Spinal Tissue Distraction Devices

• US 20070055271A1
• Filed: 08/15/2006
• Published: 03/08/2007
• Est. Priority Date: 08/16/2005
• Status: Active Grant

• Current Assignee: IZI Medical Products LLC (Halma PLC)
• Original Assignee: Benvenue Medical, Inc. (Halma PLC)
• Inventors: Schaller, Laurent
• Granted Patent: US 7,785,368 B2
• Time in Patent Office: Days
• US Class Current: 606/90
• CPC Class Codes: A61B 17/70 Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
• CPC Class Codes: A61B 17/7097 Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants disc prostheses made of inflatable chambers or pockets filled with fluid A61F2/441; replacing the nucleus pulposus A61F2002/444
• CPC Class Codes: A61B 17/8852 capable of being assembled or enlarged, or changing shape, inside the bone or disc
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0256 for the spine
• CPC Class Codes: A61F 2/44 for the spine, e.g. vertebrae, spinal discs
• CPC Class Codes: A61F 2/441 made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
• CPC Class Codes: A61F 2/442 Intervertebral or spinal discs, e.g. resilient non-disc-shaped intervertebral inflatable pockets A61F2/441; non-disc-shaped intervertebral fusion implants A61F2/4455
• CPC Class Codes: A61F 2/4455 for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages intervertebral discs A61F2/442
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2002/2835 Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/30153 rectangular
• CPC Class Codes: A61F 2002/30235 tubular, e.g. sleeves
• CPC Class Codes: A61F 2002/30263 cubical
• CPC Class Codes: A61F 2002/30289 helically-coiled
• CPC Class Codes: A61F 2002/30462 retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2002/3052 unrestrained in only one direction, e.g. moving unidirectionally
• CPC Class Codes: A61F 2002/30594 slotted, e.g. radial or meridian slot ending in a polar aperture, non-polar slots, horizontal or arcuate slots
• CPC Class Codes: A61F 2002/30601 telescopic
• CPC Class Codes: A61F 2002/30677 : Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30772 : Apertures or holes, e.g. of circular cross section
• CPC Class Codes: A61F 2002/4415 : elements of the prosthesis being arranged in a chain like manner
• CPC Class Codes: A61F 2002/448 : comprising multiple adjacent spinal implants within the same intervertebral space or within the same vertebra, e.g. comprising two adjacent spinal implants
• 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 2002/4635 : using minimally invasive surgery
• CPC Class Codes: A61F 2002/4683 : by applying ultrasonic vibrations
• CPC Class Codes: A61F 2002/4688 : having operating or control means
• CPC Class Codes: A61F 2210/0014 : using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0085 : hardenable in situ, e.g. epoxy resins
• CPC Class Codes: A61F 2220/0025 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0075 : sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0019 : rectangular
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2230/0084 : cubical
• CPC Class Codes: A61F 2230/0091 : helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/0067 : Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2310/00293 : containing a phosphorus-containing compound, e.g. apatite

Abstract

Spinal tissue distraction devices that include a member which has a pre-deployed configuration for insertion between tissue layers and a deployed configuration in which the member, by change of configuration, forms a support structure for separating and supporting layers of spinal tissue.

Claims

1. A distraction device for treating the human spine, comprising:

at least one generally elongated member having a pre-deployed configuration adapted for insertion between tissue layers and a deployed configuration for separating, supporting or both separating and supporting the tissue layers in which at least a portion of the elongated member, by change of configuration, forms a support structure, including a resident volume, between the tissue layers, said support structure having an extent in the direction between the tissue that increases as the elongated member is inserted between the tissue layers.

2. The distraction device of claim 1 in which the pre-deployed configuration is generally linear.

3. The distraction device of claim 1 in which the elongated member changes shape to define a generally coil-shaped support structure having a plurality of windings.

4. The distraction device of claim 3 in which each winding is substantially in contact with an immediately winding.

5. The distraction device of claim 1 in which the elongated member has a cross-sectional shape that assists in maintaining the shape of the support structure.

6. The distraction device of claim 1 in which the elongated member includes interfering surfaces that assist in maintaining the shape of the support structure.

7. The distraction device of claim 1 in which the support structure is substantially rigid.

8. The distraction device of claim 1 in which the elongated member has an inherent tendency to form the support structure.

9. The distraction device of claim 8 in which the elongated member is comprised of a shape memory material.

10. The distraction device of claim 1 in which the support structure includes passageways communicating with the resident volume.

11. The distraction device of claim 1 in which the at least one elongated member comprises a first elongated member and a second elongated member wherein the support structure defined by the first elongated member and the support structure defined by the second elongated member are positioned side-by-side.

12. The distraction device of claim 1 in which the at least one elongated member comprises a first elongated member and a second elongated member wherein the support structure defined by the first elongated member and the support structure defined by the second elongated member are stacked one on top of the other.

13. The distraction device of claim 1 in which the at least one elongated member comprises a first elongated member, a second elongated member, a third elongated member and a fourth elongated member wherein the support structures defined by the elongated members are arranged in a side-by-side, stacked arrangement.

