WO2021159840A1 - 一种胰岛素泵输注控制方法 - Google Patents

一种胰岛素泵输注控制方法 Download PDF

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Publication number
WO2021159840A1
WO2021159840A1 PCT/CN2020/135161 CN2020135161W WO2021159840A1 WO 2021159840 A1 WO2021159840 A1 WO 2021159840A1 CN 2020135161 W CN2020135161 W CN 2020135161W WO 2021159840 A1 WO2021159840 A1 WO 2021159840A1
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WO
WIPO (PCT)
Prior art keywords
infusion
pump body
control module
pill dose
insulin pump
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PCT/CN2020/135161
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English (en)
French (fr)
Inventor
郑攀
道尔马克
吕剑锋
Original Assignee
微泰医疗器械(杭州)有限公司
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Application filed by 微泰医疗器械(杭州)有限公司 filed Critical 微泰医疗器械(杭州)有限公司
Priority to EP20918879.6A priority Critical patent/EP4104880A1/en
Priority to US17/799,344 priority patent/US20230141293A1/en
Publication of WO2021159840A1 publication Critical patent/WO2021159840A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/172—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M2005/14208—Pressure infusion, e.g. using pumps with a programmable infusion control system, characterised by the infusion program
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/581—Means for facilitating use, e.g. by people with impaired vision by audible feedback

