RU2015135983A - Автоматическое инъекционное устройство - Google Patents

Автоматическое инъекционное устройство Download PDF

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RU2015135983A
RU2015135983A RU2015135983A RU2015135983A RU2015135983A RU 2015135983 A RU2015135983 A RU 2015135983A RU 2015135983 A RU2015135983 A RU 2015135983A RU 2015135983 A RU2015135983 A RU 2015135983A RU 2015135983 A RU2015135983 A RU 2015135983A
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syringe
housing
sleeve portion
stopper
injection device
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RU2015135983A
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Джозеф Ф. ДЖУЛИАН
Стивен РОЛФ
Стефен БИКНЕЛЛ
Джереми МАРШАЛЛ
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Эббви Байотекнолоджи Лтд.
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Publication of RU2015135983A publication Critical patent/RU2015135983A/ru

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    • A61M5/2033Spring-loaded one-shot injectors with or without automatic needle insertion
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    • A61M5/315Pistons; 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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    • A61M5/31565Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31576Constructional features or modes of drive mechanisms for piston rods
    • A61M5/31578Constructional 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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Claims (47)

1. Корпус для автоматического инъекционного устройства, включающий:
полый, по существу трубчатый кожух, включающий открытый первый конец и второй конец, причем полый по существу трубчатый кожух сконфигурирован для приема шприца со скольжением внутрь кожуха;
первый стопор на внутренней поверхности корпуса для ограничения движения шприца в первом направлении, и
второй стопор на внутренней поверхности корпуса для ограничения движения шприца во втором направлении.
2. Корпус по п. 1, кроме того, включающий выступ, сформированный между открытым первым концом и первым стопором для посадки смещающего механизма для смещения шприца в сторону от первого конца корпуса.
3. Корпус по п. 1, дополнительно включающий окно, сформированное в боковой стенке корпуса, для обеспечения возможности визуализации внутренней полости корпуса.
4. Корпус по п. 3, в котором окно включает линию заполнения в окне для индикации полной дозы вещества.
5. Корпус по п. 4, в котором вещество представляет собой ингибитор TNFα.
6. Корпус по п. 3, в котором окно по существу имеет форму замочной скважины.
7. Корпус по п. 1, кроме того, включающий кнопку запуска, соединенную со вторым концом трубчатого кожуха для селективного приведения в действия шприца для перемещения из первого,
отведенного назад положения, во второе, выступающее положение, в котором игла шприца выступает из первого конца, и, в то время как шприц находится во втором, выступающем положении, подачи давления для выталкивания вещества из шприца.
8. Шприц для использования в автоматическом инъекционном устройстве, включающий:
гильзовую часть для помещения вещества;
полую иглу, сообщающуюся по текучей среде с гильзовой частью;
пробку для герметизации гильзовой части, причем пробка выполнена смещаемой внутри гильзовой части для увеличения давления внутри гильзовой части для принуждения вещества к движению через полую иглу;
первый стопор, сформированный на промежуточной части гильзовой части, для упора стопора в корпусе автоматического инъекционного устройства для ограничения движения шприца в первом направлении; и
второй стопор, сформированный на дистальном конце гильзовой части для ограничения движения шприца относительно корпуса автоматического инъекционного устройства во втором направлении.
9. Шприц по п. 8, дополнительно включающий плунжер сначала для селективного перемещения шприца по направлению к открытому первому концу корпуса автоматического инъекционного устройства, так что игла выступает из первого конца, а в последующем, подачи давления на пробку для того, чтобы вызвать выталкивание шприцем вещества через полую иглу.
10. Шприц по п. 9, в котором плунжер включает стержень,
соединенный на первом конце с пробкой и сжимаемой расширенной центральной частью.
