DK2983745T3 - Medicinske indretninger omfattende ampuladapter med mellemkoblet modul for tørt lægemiddel - Google Patents

Medicinske indretninger omfattende ampuladapter med mellemkoblet modul for tørt lægemiddel Download PDF

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Publication number
DK2983745T3
DK2983745T3 DK14731389.4T DK14731389T DK2983745T3 DK 2983745 T3 DK2983745 T3 DK 2983745T3 DK 14731389 T DK14731389 T DK 14731389T DK 2983745 T3 DK2983745 T3 DK 2983745T3
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DK
Denmark
Prior art keywords
carrier liquid
component
dry drug
uniform
vial
Prior art date
Application number
DK14731389.4T
Other languages
English (en)
Inventor
Hugh Zachary Marks
Nimrod Lev
Amir Lev
Original Assignee
West Pharma Services Il Ltd
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Publication of DK2983745T3 publication Critical patent/DK2983745T3/da

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Classifications

    • 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
    • A61J1/2068—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
    • 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
    • A61M2209/00—Ancillary equipment
    • A61M2209/04—Tools for specific apparatus
    • A61M2209/045—Tools for specific apparatus for filling, e.g. for filling reservoirs
    • 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
    • A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • A61M5/284—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle comprising means for injection of two or more media, e.g. by mixing

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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)
  • Physics & Mathematics (AREA)
  • Fluid Mechanics (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Claims (6)

1. Medicinsk indretning (30; 70), til anvendelse i forbindelse med en nåleløs sprøjte (10), en ampul (20) og en bærevæske (26), til fyldning af den nåleløse sprøjte med en injektionsopløsning til injektion i en patient, hvilken nåleløs sprøjte haren hanforbindelse (13), ampullen har en ampulprop (22) og et ampulindre (24), den medicinske indretning har en langsgående indretningsakse (31) og omfatter: (a) en ampuladapter (32) med et skørt (34) med nedad hængende elastiske elementer (37) til teleskoperende montering på ampullen, en punkteringskanyle (46), til at punktere ampulproppen (22) ved den teleskopiske montering for strømningsforbindelse med ampullens indre (24), og en central opstående hunforbindelse (44) til strømningsforbindelse med punkteringskanylen (46) og beregnet til forbindelse med hanforbindelsen; og (b) et mellemkoblet modul (33) for tørt lægemiddel omfattende en komponent (57) til lagring af tørt lægemiddel, som lagrer en dosis (59; 73) af tørt lægemiddel, og en komponent til ensartet bærevæskefordeling indrettet til at fremme ensartet kontakt imellem komponenten (57) for lagring af tørt lægemiddel og bærevæsken (26), hvilken indretning er indrettet til at muliggøre dannelsen af injektionsopløsningen ved blanding af bærevæsken med doseringen af tørt lægemiddel og indsugning af injektionsvæsken i sprøjten, kendetegnet ved, at det mellemkoblede modul (33) for tørt lægemiddel er placeret i strømningsforbindelse imellem hunforbindelsen (44) og punkteringskanylen (46), for derved at muliggøre dannelse af injektionsopløsningen, ved at medrive doseringen af tørt lægemiddel fra komponenten til lagring af tørt lægemiddel i bærevæsken, ved indsugning af bærevæsken direkte fra ampullen igennem det mellemkoblede modul (33) for tørt lægemiddel til den nåleløse sprøjte.
2. Indretning ifølge krav 1, hvor det mellemkoblede modul (33) for tørt lægemiddel omfatter en diskret komponent (57) for lagring af tørt lægemiddel, til at lagre den nævnte dosis (59) af tørt lægemiddel, og en diskret komponent (58) til ensartet bærevæskefordeling, til at fremme den ensartede kontakt.
3. Indretning ifølge krav 1, hvor det mellemkoblede modul (33) for tørt lægemiddel omfatter en komponent (71) med to formål, til både at lagre den nævnte dosering (73) af tørt lægemiddel og til at fremme den nævnte ensartede kontakt.
4. Indretning ifølge krav 3, hvor komponenten (71) til ensartet bærevæskefordeling omfatter en overside (71A) af komponenten til ensartet bærevæskefordeling, som vender imod hunforbindelsen (44), en underside (71B) af komponenten til ensartet bærevæskefordeling, som vender imod punkteringskanylen (46), og en perifer kant (72) af komponenten til ensartet bærevæskefordeling, hvor oversiden (71A) på komponenten for ensartet bærevæskefordeling har en dosisbelægning (73) af tørt lægemiddel, som udgør komponenten til lagring af tørt lægemiddel.
5. Indretning ifølge krav 4, hvor undersiden (71B) på komponenten til ensartet bærevæskefordeling er udformet med en række radiale riller (62), som hver især afsluttes ved en udskæring (63) i den perifere kant (72) af komponenten til ensartet bærevæskefordeling, for at muliggøre strømningsforbindelse fra undersiden (71B) af komponenten til ensartet bærevæskefordeling til oversiden (71A) af komponenten til ensartet bærevæskefordeling ved indsugning med den nåleløse sprøjte (10) for at trække væskeindhold fra ampullen (20) igennem det mellemkoblede modul (33) for tørt lægemiddel direkte til den nåleløse sprøjte.
6. Indretning ifølge ethvert af kravene 1 til 3, hvor komponenten (58) til ensartet bærevæskefordeling omfatter en overside (58A) af komponenten til ensartet bære-væske-fordeling, som vender imod hunforbindelsen (44), en underside (58B) af komponenten til ensartet bærevæskefordeling, som vender imod punkteringskanylen (46), og en perifer kant (61) af komponenten til ensartet bærevæskefordeling, hvor undersiden (58B) af komponenten til ensartet bærevæskefordeling har en mangfoldighed af radiale riller (62), som hver især afsluttes i en udskæring (63) i den perifere kant (61) af komponenten til ensartet bærevæskefordeling for derved at muliggøre at bærevæske strømmer fra undersiden (58B) af komponenten til ensartet bærevæskefordeling til oversiden (58A) af komponenten til ensartet bærevæskefordeling ved indsugning med den nåleløse sprøjte (10) for at trække væskeindhold fra ampullen (20) igennem det mellemkoblede modul (33) for tørt lægemiddel direkte til den nåleløse sprøjte.
DK14731389.4T 2013-05-10 2014-05-05 Medicinske indretninger omfattende ampuladapter med mellemkoblet modul for tørt lægemiddel DK2983745T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201361821760P 2013-05-10 2013-05-10
PCT/IL2014/050405 WO2014181328A1 (en) 2013-05-10 2014-05-05 Medical devices including vial adapter with inline dry drug module

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DK2983745T3 true DK2983745T3 (da) 2018-10-22

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US (1) US9943463B2 (da)
EP (1) EP2983745B1 (da)
JP (1) JP6199483B2 (da)
CN (1) CN105228676B (da)
BR (1) BR112015027555B1 (da)
DK (1) DK2983745T3 (da)
IL (1) IL242063B (da)
WO (1) WO2014181328A1 (da)

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BR112015027555B1 (pt) 2022-02-01
EP2983745A1 (en) 2016-02-17
CN105228676B (zh) 2018-01-05
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