CN1339975A - Mobile hart-lung machine - Google Patents

Abstract

Translated fromChinese

本发明涉及一种用于通过接管或支持心肺功能来维持循环的便携式心肺机,其具有至少一根静脉血管(5)、血液泵(8)、充氧器(9)、动脉血过滤器(15)、动脉血管(4)以及管状血液循环系统(7)、自动控制系统(24)和自足式电源电压,为了能够以简单方式操纵心肺机,一方面使血液循环的元件(4、5、6、7、8、9、15、18、21)接收生物化学和生理信号并执行控制命令,另一方面自动控制元件(23、24、27、28、29、30、31、32)被设置在两个独立模件(2、3)且能被结合在一起以形成一个功能单元。

The invention relates to a portable heart-lung machine for maintaining circulation by taking over or supporting cardiopulmonary functions, having at least one venous vessel (5), a blood pump (8), an oxygenator (9), an arterial blood filter ( 15), the arterial vessels (4) as well as the tubular blood circulation system (7), the automatic control system (24) and the self-contained supply voltage, in order to be able to operate the heart-lung machine in a simple manner, on the one hand the elements of the blood circulation (4, 5, 6, 7, 8, 9, 15, 18, 21) receive biochemical and physiological signals and execute control commands, on the other hand automatic control elements (23, 24, 27, 28, 29, 30, 31, 32) are set In two independent modules (2, 3) and can be combined together to form a functional unit.

Description

Translated fromChinese

便携式心肺机Portable Heart Lung Machine

本发明涉及一种根据权利要求1前序部分所述的用于维持血液循环的心肺机。The invention relates to a heart-lung machine for maintaining blood circulation according to the preamble ofclaim 1 .

为了维持人体的血液循环，利用带有套管的心肺机从人体抽走缺氧的静脉血，并通过血液泵将其输送至充氧器，从而避免或消除由于事故或其它器官衰竭而在手术期间出现的血液循环停止或灌注缺乏。在执行人工肺功能的充氧机中，血液被补充了氧并且除去了CO₂。随后，在动脉血过滤器中进行清洗之后，富氧的动脉血通过套管被输送回病人的血液循环系统中。这类心肺机在医院中被用作固定使用。例如在WO99/59654(CARDIOVENTION)中披露了这种固定式心肺机。它包括设置在病人周围的无菌区域中的整体式充氧器和泵单元，以及在无菌区域外面并通过连接电缆与所述单元相连的控制台。该控制台具有控制装置以及用于泵和充氧器的驱动装置。In order to maintain the blood circulation of the human body, a heart-lung machine with a cannula is used to draw hypoxic venous blood from the human body and deliver it to the oxygenator through a blood pump, thereby avoiding or eliminating accidents or other organ failure during surgery cessation of blood circulation or lack of perfusion during this period. In an oxygenator that performs the function of an artificial lung, the blood is supplemented with oxygen and CO₂ is removed. Subsequently, after washing in the arterial blood filter, the oxygen-enriched arterial blood is returned to the patient's blood circulation system through the cannula. This type of heart-lung machine is used in hospitals for stationary use. Such a stationary heart-lung machine is disclosed, for example, in WO99/59654 (CARDIOVENTION). It consists of an integral oxygenator and pump unit placed in a sterile field around the patient, and a console outside the sterile field and connected to the unit by a connecting cable. The console has controls and drives for the pump and oxygenator.

DE 43 43 334 A1披露了一种便携使用的心肺机。它具有支撑结构，其在前面和背面设有提手，并设有向下延伸的站立脚。为了使心肺机的组成部件固定，设有相应的紧固装置。就这种机器而言，功能重要的元件设置成它们可自由地接近并且因此未受到保护而被损坏，这样会削弱使用过程中的可靠性。另外，该机器必须总是由两个人来搬运。DE 43 43 334 A1 discloses a heart-lung machine for portable use. It has a support structure with carrying handles on the front and back and downward extending standing feet. In order to fix the components of the heart-lung machine, corresponding fastening devices are provided. In the case of such machines, functionally important elements are arranged in such a way that they are freely accessible and thus unprotected from damage, which impairs reliability during use. In addition, the machine must always be handled by two people.

DE197 02 098 A1也披露了一种便携式心肺机。该心肺机包括：一用于将血液输送到动脉的回路；一用于从静脉中提取血的第二回路；一静脉血存储容器；一充氧器；一被设计为滚子泵的血液泵；及一形式为在驱动侧与泵相连的氧气浓缩器的氧气分配器。该机器具有一用于控制氧气浓缩器和泵的输送速度的控制器，还具有用于分散的能量供给源和/或电能存储器的连接件。虽然该心肺机也有可移动使用，但是由于其尺寸和重量的原因，因此这种心肺机通常不能由一个人操纵。由于在救护车中的空间有限，所以实际上不可能在紧急出动的情况在随时进行手术的状态下携带这种机器。在紧急出动中所要求的紧急性使长时间安装和准备都成为缺点。另外，在每一次使用之后，在再次使用之前上述心肺机必须以复杂的程序进行重新安装和清洗。结果，立即重新使用是不可能的。DE 197 02 098 A1 also discloses a portable heart-lung machine. The heart-lung machine includes: a circuit for delivering blood to an artery; a secondary circuit for drawing blood from a vein; a venous blood storage container; an oxygenator; a blood pump designed as a roller pump ; and an oxygen distributor in the form of an oxygen concentrator connected to the pump on the drive side. The machine has a controller for controlling the delivery rate of the oxygen concentrator and the pump, as well as connections for a decentralized energy supply source and/or an electrical energy store. Although the heart-lung machine is also available for mobile use, due to its size and weight, such a heart-lung machine cannot usually be operated by one person. Due to the limited space in an ambulance, it is practically impossible to carry such a machine in ready-to-operate condition in an emergency situation. The urgency required in emergency operations makes long installation and preparation times a disadvantage. Furthermore, after each use, the aforementioned heart-lung machine must be reinstalled and cleaned in a complex procedure before being used again. As a result, immediate reuse is impossible.

