RESORBABLE NANOENHANCED HEMOSTATIC STRUCTURES AND BANDAGE MATERIALS

• US 20090192429A1
• Filed: 12/05/2008
• Published: 07/30/2009
• Est. Priority Date: 12/06/2007
• Status: Active Grant

• Current Assignee: Nanosys Incorporated (Shoei Electronic Materials, Inc.)
• Original Assignee: Nanosys Incorporated (Shoei Electronic Materials, Inc.)
• Inventors: Enzerink, Robert, Daniels, R. Hugh, Li, Esther, Parce, J. Wallace, Goldman, Jay L., Dubrow, Robert S., Sahi, Vijendra
• Granted Patent: US 8,304,595 B2
• Time in Patent Office: Days
• US Class Current: 602/43
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 2017/00601 Implements entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/00884 enhancing wound closure
• CPC Class Codes: A61B 2017/00893 pharmaceutically effective
• CPC Class Codes: A61F 13/00991 for treating webs, e.g. for moisturising, coating, impregnating or applying powder
• CPC Class Codes: A61F 13/01008 characterised by the material
• CPC Class Codes: A61F 13/01034 characterised by a property
• CPC Class Codes: A61F 13/36 Surgical swabs, e.g. for absorbency or packing body cavities during surgery A61F13/38 takes precedence
• CPC Class Codes: A61F 2013/00472 with chemical means
• CPC Class Codes: A61F 2013/0054 for deep wounds
• CPC Class Codes: A61F 2013/00744 containing non-woven
• CPC Class Codes: A61F 2013/00927 with biological activity, e.g. enzymes for debriding wounds or others, collagen or growth factors
• CPC Class Codes: A61F 2013/00931 chitin
• CPC Class Codes: A61L 15/18 containing inorganic materials
• CPC Class Codes: A61L 15/42 Use of materials characterised by their function or physical properties liquid bandages A61L26/00
• CPC Class Codes: A61L 17/145 Coating
• CPC Class Codes: A61L 2400/04 Materials for stopping bleeding
• CPC Class Codes: A61L 2400/12 Nanosized materials, e.g. nanofibres, nanoparticles, nanowires, nanotubes; Nanostructured surfaces
• CPC Class Codes: A61L 26/0004 containing inorganic materials
• CPC Class Codes: A61L 26/0095 : Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
• CPC Class Codes: A61L 31/082 : Inorganic materials
• CPC Class Codes: A61L 31/128 : containing other specific inorganic fillers not covered by A61L31/126 or A61L31/127
• CPC Class Codes: D06M 23/08 : Processes in which the treating agent is applied in powder or granular form adhesives for multi-layer textile fabrics D06M17/00

Abstract

Methods, systems, and apparatuses for nanomaterial-enhanced hemostatic medical devices are provided. Hemostatic materials and structures are provided that induce coagulation of blood at a wound/opening caused by trauma, a surgical procedure, ulceration, or other cause. The hemostatic materials and structures may incorporate nanostructures and/or further hemostatic elements such as polymers and/or glass beads. The hemostatic materials and structures may be resorbable. Example embodiments include hemostatic bandages, hemostatic plugs, and hemostatic formulations.

Claims

1. A hemostatic structure, comprising:

a base structure that includes a first material; and

a plurality of nanostructures incorporated with the base structure;

wherein the nanostructures are configured to induce hemostasis when the hemostatic structure is contacted with blood.

2. The hemostatic structure of claim 1, wherein the base structure includes a woven or nonwoven fiber of the first material.

3. The hemostatic structure of claim 1, wherein the nanostructures coat the base structure.

4. The hemostatic structure of claim 1, wherein the first material is resorbable.

5. The hemostatic structure of claim 1, wherein the first material includes cotton.

6. The hemostatic structure of claim 2, wherein the first material is a natural fiber.

7. The hemostatic structure of claim 2, wherein the first material is a synthetic fiber.

8. The hemostatic structure of claim 1, wherein the first material includes oxidized cellulose.

9. The hemostatic structure of claim 1, wherein the first material includes collagen.

10. The hemostatic structure of claim 1, wherein the first material includes a biologically-derived material.

11. The hemostatic structure of claim 1, wherein the first material is an organic or inorganic polymer.

12. The hemostatic structure of claim 2, wherein the fiber is a glass microfiber.

13. The hemostatic structure of claim 1, wherein the hemostatic structure is a bandage.

14. The hemostatic structure of claim 1, wherein the base structure is a bandage.

89. The hemostatic structure of claim 1, wherein the nanostructures include silicon nanowires.

90. The hemostatic structure of claim 89, wherein the silicon nanowires have a thin naturally occurring oxide shell layer.

15. A method for forming a hemostatic structure, comprising:

incorporating nanostructures with a first material to form the hemostatic structure.

