WO2020192511A1 - 一种器官灌注教学培训系统 - Google Patents

一种器官灌注教学培训系统 Download PDF

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Publication number
WO2020192511A1
WO2020192511A1 PCT/CN2020/079872 CN2020079872W WO2020192511A1 WO 2020192511 A1 WO2020192511 A1 WO 2020192511A1 CN 2020079872 W CN2020079872 W CN 2020079872W WO 2020192511 A1 WO2020192511 A1 WO 2020192511A1
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Prior art keywords
perfusion
organ
organs
biological
circulating
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PCT/CN2020/079872
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English (en)
French (fr)
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 WO2020192511A1 publication Critical patent/WO2020192511A1/zh

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    • GPHYSICS
    • G09EDUCATION; CRYPTOGRAPHY; DISPLAY; ADVERTISING; SEALS
    • G09BEDUCATIONAL OR DEMONSTRATION APPLIANCES; APPLIANCES FOR TEACHING, OR COMMUNICATING WITH, THE BLIND, DEAF OR MUTE; MODELS; PLANETARIA; GLOBES; MAPS; DIAGRAMS
    • G09B23/00Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes
    • G09B23/28Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes for medicine
    • G09B23/285Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes for medicine for injections, endoscopy, bronchoscopy, sigmoidscopy, insertion of contraceptive devices or enemas

Definitions

  • the invention relates to a medical teaching and training system, and more specifically, to an organ perfusion teaching and training system.
  • This device can be used for mechanical perfusion preservation of large animal organs.
  • the organ and blood of pigs obtained from the slaughterhouse can be used to connect to this machine for experiments. It not only avoids ethical review, but also avoids the cycle of laboratory application and ethical application.
  • the experimental cost is cheaper, the number of organs is more abundant, and man-made interference factors such as surgical techniques are avoided, and the expensive cost of establishing a large animal laboratory is avoided.
  • One-step large-scale, high-efficiency greatly shorten the experiment cycle, greatly reduce the cost of the experiment, and reduce the interference factors to create the necessary conditions.
  • 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 prior art simulated human body device 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.
  • 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 an organ perfusion teaching and training system, which includes:
  • 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
  • Perfusion pipeline connect the liquid storage tank and the accessory blood vessels of the biological organs, and pressurize and circulate the biological organs and the accessory blood vessels under the drive of the pump;
  • Display used to display operating images
  • Base used to support, move and lift the overall device
  • the organ perfusion preservation device can pressurize and circulate the aortic system of a living body, and can perfuse single or multiple organs of the living body at the same time.
  • the organ 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 perfusion fluid returned from the portal vein system.
  • the organ 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 the pulmonary artery is perfused with the circulating perfusion fluid of the right heart.
  • system further includes: an oxygenator: used to continuously oxygenate the circulating perfusion liquid; and a plug filter: used to filter the circulating perfusion liquid.
  • the system further includes: an upper cover: for closing the organ compartment and a temperature maintaining device; a lifting column, the lifting column can adjust the height of the operating platform, wherein the operating platform supports the housing and the upper cover; and a display bracket, Used to support the monitor.
  • the system further includes: abdomen bulge, the abdomen bulge is arranged on the upper cover for simulating the human abdomen bulge, the abdomen bulge is provided with a minimally invasive instrument or an endoscopic entrance, a digestive tract operation approach, and a minimally invasive instrument Or the entrance of the endoscope is for the entry of minimally invasive surgical instruments, and the access of the digestive tract is for the entry of the soft endoscope.
  • the digestive tract operation approach includes an esophageal entrance and a rectal entrance, the esophageal entrance is used for the upper digestive tract endoscopic device to enter, and the rectal entrance is used for collecting excretion waste or for the digestive tract endoscopic device to enter.
  • an internal lighting lamp is arranged in the abdominal bulge, and a miniature exhaust fan is arranged on the upper cover facing the abdominal bulge.
  • a minimally invasive instrument gimbal arm fixing seat is arranged around the upper cover for fixing the gimbal bracket.
  • the universal bracket includes: a camera rod fixing hole, a camera rod fixing handle, and a universal structure locking handle.
  • the system further includes: a temperature temperature sensor for monitoring the temperature of the circulating perfusate in the liquid storage tank and the temperature of the biological organ 1; a flow sensor for monitoring the flow of the circulating perfusate in the perfusion pipeline; a pressure sensor , Used to monitor the pressure of the circulating perfusate in the perfusion pipeline.
  • the system also includes: a tablet computer host, a tablet computer host) having: a basic information database that records basic operator information; an operation scoring system that can collect the following parameters for quantitative evaluation: bleeding volume, operation time, and tremor And difficulty index; video and storage system, used to record and replay the operation video; network connection function, used to realize the device network connection and monitoring; can display information on the control panel and display screen.
