Method of polishing implantable medical devices to lower thrombogenecity and increase mechanical stability

• US 7,967,998 B2
• Filed: 01/03/2008
• Issued: 06/28/2011
• Est. Priority Date: 06/25/2003
• Status: Expired due to Fees

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories), Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Gale, David C., Hossainy, Syed F. A.
• Primary Examiner(s): Norton; Nadine G
• Assistant Examiner(s): Angadi; Maki A
• Application Number:
  US11/969,181
• Publication Number:
  US 20080099442A1
• Time in Patent Office: 1,272 Days
• Field of Search: 216/37, 216/39, 216/11, 216/88, 216/41, 216/103, 427/541, 427/98.8, 427/485, 623/1.15, 623/1.38, 623/901
• US Class Current: 216/83
• 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 2210/0004 bioabsorbable
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: Y10S 623/901 Method of manufacturing prosthetic device

Abstract

The present invention relates to a method of polishing an implantable medical device. The method may include positioning an implantable medical device on a support. At least a portion of a surface of the implantable medical device may include a polymer. A fluid may be contacted with at least a portion of the surface of the positioned implantable medical device. In an embodiment, the fluid may be capable of dissolving at least a portion of the polymer at or near the surface of the implantable medical device. The method may further include allowing the fluid to modify at least a portion of the surface of the positioned medical device. A majority of the contacted fluid may be removed from the surface of the implantable medical device. In certain embodiments, the modified portion of the surface may be substantially less thrombogenetic and substantially more mechanically stable than an unmodified surface.

Claims

1. A method of polishing an implantable medical device, comprising:

contacting a fluid with at least a portion of a surface of an implantable medical device, wherein at least a portion of the surface of the implantable medical device comprises a polymer, the fluid being capable of dissolving the polymer;

allowing the fluid to modify at least a portion of the surface of the implantable medical device; and

removing all or a majority of the contacted fluid from the surface of the implantable medical device, wherein the modified portion of the surface after removal of the contacted fluid is less thrombogenetic and more mechanically stable than an unmodified surface.

2. The method of claim 1, wherein the implantable medical device is a stent.

3. The method of claim 1, wherein the polymer comprises a bioabsorbable polymer.

4. The method of claim 1, wherein the polymer is selected from the group consisting of poly(N-acetylglucosamine), Chitoson, poly(trimethylene carbonate) and copolymers thereof, an ethylene vinyl alcohol copolymer, poly(butyl methacrylate), poly(vinylidene fluoride-co-hexafluoropropene), polyvinylidene fluoride, poly(L-lactic acid), poly(D,L-lactic acid), poly(caprolactone), an ethylene-vinyl acetate copolymer and polyethylene glycol.

5. The method of claim 1, wherein the fluid is allowed to modify the surface of the positioned implantable medical device for a selected period of time sufficient to reduce thrombogeneity and increase mechanical stability of the device.

6. The method of claim 1, further comprising removing at least some impurities at or near the surface of the implantable medical device prior to contacting the surface of the implantable medical device with the fluid.

7. The method of claim 1, wherein the fluid is selected from the group consisting of chloroform, acetone, chlorobenzene, ethyl acetate, 1,4-dioxane, ethylene dichloride, 2-ethylhexanol, and combinations thereof.

8. The method of claim 1, wherein the fluid comprises a mixture comprising at least two components, wherein the polymer is insoluble in at least one of the components.

9. The method of claim 1, wherein allowing the fluid to modify at least a portion of the surface of the implantable medical device comprises allowing the fluid to reduce and/or remove all or a substantial portion of features from the surface of the implantable medical device that facilitate thrombosis on or mechanical instability of the implantable medical device.

10. The method of claim 9, wherein the features comprise imperfections at or near the surface of the implantable medical device.

11. The method of claim 9, wherein the features comprise at least one jagged portion at or near the surface of the implantable medical device.

12. The method of claim 9, wherein the features comprise at least one pit at or near the surface of the implantable medical device.

13. The method of claim 9, wherein the features comprise at least one crack at or near the surface of the implantable medical device.

14. The method of claim 1, wherein allowing the fluid to modify at least a portion of the surface of the implantable medical device comprises allowing the fluid to dissolve at least a portion of the surface of the implantable medical device to form a polymer solution.

15. The method of claim 14, wherein allowing the fluid to modify at least a portion of the surface of the implantable medical device further comprises allowing the polymer solution to flow at or near the surface of the implantable medical device, and wherein the formation and flow of the polymer solution act to substantially or completely reduce and/or remove features that facilitate thrombosis on or mechanical instability of the implantable medical device.

16. The method of claim 1, wherein removing a majority of the contacted fluid from the surface of the implantable medical device comprises blowing an inert gas on the implantable medical device.

17. The method of claim 16, wherein removing a majority of the contacted fluid from the surface of the implantable medical device further comprises exposing the implantable medical device to heat and/or a vacuum.

18. The method of claim 1, wherein the polymer surface contains a drug and the fluid is a non-solvent for the drug.