BR112015005157B1 - adaptador de frasco de fármaco fêmea telescópico - Google Patents
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- A—HUMAN NECESSITIES
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- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
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- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
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Abstract
ADAPTADOR DE FRASCO DE FÁRMACO FÊMEA TELESCÓPICO. Um adaptador de frasco de fármaco fêmea telescópico incluindo um componente de ponta montado telescopicamente em um componente de saia para encaixar por pressão e perfurar um frasco de fármaco em uma posição atuada. O adaptador de frasco de fármaco fêmea telescópico é particularmente adequado para implementação em uma versão ventilada para evitar o umedecimento de seu filtro de ar durante aspiração de conteúdos líquidos de um frasco de fármaco.
Description
[0001] A invenção se refere a adaptadores de frasco de fármaco emgeral e a adaptadores de frasco de fármaco fêmea em particular.
[0002] O Pedido Internacional PCT de propriedade comum N°.PCT/IL2006/000912 intitulado “Liquid Drug Transfer Devices for Failsafe Correct Snap Fitting onto Medicinal Vials” e publicado sob a Publicação Internacional PCT N°. WO 2007/017868 ilustra e descreve dispositivos de transferência de fármaco líquido incluindo um adaptador de frasco de fármaco desenhado para alinhamento guiado com o frasco de fármaco antes do encaixe de pressão no mesmo e perfurando o mesmo para assegurar comunicação de fluxo com o interior do frasco de fármaco. A figura 4 do WO 2007/017868 ilustra um adaptador de frasco de fármaco fêmea ventilado para uso com uma seringa sem agulha.
[0003] Um adaptador de frasco de fármaco do WO 2007/017868inclui uma parede superior com um elemento de perfuração pendendo para baixo e um orifício de acesso ereto oposto em comunicação de fluxo com o elemento de perfuração. A parede superior é também formada com uma saia em geral cilíndrica circundando o elemento de perfuração. A saia em geral cilíndrica inclui pelo menos quatro elementos flexíveis direcionados axialmente, mais longos que o elemento de perfuração, para evitar que o elemento de perfuração contate uma tampa do frasco de fármaco do frasco de fármaco antes do alinhamento do adaptador de frasco de medicamento e do frasco de fármaco. Os elementos flexíveis direcionados axialmente incluem dois elementos flexíveis de retenção de frasco de fármaco não adjacentes para encaixar por pressão sobre uma abertura do frasco de fármaco para propósitos de retenção do frasco de fármaco e pelo menos dois elementos flexíveis de guia de frasco de fármaco não adjacentes mais longos que suas contrapartes de elementos flexíveis de retenção de frasco de fármaco para guiar o adaptador de frasco de fármaco com respeito a um frasco de fármaco antes do encaixe de pressão no mesmo.
[0004] Um adaptador de frasco de fármaco fêmea ventilado do WO2007/017868 inclui um elemento de perfuração de lúmen duplo tendo um lúmen de transferência de líquido e um lúmen de ventilação. O lúmen de transferência de líquido está em comunicação de fluxo com um conector fêmea para receber de modo vedante uma seringa sem agulha. O lúmen de ventilação está em comunicação de fluxo com um filtro de ar em geral circular formado na parede superior. A inversão do adaptador de frasco de fármaco fêmea ventilado para aspiração de seus conteúdos de medicamento líquido leva à entrada indesejável dos conteúdos de medicamento líquido no lúmen de ventilação e umedecimento do filtro de ar, portanto diminuindo sua capacidade de permitir que o ar filtrado passe através do mesmo para propósitos de equalização de pressão durante a aspiração.
[0005] Existe uma necessidade de adaptadores de frasco defármaco fêmeas para alinhamento guiado com relação a um frasco de fármaco para montagem no mesmo e perfuração, mas com um elemento de perfuração mais longo.
