WO2022095994A1 - Procédé et appareil de commande de perfusion de grande dose d'insuline, système, et appareil de pompe à insuline - Google Patents

Procédé et appareil de commande de perfusion de grande dose d'insuline, système, et appareil de pompe à insuline Download PDF

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Publication number
WO2022095994A1
WO2022095994A1 PCT/CN2021/129256 CN2021129256W WO2022095994A1 WO 2022095994 A1 WO2022095994 A1 WO 2022095994A1 CN 2021129256 W CN2021129256 W CN 2021129256W WO 2022095994 A1 WO2022095994 A1 WO 2022095994A1
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WIPO (PCT)
Prior art keywords
insulin
infusion
controller
insulin pump
module
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PCT/CN2021/129256
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English (en)
Chinese (zh)
Inventor
吕剑峰
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微泰医疗器械(杭州)股份有限公司
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Publication of WO2022095994A1 publication Critical patent/WO2022095994A1/fr

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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
    • A61M5/142—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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring

Definitions

  • the present invention relates to the technical field of machinery, in particular to a method, device, system and insulin pump device for controlling large-dose insulin infusion.
  • Insulin pump is an insulin infusion system that simulates the secretion of insulin by the human pancreas. It can control the blood sugar level of diabetic patients and reduce blood sugar fluctuations through continuous and micro-infusion of insulin into the human body.
  • the traditional insulin pump mostly adopts the integrated design of the medicine reservoir, the injection mechanism and the control display panel.
  • the user inputs various insulin pump operating parameters such as the basal rate plan, large-dose injection volume, etc. through the control panel buttons on the insulin pump, and controls the insulin.
  • Various states such as start and stop of the pump. It is usually necessary to set up regular and quantitative routine infusions to ensure the basic control of blood sugar levels; in addition, in special circumstances, for example, before a large amount of food is required in some occasions, the injection volume can be additionally increased. To meet the current special needs for insulin.
  • the user is required to manually operate the controller to send infusion instructions to the insulin pump.
  • Fig. 1 is a schematic diagram of the basic components of the infusion system related to the present invention.
  • the infusion system mainly includes an insulin pump and a controller, wherein the insulin pump is fixed on the human body and is connected with the controller (Fig. Take the handheld controller as an example) to communicate.
  • the insulin insulin pump has no control display panel and other components, and the volume can be made very small, and can even be directly attached to the injection site of the human body; while the portable handheld controller is responsible for inputting control commands, monitoring the operation of the insulin pump, etc. It can interact with the insulin pump through short-range wireless communication such as Bluetooth. Since there is no size limitation, the controller can be developed based on the latest mobile intelligent terminal platform, similar in appearance to a mobile phone, and equipped with modern human-computer interaction interfaces such as a large-size color touch screen, which greatly improves the user experience and the degree of device intelligence.
  • FIG. 2 is a schematic diagram of a flow of overdose caused by a communication failure.
  • the fault tolerance and failure recovery mechanism in the case of abnormal communication should be fully considered, and the insulin infusion process should be guaranteed to the greatest extent by means of communication data verification, confirmation, failure detection, and retransmission. security and reliability.
  • the present invention proposes a method, device, system and insulin pump device for controlling insulin bolus infusion, which help to improve the safety and reliability of insulin bolus infusion.
  • An insulin bolus infusion system comprising a controller and an insulin pump for infusion, wherein: the controller is used to control the insulin pump for infusion and obtain the insulin pump in the case of receiving an insulin bolus infusion instruction Save the history record of high-dose insulin infusion, and judge whether the insulin pump is infusion according to the latest history record saved by the insulin pump, and output prompt information according to the judgment result; the insulin pump is used for insulin infusion and saving the insulin of the insulin pump High-dose infusion history.
  • the prompt information includes current infusion information.
  • the controller is further configured to terminate the current process if communication with the insulin pump times out.
  • the controller is also used to obtain the last insulin bolus infusion history record saved by the insulin pump and present it on the man-machine interface, so that the user can confirm whether to send insulin. High-dose infusion instructions.
  • the controller is further configured to synchronize the locally saved insulin bolus infusion history record and the insulin bolus infusion history record saved by the insulin pump, and After synchronization, the local history of the last insulin bolus infusion is presented on the human-machine interface, so that the user can confirm whether the controller needs to send an insulin bolus infusion instruction to the insulin pump.
  • a method for controlling insulin bolus infusion comprising: step 1: a controller receives an insulin bolus infusion instruction initiated by a user through a human-machine interface; step 2: the controller queries the history of the latest insulin bolus infusion cached by an insulin pump Record; Step 3: The controller judges whether the insulin pump is infusion according to the historical record of the last insulin high-dose infusion, if so, go to Step 10, otherwise go to Step 4; Step 4: The controller obtains the latest locally saved Insulin bolus infusion history record; Step 5: The controller compares whether the latest locally saved insulin bolus infusion history record is consistent with the latest insulin bolus infusion history record cached by the insulin pump, if so, go to step 7, Otherwise, go to Step 6; Step 6: The controller obtains the insulin bolus infusion history record buffered by the insulin pump from the insulin pump and saves it locally; Step 7: The controller presents the latest locally saved insulin bolus infusion through the human-machine interface History record for the user to confirm whether the controller needs to
  • An insulin bolus infusion control device comprising: a first module for receiving an infusion operation instruction initiated by a user through a man-machine interface; a second module for querying the history of the latest insulin bolus infusion cached by an insulin pump record; the third module is used to judge whether the insulin pump is infusion according to the historical record of the last large dose of insulin infusion, if so, the tenth module is triggered, otherwise the fourth module is triggered; the fourth module is used to obtain the local The saved history of the last insulin bolus infusion; the fifth module is used to compare whether the last locally saved history of the last insulin bolus infusion is consistent with the latest history of insulin bolus infusion cached by the insulin pump, if so, Then the seventh module is triggered, otherwise the sixth module is triggered; the sixth module is used to obtain the insulin bolus infusion history record buffered by the insulin pump from the insulin pump and save it locally; the seventh module is used to present the latest The information of an infusion, for the user to confirm whether the controller
  • An insulin pump device is set in the insulin pump, comprising: a recording module for recording the progress of the current infusion after the insulin bolus infusion starts; a sending module for sending the latest insulin buffered by the insulin pump to the controller The bolus infusion history record, and all the insulin bolus infusion history records buffered by the insulin pump are sent to the controller; the receiving module is used to receive the insulin bolus infusion instruction sent by the controller.
  • the insulin pump records the fact of high-dose insulin infusion and acquires it by the controller, which is then presented to the user, so that the user can know whether the high-dose insulin infusion has been performed recently and decide whether to perform insulin high-dose infusion.
