RU2017142338A - Системы установки и извлечения имплантата - Google Patents

Системы установки и извлечения имплантата Download PDF

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RU2017142338A
RU2017142338A RU2017142338A RU2017142338A RU2017142338A RU 2017142338 A RU2017142338 A RU 2017142338A RU 2017142338 A RU2017142338 A RU 2017142338A RU 2017142338 A RU2017142338 A RU 2017142338A RU 2017142338 A RU2017142338 A RU 2017142338A
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implant
installation
link
cannula
skin
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RU2017142338A
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RU2730996C2 (ru
RU2017142338A3 (ru
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Джей С. СМИТ
Майкл Р. КОУЛ
Джеймс М. СЕЛЛЕРС
Скотт Д. ЛАУТЕНБАХ
Эми К. УИТСОН
Мэттью ВЕБЕР
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Интарсия Терапьютикс, Инк.
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    • A61M5/425Protruding skin to facilitate piercing, e.g. vacuum cylinders, vein immobilising means

Claims (72)

1. Система установки имплантата, содержащая:
- установочный инструмент, содержащий
рукояточную часть и
установочную канюлю, выполненную с возможностью перемещения внутри рукояточной части или рядом с ней относительно рукояточной части,
причем канюля имеет длину, проксимальный конец, выполненный рядом с рукояточной частью, и дистальный конец, противоположный проксимальному концу,
причем установочная канюля выполнена с возможностью доставки имплантата внутрь ткани пациента через разрез в коже пациента на месте имплантации; и
- установочную направляющую, имеющую первую поверхность и ориентирующую трубку, причем
трубка содержит проксимальный конец, выполненный с возможностью приема дистального конца установочной канюли;
дистальный конец отстоит от проксимального конца на первое расстояние;
продольная средняя ось расположена относительно первой поверхности на втором расстоянии, под углом или на втором расстоянии и под углом; и
установочная направляющая выполнена с возможностью направления установочной канюли в ткани для выполнения установки имплантата на заданную глубину установки под наружной поверхностью кожи пациента.
2. Система по п. 1, в которой по меньшей мере одно из первого расстояния, второго расстояния и угла обеспечивает направление установочной канюли и доставку имплантата на заданную глубину установки.
3. Система по п. 1, в которой установочная направляющая также содержит смотровое окно или отверстие, проходящее по длине и ширине установочной направляющей и выполненное с возможностью обеспечения доступа для осмотра и/или пальпации или прикосновения к области наружной поверхности кожи вокруг места имплантации.
4. Система по п. 1, в которой имплантат является осмотическим мини-насосом.
5. Система по п. 1, выполненная с возможностью обеспечения поворота установочной канюли внутри ориентирующей трубки.
6. Способ установки имплантата, включающий обеспечение системы установки по п. 1.
7. Способ по п. 6, также включающий по меньшей мере одно из:
загрузки имплантата в дистальный конец установочной канюли;
выполнения разреза в коже на месте имплантации;
размещения установочной направляющей на месте имплантации так, чтобы дистальный конец ориентирующей трубки выровнялся с разрезом;
вставки дистального конца загруженной установочной канюли в проксимальный конец ориентирующей трубки;
перемещения установочной канюли относительно ориентирующей трубки, пока по меньшей мере часть рукояточной части не окажется рядом с проксимальным концом ориентирующей трубки так, чтобы дистальный конец установочной канюли был направлен далее в разрез и в ткань под разрезом и/или рядом с разрезом;
выпуска имплантата из установочной канюли;
извлечения установочной канюли из кожи пациента и
извлечения установочной направляющей из кожи пациента.
8. Способ по любому из пп. 6-7, в котором имплантат выпускают из установочной канюли на заданной глубине.
9. Способ по п. 8, в котором заданная глубина составляет от приблизительно 0,5 мм до приблизительно 4,5 мм под наружной поверхностью кожи пациента.
10. Устройство установочной направляющей для использования с установочным инструментом, причем указанная направляющая содержит:
- первую поверхность и
- ориентирующую трубку, имеющую среднюю продольную ось, причем
трубка содержит проксимальный конец, выполненный с возможностью приема дистального конца установочной канюли для доставки имплантата в ткань;
дистальный конец отстоит от проксимального конца на первое расстояние;
продольная ось расположена относительно первой поверхности на втором расстоянии, под углом или на втором расстоянии и под углом и
