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RU2013123775A - Катетерные устройства, содержащие группы из нескольких электродов, для почечной нейромодуляции и соответствующие системы и способы - Google Patents

Катетерные устройства, содержащие группы из нескольких электродов, для почечной нейромодуляции и соответствующие системы и способы Download PDF

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RU2013123775A
RU2013123775A RU2013123775/14A RU2013123775A RU2013123775A RU 2013123775 A RU2013123775 A RU 2013123775A RU 2013123775/14 A RU2013123775/14 A RU 2013123775/14A RU 2013123775 A RU2013123775 A RU 2013123775A RU 2013123775 A RU2013123775 A RU 2013123775A
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energy
therapeutic
cavity
control element
elements
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Кевин МАУЧ
Марио АЛВАРАДО
Роберт Дж. БИТЕЛ
Хуанита Санчес КОУЛ
Уильям ЧАНГ
Джастин ГОШГАРИАН
Леонила РИВЕРА
Сукянг ШИН
Мишель СИЛЬВЕР
Сина СОМ
Эндрю ВУ
Дэнис ЗАРИНС
Мария Дж. ЭБОЙТЭС
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Медтроник Ардиан Люксембург С.А.Р.Л.
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    • 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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    • A61B2018/00577—Ablation
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
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    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1467—Probes or electrodes therefor using more than two electrodes on a single probe
    • A—HUMAN NECESSITIES
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    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
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    • A—HUMAN NECESSITIES
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    • 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
    • A61M25/00—Catheters; Hollow probes
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    • A61M25/0133—Tip steering devices

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Abstract

1. Катетерный аппарат для лечения человека-пациента посредством денервации почки, включающий:- терапевтический блок, имеющий центральную ось, и дистальную часть и проксимальную часть, аксиально разделенные вдоль центральной оси, где терапевтический блок включает:- множество элементов, доставляющих энергию, включающих по меньшей мере первый элемент, доставляющий энергию, и второй элемент, доставляющий энергию; и- формируемый участок, сконструированный с возможностью трансформации между состоянием доставки и развернутым состоянием, где множество элементов, доставляющих энергию, находятся на формируемом участке;- контрольный элемент, функционально связанный по меньшей мере с частью терапевтического блока, и расположенный вдоль центральной оси, так чтобы первый и второй элементы, доставляющие энергию, были аксиально и радиально отделены друг от друга вокруг контрольного элемента, и где:проксимальное перемещение контрольного элемента относительно дистальной части терапевтического блока переводит терапевтический блок в состояние доставки; и- дистальное перемещение контрольного элемента относительно дистальной части терапевтического блока переводит терапевтический блок в развернутое состояние.2. Катетерный аппарат по п.1, в котором контрольный элемент содержит трубчатый элемент, формирующий центральную полость, а центральная полость сконструирована для размещения проволочного направителя.3. Катетерный аппарат по п.1, дополнительно содержащий ствол, имеющий полость для проволочного направителя в дистальной части, где контрольный элемент вводится при скольжении в полость для проволочного направител�

Claims (37)

