CN1452863A - Continuous perfusion heart preservation device - Google Patents

一种持续灌注心脏保存装置，包括心脏和保存液存放容器、膜肺、灌注泵、位于心脏和保存液存放容器内的灌注管、进液管、出液管、取样管。进液管的一端与心脏和保存液存放容器连接，另一端与膜肺连接；出液管的一端与膜肺连接，另一端与位于心脏和保存液存放容器内的灌注管连接；取样管的一端与膜肺连接，另一端与心脏和保存液存放容器连接；灌注泵安装在进液管形成的管路中。这样可形成能进行气体交换的封闭式循环系统，使离体心脏(供心)既能从保存液中吸收氧和营养物质，又能维持心肌内环境的稳定，有利于提高离体心脏(供心)的保存效果。

A continuous perfusion heart preservation device, comprising a heart and a storage container for a preservation solution, a membrane lung, a perfusion pump, a perfusion tube located in the heart and a storage container for a storage solution, a liquid inlet tube, a liquid outlet tube, and a sampling tube. One end of the liquid inlet pipe is connected to the heart and the storage container of the preservation solution, and the other end is connected to the membrane lung; one end of the liquid outlet pipe is connected to the membrane lung, and the other end is connected to the perfusion tube located in the heart and the storage container of the preservation solution; One end is connected with the membrane lung, and the other end is connected with the heart and the storage container of the preservation solution; the perfusion pump is installed in the pipeline formed by the liquid inlet tube. In this way, a closed circulatory system capable of gas exchange can be formed, so that the isolated heart (donor heart) can not only absorb oxygen and nutrients from the preservation solution, but also maintain the stability of the inner environment of the myocardium, which is beneficial to improve the isolated heart (donor heart). heart) preservation effect.

持续灌注心脏保存装置continuous perfusion cardiac preservation device

一、技术领域1. Technical field

本发明属于离体心脏(供心)保存装置，特别涉及一种能持续对离体心脏(供心)灌注保存液的保存装置。The invention belongs to an isolated heart (donor heart) preservation device, in particular to a preservation device capable of continuously perfusing a preservation solution to an isolated heart (donor heart).

二、背景技术2. Background technology

目前，心脏移植已成为治疗终末期心脏病的有效方法，而离体心脏(供心)的保存效果直接影响着心脏移植手术的成功率。从人类第一次心脏移植至今已有30多年，供心保存液的设计千变万化，但供心保存技术却几乎无变化，“高钾停跳、低温静态保存”一直是供心保存的主要方法，与这种方法相对应的离体心脏(供心)保存装置为塑料袋和装冰块的容器，离体心脏(供心)及其保存液均装在塑料袋内，封扎好的塑料袋置于装有冰块的容器内。上述方法和保存装置的不足之处在于：1、不能为离体心脏提供心肌代谢所必需的氧和营养物质；2、无法对心肌工作的内环境调节，心肌细胞无氧代谢生成的酸性代谢产物堆积，造成心肌细胞损伤；3、低温保存损伤酶的活性，加重能量生成障碍；4、不能监测供心的保存情况。因此使用上述保存装置，离体心脏的保存效果差(移植后心功能不全发生率高)，安全保存时间短(4～6小时)。At present, heart transplantation has become an effective method for treating end-stage heart disease, and the preservation effect of the isolated heart (donor heart) directly affects the success rate of heart transplantation. It has been more than 30 years since the first human heart transplantation, the design of the donor heart preservation solution has been changing, but the preservation technology of the donor heart has hardly changed. "High potassium arrest, low temperature static preservation" has always been the main method of donor heart preservation. Corresponding to this method, the isolated heart (donor heart) preservation device is a plastic bag and a container containing ice cubes. The isolated heart (donor heart) and its preservation solution are all placed in a plastic bag, and the sealed plastic bag is placed In a container with ice cubes. The disadvantages of the above method and storage device are: 1. It cannot provide the isolated heart with oxygen and nutrients necessary for myocardial metabolism; 2. It cannot regulate the internal environment of myocardial work, and the acidic metabolites generated by anaerobic metabolism of cardiomyocytes 3. Low-temperature storage damages the activity of enzymes and aggravates energy generation disorders; 4. The preservation of the donor heart cannot be monitored. Therefore, using the above-mentioned preservation device, the preservation effect of the isolated heart is poor (high incidence of cardiac insufficiency after transplantation), and the safe preservation time is short (4-6 hours).

