DK2921191T3 - Automatisk injektionsapparat - Google Patents

Automatisk injektionsapparat Download PDF

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Publication number
DK2921191T3
DK2921191T3 DK14199837.7T DK14199837T DK2921191T3 DK 2921191 T3 DK2921191 T3 DK 2921191T3 DK 14199837 T DK14199837 T DK 14199837T DK 2921191 T3 DK2921191 T3 DK 2921191T3
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Denmark
Prior art keywords
container
needle
injection
housing
shield
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DK14199837.7T
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English (en)
Inventor
Guillaume Grunhut
Lionel Maritan
Frédéric Perot
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Becton Dickinson France
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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
    • A61M5/2033—Spring-loaded one-shot injectors with or without automatic needle insertion
    • 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
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/326—Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
    • 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
    • A61M2005/206—With automatic needle insertion
    • 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
    • A61M2005/2073—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically preventing premature release, e.g. by making use of a safety lock
    • A61M2005/208—Release is possible only when device is pushed against the skin, e.g. using a trigger which is blocked or inactive when the device is not pushed against the skin
    • 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
    • A61M2005/3103—Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle
    • A61M2005/3107—Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle for needles
    • A61M2005/3109—Caps sealing the needle bore by use of, e.g. air-hardening adhesive, elastomer or epoxy resin
    • 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
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3213—Caps placed axially onto the needle, e.g. equipped with finger protection guards
    • A61M2005/3215—Tools enabling the cap placement
    • 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
    • A61M2205/19—Constructional features of carpules, syringes or blisters
    • A61M2205/192—Avoiding coring, e.g. preventing formation of particles during puncture
    • 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
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/581—Means for facilitating use, e.g. by people with impaired vision by audible feedback
    • 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
    • A61M5/008—Racks for supporting syringes or needles
    • 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
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3202—Devices for protection of the needle before use, e.g. caps
    • A61M5/3204—Needle cap remover, i.e. devices to dislodge protection cover from needle or needle hub, e.g. deshielding devices
    • 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
    • A61M5/50—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 having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
    • A61M5/5086—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 having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile for indicating if defective, used, tampered with or unsterile

Claims (22)

