Method and apparatus for filling a cavity

• US 20050278023A1
• Filed: 06/10/2004
• Published: 12/15/2005
• Est. Priority Date: 06/10/2004
• Status: Abandoned Application

• Current Assignee: Spinal Ventures, LLC
• Original Assignee: Spinal Ventures, LLC
• Inventors: Zwirkoski, Paul A.
• Application Number:
  US10/866,219
• Publication Number:
  US 20050278023A1
• Time in Patent Office: Days
• US Class Current: 623/11.110
• CPC Class Codes: A61B 17/686 Plugs, i.e. elements forming interface between bone hole and implant or fastener, e.g. screw
• CPC Class Codes: A61B 17/7094 Solid vertebral fillers; devices for inserting such fillers
• 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 17/8635 Tips of screws
• CPC Class Codes: A61B 17/8863 Apparatus for shaping or cutting osteosynthesis equipment by medical personnel
• CPC Class Codes: A61F 2/30749 Fixation appliances for connecting prostheses to the body
• 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 2/4425 made of articulated components
• CPC Class Codes: A61F 2/46 Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
• 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 2002/302 toroidal, e.g. rings
• CPC Class Codes: A61F 2002/30331 made by longitudinally pushing a protrusion into a complementarily-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2002/30383 made by laterally inserting a protrusion, e.g. a rib into a complementarily-shaped groove
• CPC Class Codes: A61F 2002/30462 retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2002/30495 using a locking ring
• CPC Class Codes: A61F 2002/30604 modular
• CPC Class Codes: A61F 2002/30662 with rotation-limiting means
• CPC Class Codes: A61F 2002/30663 multiaxial, e.g. biaxial; multipolar, e.g. bipolar or having an intermediate shell articulating between the ball and the socket
• CPC Class Codes: A61F 2002/4415 elements of the prosthesis being arranged in a chain like manner
• CPC Class Codes: A61F 2002/443 : having two transversal endplates and at least one intermediate component
• CPC Class Codes: A61F 2002/444 : for replacing the nucleus pulposus

Abstract

An implant for filling and/or distracting a body region, particularly a non-soft tissue cavity, has a plurality of segments wherein at least two of the segments are flexibly connected. The segments have a crush-strength sufficient to create and/or maintain the distraction of two or more non-soft tissue body surfaces, and to maintain the stability of the body region. The implant may be inserted into a cavity by an applicator having a cannula with a distal opening, and a rotary driver for applying force to move the implant within the cannula.

Claims

1. A segmented implant for introduction into a body region that is at least partially surrounded by non-soft body tissue, comprising a plurality of implant segments,

wherein at least two of the plurality of implant segments are flexibly connected and wherein at least a portion of the segments provide implant segment distractibility to the body region and form stability to a body region into which the segments have been introduced.

2. The segmented implant of claim 1 wherein at least a portion of the implant segments are configured to be introduced into the body region by engaging a rotating introducer member.

3. The segmented implant of claim 1 wherein at least a portion of the flexibly connected implant segments are configured to be introducible into the body region by engaging a rotating introducer member.

4. The segmented implant of claim 1 wherein at least a portion of the segments are comprised of one or more materials having sufficient material strength to provide implant segment distractibility to the body region.

5. The segmented implant of claim 4 wherein the material strength is crush strength.

6. The segmented implant of claim 1 wherein at least a portion of the segments have one or more shapes and are comprised of one or more materials having material strength and the one or more shapes cooperate with the material strength of the materials to provide implant segment distractibility to the body region.

7. The segmented implant of claim 6 wherein the material strength is crush strength.

8. The segmented implant of claim 1 wherein at least a portion of the segments have one or more shapes and are comprised of one or more materials having material strength and the one or more shapes cooperate with the material strength of the materials to provide form stability to a body region into which the segments have been introduced.

9. The segmented implant of claim 8 wherein the material strength is crush strength.

10. The segmented implant of claim 1 wherein more than two of the plurality of implant segments are flexibly connected.

11. The segmented implant of claim 1 wherein the majority of implant segments are flexibly connected.

12. The segmented implant of claim 1 wherein the implant segments are configured to provide distractibility and form stability to a body region comprising a bone cavity.

13. The segmented implant of claim 1 wherein the implant segments are configured to provide distractibility and form stability to a body region comprising a void between tissue surfaces.

14. The segmented implant of claim 1 wherein the implant segments comprise pellets.

15. The segmented implant of claim 1 wherein the at least two of the plurality of implant segments that are flexibly connected are connected by a filament.

16. The segmented implant of claim 1 wherein the at least two of the plurality of implant segments that are flexibly connected are connected by a fiber.

17. The segmented implant of claim 1 wherein the at least two of the plurality of implant segments that are flexibly connected are within a flexible tube.

18. The segmented implant of claim 1 wherein the at least two of the plurality of implant segments that are flexibly connected are within a flexible tube comprised of a woven material.

19. The segmented implant of claim 1 further comprising a settable fluent material.

20. The segmented implant of claim 19 wherein the fluent material is a bone cement.

21. The segmented implant of claim 1 wherein at least a portion of the implant segments comprise shapes configured to cooperate in enhancing segment packing.

