DK2981310T3 - Dosisprotokolleringsapparat for et lægemiddelafgivningsapparat - Google Patents

Dosisprotokolleringsapparat for et lægemiddelafgivningsapparat Download PDF

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DK2981310T3
DK2981310T3 DK14714747.4T DK14714747T DK2981310T3 DK 2981310 T3 DK2981310 T3 DK 2981310T3 DK 14714747 T DK14714747 T DK 14714747T DK 2981310 T3 DK2981310 T3 DK 2981310T3
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indicator
sensor
drug delivery
dose
drug
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DK14714747.4T
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English (en)
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Nikolaj Frogner Krusell
Nikolaj Eusebius Jakobsen
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Novo Nordisk As
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    • 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
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • 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
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • 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
    • A61M5/178—Syringes
    • A61M5/31—Details
    • 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
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31525—Dosing
    • 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
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31545—Setting modes for dosing
    • A61M5/31548—Mechanically operated dose setting member
    • A61M5/3155—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe
    • A61M5/31553—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe without axial movement of dose setting member
    • 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
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31576—Constructional features or modes of drive mechanisms for piston rods
    • A61M5/31583—Constructional features or modes of drive mechanisms for piston rods based on rotational translation, i.e. movement of piston rod is caused by relative rotation between the user activated actuator and the piston rod
    • 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
    • G16H20/13—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 from dispensers
    • 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
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3125—Details specific display means, e.g. to indicate dose setting
    • A61M2005/3126—Specific display means related to dosing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3317—Electromagnetic, inductive or dielectric measuring 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • 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
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A61M2205/502—User interfaces, e.g. screens or keyboards
    • 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
    • A61M2205/60—General characteristics of the apparatus with identification 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
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M5/2455—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened
    • A61M5/2466—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened by piercing without internal pressure increase
    • 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
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31535—Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose
    • A61M5/31541—Means preventing setting of a dose beyond the amount remaining in the cartridge
    • 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

Claims (15)

