PT2263721E - Dispositivo de injecção do tipo caneta com manga de marcação de dose - Google Patents

Dispositivo de injecção do tipo caneta com manga de marcação de dose Download PDF

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Publication number
PT2263721E
PT2263721E PT101840858T PT10184085T PT2263721E PT 2263721 E PT2263721 E PT 2263721E PT 101840858 T PT101840858 T PT 101840858T PT 10184085 T PT10184085 T PT 10184085T PT 2263721 E PT2263721 E PT 2263721E
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PT
Portugal
Prior art keywords
sleeve
dose
dose dial
pen
drive sleeve
Prior art date
Application number
PT101840858T
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English (en)
Inventor
David Aubrey Plumptre
Robert Perkins
Robert Frederick Veasey
Original Assignee
Sanofi Aventis Deutschland
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=9954010&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=PT2263721(E) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Sanofi Aventis Deutschland filed Critical Sanofi Aventis Deutschland
Publication of PT2263721E publication Critical patent/PT2263721E/pt

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    • 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
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • 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
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • 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
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    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31525—Dosing
    • A61M5/31528—Dosing by means of rotational movements, e.g. screw-thread mechanisms
    • 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
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    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • 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
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    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31535—Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31535—Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose
    • A61M5/31536—Blocking means to immobilize a selected dose, e.g. to administer equal doses
    • A—HUMAN NECESSITIES
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    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31535—Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose
    • A61M5/31541—Means preventing setting of a dose beyond the amount remaining in the cartridge
    • A—HUMAN NECESSITIES
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    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
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    • A61M5/31546—Electrically operated dose setting, e.g. input via touch screen or plus/minus buttons
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    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31545—Setting modes for dosing
    • A61M5/31548—Mechanically operated dose setting member
    • A61M5/3155—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe
    • A61M5/31551—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe including axial movement of dose setting member
    • 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
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    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31545—Setting modes for dosing
    • A61M5/31548—Mechanically operated dose setting member
    • A61M5/31563—Mechanically operated dose setting member interacting with a displaceable stop member
    • 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
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    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31566—Means improving security or handling thereof
    • A61M5/31568—Means keeping track of the total dose administered, e.g. since the cartridge was inserted
    • 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
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    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31566—Means improving security or handling thereof
    • A61M5/3157—Means providing feedback signals when administration is completed
    • 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
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    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31576—Constructional features or modes of drive mechanisms for piston rods
    • A61M5/31583—Constructional features or modes of drive mechanisms for piston rods based on rotational translation, i.e. movement of piston rod is caused by relative rotation between the user activated actuator and the piston rod
    • A61M5/31585—Constructional features or modes of drive mechanisms for piston rods based on rotational translation, i.e. movement of piston rod is caused by relative rotation between the user activated actuator and the piston rod performed by axially moving actuator, e.g. an injection button
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
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    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/3159—Dose expelling manners
    • A61M5/31593—Multi-dose, i.e. individually set dose repeatedly administered from the same medicament reservoir
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    • A61M2005/3125—Details specific display means, e.g. to indicate dose setting
    • A61M2005/3126—Specific display means related to dosing
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    • A61M2205/00—General characteristics of the apparatus
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    • A61M2205/581—Means for facilitating use, e.g. by people with impaired vision by audible feedback
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    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/582—Means for facilitating use, e.g. by people with impaired vision by tactile feedback
    • A—HUMAN NECESSITIES
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    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31545—Setting modes for dosing
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    • A61M5/3156—Mechanically operated dose setting member using volume steps only adjustable in discrete intervals, i.e. individually distinct intervals
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    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
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    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31566—Means improving security or handling thereof
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    • A61M5/178—Syringes
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    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31576—Constructional features or modes of drive mechanisms for piston rods
    • A61M5/31578—Constructional features or modes of drive mechanisms for piston rods based on axial translation, i.e. components directly operatively associated and axially moved with plunger rod

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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Coating Apparatus (AREA)
  • Transmission Devices (AREA)

Description

DESCRIÇÃO
"DISPOSITIVO DE INJECÇÃO DO TIPO CANETA COM MANGA DE MARCAÇÃO DE DOSE" A presente invenção refere-se a dispositivos de injecção do tipo caneta, isto é, a dispositivos de injecção do tipo que proporcionam a administração por injecção de medicamentos a partir de um cartucho multidose. Em particular, a presente invenção refere-se aos dispositivos de injecção em que um utilizador pode estabelecer a dose.