18. The method of claim 15, wherein said incorporating comprises:

incorporating the nanostructures with a weave of fibers of the first material to form the hemostatic structure; and

coating the weave of fibers with the nanostructures to form the hemostatic structure; and

wherein said coating comprises;

sonicating a wafer coated with nanostructures in a liquid;

filtering the sonicated nanostructures;

suspending the filtered nanostructures in a liquid to form a nanostructure suspension;

soaking the weave of fibers in the nanostructure suspension; and

drying the soaked weave of fibers.

16-17. -17. (canceled)

19-21. -21. (canceled)

22. A hemostat, comprising:

a material; and

a plurality of nanostructures;

wherein the material and the nanostructures form a mixture.

28. The hemostat of claim 22, wherein the material comprises chitosan.

29. The hemostat of claim 28, wherein the material comprises chitosan microparticles.

30. The hemostat of claim 22, wherein the material comprises biocompatible polymers.

31. The hemostat of claim 22, wherein the nanostructures include nanofibers.

32. The hemostat of claim 31, wherein the nanofibers are coated with silicon dioxide.

33. The hemostat of claim 31, wherein the nanofibers are potassium nanofibers.

34. The hemostat of claim 31, wherein the nanofibers are silicon nanofibers functionalized with potassium.

23-27. -27. (canceled)

35-42. -42. (canceled)

43. A hemostat, comprising:

a plurality of glass beads; and

a plurality of nanostructures;

wherein the glass beads and the nanostructures are combined to form a mixture.

44. The hemostat of claim 43, wherein at least some of the glass beads have a diameter in the range of 3-10 micrometers.

45. The hemostat of claim 43, wherein the nanostructures include nanowires.

46. The hemostat of claim 45, wherein the nanowires are inorganic.

47. The hemostat of claim 43, wherein the nanowires include silicon.

48. The hemostat of claim 47, wherein the nanowires comprise a core of silicon and at least one shell layer disposed about the core comprising silicon dioxide.

49. A method for forming a hemostat, comprising:

mixing a plurality of glass beads with a plurality of nanostructures.

50. A hemostat, comprising:

a plurality of hemostatic particles;

wherein each hemostatic particle comprises a core material coated with a hemostatic material; and

wherein a rate of resorption of the core material is greater than a rate of resorption of the hemostatic material.

51-56. -56. (canceled)

57. A method for forming a hemostat, comprising:

forming a plurality of hemostatic particles by coating particles of a resorbable core material with a hemostatic material;

wherein a rate of resorption of the core material is greater than a rate of resorption of the hemostatic material.

58-59. -59. (canceled)

60. A hemostatic bandage, comprising:

a bandage material; and

a nanopowder formed of nanoparticles having an outer thin oxide layer;

wherein the nanopowder is dispersed in the bandage material.

61. The hemostatic bandage of claim 60, wherein the thin oxide layer of the nanoparticles is a naturally-occurring oxide layer.

62. The hemostatic bandage of claim 60, further comprising:

a coating of nanowires on a surface of the bandage material.

63. The hemostatic bandage of claim 62, wherein the nanowires have an outer layer of silicon dioxide.

64. A method of forming a hemostatic bandage, comprising:

dispersing in a bandage material a nanopowder formed of nanoparticles having an outer thin oxide layer.

65. The method of claim 64, wherein the thin oxide layer of the nanoparticles is a naturally-occurring oxide layer, said dispersing comprising:

dispersing in the bandage material the nanoparticles having the naturally-occurring oxide layer.

66-68. -68. (canceled)

69. A hemostatic bandage, comprising:

a bandage material; and

a first plurality of nanowires formed to each have a first length; and

a second plurality of nanowires formed to each have a second length, wherein the second length is greater than the first length;

wherein the first plurality of nanowires is dispersed in a first region of the bandage material, and the second plurality of nanowires is dispersed in a second region of the bandage material.

70-72. -72. (canceled)

73. A method for forming a hemostatic bandage, comprising:

dispersing a first plurality of nanowires formed to each have a first length in a first region of a bandage material; and

dispersing a second plurality of nanowires formed to each have a second length in a second region of the bandage material.

74-76. -76. (canceled)

77. A surgical staple, comprising:

a body having a base portion, a first leg, and a second leg, the first leg extending at a first angle from a first end of a first surface of the base portion, and the second leg extending at a second angle from a second end of the first surface of the base portion; and

a layer of nanostructures that coats at least a portion of the body.

78-81. -81. (canceled)

82. A method for forming a hemostatic surgical staple, comprising:

receiving a surgical staple having a base portion, a first leg, and a second leg, the first leg extending at a first angle from a first end of a first surface of the base portion, and the second leg extending at a second angle from a second end of the first surface of the base portion; and

coating at least a portion of the surgical staple with a layer of nanostructures.

83-88. -88. (canceled)