技术领域technical field
本发明属于生物医疗仪器领域，具体涉及一种用于待移植器官体外亚常温智能灌注保存的系统与方法。The invention belongs to the field of biomedical instruments, and in particular relates to a system and method for in vitro subnormal temperature intelligent perfusion preservation of organs to be transplanted.
背景技术Background technique
器官在离体的情况将脱离人或动物的体内环境，如果不设法为其提供适当的生存环境，则器官将逐渐衰竭坏死。器官移植已成为救治多种器官功能衰竭患者生命的有效措施之一。随着科研及医疗水平的提高，器官移植的种类和适应范围不断扩大，同时器官移植的需求也急剧增加。据卫生部统计，中国每年约有150万人需要器官移植，但每年仅有1万人能接受移植手术。限制器官移植广泛开展的主要原因，一是器官供体数量的缺乏，二是器官利用率的低下。器官资源造成浪费的原因很多，缺乏有效的器官体外支持技术、无法简单有效判断器官活性是造成浪费的重要原因之一。When an organ is in vitro, it will be separated from the internal environment of a human or animal. If an appropriate living environment is not provided for it, the organ will gradually fail and die. Organ transplantation has become one of the effective measures to save the lives of patients with multiple organ failure. With the improvement of scientific research and medical treatment, the types and scope of organ transplantation have been continuously expanded, and the demand for organ transplantation has also increased sharply. According to statistics from the Ministry of Health, about 1.5 million people in China need organ transplants every year, but only 10,000 people can receive transplants every year. The main reasons restricting the widespread development of organ transplantation are, firstly, the shortage of organ donors, and secondly, the low rate of organ utilization. There are many reasons for the waste of organ resources. One of the important reasons for the waste is the lack of effective in vitro organ support technology and the inability to simply and effectively judge organ activity.
器官体外支持技术的出现，为解决移植器官供体缺乏和维持离体过程中的器官功能提供了解决方案，大大提高了器官移植技术的临床应用。但是，目前技术条件下移植器官的保存有效时限较短，临床上离体肾脏保存时间很难超过24-30h，肝脏和心脏的有效保存时间更短，而且保存系统复杂庞大，对移植器官的运输和大范围调配提出很大挑战。持续低温机械灌流（Continuous Hypothermic Perfusion, CHP）可用来改善单纯冷冻保存的缺血损伤，但是由于CHP的灌注液温度需要维持在4℃左右，低温不可避免的导致移植器官损伤。常温（37℃）机器灌注在动物器官移植上表现出良好的效果，只是常温机器灌注需要复杂的热灌注单元和氧合系统，设备庞大的体积限制了其在临床上的广泛应用，且37℃的正常体温条件对于器官保存是否最优或者必须仍待商榷。降低灌注温度到亚常温范围（20℃～30℃）可以大大降低温度控制要求及灌注的氧需求从而简化设备，同时兼具模拟器官生理条件的优点。The emergence of extracorporeal organ support technology provides a solution to solve the shortage of transplanted organ donors and maintain the function of organs during the process of ex vivo, which greatly improves the clinical application of organ transplantation technology. However, under the current technical conditions, the effective time limit for the preservation of transplanted organs is relatively short. Clinically, it is difficult to preserve the isolated kidney for more than 24-30 hours, and the effective preservation time for the liver and heart is even shorter. Moreover, the preservation system is complex and huge, which is very difficult for the transportation of transplanted organs. And large-scale deployment poses great challenges. Continuous Hypothermic Perfusion (CHP) can be used to improve ischemic injury in simple cryopreservation, but since the temperature of CHP perfusate needs to be maintained at around 4°C, hypothermia will inevitably lead to damage to transplanted organs. Machine perfusion at room temperature (37°C) has shown good results in animal organ transplantation, but machine perfusion at room temperature requires complex thermal perfusion units and oxygenation systems. Whether normothermic conditions are optimal or necessary for organ preservation remains open to debate. Lowering the perfusion temperature to the sub-normal temperature range (20°C–30°C) can greatly reduce the temperature control requirements and perfusion oxygen demand, thereby simplifying the equipment, and at the same time has the advantage of simulating the physiological conditions of the organ.
本发明针对于此，提出了一种亚常温下器官体外智能灌流保存的系统与方法，构建全仿真脉动波灌流、温度控制和氧合供应联合的体内生理环境模拟，配合多种传感器监测各项生命指标，实现器官多功能、多参数智能化保存，并基于模块化设计提高系统的集成度以方便车载运输。本发明提供一种系统和方法通过对移植器官体外人工可控的亚常温智能化灌注来模拟器官体内生理环境，维持器官活性，延长保存时间，同时实现器官灌注过程多参数无创实时监测，根据器官活性评估自动或提示改进保存过程。本发明可减少待移植器官的缺血缺氧性损害，避免传统保存方法对器官结构及功能的影响，同时可解决待移植器官运输困难、利用率不高和离体器官冷藏条件下生物修饰困难的难题。Aiming at this, the present invention proposes a system and method for in vitro intelligent perfusion preservation of organs at subnormal temperature, constructs a fully simulated pulsating wave perfusion, temperature control and oxygenation supply combined in vivo physiological environment simulation, and cooperates with various sensors to monitor various The life index realizes multi-functional and multi-parameter intelligent preservation of organs, and improves the integration of the system based on the modular design to facilitate vehicle transportation. The present invention provides a system and method to simulate the physiological environment of the organ in vivo through artificially controllable sub-normal temperature intelligent perfusion in vitro, maintain the activity of the organ, prolong the storage time, and at the same time realize multi-parameter non-invasive real-time monitoring of the organ perfusion process, according to the organ Activity assessment automatically or prompts to improve the preservation process. The invention can reduce the ischemic and hypoxic damage of the organ to be transplanted, avoid the influence of the traditional preservation method on the structure and function of the organ, and at the same time solve the difficulty of transporting the organ to be transplanted, the low utilization rate and the difficulty of biomodification under the condition of cold storage of the isolated organ problem.
发明内容Contents of the invention
为了弥补现有移植器官体外保存技术中的不足，完善移植器官体外支持技术，本发明提供一种亚常温下移植器官体外智能灌流保存的系统与方法。In order to make up for the deficiencies in the existing in vitro preservation technology of transplanted organs and improve the in vitro support technology of transplanted organs, the present invention provides a system and method for in vitro intelligent perfusion preservation of transplanted organs at subnormal temperature.
本发明的一个目的是提供一种亚常温移植器官体外智能支持系统。该系统通过构建全仿真脉动波灌流、温度控制和氧合供应联合的体内生理环境模拟，配合多种传感器监测各项生命指标，实现器官多功能、多参数智能化保存，从而尽可能维持器官活性，延长保存时间。One object of the present invention is to provide an in vitro intelligent support system for subnormal temperature transplanted organs. The system builds a fully simulated in vivo physiological environment simulation of pulsating wave perfusion, temperature control and oxygenation supply, cooperates with a variety of sensors to monitor various vital indicators, and realizes multi-functional and multi-parameter intelligent preservation of organs, so as to maintain organ activity as much as possible , to extend the storage time.
