BR112016001905B1 - Dispositivos de transferência de líquidos para uso com recipientes para líquidos de infusão - Google Patents
Dispositivos de transferência de líquidos para uso com recipientes para líquidos de infusão Download PDFInfo
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Abstract
dispositivos de transferência de líquidos para uso com recipientes para líquidos de infusão. a presente invenção refere-se a dispositivos de transferência de líquidos com base no pedido de patente internacional wo 2007/052252 de mesmo requerente, intitulado "needless additive control valve". o dispositivos de transferência de líquidos incluem um adaptador de frasco integral e/ou um conjunto de difusão integral, para reduzir o custo e facilitar o uso por redução de etapas para o usuário.
Description
[0001] A presente invenção refere-se a dispositivos de transferência de líquido para uso com recipientes para líquidos de infusão.
[0002] O pedido de patente internacional WIPO de mesmo requerente de n° PCT/IL2006/001228, intitulado "Needless Additive Control Valve", e publicado de acordo com a publicação internacional WIPO de n° WO 2007/052252, é tencionado para uso com recipientes para líquidos de infusão, contendo um líquido de infusão e tendo um orifício intravenoso (IV) ou de administração. Os recipientes para líquidos de infusão podem ser na forma de um saco para líquido de infusão, uma garrafa para líquido de infusão e assemelhados. As válvulas de controle de aditivos desprovidas de agulha são também tencionadas para uso com dispositivos de transferência de aditivo, incluindo um conector macho e contendo um aditivo de medicamento. Os dispositivos de transferência de aditivo adequados incluem, entre outros, seringas desprovidas de agulhas, adaptadores para frascos machos e assemelhados. As válvulas de controle de aditivos desprovidas de agulhas são também tencionadas para uso com conjuntos de infusão, com uma ponta IV e um conector para fins de administração a um paciente.
[0003] As válvulas de controle de aditivos desprovidas de agulhasincluem um corpo de conector trifurcado, incluindo uma ponta IV para inserção selante em um orifício IV de um recipiente para líquido de infusão, um orifício de aditivo desprovido de agulha normalmente fechado (NC) com um conector fêmea, e um orifício IV substituto. A ponta IV tem um único lúmen, o orifício de aditivo desprovido de agulha NC tem um único lúmen, e o orifício IV substituto tem um único lúmen. Os três lúmens ficam em uma conexão fluida contínua e direta de 3 vias. O orifício IV substituto é formado de material plástico flexível adequado, por exemplo, PVC, e assemelhados, para receber selantemente uma ponta IV de um conjunto de infusão. A ponta IV substituta inclui uma membrana, tencionada para ser perfurada por inserção da ponta IV do conjunto de infusão.
[0004] Em uma concretização da válvula de controle de aditivodesprovida de agulhas, o orifício de aditivo desprovido de agulha NC é constituído por uma válvula de acesso autosselante, com uma superfície exposta enchumaçada para permitir adições múltiplas de aditivos de medicamentos. As válvulas de acesso autosselantes adequadas são descritas, entre outras, na patente U.S. 5.676.346 de Leinsing. As adições múltiplas podem ser em uma sucessão relativamente rápida, para introduzir uma maior quantidade de aditivo do que o disponível em uma única adição. Alternativamente, múltiplas adições podem ser durante o transcorrer de várias horas, dependendo da condição médica de um paciente. Em outra concretização da válvula de controle de aditivo desprovida de agulha, o orifício de aditivo desprovido de agulha NC é constituído por uma torneira operada manualmente, e assemelhados.
[0005] As Figuras 4A e 4B do pedido de patente internacional WO2007/052252 mostram o uso da válvula de controle de aditivo desprovida de agulha, com uma seringa desprovida de agulha para permitir a injeção do conteúdo da seringa em um recipiente para líquido de infusão, para formar um líquido de infusão contendo medicamento, ou a administração direta a um paciente.
[0006] As Figuras 5A e 5B do pedido de patente internacional WO2007/052252 mostram o uso da válvula de controle de aditivo desprovida de agulha, com um adaptador de frasco e um frasco, par a permitir a mistura do conteúdo do frasco com o conteúdo de líquido de infu- são, para formar um líquido para infusão com medicamento, por passagem do líquido de infusão do recipiente para líquidos de infusão no frasco, e vice-versa, uma ou mais vezes.
