Protective coating for a stent with intermediate radiopaque coating

• US 6,174,329 B1
• Filed: 08/22/1996
• Issued: 01/16/2001
• Est. Priority Date: 08/22/1996
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Yan, John Y., Callol, Joseph R.
• Primary Examiner(s): Millin, V
• Assistant Examiner(s): Koh, Choon P.
• Application Number:
  US08/701,708
• Time in Patent Office: 1,608 Days
• Field of Search: 623/1, 623/12, 623/1.34, 623/1.44, 623/1.46, 606/194, 606/195, 606/198
• US Class Current: 623/1.34
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• 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 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2310/00155 Gold or Au-based alloys
• CPC Class Codes: A61L 31/082 Inorganic materials
• CPC Class Codes: A61L 31/18 Materials at least partially X-ray or laser opaque

Abstract

The invention relates to coated stents and the method of making them. A stent that is substantially radiolucent is at least partially coated with a radiopaque layer that makes the stent visible under X-ray or fluoroscopy. A protective layer is coated on the stent and the radiopaque layer to protect both from scratches, flaking, and galvanic corrosion, and to improve both blood and bio-compatability.

Claims

1. A stent for implanting in a body lumen, comprising:

an elongated tubular body being a substantially radiolucent first metal;

a radiopaque layer of a second metal different from the first metal covering at least a portion of the elongated tubular body; and

a protective layer covering the elongated tubular body and radiopaque layer, the protective layer having a thickness effective to reduce the likelihood of galvanic corrosion between the elongated tubular body and the radiopaque layer and to protect the layers from mishandling;

wherein the protective layer includes a polymeric or a ceramic material.

2. The stent of claim 1, wherein the elongated tubular body is formed from a metallic material selected from the group consisting of stainless steel, nickel-titanium, tantalum, and titanium.

3. The stent of claim 1, wherein the elongated tubular body has a wall surface, made up of a plurality of struts each having a diameter of less than about 0.004 inch.

4. The stent of claim 1, wherein the thickness of the protective layer can vary in thickness on the elongated tubular body from about 0.01 to 25 microns and on the radiopaque layer from about 1.0 to 50 microns.

5. The stent of claim 1, wherein the protective layer is biocompatible and blood compatible.

6. The stent of claim 1, wherein the protective layer is formed from a polymeric material selected from the group consisting of Parylast®

, Parylene, polymethylene, polycarbonate-urethane copolymer, silicone rubber, hydrogels, polyvinyl alcohol, polyvinyl acetate, polycapralactone, urethanes, and PHEMA-Acrylic.

7. The stent of claim 1, wherein the protective layer is formed from a metallic material selected from the group consisting of titanium, tantalum, and titanium-alloy.

8. The stent of claim 1, wherein the protective layer is formed from a ceramic material selected from the group consisting of zirconium nitrite, graphite, pyrolytic carbon, Nedox, and titanium nitrite.

9. The stent of claim 1, wherein a second protective coating covers the protective coating to provide further protection against the electrochemical reaction that causes galvanic corrosion.

10. A method for protecting a stent from the electrochemical reaction that causes galvanic corrosion, the method comprising:

providing an elongated tubular body being substantially radiolucent first metal;

applying a radiopaque layer of a second metal different from the first metal on at least a portion of the elongated tubular body; and

applying a protective layer on the elongated tubular body and the radiopaque layer in a thickness effective to reduce the likelihood of galvanic corrosion between the elongated tubular body and the radiopaque layer and to protect the layers from mishandling;

the protective layer covering all of the radiopaque layer and that portion of the elongated tubular body not covered by the radiopaque layer;

wherein the protective layer includes a polymeric or a ceramic material.

11. The method of claim 10, wherein the method for applying the radiopaque layer includes dipping, painting, electroplating, evaporation, plasma vapor deposition, cathodic arc deposition, sputtering, laser welding or fusion, resistance welding and ion implantation.

12. The method of claim 10, wherein the method for applying the protective layer includes dipping, spraying, spin coating, plasma deposition, condensation, electrostatically, electrochemically, electroplating, evaporation, plasma vapor deposition, cathodic arc deposition, sputtering, ion implantation, and use of a fluidized bed.

13. A stent for implanting in a body lumen, comprising:

an elongated tubular body being a substantially radiolucent first metal; and

a protective layer covering the elongated tubular body, the protective layer having radiopaque means of a second metal different from the first metal for increasing visibility under fluoroscopy, the protective layer having a thickness effective to protect against the electrochemical reaction leading to galvanic corrosion;

wherein the protective layer includes a polymeric or a ceramic material.

14. The stent of claim 13, wherein the radiopaque means includes loading the protective layer material with a radiopaque agent selected from the group consisting of barium, titanium oxide, gold, or other metallic powders or particles.

15. The stent of claim 13, wherein the protective layer is covered by a second protective layer.

16. A stent for implanting in a body lumen, comprising:

an elongated tubular body being a substantially radiolucent first metal;

a protective layer covering the elongated tubular body; and

a radiopaque layer of a second metal different from the first metal covering at least a portion of the protective layer so that the stent is visible under fluoroscopic x-ray, the protective layer having a thickness effective to reduce the likelihood of galvanic corrosion between the radiopaque layer and the elongated tubular body;

wherein the protective layer includes a polymeric or a ceramic material.

17. A stent for implanting in a body lumen, comprising:

an elongated tubular body being a substantially radiolucent first metal;

a radiopaque layer of a second metal different from the first metal covering at least a portion of the elongated tubular body; and

a protective layer covering at least a portion of the elongated tubular body and having a thickness effective to reduce the likelihood of galvanic corrosion between the elongated tubular body and the radiopaque layer and wherein the protest the layer is biocompatible and blood compatible;

wherein the protective layer includes a polymeric or a ceramic material.