WO2022131436A1 - Procédé, dispositif et produit programme d'ordinateur pour fournir une notification selon la période d'utilisation d'un dispositif d'injection de médicament - Google Patents

Procédé, dispositif et produit programme d'ordinateur pour fournir une notification selon la période d'utilisation d'un dispositif d'injection de médicament Download PDF

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Publication number
WO2022131436A1
WO2022131436A1 PCT/KR2021/000317 KR2021000317W WO2022131436A1 WO 2022131436 A1 WO2022131436 A1 WO 2022131436A1 KR 2021000317 W KR2021000317 W KR 2021000317W WO 2022131436 A1 WO2022131436 A1 WO 2022131436A1
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WO
WIPO (PCT)
Prior art keywords
injection device
period
drug injection
time point
drug
Prior art date
Application number
PCT/KR2021/000317
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English (en)
Korean (ko)
Inventor
전용호
이동민
Original Assignee
이오플로우(주)
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Application filed by 이오플로우(주) filed Critical 이오플로우(주)
Priority to CN202180003018.5A priority Critical patent/CN114945989A/zh
Publication of WO2022131436A1 publication Critical patent/WO2022131436A1/fr

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    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/10ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
    • G16H20/17ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M5/14244Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168Means 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168Means 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
    • A61M5/16831Monitoring, detecting, signalling or eliminating infusion flow anomalies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168Means 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
    • A61M5/172Means 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
    • GPHYSICS
    • G08SIGNALLING
    • G08BSIGNALLING OR CALLING SYSTEMS; ORDER TELEGRAPHS; ALARM SYSTEMS
    • G08B21/00Alarms responsive to a single specified undesired or abnormal condition and not otherwise provided for
    • G08B21/18Status alarms
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M2005/14208Pressure infusion, e.g. using pumps with a programmable infusion control system, characterised by the infusion program
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/18General characteristics of the apparatus with alarm
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/27General characteristics of the apparatus preventing use
    • A61M2205/276General characteristics of the apparatus preventing use preventing unwanted use
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/50General characteristics of the apparatus with microprocessors or computers
    • A61M2205/52General characteristics of the apparatus with microprocessors or computers with memories providing a history of measured variating parameters of apparatus or patient

Definitions

  • the present disclosure provides a method, an apparatus, and a computer program product for providing a notification according to the period of use of a drug injection device.
  • Diabetes mellitus is a metabolic disorder that causes signs that blood sugar is outside the normal range due to insufficient insulin secretion or normal function. Diabetes mellitus is a complex disease that has the potential to affect individual tissues of the human body due to complications such as blindness, renal failure, heart failure, and neuropathy, and the number of diabetic patients is increasing every year.
  • An object of the present invention is to provide a method, an apparatus and a computer program product for providing a notification according to the period of use of a drug injection device.
  • the technical problem to be achieved by this embodiment is not limited to the technical problems as described above, and other technical problems may be inferred from the following embodiments.
  • a first aspect of the present disclosure is a method for providing a notification according to the period of use of a drug injection device, wherein the drug injection device is operated in an inactive mode in an active mode ( determining the time to switch to active mode) as the time to start using; based on the usable period of the drug injection device and a user-set time, providing an imminent expiration notification indicating that the expiration date of the use period of the drug injection device is imminent at a first time point when a predetermined period has elapsed from the start of use; and providing an expiration notice indicating that the use period of the drug injection device has expired at a second time point when the usable period has elapsed from the start of use.
  • a second aspect of the present disclosure provides an apparatus for providing a notification according to a period of use of a drug injection device, comprising: a memory in which at least one program is stored; and a processor that performs an operation by executing the at least one program, wherein the processor determines a time when the drug injection device is switched from an inactive mode to an active mode as a use start time, and the drug injection device can be used Based on a period and a user set time, an imminent expiration notification indicating that the expiration of the use period of the drug injection device is imminent is provided at a first time point when a predetermined period has elapsed from the start of use, and the use is possible from the start of use
  • a device may be provided that provides an expiration notification indicating that the period of use of the drug injection device has expired at a second time point when the period has elapsed.
  • a third aspect of the present disclosure includes the steps of: determining a time when the drug injection device is switched from an inactive mode to an active mode as a start time of use; providing a notification of imminent replacement of the drug injection device at a first time point when a predetermined period has elapsed from the start time of use, based on a usable period of the drug injection device and a user-set time; and providing an expiration notification that the use period of the drug injection device has expired at a second time point when the usable period has passed from the start of use; one or more computer-readable recording media storing a program to perform A computer program product comprising the may be provided.
