Systems and methods for providing prostheses

• US 20070021835A1
• Filed: 07/11/2006
• Published: 01/25/2007
• Est. Priority Date: 07/11/2005
• Status: Abandoned Application

• Current Assignee: Kyphon SARL (Medtronic Plc)
• Original Assignee: Kyphon SARL (Medtronic Plc)
• Inventors: Edidin, Avram
• Application Number:
  US11/485,244
• Publication Number:
  US 20070021835A1
• Time in Patent Office: Days
• US Class Current: 623/17.120
• CPC Class Codes: A61B 17/8805 for introducing fluid filler into bone or extracting it A61B17/7097, A61B17/8833 take precedence
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• CPC Class Codes: A61F 2/30744 End caps, e.g. for closing an endoprosthetic cavity
• CPC Class Codes: A61F 2/30767 Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
• CPC Class Codes: A61F 2/3094 Designing or manufacturing processes
• CPC Class Codes: A61F 2/30965 Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
• CPC Class Codes: A61F 2/441 made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2002/30014 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/30133 kidney-shaped or bean-shaped
• CPC Class Codes: A61F 2002/30324 differing in thickness
• CPC Class Codes: A61F 2002/30583 filled with hardenable fluid, e.g. curable in-situ
• CPC Class Codes: A61F 2002/30586 having two or more inflatable pockets or chambers
• CPC Class Codes: A61F 2002/30604 modular
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30682 Means for preventing migration of particles released by the joint, e.g. wear debris or cement particles
• CPC Class Codes: A61F 2002/444 for replacing the nucleus pulposus
• CPC Class Codes: A61F 2002/4627 with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument
• CPC Class Codes: A61F 2002/4629 : connected to the endoprosthesis or implant via a threaded connection
• CPC Class Codes: A61F 2210/0004 : bioabsorbable
• CPC Class Codes: A61F 2210/0085 : hardenable in situ, e.g. epoxy resins
• CPC Class Codes: A61F 2230/0015 : Kidney-shaped, e.g. bean-shaped
• CPC Class Codes: A61F 2250/0018 : differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0036 : differing in thickness
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2310/00023 : Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/00928 : Coating or prosthesis-covering structure made of glass or of glass-containing compounds, e.g. of bioglass

Abstract

Systems and methods for providing prostheses are described. One method comprises identifying a tissue in a treatment area. The method further comprises modifying a structural stiffness of a portion of an expansible body prosthesis disposed adjacent the tissue. The expansible body prosthesis is inserted into the treatment area.

Claims

1. A device comprising:

an expansible body prosthesis configured to be deployed in a treatment area, the expansible body prosthesis comprising an aperture configured to receive a filler material, a first substantially impermeable portion having a first structural stiffness, and a second substantially impermeable portion contiguous to the first substantially impermeable portion and having a second structural stiffness greater than the first structural stiffness, wherein the second substantially impermeable portion is configured to be disposed adjacent a tissue in the treatment area at least when the expansible body prosthesis is in an expanded state.

2. The device of claim 1, wherein the first substantially impermeable portion comprises a first thickness, and the second substantially impermeable portion comprises a second thickness greater than the first thickness.

3. The device of claim 1, wherein the first substantially impermeable portion comprises a first body material, and the second substantially impermeable portion comprises a second body material different than the first body material.

4. The device of claim 1, further comprising a brace coupled to at least one of an interior surface and an exterior surface of the second substantially impermeable portion.

5. The device of claim 1, further comprising a coating material applied to at least one of an interior surface and an exterior surface of the second substantially impermeable portion.

6. The device of claim 1, wherein at least the second substantially impermeable portion comprises a cross-linkable material.

7. The device of claim 1, wherein the aperture is configured to be sealed, and wherein the second substantially impermeable portion comprises an analog of the aperture when the aperture is sealed.

8. The device of claim 1, wherein the expansible body prosthesis is configured to be deployed in a treatment area along a path established by a cannula.

