FR2740345A1 - AUTOMATION DEVICE - Google Patents

AUTOMATION DEVICE Download PDF

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Publication number
FR2740345A1
FR2740345A1 FR9512763A FR9512763A FR2740345A1 FR 2740345 A1 FR2740345 A1 FR 2740345A1 FR 9512763 A FR9512763 A FR 9512763A FR 9512763 A FR9512763 A FR 9512763A FR 2740345 A1 FR2740345 A1 FR 2740345A1
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France
Prior art keywords
bolus
fact
time
process according
indicated
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Pending
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FR9512763A
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French (fr)
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Individual
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Individual
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Filing date
Publication date
Application filed by Individual filed Critical Individual
Priority to FR9512763A priority Critical patent/FR2740345A1/en
Priority to AU72254/96A priority patent/AU7225496A/en
Priority to PCT/IB1996/001138 priority patent/WO1997015339A1/en
Publication of FR2740345A1 publication Critical patent/FR2740345A1/en
Pending legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • 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
    • A61M15/00—Inhalators
    • A61M15/0065—Inhalators with dosage or measuring devices
    • A61M15/0068—Indicating or counting the number of dispensed doses or of remaining doses
    • A61M15/008—Electronic counters
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J7/00—Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/04—Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers
    • A61J7/0409—Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers
    • A61J7/0427—Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers with direct interaction with a dispensing or delivery system
    • A61J7/0436—Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers with direct interaction with a dispensing or delivery system resulting from removing a drug from, or opening, a container
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J7/00—Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/04—Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers
    • A61J7/0409—Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers
    • A61J7/0427—Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers with direct interaction with a dispensing or delivery system
    • A61J7/0445—Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers with direct interaction with a dispensing or delivery system for preventing drug dispensing during a predetermined time period
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J7/00—Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/04—Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers
    • A61J7/0409—Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers
    • A61J7/0481—Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers working on a schedule basis
    • A61J7/049—Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers working on a schedule basis automatically changing in response to a schedule deviation by the patient
    • 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
    • A61M2005/1401—Functional features
    • A61M2005/1405—Patient controlled analgesia [PCA]

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pulmonology (AREA)
  • Biophysics (AREA)
  • Vascular Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

A self-medication device provided with a system for counting the number of times a bolus release control is actuated and designed to prevent bolus release during a refractory period corresponding to a predetermined programme. The time remaining until the next authorised delivery of a bolus is indicated after the patient has actuated the bolus release control. A method for using the self-medication device is also provided. For a given time interval, the number of actuations of the bolus release control that did and did not result in a bolus being released is counted in order to readjust, if necessary, the programming parameters.

Description

Dispositif d'automédication
La présente invention concerne un dispositif d'automédication utilisé notamment pour l'injection d'analgésiques.Self-medication device
The present invention relates to a self-medication device used in particular for the injection of analgesics.

Un tel dispositif est connu et décrit par exemple, dans la demande américaine US 4,898,585 où un patient traité ambulatoirement, peut s'administrer, entre autres, des doses de morphine.Such a device is known and described, for example, in US application 4,898,585 where a patient treated on an outpatient basis may administer, among other things, doses of morphine.

La demande internationale WO 84 03218 présente un autre dispositif d'automédication avec programmation de la fréquence d'administration des bolus. Le patient peut de façon optionnelle influencer l'administration du médicament en actionnant une commande de l'unité de contrôle du dispositif.International application WO 84 03218 discloses another self-medication device with programming of the bolus delivery frequency. The patient may optionally influence the drug delivery by operating a control of the device control unit.

Pour des raisons de sécurité, ces dispositifs sont souvent munis d'un système de contrôle limitant la dose totale par unité de temps et la fréquence d'administration des bolus au cours de l'unité de temps.For safety reasons, these devices are often provided with a control system limiting the total dose per unit of time and the frequency of bolus administration during the unit of time.

Si "T" représente l'intervalle de temps pendant lequel aucun bolus n'est libéré et si "D" représente la dose totale maximale par unité de temps, nous avons la situation suivante: a) t < T ou m > D aucun bolus n'est administré b) t > T et m > D aucun bolus n'est administré c) t > T et m < D un bolus est administré "t" représente le temps écoulé à partir du dernier bolus administré, "m" représente la dose totale administrée au cours de l'unité de temps.If "T" represents the time interval during which no bolus is released and "D" represents the maximum total dose per unit time, we have the following situation: a) t <T or m> D no bolus is administered b) t> T and m> D no bolus is administered c) t> T and m <D a bolus is administered "t" represents the elapsed time from the last bolus administered, "m" represents the total dose administered during the unit of time.

Lorsque le dispositif se trouve dans la situation a) ou b), on parle de période réfractaire. When the device is in situation a) or b), it is called refractory period.