Definitions

  • the invention relates to the technical field of medical supplies, in particular to an insulin pump infusion control method.
  • the basic function of the insulin pump is to simulate the secretory function of the pancreas. According to the required dose of the human body, insulin is continuously infused into the user's subcutaneous dose at regular intervals to keep blood sugar stable throughout the day and achieve the purpose of controlling diabetes.
  • Existing insulin pumps mainly include an applicator and a medicine reservoir.
  • the applicator is a driving part.
  • the drive device is used to squeeze the medicine reservoir to continuously squeeze the insulin in the medicine reservoir under the skin of the user.
  • the blood sugar level of the human body is different, so the amount of insulin injection is also different; especially during a period of time after a meal, because the blood sugar level rises, the amount of insulin required is greatly increased, that is, it needs to be carried out at this time.
  • the main purpose of the present invention is to provide an insulin pump infusion control method, which can reasonably control the pill dose infusion.
  • an insulin pump infusion control method which includes: after a control module of the pump body receives a function start signal, controlling the pump body to start a pill dose infusion control mode; In this pill dose infusion control mode, the pill dose button of the control terminal or the pill dose button of the insulin pump body is operated one or more times to send an infusion amount signal to the control module, where the control terminal or the insulin pump body corresponds to the One or more operations to send out one reminder tone or multiple reminder tones of different frequencies; the control module receives the infusion volume signal, and after a limited time, also sends out the one reminder tone or multiple reminder tones of different frequencies as For the confirmation of the operation; if the control module receives the confirmation signal within a limited time, the control module controls the pump to turn on the pill dose infusion; if the control module receives the cancel signal, or if the confirmation signal is not received within the limited time , The control module controls the pump body to exit the pill dose infusion mode.
  • a function start signal is sent to the control module by operating the pill dose key of the control terminal or the pill dose key of the insulin pump body.
  • the control terminal or the insulin pump body sends the infusion volume signal to the control module within a limited time; if the infusion volume signal is not sent to the control module within the limited time, the control module Control the pump body to exit the pill dose infusion mode.
  • the operation method of sending the infusion volume signal to the control module by operating the pill dose button of the control terminal or the pill dose button of the insulin pump body is: by operating the pill dose button of the control terminal or the pill dose button of the insulin pump body.
  • the number of times adjusts the amount of insulin infusion, where each operation of the pill dose button of the control terminal or the pill dose button of the insulin pump body increases the insulin infusion amount by a fixed increment.
  • the control module of the pump body receives the function start signal, if the pump body is injecting pill dose at this time, the control module controls the pump body. Stop the pill dose infusion.
  • the pump body is controlled to emit an audible prompt signal when the pill dose infusion mode is turned on.
  • control terminal or the insulin pump body will emit n-frequency reminder tones, and the n-frequency reminder tones are pronounced in order; when the number of times the pill dose key of the control terminal or the pill dose key of the insulin pump is operated is greater than n, The reminder tone is repeated cyclically.
  • the control module receives the infusion amount signal, and after it is determined, starts the pill dose infusion operation, wherein the infusion amount signal is controlled by operating the pill dose button of the terminal Or the pill dose button of the insulin pump body is sent out.
  • the insulin pump can implement more reasonable control during the pill dose infusion, that is, the start, setting, and implementation of the pill dose infusion, and the operation is simple and quick.
  • Figure 1 is a work flow chart of the control terminal for pill dose infusion control
  • Figure 2 is a work flow chart of the pill dose key on the insulin pump body for pill dose infusion control
  • FIG. 3 is a schematic diagram of the components of the insulin pump system
  • Figure 4 is a schematic view of one side of the applicator
  • Figure 5 is a schematic view of the other side of the applicator
  • FIG. 6 is a schematic diagram of the circuit principle of the device for detecting the initial position of the putter according to the embodiment of the present invention.
  • FIG. 7 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.
  • Fig. 8 is a schematic diagram of an installation state of an infusion pressure sensor according to an embodiment of the present invention.
  • the pill dose infusion operation can be controlled by the control terminal or the pill dose key on the pump body.