WO97/16213(BAXTER)已经披露了一种便携式心肺机，其中包括血液泵、热交换器和充氧器的血液循环元件被容纳在试图用于一次性使用的装置中，并且泵马达被容纳在可重复使用的驱动装置中。这种供一次性使用的装置通过从所述驱动装置高高凸起的连接部件、由力锁合件与驱动装置连接。其它连接件与独立的驱动和自动控制装置一起存在。用于将相应的管子与该装置连接的连接件是暴露的并且容易受到损坏或干扰，尤其在移动使用中。WO97/16213 (BAXTER) has disclosed a portable heart-lung machine in which the blood circulation elements including the blood pump, heat exchanger and oxygenator are housed in a device intended for single use and the pump motor is housed in in a reusable drive unit. This single-use device is connected to the drive unit by a non-positive locking element via a connecting part protruding high from the drive unit. Other connections exist with separate drives and automatic controls. The connections for connecting the respective tubes to the device are exposed and susceptible to damage or tampering, especially in mobile use.

因此，本发明的目的在于提供一种在一开始处所述的那种类型的便携式心肺机，该心肺机能够被广泛使用并且能够被可靠且容易地操纵。It is therefore the object of the present invention to provide a portable heart-lung machine of the type mentioned at the outset, which can be used widely and which can be handled reliably and easily.

该目的可以由权利要求1的主题来实现的。其被分成具有使血液循环，接收生化和生理信号并且执行控制信号的元件的模件(“一次性模件”)以及具有驱动和自动控制元件的模件(“可重复使用模件”)，这种组成允许在使用之后快速更换供一次性使用的包含血液循环元件的模件，这样心肺机能够快速地被再次使用。考虑到模件化，应另外设置可以随时使用且以紧凑形式制造的相应的模件。由于在使用过程中在时间紧迫的情况下不必进行复杂的操作和安装措施，所以特别在使用中能够确保较高的功能可靠性。还有，血液循环元件在紧凑模件中组合在一起能够允许独立元件之间的管状血液循环系统的长度非常短，因此能够减小填充体积，这就对于病人来说是有利的。而且，为了尽可能地减少血液损伤，可精确地限定并设计模件中血液通道的路径和特性来提供令人满意的流动条件。在这方面，能够通过固定的血液管来连接例如可购得的部件，如充氧器、离心泵头、过滤器等。如果需要的话，可易于用其它部件来变换和替换被设计成盒子的一次性模件中的各个部件。This object is achieved by the subject-matter ofclaim 1 . It is divided into modules with elements that circulate the blood, receive biochemical and physiological signals and execute control signals (“disposable modules”) and modules with actuation and automatic control elements (“reusable modules”), This composition allows quick replacement of the single-use module containing the blood circulation element after use, so that the heart-lung machine can be used again quickly. In view of the modularization, corresponding modules which can be used at any time and are produced in a compact form should additionally be provided. Since no complicated handling and installation measures are necessary in time-critical situations during use, a high level of functional reliability can be ensured, especially during use. Also, combining the blood circulation elements together in a compact module allows very short lengths of the tubular blood circulation system between the individual elements, thus reducing the filling volume, which is advantageous for the patient. Furthermore, in order to minimize blood damage, the path and characteristics of the blood channels in the module can be precisely defined and designed to provide satisfactory flow conditions. In this respect, for example commercially available components such as oxygenators, centrifugal pump heads, filters etc. can be connected via fixed blood lines. The individual components in the disposable module designed as a cassette can be easily transformed and replaced with other components if desired.

从属权利要求涉及本发明的优选实施例。The dependent claims relate to preferred embodiments of the invention.

根据本发明，可以以简单的方式将两个模件结合在一起以形成一个单元，其中可以将它们一个安装在另一个顶部并且使它们以机械和电气方式彼此连接。因此，心肺机易于在移动使用中进行操纵并且可以由一个人携带。还可以用离心泵作为血液泵。通常用滚子泵作为血液泵。由于它们中的大量泵元件，所以它们较重且在操作过程中需要大量能量。另一方面，离心泵特别节能。另外，它们通过抽吸作用根据所产生的负压被区分。结果，如果不能通过血液单独的被动回流来确保充分的供给，则根据泵送速率吸进用于供应病人所需要的量。如果由于外部环境而尚未最恰当地进行病人的套管插入术或未能最优化地布置这些管子，则当将它们用于紧急情况时，这一点是特别重要的。According to the invention, two modules can be joined together in a simple manner to form a unit, wherein they can be mounted one on top of the other and connected to each other mechanically and electrically. Thus, the cardio-lung machine is easy to maneuver in mobile use and can be carried by one person. It is also possible to use a centrifugal pump as a blood pump. Typically a roller pump is used as the blood pump. Due to the large number of pump elements in them, they are heavy and require a lot of energy during operation. Centrifugal pumps, on the other hand, are particularly energy-efficient. In addition, they are differentiated according to the negative pressure generated by the suction action. As a result, if an adequate supply cannot be ensured by the passive return of blood alone, the volume required for supplying the patient is aspirated depending on the pumping rate. This is especially important when using them in emergency situations, if the cannulation of the patient has not been performed optimally or the tubes have not been optimally placed due to the external environment.

