Medical devices

• US 20050060021A1
• Filed: 09/16/2003
• Published: 03/17/2005
• Est. Priority Date: 09/16/2003
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: O'Brien, Barry, Brown, Brian
• Granted Patent: US 7,488,343 B2
• Time in Patent Office: Days
• US Class Current: 623/1.150
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61F 2250/0087 colour-coded
• CPC Class Codes: A61L 2300/00 Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
• CPC Class Codes: A61L 31/022 Metals or alloys
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: Y10T 428/24802 Discontinuous or differential coating, impregnation or bond [e.g., artwork, printing, retouched photograph, etc.]

Abstract

Medical devices, particularly stents, suitable for drug delivery and including a porous structure and/or colors are disclosed.

Claims

1. A stent device comprising:

a generally tubular member, the member including a porous structure comprising an oxide of titanium, niobium, tantalum, or an alloy thereof, the porous structure including hollow post-shaped elements.

2. The device of claim 1, wherein the porous structure is of an oxide of titanium.

3. The device of claim 1, wherein the generally tubular member comprises a therapeutic agent.

4. The device of claim 3, wherein the therapeutic agent is selected from an antithrombogenic, antioxidant, anti-inflammatory, antiproliferative, or antibiotic.

5. The device of claim 3, wherein the therapeutic agent is selected from a drug, cell, or genetic material.

6. The device of claim 1, wherein the generally tubular member includes a layer of titanium, niobium, tantalum, or an alloy thereof, that has a thickness between about 50 nm and about 500 nm.

7. The device of claim 6, wherein the porous structure is over said layer.

8. The device of claim 1, wherein the post-shaped elements have pore diameters of about 20 nm to about 200 nm.

9. The device of claim 8, wherein the post-shaped elements have pore diameters of about 70 nm to about 100 nm.

10. The device of claim 9, wherein the post-shaped elements have a post height of about 100 nm to about 200 nm.

11. The device of claim 1, wherein the porous structure is on an outer surface of the generally tubular member.

12. The device of claim 1, wherein the generally tubular member comprises titanium, niobium, tantalum, or an alloy thereof.

13. The device of claim 1, wherein said titanium, niobium, tantalum, or alloy thereof is a layer on a different metal.

14. The device of claim 13, wherein the different metal is about 90% or more of the thickness of the tubular member.

15. The device of claim 1, wherein the generally tubular member comprises stainless steel, nitinol, or a cobalt-based alloy.

16. The device of claim 1, wherein the porous structure includes a polymer.

17. The device of claim 16, wherein the polymer is a coating over the porous structure.

18. The device of claim 17, wherein the coating is a diffusion or protective layer.

19. The device of claim 17, wherein the coating is biodegradable.

20. The device of claim 16, wherein the polymer includes a therapeutic agent.

21. The device of claim 1, wherein the porous structure includes a colorant.

22. The device of claim 1, wherein the device has a color corresponding to light having a wavelength between about 370 nm and about 750 nm.

23. The device of claim 22, wherein the color corresponds to light having a wavelength of about 420 nm, about 470 nm, about 530 nm, about 580 nm, about 620 nm, or about 700 nm.

24. A stent device comprising:

a generally tubular member, the member including a porous structure of hollow post-shaped elements.

25. The device of claim 24, wherein the generally tubular member includes a therapeutic agent.

26. The device of claim 25, wherein the therapeutic agent is selected from an antithrombogenic, antioxidant, anti-inflammatory, antiproliferative, or antibiotic.

27. The device of claim 25, wherein the therapeutic agent is selected from a drug, cell, or genetic material.

28. The device of claim 24, wherein the post-shaped elements comprise a porous metal oxide.

29. The device of claim 28, wherein the porous metal oxide has a thickness between about 50 nm and about 500 nm.

30. The device of claim 28, wherein the porous metal oxide has pore diameters between about 20 nm and about 200 nm.

31. The device of claim 28, wherein the porous metal oxide is on a surface of the generally tubular member.

32. A method of making a stent, comprising:

(a) providing a metal;

(b) exposing the metal to an acid solution such that the acid solution forms a meniscus on the metal;

(c) connecting the metal as an anode in an electrical circuit in the acid solution; and

(d) applying a voltage to the circuit,

the metal being incorporated in a stent.

33. The method of claim 32, wherein the meniscus is formed sequentially on different portions of the metal.

34. The method of claim 32, wherein the acid solution comprises a hydrofluoric acid solution.

35. The method of claim 34, wherein the voltage is about 5 V to about 100 V.

36. The method of claim 34, wherein the acid solution comprises a 1.5% (by weight) hydrofluoric acid solution.

37. The method of claim 32, wherein the metal has a thickness between about 200 nm and about 400 nm.

38. The method of claim 32, further comprising applying a therapeutic agent to the stent.

39. The method of claim 32, further comprising applying a diffusion layer to the stent.

40. A method of making a stent, comprising:

(a) providing a metal;

(b) exposing the metal to an acid solution;

(c) controlling the oxygen content of the acid solution;

(d) connecting the metal as an anode in an electrical circuit in the acid solution; and

(e) applying a voltage to the circuit,

the metal being incorporated in a stent.

41. The method of claim 40, further comprising controlling the oxygen content by bubbling gas through the acid solution.

42. The method of claim 41, wherein the gas includes oxygen.

43. A family of medical devices, wherein members of said medical devices include an oxide providing a different color or color pattern.

44. The family of claim 43, wherein the color or color pattern is indicative of usage.

45. A medical device includes an oxide providing a color or color pattern indicative of manufacturing information.

46. The medical device of claim 45, wherein the manufacturing information is a lot, date, or manufacturer identification.