Estes dispositivos de injecção têm aplicação em pessoas sem treino médico formal que precisam de injecções regulares. Isto é cada vez mais comum entre os que sofrem de diabetes em que o auto-tratamento possibilita que essas pessoas conduzam uma gestão eficaz da sua diabetes.
Estas circunstâncias estabelecem vários requisitos para os dispositivos de injecção do tipo caneta deste tipo. 0 dispositivo de injecção deve ser de construção robusta, embora fácil de utilizar em termos de manipulação das peças e da compreensão do seu funcionamento por um utilizador. No caso de pessoas com diabetes, muitos utilizadores estarão fisicamente debilitados e a sua visão também pode ser deficiente. Quando o dispositivo de injecção for descartável em vez de reutilizável, o dispositivo de injecção deve ser de fabrico barato e fácil de eliminar (sendo, de um modo preferido, adequado para reciclagem). 1 0 documento ΕΡ 0937471 Α2 refere-se a uma caneta de distribuição de medicamento compreendendo um conjunto caneta-agulha, um dispositivo de retenção de ampola incluindo uma ampola contendo um medicamento a distribuir e possuindo a caneta-agulha fixa de um modo desmontável a uma extremidade distai. A caneta compreende ainda um corpo possuindo o dispositivo de retenção de ampola montado numa extremidade distai e incluindo um mecanismo de controlo de dose para definir uma dose desejada a distribuir a partir da ampola, um mecanismo de accionamento para distribuir a dose desejada a partir da ampola e um tubo cilíndrico para a interacção do mecanismo de controlo de dose com o mecanismo de accionamento. É uma vantagem da presente invenção proporcionar um dispositivo de injecção do tipo caneta melhorado. Isto é alcançado por um dispositivo de injecção com as caracteristicas da reivindicação 1.
De acordo com um primeiro aspecto da presente invenção, um dispositivo de injecção do tipo caneta compreende um corpo; uma haste de êmbolo adaptada para actuar através do corpo; uma manga de marcação de dose posicionada entre o corpo e a haste de êmbolo, possuindo a manga de marcação de dose uma rosca helicoidal com um primeiro passo; uma manga de accionamento posicionada entre a manga de marcação de dose e a haste de êmbolo, possuindo a manga de accionamento uma ranhura helicoidal com um segundo passo; 2 em que o primeiro passo da rosca helicoidal e o segundo passo da ranhura helicoidal são iguais; e em que a haste de êmbolo é rotativa em relação ao corpo.
De um modo preferido, a haste de êmbolo possui uma primeira parte roscada numa primeira extremidade e uma segunda parte roscada numa segunda extremidade; uma inserção ou flange estendendo-se radialmente para dentro está posicionada no corpo e através da qual a primeira parte roscada da haste de êmbolo pode rodar; sendo a manga de marcação de dose rotativa em relação ao corpo e à inserção; estando a manga de accionamento ligada de modo desmontável à manga de marcação de dose e ligada à haste de êmbolo para rotação em relação a esta ao longo da segunda parte roscada da haste de êmbolo; um botão está posicionado na manga de marcação de dose e é rotativo em relação à manga de marcação de dose; e são proporcionados meios de embraiagem que, após pressão do botão, permitem a rotação entre a manga de marcação de dose e a manga de accionamento.