  • the control terminal is a portable controller with a pill dose key on its man-machine interface; portable The controller wirelessly transmits information to the insulin pump.
  • Figure 1 is a working flow chart of the control terminal for pill dose infusion control; as shown in Figure 1, in the lock screen interface of the portable controller, long press the pill dose button for more than 3 seconds, if the insulin pump is currently in infusion mode and turned on If the pill dose infusion function is activated, the portable controller will sound to prompt you to enter the pill dose infusion mode.
  • the pill dose infusion mode After entering the pill dose infusion mode, press the return key or if the pill dose key is not operated for more than 10 seconds, the pill dose infusion mode will be exited. Otherwise, continue the pill dose infusion operation.
  • each operation indicates that the injection volume is increased according to the set fixed increment.
  • the portable controller will emit a tone every time the pill dose key is operated (there are 5 tones, and the operation exceeds 5 times.
  • the tone returns to the first tone again); if the pill dose button is not pressed for more than 3 seconds, the portable controller sends out a reminder signal, which is the same as the tone emitted by operating the pill dose button, that is, if the pill dose button is operated 4 times , Will emit 4 tones, and the prompt signal will also emit these 4 tones. If the return button on the portable controller is operated, or if there is no operation within 10s, the pill dose infusion mode will be exited. On the contrary, if the pill dose key is operated again within 10s, the rapid pill dose infusion will be started.
  • the control module controls the insulin pump to stop the current pill dose infusion; among them, long press the pill dose button Operation, can cancel any form of instruction to open the pill dose infusion operation, that is, the pill dose button can be used as a button for canceling the pill dose infusion. If the insulin pump is currently in infusion mode and the pill dose infusion function is turned on, the pump will make a sound to prompt to enter the pill dose infusion mode.
  • the pill dose button can also be changed to the form of a dial block that can automatically rebound. Toggling the dial block and rebounding is equivalent to pressing the button, and dialing and keeping it is equivalent to long pressing the button. Other operation modes are also possible, as long as functions similar to this embodiment can be realized.
  • the pill dose infusion mode After entering the pill dose infusion mode, if the pill dose button is not operated for more than 10 seconds, the pill dose infusion mode will be exited. Otherwise, continue the pill dose infusion operation. Among them, each operation indicates that the injection volume is increased according to the set fixed increment.
  • the insulin pump will emit a tone every time the pill dose button is operated (5 tones in total, after the operation exceeds 5 times) , The tone returns from the first tone again); more than 3 seconds is the no pill dose button, the insulin pump sends out a reminder signal, the signal is the same as the tone emitted by the pill dose button, that is, if the pill dose button is operated 4 times, it will sound 4 tones, the prompt signal also sends out the 4 tones.
  • the pill dose key After operating the pill dose key to adjust the injection volume, if there is no operation within 10s, the pill dose infusion mode will be exited. On the contrary, if the pill dose key is operated again within 10s, the rapid pill dose infusion will be started.
  • Fig. 3 is a schematic diagram of the components of the insulin pump system according to an embodiment of the present invention.
  • the drug dispenser 100, the battery 200, and the drug storage device 300 are three independent parts, which are spliced into an insulin pump system during use.
  • the battery 200 is placed in the drug storage device 300, and the drug storage device 300 and the drug storage device 100 are near the docking surface.
  • Fig. 4 is a schematic diagram of one side of the applicator according to an embodiment of the present invention
  • Fig. 5 is a schematic diagram of the other side of the applicator.
  • the applicator 100 is a reusable part, including a housing 1, a transmission assembly and a circuit board assembly; the transmission assembly and the circuit board assembly are arranged in the housing 1, and one end surface of the housing 1 is Docking surface 17; transmission components include motor 2, gear box 3, coaxial and threaded screw rod 4 and push rod 5, motor 2 is connected with the circuit board assembly, motor 2, gear box 3 and push rod 5 are arranged in a U shape , The U-shaped opening faces the mating surface 17, the output end of the motor 2 is connected to one end of the gear box 3, the other end of the gear box 3 is connected to the screw rod 4, and the end of the push rod 5 away from the gear box 3 passes through the mating surface 17 so as to Located on the outside of the housing 1; the circuit board assembly includes a printed circuit board 6, a battery connector 7 and
  • the motor 2 is connected to the flexible circuit board 8
  • the battery connector 7 is connected to the printed circuit board 6, and the battery is connected
  • the device 7 is provided with metal contacts.
  • the metal contacts protrude from the mating surface 17 so as to be located on the outside of the housing 1.
