CN114514922A - Isolated heart normal atmospheric temperature mechanical perfusion device - Google Patents
Isolated heart normal atmospheric temperature mechanical perfusion device Download PDFInfo
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- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
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- A01N1/00—Preservation of bodies of humans or animals, or parts thereof
- A01N1/10—Preservation of living parts
- A01N1/14—Mechanical aspects of preservation; Apparatus or containers therefor
- A01N1/142—Apparatus
- A01N1/143—Apparatus for organ perfusion
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Abstract
Description
技术领域technical field
本发明涉及医疗器械领域,尤其涉及一种离体心脏常温机械灌注装置。The invention relates to the field of medical devices, in particular to an isolated heart normal temperature mechanical perfusion device.
背景技术Background technique
心脏移植是治疗终末期心脏病的有效方法,目前供体心脏在离体环境下保存均采用器官保存液冷保存的方式,但其有效保存期限仅为6小时,大大限制了心脏移植的发展。心脏常温机械灌注是指通过机械灌注的方式给离体心脏灌注常温氧合血来模拟体内环境,进而实现心脏在体外环境下的正常生理功能。这一器官保存方式有望大大提高心脏的离体保存时间,并缩短冷缺血时间降低术后移植并发症。目前还未有效果良好的心脏常温机械灌注设备。Heart transplantation is an effective method for the treatment of end-stage heart disease. At present, the donor hearts are preserved in vitro by the method of organ preservation liquid cold preservation, but the effective storage period is only 6 hours, which greatly limits the development of heart transplantation. Normal-temperature mechanical perfusion of the heart refers to perfusing the isolated heart with normal-temperature oxygenated blood by mechanical perfusion to simulate the in vivo environment, thereby realizing the normal physiological function of the heart in the in vitro environment. This organ preservation method is expected to greatly improve the in vitro preservation time of the heart, shorten the cold ischemia time and reduce postoperative complications of transplantation. At present, there is no effective mechanical perfusion device for the heart at normal temperature.
发明内容SUMMARY OF THE INVENTION
为解决背景技术中存在的上述技术问题,本发明目的是研发一种离体心脏常温机械灌注装置,实现心脏在离体环境下正常搏动并维持其他生理功能。通过灌注的方式持续给予心脏供应氧气和营养,使其可以维持正常生理功能,并延长其离体保存时间;可以实时监测心脏的各项生化指标,评估其是否合适用于心脏移植。In order to solve the above-mentioned technical problems existing in the background art, the purpose of the present invention is to develop an isolated heart normal temperature mechanical perfusion device, so as to realize the normal beating of the heart and maintain other physiological functions in an isolated environment. The heart is continuously supplied with oxygen and nutrients by perfusion, so that it can maintain normal physiological function and prolong its in vitro storage time; various biochemical indicators of the heart can be monitored in real time to evaluate whether it is suitable for heart transplantation.
本发明的技术解决方案是:本发明为一种离体心脏常温机械灌注装置,其特殊之处在于:所述灌注装置包括器官保存箱、储血罐、膜式氧合器和加热水箱,储血罐上设置有两个入储血罐接口和一个出储血罐接口,器官保存箱中设置有右室引流管、左室引流管和主动脉根部灌注管,器官保存箱通过右室引流管和左室引流管分别与两个入储血罐接口连接,膜式氧合器上设置有膜肺氧气接口、膜肺出水接口、膜肺入水接口、膜肺出血接口和膜肺入血接口,膜肺入血接口与出储血罐接口连接,膜肺出血接口通过主动脉根部灌注管与器官保存箱连接,加热水箱上设置有加热水箱回水接头和加热水箱出水接头,加热水箱出水接头与膜肺入水接口连接,加热水箱回水接头与膜肺出水接口连接。The technical solution of the present invention is as follows: the present invention is an isolated heart normal temperature mechanical perfusion device, which is special in that the perfusion device includes an organ preservation box, a blood storage tank, a membrane oxygenator and a heating water tank, and the storage The blood tank is provided with two inlet blood storage tank interfaces and one outlet blood storage tank interface. The organ preservation box is provided with a right ventricular drainage tube, a left ventricular drainage tube and a perfusion tube at the root of the aorta, and the organ preservation box passes through the right ventricular drainage tube. The membrane oxygenator is provided with a membrane lung oxygen interface, a membrane lung water outlet, a membrane lung water inlet, a membrane lung hemorrhage interface, and a membrane lung blood inlet interface. The membrane lung blood inlet interface is connected with the blood storage tank interface, the membrane lung hemorrhage interface is connected with the organ preservation box through the aortic root perfusion tube, the heating water tank is provided with a heating water tank return water connector and a heating water tank outlet connector, and the heating water tank outlet connector is connected to the organ preservation box. The membrane lung water inlet interface is connected, and the heating water tank return water connector is connected with the membrane lung water outlet interface.
