EP1131118A1 - Dispositif portable et procede d'administration medicamenteuse mobile par transmission radio de donnees a des fins de commande et de programmation - Google Patents

Dispositif portable et procede d'administration medicamenteuse mobile par transmission radio de donnees a des fins de commande et de programmation

Info

Publication number
EP1131118A1
EP1131118A1 EP99960931A EP99960931A EP1131118A1 EP 1131118 A1 EP1131118 A1 EP 1131118A1 EP 99960931 A EP99960931 A EP 99960931A EP 99960931 A EP99960931 A EP 99960931A EP 1131118 A1 EP1131118 A1 EP 1131118A1
Authority
EP
European Patent Office
Prior art keywords
unit
operating unit
operating
data
delivery
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP99960931A
Other languages
German (de)
English (en)
Inventor
Ok-Kyung Cho
Yoon Ok Kim
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Phiscience Entwicklung Von Sensoren GmbH
Original Assignee
Phiscience Entwicklung Von Sensoren GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from DE19756775A external-priority patent/DE19756775A1/de
Priority claimed from DE1998153035 external-priority patent/DE19853035A1/de
Priority claimed from DE1999120896 external-priority patent/DE19920896A1/de
Application filed by Phiscience Entwicklung Von Sensoren GmbH filed Critical Phiscience Entwicklung Von Sensoren GmbH
Publication of EP1131118A1 publication Critical patent/EP1131118A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06F—ELECTRIC DIGITAL DATA PROCESSING
    • G06F15/00—Digital computers in general; Data processing equipment in general
    • G06F15/02—Digital computers in general; Data processing equipment in general manually operated with input through keyboard and computation using a built-in program, e.g. pocket calculators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/172—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/10—ICT 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
    • G16H20/17—ICT 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
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/63—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
    • 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
    • A61M2205/3507—Communication with implanted devices, e.g. external control
    • A61M2205/3523—Communication with implanted devices, e.g. external control using telemetric means
    • 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

