Intralumenal drug eluting prosthesis

• US 5,871,535 A
• Filed: 04/27/1995
• Issued: 02/16/1999
• Est. Priority Date: 02/28/1990
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Hull, Vincent W., Wolff, Rodney G.
• Primary Examiner(s): Yu, Mickey
• Assistant Examiner(s): CUDDIHY, FRANCIS KEVIN
• Application Number:
  US08/430,009
• Time in Patent Office: 1,391 Days
• Field of Search: 600/36, 606/191-200, 623/1, 623/11-12
• US Class Current: 128/898
• CPC Class Codes: A61F 2/852 Two or more distinct overlapping stents
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2250/0048 differing in mechanical expandability, e.g. in mechanical, self- or balloon expandability
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: D04C 1/02 made from particular materials
• CPC Class Codes: D10B 2509/06 Vascular grafts; stents

Abstract

A prosthesis for insertion into a lumen to limit restenosis of the lumen. The prosthesis carries restenosis-limiting drugs which elute after the device is positioned in the lumen.

Claims

1. A method for administration of a drug to the interior of a body lumen comprising:

(a) providing a catheter having mounted thereon a tubular, open-ended body including supporting elements and a preformed, flexible, polymeric element comprising at least one polymeric filament with an incorporated drug attached to the supporting elements and exposed at an exterior surface of the tubular body;

(b) inserting the catheter and tubular body into the selected portion of a body lumen to be treated;

(c) expanding the tubular body radially into contact with the wall of the selected portion of the body lumen such that a portion of the polymeric filament contacts the body lumen wall; and

(d) removing the catheter from the body lumen such that the tubular body with supporting elements and polymeric filament remains in the body lumen in contact with the body lumen wall.

2. The method of claim 1 wherein the tubular body is radially expanded by a balloon.

3. The method of claim 1 wherein the tubular body is expanded radially by axially moving a first end of the tubular body with respect to a second end of the tubular body.

4. The method of claim 1 wherein the polymeric filament includes a bioabsorbable polymer.

5. The method of claim 4 wherein the bioabsorbable polymer is selected from the group consisting of polylactic acid, polyglycolic acid, polyanhydride, and polyphosphate ester.

6. The method of claim 1 wherein the polymeric filament includes a biostable polymer.

7. The method of claim 6 wherein the biostable polymer is selected from the group consisting of silicone and polyurethane.

8. The method of claim 1 wherein the incorporated drug is an antiplatelet drug.

9. The method of claim 1 wherein the incorporated drug is an anticoagulant drug.

10. The method of claim 9 wherein the anticoagulant drug is selected from the group consisting of heparin, coumadin, protamine and hirudin.

11. The method of claim 1 wherein the incorporated drug is an anti-replicate drug.

12. The method of claim 11 wherein the anti-replicate drug is selected from the group consisting of methotrexate, colchicine, azathioprine, vincristine, vinblastine, fluorouracil, adriamycin, and mutamycin.

13. The method of claim 1 wherein the incorporated drug is an anti-inflammatory drug.

14. The method of claim 13 wherein the anti-inflammatory drug is a glucocorticoid.

15. The method of claim 1 wherein the filament is adapted to release the incorporated drug in the body lumen over a period of 4 to 6 months.

16. The method of claim 1 wherein the filament is adapted to release the incorporated drug by elution of the drug.

17. The method of claim 1 wherein the filament is adapted to degrade in the body lumen to release the incorporated drug.

18. The method of claim 1 wherein the polymeric filament is attached to the supporting elements by weaving the filament into the supporting elements.

19. The method of claim 1 wherein a plurality of polymeric filaments are woven together.

20. The method of claim 1 wherein the polymeric filament is wound around the tubular body.

21. The method of claim 20 wherein the polymeric filament is helically wound around the tubular body.

22. The method of claim 1 wherein the bonding of the polymeric filament and the support structure is accomplished by bonding them together at a juncture.

23. The method of claim 22 wherein the bonding is accomplished by heating the polymeric filament.

24. The method of claim 1 wherein the polymeric filament includes multiple polymer layers.

25. The method of claim 24 wherein the polymeric filament includes a drug-containing inner layer and an outer barrier layer.

26. The method of claim 25 wherein the barrier layer includes a polymer selected from the group consisting of silicone and polyurethane.

27. The method of claim 1 also comprising the step of retaining the polymeric filament in contact with the luminal wall until tissue overgrowth causes the polymeric filament to grow into the luminal wall.

28. A method for administration of a drug to the interior of a body lumen comprising:

(a) providing a catheter having a stent mounted thereon and a preformed, flexible, polymeric element comprising at least one polymeric filament with an incorporated drug attached to the stent and exposed at an exterior surface of the stent;

(b) inserting the catheter and stent into the selected portion of a body lumen to be treated;

(c) expanding the stent radially into contact with the wall of the selected portion of the body lumen such that a portion of the polymeric filament contacts the body lumen wall; and

(d) removing the catheter from the body lumen such that the stent with polymeric filament remains in the body lumen in contact with the body lumen wall.

29. The method of claim 28 wherein the polymeric filament includes a biostable polymer.

30. The method of claim 29 wherein the biostable polymer is selected from the group consisting of silicone and polyurethane.

31. The method of claim 28 wherein the incorporated drug is an antiplatelet drug.

32. The method of claim 28 wherein the incorporated drug is an anticoagulant drug.

33. The method of claim 32 wherein the anticoagulant drug is selected from the group consisting of heparin, coumadin, protamine and hirudin.

34. The method of claim 28 wherein the incorporated drug is an anti-replicate drug.

35. The method of claim 34 wherein the anti-replicate drug is selected from the group consisting of methotrexate, colchicine, azathioprine, vincristine, vinblastine, fluorouracil, adriamycin, and mutamycin.

36. The method of claim 28 wherein the incorporated drug is an anti-inflammatory drug.

37. The method of claim 36 wherein the anti-inflammatory drug is a glucocorticoid.

38. The method of claim 28 wherein the filament is adapted to release the incorporated drug in the body lumen over a period of 4 to 6 months.

39. The method of claim 28 wherein the filament is adapted to release the incorporated drug by elution of the drug.

40. The method of claim 28 wherein the filament is adapted to degrade in the body lumen to release the incorporated drug.

41. The method of claim 28 wherein the polymeric filament is attached to the stent by weaving the filament into the stent.

42. The method of claim 28 wherein a plurality of polymeric filaments are woven together.

43. The method of claim 28 wherein the polymeric filament is wound onto the stent.

44. The method of claim 43 wherein the polymeric filament is helically wound onto the stent.

45. The method of claim 28 wherein the bonding of the polymeric filament and the support structure is accomplished by bonding them together at a juncture.

46. The method of claim 45 wherein the bonding is accomplished by heating the polymeric filament.

47. The method of claim 28 wherein the polymeric filament includes multiple polymer layers.

48. The method of claim 47 wherein the polymeric filament includes a drug-containing inner layer and an outer barrier layer.

49. The method of claim 48 wherein the barrier layer includes a polymer selected from the group consisting of silicone and polyurethane.

50. The method of claim 28 also comprising the step of retaining the polymeric filament in contact with the luminal wall until tissue overgrowth causes the polymeric filament to grow into the luminal wall.