本发明提供的技术方案具体如下：The technical scheme provided by the invention is specifically as follows:
一种亚常温下移植器官体外智能支持系统，主要包括传感器采集模块、灌流/氧合模块、安全防护模块、人机交互模块、数据存储与分析模块、网络模块、电源管理模块、中央控制模块；An in vitro intelligent support system for transplanted organs at subnormal temperature, mainly including a sensor acquisition module, a perfusion/oxygenation module, a safety protection module, a human-computer interaction module, a data storage and analysis module, a network module, a power management module, and a central control module;
所述的传感器采集模块至少包括温度传感器、压力传感器、液位传感器、氧浓度传感器，用于检测灌流液的温度、压力、液位、氧浓度等与灌流相关的参数，同时需要有用于检测移植器官活性的生化传感器、视频采集传感器；所述的生化传感器采集的生化参数针对不同器官功能特性，可以是血液中氧浓度（pO2）、血液中二氧化碳浓度（pCO2）、乳酸脱氢酶（LDH）、 微球蛋白、肌酐、葡萄糖、碱过剩、电离钙水平或其它生理参数。The sensor acquisition module includes at least a temperature sensor, a pressure sensor, a liquid level sensor, and an oxygen concentration sensor, which are used to detect parameters related to perfusion such as temperature, pressure, liquid level, and oxygen concentration of the perfusate, and at the same time need to be used for detecting transplantation. Biochemical sensors for organ activity, video acquisition sensors; the biochemical parameters collected by the biochemical sensors are aimed at different organ functional characteristics, such as oxygen concentration in blood (pO2), carbon dioxide concentration in blood (pCO2), lactate dehydrogenase (LDH) , Microglobulin, creatinine, glucose, base excess, ionized calcium levels, or other physiological parameters.
所述的灌流/氧合模块至少包括器官盒、灌流液、热交换器、氧合器、过滤器、通道、灌流动力源，主要负责移植器官的冲洗、灌流、供氧及亚常温恒温控制。所述的器官盒应能允许器官容易且安全地在用于灌流、存储、分析、运输该待移植器官的设备之间移动的容器；所述的灌流液应能为移植器官提供必要的营养和保护；所述的热交换器应能为器官盒和灌流液提供亚常温恒温控制，可以用半导体制冷加热器组成的热交换单元并通过温度传感器反馈调控达到设定温度的恒定控制；所述的氧合器可以是中空微孔纤维膜组成的内置式小型氧合器；所述的过滤器可以滤除灌流液中的微血栓等有害物质；所述的通道为灌流液在系统内流动提供管路连接；所述的灌流动力源至少应包括电机、蠕动泵、电磁阀，以便提供可控的灌流动力和通道选择。The perfusion/oxygenation module includes at least an organ box, a perfusate, a heat exchanger, an oxygenator, a filter, a channel, and a perfusion power source, and is mainly responsible for flushing, perfusion, oxygen supply and subnormal temperature control of transplanted organs. The organ box should be a container that allows the organ to be easily and safely moved between the equipment used for perfusion, storage, analysis, and transportation of the organ to be transplanted; the perfusate should be able to provide the transplanted organ with the necessary nutrition and protection; the heat exchanger should be able to provide sub-normal temperature control for the organ box and the perfusate, and a heat exchange unit composed of a semiconductor refrigeration heater can be used to achieve constant control of the set temperature through temperature sensor feedback regulation; the described The oxygenator can be a built-in small oxygenator composed of a hollow microporous fiber membrane; the filter can filter out harmful substances such as microthrombosis in the perfusate; the channel provides a tube for the perfusate to flow in the system The perfusion power source should at least include a motor, a peristaltic pump, and a solenoid valve to provide controllable perfusion power and channel selection.
所述的安全防护模块包括开机自检模块、耗材状态确认模块、报警模块；所述的开机自检模块用于开机时检查系统各功能组件是否能正常工作；所述的耗材状态确认模块通过系统开关切换，系统是否正常启动来确定各种耗材是否已经安装到位；所述的报警模块包括温度超限报警、压力超限报警、液位与流量超限报警、气泡报警、传感器故障与执行器件故障报警；The safety protection module includes a power-on self-check module, a consumable status confirmation module, and an alarm module; the power-on self-check module is used to check whether each functional component of the system can work normally when starting up; the consumable status confirmation module passes the system Switch switching, whether the system starts normally to determine whether various consumables have been installed in place; the alarm module includes temperature over-limit alarm, pressure over-limit alarm, liquid level and flow over-limit alarm, bubble alarm, sensor failure and actuator failure Call the police;
所述的人机交互模块负责设定待保存器官的灌流/氧合参数以及灌流模式的选择，可以通过键盘或触摸屏等进行设定；该模块同时负责实时监控显示系统输出的灌流参数信息，可以通过数码管、液晶屏、点阵屏等输出显示设备实现；The human-computer interaction module is responsible for setting the perfusion/oxygenation parameters of the organ to be preserved and the selection of the perfusion mode, which can be set through the keyboard or touch screen; the module is also responsible for real-time monitoring and display of the perfusion parameter information output by the system, which can Realized by output display devices such as digital tubes, LCD screens, and dot matrix screens;
所述的数据存储与分析模块用于存储系统各项数据，包括传感器采集模块采集参数以及外围输出显示设备显示的时间、语音、图像、视频等信息，并对上述数据进行分析，给出器官舒张压、收缩压、灌流流量、器官肿胀程度、氧浓度变化等分析结果，综合评估器官活性；The data storage and analysis module is used to store various data of the system, including the acquisition parameters of the sensor acquisition module and the time, voice, image, video and other information displayed by the peripheral output display device, and analyzes the above data to give the organ dilation Comprehensive evaluation of organ activity through the analysis results of blood pressure, systolic blood pressure, perfusion flow rate, organ swelling degree, and oxygen concentration changes;
所述的网络模块用于实现运输过程待保存器官灌流参数、生化参数、GPS等信息的远程监控、定位和分析；The network module is used to realize remote monitoring, positioning and analysis of perfusion parameters, biochemical parameters, GPS and other information of organs to be preserved during transportation;
所述的电源管理模块用于完成对系统供电的开关控制、电池电量的获取与显示、电池充放电的控制、电量不足报警以及电源复位重启等操作，如针对某些需要断电后才能恢复的硬件，可以在发生故障后中央控制模块请求电源管理模块重启电源即可恢复；The power management module is used to complete the switching control of the system power supply, the acquisition and display of battery power, the control of battery charge and discharge, the alarm of insufficient power, and the reset and restart of the power supply. Hardware, after a failure, the central control module can request the power management module to restart the power supply to recover;
所述的中央控制模块主要用于接受传感器采集模块检测得到的灌流参数和人机交互模块设定的灌流参数，在进行数据分析和处理后实现整体控制逻辑。The central control module is mainly used to receive the perfusion parameters detected by the sensor acquisition module and the perfusion parameters set by the human-computer interaction module, and realize the overall control logic after data analysis and processing.