[0006] A presente invenção é direcionada a adaptadores de frascode fármaco fêmeas incluindo uma construção de componente duplo tendo um componente de ponta telescopicamente montado em um componente de saia para deslocamento manual de uma posição de configuração para uma posição atuada para montar justa e perfuração de um frasco de fármaco. O deslocamento manual do componente de ponta para o componente de saia proporciona alinhamento guiado inicial do adaptador de frasco de fármaco com relação a um frasco de fármaco antes de ser montado de modo justo no mesmo e perfurar o mesmo.
[0007] A presente invenção é particularmente vantajosa paraadaptadores de frasco de fármaco fêmeas ventilados que podem ser fornecidos com um elemento de perfuração longo tendo um lúmen de ventilação com uma abertura de lúmen de ventilação em sua ponta de perfuração. Os adaptadores de frasco de fármaco fêmeas ventilados são destinados a serem usados com seringas sem agulha cheias com um volume predeterminado de conteúdos líquidos de modo que, na inversão de um adaptador de frasco de fármaco fêmea ventilado mostrado em um frasco de fármaco com conteúdos de fármaco líquido para propósitos de aspiração, a abertura de lúmen de ventilação está acima do nível de líquido dos conteúdos de fármaco líquido de modo semelhante a um snorkel de natação. Em virtude desta disposição, conteúdos de fármaco líquido são impedidos de entrar no lúmen de ventilação e umedecer o filtro de ar.
[0008] A fim de entender a invenção e ver como pode ser realizadana prática, uma modalidade preferida será descrita agora, por meio de um exemplo não limitante somente, com referência aos desenhos anexos em que partes similares são igualmente numeradas, e em que: a figura 1 é uma representação pictórica de uma seringa, um frasco de fármaco incluindo uma seção transversal longitudinal, e um adaptador de frasco fêmea telescópico ventilado tendo um eixo de adaptador de frasco de fármaco longitudinal em uma posição de preparação; a figura 2 é uma vista explodida do adaptador de frasco de fármaco fêmea telescópico ventilado; a figura 3 é uma vista plana de topo do adaptador de frasco de fármaco fêmea telescópico ao longo do eixo de adaptador de frasco de fármaco longitudinal; a figura 4 é uma seção transversal longitudinal do adaptador de frasco de fármaco fêmea telescópico ao longo da linha A-A na figura 3 em uma posição de preparação; a figura 5 é uma seção transversal longitudinal do adaptador de frasco de fármaco fêmea telescópico ventilado ao longo da linha BB na figura 3 em sua posição de preparação; a figura 6 é uma seção transversal longitudinal do adaptador de frasco de fármaco fêmea telescópico ventilado ao longo da linha A- A na figura 3 em uma posição atuada; a figura 7 é uma seção transversal longitudinal do adaptador de frasco de fármaco fêmea telescópico ventilado ao longo da linha BB na figura 3 em uma posição atuada; a figura 8A é uma seção transversal longitudinal do adaptador de frasco de fármaco fêmea telescópico e o frasco de fármaco ao longo da linha A-A na figura 3 antes do uso; a figura 8B é uma seção transversal longitudinal do adaptador de frasco de fármaco fêmea telescópico ventilado e o frasco de fármaco ao longo da linha A-A na figura 3 de acordo com uma depressão descendente inicial do primeiro para o último; a figura 8C é uma seção transversal longitudinal do adaptador de frasco de fármaco fêmea telescópico ventilado e frasco de fármaco ao longo da linha A-A na figura 3 de acordo com uma depressão descendente contínua do primeiro para o último; a figura 8D é uma seção transversal longitudinal do adaptador de frasco de fármaco fêmea telescópico ventilado completamente montado sobre e perfurando o frasco de fármaco ao longo da linha A-A na figura 3; a figura 8E é uma seção transversal longitudinal do adaptador de frasco de fármaco fêmea telescópico ventilado completamente montado sobre e perfurando o frasco de fármaco ao longo da linha B-B na figura 3; a figura 8F é uma seção transversal longitudinal do adaptador de frasco de fármaco fêmea telescópico ventilado e o frasco de fármaco ao longo da linha A-A na figura 3 em parafuso rosqueando uma seringa sem agulha no primeiro para propósitos de injeção; e a figura 8G é uma seção transversal longitudinal do adaptador de frasco de fármaco fêmea telescópico ventilado e o frasco de fármaco ao longo da linha A-A na figura 3 depois da inversão para propósitos de aspiração.
