





本发明涉及医疗器械技术领域,特别地涉及给药驱动传动状态监控系统和方法以及装置。The present invention relates to the technical field of medical devices, and in particular to a system, method and device for monitoring the driving transmission state of drug delivery.
胰岛素泵的基本功能是模拟胰腺的分泌功能,按照人体需要的剂量将胰岛素持续地每隔一定时间向使用者的皮下进行一次推注,保持全天血糖稳定,达到控制糖尿病的目的。现有的贴敷式胰岛素泵主要包括给药器和储药器,给药器为驱动部分,利用传动组件挤压储药器,将储药器中的胰岛素持续地挤压到使用者的皮下。The basic function of the insulin pump is to simulate the secretory function of the pancreas. Insulin is continuously injected into the user's skin at regular intervals according to the dose required by the human body to keep blood sugar stable throughout the day and achieve the purpose of controlling diabetes. The existing stick-type insulin pump mainly includes a dispenser and a reservoir. The dispenser is a driving part. The transmission component is used to squeeze the reservoir to continuously squeeze the insulin in the reservoir to the user's skin. .
对于胰岛素药液的输注,应当尽可能地用量准确、输注可靠,因此需要对给药驱动的传动状态进行监控。For the infusion of insulin liquid medicine, the dosage should be as accurate as possible and the infusion should be reliable. Therefore, it is necessary to monitor the transmission state of the drug delivery drive.
发明内容Summary of the invention
有鉴于此,本发明的主要目的是提供一种给药驱动传动状态监控系统和方法以及装置,有助于提高胰岛素泵自动给药的准确性和可靠性。In view of this, the main purpose of the present invention is to provide a drug delivery drive transmission state monitoring system, method and device, which help to improve the accuracy and reliability of the automatic drug delivery of the insulin pump.
为实现上述目的,本发明提供如下技术方案:In order to achieve the above objectives, the present invention provides the following technical solutions:
一种给药驱动传动状态监控系统,用于驱动给药器推动针管内的活塞从而将药液经由针头挤出以进行皮下推注,所述给药器包括电机、齿轮箱、同轴且螺纹连接的丝杆及推杆,其中电机的输出端与齿轮箱的一端连接,齿轮箱的另一端与丝杆连接,推杆与所述活塞相互抵接;所述监控系统包括:电机转动量监控装置,用于获取电机转动的行程; 推杆初始位置检测装置,用于确认推杆的初始底部位置;控制器,用于:按照预先设定的给药指令,在需要给药的时间启动电机并且接收电机转动量监控装置提供的行程的信息,在该行程到达指定值时停止电机。A drug delivery drive transmission state monitoring system is used to drive a drug delivery device to push a piston in a needle tube to squeeze the liquid medicine through the needle for subcutaneous injection. The drug delivery device includes a motor, a gear box, a coaxial and a thread Connected screw rod and push rod, wherein the output end of the motor is connected with one end of the gear box, the other end of the gear box is connected with the screw rod, and the push rod and the piston abut against each other; the monitoring system includes: motor rotation monitoring The device is used to obtain the rotation stroke of the motor; the initial position detection device of the push rod is used to confirm the initial bottom position of the push rod; the controller is used to: start the motor at the time when the medicine is required according to the pre-set dosing instructions And receive the travel information provided by the motor rotation monitoring device, and stop the motor when the travel reaches the specified value.
可选地,所述推杆初始位置检测装置包括两部分导电触点及二者之间连接的弹性导电材料,该弹性导电材料设置在推杆表面;所述控制器还用于在所述电机启动状态下检测所述两个导电触点之间的电阻并且在该电阻小于预设值时停止所述电机。Optionally, the device for detecting the initial position of the push rod includes two parts of conductive contacts and an elastic conductive material connected between the two parts, and the elastic conductive material is arranged on the surface of the push rod; the controller is also used in the motor In the starting state, the resistance between the two conductive contacts is detected and the motor is stopped when the resistance is less than a preset value.