所述的中央控制模块与人机交互模块、数据存储与分析模块、传感器采集模块通过I/O连接，与灌流/氧合模块、安全防护模块通过驱动单元连接，与电源管理模块通过串口连接，与网络通信模块通过网络接口连接。The central control module is connected with the human-computer interaction module, the data storage and analysis module, and the sensor acquisition module through I/O, connected with the perfusion/oxygenation module and the safety protection module through the drive unit, and connected with the power management module through the serial port, Connect with the network communication module through the network interface.
本发明的另一个目的是提供应用于上述系统的器官智能灌注方法。该方法是根据移植器官体外保存的特点设计，包括器官实时生理参数的分析、灌注/氧合智能反馈调控、故障报警与安全防护、网络数据共享与远程监控等，能够实现安全有效的长时间保存。Another object of the present invention is to provide an organ intelligent perfusion method applied to the above system. This method is designed according to the characteristics of in vitro preservation of transplanted organs, including the analysis of real-time physiological parameters of organs, intelligent feedback control of perfusion/oxygenation, fault alarm and safety protection, network data sharing and remote monitoring, etc., and can achieve safe and effective long-term preservation .
该方法具体是系统开机后,首先启动电源管理模块以及安全防护模块中的开机自检模块、耗材状态确认模块，看系统是否能正常工作，待确认后进行初始化并启动传感器采集模块和人机交互模块；通过数据存储和分析模块评价器官活性，综合比较器官活性数据和人机交互模块设定的灌流/氧合参数，产生优化的灌流/氧合参数设置，根据优化设置开始亚常温下器官有氧灌流；在灌流的过程中通过中央控制模块来访问安全防护模块检测系统运行，根据安全防护模块给出的信息调整灌流/氧合模块执行或提醒操作者；灌流过程可通过数据存储和分析模块实时保存灌流参数及器官参数，也可通过网络模块进行远程监控。Specifically, after the system is turned on, first start the power management module, the power-on self-test module in the safety protection module, and the consumable status confirmation module to see if the system can work normally. After confirmation, initialize and start the sensor acquisition module and human-computer interaction. Module; evaluate organ activity through the data storage and analysis module, comprehensively compare the organ activity data with the perfusion/oxygenation parameters set by the human-computer interaction module, generate optimized perfusion/oxygenation parameter settings, and start organ regeneration at subnormal temperature according to the optimized settings. Oxygen perfusion; during the perfusion process, the central control module is used to access the operation of the safety protection module detection system, and the perfusion/oxygenation module is adjusted or the operator is reminded according to the information given by the safety protection module; the perfusion process can be passed through the data storage and analysis module Real-time storage of perfusion parameters and organ parameters, and remote monitoring through the network module.
上述方法中关键技术主要包括器官实时生理参数的分析、灌流/氧合智能反馈调控、故障报警与安全防护、网络数据共享与远程监控，具体如下：The key technologies in the above methods mainly include the analysis of real-time physiological parameters of organs, intelligent feedback control of perfusion/oxygenation, fault alarm and safety protection, network data sharing and remote monitoring, as follows:
器官实时生理参数分析：根据灌流过程传感器采集模块中压力传感器、温度传感器、氧浓度传感器采集得到的参数，经中央控制模块通过数据存储与分析模块储存并分析建立灌流温度、压力、流量、氧浓度关系表；根据传感器采集模块的数个压力传感器采集的压力参数，经中央控制模块通过数据存储与分析模块储存并分析器官血管通畅程度，同时判断血管堵塞位置；根据传感器采集模块中液位传感器采集到的参数，经中央控制模块通过数据存储与分析模块储存并分析确定是否通过加液/取样口添加所需物质，以及整个装置在运输过程是否出现侧翻或管道泄漏；根据传感器采集模块中生化传感器采集的生化参数，经中央控制模块通过数据存储与分析模块储存并分析器官功能变化；数据存储与分析模块综合分析上述数据信息，经中央控制模块通过中央控制模块实时监测灌流过程器官的活性变化；Real-time physiological parameter analysis of organs: According to the parameters collected by the pressure sensor, temperature sensor and oxygen concentration sensor in the perfusion process sensor acquisition module, the central control module stores and analyzes the perfusion temperature, pressure, flow rate and oxygen concentration through the data storage and analysis module Relationship table; according to the pressure parameters collected by several pressure sensors in the sensor collection module, the central control module stores and analyzes the patency of the organ blood vessels through the data storage and analysis module, and at the same time judges the location of blood vessel blockage; according to the data collected by the liquid level sensor in the sensor collection module The parameters received are stored and analyzed by the central control module through the data storage and analysis module to determine whether to add the required substances through the liquid addition/sampling port, and whether the entire device has rollover or pipeline leakage during transportation; according to the biochemical parameters in the sensor acquisition module The biochemical parameters collected by the sensor are stored and analyzed by the central control module through the data storage and analysis module to analyze the changes in organ function; the data storage and analysis module comprehensively analyzes the above data information, and the central control module monitors the activity changes of the organs during the perfusion process in real time through the central control module ;
灌流/氧合智能反馈调控：根据上述的移植器官实时生理参数分析，并比较人机交互模块设定的移植器官灌流模式和灌流/氧合参数，根据比较结果优化灌流模式及参数，中央控制模块控制驱动灌流/氧合模块执行灌流、热交换及供氧；其中灌流参数的反馈调控主要包括通道控制、温度调控、压力调控、氧浓度调控、流量检测与控制、气泡的防护等；Perfusion/oxygenation intelligent feedback regulation: According to the above-mentioned real-time physiological parameter analysis of transplanted organs, and compare the perfusion mode and perfusion/oxygenation parameters of transplanted organs set by the human-computer interaction module, optimize the perfusion mode and parameters according to the comparison results, and the central control module Control and drive the perfusion/oxygenation module to perform perfusion, heat exchange and oxygen supply; the feedback regulation of perfusion parameters mainly includes channel control, temperature regulation, pressure regulation, oxygen concentration regulation, flow detection and control, air bubble protection, etc.;
针对通道控制，主要依靠系统管道上放置的阀门来实现多个通道的选择开启与关闭；For channel control, it mainly relies on the valves placed on the system pipeline to realize the selective opening and closing of multiple channels;
针对温度调控，可采用半导体制冷加热器来调控系统温度以满足不同灌流模式下的温度控制需求；由于本发明是在亚常温范围（20℃～30℃）内对器官体外保存，利用半导体制冷加热器来实现对灌流液小范围的温度调节，足以达到有效控制使整个系统处在恒温状态下，且半导体制冷加热器没有运动部件，避免了因频繁开闭制冷机组所造成的能耗损失和机械损伤；For temperature control, the semiconductor refrigeration heater can be used to regulate the temperature of the system to meet the temperature control requirements in different perfusion modes; since the present invention stores organs in vitro in the subnormal temperature range (20°C-30°C), semiconductor refrigeration heating is used to The temperature adjustment of the perfusate is realized in a small range, which is enough to achieve effective control to keep the whole system in a constant temperature state, and the semiconductor refrigeration heater has no moving parts, which avoids the energy loss and mechanical damage caused by frequent opening and closing of the refrigeration unit. damage;