[0009] A figura 1 mostra uma seringa 10 que constitui uma fonte defluido fisiológico, um frasco de fármaco medicinal 20 e um adaptador de frasco de fármaco fêmea telescópico ventilado 30 para uso com a seringa 10 e o frasco de fármaco 20. A seringa 10 inclui um tambor 11 com um êmbolo 12 e um conector de trava Luer macho 13. A seringa 10 pode ser formada com outros tipos de conectores machos. A seringa 10 é preenchida com um componente líquido 14. O componente líquido 14 pode ser diluente somente. Alternativamente, o componente líquido 14 pode incluir um componente ativo.
[00010] O frasco de fármaco 20 tem um eixo de frasco de fármaco longitudinal 20A e inclui uma garrafa de frasco de fármaco 21 tendo um ressalto de frasco de fármaco 22, um aro de frasco de fármaco 23 e um gargalo de frasco de fármaco estreito intermediário 24. O aro de frasco de fármaco 23 define uma abertura de frasco 26 vedada por uma tampa de frasco de fármaco 27 tampado por uma faixa 28. O frasco de fármaco 20 contém um medicamento em pó 29 sob pressão negativa ou um fármaco líquido 29.
[00011] As figuras 1 a 7 mostram o adaptador de frasco de fármaco fêmea telescópico ventilado 30 tendo um eixo de adaptador de frasco de fármaco longitudinal 31 e inclui um componente de ponta ventilado 32, um componente de saia 33, e uma disposição de fixação 34 para prender o componente de ponta 32 no componente de saia 33 em uma posição atuada como mostrado nas figuras 6 e 7.
[00012] O componente de ponta ventilado 32 inclui uma parede superior de componente de ponta transversalmente direcionado 36 tendo um filtro de ar circular 37 e um par de aberturas de ventilação 38. O componente de ponta ventilado 32 de preferência inclui capas protetoras 38, como ilustrado e descrito no Pedido Internacional PCT de propriedade comum N°. PCT/2011/000187 intitulado “Liquid DrugTransfer Device with Vented Vial Adapter” e publicado sob Publicação Internacional PCT N°. WO 2011/104712.
[00013] A parede superior do componente de ponta 36 inclui um elemento de perfuração de lúmen duplo pendendo descendentemente 39 com uma ponta de perfuração 41 para perfurar uma tampa de frasco de fármaco e um conector fêmea ereto oposto 42. O conector fêmea 42 é de preferência um conector Luer fêmea com uma rosca de parafuso externa 43. O elemento de perfuração de lúmen duplo 39 inclui um lúmen de transferência de líquido 44 em comunicação de fluxo com o conector fêmea ereto oposto 42, o elemento de perfuração de lúmen duplo 39 inclui um lúmen de ventilação 46 tendo uma abertura de lúmen de ventilação 47 adjacente à ponta de perfuração 41 e em comunicação de fluxo com o par de aberturas de ventilação 38.
[00014] A parede superior do componente de ponta 36 inclui umasuperfície de parede de topo de componente de ponta mais superior 36A voltada para o conector fêmea ereto 42 e uma superfície de parede superior de componente de ponta mais inferior 36B voltada para o elemento de perfuração de lúmen duplo 39. O elemento de perfuração 39 tem um comprimento L1 definido entre a superfície de parede superior de componente de ponta mais inferior 36B e a ponta de perfuração 41.
[00015] A parede superior de componente de ponta 36 também inclui um par de pernas de componente de ponta pendendo descendentemente espaçadas opostas 48 laterais ao elemento de perfuração 39. As pernas de componente de ponta 48 terminam em pontas de pernas 49 se projetando internamente na direção da ponta de perfuração 41.
