WO2022095993A1 - Procédé et dispositif de commande de perfusion, système de perfusion, et dispositif de corps de pompe - Google Patents

Procédé et dispositif de commande de perfusion, système de perfusion, et dispositif de corps de pompe Download PDF

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Publication number
WO2022095993A1
WO2022095993A1 PCT/CN2021/129254 CN2021129254W WO2022095993A1 WO 2022095993 A1 WO2022095993 A1 WO 2022095993A1 CN 2021129254 W CN2021129254 W CN 2021129254W WO 2022095993 A1 WO2022095993 A1 WO 2022095993A1
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WIPO (PCT)
Prior art keywords
infusion
pump body
controller
module
history record
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Application number
PCT/CN2021/129254
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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 WO2022095993A1 publication Critical patent/WO2022095993A1/fr

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Classifications

    • 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
    • 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
    • A61M5/16804—Flow controllers
    • 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
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3331—Pressure; Flow
    • A61M2205/3334—Measuring or controlling the flow rate
    • 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
    • A61M2205/35—Communication

Definitions

  • the present invention relates to the technical field of machinery, and in particular, to an infusion control method and device, as well as an infusion system and a pump body device.
  • 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 and the large-dose injection volume through the control panel buttons on the pump body, 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 pump.
  • Fig. 1 is a schematic diagram of the basic components of an infusion system related to the present invention.
  • the infusion system mainly includes a pump body and a controller, wherein the pump body is fixed on the human body and is connected with the controller (Fig. Take the handheld controller as an example) to communicate.
  • the insulin pump body has no control and 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 pump body, etc. function and interact with the pump body through short-range wireless communication such as Bluetooth. Since there is no size limit, 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 provides an infusion control method and device, as well as an infusion system and a pump body device, which help to improve the safety and reliability of the infusion process.
  • An infusion system comprising a controller and a pump body for infusion, wherein: the controller is used to control the pump body for infusion, and obtain the infusion history record saved by the pump body, and according to the latest history saved by the pump body Record and judge whether the pump body is infusion, and output prompt information according to the judgment result; the pump body is used for infusion and save the infusion history record of the pump body.
  • the prompt information includes the current infusion progress.
  • controller is further configured to terminate the current process when the communication with the pump body times out.
  • the controller is further configured to acquire the last infusion history record saved by the pump body and present it on the man-machine interface, so that the user can confirm whether to send an infusion instruction.
  • the controller is also used to synchronize the locally saved infusion history record and the infusion history record saved by the pump body, and synchronize the latest local last time after synchronization.
  • the infusion history is presented on the human-machine interface for the user to confirm whether the controller is required to send an infusion instruction to the pump.
  • the pump body is an insulin pump.
  • An infusion control method comprising: step 1: a controller receives an infusion operation instruction initiated by a user through a man-machine interface; step 2: the controller queries the latest infusion history record cached by a pump body; step 3: the controller according to The last infusion history record determines whether the pump body is undergoing infusion, if so, go to step 10, otherwise go to step 4; step 4: the controller obtains the latest infusion history record saved locally; step 5: the controller compares Whether the last infusion history record saved locally is consistent with the last infusion history record cached by the pump body, if so, go to step 7, otherwise go to step 6; Step 6: The controller obtains the infusion cached by the pump body from the pump body History record and save to the local; Step 7: The controller presents the information of the last infusion saved locally through the man-machine interface, for the user to confirm whether the controller needs to send the infusion instruction to the pump body; Step 8: The controller according to the user If the user confirms the result is yes, go to step 9, otherwise end the
  • An infusion control device comprising: a first module, used for receiving an infusion operation instruction initiated by a user through a man-machine interface; a second module, used for querying the latest infusion history record cached by a pump body; and a third module, for judging whether the pump body is undergoing infusion according to the last infusion history record, if so, trigger the tenth module, otherwise trigger the fourth module; the fourth module is used to obtain the latest infusion history record saved locally; The fifth module is used to compare whether the last infusion history record saved locally is consistent with the last infusion history record cached by the pump body, if so, trigger the seventh module, otherwise trigger the sixth module; the sixth module, used for Obtain the infusion history record buffered by the pump body from the pump body and save it locally; the seventh module is used to present the information of the latest infusion saved locally through the human-machine interface, so that the user can confirm whether the controller needs to send the pump body to the pump body.
  • the eighth module is used to judge according to the user's confirmation result, if the user's confirmation result is yes, then the ninth module is triggered, otherwise the process ends; the ninth module is used to send the infusion instruction to the pump body; Ten modules are used to present the current infusion progress through the human-machine interface.
  • the infusion control device is provided in the controller of the insulin pump.
  • a pump body device is arranged in the pump body, comprising: a recording module for recording the progress of this infusion after the infusion starts; a sending module for sending the latest infusion history record buffered by the pump body to a controller , and all infusion history records of the pump buffer are sent to the controller; the receiving module is used to receive the infusion instructions sent by the controller.
  • the pump body is an insulin pump.
  • the pump body records the infusion facts and is acquired 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.
  • the user grasps the real situation of the infusion, the occurrence of overinfusion can be avoided more effectively.
  • Figure 1 is a schematic diagram of the essential components of an infusion system relevant to the present invention