22. The segmented implant of claim 1 wherein at least a portion of the implant segments are different sizes than at least one other implant segment of the plurality of implant segments.

23. The segmented implant of claim 1 wherein at least some of the segments are movably connected along an axis of the implant.

24. The segmented implant of claim 1 wherein the implant segments are selectively severable.

25. The segmented implant of claim 24 wherein the implant segments are remotely severable by a user.

26. The segmented implant of claim 24 wherein the implant segments are mechanically severable.

27. The segmented implant of claim 24 wherein the implant segments are chemically severable.

28. The segmented implant of claim 24 wherein the implant segments are thermally severable.

29. The segmented implant of claim 24 wherein the implant segments are electrically severable.

30. The segmented implant of claim 1 wherein said at least one of the segments comprises a radiopaque material.

31. The segmented implant of claim 1 wherein at least some of the segments comprise a biodegradable material.

32. The segmented implant of claim 1 wherein at least some of the segments comprise a material that is not substantially biodegradable.

33. The segmented implant of claim 1 wherein at least some of the segments comprise a polymer.

34. The segmented implant of claim 1 wherein at least some of the segments comprise a metal.

35. The segmented implant of claim 1 wherein at least some of the segments comprise a composite material.

36. The segmented implant of claim 1 wherein at least one of the segments comprise a medicinal.

37. The segmented implant of claim 1 wherein at least some of the segments comprise a coating.

38. The segmented implant of claim 37 wherein the coating is a medicinal coating.

39. The segmented implant of claim 37 wherein the coating is a cross-linker.

40. An implant assemblage for filling a non-soft tissue cavity comprising:

an implant comprising a plurality of flexibly connected segments configured for insertion into a bone cavity;

wherein said segments have a crush strength sufficient to maintain the distraction of two or more bone surfaces and further

wherein said implant assemblage is configured to maintain a shape within the cavity.

41. An applicator for inserting an implant into a tissue cavity comprising:

a cannula having a distal end and proximal end and a distal opening and a proximal opening;

a feed guide connected to the proximal end of said cannula so that the proximal opening of said cannula is in fluid connection with said feed guide; and

a driver at least partially within said feed guide for applying force to at least one portion of an implant wherein said force is applied by rotating at least a region of said driver in contact with the implant.

42. The applicator of claim 41 wherein said tissue cavity is a non-soft tissue cavity.

43. The applicator of claim 41 further comprising a force gauge configured to detect the force applied by said driver.

44. The applicator of claim 43 further comprising a display configured to show the force detected by said force gauge.

45. The applicator of claim 41 further comprising a trocar located at the distal end of said cannula.

46. The applicator of claim 41 further comprising a fluent material source configured to connect to said cannula for delivering a fluent material.

47. The applicator of claim 41 wherein said implant comprises one or more loose pellets.

48. The applicator of claim 41 further comprising a gripper located distally on the cannula.

49. The applicator of claim 41 wherein said implant is a segmented implant comprising a plurality of flexibly connected segments.

50. The applicator of claim 49 further comprising a cutter configured to sever a connection between at least two of said flexibly connected segments.

51. The applicator of claim 50 wherein said cutter is a mechanical cutter.

52. The applicator of claim 51 further comprising an actuator for activating said cutter by a user.

53. The applicator of claim 41 wherein said driver comprises a rotatable auger.

54. The applicator of claim 53 wherein said auger is located at least partially in said cannula.

55. The applicator of claim 41 wherein said driver comprises at least one cog.

56. The applicator of claim 41 further comprising a controller for controlling said driver.

57. The applicator of claim 56 wherein said controller is configured to control the force applied by said driver.

58. The applicator of claim 56 wherein said controller is configured to control the direction of rotation of said driver so as to allow both insertion and removal of said implant.

59. The applicator of claim 56 wherein said controller is manually controlled.

60. The applicator of claim 41 wherein said feed guide comprises a cartridge pre-loaded with said implant.

61. The applicator of claim 41 wherein said distal opening of said cannula is at least partly on a side perpendicular to the long axis of said cannula.

62. The applicator of claim 41 wherein said distal opening of said cannula opens at an angle perpendicular to the long axis of said cannula.

63. An applicator for inserting and removing an implant into a tissue cavity comprising:

a cannula having a distal end and proximal end and a distal opening and a proximal opening;

a driver at least partially within said cannula for applying force to at least one portion of an implant wherein said force is applied by rotating at least a region of said driver in contact with the implant.

64. An applicator for inserting and removing a bone filler into a bone cavity comprising:

a cannula having a distal end and proximal end and a distal opening and a proximal opening; and

a rotatable auger configured to fit at least partly into said cannula to propel a bone filling material out of said distal end of said cannula.

65. An applicator for inserting and removing a bone filler into a bone cavity comprising:

a cannula having a distal end and proximal end and a distal opening and a proximal opening; and

a rotatable cog configured to fit at least partly into said cannula to propel a bone filling material out of said distal end of said cannula.