针对灌注过程中的压力调控，采用模拟心跳节律曲线的方式，模拟器官在体内博动的压力曲线可以采用闭环反馈调节系统，如利用压力传感器作为反馈输入，蠕动泵作为靶向控制目标实现对压力的闭环控制，采用PID算法以时间轴作为参量推进控制曲线幅值；For the pressure regulation during the perfusion process, the method of simulating the heartbeat rhythm curve is adopted. The pressure curve of the pulsation of the simulated organ in the body can adopt a closed-loop feedback adjustment system, such as using a pressure sensor as a feedback input and a peristaltic pump as a targeted control target to achieve pressure control. The closed-loop control adopts the PID algorithm to advance the control curve amplitude with the time axis as a parameter;
针对灌流液中的氧浓度调控，利用氧合器来提供灌流液中所需氧气；For the regulation of the oxygen concentration in the perfusate, the oxygenator is used to provide the required oxygen in the perfusate;
针对灌流过程的流量检测与控制，可以根据每分钟蠕动泵转动次数和每次的灌流量来计算流量，实现对灌流流量的自动检测；For the flow detection and control of the perfusion process, the flow can be calculated according to the number of rotations of the peristaltic pump per minute and the perfusion flow per time, so as to realize the automatic detection of the perfusion flow;
针对灌流过程中的气泡防护，可以采用气泡探测器和多路管道系统实现对气泡的去除。本发明在灌流液进入器官的前端设置气泡探测器和两路管道系统，若无气泡时灌流液直接进入器官，否则管道切换到冲洗通路排除气泡。For the protection of air bubbles during the perfusion process, air bubble detectors and multi-channel piping systems can be used to remove air bubbles. In the present invention, a bubble detector and a two-way pipeline system are arranged at the front end of the perfusate entering the organ. If there are no bubbles, the perfusate directly enters the organ; otherwise, the pipeline is switched to the flushing channel to remove the bubbles.
故障报警与安全防护：系统通过分析传感器模块采集信息、电源管理模块信息和系统其它工作状态信息获取系统存在的故障和安全隐患，且在人机交互模块的输出器件上实时显示报警内容。对于可以通过机器自身排除的故障，系统具有自动故障排除功能。对于不可自动排除的故障，机器将采取停机等安全保护措施，并通过人机交互模块和安全防护模块通知用户，请求人工干预。例如温度、压力、流量超限报警以及气泡报警后系统会停止运转，需手动启动。Fault alarm and safety protection: The system obtains the faults and safety hazards existing in the system by analyzing the information collected by the sensor module, the information of the power management module and other working status information of the system, and displays the alarm content in real time on the output device of the human-computer interaction module. For the faults that can be eliminated by the machine itself, the system has an automatic troubleshooting function. For faults that cannot be eliminated automatically, the machine will take safety protection measures such as shutdown, and notify the user through the human-computer interaction module and safety protection module, requesting manual intervention. For example, after the temperature, pressure, flow limit alarm and bubble alarm, the system will stop running and need to be started manually.
网络数据共享与远程监控：器官灌流、保存、运输过程中各种类型的数据和信息可以被分组记录，并通过网络提供给医生、科学家或其他机构以用于研究，实现待移植器官生理参数、GPS位置等信息的远程监控。Network data sharing and remote monitoring: Various types of data and information during organ perfusion, preservation, and transportation can be grouped and recorded, and provided to doctors, scientists, or other institutions through the network for research, realizing the physiological parameters of organs to be transplanted, Remote monitoring of information such as GPS location.
与背景技术相比，本发明具有的有益效果是：Compared with background technology, the beneficial effect that the present invention has is:
1、本发明针对智能化亚常温机械灌注提出的系统解决方案，可以更真实模拟器官生理环境，且小型化生物氧合/过滤器和半导体热交换单元设计，既满足亚常温机器灌流对温度和供氧的需求，又可提高系统集成度，更为便携宜用；1. The system solution proposed by the present invention for intelligent sub-normal temperature mechanical perfusion can more realistically simulate the physiological environment of organs, and the design of miniaturized biological oxygenation/filter and semiconductor heat exchange unit can meet the requirements of sub-normal temperature machine perfusion on temperature and The demand for oxygen supply can also improve the integration of the system, making it more portable and suitable for use;
2、本发明系统具有全仿真脉动波灌流和动态仿真反馈控制技术，灌流压力更接近人体，参数调控更精准，范围更广；灌注温度可以亚常温范围（20℃～30℃）保持恒温，可以兼顾器官免疫生物修饰操作需要；2. The system of the present invention has full simulation pulsation wave perfusion and dynamic simulation feedback control technology, the perfusion pressure is closer to the human body, the parameter regulation is more precise, and the range is wider; the perfusion temperature can be maintained at a constant temperature in the sub-normal temperature range (20 ° C ~ 30 ° C), and can Taking into account the needs of organ immune biomodification operations;
3、网络模块实现运输过程待移植器官生化参数、GPS等信息的远程监控和分析。3. The network module realizes the remote monitoring and analysis of the biochemical parameters of the organ to be transplanted, GPS and other information during the transportation process.
附图说明Description of drawings
图1为本发明系统原理示意图；Fig. 1 is a schematic diagram of the principle of the system of the present invention;
图2为本发明实施例的灌流/氧合模块和传感器采集模块装置示意图；Fig. 2 is a schematic diagram of the perfusion/oxygenation module and the sensor acquisition module device according to the embodiment of the present invention;
其中1.器官，2.器官盒，2-1气体交换口，3.泵，4.过滤器，5.氧合器，6.气泡陷阱，6-1.第一通道接口，6-2.第二通道接口，6-3.第三通道接口，7.第一灌流管道，8.冲洗管道，9.第二灌流管道，10.Y型岔路管，10-1.第一分支通道管路，10-2. 第二分支通道管路，10-3.主通道管路，11.缓冲器，12.液位传感器，13.非接触式温度传感器，14-1.第一阀门，14-2.第二阀门，14-3.第三阀门，15.生化传感器，16.压力传感器，17.氧浓度传感器，18.加药/取样口，19.半导体制冷加热器，20. 接触式温度传感器，21.气泡探测器。1. Organ, 2. Organ Box, 2-1 Gas Exchange Port, 3. Pump, 4. Filter, 5. Oxygenator, 6. Bubble Trap, 6-1. First Channel Interface, 6-2. The second channel interface, 6-3. The third channel interface, 7. The first perfusion pipeline, 8. The flushing pipeline, 9. The second perfusion pipeline, 10. Y-type branch pipe, 10-1. The first branch channel pipeline , 10-2. Second branch channel pipeline, 10-3. Main channel pipeline, 11. Buffer, 12. Liquid level sensor, 13. Non-contact temperature sensor, 14-1. First valve, 14- 2. Second valve, 14-3. Third valve, 15. Biochemical sensor, 16. Pressure sensor, 17. Oxygen concentration sensor, 18. Dosing/sampling port, 19. Semiconductor refrigeration heater, 20. Contact temperature Sensor, 21. Bubble detector.
