Therapeutic intraluminal stents

• US 5,833,651 A
• Filed: 11/08/1996
• Issued: 11/10/1998
• Est. Priority Date: 11/08/1996
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Donovan, Maura G., Stein, Paul M.
• Primary Examiner(s): YASKO JR, JOHN D
• Application Number:
  US08/746,404
• Time in Patent Office: 732 Days
• Field of Search: 604/21, 604/52, 604/53, 604/265, 604/266, 604/49, 606/191-199, 606/198, 623/1, 623/11, 623/12
• US Class Current: 604/509
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: C12N 15/87 Introduction of foreign genetic material using processes not otherwise provided for, e.g. co-transformation

Abstract

This invention relates to an intraluminal stent having a lumen-wall contacting surface and a lumen-exposed surface wherein the stent comprises a first polymer composition comprising fibrin and wherein the stent is suitable to deliver virus to the wall of a lumen of the body. The invention also relates to methods for making the stent and to methods for delivering nucleic acid to cells accessible from a wall of a body lumen.

Claims

1. An intraluminal stent comprising:

a lumen-wall contacting surface;

a lumen-exposed surface;

a first polymer composition comprising fibrin, the composition covering at least a portion of the lumen-wall contacting surface of the stent; and

a virus, comprising nucleic acid, capable of delivering the nucleic acid to a cell wherein the virus is associated with the first polymer composition covering the lumen-wall contacting surface.

2. The device of claim 1, wherein the first polymer composition includes a polymer or copolymer that is viscoelastic, tear-resistant, and biocompatible.

3. The device of claim 2, wherein the first polymer composition is nonthrombogenic.

4. The device of claim 3, wherein the first polymer composition is capable of dehydration and rehydration.

5. The device of claim 1, wherein the first polymer composition additionally comprises another polymer selected from the group consisting of alginate, collagen, hyaluronic acid, polyurethane and cellulose.

6. The device of claim 1, wherein the virus is an adenovirus.

7. The device of claim 1, wherein the virus is a retrovirus.

8. The device of claim 1, wherein the nucleic acid is capable of directing expression of a protein in a cell.

9. The device of claim 1, wherein the nucleic acid is RNA.

10. The device of claim 1, wherein the nucleic acid is DNA.

11. The device of claim 1, wherein the stent further comprises a second polymer composition covering at least a portion of the first polymer composition on the lumen wall-contacting surface.

12. The device of claim 11, wherein the stent further comprises a third polymer composition covering at least a part of the lumen-exposed surface of the stent.

13. The device of claim 11, wherein the second polymer composition is biodegradable.

14. The device of claim 11, wherein the second polymer composition comprises fibrin.

15. The device of claim 13, wherein the second polymer composition comprises polylactic acid.

16. The device of claim 11, wherein the second polymer composition further comprises an anti-inflammatory compound.

17. The device of claim 16, wherein the anti-inflammatory compound is a cyclosporin.

18. The device of claim 1, wherein the stent further comprises a polymer composition covering at least a part of the lumen-exposed surface of the stent.

19. The device of claim 18 wherein the device further comprises a negatively charged polymer composition covering the lumen-exposed surface of the stent.

20. The device of claim 19 wherein the negatively charged polymer composition is selected from the group consisting of a mucopolysaccharide, dextran-sulfate, an acrylic acid polymer, polyinosinic acid and heparin or a polymer composition comprising a combination thereof.

21. A method for delivering nucleic acid to cells accessible from a wall of a body lumen comprising the steps of:

providing a stent comprising a lumen-wall contacting surface, a lumen-exposed surface, a first polymer composition comprising fibrin covering at least a portion of the lumen-wall contacting surface to form a polymer covered stent; and

virus comprising nucleic acid associated with the first polymer composition wherein the stent is capable of delivering nucleic acid to cells accessible from a wall of a body lumen;

positioning the stent in a lumen of the body; and

contacting the lumen-wall contacting surface of the stent with the wall of a lumen of the body.

22. The method of claim 21, wherein the lumen-wall contacting surface is a portion of a wall of a blood vessel.

23. The method of claim 21, wherein the lumen-wall contacting surface is a portion of a wall of a lymph vessel.

24. The method of claim 21, wherein the lumen-wall contacting surface is a portion of a wall of an intestine.

25. The method of claim 21, wherein the lumen-wall contacting surface is a portion of a wall of a respiratory airway.

26. The method of claim 21, wherein the positioning step further comprises introducing the stent into a lumen of the body using a catheter.

27. The method of claim 21, wherein the positioning step further comprises introducing the stent into a lumen of the body by surgical implantation.

28. The method of claim 21, wherein the method further comprises applying a biodegradable polymer composition to at least a portion of the lumen-wall contacting surface following the loading step.

29. A kit comprising:

a stent comprising a lumen-wall contacting surface, a lumen-exposed surface, and a first polymer composition comprising fibrin covering at least a portion of the lumen-wall contacting surface of the stent;

a virus-loading solution to be applied to the stent; and

a container to house the stent and the solution during application of the virus loading solution.

30. The kit of claim 29, further comprising virus.