  • convenience of use is provided by determining the period of use of the drug injection device based on the storage capacity and the average daily dose of the drug injection device, and providing a notification according to the period of use can do.
  • the drug while the drug is injected from the drug injection device to the user, by determining the period of use of the drug injection device based on the material of the object maintained in the state inserted into the user's body, the drug A method for safely using an injection device may be provided.
  • FIG. 1 is a block diagram of an insulin management system including a user terminal, a controller, and a drug injection device.
  • 2A to 2B are exemplary views for explaining a method of setting a drug injection amount calculator according to an embodiment.
  • FIG. 3 is a diagram illustrating an internal configuration of a drug injection device according to an embodiment.
  • FIG. 4 is a view for explaining an example of providing a notification according to the period of use of the drug injection device according to an embodiment.
  • 5 is a view for explaining an example of providing a notification according to the period of use of the drug injection device according to an embodiment.
  • FIG. 6 is a flowchart of a method of providing a notification according to the period of use of the drug injection device according to an embodiment.
  • a time when the drug injection device is switched from an inactive mode to an active mode may be determined as a start time of use.
  • an imminent expiration notification indicating that the expiration of the use period of the drug injection device is imminent may be provided at a first time point after a predetermined period from the start of use.
  • an expiration notification indicating that the use period of the drug injection device has expired may be provided at a second time point when the usable period has elapsed from the start of use.
  • FIG. 1 is a block diagram of an insulin management system including a user terminal, a controller, and a drug injection device.
  • the user terminal 1000 refers to a communication terminal capable of using a web service in a wired/wireless communication environment.
  • the user terminal 1000 may include a smartphone, a tablet PC, a PC, a smart TV, a mobile phone, a personal digital assistant (PDA), a laptop, a media player, a micro server, a global positioning system (GPS) device, an e-book terminal, It may be a terminal for digital broadcasting, a navigation system, a kiosk, an MP3 player, a digital camera, a home appliance, a device equipped with a camera, and other mobile or non-mobile computing devices.
  • PDA personal digital assistant
  • GPS global positioning system
  • the user terminal 1000 may be a wearable device such as a watch, glasses, a hair band, and a ring having a communication function and a data processing function.
  • a terminal equipped with an application capable of Internet communication may be borrowed without limitation.
  • the user terminal 1000 may be connected one-to-one with the pre-registered controller 2000 . Also, the user terminals 1000 may receive data from the controller 2000 in order to prevent control from an external device. The user terminal 1000 may transmit setting information, for example, system time information, to the controller 2000 within a preset range.
  • the controller 2000 performs a function of transmitting and receiving data to and from the drug injection device 3000 , and transmits a control signal related to injection of a drug such as insulin to the drug injection device 3000 , and blood glucose from the drug injection device 3000 . It is possible to receive a control signal related to the measurement of a biological value, such as.
  • the controller 2000 may transmit an instruction request to measure the user's current state to the drug injection device 3000 , and receive measurement data from the drug injection device 3000 in response to the instruction request.
  • the drug injection device 3000 also performs a function of measuring the user's blood sugar value, blood pressure, heart rate, etc., but should be injected into the user insulin, glucagon, anesthetic, analgesic, dopamine, growth hormone, smoking cessation aid It also performs the function of injecting drugs, such as.
  • the drug injection device 3000 may further include a storage unit for storing a substance to be periodically injected to the user, and an injection amount to be injected may be controlled to be injected from the storage unit according to an injection signal generated by the controller.
  • the drug injection device 3000 may transmit information such as a measurement value and an injection amount to the controller 2000 .
  • the drug injection device 3000 may transmit a device status message, a biometric value measurement message, a drug injection message, and the like to the controller 2000 .
  • the drug injection device 3000 may transmit a device status message including information on the remaining battery capacity of the device, whether the device is booted successfully, whether the injection is successful, and the like to the controller 2000 .
  • Messages transmitted to the controller may be transmitted to the user terminal 1000 via the controller 2000 .
  • the controller 2000 may transmit improved data obtained by processing the received messages to the user terminal 1000 .
  • the drug injection device 3000 may also be implemented to communicate only with a pre-registered controller.
  • the drug injection device 3000 includes a hardware measuring device that performs a function of measuring a user's blood sugar level, blood pressure, heart rate, etc., and a function of injecting drugs such as insulin, glucagon, anesthetic, etc. It can be divided into an injection device that performs. That is, the measuring device and the injection device may exist independently.