进一步的,加热水箱上还分别设置有加热水箱放水口和加热水箱加水口,加热水箱内设置有加热棒、温敏探头和潜水泵,潜水泵上设置有泵头出水口,潜水泵通过泵头出水口与加热水箱出水接头连接。Further, the heating water tank is also provided with a water outlet for the heating water tank and a water adding port for the heating water tank, a heating rod, a temperature-sensitive probe and a submersible pump are arranged in the heating water tank, and a water outlet of a pump head is arranged on the submersible pump, and the submersible pump passes through the pump head. The water outlet is connected with the water outlet joint of the heating water tank.
进一步的,膜肺出水接口和膜肺入水接口分别设置在膜式氧合器底部两侧,膜肺出血接口设置在膜式氧合器底部中心,膜肺入血接口设置在膜式氧合器上方一侧,膜式氧合器上方另一侧设置膜肺氧气接口。Further, the membrane lung water outlet interface and the membrane lung water inlet interface are respectively arranged on both sides of the bottom of the membrane oxygenator, the membrane lung hemorrhage interface is arranged at the bottom center of the membrane oxygenator, and the membrane lung blood inlet interface is arranged on the membrane oxygenator. On the upper side and the other side above the membrane oxygenator, there is a membrane lung oxygen interface.
进一步的,膜肺入血接口与出储血罐接口之间设置有蠕动泵。Further, a peristaltic pump is arranged between the membrane lung blood inlet interface and the blood storage tank outlet interface.
进一步的,主动脉根部灌注管上设置有流量监测装置。Further, a flow monitoring device is provided on the aortic root perfusion tube.
进一步的,主动脉根部灌注管上设置有压力监测装置。Further, a pressure monitoring device is provided on the aortic root perfusion tube.
进一步的,灌注装置还包括灌注壳体,器官保存箱设置在灌注壳体上方,储血罐和膜式氧合器分别设置在灌注壳体侧面,加热水箱设置在灌注壳体内。Further, the perfusion device further includes a perfusion housing, the organ preservation box is arranged above the perfusion housing, the blood storage tank and the membrane oxygenator are respectively arranged on the sides of the perfusion housing, and the heating water tank is arranged in the perfusion housing.
进一步的,储血罐通过血罐固定装置设置在灌注壳体上,膜式氧合器通过膜肺固定装置设置在灌注壳体上。Further, the blood storage tank is arranged on the perfusion housing through the blood tank fixing device, and the membrane oxygenator is arranged on the perfusion housing through the membrane lung fixing device.
进一步的,灌注壳体上设置有加热水箱出水接口和加热水箱回水接口,加热水箱出水接头通过加热水箱出水接口与膜肺入水接口连接,加热水箱回水接头通过加热水箱回水接口与膜肺出水接口连接。Further, the perfusion shell is provided with a heating water tank water outlet interface and a heating water tank return water interface, the heating water tank water outlet connector is connected to the membrane lung water inlet interface through the heating water tank water outlet interface, and the heating water tank return water connector is connected to the membrane lung through the heating water tank return water interface. Water outlet connection.
进一步的,灌注装置还包括控制平台,控制平台包括控制显示屏幕和中央处理器,控制显示屏幕与中央处理器连接,中央处理器分别与温敏探头、潜水泵、加热棒、流量监测装置和压力监测装置连接,控制显示屏幕设置在灌注壳体上方,中央处理器接有电源开关,电源开关设置在灌注壳体下方。Further, the perfusion device also includes a control platform, the control platform includes a control display screen and a central processing unit, the control display screen is connected with the central processing unit, and the central processing unit is respectively connected with the temperature-sensitive probe, the submersible pump, the heating rod, the flow monitoring device and the pressure. The monitoring device is connected, the control display screen is arranged above the perfusion casing, the central processing unit is connected with a power switch, and the power switch is arranged below the perfusion casing.
