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CN114858494B - A ventricular assist device testing method and a ventricular assist device testing system - Google Patents

A ventricular assist device testing method and a ventricular assist device testing system Download PDF

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CN114858494B
CN114858494B CN202210364292.1A CN202210364292A CN114858494B CN 114858494 B CN114858494 B CN 114858494B CN 202210364292 A CN202210364292 A CN 202210364292A CN 114858494 B CN114858494 B CN 114858494B
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systemic circulation
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CN114858494A (en
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李澍
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National Institutes for Food and Drug Control
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    • G01MTESTING STATIC OR DYNAMIC BALANCE OF MACHINES OR STRUCTURES; TESTING OF STRUCTURES OR APPARATUS, NOT OTHERWISE PROVIDED FOR
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Abstract

本发明公开了一种心室辅助装置测试方法及心室辅助装置测试系统,其中一种心室辅助装置测试方法,包括步骤:调节左心室模块以及体循环模块,以使模拟心率、模拟心输出量、模拟体循环阻力以及模拟体循环顺应性在预设范围内;接入心室辅助装置;调节心室辅助装置以及体循环模块,以令模拟体循环阻力以及模拟体循环顺应性在要求范围内;记录总流量、模拟主动脉平均压以及模拟心房压数据作为辅助状态数据;将辅助状态数据与标准数据比较,以评估心室辅助装置。其能够实现对心室辅助装置评估。

The present invention discloses a ventricular assist device test method and a ventricular assist device test system, wherein a ventricular assist device test method comprises the following steps: adjusting a left ventricle module and a systemic circulation module so that the simulated heart rate, simulated cardiac output, simulated systemic circulation resistance and simulated systemic circulation compliance are within a preset range; connecting a ventricular assist device; adjusting the ventricular assist device and the systemic circulation module so that the simulated systemic circulation resistance and simulated systemic circulation compliance are within a required range; recording total flow, simulated aortic mean pressure and simulated atrial pressure data as auxiliary state data; comparing the auxiliary state data with standard data to evaluate the ventricular assist device. The ventricular assist device can be evaluated.

Description

一种心室辅助装置测试方法及心室辅助装置测试系统A ventricular assist device testing method and a ventricular assist device testing system

技术领域Technical Field

本发明涉及心室辅助装置领域,特别涉及一种心室辅助装置测试方法及心室辅助装置测试系统。The present invention relates to the field of ventricular assist devices, and in particular to a ventricular assist device testing method and a ventricular assist device testing system.

背景技术Background Art

心室辅助装置植入人体后,其工作环境是人体的血液循环系统,它们两者之间是耦合的,相互之间受到影响,所以在模拟的血液循环系统中评价左心室辅助装置的性能是最有效的办法。因此,通过建立符合人体全身各大动静脉血管及其附属毛细血管的血液流变特性生理特征的模拟循环系统,替代真实的人体对心室辅助装置进行模拟正常人体血液循环过程的测试,是心室辅助装置评价过程中的必要步骤之一。然而目前缺乏针对心室辅助装置体外性能测试的标准方法,对心室辅助装置进行评估。After the ventricular assist device is implanted in the human body, its working environment is the human blood circulation system. The two are coupled and affect each other, so the most effective way to evaluate the performance of the left ventricular assist device is in a simulated blood circulation system. Therefore, by establishing a simulated circulation system that conforms to the blood rheological characteristics of the major arteries and veins and their affiliated capillaries throughout the human body, replacing the real human body to test the ventricular assist device to simulate the normal human blood circulation process is one of the necessary steps in the evaluation process of the ventricular assist device. However, there is currently a lack of standard methods for in vitro performance testing of ventricular assist devices to evaluate ventricular assist devices.

发明内容Summary of the invention

本发明旨在至少解决现有技术中存在的技术问题之一。为此,本发明提出一种心室辅助装置测试方法,其通过模拟病理状态测试心室辅助装置,以评估心室辅助装置。The present invention aims to solve at least one of the technical problems existing in the prior art. To this end, the present invention provides a ventricular assist device testing method, which tests the ventricular assist device by simulating a pathological state to evaluate the ventricular assist device.

本发明还提出心室辅助装置测试系统,其能够提供对心室辅助装置进行测试的模拟体循环测试环境,满足测试需求。The present invention also proposes a ventricular assist device testing system, which can provide a simulated systemic circulation testing environment for testing the ventricular assist device to meet the testing requirements.

根据本发明第一方面实施例的一种心室辅助装置测试方法,包括步骤:A ventricular assist device testing method according to a first aspect of an embodiment of the present invention comprises the following steps:

调节左心室模块以及体循环模块,以使模拟心率、模拟心输出量、模拟体循环阻力以及模拟体循环顺应性在预设范围内;Adjusting the left ventricle module and the systemic circulation module so that the simulated heart rate, simulated cardiac output, simulated systemic circulation resistance and simulated systemic circulation compliance are within a preset range;

接入心室辅助装置;Access to a ventricular assist device;

调节心室辅助装置以及体循环模块,以令模拟体循环阻力以及模拟体循环顺应性在要求范围内;Adjust the ventricular assist device and the systemic circulation module to make the simulated systemic circulation resistance and simulated systemic circulation compliance within the required range;

记录总流量、模拟主动脉平均压以及模拟心房压数据作为辅助状态数据;Total flow, simulated aortic mean pressure, and simulated atrial pressure data were recorded as auxiliary status data;

将辅助状态数据与标准数据比较,以评估心室辅助装置。Compare assistance status data with standard data to evaluate ventricular assist devices.

根据本发明实施例的一种心室辅助装置测试方法,至少具有如下有益效果:调节左心室模块能够调节模拟心率、模拟心输出量,调节左心室模块以及体循环模块能够调节模拟体循环阻力以及模拟体循环顺应性,以此,使得模拟心率、模拟心输出量、模拟体循环阻力以及模拟体循环顺应性在预设范围内,达到模拟病理状态的效果。接入心室辅助装置,调节心室辅助装置与体循环模块,令模拟体循环阻力与模拟体循环顺应性在要求范围内,以此,模拟接入心室辅助装置后人体的生理反馈调节,更加接近实际应用情景。待系统稳定工作后,记录总流量、模拟主动脉平均压以及模拟心房压数据作为辅助状态数据,将辅助状态数据与标准数据比较,标准数据可以是正常人体的总流量、主动脉平均压以及心房压的数值范围,以获知接入心室辅助装置后能否将病理状态改善至正常状态,进而实现对心室辅助装置评估。A ventricular assist device testing method according to an embodiment of the present invention has at least the following beneficial effects: adjusting the left ventricular module can adjust the simulated heart rate and simulated cardiac output, and adjusting the left ventricular module and the systemic circulation module can adjust the simulated systemic circulation resistance and simulated systemic circulation compliance, so that the simulated heart rate, simulated cardiac output, simulated systemic circulation resistance and simulated systemic circulation compliance are within a preset range, achieving the effect of simulating a pathological state. Connecting the ventricular assist device, adjusting the ventricular assist device and the systemic circulation module, so that the simulated systemic circulation resistance and simulated systemic circulation compliance are within the required range, so as to simulate the physiological feedback regulation of the human body after connecting the ventricular assist device, which is closer to the actual application scenario. After the system works stably, the total flow, simulated aortic mean pressure and simulated atrial pressure data are recorded as auxiliary state data, and the auxiliary state data are compared with the standard data. The standard data can be the numerical range of the total flow, aortic mean pressure and atrial pressure of a normal human body, so as to know whether the pathological state can be improved to a normal state after connecting the ventricular assist device, thereby realizing the evaluation of the ventricular assist device.

根据本发明的一些实施例,在所述接入心室辅助装置,调节心室辅助装置以及体循环模块,以令模拟体循环阻力以及模拟体循环顺应性在要求范围内的过程中:所述模拟体循环阻力在700至1600dyne·S·cm-5范围内,所述模拟体循环顺应性在0.1至2.2mL/mmHg范围内。According to some embodiments of the present invention, during the process of accessing a ventricular assist device and adjusting the ventricular assist device and a systemic circulation module so that the simulated systemic circulation resistance and the simulated systemic circulation compliance are within the required range: the simulated systemic circulation resistance is within the range of 700 to 1600 dyne·S·cm-5, and the simulated systemic circulation compliance is within the range of 0.1 to 2.2 mL/mmHg.

