RU2014149268A - Катетерные устройства, содержащие блоки из нескольких электродов, для почечной нейромодуляции и соответствующие системы и способы - Google Patents
Катетерные устройства, содержащие блоки из нескольких электродов, для почечной нейромодуляции и соответствующие системы и способы Download PDFInfo
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Abstract
1. Катетерный аппарат, включающий:- удлиненный трубчатый ствол, имеющий проксимальную часть и дистальную часть; и- терапевтический блок, расположенный на дистальной части удлиненного ствола и приспособленный к размещению в целевом участке внутри почечной артерии пациента-человека, где терапевтический блок включает поддерживающую структуру, содержащую:- контрольный элемент, имеющий предварительно заданную спиральную форму, где контрольный элемент является трубчатой структурой, содержащей полость, проходящую в ней, и состоящей из нитиноловой мультифиламентной витой проволоки; и- множество элементов, доставляющих энергию, переносимых поддерживающей структурой,- где удлиненный трубчатый ствол и терапевтический блок вместе определяют полость для проволочного направляющего элемента, сконструированную для приема при скольжении медицинского проволочного направляющего элемента; и- где аксиальное перемещение проволочного направляющего элемента относительно терапевтического блока трансформирует поддерживающую структуру между (а) низкопрофильной конфигурацией доставки и (b) развернутой конфигурацией, приводящей к принятию предварительно заданной спиральной формы контрольного элемента.2. Катетерный аппарат по п. 1, в котором терапевтический блок сконструирован для трансформации между низкопрофильной конфигурацией доставки и развернутой конфигурацией, в то время как по меньшей мере дистальная часть проволочного направляющего элемента остается в полости проволочного направляющего элемента терапевтического блока.3. Катетерный аппарат по п. 2, в котором поддерживающая структура включает усилие, восстанавливающе
Claims (28)
1. Катетерный аппарат, включающий:
- удлиненный трубчатый ствол, имеющий проксимальную часть и дистальную часть; и
- терапевтический блок, расположенный на дистальной части удлиненного ствола и приспособленный к размещению в целевом участке внутри почечной артерии пациента-человека, где терапевтический блок включает поддерживающую структуру, содержащую:
- контрольный элемент, имеющий предварительно заданную спиральную форму, где контрольный элемент является трубчатой структурой, содержащей полость, проходящую в ней, и состоящей из нитиноловой мультифиламентной витой проволоки; и
- множество элементов, доставляющих энергию, переносимых поддерживающей структурой,
- где удлиненный трубчатый ствол и терапевтический блок вместе определяют полость для проволочного направляющего элемента, сконструированную для приема при скольжении медицинского проволочного направляющего элемента; и
- где аксиальное перемещение проволочного направляющего элемента относительно терапевтического блока трансформирует поддерживающую структуру между (а) низкопрофильной конфигурацией доставки и (b) развернутой конфигурацией, приводящей к принятию предварительно заданной спиральной формы контрольного элемента.
2. Катетерный аппарат по п. 1, в котором терапевтический блок сконструирован для трансформации между низкопрофильной конфигурацией доставки и развернутой конфигурацией, в то время как по меньшей мере дистальная часть проволочного направляющего элемента остается в полости проволочного направляющего элемента терапевтического блока.
3. Катетерный аппарат по п. 2, в котором поддерживающая структура включает усилие, восстанавливающее форму, достаточное для преодоления распрямляющего усилия, обеспечиваемого дистальной частью проволочного направляющего элемента для трансформации терапевтического блока в развернутую конфигурацию, когда наиболее удаленный наконечник проволочного направляющего элемента в целом выровнен с дистальным наконечником терапевтического блока.
4. Катетерный аппарат по п. 1, в котором:
- поддерживающая структура включает восстанавливающее форму усилие, недостаточное для преодоления распрямляющего усилия, обеспечиваемого дистальным участком проволочного направляющего элемента, когда проволочный направляющий элемент находится внутри полости для проволочного направляющего элемента терапевтического блока; и
- терапевтический блок сконструирован для трансформации в развернутую конфигурацию, когда наиболее дистальную часть проволочного направляющего элемента извлекают через полость для проволочного направляющего элемента до точки, приближенной к терапевтическому блоку.