本发明提供的离体心脏常温机械灌注装置,实现心脏在离体环境下正常搏动并维持其他生理功能。通过灌注的方式持续给予心脏供应氧气和营养,使其可以维持正常生理功能,并延长其离体保存时间;可以实时监测心脏的各项生化指标,评估其是否合适用于心脏移植。其具有以下优点:The isolated heart normal temperature mechanical perfusion device provided by the present invention realizes the normal beating of the heart and maintains other physiological functions in an isolated environment. The heart is continuously supplied with oxygen and nutrients by perfusion, so that it can maintain normal physiological function and prolong its in vitro storage time; various biochemical indicators of the heart can be monitored in real time to evaluate whether it is suitable for heart transplantation. It has the following advantages:
1、本发明采用蠕动泵搏动灌注,可提供冠脉近似生理的灌注方式。1. The present invention adopts peristaltic pump pulsatile perfusion, which can provide a perfusion method that approximates the physiology of coronary artery.
2、本发明配有流量和压力传感器,可实时监测主动脉端的流量和灌注压力,并在控制面板上实时反馈显示;同时当流量或压力超过阈值时可发出警报。流量传感器同时可监测温度及气泡报警。2. The present invention is equipped with flow and pressure sensors, which can monitor the flow and perfusion pressure at the aortic end in real time, and display it in real-time feedback on the control panel; at the same time, when the flow or pressure exceeds the threshold, an alarm can be issued. The flow sensor can monitor temperature and bubble alarm at the same time.
3、膜式氧合器可通过并联血液灌流器以清除循环系统中的炎性因子,进而改善心脏移植后的存活率;此外也可并联超滤装置,当灌注液红细胞压积过低或钠钾离子浓度过高时,可通过超滤提高血红蛋白浓度或降低钠钾离子浓度,以维持循环系统中内环境稳定。3. The membrane oxygenator can be connected in parallel with a blood perfusion device to remove inflammatory factors in the circulatory system, thereby improving the survival rate after heart transplantation; in addition, an ultrafiltration device can also be connected in parallel, when the perfusate hematocrit is too low or sodium When the potassium ion concentration is too high, ultrafiltration can be used to increase the hemoglobin concentration or reduce the sodium and potassium ion concentration to maintain the stability of the internal environment in the circulatory system.
附图说明Description of drawings
图1是本发明的结构示意图;Fig. 1 is the structural representation of the present invention;
图2是本发明的右侧视图;Fig. 2 is the right side view of the present invention;
图3是本发明的后侧视图;Fig. 3 is the rear side view of the present invention;
图4是本发明的加热水箱示意图;Fig. 4 is the heating water tank schematic diagram of the present invention;
图5是本发明应用示意图。FIG. 5 is a schematic diagram of the application of the present invention.
附图标记说明如下:The reference numerals are explained as follows:
1、左肺动脉;2、右室引流管;3、左上肺静脉;4、左心房;5、左下肺静脉;6、左室引流管;7、左心室;8、下腔静脉;9、右心室;10、右下肺静脉;11、右上肺静脉;12、右肺动脉;13、上腔静脉;14、主动脉根部灌注管;15、主动脉;16、器官保存箱;17、蠕动泵;18、入储血罐接口;19、血罐固定装置;20、储血罐;21、出储血罐接口;22、膜肺氧气接口;23、加热水箱出水接口;24、加热水箱回水接口;25、膜肺出水接口;26、膜肺入水接口;27、膜式氧合器;28、膜肺固定装置;29、膜肺出血接口;30、膜肺入血接口;31、流量监测装置;32、压力监测装置;33、控制显示屏幕;34、电源开关;35、加热水箱回水接头;36、加热水箱出水接头;37、加热水箱;38、温敏探头;39、泵头出水口;40、潜水泵;41、加热水箱放水口;42、加热棒;43、加热水箱加水口。1. Left pulmonary artery; 2. Right ventricular drainage; 3. Left superior pulmonary vein; 4. Left atrium; 5. Left inferior pulmonary vein; 6. Left ventricular drainage; 7. Left ventricle; 8. Inferior vena cava; 10. Right lower pulmonary vein; 11. Right upper pulmonary vein; 12. Right pulmonary artery; 13. Superior vena cava; 14. Aortic root perfusion tube; 15. Aorta; 16. Organ storage box; 17. Peristaltic pump; 18. Storage Blood tank interface; 19. Blood tank fixing device; 20. Blood storage tank; 21. Outlet blood storage tank interface; 22. Membrane lung oxygen interface; 23. Heating water tank outlet interface; 24. Heating water tank return water interface; 25. Membrane Lung water outlet; 26, Membrane lung water inlet; 27, Membrane oxygenator; 28, Membrane lung fixation device; 29, Membrane lung hemorrhage; 30, Membrane lung blood inlet; 31, Flow monitoring device; 32, Pressure Monitoring device; 33. Control display screen; 34. Power switch; 35. Heated water tank return water connector; 36. Heated water tank outlet connector; 37. Heated water tank; 38. Temperature sensitive probe; 39. Pump head water outlet; Pump; 41. Water outlet for heating water tank; 42. Heating rod; 43. Water inlet for heating water tank.
