Method and apparatus for treating a vertebral body

• US 20040215343A1
• Filed: 03/19/2004
• Published: 10/28/2004
• Est. Priority Date: 02/28/2000
• Status: Active Grant

• Current Assignee: Spineology Incorporated
• Original Assignee: Spineology Incorporated
• Inventors: Wales, Larry, Lipschultz, Tyler, Hektner, Thomas R., Nickels, Kevin L., Hochschuler, Stephen, Johnson, Wesley
• Granted Patent: US 7,931,689 B2
• Time in Patent Office: Days
• US Class Current: 623/17.12
• 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 17/7098 wherein the implant is permeable or has openings, e.g. fenestrated screw hollow surgical screws A61B17/864
• CPC Class Codes: A61F 2/44 for the spine, e.g. vertebrae, spinal discs
• CPC Class Codes: A61F 2/4601 for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
• CPC Class Codes: A61F 2002/2817 Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
• 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 2002/30112 Rounded shapes, e.g. with rounded corners
• CPC Class Codes: A61F 2002/30131 horseshoe- or crescent- or C-shaped or U-shaped
• CPC Class Codes: A61F 2002/30156 triangular
• CPC Class Codes: A61F 2002/30586 having two or more inflatable pockets or chambers
• CPC Class Codes: A61F 2002/30787 inclined obliquely with respect to each other
• CPC Class Codes: A61F 2230/0004 Rounded shapes, e.g. with rounded corners
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0023 triangular
• CPC Class Codes: A61F 2310/00017 Iron- or Fe-based alloys, e.g. stainless steel
• CPC Class Codes: A61F 2310/00023 Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/00293 containing a phosphorus-containing compound, e.g. apatite
• CPC Class Codes: A61F 2310/00353 Bone cement, e.g. polymethylmethacrylate or PMMA

Abstract

An implantable container is used to stabilize or restore height in a vertebral body. After insertion the container is filled with a bone filler material such as bone cement.

Claims

1-19. -19. (cancelled)

20. A method of treating a vertebral body having a superior endplate and an inferior endplate, comprising the steps of:

inserting an expandable container into an vertebral body;

expanding said container within said vertebral body;

injecting a first flowable material into said container under pressure, whereby said pressure supplies a distraction force to move said superior and inferior endplates apart; and

injecting a second flowable material different from said first flowable material into said container.

21. The method of claim 20 wherein at least one of said first and second flowable materials is selected from the group comprising:

bone cement, human bone graft allograft;

human bone graft autograft;

synthetic derived bone substitute;

sulfate and/or calcium phosphate, hydroxylapatite.

22. A method of treating a vertebral body comprising the steps of:

creating a cavity in the vertebral body through an access aperture;

inserting a container into said vertebral body, said container having a fill passage coupled to said container;

deploying said container within said vertebral body;

injecting a bone filler material into said container through said fill passage; and

injecting a flowable material different from said bone filler material into said container through said fill passage.

23-27. -27. (cancelled).

28. A method of treating a vertebral body having cancellous bone therewithin comprising the steps of:

inserting a container into the cancellous bone of said vertebral body;

injecting a first bone filler into said container; and

injecting a second bone filler different from said first filler into said container.

29. The method of claim 28, wherein said first bone filler is selected to have a viscosity less than the viscosity of said second bone filler.

30. The method of claim 28, wherein said first bone filler is selected to have a chemical composition different from the chemical composition of said second bone filler.

31. The method of claim 28, wherein said first bone filler is selected to have a mechanical strength different from the mechanical strength of said second bone filler

32. The method of claim 28 wherein said container is selected to be porous.

33. The method of claim 32, wherein said first bone filler is initially introduced into said container and wherein said second bone filler is then introduced into said container to push against said first bone filler until a portion of said first bone filler flows through the porous container and interdigitates with said cancellous bone of said vertebral body.

34. The method of claim 33, wherein said container is selected to be a woven mesh.

35. The method of claim 28, wherein said container is selected to be impermeable.

36. The method of claim 35, wherein said container is selected to be elastic.

37. The method of clam 35, wherein said container is selected to be inelastic.

38. A method of treating a damaged or diseased vertebral body having a vertebral body height less than its natural height, comprising the steps of:

inserting an expandable member into said vertebral body;

expanding said member in a manner to increase the height of said vertebral body; and

permanently retaining said member in an expanded condition within said vertebral body.

39. The method of claim 38 wherein said member is an expandable container having an interior capable of being filled with a substance.

40. The method of claim 39 wherein said expandable container is comprised of an elastic material.

41. The method of claim 39 wherein said container is comprised of an inelastic material.

42. The method of claim 39 where in said expandable container is comprised of a permeable material.

43. The method of claim 39 wherein said expandable container is comprised of an impermeable material.

44. The method of claim 39 wherein a cavity is formed within said vertebral body and said expandable container is inserted into said cavity.

45. The method of claim 44 wherein said expandable container is inserted in an unexpanded condition into said cavity and expanded therein by the introduction of a substance within said container.

46. The method of claim 45 wherein said vertebral body is defined by a superior endplate and an inferior endplate and wherein said expandable container is expanded at a pressure sufficient to move the superior endplate and the inferior endplate relatively apart thereby restoring the vertebral body height.