66. A method of distracting a non-soft tissue cavity comprising:

providing an implant for filling a non-soft tissue cavity comprising a plurality of flexibly connected segments wherein said segments have a crush strength capable of distraction of two or more tissue surfaces;

inserting the flexibly connected segments into the cavity.

67. The method of claim 66 wherein the implant segments are inserted into the cavity by applying force to at least one segment of the implant.

68. The method of claim 67 further comprising measuring the applied force.

69. The method of claim 66 wherein said non-soft tissue cavity is a bone cavity.

70. The method of claim 69 wherein the bone cavity is a fractured vertebral body.

71. The method of claim 70 further comprising inserting the segmented implant into the fractured vertebral body until the normal height of the vertebra is substantially attained.

72. The method of claim 71 further comprising severing the implant behind the last segment inserted.

73. The method of claim 69 further comprising the step of providing fluent bone filler within the bone cavity.

74. The method of claim 66 wherein the implant segments are inserted into the cavity through a cannula.

75. The method of claim 66 wherein the implant segments are inserted into the tissue cavity using an auger.

76. The method of claim 69 further comprising providing a closure.

77. The method of claim 76 wherein the closure is a screw closure.

78. The method of claim 76 further comprising closing the cavity using the closure.

79. The method of claim 66 further comprising compacting the flexibly connected pellets.

80. A method of distracting a bone cavity comprising:

providing a segmented implant comprising a plurality of flexibly connected segments wherein said segments have a crush strength sufficient to maintain the distraction of two or more bone surfaces;

inserting one or more implant segments into the bone cavity.

81. A method of filling a tissue cavity comprising:

providing an implant for filling a cavity;

providing an applicator for introducing the implant into the cavity, wherein the applicator comprises a cannula configured to pass at least a region of the implant, and a rotary driver at least partially within said cannula; and

introducing the implant into the cavity by rotating the driver.

82. A method of filling a tissue cavity comprising:

providing an implant for filling a tissue cavity comprising a plurality of flexibly connected segments;

providing an applicator for introducing the implant into the cavity, wherein the applicator comprises a cannula configured to pass at least a region of the implant, and a rotary driver at least partially within said cannula; and

inserting the implant into the cavity by rotating the driver.

83. A method of filling a non-soft tissue cavity comprising:

providing an implant for filling a tissue cavity comprising a plurality of flexibly connected segments;

providing an applicator for introducing the implant into the cavity, wherein the applicator comprises a cannula configured to pass at least a region of the implant, and a rotary driver at least partially within said cannula; and

inserting the implant into the cavity by rotating the driver;

providing a closure configured to close the cavity; and

closing the cavity with the closure.

84. A kit for filling a non-soft tissue cavity comprising:

a segmented implant comprising a plurality of segments wherein at least two of the segments are flexibly connected; and

an applicator configured for inserting a segmented implant into cavity wherein the applicator comprises a cannula configured to pass at least a region of the implant, and a rotary driver at least partially within said cannula configured to apply force to at least a region of the implant.

85. The kit of claim 84 further comprising a fluent material.

86. The kit of claim 84 further comprising a feed guide.

87. The kit of claim 84 further comprising a gauge.

88. The kit of claim 87 wherein the gauge is a force gauge.

89. The kit of claim 84 further comprising a display.

90. The kit of claim 84 further comprising a closure.

91. The kit of claim 84 further comprising a compaction device.

92. A segmented implant for introduction into a body region that is at least partially surrounded by non-soft body tissue, comprising a plurality of implant segments,

wherein at least two of the plurality of implant segments are flexibly connected

wherein the segments have a shape, size, and spacing with respect to other segments;

and wherein at least a portion of the segments provide form stability to a body region into which the segments have been introduced.

93. The segmented implant of claim 92 wherein at least one segment is a substantially cubic shape with rounded edges.

94. The segmented implant of claim 92 wherein at least one segment has two or more faces.

95. The segmented implant of claim 92 wherein a plurality of the segments can interlock with other segments.

96. The segmented implant of claim 92 wherein at least one segment is configured to engage non-adjacent segments.

97. The segmented implant of claim 92 wherein at least one segment is a substantially solid shape.

98. The segmented implant of claim 92 wherein at least one segment is a substantially hollow shape.

99. The segmented implant of claim 92 wherein at least one segment is configured to have passages therethrough.

100. The segmented implant of claim 92 wherein at least one segment is a substantially different shape than at least one other segment.

101. The segmented implant of claim 100 wherein the different segment shapes are located adjacent to each other in a repeating pattern.

102. The segmented implant of claim 92 wherein at least one segment is a different size than at least one other segment.

103. The segmented implant of claim 102 wherein segments of different sizes are arranged adjacent to each other in a repeating pattern.

104. The segmented implant of claim 92 wherein at least one segment has a polygonal cross-section.

105. The segmented implant of claim 104 wherein at least one segment has a triangular cross-section.

106. The segmented implant of claim 104 wherein at least one segment has a rectangular cross-section.

107. The segmented implant of claim 92 wherein the distance between at least two adjacent segments is different than the distance between other adjacent segments.

108. The segmented implant of claim 92 wherein at least one segment is substantially slideable with respect to adjacent segments.