具体实施方式Detailed ways
下面结合附图和具体实施例,对本发明的总体方案作进一步的详细说明:Below in conjunction with the accompanying drawings and specific embodiments, the overall scheme of the present invention is described in further detail:
参见图1、2、3、4,本发明具体实施例的结构包括器官保存箱16、储血罐20、膜式氧合器27和加热水箱37,膜式氧合器27为膜肺的膜式氧合器。储血罐20上设置有两个入储血罐接口18和一个出储血罐接口21,器官保存箱16中设置有右室引流管2、左室引流管6和主动脉根部灌注管14,器官保存箱16通过右室引流管2和左室引流管6分别与两个入储血罐接口18连接,膜式氧合器27上设置有膜肺氧气接口22、膜肺出水接口25、膜肺入水接口26、膜肺出血接口29和膜肺入血接口30,膜肺出水接口25和膜肺入水接口26分别设置在膜式氧合器27底部两侧,膜肺出血接口29设置在膜式氧合器27底部中心,膜肺入血接口30设置在膜式氧合器27上方一侧,膜式氧合器27上方另一侧设置膜肺氧气接口22。加热水箱37上设置有加热水箱回水接头35和加热水箱出水接头36,其中,膜肺入血接口30与出储血罐接口21连接,膜肺出血接口29通过主动脉根部灌注管14与器官保存箱16连接,加热水箱出水接头36与膜肺入水接口26连接,加热水箱回水接头35与膜肺出水接口连接25。膜肺入血接口30与出储血罐接口21之间设置有蠕动泵17。主动脉根部灌注管14上设置有流量监测装置31和压力监测装置32。1, 2, 3, and 4, the structure of the specific embodiment of the present invention includes an
加热水箱37上还分别设置有加热水箱放水口41和加热水箱加水口43,加热水箱37内设置有加热棒42、温敏探头38和潜水泵40,潜水泵40上设置有泵头出水口39,潜水泵40通过泵头出水口39与加热水箱出水接头36连接。The
在本实施例中,本发明还包括灌注壳体,器官保存箱16设置在灌注壳体上方,储血罐20和膜式氧合器27分别设置在灌注壳体侧面,加热水箱37设置在灌注壳体内。其中储血罐20通过血罐固定装置19设置在灌注壳体上,膜式氧合器27通过膜肺固定装置28设置在灌注壳体上。灌注壳体上还设置有加热水箱出水接口23和加热水箱回水接口24,加热水箱出水接头36通过加热水箱出水接口23与膜肺入水接口26连接,加热水箱回水接头35通过加热水箱回水接口24与膜肺出水接口25连接。In this embodiment, the present invention also includes a perfusion housing, the
本发明还包括控制平台,控制平台包括控制显示屏幕33和中央处理器,控制显示屏幕33与中央处理器连接,中央处理器分别与温敏探头38、潜水泵40、加热棒42、流量监测装置31和压力监测装置32连接,控制显示屏幕33设置在灌注壳体上方,中央处理器接有电源开关34,电源开关34设置在灌注壳体下方。The present invention also includes a control platform, the control platform includes a
参见图5,本发明使用的灌注保存液主要由稀释红细胞和胶体液配制而成,可为离体心脏提供氧气和能量;其中所用红细胞系与灌注心脏同一血型。灌注液的其余成分包括:白蛋白、氯化钙、碳酸氢钠、硫酸镁、氯化钾、甘油磷酸钠、氯化钠、葡萄糖、肝素钠、抗生素、复方氨基酸、复合维生素及胰岛素。配制过程中,将上述各成分与离体心脏同血型的浓缩红细胞稀释到适当比例,并维持生理渗透压。Referring to Figure 5, the perfusion preservation solution used in the present invention is mainly prepared from diluted red blood cells and colloid, which can provide oxygen and energy to the isolated heart; the red blood cells used are of the same blood type as the perfused heart. The remaining components of the perfusate include: albumin, calcium chloride, sodium bicarbonate, magnesium sulfate, potassium chloride, sodium glycerophosphate, sodium chloride, glucose, sodium heparin, antibiotics, compound amino acids, multivitamins, and insulin. In the preparation process, the above-mentioned components and the concentrated red blood cells of the same blood type of the isolated heart are diluted to an appropriate ratio, and the physiological osmotic pressure is maintained.