  • the controller 2000 may be respectively connected to the injection device and the measurement device to generate and provide a control signal for the injection device based on a measurement value measured by the measurement device.
  • a network includes a local area network (LAN), a wide area network (WAN), a value added network (VAN), a mobile radio communication network, a satellite communication network, and their It is a data communication network in a comprehensive sense that includes a mutual combination and enables each network constituent entity to communicate smoothly with each other, and may include a wired Internet, a wireless Internet, and a mobile wireless communication network.
  • LAN local area network
  • WAN wide area network
  • VAN value added network
  • mobile radio communication network a mobile radio communication network
  • satellite communication network and their It is a data communication network in a comprehensive sense that includes a mutual combination and enables each network constituent entity to communicate smoothly with each other, and may include a wired Internet, a wireless Internet, and a mobile wireless communication network.
  • wireless communication is, for example, wireless LAN (Wi-Fi), Bluetooth, Bluetooth low energy, Zigbee, WFD (Wi-Fi Direct), UWB (ultra wideband), infrared communication (IrDA, infrared Data Association), NFC (Near Field Communication), etc. may be there, but is not limited thereto.
  • 2A to 2B are exemplary views for explaining a method of setting a drug injection amount calculator according to an embodiment.
  • a drug injection amount calculator may be mounted on the user terminal 1000 , the controller 2000 , or the drug injection device 3000 of FIG. 1 .
  • the drug injection amount calculator may be a calculator for calculating the amount of insulin to be injected to the user separately from the basal injection.
  • a medication dose calculator for example, can calculate the amount of insulin needed to lower blood sugar, which rises due to eating food or snacks.
  • the drug injection amount calculator may calculate the amount of insulin required to bring the high blood sugar into the normal blood sugar range.
  • insulin injected when food intake or high blood sugar needs to be lowered may be referred to as a bolus.
  • the drug injection amount calculator may be referred to as a bolus calculator, and the bolus calculator may calculate a bolus injection amount.
  • the bolus injection amount may be determined by various values.
  • the bolus injection amount is the current blood glucose level, carbohydrate-to-insulin ratio, correction factor, target blood glucose level, the amount of insulin remaining in body activation time during the previous bolus injection (Insulin On Board (IOB), Bolus on Board ( BOB) or Active Insulin), the correction threshold, the amount of activity, and the type and amount of food consumed.
  • IOB Insulin On Board
  • BOB Bolus on Board
  • Active Insulin Active Insulin
  • the correction factor is a measure of the blood sugar level that 1Unit of bolus insulin can lower.
  • the range of the correction factor is 1 ⁇ 400mg/dl/U, and it can be adjusted by 1mg/dl/U.
  • the calibration threshold may mean a maximum blood sugar level at which it is determined that insulin injection is necessary for blood sugar control.
  • the bolus calculator may calculate the bolus injection amount based on the user's individual bolus profile setting value, the current blood sugar value, the amount of carbohydrate consumed, and the remaining amount of insulin in the body (IOB).
  • the bolus profile setting value may be determined by a target blood sugar, a carbohydrate-to-insulin ratio, a correction factor, and an insulin duration.
  • the current blood sugar value means a blood sugar value measured within 10 minutes.
  • the user may input the current blood glucose value 210 into the drug injection amount calculator.
  • the user may omit the input of the amount of carbohydrates consumed.
  • the user may input the current blood glucose value 210 in units of mg/dl.
  • the user may input 220 mg/dl as the current blood glucose value 210 .
  • the drug injection amount calculator may calculate 2.00U as the bolus injection amount 231 based on the current blood sugar value 210 .
  • a unit that can be input as the current blood glucose value 210 may be mmol/l, but is not limited to the above-described unit example.
  • the user may input the current blood sugar value 210 and the intake amount of carbohydrate 220 into the drug injection amount calculator.
  • the user may input the current blood sugar value 210 in mg/dl unit and may input the intake carbohydrate amount 220 in g unit.
  • the user may input 220 mg/dl as the current blood sugar value 210 and input 20 g as the intake carbohydrate amount 220 .
  • the drug injection amount calculator may calculate 1.30U as the bolus injection amount 232 based on the current blood glucose value 210 and the intake carbohydrate amount 220 .
  • FIG. 3 is a diagram illustrating an internal configuration of a drug injection device according to an embodiment.
  • the drug injection device 1 may include a housing 5 covering the outside, and an attachment part 6 attached to the user's skin.
  • the drug injection device 1 has a plurality of parts disposed in the inner space between the housing 5 and the attachment part 6 .