1. Protokolleringsapparat (100, 300), der er indrettet til aftageligt at blive fastgjort til et lægemiddelafgivningsapparat (200), hvilket lægemiddelafgivningsapparat omfatter: Et lægemiddelreservoir eller middel (210) til modtagelse af et lægemiddelreservoir, lægemiddel-udstødningsmiddel, omfattende dosis-indstillingsmiddel (280), som tillader en bruger at indstille en dosisstørrelse, som skal udstødes, aktiveringsmiddel (290), der kan aktiveres mellem en første og en anden aktiveringstilstand, hvorved den første tilstand tillader indstilling af en dosisstørrelse, og hvorved den anden tilstand tillader lægemiddeludstødningsmidlet at udstøde en indstillet dosis, første indikatormiddel (240), som er indrettet til at udføre en rotationsbevægelse under drift af udstødningsmidlet i overensstemmelse med en rotationsakse, hvorved størrelsen af rotationen svarer til mængden af lægemiddel, som udstødes fra et reservoir ved hjælp af udstødningsmidlet, og andet indikatormiddel, der kan drives mellem en første indikatortilstand, som svarer til den første aktiveringstilstand, og en anden indikatortilstand, der svarer til den anden aktiveringstilstand, kendetegnet ved,at det første indikatormiddel (240) omfatter en magnet, som bevæger sig sammen dermed, hvilken magnet er udformet til at frembringe et rumligt magnetfelt, der i forhold til eksterne sensormidler varierer i overensstemmelse med den rumlige position og orientering af magneten og således det første indikatormiddel, hvorved protokolleringsapparatet omfatter: En sensor-komponentgrappe, omfattende en eller flere sensorer (345), der er indrettet til at måle et magnetfelt, svarende til mindst to akser, tilstandssensormiddel, indrettet til at detektere, om det andet indikatormiddel er i den første eller den anden indikatortilstand, og processormiddel (340), som er udformet til: (I) At bestemme, på basis af målte magnetfeltværdier, en rotationsposition for det første indikatormiddel, og (II) at beregne en udstødt dosisstørrelse på basis af bestemte rotationspositioner for det første indikatormiddel, lagringsmiddel, indrettet til at lagre en eller flere dosisstørrelser, så der dannes en protokol (log), hvorved den beregnede dosisstørrelse er baseret på rotationspositioner for det første indikatormiddel, som bestemmes, når det andet indikatormiddel er blevet detekteret som værende i den første indikatortilstand.
2. Protokolleringsapparat ifølge krav 1, hvorved det andet indikatormiddel på læ-gemiddelafgivningsapparatet omfatter en magnet, og tilstandsmidlet i proto-kolleringsapparatet omfatter en magnetisk sensor, hvorved detekteringen af indikatortilstanden er baseret på målinger fra den magnetiske sensor.
3. Protokolleringsapparat ifølge krav 2, hvorved sensor-komponentgruppen tilvejebringer tilstandssensormidlet.
4. Protokolleringsapparat ifølge krav 1, i kombination med et lægemiddelafgivningsapparat ifølge krav 1, hvorved der dannes et lægemiddelafgivnings system.
5. Protokolleringsapparat ifølge krav 2 eller krav 3, i kombination med et lægemiddelafgivningsapparat ifølge krav 2, hvorved der dannes et lægemiddelafgivningssystem.
6. Lægemiddelafgivningssystem ifølge krav 5, hvorved: Det første indikatormiddel er i form af et indikatorelement (240), der omfatter en magnet, som bevæger sig sammen dermed, hvilken magnet er udformet til at frembringe et rumligt magnetfelt, der i forhold til sensor-komponentgruppen varierer i overensstemmelse med magnetens rumlige position og orientering og således med indikatorelementet, hvorved der frembringes et rumligt magnetfelt, som varierer unikt i forhold til hver sensor, hvilket indikatorelement er indrettet til: (I) At rotere under driften af udstødningsmidlet, og at indikatorelementet (240) også udgør det andet indikatormiddel, hvilket indikatorelement er indrettet til: (II) at bevæge sig aksialt mellem positioner, der svarer til den første og den anden indikatortilstand.
7. Lægemiddelafgivningssystem ifølge krav 6, hvorved sensorkomponentgruppen også udgør den magnetiske sensor i tilstandssensormidlet.
8. Lægemiddelafgivningssystem ifølge krav 7, hvorved indikatorelementet helt eller delvist er dannet af et polymermateriale, som indeholder magnetiske partikler, hvilket polymermateriale er blevet magnetiseret for at tilvejebringe en magnet, der genererer et rumligt magnetfelt, og hvorved indikatorelementet kan være ringformet.
9. Protokolleringsapparat (100, 300), indrettet til aftageligt at blive fæstnet til et lægemiddelafgivningsapparat (200), hvilket lægemiddelafgivningsapparat omfatter: Lægemiddelbeholder eller et middel (210) til modtagelse af en lægemiddelbeholder, Lægemiddel-udstødningsmiddel, omfattende dosisindstillingsmiddel (280), der gør det muligt for en bruger at indstille en dosisstørrelse af lægemiddel, som skal udstødes, indikatorelement (240), som er indrettet til at udføre en rotationsbevægelse under funktionen af udstødningsmidlet, svarende til en rotationsakse, hvilken rotation svarer til mængden af lægemiddel, der udstødes fra en beholder ved hjælp af udstødningsmidlet, kendetegnet ved,at indikatorelementet (240) omfatter en magnet, der bevæger sig sammen dermed, hvilken magnet er udformet til at frembringe et rumligt magnetfelt, som i forhold til det eksterne sensormiddel varierer i overensstemmelse med magnetens rotationsstilling og indikatorelementets, hvilket protokolleringsapparat omfatter: Første sensormiddel, som er indrettet til at måle et magnetfelt svarende til mindst to akser, andet sensormiddel, der er indrettet til at måle en magnetisk egenskab, processormiddel (340), som er udformet til at bestemme: (I) På basis af målte værdier fra det første sensormiddel en rotationsposition for indikatorelementet, og (II) på basis af målinger fra det andet sensormiddel, en rotationsposition for indikatorelementet, hukommelsesmiddel, som er indrettet til at lagre en eller flere dosismængder med henblik på dannelse af en protokol.
10. Protokolleringsapparat ifølge krav 9, hvorved processormidlet er udformet til, på basis af målinger fra den anden sensor-komponentgruppe, at bestemme antallet af hele rotationer af indikatorelementet.
11. Protokolleringsapparat ifølge krav 9 eller krav 10, hvorved: Den første sensor-komponentgruppe anvender en første samplingsfrekvens, og den anden sensor-komponentgruppe anvender en anden, højere samplingsfrekvens.
12. Protokolleringsapparat ifølge et hvilket som helst af kravene 9 til 11, omfattende en sensor-komponentgruppe, der omfatter en eller flere sensorer (345), som er indrettet til at måle et magnetfelt, der svarer til et antal akser, hvorved det første sensormiddel er tilvejebragt ved hjælp af sensor-komponentgruppen, som operativt måler et magnetfelt svarende til et første antal akser, og det andet sensormiddel er tilvejebragt ved hjælp af sensor-komponentgruppen, der operativt måler et magnetfelt svarende til et andet, mindre antal, akser.
13. Protokolleringsapparat ifølge et hvilket som helst af kravene 9 til 12, i kombination med et lægemiddelafgivningsapparat som defineret i krav 1, hvorved der dannes et lægemiddelafgivnings system.
14. Protokolleringsapparat i kombination med et lægemiddelafgivningsapparat, hvilken kombination er defineret ifølge krav 13, hvorved: Indikatorelementet er helt eller delvist fremstillet af et polymermateriale, som indeholder magnetiske partikler, hvilket polymermateriale er blevet magnetiseret, så der tilvejebringes en magnet, som genererer det magnetiske rumfelt.
15. Protokolleringsapparat i kombination med et lægemiddelafgivningsapparat, hvilken kombination er defineret i krav 13, hvorved indikatorelementet er ringformet.
DK14714747.4T 2013-04-05 2014-04-03 Dosisprotokolleringsapparat for et lægemiddelafgivningsapparat DK2981310T3 (da)

Applications Claiming Priority (3)

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EP13162517 2013-04-05
US201361810066P 2013-04-09 2013-04-09
PCT/EP2014/056724 WO2014161952A1 (en) 2013-04-05 2014-04-03 Dose logging device for a drug delivery device

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US (1) US10376644B2 (da)
EP (1) EP2981310B1 (da)
JP (1) JP6364067B2 (da)
CN (1) CN105102023B (da)
DK (1) DK2981310T3 (da)
ES (1) ES2642819T3 (da)
PL (1) PL2981310T3 (da)
WO (1) WO2014161952A1 (da)

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