三、发明内容3. Contents of the invention

本发明针对现有技术存在的不足，提供一种能持续对离体心脏(供心)灌注保存液的保存装置，以提高离体心脏(供心)的保存效果，满足心脏移植手术的需要。The present invention aims at the deficiencies of the prior art, and provides a preservation device capable of continuously perfusing a preservation solution to an isolated heart (donor heart), so as to improve the preservation effect of the isolated heart (donor heart) and meet the needs of heart transplantation.

本发明的技术方案是：根据心脏的存活环境和条件设计保存装置，该保存装置包括心脏和保存液存放容器、设置有进气管和出气管的膜肺、灌注泵、位于心脏和保存液存放容器内的灌注管、进液管、出液管、取样管。进液管的一端与心脏和保存液存放容器连接，另一端与膜肺连接；出液管的一端与膜肺连接，另一端与位于心脏和保存液存放容器内的灌注管连接；取样管的一端与膜肺连接，另一端与心脏和保存液存放容器连接；灌注泵安装在进液管形成的管路中。这样可形成能进行气体交换的封闭式循环系统，使离体心脏(供心)既能从保存液中吸收氧和营养物质，又能维持心肌内环境的稳定。The technical solution of the present invention is: design a preservation device according to the survival environment and conditions of the heart, the preservation device includes a heart and a storage container for a preservation solution, a membrane lung provided with an air inlet pipe and an outlet pipe, a perfusion pump, a heart and a storage container for a preservation solution The perfusion tube, liquid inlet tube, liquid outlet tube and sampling tube inside. One end of the liquid inlet pipe is connected with the heart and the preservation solution storage container, and the other end is connected with the membrane lung; one end of the liquid outlet pipe is connected with the membrane lung, and the other end is connected with the perfusion tube located in the heart and the preservation solution storage container; One end is connected with the membrane lung, and the other end is connected with the heart and the preservation solution storage container; the perfusion pump is installed in the pipeline formed by the liquid inlet tube. In this way, a closed circulatory system capable of gas exchange can be formed, so that the isolated heart (donor heart) can not only absorb oxygen and nutrients from the preservation solution, but also maintain the stability of the inner environment of the myocardium.

为了使用方便、防止污染，将心脏供体的血液直接抽入心脏和保存液存放容器配制保存液，可配备取血管，该取血管插装在心脏和保存液存放容器上，一部分位于容器内，一部分位于容器外。In order to use conveniently and prevent pollution, the blood of the heart donor is directly pumped into the heart and the storage container of the storage solution to prepare the storage solution. It can be equipped with a blood vessel, which is inserted on the heart and the storage solution storage container, and part of it is located in the container. A part is located outside the container.

为了便于运输和使保存液循环过程中产生的沉淀落入容器底部，可在心脏和保存液存放容器内设置心脏放置与保存液过滤构件。In order to facilitate transportation and make the sediment produced during the circulation of the preservation solution fall to the bottom of the container, heart placement and preservation solution filter components can be arranged in the heart and the preservation solution storage container.

为了便于监测和调整保存液的压力，可设置压力控制器，该压力控制器通过管件与灌注泵和灌注管连接。In order to monitor and adjust the pressure of the preservation solution conveniently, a pressure controller can be provided, and the pressure controller is connected with the perfusion pump and the perfusion tube through a pipe fitting.

为了便于监测和调整保存液的温度，可设置温度监测仪，该温度监测仪安装在心脏和保存液存放容器内。In order to monitor and adjust the temperature of the preservation solution conveniently, a temperature monitor can be set, and the temperature monitor is installed in the heart and the preservation solution storage container.

心脏和保存液存放容器由本体和封闭件组合而成，本体由塑料或玻璃制作，本体壁为单层结构或可安装调温器件的夹层结构，封闭件为柔性罩或刚性盖板。膜肺由外壳和安装在外壳内的多排中空纤维管组成；为了便于运输，膜肺的外壳与心脏和保存液存放容器的本体为可分离式连接组合，其组合面与与心脏和保存液存放容器本体的对应组合面的形状相匹配。The heart and the preservation solution storage container are composed of a body and a closure. The body is made of plastic or glass. The body wall is a single-layer structure or a sandwich structure that can be installed with a temperature-regulating device. The closure is a flexible cover or a rigid cover. The membrane lung is composed of a shell and multiple rows of hollow fiber tubes installed in the shell; in order to facilitate transportation, the shell of the membrane lung is detachably connected with the heart and the body of the preservation solution storage container, and its combined surface is connected with the heart and the preservation fluid. The shapes of the corresponding combination surfaces of the storage container body are matched.