  • the drug injection device 1 includes a base body 50, a needle assembly 100, a storage unit 201, a driving unit 300, a driving unit 400, a clutch unit 500, a trigger member 600, and a battery ( 700) may be included.
  • the base body 50 forms a basic frame of the housing 5 , and is mounted in the inner space of the housing 5 .
  • the base body 50 may be provided in plurality.
  • a first body 50a that covers upper sides of the internal parts and a second body 50b that covers lower sides of the internal parts may be provided.
  • the first body 50a and the second body 50b may be assembled to fix the internal parts of the drug injection device 1 to a preset position.
  • the base body may be formed as an integral single frame.
  • the storage unit 201 is mounted on the base body 50 and is fluidly connected to the needle assembly 100 . Inside the storage unit 201, a plunger (not shown) moves linearly, so that the drug can be discharged with the needle (N).
  • the driving unit 300 may generate a driving force and transmit the driving force to the driving unit 400 .
  • the driving force transmitted by the driving unit 400 may linearly move the plunger 230 inside the storage unit 201 to discharge the drug.
  • the driving unit 300 may be any type of pump having a drug suction power and a drug discharge power by electricity.
  • pumps such as mechanical displacement type micropumps and electromagnetic motion type micropumps can be used.
  • a mechanical displacement micropump is a pump that uses the motion of a solid or fluid, such as a gear or diagram, to generate a pressure difference to induce the flow of a fluid.
  • Electromagnetic motion micropumps are pumps that directly use electrical or magnetic energy to move a fluid.
  • the driving unit 300 rotates the driving wheel of the driving unit 400 , and the rod moves linearly with the rotation of the driving wheel, so that a plunger (not shown) ) may be moved inside the storage unit 201 .
  • the driving unit 300 may include a membrane 320 disposed inside the cover 310 .
  • the membrane 320 may divide the inner space of the driving unit 300 into a first space S1 and a second space S2 .
  • the driving unit 300 may linearly move the driving shaft 330 by a volume change of the first space S1 and the second space S2 .
  • FIG. 4 is a view for explaining an example of providing a notification according to the period of use of the drug injection device according to an embodiment.
  • the drug injection device is maintained in an inactive mode before use, and may be switched from an inactive mode to an active mode by a predetermined operation.
  • In the inactive mode of the drug injection device power may not be supplied to at least some components inside the drug injection device.
  • the active mode of the drug infusion device power may be supplied to configurations that were not powered in the inactive mode.
  • power may not be supplied to the driving unit 300 of the drug injection device 1 in the inactive mode.
  • the driving force of the driving unit 300 is required.
  • the inactive mode power is not supplied to the driving unit 300, so the drug stored in the storage unit 201 is not injected to the user.
  • the active mode as power is supplied to the driving unit 300 of the drug injection device 1 , the drug stored in the storage unit 201 may be injected to the user.
  • the predetermined operation of switching the drug injection device 1 from the inactive mode to the active mode may be a drug replenishment operation.
  • the drug injection device 1 may further include a sensor unit for detecting drug replenishment in the storage unit 201 .
  • the plunger connected to the cover of the storage unit 201 may move linearly.
  • a connector member is attached to one side of the plunger, and the connector member moves together with the plunger and may contact at least a portion of the sensor unit.
  • the drug injection device 1 may be switched from the inactive mode to the active mode.
  • the method of switching the drug injection device 1 from the inactive mode to the active mode is not limited thereto.
  • a use start time 410 represents a time point at which the drug injection device is switched from an inactive mode to an active mode. For example, a point in time when one end of the connector member contacts at least a portion of the sensor unit may be the start point of use 410 . For example, when 80 Units or more of drugs are injected from the drug injection device to the patient, the drug injection device may be switched from the inactive mode to the active mode.
  • the controller transmits and receives data to and from the drug injection device and may control the drug injection device.
  • the controller determines that the expiration of the use period of the drug injection device is imminent at the first time point 420 after a predetermined period has passed from the start time point 410 of use. Notifications can be provided.
  • the first time point 420 may be set to any time from 1 hour to 24 hours before the time when the expiration notification is provided.
  • the controller may provide an expiration notification indicating that the use period of the drug injection device has expired at a second time point 430 after the usable period has passed from the use start time 410 .
  • the usable period of the drug injection device is, while the drug is injected from the drug injection device to the user, the material of the object that is kept inserted into the user's body and the material coated on the material (eg, membrane, etc.) may be determined based on at least one of.
