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DK3229872T3 - Dosisindstillingsmekanisme og lægemiddelafgivelsesindretning indeholdende dosisindstillingsmekanismen - Google Patents

Dosisindstillingsmekanisme og lægemiddelafgivelsesindretning indeholdende dosisindstillingsmekanismen Download PDF

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Publication number
DK3229872T3
DK3229872T3 DK15797345.4T DK15797345T DK3229872T3 DK 3229872 T3 DK3229872 T3 DK 3229872T3 DK 15797345 T DK15797345 T DK 15797345T DK 3229872 T3 DK3229872 T3 DK 3229872T3
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Denmark
Prior art keywords
dose
drum
delivery device
setting mechanism
drug delivery
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DK15797345.4T
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English (en)
Inventor
Anders Wieselblad
Thomas Bergens
Original Assignee
Shl Medical Ag
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Publication of DK3229872T3 publication Critical patent/DK3229872T3/da

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533Dosing mechanisms, i.e. setting a dose
    • A61M5/31545Setting modes for dosing
    • A61M5/31548Mechanically operated dose setting member
    • A61M5/3155Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe
    • A61M5/31551Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe including axial movement of dose setting member
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533Dosing mechanisms, i.e. setting a dose
    • A61M5/31535Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533Dosing mechanisms, i.e. setting a dose
    • A61M5/31545Setting modes for dosing
    • A61M5/31548Mechanically operated dose setting member
    • A61M5/31561Mechanically operated dose setting member using freely adjustable volume steps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31576Constructional features or modes of drive mechanisms for piston rods
    • A61M5/31578Constructional features or modes of drive mechanisms for piston rods based on axial translation, i.e. components directly operatively associated and axially moved with plunger rod
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31576Constructional features or modes of drive mechanisms for piston rods
    • A61M5/31583Constructional 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
    • A61M5/31585Constructional 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 performed by axially moving actuator, e.g. an injection button
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/2006Having specific accessories
    • A61M2005/202Having specific accessories cocking means, e.g. to bias the main drive spring of an injector
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/24Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M2005/2403Ampoule inserted into the ampoule holder
    • A61M2005/2407Ampoule inserted into the ampoule holder from the rear
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M2005/3125Details specific display means, e.g. to indicate dose setting
    • A61M2005/3126Specific display means related to dosing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533Dosing mechanisms, i.e. setting a dose
    • A61M5/31535Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose
    • A61M5/31536Blocking means to immobilize a selected dose, e.g. to administer equal doses
    • A61M2005/3154Blocking means to immobilize a selected dose, e.g. to administer equal doses limiting maximum permissible dose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/58Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/581Means for facilitating use, e.g. by people with impaired vision by audible feedback
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/58Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/582Means for facilitating use, e.g. by people with impaired vision by tactile feedback
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/24Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic

Landscapes

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

Claims (14)