  • a tablet computer host a tablet computer host having: a basic information database that records basic operator information; an operation scoring system that can collect the following parameters for quantitative evaluation: bleeding volume, operation time, and tremor And difficulty index; video and storage system, used to record and replay the operation video; network connection function, used to realize the device network connection and monitoring; can display information on the control panel and display screen.
  • system further includes: a controller configured to collect signals from a temperature sensor, a flow sensor, and a pressure sensor, and after analysis and processing, the following control can be performed:
  • the control panel and display screen display the status of the controller, and can manually adjust related parameters.
  • a minimally invasive equipment warehouse an oxygen cylinder, a bile collection and measurement device, and/or a urine collection and measurement device are provided on the base.
  • 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 medical minimally invasive training (laparoscopy, natural cavity endoscopy, surgical robots, digestive endoscopy, etc.), using a simple structure of single-intubation aortic system to circulate and perfuse multiple organs, and using large abandoned slaughterhouses Animal organs are perfused and preserved in vitro, using blood or cell-free circulating perfusion fluid to replenish energy substrates and carry oxygen to maintain organ vitality without destroying the anatomical structure of abdominal or thoracic organs, helping doctors master conventional operations or micro
  • the basic operation of innovative technology While it is close to the effect of large animal experiments to the greatest extent, it has obvious advantages such as significant cost reduction, avoiding ethical problems, and the existence of anatomical variation, maintaining a complete anatomical structure, maintaining vitality of organs, and bleeding after injury.
  • Figure 1 is a schematic plan view of the basic structure of the organ perfusion preservation device of the system of the present invention.
  • Figure 2 is a three-dimensional schematic diagram of the organ perfusion preservation device of the system of the present invention.
  • Fig. 3 is a schematic diagram of the principle of the organ perfusion preservation device of the system of the present invention.
  • Fig. 4 is a top view of the organ compartment of the organ perfusion preservation device of the system of the present invention.
  • Figure 5 is a top view of the core components of the organ perfusion preservation device of the system of the present invention.
  • Fig. 6 is a side view of the core components of the organ perfusion preservation device of the system of the present invention.
  • Figure 7 is an exploded view of the core components of the organ perfusion preservation device of the system of the present invention.
  • Figure 8 is the overall appearance of the oxygenator and plug filter assembly of the system of the present invention.
  • Figure 9 is a cross-sectional view of the oxygenator and plug filter assembly of the system of the present invention.
  • Figure 10 is a right perspective view of the entire system of the present invention.
  • Figure 11 is a left perspective view of the entire system of the present invention.
  • Figure 12 is an overall top view of the system of the present invention.
  • Figure 13 is a right side view of the overall system of the present invention.
  • Figure 14 is an overall rear view of the system of the present invention.
  • Fig. 15 is a right side perspective view of the system of the present invention with the upper cover open as a whole.
  • Fig. 16 is a left perspective view of the system of the present invention with the upper cover open as a whole.
  • Figure 17 is an overall top view of the system of the present invention with the upper cover open.
  • Figure 18 is the basic structure of the minimally invasive device entrance of the system of the present invention.
  • Figure 19 is the basic structure of the digestive endoscope entrance of the system of the present invention.
  • Figure 20 is the basic structure of the instrument hanging box of the system of the present invention.
  • Figure 21 is a schematic diagram of the camera rod universal bracket of the system of the present invention.
  • Figure 22 is a schematic diagram of the bile and urine collection device of the system of the present invention.
  • Figure 23 is a schematic diagram of the main structure of the rear part of the system of the present invention.
  • Figure 24 is a schematic diagram of the electronic control system of the system of the present invention.
  • the core component of the system of the present invention is a mechanical perfusion preservation device for biological organs.
  • the mechanical perfusion preservation device is described below with reference to Figs. 1-9.
  • 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 Used to maintain the overall temperature of the organ compartment 2, the liquid storage compartment 3 and the device;
  • the oxygenator 5 is used to oxygenate the circulating perfusion liquid, and the oxygenator 5 is connected with an oxygen cylinder 46;
  • the plug filter 6 is used to filter the circulating perfusion liquid Impurities such as thrombus, air bubbles, etc.; pump 7 is used for device perfusion power maintenance, pressurized perfusion and cyclic perfusion;
  • perfusion pipeline 8 is used to connect various key components; blood vessel cannula 9 is located at the end of perfusion pipeline 8 and connects biological organs 1.
  • the aortic system is pressurized and circulated.
  • 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 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 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 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 water bath box 10 is provided with an oxygenator heating circulation interface 63, and the oxygenator heating circulating pump 71 is used to suck warm water in the water bath box 10, and the oxygenator 5 heats the circulating perfusion liquid.
  • 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 unit, so as to use the high-frequency electrosurgical unit.
  • 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 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 system of the present invention will be described below with reference to FIGS. 10-24.