Definitions

  • the invention relates to a portable device and a method for mobile, portable, non-implantable medication supply for basal rates or basal profiles and / or bolus doses with a wireless operation or programming.
  • US 4585439 describes a "portable infusion unit" in which the piston of an ampoule is moved forward by means of a threaded rod which can be moved in the longitudinal direction by means of a rotatable sleeve. The description shows that a stepper motor is used as the drive.
  • a flexible piston rod is used instead of the threaded rod, which enables a smaller design.
  • US 5665065 presents an infusion device which has an automatic data input for values of the blood glucose concentration of the patient by means of an implantable glucose sensor.
  • a biased membrane is used as the driving force in order to administer the infusion liquid.
  • a remote control or an outsourced control unit is neither provided nor mentioned in all the fonts listed.
  • US 5735887 describes an implantable medical device.
  • the control data is entered by radio transmission.
  • the implantable device has a receiver for external control signals, but there is no indication that the implantable device itself also has a transmitter.
  • US 5843139 presents a communication system for communicating with an implanted medical device, while US 5314453 describes an antenna for transmitting operating energy to an implanted medical device.
  • the control elements are usually located on the pump itself. On the one hand, this requires a corresponding amount of space, since the control elements must have a certain minimum size for ease of use, and on the other hand the patient is forced to make settings, for example for additional bolus injections to be made directly on the pump.
  • the latter means a psychological burden for the patient, which should not be underestimated in public, since this makes him immediately recognizable as a diabetic and unfortunately, such permanent health impairment is still not completely accepted by the population.
  • the pump In order to reduce this psychological pressure, which is a burden on the patient in addition to the health situation, the pump should be as small and inconspicuous as possible, along with unobtrusive operability.
  • developments to date have been limited primarily to smaller drives and smaller medication reservoirs. Smaller reservoir sizes, however, require a more frequent replacement of the reservoirs (ampoules), which is also not desirable because, among other things, it increases the feeling of dependency.
  • the invention has for its object to provide a device that is inconspicuous in terms of comfort and operation, and which also requires no surgical intervention with the associated risk of infection and anesthesia.
  • the device according to the invention preferably consists of two components: delivery unit (non-implantable) and operating unit.
  • the operating and control elements take up the most space.
  • the regular operation of the pump should not have to be done on the pump itself, nor should the operating unit require that the delivery unit be kept ready in a conspicuous manner or even with it the control unit must be physically connected (e.g. via cable).
  • the device according to the invention provides for the first time a correspondingly inconspicuous device which takes the diabetic another big step on the way to a normal, unencumbered life.
  • Dispensing unit and operating unit therefore both have both transmitting and receiving devices and communicate wirelessly with one another.
  • the delivery unit also contains at least one medication reservoir (e.g. ampoule, tank, etc.), an energy supply (battery, rechargeable battery, etc.), the drive for medication delivery (e.g. motor with spindle, micropump, etc.), the electronic control (e.g. the drive, the operation of said transmitting and receiving device, etc.), a system clock and, if necessary, further components (for example, said emergency operating elements in order to ensure rudimentary basic functions, alarm devices such as buzzer or beeper, etc.).
  • the control unit is used to perform the following tasks: operation, control and programming of the device, display (for example of previously administered doses or amounts as well as programming, control and other data) or data input.
  • display for example of previously administered doses or amounts as well as programming, control and other data
  • data input for example, it has appropriate means, including at least one microprocessor and also a system clock.
  • It is housed in an inconspicuous everyday item, which can also perform other functions appropriate to it (e.g. wristwatch, pocket calculator, electronic pocket database, "hand-held computer”, “palm-top computer” or similar miniature computer, key fob , Pocket cosmetic set, wallet, etc.).
  • the dispensing unit is programmed and / or remotely controlled via an internal or external control unit, wherein the emitting unit can be worn on the body and has the shape of a wristwatch, for example.
  • Both said transmitter unit and the device itself have transmitting and receiving units via which they can communicate with one another.
  • the device (dispensing unit 1 can be programmed with complex dispensing patterns for the liquid to be administered, for example continuously, discontinuously with uniform or non-uniform intervals.
  • the operating unit which, as mentioned above, preferably consists of a wristwatch (analog and / or digital), also enables the normal clock and date functions, the input of data as well as the operation and programming of the dispensing unit.
  • the operating unit thus transmits to the dispensing unit all the necessary data for the quantitative and temporal control of the medication dispensing, for example in the form of a basal rate or a basal profile, and for additional, from User-selectable bolus doses and the control unit controls the Dispensing unit on the basis of data regularly exchanged by means of the communication devices.
  • the control unit and / or the delivery unit has alarm functions (eg for appointments and possible malfunctions or malfunctions). Communication between the operating unit and the delivery unit works in both directions and is preferably carried out using encrypted data protocols.
  • the delivery unit is connected directly to the body of a patient by means of a cannula or indirectly by means of a catheter.
  • the torque of a motor is transferred to a rotatable spindle, which preferably has a worm drive, via a suitable gear.
  • the rotation of the spindle moves a carriage towards the plunger piston, causing the plunger to deliver liquid from the ampoule.
  • a micropump preferably a micromembrane pump, is provided to convey liquid medication from any reservoir (tank, ampoule, etc.).
  • the operating unit is instead of a wristwatch in another inconspicuous everyday object, for example a pocket calculator, an electronic pocket database or an electronic organizer, a "hand-held computer", a "palm-top computer”” or a similar miniature computer, but also a key chain, a wallet or, for women, also in a pocket cosmetic set, etc., the objects or devices mentioned continuing to perform their normal functions or their functions being integrated into the operating unit.
  • the transmitters and receivers are a transceiver system.
  • the transmitters and receivers are a transponder system.
  • the operating unit consists of a wristwatch in which the elements for operating or controlling the dispensing unit are integrated in the dial.
  • the elements for operating or checking the dispensing unit can be folded out or pulled out of the watch case.
  • the device in addition to an operating unit and a delivery unit, the device also consists of one or more external sensors for measuring body functions, which can likewise communicate with the operating unit and transmit data to the latter.
  • the operating unit can display, save or further process this data (for example by forming mean values, relationships, time derivatives, comparing various parameters, etc.).
  • Said means of Measuring body functions are sensors for measuring body temperature (e.g. one or more resistance thermometers, thermocouples, thermopiles etc.), blood pressure (e.g. cuff with microphone, etc.), blood circulation (e.g. induction current or voltage sensor, thermal sensors, etc. .), the pulse (for example microphones, optical absorption methods, electrodes, etc.), the blood glucose concentration or the insulin level (for example biosensors) and possibly other or other measuring devices known to the person skilled in the art.
  • body temperature e.g. one or more resistance thermometers, thermocouples, thermopiles etc.
  • blood pressure e.g. cuff with microphone
  • the possibility of measuring and displaying body functions is desirable in this connection in order to allow the user of the device according to the invention to control the success of the application or to be able to better assess his physical condition, which gives him more security and so on Contributes to improving his quality of life.
  • the operating unit additionally contains an interface which makes it possible to connect the operating unit to a telecommunication device suitable for data transmission, for example a mobile telephone (cell phone), and the data transmitted from the sensors to the operating unit and possibly further processed by the latter to another place (e.g. the attending doctor).
  • a telecommunication device suitable for data transmission for example a mobile telephone (cell phone)
  • the connection via the interface can also be made to a computer, for example for long-term storage or further use of the data.
  • the dispensing unit has emergency operating elements (for example an emergency stop and an emergency bolus button).
  • the delivery unit and / or operating unit have alarm devices (e.g. buzzer, beeper, etc.) which give an alarm in critical situations (e.g. no connection between delivery unit and operating unit for a long time).
  • alarm devices e.g. buzzer, beeper, etc.
  • the mutual data transmission between operating unit and delivery unit is individually coded (for example by means of the serial number) in order to ensure that only parts belonging to one and the same device communicate with one another.
  • the range can be limited (e.g. to a maximum of one meter distance).
  • the device has means to automatically regulate the respective transmission power or the sensitivity of the respective receiver so that the lowest possible transmission power is used in each case. This ensures that the communication of the parts of the device with one another does not interfere with other devices as far as possible.
  • the delivery unit has "intelligent" electronics. This means that if there is a significant change in time zones by more than two hours (e.g. transatlantic flight), after changing the system clock (on the part of the user), the delivery unit only gradually shifts a preset basal profile according to medical recommendations (e.g. by two hours per day) .
  • bolus doses administered by the user are registered by the device in the delivery unit and / or the operating unit and checked for regularity. If, for example, the patient regularly gives a bolus (snack) between 4 p.m. and 5 p.m., this is saved.
  • the device If the bolus is then missed in one day, the device emits a signal (for example with a built-in beeper) to inform the patient of a possible omission. The patient then decides whether the bolus has just been forgotten or whether it was not required. He can then take appropriate measures.
  • a signal for example with a built-in beeper
  • the system clock can also be changed automatically, for example after radio polling of the current local time from a cellular network (e.g. using said interface) or by using time signal transmitters in conjunction with a geo-positioning system (GPS).
  • a cellular network e.g. using said interface
  • GPS geo-positioning system