[0007] As válvulas de controle de aditivos desprovidas de agulhas,com uma válvula de acesso autosselante, são agora comercialmente disponíveis da West Pharmaceutical Services, Inc., 530 Heman O. West Drive, Exton, PA 19341, www.westpharma.com, com a marca registrada VIAL2BAG. As válvulas de controle de aditivos desprovidas de agulhas têm encontrado um uso disseminado para preparação ao lado de leito de recipientes para líquidos de infusão, diferentemente da prática anterior disseminada de preparado desses recipientes para líquidos de infusão em farmácias de compostos. Além do mais, as válvulas de controle de aditivos desprovidas de agulhas têm encontrado uso mais disseminado com frascos diferentemente de com seringas.
[0008] A presente invenção é dirigida a dispositivos de transferência de líquido com base nas válvulas de controle de aditivos desprovidas de agulhas do pedido de patente internacional WO 2007/052252.
[0009] De acordo com uma primeira concretização da presenteinvenção, um dispositivo de transferência de líquidos inclui um corpo de conector trifurcado com um adaptador de frasco integral, em vez de um orifício de aditivo desprovido de agulhas NC. O dispositivo de transferência de líquido promover uma diminuição considerável de custo por eliminação do orifício de aditivo desprovido de agulhas NC, mas limita, efetivamente, seu uso a uma adição única de aditivo de medicamento a um recipiente para líquidos de infusão, diferentemente das adições múltiplas permitidas anteriormente. Consequentemente, o uso de um dispositivo de transferência de líquido, com um adaptador de frasco integral, é simplificado com relação à válvula de controle de aditivo desprovida de agulhas do pedido de patente internacional WO 2007/052252.
[00010] O adaptador de frasco integral é tencionado, de preferência, para montagem por encaixe com pressão em um frasco, para impedir sua remoção subsequente, desse modo, proporcionando uma indicação visual que o seu aditivo de medicamento foi adicionado a um recipiente para líquidos de infusão. O frasco é pelo menos parcialmente e tipicamente inteiramente cheio com líquido de infusão com medicamento de um recipiente para líquidos de infusão, durante administração a um paciente, e impede vazamento inadvertido.
[00011] De acordo com uma segunda concretização da presente invenção, um dispositivo de transferência de líquido inclui um adaptador de frasco integral e um conjunto de difusão integral. O adaptador de frasco integral proporciona as vantagens mencionadas acima, e o conjunto de infusão integral elimina o custo de um orifício IV substituto e a etapa de inserção de uma ponta IV de conjunto de infusão nele para perfuração do mesmo, desse modo, simplificando o seu uso, o que é particularmente vantajoso para administração ao lado de leito de líquidos de infusão com medicamento.
[00012] De acordo com uma terceira concretização da presente invenção, um dispositivo de transferência de líquido é similar às válvulas de controle de aditivos desprovidas de agulhas do pedido de patente internacional WO 2007/052252 mencionadas, mas inclui um conjunto de infusão integral em vez de um orifício IV substituto, similar à segunda concretização da presente invenção.
[00013] Para entender a invenção e verificar como ela pode ser conduzida na prática, as concretizações preferidas vão ser descritas a seguir, apenas por meio de exemplos não limitantes, com referência aos desenhos em anexo, nos quais as partes similares são numeradas igualmente, e em que:
[00014] a Figura 1 é uma vista ilustrada de um conjunto de administração convencional, incluindo um saco para líquido de infusão, uma válvula de controle de aditivo desprovida de agulha do pedido de patente internacional WO 2007/052252, uma seringa pré-cheia, um adaptador de frasco macho, um frasco, e um conjunto de infusão;
[00015] a Figura 2A é uma vista frontal da válvula de controle de aditivo desprovida de agulha da Figura 1 com uma válvula de acesso autosselante;
[00016] a Figura 2B é uma vista frontal da válvula de acesso autos- selante;
[00017] a Figura 3A é uma seção transversal da válvula de acesso autosselante na sua condição fechada, ao longo da linha A - A na Figura 2A;
[00018] a Figura 3B é uma seção transversal da válvula de acesso autosselante na sua condição fechada, ao longo da linha A - A na Figura 2A;
[00019] a Figura 4 é uma vista ilustrada de um conjunto de administração incluindo um saco para líquido de infusão, um dispositivo de transferência de líquido de acordo com uma primeira concretização preferida da presente invenção, um frasco, e um conjunto de infusão;
[00020] a Figura 5A é uma vista pelo topo do dispositivo de transferência de líquido da Figura 4;
[00021] a Figura 5B é uma seção transversal longitudinal do dispositivo de transferência de líquido da Figura 4, ao longo da linha A - A na Figura 5A;
[00022] a Figura 6 é uma vista ilustrada de um conjunto de administração incluindo um saco para líquido de infusão, um dispositivo de transferência de líquido de acordo com uma segunda concretização preferida da presente invenção, e um frasco; e
[00023] a Figura 7 é uma vista ilustrada de um conjunto de adminis- tração incluindo um saco para líquido de infusão, um dispositivo de transferência de líquido de acordo com uma terceira concretização preferida da presente invenção, uma seringa pré-cheia, um adaptador de frasco, e um frasco.
