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WO2000029047A1 - Portable device and method for the mobile supply of medicaments with wireless transmission of data for control or programming purposes - Google Patents

Portable device and method for the mobile supply of medicaments with wireless transmission of data for control or programming purposes Download PDF

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Publication number
WO2000029047A1
WO2000029047A1 PCT/DE1999/003678 DE9903678W WO0029047A1 WO 2000029047 A1 WO2000029047 A1 WO 2000029047A1 DE 9903678 W DE9903678 W DE 9903678W WO 0029047 A1 WO0029047 A1 WO 0029047A1
Authority
WO
WIPO (PCT)
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.)
Ceased
Application number
PCT/DE1999/003678
Other languages
German (de)
French (fr)
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 DE1998153035 external-priority patent/DE19853035A1/en
Priority claimed from PCT/DE1998/003767 external-priority patent/WO1999032174A1/en
Priority claimed from DE1999120896 external-priority patent/DE19920896A1/en
Application filed by Phiscience Entwicklung Von Sensoren GmbH filed Critical Phiscience Entwicklung Von Sensoren GmbH
Priority to EP99960931A priority Critical patent/EP1131118A1/en
Priority to KR1020017006317A priority patent/KR20010081028A/en
Publication of WO2000029047A1 publication Critical patent/WO2000029047A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • G—PHYSICS
    • G06—COMPUTING OR CALCULATING; 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

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  • Engineering & Computer Science (AREA)
  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
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  • Public Health (AREA)
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  • 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)
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  • Animal Behavior & Ethology (AREA)
  • Theoretical Computer Science (AREA)
  • Hematology (AREA)
  • General Business, Economics & Management (AREA)
  • Heart & Thoracic Surgery (AREA)
  • General Physics & Mathematics (AREA)
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Abstract

The invention relates to a portable device and a method for supplying medicaments by a mobile, portable, non-implantable means with wireless operation or programming. The device preferably consists of a delivery unit, which is directly connected to the body of the patient by a cannula or is indirectly connected by means of a catheter, and an operating unit for operating the device, programming or inputting data. This operating unit wirelessly communicates with the delivery unit. The operating unit preferably consists of a wristwatch, which in addition to performing its normal time or date functions, can be used for inputting data and for operating, monitoring and programming the delivery unit. The operating unit enables the delivery unit to control the delivery of medicaments in terms of time and quantity, in relation to a basal rate or a basal profile, and bolus doses.

Description

Tragbare Vorrichtung und Verfahren zur mobilen Medikamentenversorgung mit drahtloser Übermittlung von Daten zur Steuerung bzw. Programmierung Portable device and method for mobile medication supply with wireless transmission of data for control or programming

BESCHREIBUNGDESCRIPTION

Technisches GebietTechnical field

Die Erfindung betrifft eine tragbare Vorrichtung sowie ein Verfahren zur mobilen tragbaren nichtimplantierbaren Medikamentenversorgung für Basalraten bzw. Basal- profile und/oder Bolusgaben mit einer drahtlosen Bedienung bzw. Programmierung.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.

Stand der TechnikState of the art

Die US 4585439 beschreibt eine "tragbare Infusionseinheit", bei der mittels einer in Längsrichtung beweglichen Gewindestange mittels einer drehbaren Muffe der Kolben einer Ampulle nach vorne bewegt wird. Aus der Beschreibung geht hervor, daß als Antrieb ein Schrittmotor eingesetzt wird. In der US 5637095 wird statt der Gewindestange ein flexible Kolbenstange verwendet, die eine kleinere Bauform ermöglicht. Die US 5665065 stellt ein Infusionsgerät vor, das mittels eines implantierbaren Glucosesensors über einen automatischen Dateninput für Werte der Blutglucosekonzentration des Patienten verfügt. In der US 5716343 wird als treibende Kraft eine vorgespannte Membran benutzt, um die Infusionsflüssigkeit zu verabreichen. Eine Fernbedienung oder eine ausgelagerte Bedienungseinheit ist bei allen aufgeführten Schriften weder vorgesehen noch wird sie erwähnt.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. In US 5637095 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. In US 5716343, 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.

Die US 5735887 beschreibt eine implantierbare medizinische Vorrichtung. Die Eingabe der Steuerungsdaten erfolgt mittels Funkübertragung. Das implantierbare Gerät besitzt einen Empfänger für externe Steuersignale, es gibt jedoch keinen Hinweis darauf, daß das implantierbare Gerät auch seinerseits einen Sender aufweist.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.

Die US 5843139 stellt ein Kommunikationssystem zur Kommunikation mit einem implantierten medizinischen Gerät vor, während die US 5314453 eine Antenne zur Übertragung von Betriebsenergie zu einem implantierten medizinischen Gerät beschreibt .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.

In allen drei Fällen wird ein implantierbares Gerät benutzt, welches einen operativen Eingriff erfordert, der - wie alle invasiven Anwendungen - nicht unerhebliche Risiken birgt. Dem Aspekt einer einfachen, unauffälligen Bedienbarkeit der externen Steuereinheit wird bisher keinerlei Rechnung getragen.In all three cases, an implantable device is used, which requires a surgical intervention which, like all invasive applications, carries considerable risks. The aspect of simple, unobtrusive operability of the external control unit has so far not been taken into account.

