Stent device and method

• US 7,011,680 B2
• Filed: 05/22/2003
• Issued: 03/14/2006
• Est. Priority Date: 05/02/2001
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: InFlow Dynamics, Inc. (Boston Scientific Corporation)
• Inventors: Alt, Eckhard
• Primary Examiner(s): Stewart, Alvin J.
• Application Number:
  US10/443,266
• Publication Number:
  US 20040019376A1
• Time in Patent Office: 1,027 Days
• Field of Search: 623 142- 148
• US Class Current: 623/1.42
• 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 for implantation into body tissue comprising a surface and a coating disposed on the surface, wherein the coating comprises tacrolimus or an analogue thereof and a polymer, and wherein the coating releases a dosage of about 10 to 20 nanograms of the tacrolimus or analogue thereof per milliliter of blood volume at a selected stent implantation site to allow normal wound healing to occur while concurrently limiting an inflammatory response that would result in restenosis at the stent implantation site.

2. 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.

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

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

5. The stent of claim 1, wherein the polymer forms a biocompatible matrix to allow elution of the tacrolimus or analogue thereof.

6. A stent for implantation into a body of a patient comprising a surface and a coating disposed on the surface, wherein the coating comprises tacrolimus or an analogue thereof in a polymer, and wherein the coating is adapted to release a dosage of about 10 to 20 nanograms of the tacrolimus or analogue thereof per milliliter of blood volume at a selected stent implantation site to concurrently achieve:

(i) an immunosuppressive response sufficient to inhibit rejection of the stent by the body;

(ii) an anti-inflammatory response sufficient to inhibit stenosis at the stent implantation site; and

(iii) an anti-proliferative effect insufficient to compromise the body'"'"'s natural wound healing response at the stent implantation site,

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 6, wherein the polymer is non-biodegradable.

8. The stent of claim 6, wherein the polymer is biodegradable.

9. The stent of claim 6, wherein the polymer forms a biocompatible matrix to allow elution of the tacrolimus or analogue thereof.

10. A method of preventing restenosis by implanting the stent of claim 6 into a body lumen.

11. A stent for implantation into body tissue comprising an open-ended tubular structure having a sidewall with apertures therein, wherein:

the sidewall comprises an outer surface having a coating disposed thereon;

the coating comprises tacrolimus or an analogue thereof and a polymer, and

the coating releases a dosage of about 10 to 20 nanograms of the tacrolimus or analogue thereof per milliliter of blood volume at a selected stent implantation site to allow normal wound healing to occur while concurrently limiting an inflammatory response that would result in restenosis at the stent implantation site.

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

15. The stent of claim 11, wherein the polymer forms a biocompatible matrix to allow elution of the tacrolimus or analogue thereof.

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

17. A method of preventing restenosis comprising implanting a stent into a body lumen, wherein the stent comprises a surface and a coating disposed on the surface, wherein the coating comprises tacrolimus or an analogue thereof and a polymer, and wherein the coating releases a dosage of about 10 to 20 nanograms of the tacrolimus or analogue thereof per each milliliter of blood volume at the body lumen to allow normal wound healing to occur while concurrently limiting an inflammatory response that would result in restenosis at the body lumen.

18. The method of claim 17, wherein the dosage prevents conversion of smooth muscle cells at the stent implantation site to secretory smooth muscle cell types.

19. The method of claim 17, wherein the polymer is non-biodegradable.

20. The method of claim 17, wherein the polymer is biodegradable.

21. The method of claim 17, wherein the polymer forms a biocompatible matrix to allow elution of the tacrolimus or analogue thereof.