Coated medical device and method for manufacturing the same

• US 8,281,737 B2
• Filed: 03/09/2004
• Issued: 10/09/2012
• Est. Priority Date: 03/10/2003
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Austin, Michael, Robinson, Don, Boulais, Dennis R., Kulkarni, Praveen, Freyman, Toby, Epstein, Samuel J., Naimark, Wendy, Schwarz, Marlene
• Primary Examiner(s): EDWARDS, LAURA ESTELLE
• Application Number:
  US10/797,704
• Publication Number:
  US 20050015142A1
• Time in Patent Office: 3,136 Days
• Field of Search: 118/249, 118/261, 118/203, 118/642, 118/63, 118/DIG.3, 118/216, 118/255, 427/2.24, 427/2.25, 427/428.15
• US Class Current: 118/261
• 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 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 2420/08 Coatings comprising two or more layers
• 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: B05C 1/022 to the outer surface of hollow articles B05C1/027 takes precedence
• CPC Class Codes: B05C 1/08 using a roller or other rotating member which contacts the work along a generating line
• CPC Class Codes: B05C 1/0813 characterised by means for supplying liquid or other fluent material to the roller
• CPC Class Codes: B05C 1/0817 characterised by means for removing partially liquid or other fluent material from the roller, e.g. scrapers coating roller co-operating with dosing rollers B05C1/0834
• CPC Class Codes: B05C 1/14 using a travelling band
• CPC Class Codes: B05D 1/28 performed by transfer from the surfaces of elements carrying the liquid or other fluent material, e.g. brushes, pads, rollers

Abstract

The medical device of the invention comprises a surface comprising at least one outermost portion and a plurality of depressions. The depressions occupy at least about 80% of the surface area of the surface. The depressions contain a coating material that preferably comprises a biologically active material and/or polymer, and the outermost portion is substantially free of any coating material. The invention is also directed to a method for manufacturing a medical device. The method comprises applying a coating material to the surface of the medical device by using at least one roller.

Claims

1. A system for coating a stent having a tubular portion with an outer surface, wherein the system comprises:

a coating material source containing a coating material comprising a solvent and a biologically active material;

a first roller having a surface;

a doctor blade in proximity to the first roller surface positioned to remove excess coating material from the first roller surface; and

a second roller having a surface, wherein;

the first roller is situated relative to the coating material source so that the coating material in the coating material source is transferred to the first roller surface;

the first roller and second roller are situated relative to each other so that the first roller transfers the coating material transferred to the first roller surface to the second roller surface, and

the second roller is situated relative to the tubular portion so that the second roller transfers the coating material transferred to the second roller surface to the outer surface of the tubular portion.

2. The system of claim 1, which further comprises a reservoir that continuously supplies the coating material source with coating material.

3. The system of claim 2, wherein the reservoir is a fermentor containing cells.

4. The system of claim 2, wherein the coating material is circulated between the reservoir and the coating material source.

5. The system of claim 1 wherein the surface of the second roller comprises a plurality of grooves.

6. The system of claim 1, wherein the surface of the second roller is rougher than the surface of the first roller.

7. The system of claim 1, wherein the surface of the first roller contacts the surface of the second roller and the surface of the second roller contacts the outer surface of the tubular portion.

8. The system of claim 1, further comprising a supplemental mechanism for removing excess coating material from the surface of the first roller.

9. The system of claim 8, wherein the supplemental mechanism is at least one of a metering roller or an air knife.

10. The system of claim 1, further comprising an energy source for converting the coating material applied to the outer surface of the tubular portion into a coating.

11. The system of claim 10, wherein the energy source is a heater.

12. The system of claim 10, wherein the energy source is an ultraviolet source.

13. The system of claim 1, wherein the biologically active material comprises a genetic material.

14. The system of claim 1, wherein the biologically active material comprises an antibiotic or an antiproliferative agent.

15. The system of claim 1, wherein said first roller surface comprises an outer surface.

16. The system of claim 1, wherein a distance between the first roller and the second roller is adjustable to control the thickness of the coating material.