Radiopaque coating for biomedical devices

• US 8,002,822 B2
• Filed: 03/23/2005
• Issued: 08/23/2011
• Est. Priority Date: 01/22/2004
• Status: Active Grant

• Current Assignee: Denton Vacuum, LLC
• Original Assignee: Isoflux Incorporated
• Inventors: Glocker, David A., Romach, Mark M.
• Primary Examiner(s): Sweet; Thomas J
• Assistant Examiner(s): WOLF, MEGAN YARNALL
• Application Number:
  US11/087,909
• Publication Number:
  US 20050187466A1
• Time in Patent Office: 2,344 Days
• Field of Search: 623/1.34, 623 112- 12, 623/1.42, 623 144- 146
• US Class Current: 623/1.46
• 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: A61L 31/088 Other specific inorganic materials not covered by A61L31/084 or A61L31/086
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/18 Materials at least partially X-ray or laser opaque
• CPC Class Codes: C23C 30/00 Coating with metallic material characterised only by the composition of the metallic material, i.e. not characterised by the coating process C23C26/00, C23C28/00 take precedence

Abstract

A medical device has a porous radiopaque coating that can withstand the high strains inherent in the use of such devices without delamination. A coating of Ta is applied to a medical device, such as a stent, by vapor deposition so that the thermomechanical properties of the stent are not adversely affected. The coating preferable has high emissivity.

Claims

1. An intraluminal medical device for placement within a vascular structure comprising:

a. a flexible body; and

b. a porous columnar metallic coating comprising a plurality of independent columnar structures separated from one another by an opening and disposed on at least a portion of the flexible body, wherein

(i) the porous columnar metallic coating extends in a substantially normal direction from a surface of at least a portion of the flexible body;

(ii) flaking of the porous columnar metallic coating being less than 1% of the porous columnar metallic coated surface when the flexible body and porous columnar metallic coating are strained up to 8%; and

(iii) the combination of the size of the columnar structures of the porous columnar metallic coating and the size of the openings between the columnar structures of the porous columnar metallic coating results in an emissivity in the visible spectrum range of at least 80%.

2. The intraluminal medical device of claim 1, wherein the

flexible body partially comprises a radio transparent material and

the porous columnar metallic coating on at least a portion of the flexible body comprises Ta.

3. The intraluminal medical device of claim 2, wherein the porous columnar Ta coating thickness is between approximately 3 and 10 microns.

4. The intraluminal medical device of claim 2, wherein the porous columnar Ta coating is applied to the flexible body by a physical vapor deposition process.

5. The intraluminal medical device of claim 4, wherein the physical vapor deposition process includes one of the group of sputtering, cathodic arc deposition or thermal evaporation.

6. The intraluminal medical device of claim 2 further comprising a material in the porous columnar Ta coating, wherein the material diffuses out over time.

7. The intraluminal medical device of claim 2, wherein the flexible body comprises nitinol.

8. The intraluminal medical device of claim 2, wherein the intraluminal medical device is a stent.

9. The intraluminal medical device of claim 2, wherein the intraluminal medical device is a guide wire.

10. The intraluminal medical device of claim 2, wherein the intraluminal medical device is a catheter.

11. The intraluminal medical device of claim 1, wherein the flexible body further comprises

an elastic shape retaining body having an outer surface,

the porous columnar metallic coating is disposed on at least a portion of the outer surface, wherein the porous columnar metallic coating is applied using a physical vapor deposition process.

12. The intraluminal medical device of claim 1, wherein the flexible body further comprises

a deformable body.

13. The intraluminal medical device of claim 1, wherein the flexible body further comprises an elastic shape retaining body at least partially comprising a material having superelasticity and shape memory.

14. The intraluminal medical device of claim 13, wherein the intraluminal medical device is a stent for use in a biological vessel.

15. The intraluminal medical device of claim 13, wherein the porous columnar metallic coating is a radiopaque coating.

16. The intraluminal medical device of claim 13, wherein the flexible body comprises nitinol.

17. The intraluminal medical device of claim 1, wherein the porous columnar metallic coating is selected from the group consisting of gold, platinum, tantalum, and tungsten.

18. The intraluminal medical device of claim 1, wherein a drug is incorporated into the porous columnar metallic coating.

19. The intraluminal medical device of claim 1, wherein the intraluminal medical device is implantable and further comprises a material in the porous columnar metallic coating that diffuses out over time when implanted.

20. The intraluminal medical device of claim 19, wherein the intraluminal medical device is a stent.

21. The intraluminal medical device of claim 1, wherein the intraluminal medical device is a guide wire.

22. The intraluminal medical device of claim 1, wherein the intraluminal medical device is a stent.

23. The intraluminal medical device of claim 1, wherein the intraluminal medical device is a catheter.

24. An intraluminal medical device for placement within a vascular structure comprising:

a. a flexible body fabricated from a shape memory alloy having an A_f value below body temperature; and

b. a porous columnar metallic coating disposed on at least a portion of the flexible body comprising a plurality of independent columnar structures separated from one another by an opening, wherein

(i) the independent columnar structures extend in a substantially normal direction from a surface of at least a portion of the flexible body;

(ii) the flexible body and porous columnar metallic coating are operable to withstand strains up to 8%, wherein flaking of the porous columnar metallic coating is less than 1%; and

(iii) the combination of the sizes of the independent columnar structures of the porous columnar metallic coating and the sizes of the openings between the independent columnar structures results in an emissivity in the visible spectrum range of at least 80%.

25. The intraluminal medical device of claim 24, wherein the shape memory alloy comprises nitinol.

26. The intraluminal medical device of claim 24, wherein the intraluminal medical device further comprises a material disposed within the porous columnar metallic coating, the material diffusing from the porous columnar metallic coating for a period of time after implantation of the intraluminal medical device within the vascular structure.

27. An intraluminal stent, comprising:

a. a substrate body fabricated from a shape memory alloy, wherein the shape memory alloy comprises first A_f value below body temperature before a porous columnar metallic coating is applied to a surface of at least a portion of the substrate body; and

b. the porous columnar metallic coating comprising a plurality of independent columnar structures separated from one another by a space, wherein each of the independent columnar structures extend in a substantially normal direction from the surface of at least a portion of the substrate body and the porous columnar metallic coating has an emissivity in the visible spectrum range of at least 80%.

28. The intraluminal stent of claim 27, wherein the intraluminal stent further comprises a material disposed within the porous columnar metallic coating, the material diffusing from the porous columnar metallic coating for a period of time after implantation of the intraluminal stent within a luminal structure.

29. The intraluminal stent of claim 27, wherein flaking of the porous columnar metallic coating is less than 1% when the intraluminal stent is strained up to 8%.

30. The intraluminal stent of claim 27, wherein the shape memory alloy further comprises a second A_f after the porous columnar metallic coating is disposed on the surface of at least a portion of the substrate body, the second A_f is below body temperature.