RU2009131598A - Медицинский продукт для лечения обтураций просветов организма и для предупреждения угрожающих повторных обтураций - Google Patents

Медицинский продукт для лечения обтураций просветов организма и для предупреждения угрожающих повторных обтураций Download PDF

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RU2009131598A
RU2009131598A RU2009131598/15A RU2009131598A RU2009131598A RU 2009131598 A RU2009131598 A RU 2009131598A RU 2009131598/15 A RU2009131598/15 A RU 2009131598/15A RU 2009131598 A RU2009131598 A RU 2009131598A RU 2009131598 A RU2009131598 A RU 2009131598A
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coating
catheter balloon
outlet
folds
coating solution
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Эрика ХОФФМАНН (DE)
Эрика Хоффманн
Роланд ХОРРЕС (DE)
Роланд Хоррес
Фолькер ФАУСТ (DE)
Фолькер Фауст
Хельмут ШРАЙБЕР (DE)
Хельмут ШРАЙБЕР
ХОЛЬСТ Армин ФОН (DE)
ХОЛЬСТ Армин ФОН
Михель ХОФФМАНН (DE)
Михель Хоффманн
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Хемотек АГ (DE)
Хемотек Аг
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    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/08—Materials for coatings
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1027—Making of balloon catheters
    • A61M25/1029—Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M25/00—Catheters; Hollow probes
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M25/00—Catheters; Hollow probes
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
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    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
    • A61L2300/606—Coatings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/80—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special chemical form
    • A61L2300/802—Additives, excipients, e.g. cyclodextrins, fatty acids, surfactants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2420/00—Materials or methods for coatings medical devices
    • A61L2420/02—Methods for coating medical devices
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M2025/0057—Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
    • A—HUMAN NECESSITIES
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    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1027—Making of balloon catheters
    • A61M25/1029—Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
    • A61M2025/1031—Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1088—Balloon catheters with special features or adapted for special applications having special surface characteristics depending on material properties or added substances, e.g. for reducing friction

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Abstract

1. Способ покрытия катетер-баллона определенным количеством фармакологического биологически активного вещества, причем в способе нанесения покрытия используют устройство для нанесения покрытия с дозирующим приспособлением для выпуска измеримого количества раствора для покрытия посредством выпускного приспособления целенаправленно на поверхность катетер-баллона. ! 2. Способ по п.1, причем в случае выпускного приспособления речь идет о сопле, множестве сопл, нити, сетке из нитей, куске текстиля, полосках кожи, губке, шаре, шприце, игле, канюле или капилляре. ! 3. Способ по п.1, причем в случае способа нанесения покрытия речь идет о способе нанесения покрытия разбрызгиванием, способе пипетирования, капиллярном способе, способе нанесения покрытия в складки распылением, способе волочения, способе волочения нити или шаровом способе. ! 4. Способ по п.1, причем раствор для покрытия содержит фармакологическое биологически активное вещество вместе с, по меньшей мере, одним посредником транспорта, эфиром лимонной кислоты, контрастным средством, полимером, полисахаридом, пептидом, нуклеотидом, маслом, жиром, воском, жирной кислотой, эфиром жирной кислоты, гидрогелем, солью, растворителем, фармакологически приемлемым вспомогательным веществом или смесью вышеуказанных веществ. ! 5. Способ по любому из пп.1-4, включающий следующие стадии: ! а) получение сложенного, сжатого катетер-баллона; ! b) подготовка устройства для нанесения покрытия с выпускным отверстием, пригодным для точечного выпуска раствора для покрытия; ! с) установление выпускного отверстия, пригодного для точечного выпуска раствора для покрытия, у проксимально

Claims (42)