  • the usable period of the drug injection device may be determined based on the structure of the object maintained in a state of being inserted into the user's body while the drug is injected from the drug injection device to the user. That is, the usable period of the drug injection device may be determined according to how long the object can be maintained while being inserted into the user's body.
  • the drug injection device 1 is attached to the user.
  • the user attaches the drug injection device 1 to the user, rotates the needle assembly 100, and inserts the needle N and the cannula into the skin.
  • the needle N is inserted into the skin together with the cannula, and may induce the cannula to be inserted into the skin.
  • the needle (N) is withdrawn from the skin, maintaining a state connected to the cannula.
  • the needle N moves upward while the cannula is inserted into the skin. At least a part of the cannula and the needle (N) is connected, and forms and maintains a path through which the drug solution moves.
  • the cannula is maintained in a state inserted into the user's body, and the drug stored in the storage unit 201 may be injected to the user through the cannula.
  • the usable period of the drug injection device may be determined based on the material of the cannula. Depending on the material of the cannula, the period for which safety is ensured when the cannula is maintained in a state of being inserted into the human body may vary.
  • the material of the cannula may include Teflon, and in this case, the usable period of the drug injection device may be set to 3.5 days.
  • the controller may provide an expiration notification indicating that the use period of the drug injection device has expired.
  • Teflon when other materials as well as Teflon are included as the material of the cannula, or when a material other than Teflon is included, the usable period may be set differently.
  • the user may be provided with an imminent expiration notification by setting an arbitrary time before the usable period of the drug injection device has elapsed. For example, if the usable period of the drug injection device is set to 3.5 days (84 hours), and the user set time is 1 hour, 83 hours (84 hours - 1 hour) have elapsed from the start time 410 of use. At one time point 420 , the controller may provide an imminent expiration notification indicating that the expiration date of the use period of the drug injection device is imminent.
  • the usable period of the drug injection device has been described as being determined based on the material of the cannula, but with the needle (N) inserted into the body If maintained, the usable period of the drug injection device may be determined based on the material of the needle (N).
  • the usable period of the drug injection device may be determined based on the storage capacity and the average daily dose.
  • the storage capacity and the average daily dose may be expressed in units of units.
  • the unit unit may mean a minimum unit when the drug stored in the storage unit is injected into the human body by the driving unit pump.
  • the average daily dose may be an average daily dose calculated by the dose statistics of a plurality of patients, rather than the average daily dose for each individual patient.
  • the average daily dose may vary depending on the number of type diabetes patients calculated by the dose statistics. For example, the average daily dose of patients with type 2 diabetes may be set to be higher than the average daily dose of patients with type 1 diabetes.
  • the average daily dose may vary depending on the concentration of the drug stored in the drug injection device. For example, when a drug containing 100Unit in 1ml is administered to a patient, and when a drug containing 200Unit or 500Unit in 1ml is administered to a patient, the average daily dose may be set differently.
  • the controller may provide an expiration notification indicating that the use period of the drug injection device has expired.
  • the user may be provided with an imminent expiration notification before the usable period is reached. For example, if the usable period of the drug injection device is set to 3.5 days (84 hours), and the user set time is 1 hour, 83 hours (84 hours - 1 hour) have elapsed from the start time 410 of use. At one time point 420 , the controller may provide an imminent expiration notification indicating that the expiration date of the use period of the drug injection device is imminent.
  • the usable period of the drug injection device may vary.
  • the usable period of the drug injection device is the material of the object that remains inserted into the user's body while the drug is injected from the drug injection device to the user, the material coated on the material, and the structure of the object It may be determined based on at least one of, the storage capacity and the average daily dose.
  • the controller compares the first period in which safety is ensured when the cannula is maintained in a state inserted into the human body and the second period calculated based on the storage capacity and the average daily dose of the drug injection device. You can decide how long you can use it.
  • the second period The second time point 430 may be set to 3 days, which is the shorter period of the first period (4 days) and the second period (3 days).
  • the second time point 430 may be set to 3.5 days, which is a shorter period of the first period (3.5 days) and the second period (4 days).
  • the controller adjusts the usable period of the drug injection device in consideration of the change. can be updated.
  • the controller may provide an imminent expiration notification and an expiration notification via the drug infusion device.
  • the controller may directly provide an imminent expiration notification and an expiration notification.
  • the controller may transmit data to the user terminal and provide an imminent expiration notification and an expiration notification from the user terminal.
  • 5 is a view for explaining an example of providing a notification according to the period of use of the drug injection device according to an embodiment.