  • the user grasps the real situation of large-dose insulin infusion the occurrence of excessive insulin infusion can be avoided more effectively.
  • FIG. 1 is a schematic diagram of the essential components of an insulin infusion system related to the present invention
  • Fig. 2 is a schematic diagram of a process of over-infusion of insulin caused by communication failure
  • FIG. 3 is a schematic diagram of an insulin bolus infusion control method according to an embodiment of the present invention.
  • the controller determines whether the insulin pump is infusion according to the latest historical record of insulin large-dose infusion saved by the insulin pump, And display prompt information on the man-machine interface of the controller. Specifically, if an infusion is in progress, the current infusion progress is displayed, otherwise, text such as "currently no bolus infusion" or other text is displayed. Each insulin bolus infusion history contains information on the bolus infusion status, which can be used to determine whether an infusion is in progress.
  • This status information can be represented by the bolus infusion rate, when the rate is greater than zero, it indicates that a bolus infusion is in progress, and a rate of zero indicates that there is currently no infusion.
  • the insulin pump will generate a history record each. In the history record at the start time, the insulin bolus infusion rate is greater than zero. , in the history at the end time, the insulin bolus rate is equal to zero.
  • the bolus infusion rate is determined by the structure of the product. Therefore, if the bolus rate recorded in the last history of the insulin pump is not zero, it means that the bolus infusion is still in progress.
  • the insulin pump can keep a historical record of its insulin bolus infusion, so the controller can obtain this record from the insulin pump and provide it to the user.
  • the controller can be equipped with a larger memory than the insulin pump to save more history for the user to view or perform data analysis, the controller can also save the above history locally and display the most recent insulin event.
  • the controller first obtains the locally saved historical records. Considering that the abnormal communication may cause the historical records not to be fully transmitted to the controller, the controller compares the local recent historical records with the most recent historical records obtained from the insulin pump at this time. Make a comparison, and take the one saved by the insulin pump as the criterion, that is, synchronize the content saved by the controller to the content saved by the insulin pump in the case of inconsistency between the two.
  • FIG. 3 is a schematic diagram of an infusion control method according to an embodiment of the present invention, including the following steps 1 to 10 .
  • Step 1 The controller receives the insulin large-dose infusion operation instruction initiated by the user through the man-machine interface;
  • Step 2 The controller queries the latest insulin bolus infusion history record cached by the insulin pump;
  • Step 3 The controller judges whether the insulin pump is infusion according to the historical record of the most recent insulin high-dose infusion, if so, it goes to step 10, otherwise, it goes to step 4;
  • Step 4 The controller obtains the history record of the last insulin bolus infusion saved locally;
  • Step 5 The controller compares whether the latest history of insulin bolus infusion saved locally is consistent with the latest history of insulin bolus infusion cached by the insulin pump. If so, go to step 7, otherwise go to step 6;
  • Step 6 The controller performs record synchronization, obtains the insulin high-dose infusion history record buffered by the insulin pump from the insulin pump, and saves it locally;
  • Step 7 The controller presents the history record of the last insulin bolus infusion saved locally through the human-machine interface, so that the user can confirm whether the controller needs to send the insulin bolus infusion instruction to the insulin pump;
  • Step 8 The controller judges whether to send an infusion instruction according to the user's confirmation result, if the user's confirmation result is yes, then go to Step 9, otherwise end the process;
  • Step 9 The controller sends an insulin bolus infusion instruction to the insulin pump
  • Step 10 The controller presents the current insulin bolus infusion progress through the man-machine interface.
  • timeout processing is omitted in the above listed steps.
  • the timeout judgment as shown in the figure can be added to the relevant steps, and the process is directly ended when the communication between the controller and the insulin pump times out. , and can present prompt information to the user.
  • the infusion control device software is set in the controller to realize the above control method, which may include the following functional modules:
  • the first module is used for receiving the infusion operation instruction initiated by the user through the man-machine interface
  • the second module is used to query the history record of the last insulin bolus infusion cached by the insulin pump;
  • the third module is used for judging whether the insulin pump is infusion according to the historical record of the last insulin high-dose infusion, if so, triggering the tenth module, otherwise triggering the fourth module;
  • the fourth module is used to obtain the history record of the latest high-dose insulin infusion saved locally;
  • the fifth module is used to compare whether the latest history record of high-dose insulin infusion saved locally is consistent with the last record of high-dose insulin infusion cached by the insulin pump, if so, trigger the seventh module, otherwise trigger the sixth module;
  • the sixth module is used to obtain the insulin bolus infusion history record buffered by the insulin pump from the insulin pump and save it locally;
  • the seventh module is used to present the information of the latest infusion through the man-machine interface, so that the user can confirm whether the controller needs to send the infusion instruction to the insulin pump;
  • the eighth module is used to judge according to the user's confirmation result, if the user's confirmation result is yes, then trigger the ninth module, otherwise end the process;
  • the ninth module is used to send an infusion instruction to the insulin pump
  • the tenth module is used to present the current infusion progress through the man-machine interface.
  • control mode can be set in the controller of the insulin pump to control the insulin pump that performs the insulin infusion operation.
  • a timeout processing module can be set up in the software to abort the current process when the communication between the controller and the insulin pump times out, and can also issue a prompt to the user.
  • an insulin pump device as software can also be set in the insulin pump, including a recording module, a sending module and a receiving module, wherein the recording module is used to record the progress of this infusion after the large-dose infusion of insulin starts; the sending module uses It is used to send the last insulin bolus infusion history record of the insulin pump buffer to the controller, and it is used to send all the insulin bolus infusion history records of the insulin pump buffer to the controller; the receiving module is used to receive the information sent by the controller. Insulin bolus infusion instructions.
  • the recording module here records after the administration mechanism of the insulin pump acts to start the infusion, and confirms that the record conforms to the fact that the infusion occurred.
  • a special high-dose infusion control and confirmation process is used to ensure that safety risks such as wrong infusion or over-infusion will not occur.
  • the insulin pump is successful. Receiving this command will start a bolus injection, and the insulin pump needs to return a confirmation of the command to the controller, so that the controller knows that the command has been successfully received. If the confirmation information is not received by the controller due to wireless communication interference and other reasons at this time, the controller will consider the command sending failed and display the relevant prompt information. The user mistakenly believes that the bolus infusion of the insulin pump has not started, and it is very likely that the bolus infusion command will be issued again through the controller.
  • the insulin pump records the infusion facts and acquires them by the controller, which is then presented to the user, so that the user can know whether the infusion has been actually performed recently and decide whether to perform the infusion. When the user grasps the real situation of the infusion, the occurrence of overinfusion can be avoided more effectively.