9. The device of claim 1, wherein the expansible body prosthesis is configured to replace an intervertebral disc.

10. The device of claim 1, wherein the expansible body prosthesis is configured for placement inside an intervertebral disc.

11. The device of claim 1, wherein the expansible body prosthesis is configured to replace at least a portion of an intervertebral disc nucleus.

12. The device of claim 1, wherein the expansible body prosthesis further comprises a detachable coupling configured to detachably couple the expansible body prosthesis with an elongate member.

13. The device of claim 1, further comprising an annular buttress.

14. A device comprising:

an expansible body prosthesis configured to be deployed in a treatment area, the expansible body prosthesis comprising an aperture configured to receive a filler material, a first substantially impermeable portion, and a second substantially impermeable portion contiguous to the first substantially impermeable portion and configured to be disposed adjacent a tissue in the treatment area at least when the expansible body prosthesis is in an expanded state, wherein at least the second substantially impermeable portion of the expansible body prosthesis comprises a body material comprising a variable structural stiffness.

15. The device of claim 14, wherein the first substantially impermeable portion comprises a first thickness, and the second substantially impermeable portion comprises a second thickness greater than the first thickness.

16. The device of claim 14, wherein the first substantially impermeable portion comprises a first body material, and the second substantially impermeable portion comprises a second body material different than the first body material.

17. The device of claim 14, further comprising a brace coupled to at least one of an interior surface and an exterior surface of the second substantially impermeable portion.

18. The device of claim 14, further comprising a coating material applied to at least one of an interior surface and an exterior surface of the second substantially impermeable portion.

19. The device of claim 14, wherein at least the second substantially impermeable portion comprises a cross-linkable material.

20. The device of claim 14, wherein the aperture is configured to be sealed, and wherein the second substantially impermeable portion comprises an analog of the aperture when the aperture is sealed.

21. The device of claim 14, wherein the expansible body prosthesis is configured to be deployed in a treatment area along a path established by a cannula.

22. The device of claim 14, wherein the expansible body prosthesis is configured to replace an intervertebral disc.

23. The device of claim 14, wherein the expansible body prosthesis is configured for placement inside an intervertebral disc.

24. The device of claim 14, wherein the expansible body prosthesis is configured to replace at least a portion of an intervertebral disc nucleus.

25. The device of claim 14, wherein the expansible body prosthesis further comprises a detachable coupling configured to detachably couple the expansible body prosthesis with an elongate member.

26. The device of claim 14, further comprising an annular buttress.

27. A method comprising:

identifying a tissue in a treatment area;

modifying a structural stiffness of a portion of an expansible body prosthesis; and

inserting the expansible body prosthesis into the treatment area.

28. The method of claim 27, wherein identifying the tissue in the treatment area comprises identifying a characteristic of the tissue.

29. The method of claim 28, wherein modifying the structural stiffness of the portion of the expansible body prosthesis comprises modifying the structural stiffniess of the portion in relation to the characteristic of the tissue.

30. The method of claim 27, wherein identifying the characteristic of the tissue comprises identifying at least one of a damaged tissue, a weakened tissue, and a tissue susceptible to further damage.

31. The method of claim 27, wherein modifying the structural stiffness of the portion of the expansible body prosthesis comprises increasing the structural stiffness of the portion of the expansible body prosthesis.

32. The method of claim 27, wherein modifying the structural stiffness of the portion of the expansible body prosthesis comprises fabricating the portion of the expansible body prosthesis from at least one of a different thickness and a different body material than a second portion of the expansible body prosthesis.

33. The method of claim 27, wherein modifying the structural stiffness of the portion of the expansible body prosthesis comprises coupling a brace to at least one of an interior surface and an exterior surface of the portion.

34. The method of claim 27, wherein modifying the structural stiffness of the portion of the expansible body prosthesis comprises coating at least one of an interior surface and an exterior surface of the portion with a material configured to modify the structural stiffness of the portion.