根据本发明的一些实施例,在所述调节左心室模块以及体循环模块,以使模拟心率、模拟心输出量、模拟体循环阻力以及模拟体循环顺应性在预设范围内后,还包括步骤:记录总流量、模拟主动脉平均压以及模拟心房压数据作为基线状态数据;According to some embodiments of the present invention, after adjusting the left ventricle module and the systemic circulation module so that the simulated heart rate, simulated cardiac output, simulated systemic circulation resistance and simulated systemic circulation compliance are within a preset range, the steps further include: recording total flow, simulated aortic mean pressure and simulated atrial pressure data as baseline state data;

在所述记录总流量、模拟主动脉平均压以及模拟心房压数据作为辅助状态数据后,还包括步骤:撤除心室辅助装置;记录模拟心率、模拟心输出量、模拟体循环阻力以及模拟体循环顺应性数据作为回归状态数据;将回归状态数据与基线状态数据比较,以评估系统鲁棒性。After recording the total flow, simulated aortic mean pressure and simulated atrial pressure data as auxiliary state data, the method also includes the steps of: removing the ventricular assist device; recording the simulated heart rate, simulated cardiac output, simulated systemic circulation resistance and simulated systemic circulation compliance data as regression state data; and comparing the regression state data with the baseline state data to evaluate the robustness of the system.

根据本发明第二方面实施例的心室辅助装置测试系统,包括:左心室模块,设置有左心室腔,所述左心室模块包括第一驱动单元,所述第一驱动单元能够驱使所述左心室腔收缩;体循环模块,设置有体循环通道,所述体循环通道与所述左心室腔连通,所述体循环模块包括第一阻性调节件,所述第一阻性调节件能够调节所述体循环通道的流体阻力;左心房模块,设置有左心房腔,所述左心房腔分别与所述左心室腔以及所述体循环通道连通以形成体循环回路;检测模块,分别与所述左心室模块以及所述体循环模块连接,所述检测模块能够检测所述左心室模块的输入压力、所述左心室模块的输出压力以及所述体循环通道的流量。According to a second aspect of an embodiment of the present invention, a ventricular assist device testing system includes: a left ventricular module, provided with a left ventricular cavity, the left ventricular module includes a first driving unit, the first driving unit can drive the left ventricular cavity to contract; a systemic circulation module, provided with a systemic circulation channel, the systemic circulation channel is connected to the left ventricular cavity, the systemic circulation module includes a first resistive adjusting component, the first resistive adjusting component can adjust the fluid resistance of the systemic circulation channel; a left atrium module, provided with a left atrium cavity, the left atrium cavity is respectively connected to the left ventricular cavity and the systemic circulation channel to form a systemic circulation loop; a detection module, respectively connected to the left ventricular module and the systemic circulation module, the detection module can detect the input pressure of the left ventricular module, the output pressure of the left ventricular module and the flow rate of the systemic circulation channel.

根据本发明实施例的心室辅助装置测试系统,至少具有如下有益效果:由于心室辅助装置主要影响人体的体循环,因此,通过左心室模块、体循环模块以及左心房模块模拟体循环,左心室腔、体循环通道以及左心房形成体循环回路,第一驱动单元驱使左心室腔收缩,以模拟心室收缩,能够控制模拟心率、模拟心输出量的功能,体循环模块能够模拟体循环顺应性、第一阻性调节件能够模拟体循环阻力,左心房腔为左心室腔提供前负荷,以此结构,能够提供对心室辅助装置进行测试的模拟体循环测试环境,满足测试需求。The ventricular assist device test system according to the embodiment of the present invention has at least the following beneficial effects: since the ventricular assist device mainly affects the human body's systemic circulation, the systemic circulation is simulated by the left ventricular module, the systemic circulation module and the left atrial module, the left ventricular cavity, the systemic circulation channel and the left atrium form a systemic circulation loop, the first driving unit drives the left ventricular cavity to contract to simulate ventricular contraction, and can control the functions of simulating heart rate and simulating cardiac output, the systemic circulation module can simulate systemic circulation compliance, the first resistive adjustment component can simulate systemic circulation resistance, and the left atrial cavity provides preload for the left ventricular cavity. With this structure, a simulated systemic circulation test environment for testing the ventricular assist device can be provided to meet the testing requirements.

根据本发明的一些实施例,还包括心室辅助装置,所述心室辅助装置分别与所述左心室腔以及所述体循环通道连通。According to some embodiments of the present invention, a ventricular assist device is further included, and the ventricular assist device is communicated with the left ventricular cavity and the systemic circulation channel respectively.

根据本发明的一些实施例,所述左心室模块还包括第一容器以及第一单向阀,所述第一驱动单元与所述第一容器连接以形成所述左心室腔,所述第一单向阀的输入端与所述左心室腔连通,所述第一单向阀的输出端与所述体循环通道连通。According to some embodiments of the present invention, the left ventricular module also includes a first container and a first one-way valve, the first drive unit is connected to the first container to form the left ventricular cavity, the input end of the first one-way valve is connected to the left ventricular cavity, and the output end of the first one-way valve is connected to the systemic circulation channel.

根据本发明的一些实施例,所述第一驱动单元包括气缸、二位三通阀以及比例阀,所述气缸与所述第一容器连接以形成所述左心室腔,所述二位三通阀设置有第一阀口、第二阀口以及第三阀口,所述第一阀口与所述气缸连通,所述第二阀口与所述比例阀连接,所述比例阀能够与外部气源连通,所述第三阀口与外界连通,所述二位三通阀切换工位能够控制所述第一阀口与所述第二阀口连通或者所述第一阀口与所述第三阀口连通。According to some embodiments of the present invention, the first drive unit includes a cylinder, a two-position three-way valve and a proportional valve, the cylinder is connected to the first container to form the left ventricular cavity, the two-position three-way valve is provided with a first valve port, a second valve port and a third valve port, the first valve port is connected to the cylinder, the second valve port is connected to the proportional valve, the proportional valve can be connected to an external air source, the third valve port is connected to the outside world, and the switching position of the two-position three-way valve can control the first valve port to be connected to the second valve port or the first valve port to be connected to the third valve port.

根据本发明的一些实施例,所述体循环模块还包括第二容器,所述第二容器设置有第一密封腔以及与所述第一密封腔连通的第一补充阀,所述第一密封腔与所述左心室腔连通,所述第二容器通过所述第一阻性调节件与所述左心房模块连接以使得所述第一密封腔与所述左心房腔连通;所述体循环模块还包括第三容器,所述设置有第一开放性容腔,所述第二容器通过所述第一阻性调节件与所述第三容器连接以使得所述第一密封腔与所述第一开放性容腔连通,所述第一开放性容腔与所述左心房腔连通。According to some embodiments of the present invention, the systemic circulation module also includes a second container, the second container is provided with a first sealed cavity and a first replenishing valve connected to the first sealed cavity, the first sealed cavity is connected to the left ventricular cavity, the second container is connected to the left atrium module through the first resistive adjustment member so that the first sealed cavity is connected to the left atrium cavity; the systemic circulation module also includes a third container, which is provided with a first open cavity, the second container is connected to the third container through the first resistive adjustment member so that the first sealed cavity is connected to the first open cavity, and the first open cavity is connected to the left atrium cavity.

根据本发明的一些实施例,所述左心房模块包括第四容器、第二驱动单元以及第二单向阀,所述第二驱动单元与所述第四容器连接以形成所述左心房腔,所述第二驱动单元能够驱使所述左心房腔收缩,所述第二单向阀的输入端与所述左心房腔连通,所述第二单向阀的输出端与所述左心室腔连通;或者,所述左心房模块包括第四容器以及第二单向阀,所述第四容器形成所述左心房腔,所述第二单向阀的输入端与所述左心房腔连通,所述第二单向阀的输出端与所述左心室腔连通。According to some embodiments of the present invention, the left atrium module includes a fourth container, a second drive unit and a second one-way valve, the second drive unit is connected to the fourth container to form the left atrium cavity, the second drive unit can drive the left atrium cavity to contract, the input end of the second one-way valve is connected to the left atrium cavity, and the output end of the second one-way valve is connected to the left ventricle cavity; or, the left atrium module includes a fourth container and a second one-way valve, the fourth container forms the left atrium cavity, the input end of the second one-way valve is connected to the left atrium cavity, and the output end of the second one-way valve is connected to the left ventricle cavity.

根据本发明的一些实施例,还包括右心室模块、右心房模块以及肺循环模块,所述右心室模块设置有右心室腔,所述右心房模块设置有右心房腔,所述肺循环模块设置有肺循环通道,所述左心室腔、所述体循环通道、所述右心房腔、所述右心室腔、所述肺循环通道以及所述左心房腔依次连通形成人体循环回路。According to some embodiments of the present invention, it also includes a right ventricle module, a right atrium module and a pulmonary circulation module, the right ventricle module is provided with a right ventricular cavity, the right atrium module is provided with a right atrium cavity, the pulmonary circulation module is provided with a pulmonary circulation channel, the left ventricular cavity, the systemic circulation channel, the right atrium cavity, the right ventricle cavity, the pulmonary circulation channel and the left atrium cavity are connected in sequence to form a human body circulation loop.