[00024] As Figuras 1, 2A, 2B, 3A e 3B correspondem às Figuras 1, 2A, 2B, 3A e 3B do pedido de patente internacional WO 2007/052252, respectivamente.
[00025] A Figura 1 mostra um saco para líquido de infusão 10, contendo um líquido de infusão e tendo um orifício intravenoso (IV) ou de administração 11, e um orifício de aditivo 12. A Figura 1 também mostra uma válvula de controle de aditivo desprovida de agulha do pedido de patente internacional WO 2007/052252 13, e um dispositivo de transferência de aditivo 14 tendo um conector de trava Luer macho 16. O dispositivo de transferência de aditivo 14 pode ser constituído por uma seringa 17, um adaptador de frasco 18 para montagem telescópica por encaixe com pressão em um frasco 19, e assemelhados. A seringa 17 é pré-enchida com um medicamento líquido para injeção no saco para líquido de infusão 10, para administração a um paciente, ou para administração direta a um paciente. O frasco 19 inclui uma garrafa de frasco 20A selada por uma tampa de frasco 20B. O frasco 19 contém o conteúdo de frasco na forma de um aditivo de medicamento líquido ou um medicamento em pó liofilizado requerendo reconstituição antes de administração. O conteúdo do frasco é tencionado para ser introduzido no saco para líquido de infusão 10, para mistura com o líquido de infusão para formar um líquido de infusão com medicamento para administração a um paciente.
[00026] A Figura 1 mostra adicionalmente um conjunto de infusão convencional 50, com uma ponta IV 51 para inserção selada no orifício IV 11. O conjunto de infusão 50 inclui adicionalmente um primeiro tubo 52, uma pinça 53, uma câmara de gotejamento 54, uma pinça de rolamento 57, um conector Luer macho 58, e uma blindagem Luer 59. O primeiro tubo 52 tem, tipicamente, as dimensões de 4,1 mm x 200 mm, e o segundo tubo 56 tem, tipicamente, as dimensões de 4,1 mm e 500 mm.
[00027] A Figura 2a tem a válvula de controle de aditivo desprovida de agulha do pedido de patente internacional WO 2007/052252 13, que tem um corpo de conector trifurcado 21. O corpo de conector tri- furcado 21 inclui uma ponta IV 22, para inserção selante no orifício IV 11. A ponta IV 22 é formada de um material plástico rígido adequado, tal como policarbonato e assemelhados. A ponta IV 22 inclui uma extremidade pontuda 23 com aberturas dispostas perifericamente 24, um lúmen 26 e uma abertura de saída 27. A ponta IV 22 é formada integralmente como uma estrutura monolítica moldada por injeção, com um flange circular 28 para limitar a inserção no orifício IV 11, e um ori-fício de aditivo desprovido de agulha normalmente fechado (NC) 29, disposto no sentido da abertura de saída 27.
[00028] O orifício de aditivo desprovido de agulha 29 tem um lúmen 31 e é equipado com uma válvula de acesso autosselante 32, para receber por um acoplamento de rosca um conector de trava Luer macho 16. A válvula de acesso 32 tem uma superfície externa escalonada 33, incluindo uma superfície de apoio 34 e um aro 36. A válvula de acesso 32 aloja um elemento de válvula autosselante de silicone 37, com uma parte principal tubular 38 e uma parte de entrada desprovida de agulha cilíndrica 39. A parte de entrada desprovida de agulha 39 tem uma superfície de entrada exposta 41 e uma fenda pré-formada 42 estendendo-se ao longo dela (ver a Figura 2B).
[00029] O elemento de válvula 37 tem um comprimento natural L1 e é dimensionado de modo que a superfície de entrada 41 fique rente ao aro 36, desse modo, permitindo que a superfície de entrada fique facilmente enchumaçada para fins de esterilização (ver a Figura 3A). Um conector Luer macho 16, acoplado por rosca na válvula de acesso 32, avança até que entre em contato com a superfície de apoio 34. Durante o seu avanço, o conector Luer macho 16 comprime o elemento de válvula 37 a um comprimento comprimido L2 < L1, que divide a parte de entrada 39 ao longo da sua fenda pré-formada 42, para permitir comunicação fluida entre um dispositivo de transferência de aditivo e o lúmen 31 (ver a Figura 3B).