本发明提供的持续灌注心脏保存装置的使用方法：首先将保存液装入心脏和保存液存放容器，然后将从供体取出的心脏放入上述存放容器并将灌注管与插入离体心脏主动脉根部的的灌注管连接即可实现对离体心脏持续灌注保存液。The method of using the continuous perfusion heart preservation device provided by the present invention: first, put the preservation solution into the heart and the preservation solution storage container, then put the heart taken out from the donor into the above storage container and insert the perfusion tube into the aorta of the isolated heart The connection of the perfusion tube at the root can realize the continuous perfusion of preservation solution to the isolated heart.

本发明具有以下有益效果：The present invention has the following beneficial effects:

1、能够对心脏持续灌注保存液，持续、稳定地为离体心脏提供心肌代谢所必需的氧和营养物质，满足离体心脏(供心)停跳时的能量需要。1. It can continuously perfuse the heart with preservation solution, continuously and stably provide the isolated heart with oxygen and nutrients necessary for myocardial metabolism, and meet the energy demand of the isolated heart (donor heart) when it stops beating.

2、维持心肌细胞的内环境稳定，为移植后心脏复跳创造良好的条件。2. Maintain the stability of the internal environment of cardiomyocytes and create good conditions for heart rejuvenation after transplantation.

3、减少了无氧代谢生成的酸性代谢产物对心肌细胞的损伤。3. It reduces the damage to cardiomyocytes caused by the acidic metabolites generated by anaerobic metabolism.

4、离体心脏(供心)保存温度可通过配置调温器件调整，不局限于较低温度，因而既不必担心代谢增加导致的能量缺乏，又能避免酶活性下降导致的能量缺乏。4. The storage temperature of the isolated heart (donor heart) can be adjusted by configuring a thermostat, not limited to lower temperatures, so there is no need to worry about energy shortage caused by increased metabolism, and energy shortage caused by decreased enzyme activity can be avoided.

5、能随时监测离体心脏(供心)的保存情况和保存液的变化情况。5. It can monitor the preservation of the isolated heart (donor heart) and the change of the preservation solution at any time.

6、保存液可循环使用，有利于降低保存成本。6. The preservation solution can be recycled, which is beneficial to reduce the preservation cost.

7、操作简单，可控性强。7. Simple operation and strong controllability.

8、体积小，运输方便。8. Small size, easy to transport.

四、附图说明4. Description of drawings

图1是本发明所提供的持续灌注心脏保存装置的第一种结构图；Fig. 1 is the first structural diagram of the continuous perfusion heart preservation device provided by the present invention;

图2是本发明所提供的持续灌注心脏保存装置的第二种结构图；Fig. 2 is a second structural diagram of the continuous perfusion heart preservation device provided by the present invention;

图3是本发明所提供的持续灌注心脏保存装置的第三种结构图；Fig. 3 is a third structural diagram of the continuous perfusion heart preservation device provided by the present invention;

图4是本发明所提供的持续灌注心脏保存装置的第四种结构图；Fig. 4 is a fourth structural diagram of the continuous perfusion heart preservation device provided by the present invention;

图5是本发明所提供的持续灌注心脏保存装置的第五种结构图；Fig. 5 is a fifth structural diagram of the continuous perfusion heart preservation device provided by the present invention;

图6是膜肺的一种结构图；Fig. 6 is a kind of structural diagram of membrane lung;

图7是心脏放置与保存液过滤构件的一种结构图；Fig. 7 is a structural diagram of heart placement and preservation fluid filter member;

图8是图7的A-A剖视图。Fig. 8 is a cross-sectional view along line A-A of Fig. 7 .

图中，1—心脏和保存液存放容器、2—柔性罩、3—灌注管、4—取样管、5—出液管、6—膜肺、7—连接构件、8—进气管、9—出气管、10—灌注泵、11—进液管、12—心脏放置与保存液过滤构件、13—取血管、14—压力控制器、15—盖板、16—温度监测仪、17—外壳、18—中空纤维管、19—柔性垫、20—过滤网。In the figure, 1—heart and preservation solution storage container, 2—flexible cover, 3—perfusion tube, 4—sampling tube, 5—liquid outlet tube, 6—membrane lung, 7—connecting member, 8—intake tube, 9— Air outlet pipe, 10—perfusion pump, 11—liquid inlet pipe, 12—heart placement and preservation fluid filter member, 13—blood vessel collection, 14—pressure controller, 15—cover plate, 16—temperature monitor, 17—shell, 18—hollow fiber tube, 19—flexible pad, 20—filter.