本发明的附加方面和优点将在下面的描述中部分给出,部分将从下面的描述中变得明显,或通过本发明的实践了解到。Additional aspects and advantages of the present invention will be given in part in the following description and in part will be obvious from the following description, or will be learned through practice of the present invention.

附图说明BRIEF DESCRIPTION OF THE DRAWINGS

本发明的上述和/或附加的方面和优点从结合下面附图对实施例的描述中将变得明显和容易理解,其中:The above and/or additional aspects and advantages of the present invention will become apparent and easily understood from the description of the embodiments in conjunction with the following drawings, in which:

图1为本发明其中一种实施例的方法流程图;FIG1 is a flow chart of a method according to an embodiment of the present invention;

图2为本发明其中一种实施例的结构示意图;FIG2 is a schematic structural diagram of one embodiment of the present invention;

图3为本发明其中一种实施例中第一驱动单元的结构示意图。FIG. 3 is a schematic structural diagram of a first driving unit in one embodiment of the present invention.

具体实施方式DETAILED DESCRIPTION

下面详细描述本发明的实施例,所述实施例的示例在附图中示出,其中自始至终相同或类似的标号表示相同或类似的元件或具有相同或类似功能的元件。下面通过参考附图描述的实施例是示例性的,仅用于解释本发明,而不能理解为对本发明的限制。Embodiments of the present invention are described in detail below, examples of which are shown in the accompanying drawings, wherein the same or similar reference numerals throughout represent the same or similar elements or elements having the same or similar functions. The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain the present invention, and cannot be understood as limiting the present invention.

在本发明的描述中,需要理解的是,涉及到方位描述,例如上、下、前、后、左、右等指示的方位或位置关系为基于附图所示的方位或位置关系,仅是为了便于描述本发明和简化描述,而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作,因此不能理解为对本发明的限制。In the description of the present invention, it should be understood that descriptions involving orientations, such as up, down, front, back, left, right, etc., and orientations or positional relationships indicated are based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as a limitation on the present invention.

在本发明的描述中,如果有描述到第一、第二只是用于区分技术特征为目的,而不能理解为指示或暗示相对重要性或者隐含指明所指示的技术特征的数量或者隐含指明所指示的技术特征的先后关系。In the description of the present invention, if there is a description of first and second, it is only for the purpose of distinguishing the technical features, and cannot be understood as indicating or implying the relative importance or implicitly indicating the number of the indicated technical features or implicitly indicating the order of the indicated technical features.

本发明的描述中,除非另有明确的限定,设置、安装、连接等词语应做广义理解,所属技术领域技术人员可以结合技术方案的具体内容合理确定上述词语在本发明中的具体含义。In the description of the present invention, unless otherwise clearly defined, terms such as setting, installing, connecting, etc. should be understood in a broad sense, and technicians in the relevant technical field can reasonably determine the specific meanings of the above terms in the present invention based on the specific content of the technical solution.

如图1所示,根据本发明实施例的一种心室辅助装置测试方法,包括步骤:As shown in FIG1 , a ventricular assist device testing method according to an embodiment of the present invention comprises the following steps:

调节左心室模块100以及体循环模块200,以使模拟心率、模拟心输出量、模拟体循环阻力以及模拟体循环顺应性在预设范围内;Adjusting the left ventricle module 100 and the systemic circulation module 200 so that the simulated heart rate, simulated cardiac output, simulated systemic circulation resistance and simulated systemic circulation compliance are within a preset range;

接入心室辅助装置500;Access to ventricular assist device 500;

调节心室辅助装置500以及体循环模块200,以令模拟体循环阻力以及模拟体循环顺应性在要求范围内;Adjusting the ventricular assist device 500 and the systemic circulation module 200 to make the simulated systemic circulation resistance and the simulated systemic circulation compliance within the required range;

记录总流量、模拟主动脉平均压以及模拟心房压数据作为辅助状态数据;Total flow, simulated aortic mean pressure, and simulated atrial pressure data were recorded as auxiliary status data;

将辅助状态数据与标准数据比较,以评估心室辅助装置500。The assistance status data is compared with standard data to evaluate the ventricular assist device 500.

调节左心室模块100能够调节模拟心率、模拟心输出量,调节左心室模块100以及体循环模块200能够调节模拟体循环阻力以及模拟体循环顺应性,以此,使得模拟心率、模拟心输出量、模拟体循环阻力以及模拟体循环顺应性在预设范围内,达到模拟病理状态的效果。接入心室辅助装置500,调节心室辅助装置500与体循环模块200,令模拟体循环阻力与模拟体循环顺应性在要求范围内,以此,模拟接入心室辅助装置500后人体的生理反馈调节,更加接近实际应用情景。待系统稳定工作后,记录总流量、模拟主动脉平均压以及模拟心房压数据作为辅助状态数据,将辅助状态数据与标准数据比较,标准数据可以是正常人体的总流量、主动脉平均压以及心房压的数值范围,以获知接入心室辅助装置500后能否将病理状态改善至正常状态,进而实现对心室辅助装置500评估。Adjusting the left ventricle module 100 can adjust the simulated heart rate and simulated cardiac output, and adjusting the left ventricle module 100 and the systemic circulation module 200 can adjust the simulated systemic circulation resistance and simulated systemic circulation compliance, so that the simulated heart rate, simulated cardiac output, simulated systemic circulation resistance and simulated systemic circulation compliance are within the preset range, achieving the effect of simulating the pathological state. Connecting the ventricular assist device 500, adjusting the ventricular assist device 500 and the systemic circulation module 200, so that the simulated systemic circulation resistance and simulated systemic circulation compliance are within the required range, so as to simulate the physiological feedback regulation of the human body after connecting the ventricular assist device 500, which is closer to the actual application scenario. After the system works stably, the total flow, simulated aortic mean pressure and simulated atrial pressure data are recorded as auxiliary state data, and the auxiliary state data are compared with the standard data. The standard data can be the numerical range of the total flow, aortic mean pressure and atrial pressure of a normal human body, so as to know whether the pathological state can be improved to the normal state after connecting the ventricular assist device 500, and then realize the evaluation of the ventricular assist device 500.

心室辅助装置500植入体内后,由于心室辅助装置500与人体循环系统是密切联系的,其加入会影响人体循环系统的血流动力学,人体的生理反馈调节作用会进一步改变人体循环系统的血流动力学。对于体外模拟循环系统,则需要通过调节的心室辅助装置500以及体循环模块200的方式,模拟人体的生理反馈调节对人体循环系统血流动力学的影响。After the ventricular assist device 500 is implanted in the body, since the ventricular assist device 500 is closely connected with the human circulatory system, its insertion will affect the hemodynamics of the human circulatory system, and the physiological feedback regulation of the human body will further change the hemodynamics of the human circulatory system. For the in vitro simulated circulatory system, it is necessary to simulate the influence of the physiological feedback regulation of the human body on the hemodynamics of the human circulatory system by adjusting the ventricular assist device 500 and the systemic circulation module 200.

在本发明的一些实施例中,标准数据可以为:总流量在3.5至8.0L/min范围内;模拟主动脉平均压在60至140mmHg范围内;模拟心房压小于接入心室辅助装之前的数值。In some embodiments of the present invention, standard data may be: total flow in the range of 3.5 to 8.0 L/min; simulated aortic mean pressure in the range of 60 to 140 mmHg; simulated atrial pressure is less than the value before access to the ventricular assist device.

在本发明的一些实施例中,在接入心室辅助装置500,调节心室辅助装置500以及体循环模块200,以令模拟体循环阻力以及模拟体循环顺应性在要求范围内的过程中:模拟体循环阻力在700至1600dyne·S·cm-5范围内,模拟体循环顺应性在0.1至2.2mL/mmHg范围内。In some embodiments of the present invention, during the process of connecting the ventricular assist device 500, the ventricular assist device 500 and the systemic circulation module 200 are adjusted so that the simulated systemic circulation resistance and the simulated systemic circulation compliance are within the required range: the simulated systemic circulation resistance is within the range of 700 to 1600 dyne·S·cm -5 , and the simulated systemic circulation compliance is within the range of 0.1 to 2.2 mL/mmHg.

将模拟体循环阻力限制在700至1600dyne·S·cm-5范围内并且将模拟体循环顺应性限制在0.1至2.2mL/mmHg范围内,能够更加贴近实际应用于人体时情况,有利于提高体外模拟以及评估心室辅助装置500的准确性。Limiting the simulated systemic circulation resistance within the range of 700 to 1600 dyne·S·cm -5 and limiting the simulated systemic circulation compliance within the range of 0.1 to 2.2 mL/mmHg can be closer to the actual situation when applied to the human body, which is conducive to improving the accuracy of in vitro simulation and evaluation of the ventricular assist device 500.

