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HRP20100634T1 - Sklopovi za višedozne bočice za lijekove i adapteri za njih - Google Patents

Sklopovi za višedozne bočice za lijekove i adapteri za njih Download PDF

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Publication number
HRP20100634T1
HRP20100634T1 HR20100634T HRP20100634T HRP20100634T1 HR P20100634 T1 HRP20100634 T1 HR P20100634T1 HR 20100634 T HR20100634 T HR 20100634T HR P20100634 T HRP20100634 T HR P20100634T HR P20100634 T1 HRP20100634 T1 HR P20100634T1
Authority
HR
Croatia
Prior art keywords
adapter
vial
spike
retaining element
extraction
Prior art date
Application number
HR20100634T
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English (en)
Inventor
Weitzel Dietmar
Hoffmann Astrid
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Novartis Ag
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Publication of HRP20100634T1 publication Critical patent/HRP20100634T1/hr

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    • 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096—Combination of a vial and a syringe for transferring or mixing their contents
    • 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/201—Piercing means having one piercing end
    • 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048—Connecting means
    • A61J1/2055—Connecting means having gripping means
    • 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2068—Venting means
    • A61J1/2075—Venting means for external venting
    • 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2079—Filtering means
    • A61J1/2082—Filtering means for gas filtration
    • 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2079—Filtering means
    • A61J1/2086—Filtering means for fluid filtration
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00—Metal working
    • Y10T29/49—Method of mechanical manufacture
    • Y10T29/49826—Assembling or joining

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  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Auxiliary Devices For And Details Of Packaging Control (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Reduction Or Emphasis Of Bandwidth Of Signals (AREA)
  • Addition Polymer Or Copolymer, Post-Treatments, Or Chemical Modifications (AREA)
  • Executing Machine-Instructions (AREA)
  • Ultra Sonic Daignosis Equipment (AREA)
  • Supplying Of Containers To The Packaging Station (AREA)

Abstract

Adapter (60) konfiguriran tako da spoji ekstrakcijski šiljak (withdrawal spike) (30) s bočicom za lijek (10) radi održavanja sterilnosti unutar nje i nakon izvlačenja prve doze iz nje, kod čega adapter (60) sadrži: šuplje tijelo (62) definirano vanjskom stijenkom (63) koje ima prvi kraj (64) i drugi kraj (66); prvi zadržni element na prvom kraju (64) i drugi zadržni element na drugom kraju (66); kod čega se ekstrakcijski šiljak (30) može namjestiti u predodređeni položaj s obzirom na bočicu (10); naznačen time, da: bočica jest bočica za više doza; prvi zadržni element jest prilagođen da nepovratno zahvati barem dio višedozne bočice (10); idrugi zadržni element jest prilagođen da nepovratno zahvati barem dio ekstrakcijskog šiljka (30). Patent sadrži još 29 patentnih zahtjeva.

Claims (30)

