DK2555820T3 - Dispenseringsanordning til follikelstimulerende hormonopløsning uden konserveringsmidler - Google Patents

Dispenseringsanordning til follikelstimulerende hormonopløsning uden konserveringsmidler Download PDF

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DK2555820T3
DK2555820T3 DK11801536T DK11801536T DK2555820T3 DK 2555820 T3 DK2555820 T3 DK 2555820T3 DK 11801536 T DK11801536 T DK 11801536T DK 11801536 T DK11801536 T DK 11801536T DK 2555820 T3 DK2555820 T3 DK 2555820T3
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needle
fsh
needle shield
cartridge
plunger rod
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DK11801536T
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V Bryan Lawlis
Kirk J Hayenga
Darlene P Horton
Lucio Giambattista
David Desalvo
Antonio Bendek
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Carebay Holding Ltd Company No 681498
Itero Biopharmaceuticals Inc
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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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/24—Follicle-stimulating hormone [FSH]; Chorionic gonadotropins, e.g. HCG; Luteinising hormone [LH]; Thyroid-stimulating hormone [TSH]
    • 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
    • A61M5/3146—Priming, e.g. purging, reducing backlash or clearance
    • 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
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31545—Setting modes for dosing
    • A61M5/31548—Mechanically operated dose setting member
    • A61M5/3156—Mechanically operated dose setting member using volume steps only adjustable in discrete intervals, i.e. individually distinct intervals
    • 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
    • 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
    • A61M2005/2006—Having specific accessories
    • A61M2005/2013—Having specific accessories triggering of discharging means by contact of injector with patient body
    • 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
    • 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
    • A61M5/178—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
    • A61M5/31566—Means improving security or handling thereof
    • A61M5/3157—Means providing feedback signals when administration is completed
    • 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
    • A61M5/31578—Constructional 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
    • 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
    • A61M5/34—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub
    • A61M5/347—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub rotatable, e.g. bayonet or screw

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Anesthesiology (AREA)
  • Vascular Medicine (AREA)
  • Hematology (AREA)
  • Endocrinology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Reproductive Health (AREA)
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  • Environmental & Geological Engineering (AREA)
  • Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Epidemiology (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Claims (19)

