IP Library Granted Patent US 9,833,309
Granted Patent B2
US 9,833,309 · App. 13/224,103 · Granted Dec 5, 2017

Thin film vascular stent and biocompatible surface treatment

Inventors: Daniel S. Levi (Pacific Palisades, CA); Gregory P. Carman (Los Angeles, CA); Youngjae Chun (Los Angeles, CA); Fernando Vinuela (Los Angeles, CA)
Assignee: THE REGENTS OF THE UNIVERSITY OF CALIFORNIA
A61F2/07A61B17/12022A61B17/12118A61F2/95A61L31/022A61B2017/1205A61F2/91A61F2/92A61F2002/077A61F2002/823A61L2400/18
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Quick Facts
Patent No.
US 9,833,309
App. No.
13/224,103
Granted
Dec 5, 2017
Kind
B2
Abstract

A vascular implant, comprising a sheet comprising thin film nickel titanium (NiTi), wherein the sheet has at least one super-hydrophilic surface having a water contact angle of less than approximately 5 degrees. The sheet is configured to have a compacted form having a first internal diameter and a deployed form having a second internal diameter larger than the first internal diameter. The sheet may be delivered into a blood vessel in the compacted form and expanded to its deployed form at a treatment location within the blood vessel, wherein the stent is configured to expand onto an internal surface of the blood vessel and exert a radial force on said internal surface.

Claims (136)

1. A vascular implant, comprising:

a thin film of nickel titanium (NiTi);

a non-native titanium monoxide (TiO) layer on the thin film of nickel titanium; and

a super-hydrophilic surface comprising a plurality of hydroxyl groups bonded to the non-native titanium monoxide layer.

2. The implant of claim 1 , wherein the super-hydrophilic surface has a water contact angle of less than approximately 5 degrees.

3. The implant of claim 1 , wherein the super-hydrophilic surface is configured to deter platelet adhesion at a rate of less than 3 parts per mm 2 when subjected to platelet rich plasma for 3 or more hours.

4. The implant of claim 1 , wherein the thin film has a winding number greater than one.

5. The implant of claim 1 , wherein the thin film has a winding number less than one.

6. The implant of claim 1 , wherein the thin film is non-perforated.

7. The implant of claim 1 , wherein the thin film comprises a plurality of sections, and wherein at least one section of the plurality of sections has properties distinct from at least one other section of the plurality of sections.

8. The implant of claim 7 , wherein a first section of the plurality of sections is perforated and a second section of the plurality of sections is non-perforated.

9. The implant of claim 1 , wherein the thin film has a tab-and-slot configuration.

10. The implant of claim 1 :

wherein the vascular implant comprises a stent configured to be installed adjacent a vascular aneurysm; and

wherein the vascular implant has a thickness ranging between about 2 μm and about 12 μm.

11. The implant of claim 1 :

wherein the vascular implant comprises a stent configured to be installed adjacent a cerebral aneurysm; and

wherein the vascular implant has a thickness ranging between about 4 μm and about 8 μm.

12. The implant of claim 10 :

wherein the stent comprises a truss comprising one or more members configured to be disposed in a compressed form when constrained inside a catheter;

wherein the truss is configured to automatically expand at a treatment site when not constrained inside said catheter;

wherein the thin film is disposed over the truss covers the truss in the compacted from; and

wherein the thin film is configured to expand with expansion of said truss.

13. The implant of claim 10 , wherein the stent comprises:

a generally rectangular thin film sheet wrapped into a generally tubular shape having a longitudinal and radial direction;

wherein two distal edges of the sheet define two ends of the tubular shape;

wherein two longitudinal edges of the sheet overlap; and

wherein the sheet has a compacted form with a first internal diameter and a deployed form with a second internal diameter larger than the first internal diameter.

14. The implant of claim 13 :

wherein the stent is configured to be delivered into a blood vessel in the compacted form;

wherein the stent is configured to be expanded to its deployed form at a treatment location within the blood vessel; and

wherein the stent is configured to expand onto an internal surface of the blood vessel and exert a radial force on said internal surface.

15. The implant of claim 1 , wherein the implant consists essentially of the thin film, the super-hydrophilic surface, and titanium monoxide layer.

16. The implant of claim 1 , further comprising a self-contained constraining device.

17. The implant of claim 1 , wherein the non-native titanium monoxide layer is approximately 100 nm thick.

18. A method for generating a super-hydrophilic surface of a vascular implant, comprising:

fabricating a thin film of nickel titanium (NiTi), wherein the thin film includes a native oxide layer of titanium dioxide;

removing the native oxide layer using a buffered oxide etchant; and

after removing the native oxide layer, generating a titanium monoxide (TiO) layer bonded to a plurality of hydroxyl groups by immersing the thin film in a hydrogen peroxide solution.