Ainsi, lorsque l'une ou l'autre des valeurs limites a été atteinte, le patient se voit dans l'impossibilité de recevoir une dose supplémentaire. Thus, when one or the other of the limit values has been reached, the patient is unable to receive an additional dose.

La dose maximale et la fréquence d'administration des bolus sont déterminées à partir d'un modèle de calcul ou fixées par un médecin.The maximum dose and frequency of bolus administration are determined from a calculation model or determined by a physician.

Par ailleurs, le nombre de bolus qui ont été demandés pendant un intervalle de temps donné et le nombre de bolus effectivement délivrés pendant ce même intervalle de temps sont comptabilisés afin de déterminer la qualité du traitement reçu et de réajuster, le cas échéant, les paramètres de programmation.Furthermore, the number of boluses that have been requested during a given time interval and the number of boluses actually delivered during that same time interval are counted to determine the quality of the treatment received and readjust, if necessary, the parameters. programming.

Or, il s'est avéré que les dispositifs de l'état de la technique souffrent d'un défaut important:
Avec un dispositif affichant la fréquence d'administration
des bolus et le temps réfractaire restant, le patient
n'actionne pas la commande bolus pendant l'intervalle de
temps réfractaire puisqu'il sait qu'aucun bolus ne lui sera
administré. Par conséquent, pendant la période réfractaire,
le système ne pourra comptabiliser d'éventuelles demandes
correspondant à un besoin du patient non couvert par le
traitement en cours.However, it has been found that the devices of the state of the art suffer from a major defect:
With a device displaying the frequency of administration
bolus and refractory time remaining, the patient
does not operate the bolus command during the interval of
refractory time since he knows that no bolus will be
administered. Therefore, during the refractory period,
the system will not be able to count any requests
corresponding to a need of the patient not covered by the
ongoing treatment.

Inversément, avec un dispositif n'affichant pas la période
réfractaire, le patient aura tendance a actionner la
commande bolus plusieurs fois pendant la période
réfractaire pour obtenir satisfaction. Le nombre
d'actionnements supplémentaires (demandes "parasites") de
la commande bolus correspondant à un même besoin est
inclus dans le décompte final, de sorte que, tout comme
dans le cas précédent, l'analyse des demandes
comptabilisées reflète mal ou pas du tout l'efficacité du
traitement reçu.Conversely, with a device not displaying the period
refractory, the patient will tend to operate the
bolus command several times during the period
refractory to obtain satisfaction. The number
additional operations ("parasitic" requests) from
the bolus command corresponding to the same need is
included in the final count, so that just like
in the previous case, the analysis of the requests
accounted for poorly or not at all the effectiveness of the
received treatment.

La présente invention vise à estimer plus précisément l'adéquation du traitement reçu avec l'analyse des besoins réels du patient au cours du traitement. The present invention aims to estimate more precisely the adequacy of the treatment received with the analysis of the real needs of the patient during the treatment.

Dans ce but, la solution consiste à indiquer le temps restant jusqu'au prochain bolus disponible lorsque l'on se trouve dans la période réfractaire, uniquement après que le patient ait actionné la commande bolus.For this purpose, the solution is to indicate the time remaining until the next bolus available when one is in the refractory period, only after the patient has actuated the bolus command.

L'indication du temps restant a pour effet de renseigner le patient, de sorte que ce dernier actionnera une seule fois le bouton pendant la période réfractaire, tout en permettant de comptabiliser la demande non-autorisée et non-satisfaite. Les actionnements du bouton correspondant à un même besoin (actionnements "parasites") sont ainsi éliminés. Par conséquent, à la fin du traitement, l'analyse du nombre d'actionnements reflète plus précisément les besoins réels du patient au cours du traitement.The indication of the remaining time has the effect of informing the patient, so that the latter will operate once the button during the refractory period, while allowing to record the unauthorized and unsatisfied request. The operations of the button corresponding to the same need ("parasitic" actuations) are thus eliminated. Therefore, at the end of treatment, the analysis of the number of actuations more accurately reflects the actual needs of the patient during treatment.

Afin d'optimiser l'analyse des besoins réels du patient, le temps restant peut n'être affiché que pendant une certaine durée, inférieure à la période réfractaire. Ceci aura pour effet, notamment pour des temps réfractaires longs, d'enregistrer un nombre supplémentaire de demandes "non-parasites" du patient.In order to optimize the analysis of the real needs of the patient, the remaining time may only be displayed for a certain duration, less than the refractory period. This will have the effect, especially for long refractory times, of recording an additional number of "non-parasitic" requests from the patient.