参照图1,在本发明的一些实施例中,在调节左心室模块100以及体循环模块200,以使模拟心率、模拟心输出量、模拟体循环阻力以及模拟体循环顺应性在预设范围内后,还包括步骤:记录总流量、模拟主动脉平均压以及模拟心房压数据作为基线状态数据;1 , in some embodiments of the present invention, after adjusting the left ventricle module 100 and the systemic circulation module 200 so that the simulated heart rate, simulated cardiac output, simulated systemic circulation resistance and simulated systemic circulation compliance are within a preset range, the steps further include: recording total flow, simulated aortic mean pressure and simulated atrial pressure data as baseline state data;

在记录总流量、模拟主动脉平均压以及模拟心房压数据作为辅助状态数据后,还包括步骤:撤除心室辅助装置500,记录模拟心率、模拟心输出量、模拟体循环阻力以及模拟体循环顺应性数据作为回归状态数据;将回归状态数据与基线状态数据比较,以评估系统鲁棒性。After recording the total flow, simulated aortic mean pressure and simulated atrial pressure data as auxiliary state data, the method also includes the steps of: removing the ventricular assist device 500, recording the simulated heart rate, simulated cardiac output, simulated systemic circulation resistance and simulated systemic circulation compliance data as regression state data; comparing the regression state data with the baseline state data to evaluate the system robustness.

模拟病例状态后,接入心室辅助装置500之前,记录总流量、模拟主动脉平均压以及模拟心房压数据作为基线状态数据。在接入心室辅助装置500测试完并且停止心室辅助装置500工作撤除后,记录模拟心率、模拟心输出量、模拟体循环阻力以及模拟体循环顺应性数据作为回归状态数据。将回归状态数据与基线状态数据比较,能够获知心室辅助装置500接入前和撤除后系统运行状态数据变化,若基线状态数据与回归状态数据基本相同,即系统特性参数稳定,则鲁棒性较强。以此,通过将回归状态数据与基线状态数据相比较,能够评价系统整体的鲁棒性是否满足要求。After simulating the case state and before connecting the ventricular assist device 500, record the total flow, simulated aortic mean pressure, and simulated atrial pressure data as baseline state data. After connecting the ventricular assist device 500 for testing and stopping the operation of the ventricular assist device 500, record the simulated heart rate, simulated cardiac output, simulated systemic circulation resistance, and simulated systemic circulation compliance data as regression state data. By comparing the regression state data with the baseline state data, the changes in the system operation state data before and after the ventricular assist device 500 is connected and removed can be known. If the baseline state data is basically the same as the regression state data, that is, the system characteristic parameters are stable, then the robustness is strong. In this way, by comparing the regression state data with the baseline state data, it is possible to evaluate whether the overall robustness of the system meets the requirements.

参考图1,在本发明的一些实施例中,在撤除心室辅助装置500,记录模拟心率、模拟心输出量、模拟体循环阻力以及模拟体循环顺应性数据作为回归状态数据的步骤后,重新返回调节左心室模块100以及体循环模块200,以使模拟心率、模拟心输出量、模拟体循环阻力以及模拟体循环顺应性在预设范围内的步骤进行循环。Referring to Figure 1, in some embodiments of the present invention, after removing the ventricular assist device 500 and recording the simulated heart rate, simulated cardiac output, simulated systemic circulation resistance and simulated systemic circulation compliance data as the regression state data, the step of returning to adjust the left ventricle module 100 and the systemic circulation module 200 is repeated to cycle the simulated heart rate, simulated cardiac output, simulated systemic circulation resistance and simulated systemic circulation compliance within a preset range.

在撤除心室辅助装置500后,重新调节左心室模块100以及体循环模块200,以模拟另一病理状态,再次对心室辅助装置500进行测试,在多次循环测试后,能够更加详细获知心室辅助装置500在不同病理状态下的效果,有利于更加详细准确评估心室辅助装置500。After the ventricular assist device 500 is removed, the left ventricular module 100 and the systemic circulation module 200 are readjusted to simulate another pathological state, and the ventricular assist device 500 is tested again. After multiple cycles of testing, the effect of the ventricular assist device 500 under different pathological states can be known in more detail, which is conducive to a more detailed and accurate evaluation of the ventricular assist device 500.

参照图2,根据本发明的第二方面实施例的心室辅助装置测试系统,包括:左心室模块100,设置有左心室腔101,左心室模块100包括第一驱动单元110,第一驱动单元110能够驱使左心室腔101收缩;体循环模块200,设置有体循环通道201,体循环通道201与左心室腔101连通,体循环模块200包括第一阻性调节件210,第一阻性调节件210能够调节体循环通道201的流体阻力;左心房模块300,设置有左心房腔301,左心房腔301分别与左心室腔101以及体循环通道201连通以形成体循环回路;检测模块400,分别与左心室模块100以及体循环模块200连接,检测模块400能够检测左心室模块100的输入压力、左心室模块100的输出压力以及体循环通道201的流量。2 , a ventricular assist device testing system according to a second embodiment of the present invention includes: a left ventricular module 100, provided with a left ventricular cavity 101, the left ventricular module 100 includes a first driving unit 110, the first driving unit 110 can drive the left ventricular cavity 101 to contract; a systemic circulation module 200, provided with a systemic circulation channel 201, the systemic circulation channel 201 is connected to the left ventricular cavity 101, the systemic circulation module 200 includes a first resistive adjusting member 210, the first resistive adjusting member 210 can adjust the fluid resistance of the systemic circulation channel 201; a left atrium module 300, provided with a left atrium cavity 301, the left atrium cavity 301 is respectively connected to the left ventricular cavity 101 and the systemic circulation channel 201 to form a systemic circulation loop; a detection module 400, respectively connected to the left ventricular module 100 and the systemic circulation module 200, the detection module 400 can detect the input pressure of the left ventricular module 100, the output pressure of the left ventricular module 100 and the flow rate of the systemic circulation channel 201.

由于心室辅助装置500主要影响人体的体循环,因此,通过左心室模块100、体循环模块200以及左心房模块300模拟体循环,左心室腔101、体循环通道201以及左心房形成体循环回路,第一驱动单元110驱使左心室腔101收缩,以模拟心室收缩,能够控制模拟心率、模拟心输出量的功能,体循环模块200能够模拟体循环顺应性、第一阻性调节件210能够模拟体循环阻力,左心房腔301为左心室腔101提供前负荷,以此结构,能够提供对心室辅助装置500进行测试的模拟体循环测试环境,满足测试需求。Since the ventricular assist device 500 mainly affects the body's systemic circulation, the systemic circulation is simulated by the left ventricle module 100, the systemic circulation module 200 and the left atrial module 300. The left ventricular cavity 101, the systemic circulation channel 201 and the left atrium form a systemic circulation loop. The first drive unit 110 drives the left ventricular cavity 101 to contract to simulate ventricular contraction. It can control the functions of simulating heart rate and simulating cardiac output. The systemic circulation module 200 can simulate systemic circulation compliance, the first resistive adjustment component 210 can simulate systemic circulation resistance, and the left atrial cavity 301 provides preload for the left ventricular cavity 101. With this structure, a simulated systemic circulation test environment for testing the ventricular assist device 500 can be provided to meet the test requirements.

参照图2,在本发明的一些实施例中,还包括心室辅助装置500,心室辅助装置500分别与左心室腔101以及体循环通道201连通。2 , in some embodiments of the present invention, a ventricular assist device 500 is further included, and the ventricular assist device 500 is communicated with the left ventricular cavity 101 and the systemic circulation channel 201 respectively.

心室辅助装置500辅助左心室模块100将左心室腔101中的液体输送至体循环通道201,实现辅助心室泵射液体的效果,能够模拟接入人体后的工作情况。The ventricular assist device 500 assists the left ventricular module 100 in delivering the fluid in the left ventricular cavity 101 to the systemic circulation channel 201, thereby achieving the effect of assisting the ventricle in pumping fluid, and can simulate the working conditions after being connected to the human body.

参照图2,在本发明的一些实施例中,左心室模块100还包括第一容器120以及第一单向阀130,第一驱动单元110与第一容器120连接以形成左心室腔101,第一单向阀130的输入端与左心室腔101连通,第一单向阀130的输出端与体循环通道201连通。Referring to Figure 2, in some embodiments of the present invention, the left ventricular module 100 also includes a first container 120 and a first one-way valve 130, the first driving unit 110 is connected to the first container 120 to form a left ventricular cavity 101, the input end of the first one-way valve 130 is connected to the left ventricular cavity 101, and the output end of the first one-way valve 130 is connected to the systemic circulation channel 201.

第一驱动单元110与第一容器120围成左心室腔101,左心室腔101通过第一单向阀130与体循环通道201连通,能够模拟主动脉瓣的效果,使得第一驱动单元110驱使左心室腔101收缩时,液体只能够从左心室腔101流向体循环通道201。The first driving unit 110 and the first container 120 form a left ventricular cavity 101, and the left ventricular cavity 101 is connected to the systemic circulation channel 201 through the first one-way valve 130, which can simulate the effect of the aortic valve, so that when the first driving unit 110 drives the left ventricular cavity 101 to contract, the liquid can only flow from the left ventricular cavity 101 to the systemic circulation channel 201.