35. The method of claim 27, wherein at least the portion of the expansible body prosthesis comprises a cross-linkable material, and wherein modifying the structural stiffness of the portion of the expansible body prosthesis comprises cross-linking the portion.

36. The method of claim 27, wherein modifying the structural stiffniess of the portion of the expansible body prosthesis comprises modifying the structural stiffness of the portion of the expansible body prosthesis prior to inserting the expansible body prosthesis into the treatment area.

37. The method of claim 27, wherein modifying the structural stiffness of the portion of the expansible body prosthesis comprises modifying the structural stiffness of the portion of the expansible body prosthesis subsequent to insertion of the expansible body prosthesis into the treatment area.

38. The method of claim 27, further comprising expanding the expansible body prosthesis in the treatment area.

39. The method of claim 27, further comprising maneuvering the expansible body prosthesis in the treatment area to align the portion of the expansible body prosthesis with the tissue.

40. The method of claim 27, further comprising detachably coupling the expansible body prosthesis an elongate member.

41. The method of claim 27, wherein the treatment area is located within an intervertebral disc.

42. The method of claim 41, wherein identifying the tissue in the treatment area comprises identifying a weakened area of an annulus of the intervertebral disc.

43. The method of claim 27, wherein the expansible body prosthesis is configured to replace an intervertebral disc.

44. The method of claim 27, wherein the expansible body prosthesis is configured for placement in an intervertebral disc.

45. The method of claim 27, wherein the expansible body prosthesis is configured to replace at least a portion of an intervertebral disc nucleus.

46. The method of claim 27, further comprising providing access to the treatment area.

47. The method of claim 46, and wherein providing access to the treatment area comprises providing access to a nucleus of an intervertebral disc through its annulus.

48. The method of claim 27, wherein inserting the expansible body prosthesis into the treatment area comprises inserting the expansible body prosthesis into the treatment area along a path established by a cannula.

49. A kit comprising:

a package configured to maintain its contents in a sterile condition; and

at least one sterilized expansible body prosthesis configured to be deployed in a treatment area, the sterilized expansible body prosthesis comprising an aperture configured to receive a filler material, a first substantially impermeable portion having a first structural stiffness, and a second substantially impermeable portion contiguous to the first substantially impermeable portion and having a second structural stiffness greater than the first structural stiffness, wherein the second substantially impermeable portion is configured to be disposed adjacent a tissue in the treatment area at least when the sterilized expansible body prosthesis is in an expanded state.

50. The kit of claim 49, further comprising:

a sterilized elongate member configured to at least temporarily couple with the aperture of the at least one expansible body prosthesis.

51. The kit of claim 49, further comprising:

a container at least partially filled with the filler material.

52. The kit of claim 49, further comprising:

a sterilized tool configured to at least one of cut and remove tissue.

53. The kit of claim 49, wherein the at least one sterilized expansible body prosthesis comprises a plurality of sterilized expansible bodies, wherein at least the second substantially impermeable portion of each sterilized expansible body prosthesis comprises a unique configuration.

54. The kit of claim 49, further comprising:

a sterilized brace configured to be coupled to at least one of an interior surface and an exterior surface of at least the second substantially impermeable portion of the at least one sterilized expansible body prosthesis.

55. The kit of claim 49, further comprising:

a coating material configured to be applied to at least one of an interior surface and an exterior surface of at least the second substantially impermeable portion of the at least one sterilized expansible body prosthesis.

56. The kit of claim 49, wherein at least the second substantially impermeable portion of the at least one sterilized expansible body prosthesis comprises a cross-linkable material;

and further comprising;

a sterilized tool configured to cross-link at least a portion of the cross-linkable material.

57. The kit of claim 49, further comprising:

a sterilized access tool configured to provide at least one of access and navigation to the treatment area.

58. The kit of claim 49, further comprising:

a sterilized cannula configured to establish a path to the treatment area.

59. The kit of claim 49, wherein the expansible body prosthesis is configured to replace an intervertebral disc.

60. The kit of claim 49, wherein the expansible body prosthesis is configured for placement inside an intervertebral disc.