五、具体实施方式5. Specific implementation

实施例1：Example 1:

本实施例中的持续灌注心脏保存装置的结构如图1所示，包括心脏和保存液存放容器1、设置有进气管8和出气管9的膜肺6、灌注泵10、插装在心脏和保存液存放容器1上的取血管13、位于心脏和保存液存放容器1内的灌注管3、安装在心脏和保存液存放容器1下部的心脏放置与保存液过滤构件12、进液管11、出液管5、取样管4。进液管11为硅橡胶管，其一端与心脏和保存液存放容器1连接，另一端与膜肺6连接；出液管5为硅橡胶管，其一端与膜肺6连接，另一端与位于心脏和保存液存放容器内的灌注管3连接；取样管4为硅橡胶管，其一端与膜肺6连接，另一端与心脏和保存液存放容器1连接；灌注泵10为流量可调的转子微型泵，安装在进液管11形成的管路中。心脏和保存液存放容器1的形状和构造如图1所示，由透明塑料制作的单层结构刚性本体和塑料薄膜制作的柔性罩2组合而成，本体的形状为椭圆筒体，其与膜肺的组合面为平面。膜肺6的结构如图6所示，由外壳17和安装在外壳内的多排中空纤维管18组成；膜肺6的外壳17为弧面与平面形成的柱状体，如图1所示，外壳17与心脏和保存液存放容器1的本体的组合面为平面，组合的连接方式为粘接，连接构件7是组合面上设置的不干胶。安装在心脏和保存液存放容器1下部的心脏放置与保存液过滤构件12为形状与存放容器本体匹配的板状体，其上层为可变形的柔性垫(例如，海绵垫)19，其下层为过滤网20，如图7、图8所示。The structure of the continuous perfusion heart preservation device in this embodiment is shown in Figure 1, including a heart and a preservation solution storage container 1, a membrane lung 6 provided with an air inlet pipe 8 and an air outlet pipe 9, a perfusion pump 10, inserted in the heart and The blood vessel 13 on the preservation solution storage container 1, the perfusion tube 3 located in the heart and the preservation solution storage container 1, the heart placement and preservation solution filter member 12 installed at the bottom of the heart and the preservation solution storage container 1, the liquid inlet tube 11, Outlet pipe 5, sampling pipe 4. The liquid inlet pipe 11 is a silicone rubber tube, one end of which is connected to the heart and the storage container 1 of the preservation solution, and the other end is connected to the membrane lung 6; the liquid outlet pipe 5 is a silicone rubber tube, one end of which is connected to the membrane lung 6, and the other end is connected to The heart is connected to the perfusion tube 3 in the preservation solution storage container; the sampling tube 4 is a silicone rubber tube, one end of which is connected to the membrane lung 6, and the other end is connected to the heart and the preservation solution storage container 1; the perfusion pump 10 is a flow-adjustable rotor The micropump is installed in the pipeline formed by the liquid inlet pipe 11. The shape and structure of the heart and the preservation solution storage container 1 are shown in Figure 1. It is composed of a single-layer structure rigid body made of transparent plastic and a flexible cover 2 made of plastic film. The composite surface of the lung is a plane. The structure of membrane lung 6 is as shown in Figure 6, and is made up of shell 17 and the multiple rows of hollow fiber tubes 18 installed in the shell; The combination surface of the shell 17 and the body of the heart and the preservation solution storage container 1 is a plane, and the combined connection method is bonding, and the connecting member 7 is a self-adhesive provided on the combined surface. The heart placed on the lower part of the heart and the preservation fluid storage container 1 is placed and the preservation fluid filter member 12 is a plate-shaped body whose shape matches the storage container body, the upper layer is a deformable flexible pad (for example, a sponge pad) 19, and the lower layer is a Filter screen 20, as shown in Fig. 7, Fig. 8.

实施例2：Example 2:

