Medical devices having a temporary radiopaque coating

• US 20080008654A1
• Filed: 07/07/2006
• Published: 01/10/2008
• Est. Priority Date: 07/07/2006
• Status: Abandoned Application

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Clarke, John T., O'Brien, Barry
• Application Number:
  US11/481,943
• Publication Number:
  US 20080008654A1
• Time in Patent Office: Days
• US Class Current: 424/9.4
• CPC Class Codes: A61L 2400/12 Nanosized materials, e.g. nanofibres, nanoparticles, nanowires, nanotubes; Nanostructured surfaces
• CPC Class Codes: A61L 27/306 Other specific inorganic materials not covered by A61L27/303 - A61L27/32
• CPC Class Codes: A61L 27/446 with other specific inorganic fillers other than those covered by A61L27/443 or A61L27/46
• CPC Class Codes: A61L 29/106 Inorganic materials other than carbon
• CPC Class Codes: A61L 29/18 Materials at least partially X-ray or laser opaque
• CPC Class Codes: A61L 31/088 Other specific inorganic materials not covered by A61L31/084 or A61L31/086
• CPC Class Codes: A61L 31/128 containing other specific inorganic fillers not covered by A61L31/126 or A61L31/127
• CPC Class Codes: A61L 31/18 Materials at least partially X-ray or laser opaque

Abstract

A medical device comprising radiopaque water-dispersible metallic nanoparticles, wherein the nanoparticles are released from the medical device upon implantation of the device. The medical device of the present invention is sufficiently radiopaque for x-ray visualization during implantation, but loses its radiopacity after implantation to allow for subsequent visualization using more sensitive imaging modalities such as CT or MRI.

The nanoparticles are formed of a metallic material and have surface modifications that impart water-dispersibility to the nanoparticles. The nanoparticles may be any of the various types of radiopaque water-dispersible metallic nanoparticles that are known in the art. The nanoparticles may be adapted to facilitate clearance through renal filtration or biliary excretion. The nanoparticles may be adapted to reduce tissue accumulation and have reduced toxicity in the human body. The nanoparticles may be applied directly onto the medical device, e.g., as a coating, or be carried on the surface of or within a carrier coating on the medical device, or be dispersed within the pores of a porous layer or porous surface on the medical device. The medical device itself may be biodegradable and may have the nanoparticles embedded within the medical device itself or applied as or within a coating on the biodegradable medical device. The nanoparticles may be released by diffusion through the carrier coating, disruption of hydrogen bonds between the nanoparticles and the carrier coating, degradation of the nanoparticle coating, degradation of the carrier coating, diffusion of the nanoparticles from the medical device, or degradation of the medical device carrying the nanoparticles.

Claims

1. A medical device comprising radiopaque water-dispersible metallic nanoparticles, wherein the nanoparticles are released from the medical device upon implantation of the medical device into a patient.

2. The medical device of claim 1, wherein the nanoparticles have surface modifications.

3. The medical device of claim 2, wherein the surface modifications comprise water-soluble functional groups.

4. The medical device of claim 2, wherein the surface modifications comprise hydrophilic functional groups.

5. The medical device of claim 2, wherein the surface modifications comprise organic molecules complexed to the surface of the nanoparticles.

6. The medical device of claim 2, wherein the surface modifications comprise soluble metal oxides or soluble mixed metal oxides.

7. The medical device of claim 1, wherein the nanoparticles are adapted to improve biocompatibility of the nanoparticles.

8. The medical device of claim 7, wherein the wherein the nanoparticles are adapted to reduce accumulation of the nanoparticles in body tissue.

9. The medical device of claim 7, wherein the nanoparticles are adapted to reduce toxicity of the nanoparticles in the human body.

10. The medical device of claim 7, wherein the nanoparticles have an average diameter of less than about 100 nm.

11. The medical device of claim 7, wherein the nanoparticles have surface modifications that are hydrophilic.

12. The medical device of claim 8, wherein the nanoparticles are adapted to decrease extravasation from the blood circulation of a human body.

13. The medical device of claim 1, wherein the nanoparticles are adapted to facilitate elimination by the body.

14. The medical device of claim 13, wherein the nanoparticles are adapted to increase renal clearance of the nanoparticles.

15. The medical device of claim 14, wherein the nanoparticles have an average diameter of less than about 10 nm.

16. The medical device of claim 15, wherein the nanoparticles have a neutral or positive electrostatic charge.

17. The medical device of claim 13, wherein the nanoparticles are adapted to improve biliary excretion of the nanoparticles.

18. The medical device of claim 17, wherein the nanoparticles have surface modifications that increase uptake by the mononuclear phagocytic system.

19. The medical device of claim 18, wherein the surface modifications are hydrophobic.

20. The medical device of claim 1, wherein the medical device further comprises a carrier coating.

21. The medical device of claim 20, wherein the nanoparticles are carried on the surface of the carrier coating.

22. The medical device of claim 21, wherein the nanoparticles are bonded to the carrier coating via hydrogen bonds.

23. The medical device of claim 20, wherein the nanoparticles are dispersed within the carrier coating.

24. The medical device of claim 23, wherein the nanoparticles diffuse out of the carrier coating upon exposure to an aqueous environment.

25. The medical device of claim 20, wherein the carrier coating comprises a polymer.

26. The medical device of claim 25, wherein the polymer is a biodegradable polymer.

27. The medical device of claim 20, wherein the carrier coating comprises a porous material.

28. The medical device of claim 27, wherein the porous material is a porous carbon material.

29. The medical device of claim 27, wherein the porous material is a porous metallic material or porous metallic oxide material.

30. The medical device of claim 1, wherein the medical device further comprises a porous surface, and wherein the nanoparticles are dispersed within the pores of the porous surface.

31. The medical device of claim 1, wherein the medical device is biodegradable.

32. A medical device comprising radiopaque surface-modified metallic nanoparticles, wherein the nanoparticles are released from the medical device upon implantation of the medical device.

33. The medical device of claim 32, wherein the surface modifications impart water-dispersibility to the nanoparticles.

34. The medical device of claim 32, wherein the surface modifications impart water-solubility to the nanoparticles.

35. The medical device of claim 32, wherein the surface modifications impart colloid stability to the nanoparticles.

36. The medical device of claim 32, further comprising a carrier coating, and wherein the nanoparticles are carried on the surface of or within the carrier coating.