  • the system of the present invention is mainly used for medical minimally invasive training (surgical laparoscopy, natural cavity endoscopy, surgical robots, medical digestive endoscopy, etc.), using a simple structure of perfusing multiple organs with a single cannula in the aortic system.
  • Organs of large animal origin 1 obtained from pig farms are perfused and stored in vitro.
  • Using blood or cell-free circulating perfusion fluid 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 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 significant cost reduction, avoiding ethical issues, and the existence of anatomical variations, maintaining a complete normal anatomical structure, maintaining vitality of organs, and bleeding after operation injuries.
  • the overall structure of the system of the present invention can be divided into three parts: the upper part, the lower part, and the lifting column 43.
  • the upper part is the core component
  • the lower part is mainly the base and main accessories.
  • the upper part mainly includes the case shell 40 and the upper cover 55, as well as the core components inside them: biological organ 1, organ bin 2, water bath tank 10, pump 7, oxygenator 5, plug filter 6, circulation pipeline 8.
  • the upper part is also provided with a display 35, a display stand 36 supporting the display 35, abdomen bulge 37, a minimally invasive instrument or endoscope entrance 38, a tablet computer host 39, a water bath temperature controller 42, an instrument hanging box 45, etc.
  • a heater compartment 52 capable of accommodating the water bath box 10 is provided inside the cabinet shell 40.
  • the display 35 is used to display operation images or other operation information, and the display content of the display 35 comes from the operation images transmitted by the laparoscope or digestive endoscopy host in the minimally invasive equipment compartment 48, or the operation teaching video transmitted by the tablet computer host 39 .
  • the abdomen bulge 37 is arranged on the upper cover 55.
  • the abdomen bulge 37 includes, but is not limited to, round, oval, etc.
  • the abdominal bulge 37 is used to simulate the state of a human abdomen or a laparoscopic pneumoperitoneum.
  • the minimally invasive instrument or endoscope inlet 38 is provided on the abdominal bulge 37 and is used to accommodate laparoscopic instruments or endoscopic tubes.
  • An internal lighting lamp 56 is provided in the abdominal bulge 37 for lighting during operation.
  • the organ bin fixing knob 59 is used to fasten the organ bin 2 and fasten the organ bin 2 to the water bath box 10 to prevent the warm water buoyancy in the water bath box 10 below the organ bin 2 from causing the organ bin 2 to float.
  • a handle 44 is provided at the lower front of the chassis shell 40 for hanging an equipment hanging box 45, and the equipment hanging box 45 is used for accommodating training equipment for standby.
  • a minimally invasive instrument gimbal arm fixing seat 53 is provided around the upper cover 55 for fixing the gimbal bracket (including the camera rod fixing hole 18, the camera rod fixing handle 19, and the universal structure locking handle 20, as shown in Figure 21), It is used to adjust and tighten the camera rod of the minimally invasive device, which is convenient for one person to operate, instead of an assistant; at the front end of the upper cover 55, there is a micro exhaust fan 41 facing the abdominal bulge 37.
  • the micro exhaust fan 41 is used to exclude the organ compartment 2 and The water vapor generated by the evaporation of the water bath 10 and the smoke generated by the high-frequency electric knife burning the biological organ 1 during the operation.
  • the upper cover 55 has an upper cover hinge 62 that can be rotated to open and close.
  • the tablet host 39 has a basic information database that records basic information of the operator; it has an operation scoring system that can collect the following parameters for evaluation: bleeding volume, operation time, tremor, difficulty coefficient and other indicators.
  • the tablet host 39 has a video recording and storage system for recording and replaying operation videos.
  • the tablet host 39 has a network connection function to realize device networking.
  • the tablet host 39 can also be connected to an electronic control system, and has the functions of a control panel and a display screen 83, as described in the second part.
  • the lower part mainly takes the base 61 as the core, and a number of casters 49 are symmetrically distributed on the outer circumference.
  • the upper part of the base 61 is provided with a minimally invasive equipment compartment 48 and an electric knife compartment 47, and an oxygen cylinder 46 is provided at the rear of the base 61.
  • the minimally invasive equipment compartment 48 is used for accommodating the laparoscope or digestive endoscopy host
  • the electrosurgical unit 47 is used for accommodating high-frequency electrosurgical units.
  • the oxygen cylinder 46 is used for oxygen supply and is placed on the oxygen cylinder holder 57.
  • the outlet of the oxygen cylinder 46 is provided with an oxygen flow adjustment meter 51 for adjusting the gas output of the oxygen cylinder 46.
  • the height of the lifting column 43 can be adjusted, and the height of the operating surface of the machine can be adjusted to adapt to the height of different operators.
  • the upper cover 55 has a hinge 62 that can be rotated to open and close the upper cover, which is convenient to open the upper cover 55 and quickly replace consumables such as the organ compartment 2, oxygenator 5, and filter 6; 37 has internal lighting 56 inside.