可选地,还包括输注压力传感器,用于检测所述推杆受到的压力。Optionally, an infusion pressure sensor is also included to detect the pressure on the push rod.
可选地,所述输注压力传感器为薄片式压力传感器,安装在所述丝杆的末端端面和齿轮箱中的固定端面之间。Optionally, the infusion pressure sensor is a sheet-type pressure sensor, which is installed between the end face of the screw rod and the fixed end face in the gear box.
一种给药驱动传动状态监控方法,应用于本发明的监控系统,该方法包括:控制器根据推杆初始位置检测装置提供的信息确认推杆位于初始底部位置;控制器按照预先设定的给药指令,在需要给药的时间启动电机并且接收电机转动量监控装置提供的当前电机行程的数据,在该行程到达指定值时停止电机,该指令值由所述给药指令中的给药量、药仓截面积、以及所述丝杆的导程确定。A method for monitoring the driving transmission state of drug delivery is applied to the monitoring system of the present invention. The method includes: the controller confirms that the push rod is located at the initial bottom position according to the information provided by the initial position detection device of the push rod; The medicine instruction is to start the motor at the time when the medicine is needed and receive the current motor stroke data provided by the motor rotation amount monitoring device, and stop the motor when the stroke reaches a specified value. The instruction value is determined by the amount of medicine in the medicine instruction , The cross-sectional area of the medicine bin and the lead of the screw rod are determined.
一种给药驱动传动状态监控方法,应用于权利要求3或4所述的监控系统,该方法包括:控制器根据推杆初始位置检测装置提供的信息确认推杆位于初始底部位置;控制器按照预先设定的给药指令,在需要给药的时间启动电机并且接收电机转动量监控装置提供的当前电机行程的数据,在该行程到达指定值时停止电机,该指定值由所述给药指令中的给药量、药仓截面积、以及所述丝杆的导程确定;在所述电机启动状态下,控制器接收所述输注压力传感器提供的压力的信息,在该压力大于等于设定值时输出报警信息。A method for monitoring the driving transmission state of drug delivery, applied to the monitoring system of
一种给药驱动传动状态监控装置,设置在本发明的控制器中,该装置包括:推杆位置确认模块,用于根据推杆初始位置检测装置提供的信息确认推杆位于初始底部位置;定期给药模块,用于按照预先设定的给药指令,在需要给药的时间启动电机并且接收电机转动量监控装置提供的当前电机行程的数据,在该行程到达指定值时停止电机,该指令值由所述给药指令中的给药量、药仓截面积、以及所述丝杆的导程确定。A drug delivery drive transmission state monitoring device is provided in the controller of the present invention. The device includes: a push rod position confirmation module for confirming that the push rod is located at the initial bottom position according to the information provided by the push rod initial position detection device; The drug delivery module is used to start the motor at the time when the drug is needed according to the preset drug delivery instruction and receive the current motor stroke data provided by the motor rotation monitoring device, and stop the motor when the stroke reaches the specified value. This instruction The value is determined by the dose, the cross-sectional area of the drug chamber, and the lead of the screw in the dosing instruction.
一种给药驱动传动状态监控装置,设置在本发明的控制器中,该装置包括:推杆位置确认模块,用于根据推杆初始位置检测装置提供的信息确认推杆位于初始底部位置;定期给药模块,用于按照预先设定的给药指令,在需要给药的时间启动电机并且接收电机转动量监控装置提供的当前电机行程的数据,在该行程到达指定值时停止电机,该指定值由所述给药指令中的给药量、药仓截面积、以及所述丝杆的导程确定;输注压力监控模块,用于在所述电机启动状态下,接收所述输注压力传感器提供的压力的信息,在该压力大于等于设定值时输出报警信息。A drug delivery drive transmission state monitoring device is provided in the controller of the present invention. The device includes: a push rod position confirmation module for confirming that the push rod is located at the initial bottom position according to the information provided by the push rod initial position detection device; The drug delivery module is used to start the motor at the time when the drug is needed according to the pre-set drug delivery instructions and receive the current motor stroke data provided by the motor rotation monitoring device, and stop the motor when the stroke reaches the specified value. The value is determined by the dose, the cross-sectional area of the drug bin, and the lead of the screw rod in the dosing instruction; the infusion pressure monitoring module is used to receive the infusion pressure when the motor is activated The pressure information provided by the sensor, when the pressure is greater than or equal to the set value, output alarm information.