Üblicherweise befinden sich bei externen (d.h. nichtim- plantierbaren) handelsüblichen Insulinpumpen die Bedienungselemente an der Pumpe selbst. Dies bedingt einerseits einen entsprechenden Platzverbrauch, da die Bedienungselemente zur leichten Bedienbarkeit eine gewisse Mindestgröße aufweisen müssen, andererseits ist der Patient gezwungen, Einstellungen, z.B. auch für zusätzlichen Bolusgaben, direkt an der Pumpe vorzunehmen. Letzteres bedeutet in der Öffentlichkeit eine nicht zu unterschätzende psychische Belastung für den Patienten, da er sich damit unmittelbar als Diabetiker zur erkennen gibt und eine solche permanente gesundheitliche Beeinträchtigung leider immer noch keine vollständige Akzeptanz in der Bevölkerung besitzt. Um diesen psychischen Druck, der den Patienten zusätzlich zur gesundheitlichen Situation belastet, zu verringern, ist eine möglichst kleine und unauffällige Bauweise der Pumpe zusammen mit einer unauffälligen Bedienbarkeit erwünscht. Die bisherigen Entwicklungen beschränken sich jedoch in erster Linie auf kleinere Antriebe und kleinere Medikamentenreservoire. Kleinere Reservoirgrößen erfordern aber einen häufigeren Austausch der Reservoire (Ampullen) , was ebenfalls nicht gewünscht wird, da es unter anderem das Gefühl der Abhängigkeit verstärkt.In the case of external (ie non-implantable) commercially available insulin pumps, 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. 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. However, 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.

Die US 5376070 (Purvis, et al . ) beschreibt ein "Daten- Transfersystem für eine Infusionspumpe", das es ermöglicht, die Infusionspumpe zu programmieren, ohne daß die Funktion der Pumpe während des Programmiervorgangs beeinträchtigt wird. Um dies zu erreichen bedient sich Purvis einer optischen Kommunikation zwischen der Pumpe und einer Andockstation, in welche die Infusionspumpe eingesteckt werden oder zu de sie sich zumindest in einer "vorbestimmten Position" befinden muß. Obwohl die Arbeit der Pumpe während der Übertragung der Daten nicht beeinträchtigt wird, ist eine unauffällige Bedienung der Infusionspumpe aufgrund der verwendeten Andockstation nicht möglich. Darüber hinaus verhindert die optische Übertragung, daß die Pumpe während der Programmierung verdeckt, beispielsweise unter der Kleidung, getragen werden kann.US 5376070 (Purvis, et al.) Describes a "data transfer system for an infusion pump" which enables the infusion pump to be programmed without affecting the function of the pump during the programming process. To achieve this, Purvis uses optical communication between the pump and a docking station, into which the infusion pump is inserted or to which it must at least be in a "predetermined position". Although the work of the pump is not impaired during the transfer of the data, an unobtrusive operation of the infusion pump is not possible due to the docking station used. In addition, the optical transmission prevents the pump during the Programming hidden, for example under clothing, can be worn.

Darstellung der ErfindungPresentation of the invention

Der Erfindung liegt die Aufgabe zugrunde, eine Vorrichtung anzugeben, die im Hinblick auf Tragekomfort und Bedienung unauffällig ist, und die darüber hinaus keinen operativen Eingriff mit dem damit Verbundenen Infektions- und Narkoserisiko erfordert.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.

Eine erfindungsgemäße Lösung dieser Aufgabe ist im Patentanspruch 1 angegeben. Weiterhildungen der Erfindung sind Gegenstand der Ansprüche 2 folgende.An inventive solution to this problem is specified in claim 1. Further developments of the invention are the subject of claims 2 and following.

Die erfindungsgemäße Vorrichtung besteht bevorzugt aus zwei Komponenten: Abgabeeinheit (nichtimplantierbar) und Bedienungseinheit.The device according to the invention preferably consists of two components: delivery unit (non-implantable) and operating unit.

Bei handelsüblichen Insulinpumpen beanspruchen neben dem Medikamentenreservoir (z.B. Ampulle) und dem Antrieb (z.B. Motor) die Bedienungs- und Steuerelemente mit den meisten Platz. Die Auslagerung einer Bedienungseinheit (abgesehen von minimalen Notfall-Bedienungselementen wie beispielsweise eine Not-Aus- und eine Not-Bolus-Taste) an einen von der verbleibenden Abgabeeinheit räumlich getrennten Ort, bedeutet daher eine erhebliche Platzersparnis bezüglich der Abgabeeinheit und ermöglicht eine kleinere und somit unauffälligere Bauform. Die reguläre Bedienung der Pumpe sollte weder an der Pumpe selbst erfolgen müssen, noch sollte es die Bedienungseinheit erfordern, daß die Abgabeeinheit in auffälliger Weise bereitgehalten oder gar mit der Bedienungseinheit physikalisch (z.B. via Kabel) verbunden werden muß. Der Patient sollte in die Lage versetzt werden, alle notwendigen Eingaben und Einstellungen so unauffällig vorzunehmen zu können, daß andere Personen, mit denen er beispielsweise in einem Restaurant, in einer Konferenz oder anderweitig zusammen kommt, dies nicht bemerken und somit auch seine Krankheit nicht erkennen können. Obwohl diese Forderungen schon seit langem bestehen, wird mit der erfindungsgemäßen Vorrichtung erstmals eine entsprechend unauffällige Vorrichtung bereitgestellt, die den Diabetiker einen weiteren großen Schritt auf dem Weg zu einem normalen, unbelasteten Leben voran bringt.In commercial insulin pumps, in addition to the medication reservoir (eg ampoule) and the drive (eg motor), the operating and control elements take up the most space. The relocation of an operating unit (apart from minimal emergency operating elements such as an emergency stop and an emergency bolus button) to a location that is spatially separate from the remaining delivery unit, therefore means a considerable space saving with respect to the delivery unit and enables a smaller and therefore smaller size less conspicuous design. 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 patient should be able to make all the necessary entries and settings so that they are so inconspicuous that other people with whom he comes together, for example in a restaurant, in a conference or otherwise, do not notice this and therefore do not recognize his illness can. Although these requirements have existed for a long time, 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.