  • the organ bin fixing knob 59 is used to fasten the organ bin 2 and fasten the organ bin 2 with the water bath box 10 to prevent the organ bin 2 from floating due to buoyancy, and maintain a sufficient contact area to improve the heat transfer efficiency.
  • the pump 7 is fixed inside the casing 40, and the oxygenator 5 and the plug filter 6 are collectively placed in the same casing 54 and fixed inside the casing 40.
  • the upper cover 55 has a minimally invasive instrument or an endoscope entrance 38, which is mainly a camera rod for laparoscopy training and a minimally invasive surgical instrument approach for training.
  • the specific structure of the minimally invasive instrument or endoscope entrance 38 includes: a screw cap 38-1, a silicone sealing sheet 38-2, and a screw base 38-3.
  • the screw cap 38-1 fastens the silicone sealing sheet 38-2 to the screw base 38-3, not only for sealing the upper cover, but also for simulating minimally invasive device puncture.
  • the upper cover 55 has a digestive tract operation approach 12, including the esophagus entrance 11 and the rectal entrance 13, which mainly simulate the structure of the human esophagus and anus for the entry of the soft endoscope for digestive endoscopy for training in digestive endoscopy training. It preferably includes an esophageal entrance 11 for the entry of devices such as upper gastrointestinal endoscopes such as gastroscopes; preferably includes a rectal entrance 13 for collecting excretion waste, or entry of digestive tract endoscopy devices such as colonoscopes.
  • the instrument hanging box 45 includes: an instrument insertion hole 45-1, a hook 45-2 and an instrument box main body 45-3.
  • the instrument box body 45-3 has a hollow structure, and the side has an instrument insertion hole 45-1 and a hook 45-2, and the hook 45-2 extends perpendicular to the instrument box body.
  • the hook 45-2 extends perpendicular to the instrument box body.
  • the equipment hanging box 45 can be hung on the handle 44 at the front of the teaching training device.
  • the camera rod universal bracket includes a camera rod fixing hole 18, a camera rod fixing handle 19 and a universal structure locking handle 20.
  • the camera rod fixing hole 18 is used to accommodate the camera rod of the minimally invasive device
  • the camera rod fixing handle 19 is used to lock the camera rod
  • the universal structure locking handle 20 is used to adjust and lock the universal structure, which is convenient for single operation and replaces an assistant.
  • the system of the present invention also has a bile collecting and measuring device 16 and a urine collecting and measuring device 17 for collecting bile and urine and dynamically observing organ vitality.
  • the bile collecting and measuring device 16 and the urine collecting and measuring device 17 are arranged on the side of the casing 40.
  • the system of the present invention also includes an electronic control system.
  • the power supply of the electronic control system relies on a low-voltage DC power supply 82 located in the power supply box 21 (see FIG. 23).
  • the power supply box 21 is located at the rear of the chassis shell 40.
  • the core of the electronic control system of the system of the present invention is the controller 67, and the electronic control system includes the controller 67, a control panel and a display screen 83.
  • Figure 24 shows the schematic circuit diagram of the electronic control system. Among them, after the signals of the temperature sensor 68, the flow sensor 66, and the pressure sensor 69 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 speed of the pump 7 to prevent abnormal perfusion pressure or flow.
  • the perfusion line clamp valve 70 is in an open and closed state, and an alarm device 84 is used to give a timely alarm when an abnormal situation occurs in the device.
  • the controller 67 is located near the power supply box 21.
  • the controller 67 collects the signals of the temperature sensor 68, the flow sensor 66, and the pressure sensor 69. After analysis and processing, the following controls can be performed: 1) Control the speed of the pump 7 to prevent abnormal perfusion pressure or flow , To avoid or flow abnormalities, or even cause damage to the biological organs 1; 2) Control the oxygenator heating circulation pump 71 and the temperature maintaining device 4 to maintain the temperature of the biological organs 1 and the circulation pipeline 8; 3) Control the lifting column 43 Highly adaptable to operators of different heights; 4) Control the brightness of the internal lighting lamp 56 to provide the best brightness for training operations; 5) Control the perfusion pipeline clamp valve 70 to adjust the opening and closing status of the perfusion pipeline 8 in time; 6) Abnormalities in the device
  • the alarm device 84 is used to give a timely alarm.
  • the control panel and display screen 83 are used to display the status of the controller 67 and can manually adjust related parameters.