De um modo preferido, o dispositivo de injecção compreende ainda uma porca que é rotativa em relação à manga de accionamento e passível de ser deslocada axialmente, mas sem poder rodar, em relação ao corpo. 3
De um modo mais preferido, a manga de accionamento está dotada, numa primeira extremidade , com primeira e segunda flanges com uma rosca intermédia entre a primeira e segunda flanges, estando a porca disposta entre a primeira e segunda flanges e fixa ao corpo por um meio estriado. Além disso, pode ser proporcionado um primeiro batente radial numa segunda face da porca e pode ser proporcionado um segundo batente radial numa primeira face da segunda flange.
De um modo preferido, a primeira rosca da haste de êmbolo está disposta em oposição à segunda rosca da haste de êmbolo.
De um modo preferido, uma segunda extremidade da embraiagem está dotada com uma pluralidade de dentes de engate adaptados para se engatarem numa segunda extremidade da manga de marcação de dose.
De um modo preferido, o dispositivo de injecção do tipo caneta inclui ainda um meio de aviso disposto entre o meio de embraiagem e o meio estriado proporcionado no corpo.
De um modo mais preferido, o meio de aviso compreende uma manga dotada, numa primeira extremidade, com um braço estendendo-se de um modo helicoidal, uma extremidade livre do braço possuindo um elemento dentado e, numa segunda extremidade, com uma pluralidade de dentes de serra direccionados de modo circunferencial adaptados para se engatarem numa correspondente pluralidade de dentes de serra circunferenciais proporcionados no meio de embraiagem. 4
Em alternativa, o meio de aviso compreende uma manga dotada, numa primeira extremidade, com, pelo menos, um braço estendendo-se de um modo helicoidal e, pelo menos, um elemento de mola, uma extremidade livre do braço possuindo um elemento dentado e, numa segunda extremidade, com uma pluralidade de dentes de serra direccionados de modo circunferencial adaptados para se engatarem numa correspondente pluralidade de dentes de serra direccionados de modo circunferencial proporcionados no meio de embraiagem.
De um modo preferido, o corpo principal está dotado com uma pluralidade de batentes de dose máxima adaptados para serem contactados por um batente radial proporcionado na manga de marcação de dose. De um modo mais preferido, pelo menos, um dos batentes de dose máxima compreende um batente radial posicionado entre uma estria helicoidal e o meio estriado proporcionado numa segunda extremidade do corpo. Em alternativa, pelo menos, um dos batentes de dose máxima compreende uma parte de uma parte de janela elevada proporcionada numa segunda extremidade do corpo.
De um modo preferido, a manga de marcação de dose está dotada com uma pluralidade de elementos estendendo-se radialmente adaptados para contactarem uma correspondente pluralidade de batentes radiais proporcionados numa segunda extremidade do corpo. A invenção será agora descrita fazendo referência aos desenhos anexos, nos quais: - A Figura 1 mostra uma vista em corte de um dispositivo de injecção do tipo caneta, de acordo com a presente invenção, numa primeira posição com cartucho cheio; 5 A Figura 2 mostra uma vista em corte do dispositivo de injecção do tipo caneta da Figura 1 numa segunda posição de primeira dose máxima marcada; A Figura 3 mostra uma vista em corte do dispositivo de injecção do tipo caneta da Figura 1 numa terceira posição de primeira dose máxima distribuída; A Figura 4 mostra uma vista em corte do dispositivo de injecção do tipo caneta da Figura 1 numa quarta posição de dose final marcada; A Figura 5 mostra uma vista em corte do dispositivo de injecção do tipo caneta da Figura 1 numa quinta posição de dose final distribuída; A Figura 6 mostra uma vista cortada de um primeiro pormenor do dispositivo de injecção do tipo caneta da Figura 1; A Figura 7 mostra uma vista parcialmente cortada de um segundo pormenor do dispositivo de injecção do tipo caneta da Figura 1; A Figura 8 mostra uma vista parcialmente cortada de um terceiro pormenor do dispositivo de injecção do tipo caneta da Figura 1; A Figura 9 mostra o movimento relativo de partes do dispositivo de injecção do tipo caneta mostrado na Figura 1 durante a marcação de aumento de dose; 6 A Figura 10 mostra o movimento relativo de partes do dispositivo de injecção do tipo caneta mostrado na Figura 1 durante a marcação de diminuição de dose; A Figura 11 mostra o movimento relativo de partes do dispositivo de injecção do tipo caneta mostrado na Figura 1 durante a distribuição de uma dose; A Figura 12 mostra uma vista parcialmente cortada do dispositivo de injecção do tipo caneta da Figura 1 na segunda posição de primeira dose máxima marcada; A Figura 13 mostra uma vista parcialmente cortada do dispositivo de injecção do tipo caneta da Figura 1 na guarta posição de dose final marcada; A Figura 14 mostra uma vista parcialmente cortada do dispositivo de injecção do tipo caneta da Figura 1 numa das, primeira, terceira ou quinta posições; A Figura 15 mostra uma vista cortada de uma primeira parte de um corpo principal do dispositivo de injecção do tipo caneta da Figura 1; e A Figura 16 mostra uma vista cortada de uma segunda parte do corpo principal do dispositivo de injecção do tipo caneta da Figura 1.