  • the printed circuit board 6 is L-shaped, and one side of the L-shape is located on the mating surface 17 and the motor 2 away from the gear. Between one end of the box 3, the other side is between the motor 2 and the push rod 5.
  • the medicine reservoir 300 is a disposable part. After the liquid medicine in the medicine reservoir 300 is used up, the medicine reservoir 300 is discarded and cannot be reused; while the battery 200 and the dispenser 100 are the reusable parts, and the battery 200 adopts
  • the rechargeable battery is equipped with an adapter and can be recharged and reused.
  • the medicine storage 300 is provided with a battery cavity for placing the battery 200. When splicing, the battery 200 is placed in the battery cavity. When the medicine storage 300 is discarded, the battery 200 can be taken out. Use it again.
  • 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.
  • FIG. 6 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. 6.
  • the end of the push rod 5 is provided with a conductive sheet 401, and two conductive contacts 403 are provided on the surface of the base 402 where the push rod and the screw rod are located.
  • the conductive sheet is at the same time
  • the two conductive contacts are contacted to conduct the two contacts, and the controller detects the resistance (or current) between the two conductive contacts 403 to confirm whether the push rod 5 is at the initial bottom position.
  • the sheet 401 is replaced with an elastic conductive material.
  • the elastic conductive material may be, for example, conductive rubber, which has certain elasticity and can avoid the stability problem of electrical conduction when two rigid objects are in contact.
  • the push rod retreats to the initial bottom position, compress the elastic conductive material to increase its conductance.
  • the conductance of the elastic conductive material can be lower than the preset value when the push rod is at the initial bottom position. In this way, the controller detects the resistance between the two conductive contacts and compares it with the preset value to confirm whether the push rod is at the initial bottom position. When the push rod reaches the initial bottom position, the rotation of the motor should be stopped.
  • the controller can be used to start the motor at the time when the drug 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.
  • the user can edit the medication information in a control terminal (portable controller).
  • the medication information includes daily infusion, fixed increments during adjustment, etc.
  • the control terminal converts the medication information into the program in the controller.
  • the medication instructions used mainly include the time of medication and the stroke of the stepper motor reflecting the amount of medication, which are then sent to the controller in a wireless manner such as infrared or bluetooth.
  • 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 control terminal.
  • the control terminal can calculate the forward distance of the screw rod for each step of the motor advancement 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 medicament to get the time of this medicine.
  • 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.
  • FIG. 7 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.
  • an impeller 502 is installed on the rotating shaft 501 of the stepper motor 500, on the inner wall of the housing near the impeller or a base extending from the inner wall of the housing, or in the cavity where the stepper motor 500 is located.
  • the first light sensor 503 and the second light sensor 504 are fixed, and the angle between the two is an integer multiple of the step length (in angle) of the rotation of the stepping motor.
  • 20 steps of the stepping motor are 360 degrees, and each step of rotation is 18 degrees, and the angle between the two light sensors can be set to 90 degrees.
  • the impeller 502 rotates, the light is cut to be sensed by the light sensor, and the light sensor sends a corresponding digital signal to the controller to obtain the number of steps of the motor.
  • the light sensor here can use a U-shaped photocoupler, a through-beam photoelectric switch, etc., and needs to be able to sense changes in light caused by the rotation of the impeller.
  • 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 line 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. 8, which is an embodiment according to the present invention. Schematic diagram of the installation state of the infusion pressure sensor.
  • the sheet-type pressure sensor 600 is sandwiched between an end surface 601 of the screw rod and the inner wall of the housing 1 of the applicator (the housing is schematically shown in the figure). In addition, it can also be installed between the end surface and the base or other connecting objects on the inner wall of the housing, as long as the sheet-type pressure sensor can sense the reaction force from the push rod that the screw receives when the push rod is driven. Can.
  • the sheet-type pressure sensor 600 converts the sensed pressure into a digital signal and then sends it to the controller (the controller and its connection with the sheet-type pressure sensor 600 are not shown in the figure).
  • 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 and the motor rotation 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.