根据本发明，在血液流过的泵头和血液泵的泵驱动机构被分别设置在相应的模件中。在这些模件被结合在一起的情况下，泵头和泵驱动机构通过联接器相互连接。由于与血液接触的这些元件被设置在单一的设计成无菌包装装置的一次性模件中，所以能够降低供一次性使用的模件的成本以及便携式心肺机的操作成本。According to the invention, the pump head through which the blood flows and the pump drive of the blood pump are respectively arranged in corresponding modules. Where these modules are combined, the pump head and pump drive are interconnected by couplings. Since the elements in contact with blood are provided in a single disposable module designed as a sterile packaging device, the cost of the module for single use and the operating cost of the portable heart-lung machine can be reduced.

根据本发明的优选实施例，各个血液循环元件之间的连接件包括软管和/或刚性管以优化及实现标准化血流动力学效果并增加内部刚性。体外循环回路的血液循环部件和连接它们的管道通过固定或紧固装置被固定在模件壳体中。这种系统比直接插入的管连接件更可靠，并且有助于一次性模件中各个元件的刚性和更好的固定。According to a preferred embodiment of the invention, the connections between the various blood circulation elements comprise flexible and/or rigid tubes to optimize and achieve standardized hemodynamic effects and increase internal rigidity. The blood circulation components of the extracorporeal circuit and the tubing connecting them are fixed in the modular housing by fixing or fastening means. Such a system is more reliable than direct insertion tube connections and contributes to rigidity and better fixation of the individual elements in the disposable module.

已经证实，便于使至少一些血液循环元件与模件形成整体，例如注模成型件。如果血液循环系统或例如在模件中的其它血液循环元件的壳体是一次性用模件的整体部分的话，则后者能够进一步减小尺寸并且可以以整体形式生产。还可以想到使具有血液循环元件和血液循环系统的模件外壳采用盒子的形式，可以通过固定装置将可购得的血液循环元件，例如充氧器、血液泵、离心泵的泵头、动脉血过滤器等安装在该盒子中。特另被设计为用于本发明心肺机的充氧器、泵、过滤器或类似的血液循环元件与它们自己的血液管道、供气管道等使用的部件也可被安装在该例如被设计为注模成型件的盒子内。这样便允许一次性模件更加整体化和更紧凑。It has proven convenient to integrate at least some of the blood circulation elements with the molding, for example an injection molded part. The latter can be further reduced in size and can be produced in one piece if the housing of the blood circulation system or, for example, other blood circulation elements in the module is an integral part of the disposable module. It is also conceivable to have the modular housing with the blood circulation elements and the blood circulation system in the form of a box into which commercially available blood circulation elements such as oxygenators, blood pumps, pump heads of centrifugal pumps, arterial blood A filter and the like are installed in the box. Parts specially designed for the use of oxygenators, pumps, filters or similar blood circulation elements of the heart-lung machine of the present invention with their own blood lines, air supply lines, etc. Injection molded parts inside the box. This allows for a more integrated and compact disposable module.

为了在心肺机工作期间的任意时刻提供对血流的光学检验，该一次性模件具有透明的外壳。To provide optical inspection of blood flow at any time during operation of the heart-lung machine, the disposable module has a transparent housing.

已经证实接收生物化学和生理信号的元件优选传感器，这些传感器尤其能够检测血液的PH数值、血液的pCO₂、血液的pO₂、血液温度、血液流速、FiO₂、气体温度、气体流速、气体的pO₂、气体的pCO₂、水温、泵的转速或者流至泵驱动机构的当前流量。Components that have proven to receive biochemical and physiological signals are preferably sensors that are especially capable of detecting blood pH, blood pCO₂ , blood pO₂ , blood temperature, blood flow rate, FiO₂ , gas temperature, gas flow rate, gas pO₂ , pCO₂ of the gas, water temperature, pump speed or current flow to the pump drive.

根据本发明，用于检测参数的、用于指示目的和用作声音、光学或声光警报以及用于处理用于控制目的的数值的传感器与驱动和自动控制系统相连。它们尤其能自动控制血液泵的泵驱动机构，并且在与血液流量的设定点数值偏离的情况下，给出声音、光学或声光警报。这样，病人状态的任何可能的失常和/或变化都迅速且可靠地被指示出，并且可以采取适当的行动。为了监测血液流量，在不与血液接触的情况下在数量上监测血液流量的流量传感器也可以设置在动脉管上。血液泵的泵送速率优选在2升/分钟和10升/分钟之间，并且可以以无级变速的方式或以不连续递增方式通过自动控制系统对其进行控制。According to the invention, sensors for detecting parameters, for indication purposes and as audible, optical or acousto-optic alarms and for processing values for control purposes are connected to the drive and automatic control system. In particular, they automatically control the pump drive of the blood pump and give an audible, optical or acousto-optic alarm in the event of a deviation from a setpoint value for the blood flow. In this way, any possible disturbances and/or changes in the patient's state are quickly and reliably indicated and appropriate actions can be taken. In order to monitor the blood flow, flow sensors which quantitatively monitor the blood flow without coming into contact with the blood can also be arranged on the arterial line. The pumping rate of the blood pump is preferably between 2 liters/minute and 10 liters/minute and can be controlled by an automatic control system either in a continuously variable manner or in discrete increments.