  • a timeline to which a third viewpoint 550 and a fourth viewpoint 540 are further added is shown.
  • the drug injection device may further include a service period in addition to the usable period.
  • the drug infusion device may operate in an active mode during the usable period and the service period. That is, even if the usable period has elapsed, the drug injection device may operate normally if the service period does not elapse.
  • the usable period may be a period known to the user through the manuals, whereas the service period may be a period unknown to the user.
  • the drug injection device operates normally in the active mode even during the service period and injects the drug to the user, so that the user can receive the drug from the drug injection device for a certain period even when the usable period expires.
  • the controller based on the usable period of the drug injection device, the service period, and the user set time, discards that the drug injection device is about to be discarded at a fourth time point 540 after a predetermined period has passed from the use start time 510 .
  • An imminent notification can be provided.
  • the fourth time point 540 is a time point before the usable period and the service period elapse from the use start time 510 .
  • the controller may provide a discard notification indicating that the drug injection device should be discarded at a third time point 550 after the usable period and service period from the start of use 510 .
  • the third time point 550 may be a time when 12 hours have passed since the second time point 540 .
  • the usable period and service period of the drug injection device are, while the drug is injected from the drug injection device to the user, the material of the object that remains inserted into the user's body, the material coated on the material, and the It may be determined based on at least one of the structures of the object.
  • the usable period and service period of the drug injection device may be determined based on the material of the cannula. Depending on the material of the cannula, the period for which safety is guaranteed when the cannula is maintained in the human body may vary, so the usable period and service period of the drug injection device may be set differently depending on the material of the cannula .
  • the material of the cannula may include Teflon, and in this case, the usable period and service period of the drug injection device may be set to 4 days.
  • the controller may provide a discard notification indicating that the drug injection device should be discarded.
  • the usable period may be set differently.
  • the user may be provided with an imminent disposal notification by setting an arbitrary time before the expiration of the service period after the expiration of the usable period of the drug injection device.
  • the usable period and service period of the drug injection device are set to 4 days (96 hours), and when the user set time is 1 hour, 95 hours (96 hours - 1 hour) from the start of use 510
  • the controller may provide an imminent disposal notification indicating that the expiry of the period indicating that the drug injection device is imminent is imminent.
  • the usable period and service period of the drug injection device may be determined based on the storage capacity and the average daily dose.
  • the controller may provide a discard notification indicating that the drug injection device should be discarded.
  • the user may be provided with an imminent disposal notification by setting an arbitrary time before the expiration of the service period after the expiration of the usable period of the drug injection device.
  • the usable period and service period of the drug injection device are set to 4 days (96 hours), and when the user set time is 1 hour, 96 hours (96 hours - 1 hour) from the start time of use 510
  • the controller may provide an imminent disposal notification indicating that the disposal of the drug injection device is imminent.
  • the usable period and service period of the drug injection device include the material of the object that remains inserted into the user's body while the drug is injected from the drug injection device to the user, the material coated on the material, and the It may be determined based on at least one of the subject's structures, the storage capacity, and the average daily dose.
  • the controller compares the first period in which safety is ensured when the cannula is kept inserted into the human body and the second period calculated based on the storage capacity and the average daily dose to use the drug injection device. It is possible to determine the available period and service period.
  • the second period The three time points 550 may be set to 3 days, which is the shorter period of the first period (4 days) and the second period (3 days).
  • the third time point 550 may be set to 3.5 days, which is a shorter period of the first period (3.5 days) and the second period (4 days).
  • a first time point 520 indicating that the use period of the drug injection device is about to expire and a second time point 530 for providing an expiration notification indicating that the use of the drug injection device has expired may be arbitrarily set.
  • the third time point 550 is set to 4 days (96 hours) after the use start time 510 has elapsed
  • the second time point 530 is 3.5 days (84 hours) from the use start time 510 .
  • the first time point 520 may be set after 83 hours have elapsed from the use start time point 510 .
  • the usable period of the drug infusion device is determined based on the storage capacity and the average daily dose, and the total period of the drug infusion device plus the service period is the drug from the drug infusion device to the user. This may be determined based on at least one of a material of the object maintained in a state inserted into the user's body during the injection, a material coated on the material, and a structure of the object.
  • the controller may determine a first period for which safety is ensured when the cannula is maintained in the human body as the total period, and use the second period calculated based on the storage capacity and the average daily dose period can be determined.
  • the second period The third time point 550 may be set as a first period of 4 days, and the second time point 530 may be set as a second period of 3 days.