Dans un mode de réalisation préférentiel (voir figure) mais non limitatif de l'invention, le dispositif se présente sous la forme d'une pompe munie d'une unité de contrôle présentant un tableau de commandes et d'affichage du temps. La dose totale maximale et la fréquence maximale d'administration des bolus sont programmées initialement et un système comptabilise le nombre d'actionnements de la commande de libération du bolus et le nombre de bolus effectivement administrés. Un réservoir contenant le médicament est connecté à la pompe.In a preferred embodiment (see figure) but not limiting of the invention, the device is in the form of a pump provided with a control unit having a control panel and time display. The maximum total dose and the maximum bolus delivery frequency are initially programmed and a system counts the number of bolus release control actuations and the number of boluses actually delivered. A reservoir containing the drug is connected to the pump.

Le temps restant jusqu'au prochain bolus s'affiche uniquement pendant la période réfractaire et lorsque le patient actionne la commande de libération d'un bolus.The time remaining until the next bolus is displayed only during the refractory period and when the patient actuates the bolus release command.

Dans un autre mode de réalisation, l'unité de contrôle est également munie d'un indicateur sonore du temps restant. Cette option s'adresse aux personnes aveugles. In another embodiment, the control unit is also provided with a sound indicator of the remaining time. This option is for blind people.

Dans un autre mode de réalisation, la fréquence d'administration des bolus est variable.In another embodiment, the bolus delivery frequency is variable.

L'invention concerne également un procédé consistant en la réalisation d'un dispositif d'automédication, programmé de façon à prévenir l'administration d'un bolus pendant une période réfractaire, caractérisé par le fait que lorsque l'on se trouve dans la période réfractaire, le temps restant jusqu'au prochain bolus disponible est indiqué uniquement après que le patient ait actionné la commande de libération d'un bolus.The invention also relates to a method consisting of the realization of a self-medication device, programmed to prevent the administration of a bolus during a refractory period, characterized in that when one is in the period The remaining time to the next available bolus is refractory only after the patient has actuated the bolus release command.

Au terme du traitement, on comptabilise le nombre d'actionnements de la commande de libération des bolus ayant donné lieu à un bolus et n'ayant pas donné lieu à un bolus, afin de définir précisément le degré de couverture des besoins réels du patient. At the end of the treatment, the number of bolus release control operations that have given rise to a bolus and not a bolus is counted to precisely define the degree of coverage of the actual needs of the patient.

Claims (9)

Revendicationsclaims 1. Procédé pour la mise en oeuvre d'un dispositif1. Method for implementing a device d'automédication, permettant de comptabiliser le nombre self-medication, allowing the number to be counted de fois que la commande de libération d'un bolus est of times that the command to release a bolus is actionnée tout en prévenant l'administration d'un bolus actuated while preventing the administration of a bolus lorsque l'on se trouve dans une période réfractaire when one is in a refractory period correspondant à une programmation donnée, caractérisé corresponding to a given programming, characterized par le fait que le temps restant jusqu'au prochain bolus by the fact that the time remaining until the next bolus autorisé est indiqué uniquement après actionnement de la authorized is indicated only after activation of the commande de libération du bolus. bolus release control. 2. Procédé selon la revendication 1 caractérisé par le fait que2. Method according to claim 1 characterized by the fact that le temps restant est indiqué pendant tout l'intervalle de the remaining time is indicated during the entire interval of temps se situant entre l'instant où la commande de time between the moment the order libération du bolus est actionnée et l'instant où le prochain bolus release is activated and the moment when the next bolus est à nouveau autorisé. bolus is allowed again. 3. Procédé selon la revendication 1 caractérisé par le fait que3. Method according to claim 1 characterized in that le temps restant est indiqué pendant une durée the remaining time is indicated for a duration programmée. programmed. 4. Procédé selon la revendication 3 caractérisé par le fait que4. Method according to claim 3 characterized by the fact that la durée est programmée en fonction de la durée de la the duration is programmed according to the duration of the période réfractaire. refractory period. 5. Procédé selon l'une quelconque des revendications5. Process according to any one of the claims précédentes caractérisé par le fait que le temps restant est preceded by the fact that the remaining time is affiché visuellement. displayed visually. 6. Procédé selon l'une quelconque des revendications6. Process according to any one of the claims précédentes caractérisé par le fait que le temps restant est preceded by the fact that the remaining time is indiqué également sous forme de message sonore. also indicated as a sound message. 7. Procédé selon l'une quelconque des revendications7. Process according to any one of the claims précédentes caractérisé par le fait que la fréquence characterized by the fact that the frequency d'administration des bolus est variable.  bolus administration is variable. 8. Procédé selon l'une quelconque des revendications8. Process according to any one of the claims précédentes, caractérisé par le fait que pour un intervalle preceding, characterized by the fact that for an interval de temps donné, on comptabilise le nombre given time, we count the number d'actionnements de la commande de libération d'un bolus actuation of the bolus release control ayant donné lieu à un bolus et n'ayant pas donné lieu à un gave rise to a bolus and did not result in a bolus. bolus. 9. Procédé selon l'une quelconque des revendications9. Process according to any one of the claims précédentes caractérisé par le fait que l'on compare le previous characterized by the fact that we compare the nombre de bolus demandés et effectivement reçus pour en number of boluses requested and actually received for déduire la qualité du traitement administré au patient.  deduce the quality of the treatment given to the patient.
FR9512763A 1995-10-26 1995-10-26 AUTOMATION DEVICE Pending FR2740345A1 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
FR9512763A FR2740345A1 (en) 1995-10-26 1995-10-26 AUTOMATION DEVICE
AU72254/96A AU7225496A (en) 1995-10-26 1996-10-24 Self-medication device
PCT/IB1996/001138 WO1997015339A1 (en) 1995-10-26 1996-10-24 Self-medication device

