Medical devices comprising nanocomposites

• US 20030093107A1
• Filed: 09/27/2002
• Published: 05/15/2003
• Est. Priority Date: 09/28/2001
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Chen, John J., Weber, Jan, Miller, Paul J., Parsonage, Edward, Horn, Daniel J., Devens, Douglas A. Jr.
• Granted Patent: US 7,591,831 B2
• Time in Patent Office: Days
• US Class Current: 606/194
• CPC Class Codes: A61F 2/0108 Both ends closed, i.e. legs gathered at both ends
• CPC Class Codes: A61F 2/02 Prostheses implantable into the body closure means for urethra or rectum or for artificial body openings therefor A61F2/0004
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61L 29/126 having a macromolecular matrix
• CPC Class Codes: A61L 31/125 having a macromolecular matrix
• CPC Class Codes: Y10S 623/90 Stent for heart valve
• CPC Class Codes: Y10S 977/905 Specially adapted for travel through blood circulatory system

Abstract

The present invention provides medical devices comprising nanocomposite materials. By utilizing nanocomposites in the production thereof, the inventive medical devices can be produced with various advantageous properties. Methods of producing the inventive medical devices are also provided. Inasmuch as the inventive devices are expected to provide certain advantages in their use, there is also provide a method of medical care including methods of treatment or diagnosis, wherein the inventive devices are brought into therapeutic contact with a body to be treated or diagnosed thereby.

Claims

1. A medical device wherein at least one component thereof is prepared from a nanocomposite material comprising;

a matrix material;

at least one plurality of nanoparticulate filler particles.

2. The medical device of claim 1, wherein the nanocomposite material further comprises a functionalizer, a compatibilizer, a dispersant or combinations thereof.

3. The medical device of claim 1, wherein the device is a transluminal medical device.

4. The medical device of claim 3, wherein the at least one component comprises at least one layer of a multilayered transluminal device.

5. The medical device of claim 4, wherein the at least one component comprises an inner lumen wall of a multilumen catheter.

6. The medical device of claim 4, wherein the at least one component comprises an outer lumen wall of a multilumen catheter.

7. The medical device of claim 4, wherein at least one layer of the multilayered transluminal device is tapered in thickness along a longitudinal axis thereof.

8. The medical device of claim 3, wherein flexibility of the device varies along a longitudinal axis thereof.

9. The medical device of claim 4, wherein the multilayer transluminal medical device comprises at least one nanocomposite layer and at least one non-nanocomposite layer.

10. The medical device of claim 4, wherein the multilayer transluminal medical device comprises at least two nanocomposite layers separated by at least one non-nanocomposite layer.

11. The medical device of claim 4, wherein the multilayer transluminal medical device comprises at least a first and a second nanocomposite layer, wherein the first and second nanocomposite layers are comprised of different nanocomposites.

12. The medical device of claim 4, wherein at least one of the first and second nanocomposite layers further comprises at least a first functionalizer, and are otherwise comprised of the same nanocomposite.

13. The medical device of claim 4, wherein the multilayer transluminal medical device comprises at least a first and a second nanocomposite layer, wherein the first and second nanocomposite layers further comprise at least a first and a second functionalizer respectively, and otherwise are comprised of the same nanocomposite.

14. The medical device of claim 1, wherein the at least one component comprises an expandable balloon comprising at least two layers.

15. The medical device of claim 14, wherein each of at least two layers comprises a different functionalizer and are otherwise comprised of the same nanocomposite material.

16. The medical device of claim 1, wherein the matrix material comprises a thermoset material.

17. The medical device of claim 16, wherein the thermoset material comprises a nitrile butadiene elastomer, a silicone, an epoxy, a isocyanate, EPDM, epichlorohydrin, or a copolymer, block copolymer or polymer blend of these.

18. The medical device of claim 1, wherein the matrix material comprises a thermoplastic material.

19. The medical device of claim 18, wherein the thermoplastic material comprises a polyolefin, a polyamide, a polyester, a polyether, a polyurethane, a polyurea, a polyvinyl, a polyacrylic, a fluoropolymer or a copolymer, block copolymer or blend of any of these.