[00016] O componente de saia 33 inclui uma parede superior de componente de saia direcionada transversalmente 51 tendo uma abertura central 52 e uma saia substancialmente cilíndrica pendendo descendentemente 53. A saia 53 inclui vários elementos flexíveis de frasco de fármaco 54 definindo uma cavidade de aro de frasco de fármaco 56 para receber de modo justo o aro de frasco de fármaco 23 na mesma e uma margem de componente de saia 57 afastada da parede superior de componente de saia 51. Os elementos flexíveis de frasco de fármaco 54 de preferência incluem projeções direcionadas para dentro 58 para encaixar por pressão no aro de frasco de fármaco 23.
[00017] A parede superior de componente de saia 51 inclui uma superfície de parede superior de componente de saia mais superior 51A voltada para o componente de ponta 32 e uma superfície de parede superior de componente de saia mais inferior 51B voltado para a saia 53. A saia 53 tem um comprimento L2 definido entre a superfície de parede superior de componente de saia mais superior 51A e a margem do componente de saia 57.
[00018] Dois elementos flexíveis de frasco de fármaco opostos 54A têm aberturas de ponta de perna 59 para receber inicialmente as pontas de perna 49 para espaçar inicialmente a parede superior de componente de ponta 36 da parede superior de componente de saia 51 com o elemento de perfuração 39 se projetando através da abertura central 52 em uma posição de preparação do adaptador de frasco de fármaco fêmea telescópico 30. Os elementos flexíveis de frasco de fármaco 54A são de preferência formados com superfícies externas lisas 61 abaixo das aberturas de ponta de perna 59 para permitir o movimento deslizante suave das pontas de pernas 49 para a margem de componentes de saia 57.
[00019] Na posição de preparação, a superfície de parede superior de componente de ponta mais inferior 36B e a superfície de parede superior de componente de saia mais superior 51A são separadas por um comprimento L3. Na posição de preparação, L1<L2+L3 de modo que a ponta de perfuração 41 não se projeta além da margem de componente de saia 57 que levaria a ponta de perfuração 41 a contatar uma tampa de frasco de fármaco 27 antes do alinhamento correto do adaptador de frasco de fármaco fêmea telescópico ventilado 30 com um frasco de fármaco 20. O elemento de perfuração 39 e a saia 53 são de preferência dimensionados de modo que L1>L2 de modo que a abertura de ponta de ventilação 47 se projeta além da margem de componente de saia 57 na posição atuada em que o componente de ponta 32 contata completamente o componente de saia 33.
[00020] A disposição de fixação 34 inclui um par de presilhas de encaixe de pressão opostas 62 ortogonais ao par de pernas de componente de ponta opostas 48.
[00021] As figuras 8A a 8G mostram o uso da seringa sem agulha 10, o frasco de fármaco 20 e o adaptador de frasco de fármaco fêmea telescópico ventilado 30. A seringa sem agulha 10 é cheia com um volume predeterminado de conteúdos líquidos 29 para assegurar um efeito do tipo snorkel de modo que os conteúdos líquidos não molham o filtro circular 37 como descrito aqui abaixo com respeito à figura 8G.
[00022] A figura 8A mostra o adaptador de frasco de fármaco fêmea 30 em sua posição de preparação e em alinhamento coaxial com o frasco de fármaco 20 pronto para encaixar por pressão no mesmo e perfurar o mesmo.
[00023] A figura 8B mostra uma depressão descendente inicial do adaptador de frasco de fármaco fêmea 30 para o frasco de fármaco 20 como indicado pela seta A. as pontas de perna 49 conferem uma força descendente no componente de saia 33. Os elementos flexíveis 54 asseguram que o componente de pico 32 seja alinhado com o componente de saia 33 no caso de desalinhamento antes que a ponta de perfuração 41 comece a perfurar a tampa de frasco de fármaco 27.