具体实施方式Detailed ways
下面结合附图对本发明做进一步的分析。The present invention is further analyzed below in conjunction with accompanying drawing.
图1给出亚常温移植器官体外智能支持系统原理示意图。Figure 1 shows a schematic diagram of the principle of the subnormal temperature transplanted organ in vitro intelligent support system.
系统开机后,首先启动电源管理模块以及安全防护模块中的开机自检模块、耗材状态确认模块，看系统是否能正常工作，待确认后进行初始化并启动传感器采集模块和人机交互模块，通过数据存储和分析模块综合评价器官活性，综合比较器官活性数据和人机交互模块设定的灌流/氧合参数产生优化的灌流/氧合参数设置，根据优化设置开始亚常温下器官有氧灌流，并在灌流的过程中通过中央控制模块来访问安全防护模块检测系统运行，根据安全防护模块给出的信息调整灌流/氧合模块执行或提醒操作者。灌流过程可通过数据存储和分析模块实时保存灌流参数及器官参数，也可通过网络模块进行远程监控。After the system is turned on, first start the power management module, the power-on self-test module in the safety protection module, and the consumable status confirmation module to see if the system can work normally. After confirmation, initialize and start the sensor acquisition module and human-computer interaction module. The storage and analysis module comprehensively evaluates organ activity, comprehensively compares the organ activity data with the perfusion/oxygenation parameters set by the human-computer interaction module to generate optimized perfusion/oxygenation parameter settings, and starts organ aerobic perfusion at subnormal temperature according to the optimized settings, and During the perfusion process, the central control module accesses the safety protection module to detect the operation of the system, and adjusts the execution of the perfusion/oxygenation module or reminds the operator according to the information given by the safety protection module. The perfusion process can save perfusion parameters and organ parameters in real time through the data storage and analysis module, and can also be remotely monitored through the network module.
图2给出亚常温移植器官体外智能支持系统中灌流/氧合模块和传感器采集模块的一种实施例装置示意图；Figure 2 shows a schematic diagram of an embodiment of a perfusion/oxygenation module and a sensor acquisition module in a subnormal temperature transplanted organ in vitro intelligent support system;
如图2所示，器官1保存期间放置在一个器官盒2内，器官盒2的底部装有半导体制冷加热器19以实现整个保存期间的亚常温恒温控制，器官盒2的顶部安装有气体交换口2-1以起到过滤细菌、交换气体、维持器官盒气压稳定的作用，器官盒侧面安装有接触式温度传感器20以测量器官盒2内灌流液的温度，器官盒外壁装有液位传感器12。As shown in Figure 2, the organ 1 is placed in an organ box 2 during storage. The bottom of the organ box 2 is equipped with a semiconductor cooling heater 19 to achieve sub-normal temperature control during the entire storage period. The top of the organ box 2 is equipped with a gas exchange Port 2-1 is used to filter bacteria, exchange gas, and maintain the stability of the air pressure of the organ box. A contact temperature sensor 20 is installed on the side of the organ box to measure the temperature of the perfusate in the organ box 2. A liquid level sensor is installed on the outer wall of the organ box 12.
器官盒2与灌流/氧合器件通过第一灌流管道7连通，其中灌流/氧合器件从靠近器官盒2端开始依次由泵3、过滤器4、氧合器5通过第一灌流管道7串联组成，且过滤器4上开有液体出口，该液体出口与缓冲器11连通，从而起到平缓灌流压力的作用；The organ box 2 communicates with the perfusion/oxygenation device through the first perfusion pipeline 7, wherein the perfusion/oxygenation device is sequentially connected in series by the pump 3, the filter 4, and the oxygenator 5 through the first perfusion pipeline 7 from the end close to the organ box 2 Composition, and the filter 4 is provided with a liquid outlet, which communicates with the buffer 11, thereby playing the role of gentle perfusion pressure;
所述的第一灌流管道7的靠近泵3一端伸入至器官盒2内底部，同时要求该管道不与放置在器官盒2内的待转移器官1接触，第一灌流管道7的靠近氧合器5一端通入气泡陷阱6的第一通道接口6-1伸入气泡陷阱6；The end of the first perfusion pipeline 7 close to the pump 3 extends into the bottom of the organ box 2, and at the same time it is required that the pipeline does not contact the organ to be transferred 1 placed in the organ box 2, and the end of the first perfusion pipeline 7 near the oxygenation One end of the device 5 leads into the first channel interface 6-1 of the bubble trap 6 and extends into the bubble trap 6;
所述的气泡陷阱6的第二通道接口6-2通过Y型岔路管10伸入器官盒2内，其中Y型岔路管10的主通道管路10-3通过气泡陷阱6的第二通道接口24_2伸入气泡陷阱6，第一分支通道管路10-1伸入至器官盒2内灌流液液面下方，第二分支通道管路10-2与器官1的动脉连通；气泡陷阱6的第三通道接口6-3通过冲洗管道8伸入器官盒2内，构成冲洗回路；第二灌流管道9的一端与器官1的静脉连通，另一端伸入器官盒2内灌流液液面下方。The second channel interface 6-2 of the air bubble trap 6 extends into the organ box 2 through the Y-shaped branch pipe 10, wherein the main channel pipeline 10-3 of the Y-shaped branch pipe 10 passes through the second channel interface of the air bubble trap 6 24_2 extends into the air bubble trap 6, the first branch channel pipeline 10-1 extends below the perfusate liquid level in the organ box 2, and the second branch channel pipeline 10-2 communicates with the artery of the organ 1; the first branch channel pipeline 10-2 of the air bubble trap 6 The three-channel interface 6-3 extends into the organ box 2 through the flushing pipeline 8 to form a flushing circuit; one end of the second perfusion pipeline 9 communicates with the vein of the organ 1, and the other end extends into the organ box 2 below the level of the perfusate.
在气泡陷阱6内，分别从第一通道接口6-1与第二通道接口6-2伸入气泡陷阱6的管道长度相同，且长于从第三通道接口6-3伸入气泡陷阱6的管道长度，以方便捕获灌流液中的气泡。In the air bubble trap 6, the lengths of the pipes extending into the air bubble trap 6 from the first channel interface 6-1 and the second channel interface 6-2 are the same, and longer than the pipes extending into the air bubble trap 6 from the third channel interface 6-3 length to facilitate trapping air bubbles in the perfusate.