1. Engangsanordning (100, 1000,1100) til selvdispensering af en follikelstimulerende hormonopløsning, hvor anordningen omfatter: et langstrakt hovedhylster (110, 1010, 1110); en langstrakt logflynder (118); en knap (160, 1015, 1115) ; en stempelstang (116); en nålesamling (140); og en patronholder (150) og hvor det langstrakte hovedhylster har distale (111) og proksimale (112) dele, der er arrangeret langs en longitudinal akse; kendetegnet ved, at den langstrakte logflynder er forbundet med den proksimale del af hovedhylsteret og roterbar omkring den longitudinale akse i henhold til hovedhylsteret; at knappen udgår fra den proksimale del af hylsteret og er roterbar i henhold til hovedhylsteret mellem en låseposition og syv eller færre særskilte doseringspositioner til indstilling af en variabel dosis dispensering af follikelstimulerende hormon (FSH) opløsning, hvor knappen har elementer (908), der er arrangeret longitudinalt og med mellemrum og som henholdsvist svarer til låsepositionen og de syv eller færre særskilte doseringspositioner; at stempelstangen går roterbart i indgreb med en del af logflynderen og er longitudinalt fjederspændt, og at stempelstangen er roterbart låst fast til knappen i låsepositionen på det element, der svarer til låsepositionen, og stempelstangen er trinvist bevægelig langs den longitudinale akse mellem det element, der svarer til låsepositionen og et af elementerne af de syv eller færre særskilte doseringspositioner; at nålesamlingen er en varigt indkapslet nålesamling, der har en varigt fastgjort nål, hvor nålen har en intern ende (425) og en funktionel ende (424); at patron hylsteret er proksimalt fastgjort til nålesamlingen, og patron hylsteret indeholder en langstrakt lægemiddel-patron (130), der indeholder FSH opløsningen, og hvor FSH opløsningen er steril og fri for konserveringsmidler, således at anordningen udelukkende er en engangsanordning, og hvor lægemiddel-patronen er varigt indkapslet i patronholderen og har en gennemtrængelig membran (133), der støder op til den interne ende af nålen og et bevægeligt stempel (131,132), der støder op til stempelstangen, og hvor lægemiddel-patronen er væskemæssigt sat ud af forbindelse med den interne ende af nålen, når knappen er i låseposition; og ved, at anordningen yderligere omfatter en nåleskærm (120, 1025, 1125), der, i henhold til hovedhylsteret, er bevægelig langs den longitudinale akse, mellem en dækningsposition, der er distal i forhold til den funktionelle ende af nålen, og en injektionsposition, der er proksimal i forhold til den funktionelle ende af nålen, hvor nåleskærmen er fjederspændt, således at den normalt er placeret i dækningspositionen og hvor nåleskærmen er uigennemsigtig for, i alt væsentligt, at blokere brugerens syn af den funktionelle ende af nålen i dækningspositionen, og hvor nåleskærmen har en kamskive eller tilhænger, som, roterbart og longitudinalt passer sammen med henholdsvis en tilhænger eller et stopbøsningsdæksel af logflynderen under et kompressionsslag af nåleskærmen fra dækningpositionen til injektionspositionen; og en aftagelig kapsel (410, 1020,1120), der er anbragt således, at den dækker den funktionelle ende af nålen, hvor nålesamlingen eller lægemiddel-patronen, via indvirkning med henholdsvis kapslen eller stempelstangen, er bevægelig langs den longitudinale akse til en spædningsposition, hvilket bevirker, at den interne ende af nålen trænger igennem membranen og forbindes væskemæssigt med lægemiddelpatronen for at præparere nålen med FSH opløsning, og hvor, under kompressionsslaget, nåleskærmen bevæger sig til injektionspositionen og roterer logflynderen, således at denne roterbart går i indgreb med stempelstangen og får stempelstangen til at bevæge sig hen til et af elementerne af de syv eller færre særskilte doseringspositioner og sammentrykker det bevægelige stempel, således at det leverer en tilsvarende særskilt dosis FSH opløsning fra den funktionelle ende af nålen, og hvor de nødvendige skridt, som brugeren skal tage for at stille den uemballerede anordning fra låsepositionen til klar-til-brug positionen, er fire eller færre.
2. Anordning, ifølge krav 1, hvor knappen er roterbar i henhold til hovedhylsteret mellem låsepositionen og en spædningsposition.
3. Anordning, ifølge krav 2, hvor knappen omfatter et spædningselement, der er anbragt longitudinalt og med mellemrum, og som svarer til spædningspositionen, idet spædningselementet er anbragt mellem låsepositionen og de syv eller færre særskilte doseringspositioner.