[00024] A figura 8C mostra que a depressão descendente contínua do adaptador de frasco de fármaco 30 na direção do frasco de fármaco 20 como indicado pela seta B faz o elemento de perfuração 39 perfurar a tampa de frasco de fármaco 27. O frasco de fármaco 20 impele as pontas de perna 49 radialmente para fora a partir das aberturas de ponta de perna 59. No caso de frasco de fármaco de pressão negativa 20, o ar entra no frasco de fármaco 20 por meio do lúmen de transferência de líquido 44 e o lúmen de ventilação 46.
[00025] As figuras 8D e 8E mostram a depressão descendente completa do adaptador de frasco de fármaco 30 na direção do frasco de fármaco 20 até que o primeiro 30 encaixa por pressão e perfura a tampa de frasco de fármaco 27 como indicado pela seta C. O componente de ponta 32 para contra o componente de saia 33. As pontas de perna 49 deslizam ao longo das superfícies externas lisas 61 na direção da margem de componente de saia 57. A disposição de fixação 34 é engatada para prender o adaptador de frasco de fármaco 30 e o frasco de fármaco 20.
[00026] A figura 8F mostra a seringa 10 pronta para montagem de rosca de parafuso no adaptador de frasco de fármaco fêmea 30 para injeção de seus conteúdos líquidos 29. A montagem da seringa 10, do frasco de fármaco 20 e do adaptador de frasco de fármaco fêmea 30 é agitada gentilmente para assegurar a reconstituição completa de conteúdos de pó. Em injeção dos conteúdos líquidos, o ar sai do frasco de fármaco 20 por meio do lúmen de ventilação 46 e das aberturas de ventilação 38.
[00027] A figura 8G mostra a inversão da montagem da figura 8F para aspiração dos conteúdos de fármaco líquido do frasco de fármaco 20 na seringa 10 como indicado pela seta D para propósitos de administração. A abertura de lúmen de ventilação 47 está acima do nível de líquido dos conteúdos líquidos de fármaco para se assemelhar a um snorkel de natação de modo que o filtro de ar 37 não seja molhado. O ar é aspirado para dentro do frasco de fármaco 20 por meio das aberturas de ventilação 38, do filtro de ar 37 e do lúmen de ventilação 46.
[00028] Enquanto a invenção foi descrita com respeito a um número limitado de modalidades, será apreciado que muitas variações, modificações e outras aplicações da invenção podem ser feitas dentro do escopo das reivindicações anexas.
Claims (5)
1. Adaptador de frasco de fármaco fêmea telescópico (30) para uso com um frasco de fármaco (20) incluindo uma garrafa de frasco de fármaco (21) contendo um medicamento (29), e um aro de frasco de fármaco (23) definindo uma abertura de frasco de fármaco (26) tampada por uma tampa de frasco de fármaco (27), o adaptador de frasco de fármaco (20) tendo um eixo de adaptador de frasco de fármaco longitudinal (31) e que compreende: (a) um componente de ponta (32) incluindo uma parede superior de componente de ponta (36) direcionado transversalmente tendo: i) um elemento de perfuração pendendo descendente (39) com uma ponta de perfuração (41) para perfurar a tampa de frasco de fármaco (27) e um conector fêmea ereto oposto (42) em comunicação de fluxo com o dito elemento de perfuração (39), e ii) pelo menos duas pernas de componente de ponta pendendo para baixo espaçadas (48) laterais ao dito elemento de perfuração (39); e (b) um componente de saia (33) incluindo uma parede superior de componente de saia (51) direcionada transversalmente tendo uma abertura central (52), uma saia substancialmente cilíndrica pendendo para baixo (53) de vários elementos flexíveis de frasco de fármaco (54) e uma margem de componente de saia (57) afastado da dita parede superior de componente de saia (51), os ditos vários elementos flexíveis de frasco de fármaco (54) definindo uma cavidade de aro de frasco de fármaco (56) para receber de modo justo o aro de frasco de fármaco (23) na mesma, caracterizado pelo fato de que, as duas pelo menos duas pernas de componente de ponta terminando nas pontas de perna (49) se projetado para dentro emdireção à dita ponta de perfuração (41), pelo menos dois dos ditos elementos flexíveis de frasco de fármaco tendo aberturas de ponta de perna (59) para receber inicialmente as ditas pontas de perna (49) em uma posição de preparação do adaptador de frasco de fármaco fêmea telescópico (30) para espaçar inicialmente a dita parede superior do componente de ponta (36) da dita parede superior de componente de saia (51) com o dito elemento de perfuração (39) se projetando através da dita abertura central (52), e a disposição sendo tal que ao impelir o adaptador de frasco de fármaco (30) na direção de um frasco de fármaco (20) posicionado abaixo do dito adaptador de frasco de fármaco (30) e deslocamento deslizante manual do dito componente de ponta (32) na direção do dito componente de saia (33) para parar contra o mesmo em uma posição atuada do adaptador de frasco de fármaco fêmea telescópico (30), os ditos elementos flexíveis de frasco de fármaco (54) recebem de modo justo o aro de frasco de fármaco (23) na dita cavidade de aro de frasco de fármaco (56), o dito elemento de perfuração (39) perfura a tampa de frasco de fármaco (27) e as ditas pontas de pernas (49) são impelidas radialmente para fora a partir das suas aberturas de ponta de perna correspondentes (59) para deslizar para baixo ao longo de seus elementos flexíveis de frasco de fármaco (54) correspondentes para a dita margem de componente de saia (57).
2. Adaptador, de acordo com a reivindicação 1, caracterizado pelo fato de que ainda compreende uma disposição de fixação (34) para prender o dito componente de ponta (32) no dito componente de saia (33) na dita posição atuada.
3. Adaptador, de acordo com a reivindicação 2, caracterizado pelo fato de que o dito componente de ponta (32) inclui um par de pernas de componente de ponta opostas (48) e a dita disposição de fixação (34) inclui um par de presilhas de encaixe de pressão opostas (62) ortogonais ao dito par de pernas de componente de ponta opostas (48).
4. Adaptador, de acordo com qualquer uma das reivindicações 1 a 3, caracterizado pelo fato de que o dito elemento de perfuração (39) se projeta além da dita margem de componente de saia (57) na dita posição atuada.
5. Adaptador, de acordo com qualquer uma das reivindicações 1 a 4, caracterizado pelo fato de que o dito componente de ponta (32) é ventilado, a dita parede superior de componente de ponta (36) inclui um filtro de ar circular (37) e pelo menos uma abertura de ventilação (38), e o dito elemento de perfuração (39) inclui um lúmen de transferência de líquido (44) em comunicação de fluxo com o dito conector fêmea ereto oposto (42) e um lúmen de ventilação (46) em comunicação de fluxo com o dito filtro de ar (37), e o dito lúmen de ventilação inclui uma abertura de lúmen de ventilação (47) adjacente à dita ponta de perfuração (41).
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2012
- 2012-10-17 JP JP2015531685A patent/JP5868555B2/ja active Active
- 2012-10-17 US US14/425,482 patent/US9339438B2/en active Active
- 2012-10-17 DK DK12794513.7T patent/DK2872100T3/en active
- 2012-10-17 CN CN201280075575.9A patent/CN104703573B/zh active Active
- 2012-10-17 BR BR112015005157-0A patent/BR112015005157B1/pt active IP Right Grant
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EP2872100A1 (en) | 2015-05-20 |
IL237493A0 (en) | 2015-04-30 |
IN2015DN02677A (pt) | 2015-09-04 |
WO2014041529A1 (en) | 2014-03-20 |
CN104703573A (zh) | 2015-06-10 |
CN104703573B (zh) | 2016-06-08 |
BR112015005157A2 (pt) | 2017-07-04 |
JP5868555B2 (ja) | 2016-02-24 |
EP2872100B1 (en) | 2017-03-29 |
US9339438B2 (en) | 2016-05-17 |
IL237493B (en) | 2018-08-30 |
DK2872100T3 (en) | 2017-07-10 |
JP2015528368A (ja) | 2015-09-28 |
US20150231034A1 (en) | 2015-08-20 |
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Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 17/10/2012, OBSERVADAS AS CONDICOES LEGAIS. |