1. Катетерный аппарат для лечения человека-пациента посредством денервации почки, включающий:
- терапевтический блок, имеющий центральную ось, и дистальную часть и проксимальную часть, аксиально разделенные вдоль центральной оси, где терапевтический блок включает:
- множество элементов, доставляющих энергию, включающих по меньшей мере первый элемент, доставляющий энергию, и второй элемент, доставляющий энергию; и
- формируемый участок, сконструированный с возможностью трансформации между состоянием доставки и развернутым состоянием, где множество элементов, доставляющих энергию, находятся на формируемом участке;
- контрольный элемент, функционально связанный по меньшей мере с частью терапевтического блока, и расположенный вдоль центральной оси, так чтобы первый и второй элементы, доставляющие энергию, были аксиально и радиально отделены друг от друга вокруг контрольного элемента, и где:
проксимальное перемещение контрольного элемента относительно дистальной части терапевтического блока переводит терапевтический блок в состояние доставки; и
- дистальное перемещение контрольного элемента относительно дистальной части терапевтического блока переводит терапевтический блок в развернутое состояние.
2. Катетерный аппарат по п.1, в котором контрольный элемент содержит трубчатый элемент, формирующий центральную полость, а центральная полость сконструирована для размещения проволочного направителя.
3. Катетерный аппарат по п.1, дополнительно содержащий ствол, имеющий полость для проволочного направителя в дистальной части, где контрольный элемент вводится при скольжении в полость для проволочного направителя, и сконструирован с возможностью выдвижения и втягивания относительно терапевтического блока.
4. Катетерный аппарат по п.1, в котором терапевтический блок содержит предварительно сформированную спиральную структуру.
5. Катетерный аппарат по п.1, в котором контрольный элемент содержит стилет.
6. Катетерный аппарат, включающий:
- удлиненный трубчатый ствол, определяющий по меньшей мере одну полость;
- терапевтический блок, расположенный дистально на удлиненном стволе, где терапевтический блок определяет центральную ось и имеет дистальную часть и проксимальную часть, аксиально разделенный по центральной оси, где терапевтический блок включает:
- множество элементов, доставляющих энергию, включающих по меньшей мере первый элемент, доставляющий энергию, и второй элемент, доставляющий энергию; и
- поддерживающий элемент, выполненный с возможностью трансформации между конфигурацией доставки и развернутой конфигурацией;
- контрольный элемент, связанный с дистальной частью терапевтического блока и расположенный вдоль центральной оси так, чтобы первый и второй элементы, доставляющие энергию, были аксиально и радиально отделены друг от друга вокруг контрольного элемента, где:
- дистальное перемещение контрольного элемента относительно удлиненного ствола переводит терапевтический блок в состояние доставки; и
проксимальное перемещение контрольного элемента относительно удлиненного ствола переводит терапевтический блок в развернутое состояние; и
направляющий блок, соединенный с терапевтическим блоком и расположенный вдоль центральной оси терапевтического блока; где направляющий блок включает трубчатый элемент, имеющий отверстие, расположенное на проксимальной части терапевтического блока для введения и удаления проволочного направителя.
7. Катетерный аппарат по п.6, в котором терапевтический блок содержит множество спиральных элементов, расположенных вокруг внутреннего элемента.
8. Катетерный аппарат по п.6, в котором конфигурация доставки терапевтического блока определяет профиль доставки примерно 0,085 дюймов (2,16 мм).
9. Катетерный аппарат по п.6, в котором дистальный конец удлиненного ствола дополнительно содержит скошенный или наклонный вырез, выполненный по размеру и форме для размещения проксимального конца контрольного элемента.
10. Катетерный аппарат по п.6, в котором удлиненный ствол содержит первую полость и вторую полость, и в котором контрольный элемент располагается с возможностью скольжения в первой полости, а множество элементов, доставляющих энергию, располагаются во второй полости.
11. Катетерный аппарат для внутрисосудистой модуляции нервов почки, включающий:
- удлиненный ствол, имеющий проксимальную часть и дистальную часть, где дистальная часть ствола сконструирована для внутрисосудистой доставки в почечную артерию человека-пациента;
- спиральную структуру, расположенную на дистальной части удлиненного ствола или рядом с ней, где спиральная структура сконструирована с возможностью трансформации между низкопрофильной конфигурацией и развернутой конфигурацией; и
- по меньшей мере два элемента, доставляющих энергию, связанных со спиральной структурой, где элементы, доставляющие энергию, сконструированы для термического подавления нервного сообщения вдоль почечной артерии; и
где указанные элементы, доставляющие энергию, прикреплены вокруг спиральной структуры так, чтобы в развернутой конфигурации спиральная структура и элементы, доставляющие энергию, определяли профиль доставки 0,085 дюймов (2,16 мм) или меньше, и
- где в развернутой конфигурации элементы, доставляющие энергию, из спиральной структуры сконструированы для сохранения устойчивого контакта со стенкой почечной артерии.
12. Катетерный аппарат по п.11, дополнительно содержащий контрольный элемент, сконструированный с возможностью перемещения относительно спиральной структуры для изменения спиральной структуры между низкопрофильной конфигурацией и развернутой конфигурацией.
13. Катетерный аппарат по п.11, в котором контрольный элемент определяет центральную полость, и в котором центральная полость сконструирована для размещения проволочного направителя для размещения спиральной структуры в целевом участке внутри почечной артерии пациента.
14. Катетерный аппарат по п.11, дополнительно содержащий доставляющую оболочку, по меньшей мере частично окружающую спиральную структуру в низкопрофильной конфигурации.
15. Катетерный аппарат по п.11, в котором удлиненный ствол содержит полость для проволочного направителя, и где катетерный аппарат дополнительно содержит проволочный направитель, располагаемый в полости для проволочного направителя, и проходящий к участку лечения в почечной артерии.
16. Катетерный аппарат по п.11, в котором спиральная структура содержит плетеный кабель.