参照图2和图3,在本发明的一些实施例中,第一驱动单元110包括气缸111、二位三通阀112以及比例阀113,气缸111与第一容器120连接以形成左心室腔101,二位三通阀112设置有第一阀口、第二阀口以及第三阀口,第一阀口与气缸111连通,第二阀口与比例阀113连接,比例阀113能够与外部气源连通,第三阀口与外界连通,二位三通阀112切换工位能够控制第一阀口与第二阀口连通或者第一阀口与第三阀口连通。2 and 3, in some embodiments of the present invention, the first drive unit 110 includes a cylinder 111, a two-position three-way valve 112 and a proportional valve 113. The cylinder 111 is connected to the first container 120 to form a left ventricular chamber 101. The two-position three-way valve 112 is provided with a first valve port, a second valve port and a third valve port. The first valve port is connected to the cylinder 111, the second valve port is connected to the proportional valve 113, the proportional valve 113 can be connected to an external air source, and the third valve port is connected to the outside world. The switching position of the two-position three-way valve 112 can control the first valve port to be connected to the second valve port or the first valve port to be connected to the third valve port.

通过控制比例阀113的开度,能够控制外部气源输送气体至气缸111的速度,即控制左心室腔101的收缩速度,通过控制二位三通阀112切换工位的频率,能够控制左心室腔101的收缩频率,以此,通过控制比例阀113与二位三通阀112,能够控制左心室腔101的收缩频率以及每次收缩排除的液体量,即能够控制模拟心率以及模拟心搏量,根据心输出量等于心率与心搏量的积,亦能够控制模拟心输出量。以此结构,能够达到模拟左心室的目的,实现控制模拟心率、模拟心输出量的效果。By controlling the opening of the proportional valve 113, the speed of the external gas source delivering gas to the cylinder 111 can be controlled, that is, the contraction speed of the left ventricular cavity 101 can be controlled. By controlling the frequency of the switching position of the two-position three-way valve 112, the contraction frequency of the left ventricular cavity 101 can be controlled. Thus, by controlling the proportional valve 113 and the two-position three-way valve 112, the contraction frequency of the left ventricular cavity 101 and the amount of liquid discharged in each contraction can be controlled, that is, the simulated heart rate and the simulated cardiac output can be controlled. Since the cardiac output is equal to the product of the heart rate and the cardiac output, the simulated cardiac output can also be controlled. With this structure, the purpose of simulating the left ventricle can be achieved, and the effect of controlling the simulated heart rate and the simulated cardiac output can be realized.

参考图3,在本发明的一些实施例中,第一驱动单元110还可以包括减压阀114,比例阀113通过减压阀114能够与外部气源连接。3 , in some embodiments of the present invention, the first driving unit 110 may further include a pressure reducing valve 114 , and the proportional valve 113 may be connected to an external gas source via the pressure reducing valve 114 .

通过设置有减压阀114,能够在外部气源压力过高时进行减压,能够防止气体压力过大,提高可靠性。By providing the pressure reducing valve 114 , it is possible to reduce the pressure when the external gas source pressure is too high, thereby preventing the gas pressure from being too high and improving reliability.

参照图2,在本发明的一些实施例中,体循环模块200还包括第二容器220,第二容器220设置有第一密封腔221以及与第一密封腔221连通的第一补充阀222,第一密封腔221与左心室腔101连通,第二容器220通过第一阻性调节件210与左心房模块300连接以使得第一密封腔221与左心房腔301连通。Referring to Figure 2, in some embodiments of the present invention, the systemic circulation module 200 also includes a second container 220, the second container 220 is provided with a first sealed cavity 221 and a first replenishing valve 222 connected to the first sealed cavity 221, the first sealed cavity 221 is connected to the left ventricular cavity 101, and the second container 220 is connected to the left atrium module 300 through the first resistive adjustment member 210 so that the first sealed cavity 221 is connected to the left atrium cavity 301.

第二容器220设置有第一密封腔221,第一密封容腔中储存有液体,能够模拟血容量,通过第一补充阀222向第一密封容腔内补充液体能够调节血容量,由于体循环顺应性和变化的体积与变化的压力的比值相关,通过第二容器220与第一阻性调节件210配合能够调节模拟体循环顺应性,以此结构,能够调节模拟血容量、模拟体循环顺应性,结构简单,方便实施。The second container 220 is provided with a first sealed cavity 221, in which liquid is stored to simulate blood volume. Blood volume can be adjusted by replenishing liquid into the first sealed cavity through the first replenishing valve 222. Since the compliance of the body circulation is related to the ratio of the changing volume to the changing pressure, the second container 220 can cooperate with the first resistive adjustment element 210 to adjust the simulated body circulation compliance. With this structure, the simulated blood volume and the simulated body circulation compliance can be adjusted. The structure is simple and easy to implement.

参照图2,在本发明的一些实施例中,体循环模块200还包括第三容器230,设置有第一开放性容腔231,第二容器220通过第一阻性调节件210与第三容器230连接以使得第一密封腔221与第一开放性容腔231连通,第一开放性容腔231与左心房腔301连通。2 , in some embodiments of the present invention, the systemic circulation module 200 further includes a third container 230 , which is provided with a first open cavity 231 , and the second container 220 is connected to the third container 230 via a first resistive adjustment member 210 so that the first sealed cavity 221 is in communication with the first open cavity 231 , and the first open cavity 231 is in communication with the left atrial cavity 301 .

第三容器230设置有第一开放性容腔231,第一开放性容腔231中储存有液体,以此结构,第一密封腔221模拟主动脉容性,第一开放性容腔231模拟主静脉容性,能够更加接近模拟人体循环系统,有利于提高测试心室辅助装置500的准确性。The third container 230 is provided with a first open cavity 231, in which liquid is stored. With this structure, the first sealed cavity 221 simulates the aorta capacitive capacity, and the first open cavity 231 simulates the aorta capacitive capacity, which can more closely simulate the human circulatory system and is conducive to improving the accuracy of testing the ventricular assist device 500.

第一密封腔221、第一阻性调节件210以及第一开放性容腔231形成体循环通道201。The first sealed cavity 221 , the first resistive adjustment member 210 and the first open cavity 231 form a systemic circulation channel 201 .

在本发明的一些实施例中,第一阻性调节件210为节流阀或电磁比例控制阀。In some embodiments of the present invention, the first resistive adjustment member 210 is a throttle valve or an electromagnetic proportional control valve.

通过控制节流阀、比例控制阀的开度,能够实现调节体循环通道201阻力的效果。By controlling the opening of the throttle valve and the proportional control valve, the effect of adjusting the resistance of the systemic circulation channel 201 can be achieved.

参照图2,在本发明的一些实施例中,左心房模块300包括第四容器310、第二驱动单元320以及第二单向阀330,第二驱动单元320与第四容器310连接以形成左心房腔301,第二驱动单元320能够驱使左心房腔301收缩,第二单向阀330的输入端与左心房腔301连通,第二单向阀330的输出端与左心室腔101连通。Referring to Figure 2, in some embodiments of the present invention, the left atrium module 300 includes a fourth container 310, a second drive unit 320 and a second one-way valve 330. The second drive unit 320 is connected to the fourth container 310 to form a left atrium cavity 301. The second drive unit 320 can drive the left atrium cavity 301 to contract. The input end of the second one-way valve 330 is connected to the left atrium cavity 301, and the output end of the second one-way valve 330 is connected to the left ventricle cavity 101.

第二驱动单元320与第四容器310围成左心房腔301,第二驱动单元320驱使左心房腔301收缩,能够模拟心房收缩,第二单向阀330能够模拟房室瓣,限制液体只能从左心房腔301流向左心室腔101,以此能够更真实模拟人体心脏工作环境,有利于提高测试心室辅助装置500的准确性。The second driving unit 320 and the fourth container 310 form a left atrial cavity 301. The second driving unit 320 drives the left atrial cavity 301 to contract, which can simulate atrial contraction. The second one-way valve 330 can simulate the atrioventricular valve, limiting the flow of liquid from the left atrial cavity 301 to the left ventricular cavity 101. This can more realistically simulate the working environment of the human heart, which is conducive to improving the accuracy of testing the ventricular assist device 500.

第二驱动单元320的结构可以是与第一驱动单元110相同的实施方式,即第二驱动单元320包括气缸111、二位三通阀112以及比例阀113的实施方式。The structure of the second driving unit 320 may be the same as that of the first driving unit 110 , that is, the second driving unit 320 includes a cylinder 111 , a two-position three-way valve 112 , and a proportional valve 113 .