所述的器官盒2、灌流/氧合器件、气泡陷阱6、Y型岔路管10、第二灌流管道9组成灌流回路，灌流液在此回路对器官灌流。The organ box 2, the perfusion/oxygenation device, the air bubble trap 6, the Y-shaped branch pipe 10, and the second perfusion pipeline 9 form a perfusion circuit, and the perfusate perfuses the organs in this circuit.
所述的第一灌流管道7的气泡陷阱6与氧合器5之间的部分管道上留有加液/取样口18，以方便灌流液液位过低时加液，或者提取回路中液体进行分析，同时设有氧浓度传感器17，用来检测灌流开始前灌流液中氧浓度；所述的第一灌流管道7的泵3与过滤器4之间的部分管道上设有压力传感器16，用以监测泵3的灌注压力；A part of the pipeline between the bubble trap 6 of the first perfusion pipeline 7 and the oxygenator 5 is left with a liquid addition/sampling port 18 to facilitate the addition of liquid when the level of the perfusate is too low, or to extract the liquid in the circuit for Analysis, while an oxygen concentration sensor 17 is provided to detect the oxygen concentration in the perfusate before the start of perfusion; the part of the pipeline between the pump 3 and the filter 4 of the first perfusion pipeline 7 is provided with a pressure sensor 16. to monitor the perfusion pressure of the pump 3;
在Y型岔路管10的主通道管路10-3上安装第一阀门14-1，用以控制灌流的开启和关闭；Y型岔路管10的第一分支通道管路10-1安装第三阀门14-3，用以控制灌流预备模式的开启和关闭；在冲洗回路冲洗管道8上安装第二阀门14-2，用以控制冲洗的开启与关闭。The first valve 14-1 is installed on the main passage pipeline 10-3 of the Y-type branch pipe 10 to control the opening and closing of perfusion; the first branch passage pipeline 10-1 of the Y-type branch pipe 10 installs the third The valve 14-3 is used to control the opening and closing of the perfusion preparation mode; the second valve 14-2 is installed on the flushing pipeline 8 of the flushing circuit to control the opening and closing of the flushing.
在与气泡陷阱6的第一通道接口6-1、第二通道接口6-2连通的管路上分别串入气泡探测器13，用来检测灌流开始前回路中是否存在气泡，以及灌流过程是否产生气泡。Bubble detectors 13 are connected in series with the first channel interface 6-1 and the second channel interface 6-2 of the bubble trap 6, respectively, to detect whether there are air bubbles in the circuit before the perfusion starts, and whether there are bubbles in the perfusion process. bubble.
在器官动脉入口处Y型岔路管10的第二分支通道管路10-2上安装有生化传感器15、压力传感器16，用以检测进入到灌流前器官活性和灌流液的压力；在器官静脉出口处第二灌流管道9上分别串入氧浓度传感器17、生化传感器15，分别检测灌流后器官含氧量、器官活性；A biochemical sensor 15 and a pressure sensor 16 are installed on the second branch channel pipeline 10-2 of the Y-shaped branch pipe 10 at the organ artery entrance, to detect the organ activity and the pressure of the perfusate before entering into the perfusion; An oxygen concentration sensor 17 and a biochemical sensor 15 are respectively connected in series on the second perfusion pipeline 9 to respectively detect the oxygen content and organ activity of the organ after perfusion;
气泡陷阱6外壁装有液位传感器12和非接触式温度传感器13，分别用于检测气泡陷阱6内储液的液位和温度。The outer wall of the bubble trap 6 is equipped with a liquid level sensor 12 and a non-contact temperature sensor 13, which are used to detect the liquid level and temperature of the liquid stored in the bubble trap 6, respectively.
本发明提出了四种灌流模式，分别为冲洗模式、预备模式、恒压灌流模式、脉动灌流模式，其目的在于确保器官灌流的安全稳定。冲洗模式和预备模式用于排除整个灌流液路中的气泡，恒压灌流模式和脉动灌流模式为器官正常灌流的工作模式。The present invention proposes four perfusion modes, which are flushing mode, preparation mode, constant pressure perfusion mode, and pulsating perfusion mode, with the purpose of ensuring the safety and stability of organ perfusion. The flushing mode and preparatory mode are used to eliminate air bubbles in the entire perfusion fluid path, and the constant pressure perfusion mode and pulsating perfusion mode are working modes for normal organ perfusion.
1. 冲洗模式1. Flush mode
如图2所示灌流系统示意图，在该模式下，第一阀门14-1关闭，第二阀门14-2开启，氧合器5关闭停止提供氧气。泵3运转，将液体由冲洗管道8排出，从而排除经泵3、过滤器4、氧合器5、气泡陷阱6、氧浓度传感器17、加药/取样口18、气泡探测器21、生化传感器15、冲洗管道8中的气泡。通过观测或采用气泡探测器自动检测的方式待该灌流回路中的气泡排除之后可以停止冲洗模式。As shown in FIG. 2 , the schematic diagram of the perfusion system, in this mode, the first valve 14-1 is closed, the second valve 14-2 is opened, and the oxygenator 5 is closed to stop supplying oxygen. The pump 3 is running, and the liquid is discharged from the flushing pipeline 8, thereby eliminating the liquid through the pump 3, the filter 4, the oxygenator 5, the air bubble trap 6, the oxygen concentration sensor 17, the dosing/sampling port 18, the air bubble detector 21, and the biochemical sensor 15. Flush the air bubbles in the pipeline 8. The flushing mode can be stopped after the air bubbles in the perfusion circuit are eliminated through observation or automatic detection by the bubble detector.
2. 预备模式2. Ready mode
如图2所示灌流系统示意图，在该模式下，第一阀门14-1开启，第二阀门14-2关闭，第三阀门14-3开启，氧合器5关闭不提供氧气。泵3运转，将液体由第一分支通道管路10-1排出，从而排除经泵3、过滤器4、氧合器5、气泡陷阱6、氧浓度传感器17、加药/取样口18、气泡探测器21、Y型岔路管10、第一分支通道管路10-1中的气泡。通过观测或采用气泡探测器自动检测的方式检测灌流回路中是否存在气泡,待气泡排除之后可以停止预备模式。As shown in the schematic diagram of the perfusion system in FIG. 2 , in this mode, the first valve 14-1 is opened, the second valve 14-2 is closed, the third valve 14-3 is opened, and the oxygenator 5 is closed without providing oxygen. The pump 3 is running, and the liquid is discharged from the first branch channel pipeline 10-1, thereby eliminating the liquid through the pump 3, the filter 4, the oxygenator 5, the bubble trap 6, the oxygen concentration sensor 17, the dosing/sampling port 18, and the air bubbles. Bubbles in the detector 21, the Y-shaped branch pipe 10, and the first branch channel pipeline 10-1. Detect whether there are air bubbles in the perfusion circuit by observation or automatic detection by the air bubble detector, and the preparation mode can be stopped after the air bubbles are eliminated.