61. The kit of claim 49, wherein the expansible body prosthesis is configured to replace at least a portion of an intervertebral disc nucleus.

62. The kit of claim 49, further comprising an element configured to seal the aperture in the expansible body prosthesis when coupled to at least a portion of an edge of a body material of the expansible body prosthesis adjacent the aperture.

63. The kit of claim 49, further comprising a container at least partially filled with an adhesive configured to seal the aperture in the expansible body prosthesis when applied to least one of an interior surface and an exterior surface of a body material of the expansible body prosthesis.

64. A kit comprising:

a package configured to maintain its contents in a sterile condition; and

at least one sterilized expansible body prosthesis configured to be deployed in a treatment area, the at least one sterilized expansible body prosthesis comprising an aperture configured to receive a filler material, a first substantially impermeable portion, and a second substantially impermeable portion contiguous to the first substantially impermeable portion and configured to be disposed adjacent a tissue in the treatment area at least when the at least one sterilized expansible body prosthesis is in an expanded state, wherein at least the second substantially impermeable portion of the at least one sterilized expansible body prosthesis comprises a body material comprising a variable structural stiffness.

65. The kit of claim 64, further comprising:

a sterilized elongate member configured to at least temporarily couple with the aperture of the at least one sterilized expansible body prosthesis.

66. The kit of claim 64, further comprising:

a container at least partially filled with the filler material.

67. The kit of claim 64, further comprising:

a sterilized tool configured to at least one of cut and remove tissue.

68. The kit of claim 64, wherein the at least one sterilized expansible body prosthesis comprises a plurality of sterilized expansible bodies, wherein at least the second substantially impermeable portion of each sterilized expansible body prosthesis comprises a unique configuration.

69. The kit of claim 64, further comprising:

a sterilized brace configured to be coupled to at least one of an interior surface and an exterior surface of at least the second substantially impermeable portion of the at least one sterilized expansible body prosthesis.

70. The kit of claim 64, further comprising:

a coating material configured to be applied to at least one of an interior surface and an exterior surface of at least the second substantially impermeable portion of the at least one sterilized expansible body prosthesis.

71. The kit of claim 64, wherein the body material comprises a cross-linkable material;

and further comprising;

a sterilized tool configured to cross-link at least a portion of the cross-linkable material.

72. The kit of claim 64, further comprising:

a sterilized access tool configured to provide at least one of access and navigation to the treatment area.

73. The kit of claim 64, further comprising:

a sterilized cannula configured to establish a path to the treatment area.

74. The kit of claim 64, further comprising an element configured to seal the aperture in the expansible body prosthesis when coupled to at least a portion of an edge of a body material of the expansible body prosthesis adjacent the aperture.

75. The kit of claim 64, further comprising a container at least partially filled with an adhesive configured to seal the aperture in the expansible body prosthesis when applied to least one of an interior surface and an exterior surface of a body material of the expansible body prosthesis.

76. A method comprising:

detachably coupling an expansible body prosthesis comprising an aperture and configured to replace at least a portion of an intervertebral disc to a distal end of an elongate member;

inserting the expansible body prosthesis into a treatment area along a path established by a cannula;

at least partially expanding the expansible body prosthesis in the treatment area through the aperture; and

simultaneously sealing the aperture and detaching the elongate member from the expansible body prosthesis.

77. The method of claim 76, further comprising maneuvering the expansible body in the treatment area to detach the elongate member from the expansible body.

78. The method of claim 76, wherein the expansible body prosthesis comprises a frangible coupling configured to rupture upon a predetermined condition.

79. The method of claim 78, wherein the predetermined condition comprises an expansible body prosthesis interior pressure level reaching a predetermined threshold level.

80. The method of claim 78, wherein the predetermined condition comprises an expansible body prosthesis temperature level reaching a predetermined threshold level.

81. The method of claim 78, wherein the predetermined condition comprises an expansible body prosthesis interior fluid volume pressure level reaching a predetermined threshold level.