1. Apparat (1) til automatisk injektion af et produkt (3) på et injektionssted (4), hvilket produkt bæres af en beholder (50), som har en åben, proximal ende og en i det væsentlige lukket, distal ende, og med et reservoir defineret derimellem, og en nål (6) tilvejebragt i den distale ende samt i fluidforbindelse med reservoiret for at tilvejebringe en udgangsport for produktet (3) fra beholderen, samt et stempel (7), der er tilvejebragt i beholderen og kan bevæges i forhold til beholderen, hvorved stemplets bevægelse bevirker, at produktet udstødes fra beholderen gennem nålen, hvilket apparat omfatter: et hus (8) med i hovedsagen cylindrisk form af beholderen, hvilken beholder kan bevæges i forhold til huset mellem en begyndelsesposition, i hvilken en nålespids ikke strækker sig ud over en distal ende af huset, og i hvilken beholderen er i en af en passiv tilstand og en aktiv tilstand, og til en indsætningsposition, som distalt har en afstand til begyndelsespositionen, og hvori nålens spids strækker sig ud over husets distale ende, hvorved beholderens bevægelse ud fra dens begyndelsesposition hindres, når beholderen er i sin passive tilstand, og tillades, når beholderen er i sin aktive tilstand, og et sikkerheds skjold (10), der er koblet til huset (8) med henblik på bevægelse mellem en første position og en anden position, i hvilken nålens spids ikke strækker sig ud over en distal ende af sikkerheds skjoldet, bevægelse af sikkerhedsskjoldet (10) ud fra dets første position, hvorved beholderen (50) bringes i sin aktive tilstand, hvilket sikkerheds skjold (10) kan bevæges til dets anden position, når beholderen (50) er i indsætningspositionen, hvilket sikkerhedsskjold (10) er fastgjort mod proximal bevægelse, når det er i den anden position, et nåleskjold (2), som er koblet til en skærmfjemer (15), der er koblet til huset (8) og dækker nålen (6) før anvendelse af apparatet, fjernelse af nålen (2) fra apparatet uden rotation af nåleskjoldet, kendetegnet ved, at skærmfjerneren (15) og huset (8) er udstyret med føringsmidler (40, 41), som er udformet til at tillade langsgående forskydning af nåleskjoldet (2) i forhold til huset (8), mens dettes rotation forhindres, når nåleskjoldet (2) fjernes fra apparatet (1).
2. Apparat ifølge krav 1, kendetegnet ved, at føringsmidlet inkluderer mindst én langsgående rille (40), som er tilvejebragt på skærmfjerneren (15) eller på huset (8), og mindst én langsgående ribbe (41), der er tilvejebragt på henholdsvis huset (8) eller på skærmfjerneren (15), hvilken ribbe (41) er i indgreb i rillen (40) og glider inden i rillen (40), når skærmfjerneren (15) fjernes fra apparatet (1).
3. Apparat ifølge et af kravene 1 til 2, kendetegnet ved, at en del af føringsmidlet (40, 41) er tilvejebragt på skærmfjerneren (15).
4. Apparat ifølge krav 1, kendetegnet ved, at apparatet ydermere omfatter: Første forspændingsmiddel (30), der er koblet til huset med henblik på forspænding af beholderen mod indsætningspositionen, hvilket første forspændingsmiddel er i en af en komprimeret og en strakt tilstand, og andet forspændingsmiddel (31), der er koblet til sikkerheds skjoldet med henblik på forspænding af sikkerheds skjoldet mod dets anden position.
5. Apparat ifølge krav 4, kendetegnet ved, at apparatet ydermere omfatter: første tilbageholdelsesmidler (21, 29) i huset, og som er indrettet til at fastholde det første for spændingsmiddel i dets komprimerede tilstand, et første de-aktiveringsmiddel (23), som kan aktiveres for at frigøre første tilbageholdelsesmidler, hvilken første de-aktiveringsmiddel er i en af en passiv tilstand, i hvilken det første de-aktiveringsmiddel ikke kan bevirke frigørelse af første tilbageholdelsesmidler, og en aktiv tilstand, i hvilken første de-aktiveringsmiddel kan bevirke frigørelse af første tilbageholdelsesmidler, hvorved bevægelse af sikkerheds skjoldet ud fra dets første position bevirker overgang af første de-aktiveringsmiddel fra dets passive tilstand til dets aktive tilstand.
6. Apparat ifølge krav 5, kendetegnet ved, at det ydermere omfatter: Andet tilbageholdelsesmidler (9, 12), der er tilvejebragt på mindst et af huset og sikkerhedsskjoldet for at hindre bevægelse af sikkerheds skjoldet til dets anden position.
7. Apparat ifølge krav 6, hvorved det andet tilbageholdelsesmiddel omfatter en bøjelig tunge (12) og en anslagsoverflade (9).
8. Apparat ifølge krav 6 og 7, kendetegnet ved, at apparatet ydermere omfatter: Første indgrebsmidler (26, 27), der er i stand til at frigive andet tilbageholdelsesmidler, hvorved der muliggøres bevægelse af sikkerheds skjoldet til sin anden position under forspændingen fra det andet forspændingsmiddel.
9. Apparat ifølge krav 8, hvorved det første indgrebsmiddel omfatter en indre ring (26), som er koblet til beholderen og omfatter et ben (27, der virker sammen med den fleksible tunge med henblik på frigivelse af den fleksible tunge fra anslagsoverfladen, når beholderen bevæger sig til indsætningspositionen.
