BR112012020829B1 - dispositivo de transferência de droga líquida para usar com um frasco medicinal - Google Patents

dispositivo de transferência de droga líquida para usar com um frasco medicinal Download PDF

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BR112012020829B1
BR112012020829B1 BR112012020829A BR112012020829A BR112012020829B1 BR 112012020829 B1 BR112012020829 B1 BR 112012020829B1 BR 112012020829 A BR112012020829 A BR 112012020829A BR 112012020829 A BR112012020829 A BR 112012020829A BR 112012020829 B1 BR112012020829 B1 BR 112012020829B1
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bottle
upper wall
opening
lumen
vial
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BR112012020829A
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BR112012020829A2 (pt
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Lev Nimrod
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Medimop Medical Projects Ltd
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Priority claimed from IL209101A external-priority patent/IL209101A0/en
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Publication of BR112012020829A2 publication Critical patent/BR112012020829A2/pt
Publication of BR112012020829B1 publication Critical patent/BR112012020829B1/pt

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096Combination of a vial and a syringe for transferring or mixing their contents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006Piercing means
    • A61J1/201Piercing means having one piercing end
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048Connecting means
    • A61J1/2055Connecting means having gripping means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2068Venting means
    • A61J1/2075Venting means for external venting
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2079Filtering means
    • A61J1/2082Filtering means for gas filtration

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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)
  • Closures For Containers (AREA)

Abstract

dispositivo de transferência de droga líquida com adaptador de frasco ventilado. a presente invenção a dispositivos de transferência de droga líquida incluindo um adaptador de frasco ventiladop tendo uma parede superior, uma ponta dependente para baixo, e uma ponta perfuradora do lúmen duplo. a parede superior inclui aqberturas de ventilação em comunicação fluida com um filtro de ar subjacente e capas protetoras para proteger as aberturas de ventilação de respingos. as capas em forma de cobertura são preferivelmente na forma de um quarto de esferas com aberturas da tampa voltadas radialmente para baixo.