установочная направляющая выполнена с возможностью направления установочной канюли установочного инструмента в ткань для выполнения установки имплантата на заданную глубину установки под наружной поверхностью кожи пациента.
11. Установочная направляющая по п. 10, обеспечивающая возможность поворота установочной канюли внутри ориентирующей трубки.
12. Установочная направляющая по п. 10, также содержащая смотровое окно или отверстие, проходящее по длине и ширине первой поверхности и выполненное с возможностью обеспечения доступа для осмотра и/или пальпации области наружной поверхности кожи вокруг места вставки имплантата.
13. Установочная направляющая по п. 10, причем глубина установки составляет от приблизительно 0,5 мм до приблизительно 4,5 мм под наружной поверхностью кожи пациента.
14. Установочная направляющая по п. 10, в которой ориентирующая трубка выполнена с возможностью приема установочной канюли и направления ее в ткань.
15. Установочная направляющая по п. 10, выполненная из материала, являющегося полупрозрачным или по существу прозрачным.
16. Установочная направляющая по п. 10, в которой ориентирующая трубка выполнена под наклоном относительно обратной стороны направляющей.
17. Установочная направляющая по п. 10, которую пользователь не может легко изогнуть или искривить по длине или по ширине.
18. Инструмент для извлечения имплантата, содержащий:
первое звено;
второе звено, выполненное так, чтобы отстоять от первого звена по существу параллельно ему по меньшей мере во время использования;
первое отверстие, выполненное на дистальном конце первого звена;
второе отверстие, выполненное на дистальном конце второго звена;
причем:
первое отверстие выполнено с возможностью охватывания первого конца установленного имплантата;
второе отверстие выполнено с возможностью охватывания второго конца установленного имплантата и
фиксирующее устройство выполнено с возможностью удержания первого звена и второго звена на расстоянии друг от друга при сведении звеньев вместе.
19. Инструмент для извлечения имплантата по п. 18, также содержащий соединительный механизм для соединения первого и второго звеньев.
20. Инструмент для извлечения имплантата по п. 18, в котором фиксирующее устройство содержит храповой механизм или фрикционный фиксирующий механизм.
21. Инструмент для извлечения имплантата по п. 18, в котором первое отверстие и второе отверстие выполнены из проволоки из нержавеющей стали.
22. Инструмент для извлечения имплантата по п. 21, в котором первое отверстие и второе отверстие являются в основном круглыми, овальными или квадратными.
23. Инструмент для извлечения имплантата по п. 19, в котором соединительный механизм содержит пружину или витую проволоку.
24. Инструмент для извлечения имплантата по п. 18, также содержащий ручку, содержащую:
первую захватную часть, прикрепленную к первому звену;
вторую захватную часть, прикрепленную ко второму звену; и
соединительный элемент, расположенный между первым звеном и вторым звеном.
25. Инструмент для извлечения имплантата по п. 18, в котором первое и второе звенья, первый и второй концы и соединительный механизм выполнены из одного отрезка проволоки.
26. Способ извлечения имплантата, включающий
обеспечение инструмента для извлечения по п. 18.
27. Способ по п. 26, также включающий по меньшей мере одно из:
расположения первого звена на первом конце имплантата, причем имплантат находится под наружной поверхностью кожи пациента;
охватывания первого конца имплантата и прилегающей кожи первым отверстием;
определение местоположения второго конца имплантата;
охватывания второго конца имплантата и прилегающей кожи вторым отверстием;
сдавливания или иного принудительного сближения первого звена и второго звена к первому положению, причем когда первое звено и второе звено находятся в первом положении, вокруг имплантата образуется выпуклость в коже, в которую заключены первый и/или второй концы имплантата;
выполнения разреза в коже пациента рядом с выпуклостью в коже у первого или второго конца имплантата и
сдавливания первого звена и второго звена ко второму положению, причем когда первое звено и второе звено находятся во втором положении, второй конец имплантата выходит из кожи пациента через разрез.
28. Способ по п. 27, в котором первый и второй концы имплантата располагают внутри первого и второго отверстий.
29. Способ по п. 27 или 28, в котором фиксирующее устройство выполнено с возможностью удержания первого звена и второго звена в первом положении во время выполнения разреза.
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