本发明的具体使用方式如下:The specific usage mode of the present invention is as follows:
1)心脏获取及插管;1) Heart acquisition and intubation;
在主动脉根部缝合包,冷灌注心脏停跳后离断各个大血管,分别结扎下腔静脉8、上腔静脉13、右下肺静脉10、右上肺静脉11、左上肺静脉3和右肺动脉12,从左肺动脉1或肺动脉主干插入右室引流管2至右心室9;从左下肺静脉5插入左室引流管6至左心室7,即左心房4;从主动脉15插入主动脉根部灌注管14,并结扎固定。The bag was sutured at the root of the aorta, the large blood vessels were cut off after cold perfusion cardiac arrest, and the
2)器官灌注2) Organ perfusion
使用灌注管连接,灌注液依次通过器官保存箱16中的右室引流管2和左室引流管6连接入储血罐接口18进入储血罐20,并通过出储血罐接口21、蠕动泵17及膜肺入血接口30进入膜式氧合器27行变温及氧合,其中膜肺入水接口26通过加热水箱出水接口23与加热水箱出水接头36连接,所述膜肺出水接口25通过加热水箱回水接口24与加热水箱回水接头35,保证膜肺与加热水箱相连,由两侧的热水负责给膜式氧合器27中心的灌注液进行加热,实现其变温功能;同时膜肺氧气接口22与外界氧源连接,保障膜式氧合器27的供氧。经过氧合及变温后的灌注液从膜肺出血接口29流出膜肺通过流量监测装置31和压力监测装置连接32以及器官保存箱16中的主动脉根部灌注管14,对主动脉及冠脉进行灌注15。系统监测的压力和流量数据可实时在控制显示屏幕33显示,并可调整蠕动泵17转速以调整系统流量。当动脉端压力或者流量超出阈值时,系统就会报警提示。Using the perfusion tube connection, the perfusate is sequentially connected to the blood
膜式氧合器27可通过并联血液灌流器以清除循环系统中的炎性因子,进而改善心脏移植后的存活率;此外也可并联超滤装置,当灌注液红细胞压积过低或钠钾离子浓度过高时,可通过超滤提高血红蛋白浓度或降低钠钾离子浓度,以维持循环系统中内环境稳定。The
加热水箱37可通过加热水箱加水口43进行加水,也可以从加热水箱放水口41进行放水。设备开机后,在控制显示屏幕33设置水箱温度,经加热棒42给加热水箱37中的水加热,并通过温敏探头38监测加热水箱37中液体温度,待温度达到设定温度后,可在控制显示屏幕33启动潜水泵40,加热的水可经泵头出水口39、加热水箱出水接头36连接加热水箱出水接口23并通过膜式氧合器27对灌注液行变温处理,加热的水通过膜肺出水接口25,加热水箱回水接口24和加热水箱回水接头35回流至加热水箱37,完成加热水箱37中水的自循环。The
本发明内容及上述实施例中未具体叙述的技术内容同现有技术。The content of the present invention and the technical content not specifically described in the above embodiments are the same as the prior art.
以上,仅为本发明公开的具体实施方式,但本发明公开的保护范围并不局限于此,本发明公开的保护范围应以权利要求的保护范围为准。The above are only specific embodiments disclosed in the present invention, but the protection scope disclosed in the present invention is not limited thereto, and the protection scope disclosed in the present invention should be subject to the protection scope of the claims.
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