根据本发明另一个实施例，可由外侧操纵的可封闭式填充和排放口被设置在位于血液泵上游的用于接收静脉血的存储容器、动脉血过滤器和/或充氧器上，从而允许存储容器能够在该心肺机开始工作时彻底且简单地被填充和排放。它们特别适用于引动溶液或药剂(例如用于降低凝结作用的肝素)的输入。存储容器在该情况中可以被设计成袋。这种存储容器用作缓冲器，以便补偿变化的血液的流进和流出。袋的使用使得存储容器能够以简单的方式与分别接收的血液量相适应。According to another embodiment of the invention, a sealable fill and drain port operable from the outside is provided on the storage container for receiving venous blood, the arterial blood filter and/or the oxygenator upstream of the blood pump, thereby allowing The storage container can be completely and simply filled and drained when the heart-lung machine is started. They are particularly suitable for priming the infusion of solutions or agents such as heparin for reducing clotting. The storage container can in this case be designed as a bag. Such a storage container acts as a buffer in order to compensate for varying blood inflows and outflows. The use of bags enables the storage container to be adapted in a simple manner to the blood volume respectively received.

根据本发明，在充氧器上可以设有温度控制装置，例如可采用热交换器的形式，该热交换器可以通过水来操作并且血液从该热交换器中流过，以便在将血液输送回病人身体之前按要求控制血液的温度。According to the invention, temperature control means may be provided on the oxygenator, for example in the form of a heat exchanger which may be operated by water and through which blood flows, in order to return the blood to the The patient's body previously controlled the temperature of the blood as required.

预填充的引动溶液的作用在于，心肺机在循环操作中与病人相连之前，完全排空心肺机并使其保持在随时待命的状态。为此，血液循环系统具有预旁路过滤器，该过滤器被连接作为动脉管和静脉管之间的旁路，并且引动溶液在它被操纵用于病人之前通过该旁路进行循环。另外，在动脉过滤器可能堵塞的情况下，能够通过可从外面操纵的旁路来保持血液循环。The purpose of the pre-filled priming solution is to completely drain the heart-lung machine and keep it ready for use before it is connected to a patient in cycling operation. For this purpose, the blood circulation system has a pre-bypass filter which is connected as a bypass between the arterial line and the venous line and through which the priming solution is circulated before it is administered to the patient. In addition, blood circulation can be maintained by an externally operable bypass in the event of possible clogging of the arterial filter.

在本发明思想的改进中，自动控制系统具有用于与用户进行对话的输入装置和输出装置，尤其有按钮/控制件和/或显示器，还有用于在该心肺机工作过程中进行初始化和功能控制的程序，以便确保简单的操作控制。In a refinement of the inventive concept, the automatic control system has input and output devices for dialogue with the user, in particular buttons/controls and/or displays, and also for initialization and functioning during operation of the heart-lung machine Controlled procedures in order to ensure easy operational control.

自足式电源电压根据本发明可被设计为蓄电池，并且具有用于指示其充电状态的指示器。因此能够及时地探测该蓄电池的即将发生的放电，以便如果需要采取措施提供外部电源。在此期间，该泵可以用机械手动曲柄来操纵。According to the invention, the self-contained supply voltage can be designed as an accumulator and have an indicator for its state of charge. An imminent discharge of the accumulator can thus be detected in good time so that measures can be taken to provide an external power supply if necessary. During this time, the pump can be operated with a mechanical hand crank.

该心肺机最好还具有用于连接外部电源的连接件，以使蓄电池能够例如在救护车中进行充电或允许在蓄电池已耗尽的情况下时用外部电源进行操作。The heart-lung machine preferably also has a connection for an external power source, so that the accumulator can be charged, for example in an ambulance, or it can be operated with an external power source when the accumulator is depleted.

下面，将根据在附图中所示的说明性实施例对本发明进行详细地说明，其中：In the following, the invention will be described in detail according to illustrative embodiments shown in the accompanying drawings, in which:

图1显示了从本发明的便携式心肺机的上方倾斜看去的视图，它具有彼此隔开的模件。Figure 1 shows an oblique view from above of a portable heart-lung machine according to the invention, with modules spaced apart from each other.

图2显示了在图1中所示的心肺机的视图，该心肺机具有结合在一起的模件；Figure 2 shows a view of the heart-lung machine shown in Figure 1 with the modules joined together;

图3显示了图1中心肺机的血液循环元件的示意图；Figure 3 shows a schematic diagram of the blood circulation components of the heart-lung machine of Figure 1;

图4显示了图1中心肺机的正视图；Fig. 4 shows the front view of the center-lung machine of Fig. 1;

图5显示了从在图1中所示的心肺机上方所示的视图，及Figure 5 shows a view from above the heart-lung machine shown in Figure 1, and

图6显示了图1的心肺机的侧视图。FIG. 6 shows a side view of the heart-lung machine of FIG. 1 .

在图1中所示的便携式心肺机1包括两个独立的模件2和3。容纳在预定用作一次性使用的第一模件2(“一次性模件”)中的元件能使血液循环，接收生物化学和生理信号且执行控制命令，容纳在可重复使用的第二模件3中的是驱动和控制元件。这两个模件2和3能被结合在一起形成一个功能单元，它们通过固定元件(未示出)(参照图2)将一个模件安装在另一个模件的顶部且以机械方式彼此相连，同时相互电气联接。在结合在一起的状态下，心肺机1在被填充了引动溶液之后便可随时使用，并且能够通过动脉管和静脉管4和5连接至被供给的病人的血液循环。The portable heart-lung machine 1 shown in FIG. 1 comprises twoseparate modules 2 and 3 . Components housed in afirst module 2 intended for single use (“disposable module”), capable of circulating blood, receiving biochemical and physiological signals and executing control commands, housed in a reusable second module Item 3 is the drive and control element. The twomodules 2 and 3 can be joined together to form a functional unit, which are mounted one on top of the other and mechanically connected to each other by fixing elements (not shown) (cf. Figure 2) , while being electrically connected to each other. In the combined state, the heart-lung machine 1 is ready for use after being filled with a priming solution and can be connected via the arterial andvenous lines 4 and 5 to the blood circulation of the supplied patient.