14. The distraction device of claim 1 further including an energy source that produces ultrasonic vibrations operatively connected to the elongated member to assist in inserting the elongated member between tissue layers.

15. A distraction system for treating the human spine, comprising:

a cannula having a proximal end portion, a distal end portion and a lumen extending therebetween, said distal end portion adapted to be located adjacent or between the layers of tissue; and

at least one generally elongated member having a pre-deployed configuration adapted for passing through the lumen of the cannula and exiting the distal end portion of the cannula to a location between tissue layers and a deployed configuration for separating, supporting or both separating and supporting the tissue layers in which at least a portion of said elongated member, by change of configuration, defines a support structure including a resident volume when said portion exits the distal end portion of the cannula, said support structure having an extent in the direction between the tissue that increases as the elongated member exits the distal end portion of the cannula.

16. The distraction system of claim 15 in which the elongated member changes shape to define a generally coil-shaped support structure having a plurality of windings.

17. The distraction system of claim 16 in which each winding is substantially in contact with an immediately adjacent winding.

18. The distraction system of claim 15 in which the elongated member has a cross-sectional shape that assists in maintaining the shape of the support structure.

19. The distraction system of claim 15 in which the elongated member includes interfering surfaces that assist in maintaining the shape of the support structure.

20. The distraction system of claim 15 in which the support structure is substantially rigid.

21. The distraction system of claim 15 in which the elongated member has an inherent tendency to form the support structure.

22. The distraction system of claim 21 in which the elongated member is comprised of a shape memory material.

23. The distraction system of claim 15 in which the support structure includes passageways communicating with the resident volume.

24. The distraction system of claim 15 in which the at least one elongated member comprises a first elongated member and a second elongated member wherein the support structure defined by the first elongated member and the support structure defined by the second elongated member are positioned side-by-side.

25. The distraction system of claim 15 in which the at least one elongated member comprises a first elongated member and a second elongated member wherein the support structure defined by the first elongated member and the support structure defined by the second elongated member are stacked one on top of the other.

26. The distraction system of claim 15 in which the at least one elongated member comprises a first elongated member, a second elongated member, a third elongated member and a fourth elongated member wherein the support structures defined by the elongated members are arranged in a side-by-side, stacked arrangement.

27. The distraction system of claim 15 further including an energy source that produces ultrasonic vibrations operatively connected to the elongated member to assist in inserting the elongated member between tissue layers.

28. An intravertebral distraction device insertable between a superior endplate and an inferior endplate of a vertebral body, comprising:

at least one generally elongated member having a pre-deployed configuration adapted for insertion into the vertebral body, and a deployed configuration in which at least a portion of said elongated member, by change of configuration, defines a support structure that separates, supports or both separates and supports the superior and inferior endplates when said portion is located within the vertebral body, the support structure including a resident volume.

29. The distraction device of claim 28 in which the pre-deployed configuration is generally linear.

30. The distraction device of claim 28 in which the elongated member changes shape to define a generally coil-shaped support structure having a plurality of windings.

31. The distraction device of claim 30 in which each winding is substantially in contact with an immediately adjacent winding.

32. The distraction device of claim 28 in which the support structure has an extent in the direction of the separated superior and inferior endplates, said extent increasing as the elongated member is inserted into the vertebral body.

33. The distraction device of claim 28 in which the elongated member has a cross-sectional shape that assists in maintaining the shape of the support structure.

34. The distraction device of claim 28 in which the elongated member includes interfering surfaces that assist in maintaining the shape of the support structure.

35. The distraction device of claim 28 in which the support structure is substantially rigid.

36. The distraction device of claim 28 in which the elongated member has an inherent tendency to form the support structure.

37. The distraction device of claim 36 in which the elongated member is comprised of a shape memory material.

38. The distraction device of claim 28 in which the support structure includes passageways communicating with the resident volume.

39. The distraction device of claim 28 in which the at least one elongated member comprises a first elongated member and a second elongated member wherein the support structure defined by the first elongated member and the support structure defined by the second elongated member are positioned side-by-side.

40. The distraction device of claim 28 in which the at least one elongated member comprises a first elongated member and a second elongated member wherein the support structure defined by the first elongated member and the support structure defined by the second elongated member are stacked one on top of the other.

41. The distraction device of claim 28 in which the at least one elongated member comprises a first elongated member, a second elongated member, a third elongated member and a fourth elongated member wherein the support structures defined by the elongated members are arranged in a side-by-side, stacked arrangement.

42. The distraction device of claim 28 further including an energy source that produces ultrasonic vibrations operatively connected to the elongated member to assist in inserting the elongated member into the vertebral body.

43. An intravertebral distraction device insertable between a superior endplate and an inferior endplate of a vertebral body without forming a cavity within cancellous bone tissue therebetween, comprising:

at least one generally elongated member having a pre-deployed configuration adapted for insertion into the vertebral body, the elongated member being adapted to traverse through cancellous bone tissue within the vertebral body and, by change of configuration, form a support structure that separates, supports or both separates and supports the superior and inferior endplates without creating a cavity in cancellous bone tissue between the endplates.