19. The method of claim 18 , wherein the super-hydrophilic surface has a water contact angle of less than approximately 5 degrees.

20. The method of claim 19 , wherein the super-hydrophilic surface is configured to deter platelet adhesion at a rate of less than 3 parts per mm 2 when subjected to platelet rich plasma for 3 or more hours.

21. The method of claim 18 , further comprising:

passivating the thin film in a nitric acid solution prior to the immersing of the film in the hydrogen peroxide solution.

22. The method of claim 21 , further comprising:

immersing the thin film in a cleaning pretreatment dip comprising one or more of the following:

acetone, methanol, and alcohol.

23. The method of claim 18 , wherein the buffered oxide etchant comprises an aqueous NH 4 -HF etchant.

24. The method of claim 18 , wherein the thin film is fabricated using DC sputter deposition.

25. The method of claim 18 , wherein the thin film has a thickness of less than about 30 μm.

26. The method of claim 25 :

wherein the thin film has a thickness ranging between about 2 μm and about 12 μm.

27. The method of claim 26 :

wherein the thin film has a thickness ranging between about 4 μm and about 8 μm.

28. The method of claim 18 , further comprising:

storing the thin film in a high-humidity environment to maintain the super-hydrophilic surface.

29. The method of claim 28 , wherein the environment comprises a container comprising deionized water.

30. The method of claim 18 , wherein immersion of the thin film in a hydrogen peroxide solution is performed at a temperature below boiling temperature.

31. A method of forming a hydrophilic thin film sheet of nickel titanium, comprising:

obtaining a thin film of nickel titanium, the thin film having a native titanium dioxide layer;

removing the native titanium dioxide layer by applying a surface treatment to the thin film of nickel titanium; and

generating a titanium monoxide (TiO) layer having a super-hydrophilic surface by immersing the thin-film sheet in a concentration of hydrogen peroxide (H 2 O 2 ).

32. The method of claim 31 , wherein the thin film is stored in a high-humidity environment prior to delivery within a body.

33. A system for treating a vascular condition, comprising:

a vascular implant, comprising:

a thin film of nickel titanium (NiTi);

a titanium monoxide (TiO) layer on the thin film of nickel titanium; and

a super-hydrophilic surface comprising a plurality of hydroxyl groups bonded to the titanium monoxide layer; and

a storage container for the vascular implant, the storage container configured to maintain a high-humidity environment for the vascular implant.

34. The system of claim 33 , wherein the super-hydrophilic surface has a water contact angle of less than approximately 5 degrees.

35. The system of claim 33 , wherein the super-hydrophilic surface is configured to deter platelet adhesion at a rate of less than 3 parts per mm 2 when subjected to platelet rich plasma for 3 or more hours.

36. The system of claim 33 , wherein the super-hydrophilic surface is fabricated by immersion of the thin film in a hydrogen peroxide solution.

37. The system of claim 33 , wherein the thin film has a thickness of less than about 30 μm.

38. The system of claim 37 ,

wherein the thin film comprises a stent configured to be installed adjacent a vascular aneurysm; and

wherein the thin film has a thickness ranging between about 2 μm and about 12 μm.

39. The system of claim 38 :

wherein the stent is configured to be installed adjacent a cerebral aneurysm; and

wherein the thin film has a thickness ranging between about 4 μm and about 8 μm.

40. The system of claim 38 , wherein the stent comprises:

a generally rectangular thin film sheet wrapped into a generally tubular shape having a longitudinal and radial direction;

wherein two distal edges of the sheet define two ends of the tubular shape;

wherein two longitudinal edges of the sheet overlap; and

wherein the sheet has a compacted form with a first internal diameter and a deployed form with a second internal diameter larger than the first internal diameter.

41. The system of claim 40 , further comprising:

a catheter configured to be delivered into a blood vessel;

wherein the stent is configured to be delivered in the compacted form inside the catheter;

wherein the stent is configured to be deployed out the catheter and expanded to its deployed form at a treatment location associated with the aneurysm; and

wherein the stent is configured to expand onto an internal surface of the blood vessel and exert a radial force on said internal surface.

42. The system of claim 33 :

wherein the storage container comprises a container configured to house the thin film and a humidifying element.

43. The system of claim 42 , further comprising:

a catheter configured to be delivered into a blood vessel;

wherein the container is configured to house the catheter with the stent installed in a compacted form inside said catheter.

