RU2400256C2 - Захват эндотелиальных клеток-предшественников элюирующим лекарственные средства имплантируемым медицинским устройством - Google Patents

Захват эндотелиальных клеток-предшественников элюирующим лекарственные средства имплантируемым медицинским устройством Download PDF

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RU2400256C2
RU2400256C2 RU2008120126/15A RU2008120126A RU2400256C2 RU 2400256 C2 RU2400256 C2 RU 2400256C2 RU 2008120126/15 A RU2008120126/15 A RU 2008120126/15A RU 2008120126 A RU2008120126 A RU 2008120126A RU 2400256 C2 RU2400256 C2 RU 2400256C2
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Russia
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medical device
implantable medical
group
ligand
vascular
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RU2008120126/15A
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English (en)
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RU2008120126A (ru
Inventor
Роберт Джон Джр. КОТТОНЕ (US)
Роберт Джон Джр. КОТТОНЕ
Стивен М. РОУЛЕНД (US)
Стивен М. РОУЛЕНД
Шерри ПАРКЕР (US)
Шерри ПАРКЕР
Мег ЙОКЛАВИЧ (US)
Мег ЙОКЛАВИЧ
Майкл Джон Брэдли КУТРЫК (CA)
Майкл Джон Брэдли КУТРЫК
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Орбуснеич Медикал, Инк.
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Abstract

Изобретение относится к медицине. Описано медицинское устройство для имплантации в сосуды или просветные структуры в теле, которое стимулирует положительную реконструкцию кровеносных сосудов. Медицинское устройство, такое как стент и синтетический трансплантат, покрыто фармацевтической композицией, состоящей из матрицы с контролируемым высвобождением одного или нескольких фармацевтических веществ, предназначенных для непосредственной доставки лекарственных средств в окружающие ткани. Кроме того, покрытие на медицинском устройстве содержит лиганд, такой как пептид, антитело или малая молекула, предназначенный для захвата эндотелиальных клеток-предшественников на контактирующей с кровью поверхности устройства для восстановления эндотелия на участке стеноза. В частности, покрытые лекарственным средством стенты предназначены для использования, например, в процедурах баллонной ангиопластики для предупреждения или ингибирования рестеноза. Устройство представляет собой биологически совместимую систему для доставки терапевтических средств локально безопасным и контролируемым образом. 23 з.п. ф-лы, 57 ил., 2 табл.

Description

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Claims (24)