  • Methods of providing an imminent expiration notification, an expiration notification, an imminent retirement notification, and a retirement notification may be different from each other.
  • the vibration cycle, vibration intensity, LED color display, LED blinking cycle, and notification repeat cycle of each notification may be different from each other. The user can easily determine whether the notification corresponds to an imminent expiration notification, an expiration notification, an imminent retirement notification, or a retirement notification only by the manner in which the notification is provided.
  • FIG. 6 is a flowchart of a method of providing a notification according to the period of use of the drug injection device according to an embodiment.
  • the controller may communicate with the drug injection device.
  • the controller may be a component included in a user terminal such as a smart phone or a PC, or may be a component independent of the user terminal.
  • the controller may be a component included in the drug injection device.
  • the drug injection device and the controller perform communication using a network.
  • the controller may determine a time when the drug injection device is switched from the inactive mode to the active mode as the start time of use.
  • the drug injection device may be switched from an inactive mode to an active mode by a predetermined operation.
  • the predetermined operation may be a drug replenishment operation.
  • one end of the connector member connected to the plunger may be in contact with at least a portion of the sensor unit while the plunger connected to the cover of the reservoir moves linearly.
  • the drug injection device may be switched from the inactive mode to the active mode.
  • the drug injection device may transmit an active mode switching signal to the controller.
  • the controller may determine the time when the active mode switching signal is received from the drug injection device as the start time of use.
  • a communication network between the controller and the drug injection device may not be formed.
  • the drug injection device may be switched to the active mode with the controller to transmit elapsed time information.
  • step 620 the controller provides an expiration imminent notification indicating that the expiration date of the drug injection device is imminent at a first time point when a predetermined period has passed from the start of use, based on the usable period of the drug injection device and the user set time can do.
  • the controller may provide an expiration notification indicating that the use period of the drug injection device has expired at a second time point when the usable period has passed from the start of use.
  • the usable period of the drug injection device may be determined based on the material of the object maintained in the user's body while the drug is injected from the drug injection device to the user. In another embodiment, the usable period of the drug injection device may be determined based on the storage capacity and the average daily dose. In another embodiment, the usable period of the drug injection device is based on the material of the subject, the storage capacity, and the average daily dose of the subject that remains inserted into the user's body while the drug is injected from the drug injection device to the user. can be decided.
  • the drug injection device may further include a service period in addition to the usable period.
  • the drug infusion device may operate in an active mode during the usable period and the service period. That is, even if the usable period has elapsed, the drug injection device may operate normally if the service period does not elapse.
  • the controller controls the drug at a fourth time point after a predetermined period from the start of use based on the usable period, service period, and user set time of the drug injection device.
  • An imminent disposal notification may be provided that the disposition of the injection device is imminent.
  • the fourth time point is a time point before the usable period and service period elapse from the use start time 510 .
  • the controller may provide a discard notification that the drug injection device should be discarded at a third time point after the usable period and the service period from the start of use.
  • the usable period and service period of the drug injection device may be determined based on the material of the object that is maintained in a state inserted into the user's body while the drug is injected from the drug injection device to the user. In another embodiment, the usable period and service period of the drug injection device may be determined based on the storage capacity and the average daily dose. In another embodiment, the usable period of the drug injection device is based on the material of the subject, the storage capacity, and the average daily dose of the subject that remains inserted into the user's body while the drug is injected from the drug injection device to the user. can be decided.
  • the drug injection device further includes a service period in addition to the usable period, the first time point indicating that the usage period of the drug injection device is imminent and the second time point for providing an expiration notification indicating that the use of the drug injection device has expired are arbitrarily can be set.
  • Various embodiments of the present disclosure may be implemented as software (eg, a program) including one or more instructions stored in a storage medium readable by a machine.
  • the processor of the device may call at least one of the one or more instructions stored from the storage medium and execute it. This makes it possible for the device to be operated to perform at least one function according to the called at least one command.
  • the one or more instructions may include code generated by a compiler or code executable by an interpreter.
  • the device-readable storage medium may be provided in the form of a non-transitory storage medium.
  • 'non-transitory' only means that the storage medium is a tangible device and does not contain a signal (eg, electromagnetic wave), and this term is used in cases where data is semi-permanently stored in the storage medium and It does not distinguish between temporary storage cases.
  • a signal eg, electromagnetic wave
  • the method according to various embodiments of the present disclosure may be provided by being included in a computer program product.
  • Computer program products can be traded between sellers and buyers as commodities.