Abgabeeinheit und Bedienungseinheit weisen deshalb beide sowohl Sende- als auch Empfangseinrichtungen auf und kommunizieren drahtlos miteinander. Die Abgabeeinheit enthält darüber hinaus mindestens ein Medikamentenreservoir (z.B. Ampulle, Tank, etc.), eine Energieversorgung (Batterie, Akku, etc.), den Antrieb zur Medikamentenförderung (z.B. Motor mit Spindel, Mikropumpe, etc.), die elektronische Steuerung (z.B. des Antriebs, des Betriebs der besagten Sende- und Empfangseinrichtung, etc.), eine Systemuhr und gegebenenfalls weitere Bauelemente (z.B. besagte Notfall-Bedienungselemente um rudimentäre Basisfunktionen zu gewährleisten, Alarmgeber wie Summer oder Piepser, etc.) . Die Bedienungseinheit dient zur Bewältigung folgender Aufgaben: Bedienung, Kontrolle und Programmierung der Vorrichtung, Anzeige (z.B. von bisher verabreichten Dosierungen bzw. Mengen sowie Programmier-, Kontroll- und sonstigen Daten), bzw. Dateneingabe. Dazu verfügt sie über entspre- chende Mittel, unter anderem mindestens einen Mikroprozessor und ebenfalls eine Systemuhr. Sie ist in einem unauffälligen Gegenstand des täglichen Bedarfs untergebracht, der zusätzlich andere - ihm gemäße - Funktionen erfüllen kann (z.B. Armbanduhr, Taschenrechner, elektronische Taschendatenbank, "Hand-Held-Computer" , "Palm-Top-Computer" oder ähnlicher Miniaturcomputer, Schlüsselanhänger, Taschenkosmetikset , Brieftasche, etc . ) .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. For this purpose, 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.).

Eine Ausführungsart sieht vor, daß die Abgabeeinheit über eine interne oder externe Bedienungseinheit programmiert und/oder ferngesteuert wird, wobei die Emgabeemheit am Körper getragen werden kann und zum Beispiel die Form einer Armbanduhr besitzt. Sowohl besagte Emgabeemheit als auch die Vorrichtung selbst besitzen Sende- und Empfangseinheiten über die sie miteinander kommunizieren können. Die Vorrichtung (Abgabeeinheit 1 kann mit komplexen Abgabemustern für die zu verabreichend Flüssigkeit z.B. kontinuierlich, diskontinuierlich mit gleichmäßigen oder ungleichmäßigen Intervallen programmiert werden. Die Bedienungseinheit, die, wie oben erwähnt, bevorzugt aus einer Armbanduhr (analog und/oder digital) besteht, ermöglicht neben den normalen Uhr- bzw. Datumsfunktionen die Eingabe von Daten sowie die Bedienung und Programmierung der Abgabeeinheit. Die Bedienungseinheit übermittelt so der Abgabeeinheit alle notwendigen Daten zur mengenmäßigen und zeitlichen Steuerung der Medikamentenabgabe, beispielsweise in Form einer Basalrate oder eines Basalprofils, sowie für zusätzliche, vom Benutzer wählbare, Bolusgaben. Zusätzlich kontrolliert die Bedienungseinheit die Abgabeeinheit auf der Grundlage von mittels der Kommunikationseinrichtungen regelmäßig ausgetauschten Daten. Außerdem verfügt die Bedienungseinheit und/oder die Abgabeeinheit über Alarmfunktionen (z.B. für Termine und eventuelle Funktionsstörungen bzw. Fehlfunktionen) . Die Kommunikation zwischen Bedienungseinheit und Abgabeeinheit funktioniert in beide Richtungen und findet bevorzugt mittels verschlüsselter Datenprotokolle statt.One embodiment provides that 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. In addition, 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.

In einer Weiterbildung der Ausführungsform ist die Abgabeeinheit direkt, mittels einer Kanüle, oder indirekt, mittels eines Katheters, mit dem Körper eines Patienten verbunden. Zur Förderung flüssiger Medikamente aus einer Ampulle wird das Drehmoment eines Motors über ein geeignetes Getriebe auf eine drehbare Spindel übertragen, die bevorzugt einen Schneckentrieb besitzt. Die Drehung der Spindel bewegt einen Schlitten in Richtung auf den Kolben der Ampulle, wodurch der Kolben Flüssigkeit aus der Ampulle fördert.In a development of the embodiment, the delivery unit is connected directly to the body of a patient by means of a cannula or indirectly by means of a catheter. To deliver liquid medication from an ampoule, 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.

In einer abgewandelten Ausführungsform ist statt des Motors mit Getriebe und Spindel eine Mikropumpe, bevorzugt eine Mikromembranpumpe, zur Förderung flüssiger Medikamente aus einem beliebigen Reservoir (Tank, Ampulle, etc.) vorhanden.In a modified embodiment, instead of the motor with gear and spindle, a micropump, preferably a micromembrane pump, is provided to convey liquid medication from any reservoir (tank, ampoule, etc.).

