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

• US 8,663,317 B2
• Filed: 09/14/2012
• Issued: 03/04/2014
• Est. Priority Date: 03/06/2000
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: De Scheerder, Ivan, Sohier, Jurgen, van der Leden, Natasja, Van Humbeeck, Jan
• Primary Examiner(s): Stewart, Alvin J.
• Application Number:
  US13/616,251
• Publication Number:
  US 20130004650A1
• Time in Patent Office: 536 Days
• Field of Search: 623/1.111, 623/1.15, 623/1.12, 623 118- 12, 623 139- 146, 623 237- 2376, 216/53, 216/57, 219/121.84, 219/121.67, 219/121.72, 219/121.69, 219/121.7, 424422-426
• 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

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 method of preparing a radially expandable prosthesis comprising:

providing a metallic blank;

lasing the metallic blank with a liquid guided laser to produce a plurality of struts and a plurality of blind holes in the metallic blank, thereby forming the prosthesis from the metallic blank, the liquid guided laser emitting liquid at a pressure between 20 and 500 bars;

electrochemically polishing the prosthesis; and

applying a therapeutic agent to at least a portion of the prosthesis.

2. The method of claim 1 further comprising covering the prosthesis with a titanium nitride coating having a thickness between 0.1 and 500 μ

m.

3. The method of claim 1 further comprising covering the prosthesis with a porous tin coating.

4. The method of claim 3, wherein covering the prosthesis comprises applying the porous tin coating via physical vapor deposition.

5. The method of claim 3, wherein covering the prosthesis comprises applying the porous tin coating via chemical vapor deposition.

6. The method of claim 1, wherein the step of electrochemically polishing comprises providing an electrochemical solution, the electrochemical solution comprising perchloric acid and carboxylic acid.

7. The method of claim 1, wherein the step of electrochemically polishing comprises providing an electrochemical solution, the electrochemical solution comprising sulfuric acid and hydrofluoric acid.

8. The method of claim 1 further comprising pickling the prosthesis with a solution comprising hydrofluoric acid and nitric acid.

9. The method of claim 1, wherein the step of electrochemically polishing comprises providing an electrochemical solution, the electrochemical solution comprising 20 to 80 volume parts of a 95 to 97% by weight sulfuric acid solution, 5 to 20 volume parts of a 48 to 51% by weight hydrofluoric acid solution, and 10 to 30 volume parts of a 99.8% by weight acetic acide solution.

10. The method of claim 1 further comprising checking surface smoothness of the prosthesis with scanning electron microscopy.

11. The method of claim 1, wherein the blind holes are conical.

12. The method of claim 1, wherein the laser has a nozzle, the nozzle having an inner diameter of 20 to 100 μ

m.

13. The method of claim 12, wherein the liquid guided laser emits liquid at a pressure of 150 bars.

14. The method of claim 1, wherein the laser has a nozzle, the nozzle having an inner diameter of 40 to 60 μ

m.

15. The method of claim 1 further comprising cleaning the stent with an ultrasonic cleaner.

16. The method of claim 1, wherein the liquid guided laser emits liquid at a pressure between 100 and 300 bars.