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Abstract

本发明提出一种器官灌注教学培训系统,包括:器官仓(2):用于容纳生物体器官(1)及附属血管;储液仓(3):位于所述器官仓(2)下方,用于存储循环灌注液;温度维持装置(4):用于维持生物体器官(1)的温度;灌注管路(8):连接储液仓(3)与生物体器官(1)的附属血管,在泵(7)的驱动下,对所述生物体器官(1)及附属血管进行加压、循环灌注;泵(7):对循环管路(8)进行加压,对所述生物体器官(1)及附属血管进行加压、循环灌注;显示器(35),用于显示操作录像;底座(61),用于支撑、移动、升降整体装置;器官灌注保存装置,能够同时灌注单个或多个生物体器官(1)。本发明可同时灌注多个器官。

Description

一种器官灌注教学培训系统 技术领域
本发明涉及一种医用教学培训系统,更具体地,涉及一种器官灌注教学培训系统。
背景技术
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。
本装置可用于大动物器官机械灌注保存,在动物伦理与保护制度日益严格的形势下,可利用从屠宰场获取的猪的器官及血液,连接本机进行实验。不仅避免伦理的审查,而且避免了实验室申请及伦理申请的周期,实验成本更加廉价,器官数量更充足,避免手术技术等人为干扰因素,而且避免了建立大动物实验室的昂贵成本,为下一步规模化、高效化、大幅度缩短实验周期、大幅度减少实验成本、减少干扰因素创造必要条件。
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。
该现有技术的模拟人体装置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。
发明内容
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。
本发明公开一种器官灌注教学培训系统,包括:
器官仓:用于容纳生物体器官及附属血管;
储液仓:位于所述器官仓下方,用于存储循环灌注液;
温度维持装置:用于维持生物体器官的温度;
灌注管路:连接储液仓与生物体器官的附属血管,在泵的驱动下,对所述生物体器官及附属血管进行加压、循环灌注;
泵:对循环管路进行加压,对所述生物体器官及附属血管进行加压、循环灌注;
显示器,用于显示操作图像;
底座,用于支撑、移动和升降整体装置;
所述器官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。
进一步,所述器官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。
进一步,所述器官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。
进一步,所述的系统还包括:氧合器:用于将循环灌注液持续氧合;滤栓器:用于过滤循环灌注液。
进一步,所述的系统还包括:上盖:用于封闭器官仓及温度维持装置;升降柱,所述升降柱能够调节操作平台的高度,其中所述操作平台支撑外壳及上盖;显示器支架,用于支撑显示器。
进一步,所述的系统还包括:腹部膨隆,腹部膨隆设置在上盖上,用于模拟人体腹部隆起,所述腹部膨隆上具有微创器械或内镜入口、消化道操作入路,微创器械或内镜入口供外科微创手术器械进入,消化道操作入路供消化内镜软镜进入。
进一步,所述消化道操作入路包括食道入口和直肠入口,食道入口用于上消化道内镜装置进入,直肠入口用于收集排泄废物或供消化道内镜装置进入。
进一步,所述腹部膨隆内设置有内照明灯,在上盖上对着所述腹部膨隆设置有微型排风扇。
进一步,上盖周围设置有微创器械万向臂固定座,用于固定万向支架。
进一步,所述万向支架包括:摄像杆固定孔、摄像杆固定手柄以及万向结构锁定手柄。
进一步,所述的系统还包括:温度温度传感器,用于监测储液仓内的循环灌注液、生物体器官1的温度;流量传感器,用于监测灌注管路内循环灌注液的流量;压力传感器,用于监测灌注管路内的循环灌注液的压力。
进一步,所述的系统还包括:平板电脑主机,平板电脑主机)具有:基本信息数据库,记录操作者基本信息;具有操作评分系统,能够搜集以下参数进行量化评估:出血量、手术时间、颤抖度和难度系数指标;录像及存储系统,用以记录操作视频,并可回放;网络连接功能,用以实现装置网络连接及监控;能够在控制面板及显示屏上显示信息。
进一步,所述的系统还包括:控制器,所述控制器被配置为收集温度传感器、流量传感器、压力传感器的信号,经过分析处理后,可进行如下控制:
控制泵的转速防止灌注压力或流量异常,避免或流量异常,甚至导致损坏生物体器官;
控制氧合器加热循环泵及温度维持装置来维持生物体器官及循环管路的温度,其中氧合器加热循环泵用于将水浴箱内温水抽出,来对氧合器进行循环加热;
控制升降柱的高度适应不同身高操作者;控制内照明灯亮度,为培训操作提供最佳亮度;
控制灌注管路钳制阀及时调整灌注管路的开合状态;在装置发生异常情况时通过警报装置进行及时警报;
控制面板及显示屏显示控制器的状态,并能够手动调整相关参数。
进一步,所述器官仓内部有膈肌悬挂结构,用于悬挂膈肌,以模拟临近器官的正常解剖位置。
进一步,所述底座上设置有微创设备仓、氧气瓶、胆汁收集计量装置和/或尿液收集计量装置。
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;
另外,本发明的有益效果还包括:
本发明的装置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循环灌注多器官的简便结构,利用屠宰场废弃的大动物器官,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,保持完整解剖结构,器官保持活力,损伤后有出血等明显优势。
附图说明
图1是本发明系统的器官灌注保存装置的基本结构平面示意图。
图2是本发明系统的器官灌注保存装置的立体示意图。