5. Катетерный аппарат по п. 1, в котором дистальная часть терапевтического блока дополнительно включает гибкий изогнутый наконечник, сконструированный для обеспечения отверстия для проволочного направляющего элемента, и в развернутой конфигурации, для отведения проволочного направляющего элемента от стенки почечной артерии.
6. Катетерный аппарат по п. 5, в котором гибкий изогнутый наконечник состоит из полиэфир-блок-амидного сополимера.
7. Катетерный аппарат по п. 5, в котором гибкий изогнутый наконечник состоит из термопластического полиэфируретанового материала.
8. Катетерный аппарат по п. 7, в котором гибкий изогнутый наконечник состоит из примерно 5-30 вес. % силоксана, смешанного с термопластическим полиэфируретановым материалом.
9. Катетерный аппарат по п. 1, в котором в развернутой конфигурации элементы, доставляющие энергию, переносимые поддерживающей структурой, отделены друг от друга по продольной оси почечной артерии и конструированы для сохранения контакта со стенкой почечной артерии.
10. Катетерный аппарат по п. 1, в котором элементы, доставляющие энергию, содержат серию ленточных электродов.
11. Катетерный аппарат по п. 10, в котором по меньшей мере один из ленточных электродов содержит суженные концевые части, и в котором суженные концевые части сконструированы для обеспечения тупого угла между внешней поверхностью поддерживающей структуры и внешней поверхностью по меньшей мере одного ленточного электрода.
12. Катетерный аппарат по п. 1, в котором терапевтический блок содержит четыре элемента, доставляющих энергию.
13. Катетерный аппарат по п. 1, дополнительно содержащий втяжной загружающий инструмент, окружающий и ограничивающий по меньшей мере продольную часть терапевтического блока в низкопрофильной конфигурации доставки.
14. Катетерный аппарат по п. 13, в котором загружающий инструмент содержит дистальную концевую часть, имеющую округленные углы.
15. Система ренальной нейромодуляции для лечения пациента-человека, включающая:
- удлиненный ствол, имеющий проксимальный конец и дистальный конец, где дистальный конец ствола сконструирован для внутрисосудистой доставки по процедурному проволочному направляющему элементу в почечную артерию пациента;
- трубчатую спиральную структуру с предварительно заданной формой, расположенную на дистальном конце удлиненного ствола или рядом с ним, где спиральная структура сконструирована для трансформации между нерасширенной конфигурацией и расширенной конфигурацией, имеющей тенденцию к принятию формы спиральной структуры с предварительно заданной формой, и где спиральная структура построена, по меньшей мере отчасти, из мультифиламентной нитиноловой проволоки; и
- множество электродов, связанных со спиральной структурой;
- где удлиненный ствол и спиральная структура вместе определяют полость для проволочного направляющего элемента в них, и где
- полость для проволочного направляющего элемента сконструирована для приема при соскальзывании процедурного проволочного направляющего элемента для размещения спиральной структуры в целевом участке лечения в кровеносном сосуде почки пациента, и удерживания спиральной структуры в нерасширенной конфигурации, и где
- проксимальное перемещение процедурного проволочного направляющего элемента через полость для проволочного направляющего элемента относительно спиральной структуры так, чтобы дистальная концевая часть проволочного направляющего элемента по меньшей мере отчасти находилась в полости для проволочного направляющего элемента, трансформирует спиральную структуру до расширенной конфигурации.
16. Система по п. 15, где процедурный проволочный направляющий элемент содержит дистальную часть, имеющую вариабельную гибкость, и кроме того, где по меньшей мере область дистальной части проволочного направляющего элемента сконструирована для сохранения внутри части полости для проволочного направляющего элемента, определенной спиральной структурой, когда спиральная структура находится в расширенной конфигурации.
17. Система по п. 15, дополнительно включающая гибкую трубку, покрывающую спиральную структуру и находящуюся с ней в тесном контакте.