Abstract

一种胰岛素泵丸剂量输注控制方法，泵体的控制模块接收到功能开启信号后，控制泵体开启一种丸剂量输注控制模式；在此丸剂量输注控制模式下，通过一次或多次操作控制终端的丸剂量键或胰岛素泵体的丸剂量键向控制模块发送输注量信号；若控制模块在限定时间内接收到确认信号，则控制模块控制泵体开启丸剂量输注；若控制模块接收到取消信号，或者，在限定时间内未接收到确认信号，则控制模块控制泵体退出丸剂量输注模式。利用该方法，使得胰岛素泵在进行丸剂量输注时，可实施更加合理的控制，即丸剂量输注的启动、设置、以及实施，操作简单快捷。

Description

一种胰岛素泵输注控制方法 技术领域
本发明涉及医疗用品技术领域，特别地涉及一种胰岛素泵输注控制方法。
背景技术
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常规剂量输注，保持全天血糖稳定，达到控制糖尿病的目的。现有的胰岛素泵主要包括给药器和储药器，给药器为驱动部分，利用驱动装置挤压储药器，将储药器中的胰岛素持续地挤压到使用者的皮下。
其中，在一天之中，人体的血糖值是不同的，因此胰岛素的注射量也不同；尤其是餐后一段时间内，由于血糖值升高，需要的胰岛素量则大大提高，即此时需要进行高于上述常规剂量的丸剂量输注，相应地，需要对胰岛素泵的丸剂量输注进行合理的控制。
发明内容
有鉴于此，本发明的主要目的是提供一种胰岛素泵输注控制方法，能够对丸剂量输注进行合理的控制。
为实现上述目的，根据本发明的一个方面，提供了一种胰岛素泵输注控制方法，包括：泵体的控制模块接收到功能开启信号后，控制泵体开启一种丸剂量输注控制模式；在此丸剂量输注控制模式下，通过一次或多次操作控制终端的丸剂量键或胰岛素泵体的丸剂量键向控制模块发送输注量信号，其中，控制终端或胰岛素泵体相应所述一次或多次操作发出1个提醒音调或者多个不同频率的提醒音调；控制模块接收输注量信号，并在限定时间后也发出所述1个提醒音调或者多 个不同频率的提醒音调以作为对于所述操作的确认；若控制模块在限定时间内接收到确认信号，则控制模块控制泵体开启丸剂量输注；若控制模块接收到取消信号，或者，在限定时间内未接收到确认信号，则控制模块控制泵体退出丸剂量输注模式。
可选地，通过操作控制终端的丸剂量键或胰岛素泵体的丸剂量键向控制模块发送功能开启信号。
可选地，泵体的控制模块接收功能开启信号后，控制终端或胰岛素泵体在限定时间内向控制模块发送输注量信号；若未在限定时间内向控制模块发送输注量信号，则控制模块控制泵体退出丸剂量输注模式。
可选地，通过操作控制终端的丸剂量键或胰岛素泵体的丸剂量键向控制模块发送输注量信号的操作方法为：通过操作控制终端的丸剂量键或胰岛素泵体的丸剂量键的次数调节胰岛素的输注量，其中，每次操作控制终端的丸剂量键或胰岛素泵体的丸剂量键胰岛素的输注量按固定增量增加。
可选地，通过操作胰岛素泵体的丸剂量键向控制模块发送功能开启信号，泵体的控制模块接收功能开启信号时，若此时泵体正在进行丸剂量输注，则控制模块控制泵体停止丸剂量输注。
可选地，控制泵体开启丸剂量输注模式时发出声响提示信号。
可选地，控制终端或胰岛素泵体会发出n种频率的提醒音调，n种频率的提醒音调发音顺序排列；当操作控制终端的丸剂量键或胰岛素泵体的丸剂量键的次数大于n时，提醒音调循环重复发出。
根据本发明的技术方案，在丸剂量输注模式下，控制模块接收输 注量信号，待确定之后，开启丸剂量输注操作，其中，该输注量信号由通过操作控制终端的丸剂量键或胰岛素泵体的丸剂量键发出。
利用该方法，使得胰岛素泵在进行丸剂量输注时，可实施更加合理的控制，即丸剂量输注的启动、设置、以及实施，操作简单快捷。
附图说明
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：
图1是控制终端进行丸剂量输注控制的工作流程图；
图2是胰岛素泵体上丸剂量键进行丸剂量输注控制的工作流程图；
图3是胰岛素泵系统的组成部分的示意图；
图4是给药器的一侧的示意图；图5是该给药器的另一侧的示意图；
图6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；
图7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；
图8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。
具体实施方式
本实施例中，对于丸剂量输注操作，可使用控制终端控制，也可由泵体上的丸剂量键控制，其中，控制终端为便携式控制器，其人机界面上设有丸剂量键；便携式控制器对胰岛素泵采用无线方式进行信息传输。
图1是控制终端进行丸剂量输注控制的工作流程图；如图1所示，在便携式控制器锁屏界面下，长按丸剂量键3秒以上，若胰岛素泵当 前为输注模式且开启了丸剂量输注功能，则便携式控制器发出声响提示进入丸剂量输注模式。
进入丸剂量输注模式后，操作返回键或者超过10s未操作丸剂量键，则退出丸剂量输注模式。反之，则继续进行丸剂量输注操作。其中，每操作1次，表示按照设定的固定增量增加注射量，在操作丸剂量键过程中，每操作一次丸剂量键便携式控制器会发出一个音调(音调共5个，操作超出5次后，音调返回重新从第1个音调开始)；超过3秒为未按丸剂量键，便携式控制器发出提示信号，该信号与操作丸剂量键发出的音调相同，即假设操作4次丸剂量键，会发出4个音调，提示信号同样发出该4个音调。若操作便携式控制器上的返回键，或者，在10s内无操作，则退出丸剂量输注模式。相反的，10s内再次操作丸剂量键，则开启快速丸剂量输注。
如图2所示，长按泵体上丸剂量键3秒以上，若胰岛素泵当前正在进行丸剂量输注，则控制模块控制胰岛素泵停止当前丸剂量输注；其中，长按丸剂量键的操作，可以取消任何形式指令开启的丸剂量输注操作，即该丸剂量键可作为取消丸剂量输注按键使用。若胰岛素泵当前为输注模式且开启了丸剂量输注功能，则泵体发出声响提示进入丸剂量输注模式。丸剂量键也可以改为能够自动回弹的拨块的形式，拨动拨块并回弹相当于按一下按键，拨住并保持不回弹相当于长按按键。也可以是其他操作方式，只要能实现与本实施方式类似的功能即可。
进入丸剂量输注模式后，超过10s未操作丸剂量键，则退出丸剂量输注模式。反之，则继续进行丸剂量输注操作。其中，每操作1次，表示按照设定的固定增量增加注射量，在操作丸剂量键过程中，每操作一次丸剂量键胰岛素泵会发出一个音调(音调共5个，操作超出5次后，音调返回重新从第1个音调开始)；超过3秒为未丸剂量键，胰岛素泵发出提示信号，该信号与操作丸剂量键发出的音调相同，即 假设操作4次丸剂量键，会发出4个音调，提示信号同样发出该4个音调。操作丸剂量键调整注射量后，若10s内无操作，则退出丸剂量输注模式。相反的，10s内再次操作丸剂量键，则开启快速丸剂量输注。
本实施例中，关于胰岛素泵的丸剂量输注，参考图3至图5，其中图3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。
图4是根据本发明实施方式的给药器的一侧的示意图，图5是该给药器的另一侧的示意图。如图4和图5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。
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。
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。
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6所示，图6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6中未示出。在图6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。
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。
因为胰岛素是每隔一段时间就需要输注一次(包括日常的间断地定量注射，以及丸剂量输注)，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。可由用户在一个控制终端(便携式控制器)中进行编辑给药信息，该给药信息包括日常输注量、调节时的固定增量等，控制终端将给药信息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。
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控制终端时进行设定。控制终端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。
为此本实施例中采用图7所示的计数器来获取电机的步数，图7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7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。
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8，图8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。
如图8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)。
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。
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。