20. The medical device of claim 19, wherein the thermoplastic material is a nylon.

21. The medical device of claim 20, wherein the nylon is nylon 12.

22. The medical device of claim 19, wherein the thermoplastic material is a polyether amide block copolymer

23. The medical device of claim 1, wherein the filler particles comprise synthetic or natural phyllosilicate, monomeric silicate, carbon or ceramic nanotubes, nanowires or nanofibers, metal or metal oxide powder, magnetic or paramagnetic powder, temperature sensitive polymer, biodegradable polymer, dendrimer or dendrimer metal complex, or a combination of these.

24. The medical device of claim 23, wherein the filler particles comprise one or more phyllosilicates.

25. The medical device of claim 24, wherein the filler particles comprise one or more clays.

26. The medical device of claim 25, wherein at least one of the clays comprises montmorillonite.

27. The medical device of claim 23, wherein the filler particles comprise one or more polyhedral oligomeric silsequioxanes.

28. The medical device of claim 23, wherein the filler particles comprise one or more carbon or ceramic nanotubes, nanowires or nanofibers.

29. The medical device of claim 28, wherein the filler particles comprise one or more carbon nanotubes.

30. The medical device of claim 1, wherein the at least one component comprises a catheter shaft.

31. The medical device of claim 1, wherein the at least one component comprises a balloon.

32. The medical device of claim 1, wherein the medical device is a guide catheter.

33. The medical device of claim 1, wherein the at least one component comprises a stent delivery catheter.

34. A method of making at least a component of a medical device, comprising:

selecting a nanoparticle filler material;

selecting a matrix material;

preparing a nanocomposite from the filler material and the matrix material; and

preparing at least a component of the medical device with the nanocomposite.

35. The method of claim 34, wherein the medical device is a transluminal medical device.

36. The method of claim 35, wherein the medical device is a multilayer transluminal medical device.

38. The method of claim 36, wherein the at least one component comprises a length of catheter shafting.

39. The method of claim 38, wherein the step of preparing at least a component of the medical device comprises providing one layer to be tapered in thickness along a longitudinal axis thereof.

40. The method of claim 38, wherein the step of preparing at least a component of the medical device comprises providing a variability in flexibility along a longitudinal axis thereof.

41. The method of claim 38, wherein the filler material comprises a plurality of carbon nanotubes, nanofibers, or nanowires.

42. The method of claim 41, wherein at least a portion of the plurality of carbon nanotubes, nanofibers, or nanowires is functionalized with glucosamine, or carboxylic acid.

43. The method of claim 41, wherein the length of shafting is provided by contacting at least a portion of a first layer of the length of shafting with a solution comprising the carbon nanoparticles and providing the second layer to be deposited over at least a portion of the carbon nanoparticles.

44. The method of claim 43, wherein the solution of carbon nanoparticles further comprises a dispersant.

45. The method of claim 44, wherein the dispersant comprises gum arabic.

46. The method of claim 35, wherein the medical device is a cardiovascular medical device.

47. The method of claim 46, wherein the cardiovascular medical device is a balloon catheter.

48. An apparatus for forming a polymer extrudate, the apparatus comprising:

a polymer extruder, the polymer extruder comprising an extruder head for extruding a polymer melt, the extruder head having at least one ultrasonic transducer functionally engaged thereto, the at least one ultrasonic transducer constructed and arranged to transmit at least one modulated ultrasonic wave to the extruder head, the at least one modulated ultrasonic wave having at least one amplitude and at least one modulation, the at least one amplitude and the at least one modulation of the wave imparting substantially uniform vibrations to at least the entire extruder head.

49. A method of medical care comprising bringing a medical device into therapeutic contact with a body to effectuate a treatment or diagnosis thereof, wherein the medical device comprises at least one nanocomposite material.

50. The method of claim 49, wherein the method of medical care is a method of treatment.

51. The method of claim 50, wherein the medical device is a transluminal medical device.

52. The method of claim 51, wherein the medical device comprises a catheter.

53. The method of claim 52, wherein the medical device comprises a balloon.

54. The method of claim 51, wherein the medical device is a guide catheter.

55. The method of claim 51, wherein the medical device is a stent delivery catheter.

56. The method of claim 53, wherein the treatment is angioplasty.

57. The method of claim 49, wherein the method of medical care is a diagnostic method.

58. The method of claim 57, wherein the medical device is a transluminal medical device.

59. The medical device of claim 58, wherein the medical device comprises a catheter.

60. The method of claim 59, wherein the diagnostic method is angiography.