10. Apparat ifølge krav 5, kendetegnet ved, at det første de-aktiveringsmiddel er en trykknap (23) med en distal ende (24), og ved, at apparatet endvidere omfatter: - tredje tilbageholdelsesmidler, som er indrettet til at bibeholde trykknappen i dens passive tilstand, hvilke tredje tilbageholdelsesmidler omfatter et i radial retning bøjeligt ben (20), som er tilvejebragt på en ydre bøsning (19), hvilken ydre bøsning er koblet til huset, hvorved trykknappens distale ende er blokeret mod aksial og distal forskydning ved hjælp af det radialt bøjelige ben (20), - hvorved sikkerheds skjoldet (10) ydermere omfatter en tand (13), som griber ind i det tredje tilbageholdelsesmiddel, når sikkerhedsskjoldet bevæges ud fra sin første position med henblik på at afbøje det i radial retning bøjelige ben og muliggøre overgang af trykknappen fra dens passive tilstand til dens aktive tilstand.
11. Apparat ifølge krav 10, kendetegnet ved, at apparatet endvidere omfatter en stempelstang (28) for at bevirke, at stemplet bevæger sig i forhold til beholderen, hvorved det første tilbageholdelsesmiddel omfatter en bøjelig tand (21), som er tilvejebragt på en af den ydre bøsning (19) og stempelstangen (28) og i indgreb med et radialt stop (29), der er tilvejebragt på en af stempelstangen og den ydre bøsning, hvilken trykknap omfatter en tand (25), der er i stand til at virke sammen med den bøjelige tand med henblik på at frigøre den bøjelige tand (21) fra det radiale stop under manuelt tryk, der udøves på trykknappen i dens aktive tilstand, hvorved der sker de-aktivering af det første tilbageholdelsesmiddel, og beholderen bringes til at bevæge sig fra sin begyndelsesposition til sin indsætningsposition.
12. Apparat ifølge krav 9, kendetegnet ved, at det ydermere omfatter låsemidler (18, 33), der er indrettet til at hindre bevægelse af den indre ring (26), når det første de-aktiveringsmiddel befinder sig i sin passive tilstand, hvilket låsemiddel er i stand til at blive oplåst ved bevægelsen af sikkerheds skjoldet (10) ud fra dets første position.
13. Apparat ifølge krav 12, kendetegnet ved, at første forspændingsmiddel omfatter automatiske injektionsmidler (30), der er indrettet således, at stempelstangen bringes til at bevæge stemplet inden i beholderen, når beholderen er i indsætningspositionen, hvorved det bevirkes, at produktet (4) automatisk udstødes fra beholderen uden nogen som helst manuel handling fra brugeren.
14. Apparat ifølge krav 13, hvorved det automatiske injektionsmiddel er arrangeret rundt om stempelstangen.
15. Apparat ifølge krav 13, hvorved det automatiske injektionsmiddel er anbragt i stempelstangen.
16. Apparat ifølge et af kravene 1 til 15, ydermere omfattende injektions styringsmidler (30, 32) til frembringelse af en hørbar indikator, når stemplet befinder sig nær ved beholderens distale ende, og produktet stort set helt er udstødt fra beholderen, hvorved brugeren informeres om, at injektion af produktet er afsluttet, hvilket injektionsstyringsmiddel (30, 32) frembringer en hørbar indikator, uanset om brugeren opretholder tryk mod første de-aktiveringsmiddel (23).
17. Apparat ifølge krav 16, kendetegnet ved, at injektionsstyringsmidlet (30, 32) omfatter: en stempelstang (28) for at bevirke, at stemplet bevæger sig i forhold til beholderen, første forspændingsmiddel (30), der er koblet til mindst et af huset og stempelstangen, hvilket første forspændingsmiddel er i en af en komprimeret tilstand og en udstrakt tilstand, og midler til samvirkning med det første forspændingsmiddel for at tilvejebringe en injektionsstatusangivelse til en bruger af apparatet.
18. Apparat ifølge krav 17, kendetegnet ved, at det første forspændingsmiddel i det mindste omfatter en fjeder.
19. Apparat ifølge krav 1, kendetegnet ved, at apparatet ydermere omfatter svindelkonstateringsmidler, der aftageligt er koblet til huset for at afskærme nålen før anvendelse af apparatet, hvilket svindel-konstateringsmiddel er i en af en tilstand før anvendelse og en tilstand efter anvendelse, hvilken tilstand efter anvendelse hindrer genbrug af svindel-konstateringsmidlet med apparatet.
20. Apparat ifølge krav 19, kendetegnet ved, at apparatet ydermere omfatter svindelkonstateringsmidler, som aftageligt er koblet til huset for at afskærme nålen før anvendelse af apparatet, hvilket svindel-konstateringsmiddel er i en af en tilstand før anvendelse og en tilstand efter anvendelse, hvilken tilstand efter anvendelse tilvejebringer en visuel indikation af, at svindel-konstateringsmidlet er blevet fjernet fra apparatet.
21. Apparat ifølge krav 19 eller 20, hvorved svindel-konstateringsmidlet omfatter af-skærmningsfjerneren (15), der er koblet til nåleafskærmningen (2), hvilken tilstand efter anvendelse tilvejebringer indikation af, at svindel-konstateringsmidlet har været fjernet fra apparatet.
22. Apparat ifølge et af kravene 1, 2, 4 eller 5, kendetegnet ved, at nåleafskærmningen består af gummi eller elastomermateriale, i hvilket nålen er indlejret.
DK14199837.7T 2006-04-11 2007-04-11 Automatisk injektionsapparat DK2921191T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR0603200A FR2899482A1 (fr) 2006-04-11 2006-04-11 Dispositif d'injection automatique
EP07735010.6A EP2007450B2 (en) 2006-04-11 2007-04-11 Automatic injection device