Fazendo primeiro referência às Figuras 1 a 5, pode ver-se um dispositivo de injecção do tipo caneta de acordo com a presente invenção em várias posições. 7 0 dispositivo de injecção do tipo caneta compreende um corpo possuindo uma primeira parte 2 de retenção de cartucho e uma segunda parte 4 de corpo principal. Uma primeira extremidade do meio 2 de retenção de cartucho e uma segunda extremidade do corpo 4 principal estão fixas uma à outra por caracteristicas 6 de retenção. Na forma de realização ilustrada, o meio 2 de retenção de cartucho está fixo dentro da segunda extremidade do corpo 4 principal.
Proporciona-se um cartucho 8, a partir do qual podem ser distribuídas várias doses de medicamento, na parte 2 de retenção de cartucho. Um êmbolo 10 está retido numa primeira extremidade do cartucho 8 .
Uma tampa 12 desmontável está retida de um modo separável sobre uma segunda extremidade da parte 2 de retenção de cartucho. Em utilização, a tampa 12 desmontável pode ser substituída, por um utilizador, por uma unidade de agulha adequada (não mostrada). Utiliza-se uma tampa 14 substituível para cobrir a parte 2 de retenção de cartucho que se estende a partir do corpo 4 principal. De um modo preferido, as dimensões exteriores da tampa 14 substituível são semelhantes ou idênticas às dimensões exteriores do corpo 4 principal para proporcionar a impressão de um todo unitário quando a tampa 14 substituível está na posição de cobertura da parte 2 de retenção de cartucho.
Na forma de realização ilustrada, proporciona-se uma inserção 16 numa primeira extremidade do corpo 4 principal. A inserção 16 está fixa, impedida de movimento rotacional ou longitudinal. A inserção 16 está dotada com uma abertura 18 circular roscada estendendo-se através dela. Em alternativa, a inserção pode ser formada de um modo integrante com o corpo 4 principal com a forma de uma flange dirigida radialmente para dentro possuindo uma rosca interna.
Uma primeira rosca 19 estende-se a partir de uma primeira extremidade de uma haste 20 de êmbolo. A haste 20 de êmbolo possui uma secção geralmente circular. A primeira extremidade da haste 20 de êmbolo estende-se através da abertura 18 roscada na inserção 16. Uma base 22 de pressão está posicionada na primeira extremidade da haste 20 de êmbolo. A base 22 de pressão está disposta para contactar uma segunda extremidade do êmbolo 10 de cartucho. Uma segunda rosca 24 estende-se a partir de uma segunda extremidade da haste 20 de êmbolo. Na forma de realização ilustrada, a segunda rosca 24 compreende uma série de roscas parciais em vez de uma rosca completa. A forma de realização ilustrada é mais fácil de fabricar e ajuda a reduzir a força total necessária a um utilizador para obrigar o medicamento a ser distribuído. A primeira rosca 19 e a segunda rosca 24 estão dispostas em oposição. A segunda extremidade da haste 20 de êmbolo está dotada com uma reentrância de recepção.