1. Adapter (60) konfiguriran tako da spoji ekstrakcijski šiljak (withdrawal spike) (30) s bočicom za lijek (10) radi održavanja sterilnosti unutar nje i nakon izvlačenja prve doze iz nje, kod čega adapter (60) sadrži: šuplje tijelo (62) definirano vanjskom stijenkom (63) koje ima prvi kraj (64) i drugi kraj (66); prvi zadržni element na prvom kraju (64) i drugi zadržni element na drugom kraju (66); kod čega se ekstrakcijski šiljak (30) može namjestiti u predodređeni položaj s obzirom na bočicu (10); naznačen time, da: bočica jest bočica za više doza; prvi zadržni element jest prilagođen da nepovratno zahvati barem dio višedozne bočice (10); i drugi zadržni element jest prilagođen da nepovratno zahvati barem dio ekstrakcijskog šiljka (30).
2. Adapter (60) prema patentnom zahtjevu 1, naznačen time, da prvi zadržni element sadrži barem jedno prvo izbočenje (78) koje se pruža prema unutra.
3. Adapter (60) prema patentnom zahtjevu 2, naznačen time, da je to ili svako prvo izbočenje (78) smješteno na slobodnom kraju (80) pripadajućeg jezičca (82) koji se može elastično ugibati i koji je oblikovan parom proreza (84) u vanjskoj stijenci (63), kod čega se prorezi (84) pružaju barem djelomično od prvog kraja (64) prema drugom kraju (66) vanjske stijenke (63).
4. Adapter (60) prema patentnom zahtjevu 3, naznačen time, da to ili svako prvo izbočenje (78) uključuje nazubljenu plohu za zahvaćanje barem dijela višedozne bočice (10).
5. Adapter (60) prema patentnom zahtjevu 3 ili patentnom zahtjevu 4, naznačen time, da vanjska stijenka (63) uključuje stanjeni dio između krajeva parova proreza (84) na fiksnom kraju toga ili svakog jezičca (82) da se pomogne ugibanju jezičca.
6. Adapter (60) prema bilo kojem od patentnih zahtjeva 1 do 5, naznačen time, da nadalje sadrži prirubnicu (74) koja se pruža iz drugog kraja (66).
7. Adapter (60) prema patentnom zahtjevu 6, naznačen time, da drugi zadržni element sadrži barem jedno drugo izbočenje (92) koje se pruža prema unutra, smješteno na vanjskom obodu prirubnice (74).
8. Adapter (60) prema patentnom zahtjevu 7, naznačen time, da je to ili svako drugo izbočenje (92) smješteno na slobodnom kraju (94) pripadajućeg jezičca (96) koji se može elastično ugibati i ima fiksirani kraj na vanjskom obodu prirubnice (74).
9. Adapter (60) prema patentnom zahtjevu 8, naznačen time, da to ili svako drugo izbočenje (92) uključuje nazubljenu plohu za zahvaćanje barem dijela ekstrakcijskog šiljka (30).
10. Adapter (60) prema patentnom zahtjevu 8 ili patentnom zahtjevu 9, naznačen time, da taj ili svaki jezičac (96) uključuje stanjeni dio (100) na fiksiranom kraju da se pomogne ugibanju jezičca.
11. Adapter (60) prema bilo kojem od patentnih zahtjeva 6 do 10, naznačen time, da prirubnica (74) sadrži prstenasti disk koji uključuje obodni naplatak (76) koji se pruža oko barem dijela oboda prirubnice, a prirubnica (74) i obodni naplatak (76) su konfigurirani tako da prihvate kućište ekstrakcijskog šiljka (30).
12. Adapter (60) prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da nadalje sadrži čašicu (68) koja strši iz prvog kraja tijela (62).
13. Adapter (60) prema patentnom zahtjevu 12, naznačen time, da je čašica (68) konfigurirana tako da obavija barem dio višedozne bočice (10), kod čega unutarnja ploha čašice (68) ima oblik prilagođen da pristaje konturi relevantnog dijela višedozne bočice (10).
14. Adapter (60) prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da nadalje sadrži barem jednu plohu (104) za čvrsto zahvaćanje.
15. Adapter (60) prema patentnom zahtjevu 14, naznačen time, da postoji par suprotnih ploha (104) za čvrsto zahvaćanje, a svaka je smještena na vanjskoj plohi zadebljanja (106) koje strši prema vani iz vanjske stijenke (63) tijela (62).
16. Adapter (60) prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da adapter ima jedinstveni komad.
17. Adapter (60) prema patentnom zahtjevu 16, naznačen time, da adapter sadrži termoplastični kalupljeni komad.
18. Sklop, naznačen time, da sadrži: višedoznu bočicu (10); ekstrakcijski šiljak (30) prilagođen da omogući više sterilnih izvlačenja koja treba izuzeti iz višedozne bočice (10); i adapter (60) u skladu s bilo kojim od prethodnih patentnih zahtjeva, kod čega prvi zadržni element na prvom kraju (64) adaptera (60) nepovratno zahvaća barem dio višedozne bočice (10); i drugi zadržni element na drugom kraju (66) adaptera (60) nepovratno zahvaća barem dio ekstrakcijskog šiljka (30).
19. Sklop prema patentnom zahtjevu 18, naznačen time, da višedozna bočica (10) sadrži: vanjsku ljusku (12) koja određuje unutarnju komoricu (20) s otvorom; i kapicu (24) koja hermetički brtvi otvor.
20. Sklop prema patentnom zahtjevu 19, naznačen time, da komorica (20) sadrži više doza sastojka, kao što je cjepivo protiv gripe.
