Method of supporting and distracting opposing vertebral bodies of a spine

• US 8,337,531 B2
• Filed: 02/27/2012
• Issued: 12/25/2012
• 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): Robert, Eduardo C
• Assistant Examiner(s): COMSTOCK, DAVID C
• Application Number:
  US13/406,030
• Publication Number:
  US 20120158141A1
• Time in Patent Office: 302 Days
• Field of Search: 606/246, 606/279, 606/313, 606/90, 606/105, 606/99, 606/86.A, 623 1711- 1716
• US Class Current: 606/279
• 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 is provided for distracting, in a given direction, and supporting opposing vertebral bodies. A plurality of wafers are consecutively inserted between the vertebral bodies to create a column of wafers. The column of wafers is oriented between the vertebral bodies so as to expand in the given direction as the wafers are consecutively added to the column.

Claims

1. A method of supporting and distracting opposing vertebral bodies of a spine in a space therebetween, comprising the steps of:

inserting into said space between said vertebral bodies in a direction of introduction an expandable device including a top element having an upper contact surface, an opposite bottom element having a lower contact surface and an expandable intermediate structure therebetween, said upper contact surface engaging the lower surface of an upper vertebral body and said lower contact surface engaging the upper surface of a lower vertebral body, said device having a maximum unexpanded height that is defined by the distance between said upper contact surface and said lower contact surface when said device is in an unexpanded condition, said expandable intermediate structure capable during expansion of moving said upper contact surface and said lower contact surface apart in an expansion direction along the axis of said spine while maintaining said upper contact surface and said lower contact surface in a substantially fixed position relative to each other in the direction of introduction, said expandable intermediate structure comprising an intermediate element movable between said top element and said bottom element in said direction of introduction that is generally normal to the direction of the device expansion, said intermediate element including a lifting surface engaging a cooperative engagement surface on one of said top element and said bottom element during movement of said intermediate element and a cooperative constraint between said intermediate element and one of said top element and said bottom element configured to limit relative movement therebetween in the direction of introduction upon completion of expansion;

expanding said expandable device within said space by moving said intermediate element to move said top element and said bottom element to thereby distract and support said vertebral bodies along the axis of said spine, said device defining an expanded height between said upper contact surface and said lower contact surface when said device is in an expanded condition; and

ending said expansion when said expanded height is at least 1.5 times the unexpanded height.

2. The method of claim 1, further comprising an inserter releasably coupled to said expandable device, said inserter remaining coupled during expansion of said intermediate structure and released upon completion of expansion of said intermediate structure.

3. The method of claim 2, wherein said top element and said bottom element are movable relatively apart from each other substantially only along the axis of the spine during expansion of said expandable device.

4. The method of claim 3, wherein said expandable intermediate structure comprises a plurality of intermediate elements each configured to be movably supported by said inserter and slidably received between said top element and said bottom element one of atop and beneath one another and upon such receipt causing said movement of said top element and said bottom element.

5. The method of claim 4, wherein said top element and said bottom element are initially jointly introduced into said space and said intermediate elements are then sequentially introduced individually between said top element then said bottom element.

6. The method of claim 5, wherein said bottom element is releasably coupled to said inserter and said plurality of said intermediate elements are introduced one intermediate element beneath the other.

7. The method of claim 6, wherein a preceding intermediate element is held in a position substantially preventing movement in the direction of introduction while a subsequent intermediate element is introduced beneath said preceding intermediate element.

8. The method of claim 7, wherein said intermediate elements each comprise cooperative constraints therebetween allowing slidable insertion relative to each other during introduction and interlocking engagement therebetween upon completion of said introduction.

9. The method of claim 1, further comprising the step of introducing a filler material into said space between the vertebral bodies in contact with said expandable device.

10. The method of claim 9, wherein said top element, said bottom element and said intermediate structure each have at least one hole, said holes being in communication and wherein said filler material is introduced into said holes.

11. The method of claim 1, wherein a stop is formed on said bottom element at a leading end thereof to limit relative movement between said intermediate element and said bottom element in the direction of introduction upon completion of expansion.

12. A method of supporting and distracting opposing vertebral bodies of a spine in a space therebetween, comprising the steps of:

placing an access channel adjacent said space between said opposing vertebral bodies;

inserting through said access channel into said space between said vertebral bodies in a direction of introduction an expandable device having an upper contact surface, an opposite lower contact surface and an expandable intermediate structure therebetween, said upper contact surface engaging the lower surface of an upper vertebral body and said lower contact surface engaging the upper surface of a lower vertebral body, said device having a maximum unexpanded height that is defined by the distance between said upper contact surface and said lower contact surface when said device is in an unexpanded condition, said expandable intermediate structure capable during expansion of moving said upper contact surface and said lower contact surface apart in an expansion direction along the axis of said spine while maintaining said upper contact surface and said lower contact surface in a substantially fixed position relative to each other in the direction of introduction;

expanding said expandable device within said space by expanding said intermediate structure to move said upper contact surface and said lower contact surface to thereby distract and support said vertebral bodies along the axis of said spine, said device defining an expanded height between said upper contact surface and said lower contact surface when said implant is in an expanded condition; and

ending said expansion when said expanded height is greater than two times the unexpanded height.

13. The method of claim 12, wherein said expandable device comprises a top element including said upper contact surface and a bottom element including said lower contact surface, said top element and said bottom element being movable relatively apart from each other substantially only along the axis of the spine during expansion of said expandable structure.

14. The method of claim 12, wherein the upper contact surface of said top element has an area greater than said intermediate structure.

15. The method of claim 14, wherein the lower contact surface of said bottom element has an area greater than said intermediate structure.

16. The method of claim 12, further comprising an inserter releasably coupled to said expandable device, said inserter remaining coupled during expansion of said intermediate structure and released upon completion of expansion of said intermediate structure.

17. The method of claim 16, wherein said top element and said bottom element are movable relatively apart from each other substantially only along the axis of the spine during expansion of said expandable device.

18. The method of claim 17, wherein said expandable intermediate structure comprises a plurality of intermediate elements each configured to be movably supported by said inserter and slidably received between said top element and said bottom element and upon such receipt causing said movement of said top element and said bottom element.

19. The method of claim 18, wherein said top element and said bottom element are initially jointly introduced into said space and said intermediate elements are then sequentially introduced individually between said top element then said bottom element.

20. The method of claim 19, wherein said bottom element is releasably coupled to said inserter and said plurality of said intermediate elements are introduced one intermediate element beneath the other.

21. The method of claim 20, wherein a preceding intermediate element is held in a position substantially preventing movement in the direction of introduction while a subsequent intermediate element is introduced beneath said preceding intermediate element.

22. The method of claim 21, wherein said intermediate elements each comprise cooperative constraints therebetween allowing slidable insertion relative to each other during introduction and interlocking engagement therebetween upon completion of said introduction.

23. The method of claim 12, further comprising the step of introducing a filler material into said space between the vertebral bodies in contact with said expandable device.

24. The method of claim 23, wherein said method comprises spinal interbody fusion and wherein said filler material comprises a fusion promoting composition.

25. The method of claim 12, wherein said space between said vertebral bodies is accessed by an approach selected from the group of procedures consisting of anterior, posterior, posterior lateral and extrapedicular.