Publications (1)

Publication Number Publication Date
DK2921191T3 true DK2921191T3 (da) 2018-11-26

Family

ID=36942436

Family Applications (2)

Application Number Title Priority Date Filing Date
DK07735010.6T DK2007450T4 (da) 2006-04-11 2007-04-11 Automatisk injektionsindretning
DK14199837.7T DK2921191T3 (da) 2006-04-11 2007-04-11 Automatisk injektionsapparat

Family Applications Before (1)

Application Number Title Priority Date Filing Date
DK07735010.6T DK2007450T4 (da) 2006-04-11 2007-04-11 Automatisk injektionsindretning

Country Status (9)

Country Link
US (1) US7976499B2 (da)
EP (3) EP2921191B1 (da)
JP (1) JP5175838B2 (da)
CN (1) CN101454032B (da)
DK (2) DK2007450T4 (da)
ES (3) ES2532127T5 (da)
FR (1) FR2899482A1 (da)
HU (2) HUE041887T2 (da)
WO (1) WO2007132353A2 (da)

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EP2921191B1 (en) 2018-08-15
EP2007450B1 (en) 2014-12-24
WO2007132353A3 (en) 2008-03-20
EP2921191A1 (en) 2015-09-23
ES2532127T3 (es) 2015-03-24
WO2007132353A2 (en) 2007-11-22
EP3345638B1 (en) 2020-03-11
CN101454032B (zh) 2011-11-16
EP3345638A1 (en) 2018-07-11
CN101454032A (zh) 2009-06-10
ES2532127T5 (es) 2018-11-07
FR2899482A1 (fr) 2007-10-12
EP2007450A2 (en) 2008-12-31
HUE041887T2 (hu) 2019-06-28
DK2007450T4 (da) 2018-11-12
EP2007450B2 (en) 2018-08-01
JP2009533124A (ja) 2009-09-17
ES2784426T3 (es) 2020-09-25
US20090312705A1 (en) 2009-12-17
HUE024866T2 (en) 2016-02-29
US7976499B2 (en) 2011-07-12
ES2691869T3 (es) 2018-11-29
DK2007450T3 (da) 2015-03-09
JP5175838B2 (ja) 2013-04-03

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