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1. WO2006115847 - COATED ENDOPROSTHESES

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[ EN ]

WHAT IS CLAIMED IS:

1. An implantable endoprosthesis comprising a tubular member having a coating comprising a polymeric material including a reaction product of a polyol, an isocyanate and a silsesquioxane having at least two pendent hydroxyl groups.

2. The implantable endoprosthesis of claim 1, wherein the coating includes a therapeutic agent.

3. The implantable endoprosthesis of claim 2, wherein the coating includes between about 1 percent by weight and about 35 by weight therapeutic agent.

4. The implantable endoprosthesis of claim 2, wherein the therapeutic agent inhibits restenosis.

5. The implantable endoprosthesis of claim 4, wherein the therapeutic agent that inhibits restenosis comprises paclitaxel.

6. The implantable endoprosthesis of claim 2, wherein the polymeric material fully releases its therapeutic agent in less than seven days in blood at body temperature.

7. The implantable endoprosthesis of claim 1, wherein the polymeric material fully degrades in less than 365 days in blood at body temperature.

8. The implantable endoprosthesis of claim 1, wherein the polyol is selected from the group consisting of be polyethylene glycol, polycaprolactone polyol, polycyclooctene polyol, trans- 1,4 butadiene polyol, transisoprene polyol, polynorbornene polyol, polymethacrylate copolymer polyol, polycaprolactone-polylactide copolymer polyol, polycaprolactone-polyglycolide copolymer polyol, polycaprolactone-polylactide-polyglycolide copolymer polyol, polylactide polyol, polycaprolactone-poly(β- hydroxybutyric acid) copolymer polyol, pory(β-hydroxybutyric acid) polyol, and mixtures thereof.

9. The implantable endoprosthesis of claim 1, wherein the polyol has only two pendent hydroxyl groups, and wherein the hydroxyl groups are disposed at ends of the polyol.

10. The implantable endoprosthesis of claim 1, wherein the isocyanate comprises a diisocyanate.

11. The implantable endoprosthesis of claim 10, wherein the diisocyanate is selected from the group consisting of 4,4'-diphenyl methylene diisocyanate, toluene-2,4-diisocyanate, toluene-2,6-diisocyanate, hexamethylene-l,6-diisocyanate, isophorone diisocyanate, and hydrogenated 4,4'-diphenylmethylene diisocyanate, and mixtures thereof.

12. The implantable endoprosthesis of claim 1, wherein the silsesquioxane selected from the group consisting l-(2-trans~cyclohexanedioi)ethyl-3, 5,7,9,11, 13,15-isobutylpentacyclo-[9.5.1.13'9.15'15. I7'13]octasiloxane, 2-ethyl-2-[3-[[(heptaisobutylpentacyclo-[9.5.1.13'9.15'15.17'13]octasiloxanyl)oxy]dimethylsilyl]-propoxy]propane-l,3-diol, l-(2,3-propanediol)propoxy-3,5,7,9,ll, 13,15-isobutylpentacyclo-[9.5.1.13'9.l5>15.l7ll3]octasiloxane, 2-ethyl-2-[3-[[(heptaisobutylpentacyclo-[9.5.1.13)9.l5'15.l7>13]octasiloxanyl)oxy]dimethylsilyl]-propoxy]methyl]-l,3-propanediol, and mixtures {hereof.

13. The implantable endoprosthesis of claim 1, wherein a weight ratio of the polyol to the silsesquioxane is from about 1:2 to about 1:30.

14. The implantable endoprosthesis of claim 1, wherein the coating has a thickness of between about 3 micron and about 50 micron before the implantable endoprosthesis is expanded.

15. The implantable endoprosthesis of claim 1, wherein a coverage of the polymeric material on the tubular member is from about 0.1 μg per square millimeter of surface area of the tubular member to about 10 μg per square millimeter of surface area of the tubular member.

16. The implantable endoprosthesis of claim 1, wherein the tubular member comprises a material selected from the group consisting of alloys, bioresorbable metals, metal oxides, bioresorbable polymers, and mixtures thereof.

17. The implantable endoprosthesis of claim 1, wherein the polymeric material has an absolute molecular weight of greater than about 50,000.

18. The implantable endoprosthesis of claim I5 wherein the polyol comprises
polycaprolactone-polylactide copolymer, and the silsesquioxane comprises 2-ethyl-2-[3-[[(heptaisobutylpentacyclo-[9.5.1.13'9.15'15.17<13]octasiloxanyl)oxy]dimethylsilyl]-propoxy]methyl]-l,3-propanediol.

19. The implantable endoprosthesis of claim 1, wherein the polyol has an absolute molecular weight of from about 5,000 to about 20,000.

20. The implantable endoprosthesis of claim 1, wherein the polymeric material has a glass transition temperature of less than 100 0C.

21. The implantable endoprosthesis of claim 1, wherein the polymeric material has a glass transition temperature of within about 10 0C of nominal human body temperature.

22. The implantable endoprosthesis of claim 1, wherein the polymeric material has a storage modulus at 25 0C of less than 1,000 MPa.

23. A method of treating a cavity or lumen in a mammal, the method comprising: inserting, into the lumen or cavity of the mammal, an implantable endoprosthesis comprising a tubular member having a coating comprising a polymeric material including a reaction product of a polyol, an isocyanate and a silsesquioxane having at least two pendent hydroxyl groups; and
expanding the implantable endoprosthesis within the cavity or lumen of the mammal.

24. The method of claim 23, wherein the expanding is performed with a balloon.

25. The method of claim 23, wherein the lumen is a vascular lumen.

26. An implantable endoprosthesis comprising a tubular member that is expandable from a first size to a second size and having a coating comprising a polymeric material and a therapeutic agent, wherein during expansion of the implantable endoprosthesis from a first size to a second size, the coating does not substantially crack.

27. The implantable endoprosthesis of claim 26, wherein the polymeric material comprises a reaction product of a polyol, an isocyanate and a silsesquioxane having at least two pendent hydroxyl groups.

28. An implantable endoprosthesis comprising a tubular member having a coating comprising a polymeric material and a therapeutic agent, wherein during routine chemical sterilization of the implantable endoprosthesis with ethylene oxide, the coating does not slough off the tubular member.

29. The implantable endoprosthesis of claim 28, wherein the polymeric material comprises a reaction product of a polyol, an isocyanate and a silsesquiqxane having at least two pendent hydroxyl groups.

30. An implantable endoprosthesis comprising a tubular member having a coating comprising a polymeric material including a reaction product of a polyol and an isocyanate.

31. The implantable endoprosthesis of claim 30, wherein the reaction product also includes a silsesquioxane having at least two pendent hydroxyl groups.

32. The implantable endoprosthesis of claim 30, wherein the coating includes a therapeutic agent.

33. An implantable endoprosthesis comprising a polymeric material including a reaction product of a polyol, an isocyanate and a silsesquioxane having at least two pendent hydroxyl groups.

34. The implantable endoprosthesis of claim 33, wherein the implantable endoprosthesis comprises a tubular member, and wherein the polymeric material forms a coating on the tubular member.

35. The implantable endoprosthesis of claim 34, wherein the tubular member is formed from a metal.

36. The implantable endoprosthesis of claim 35, wherein the metal is degradable or corrodible in biological systems.

37. The implantable endoprosthesis of claim 36, wherein the metal comprises magnesium or a magnesium alloy.