1. Способ покрытия катетер-баллона определенным количеством фармакологического биологически активного вещества, причем в способе нанесения покрытия используют устройство для нанесения покрытия с дозирующим приспособлением для выпуска измеримого количества раствора для покрытия посредством выпускного приспособления целенаправленно на поверхность катетер-баллона.
2. Способ по п.1, причем в случае выпускного приспособления речь идет о сопле, множестве сопл, нити, сетке из нитей, куске текстиля, полосках кожи, губке, шаре, шприце, игле, канюле или капилляре.
3. Способ по п.1, причем в случае способа нанесения покрытия речь идет о способе нанесения покрытия разбрызгиванием, способе пипетирования, капиллярном способе, способе нанесения покрытия в складки распылением, способе волочения, способе волочения нити или шаровом способе.
4. Способ по п.1, причем раствор для покрытия содержит фармакологическое биологически активное вещество вместе с, по меньшей мере, одним посредником транспорта, эфиром лимонной кислоты, контрастным средством, полимером, полисахаридом, пептидом, нуклеотидом, маслом, жиром, воском, жирной кислотой, эфиром жирной кислоты, гидрогелем, солью, растворителем, фармакологически приемлемым вспомогательным веществом или смесью вышеуказанных веществ.
5. Способ по любому из пп.1-4, включающий следующие стадии:
а) получение сложенного, сжатого катетер-баллона;
b) подготовка устройства для нанесения покрытия с выпускным отверстием, пригодным для точечного выпуска раствора для покрытия;
с) установление выпускного отверстия, пригодного для точечного выпуска раствора для покрытия, у проксимального или у дистального конца складки катетер-баллона;
d) выделение определенного количества раствора для покрытия через выпускное отверстие у проксимального или дистального конца складки; и
е) заполнение складки раствором для покрытия на основании капиллярного действия.
6. Способ по п.5, причем складка заполняется в течение от 5 до 80 с.
7. Способ по п.5, причем катетер-баллон во время заполнения складки наклонен на 10-65° и заполнение складок происходит от вышележащего конца.
8. Способ по п.5, причем раствор для покрытия не должен нагнетаться из устройства для нанесения покрытия, а складка заполняется на основании капиллярного действия и при наклоненном катетер-баллоне на основании силы тяжести складки.
9. Способ по п.5, причем катетер-баллон вращается и последовательно заполняются все складки.
10. Способ по п.5, причем устройство для нанесения покрытия обладает множеством выпускных отверстий одновременного покрытия множества складок катетер-баллона.
11. Способ по п.5, включающий дополнительно стадию способа f):
f) высушивание раствора для покрытия в складке, причем во время высушивания катетер-баллон вращают вокруг его продольной оси в направлении отверстия складок.
12. Способ по любому из пп.1-4, включающий следующие стадии:
а) получение сложенного, сжатого катетер-баллона;
b) подготовка устройства для нанесения покрытия с, по меньшей мере, одним соплом или, по меньшей мере, одним шприцеобразным выпускным отверстием;
с) установление сопла или выпускного отверстия у проксимального или у дистального конца складки катетер-баллона;
d) передвижение сопла или выпускного отверстия относительно складки вдоль складки; и
е) выделение определенного потока раствора для покрытия в расчете на время и на проходимое расстояние.
13. Способ по п.12, причем сопло или выпускное отверстие находится в середине складки.
14. Способ по п.12, причем складка заполняется в течение от 5 до 80 с.
15. Способ по п.12, причем устройство для нанесения покрытия имеет соответствующее числу складок число сопл или выпускных отверстий и все складки заполняются одновременно.
16. Способ по п.12, причем раствор для покрытия после удаления растворителя имеет температуру плавления или температуру затвердевания ниже 20°С.
17. Способ по п.12, причем используют маслянистый или пастообразный раствор для покрытия, который неполностью высыхает в складках.
18. Способ по п.12, включающий далее стадию способа f):
f) высушивание раствора для покрытия в складке или равномерное распределение покрытия в складке, причем катетер-баллон вращают вокруг его продольной оси в направлении отверстия складок.
19. Способ по любому из пп.1-4, включающий следующие стадии:
а) получение сложенного, сжатого катетер-баллона;
b) подготовка устройства для нанесения покрытия с множеством последовательно расположенных выпускных отверстий;
с) введение множества последовательно расположенных выпускных отверстий под складку катетер-баллона;
d) одновременный выпуск определенного количества раствора для покрытия из выпускных отверстий в складку; и
е) высушивание раствора для покрытия в складках.
20. Способ по п.19, причем выпускные отверстия находятся в середине складки.
21. Способ по п.19, причем складка заполняется в течение от 5 до 80 с.
