Vascular and endoluminal stents with iridium oxide coating

• US 5,980,566 A
• Filed: 04/11/1998
• Issued: 11/09/1999
• Est. Priority Date: 04/11/1998
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Eckhard Alt, Lawrence J. Stotts
• Inventors: Stotts, Lawrence J., Alt, Eckhard
• Primary Examiner(s): Willse, David H.
• Assistant Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US09/059,054
• Time in Patent Office: 577 Days
• Field of Search: 623/1, 623/12, 604/198
• US Class Current: 623/23.7
• 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 2002/91541 Adjacent bands are arranged out of phase
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2210/0095 radioactive
• CPC Class Codes: A61F 2310/00598 Coating or prosthesis-covering structure made of compounds based on metal oxides or hydroxides
• CPC Class Codes: A61F 2310/0088 Coating made of titanium nitride
• CPC Class Codes: A61N 5/1002 Intraluminal radiation therapy

Abstract

A vascular stent adapted to be implanted in a blood vessel of a human patient to enhance the flow of blood therethrough, includes an elongate biocompatible metal member of cylindrical shape and tubular sidewall with a pattern of multiple openings therethrough and open ends. The stent has an insertion outer diameter sufficiently small to enable it to be inserted into and advanced through a portion of the vascular system of the body to a preselected point within a coronary artery. The sidewall has a thin adherent coating of iridium oxide covering substantially its entire exposed surface, including the outward-facing surface between openings, the edges of the openings, the inward-facing surface between openings, and the edge of each of the open ends. The coating is of substantially uniform thickness throughout its coverage of the surface of the sidewall, and serves to reduce irritation of tissue of the inner lining of the vessel wall into which the outward-facing surface of the stent comes into contact. The tissue may project as well into the openings in the sidewall to contact the edges thereof. The iridium oxide coating has a biodegradable carrier of drugs applied thereto for beneficial localized action, as by incorporating into the carrier along the inward-facing surface an anticoagulant drug to reduce attachment of thrombi with blood flow through the lumen of the stent. Although it may be composed of multiple layers, the iridium oxide coating is sufficiently thin and flexible to resist flaking during deployment, and the core member has sufficient rigidity when so deployed to resist collapse.

Claims

1. A vascular stent constructed to be implanted in a blood vessel of a human patient to enhance the flow of blood therethrough, comprising an elongate metal member which is biologically compatible with the blood and tissue of the human body, said metal member having a cylindrical shape to form a tubular sidewall with a multiplicity of openings lying in a predetermined pattern therethrough and with open ends, and having an insertion outer diameter which is sufficiently small to enable the metal member to be inserted into and traverse a portion of the vascular system of the body to a preselected site within a coronary artery, and a thin adherent coating of iridium oxide substantially covering the surface of the tubular sidewall.

2. The vascular stent of claim 1, wherein the iridium oxide coating covers substantially the entire exposed surface of the tubular sidewall, including the outward-facing surface between the openings in the sidewall, the surface along the edges of the openings in the sidewall, the inward-facing surface between the openings in the sidewall, and the surface along the edge of each of the open ends of the metal member.

3. The vascular stent of claim 2, wherein the iridium oxide coating is of substantially uniform thickness throughout its coverage of substantially the entire exposed surface of the tubular sidewall.

4. The vascular stent of claim 3, wherein the iridium oxide coating has a thickness in a range from approximately 10 nanometers to approximately 5 micrometers.

5. The vascular stent of claim 4, wherein said coating thickness is less than 500 nanometers.

6. The vascular stent of claim 2, wherein at least the inward-facing surface is additionally coated with a biodegradable drug carrier.

7. The vascular stent of claim 1, wherein the metal member has an expansion outer diameter to which the stent is selectively deployable by exertion of radial forces outwardly on the tubular sidewall to increase its diameter to said expansion diameter from said insertion diameter, sufficiently to engage tissue of the inner lining of the coronary artery at said preselected site, said iridium oxide coating being sufficiently flexible to resist cracking and separation when said outward radial forces are being exerted to increase the stent diameter, said metal member having sufficient mechanical strength when so deployed to resist collapse under forces exerted by recoil of the coronary artery wall.

8. The vascular stent of claim 7, wherein the iridium oxide coating covers substantially the entire exposed surface of the tubular sidewall, including the outward-facing surface between the openings in the sidewall, the surface along the edges of the openings in the sidewall, the inward-facing surface between the openings in the sidewall and the surface along the edge of each of the open ends of the metal member.

9. The vascular stent of claim 8, wherein the iridium oxide coating is of substantially uniform thickness throughout its coverage of substantially the entire exposed surface of the sidewall.

10. The vascular stent of claim 9, wherein the iridium oxide coating has a thickness in a range from approximately 10 nanometers to approximately 5 microns.

11. The vascular stent of claim 10, wherein said coating thickness is less than about 500 nanometers.

12. The vascular stent of claim 8, wherein the surface of the iridium oxide coating is additionally coated with a biodegradable drug carrier.

13. The vascular stent of claim 1, wherein said iridium oxide coating comprises multiple thin layers of iridium oxide.

14. The vascular stent of claim 1, wherein said iridium oxide coating has a radioactivity level to irradiate tissue adjacent the surface of the stent when implanted in a coronary artery, and sufficient to deliver a radiation dosage which is effective to inhibit stenosis of the inner lining of the artery wall at said preselected site thereof.

15. The vascular stent of claim 8, wherein said iridium oxide coating comprises multiple thin layers of iridium oxide.

16. The vascular stent of claim 8, wherein said iridium oxide coating has a radioactivity level to irradiate tissue adjacent the surface of the stent when implanted in a coronary artery, and sufficient to deliver a radiation dosage which is effective to inhibit stenosis of the inner lining of the artery wall at said preselected site thereof.

17. A vascular or endoluminal stent for deployment in a human body to hold a natural duct or tract thereof open for passage of fluids or solids therethrough, comprising a metal duct or tract of selected length having open ends and a wall laced with openings therethrough and expandable radially from a first diameter smaller than the lumen diameter of the natural duct or tract in which the stent is to be deployed to a second diameter at least slightly larger than said lumen diameter, with sufficient rigidity in its deployed expanded state to resist collapse under radial pressure exerted inwardly on the wall of the stent by the wall of the natural duct or tract in which it is deployed, and a thin coating of iridium oxide on at least the outer surface of the wall of the stent.

18. The vascular or endoluminal stent of claim 17, wherein said coating of iridium oxide also covers the inner surface of the wall of the stent.

19. The vascular or endoluminal stent of claim 18, wherein said coating of iridium oxide is sufficiently flexible to resist flaking and shedding during radial expansion from said first diameter to said second diameter.

20. The vascular or endoluminal stent of claim 17, wherein said iridium oxide coating comprises multiple thin layers of iridium oxide.

21. The vascular or endoluminal stent of claim 17, wherein said iridium oxide coating has a radioactivity level sufficient, when the stent is deployed at the selected site, to deliver a radiation dosage to tissue of the inner lining of the wall of the duct or tract along a preselected region thereof, which is effective to inhibit stenosis thereat.

22. The vascular or endoluminal stent of claim 17, wherein the surface of the iridium oxide coating is additionally coated with a biodegradable drug carrier for timed release of drugs carried within said carrier for localized inhibition of fibrosis and thrombosis.