Uma manga 30 de accionamento estende-se em torno da haste 2 0 de êmbolo. A manga 30 de accionamento é geralmente cilíndrica. A manga 30 de accionamento está dotada, numa primeira extremidade, com uma primeira flange 32 estendendo-se radialmente. Uma segunda flange 34 estendendo-se radialmente é proporcionada espaçada de uma distância ao longo da manga 30 de accionamento a partir da primeira flange 32. Proporciona-se uma rosca 36 intermédia numa parte exterior da manga 30 de accionamento estendendo-se entre a primeira flange 32 e a segunda flange 34. Uma ranhura 38 helicoidal estende-se ao longo 9 da superfície interna da manga 30 de accionamento. A segunda rosca 24 da haste 20 de êmbolo está adaptada para trabalhar dentro da ranhura 38 helicoidal.
Uma primeira extremidade da primeira flange 32 está adaptada para se ajustar a um segundo lado da inserção 16.
Uma porca 40 está posicionada entre a manga 30 de accionamento e o corpo 2 principal, disposta entre a primeira flange 32 e a segunda flange 34. Na forma de realização ilustrada, a porca 40 é uma meia-porca. Isto auxilia a montagem do dispositivo de injecção. A porca 40 possui uma rosca interna que se ajusta à rosca 36 intermédia. A superfície exterior da porca 40 e uma superfície interna do corpo 4 principal estão fixas uma à outra por estrias 42 (ver Figuras 10, 11, 15 e 16) para impedir a rotação relativa entre a porca 40 e o corpo 4 principal, embora permitindo movimento longitudinal relativo entre eles.
Forma-se um rebordo 37 entre uma segunda extremidade da manga 30 de accionamento e uma extensão 38 proporcionada na segunda extremidade da manga 30 de accionamento. A extensão 38 possui diâmetros reduzidos, interior e exterior, em comparação com o resto da manga 30 de accionamento. Uma segunda extremidade da extensão 38 está dotada com uma flange 39 dirigida radialmente para fora.
Um dispositivo 50 de aviso e uma embraiagem 60 estão dispostos em torno da manga 30 de accionamento, entre a manga 30 de accionamento e uma manga 70 de marcação de dose (a descrever abaixo) . 10 0 dispositivo 50 de aviso está posicionado adjacente à segunda flange 34 da manga 30 de accionamento. O dispositivo 50 de aviso é geralmente cilíndrico e está dotado, numa primeira extremidade, com um braço 52 flexível estendendo-se de um modo helicoidal (mostrado muito distintamente na Figura 6). Uma extremidade livre do braço 52 está dotada com um elemento 54 dentado dirigido radialmente. Uma segunda extremidade do dispositivo 50 de aviso está dotada com uma série de dentes 56 de serra direccionados de modo circunferencial (cf Figura 7). Cada dente de serra compreende uma superfície dirigida longitudinalmente e uma superfície inclinada.
Numa forma de realização alternativa (não mostrada) o meio de aviso inclui ainda, pelo menos, um elemento de mola. O, pelo menos um, elemento de mola ajuda na reposição do meio 60 de embraiagem a seguir à distribuição. O meio 60 de embraiagem está posicionado adjacente à segunda extremidade da manga 30 de accionamento. O meio 60 de embraiagem é geralmente cilíndrico e está dotado, numa primeira extremidade, com uma série de dentes 66 de serra direccionados de modo circunf erencial (ver a Figura 7). Cada dente de serra compreende uma superfície dirigida longitudinalmente e uma superfície inclinada. Em direcção à segunda extremidade 64 do meio 60 de embraiagem está posicionada uma flange 62 dirigida radialmente para dentro. A flange 62 do meio 60 de embraiagem está disposta entre o rebordo 37 da manga 30 de accionamento e a flange 39 dirigida radialmente para fora, da extensão 38. A segunda extremidade do meio 60 de embraiagem está dotada com uma pluralidade de dentes 65 de engate (Figura 8) . A embraiagem 60 está fixa à manga 30 de accionamento por meio de estrias (não 11 mostradas) para impedir a rotação relativa entre a embraiagem 60 e a manga 30 de accionamento.