本实施例中的持续灌注心脏保存装置的结构如图2所示，与实施例1不同之处在于：1、增设有压力控制器14，该压力控制器通过管件与灌注泵10和灌注管3连接。2、心脏和保存液存放容器1的形状和构造如图2所示，由透明塑料制作的单层结构刚性本体和塑料制作的刚性盖板15组合而成，本体的形状为梯形槽，其与膜肺的组合面为斜面。3、膜肺6的外壳17为斜面与平面形成的棱柱体，如图2所示，外壳17与心脏和保存液存放容器1的本体的组合面为斜面，组合的连接方式为挂接，连接构件7是组合面上设置的挂钩和挂套。The structure of the continuous perfusion heart preservation device in this embodiment is shown in Figure 2. The difference from Embodiment 1 is: 1. A pressure controller 14 is added, and the pressure controller is connected with the perfusion pump 10 and the perfusion tube 3 through the pipe fittings. connect. 2. The shape and structure of the heart and the preservation solution storage container 1 are as shown in Figure 2. It is composed of a single-layer structure rigid body made of transparent plastic and a rigid cover plate 15 made of plastic. The shape of the body is a trapezoidal groove. The combined surface of the membrane lung is an inclined plane. 3. The shell 17 of the membrane lung 6 is a prism formed by an inclined plane and a plane. As shown in FIG. Component 7 is a hook and a hanging sleeve provided on the combined surface.

实施例3：Example 3:

本实施例中的持续灌注心脏保存装置的结构如图3所示，与实施例1不同之处在于：1、增设了温度监测仪16，该温度监测仪安装在心脏和保存液存放容器1内。2、心脏和保存液存放容器1的形状和构造如图3所示，由透明塑料制作的单层结构刚性本体和塑料薄膜制作的柔性罩2组合而成，本体为矩形槽。3、膜肺6的外壳17为立方体，如图3所示。The structure of the continuous perfusion heart preservation device in this embodiment is as shown in Figure 3. The difference from Embodiment 1 is: 1. A temperature monitor 16 is added, which is installed in the heart and the preservation solution storage container 1 . 2. The shape and structure of the heart and preservation solution storage container 1 are shown in Figure 3. It is composed of a single-layer structure rigid body made of transparent plastic and a flexible cover 2 made of plastic film. The body is a rectangular groove. 3. The shell 17 of the membrane lung 6 is a cube, as shown in FIG. 3 .

实施例4：Example 4:

本实施例中的持续灌注心脏保存装置的结构如图4所示，与实施例1不同之处在于：1、心脏和保存液存放容器1的形状和构造如图4所示，由透明塑料制作的可安装调温器件的夹层结构刚性本体和塑料薄膜制作的柔性罩2组合而成，本体为圆筒体，其与膜肺的组合面为圆弧面。2、膜肺6的外壳17为弧形柱，如图4所示，外壳17与心脏和保存液存放容器1的本体的组合面为圆弧面，组合的连接方式为挂接，连接构件7是组合面上设置的挂钩和挂套。The structure of the continuous perfusion heart preservation device in this embodiment is as shown in Figure 4, and the difference from Embodiment 1 is: 1. The shape and structure of the heart and the preservation solution storage container 1 are as shown in Figure 4, made of transparent plastic The rigid body of the sandwich structure which can be installed with temperature-regulating devices and the flexible cover 2 made of plastic film are combined. The body is a cylinder, and the combined surface with the membrane lung is an arc surface. 2. The shell 17 of the membrane lung 6 is an arc-shaped column. As shown in FIG. It is a hook and a hanging cover arranged on the combination surface.

实施例5：Example 5:

本实施例中的持续灌注心脏保存装置的结构如图5所示，与实施例1不同之处在于：1、增设有压力控制器14，该压力控制器通过管件与灌注泵10和灌注管3连接。2、增设了温度监测仪16，该温度监测仪安装在心脏和保存液存放容器1内。3、心脏和保存液存放容器1的形状和构造如图5所示，由透明塑料制作的可安装调温器件的夹层结构刚性本体和塑料薄膜制作的柔性罩2组合而成，本体为圆筒体，其与膜肺的组合面为圆弧面。4、膜肺6的外壳17为弧形柱，如图5所示，外壳17与心脏和保存液存放容器1的本体的组合面为圆弧面，组合的连接方式为挂接，连接构件7是组合面上设置的挂钩和挂套。The structure of the continuous perfusion heart preservation device in this embodiment is shown in Figure 5. The difference from Embodiment 1 is: 1. A pressure controller 14 is added, and the pressure controller is connected with the perfusion pump 10 and the perfusion tube 3 through the pipe fittings. connect. 2. A temperature monitor 16 is added, which is installed in the heart and the preservation solution storage container 1 . 3. The shape and structure of the heart and preservation solution storage container 1 are shown in Figure 5. It is composed of a sandwich structure rigid body made of transparent plastic that can be installed with a temperature-regulating device and a flexible cover 2 made of plastic film. The body is a cylinder. body, and its combined surface with the membrane lung is an arc surface. 4. The shell 17 of the membrane lung 6 is an arc-shaped column. As shown in FIG. It is a hook and a hanging cover arranged on the combination surface.