警报可以在控制面板及显示屏83上显示。As shown in FIG. 10, the organ perfusion preservation device of the present invention further includes an electronic control system, and the electronic control system is powered by a low-voltage DC power supply 82. The electronic control system includes a controller 67, a control panel and a display screen 83. Figure 10 shows the schematic circuit diagram of the electronic control system. Among them, the device of the present invention may be equipped with a lifting column 43, which is installed under the liquid storage bin 3, and can raise the height of the liquid storage bin 3 (together with the organ bin 2). The device of the present invention also includes a temperature sensor 68, a flow sensor 66, a pressure sensor 69, and a bubble sensor 85. After the signals of the sensors are transmitted to the controller 67 for analysis and processing, the controller 67 controls the temperature of the temperature maintaining device 4 and controls the pump 7. To prevent abnormal perfusion pressure or flow rate, control the opening and closing state of the perfusion pipeline clamp valve 70, and provide timely alarm through the alarm device 84 when an abnormal situation occurs in the device. The alarm can be displayed on the control panel and the display 83.
如图11所示,本发明的系统还具有胆汁收集计量装置16,尿液收集计量装置17,用以收集胆汁、尿液,动态观察器官活力。As shown in Fig. 11, the system of the present invention also has a bile collection and measurement device 16 and a urine collection and measurement device 17 for collecting bile and urine and dynamically observing organ vitality.
以上所述的实施例,只是本发明较优选的具体实施方式,本领域的技术人员在本发明技术方案范围内进行的通常变化和替换都应包含在本发明的保护范围内。The above-mentioned embodiments are only preferred specific implementations of the present invention, and the usual changes and substitutions made by those skilled in the art within the scope of the technical solution of the present invention should be included in the protection scope of the present invention.

Claims (15)

  1. 一种生物体器官的机械灌注保存装置,其特征在于,包括:A mechanical perfusion preservation device for biological organs, which is characterized in that it comprises:
    器官仓(2):用于容纳生物体器官及附属血管;Organ warehouse (2): used to house the organs and accessory blood vessels;
    储液仓(3):位于所述器官仓(2)下方,用于存储循环灌注液;Liquid storage bin (3): located below the organ bin (2), used to store circulating perfusion fluid;
    温度维持装置(4):用于维持生物体器官及循环液的温度;Temperature maintenance device (4): used to maintain the temperature of biological organs and circulating fluid;
    氧合器(5):用于将循环灌注液持续氧合;Oxygenator (5): used to continuously oxygenate the circulating perfusate;
    滤栓器(6):用于过滤循环灌注液;Plug filter (6): used to filter circulating perfusate;
    泵(7):对循环灌注液进行加压;Pump (7): pressurize the circulating perfusate;
    灌注管路(8):依次连接储液仓(3)、滤栓器(6)及氧合器(5),并在泵(7)的驱动下,对所述生物体器官进行加压、循环灌注;Perfusion pipeline (8): connect the reservoir (3), the plug filter (6) and the oxygenator (5) in sequence, and pressurize the biological organs under the drive of the pump (7). Circulation perfusion
    所述机械灌注保存装置能够对生物体的主动脉系统进行加压、循环灌注,能够同时灌注单个或多个生物体器官。The mechanical perfusion preservation device can pressurize and circulate the aortic system of an organism, and can perfuse a single or multiple organism organs at the same time.
  2. 根据权利要求1所述的灌注保存装置,其特征在于,The perfusion preservation device according to claim 1, wherein:
    所述机械灌注保存装置能够通过腹主动脉系统同时灌注多个腹部器官,其中肝脏门静脉(76)无需插管,通过门静脉系统回流的循环灌注液进行灌注。The mechanical perfusion preservation device can simultaneously perfuse multiple abdominal organs through the abdominal aortic system, wherein the liver portal vein (76) does not need to be cannulated, and is perfused with the circulating perfusion fluid returned from the portal vein system.
  3. 根据权利要求1所述的灌注保存装置,其特征在于,The perfusion preservation device according to claim 1, wherein:
    所述机械灌注保存装置能够通过胸主动脉系统同时灌注多个胸部器官,其中肺动脉无需插管,通过右心的循环灌注液进行灌注。The mechanical perfusion preservation device can simultaneously perfuse multiple thoracic organs through the thoracic aortic system, wherein the pulmonary artery does not need to be intubated, and is perfused with the circulating perfusion fluid of the right heart.
  4. 根据权利要求1所述的灌注保存装置,其特征在于,还包括:The perfusion preservation device according to claim 1, further comprising:
    血管插管(9),所述血管插管(9)位于灌注管路(8)末端,用于连接生物体器官(1)附属血管进行灌注。The blood vessel cannula (9) is located at the end of the perfusion pipeline (8) and is used to connect the accessory blood vessels of the biological organ (1) for perfusion.