[00030] O corpo de conector trifurcado 21 inclui um orifício de administração 43, constituído por um orifício IV substituto tendo um lú- men 44 e uma membrana selante 46. O lúmen 44 fica em comunicação de escoamento contínuo com o orifício de saída 27. O orifício IV substituto 43 é um orifício IV convencional, similar ao orifício IV 11, feito de material plástico flexível, por exemplo, PVC, e assemelhados, para receber selantemente uma ponta IV de diâmetro de cerca de 5 a 6 mm. O orifício IV substituto 43 é tencionado para receber selantemente a ponta IV 51.
[00031] A Figura 4 mostra um conjunto de administração 100, incluindo um saco para líquido de infusão 10, um dispositivo de transferência de líquido 101, um frasco 19 e um conjunto de infusão 50. O dispositivo de transferência de líquido 101 é de construção similar à válvula de controle de aditivo desprovida de agulha 13 e inclui, consequentemente, uma ponta IV 22, um orifício de aditivo desprovido de agulha 29 e um orifício de administração 43. O dispositivo de transferência de líquido 101 difere da válvula de controle de aditivo desprovida de agulha 13, pois o orifício de aditivo desprovido de agulha 29 é constituído por um adaptador de frasco integral 102. Esse dispositivo 101 também inclui uma blindagem 103 para proteger a ponta IV 22.
[00032] As Figuras 5A e 5B mostram o adaptador de frasco integral 102, que tem um projeto convencional incluindo uma saia 104 para montagem por encaixe com pressão em um frasco 19, e um elemento de perfuração 106, para perfurar sua tampa de frasco 20B para comunicação fluida com uma parte interna do frasco por encaixe com pressão do adaptador de frasco integral 102 em um frasco 19. O elemento de perfuração 106 fica em comunicação fluida contínua e direta com a ponta IV 22 e o orifício IV substituto 43.
[00033] O uso do kit de administração 100 é apresentado a seguir. A ponta IV 22 é inserida selantemente no orifício IV 11, e o adaptador de frasco 102 é encaixado com pressão em um frasco 19, para adicionar seu aditivo de medicamento ao saco para líquido de infusão 10. Essa adição é tipicamente obtida por aperto do saco para líquido de infusão 10, para impelir o líquido de infusão no frasco 19 e depois inverter o saco para líquido de infusão 10, de modo que o conteúdo do frasco seja drenado. No caso no qual o frasco 19 inclui um aditivo de medicamento liofilizado, o líquido de infusão dissolve o mesmo. Essa dissolução pode requerer vários ciclos de impelir o líquido de infusão no frasco 19 e drenar o conteúdo do frasco no saco de infusão 10. De-pois, a ponta IV 51 é inserida selantemente no orifício IV substituto do dispositivo de transferência de líquido 43, para fins de administração a um paciente.
[00034] A Figura 6 mostra um conjunto de administração 110, incluindo um saco para líquido de infusão 10, um dispositivo de transferência de líquido 111 e um frasco 19. O dispositivo de transferência de líquido 111 é de construção similar ao dispositivo de transferência de líquido 101, e, consequentemente, inclui uma ponta IV 22, um orifício de aditivo desprovido de agulha 29 e um orifício de administração 43. O dispositivo de transferência de líquido 111 difere do dispositivo de transferência de líquido 101, uma vez que o dispositivo 111 inclui um orifício de administração 43, constituído por um conjunto de infusão integral 122 em vez de um orifício IV substituto. O conjunto de infusão integral 112 é similar ao conjunto de infusão 50, exceto que o primeiro tubo 52 é conectado diretamente ao corpo do conector 21.
[00035] O uso do dispositivo de transferência de líquido 111 é similar ao uso do dispositivo de transferência 110 em termos de adição de aditivo de medicamento ao saco para líquido de infusão 10.
[00036] A Figura 7 mostra um conjunto de administração 120 incluindo um saco para líquido de infusão 10, um dispositivo de transferência de aditivo 14 e um dispositivo de transferência de líquido 121. O dispositivo de transferência de líquido 121 é de construção similar à válvula de controle de aditivo desprovida de agulha 13 e inclui, consequentemente, uma ponta IV 22, um orifício de aditivo desprovido de agulha 29 e um orifício de administração 43. O dispositivo de transferência de líquido 121 difere da válvula de controle de aditivo desprovida de agulha 13, pois o dispositivo 121 inclui um orifício de administração 43, constituído por um conjunto de difusão integral 122, em vez de um orifício IV substituto. O uso do dispositivo de transferência de líquido 121 é similar ao dispositivo de controle de aditivo desprovido de agulha do pedido de patente internacional WO 2007/0522252 13, exceto que o seu conjunto de infusão 122 pode ser conectado diretamente a um paciente.