44. The distraction device of claim 43 in which the pre-deployed configuration is generally linear.

45. The distraction device of claim 43 in which the elongated member changes shape to define a generally coil-shaped support structure having a plurality of windings.

46. The distraction device of claim 45 in which each winding is substantially in contact with an immediately winding.

47. The distraction device of claim 43 in which the support structure has an extent measured in the direction of the separation of the endplates, said extent increasing as the elongated member is inserted into the vertebral body.

48. The distraction device of claim 43 in which the elongated member has a cross-sectional shape that assists in maintaining the shape of the support structure.

49. The distraction device of claim 43 in which the elongated member includes interfering surfaces that assist in maintaining the shape of the support structure.

50. The distraction device of claim 43 in which the support structure is substantially rigid.

51. The distraction device of claim 43 in which the elongated member has an inherent tendency to form the form the support structure.

52. The distraction device of claim 51 in which the elongated member is comprised of a shape memory material.

53. The distraction device of claim 43 in which the support structure comprises a resident volume and includes passageways communicating with the resident volume.

54. The distraction device of claim 43 in which the at least one elongated member comprises a first elongated member and a second elongated member wherein the support structure defined by the first elongated member and the support structure defined by the second elongated member are positioned side-by-side.

55. The distraction device of claim 43 in which the at least one elongated member comprises a first elongated member and a second elongated member wherein the support structure defined by the first elongated member and the support structure defined by the second elongated member are stacked one on top of the other.

56. The distraction device of claim 43 in which the at least one elongated member comprises a first elongated member, a second elongated member, a third elongated member and a fourth elongated member wherein the support structures defined by the elongated members are arranged in a side-by-side, stacked arrangement.

57. The distraction device of claim 43 further including an energy source that produces ultrasonic vibrations operatively connected to the elongated member to assist in inserting the elongated member between the superior and inferior vertebrae.

58. An intervertebral distraction device insertable between endplates of a superior vertebra and an inferior vertebra, comprising:

at least one generally elongated member having a pre-deployed configuration adapted for insertion between a superior vertebra and an inferior vertebra, and a deployed configuration in which at least a portion of the elongated member, by change of configuration, defines a support structure that separates, supports or separates and supports the superior and inferior vertebrae, said support structure having an extent in the direction between vertebrae that increases as the elongated member is inserted between the superior and inferior vertebrae.

59. The distraction device of claim 58 in which the elongated member changes shape to define a generally coil-shaped support structure having a plurality of windings.

60. The distraction device of claim 59 in which each winding is substantially in contact with an immediately adjacent winding.

61. The distraction device of claim 58 in which the elongated member has a cross-sectional shape that assists in maintaining the shape of the support structure.

62. The distraction device of claim 58 in which the elongated member includes interfering surfaces that assist in maintaining the shape of the support structure.

63. The distraction device of claim 58 in which the support structure is substantially rigid.

64. The distraction device of claim 58 in which the elongated member has an inherent tendency to form the form the support structure.

65. The distraction device of claim 64 in which the elongated member is comprised of a shape memory material.

66. The distraction device of claim 58 in which the at least one elongated member comprises a first elongated member and a second elongated member wherein the support structure defined by the first elongated member and the support structure defined by the second elongated member are positioned side-by-side.

67. The distraction device of claim 58 in which the at least one elongated member comprises a first elongated member and a second elongated member wherein the support structure defined by the first elongated member and the support structure defined by the second elongated member are stacked one on top of the other.

68. The distraction device of claim 58 in which the at least one elongated member comprises a first elongated member, a second elongated member, a third elongated member and a fourth elongated member wherein the support structures defined by the elongated members are arranged in a side-by-side, stacked arrangement.

69. The distraction device of claim 58 further including an energy source that produces ultrasonic vibrations operatively connected to the elongated member to assist in inserting the elongated member into the vertebral body.

70. An intravertebral distraction device for inserting into a vertebral body and separating opposed endplates of a vertebral body, comprising:

at least one generally elongated member having a pre-deployed configuration adapted for insertion into the body of a human vertebra between the opposed endplates thereof, and a deployed configuration comprising a stacked plurality of windings that increases in extent between the endplates as the elongated member is inserted therebetween;

the elongated member being predisposed to form itself into the deployed configuration upon insertion into the vertebral body.

71. The distraction device of claim 70 in which the pre-deployed configuration is generally linear.

72. The distraction device of claim 70 in which the elongated member has a cross-sectional shape that assists in maintaining the shape of the support structure.

73. The distraction device of claim 70 in which the elongated member includes interfering surfaces that assist in maintaining the shape of the support structure.

74. The distraction device of claim 70 in which the elongated member is comprised of a shape memory material.

75. A three dimensional support structure adapted to be formed within a confined space within the human spine having a smaller access opening and said support structure comprising a member having a predeployed configuration suitable for insertion into the confined space through the access opening, said member being adapted to form the three dimensional support structure upon insertion into the confined space.