根据图3的示意图说明一次性模件2的结构和操作模式。病人的缺氧血通过静脉管5流至装有血液循环元件的心肺机1的模件2。在这种情况下静脉管5与用于接收静脉血的封闭式存储容器6相连。且通过血液循环系统7，存储容器6通过血液泵8与用于给血液补氧和用于消除二氧化碳的充氧器9相连。气体连接件10经过过滤器11通入充氧器9，并且用于与外部气体源相连。因此，能够依靠移动式氧气和二氧化碳罐或医院用氧气供应系统而在充氧器9中进行气体交换。在充氧器9上还设有温度控制装置12，温度控制介质流经回路13流过温度控制装置。为了控制血液的温度，血液循环系统7具有伸入温度控制装置12的部分14。在血液循环系统7中的充氧器9的下游设有用于净化血液的动脉血过滤器15。在动脉血过滤器15周围设有支管16，支管16可通过一个阀门17由外侧操纵，以允许即使在动脉血过滤器15堵塞的可能情况下也能维持血液循环。用于使血液返回至病人的动脉血管4与动脉血过滤器15相连。为了非接触地监测血液的流量，在动脉血管4上设有一流量传感器18，该传感器用于探测血液流量和将其通知自动控制系统24。The structure and mode of operation of thedisposable module 2 are explained on the basis of the schematic diagram in FIG. 3 . The hypoxic blood of the patient flows through thevenous tube 5 to themodule 2 of the heart-lung machine 1 equipped with blood circulation components. In this case thevenous line 5 is connected to aclosed storage container 6 for receiving venous blood. And through theblood circulation system 7 , thestorage container 6 is connected with theoxygenator 9 for oxygenating the blood and eliminating carbon dioxide through theblood pump 8 . Agas connection 10 leads into theoxygenator 9 via afilter 11 and is intended to be connected to an external gas source. Thus, gas exchange in theoxygenator 9 can be carried out by means of a portable oxygen and carbon dioxide tank or a hospital oxygen supply system. Atemperature control device 12 is also provided on theoxygenator 9, and the temperature control medium flows through thecircuit 13 and flows through the temperature control device. To control the temperature of the blood, theblood circulation system 7 has a section 14 protruding into thetemperature control device 12 . Anarterial blood filter 15 for purifying the blood is provided downstream of theoxygenator 9 in theblood circulation system 7 . Around thearterial blood filter 15 there is abranch line 16 which can be actuated from the outside by means of avalve 17 in order to allow blood circulation to be maintained even in the event of a possible clogging of thearterial blood filter 15 . Thearterial blood vessel 4 for returning blood to the patient is connected to anarterial blood filter 15 . In order to monitor the blood flow in a non-contact manner, aflow sensor 18 is provided on thearterial vessel 4 which detects the blood flow and communicates it to anautomatic control system 24 .

图4显示了具有一次性模件2的心肺机1的正视图，该心肺机具有血液循环元件以及带有驱动和控制元件的可重复使用的模件3。具有温度控制装置12的充氧器9位于一次性模件2底部。设计为袋子的用于容纳静脉血的存储容器6设置在倾斜固定件19上的充氧器9上方。血液泵8与充氧器9一起位于模件2的底部上。该血液泵被设计为离心泵，且具有一个泵头21，该泵头通过联接器22与设置在可重复使用的模件3中的泵驱动机构23相连。联接器22是一种电磁联接器。动脉血过滤器15设置在血液泵8上方，过滤器与动脉血管4相连并且在其上设有带有阀门17的支管16。非接触流量传感器18正好设置在动脉血管4离开模件2的位置前面。这些血液循环元件通过血液循环系统7的导管相互联接。Figure 4 shows a front view of a heart-lung machine 1 with adisposable module 2 with blood circulation elements and a reusable module 3 with drive and control elements. Anoxygenator 9 with atemperature control device 12 is located at the bottom of thedisposable module 2 . Astorage container 6 designed as a bag for containing venous blood is arranged above theoxygenator 9 on aninclined mount 19 . Theblood pump 8 is located on the bottom of themodule 2 together with theoxygenator 9 . The blood pump is designed as a centrifugal pump and has apump head 21 which is connected via acoupling 22 to a pump drive 23 arranged in the reusable module 3 . Thecoupler 22 is an electromagnetic coupler. Thearterial blood filter 15 is arranged above theblood pump 8 , the filter is connected to thearterial blood vessel 4 and abranch pipe 16 with avalve 17 is provided thereon. Thenon-contact flow sensor 18 is arranged just in front of the position where thearterial vessel 4 leaves themodule 2 . These blood circulation elements are connected to one another via conduits of theblood circulation system 7 .