3．恒压灌流模式3. constant pressure perfusion mode
如图2所示灌流系统示意图，在该模式下，器官的动脉血管与Y型岔路管10的第二分支通道管路10-2相接，第一阀门14-1开启，第二阀门14-2关闭,第三阀门14-3关闭，氧合器5开启提供氧气。泵3连续运转，灌流液经泵3、过滤器4、氧合器5、气泡陷阱6、氧浓度传感器17、加药/取样口18、气泡探测器21、Y型岔路管10、管道10-3、生化传感15、压力传感器16、第二分支通道管路10-2进入器官。经器官静脉血管连接第二灌流通道9将灌流液排到器官盒内形成灌流回路。在该模式下，通过Y型岔路管10的第二分支通道管路10-2上的压力传感器15实时获取当前灌注压力，从而进行反馈调节，控制灌流压力处于恒定模式下。As shown in Figure 2, the schematic diagram of the perfusion system, in this mode, the arterial blood vessels of the organ are connected to the second branch channel pipeline 10-2 of the Y-shaped branch pipe 10, the first valve 14-1 is opened, and the second valve 14- 2 is closed, the third valve 14-3 is closed, and the oxygenator 5 is opened to provide oxygen. The pump 3 runs continuously, and the perfusate passes through the pump 3, the filter 4, the oxygenator 5, the bubble trap 6, the oxygen concentration sensor 17, the dosing/sampling port 18, the bubble detector 21, the Y-shaped branch tube 10, and the pipeline 10- 3. The biochemical sensor 15, the pressure sensor 16, and the second branch channel pipeline 10-2 enter the organ. The perfusion fluid is discharged into the organ box by connecting the second perfusion channel 9 through the organ vein to form a perfusion circuit. In this mode, the current perfusion pressure is obtained in real time by the pressure sensor 15 on the second branch channel pipeline 10-2 of the Y-shaped branch tube 10, so as to perform feedback adjustment and control the perfusion pressure in a constant mode.
4.脉动灌流模式4. Pulse perfusion mode
如图2所示灌流系统示意图，在该模式下，器官的动脉血管与Y型岔路管10的第二分支通道管路10-2相接，第一阀门14-1开启，第二阀门14-2关闭,第三阀门14-3关闭，氧合器5开启提供氧气。泵3以脉动方式运转，液体按上述3所示恒压过流模式中的灌流通路进入器官，经器官静脉血管连接第二灌流通道9将灌流液排到器官盒内形成灌流回路。泵以加速-恒速-减速-恒速周期性的方式运转，可以模拟人体心跳节律的方式设置驱动泵的波形、频率及幅度，使得输出的灌注液产生脉动效果，更好的模拟人体供氧供血的模式。通过Y型岔路管10的第二分支通道管路10-2上压力传感器15实时获取进入器官前灌流液的当前灌注压力，从而进行反馈调节，控制脉动压力处于设定范围内。As shown in Figure 2, the schematic diagram of the perfusion system, in this mode, the arterial blood vessels of the organ are connected to the second branch channel pipeline 10-2 of the Y-shaped branch pipe 10, the first valve 14-1 is opened, and the second valve 14- 2 is closed, the third valve 14-3 is closed, and the oxygenator 5 is opened to provide oxygen. The pump 3 operates in a pulsating manner, and the liquid enters the organ according to the perfusion channel in the constant pressure overcurrent mode shown in 3 above, and connects the second perfusion channel 9 through the organ vein to discharge the perfusate into the organ box to form a perfusion circuit. The pump operates in a periodic manner of acceleration-constant speed-deceleration-constant speed. The waveform, frequency and amplitude of the driving pump can be set in a way that simulates the human heartbeat rhythm, so that the output perfusate produces a pulsating effect, which better simulates the oxygen supply of the human body. The pattern of blood supply. The pressure sensor 15 on the second branch channel 10 - 2 of the Y-shaped branch tube 10 obtains the current perfusion pressure of the perfusate before entering the organ in real time, so as to perform feedback adjustment and control the pulsating pressure within the set range.
两个氧浓度传感器17对灌流液中的氧气浓度进行采样，其中一个氧浓度传感器17要放在氧合器5之后，这样有利于氧合器5提供氧气的合理控制。这里的氧合器优选小型膜式氧合器，优选内置式的中空微孔纤维膜制成的两段式氧合器。另一个氧浓度传感器17接在器官的静脉输出上进行采样，通过对剩余氧气量的采集我们可以知道器官正常代谢所消耗的氧气量。Two oxygen concentration sensors 17 sample the oxygen concentration in the perfusate, and one of the oxygen concentration sensors 17 should be placed after the oxygenator 5, which is beneficial to the reasonable control of oxygen provided by the oxygenator 5. The oxygenator here is preferably a small membrane oxygenator, preferably a two-stage oxygenator made of a built-in hollow microporous fiber membrane. Another oxygen concentration sensor 17 is connected to the venous output of the organ for sampling, and we can know the amount of oxygen consumed by the normal metabolism of the organ through the collection of the remaining oxygen amount.
通过氧合器5之后的氧浓度传感器17获取的氧含量信息可以控制调节氧合器5的给养量，达到预期的设定值。采集器官静脉血管连接的第二灌流通道9上的氧浓度传感器17获取的氧含量信息，通过数据分析从而可以获悉器官耗氧量等信息。The oxygen content information acquired by the oxygen concentration sensor 17 after the oxygenator 5 can control and adjust the nutrient amount of the oxygenator 5 to reach the expected set value. The oxygen content information obtained by the oxygen concentration sensor 17 on the second perfusion channel 9 connected to the organ vein and blood vessels is collected, and the oxygen consumption of the organ and other information can be obtained through data analysis.
灌流液经过过滤器4中的滤膜，可滤除灌液中循环的脂肪粒、血栓等有害物质；所述的滤膜需放置在缓冲器11的液面以下，缓冲器可以起到收纳有害物质同时缓冲泵3输出压力的作用，使输出的压力平缓，过渡性好。The perfusate passes through the filter membrane in the filter 4, which can filter out harmful substances such as fat particles and thrombus circulating in the perfusate; the filter membrane needs to be placed below the liquid level of the buffer 11, and the buffer can store harmful substances. The substance acts as a buffer against the output pressure of the pump 3 at the same time, so that the output pressure is gentle and the transition is good.
加药/取样口18可以用于向灌流回路中加入药物，或者从灌流回路取出液体，从而可以对器官进行治疗或研究。The dosing/sampling port 18 can be used to add medicine to the perfusion circuit, or to withdraw fluid from the perfusion circuit, so that the organ can be treated or studied.