44. A vascular implant, comprising:

a thin film of nickel titanium (NiTi) having a compacted form with a first internal diameter and a deployed form with a second internal diameter larger than the first internal diameter, wherein a native oxide layer of titanium dioxide has been removed from the thin film of nickel titanium; and

a non-native titanium monoxide (TiO) layer on the thin film of nickel titanium, the non-native titanium monoxide layer having a super-hydrophilic surface;

wherein the implant is configured to be delivered into a blood vessel in the compacted form;

wherein the implant is configured to expand to its deployed form at a treatment location within the blood vessel; and

wherein the implant is configured to expand onto an internal surface of the blood vessel and exert a radial force on said internal surface.

45. The implant of claim 44 :

wherein the thin film comprises a generally rectangular thin film sheet wrapped into a generally tubular shape having a longitudinal and radial direction;

wherein two distal edges of the sheet define two ends of the tubular shape;

wherein two longitudinal edges of the sheet overlap in the compacted form; and

wherein the sheet comprises at least one super-hydrophilic surface.

46. The implant of claim 44 , wherein the implant further comprises one or more radio-opaque markers.

47. The implant of claim 44 , wherein the thin film comprises a phase transforming thin film.

48. The implant of claim 44 :

wherein the vascular implant comprises a stent configured to be installed at a treatment site associated with a vascular aneurysm; and

wherein the vascular implant has a thickness ranging between about 4 μm and about 12 μm.

49. The implant of claim 48 :

wherein the stent comprises a truss comprising one or more members configured to be disposed in a compressed form when constrained inside a catheter;

wherein the truss is configured to automatically expand at the treatment site when not constrained inside said catheter;

wherein the thin film is disposed over the truss covers the truss in the compacted from; and

wherein the thin film is configured to expand with expansion of said truss.

50. The implant of claim 44 :

wherein the vascular implant comprises a stent configured to be installed at a treatment site associated with a cerebral aneurysm; and

wherein the vascular implant has a thickness ranging between about 4 μm and about 8 μm.

51. The implant of claim 50 , wherein the super-hydrophilic surface has a water contact angle of less than approximately 5 degrees.

52. The implant of claim 51 , wherein the super-hydrophilic surface is configured to deter platelet adhesion at a rate of less than 3 parts per mm 2 when subjected to platelet rich plasma for 3 or more hours.

53. The implant of claim 51 , wherein the non-native titanium monoxide layer is approximately 100 nm thick.

54. The implant of claim 44 , wherein the implant is configured such that the radial force is larger than a drag force imparted on said implant from blood flow on said internal surface.

55. A method for treating a vascular condition, comprising:

wrapping a sheet comprising thin film nickel titanium (NiTi) and a non-native titanium monoxide layer into a generally tubular shape having a longitudinal and radial direction, wherein the titanium monoxide layer comprises titanium monoxide bonded to a plurality of hydroxyl groups to form a super-hydrophilic surface;

the sheet having a compacted form having a first internal diameter and a deployed form having a second internal diameter larger than the first internal diameter;

installing the sheet in the compacted form into a catheter; and

delivering the catheter to a treatment location inside a blood vessel;

wherein the sheet is configured to be deployed out of the catheter and expanded to its deployed form at the treatment location; and

wherein the sheet is configured to expand onto an internal surface of the blood vessel and exert a radial force on said internal surface.

56. The method of claim 55 , wherein the radial force is larger than a drag force imparted on said sheet from blood flow on said internal surface.

57. The method of claim 56 :

wherein the thin film comprises a stent configured to be installed adjacent a vascular aneurysm; and

wherein the thin film has a thickness ranging between about 4 μm and about 12 μm.

58. The method of claim 57 :

wherein the stent is configured to be installed adjacent a cerebral aneurysm; and

wherein the thin film has a thickness ranging between about 4 μm and about 8 μm.

59. The method of claim 57 , wherein the super-hydrophilic surface has a water contact angle of less than approximately 5 degrees.

Assignments (2)
CONFIRMATORY LICENSE Recorded Jun 26, 2014
From: UNIVERSITY OF CALIFORNIA LOS ANGELES
To: US ARMY, SECRETARY OF THE ARMY
Reel/Frame 033244/0506 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 23, 2013
From: LEVI, DANIEL S.; CARMAN, GREGORY P.; CHUN, YOUNGJAE; VINUELA, FERNANDO
To: THE REGENTS OF THE UNIVERSITY OF CALIFORNIA
Reel/Frame 031256/0533 →
Continuity (4)
Continuation PCTUS2010026430 · Mar 5, 2010
Provisional Application 61158200 · Mar 6, 2009
Provisional Application 61158221 · Mar 6, 2009
Related Publication 20140249614A1 · Sep 4, 2014