Multi-layered radiopaque coating on intravascular devices

• US 7,077,837 B2
• Filed: 11/15/2001
• Issued: 07/18/2006
• Est. Priority Date: 11/20/2000
• Status: Expired due to Fees

• Current Assignee: Implant Sciences Corporation
• Original Assignee: Implant Sciences Corporation
• Inventors: Sahagian, Richard
• Primary Examiner(s): HO, UYEN T
• Application Number:
  US09/999,349
• Publication Number:
  US 20020138130A1
• Time in Patent Office: 1,706 Days
• Field of Search: 623/1.15, 623/1.12, 623/1.13, 623/1.34, 623/1.46, 623/1.44, 623/1.45, 427/2.25, 427/2.24, 427/446, 427/456, 427/528, 427/531, 427/564
• US Class Current: 623/1.15
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61L 31/18 Materials at least partially X-ray or laser opaque

Abstract

Intravascular devices having a radiopaque layer thereon for visualization are provided. The devices further includes a capping layer on the radiopaque layer to prevent exposure of the radiopaque material to surrounding tissues. A method of coating the device is also provided. The method includes using an unbalanced magnetic field magnetron to generate, from a source, metal atoms for coating and bombarding ions for compressing deposited metal atoms to the surface of the device.

Claims

1. An intravascular device comprising:

a substrate surface;

a layer of a radiopaque material on the substrate surface and having a thickness sufficient to permit visualization;

a capping layer positioned on the layer of radiopaque material to prevent exposure of the layer of radiopaque material to surrounding tissue; and

at least one adhesion layer disposed between the radiopaque material and the substrate surface, wherein a first part of the adhesion layer adjacent to the substrate surface has a different composition than a combination of the radiopaque material and a material in the substrate surface and wherein a second part of the adhesion layer adjacent to the layer of radiopaque material has a combination of the material used for the first part of the adhesion layer and the radiopaque material.

2. An intravascular device as set forth in claim 1, wherein the substrate surface comprises a metallic material.

3. An intravascular device as set forth in claim 2, wherein the metallic material includes one of stainless steel, nickel-based steel, cobalt-chrome, titanium alloys, and nitinol.

4. An intravascular device as set forth in claim 2, wherein the metallic material is flexible.

5. An intravascular device as set forth in claim 1, wherein the layer of radiopaque material is made from a pliable and malleable material to provide the layer with flexibility.

6. An intravascular device as set forth in claim 1, wherein the layer of radiopaque material comprises gold.

7. An intravascular device as set forth in claim 1, wherein the layer of radiopaque material has a thickness ranging from about 1 micron to about 15 microns.

8. An intravascular device as set forth in claim 1, wherein the capping layer comprises a biocompatible material.

9. An intravascular device as set forth in claim 8, wherein the biocompatible material comprises a metallic material.

10. An intravascular device as set forth in claim 9, wherein the metallic material includes one of platinum alloys, platinum-iridium, palladium, and tantalum.

11. An intravascular device as set forth in claim 1, wherein the capping layer has a thickness ranging from about 0.5 micron to about 1.0 micron.

12. An intravascular device as set forth in claim 1, further including a transition layer situated between the capping layer and the layer of radiopaque material to enhance bonding between the capping layer and the layer of radiopaque material.

13. An intravascular device as set forth in claim 12, wherein the transition layer comprises a mixture of the radiopaque material and material comprising the capping layer.

14. An intravascular device as set forth in claim 13, wherein the transition layer comprises a mixture of gold and platinum-iridium.

15. An intravascular device as set forth in claim 13, wherein the transition layer has a thickness ranging from about 0.25 microns to about 0.5 microns.

16. An intravascular stent comprising:

a flexible expandable body having a surface;

a layer of a radiopaque material on the surface and having a thickness sufficient to permit visualization;

an adhesion layer between the layer of radiopaque material and the surface to enhance bonding between the layer of radiopaque material and the surface; and

a capping layer positioned on the layer of radiopaque material to prevent exposure of the layer of radiopaque material to surrounding tissue, wherein a first part of the adhesion layer adjacent to the flexible expandable body has a different composition than a combination of the radiopaque material and a material in the flexible expandable body and wherein a second part of the adhesion layer adjacent to the layer of radiopaque material has a combination of the material used for the first part of the adhesion layer and the radiopaque material.

17. An intravascular stent as set forth in claim 16, wherein the layer of radiopaque material is made from a pliable and malleable material to provide the layer with flexibility.

18. An intravascular stent as set forth in claim 16, wherein the capping layer comprises a biocompatible material.

19. An intravascular stent as set forth in claim 16, wherein the layer of radiopaque material comprises gold.

20. An intravascular stent as set forth in claim 16, wherein the capping layer includes one of platinum alloys, platinum-iridium, palladium, and tantalum.

21. An intravascular stent as set forth in claim 16, further including a transition layer situated between the capping layer and the layer of radiopaque material to enhance bonding between the capping layer and the layer of radiopaque material.

22. An intravascular device as set forth in claim 21, wherein the transition layer has a thickness ranging from about 0.25 microns to about 0.5 microns.

23. An intravascular stent as set forth in claim 21, wherein the transition layer comprises a mixture of the radiopaque material and material comprising the capping layer.

24. An intravascular stent as set forth in claim 21, wherein the transition layer comprises a mixture of gold and platinum-iridium.