18. Система по п. 17, где множество электродов связано с гибкой трубкой с применением адгезивного материала.
19. Система по п. 15, где множество электродов состоит из золота.
20. Система по п. 15, где множество электродов по отдельности соединяется с источником энергии вне пациента, и где источник энергии способен к индивидуальному контролю энергии, доставляемой к каждому электроду во время лечения.
21. Способ выполнения ренальной нейромодуляции, включающий:
- внутрисосудистую доставку катетера для ренальной нейромодуляции в низкопрофильной конфигурации доставки по проволочному направляющему элементу к целевому участку лечения в кровеносном сосуде почки пациента - человека, и по меньшей мере поблизости от почечного нерва пациента, где катетер для ренальной модуляции содержит:
- удлиненный ствол; и
- многоэлектродную матрицу, расположенную на дистальной части ствола, и состоящую, по меньшей мере отчасти, из трубчатой структуры, образованной из мультифиламентной нитиноловой проволоки;
- извлечение проволочного направляющего элемента в проксимальном направлении, до тех пор пока катетер не трансформируется из низкопрофильной конфигурации доставки в развернутую конфигурацию, где трубчатая структура имеет радиально расширенную, в целом спиральную форму, сконструированную для контакта со стенкой кровеносного сосуда почки и для обеспечения кровотока через сосуд; и
- избирательную доставку энергии к одному или нескольким электродам из многоэлектродной матрицы для подавления передачи нервных импульсов по почечному нерву.
22. Способ по п. 21, где избирательная доставка энергии к одному или нескольким электродам из многоэлектродной матрицы включает получение множества поражений в необходимом режиме вдоль кровеносного сосуда почки.
23. Способ по п. 22, где отдельные электроды из многоэлектродной матрицы достаточно удалены друг от друга, так чтобы поражения не перекрывались.
24. Способ по п. 21, дополнительно включающий прикрепление внешнего заземления снаружи пациента, и где избирательная доставка энергии к одному или нескольким электродам дополнительно включает доставку электрического поля в однополярном режиме между каждым из электродов и внешним заземлением.
25. Способ по п. 21, в котором избирательная доставка энергии включает избирательную доставку электрического поля в биполярном режиме между электродами из многоэлектродной матрицы.
26. Способ по п. 21, в котором извлечение проволочного направляющего элемента в проксимальном направлении, пока не трансформируется терапевтический блок, включает лишь частичное извлечение проволочного направляющего элемента из терапевтического блока, так чтобы по меньшей мере часть проволочного направляющего элемента оставалась в терапевтическом блоке после трансформации терапевтического блока в развернутую конфигурацию.
27. Способ по п. 21, в котором извлечение проволочного направляющего элемента в проксимальном направлении, пока не трансформируется терапевтический блок, включает полное извлечение проволочного направляющего элемента из терапевтического блока, так чтобы наиболее удаленная часть проволочного направляющего элемента была извлечена до точки, приближенной к терапевтическому блоку.
28. Способ по п. 21, где целевой участок лечения содержит первый целевой участок лечения, и где способ дополнительно включает:
- продвижение проволочного направляющего элемента в дистальном направлении после избирательной доставки энергии к одному или нескольким электродам из многоэлектродной матрицы, для трансформации многоэлектродной матрицы из развернутой конфигурации обратно в низкопрофильную конфигурацию доставки;
- перемещение катетера ко второму участку лечения, отличающемуся от первого участка лечения;
- извлечение проволочного направляющего элемента в проксимальном направлении для повторной трансформации терапевтического блока из конфигурации доставки в развернутую конфигурацию; и
- избирательную доставку энергии к одному или нескольким электродам из многоэлектродной матрицы, расположенной во втором целевом участке лечения.
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RU2762347C2 (ru) * | 2017-01-23 | 2021-12-20 | Конинклейке Филипс Н.В. | Исполнительное устройство на основе электроактивного материала |
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RU2812039C1 (ru) * | 2020-07-02 | 2024-01-22 | Стимвиа С.Р.О. | Устройство для селективной нейромодуляции |
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