  • Fig. 2 is a schematic diagram of a process of over-infusion caused by communication failure
  • FIG. 3 is a schematic diagram of an infusion control method according to an embodiment of the present invention.
  • the controller determines whether the pump is infusion according to the latest historical record saved by the pump, and controls The man-machine interface of the device presents prompt information. 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 history record contains bolus infusion status information that 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 pump At the start time and end time of high-dose infusion (marked by the start and stop of the insulin pump administration mechanism), the pump will generate a history record. In the history of the moment, the bolus rate is equal to zero. The bolus infusion rate is determined by the structure of the product. Therefore, if the bolus rate of the last history of the pump is not zero, it means that the bolus infusion is still in progress. Compared with the method of directly detecting the liquid flow, this method of judging according to the speed is easier to realize.
  • the pump can keep a historical record of its infusion, so the controller can obtain this record from the pump and provide it to the user.
  • the controller can be equipped with a larger memory than the pump body to save more history for the user to view or perform data analysis, the controller can also save the above history locally, and present the most recent high dose.
  • the controller first obtains the locally saved historical records. Considering that the abnormal communication may cause the historical records not to be completely transmitted to the controller, the controller compares the local recent historical records with the most recent historical records obtained from the pump body. Compare and take the one saved by the pump body as the criterion, that is, synchronize the content saved by the controller to the content saved by the pump body if the two are inconsistent.
  • 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 infusion operation instruction initiated by the user through the man-machine interface
  • Step 2 The controller queries the latest infusion history record cached by the pump body
  • Step 3 The controller determines whether the pump body is infusion according to the last infusion history record, if so, it goes to step 10, otherwise it goes to step 4;
  • Step 4 The controller obtains the last infusion history record saved locally
  • Step 5 The controller compares whether the last infusion history record saved locally is consistent with the last infusion history record cached by the pump body, if so, go to step 7, otherwise go to step 6;
  • Step 6 The controller performs record synchronization, obtains the infusion history record buffered by the pump body from the pump body and saves it locally;
  • Step 7 The controller presents the latest infusion history record saved locally through the man-machine interface, so that the user can confirm whether the controller is required to send an infusion instruction to the pump body;
  • 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 infusion instruction to the pump body
  • Step 10 The controller presents the current 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 pump is overtime. , 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 latest infusion history record of the pump cache
  • the third module is used for judging whether the pump body is undergoing infusion according to the last infusion history record, if so, triggering the tenth module, otherwise triggering the fourth module;
  • the fourth module is used to obtain the latest infusion history record saved locally
  • the fifth module is used to compare whether the last infusion history record saved locally is consistent with the last infusion history record cached by the pump body, if so, trigger the seventh module, otherwise trigger the sixth module;
  • the sixth module is used to obtain the infusion history record buffered by the pump body from the pump body and save it locally;
  • the seventh module is used to present the information of the last infusion saved locally through the man-machine interface, so that the user can confirm whether the controller is required to send an infusion instruction to the pump body;
  • 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 pump body
  • the tenth module is used to present the current infusion progress through the man-machine interface.
  • control methods can be set in various types of infusion controllers to control the pump body that performs the infusion operation, for example, in the controller of an insulin pump.
  • a timeout processing module can also be set in the software to terminate the current process when the communication between the controller and the pump body times out, and can also issue a prompt to the user.
  • a pump body device as software can also be provided in the pump body, 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 start of the infusion;
  • the controller sends the last infusion history record buffered by the pump body, and is used to send all the infusion history records buffered by the pump body to the controller;
  • the receiving module is used to receive the infusion instruction sent by the controller.
  • the recording module here records after the start of the infusion to confirm that the record matches 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 pump body when the user initiates a large-dose injection command through the controller, the pump body is After receiving this command, it will start to inject a large dose, and the pump body needs to return the confirmation information 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 large-dose infusion of the pump has not started, and it is very likely that the large-dose infusion command will be issued again through the controller.
  • the pump body 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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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

Sont divulgués un procédé et un dispositif de commande de perfusion, un système de perfusion, et un dispositif de corps de pompe, facilitant l'amélioration de la sécurité et de la fiabilité du processus de perfusion. Le système de perfusion comprend un dispositif de commande et un corps de pompe utilisés pour la perfusion. Le dispositif de commande est conçu pour commander le corps de pompe afin d'effectuer la perfusion, obtenir un enregistrement d'historiques de perfusion stocké dans le corps de pompe, déterminer, en fonction du dernier enregistrement d'historiques stocké dans le corps de pompe, si le corps de pompe effectue la perfusion, et émettre des informations d'alerte de sortie en fonction d'un résultat de détermination ; et le corps de pompe est conçu pour effectuer la perfusion et stocker les enregistrements d'historiques de perfusion du corps de pompe.
PCT/CN2021/129254 2020-11-09 2021-11-08 Procédé et dispositif de commande de perfusion, système de perfusion, et dispositif de corps de pompe WO2022095993A1 (fr)

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CN202011240128.7A CN112472913A (zh) 2020-11-09 2020-11-09 输注控制方法和装置以及输注系统和泵体装置
CN202011240128.7 2020-11-09

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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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