Stent covered by a layer having a layer opening

• US 20050228482A1
• Filed: 09/23/2004
• Published: 10/13/2005
• Est. Priority Date: 09/26/2003
• Status: Abandoned Application

• Current Assignee: Miriam Lazur, William Herzog, Yi-Ju Zhao
• Original Assignee: Miriam Lazur, William Herzog, Yi-Ju Zhao
• Inventors: Herzog, William, Zhao, Yi-Ju, Lazur, Miriam
• Application Number:
  US10/950,307
• Publication Number:
  US 20050228482A1
• Time in Patent Office: Days
• US Class Current: 623/1.150
• 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 2002/91541 Adjacent bands are arranged out of phase
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir

Abstract

A drug eluting stent has a frame with at least one frame opening, and the frame is covered with an outer continuous layer and/or an inner continuous layer. The outer and/or inner layers further include a layer opening that at least partially overlaps with the frame opening to form a continuous opening having a size that allows endothelialization when the stent is implanted into a blood vessel.

Claims

1. A stent, comprising:

a cylindrical frame having an outer surface, an inner surface, and a plurality of frame openings extending from the outer surface to the inner surface;

at least one of a continuous inner layer coupled to the inner surface and having an inner layer opening, and a continuous outer layer coupled to the outer surface and having an outer layer opening;

wherein at least one of the frame openings, and at least one of the inner layer opening and the outer layer opening coincide such that an aperture is formed having a size sufficient to allow endothelialization, and

wherein a pharmaceutically active agent is associated with at least one of the inner layer, the inner surface, another one of the frame openings, the outer surface, and the outer layer.

2. The stent of claim 1 comprising the continuous inner layer and the continuous outer layer.

3. The stent of claim 1 wherein the pharmaceutically active agent is disposed onto the inner surface and the outer surface.

4. The stent of claim 1 wherein the pharmaceutically active agent is disposed within the another one of the frame openings.

5. The stent of claim 1 wherein the pharmaceutically active agent is covered by the inner layer.

6. The stent of claim 1 wherein the pharmaceutically active agent is covered by the outer layer.

7. The stent of claim 1 wherein the pharmaceutically active agent is disposed in a polymeric matrix that is coated onto the cylindrical frame and at least partially covered by the continuous outer layer.

8. The stent of claim 1 wherein the pharmaceutically active agent has an activity selected from the group consisting of modulation of vascular tone, inhibition of neutrophil adhesion, enhancement of macrophage-mediated microbial killing, inhibition of platelet adhesion, inhibition of platelet aggregation, and inhibition of smooth muscle cell proliferation.

9. The stent of claim 1 wherein at least one of the continuous inner and outer layers is fabricated from a material that allows diffusion of a gas and that prevents diffusion of a liquid.

10. The stent of claim 1 wherein at least one of the continuous inner and outer layers is fabricated from a fluorinated synthetic polymer.

11. The stent of claim 1 wherein the cylindrical frame, the inner layer, and the outer layer are fabricated from a material that allows radial expansion of the stent.

12. The stent of claim 1 wherein the cylindrical frame comprises a metal.

13. A composite stent having a cylindrical multilayer structure comprising an inner layer at least partially surrounded by a frame layer that is at least partially enclosed by an outer layer, and further comprising an opening extending through the multilayer structure, wherein the opening has a size sufficient to allow endothelialization when the composite stent is implanted into a blood vessel.

14. The composite stent of claim 13 further comprising a pharmaceutical agent that provides a pharmaceutically active compound to a site of implantation of the composite stent.

15. The composite stent of claim 14 wherein the pharmaceutical agent is present in a location selected from the group consisting of the inner layer, the outer layer, a surface of the frame layer, and a release layer that is located between the frame layer and at least one of the inner layer and the outer layer.

16. The composite stent of claim 13 wherein the pharmaceutically active compound is nitric oxide.

17. The composite stent of claim 13 wherein the opening has an area between about 5% and 25% of a total area of the composite stent.

18. The composite stent of claim 13 further comprising a frame layer opening that is at least partially covered by at least one of the outer layer and the inner layer.

19. The composite stent of claim 13 further comprising between one and twenty additional openings that have a size sufficient to allow endothelialization when the composite stent in implanted into the blood vessel.

20. The composite stent of claim 13 wherein the opening is part of a terminal circumference of the stent.