In einer weiteren abgewandelten Ausführungsform ist die Bedienungseinheit statt in einer Armbanduhr in einem anderen unauffälligen Gegenstand des täglichen Bedarfs, z.B. einem Taschenrechner, einer elektronischen Taschendatenbank bzw. einem elektronischen Terminplaner, einem "Hand-Held-Computer", einem "Palm-Top-Computer" oder einem ähnlichen Miniaturcomputer, aber auch einem Schlüsselanhänger, einer Brieftasche oder, bei Damen, auch in einem Taschenkosmetikset, etc. untergebracht, wobei die genannten Gegenstände bzw. Geräte ihre normalen Funktionen weiterhin erfüllen bzw. deren Funktionen in die Bedienungseinheit integriert werden.In a further modified embodiment, 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.

In einer bevorzugten Ausführungsart handelt es sich bei Sendern und Empfängern um ein Transceiversystem.In a preferred embodiment, the transmitters and receivers are a transceiver system.

In einer weiteren Ausführungsart handelt es sich bei Sendern und Empfängern um ein Transpondersystem.In a further embodiment, the transmitters and receivers are a transponder system.

In einer Ausführungsart besteht die Bedienungseinheit aus einer Armbanduhr bei der die Elemente zur Bedienung bzw. Kontrolle der Abgabeeinheit im Zifferblatt integriert sind.In one embodiment, the operating unit consists of a wristwatch in which the elements for operating or controlling the dispensing unit are integrated in the dial.

In einer weiteren Ausführungsart sind die Elemente zur Bedienung bzw. Kontrolle der Abgabeeinheit aus dem Uhrgehäuse herausklappbar oder herausziehbar.In a further embodiment, the elements for operating or checking the dispensing unit can be folded out or pulled out of the watch case.

In einer Weiterentwicklung der genannten Ausführungs- formen besteht die Vorrichtung neben einer Bedienungs- einheit und einer Abgabeeinheit zusätzlich aus ein oder mehreren externen Sensoren zur Messung von Körperfunktionen, die ebenfalls mit der Bedienungseinheit kommunizieren können und Daten an diese übermitteln. Die Bedienungseinheit kann diese Daten anzeigen, speichern bzw. weiterverarbeiten (z.B. durch Bildung von Mittelwerten, Verhältnissen, zeitlichen Ableitungen, Vergleichen verschiedener Parameter, etc.) . Besagte Mittel zur Messung von Körperfunktionen sind Sensoren zur Messung der Körpertemperatur (z.B. ein oder mehrere Widerstandsthermometer, Thermoelemente, Thermopiles etc.), des Blutdrucks (z.B. Manschette mit Mikrophon, etc.), der Durchblutung (z.B. Induktionsstrom bzw. -spannungs Sensor, thermische Sensoren, etc.), des Pulses (z.B. Mikrofone, optische Absorptionsverfahren, Elektroden, etc.), der Blutglucosekonzentration bzw. des Insulinspiegels (z.B. Biosensoren) und gegebenenfalls andere bzw. weitere dem Fachmann bekannte Meßeinrichtungen.In a further development of the above-mentioned embodiments, 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.

Die Möglichkeit der Messung und Anzeige von Körperfunktionen ist in diesem Zusammenhang wünschenswert, um es dem Anwender der erfindungsgemäßen Vorrichtung zu gestatten, den Erfolg der Anwendung zu kontrollieren, bzw. seinen körperlichen Zustand besser einschätzen zu können, was ihm mehr Sicherheit vermittelt und so zur weiteren Verbesserung seiner Lebensqualität beiträgt.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.

In einer weiteren Modifikation der vorgenannten Ausführungsformen beinhaltet die Bedienungseinheit zusätzlich ein Interface, das es ermöglicht, die Bedienungseinheit mit einem zur Datenübertragung geeigneten Telekommunikationsgerät, beispielsweise einem mobilen Telefon (Handy) zu verbinden und die von den Sensoren zur Bedienungseinheit übertragenen und von dieser gegebenenfalls weiterverarbeiteten Daten an eine andere Stelle (z.B. den behandelnden Arzt) zu übermitteln. Der Anschluß über das Interface kann auch an einen Computer erfolgen, beispielsweise zur langfristigen Speicherung bzw. weiteren Verwendung der Daten. In einer bevorzugten Variation der obigen Ausführungs- arten weist die Abgabeeinheit Notfall-Bedienungselemente (z.B. eine Not-Aus- und eine Not-Bolus-Taste) auf .In a further modification of the aforementioned embodiments, 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). The connection via the interface can also be made to a computer, for example for long-term storage or further use of the data. In a preferred variation of the above embodiments, the dispensing unit has emergency operating elements (for example an emergency stop and an emergency bolus button).

In einer weiteren bevorzugten Variation der obigen Ausführungsarten besitzen Abgabeeinheit und/oder Bedienungseinheit Alarmgeber (z.B. Summer, Piepser, etc.), die bei kritischen Situationen Alarm geben (z.B. längere Zeit keine Verbindung zwischen Abgabeeinheit und Bedienungseinheit) .In a further preferred variation of the above embodiments, 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).