  • Computer programs products are distributed in the form of a device-readable storage medium (eg compact disc read only memory (CD-ROM)), or through an application store (eg Play StoreTM) or between two user devices. It can be distributed directly or online (eg, downloaded or uploaded).
  • a device-readable storage medium eg compact disc read only memory (CD-ROM)
  • an application store eg Play StoreTM
  • It can be distributed directly or online (eg, downloaded or uploaded).
  • online distribution at least a part of a computer, a program, and a product may be temporarily stored or temporarily created in a machine-readable storage medium such as a server of a manufacturer, a server of an application store, or a memory of a relay server.
  • unit may be a hardware component such as a processor or circuit, and/or a software component executed by a hardware component such as a processor.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Hematology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Primary Health Care (AREA)
  • Medical Informatics (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Business, Economics & Management (AREA)
  • Emergency Management (AREA)
  • Physics & Mathematics (AREA)
  • General Physics & Mathematics (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

La présente invention peut concerner un procédé, un dispositif et un produit programme d'ordinateur en vue de fournir une notification selon la période d'utilisation d'un dispositif d'injection de médicament. Dans la présente invention, il est possible de déterminer qu'un point temporel auquel le dispositif d'injection de médicament passe d'un mode inactif à un mode actif est un point temporel de début d'utilisation. En outre, il est possible de fournir, sur la base de la période d'utilisation possible du dispositif d'injection de médicament et d'un temps de réglage d'utilisateur, une notification d'expiration imminente indiquant que l'expiration de la période d'utilisation du dispositif d'injection de médicament est imminente, à un premier point temporel auquel une période prédéterminée s'est écoulée à partir du point temporel de début d'utilisation. En outre, il est possible de fournir une notification d'expiration indiquant que la période d'utilisation du dispositif d'injection de médicament a expiré, à un second point temporel auquel la période d'utilisation possible s'est écoulée à partir du point temporel de début d'utilisation.
PCT/KR2021/000317 2020-12-17 2021-01-11 Procédé, dispositif et produit programme d'ordinateur pour fournir une notification selon la période d'utilisation d'un dispositif d'injection de médicament WO2022131436A1 (fr)

Priority Applications (1)

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CN202180003018.5A CN114945989A (zh) 2020-12-17 2021-01-11 提供根据药物输注装置的使用时间的通知的方法、装置及计算机程序制品

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KR1020200177569A KR102419031B1 (ko) 2020-12-17 2020-12-17 약물 주입 장치의 사용 기간에 따른 알림을 제공하는 방법, 장치 및 컴퓨터 프로그램 제품
KR10-2020-0177569 2020-12-17

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR100607128B1 (ko) * 2003-12-03 2006-08-01 주식회사 우영메디칼 약물 정량 자동주입 제어장치 및 그 제어방법
JP2013188519A (ja) * 2008-12-22 2013-09-26 Panasonic Corp 薬剤投与装置
JP2017507703A (ja) * 2014-02-05 2017-03-23 バイオエヌテック アーゲーBioNTech AG カニューレ、注射または注入装置、およびカニューレまたは注射もしくは注入装置を使用する方法
KR20170135362A (ko) * 2016-05-31 2017-12-08 주식회사 필로시스 인슐린 자동관리 시스템
KR20200110970A (ko) * 2019-03-18 2020-09-28 주식회사 필로시스 약물 주입 가이드 방법 및 장치

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR102359279B1 (ko) * 2019-06-12 2022-02-08 이오플로우 주식회사 사용자 단말 및 사용자 단말을 통한 약물을 자동으로 주입 후 상태를 관리하는 방법

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR100607128B1 (ko) * 2003-12-03 2006-08-01 주식회사 우영메디칼 약물 정량 자동주입 제어장치 및 그 제어방법
JP2013188519A (ja) * 2008-12-22 2013-09-26 Panasonic Corp 薬剤投与装置
JP2017507703A (ja) * 2014-02-05 2017-03-23 バイオエヌテック アーゲーBioNTech AG カニューレ、注射または注入装置、およびカニューレまたは注射もしくは注入装置を使用する方法
KR20170135362A (ko) * 2016-05-31 2017-12-08 주식회사 필로시스 인슐린 자동관리 시스템
KR20200110970A (ko) * 2019-03-18 2020-09-28 주식회사 필로시스 약물 주입 가이드 방법 및 장치

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KR20220099938A (ko) 2022-07-14
CN114945989A (zh) 2022-08-26
KR102419031B1 (ko) 2022-07-11
TW202226265A (zh) 2022-07-01

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