参照图2,在本发明的一些实施例中,左心房模块300包括第四容器310以及第二单向阀330,第四容器310形成左心房腔301,第二单向阀330的输入端与左心房腔301连通,第二单向阀330的输出端与左心室腔101连通。Referring to Figure 2, in some embodiments of the present invention, the left atrium module 300 includes a fourth container 310 and a second one-way valve 330, the fourth container 310 forms the left atrium cavity 301, the input end of the second one-way valve 330 is connected to the left atrium cavity 301, and the output end of the second one-way valve 330 is connected to the left ventricular cavity 101.

通过第四容器310形成左心房腔301,为左心室腔101提供前负荷,第二单向阀330能够模拟房室瓣,限制液体只能从左心房腔301流向左心室腔101,结构简单,便于实施。The left atrial cavity 301 is formed by the fourth container 310 to provide a preload for the left ventricular cavity 101. The second one-way valve 330 can simulate the atrioventricular valve to limit the liquid to flow from the left atrial cavity 301 to the left ventricular cavity 101. The structure is simple and easy to implement.

参照图2,在本发明的一些实施例中,检测模块400包括第一压力传感器410、第二压力传感器420以及第一流量传感器430,第一压力传感器410与左心室模块100的输出端连接,第二压力传感器420与左心室的输入端连接,第一流量传感器430与体循环模块200连接。Referring to Figure 2, in some embodiments of the present invention, the detection module 400 includes a first pressure sensor 410, a second pressure sensor 420 and a first flow sensor 430. The first pressure sensor 410 is connected to the output end of the left ventricle module 100, the second pressure sensor 420 is connected to the input end of the left ventricle, and the first flow sensor 430 is connected to the systemic circulation module 200.

第一压力传感器410与左心室模块100的输出端连接,能够检测左心室腔101的输出压力,即能够获知模拟主动脉平均压的数值。第二压力传感器420与左心室模块100的输入端连接,能够检测左心室腔101与左心房腔301之间的压力,即能够获知模拟心房压的数值。第一流量传感器430与体循环模块200连接,能够检测流经体循环通道201的流量,即能够获知总流量的数值。The first pressure sensor 410 is connected to the output end of the left ventricle module 100, and can detect the output pressure of the left ventricle cavity 101, that is, the value of the simulated aortic mean pressure can be obtained. The second pressure sensor 420 is connected to the input end of the left ventricle module 100, and can detect the pressure between the left ventricle cavity 101 and the left atrial cavity 301, that is, the value of the simulated atrial pressure can be obtained. The first flow sensor 430 is connected to the systemic circulation module 200, and can detect the flow through the systemic circulation channel 201, that is, the value of the total flow can be obtained.

参考图2,在本发明的一些实施例中,检测模块400还包括第二流量传感器440,第二流量传感器440与心室辅助装置500连接。Referring to FIG. 2 , in some embodiments of the present invention, the detection module 400 further includes a second flow sensor 440 , and the second flow sensor 440 is connected to the ventricular assist device 500 .

通过第二流量传感器440检测心室辅助装置500的泵射量,能够更加详细获知心室辅助装置500的工作状态。By detecting the pumping volume of the ventricular assist device 500 through the second flow sensor 440, the working status of the ventricular assist device 500 can be known in more detail.

参照图2,在本发明的一些实施例中,还包括右心室模块600、右心房模块700以及肺循环模块800,右心室模块600设置有右心室腔601,右心房模块700设置有右心房腔701,肺循环模块800设置有肺循环通道801,左心室腔101、体循环通道201、右心房腔701、右心室腔601、肺循环通道801以及左心房腔301依次连通形成人体循环回路。2 , in some embodiments of the present invention, a right ventricle module 600, a right atrium module 700 and a pulmonary circulation module 800 are also included. The right ventricle module 600 is provided with a right ventricular cavity 601, the right atrium module 700 is provided with a right atrium cavity 701, the pulmonary circulation module 800 is provided with a pulmonary circulation channel 801, and the left ventricular cavity 101, the systemic circulation channel 201, the right atrium cavity 701, the right ventricular cavity 601, the pulmonary circulation channel 801 and the left atrium cavity 301 are connected in sequence to form a human body circulation loop.

右心室模块600、右心房模块700以及肺循环模块800能够模拟肺循环系统,配合左心室模块100、左心房模块300以及体循环模块200模拟的体循环系统能够形成完整的人体循环系统,左心室腔101、体循环通道201、右心房腔701、右心室腔601、肺循环通道801以及左心房腔301依次连通形成人体循环回路,能够更加真实模拟人体循环系统,有利于提高对心室辅助装置500测试的准确性。The right ventricle module 600, the right atrium module 700 and the pulmonary circulation module 800 can simulate the pulmonary circulation system, and cooperate with the left ventricle module 100, the left atrium module 300 and the systemic circulation module 200 to simulate the systemic circulation system to form a complete human circulatory system. The left ventricular cavity 101, the systemic circulation channel 201, the right atrial cavity 701, the right ventricular cavity 601, the pulmonary circulation channel 801 and the left atrial cavity 301 are connected in sequence to form a human circulation loop, which can more realistically simulate the human circulatory system and is conducive to improving the accuracy of the test of the ventricular assist device 500.

右心室模块600与左心室模块100的结构可以相同,即右心室模块600包括第五容器610、第三驱动单元620以及第三单向阀630,第三驱动单元620与第五容器610连接形成右心室腔601,右心室模块600通过第三单向阀630与肺循环模块800连接。右心房模块700可以是包括第六容器710、第四驱动单元720以及第四单向阀730的实施方式,第四驱动单元720与第六容器710连接形成右心房腔701,右心房模块700通过第四单向阀730与左心室模块100连接。第三驱动单元620的结构与第四驱动单元720的结构可以是与第一驱动单元110结构相同的实施方式,即第三驱动单元620、第四驱动单元720分别包括气缸111、二位三通阀112以及比例阀113。The structure of the right ventricle module 600 and the left ventricle module 100 may be the same, that is, the right ventricle module 600 includes a fifth container 610, a third drive unit 620 and a third one-way valve 630, the third drive unit 620 and the fifth container 610 are connected to form a right ventricle chamber 601, and the right ventricle module 600 is connected to the pulmonary circulation module 800 through the third one-way valve 630. The right atrium module 700 may be an embodiment including a sixth container 710, a fourth drive unit 720 and a fourth one-way valve 730, the fourth drive unit 720 and the sixth container 710 are connected to form a right atrium chamber 701, and the right atrium module 700 is connected to the left ventricle module 100 through the fourth one-way valve 730. The structure of the third drive unit 620 and the structure of the fourth drive unit 720 may be an embodiment having the same structure as the first drive unit 110, that is, the third drive unit 620 and the fourth drive unit 720 respectively include a cylinder 111, a two-position three-way valve 112 and a proportional valve 113.

肺循环模块800的结构可以与体循环模块200的结构相同,即肺循环模块800包括第七容器810、第二阻性调节件820以及第八容器830的实施方式,第七容器810设置有第二密封腔811以及与第二密封腔811连通的第二补充阀812le,第八容器830设置有第二开放性容腔831,第七容器810通过第二阻性调节件820与第八容器830连接以使得第二密封腔811与第二开放性容腔连通831,第二密封腔811与右心室腔601连通,第二开放性容腔831与左心房腔301连通。The structure of the pulmonary circulation module 800 can be the same as that of the systemic circulation module 200, that is, the pulmonary circulation module 800 includes an embodiment of a seventh container 810, a second resistive adjustment member 820 and an eighth container 830, the seventh container 810 is provided with a second sealed cavity 811 and a second replenishing valve 812le connected to the second sealed cavity 811, the eighth container 830 is provided with a second open cavity 831, the seventh container 810 is connected to the eighth container 830 through the second resistive adjustment member 820 so that the second sealed cavity 811 is connected to the second open cavity 831, the second sealed cavity 811 is connected to the right ventricular cavity 601, and the second open cavity 831 is connected to the left atrial cavity 301.

第二密封腔811、第二阻性调节件820以及第二开放性容腔831形成肺循环通道801。第二阻性调节件820可以是为节流阀或电磁比例控制阀等器件的实施方式。The second sealed cavity 811, the second resistive adjusting member 820 and the second open volume 831 form a pulmonary circulation channel 801. The second resistive adjusting member 820 may be implemented as a throttle valve or an electromagnetic proportional control valve.