根据本发明的技术方案,采用推杆初始位置检测装置确认推杆的初始底部位置,由控制器结合电机转动量监控装置对步进电机的启停加以控制,实现了精确给药。在输注过程中进行输注压力监控,在压力异常时发出报警信号,提高了给药的可靠性。According to the technical scheme of the present invention, the initial position detection device of the push rod is adopted to confirm the initial bottom position of the push rod, and the start and stop of the stepping motor are controlled by the controller and the motor rotation amount monitoring device, thereby realizing accurate drug delivery. The infusion pressure is monitored during the infusion process, and an alarm signal is issued when the pressure is abnormal, which improves the reliability of the drug delivery.
为了说明而非限制的目的,现在将根据本发明的优选实施例、特别是参考附图来描述本发明,其中:For purposes of illustration and not limitation, the present invention will now be described according to preferred embodiments of the present invention, particularly with reference to the accompanying drawings, in which:
图1是根据本发明实施方式的胰岛素泵系统的组成部分的示意图;Figure 1 is a schematic diagram of the components of an insulin pump system according to an embodiment of the present invention;
图2是根据本发明实施方式的给药器的一侧的示意图,图3是该 给药器的另一侧的示意图;Fig. 2 is a schematic diagram of one side of the applicator according to an embodiment of the present invention, and Fig. 3 is a schematic diagram of the other side of the applicator;
图4是根据本发明实施方式的推杆初始位置检测装置的电路原理示意图;4 is a schematic diagram of the circuit principle of a device for detecting the initial position of a push rod according to an embodiment of the present invention;
图5是根据本发明实施方式的获取步进电机步数的装置的示意图;FIG. 5 is a schematic diagram of a device for obtaining the number of steps of a stepping motor according to an embodiment of the present invention;
图6是根据本发明实施方式的输注压力传感器的安装状态的示意图。Fig. 6 is a schematic diagram of an installation state of an infusion pressure sensor according to an embodiment of the present invention.
以下以胰岛素泵为例对本发明实施方式加以说明。以下先介绍胰岛素泵系统的结构。In the following, an insulin pump is taken as an example to describe the embodiments of the present invention. The following first introduces the structure of the insulin pump system.
对于一般的胰岛素泵系统来说,通常可分为给药部分和储药部分,前者中主要包含用于驱动活塞的传动组件,该活塞的作用类似于注射器的活塞,将储药部分的药液腔中的药液经由管路和针头(通常是皮下的留置针)注入人体。传动组件一般包含电机以及用来给电机的输出进行传递的齿轮组,另可选择同轴且螺纹连接的丝杆和推杆,以将旋转运动转换为直线运动,从而推动活塞。该电机为步进电机,从而能够按照确定的步数进行输出。齿轮组通常置于齿轮箱内,齿轮箱一端与电机的输出端连接,另一端与丝杆连接,推杆与活塞抵接。这样电机的旋转输出经传递和方向转换之后变为施加在活塞上的直线方向的推力。For a general insulin pump system, it can usually be divided into a drug delivery part and a drug storage part. The former mainly contains a transmission component for driving a piston. The piston acts like a piston in a syringe. The liquid medicine in the cavity is injected into the human body through a tube and a needle (usually an indwelling needle under the skin). The transmission assembly generally includes a motor and a gear set used to transmit the output of the motor. In addition, coaxial and threaded screw rods and push rods can be selected to convert rotary motion into linear motion to push the piston. The motor is a stepping motor, so it can output according to a certain number of steps. The gear set is usually placed in a gear box, one end of the gear box is connected with the output end of the motor, the other end is connected with the screw rod, and the push rod abuts against the piston. In this way, the rotation output of the motor is transferred and converted into a linear thrust applied to the piston.