带有按钮25和显示器26的自动控制系统24设置在可重复使用的模件3中。按钮25和显示器26还可以设计成接触屏式。除了自动控制系统24之外，在模件3上设有：一用于指示蓄电池充电状态的指示器27，用于手动地控制离心泵8的泵送速度的控制器28和转速指示器29，还有用于与外部电源电压连接的连接件30。还设有一中央开/闭开关31和一指示灯32。另外，模件3具有用于自足式电源的蓄电池(未示出)。Anautomatic control system 24 withbuttons 25 and adisplay 26 is provided in the reusable module 3 . Thebutton 25 and thedisplay 26 can also be designed as a touch screen. In addition to theautomatic control system 24, the module 3 is provided with: anindicator 27 for indicating the state of charge of the storage battery, acontroller 28 and arotational speed indicator 29 for manually controlling the pumping speed of thecentrifugal pump 8, There is also aconnection 30 for connection to an external supply voltage. A central on/offswitch 31 and anindicator light 32 are also provided. In addition, the module 3 has an accumulator (not shown) for a self-contained power supply.

一次性模件2具有透明的模件外壳33，而具有驱动和控制元件的可重复使用的模件3具有不透明的模件外壳34。提手35安装在一次性模件2的透明模件外壳33的顶面。Thedisposable module 2 has atransparent module housing 33 , while the reusable module 3 with drive and control elements has anopaque module housing 34 . Thehandle 35 is mounted on the top surface of thetransparent module housing 33 of thedisposable module 2 .

图5以平面图显示了设置在一次性模件2中的血液循环元件。静脉血管5与存储容器6相连。通过血液循环系统7，存储容器6经过血液泵8与充氧器9(未示出)相连，该充氧器的出口通过动脉血过滤器15通入动脉血管4中。FIG. 5 shows the blood circulation element arranged in thedisposable module 2 in plan view. Thevenous vessel 5 is connected to astorage container 6 . Via ablood circulation system 7 , thestorage container 6 is connected via ablood pump 8 to an oxygenator 9 (not shown), the outlet of which opens into thearterial vessel 4 via anarterial blood filter 15 .

在图6中，从侧面表示出心肺机1，它具有用于连接动、静脉血管4和5的连接件。还可以看见温度控制装置12中回路13的出口以及还有带有过滤器11的气体连接件10。未示出的是在图3中示意性显示出的连接导管36，它具有在静脉血管4和动脉血管5之间的预旁路过滤器37。通过打开未示出的且能够从外侧操纵的关闭件并通过同时夹住切断管4和5，能够完成血液循环元件的内部循环。在将心肺机1连接至病人之前的这种循环操作中，通过存储容器6上的排放阀38和40能够使血液循环元件完全排空。为此，排放管39也与动脉血过滤器15和充氧器9相连。In FIG. 6 , a heart-lung machine 1 is shown from the side, which has connection elements for connecting arterial andvenous vessels 4 and 5 . Also visible is the outlet of thecircuit 13 in thetemperature control device 12 and also thegas connection 10 with thefilter 11 . Not shown is the connecting line 36 shown schematically in FIG. 3 , which has a pre-bypass filter 37 between thevenous vessel 4 and thearterial vessel 5 . The internal circulation of the blood circulation element can be accomplished by opening a closure (not shown) which can be actuated from the outside and by simultaneously clamping the shut-offtubes 4 and 5 . During this cycle operation before connecting the heart-lung machine 1 to the patient, the blood circulation element can be completely emptied via thedrain valves 38 and 40 on thestorage container 6 . To this end, thedischarge line 39 is also connected to thearterial blood filter 15 and theoxygenator 9 .

上述便携式心肺机1的操作模式如下：The operation modes of the above-mentioned portable heart-lung machine 1 are as follows:

在便携式心肺机1的工作期间，缺氧血经过静脉血管5流入存储容器6。通过静脉血管5和/或存储容器6上的阀38、40能够实现引动溶液、药剂等的输送。通过离心泵8从存储容器6将血液泵送进对血液补充氧的充氧器9中。在充氧器9中的气体交换过程中，血液流经能够控制血液温度的温度控制装置12。为此，能够将最好是水的温度控制介质通过回路13、从外面送入温度控制装置12中。经过气体连接件10将氧气或氧气混合物引入充氧器9内。一旦已经对血液补充完氧，血液便流经动脉血过滤器15以便进行净化，所述动脉血过滤器装配有支管16。如果在工作期间动脉血过滤器15被堵住，则可手动将支管16打开以便维持病人的血液循环。随后，通过动脉血管4、经流量传感器18使血液输送回病人。During operation of the portable heart-lung machine 1 , oxygen-poor blood flows into thestorage container 6 via thevenous blood vessel 5 . Delivery of priming solutions, medicaments, etc. can be achieved via thevalves 38 , 40 on thevenous vessel 5 and/or thestorage container 6 . The blood is pumped from thestorage container 6 by means of acentrifugal pump 8 into anoxygenator 9 which oxygenates the blood. During the gas exchange in theoxygenator 9, the blood flows through atemperature control device 12 capable of controlling the temperature of the blood. For this purpose, a temperature control medium, preferably water, can be fed into thetemperature control device 12 from outside via thecircuit 13 . Oxygen or an oxygen mixture is introduced into theoxygenator 9 via thegas connection 10 . Once the blood has been oxygenated, it passes through anarterial blood filter 15 equipped with abranch 16 for purification. If thearterial blood filter 15 is blocked during operation, thebranch tube 16 can be manually opened in order to maintain the patient's blood circulation. The blood is then conveyed back to the patient via thearterial vessel 4 via theflow sensor 18 .

流量传感器18测量出动脉血管4中的血液流量，并且它通过电插入接触件20(参照图1)与便携式心肺机1的自动控制系统24相连。根据所测量的流量，自动控制系统24控制泵驱动机构23。当达到临界值时，自动控制系统24产生相应的声音、光学或声光警报。Theflow sensor 18 measures the blood flow in thearterial vessel 4 and it is connected to theautomatic control system 24 of the portable heart-lung machine 1 via electrical insertion contacts 20 (cf. FIG. 1 ). Based on the measured flow, anautomatic control system 24 controls the pump drive mechanism 23 . When a critical value is reached, theautomatic control system 24 generates a corresponding sound, light or acousto-optic alarm.

