Intraluminar perforated radially expandable drug delivery prosthesis and a method for the production thereof

• US 20060129231A1
• Filed: 02/14/2006
• Published: 06/15/2006
• Est. Priority Date: 03/06/2000
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Sohier, Jurgen, De Scheerder, Ivan, Van Humbeeck, Jan, van der Leden, Natasja
• Granted Patent: US 7,789,907 B2
• Time in Patent Office: Days
• US Class Current: 623/1.160
• 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 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61L 2300/00 Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
• CPC Class Codes: A61L 2400/18 Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
• CPC Class Codes: A61L 31/022 Metals or alloys
• CPC Class Codes: A61L 31/088 Other specific inorganic materials not covered by A61L31/084 or A61L31/086
• CPC Class Codes: Y10T 29/49996 Successive distinct removal operations

Abstract

A radially expandable prosthesis for implantation in a lumen comprises a tubular wall having an inner surface and an outer surface. The tubular wall is provided with cuts to form solid struts which have a thickness and which enables the prosthesis to expand. The solid struts have reservoirs made therethrough in the form of perforating holes for containing a therapeutic agent. The perforating holes each have an inner opening and an outer opening of substantially the same size. The prosthesis, including said perforating holes, has a smooth electrochemically polished surface.

Claims

1. A radially expandable prosthesis for implantation in a lumen comprising a tubular wall having an inner surface and an outer surface, the tubular wall provided with cuts forming solid struts having a predetermined thickness and enabling the prosthesis to expand, said solid struts having a longitudinal direction and having reservoirs made in said outer surface for containing a therapeutic agent, wherein at least a number of said reservoirs are perforating holes over the entire thickness of the strut through the strut to form an outer opening at the outer surface of the tubular wall and an inner opening at the inner surface of the tubular wall, said inner opening having a size and said outer opening having a size, the size of the inner opening being substantially the same as the size of the outer opening, the prosthesis, including said perforating holes, having a smooth electrochemically polished surface.

2. The prosthesis of claim 1 wherein said inner opening and said outer opening each comprise a width, measured perpendicularly to said longitudinal direction, larger than 20 μ

m but smaller than 100 μ

m and a length, measured in said longitudinal direction, at most five times said width

3. The prosthesis of claim 2, wherein said length is substantially equal to said width.

4. The prosthesis of claim 2, wherein said width is larger than 30 μ

m.

5. The prosthesis of claim 2, wherein each of said inner opening and said outer opening is situated in one of said struts having a strut width defined as measured between a first longitudinal edge of the outer surface of the strut and a second longitudinal edge of said outer surface, the width of said inner opening and said outer opening being smaller than said strut width.

6. The prosthesis of claim 1, wherein said perforating holes are divided according to the longitudinal directions of the struts on said struts.

7. The prosthesis of claim 2, wherein said length comprises at most three times said width.

8. The prosthesis of claim 3, wherein said inner opening and said outer opening are substantially circular.

9. The prosthesis of claim 2, wherein said width is smaller than 60 μ

m.

10. The prosthesis of claim 9, wherein said width is smaller than or equal to 50 μ

m.

11. The prosthesis of claim 5, wherein the width of said inner opening and said outer opening respectively comprise at most 60% of said strut width.

12. The prosthesis of claim 11, wherein the width of said outer opening comprises at most 50% of said strut width.

13. The prosthesis of claim 6, wherein said holes are divided on a substantially constant mutual distance on the struts.

14. The prosthesis of claim 1 further comprising an effective amount of at least one therapeutic agent.

15. The prosthesis of claim 14, wherein said therapeutic agent is only contained in said perforating holes.

16. The prosthesis of claim 2, wherein the width of one of the inner opening and the outer opening of said perforating hole is smaller than the thickness of the solid strut.

17. The prosthesis of claim 14 further comprising a coating containing the therapeutic agent on the surface of the prosthesis, the amount of the therapeutic agent in said holes being one hundred to one thousand times the amount in said coating.

18. The prosthesis of claim 14 further comprising at least one polymer layer wherein the at least one therapeutic agent is provided in a releasable combination with the at least one polymer.

19. The prosthesis of claim 18 wherein the releasable combination comprises a plurality of layers.

20. The prosthesis of claim 19 further comprising at least one barrier layer.

21. The prosthesis of claim 18 wherein the at least one polymer layer is bioabsorbable.

22. The prosthesis of claim 21 wherein the at least one polymer layer comprises poly(lactide-co-glycolide).

23. The prosthesis of claim 1 wherein said outer opening is defined by an outer edge, wherein the outer edge is beveled relative to the outer surface of the tubular wall.

24. The prosthesis of claim 23 wherein said inner opening is defined by an inner edge, wherein the inner edge is beveled relative to the inner surface of the tubular wall.

25. A radially expandable prosthesis for implantation in a lumen comprising a tubular wall having an inner surface and an outer surface, the tubular wall being provided with cuts forming solid struts having a predetermined thickness and enabling the prosthesis to expand, said solid struts having a longitudinal direction and having reservoirs made in the outer surface for containing a therapeutic agent, wherein at least a number of said reservoirs are through holes extending through the entire thickness of the strut to form an outer opening at the outer surface of the tubular wall and an inner opening at the inner surface of the tubular wall which are substantially the same size, the inner opening and the outer opening each having a width, measured perpendicularly to said longitudinal direction, larger than 20 μ

m but smaller than 100 μ

m and a length, measured in said longitudinal direction, at most five times said width, the prosthesis, including said perforating holes, having a smooth electrochemically polished surface.

26. The prosthesis of claim 25 further comprising an effective amount of at least one therapeutic agent, the at least one therapeutic agent being positioned at least partially within the reservoirs.

27. The prosthesis of claim 26 further comprising a concentration of the at least one therapeutic agent, the concentration being greatest in the through holes.