图3是本发明系统的器官灌注保存装置的原理示意图。
图4是本发明系统的器官灌注保存装置的器官仓俯视图。
图5是本发明系统的器官灌注保存装置的核心部件俯视图。
图6是本发明系统的器官灌注保存装置的核心部件侧视图。
图7是本发明系统的器官灌注保存装置的核心部件爆炸图。
图8是本发明系统的氧合器及滤栓器组件整体外观。
图9是本发明系统的氧合器及滤栓器组件剖面图。
图10是本发明系统整体右侧立体图。
图11是本发明系统整体左侧立体图。
图12是本发明系统整体俯视图。
图13是本发明系统整体右视图。
图14是本发明系统的整体后视图。
图15是本发明系统的上盖敞开整体右侧立体图。
图16是本发明系统的上盖敞开整体左侧立体图。
图17是本发明系统的上盖敞开整体俯视图。
图18是本发明系统的微创器械入口基本结构。
图19是本发明系统的消化内镜入口基本结构。
图20是本发明系统的器械挂盒基本结构。
图21是本发明系统的摄像杆万向支架示意图
图22是本发明系统的胆汁、尿液收集装置示意图。
图23是本发明系统后部主要结构示意图。
图24是本发明系统的电子控制系统示意图。
附图标记:
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,11-食道入口,12-消化道操作入路,13-直肠入口,14-膈肌悬挂,16-胆汁收集计量装置,17-尿液收集计量装置,18-摄像杆固定孔,19-摄像杆固定手柄,20-万向结构锁定手柄,21-电源盒,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,35-显示器,36-显示器支架,37-腹部膨隆,38-微创器械或内镜入口,38-1螺旋帽,38-2硅胶密封片,38-3螺旋底座,39-平板电脑主机,40-机箱外壳,41-微型排风扇,42-温度控制器,43-升降柱,44-把手,45-器械挂盒,45-1器械插孔,45-2挂钩,45-3器械盒主体,46-氧气瓶,47-电刀仓,48-微创设备仓,49-脚轮,50-氧合器及滤栓器仓,51-氧气流量调节表,52-加热器仓,53-微创器械万向臂固定座,54-氧合器及滤栓器外壳,55-上盖,56-内照明灯,57-氧气瓶支架,58-器官仓搁板,59-器官仓固定旋钮,60-回流管路,61-底座,62-上盖合页,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。
具体实施方式
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。
本发明的系统的核心部件是用于生物体器官的机械灌注保存装置,下面参照图1-图9描述该机械灌注保存装置。
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。
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。
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。
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。
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。
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。
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。
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。
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。
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。
如图1-3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;
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。
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。
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。
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。
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。
下面参照图4-9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。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。
水浴箱10的外壁设置有氧合器加热循环接口63,通过氧合器加热循环泵71用于抽吸水浴箱10内的温水,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。
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。
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,作为高频电刀的负极板,以便使用高频电刀。
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。
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。
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。
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。