4. Anordning, ifølge krav 3, hvor rotering af knappen til eller forbi spædningspositionen bevirker, at stempelstangen roteres fra låsepositionen og bevæges trinvist stigende langs den longitudinale akse mellem det element, der svarer til låsepositionen og spædningselementet.
5. Anordning, ifølge krav 4, hvor stempelstangen bevæges trinvist stigende langs den longitudinale akse for at bevæge lægemiddel-patronen ind i nålesamlingen og bevirke, at membranen bliver punkteret ved den funktionelle ende af nålen, og at nålen præpareres med FSH opløsningen.
6. Anordning, ifølge krav 5, hvor de nødvendige skridt, som brugeren skal tage for at sætte den uemballerede anordning fra låsepositionen til klar-til-brug positionen, omfatter: at præparere nålen med FSH opløsningen ved at rotere knappen fra låsepositionen, forbi spædningspositionen, til en af de syv eller færre særskilte doseringspositioner; og fjerne nålens kapsel.
7. Anordning, ifølge krav 6, hvor distal bevægelse af hovedhylsteret i henhold til, at nåleskærmen holdes op imod relativt ubevægeligt væv, fremkalder kompressionsslaget.
8. Anordning, ifølge krav 6, hvor logflynderknappen er synligt markeret med særskilte positioner, der angiver de syv eller færre særskilte doseringspositioner.
9. Anordning, ifølge krav 8, hvor spædningspositionen ikke er markeret på knappen.
10. Anordning, ifølge krav 1, hvor nålesamlingen omfatter et nav (421), der er fastgjort til nålen og hvor navet går i gevind (423,431) med et holdeelement (430) af nålesamlingen.
11. Anordning, ifølge krav 10, hvor den aftagelige kapsel roterbart går i indgreb med holdeelementet, og hvor rotation af den aftagelige kapsel frigør den aftagelige kapsel fra anordningen og desuden bevæger navet i en proksimal retning i henhold til holdeelementet og følgelig bevirker, at membranen bliver punkteret ved den funktionelle ende af nålen, og at nålen bliver præpareret med FSH opløsningen.
12. Anordning, ifølge krav 11, hvor de nødvendige skridt, som brugeren skal tage for at indstille den uemballerede anordning fra låsepositionen til klar-til-brug positionen, omfatter: at præparere nålen med FSH opløsning ved at fjerne nålekapslen; og rotere knappen fra låsepositionen til en af de syv eller færre særskilte doseringspositioner.
13. Anordning, ifølge krav 12, hvor distal bevægelse af hovedhylsteret i henhold til at nåleskærmen holdes op imod relativt ubevægeligt væv, bevirker kompressionsslaget.
14. Anordning, ifølge krav 1, hvor nåleskærmen omfatter et låseelement, som griber ind i logflynderen eller hovedhylsteret under et dekompressionsslag af nåleskærmen fra injektionspositionen til en udgangsposition for at genvinde den funktionelle ende af nålen, og hvor nåleskærmen er ubevægelig i henhold til hovedhylsteret, efter at den er gået tilbage til udgangspositionen.
15. Anordning, ifølge krav 1, hvor stempelstangen kommer i kontakt med et af elementerne af de syv eller færre særskilte doseringspositioner med tilstrækkelig kraft til at fremkalde et hørligt klik, der skal høres af brugeren.
16. Anordning, ifølge krav 1, hvor lægemiddel-patronen har et rumfang på 1,5 ml.
17. Anordning, ifølge krav 16, hvor stempelstangen er konfigureret til at levere en maksimal dosis af FSH opløsningen senest fem sekunder efter, at nåleskærmen er blevet placeret i injektionspositionen.
18. Anordning, ifølge krav 1, hvor FSH opløsningen ikke indeholder benzylalkohol eller m-cresol.
19. Anordning, ifølge krav 1, hvor nåleskærmen totalt blokerer brugerens syn af nålens funktionelle ende i dækningspositionen, når den distale ende af nåleskærmen holdes op mod brugerens væv før og efter indtræffelsen af kompressionsslaget.
DK11801536T 2010-07-02 2011-07-05 Dispenseringsanordning til follikelstimulerende hormonopløsning uden konserveringsmidler DK2555820T3 (da)

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US36131910P 2010-07-02 2010-07-02
PCT/US2011/042972 WO2012003516A2 (en) 2010-07-02 2011-07-05 Preservative-free follicle stimulating hormone solution delivery device

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DK2555820T3 true DK2555820T3 (da) 2015-03-23

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US (2) US8361025B2 (da)
EP (1) EP2555820B1 (da)
JP (1) JP5865368B2 (da)
CN (1) CN103328026B (da)
AU (1) AU2011274341A1 (da)
BR (1) BR112012033606A2 (da)
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