Intravascular stent and method for conditioning the surfaces thereof

• US 5,344,425 A
• Filed: 02/06/1992
• Issued: 09/06/1994
• Est. Priority Date: 09/14/1990
• Status: Expired due to Fees

• Current Assignee: Interface Biomedical Laboratories Incorporated
• Original Assignee: Interface Biomedical Laboratories Corp.
• Inventors: Sawyer, Philip N.
• Primary Examiner(s): Thaler, Michael H.
• Application Number:
  US07/832,199
• Time in Patent Office: 943 Days
• Field of Search: 606/191, 606/198, 600/36, 623/901, 623/1, 623/12
• US Class Current: 606/198
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2250/0036 differing in thickness
• CPC Class Codes: Y10S 623/901 Method of manufacturing prosthetic device
• CPC Class Codes: Y10S 623/921 Blood vessel

Abstract

An anti-turbulent, anti-thrombogenic intravascular stent of a helically shaped titanium or aluminum strip having an airfoil on internal surfaces thereof for increasing blood flow through the stent without creating areas of stagnant or turbulent flow therein. Also, a method for cleaning the stent for optimum performance in the intended application, and the stents which are cleaned by the process, and novel devices for introducing the stents of the invention into the body of a patient.

Claims

1. A method for preparing a titanium stent by conditioning the surfaces thereof prior to introduction into the body of a subject, which comprises:

forming a stent by cutting or machining a titanium strip to a desired size and configuration;

cleaning the surfaces of the stent to remove dirt and organic material therefrom;

pickling the cleaned stent with an oxidizing acid to provide a substantially uniform oxide layer thereon;

electrochemically polishing the surfaces of the pickled stent;

removing oxides from the surfaces of the stent after the polishing step by treatment with an acidic solution; and

retaining the stent in a substantially oxygen free environment after the oxide-removing step until use thereof.

2. The method of claim 1 wherein the pickling step comprises treating the surfaces of the stent with nitric acid, hydrofluoric acid, or mixtures thereof.

5. The method of claim 2 wherein the stent is retained in a solution of substantially oxygen free distilled water or in the presence of an inert gas.

6. The method of claim 1 wherein the dirt and organic substances are removed from the surfaces of the stent by immersing the stent into a detergent solution.

7. The method of claim 6 which further comprises washing the stent after detergent cleaning and thereafter subjecting the washed stent to the surface polishing step wherein the stent is electrochemically cleaned in a basic solution.

8. The method of claim 7 which further comprises washing the electrochemically cleaned stent and thereafter subjecting the cleaned stent to the oxide removal step wherein the stent is immersed into an acidic solution.

9. The method of claim 8 which further comprises washing the stent after immersion into the acidic solution with a first solution of substantially oxygen free distilled water prior to retaining the stent in a second solution of substantially oxygen free distilled water or in the presence of an inert gas.

10. The method of claim 14 which further comprises forming the stent of titanium;

selecting the basic solution to include concentrated sodium hydroxide;

selecting the electrochemically cleaning step to include electrically connecting the stent to a source of electrons to cathodically clean the surfaces thereof; and

selecting the acid solution to be concentrated hydrochloric acid.

11. The method of claim 6 which further comprises selecting the oxidizing acid for the pickling step to be a strong inorganic acid.

12. The method of claim 11 wherein the detergent solution comprises a concentrated liquid detergent, and the stent is immersed into the concentrated liquid detergent after formation.

13. The method of claim 11 wherein the electrochemical polishing step comprises electrochemically cleaning the surfaces of the stent in a basic solution with the stent electrically connected to a source of electrons.

14. The method of claim 13 wherein the stent is electrically connected to the negative pole of a battery and is immersed into the basic solution with an anode of a noble metal that is electrically connected to the positive pole of the battery.

15. The method of claim 13 wherein the oxides are removed from the surfaces of the stent by immersing the stent into an acidic solution.

16. The method of claim 15 which further comprises washing the stent between one or more of the surface conditioning steps.

17. A cleaned and conditioned stent prepared according to the method of claim 1.

3. The method of claim 3 wherein the oxides are removed from the surfaces of the stent by immersing the stent into an acidic solution.

4. The method of claim 3 wherein the acidic solution comprises a concentrated inorganic acid, and the oxide removing step is conducted after the polishing step.