本发明实施方式提出的一种胰岛素泵系统如图1、图2和图3所示。其中图1是根据本发明实施方式的胰岛素泵系统的组成部分的示意图。给药器100、电池200和储药器300为独立的三部分,使用时拼接成胰岛素泵系统,电池200置于储药器300内,储药器300和给药器100在靠近对接面处,一者比另一者的口径略大,因此二者能够部分地套接,如图1所示。An insulin pump system proposed by the embodiment of the present invention is shown in FIG. 1, FIG. 2 and FIG. 3. Fig. 1 is a schematic diagram of the components of an insulin pump system according to an embodiment of the present invention. The
图2是根据本发明实施方式的给药器的一侧的示意图,图3是该给药器的另一侧的示意图。如图2和图3所示,给药器100为重复使用部分,包括壳体1、传动组件及电路板组件;传动组件及电路板组件设于壳体1内,壳体1的一个端面为对接面17;传动组件包括电机2、齿轮箱3、同轴且螺纹连接的丝杆4及推杆5,电机2与电路板组件连接,电机2、齿轮箱3及推杆5呈U形布置,该U形开口朝向对接面17,电机2的输出端与齿轮箱3的一端连接,齿轮箱3的另一端与丝杆4连接,推杆5远离齿轮箱3的一端穿过对接面17从而位于壳体1的外侧;电路板组件包括印制电路板6、电池连接器7和柔性电路板8,电机2与柔性电路板8连接,电池连接器7与印制电路板6连接,电池连接器7上设有金属触点,金属触点凸出于对接面17从而位于壳体1的外侧,印制电路板6呈L形,该L形一条边位于对接面17与电机2的远离齿轮箱3的一端之间,另一条边位于电机2及推杆5之间。Fig. 2 is a schematic diagram of one side of the applicator according to an embodiment of the present invention, and Fig. 3 is a schematic diagram of the other side of the applicator. As shown in Figures 2 and 3, the
储药器300为一次性使用部分,储药器300中的药液用完之后,该储药器300废弃,不能重复使用;而电池200及给药器100则是重复使用部分,电池200采用充电电池,配置有适配器,可充电重复使用,在储药器300中设置有放置电池200的电池腔,拼接时电池200放置在电池腔内,储药器300废弃时,将电池200取出,可再次使用。The
本发明实施方式提出的给药驱动传动状态监控系统,主要包括用于获取电机转动的行程的电机转动量监控装置和用于确认推杆的初始底部位置的推杆初始位置检测装置,以及控制器,用于对电机的启停进行控制。The drug delivery drive transmission state monitoring system proposed by the embodiment of the present invention mainly includes a motor rotation amount monitoring device for obtaining the rotation stroke of the motor, a push rod initial position detection device for confirming the initial bottom position of the push rod, and a controller , Used to control the start and stop of the motor.
