Stent device and method

• US 7,625,410 B2
• Filed: 01/23/2006
• Issued: 12/01/2009
• Est. Priority Date: 05/02/2001
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Alt, Eckhard
• Primary Examiner(s): Stewart; Alvin J
• Application Number:
  US11/338,452
• Publication Number:
  US 20060122690A1
• Time in Patent Office: 1,408 Days
• Field of Search: 623 142- 154, 623/1.13, 623/1.15
• US Class Current: 623/42
• 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 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/9155 Adjacent bands being connected to each other
• 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 2300/606 Coatings
• CPC Class Codes: A61L 31/088 Other specific inorganic materials not covered by A61L31/084 or A61L31/086
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/14 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61L 33/0076 Chemical modification of the substrate
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

A stent for delivering a therapeutic dose of the immnuosupressant tacrolimus is disclosed.

Claims

1. A stent having at least a portion which is implantable into the body of a subject comprising a surface and a coating comprising tacrolimus and a polymer, wherein at least a part of the stent is metallic and the coating is disposed on at least part of the metallic stent portion, and wherein the coating is formulated to deliver an intracellular level of tacrolimus in adjacent tissue of about 5 ng/ml of tissue to about 20 ng/ml of tissue while providing a systemic dosage that is 10^5-6 lower than needed for a systemic action.

2. The stent of claim 1, wherein the surface is porous.

3. The stent of claim 1, wherein the tacrolimus is uniformly distributed in the coating.

4. The stent of claim 1, wherein the coating comprises 20% by weight of tacrolimus.

5. The stent of claim 1, wherein the coating has a thickness of about 10 μ

m.

6. The stent of claim 1, wherein the dosage prevents conversion of smooth muscle cells at the stent implantation site to secretory smooth muscle cell types.

7. The stent of claim 1, wherein the polymer is non-biodegradable.

8. The stent of claim 1, wherein the polymer is biodegradable.

9. The stent of claim 1, wherein the polymer forms a biocompatible matrix to allow elution of the tacrolimus.

10. A method of preventing restenosis by implanting the stent of claim 1 into a body lumen.

11. A stent having at least a portion which is implantable into the body of a subject comprising an open-ended metallic tubular structure having a sidewall with apertures therein, wherein the sidewall comprises an outer surface having a coating disposed thereon, wherein the coating is formulated to deliver an intracellular level of tacrolimus in adjacent tissue of about 5 ng/ml of tissue to about 20 ng/ml of tissue while providing a systemic dosage that is 10^5-6 lower than needed for a systemic.

12. The stent of claim 11, wherein the dosage prevents conversion of smooth muscle cells at the stent implantation site to secretory smooth muscle cell types.

13. The stent of claim 11, wherein the polymer is non-biodegradable.

14. A method of preventing restenosis by implanting the stent of claim 11 into a body lumen.

15. The stent of claim 11, wherein the surface is porous.

16. The stent of claim 11, wherein the tacrolimus is uniformly distributed in the coating.

17. The stent of claim 11, wherein the coating comprises 20% by weight of tacrolimus.

18. The stent of claim 11, wherein the coating has a thickness of about 10 μ

m.

19. Ten stent of claim 11, wherein the polymer is biodegradable.

20. The stent of claim 11, wherein the polymer forms a biocompatible matrix to allow elution of the tacrolimus.