1. Имплантируемое медицинское устройство, имеющее просветную поверхность и покрытие, отличающееся тем, что покрытие содержит один или несколько слоев неполимерной матрицы, одно или несколько фармацевтических веществ и лиганд, прикрепленный к указанной матрице и предназначенный для захвата циркулирующих клеток-предшественников на просветной поверхности указанного устройства после имплантации указанного медицинского устройства пациенту, при этом неполимерная матрица выполнена из пористого материала, содержащего наночастицы, где наночастицы содержат металл или металлический сплав.
2. Имплантируемое медицинское устройство по п.1, отличающееся тем, что медицинское устройство представляет собой стент, сосудистый трансплантат, синтетический трансплантат, сердечный клапан, катетер, сосудистый протезный фильтр, электрокардиостимулятор, отведение электрокардиостимулятора, дефибриллятор, перегородочное устройство для закрытия открытого овального окна, сосудистый клипс, окклюдатор для коррекции аневризмы сосудов, трансплантат для гемодиализа, катетер для гемодиализа, предсердно-желудочковый шунт, устройство или компоненты трансплантата для коррекции аневризмы аорты, венозный клапан, датчик, шов, клипс сосудистого анастомоза, постоянно находящийся внутри венозный или артериальный катетер, влагалище сосуда или канал доставки лекарственного средства.
3. Имплантируемое медицинское устройство по п.1, отличающееся тем, что лиганд выбирается из группы, состоящей из антитела, фрагмента антитела или их сочетания, белов, пептидов и малых молекул.
4. Имплантируемое медицинское устройство по п.1, отличающееся тем, что лиганд обладает специфичностью к ним и связывает антиген или молекулу клеточной мембраны, выбранные из группы, состоящей из CD 133, CD45, CD34, CD31, CD14, CDw90, CD117, VEGFR-1, VEGFR-2, Muc-18 (CD146), CD130, антигена стволовой клетки (Sca-1), фактора 1 стволовой клетки (SCF/c-Kit-лиганд), Tie-2, H-2Kk и HLA-DR главного комплекса гистосовместимости.
5. Имплантируемое медицинское устройство по п.1, отличающееся тем, что неполимерная матрица образована из наночастиц, создающих пористые отверстия диаметром примерно 5 нм - 5 мкм, а лиганд представляет собой антитело, фрагменты антитела или их комбинации.
6. Имплантируемое медицинское устройство по п.5, отличающееся тем, что антителом или фрагментом антитела является анти-С034 или анти-CD133.
7. Имплантируемое медицинское устройство по п.1, отличающееся тем, что одно фармацевтическое вещество или несколько фармацевтических веществ выбирается/выбираются из группы, состоящей из вазодилататоров, антибиотиков/противомикробных средств, антипролиферативных средств, противоопухолевых средств, антиоксидантов, факторов роста эндотелия, ингибиторов роста и/или миграции клеток гладкой мышцы, ингибиторов тромбина, иммуносупрессантов, средств против агрегации тромбоцитов, ингибиторов синтеза коллагена, терапевтических антител, доноров окиси азота, антисмысловых олигонуклеотидов, ранозаживляющих средств, конструктов переноса терапевтических генов, пептидов, белков, компонентов внеклеточного матрикса, тромболитических средств, антиметаболитов, агонистов фактора роста, антимиточеских средств, стероидов, стероидных противовоспалительных средств, хемокинов, агонистов рецептора-альфа, активированного пролифератором, агонистов рецептора-дельта, активированного пролифератором; агонистов рецептора-гамма, активированного пролифератором, нестероидных противовоспалительных средств, ингибиторов ангиотензин-превращающего фермента, утилизаторов свободных радикалов, ингибиторов семейства рецептора CX3CR1 и противораковых химиотерапевтических средств.
8. Имплантируемое медицинское устройство по п.1, отличающееся тем, что указанное одно или несколько фармацевтических веществ выбирается/выбираются из группы, состоящей из агонистов рецептора-альфа, активированного пролифератором пероксисом, агонистов рецептора-дельта, активированного пролифератором пероксисом; агониста рептора-гамма, активированного пролифератором пероксисом, кальцитонин ген-родственного пептида (a-CGRP), хемоаттрактантного белка-1 моноцитов, аденозина, простациклинов, тахикининов, сиалокининов, нейрокининов, ингибиторов ароматазы, активатора плазминогена, эритропоэтина, дарбепотина, сериновой протеиназы-1 (СЕПР-1) и металлопротеаз.
9. Имплантируемое медицинское устройство по п.5, отличающееся тем, что указанные вазодилататоры составляют примерно 1-99 мас.% композиции.
