Method of providing spinal interbody fusion

• US 8,535,353 B2
• Filed: 07/06/2011
• Issued: 09/17/2013
• Est. Priority Date: 03/08/2001
• Status: Expired due to Term

• Current Assignee: Spine Wave Incorporated
• Original Assignee: Spine Wave Incorporated
• Inventors: Johnson, Wes, Lipschultz, Tyler, Wales, Larry, Kieval, Robert
• Primary Examiner(s): Philogene, Pedro
• Assistant Examiner(s): COMSTOCK, DAVID C
• Application Number:
  US13/176,830
• Publication Number:
  US 20110264228A1
• Time in Patent Office: 804 Days
• Field of Search: 606/246, 606/279, 606/90, 606/102, 606/86.A, 606/99, 623/17.11, 623/17.16
• 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 interbody fusion including 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 providing spinal interbody fusion, comprising the steps of:

accessing the intradiscal space between two generally opposed upper and lower vertebral bodies;

placing an access channel adjacent said vertebral bodies in communication with said intradiscal space;

removing nucleus material from said intradiscal space through said access channel;

inserting through said access channel and into said intradiscal space an expandable implant, said implant having an upper contact surface engaging the lower surface of said upper vertebral body, a lower contact surface engaging the upper surface of said lower vertebral body and an expandable intermediate structure therebetween, said expandable intermediate structure capable during expansion of moving said upper contact surface and said lower contact surface apart in a direction along the axis of said spine while maintaining said upper contact surface and said lower contact surface in a relatively fixed position against the respective verterbral bodies;

expanding said expandable implant within said intradiscal 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; and

monitoring the tension in the annulus of the disc between said vertebral bodies during the expansion as an indication of stability of said vertebral bodies and then ending the expansion of said expandable structure upon substantial achievement of said stability.

2. The method of claim 1, wherein said access channel is expandable and wherein after placing said access channel, said channel is expanded to provide an increased opening through said channel.

3. The method of claim 1, further comprising an inserter releasably coupled to said expandable structure, said inserter being configured for insertion through said access channel and remaining coupled during expansion of said intermediate structure and released upon completion of expansion of said intermediate structure.

4. The method of claim 1, wherein said expandable structure 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.

5. The method of claim 4, 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.

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

7. The method of claim 6, 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.

8. The method of claim 7, 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.

9. The method of claim 8, 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.

10. The method of claim 4, further comprising the step of introducing through said access channel a filler material comprising a fusion promoting composition into said intradiscal space.

11. The method of claim 10, 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.

12. A method of providing spinal interbody fusion, comprising the steps of:

accessing the intradiscal space between two generally opposed upper and lower vertebral bodies, said intradiscal space containing nucleus material within an outer disc annulus;

removing nucleus material from said intradiscal space;

inserting into said intradiscal space an expandable implant, said implant having an upper contact surface engaging the lower surface of said upper vertebral body, a lower contact surface engaging the upper surface of said lower vertebral body and an expandable intermediate structure therebetween, said expandable intermediate structure capable during expansion of gradually moving said upper surface and said lower contact surface apart along the axis of said spine a sufficient distance to cause gradual tension in said disc annulus while maintaining said upper contact surface and said lower contact surface in a relatively fixed position against the respective verterbral bodies;

expanding said expandable implant within said intradiscal 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;

monitoring the tension in the annulus of the disc as an indication of stability of said vertebral bodies;

determining based on the tension in said annulus whether substantial stability of said vertebral bodies has been achieved; and

then ending the expansion of said expandable structure upon substantial achievement of said stability.

13. The method of claim 12, further comprising the step of placing an access channel adjacent said vertebral bodies in communication with said intradiscal space.

14. The method of claim 13, further comprising the step of inserting said expandable implant into said intradiscal space through said access channel.

15. The method of claim 13, wherein said access channel is expandable, and wherein said access channel is expanded prior to insertion of said expandable implant.

16. The method of claim 13, further comprising an inserter releasably coupled to said expandable structure, said inserter being configured for insertion through said access channel and remaining coupled during expansion of said intermediate structure and released upon completion of expansion of said intermediate structure.

17. The method of claim 12, wherein said expandable structure 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.

18. The method of claim 17, wherein said top element comprises a radiopaque marker and said bottom element comprises a radiopaque marker to enable fluoroscope visualization of the movement of said top element and said bottom element during expansion of said implant along the axis of said spine.

19. The method of claim 17, wherein said top element, said bottom element and said intermediate structure each have at least one hole for flow therethrough of filler material, said implant further having a filler material receiving orifice defining a pathway into said implant, all of such holes and said orifice being in fluid communication, and further comprising the step of introducing filler material comprising a fusion promoting composition into said orifice to said holes after ending said expansion step.

20. The method of claim 19, further comprising an injection channel for introducing said filler material into said implant filler receiving orifice, said injection channel being configured for passing through said access channel.