21. Sklop prema patentnom zahtjevu 19 ili patentnom zahtjevu 20, naznačen time, da se kapica (24) prihvaća u šuplje tijelo (62) adaptera (60) i zahvaća prvim zadržnim elementom.
22. Sklop prema patentnom zahtjevu 19, 20 ili 21, naznačen time, da kapica (24) sadrži pregradnu membranu (26).
23. Sklop prema bilo kojem od patentnih zahtjeva 18 do 22, naznačen time, da ekstrakcijski šiljak (30) sadrži: kućište (32); i probojni trn (34), kod čega trn (34) strši centralno i okomito iz kućišta (32).
24. Sklop prema patentnom zahtjevu 23, naznačen time, da navedeni predodređeni položaj sadrži trn (32) ekstrakcijskog šiljka (30) koji je uveden kroz kapicu (24) bočice za predodređenu duljinu.
25. Sklop prema patentnom zahtjevu 23 ili patentnom zahtjevu 24, naznačen time, da se kućište (32) ekstrakcijskog šiljka prihvaća u prirubnicu (74) adaptera i zahvaća drugim zadržnim elementom.
26. Postupak sklapanja sklopa za davanje više doza sastojka, naznačen time, da sadrži stupnjeve: priprema višedozne bočice (10) koja sadrži sastojak; priprema ekstrakcijskog šiljka (30) prilagođenog da se može izvući više doza iz višedozne bočice (10); priprema adaptera (60) kako je definirano bilo kojim od patentnih zahtjeva 1 do 17; pričvršćivanje adaptera (60) na višedoznu bočicu (10); i pričvršćivanje ekstrakcijskog šiljka (30) na adapter (60).
27. Postupak prema patentnom zahtjevu 26, naznačen time, da navedena višedozna bočica (10) sadrži vanjsku ljusku (12) koja definira unutarnju komoricu (20) s otvorom i kapicu (24) koja hermetički brtvi otvor, i kod čega adapter (60) uključuje značajke iz patentnog zahtjeva 4, a stupanj pričvršćivanja adaptera (60) na višedoznu bočicu (10) sadrži: zahvaćanje nazubljene plohe tog ili svakog prvog izbočenja (78) s kapicom (24) bočice; elastično ugibanje prema vani pripadajućeg jezičca (82) koji se može ugibati, u ugnuti položaj putem odnosne osne sile između višedozne bočice (10) i adaptera (60); i prelaženje kapice (24) preko tog ili svakog prvog izbočenja (78), kod čega se to ili svako prvo izbočenje (78) stoga vraća iz ugnutog položaja da zadrži kapicu (24) unutar šupljeg tijela (62).
28. Postupak prema patentnom zahtjevu 26 ili patentnom zahtjevu 27, naznačen time, da ekstrakcijski šiljak (30) sadrži kućište (32) i probojni trn (34), kod čega trn (34) strši centralno i okomito iz kućišta (32), i kod čega adapter (60) uključuje značajke iz patentnog zahtjeva 9, a stupanj pričvršćivanja ekstrakcijskog šiljka (30) na adapter (60) sadrži: zahvaćanje nazubljene plohe tog ili svakog drugog izbočenja (92) s kućištem (32) šiljka; elastično ugibanje prema vani pripadajućeg jezičca (96) koji se može ugibati, u ugnuti položaj putem odnosne osne sile između šiljka (30) i adaptera (60); i prelaženje kućišta (32) preko tog ili svakog drugog izbočenja (92), kod čega se to ili svako drugo izbočenje (92) stoga vraća iz ugnutog položaja da zadrži kućište (32) šiljka prema prirubnici (74) adaptera.
29. Postupak za pripremanje više doza sastojka, naznačen time, da sadrži stupnjeve: sklapanje sklopa u skladu s bilo kojim od patentnih zahtjeva 26 do 29; uvođenje injekcijske naprave u ekstrakcijski šiljak (30); izvlačenje u biti sterilne doze sastojka iz višedozne bočice (10) u injekcijsku napravu kroz šiljak (30); i ponavljanje stupnjeva uvođenja i izvlačenja koristeći daljnje injekcijske naprave.
30. Postupak prema bilo kojem od patentnih zahtjeva 26 do 29, naznačen time, da sastojak sadrži cjepivo, kao što je cjepivo protiv gripe.
HR20100634T 2007-03-26 2008-03-26 Sklopovi za višedozne bočice za lijekove i adapteri za njih HRP20100634T1 (hr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB0705782A GB0705782D0 (en) 2007-03-26 2007-03-26 Vial assemblies
PCT/IB2008/001666 WO2008117178A2 (en) 2007-03-26 2008-03-26 Multidose vial assemblies and adapters therefor

Publications (1)

Publication Number Publication Date
HRP20100634T1 true HRP20100634T1 (hr) 2011-02-28

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Application Number Title Priority Date Filing Date
HR20100634T HRP20100634T1 (hr) 2007-03-26 2008-03-26 Sklopovi za višedozne bočice za lijekove i adapteri za njih

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Country Link
US (1) US8628508B2 (hr)
EP (1) EP2134311B1 (hr)
JP (1) JP4928631B2 (hr)
CN (1) CN101677906A (hr)
AT (1) ATE485802T1 (hr)
AU (1) AU2008231552B2 (hr)
CA (1) CA2681903C (hr)
CY (1) CY1111245T1 (hr)
DE (1) DE602008003211D1 (hr)
DK (1) DK2134311T3 (hr)
EA (1) EA015648B1 (hr)
ES (1) ES2351950T3 (hr)
GB (1) GB0705782D0 (hr)
HR (1) HRP20100634T1 (hr)
NZ (1) NZ579865A (hr)
PL (1) PL2134311T3 (hr)
PT (1) PT2134311E (hr)
SI (1) SI2134311T1 (hr)
WO (1) WO2008117178A2 (hr)

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