另外设置在一次性模件2中的还有用于接收生物化学或生理信号的传感器(未示出)，这些传感器用来监测心肺机1的功能。这些传感器的信号通过类似于插入式接触件20的接触件被传送到自动控制系统24，从而对于所有接触件而言也能在多插头中被集合在一起。这就能够更易于将两个模件2和3结合在一起。用于执行控制信号的元件，如电动阀也可被设置在一次性模件2中，且可通过电接触件由自动控制系统24被触发。Also provided in thedisposable module 2 are sensors (not shown) for receiving biochemical or physiological signals, which are used to monitor the function of the heart-lung machine 1 . The signals of these sensors are transmitted to theautomatic control system 24 via contacts similar to the plug-in contacts 20 so that all contacts can also be combined together in the multiplug. This makes it easier to join the twomodules 2 and 3 together. Elements for implementing control signals, such as electric valves, can also be provided in thedisposable module 2 and can be activated by theautomatic control system 24 via electrical contacts.

为了使病人脱离心肺机1，通过自动控制系统24连续降低血液泵8的泵送速度同时检测并配合心脏的填充状态。只要病人重新处于稳定状态，才能够随后关闭心肺机1。在关闭之后，带有血液循环元件的一次性模件2能够通过松开紧固件以简单方式、由带有驱动和控制元件的可重复使用的模件3分离，并且能够用新的无菌一次性模件2来替换。在关闭紧固件并填充引动溶液之后，心肺机1可随时再次被使用。In order to remove the patient from the heart-lung machine 1, the pumping speed of theblood pump 8 is continuously reduced by theautomatic control system 24 while detecting and matching the filling state of the heart. The heart-lung machine 1 can then be switched off only once the patient is in a stable state again. After closing, thedisposable module 2 with blood circulation elements can be separated in a simple manner by loosening the fasteners from the reusable module 3 with drive and control elements and can be replaced with a new sterileDisposable module 2 to replace. After closing the fastener and filling the priming solution, the heart-lung machine 1 can be used again at any time.

这样便提供了一种便携式心肺机1，该心肺机根据其模件式结构包括一次性模件2和一可重复使用模件3，该心肺机能够迅速投入使用并且由于这两个模件2和3的紧凑性，所以能够由一个人来操纵，因此特别适用于紧急使用。This provides a portable heart-lung machine 1 which, according to its modular structure, comprises adisposable module 2 and a reusable module 3, which can be put into use quickly and thanks to the twomodules 2 And 3's compactness, so it can be operated by one person, so it is especially suitable for emergency use.

通过加设用于排放、抽吸和使心脏稳定的抽吸装置/心麻痹处理系统，该便携式心肺机1也适用于在医院中固定使用，例如用于心脏外科手术。The portable heart-lung machine 1 is also suitable for stationary use in hospitals, for example for cardiac surgery, by adding a suction device/cardioplegic treatment system for venting, suctioning and stabilizing the heart.

Claims (14)