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。
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。
下面参照图10-图24描述本发明的系统。本发明的系统主要用于医学微创训练(外科腹腔镜、自然腔道内镜、手术机器人、内科消化内镜等),利用主动脉系统内的单根插管灌注多器官的简便结构,利用养猪场获取的大动物来源生物体器官1,在体外灌注保存。利用血液或无细胞型循环灌注液,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,保持完整的正常解剖结构,器官保持活力,操作损伤后出血等明显优势。
如图10至图17所示,本发明的系统整体结构可划分为上半部分、下半部分、升降柱43三大部分,上半部分为核心部件,下半部分主要是底座及主要附件。上半部分主要包括机箱外壳40及上盖55,以及位于它们内部的核心部件:生物体器官1、器官仓2、水浴箱10、泵7、氧合器5、滤栓器6、循环管路8、回流管路60、血管插管连接部64及血管插管9等。此外,上半部分还设置有显示器35、支撑显示器35的显示器支架36、腹部膨隆37、微创器械或内镜入口38、平板电脑主机39、水浴箱温度控制器42、器械挂盒45等。机箱外壳40内部设有可容纳水浴箱10的加热器仓52。
其中,显示器35用于显示操作图像或其他操作信息,显示器35的显示内容来自于微创设备仓48内的腹腔镜或消化内镜主机传输的操作图像,或者平板电脑主机39传输的手术教学录像。腹部膨隆37设置在上盖55上,腹部膨隆37包括但不限于圆形、椭圆形等,腹部膨隆37用于模拟人体腹部或腹腔镜气腹状态。微创器械或内镜入口38设置在腹部膨隆37上,用于容纳腹腔镜器械或内镜软管。腹部膨隆37内设置有内照明灯56,用于操作时照明。器官仓固定旋钮59用于紧固器官仓2,将器官仓2与水浴箱10紧固,防止器官仓2下方的水浴箱10内的温水浮力导致器官仓2浮起。机箱外壳40前下方设置有把手44,用于悬挂器械挂盒45,器械挂盒45用于容纳训练器械供备用。
上盖55周围设置有微创器械万向臂固定座53,用于固定万向支架(包括摄像杆固定孔18,摄像杆固定手柄19以及万向结构锁定手柄20,如图21所示),用于调节并紧固微创装置的摄像杆,便于单人操作,替代助手;在上盖55的前端,朝着腹部膨隆37处设置有微型排风扇41,微型排风扇41用于排除器官仓2及水浴箱10蒸发产生的水蒸汽以及手术中高频电刀烧灼生物体器官1产生的烟雾。此外,上盖55有可以旋转开合上盖合页62。
平板电脑主机39具有基本信息数据库,记录操作者基本信息;有操作评分系统,能够搜集以下参数进行评估:出血量、手术时间、颤抖度、难度系数等指标。平板电脑主机39具有录像及存储系统,用以记录操作视频,并可回放。平板电脑主机39具有网络连接功能,用以实现装置网络化。平板电脑主机39还可连接电子控制系统,具有控制面板及显示屏83的功能,如第二部分所述。
下半部分主要以底座61为核心,其外周对称分布若干脚轮49,底座61上部设置有微创设备仓48和电刀仓47,底座61后部有氧气瓶46。其中,微创设备仓48用于容纳腹腔镜或消化内镜主机,电刀仓47用于容纳高频电刀。氧气瓶46用于氧气供应,放置在氧气瓶支架57上,氧气瓶46的出口处设置有氧气流量调节表51,用于调节氧气瓶46的出气量。升降柱43可调节高度,可调整机器操作面高度适应不同操作者身高。
如图15-图17所示,上盖55有可以旋转开合上盖合页62,便于翻开上盖55,快速更换器官仓2、氧合器5、滤栓器6等耗材;腹部膨隆37内部有内照明灯56。器官仓固定旋钮59用于紧固器官仓2,将器官仓2与水浴箱10紧固,防止浮力导致器官仓2浮起,并保持足够接触面积提高热传导效率。泵7固定在机箱外壳40内部,氧合器5及滤栓器6被集中放置于同一外壳54内,固定在机箱外壳40内部。
如图18所示,上盖55上具有微创器械或内镜入口38,主要是供腹腔镜训的摄像杆、外科微创手术器械入路,进行培训训练。其中微创器械或内镜入口38具体结构包括:螺旋帽38-1、硅胶密封片38-2和螺旋底座38-3。螺旋帽38-1将硅胶密封片38-2紧固于螺旋底座38-3,不仅可密封上盖,而且用于模拟微创器械穿刺。
如图19所示,上盖55上具有消化道操作入路12,包括食道入口11,直肠入口13,主要是模拟人体食道、肛门的结构,供消化内镜软镜进入,进行消化内镜培训训练。优选地包括食 道入口11,用于胃镜等上消化道内镜等装置进入;优选地包括直肠入口13,用于收集排泄废物,或结肠镜等消化道内镜装置进入。
如图20所示,器械挂盒45包括:器械插孔45-1、挂钩45-2和器械盒主体45-3。其中,器械盒主体45-3为中空结构,侧面具有器械插孔45-1及挂钩45-2,挂钩45-2垂直于器械盒主体伸出。通过挂钩45-2,器械挂盒45可以挂在教学培训装置的前方的把手44上。
如图21所示,摄像杆万向支架包括摄像杆固定孔18,摄像杆固定手柄19以及万向结构锁定手柄20。其中,摄像杆固定孔18用于容纳微创装置的摄像杆,摄像杆固定手柄19用于锁定摄像杆,万向结构锁定手柄20用于调节万向结构并锁定,便于单人操作,替代助手;
如图22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。胆汁收集计量装置16及尿液收集计量装置17设置在机箱外壳40侧面。
本发明的系统还包括电子控制系统,电子控制系统的供电依靠位于电源盒21(见图23)内的低压直流电源82。电源盒21位于机箱外壳40后部。
如图24所示,本发明的系统的电子控制系统的核心为控制器67,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24显示了该电子控制系统的电路原理图。其中,温度传感器68、流量传感器66、压力传感器69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。
