Apparatus for spinal fusion

• US 8,206,398 B2
• Filed: 09/08/2010
• Issued: 06/26/2012
• 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
• Application Number:
  US12/877,693
• Publication Number:
  US 20110009870A1
• Time in Patent Office: 657 Days
• Field of Search: 606/246, 606/279, 606/99, 606/104, 606/90, 606/105, 606/86.A, 623 1711- 1716
• US Class Current: 606/90
• 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. An expandable implant includes a plurality of elements are consecutively inserted between the two tissue surfaces to create a column of elements. The column of elements is oriented between the tissue surfaces so as to expand in the given direction as the elements are consecutively added to the column. The expandable implant includes a constraint including a cooperative engagement structure between adjacent elements.

Claims

1. An apparatus for spinal fusion, comprising:

an expandable implant for implantation into the intradiscal space between opposing vertebrae of a spine, said implant being configured for expansion in a first direction and comprising an upper element and a lower element movable relative to each other in said first direction;

an elongate inserter releasably coupled to said expandable implant; and

an expandable intermediate structure between said upper element and said lower element capable of moving said upper element and said lower element within said intradiscal space in said first direction during expansion;

said upper element, said lower element, and said intermediate structure each having 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.

2. The apparatus of claim 1, further comprising a filler material disposed in said holes.

3. The apparatus of claim 2, further comprising an access channel for introducing said filler material into the holes in said implant.

4. The apparatus of claim 1, wherein said implant includes a radiopaque material for observation under fluoroscopy.

5. The apparatus of claim 4, wherein said radiopaque material is on a surface of said implant.

6. The apparatus of claim 4, wherein each of said upper element and said lower element comprises a non-metallic composite material and wherein said radiopaque material is disposed in each of said upper element and said lower element to enable fluoroscopic visualization of the movement of said upper element and said lower element during expansion of said implant.

7. The apparatus of claim 1, wherein said implant is configured as a wedge, an outer surface of said upper element and an outer surface of said lower element being angled relative to each other.

8. The apparatus of claim 1, wherein one of said upper element, said lower element and said intermediate structure includes said orifice.

9. An apparatus for spinal fusion, comprising:

an expandable implant for implantation into the intradiscal space between opposing vertebrae of a spine, said implant being configured for expansion in a first direction and comprising an upper element and a lower element movable relative to each other in said first direction, said implant being curved in a plane generally normal to said first direction;

an elongate inserter one end of which is releasably coupled to said expandable implant, said inserter comprising a track curved in a plane generally normal to said first direction;

an intermediate element configured for insertion by the track of said inserter between said upper element and said lower element, said intermediate element being curved in the same plane as said track; and

a constraint including cooperative engagement structure between said intermediate element and one of said upper element and said lower element to allow said upper element and said lower element to move apart in substantially only said first direction.

10. An apparatus for spinal fusion, comprising:

an expandable implant for implantation into the intradiscal space between opposing vertebrae of a spine, said implant being configured for expansion in a first direction and comprising an upper element and a lower element movable relative to each other in said first direction;

an elongate inserter releasably coupled to said expandable implant;

an expandable intermediate structure between said upper element and said lower element capable of moving said upper element and said lower element within said intradiscal space in said first direction during expansion;

said upper element, said lower element, and said intermediate structure each having 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

an access channel in communication with said holes and being sized and configured to receive said expandable implant in an unexpanded condition with said inserter coupled thereto.

11. The apparatus of claim 10, wherein said access channel is configured to receive one or more instruments for at least removing a portion of nucleus material in said intradiscal space.

12. The apparatus of claim 10, wherein said access channel is expandable.

13. The apparatus of claim 10, further comprising an injection channel for introducing said filler material into said filler material orifice, said injection channel being sized and configured for passing through said access channel.