Translated fromChinese

1.一种便携式心肺机，用于通过接管或支持心肺功能来维持循环，它具有至少一根静脉血管(5)、一个血液泵(8)、一个充氧器(9)、一个动脉血过滤器(15)、一根动脉血管(4)，以及一个管状血液循环系统(7)、一个自动控制系统(24)和自足式电源，其特征在于，一方面能使血液循环的元件(4、5、6、7、8、9、15、18、21)接收生物化学和生理信号，并且执行控制命令，另一方面所述驱动和自动控制元件(23、24、27、28、29、30、31、32)被设置在两个分离的模件(2、3)中并且能被结合在一起以形成一个功能单元。1. A portable heart-lung machine for maintaining circulation by taking over or supporting cardiopulmonary function, it has at least one venous vessel (5), a blood pump (8), an oxygenator (9), an arterial blood filter device (15), an arterial vessel (4), and a tubular blood circulation system (7), an automatic control system (24) and a self-contained power supply, it is characterized in that, on the one hand, the elements (4, 5, 6, 7, 8, 9, 15, 18, 21) receive biochemical and physiological signals, and execute control commands, on the other hand, the driving and automatic control elements (23, 24, 27, 28, 29, 30 , 31, 32) are set in two separate modules (2, 3) and can be combined to form a functional unit.2.根据权利要求1所述的心肺机，其特征在于，被结合在一起的模件(2、3)能够将一个模件安装在另一个模件的顶部且它们能够以机械和电气方式彼此连接在一起。2. A heart-lung machine according to claim 1, characterized in that the modules (2, 3) being joined together enable one module to be mounted on top of the other and they can be mechanically and electrically connected to each other connected together.3.根据权利要求1或2所述的心肺机，其特征在于，血液泵(8)的血液循环部件，特别是离心泵的泵头(21)被一体形成在具有使血液循环、接收生物化学和生理信号且执行控制命令的元件(4、5、6、7、8、9、15、18、21)的模件(2)(“一次性模件”)中，并且所述血液泵的泵驱动机构(23)一体成形在具有驱动和自动控制元件(23、24、27、28、29、30、31、32)的模件(3)(“可重复使用的模件”)中，并且当这两个模件(2、3)合并在一起时它们可以通过连接件(22)彼此相连。3. The heart-lung machine according to claim 1 or 2, characterized in that the blood circulation components of the blood pump (8), especially the pump head (21) of the centrifugal pump, are integrally formed with the functions of making blood circulate, receiving biochemical and physiological signals and elements (4, 5, 6, 7, 8, 9, 15, 18, 21) that execute control commands (2) (“disposable modules”), and the blood pump’s the pump drive mechanism (23) is integrally formed in a module (3) ("reusable module") with drive and automatic control elements (23, 24, 27, 28, 29, 30, 31, 32), And when these two modules (2, 3) are merged together they can be connected to each other by connecting piece (22).4.根据权利要求1至3中任一条所述的心肺机，其特征在于，各个血液循环元件之间的连接件包括软管和/或刚性管以优化血流动力学效果并使其实现标准化，且能够增加内部刚性。4. A heart-lung machine according to any one of claims 1 to 3, characterized in that the connections between the individual blood circulation elements comprise flexible and/or rigid tubes to optimize and standardize the hemodynamic effect , and can increase the internal rigidity.5.根据权利要求1至4中任一条所述的心肺机，其特征在于，体外循环回路的血液循环元件以及连接它们的导管通过固定或紧固装置被设置和/或固定在模件外壳中。5. The heart-lung machine according to any one of claims 1 to 4, characterized in that the blood circulation elements of the extracorporeal circulation circuit and the conduits connecting them are arranged and/or fixed in the modular housing by fixing or fastening means .6.根据权利要求1至5中任一条所述的心肺机，其特征在于，至少一部分血液循环元件(4、5、6、7、8、9、15、21)与一次性模件(2)一体成形，特别形成为一种整体注射成型件。6. The heart-lung machine according to any one of claims 1 to 5, characterized in that at least a part of the blood circulation elements (4, 5, 6, 7, 8, 9, 15, 21) and the disposable module (2 ) are integrally formed, in particular formed as an integral injection molded part.7.根据权利要求1至6中任一条所述的心肺机，其特征在于，所述一次性模件(2)具有透明的模件外壳(33)。7. The heart-lung machine according to any one of claims 1 to 6, characterized in that the disposable module (2) has a transparent module housing (33).8.根据权利要求1至7中任一条所述的心肺机，其特征在于，接收生物化学和生理信号的元件是这样的传感器，其特别能够探测血液PH值、血液的pCO₂、血液的pO₂、血液温度、血液流速、FiO₂、气体温度、气体流速、气体的pO₂、气体的pCO₂、水温、泵的转速或者流到泵驱动机构的当前流量。8. The heart-lung machine according to any one of claims 1 to 7, characterized in that the element receiving biochemical and physiological signals is a sensor which is particularly capable of detecting blood pH, blood pCO₂ , blood pO_2. Blood temperature, blood flow rate,_FiO2 , gas temperature, gas flow rate,_pO2 of gas,_pCO2 of gas, water temperature, pump speed or current flow to the pump drive mechanism.9.根据前面权利要求中任一条所述的心肺机，其特征在于，用于探测参数，用于指示目的和用作声音、光学或声光警报以及用于处理控制目的值的传感器(18)与驱动和自动控制系统(24)相连。9. Heart-lung machine according to any one of the preceding claims, characterized by sensors (18) for detecting parameters, for indication purposes and as audible, optical or acousto-optic alarms and for processing values for control purposes Link to drive and automatic control system (24).10.根据前面权利要求中任一条所述的心肺机，其特征在于，可由外侧操纵的可封闭式填充口和排放口(38，40)被设置在位于血液泵(8)上游的用于接收静脉血的存储容器(6)、动脉血过滤器(15)和/或充氧器(9)上。10. Heart-lung machine according to any one of the preceding claims, characterized in that sealable fill and drain ports (38, 40) actuatable from the outside are arranged upstream of the blood pump (8) for receiving Storage container (6) for venous blood, arterial blood filter (15) and/or oxygenator (9).11.根据权利要求1至10中任一条所述的心肺机，其特征在于，血液循环系统(7)具有一旁路过滤器(37)，该过滤器被连接作为静脉血管(5)和导向病人的动脉血管(4)之间的支管，并且引动溶液在它被操纵用于病人之前循环通过该旁路过滤器。11. The heart-lung machine according to any one of claims 1 to 10, characterized in that the blood circulation system (7) has a bypass filter (37) which is connected as a venous vessel (5) and leads to the patient The branch line between the arterial vessels (4) and induce the solution to circulate through the bypass filter before it is manipulated for the patient.12.根据权利要求1至11中任一条所述的心肺机，其特征在于，自动控制系统(24)具有用于与使用者进行对话的一个输入装置和一个输出装置，尤其应具有按钮/控制件(25，28)和/或显示屏(26)，以及一用于在心肺机(1)工作期间进行初始化和功能控制的程序。12. The heart-lung machine according to any one of claims 1 to 11, characterized in that the automatic control system (24) has an input device and an output device for dialogue with the user, in particular buttons/controls components (25, 28) and/or display (26), and a program for initialization and function control of the heart-lung machine (1) during operation.13.根据权利要求1至12中任一条所述的心肺机，其特征在于，自足式电源包括一蓄电池和用于指示充电状态的指示器(27)。13. Heart-lung machine according to any one of claims 1 to 12, characterized in that the self-contained power supply comprises a battery and an indicator (27) for indicating the state of charge.14.根据权利要求1至13中任一条所述的心肺机，其特征在于，设有用于外部电源的连接件(30)。14. Heart-lung machine according to any one of claims 1 to 13, characterized in that a connection (30) for an external power supply is provided.

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