Description

Relatório Descritivo da Patente de Invenção para DISPOSITIVO DE TRANSFERÊNCIA DE DROGA LÍQUIDA PARA USAR COM UM FRASCO MEDICINAL.
Campo da invenção [0001] A invenção refere-se aos dispositivos de transferência de droga líquida em geral e dispositivos de transferência de droga líquida incluindo um adaptador de frasco ventilado em particular.
Antecedentes da invenção [0002] A Patente Norte-americana No. 6,139,534 para Niedospial,
Jr. et al. ilustra e descreve um dispositivo de transferência de droga líquida constituído por um adaptador de frasco ventilado tendo um eixo do frasco longitudinal e incluindo uma parede superior com uma série de abertura de ventilações direcionadas axiais, um filtro de ar anular subjacente à série de aberturas de ventilação, uma ponta dependente para baixo para de forma telescópica receber um frasco nele, uma ponta perfuradora do lúmen duplo central dependente para baixo e uma porta da transferência de líquido central direcionada opostamente. A ponta perfuradora do lúmen duplo inclui um par de lumens adjacentes axiais, a saber, um lúmen de transferência de líquido e um lúmen de ventilação. A porta da transferência de líquido está em comunicação fluida com o lúmen de transferência de líquido. As aberturas de ventilação estão em comunicação fluida com o lúmen de ventilação através do filtro de ar. O adaptador de frasco ventilado inclui um septo de pré-ramificação elastomérica para manter a esterilidade dos conteúdos do frasco. O uso do adaptador de frasco ventilado pode levar aos conteúdos de droga líquida inadvertidamente drenando em uma ou mais das aberturas de ventilação ou uma ou mais aberturas de ventilação sendo respingadas pelos conteúdos de droga líquida, assim umedecendo o filtro de ar subjacente ao detrimento de sua operação.
Petição 870190110374, de 30/10/2019, pág. 4/15
2/5 [0003] Os dispositivos de transferência de droga líquida com adaptadores de frasco ventilados também são ilustrados e descritos no inter alia Patente Norte-americana No. 4,834,744 para Ritson, Patente Norte-americana Nos. 6,503,240, 6,544,246, 6,655,246, 6,997,917 e 7,799,009 também para Niedospial, Jr. et al., Patente Norte-americana No. 7,192,423 para Wong, Patente Norte-Americana No. 7,452,348 para Hasegawa, Publicação do Pedido de Patente Norte-americana No. US 2007/0156112 para Walsh, Publicação do Pedido de Patente Norte-americana No. US 2008/0172024 para Yow.
Sumário da invenção [0004] A presente invenção é direcionada aos dispositivos de transferência de droga líquida incluindo um adaptador de frasco ventilado descrito até agora. A presente invenção é direcionada ao fornecimento de tal adaptador de frasco ventilado com capas protetoras individuais para proteger suas aberturas de ventilação para excluindo os conteúdos de droga líquida que entram em uma abertura de ventilação devido ao dreno, respingo e semelhantes, e umedecimento do seu filtro de ar subjacente ao detrimento de sua operação. A presente invenção pode incluir uma tampa manualmente colocada para colocar em uma porta de acesso do líquido para manter a esterilidade dos conteúdos. De forma alternativa, a presente invenção pode incluir um septo de pré-ramificação elastomérica para manter a esterilidade dos conteúdos do frasco.
[0005] A presente invenção pode ser igualmente aplicada a uma ampla faixa de dispositivos de transferência de droga líquida incluindo adaptadores de frasco ventilados para uso com frascos de diferentes tamanhos, a saber, 13mm, 20mm, e semelhante. Os dispositivos de transferência de droga líquida podem ser constituídos pelos adaptadores do frasco incluindo adaptadores do frasco fêmea, adaptadores do frasco macho, e semelhantes. Outros dispositivos de
Petição 870190110374, de 30/10/2019, pág. 5/15
3/5 transferência de droga líquida incluem, por exemplo, dispositivos de transferência de droga líquida ilustrados e descritos geralmente na Patente Norte-americana No. 6,558,365 para Zinger et al., dispositivos de transferência de droga líquida em linha ilustrados e descritos geralmente na publicação Internacional PCT No. WO 2005/105014, e semelhante.
Breve Descrição dos Desenhos [0006] Para entender a invenção e para ver como esta pode ser realizada na prática, modalidades preferidas agora serão descritas, em forma de exemplos não limitativos apenas com referência aos desenhos anexos nos quais partes semelhantes possuem números semelhantes, e em que:
a figura 1 é uma representação pictorial de uma seringa, um frasco e um adaptador de frasco ventilado fêmea tendo um eixo do frasco longitudinal;
a figura 2 é uma vista plana superior do adaptador de frasco ventilado ao longo do eixo do frasco longitudinal;
a figura 3 é um corte transversal longitudinal do adaptador de frasco ventilado da figura 1 ao longo da linha A-A na figura 2;
a figura 4 é um corte transversal longitudinal do adaptador de frasco ventilado da figura 1 ao longo da linha B-B na figura 2; e a figura 5 é uma representação pictorial de um dispositivo de transferência de droga líquida com um adaptador de frasco ventilado desmontável.
Descrição detalhada das modalidades preferidas da Invenção [0007] A figura 1 mostra uma seringa 10 que constitui uma fonte de fluido fisiológico, um frasco medicinal 20 e um dispositivo de transferência de droga líquida 30 constituído por um adaptador de frasco ventilado fêmea para uso com a seringa 10 e o frasco 20. A seringa 10 inclui um cilindro 11 com um êmbolo 12 e um conector Luer
Petição 870190110374, de 30/10/2019, pág. 6/15
4/5 macho 13. A seringa 10 pode ser formadas com outros tipos de conectores macho. O frasco 20 inclui uma garrafa coberta aberta 21 vedada por uma tampa do frasco 22 protegida por uma faixa metálica 23. O frasco 20 contém uma droga em pó ou droga líquida 24 sob pressão negativa. A seringa 10 tipicamente contém diluente para reconstituição dos conteúdos do frasco 24.
[0008] As figures 1 a 4 mostram o adaptador de frasco ventilado fêmea 30 que tem um eixo do frasco longitudinal 31 e inclui uma parede superior transversal 32 tendo uma ponta dependente para baixo 33 com membros flexivos 34 para encaixe no frasco 20. O adaptador do frasco 30 inclui uma ponta perfuradora dependente para baixo do lúmen duplo 36 para perfurar a tampa do frasco 22 encaixando a ponta 33 no frasco 20. A ponta perfuradora 36 inclui uma base 36A em direção à parede superior 32 e termina em uma extremidade da ponta 36B. A ponta perfuradora 36 inclui um par de lumens axiais, a saber, um lúmen de transferência de líquido 37 e um lúmen de ventilação 38. O lúmen de transferência de líquido 37 inclui uma porta 37A em direção à extremidade da ponta 36B. O lúmen de ventilação 38 tem uma porta 38A em direção à extremidade da ponta 36B.
[0009] O adaptador do frasco 30 também inclui uma porta da transferência de líquido axial central 39 opostamente direcionada à ponta perfuradora 36 e em comunicação fluida com o lúmen de transferência de líquido 37. A porta da transferência de líquido 39 termina em um conector Luer fêmea 41 para engate de rosca com o conector Luer macho 13 da seringa. O adaptador do frasco 30 inclui uma tampa manualmente colocada 42 para vedar o conector Luer fêmea 41.
[00010] A parede superior 32 inclui um par de aberturas de ventilação axiais opostas diametrais 43. Um filtro de ar anular 44 está
Petição 870190110374, de 30/10/2019, pág. 7/15
5/5 disposto sob a parede superior 32. As aberturas de ventilação 43 estão em comunicação fluida com o lúmen de ventilação 38 através do filtro de ar 44. O filtro de ar 44 filtra a entrada de ar extraído no frasco 20 na perfuração da tampa do frasco 22.
[00011] A parede superior 32 é formada com um par de capas protetoras 46 montadas sobre as aberturas de ventilação 43 para proteger as aberturas de ventilação 43 na vista plana superior da figura 2. As capas protetoras 46 são preferivelmente formadas de um quarto de esfera. As capas protetoras 46 têm uma abertura da tampa 47 acima da parede superior 32 e voltada radialmente para for a com relação ao eixo do frasco longitudinal 31. As capas protetoras 46 excluem os conteúdos de droga líquida inadvertidamente que umedecem o filtro de ar 44 através das aberturas de ventilação 43 durante o uso do adaptador do frasco 30.
[00012] A figura 5 mostra um dispositivo de transferência de droga líquida 50 da Patente Norte-americana No. 6,558,365 com um adaptador de frasco ventilado desmontável 51 semelhante ao adaptador de frasco ventilado 30.
[00013] Enquanto a invenção foi descrita com relação a um número limitado de modalidades, será observado que muitas variações, modificações e outras aplicações da invenção podem ser inseridas do escopo das reivindicações anexas.