10. Имплантируемое медицинское устройство по п.5, отличающееся тем, что указанное покрытие на указанном медицинском устройстве содержит несколько слоев, содержащих один или несколько вазодилататоров.
11. Имплантируемое медицинское устройство по п.1, отличающееся тем, что указанное покрытие содержит один или несколько слоев полимерной матрицы, содержащей эластин, тропоэластин, поперечно-сшитый тропоэластин или их комбинации, одно или несколько фармацевтических веществ, лиганд, прикрепленный к указанной матрице и предназначенный для связывания с циркулирующими клетками-предшественниками на просветной поверхности устройства in vivo, и один или несколько фармацевтически приемлемых носителей.
12. Имплантируемое медицинское устройство по п.1, отличающееся тем, что циркулирующие клетки-предшественники представляют собой генетически модифицированную клетку, имеющую поверхностную молекулу для связывания с указанным лигандом in vivo, которая экспрессируется и кодируется из конструкта ДНК или РНК с одним или несколькими фармацевтическими веществами.
13. Имплантируемое медицинское устройство по п.12, отличающееся тем, что указанный конструкт ДНК или РНК кодирует простатический специфический белок и фактор роста эндотелия сосудов.
14. Имплантируемое медицинское устройство по п.11, отличающееся тем, что покрытие также содержит один или несколько барьерных слоев между указанным одним или несколькими слоями полимерной матрицы, содержащей указанные фармацевтические вещества.
15. Имплантируемое медицинское устройство по п.14, отличающееся тем, что барьерный слой содержит биодеградируемый и/или биоабсорбирующийся материал.
16. Имплантируемое медицинское устройство по п.15, отличающееся тем, что биодеградируемый материал представляет собой подходящий биодеградируемый полимер, выбранный из группы, состоящей из полиэфиров, поликарбоновой кислоты, полиангидридов, полиортоэфиров, полисахаридов, полиаминокислот, полиэтиленоксида, полифосфазенов, полимолочной кислоты, полигликолевой кислоты, полидиоксанона, полипропиленфумарата, полидепсипептидов, поликапролактона, поли-D,L-лактид-со-капролактона, поли поликарполактон-со-бутилакрилата, полигидроксибутирата валерата, поликарбонатов, кальция фосфатов, полигликозаминогликанов, белков и полипептидов.
17. Имплантируемое медицинское устройство по п.16, отличающееся тем, что полиэфирный полимер представляет собой полимолочную кислоту (PLA), полигликолевую кислоту (PGA), PLGA, полипропиленфумарат (PPF), поликарполактон (PCL), полимерцементный раствор (РСС), тетраметилоксициклогексанол (ТМС) и/или любой их сополимер.
18. Имплантируемое медицинское устройство по п.16, отличающееся тем, что полиангидриды представляют собой полимеры малеинового ангидрида.
19. Имплантируемое медицинское устройство по п.16, отличающееся тем, что поликарбонат представляет собой поликарбонаты, производные тирозина и/или арилаты, полииминокарбонаты, полидиметилтриметилкарбонаты или цианоакрилат.
20. Имплантируемое медицинское устройство по п.16, отличающееся тем, что полисахариды представляют собой один или несколько, выбранного или выбранных из группы, состоящей из гиалуроновой кислоты, целлюлозы, гидроксипропилметилцеллюлозы, желатина, крахмалов, декстранов, альгинатов и их производных.
21. Имплантируемое медицинское устройство по п.16, отличающееся тем, что сополимеры полилактида и полигликолевой кислоты выбираются из группы, состоящей из поли-L-молочной кислоты (PLLA), поли-D,L-лактида, сополимера полимолочной кислоты и гликолевой кислоты и 50/50 DL-лактид-со-гликолида.
22. Имплантируемое медицинское устройство по п.15, отличающееся тем, что биодеградируемый полимер представляет собой поверхностно разрушающийся полимер, выбранный из группы, состоящей из полигидроксибутирата и его сополимеров, поликапролактона, кристаллических или аморфных полиангидридов, сополимеров малеинового ангидрида и цинка-кальция фосфата.
23. Имплантируемое медицинское устройство по п.1 для использования при лечении болезни сосудов.
24. Имплантируемое медицинское устройство по п.1 для использования при лечении рестеноза.
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EP1948069A4 (en) 2011-10-19
IL190985A0 (en) 2008-12-29
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CN104013996A (zh) 2014-09-03
CA2626805C (en) 2016-05-17
CA2626805A1 (en) 2007-05-24
WO2007059253A3 (en) 2007-10-18
JP2009515659A (ja) 2009-04-16
EP1948069A2 (en) 2008-07-30
CN101309653A (zh) 2008-11-19
RU2008120126A (ru) 2009-12-27
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