Claims (7)

  1. 一种胰岛素泵输注控制方法，其特征在于，包括：
    泵体的控制模块接收到功能开启信号后，控制泵体开启一种丸剂量输注控制模式；
    在此丸剂量输注控制模式下，通过一次或多次操作控制终端的丸剂量键或胰岛素泵体的丸剂量键向控制模块发送输注量信号，其中，控制终端或胰岛素泵体相应所述一次或多次操作发出1个提醒音调或者多个不同频率的提醒音调；
    控制模块接收输注量信号，并在限定时间后也发出所述1个提醒音调或者多个不同频率的提醒音调以作为对于所述操作的确认；
    若控制模块在限定时间内接收到确认信号，则控制模块控制泵体开启丸剂量输注；若控制模块接收到取消信号，或者，在限定时间内未接收到确认信号，则控制模块控制泵体退出丸剂量输注模式。
  2. 根据权利要求1所述的胰岛素泵输注控制方法，其特征在于，通过操作控制终端的丸剂量键或胰岛素泵体的丸剂量键向控制模块发送功能开启信号。
  3. 根据权利要求2所述的胰岛素泵输注控制方法，其特征在于，泵体的控制模块接收功能开启信号后，控制终端或胰岛素泵体在限定时间内向控制模块发送输注量信号；
    若未在限定时间内向控制模块发送输注量信号，则控制模块控制泵体退出丸剂量输注模式。
  4. 根据权利要求2所述的胰岛素泵输注控制方法，其特征在于，通过操作控制终端的丸剂量键或胰岛素泵体的丸剂量键向控制模块发送输注量信号的操作方法为：
    通过操作控制终端的丸剂量键或胰岛素泵体的丸剂量键的次数调节胰岛素的输注量，其中，每次操作控制终端的丸剂量键或胰岛素泵 体的丸剂量键胰岛素的输注量按固定增量增加。
  5. 根据权利要求2所述的胰岛素泵输注控制方法，其特征在于，通过操作胰岛素泵体的丸剂量键向控制模块发送功能开启信号，若此时泵体正在进行任何形式的丸剂量输注，则控制模块控制泵体停止丸剂量输注。
  6. 根据权利要求1至6中任一项所述的胰岛素泵输注控制方法，其特征在于，控制泵体开启丸剂量输注模式时发出声响提示信号。
  7. 根据权利要求1至6中任一项所述的胰岛素泵输注控制方法，其特征在于，控制终端或胰岛素泵体会发出n种频率的提醒音调，n种频率的提醒音调发音顺序排列；
    当操作控制终端的丸剂量键或胰岛素泵体的丸剂量键的次数大于n时，提醒音调循环重复发出。
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Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111317889B (zh) * 2020-02-14 2022-06-24 微泰医疗器械(杭州)股份有限公司 一种胰岛素泵输注控制方法
CN113975488A (zh) * 2021-11-18 2022-01-28 荣科(苏州)医疗科技有限公司 一种具有一键检查功能的伤口冲洗引流治疗系统及方法