Claims (3)

  1. REIVINDICAÇÕES
    1. Dispositivo de transferência de droga líquida (30) para usar com um frasco medicinal (20) incluindo uma garrafa contendo um medicamento, uma abertura de frasco interrompida por uma tampa de frasco, e um gargalo estreito que intermedeia a garrafa e a abertura de frasco, o dispositivo de transferência de droga líquida compreendendo um adaptador de frasco ventilado (30) possuindo um eixo de frasco longitudinal (31) e incluindo uma parede superior (32) transversal ao dito eixo longitudinal, uma borda substancialmente cilíndrica (33) possuindo membros flexivos (34) presos resilientemente à dita parede superior e para baixo dependendo disso para receber de forma telescópica e deslizante a abertura de frasco no mesmo, um filtro de ar anular (44) disposto sob a dita parede superior, uma ponta perfuradora de lúmen duplo dependente para baixo (36) para perfurar a tampa de frasco (22) para estabelecer comunicação fluida com a garrafa interior, a dita ponta perfuradora possuindo uma base (36A) adjacente à dita parede superior e uma extremidade perfuradora (36b), a dita extremidade perfuradora incluindo um par de lumens direcionados axiais se estendendo a partir da dita base para a dita extremidade perfuradora, o dito par de lumens direcionados axiais incluindo um lúmen de transferência de líquido (37) e um lúmen de ventilação (38), uma porta da transferência de líquido (37A) em comunicação fluida com o dito lúmen de transferência de líquido, pelo menos uma abertura de ventilação direcionada axial (43) formada na dita parede superior e em comunicação fluida com o dito lúmen de ventilação através do dito filtro de ar, a dita porta de transferência de líquido e a dita pelo menos uma abertura de ventilação estando em comunicação fluida com a
    Petição 870190110374, de 30/10/2019, pág. 9/15
  2. 2/2 garrafa recebendo de forma deslizante o frasco no adaptador de frasco caracterizado pelo fato de que a dita parede superior é formada com um número correspondente de pelo menos uma capa protetora como pelo menos uma dita abertura de ventilação de modo que cada abertura de ventilação da dita pelo menos uma abertura de ventilação seja individualmente coberta por uma capa protetora (46) respectiva do dito número correspondente de pelo menos uma capa protetora em uma vista plana superior do dito adaptador de frasco ventilado ao longo do dito eixo de frasco longitudinal e cada dita capa protetora é formada na dita parede superior e possui uma abertura de tampa (47) voltada radial para fora em relação ao dito eixo de frasco longitudinal.
    2. Dispositivo, de acordo com a reivindicação 1, caracterizado pelo fato de que cada dita capa protetora possui uma forma de um quarto de esfera.
  3. 3. Dispositivo, de acordo com a reivindicação 1 ou 2, caracterizado pelo fato de que ainda compreende uma tampa manualmente colocada (42) para vedar a dita porta de acesso de líquido.
BR112012020829A 2010-02-24 2011-02-23 dispositivo de transferência de droga líquida para usar com um frasco medicinal BR112012020829B1 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IL20414110 2010-02-24
IL209101A IL209101A0 (en) 2010-11-04 2010-11-04 Vented vial adapter
PCT/IL2011/000187 WO2011104712A1 (en) 2010-02-24 2011-02-23 Liquid drug transfer device with vented vial adapter

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BR112012020829A2 BR112012020829A2 (pt) 2016-06-28
BR112012020829B1 true BR112012020829B1 (pt) 2020-04-14

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US (1) US8753325B2 (pt)
EP (1) EP2512398B1 (pt)
JP (1) JP5709905B2 (pt)
CN (1) CN102781396B (pt)
BR (1) BR112012020829B1 (pt)
DK (1) DK2512398T3 (pt)
IL (1) IL219793A (pt)
WO (1) WO2011104712A1 (pt)

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CN102781396B (zh) 2015-01-07
JP2013520273A (ja) 2013-06-06
CN102781396A (zh) 2012-11-14
DK2512398T3 (da) 2014-10-13
WO2011104712A1 (en) 2011-09-01
US20130046269A1 (en) 2013-02-21
US8753325B2 (en) 2014-06-17
IL219793A (en) 2015-01-29
BR112012020829A2 (pt) 2016-06-28
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IL219793A0 (en) 2012-07-31
EP2512398B1 (en) 2014-08-27

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