In einer grundlegenden bevorzugten Variation der obigen Ausführungsarten ist die wechselseitige Datenübertragung zwischen Bedienungseinheit und Abgabeeinheit individuell (z.B. mittels der Seriennummer) codiert, um sicherzustellen, daß nur zusammengehörige Teile ein und derselben Vorrichtung miteinander kommunizieren. Um Querempfindlichkeiten zu anderen Geräten zu vermeiden, stehen im Falle einer Funkübertragung mehrere Kanäle zur Verfügung, so daß neben einem Zeitmultiplexmg auch ein Kanalmultiplexing genutzt wird. Zudem kann die Reichweite begrenzt werden (z.B. auf maximal einen Meter Abstand) . Die Vorrichtung besitzt als Teil der Steuerung Mittel, die jeweilige Sendeleistung bzw. die Empfindlichkeit des jeweiligen Empfängers automatisch so zu regeln, daß jeweils die niedrigste mögliche Sendeleistung verwendet wird. Dadurch wird gewährleistet, daß die Kommunikation der Teile der Vorrichtung untereinander andere Geräte möglichst nicht stört. In wiederum einer weiteren bevorzugten Variation der obigen Ausführungsarten verfügt die Abgabeeinheit über eine "intelligente" Elektronik. Das bedeutet, daß die Abgabeeinheit bei einem wesentlichen Wechsel von Zeitzonen, um mehr als beispielsweise zwei Stunden (z.B. Transatlantikflug) , nach dem Umstellen der Systemuhr (seitens des Benutzers) ein voreingestelltes Basalpro- fil gemäß ärztlichen Empfehlungen nur allmählich verschiebt (z.B. um zwei Stunden pro Tag) . Darüber hinaus werden vom Benutzer verabreichte Bolusgaben von der Vorrichtung in der Abgabeeinheit und/oder der Bedienungseinheit registriert und auf Regelmäßigkeit hin untersucht. Gibt der Patient z.B. regelmäßig zwischen 16 und 17 Uhr manuell einen Bolus (Zwischenmahlzeit) , so wird das gespeichert. Bleibt die Bolusgabe dann an einem Tag aus, gibt die Vorrichtung ein Signal (z.B. mit einem eingebauten Piepser) , um den Patienten auf eine mögliche Unterlassung hinzuweisen. Der Patient entscheidet dann, ob der Bolus nur vergessen wurde oder ob er gar nicht erforderlich war. Er kann dann entsprechende Maßnahmen treffen.In a basic preferred variation of the above embodiments, 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. In order to avoid cross-sensitivity to other devices, several channels are available in the case of radio transmission, so that channel multiplexing is used in addition to time multiplexing. In addition, the range can be limited (e.g. to a maximum of one meter distance). As part of the control, 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. In yet another preferred variation of the above embodiments, 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) . In addition, 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. 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.

Das umstellen der Systemuhr kann gegebenenfalls auch automatisch erfolgen, beispielsweise nach Funkabfrage der geltenden Ortszeit aus einem Mobilfunknetz (z.B. unter Verwendung von besagtem Interface) oder durch Nutzung von Zeitzeichensendern in Verbindung mit einem Geo-Positionierungs-System (GPS) . If necessary, 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).