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Abstract

La présente invention concerne un procédé et un appareil de commande de perfusion de grande dose d'insuline, un système, ainsi qu'un appareil de pompe à insuline, qui sont utiles pour améliorer la sécurité et la fiabilité d'un processus de perfusion de grande dose d'insuline. Un système de perfusion comprend un dispositif de commande et une pompe à insuline utilisée pour une perfusion ; le dispositif de commande est utilisé pour commander, lors de la réception d'une instruction de perfusion de grande dose d'insuline, la pompe à insuline à effectuer une perfusion, obtenir un enregistrement historique de perfusion de grande dose d'insuline sauvegardé par la pompe à insuline, déterminer, selon un dernier enregistrement historique sauvegardé par la pompe à insuline, si la pompe à insuline effectue ou non une perfusion, et, selon un résultat de détermination, délivrer des informations d'invite ; et la pompe à insuline est utilisée pour effectuer une perfusion d'insuline et sauvegarder l'enregistrement historique de perfusion de grande dose d'insuline de la pompe à insuline.
PCT/CN2021/129256 2020-11-09 2021-11-08 Procédé et appareil de commande de perfusion de grande dose d'insuline, système, et appareil de pompe à insuline WO2022095994A1 (fr)

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CN202011240130.4 2020-11-09
CN202011240130.4A CN112516408A (zh) 2020-11-09 2020-11-09 胰岛素大剂量输注控制方法、装置、系统和胰岛素泵装置

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CN112472913A (zh) * 2020-11-09 2021-03-12 微泰医疗器械(杭州)有限公司 输注控制方法和装置以及输注系统和泵体装置
CN112516408A (zh) * 2020-11-09 2021-03-19 微泰医疗器械(杭州)有限公司 胰岛素大剂量输注控制方法、装置、系统和胰岛素泵装置

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