控制器67位于电源盒21附近,控制器67收集温度传感器68、流量传感器66、压力传感器69的信号,经过分析处理后,可进行如下控制:1)控制泵7的转速防止灌注压力或流量异常,避免或流量异常,甚至导致损坏生物体器官1;2)控制氧合器加热循环泵71及温度维持装置4来维持生物体器官1及循环管路8的温度;3)控制升降柱43的高度适应不同身高操作者;4)控制内照明灯56亮度,为培训操作提供最佳亮度;5)控制灌注管路钳制阀70及时调整灌注管路8开合状态;6)在装置发生异常情况时通过警报装置84进行及时警报。控制面板及显示屏83用于显示控制器67的状态,并可手动调整相关参数。
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。

Claims (15)

  1. 一种器官灌注教学培训系统,其特征在于,包括:
    器官仓(2):用于容纳生物体器官(1)及附属血管;
    储液仓(3):位于所述器官仓(2)下方,用于存储循环灌注液;
    温度维持装置(4):用于维持生物体器官(1)的温度;
    灌注管路(8):连接储液仓(3)与生物体器官(1)的附属血管,在泵(7)的驱动下,对所述生物体器官(1)及附属血管进行加压、循环灌注;
    泵(7):对循环管路(8)进行加压,对所述生物体器官(1)及附属血管进行加压、循环灌注;
    显示器(35),用于显示操作图像;
    底座(61),用于支撑、移动和升降整体装置;
    所述器官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(1)。
  2. 根据权利要求1所述的系统,其特征在于,
    所述器官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。
  3. 根据权利要求1所述的系统,其特征在于,所述器官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。
  4. 根据权利要求1所述的系统,其特征在于,还包括:
    氧合器(5):用于将循环灌注液持续氧合;
    滤栓器(6):用于过滤循环灌注液。
  5. 根据权利要求1所述的系统,其特征在于,还包括:
    上盖(55):用于封闭器官仓(2)及温度维持装置(4);
    升降柱(43),所述升降柱(43)能够调节操作平台的高度,其中所述操作平台支撑外壳(40)及上盖(55);
    显示器支架(36),用于支撑显示器(35)。
  6. 根据权利要求5所述的系统,其特征在于,还包括:
    腹部膨隆(37),腹部膨隆(37)设置在上盖(55)上,用于模拟人体腹部隆起,所述腹部膨隆(37)上具有微创器械或内镜入口(38)、消化道操作入路(12),微创器械或内镜入口(38)供外科微创手术器械进入,消化道操作入路(12)供消化内镜软镜进入。
  7. 根据权利要求6所述的系统,其特征在于,
    所述消化道操作入路(12)包括食道入口(11)和直肠入口(13),食道入口(11)用于上消化道内镜装置进入,直肠入口(13)用于收集排泄废物或供消化道内镜装置进入。
  8. 根据权利要求6所述的系统,其特征在于,
    所述腹部膨隆(37)内设置有内照明灯(56),在上盖(55)上对着所述腹部膨隆(37)设置有微型排风扇(41)。
  9. 根据权利要求5所述的系统,其特征在于,
    上盖(55)周围设置有微创器械万向臂固定座(53),用于固定万向支架。
  10. 根据权利要求9所述的系统,其特征在于,所述万向支架包括:
    摄像杆固定孔(18)、摄像杆固定手柄(19)以及万向结构锁定手柄(20)。
  11. 根据权利要求1所述的系统,其特征在于,还包括:
    温度传感器(68),用于监测储液仓(3)内的循环灌注液、生物体器官1的温度;
    流量传感器(66),用于监测灌注管路(8)内循环灌注液的流量;
    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。
  12. 根据权利要求1所述的系统,其特征在于,还包括:
    平板电脑主机(39),平板电脑主机(39)具有:基本信息数据库,记录操作者基本信息;具有操作评分系统,能够搜集以下参数进行量化评估:出血量、手术时间、颤抖度和难度系数指标;录像及存储系统,用以记录操作视频,并可回放;网络连接功能,用以实现装置网络连接及监控;能够在控制面板及显示屏(83)上显示信息。
  13. 根据权利要求11所述的系统,其特征在于,还包括:
    控制器(67),所述控制器(67)被配置为收集温度传感器(68)、流量传感器(66)、压力传感器(69)的信号,经过分析处理后,可进行如下控制:
    控制泵(7)的转速防止灌注压力或流量异常,避免或流量异常,甚至导致损坏生物体器官(1);
    控制氧合器加热循环泵(71)及温度维持装置(4)来维持生物体器官(1)及循环管路(8)的温度,其中氧合器加热循环泵(71)用于将水浴箱(10)内温水抽出,来对氧合器(5)进行循环加热;
    控制升降柱(43)的高度适应不同身高操作者;控制内照明灯(56)亮度,为培训操作提供最佳亮度;
    控制灌注管路钳制阀(70)及时调整灌注管路(8)的开合状态;在装置发生异常情况时通过警报装置(84)进行及时警报;
    控制面板及显示屏(83)显示控制器(67)的状态,并能够手动调整相关参数。
  14. 根据权利要求2所述的系统,其特征在于,
    所述器官仓(2)内部有膈肌悬挂结构(14),用于悬挂膈肌(22),以模拟临近器官的正常解剖位置。
  15. 根据权利要求1所述的系统,其特征在于,
    所述底座(61)上设置有微创设备仓(48)、氧气瓶(46)、胆汁收集计量装置(16)和/或尿液收集计量装置(17)。
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