Claims

Patentansprüche claims 1. Vorrichtung zur mobilen tragbaren nichtimplantier- baren Medikamentenversorgung für Basalraten bzw. Basalprofile und/oder Bolusgaben, bestehend aus mindestens einer Abgabeeinheit für flüssige Medikamente und mindestens einer Bedienungseinheit zur Eingabe von Daten sowie zur drahtlosen Bedienung, Kontrolle und Programmierung der Abgabeeinheit und zur Anzeige von Daten (z.B. von bisher verabreichten Dosierungen bzw. Mengen sowie Programmier-, Kontroll- und sonstigen Daten) und gegebenenfalls ein oder mehreren Sensoren zur Messung von Körperfunktionen dadurch gekennzeichnet, daß1. Device for mobile, portable, non-implantable medication supply for basal rates or basal profiles and / or bolus doses, consisting of at least one dispensing unit for liquid medication and at least one operating unit for inputting data and for wireless operation, control and programming of the dispensing unit and for displaying Data (for example of previously administered doses or amounts as well as programming, control and other data) and, if appropriate, one or more sensors for measuring body functions, characterized in that Bedienungseinheit und Abgabeeinheit räumlich voneinander getrennt sind und keinen körperlichen Kontakt zueinander haben, Bedienungseinheit und Abgabeeinheit jeweils Mittel zur wechselseitigen drahtlosen Kommunikation miteinander besitzen, die Bedienungseinheit in einem unauffälligen Gegenstand des täglichen Bedarfs integriert ist, dessen Form und Funktion im Wesentlichen gewahrt bleibt .The operating unit and the dispensing unit are spatially separated from one another and have no physical contact with one another, the operating unit and the dispensing unit each have means for mutual wireless communication with one another, the operating unit is integrated in an inconspicuous everyday object, the shape and function of which are essentially preserved. 2. Vorrichtung nach Anspruch 1, dadurch gekennzeichnet, daß die Bedienungseinheit am Körper getragen werden kann und zum Beispiel die Form und zusätzlich auch die Funktion einer Armbanduhr besitzt und die Abgabeeinheit über eine Bedienungseinheit programmiert und/oder fernbedient wird.2. Device according to claim 1, characterized in that the operating unit can be worn on the body and has, for example, the shape and also the function of a wristwatch and the dispensing unit is programmed and / or operated remotely via an operating unit. 3. Vorrichtung nach Anspruch 1, dadurch gekennzeichnet, daß besagter unauffälliger Gegenstand des täglichen Bedarfs ein Taschenrechner, eine elektronische Taschendatenbank bzw. ein elektronischer Terminplaner, ein "Hand-Held- Computer", ein "Palm-Top-Computer" oder ein ähnlicher Miniaturcomputer aber auch ein Schlüsselanhänger, eine Brieftasche, ein Taschenkosmetikset oder ähnlicher, geeigneter Gegenstand ist.3. Apparatus according to claim 1, characterized in that said inconspicuous object of daily use is a 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 keychain, a wallet, a pocket cosmetic set or similar, suitable object. 4. Vorrichtung nach einem der Ansprüche 1 bis 3 dadurch gekennzeichnet, daß die Abgabeeinheit eine Insulinpumpe ist.4. Device according to one of claims 1 to 3, characterized in that the delivery unit is an insulin pump. 5. Vorrichtung nach einem der Ansprüche 1 bis 4 dadurch gekennzeichnet, daß besagte Mittel zur wechselseitigen drahtlosen Kommunikation zwischen Bedienungseinheit und Abgabeeinheit aus Ultraschallsendern, magnetischen Impulssendern oder aus Funksendern sowie jeweils entsprechenden Empfängern bestehen und gemeinsam ein System, z.B. ein Transceiversystem, bilden, so daß sowohl besagte Bedienungseinheit als auch die Abgabeeinheit über diese Sende- und Empfangseinheiten miteinander kommunizieren können. 5. Device according to one of claims 1 to 4, characterized in that said means for mutual wireless communication between the control unit and the dispensing unit consist of ultrasonic transmitters, magnetic pulse transmitters or radio transmitters and corresponding receivers and together form a system, for example a transceiver system, so that Both said operating unit and the delivery unit can communicate with one another via these transmitting and receiving units. 6. Vorrichtung nach einem der Ansprüche 1 bis 5 dadurch gekennzeichnet, daß besagte Mittel zur wechselseitigen drahtlosen Kommunikation zwischen Bedienungseinheit und Abgabeeinheit aus einem Transpondersystem bestehen.6. Device according to one of claims 1 to 5, characterized in that said means for mutual wireless communication between the control unit and delivery unit consist of a transponder system. 7. Vorrichtung nach einem der Ansprüche 1 bis 6 dadurch gekennzeichnet, daß die Elemente zur Bedienung bzw. Kontrolle der Abgabeeinheit und zur Funktions- bzw. Datenanzeige im Gehäuse der Bedienungseinheit integriert sind.7. Device according to one of claims 1 to 6, characterized in that the elements for operating or controlling the dispensing unit and for function or data display are integrated in the housing of the operating unit. 8. Vorrichtung nach einem der Ansprüche 1 bis 6 dadurch gekennzeichnet, daß die Elemente zur Bedienung bzw. Kontrolle der Abgabeeinheit aus dem Gehäuse der Bedienungseinheit auf einem heraus- klappbaren Element oder auf einem herausziehbaren Schlitten angebracht sind.8. Device according to one of claims 1 to 6, characterized in that the elements for operating or controlling the dispensing unit from the housing of the operating unit are mounted on a fold-out element or on a pull-out slide. 9. Vorrichtung nach einem der Ansprüche 1 bis 8 dadurch gekennzeichnet, daß Mittel zur Verschlüsselung der zur Kommunikationsdaten zwischen Bedienungseinheit und Abgabeeinheit vorhanden sind, welche die Anwendung verschlüsselter Datenprotokolle (z.B. mittels einer Seriennummer) ermöglichen.9. Device according to one of claims 1 to 8, characterized in that means for encrypting the communication data between the operating unit and the delivery unit are provided, which enable the use of encrypted data protocols (e.g. by means of a serial number). 10. Vorrichtung nach einem der Ansprüche 1 bis 9 dadurch gekennzeichnet, daß Mittel zur Erzeugung von Alarmsignalen vorhanden sind, die Alarmfunktionen aufgrund von Terminen und/oder eventuellen Funktionsstörungen bzw. Fehlfunktionen wahrnehmen. 