所述的气泡陷阱6为三通道结构。正常灌流情况下，经第一通道接口6-1和第二通道接口6-2连通的管路形成灌流通路，经第三通道接口6-3的灌流通路被第二阀门14-2阻塞。当从第一灌流管道7进入的气泡经过气泡陷阱时，气泡将滞留在气泡陷阱中灌流液上层。通过如上所述冲洗模式，可排除气泡陷阱中富集的气泡。The bubble trap 6 is a three-channel structure. Under normal perfusion conditions, the pipeline connected through the first channel interface 6-1 and the second channel interface 6-2 forms a perfusion path, and the perfusion path through the third channel interface 6-3 is blocked by the second valve 14-2. When the air bubbles entering from the first perfusion pipeline 7 pass through the air bubble trap, the air bubbles will remain in the upper layer of the perfusate in the air bubble trap. Bubbles accumulated in the bubble trap can be removed by flushing mode as described above.
在正常的恒压或脉动灌流模式下，需要间隔一段时间运行冲洗模式。目的是为了防止超过传感器检测精度的微量气泡长时间累积，在气泡陷阱6中形成大气泡。一般情况下，气泡探测器21在此模式下探测不到气泡，若位于第一灌流管道7上的气泡探测器21采集到气泡，系统可切换到冲洗模式将气泡排除。若位于Y型岔路管10上的气泡探测器21采集到气泡，可打开第三阀门14-3排除气泡。In normal constant pressure or pulsatile perfusion mode, it is necessary to run flush mode at intervals. The purpose is to prevent the accumulation of micro air bubbles exceeding the detection accuracy of the sensor for a long time and form large air bubbles in the air bubble trap 6 . Generally, the air bubble detector 21 cannot detect air bubbles in this mode. If the air bubble detector 21 on the first perfusion pipeline 7 collects air bubbles, the system can switch to the flushing mode to remove the air bubbles. If the bubble detector 21 located on the Y-shaped branch pipe 10 collects bubbles, the third valve 14-3 can be opened to remove the bubbles.
接触式温度传感器20可以监控器官所在环境温度，非接触式温度传感器13可以监控灌流液中的温度。这里灌流液温度的测量选择在气泡陷阱6处，可以方便使用非接触式温度传感器，如红外温度传感器。半导体制冷加热器19可维持器官在某一恒定温度下，保证器官灌流的正常温度要求。The contact temperature sensor 20 can monitor the ambient temperature of the organ, and the non-contact temperature sensor 13 can monitor the temperature in the perfusate. Here, the temperature of the perfusate is measured at the bubble trap 6, which can facilitate the use of a non-contact temperature sensor, such as an infrared temperature sensor. The semiconductor refrigeration heater 19 can maintain the organ at a certain constant temperature to ensure the normal temperature requirement of organ perfusion.
位于器官盒2侧面的液位传感器12可以测定器官盒中灌流液的液位从而测定液体体积，可以用于检测器官液体环境，防止意外情况发生，如因灌流管道破裂导致灌流液流失。位于气泡陷阱12的液位传感器12可以测定气泡陷阱的液位从而测定气泡陷阱中液体的体积，防气泡陷阱中积累过多气泡。The liquid level sensor 12 located on the side of the organ box 2 can measure the liquid level of the perfusate in the organ box to measure the volume of the liquid, and can be used to detect the liquid environment of the organ to prevent accidents, such as the loss of perfusate due to rupture of the perfusion pipeline. The liquid level sensor 12 located in the bubble trap 12 can measure the liquid level of the bubble trap so as to measure the volume of the liquid in the bubble trap, so as to prevent excessive accumulation of bubbles in the bubble trap.
生化传感器15可以方便用户生化反应监测，进行器官参数的监测和分析。The biochemical sensor 15 can facilitate the user to monitor biochemical reactions, and monitor and analyze organ parameters.
本发明还提出了利用灌流管道堵塞前后两端的压差剧烈变化来检测管道的堵塞情况，并精确确定其堵塞位置，这里我们设置两个压力传感器来实现。当管道堵塞时，系统自动报警，在首端发出一个脉冲正压波，正压波沿管路传播遇到堵塞物时反射回来，在管路首端可获得两次正压波信息，并利用小波变换提取压力突变信息，获得正压波两次通过压力传感器的时间差，最后综合正压波的传播速度可以确定管路堵塞的位置。The present invention also proposes to detect the clogging situation of the pipeline by using the drastic change of the pressure difference between the two ends of the perfusion pipeline before and after the clogging, and accurately determine the clogging position. Here we set two pressure sensors to realize it. When the pipeline is blocked, the system will automatically alarm and send out a pulsed positive pressure wave at the head end. The wavelet transform extracts the pressure mutation information, obtains the time difference of the positive pressure wave passing through the pressure sensor twice, and finally integrates the propagation speed of the positive pressure wave to determine the location of the pipeline blockage.
本发明通过构建全仿真脉动波灌流、温度控制和氧合供应联合的体内生理环境模拟，配合多种传感器监测各项生命指标，实现器官多功能、多参数智能化保存，并基于模块化设计提高系统的集成度以方便车载运输。本发明提出的移植器官体外支持系统可以自动完成器官生理状态检测，根据检测到的条件和手动输入的参数自动调节灌注液中的相应参数，进行亚常温恒温灌注。本发明提供的器官灌流保存方法可减少待移植器官的缺血缺氧性损害，避免传统保存方法对器官结构及功能的影响，同时可解决待移植器官运输困难、利用率不高和离体器官冷藏条件下生物修饰困难的难题。本发明同时可促进器官移植相关技术的发展，如为器官体外结构功能变化监测研究提供研究平台，或者为器官移植前免疫抗原修饰等提供研究平台。The present invention realizes multifunctional and multi-parameter intelligent preservation of organs by constructing an in vivo physiological environment simulation of a combination of fully simulated pulsating wave perfusion, temperature control and oxygenation supply, and cooperates with various sensors to monitor various vital indicators, and improves organ preservation based on modular design. The integration of the system is convenient for vehicle transportation. The transplanted organ in vitro support system proposed by the present invention can automatically complete the detection of the physiological state of the organ, automatically adjust the corresponding parameters in the perfusate according to the detected conditions and manually input parameters, and perform subnormal temperature constant temperature perfusion. The organ perfusion preservation method provided by the present invention can reduce the ischemic and hypoxic damage of the organ to be transplanted, avoid the influence of the traditional preservation method on the structure and function of the organ, and at the same time solve the difficulty in transportation of the organ to be transplanted, the low utilization rate and the problem of isolated organs. Difficult conundrums of biomodification under refrigeration. At the same time, the invention can promote the development of organ transplantation-related technologies, such as providing a research platform for the monitoring of organ structure and function changes in vitro, or providing a research platform for immune antigen modification before organ transplantation.
上述实施例并非是对于本发明的限制，本发明并非仅限于上述实施例，只要符合本发明要求，均属于本发明的保护范围。The above embodiments do not limit the present invention, and the present invention is not limited to the above embodiments, as long as the requirements of the present invention are met, they all belong to the protection scope of the present invention.
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