47. The method of claim 46 wherein said substance introduced into said expandable container is bone filler.

48. The method of claim 47 wherein said bone filler is a hardenable substance introduced by injection into said container in a fluid state to expand said container and therein allowed to harden to maintain said container in said expanded state.

49. The method of claim 48 wherein said vertebral body comprises cancellous bone, wherein said cavity is formed within said cancellous bone, wherein said expandable container is permeable and disposed within said cavity and wherein said fluid bone filler is injected into said permeable container at a pressure sufficient to cause at least a portion of said bone filler to pass through said permeable container to interdigitate with said cancellous bone before said fluid bone filler hardens.

50. The method of claim 44 wherein said vertebral body comprises cancellous bone, said cavity is formed within said cancellous bone, and bone filler is introduced into said expandable container.

51. The method of claim 50 wherein said container is permeable, wherein said bone filler is injected into said container in a fluid state under pressure to expand said container, said bone filler being introduced into said cancellous bone through said permeable container.

52. A method of treating a damaged or diseased vertebral body, said vertebral body having opposed superior and inferior endplates spaced apart at a spacing defining the vertebral body height, said vertebral body height being less than the natural height as a result of said damage or disease, comprising the steps of:

inserting into said vertebral body an expandable container having a porous outer membrane;

introducing a substance under pressure into said container, said container membrane porosity being sufficient to provide resistance to the introduction of said substance; and

filling said container with a sufficient volume of substance to generate force sufficient to move apart said endplates thereby increasing the vertebral height of said vertebral body to substantially its natural height.

53. The method of claim 52 wherein said expandable container is comprised of an elastic material.

54. The method of claim 52 wherein said expandable container is comprised of an inelastic material.

55. The method of claim 52 wherein said outer membrane of said expandable container is selected from the group of porous materials comprising meshes and screens.

56. The method of claim 52 wherein said vertebral body comprises cancellous bone therewithin and between said endplates, wherein a cavity is formed within said cancellous bone and said container is inserted into said cavity.

57. The method of claim 56 wherein the outer membrane of said expandable container is sufficiently porous to allow at least a portion of said substance to pass through and interdigitate with said cancellous bone to thereby reinforce and stabilize said vertebral body.

58. The method of claim 57 wherein said substance is a hardenable bone filler introduced by injection into said container in a fluid state at a pressure to expand said container and to cause at least a portion of said fluid bone filler to pass through said outer membrane and interdigitate with said cancellers bone before said fluid bone filler hardens.

59. The method of claim 52 wherein said substance is selected from the group of bone filler materials comprising bone cement, human bone graft allograft, human bone graft autograft, synthetic bone substitute, sulfate and/or calcium phosphate, hydroxyapatite and bioresorbable polymers.

60. The method of claim 52 wherein said container has a fill passage coupled to said container and wherein said fill passage is sealed upon filling said container with a sufficient volume of substance.

61. The method of claim 56 wherein a substance is introduced into said cancellous bone adjacent said container.

62. The method of claim 61 wherein the outer membrane of said expandable container is sufficiently porous to allow at least a portion of said substance to pass through said membrane, said substance introduced into said cancellous bone adjacent said container being a portion of said substance passing through membrane.

63. A method of treating a damaged or diseased vertebral body, said vertebral body comprising spaced opposing superior and inferior endplates and cancellous bone therewithin, said spacing between said superior and inferior endplates defining a vertebral height that is less than the natural height therebetween as a result of damage or disease, said method comprising the steps of:

i) forming a cavity in said cancellous bone;

ii) inserting into said cavity an expandable container;

iii) filling said expandable container with a substance in sufficient volume to expand said container against said cancellous bone and to thereby generate sufficient force to move apart said superior and inferior endplates and substantially restore the natural height of said vertebral body, said container upon being expanded enlarging said cavity simultaneously with the filling of said container by said substance, there being no unfilled void created by said expanded container; and

iv) permanently retaining said filled container in said expanded condition within said vertebral body.

64. A method of treating a damaged or diseased vertebral body, said vertebral body comprising spaced opposing superior and inferior endplates and cancellous bone therewithin, said spacing between said superior and inferior endplates defining a vertebral height that is less than the natural height therebetween as a result of damage or disease, said method comprising the steps of:

i) forming a cavity in said cancellous bone;

ii) inserting into said cavity an expandable member;

expanding said expandable member against said cancellous bone to thereby generate sufficient force to move apart said superior and inferior endplates and substantially restore the natural height of said vertebral body, said cavity being enlarged simultaneously with the expansion of said expandable member, there being no unfilled void created by said expanded member; and

iii) permanently retaining said expandable member in said expanded condition within said vertebral body.

65. The method of claim 64 wherein said expandable member is a container having a fill passage coupled to said container and wherein said container is expanded by filling said container through said fill passage with a substance under pressure.

66. The method of claim 65 wherein a substance is introduced into said cancellous bone adjacent said container.

67. The method of claim 66 wherein said container is sufficiently porous to allow at least a portion of said substance to pass through said container, said substance introduced into said cancellous bone adjacent said container being a portion of said substance passing through container.