10. Device according to one of claims 1 to 9, characterized in that means for generating alarm signals are available, the alarm functions perceive due to appointments and / or possible malfunctions or malfunctions. 11. Vorrichtung nach einem der Ansprüche 1 bis 10 dadurch gekennzeichnet, daß besagte externe Sensoren Mittel zur Messung von Körperfunktionen sind, die ebenfalls mit der Bedienungseinheit kommunizieren können und Daten an die Bedienungseinheit übermitteln.11. Device according to one of claims 1 to 10, characterized in that said external sensors are means for measuring body functions, which can also communicate with the control unit and transmit data to the control unit. 12. Vorrichtung nach einem der Ansprüche 1 bis 11 dadurch gekennzeichnet, daß besagte Mittel zur Messung von Körperfunktionen Sensoren zur Messung der Körpertemperatur, des Blutdrucks, der Durchblutung, des Pulses, der Blutglucosekonzentration bzw. des Insulinspiegels und/oder andere bzw. weitere dem Fachmann bekannte Meßeinrichtungen sind.12. Device according to one of claims 1 to 11, characterized in that said means for measuring body functions sensors for measuring body temperature, blood pressure, blood flow, pulse, blood glucose concentration or insulin level and / or others or others to the expert are known measuring devices. 13. Vorrichtung nach Anspruch 12 dadurch gekennzeichnet, daß die Bedienungseinheit zusätzlich Mittel zur Anzeige, Speicherung und Weiterverarbeitung der von den Sensoren übermittelten Daten besitzt.13. The apparatus according to claim 12, characterized in that the operating unit additionally has means for displaying, storing and further processing the data transmitted by the sensors. 14. Vorrichtung nach einem der Ansprüche 9 oder 13 dadurch gekennzeichnet, daß die Bedienungseinheit zusätzlich ein Interface besitzt, das es ermöglicht, die Bedienungseinheit mit einem zur Datenübertrag geeigneten Telekommunikationsgerät, beispielsweise einem mobilen Telefon (Handy) oder auch mit einem Computer, zu verbinden und die von den Sensoren zur Bedienungseinheit übertragenen und von dieser gegebenenfalls weiterverarbeiteten Daten an eine andere Stelle zu übermitteln. 14. Device according to one of claims 9 or 13, characterized in that the operating unit additionally has an interface which makes it possible to connect the operating unit with a telecommunication device suitable for data transmission, for example a mobile telephone (cell phone) or also with a computer, and to transmit the data transmitted from the sensors to the operating unit and possibly further processed by the latter to another location. 15. Vorrichtung nach einem der Ansprüche 1 bis 14 dadurch gekennzeichnet, daß die Abgabeeinheit Notfall-Bedienungselemente (z.B. eine Not-Aus- und eine Not-Bolus-Taste) aufweist.15. The device according to one of claims 1 to 14, characterized in that the dispensing unit has emergency controls (e.g. an emergency stop and an emergency bolus button). 16. Vorrichtung nach einem der Ansprüche 1 bis 15 dadurch gekennzeichnet, daß Abgabeeinheit und/oder Bedienungseinheit Alarmgeber (z.B. Summer, Piepser, etc.) besitzen, die bei kritischen Situationen Alarm geben (z.B. Fehlfunktion, längere Zeit keine Verbindung zwischen Abgabeeinheit und Bedienungseinheit, etc.) .16. The device according to one of claims 1 to 15, characterized in that the dispensing unit and / or operating unit have alarm devices (eg buzzer, beeper, etc.) which give alarm in critical situations (eg malfunction, no connection for a long time between the dispensing unit and operating unit, Etc.) . 17. Vorrichtung nach einem der Ansprüche 1 bis 16 dadurch gekennzeichnet, daß die Abgabeeinheit eine geeignete elektronische Schaltung besitzt, beispielsweise einen Mikroprozessor, die bei einem wesentlichen Wechsel von Zeitzonen (z.B. Transatlantikflug) nach dem Umstellen der Systemuhr (seitens des Benutzers) ein voreingestelltes Basalpro- fil gemäß gängiger ärztlichen Empfehlungen nur allmählich verschiebt (z.B. um zwei Stunden pro Tag) und darüber hinaus vom Benutzer manuell verabreichte Bolusgaben von der Vorrichtung in der Abgabeeinheit und/oder der Bedienungseinheit registriert und auf Regelmäßigkeit hin untersucht werden und bei Ausbleiben einer normalerweise verabreichten Bolusgabe über eine bestimmte Zeit hinaus ein Signal (z.B. durch besagte Mittel zur Erzeugung von Alarmsignalen) abgibt. 17. The device according to any one of claims 1 to 16, characterized in that the dispensing unit has a suitable electronic circuit, for example a microprocessor, which with a substantial change of time zones (eg transatlantic flight) after changing the system clock (on the part of the user) a preset Basalpro fil is only gradually shifted (e.g. by two hours per day) in accordance with current medical recommendations and, in addition, bolus administered manually by the user is registered by the device in the dispensing unit and / or the operating unit and checked for regularity and in the absence of a normally administered bolus emits a signal beyond a certain time (for example by said means for generating alarm signals). 18. Vorrichtung nach einem der Ansprüche 1 bis 17, dadurch gekennzeichnet, daß besagte Funksender und -empfänger mehrkanalig sind, so daß zur Vermeidung von Querempfindlichkeiten mit anderen Geräten neben einem Zeitmultiplexmg auch ein Kanalmultiple- xing ermöglicht wird und daß die Vorrichtung außerdem Mittel besitzt, welche die jeweilige Sendeleistung bzw. die Empfindlichkeit des jeweiligen Empfängers automatisch so regeln, daß jeweils die niedrigste mögliche Sendeleistung verwendet wird wodurch gewährleistet wird, daß die Vorrichtung andere Geräte möglichst nicht stört.18. Device according to one of claims 1 to 17, characterized in that said radio transmitter and receiver are multi-channel, so that in order to avoid cross-sensitivities with other devices in addition to time multiplexing, a channel multiplexing is also possible and that the device also has means, which automatically regulate the respective transmission power or the sensitivity of the respective receiver so that the lowest possible transmission power is used, thereby ensuring that the device does not interfere with other devices as far as possible. 