  5. 根据权利要求4所述的灌注保存装置,其特征在于,The perfusion preservation device according to claim 4, wherein:
    血管插管(9)具有相应侧孔,所述侧孔的内径与血管插管(9)在主动脉系统内的不同分支对应的位置及内径相匹配。The blood vessel cannula (9) has a corresponding side hole, and the inner diameter of the side hole is matched with the corresponding positions and inner diameters of the different branches of the blood vessel cannula (9) in the aortic system.
  6. 根据权利要求1所述的灌注保存装置,其特征在于,The perfusion preservation device according to claim 1, wherein:
    所述温度维持装置(4)为水浴箱(10),所述器官仓(2)和所述储液仓(3)放置在所述水浴箱(10)内。The temperature maintaining device (4) is a water bath box (10), and the organ warehouse (2) and the liquid storage warehouse (3) are placed in the water bath box (10).
  7. 根据权利要求6所述的灌注保存装置,其特征在于,还包括:The perfusion preservation device according to claim 6, further comprising:
    氧合器加热循环泵(71),其用于将水浴箱(10)内温水抽出,来对氧合器(5)进行循环加热。The oxygenator heating circulation pump (71) is used for pumping out warm water in the water bath (10) to heat the oxygenator (5) in circulation.
  8. 根据权利要求6所述的灌注保存装置,其特征在于,还包括:The perfusion preservation device according to claim 6, further comprising:
    温度维持装置(4)包括温度控制器(42),温度控制器(42)能够控制所述水浴箱(10)的温度。The temperature maintaining device (4) includes a temperature controller (42), and the temperature controller (42) can control the temperature of the water bath (10).
  9. 根据权利要求1所述的灌注保存装置,其特征在于,还包括:The perfusion preservation device according to claim 1, further comprising:
    温度维持装置(4)为压缩机、冰块或者超低温剂,用于维持储液仓(3)、器官仓(2)及生物体器官的低温。The temperature maintaining device (4) is a compressor, ice cubes or ultra-low temperature agent, which is used to maintain the low temperature of the liquid storage tank (3), the organ tank (2) and the biological organs.
  10. 根据权利要求6所述的灌注保存装置,其特征在于,还包括:The perfusion preservation device according to claim 6, further comprising:
    温度传感器(68),用于监测储液仓(3)内的循环灌注液及生物体器官的温度;The temperature sensor (68) is used to monitor the temperature of the circulating perfusion fluid and the biological organs in the liquid storage tank (3);
    流量传感器(66),用于监测灌注管路(8)内的循环灌注液的流量;A flow sensor (66) for monitoring the flow of the circulating perfusion liquid in the perfusion pipeline (8);
    压力传感器(69),用于监测灌注管路(8)内的循环灌注液的压力;A pressure sensor (69) for monitoring the pressure of the circulating perfusion liquid in the perfusion pipeline (8);
    气泡传感器(85),用于监测灌注管路(8)内是否有气泡。The bubble sensor (85) is used to monitor whether there are bubbles in the perfusion pipeline (8).
  11. 根据权利要求10所述的灌注保存装置,其特征在于,还包括:The perfusion preservation device according to claim 10, further comprising:
    控制器(67),其收集温度传感器(68)的信号,并基于所述信号控制温度维持装置(4)。The controller (67) collects the signal of the temperature sensor (68) and controls the temperature maintaining device (4) based on the signal.
  12. 根据权利要求10所述的灌注保存装置,其特征在于,还包括:The perfusion preservation device according to claim 10, further comprising:
    控制器(67),其收集流量传感器(66)和压力传感器(69)的信号,并基于所述信号控制泵(7)。The controller (67) collects the signals of the flow sensor (66) and the pressure sensor (69), and controls the pump (7) based on the signals.
  13. 根据权利要求10所述的灌注保存装置,其特征在于,还包括:The perfusion preservation device according to claim 10, further comprising:
    控制器(67),其收集流量传感器(66)、压力传感器(69)和气泡传感器(85)的信号,并基于所述信号控制灌注管路钳制阀(70),所述灌注管路钳制阀(70)能够停止灌注管路(8)的灌注。The controller (67) collects the signals of the flow sensor (66), the pressure sensor (69) and the air bubble sensor (85), and controls the perfusion line clamp valve (70) based on the signals (70) The filling of the filling line (8) can be stopped.
  14. 根据权利要求1所述的灌注保存装置,其特征在于,The perfusion preservation device according to claim 1, wherein:
    所述器官仓(2)底部具有器官仓搁板(58),器官仓搁板(58)具有通孔与所述储液仓(3)相通。The bottom of the organ bin (2) is provided with an organ bin shelf (58), and the organ bin shelf (58) has a through hole communicating with the liquid storage bin (3).
  15. 根据权利要求1所述的灌注保存装置,其特征在于,还包括:The perfusion preservation device according to claim 1, further comprising:
    收集胆汁的胆汁收集计量装置(16)和收集尿液的尿液收集计量装置(17),以动态观察生物体器官(1)的活力。The bile collecting and measuring device (16) for collecting bile and the urine collecting and measuring device (17) for collecting urine are used to dynamically observe the vitality of the biological organ (1).
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