22. Способ по п.19, причем устройство для нанесения покрытия имеет соответствующее числу складок число последовательно расположенных в большом количестве выпускных отверстий и все складки заполняются одновременно.
23. Способ по п.19, причем раствор для покрытия после удаления растворителя имеет температуру плавления или температуру затвердевания ниже 20°С.
24. Способ по п.19, причем используют маслянистый или пастообразный раствор для покрытия, который неполностью высыхает в складках.
25. Способ по п.19, включающий далее стадию способа f):
f) высушивание раствора для покрытия в складке или равномерное распределение покрытия в складке, причем катетер-баллон вращают вокруг его продольной оси в направлении отверстия складок.
26. Способ по любому из пп.1-4, включающий следующие стадии:
а) получение катетер-баллона в сложенном, частично раздутом или полностью раздутом состоянии;
b) подготовка устройства для нанесения покрытия с выпускным приспособлением;
c) формирование капли из раствора для покрытия в выпускном приспособлении;
d) волочение капли по поверхности, на которую наносят покрытие, катетер-баллона без касания самого выпускного приспособления поверхности катетер-баллона; и
е) дополнительное дозирование раствора для покрытия, так что капля, по существу, сохраняет свою величину.
27. Способ по п.26, причем только целенаправленно заполняют складки катетер-баллона тем, что каплю волокут через отверстие складок.
28. Способ по п.26, причем поверхность катетер-баллона перед нанесением покрытия смачивают растворителем.
29. Способ по п.26, причем выпускное приспособление представляет собой иглу, шприц, канюлю, пипетку или сопло.
30. Способ по любому из пп.1-4, включающий следующие стадии:
а) получение катетер-баллона в сложенном, частично раздутом или полностью раздутом состоянии;
b) подготовка устройства для нанесения покрытия с выпускным приспособлением в форме нити, губки, полоски кожи или куска текстиля;
с) приготовление раствора для покрытия;
d) пропитка выпускного приспособления раствором для покрытия;
е) перенесение раствора для покрытия от выпускного приспособления на покрываемую поверхность катетер-баллона; и
f) дополнительное дозирование раствора для покрытия, так что происходит равномерный выпуск раствора для покрытия от выпускного приспособления на покрываемую поверхность катетер-баллона.
31. Способ по п.30, причем перенесение раствора для покрытия от выпускного приспособления на покрываемую поверхность катетер-баллона согласно стадии е) происходит за счет волочения выпускного приспособления по покрываемой поверхности катетер-баллона.
32. Способ по п.30, причем только целенаправленно заполняются складки катетер-баллона тем, что выпускное приспособление волокут через отверстие складок или через складки.
33. Способ по п.30, причем поверхность катетер-баллона перед нанесением покрытия смачивают растворителем.
34. Способ по п.30, причем выпускное приспособление состоит из материала, который не может повреждать катетер-баллон.
35. Способ по п.30, причем все складки катетер-баллона заполняются или покрываются одновременно.
36. Способ по п.30, причем на всю поверхность катетер-баллона наносят покрытие одновременно с помощью большого количества нитей, полосок кожи, куска текстиля или сетки из нитей.
37. Способ по любому из пп.1-4, включающий следующие стадии:
а) подготовка устройства для нанесения покрытия с шарообразной головкой для перенесения раствора для покрытия на поверхность покрываемого катетер-баллона;
b) приготовление раствора для покрытия с доступом к шарообразной головке;
с) установление шарообразной головки устройства для нанесения покрытия на покрываемую поверхность катетер-баллона;
d) оказание давления на шарообразную головку устройства для нанесения покрытия с целью способствования вытеканию раствора для покрытия; и
е) обкатывание покрываемой поверхности катетер-баллона шарообразной головкой при перенесении раствора для покрытия на покрываемую поверхность катетер-баллона.
38. Способ по п.37, причем всю покрываемую поверхность катетер-баллона обкатывают и наносят покрытие за счет прохождения с помощью шарообразной головки.
39. Способ по п.37, причем толщину слоя регулируют через оказываемое на шарообразную головку давление и скорость передвижения шарообразной головки по покрываемой поверхности катетер-баллона.
40. Устройство для нанесения покрытия на поверхности катетер-баллонов, включающее приспособление для нанесения покрытия с шарообразной головкой с подводом для раствора для покрытия к шарообразной головке и регулированием установления шарообразной головки на поверхности катетер-баллона и обкатки покрываемой поверхности катетер-баллона шарообразной головкой.
41. Устройство по п.40, причем шарообразная головка состоит из резинообразного материала, а не из металла.
42. Катетер-баллон с нанесенным покрытием, получаемый согласно способу по любому из пп.1-39.
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