参照图2,在本发明的一些实施例中,还包括切换模块,切换模块分别与体循环模块200以及肺循环模块800连接,切换模块能够切换控制左心室腔101、体循环通道201以及左心房腔301依次连通形成体循环回路或者左心室腔101、体循环通道201、右心房腔701、右心室腔601、肺循环通道801以及左心房腔301依次连通形成人体循环回路。2 , in some embodiments of the present invention, a switching module is further included, which is connected to the systemic circulation module 200 and the pulmonary circulation module 800 respectively. The switching module can switch and control the left ventricular cavity 101, the systemic circulation channel 201 and the left atrial cavity 301 to be connected in sequence to form a systemic circulation loop, or the left ventricular cavity 101, the systemic circulation channel 201, the right atrial cavity 701, the right ventricular cavity 601, the pulmonary circulation channel 801 and the left atrial cavity 301 to be connected in sequence to form a human body circulation loop.

通过切换模块在体循环回路和人体循环回路之间切换,能够根据实际测试需求,只使用体循环回路或者使用完整的人体循环回路对心室辅助装置500进行测试,令使用更加灵活,满足测试使用需求。By switching between the systemic circulation circuit and the human body circulation circuit through the switching module, the ventricular assist device 500 can be tested using only the systemic circulation circuit or the complete human body circulation circuit according to actual test requirements, making the use more flexible and meeting the test requirements.

参照图2,在本发明的一些实施例中,切换模块包括第一循环切换阀910、第二循环切换阀920以及第三循环切换阀930,体循环模块200通过第一循环切换阀910与左心房模块300连接以使得体循环通道201能够与左心房腔301连通,体循环模块200通过第二循环切换阀920与右心房模块700连接以使得体循环通道201能够与右心房腔701连通,肺循环模块800通过第三循环切换阀930与左心房模块300连接以使得肺循环通道801能够与左心房腔301连通。2 , in some embodiments of the present invention, the switching module includes a first circulation switching valve 910, a second circulation switching valve 920 and a third circulation switching valve 930. The systemic circulation module 200 is connected to the left atrium module 300 through the first circulation switching valve 910 so that the systemic circulation channel 201 can communicate with the left atrium cavity 301. The systemic circulation module 200 is connected to the right atrium module 700 through the second circulation switching valve 920 so that the systemic circulation channel 201 can communicate with the right atrium cavity 701. The pulmonary circulation module 800 is connected to the left atrium module 300 through the third circulation switching valve 930 so that the pulmonary circulation channel 801 can communicate with the left atrium cavity 301.

当第一循环切换阀910开通并且第二循环切换阀920以及第三循环切换阀930截至时,左心室腔101、体循环通道201以及左心房腔301依次连通形成体循环回路;当第一循环切换阀910截至并且第二循环切换阀920以及第三循环切换阀930开通时,左心室腔101、体循环通道201、右心房腔701、右心室腔601、肺循环通道801以及左心房腔301依次连通形成人体循环回路。以此,通过控制第一循环切换阀910、第二循环切换阀920以及第三循环切换阀930,便可实现在体循环回路和人体循环回路之间切换,结构简单,便于实施。When the first circulation switching valve 910 is opened and the second circulation switching valve 920 and the third circulation switching valve 930 are closed, the left ventricle cavity 101, the systemic circulation channel 201 and the left atrial cavity 301 are connected in sequence to form a systemic circulation loop; when the first circulation switching valve 910 is closed and the second circulation switching valve 920 and the third circulation switching valve 930 are opened, the left ventricle cavity 101, the systemic circulation channel 201, the right atrial cavity 701, the right ventricle cavity 601, the pulmonary circulation channel 801 and the left atrial cavity 301 are connected in sequence to form a human body circulation loop. In this way, by controlling the first circulation switching valve 910, the second circulation switching valve 920 and the third circulation switching valve 930, switching between the systemic circulation loop and the human body circulation loop can be achieved, and the structure is simple and easy to implement.

以上所述实施例的各技术特征可以进行任意的组合,为使描述简洁,未对上述实施例中的各个技术特征所有可能的组合都进行描述,然而,只要这些技术特征的组合不存在矛盾,都应当认为是本说明书记载的范围。The technical features of the above-described embodiments may be arbitrarily combined. To make the description concise, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

当然,本发明创造并不局限于上述实施方式,熟悉本领域的技术人员在不违背本发明精神的前提下还可作出等同变形或替换,这些等同的变型或替换均包含在本申请权利要求所限定的范围内。Of course, the invention is not limited to the above-mentioned embodiments, and those skilled in the art may make equivalent modifications or substitutions without violating the spirit of the invention, and these equivalent modifications or substitutions are all included in the scope defined by the claims of this application.

Claims (7)