推杆的初始底部位置是推杆未伸出时的位置,此时药液腔中的药液基本上为满格状态。为了确认推杆处于初始底部位置,一种方式是如图4所示,图4是根据本发明实施方式的推杆初始位置检测装置的电路原理示意图,该装置主要包括两个导电触点及二者之间的导电片。本实施方式中的推杆外部还有一个套筒,在图4中未示出。在图4中, 推杆5的端部设置导电片401,在推杆和丝杆共同所处的基座402表面设置2个导电触点403,当推杆处于初始底部位置时,导电片同时接触这2个导电触点从而将这2个触点导通,控制器检测这两个导电触点403之间的电阻(或者电流)即可确认推杆5是否处于初始底部位置。The initial bottom position of the push rod is the position when the push rod is not extended. At this time, the liquid medicine in the liquid medicine cavity is basically full. In order to confirm that the push rod is at the initial bottom position, one way is as shown in FIG. 4, which is a schematic diagram of the circuit principle of a device for detecting the initial position of the push rod according to an embodiment of the present invention. The device mainly includes two conductive contacts and two Between the conductive sheet. There is also a sleeve outside the push rod in this embodiment, which is not shown in FIG. 4. In Figure 4, the end of the
另一种确认推杆处于初始底部位置的方式是在推杆和丝杆共同所处的基座表面设置2个触点以及连通这2个触点的弹性导电材料,即把图4中的导电片401替换为弹性导电材料。弹性导电材料例如可以是导电橡胶,其具有一定的弹性,能够避免两个刚性物体接触时电气导通的稳定性问题。当推杆向初始底部位置回退时,压缩弹性导电材料使其电导增加,通过合适地选择弹性导电材料的参数及厚度,可以使推杆位于初始底部位置时弹性导电材料的电导小于预设值,这样,控制器检测这两个导电触点之间的电阻并与预设值比较,即可确认推杆是否处于初始底部位置。在推杆到达初始底部位置时即应当停止电机的转动。Another way to confirm that the push rod is at the initial bottom position is to set two contacts on the surface of the base where the push rod and the screw rod are located together, and the elastic conductive material that connects the two contacts, that is, the conductive material in Figure 4 The
因为胰岛素是每隔一段时间就需要输注一次,所以控制器可用于按照预先设定的给药指令,在需要给药的时间启动电机并且接收电机转动量监控装置提供的行程的信息,在该行程到达指定值时停止电机。可由用户在一个终端设备中进行编辑给药信息,终端设备将其转换为控制器中的程序能够使用的给药指令,其中主要包括给药的时间和反映了给药量的步进电机的行程,然后以红外或蓝牙等无线方式发送给控制器。Because insulin needs to be infused every certain period of time, the controller can be used to start the motor at the time when the drug is required according to the pre-set administration instruction and receive the travel information provided by the motor rotation monitoring device. Stop the motor when the stroke reaches the specified value. The user can edit the medication information in a terminal device, and the terminal device converts it into medication instructions that can be used by the program in the controller, which mainly includes the time of medication and the stroke of the stepper motor reflecting the amount of medication , And then send it to the controller in a wireless manner such as infrared or Bluetooth.
上述的指定值由给药指令中的给药量、药仓截面积、以及丝杆的导程确定。给药时间和给药量可由用户使用上述终端设备时进行设定。终端设备根据导程及中径和齿轮箱的传动比可以计算出电机每前进1步,丝杆向前推进的距离,再结合本次给药量和药仓截面积即可得出本次给药时电机应当步进的步数,即上述指定值。在输注时获取电机步进的步数,到达本次给药时电机应当步进的步数时即停止电机。The above-mentioned specified value is determined by the dose, the cross-sectional area of the drug chamber, and the lead of the screw in the dosing instruction. The administration time and dosage can be set by the user when using the above-mentioned terminal device. The terminal device can calculate the distance that the screw rod advances for each step of the motor according to the lead, the pitch diameter and the transmission ratio of the gearbox, and then combine the dose of this time and the cross-sectional area of the drug bin to get the time of this drug delivery. The number of steps the motor should step, that is, the specified value above. Obtain the number of steps of the motor during the infusion, and stop the motor when the number of steps the motor should be stepped during this administration is reached.