14. An apparatus for spinal fusion, comprising:

an expandable implant for implantation into the intradiscal space between opposing vertebrae of a spine, said implant being configured for expansion in a first direction and comprising an upper element and a lower element movable relative to each other in said first direction;

an elongate inserter releasably coupled to said expandable implant; and

an expandable intermediate structure between said upper element and said lower element capable of moving said upper element and said lower element within said intradiscal space in said first direction during expansion, wherein said expandable intermediate structure comprises a plurality of intermediate elements each disposed for linear arrangement on said inserter and for sequential individual slidable insertion into said implant, one beneath the other causing expansion of said intermediate structure and said movement of said upper element and said lower element in said first direction,

said upper element, said lower element, and said intermediate structure each having 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.

15. The apparatus of claim 14, wherein at least one of said intermediate elements comprises a leading lifting surface and said upper element comprises a trailing receiving surface, said lifting surface of said at least one intermediate element being configured to engage said trailing receiving surface of said upper element and to lift said upper element during insertion of said intermediate element.

16. The apparatus of claim 15, wherein said at least one intermediate element and said upper element comprise complementary configurations that allow sliding engagement therebetween during insertion and interlocking engagement upon insertion.

17. The apparatus of claim 14, wherein said intermediate elements comprise said complementary configurations therebetween.

18. An apparatus for spinal fusion, comprising:

an expandable implant for implantation into the intradiscal space between opposing vertebrae of a spine, said implant being configured for expansion in a first direction and comprising an upper element of non-metallic composite material and a lower element of non-metallic composite material movable relative to each other in said first direction, each of said upper element and said lower element containing a radiopaque material to enable fluoroscopic visualization of the movement of said upper element and said lower element in said first direction during expansion of said implant;

an expandable intermediate structure between said upper element and said lower element capable of moving said upper element and said lower element within said intradiscal space in said first direction during expansion;

said upper element, said lower element, and said intermediate structure each having at least one hole for flow therethrough of filler material, all of such holes being in fluid communication, and

an elongate inserter releasably coupled to said expandable implant.

19. The apparatus of claim 18, wherein said expandable intermediate structure is capable of moving said upper element and said lower element within said intradisacl space only in said first direction.

20. The apparatus of claim 18, wherein said inserter is configured to deliver filler material to said expandable implant.

21. The apparatus of claim 18, further comprising an injection channel for introducing filler material to said expandable implant.

22. The apparatus of claim 18, further comprising an access channel configured to receive one or more instruments for at least removing a portion of nucleus material in said intradiscal space.

23. The apparatus of claim 22, wherein said access channel is sized and configured to receive said expandable implant in an unexpanded condition with said inserter coupled thereto.

24. The apparatus of claim 23, wherein said access channel is expandable.

25. The apparatus of claim 18, wherein said radiopaque material in each of said upper element and said lower element is a radiopaque marker, each of said upper element and said lower element having a respective hole within which each of said markers is disposed.

26. An apparatus for spinal fusion, comprising:

an expandable implant for implantation into the intradiscal space between opposing vertebrae of a spine, said implant being configured for expansion in a first direction and comprising an upper element and a lower element movable relative to each other in said first direction;

an elongate inserter one end of which is releasably coupled to said expandable implant;

an intermediate element configured for insertion by said inserter between said upper element and said lower element in a second direction substantially normal to said first direction; and

cooperative engagement structure between said intermediate element and at least one of said upper element and said lower element to allow said intermediate element to move into said implant in said second direction substantially normal to said first direction and cause said upper element and said lower element to move apart in said first direction to an expanded position, said cooperative engagement structure including a constraint to restrain said intermediate element from slipping out from said implant and thereby retain said upper element and said lower element in said expanded position.

27. The apparatus of claim 26, wherein said inserter effects movement of said intermediate element into said implant.

28. The apparatus of claim 26, wherein said implant includes a radiopaque material for observation under fluoroscopy.

29. The apparatus of claim 28, wherein each of said upper element and said lower element comprises a non-metallic composite material and wherein said radiopaque material is disposed in each of said upper element and said lower element to enable fluoroscopic visualization of the movement of said upper element and said lower element during expansion of said implant.

30. The apparatus of claim 26, wherein said upper element, said lower element, and said intermediate element each having at least one hole for flow therethrough of filler material, all of such holes being in fluid communication.