19. Verfahren zur mobilen tragbaren nichtimplantierba- ren Medikamentenversorgung für Basalraten bzw. Ba- salprofile und/oder Bolusgaben dadurch gekennzeichnet, daß die Vorrichtung aus einer Bedienungseinheit und einer Abgabeeinheit besteht und gegebenenfalls aus einem oder mehreren Sensoren, die Bedienungseinheit und die Abgabeeinheit räumlich voneinander getrennt sind, Bedienungseinheit und Abgabeeinheit drahtlos miteinander kommunizieren können, die Bedienungseinheit in einen unauffälligen Gegenstand des täglichen Bedarfs, beispielsweise einer Armbanduhr, einem Taschenrechner, einer elektronischen Taschendatenbank bzw. einem elektronischen Terminplaner, einem "Hand-Held-Computer", einem "Palm-Top- Computer" oder einem ähnlichen Miniaturcomputer aber auch einem Schlüsselanhänger, einer Brieftasche, einem Taschenkosmetikset oder einem ähnlichen, geeigneten Gegenstand integriert ist, dessen Form und Funktion im wesentlichen gewahrt bleibt.19. A method for mobile, portable, non-implantable medication supply for basal rates or basal profiles and / or bolus doses, characterized in that the device consists of an operating unit and a delivery unit and optionally one or more sensors, the operating unit and the delivery unit are spatially separated from one another are, control unit and delivery unit can communicate wirelessly with one another, the control unit into an inconspicuous everyday object, for example a wristwatch, 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, one Wallet, a pocket cosmetic set or a similar, suitable object is integrated, the shape and function of which are essentially preserved. 20. Verfahren nach Anspruch 19, dadurch gekennzeichnet, daß der Anwender in die Lage versetzt wird, Einstellungen an der Vorrichtung unauffällig vorzunehmen, d.h. der Anwender kann die Bedienung der Vorrichtung so vornehmen, daß seine Privatsphäre, in diesem Fall gegeben durch seinen Gesundheitszustand, gewahrt bleibt, was unter anderem dadurch erreicht wird, daß die Bedienungseinheit z.B. durch Verwendung einer Funkübertragung beliebig orientierbar ist.20. The method according to claim 19, characterized in that the user is enabled to make adjustments to the device unobtrusively, i.e. the user can operate the device in such a way that his privacy, in this case given by his state of health, is preserved, which is achieved, among other things, by the fact that the operating unit e.g. can be oriented as desired by using radio transmission. 21. Verfahren nach Anspruch 20, dadurch gekennzeichnet, daß die Kommunikation zwischen Bedienungseinheit und Abgabeeinheit verschlüsselt erfolgt (z.B. mittels einer Seriennummer) und daß darüber hinaus sowohl ein Zeit- als auch ein Kanalmultiplexing verwendet wird, um Querempfindlichkeiten zu anderen Geräten zu vermeiden und daß außerdem die jeweilige Sendeleistung bzw. die Empfindlichkeit des jeweiligen Empfängers automatisch so geregelt wird, daß jeweils die niedrigste mögliche Sendeleistung verwendet wird.21. The method according to claim 20, characterized in that the communication between the control unit and delivery unit is encrypted (for example by means of a serial number) and that in addition both time and channel multiplexing is used to avoid cross-sensitivity to other devices and that also the respective transmission power or the sensitivity of the respective receiver is automatically regulated so that the lowest possible transmission power is used in each case. 22. Verfahren nach einem der Ansprüche 19 bis 21, dadurch gekennzeichnet, daß die Bedienungseinheit Daten, die sie von besagten Sensoren empfängt, an- zeigt, speichert und/oder weiterverarbeitet (z.B. durch Bildung von Mittelwerten, Verhältnissen, zeitlichen Ableitungen, Vergleichen verschiedener Parameter, etc.).22. The method according to any one of claims 19 to 21, characterized in that the operating unit receives data that it receives from said sensors shows, saves and / or further processed (e.g. by forming mean values, relationships, time derivatives, comparing different parameters, etc.). 23. Verfahren nach einem der Ansprüche 19 bis 22, dadurch gekennzeichnet, daß bei einem Wechsel von Zeitzonen (z.B. Transatlantikflug) nach dem Umstellen der Systemuhr (seitens des Benutzers) ein voreingestelltes Basalprofil gemäß gängigen ärztlichen Empfehlungen nur allmählich zeitlich an die Zeitumstellung angeglichen wird (z.B. um zwei Stunden pro Tag) und daß darüber hinaus vom Benutzer manuell verabreichte Bolusgaben von der Vorrichtung in der Abgabeeinheit und/oder der Bedienungseinheit registriert und auf Regelmäßigkeit hin untersucht werden und bei Ausbleiben einer normalerweise verabreichten Bolusgabe über eine bestimmte Zeit hinaus, ein Signal (z.B. mit einem eingebauten Piepser) abgegeben wird. 23. The method according to any one of claims 19 to 22, characterized in that when changing time zones (eg transatlantic flight) after changing the system clock (on the part of the user), a preset basal profile is only gradually adapted to the time change in accordance with common medical recommendations ( e.g. by two hours a day) and that, in addition, bolus administered manually by the user is registered by the device in the delivery unit and / or the control unit and checked for regularity and, if there is no normal bolus administered for a certain time, a signal ( e.g. with a built-in beeper).
PCT/DE1999/003678 1997-12-19 1999-11-18 Portable device and method for the mobile supply of medicaments with wireless transmission of data for control or programming purposes Ceased WO2000029047A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP99960931A EP1131118A1 (en) 1997-12-19 1999-11-18 Portable device and method for the mobile supply of medicaments with wireless transmission of data for control or programming purposes
KR1020017006317A KR20010081028A (en) 1998-11-18 1999-11-18 Portable device and method for the mobile supply of medicaments with wireless transmission of data for control or programming purposes

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
DE19853035.8 1998-11-18
DE1998153035 DE19853035A1 (en) 1998-11-18 1998-11-18 Portable appts for injection or infusion
PCT/DE1998/003767 WO1999032174A1 (en) 1997-12-19 1998-12-21 Portable medicament dispenser for time delayed administration of injection or infusion preparations
DEPCT/DE98/03767 1998-12-21
DE1999120896 DE19920896A1 (en) 1999-05-06 1999-05-06 Portable unit for the supply of medicaments to a patient comprises a delivery unit connected to the patient by e.g. a catheter, and an operating unit which has wireless communication with the delivery unit
DE19920896.4 1999-05-06

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EP1131118A1 (en) 2001-09-12

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