Apparatus and kit for distraction of tissue surfaces

• US 8,075,623 B2
• Filed: 08/18/2010
• Issued: 12/13/2011
• Est. Priority Date: 03/08/2001
• Status: Expired due to Term

• Current Assignee: Spine Wave Incorporated
• Original Assignee: Spine Wave Incorporated
• Inventors: Johnson, Wesley D., Lipschultz, Tyler, Wales, Larry, Kieval, Robert
• Primary Examiner(s): Barrett, Thomas C.
• Assistant Examiner(s): Boles, Sameh
• Application Number:
  US12/858,978
• Publication Number:
  US 20110009971A1
• Time in Patent Office: 482 Days
• Field of Search: 606/90, 606/190, 606246-279, 606/300, 623/17.16
• US Class Current: 623/17.16
• CPC Class Codes: A61B 17/025 Joint distractors
• CPC Class Codes: A61B 17/66 Alignment, compression or distraction mechanisms
• 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 2017/0256 for the spine
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/44 for the spine, e.g. vertebrae, spinal discs
• 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 2/4455 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 2/447 substantially parallelepipedal, e.g. having a rectangular or trapezoidal cross-section
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2002/30075 swellable, e.g. when wetted
• CPC Class Codes: A61F 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/30237 partial tubes
• CPC Class Codes: A61F 2002/30261 parallelepipedal
• CPC Class Codes: A61F 2002/30385 the rib and groove having non-parallel, e.g. conically-tapered, cooperating sides, e.g. having a trapezoidal front cross-section
• CPC Class Codes: A61F 2002/30387 Dovetail connection
• CPC Class Codes: A61F 2002/30392 Rotation
• CPC Class Codes: A61F 2002/304 with additional means for limiting said sliding
• CPC Class Codes: A61F 2002/30448 : using adhesives
• CPC Class Codes: A61F 2002/30449 : the adhesive being cement
• CPC Class Codes: A61F 2002/30462 : retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2002/30476 : locked by an additional locking mechanism
• CPC Class Codes: A61F 2002/3049 : using a slidable sleeve covering the connection
• CPC Class Codes: A61F 2002/305 : Snap connection
• CPC Class Codes: A61F 2002/30599 : stackable
• CPC Class Codes: A61F 2002/30604 : modular
• CPC Class Codes: A61F 2002/30616 : Sets comprising a plurality of prosthetic parts of different sizes or orientations
• 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 2002/4485 : comprising three or more 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 2002/4666 : for measuring force, pressure or mechanical tension
• CPC Class Codes: A61F 2210/0061 : swellable
• CPC Class Codes: A61F 2220/0025 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/005 : using adhesives
• 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 2230/0069 : cylindrical
• CPC Class Codes: A61F 2230/0082 : parallelepipedal
• CPC Class Codes: A61F 2250/0063 : Nested prosthetic parts
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers
• 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 2310/00029 : Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium
• CPC Class Codes: A61F 2310/00071 : Nickel or Ni-based alloys
• CPC Class Codes: A61F 2310/00203 : containing alumina or aluminium oxide
• CPC Class Codes: A61F 2310/00239 : containing zirconia or zirconium oxide ZrO2
• 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
• CPC Class Codes: A61F 2310/00359 : Bone or bony tissue
• CPC Class Codes: A61F 2310/00365 : Proteins; Polypeptides; Degradation products thereof
• CPC Class Codes: Y10S 606/907 : Composed of particular material or coated
• CPC Class Codes: Y10S 606/912 : Radiolucent material
• CPC Class Codes: Y10S 606/914 : Toolkit for installing or removing spinal positioner or stabilizer

Abstract

An apparatus and method for distracting, in a given direction, and supporting two tissue surfaces. A plurality of wafers are consecutively inserted between the two tissue surfaces to create a column of wafers. The column of wafers is oriented between the tissue surfaces so as to expand in the given direction as the wafers are consecutively added to the column.

Claims

1. A kit for use in the distraction of tissue surfaces in a given direction, comprising;

a plurality of elements adapted to be inserted in contact with each other between tissue surfaces to be distracted and to form upon insertion a stacked support structure that generates sufficient outward force to distract said tissue surfaces, wherein each of said elements includes a leading end and a trailing end, the leading end of at least one of said elements comprising a lifting surface, said elements comprising complementary cooperating interfaces configured to restrain elements from slipping out of the structure; and

an inserter for consecutively inserting a plurality of elements between said tissue surfaces in a manner such that such elements are placed in contact with each other in a direction generally extending in the given direction with the lifting surface of said at least one element placed against the trailing end of a preceding element, said inserter comprising a delivery track for supporting said elements linearly one behind the other, said inserter further comprising a pusher to move said elements into said tissue.

2. The kit of claim 1 further including bone filler.

3. The kit of claim 2, wherein said structure defines one or more channels to facilitate the movement of bone filler into and through said structure.

4. The kit of claim 2, wherein said tissue surfaces are superior and inferior surfaces of a damaged or diseased vertebral body in a spine, and wherein said elements are configured for consecutive receipt into said vertebral body to form said structure between said superior and inferior surfaces of said vertebral body.

5. The kit of claim 4, wherein said bone filler comprises bone cement.

6. The kit of claim 2, wherein said tissue surfaces are superior and inferior endplate surfaces of opposing vertebral bodies in a spine, and wherein said elements are configured for consecutive receipt between said vertebral bodies to form said structure between said superior and inferior endplate surfaces of said opposing vertebral bodies.

7. The kit of claim 6, wherein said bone filler comprises a material to facilitate fusion between said opposing vertebral bodies.

