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

• US 7,135,039 B2
• Filed: 03/06/2001
• Issued: 11/14/2006
• Est. Priority Date: 03/06/2000
• Status: Expired due to Fees

• Current Assignee: Advanced Laser Applications Holding S.A.
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: van der Leden, Natasja, Sohier, Jürgen, De Scheerder, Ivan, Van Humbeeck, Jan
• Primary Examiner(s): Stewart, Alvin J.
• Application Number:
  US09/798,990
• Publication Number:
  US 20020007209A1
• Time in Patent Office: 2,079 Days
• Field of Search: 623/1.15, 623/1.43, 623 139- 142, 623/1.34
• US Class Current: 623/1.42
• 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

The radially expandable prosthesis for implantation in a lumen comprises a tubular wall produced from sheet metal and showing cuts enabling the prosthesis to expand. By using water guided laser cutting technology to make these cuts and/or specific electrochemical polishing technology a more biocompatible prosthesis is obtained, causing less thrombogenicity and less foreign body reaction. By covering an intraluminal prosthesis with a titaniumnitride coating the biocompatibility of the prosthesis is improved. By applying perforating or non-perforating holes (4) and filling these holes with a therapeutic agent, the intraluminal prosthesis can be used to locally administer medicines, genes and or other substances to prevent in this way thrombotic occlusions and/or neointimal hyperplasia and prosthesis narrowing. Using this specific perforated prosthesis design the total drug capacity can be increased and also the drug release time prolongs significantly.

Claims

1. A radially expandable prosthesis for implantation in a lumen comprising a tubular wall showing an inner surface and an outer surface, the tubular wall is provided with cuts forming solid struts having a predetermined thickness and enabling the prosthesis to expand, said solid struts having a longitudinal direction and showing 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 being smaller than said outer opening, said outer opening 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.

2. The prosthesis as claimed in claim 1, wherein said length is substantially equal to said width.

3. The prosthesis as claimed in claim 2, wherein said outer opening is substantially circular.

4. The prosthesis as claimed in claim 1, wherein said width is larger than 30 μ

m.

5. The prosthesis as claimed in claim 1, wherein 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 outer opening being smaller than said strut width.

6. The prosthesis as claimed in claim 5, wherein the width of said outer opening comprises at most 60% of said strut width.

7. The prosthesis as claimed in claim 6, wherein the width of said outer opening comprises at most 50% of said strut width.

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

9. The prosthesis as claimed in claim 8, wherein said holes are divided on a substantially constant mutual distance on the struts.

10. The prosthesis as claimed in claim 1, wherein at least a bottom portion of said perforating hole narrows conically towards said inner opening.

11. The prosthesis as claimed in claim 1, wherein said length comprises at most three times said width.

12. The prosthesis as claimed in claim 1, wherein said width is smaller than 60 μ

m.

13. The prosthesis as claimed in claim 12, wherein said width is smaller than or equal to 50 μ

m.

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

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

16. The prosthesis as claimed in 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.

17. The prosthesis as claimed in claim 1, wherein the width of the outer opening of said perforating hole is smaller than the thickness of the solid strut.

18. A radially expandable prosthesis for implantation in a lumen comprising a tubular wall showing an inner surface and an outer surface, the tubular wall is provided with cuts forming solid struts having a predetermined thickness and enabling the prosthesis to expand, said solid struts having a longitudinal direction and showing 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 outer opening 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, wherein at least a bottom portion of said perforating hole narrows conically towards said inner opening.