Vascular and endoluminal stents

• US 5,824,045 A
• Filed: 10/21/1996
• Issued: 10/20/1998
• Est. Priority Date: 10/21/1996
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: InFlow Dynamics, Inc. (Boston Scientific Corporation)
• Inventors: Alt, Eckhard
• Primary Examiner(s): Buiz, Michael Powell
• Assistant Examiner(s): REIP, DAVID OWEN
• Application Number:
  US08/733,553
• Time in Patent Office: 729 Days
• Field of Search: 606/191, 606/194, 606/195, 606/198, 623/1, 623/12
• US Class Current: 623/1.15
• 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 2230/0054 V-shaped
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2310/00568 Coating made of gold or Au-based alloys

Abstract

A vascular or endoluminal stent is adapted for deployment in a vessel or tract of a patient to maintain an open lumen therein. The stent includes a biocompatible metal hollow tube having a multiplicity of openings through an open-ended tubular wall thereof, the tube constituting a single member from which the entire stent is fabricated, and a thin, tightly adherent layer of gold overlying the entire exposed surface area of the tube including edges of the openings as well as exterior and interior surfaces and ends of the wall. The layer may include at least a trace of another noble metal to improve the adherence of the layer to the underlying metal surface of the tube. Plural tightly bonded films superposed one atop another may be used to form a composite layer, but in any event the overall layer has a thickness in a range from approximately 1 micron to approximately 20 microns. The gold coating serves to reduce thrombogenicity, enhance fluoroscopic visibility, and reduce allergic reaction relative to that experienced with implantation of stainless steel and other metal stents in the human body.

Claims

1. A vascular or endoluminal stent adapted for deployment in a vessel or tract of a patient to maintain an open lumen therein, comprising:

a biocompatible metal hollow tube having a multiplicity of openings through an open-ended tubular wall thereof, said tube constituting a single member from which the entire stent is fabricated and having a predetermined inner diameter in a production state and adapted to be expanded to a larger diameter for deployment in said vessel or tract, and

a thin, tightly adherent coating of gold of substantially uniform thickness and density overlying the entire exposed surface area of the tube including edges of said openings as well as exterior and interior surfaces and ends of said wall,

said gold coating being composed of plural tightly bonded layers superposed atop one another.

2. The stent of claim 1, wherein the gold coating includes at least a trace of another noble metal to improve the adherence of the foundation layer in physical contact with said exposed surface area to the underlying metal surface of the tube.

3. The stent of claim 1, wherein the gold coating has a thickness in a range from approximately 1 micron to approximately 20 microns.

4. The stent of claim 3, wherein the gold coating has a thickness of approximately 5 microns.

5. A vascular or endoluminal stent adapted for deployment in a vessel or tract of a patient to maintain an open lumen therein, comprising:

a generally cylindrical open-ended biocompatible metal element having a multiplicity of radial through-holes therein, and

a thin, substantially uniform noble metal coating over the entire exposed surface of the cylindrical element including the edges of the through-holes as well as interior and exterior surfaces and ends of the cylindrical element and forming a tight bond therewith resistant to rupture while undergoing radial expansion and longitudinal contraction of the cylindrical element during deployment of the stent, said noble metal coating including at least two homogeneous layers, the layer residing directly upon the surface of the cylindrical element being a foundation layer deposited by a process to enhance adhesion thereto.

6. The stent of claim 5, wherein said noble metal coating is composed primarily of gold.

7. The stent of claim 5, wherein the foundation layer of said noble metal coating is an ion beam deposition.

8. The stent of claim 7, wherein the number of said homogeneous layers is two, and the layer of said noble metal coating atop said foundation layer is an electroplate.

9. The stent of claim 5, wherein said metal element is a wire mesh.

10. The stent of claim 5, wherein said metal element is a hollow tube.

11. A method of fabricating a vascular or endoluminal stent adapted for deployment in a vessel or tract of a patient to maintain an open lumen therein, comprising the steps of:

forming an open-ended tubular biocompatible metal element with through-holes in the wall thereof sufficient in size and number to enable radial expansion of the element,

coating the entire surface of the tubular metal element including exterior and interior surfaces and ends of said wall and edges of said through-holes therein with a thin, tightly adherent coat of substantially uniform thickness of noble metal,

wherein said coating step includes the steps of vapor depositing a first foundation layer onto the entire surface of said element, followed by galvanically depositing a second layer onto the entire exposed surface of said first foundation layer.

12. The method of claim 11, wherein the step of coating comprises depositing the noble metal over said entire surface of the tubular metal element to a thickness in a range from 1 to 20 microns.

13. The method of claim 12, wherein the step of galvanically depositing produces a thickness of said noble metal coat in a range of from 3 to 6 microns.

14. The method of claim 12, wherein the noble metal is gold.

15. The method of claim 12, wherein the noble metal is gold alloy.

16. A method of fabricating a vascular or endoluminal stent adapted for deployment in a vessel or tract of a patient to maintain an open lumen therein, comprising the step of forming an open-ended tubular biocompatible metal element with through-holes in the wall thereof, and coating the entire surface of the tubular metal element including exterior and interior surfaces and ends of said wall and edges of said through-holes therein with a thin, tightly adherent layer of noble metal, wherein the step of coating comprises depositing the noble metal over said entire surface of the tubular metal element to a thickness in a range from 1 to 20 microns, and including pre-opening the stent either before or after applying the noble metal coating.

17. A stent for insertion into and placement at a target site in a vessel of a patient for maintaining the lumen of said vessel open, comprising:

a tubular, thin-walled, open-ended metal structure having a multiplicity of through-holes in the side wall thereof to allow radial expansion upon exertion of pressure on the side wall from within the lumen of the stent for placement at said target site in the vessel, and

a thin coating of at least one noble metal of substantially uniform thickness overlying the entire exposed surface of the tubular structure including the interior and exterior surfaces and the edges of the through-holes and end surfaces thereof, said coating composed of two separate contiguous overlying layers, a first of said layers residing against and in adherent relation to said entire exposed surface of the tubular structure, and the second of said layers bonded to the first layer and combining therewith to resist rupture of said coating during radial expansion of said tubular structure.