1. Dosisindstillingsmekanisme til en lægemiddelafgivelsesindretning, hvor dosisindstillingsmekanismen omfatter: - et rørformet legeme (10) med et langsgående spor (18) af en forudbestemt længde; - en dosistromle (40), der er koaksial med det rørformede legeme (10) og kan bevæge sig aksialt og roterende i forhold til det rørformede legeme (10); - et stoplegeme (90), der kan bevæges aksialt, men er låst imod drejning i forhold til det rørformede legeme (10) og yderligere står i en aksialt afhængig forbindelse med dosistromlen (40); kendetegnet ved, at stoplegemet (90) omfatter en sporfølger (98) i indgreb med det langsgående spor (18), således at rotationsbevægelse af dosistromlen (40) i forhold til det rørformede legeme (10) kan forårsage en maksimal aksial forskydning af dosistromlen (40) og stoplegemet (90) i forhold til det rørformede legeme (10) svarende til den forudbestemte længde.
2. Dosisindstillingsmekanisme til en lægemiddelafgivelsesindretning ifølge krav 1, hvor dosistromlen (40) står i en første gevindforbindelse med det rørformede legeme (10).
3. Dosisindstillingsmekanisme til en lægemiddelafgivelsesindretning ifølge krav 2, hvor sporfølgeren (98) er et radialt fremspring i indgreb med det langsgående spor (18), således at rotationsbevægelse af dosistromlen (40) forårsager en rotationslåst aksial bevægelse af stoplegemet (90) i forhold til det rørformede legeme (10).
4. Dosisindstillingsmekanisme til en lægemiddelafgivelsesindretning ifølge krav 1, hvor den forudbestemte længde er defineret som en afstand mellem en indledende position af sporfølgeren i forhold til det langsgående spor og en distal endevæg (18a) af det langsgående spor (18).
5. Dosisindstillingsmekanisme til en lægemiddelafgivelsesindretning ifølge krav 4, hvor stoplegemet (90) er i den aksialt afhængige forbindelse mellem den indledende position og endevæggen (18a), således at sporfølgerens (98) tryk mod den distale endevæg (18a) hindrer dosistromlen (40) i yderligere aksial forskydning.
6. Dosisindstillingsmekanisme til en lægemiddelafgivelsesindretning ifølge krav 1, yderligere omfattende en dosistromlefølger (100) og en dosisspærrebøsning (110), hvor dosistromlefølgeren (100) er aksialt og rotationsmæssigt forbundet til dosistromlen (40), og hvor dosisspærrebøsningen (110) kan bevæges aksialt, men rotationslåst i forhold til dosistromlefølgeren (100).
7. Dosisindstillingsmekanisme til en lægemiddelafgivelsesindretning ifølge krav 6, hvor dosistromlefølgeren (100) omfatter distale, radialt elastiske holdeelementer (102), der er konfigureret til at interagere med en skrå kant (42) af dosistromlen (40), hvor dosistromlefølgeren (100) ydermere omfatter en proksimal støttering (105), således at stoplegemet (90) presses distalt mod en proksimal overflade af dosistromlen ved hjælp af støtteringen (105) af dosistromlefølgeren (100) ved interaktionen mellem de radialt fleksible holdeelementer (102) og den skrå kant (42).
8. Dosisindstillingsmekanisme til en lægemiddelafgivelsesindretning ifølge krav 7, hvor den proksimale overflade af dosistromlen er en første bølget overflade (45), og hvor en distal periferioverflade af stoplegemet (90) er en anden bølgeoverflade (95), således at drejning af dosistromlen (40) i forhold til stoplegemet (90) frembringer et taktilt og hørbart feedback-signal.
9. Dosisindstillingsmekanisme til en lægemiddelafgivelsesindretning ifølge krav 8, hvor en proksimalt rettet kraft påført mod dosistromlefølgeren (100) forårsager, at det distale tryk på stoplegemet (90) frigives af støtteringen (105).
10. Dosisindstillingsmekanisme til en lægemiddelafgivelsesindretning ifølge krav 7, hvor stoplegemet (90) er anbragt radialt udenfor en aflang halvrørformet bøsning (106) af dosistromlefølgeren (100), og hvor den halvrørformede bøsning (106) forbinder den proksimale støttering (105) med en distal gaffelformet bøsning (107) af dosistromlefølgeren (100).
11. Dosisindstillingsmekanisme til en lægemiddelafgivelsesindretning ifølge krav 10, hvor den gaffelformede bøsning (107) omfatter distalt forlængede arme (101), hvor de distalt forlængede arme omfatter holdeelementerne (102), og hvor de distalt forlængede arme er elastiske i den radiale retning.
12. Dosisindstillingsmekanisme til en lægemiddelafgivelsesindretning ifølge krav 7 eller 11, hvor holdeelementerne (102) er anbragt med skrå proksimale og distale overflader.
13. Dosisindstillingsmekanisme til en lægemiddelafgivelsesindretning ifølge krav 6, yderligere omfattende en gevindforsynet stempelstang (20) og en spærrering (26), hvor dosisspærrebøsningen (110) står i en anden gevindforbindelse med den gevindforsynede stempelstang (20), og hvor spærreringen (26) er fast forbundet til den gevindforsynede stempelstang (20).
14. Lægemiddelafgivelsesindretning omfattende en dosisindstillingsmekanisme ifølge ethvert af kravene 1-13.
DK15797345.4T 2014-12-12 2015-11-19 Dosisindstillingsmekanisme og lægemiddelafgivelsesindretning indeholdende dosisindstillingsmekanismen DK3229872T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
SE1451528 2014-12-12
PCT/EP2015/077139 WO2016091554A1 (en) 2014-12-12 2015-11-19 Dose setting mechanism and medicament delivery device comprising the dose setting mechanism

Publications (1)

Publication Number Publication Date
DK3229872T3 true DK3229872T3 (da) 2019-04-15

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US (5) US10518036B2 (da)
EP (1) EP3229872B1 (da)
JP (1) JP6359774B2 (da)
KR (1) KR101976299B1 (da)
CN (1) CN106999667B (da)
DK (1) DK3229872T3 (da)
TW (1) TWI586397B (da)
WO (1) WO2016091554A1 (da)

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US11607500B2 (en) 2023-03-21
WO2016091554A1 (en) 2016-06-16
USD820440S1 (en) 2018-06-12
US20170340830A1 (en) 2017-11-30
KR20170084211A (ko) 2017-07-19
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US10518036B2 (en) 2019-12-31
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