Na forma de realização ilustrada, o dispositivo 50 de aviso e a embraiagem 60 estendem-se, cada um deles, aproximadamente metade do comprimento da manga 30 de accionamento. Contudo, será compreendido que são possíveis outras disposições referentes aos comprimentos relativos destas peças. O dispositivo 50 de aviso e o meio 60 de embraiagem estão normalmente engatados, isto é, como mostrado na figura 7. A manga 70 de marcação de dose é proporcionada no exterior do dispositivo 50 de aviso e do meio 60 de embraiagem e do corpo 4 principal radialmente para dentro. Proporciona-se uma ranhura 74 helicoidal em torno de uma superfície exterior da manga 70 de marcação de dose. 0 corpo 4 principal está dotado com uma janela 44 através da qual se pode ver uma parte da superfície exterior da manga de marcação de dose. 0 corpo 4 principal está ainda dotado com uma estria 46 helicoidal, adaptada para ser encaixada na ranhura 74 helicoidal, na superfície exterior da manga 70 de marcação de dose. A estria 46 helicoidal estende-se num único varrimento da superfície interior do corpo 4 principal. Proporciona-se um primeiro batente 100 entre as estrias 42 e a estria 46 helicoidal (Figura 15). Um segundo batente 102, disposto com um ângulo de 180° relativamente ao primeiro batente 100 é formado por uma estrutura circundante da janela 44 no corpo 4 principal (Figura 16). 12
De um modo conveniente, uma indicação visual da dose que pode ser marcada, por exemplo, números de referência (não mostrados), é proporcionada na superfície exterior da manga 70 de marcação de dose. De um modo conveniente, a janela 44 apenas permite a visualização de uma indicação visual da dose marcada no momento.
Uma segunda extremidade da manga 70 de marcação de dose está dotada com uma flange dirigida para dentro com a forma de vários elementos 75 estendendo-se radialmente. Um marcador 76 de dose está disposto em torno de uma superfície exterior da segunda extremidade da manga 70 de marcação de dose. Um diâmetro exterior do marcador 76 de dose corresponde, de um modo preferido, ao diâmetro exterior do corpo 4 principal. O marcador 76 de dose está fixo à manga 70 de marcação de dose de modo a impedir movimento relativo entre eles. O marcador 76 de dose está dotado com uma abertura 78 central. Uma reentrância 80 anular posicionada na segunda extremidade do marcador 76 de dose estende-se em torno da abertura 78.
Um botão 82 de secção geralmente em "1" é proporcionado numa segunda extremidade do dispositivo de injecção do tipo caneta. Uma haste 84 do botão 82 pode estender-se através da abertura 78 no marcador 76 de dose, através do diâmetro interior da extensão 38 da manga 30 de accionamento e para dentro da reentrância 26 de recepção da haste 20 de êmbolo. A haste 84 está retida para movimento axial limitado na manga 30 de accionamento e impedida de rotação em relação a ela. Uma cabeça 85 do botão 82 é geralmente circular. Uma saia 86 depende de uma periferia da cabeça 85. A saia 86 está adaptada para ser encaixada na reentrância 80 anular do marcador 76 de dose. 13
De seguida descrever-se-á o funcionamento do dispositivo de injecção do tipo caneta de acordo com a presente invenção. Nas Figuras 9, 10 e 11, as setas A, B, C, D, E, F e G representam os respectivos movimentos do botão 82, do marcador 76 de dose, da manga 70 de marcação de dose, da manga 30 de accionamento, do meio 60 de embraiagem, do dispositivo 50 de aviso e da porca 40.