Landscapes

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

Abstract

L'invention concerne un dispositif portable et un procédé d'administration médicamenteuse externe à l'aide de ce dispotif portable par commande radio ou programmation. Ce dispositif comprend, de préférence, une unité de délivrance reliée à l'organisme du patient directement par une canule ou indirectement à l'aide d'un cathéter ainsi qu'une unité de commande qui est destinée à l'entrée de données, à la commande et la programmation de l'unité de délivrance et qui communique sans fil avec l'unité de délivrance. L'unité de commande comprend, de préférence, une montre qui, outre les fonctions normales heure et date, permet l'entrée de données, la commande, le contrôle et la programmation de l'unité de délivrance. L'unité de commande permet à l'unité de délivrance de commander le temps et le dosage du médicament délivré tant en ce qui concerne un taux ou un profil de basal qu'une dose de bolus.
EP99960931A 1997-12-19 1999-11-18 Dispositif portable et procede d'administration medicamenteuse mobile par transmission radio de donnees a des fins de commande et de programmation Withdrawn EP1131118A1 (fr)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
DE19756775A DE19756775A1 (de) 1997-08-01 1997-12-19 Tragbarer Medikamentenspender zur zeitverzögerten Verabreichung von Injektions- oder Infusionspräparaten
DE1998153035 DE19853035A1 (de) 1998-11-18 1998-11-18 Tragbares Mikrodosiersystem zur zeitverzögerten Abgabe von Flüssigkeiten
DE19853035 1998-11-18
DE19756775 1998-12-21
DE1999120896 DE19920896A1 (de) 1999-05-06 1999-05-06 Tragbare Vorrichtung und Verfahren zur mobilen Medikamentenversorgung mit drahtloser Übermittlung von Daten zur Steuerung bzw. Programmierung
DE19920896 1999-05-06
PCT/DE1999/003678 WO2000029047A1 (fr) 1998-11-18 1999-11-18 Dispositif portable et procede d'administration medicamenteuse mobile par transmission radio de donnees a des fins de commande et de programmation

Publications (1)

Publication Number Publication Date
EP1131118A1 true EP1131118A1 (fr) 2001-09-12

Family

ID=27208838

Family Applications (1)

Application Number Title Priority Date Filing Date
EP99960931A Withdrawn EP1131118A1 (fr) 1997-12-19 1999-11-18 Dispositif portable et procede d'administration medicamenteuse mobile par transmission radio de donnees a des fins de commande et de programmation

Country Status (3)

Country Link
EP (1) EP1131118A1 (fr)
KR (1) KR20010081028A (fr)
WO (1) WO2000029047A1 (fr)

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Also Published As

Publication number Publication date
KR20010081028A (ko) 2001-08-25
WO2000029047A1 (fr) 2000-05-25

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