为此本实施例中采用图5所示的计数器来获取电机的步数,图5是根据本发明实施方式的获取步进电机步数的装置的示意图。如图5所示,步进电机500的旋转轴501上安装有叶轮502,在叶轮附近的壳体内壁或由壳体内壁延伸出的基座上,或者是步进电机500所处的腔体内,固定有第一光传感器503和第二光传感器504,二者夹角是步进电机转动步长(以角度计)的整数倍。例如步进电机20步为一圈即360度,则每转动1步为18度,上述两个光传感器的夹角即可设置为90度。叶轮502在转动时切割光线从而被光传感器感知,光传感器即向控制器发送相应的数字信号从而实现电机步数的获取。这里的光传感器可以采用U型光耦、对射式光电开关等,需要能够感知叶轮转动引起的光线变化。For this reason, in this embodiment, the counter shown in FIG. 5 is used to obtain the number of steps of the motor. FIG. 5 is a schematic diagram of a device for obtaining the number of steps of a stepping motor according to an embodiment of the present invention. As shown in Figure 5, an
在输注过程中,控制器实时监控输注管路的压力,如果其超过一定的设定值,则认为输注管路堵塞,此时发出报警信息,可由蜂鸣器或者发光装置接收并且以声音、闪光等方式提醒用户。因为输注管路的压力与推杆上的压力呈正相关的关系,所以本实施方式中,采用薄片式压力传感器采集推杆受到的压力,具体可参照图6,图6是根据本发明实施方式的输注压力传感器的安装状态的示意图。During the infusion process, the controller monitors the pressure of the infusion line in real time. If it exceeds a certain set value, the infusion line is considered to be blocked. At this time, an alarm message is issued, which can be received by a buzzer or light-emitting device and displayed as Sound, flashing and other ways to remind users. Because the pressure of the infusion pipeline is positively correlated with the pressure on the push rod, in this embodiment, a sheet-type pressure sensor is used to collect the pressure on the push rod. For details, refer to FIG. 6, which is an embodiment of the present invention. Schematic diagram of the installation state of the infusion pressure sensor.
如图6所示,该薄片式压力传感器600夹在丝杆的一个端面601与给药器的壳体1的内壁之间(图中壳体为简略示意)。另外也可以安装在该端面与壳体内壁上的基座或其他连接物之间,只要是能够使该薄片式压力传感器能够感知丝杆在驱动推杆时受到的来自于推杆的反作用力即可。薄片式压力传感器600将感测到的压力转换成数字信号之后发送给控制器(控制器及其与薄片式压力传感器600的连线在图中未示出)。As shown in FIG. 6, the sheet-type pressure sensor 600 is sandwiched between one end surface 601 of the screw rod and the inner wall of the
根据本发明实施方式的技术方案,采用推杆初始位置检测装置确认推杆的初始底部位置,由控制器结合电机转动量监控装置对步进电 机的启停加以控制,实现了精确给药。在输注过程中进行输注压力监控,在压力异常时发出报警信号,提高了给药的可靠性。According to the technical solution of the embodiment of the present invention, the initial position detection device of the push rod is used to confirm the initial bottom position of the push rod, and the start and stop of the stepping motor are controlled by the controller combined with the motor rotation monitoring device to realize accurate drug delivery. The infusion pressure is monitored during the infusion process, and an alarm signal is issued when the pressure is abnormal, which improves the reliability of the drug delivery.
上述具体实施方式,并不构成对本发明保护范围的限制。本领域技术人员应该明白的是,取决于设计要求和其他因素,可以发生各种各样的修改、组合、子组合和替代。任何在本发明的精神和原则之内所作的修改、等同替换和改进等,均应包含在本发明保护范围之内。The foregoing specific implementations do not constitute a limitation on the protection scope of the present invention. Those skilled in the art should understand that, depending on design requirements and other factors, various modifications, combinations, sub-combinations, and substitutions can occur. Any modification, equivalent replacement and improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201911345149.2 | 2019-12-24 | ||
| CN201911345149.2ACN111135381A (en) | 2019-12-24 | 2019-12-24 | Drug delivery drive transmission state monitoring system, method and device |
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| WO2021129403A1true WO2021129403A1 (en) | 2021-07-01 |
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| PCT/CN2020/135160CeasedWO2021129403A1 (en) | 2019-12-24 | 2020-12-10 | Monitoring system, method, and apparatus for driving state of dosing drive |
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| WO (1) | WO2021129403A1 (en) |
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