17. Катетерный аппарат по п.11, в котором спиральная структура содержит трубчатую поддерживающую структуру, имеющую центральную полость.
18. Катетерный аппарат по п.11, в котором спиральная структура содержит электропроводный материал, и в котором электропроводный материал составляет часть элемента, доставляющего энергию.
19. Катетерный аппарат по п.18, в котором электропроводный материал только частично покрыт электроизолирующим материалом.
20. Катетерный аппарат, включающий:
- удлиненный ствол, содержащий внешний ствол и внутренний ствол, где удлиненный ствол имеет проксимальную часть и дистальную часть, и где дистальная часть удлиненного ствола сконструирована для внутрисосудистой доставки в почечную артерию человека-пациента;
- лечебную секцию на дистальной части удлиненного ствола, где лечебная секция расположена между дистальным концом внешнего ствола и дистальным концом внутреннего ствола, и где дистальный конец лечебной секции соединяется с возможностью скольжения с дистальным концом внутреннего ствола через двухполостную манжету;
- множество элементов, доставляющих энергию, расположенных на лечебной секции; и
- предварительно сформированную секцию, связанную с лечебной секцией, где предварительно сформированная секция сконструирована для обеспечения формы лечебной секции, трансформируя таким образом лечебную секцию из выпрямленной конфигурации доставки в развернутую конфигурацию для приведения элементов, доставляющих энергию, в контакт с тканью в участке лечения.
21. Катетерный аппарат по п.20, в котором лечебная секция дополнительно содержит изолятор, расположенный между элементами, доставляющими энергию, и предварительно сформированной секцией, для обеспечения электроизоляции элементов, доставляющих энергию, от предварительно сформированной секции, и где изолятор сформирован из материала, обеспечивающего перенос термической энергии между элементами, доставляющими энергию, и компонентом с памятью формы.
22. Катетерный аппарат по п.20, в котором изолятор сформирован из термопластического материала, имеющего керамический наполнитель, смешанный с ним.
23. Катетерный аппарат по п.20, в котором:
- элементы, доставляющие энергию, электрически соединены с источником энергии по меньшей мере через один провод, имеющий проксимальный конец, связанный с источником энергии, и дистальный конец, связанный с элементом, доставляющим энергию; и
- по меньшей мере один провод является бифилярным проводом, включающим первый медный проводник, второй медный или никелевый проводник, и изолятор, окружающий каждый из первого и второго проводников, для их электроизоляции друг от друга.
24. Катетерный аппарат по п.23, в котором лечебная секция содержит серию ленточных электродов.
25. Катетерный аппарат по п.23, в котором развернутая конфигурация предварительно сформированной секции представляет собой спираль.
26. Катетерный аппарат по п.20, в котором предварительно сформированная секция содержит нитинол.
27. Катетерный аппарат по п.26, в котором предварительно сформированная секция содержит твердый провод, покрытый тонким слоем изолирующего материала.
28. Катетерный аппарат по п.20, в котором предварительно сформированная секция имеет полость, выполненную по размеру для размещения проволочного направителю.
29. Катетерный аппарат по п.20, в котором предварительно сформированная секция является полимерной.
30. Катетерный аппарат по п.20, в котором предварительно сформированная секция содержит материал с памятью формы, сконструированный для изменения формы при температуре трансформации примерно от 40°C до 45°C.
31. Катетерный аппарат по п.20, дополнительно содержащий изолятор, соединенный с предварительно сформированной секцией, где изолятор включает трубчатую оболочку, имеющую полость изолятора.
32. Катетерный аппарат по п.31, в котором проксимальный конец изолятора прикреплен к внутренней поверхности внешней оболочки, а дистальный конец изолятора располагается в двухполостной манжете.
33. Катетерный аппарат по п.20, дополнительно содержащий ствол для проволочного направителя внутри двухполостной манжеты.
34. Катетерный аппарат, содержащий:
- удлиненный трубчатый ствол, содержащий по меньшей мере одну полость;
- терапевтический блок, расположенный днетально от удлиненного ствола, где терапевтический блок определяет центральную ось, и имеет дистальную часть и проксимальную часть, аксиально разделенные вдоль центральной оси, где терапевтический блок включает:
- множество элементов, доставляющих энергию, включающих по меньшей мере первый элемент, доставляющий энергию, и второй элемент, доставляющий энергию; и
поддерживающий элемент, сконструированный с возможностью трансформации между конфигурацией доставки и развернутой конфигурацией;
- трубчатый стволовой элемент, сцепленный с дистальной частью терапевтического блока и расположенный вдоль центральной оси, так чтобы аксиальное перемещение первого и второго элементов, доставляющих энергию, из трубчатого стволового элемента относительно удлиненного ствола переводило терапевтический блок в одну из конфигурации доставки или развернутой конфигурации; и
- проволочный направитель, расположенный внутри трубчатого стволового элемента.
35. Катетерный аппарат для лечения человека-пациента посредством денервации почки, включающий:
- удлиненный трубчатый ствол;
- терапевтический блок, имеющий центральную ось, и дистальную часть и проксимальную часть, аксиально разделенные по центральной оси, где терапевтический блок включает:
- поддерживающую структуру, избирательно трансформируемую между конфигурацией доставки и развернутой конфигурацией;
- множество элементов, доставляющих энергию, расположенных на поддерживающей структуре; и
- контрольный элемент, помещенный с возможностью скольжения в ствол и функционально связанный с дистальной частью терапевтического блока, где:
проксимальное перемещение контрольного элемента переводит терапевтический блок в развернутую конфигурацию; и
- дистальное перемещение контрольного элемента переводит терапевтический блок в конфигурацию доставки.
36. Катетерный аппарат по п.35, в котором терапевтический блок содержит шесть элементов, доставляющих энергию.
37. Катетерный аппарат по п.35, в котором удлиненный трубчатый ствол и контрольный элемент определяют центральную полость, и в котором центральная полость сконструирована для размещения проволочного направителя для расположения терапевтического блока в целевом участке внутри почечной артерии пациента.
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