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101663059A (zh) * 2007-03-19 2010-03-03 梅丁格有限公司 药物输送设备中选择单次剂量的用户接口
US20110098638A1 (en) * 2009-10-27 2011-04-28 Medtronic Minimed, Inc. Sensor-Augmented Medication Infusion System
CN104010565A (zh) * 2011-12-29 2014-08-27 霍夫曼-拉罗奇有限公司 具有飞行模式的手持式糖尿病管理器
US20150057518A1 (en) * 2000-01-21 2015-02-26 Medtronic Minimed, Inc. Microprocessor controlled ambulatory medical apparatus with hand held communication device
US20180147348A1 (en) * 2016-11-30 2018-05-31 Animas Corporation Audio bolus with improved safety for use in a drug delivery system
CN111317889A (zh) * 2020-02-14 2020-06-23 微泰医疗器械(杭州)有限公司 一种胰岛素泵输注控制方法

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6554798B1 (en) * 1998-08-18 2003-04-29 Medtronic Minimed, Inc. External infusion device with remote programming, bolus estimator and/or vibration alarm capabilities
US20030212379A1 (en) * 2002-02-26 2003-11-13 Bylund Adam David Systems and methods for remotely controlling medication infusion and analyte monitoring
KR100636336B1 (ko) * 2004-11-04 2006-10-19 이홍규 혈당의 효율적 조절을 가능케 하는 삼중 기능을 갖는인슐린 펌프 및 이를 보조하는 생리수 시린지를 포함하는인슐린 투여 시스템
US7515060B2 (en) * 2006-10-17 2009-04-07 Smiths Medical Md, Inc. Insulin pump for the visually impaired
CN101214399A (zh) * 2008-01-11 2008-07-09 西北工业大学 分体式胰岛素泵
JP2010051720A (ja) * 2008-08-29 2010-03-11 Jms Co Ltd 輸液装置
CN203329123U (zh) * 2013-07-18 2013-12-11 中国人民解放军第四军医大学 一种便携式野外快速输液一体盒
CN104735236A (zh) * 2013-12-20 2015-06-24 比亚迪股份有限公司 移动终端的操控装置和操控方法
CN104218963A (zh) * 2014-08-28 2014-12-17 腾讯科技（深圳）有限公司 执行控制操作的方法、可穿戴设备和终端
CN104524664B (zh) * 2014-12-12 2018-06-26 深圳市理邦精密仪器股份有限公司 一种胰岛素注射设备的控制方法、装置及系统
EP3310412A1 (en) * 2015-06-19 2018-04-25 Roche Diabetes Care GmbH A control apparatus and method for controlling a medical system, a portable device, an arrangement, and a computer program product
CN106600781B (zh) * 2016-12-14 2019-03-08 江苏宏宝工具有限公司 一种控制智能车锁关锁方法、装置、智能车锁及单车
EP3568859A1 (en) * 2017-01-13 2019-11-20 Bigfoot Biomedical, Inc. Insulin delivery methods, systems and devices

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20150057518A1 (en) * 2000-01-21 2015-02-26 Medtronic Minimed, Inc. Microprocessor controlled ambulatory medical apparatus with hand held communication device
CN101663059A (zh) * 2007-03-19 2010-03-03 梅丁格有限公司 药物输送设备中选择单次剂量的用户接口
US20110098638A1 (en) * 2009-10-27 2011-04-28 Medtronic Minimed, Inc. Sensor-Augmented Medication Infusion System
CN104010565A (zh) * 2011-12-29 2014-08-27 霍夫曼-拉罗奇有限公司 具有飞行模式的手持式糖尿病管理器
US20180147348A1 (en) * 2016-11-30 2018-05-31 Animas Corporation Audio bolus with improved safety for use in a drug delivery system
CN111317889A (zh) * 2020-02-14 2020-06-23 微泰医疗器械(杭州)有限公司 一种胰岛素泵输注控制方法

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