[00037] Ainda que a invenção tenha sido descrita com relação a um número limitado de concretizações, vai-se considerar que muitas variações, modificações e outras aplicações da invenção podem ser feitas dentro do âmbito das reivindicações em anexo.
Claims (2)
1. Dispositivo de transferência de líquido (101, 111, 121), caracterizado pelo fato de que é para uso com um recipiente para líquido de infusão, contendo um líquido de infusão e tendo um orifício intravenoso (IV) para administrar o líquido de infusão, um frasco (19) incluindo uma garrafa de frasco (20A) selada por uma tampa de frasco (20B) e contendo um aditivo de medicamento, e um conjunto de infusão (50) incluindo uma ponta IV para inserção selante em um orifício IV e um conector para fins de administração a um paciente, o dispositivo de transferência de líquido (101, 111, 121) compreendendo um corpo de conector trifurcado (21) tendo:i) uma ponta IV para inserção selante no orifício IV de recipiente para líquido de infusão;ii) um orifício de aditivo desprovido de agulha (29) constituído por um adaptador de frasco (18) integral para montagem telescópica no frasco (19), o dito adaptador de frasco (18) integral incluindo uma cânula de perfuração, para perfurar a tampa de frasco (20B) na dita montagem do dito adaptador de frasco (18) no frasco (19), para comunicação fluida com ele; eiii) um orifício de administração (43) constituído por um orifício IV substituto para recebimento de forma selante da ponta IV do conjunto de infusão (50),a dita ponta IV, o dito adaptador de frasco (18) integral e o dito orifício de administração (43) estando em comunicação fluida contínua e direta em 3 vias, desse modo, permitindo introdução inicial do aditivo de medicamento do frasco (19) no recipiente para líquido de infusão através do adaptador de frasco (18) e a ponta IV, para mistura com o líquido de infusão para formar um líquido de infusão com medicamento, e administração subsequente do líquido de infusão com medicamento a um paciente a partir do recipiente para líquido de infusão através da ponta IV e do orifício de administração (43) até o conjunto de infusão (50).
2. Dispositivo de transferência de líquido (101, 111, 121), caracterizado pelo fato de que é para uso com um recipiente para líquido de infusão, contendo um líquido de infusão e tendo um orifício intravenoso (IV) para administrar o líquido de infusão, e um frasco (19) incluindo uma garrafa de frasco (20A) selada por uma tampa de frasco (20B) e contendo um aditivo de medicamento, o dispositivo de transferência de líquido (101, 111, 121) compreendendo um corpo de conector trifurcado (21) tendo:i) uma ponta IV para inserção selante no orifício IV de recipiente para líquido de infusão;ii) um orifício de aditivo desprovido de agulha (29) constituído por um adaptador de frasco (18) integral para montagem telescópica no frasco (19), o dito adaptador de frasco (18) integral incluindo uma cânula de perfuração, para perfurar a tampa de frasco (20B) na dita montagem do dito adaptador de frasco (18) no frasco (19), para comunicação fluida com ele; eiii) um orifício de administração (43) constituído por um conjunto de infusão (50) integral, com um conector para fins de administração a um paciente,a dita ponta IV, o dito adaptador de frasco (18) integral e o dito orifício de administração (43) estando em comunicação fluida contínua e direta em 3 vias, desse modo, permitindo introdução inicial do aditivo de medicamento do frasco (19) no recipiente para líquido de infusão através do adaptador de frasco (18) e a ponta IV para mistura com o líquido de infusão para formar um líquido de infusão com medicamento, e administração subsequente do líquido de infusão com medicamento a um paciente a partir do recipiente para líquido de infusão através da ponta IV e do orifício de administração (43) até o conjunto de infusão (50).
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GB2578705B (en) | 2020-11-11 |
BR112016001905A2 (pt) | 2017-08-01 |
GB201602766D0 (en) | 2016-03-30 |
IL243896B (en) | 2020-07-30 |
FR3009495A3 (fr) | 2015-02-13 |
GB2533714B (en) | 2020-04-08 |
IL243896A0 (en) | 2016-04-21 |
FR3009495B3 (fr) | 2015-10-02 |
DK201600035U1 (da) | 2016-03-11 |
CN205626622U (zh) | 2016-10-12 |
KR200486088Y1 (ko) | 2018-04-02 |
GB2578705A (en) | 2020-05-20 |
WO2015019343A1 (en) | 2015-02-12 |
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