RU2016120663A - Стент с тонкими каркасными элементами из биорассасывающегося полимера с высокой усталостной и радиальной прочностью и способ его изготовления - Google Patents

Стент с тонкими каркасными элементами из биорассасывающегося полимера с высокой усталостной и радиальной прочностью и способ его изготовления Download PDF

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RU2016120663A
RU2016120663A RU2016120663A RU2016120663A RU2016120663A RU 2016120663 A RU2016120663 A RU 2016120663A RU 2016120663 A RU2016120663 A RU 2016120663A RU 2016120663 A RU2016120663 A RU 2016120663A RU 2016120663 A RU2016120663 A RU 2016120663A
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stent
tube
temperature
deformation
coating
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RU2016120663A
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RU2667649C2 (ru
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Раджникант Гандалал ВИАС
Прамод Кумар МИНОЧА
Девешкумар Махендралал КОТХВАЛА
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Мерил Лайф Сайенсиз Пвт. Лтд.
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Claims (28)

1. Способ изготовления биоразлагаемого полимерного стента, выполненного из PLLA (поли-L-лактида), с толщиной каркасных элементов, составляющей мерее 130 мкм, включающий:
(а) деформирование экструдированной трубки из поли-L-лактида (PLLA) в аксиальном направлении при 70°С - 80°С посредством приложения осевого усилия до тех пор, пока не будет достигнуто заданное удлинение, и последующее расширение трубки в радиальном направлении при температуре от 70°С до 80°С за счет приложения давления к трубке посредством инертного газа в три этапа, а именно 250-280 фунтов на кв. дюйм на этапе 1, 375-410 фунтов на кв. дюйм на этапе 2 и 500-530 фунтов на кв. дюйм на этапе 3;
(b) нагрев трубки после деформирования в радиальном направлении при том же режиме давления до температуры от 100°С до 110°С и поддержание ее в течение промежутка времени до 2 мин, и последующее охлаждение до 20°С за 20-30 с для получения готовой деформированной трубки;
с) вырезание заданного рисунка каркасной структуры на деформированной трубке посредством лазерной обработки;
(d) отжиг стента, полученного лазерной резкой, перед размещением или после размещения радионепроницаемых маркеров;
(е) очистку отожженного стента с радионепроницаемыми маркерами путем использования растворителя для удаления неровностей и получения гладкой поверхности;
(f) нанесение на очищенный стент покрытия из композиции антипролиферативного лекарственного средства и полимера-носителя способом нанесения покрытия распылением;
(g) обжатие стента с покрытием или без покрытия на баллоне предварительно стерилизованного подающего катетера в чистой среде; и
(h) стерилизацию системы из обжатого стента и катетера способом облучения электронным пучком при дозе облучения электронным пучком, составляющей менее 20 кГр, без снижения эффективности стерилизации.
2. Способ изготовления биоразлагаемого полимерного стента, выполненного из PLLA (поли-L-лактида), по п.1, в котором экструдированная трубка из поли-L-лактида (PLLA) характеризуется среднемассовой молекулярной массой Mw в диапазоне от 590000 до 620000, среднечисленной молекулярной массой Mn в диапазоне от 350000 до 370000 и кристалличностью в диапазоне от 7% до 12%.
3. Способ по п.1, в котором деформирование трубки в аксиальном направлении выполняют при температуре от 74°С до 76°С при коэффициенте осевого удлинения от 1,4 до 1,7 и поддержании термобарического режима в течение 15-20 с.
4. Способ по п.1, в котором деформирование трубки в радиальном направлении выполняют при температуре от 74°С до 76°С при коэффициенте радиальной деформации от 3 до 5 за счет приложения давления к трубке посредством азота в три этапа и поддержания термобарического режима в течение 15-20 с на каждом этапе приложения давления.
5. Способ по п.1, в котором трубку после деформирования в радиальном направлении нагревают до температуры от 100°С до 110°С при одновременном поддержании давления и выдерживают в течение промежутка времени от 30 с до 2 мин и затем охлаждают до 20°С за 20-30 с для получения готовой деформированной трубки.
6. Способ по п.1, в котором операцию лазерной резки готовой деформированной трубки выполняют при длине волны от 1300 до 1600 нм.
7. Способ по п.1, в котором каркасная структура стента содержит рисунок с рядами каркасных элементов с синусоидальной формой, в которой вершины одного ряда выровнены относительно впадин последующего ряда и в которой впадина одного ряда соединена прямолинейными каркасными элементами, образующими поперечные связи с вершиной последующего ряда в каждом третьем подобном месте в центральной части и в каждой вершине и впадине в концевых частях.
8. Способ по п.1, в котором отжиг выполняют при температуре от 100°С до 110°С в течение периода, варьирующегося от 3 часов до 4 часов, в вакууме до 650-700 мм ртутного столба с последующим охлаждением стента до температуры окружающей среды за 25-30 с.
9. Способ по п.1, в котором очистку отожженного стента выполняют путем вращения в перхлорэтилене, как таковом или разбавленном соответствующим растворителем, или в смеси изопропилового спирта и хлороформа.
10. Способ по п.1, в котором шесть радионепроницаемых маркеров, изготовленных из платины с формой трехосного эллипсоида, закрепляют на образующих поперечные связи, каркасных элементах, по три на обоих концах стента, при этом указанные маркеры размещают на одинаковом угловом расстоянии друг от друга, составляющем 120°, так, что они дают четкое представление о положении стента, а также о раскрытом состоянии стента на концах на двух стандартных ортогональных изображениях без помощи оптической когерентной томографии (ОСТ) или внутрисосудистого ультразвукового исследования (IVUS).
11. Способ по п.1, в котором стент покрывают составом из сиролимуса с биоразлагаемым полимером, а именно PDLLA, в процентном отношении масс 50:50 и с дозой сиролимуса, составляющей 1,25 мкг на 1 мм2 площади стента.
12. Способ по п.11, в котором нанесение покрытия выполняют, используя нанесение покрытия методом распыления.
13. Способ по п.1, в котором стент с покрытием или без покрытия подвергают обжатию на предварительно стерилизованном баллоне подающего катетера в чистой атмосфере при 25°С - 40°С за 6-8 этапов и при времени выдержки, составляющем 200-310 с.
14. Способ по п.1, в котором стент стерилизуют, используя технологические операции, указанные ниже:
(а) подвергание компонентов, отличных от стента, процессу стерилизации этиленоксидом (ЕТО);
(b) обжатие нестерилизованного стента на баллоне стерилизованного катетера по п.13 в чистой среде; и
(с) подвергание всей системы стента стерилизации облучением электронным пучком при дозе от 6 до 12 кГр, предпочтительно от 6 до 10 кГр, при температуре от 15°С до 25°С.
15. Способ по п.14, в котором процесс стерилизации приводит к бионагрузке, составляющей менее 3 колониеобразующих единиц, и гарантированного уровня стерильности, то есть SAL, соответствующего «шестикратному логарифмическому уменьшению», то есть 10-6, которые достигают без какого-либо существенного воздействия на оптическое вращение или кристалличность.
16. Способ по пп.1-15, в котором получают стент с толщиной каркасных элементов, составляющей 100-110 мкм, с радиальной прочностью 20-25 Н в зависимости от размера стента и достаточной усталостной прочностью.
17. Расширяемый баллоном стент, изготовленный из биорассасывающегося полимера, с тонкими каркасными элементами (с толщиной каркасных элементов, составляющей 130 мкм или менее, предпочтительно 100-110 мкм) с высокой усталостной и радиальной прочностью.
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