1.心室辅助装置测试系统,其特征在于,包括:1. A ventricular assist device testing system, comprising: 左心室模块(100),设置有左心室腔(101),所述左心室模块(100)包括第一驱动单元(110),所述第一驱动单元(110)能够驱使所述左心室腔(101)收缩;A left ventricular module (100) is provided with a left ventricular cavity (101), wherein the left ventricular module (100) comprises a first driving unit (110), wherein the first driving unit (110) is capable of driving the left ventricular cavity (101) to contract; 体循环模块(200),设置有体循环通道(201),所述体循环通道(201)与所述左心室腔(101)连通,所述体循环模块(200)包括第一阻性调节件(210),所述第一阻性调节件(210)能够调节所述体循环通道(201)的流体阻力;A systemic circulation module (200) is provided with a systemic circulation channel (201), wherein the systemic circulation channel (201) is in communication with the left ventricular cavity (101), and the systemic circulation module (200) comprises a first resistance adjusting component (210), wherein the first resistance adjusting component (210) is capable of adjusting the fluid resistance of the systemic circulation channel (201); 左心房模块(300),设置有左心房腔(301),所述左心房腔(301)分别与所述左心室腔(101)以及所述体循环通道(201)连通以形成体循环回路;A left atrium module (300) is provided with a left atrium cavity (301), wherein the left atrium cavity (301) is respectively connected to the left ventricle cavity (101) and the systemic circulation channel (201) to form a systemic circulation loop; 检测模块(400),分别与所述左心室模块(100)以及所述体循环模块(200)连接,所述检测模块(400)能够检测所述左心室模块(100)的输入压力、所述左心室模块(100)的输出压力以及所述体循环通道(201)的流量;a detection module (400) connected to the left ventricle module (100) and the body circulation module (200), respectively, the detection module (400) being capable of detecting the input pressure of the left ventricle module (100), the output pressure of the left ventricle module (100) and the flow rate of the body circulation channel (201); 还包括心室辅助装置(500),所述心室辅助装置(500)分别与所述左心室腔(101)以及所述体循环通道(201)连通;Also included is a ventricular assist device (500), wherein the ventricular assist device (500) is respectively in communication with the left ventricular cavity (101) and the systemic circulation channel (201); 还包括右心室模块(600)、右心房模块(700)以及肺循环模块(800),所述右心室模块(600)设置有右心室腔(601),所述右心房模块(700)设置有右心房腔(701),所述肺循环模块(800)设置有肺循环通道(801),所述左心室腔(101)、所述体循环通道(201)、所述右心房腔(701)、所述右心室腔(601)、所述肺循环通道(801)以及所述左心房腔(301)依次连通形成人体循环回路;It also includes a right ventricle module (600), a right atrium module (700) and a pulmonary circulation module (800), wherein the right ventricle module (600) is provided with a right ventricle cavity (601), the right atrium module (700) is provided with a right atrium cavity (701), the pulmonary circulation module (800) is provided with a pulmonary circulation channel (801), and the left ventricle cavity (101), the body circulation channel (201), the right atrium cavity (701), the right ventricle cavity (601), the pulmonary circulation channel (801) and the left atrium cavity (301) are sequentially connected to form a human body circulation loop; 所述检测模块(400)包括第一压力传感器(410)、第二压力传感器(420)以及第一流量传感器(430),所述第一压力传感器(410)与所述左心室模块(100)的输出端连接,所述第二压力传感器(420)与所述左心室的输入端连接,所述第一流量传感器(430)与所述体循环模块(200)连接;The detection module (400) comprises a first pressure sensor (410), a second pressure sensor (420) and a first flow sensor (430), wherein the first pressure sensor (410) is connected to an output end of the left ventricle module (100), the second pressure sensor (420) is connected to an input end of the left ventricle, and the first flow sensor (430) is connected to the body circulation module (200); 还包括切换模块,所述切换模块分别与所述体循环模块(200)以及所述肺循环模块(800)连接,所述切换模块能够切换控制所述左心室腔(101)、所述体循环通道(201)以及所述左心房腔(301)依次连通形成体循环回路或者所述左心室腔(101)、所述体循环通道(201)、所述右心房腔(701)、所述右心室腔(601)、所述肺循环通道(801)以及所述左心房腔(301)依次连通形成人体循环回路。The invention also includes a switching module, which is connected to the systemic circulation module (200) and the pulmonary circulation module (800) respectively. The switching module can switch and control the left ventricular cavity (101), the systemic circulation channel (201) and the left atrial cavity (301) to be connected in sequence to form a systemic circulation loop, or the left ventricular cavity (101), the systemic circulation channel (201), the right atrial cavity (701), the right ventricular cavity (601), the pulmonary circulation channel (801) and the left atrial cavity (301) to be connected in sequence to form a human body circulation loop. 2.根据权利要求1所述的心室辅助装置测试系统,其特征在于:所述左心室模块(100)还包括第一容器(120)以及第一单向阀(130),所述第一驱动单元(110)与所述第一容器(120)连接以形成所述左心室腔(101),所述第一单向阀(130)的输入端与所述左心室腔(101)连通,所述第一单向阀(130)的输出端与所述体循环通道(201)连通。2. The ventricular assist device testing system according to claim 1, characterized in that: the left ventricle module (100) further comprises a first container (120) and a first one-way valve (130), the first drive unit (110) is connected to the first container (120) to form the left ventricle cavity (101), the input end of the first one-way valve (130) is communicated with the left ventricle cavity (101), and the output end of the first one-way valve (130) is communicated with the systemic circulation channel (201). 3.根据权利要求2所述的心室辅助装置测试系统,其特征在于:所述第一驱动单元(110)包括气缸(111)、二位三通阀(112)以及比例阀(113),所述气缸(111)与所述第一容器(120)连接以形成所述左心室腔(101),所述二位三通阀(112)设置有第一阀口、第二阀口以及第三阀口,所述第一阀口与所述气缸(111)连通,所述第二阀口与所述比例阀(113)连接,所述比例阀(113)能够与外部气源连通,所述第三阀口与外界连通,所述二位三通阀(112)切换工位能够控制所述第一阀口与所述第二阀口连通或者所述第一阀口与所述第三阀口连通。3. The ventricular assist device test system according to claim 2, characterized in that: the first drive unit (110) comprises a cylinder (111), a two-position three-way valve (112) and a proportional valve (113), the cylinder (111) is connected to the first container (120) to form the left ventricular chamber (101), the two-position three-way valve (112) is provided with a first valve port, a second valve port and a third valve port, the first valve port is communicated with the cylinder (111), the second valve port is connected to the proportional valve (113), the proportional valve (113) can be communicated with an external air source, the third valve port is communicated with the outside, and the switching position of the two-position three-way valve (112) can control the first valve port to be connected to the second valve port or the first valve port to be connected to the third valve port. 4.根据权利要求1所述的心室辅助装置测试系统,其特征在于:所述体循环模块(200)还包括第二容器(220),所述第二容器(220)设置有第一密封腔(221)以及与所述第一密封腔(221)连通的第一补充阀(222),所述第一密封腔(221)与所述左心室腔(101)连通,所述第二容器(220)通过所述第一阻性调节件(210)与所述左心房模块(300)连接以使得所述第一密封腔(221)与所述左心房腔(301)连通;4. The ventricular assist device testing system according to claim 1, characterized in that: the systemic circulation module (200) further comprises a second container (220), the second container (220) is provided with a first sealed cavity (221) and a first replenishing valve (222) communicating with the first sealed cavity (221), the first sealed cavity (221) is communicated with the left ventricular cavity (101), the second container (220) is connected to the left atrium module (300) via the first resistive adjusting member (210) so that the first sealed cavity (221) is communicated with the left atrium cavity (301); 所述体循环模块(200)还包括第三容器(230),所述设置有第一开放性容腔(231),所述第二容器(220)通过所述第一阻性调节件(210)与所述第三容器(230)连接以使得所述第一密封腔(221)与所述第一开放性容腔(231)连通,所述第一开放性容腔(231)与所述左心房腔(301)连通。The systemic circulation module (200) further comprises a third container (230) provided with a first open cavity (231); the second container (220) is connected to the third container (230) via the first resistive adjustment member (210) so that the first sealed cavity (221) is in communication with the first open cavity (231); and the first open cavity (231) is in communication with the left atrial cavity (301). 5.根据权利要求1所述的心室辅助装置测试系统,其特征在于:所述左心房模块(300)包括第四容器(310)、第二驱动单元(320)以及第二单向阀(330),所述第二驱动单元(320)与所述第四容器(310)连接以形成所述左心房腔(301),所述第二驱动单元(320)能够驱使所述左心房腔(301)收缩,所述第二单向阀(330)的输入端与所述左心房腔(301)连通,所述第二单向阀(330)的输出端与所述左心室腔(101)连通;5. The ventricular assist device testing system according to claim 1, characterized in that: the left atrium module (300) comprises a fourth container (310), a second drive unit (320) and a second one-way valve (330), the second drive unit (320) is connected to the fourth container (310) to form the left atrium chamber (301), the second drive unit (320) can drive the left atrium chamber (301) to contract, the input end of the second one-way valve (330) is communicated with the left atrium chamber (301), and the output end of the second one-way valve (330) is communicated with the left ventricle chamber (101); 或者,所述左心房模块(300)包括第四容器(310)以及第二单向阀(330),所述第四容器(310)形成所述左心房腔(301),所述第二单向阀(330)的输入端与所述左心房腔(301)连通,所述第二单向阀(330)的输出端与所述左心室腔(101)连通。Alternatively, the left atrium module (300) includes a fourth container (310) and a second one-way valve (330), the fourth container (310) forms the left atrium chamber (301), the input end of the second one-way valve (330) is connected to the left atrium chamber (301), and the output end of the second one-way valve (330) is connected to the left ventricle chamber (101). 6.一种使用权利要求1至5任一项权利要求所述的心室辅助装置测试系统的心室辅助装置测试方法,其特征在于,包括步骤:6. A ventricular assist device testing method using the ventricular assist device testing system according to any one of claims 1 to 5, characterized in that it comprises the steps of: 调节左心室模块(100)以及体循环模块(200),以使模拟心率、模拟心输出量、模拟体循环阻力以及模拟体循环顺应性在预设范围内;Adjusting the left ventricle module (100) and the systemic circulation module (200) so that the simulated heart rate, simulated cardiac output, simulated systemic circulation resistance and simulated systemic circulation compliance are within a preset range; 接入心室辅助装置(500);Access to a ventricular assist device (500); 调节心室辅助装置(500)以及体循环模块(200),以令模拟体循环阻力以及模拟体循环顺应性在要求范围内;Adjusting the ventricular assist device (500) and the systemic circulation module (200) so that the simulated systemic circulation resistance and the simulated systemic circulation compliance are within a required range; 记录总流量、模拟主动脉平均压以及模拟心房压数据作为辅助状态数据;Total flow, simulated aortic mean pressure, and simulated atrial pressure data were recorded as auxiliary status data; 将辅助状态数据与标准数据比较,以评估心室辅助装置(500);comparing the assist status data with standard data to evaluate the ventricular assist device (500); 在所述调节左心室模块(100)以及体循环模块(200),以使模拟心率、模拟心输出量、模拟体循环阻力以及模拟体循环顺应性在预设范围内后,还包括步骤:After the left ventricle module (100) and the systemic circulation module (200) are adjusted so that the simulated heart rate, simulated cardiac output, simulated systemic circulation resistance and simulated systemic circulation compliance are within a preset range, the step further includes: 记录总流量、模拟主动脉平均压以及模拟心房压数据作为基线状态数据;Total flow, simulated aortic mean pressure, and simulated atrial pressure data were recorded as baseline status data; 在所述记录总流量、模拟主动脉平均压以及模拟心房压数据作为辅助状态数据后,还包括步骤:After recording the total flow, simulated aortic mean pressure and simulated atrial pressure data as auxiliary state data, the following steps are also included: 撤除心室辅助装置(500);Removal of ventricular assist device (500); 记录模拟心率、模拟心输出量、模拟体循环阻力以及模拟体循环顺应性数据作为回归状态数据;The simulated heart rate, simulated cardiac output, simulated systemic circulation resistance and simulated systemic circulation compliance data were recorded as regression state data; 将回归状态数据与基线状态数据比较,以评估系统鲁棒性。The regressed state data is compared with the baseline state data to evaluate the system robustness. 7.根据权利要求6所述的一种心室辅助装置测试方法,其特征在于,在所述接入心室辅助装置(500),调节心室辅助装置(500)以及体循环模块(200),以令模拟体循环阻力以及模拟体循环顺应性在要求范围内的过程中:7. A ventricular assist device testing method according to claim 6, characterized in that, during the process of connecting the ventricular assist device (500), adjusting the ventricular assist device (500) and the systemic circulation module (200) so that the simulated systemic circulation resistance and the simulated systemic circulation compliance are within a required range: 所述模拟体循环阻力在700至1600dyne·S·cm-5范围内,所述模拟体循环顺应性在0.1至2.2mL/mmHg范围内。The simulated systemic circulation resistance is in the range of 700 to 1600 dyne·S·cm -5 , and the simulated systemic circulation compliance is in the range of 0.1 to 2.2 mL/mmHg.
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