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
FR9512763A FR2740345A1 (en) 1995-10-26 1995-10-26 AUTOMATION DEVICE

Publications (1)

Publication Number Publication Date
FR2740345A1 true FR2740345A1 (en) 1997-04-30

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FR9512763A Pending FR2740345A1 (en) 1995-10-26 1995-10-26 AUTOMATION DEVICE

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FR (1) FR2740345A1 (en)
WO (1) WO1997015339A1 (en)

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WO2006125692A1 (en) * 2005-05-26 2006-11-30 Novo Nordisk A/S A dosing operation in a medical device
US8052655B2 (en) 2006-09-29 2011-11-08 Novo Nordisk A/S Injection device with electronic detecting means
US8197450B2 (en) 2005-04-24 2012-06-12 Novo Nordisk A/S Injection device
US8202256B2 (en) 2000-06-16 2012-06-19 Novo Nordisk A/S Injection device
US8221356B2 (en) 2004-10-21 2012-07-17 Novo Nordisk A/S Medication delivery system with a detector for providing a signal indicative of an amount of a set and/or ejected dose of drug
US8226618B2 (en) 2006-05-16 2012-07-24 Novo Nordisk A/S Gearing mechanism for an injection device
US8298194B2 (en) 2006-03-10 2012-10-30 Novo Nordisk A/S Injection device and a method of changing a cartridge in the device
US8353878B2 (en) 2007-03-23 2013-01-15 Novo Nordisk A/S Injection device comprising a locking nut
US8361036B2 (en) 2006-03-10 2013-01-29 Novo Nordisk A/S Injection device having a gearing arrangement
US8708957B2 (en) 2007-12-31 2014-04-29 Novo Nordisk A/S Electronically monitored injection device
US8894611B2 (en) 2008-08-29 2014-11-25 Novo Nordisk A/S Medical injection device with time delay indicator
US9101723B2 (en) 2006-03-20 2015-08-11 Novo Nordisk A/S Electronic module for mechanical medication delivery devices
US9108006B2 (en) 2007-08-17 2015-08-18 Novo Nordisk A/S Medical device with value sensor
US9192727B2 (en) 2006-05-18 2015-11-24 Novo Nordisk A/S Injection device with mode locking means
US9314573B2 (en) 2004-10-21 2016-04-19 Novo Nordisk A/S Injection device with means for signalling the time since the last injection
US9533106B2 (en) 2011-12-29 2017-01-03 Novo Nordisk A/S Torsion-spring based wind-up auto injector pen with dial-up/dial-down mechanism
USRE46363E1 (en) 2004-10-21 2017-04-11 Novo Nordisk A/S Dial-down mechanism for wind-up pen
US10383996B2 (en) 2004-10-21 2019-08-20 Novo Nordisk A/S Injection device with a processor for collecting ejection information

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FR2748310A1 (en) 1996-05-03 1997-11-07 Debiotech Sa DEVICE FOR CLOSING A FLEXIBLE TUBE
GB0003197D0 (en) 2000-02-11 2000-04-05 Aid Medic Ltd Improvements in and relating to controlling drug delivery
US20020151875A1 (en) * 2000-12-04 2002-10-17 Markus Haller Patient activated administration of drug bolus from implantable drug delivery system
US8096987B2 (en) * 2008-12-05 2012-01-17 The Alfred E. Mann Foundation For Scientific Research Methods and apparatus for translating a continuous-delivery into a plurality of periodic bolus deliveries

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US8206361B2 (en) 2000-06-16 2012-06-26 Novo Nordisk A/S Injection device
US9022991B2 (en) 2000-06-16 2015-05-05 Novo Nordisk A/S Injection device
US8202256B2 (en) 2000-06-16 2012-06-19 Novo Nordisk A/S Injection device
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Publication number Publication date
AU7225496A (en) 1997-05-15
WO1997015339A1 (en) 1997-05-01

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