Para marcar uma dose (Figura 9), um utilizador roda o marcador 76 de dose (seta A) . Com o dispositivo 50 de aviso e o meio 60 de embraiagem engatados, a manga 30 de accionamento, o dispositivo 50 de aviso, o meio 60 de embraiagem e a manga 70 de marcação de dose rodam com o marcador 76 de dose. O dispositivo 50 de aviso e o meio 60 de embraiagem proporcionam uma informação de retorno audível e táctil da dose a ser marcada. É transmitido um momento através dos dentes 56, 66 de serra entre o dispositivo 50 de aviso e o meio 60 de embraiagem. 0 braço 52 flexível deforma-se e arrasta o elemento 54 dentado sobre as estrias 42 para produzir um estalido. De um modo preferido, as estrias 42 estão dispostas de tal modo que cada estalido corresponde a uma dose unitária. A ranhura 74 helicoidal na manga 70 de marcação de dose e a ranhura 38 helicoidal na manga 30 de accionamento possuem o mesmo passo. Isto permite que a manga 70 de marcação de dose (seta C) se estenda a partir do corpo 4 principal e da manga 30 de accionamento (seta D) para subir a haste 20 de êmbolo à mesma velocidade. No limite do percurso, um batente 104 radial na manga 70 de marcação de dose engata-se no primeiro batente 100 ou no segundo batente 102 proporcionados no corpo 4 principal para impedirem mais movimento. A rotação da haste 20 de êmbolo é 14 impedida devido às direcções opostas das roscas colocadas e conduzidas na haste 20 de êmbolo. A porca 40, fixa ao corpo 4 principal, é avançada ao longo da rosca 36 intermédia pela rotação da manga 30 de accionamento (seta D) . Quando se atinge a posição de dose final distribuída (Figuras 4, 5 e 13), um batente 106 radial, formado numa segunda superfície da porca 40, contacta um batente 108 radial numa primeira superfície da segunda flange 34 da manga 30 de accionamento, impedindo a porca 40 e a manga 30 de accionamento de continuarem a rodar.
Numa forma de realização alternativa (não mostrada), uma primeira superfície da porca 40 é dotada com um batente radial para contacto com um batente radial proporcionado numa segunda superfície da primeira flange 32. Isto ajuda a situar a porca 40 na posição de cartucho cheio durante a montagem do dispositivo de injecção do tipo caneta.
Se um utilizador marcar inadvertidamente uma quantidade maior do que a dosagem desejada, o dispositivo de injecção do tipo caneta permite que a dosagem seja corrigida sem a distribuição do medicamento do cartucho (Figura 10). O marcador 76 de dose é rodado ao contrário. Isto obriga o sistema a actuar de modo inverso. O braço 52 flexível actua agora como um roquete impedindo o dispositivo de aviso de rodar. O momento transmitido através do meio 60 de embraiagem obriga os dentes 56, 66 de serra a deslocarem-se uns sobre os outros para criarem os estalidos correspondentes à redução da dose marcada. De um modo preferido, os dentes 56, 66 de serra estão dispostos de modo que a extensão circunferencial de cada dente de serra corresponde a uma dose unitária. 15
Quando marcou a dose desejada, o utilizador pode, depois, distribuir esta dose premindo o botão 82 (Figura 11). Isto desloca o meio 60 de embraiagem axialmente em relação à manga 70 de marcação de dose obrigando os dentes 65 de engate a desengatarem-se. Contudo o meio 60 de embraiagem permanece fixo, em rotação, à manga 30 de accionamento. A manga 70 de marcação de dose e o marcador 76 de dose associado estão agora livres para rodar, (orientados pela estria 46 helicoidal posicionada na ranhura 74 helicoidal). O movimento axial deforma o braço 52 flexível do dispositivo 50 de aviso para assegurar que os dentes 56, 66 de serra não possam ser passados durante a distribuição. Isto impede a manga 30 de accionamento de rodar em relação ao corpo 4 principal embora seja ainda livre para se deslocar axialmente em relação a ele. Esta deformação é, subsequentemente, utilizada para impelir o dispositivo 50 de aviso e a embraiagem 60, de novo ao longo da manga 30 de accionamento para restabelecer a ligação entre a embraiagem 60 e a manga 70 de marcação de dose quando se remove a pressão do botão 82. O movimento axial longitudinal da manga 30 de accionamento obriga a haste 20 de êmbolo a rodar através da abertura 18 na inserção 16, para, desse modo, avançar o êmbolo 10 no cartucho 8. Uma vez que a dose marcada tenha sido distribuída, a manga 70 de marcação de dose fica impedida de mais rotação pelo contacto de uma pluralidade de elementos 110 (Figura 14), que se estendem a partir do marcador 76 de dose, com uma correspondente pluralidade de batentes 112 formados no corpo 4 principal (Figuras 15 e 16). Na forma de realização ilustrada, os elementos 110 estendem-se axialmente a partir do marcador 76 de 16
dose e possuem uma superfície de extremidade inclinada. A dos um posição de dose zero é determinada pelo contacto de um bordos estendendo-se axialmente, dos elementos 110, com correspondente batente 112.