11. Шприц по п. 9, в котором плунжер дополнительно включает индикатор для индикации того, когда шприц произвел выталкивание по существу всего вещества через полую иглу.
12. Шприц по п. 8, дополнительно включающий дозу ингибитора TNFα, загруженную в гильзовую часть шприца.
13. Шприц по п. 8, дополнительно включающий дозу адалимумаба в рецептуре, где рецептура включает адалимумаб, хлорид натрия, одноосновный дигидрофосфат натрия, двухосновный дигидрофосфат натрия, цитрат натрия, моногидрат лимонной кислоты, маннит, полисорбат 80 и воду.
14. Шприц по п. 13, кроме того, включающий дозу 40 мг адалимумаба.
15. Шприц по п. 12 или 13, кроме того, включающий гидроксид натрия.
16. Корпус для автоматического инъекционного устройства, включающий:
полый, по существу трубчатый кожух, включающий открытый первый конец и второй конец, причем полый по существу трубчатый кожух сконфигурирован для приема шприца со скольжением внутрь кожуха;
первый стопор на внутренней поверхности корпуса для ограничения движения шприца в первом направлении, и
второй стопор на внутренней поверхности корпуса для ограничения движения шприца во втором направлении;
окно, сформированное в боковой стенке корпуса, для
обеспечения возможности визуализации внутренней полости корпуса и для визуализации вещества, содержащегося в шприце до инъекции.
17. Корпус по п. 16, дополнительно содержащий выступ, сформированный между открытым первым концом и первым стопором для посадки смещающего механизма для смещения шприца в сторону от первого конца корпуса.
18. Корпус по п. 16, дополнительно включающий окно, сформированное в боковой стенке корпуса, для обеспечения возможности визуализации внутренней полости корпуса.
19. Корпус по п. 16, дополнительно включающий кнопку запуска, соединенную со вторым концом трубчатого кожуха для селективного приведения в действия шприца для перемещения из первого, отведенного назад положения, во второе, выступающее положение, в котором игла шприца выступает из первого конца, и, в то время как шприц находится во втором, выступающем положении, подачи давления для выталкивания вещества из шприца.
20. Узел шприца и держателя для использования в автоматическом инъекционном устройстве, содержащий:
гильзовую часть для содержания вещества, заключенную в удерживающую втулку;
полую иглу в жидкостном сообщении с гильзовой частью;
пробку для герметизации гильзовой части, причем пробка выполнена с возможностью перемещения в гильзовой части для выталкивания вещества через полую иглу;
первый стопор, сформированный на промежуточной части гильзовой части, для упора первого стопора в корпусе автоматического инъекционного устройства для ограничения
движения гильзовой части в первом направлении относительно корпуса; и
второй стопор, сформированный на дистальном конце гильзовой части для упора второго стопора в корпусе для ограничения движения гильзовой части относительно корпуса автоматического инъекционного устройства во втором противоположном направлении; и
плунжер для селективного перемещения шприца по направлению к открытому первому концу корпуса автоматического инъекционного устройства, так что игла выступает из первого конца, и для подачи давления на пробку для того, чтобы вызвать выталкивание шприцем вещества через полую иглу, причем плунжер содержит стержень, выполненный с возможностью соединения на первом конце с пробкой шприца и имеет сжимаемую расширенную центральную часть расположенную продольно между первой сплошной частью и второй сплошной частью фланец между вторым концом стержня и сжимаемой расширенной центральной частью стержня.
21. Узел по п. 20, в котором плунжер дополнительно включает индикатор для индикации того, когда шприц произвел выталкивание по существу всего вещества через полую иглу.
22. Узел по п. 20, дополнительно содержащий дозу ингибитора TNFα, загруженную в гильзовую часть шприца.
23. Узел по п. 20, дополнительно включающий дозу адалимумаба в препарате, причем препарат включает адалимумаб, хлорид натрия, одноосновный дигидрофосфат натрия, двухосновный дигидрофосфат натрия, цитрат натрия, моногидрат лимонной кислоты, маннит, полисорбат 80 и воду.
24. Узел по п. 23, дополнительно содержащий включает дозу 40 мг адалимумаба.
25. Узел по п. 22 или 23, дополнительно содержащий гидроксид натрия.
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