8. The kit of claim 1, wherein said elements each have a generally rectangular cross-section.

9. The kit of claim 1, wherein each of said elements has generally flat and substantially parallel top and bottom surfaces, said cooperating interfaces being defined by a projecting ridge on a top or bottom surface of one element and a mating groove on a respective bottom or top surface of an adjacent element.

10. The kit of claim 9, wherein said cooperating surfaces further include a mating interlock spaced from said cooperating ridge and groove in the direction of insertion.

11. The kit of claim 1, wherein said elements are tethered together to form a continuous linear string of elements.

12. The kit of claim 11, wherein said tether is formed of a thin section of deformable material defining said string of spaced individual elements each joined by a tether.

13. The kit of claim 12, wherein said elements and said tethers are integrally formed from a continuous piece of material.

14. The kit of claim 1, wherein at least the leading end of one of said elements comprising an angled surface.

15. The kit of claim 1, wherein said tissue surfaces are defined by surfaces of a damaged or fractured tibia, wherein said elements are configured for receipt between said surfaces to form said structure between said surfaces.

16. An apparatus for sequentially inserting wafers, stackable consecutively to form a stack extending in a given direction into a body tissue space to be distracted, the apparatus comprising;

a source comprising a plurality of wafers;

an inserter configured to sequentially individually advance each of said wafers from said source of wafers into the space to be distracted, said inserter having a distal end for extending into said body tissue space;

a first wafer supported by said inserter at said distal end, said first wafer defining a support surface for supporting, and a stop surface for preventing movement of, subsequent wafers received from said inserter; and

a connection mechanism releasably connecting said first wafer to said inserter.

17. The apparatus of claim 16, wherein said first wafer is of size greater than the size of subsequently received wafers.

18. The apparatus of claim 17, wherein said inserter supports said source of wafers.

19. The apparatus of claim 16, wherein said connection mechanism is capable of supporting forces generated during the consecutive stacking of wafers and to cause separation of said first wafer from said inserter upon movement of said inserter away from said stack of wafers once formed in said body tissue.

20. The apparatus of claim 19, wherein said connection mechanism comprises a releasable press fit between said first wafer and said inserter.

21. The apparatus of claim 19 wherein said connection mechanism comprises a breakable adhesive bond between said first wafer and said inserter.

22. The apparatus of claim 19 wherein said connection mechanism comprises a releasable mechanical coupling between said first wafer and said inserter.

23. The apparatus of claim 16, wherein said first wafer is substantially flat.

24. The apparatus of claim 16, wherein said first wafer is curved in a plane generally normal to said given direction.

25. The apparatus of claim 24, wherein said inserter comprises a guide track for inserting said first wafer into said body tissue space, said guide track being curved in the same plane as said first wafer.

26. A kit for use in the distraction of tissue surfaces in a given direction, comprising;

a plurality of elements adapted to be inserted in contact with each other between tissue surfaces to be distracted and to form upon insertion a stacked support structure that generates sufficient outward force to distract said tissue surfaces, said elements comprising complementary cooperating interfaces configured to restrain elements from slipping out of the structure, wherein said cooperating interfaces of elements are defined by a concave surface on one element and a mating convex surface on the adjacent contacting element; and

an inserter for consecutively inserting a plurality of elements between said tissue surfaces in a manner such that such elements are placed in contact with each other in a direction generally extending in the given direction, said inserter comprising a delivery track for supporting said elements linearly one behind the other, said inserter further comprising a pusher to move said elements into said tissue.

27. An apparatus for sequentially inserting a plurality of elements into a body tissue space to be distracted, the apparatus comprising:

a plurality of elements;

an inserter configured to support said elements in a linear array and to sequentially individually advance each of said elements into the space to be distracted between tissue surfaces, said elements adapted to be inserted in contact with each other between said tissue surfaces and to form upon insertion a stacked support structure that generates sufficient outward force to distract said tissue surfaces, said inserter having a distal end for extending into said body tissue space;

a first element supported by said inserter at said distal end, said first element defining a contact surface for contacting at least one of said subsequent elements received from said inserter; and

a connection mechanism releasably connecting said first element to said inserter and holding said first element in place relative to said inserter while said subsequent elements are inserted.

28. The apparatus of claim 27, wherein said connection mechanism comprises a releasable press fit between said first element and said inserter.

29. The apparatus of claim 27, wherein said connection mechanism comprises a breakable adhesive bond between said first element and said inserter.

30. The apparatus of claim 27, wherein said connection mechanism comprises a releasable mechanical coupling between said first element and said inserter.

31. The apparatus of claim 27, wherein said inserter comprises a guide track for inserting said first element into said body tissue space.

32. The apparatus of claim 27, wherein said elements are tethered together to form a continuous linear string of elements.

33. The apparatus of claim 32, wherein said tether is formed of a thin section of deformable material defining said string of elements each joined by a tether.

34. The apparatus of claim 33, wherein said elements and said tethers are integrally formed from a continuous piece of material.

35. The apparatus of claim 27, wherein said tissue surfaces are superior and inferior surfaces of a damaged or diseased vertebral body in a spine, and wherein said elements are configured for consecutive receipt into said vertebral body to form said structure between said superior and inferior surfaces of said vertebral body.

36. The apparatus of claim 27, wherein said tissue surfaces are superior and inferior endplate surfaces of opposing vertebral bodies in a spine, and wherein said elements are configured for consecutive receipt between said vertebral bodies to form said structure between said superior and inferior endplate surfaces of said opposing vertebral bodies.

37. The apparatus of claim 27, further including an access channel adapted to be placed through said tissue in communication with said space to be distracted, said access channel being configured to receive therethrough the distal end of said inserter with said first element being supported thereon.

38. The apparatus of claim 37, wherein said access channel is expandable.

39. The apparatus of claim 27, further including a bone filler.