Lisboa, 7 de Junho de 2013 17

Claims (3)

  1. REIVINDICAÇÕES 1. Dispositivo de injecção do tipo caneta compreendendo um corpo ( 4) ; uma haste (20) de êmbolo adaptada para actuar através do corpo; uma manga (70) de marcação de dose posicionada entre o corpo e a haste de êmbolo, a manga de marcação de dose possuindo uma rosca (74) helicoidal com um primeiro passo; uma manga (30) de accionamento posicionada entre a manga de marcação de dose e a haste de êmbolo, a manga de accionamento possuindo uma ranhura (38) helicoidal com um segundo passo; em que o primeiro passo da rosca (74) helicoidal e o segundo passo da ranhura (38) helicoidal são iguais; caracterizado por a haste (20) de êmbolo ser rotativa em relação ao corpo (4).
  2. 2. Dispositivo de injecção do tipo caneta de acordo com a reivindicação 1, caracterizado por a rotação da haste (20) de êmbolo ser impedida durante a marcação de uma dose e por a haste (20) de êmbolo ser obrigada a rodar durante a distribuição de uma dose marcada.
  3. 3. Dispositivo de injecção do tipo caneta de acordo com a reivindicação 1 ou 2, caracterizado por uma inserção (16) 1 ser proporcionada numa primeira extremidade do corpo (4), sendo a inserção (16) fixa, impedida de movimento rotacional ou longitudinal. Dispositivo de injecção do tipo caneta de acordo com a reivindicação 3, caracterizado por a inserção (16) estar dotada com uma abertura (18) circular roscada estendendo-se através dela, em que uma primeira extremidade da haste (20) de êmbolo se estende através da abertura (18) roscada na inserção (16) . Lisboa, 7 de Junho de 2013
PT101840858T 2003-03-03 2004-03-03 Dispositivo de injecção do tipo caneta com manga de marcação de dose PT2263721E (pt)

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PT04716568T PT1603610E (pt) 2003-03-03 2004-03-03 Dispositivo de injecção do tipo caneta com manga de marcação de dose
PT101843472T PT2281592E (pt) 2003-03-03 2004-03-03 Dispositivo de injecção do tipo caneta com manga de marcação de dose
PT101841633T PT2263722E (pt) 2003-03-03 2004-03-03 Dispositivo de injecção do tipo caneta com manga de marcação de dose
PT101845162T PT2263724E (pt) 2003-03-03 2004-03-03 Dispositivo de injecção do tipo caneta com manga de marcação de dose
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PT04716584T PT1603611E (pt) 2003-03-03 2004-03-03 Mecanismo de accionamento para dispositivo de distribuição de fármaco
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PT101840858T PT2263721E (pt) 2003-03-03 2004-03-03 Dispositivo de injecção do tipo caneta com manga de marcação de dose
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PT04716584T PT1603611E (pt) 2003-03-03 2004-03-03 Mecanismo de accionamento para dispositivo de distribuição de fármaco
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