Methods of distracting tissue layers of the human spine

• US 8,801,787 B2
• Filed: 06/16/2011
• Issued: 08/12/2014
• Est. Priority Date: 08/16/2005
• Status: Active Grant

• Current Assignee: IZI Medical Products LLC (Halma PLC)
• Original Assignee: Benvenue Medical, Inc. (Halma PLC)
• Inventors: Schaller, Laurent
• Primary Examiner(s): Robert, Eduardo C
• Assistant Examiner(s): HARVEY, JULIANNA NANCY
• Application Number:
  US13/162,021
• Publication Number:
  US 20110307064A1
• Time in Patent Office: 1,153 Days
• Field of Search: 623 1711- 1716, 606/279, 606/90, 606/105
• US Class Current: 623/17.11
• CPC Class Codes: A61B 17/70 Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
• 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 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/0256 for the spine
• CPC Class Codes: A61F 2/44 for the spine, e.g. vertebrae, spinal discs
• CPC Class Codes: A61F 2/441 made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
• 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 2/4455 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 2/4611 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 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/30153 rectangular
• CPC Class Codes: A61F 2002/30235 tubular, e.g. sleeves
• CPC Class Codes: A61F 2002/30263 cubical
• CPC Class Codes: A61F 2002/30289 helically-coiled
• CPC Class Codes: A61F 2002/30462 retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2002/3052 unrestrained in only one direction, e.g. moving unidirectionally
• CPC Class Codes: A61F 2002/30594 slotted, e.g. radial or meridian slot ending in a polar aperture, non-polar slots, horizontal or arcuate slots
• CPC Class Codes: A61F 2002/30601 telescopic
• CPC Class Codes: A61F 2002/30677 : Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• 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 2002/448 : comprising multiple adjacent spinal implants within the same intervertebral space or within the same vertebra, e.g. comprising two 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 2002/4635 : using minimally invasive surgery
• CPC Class Codes: A61F 2002/4683 : by applying ultrasonic vibrations
• CPC Class Codes: A61F 2002/4688 : having operating or control means
• CPC Class Codes: A61F 2210/0014 : using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0085 : hardenable in situ, e.g. epoxy resins
• CPC Class Codes: A61F 2220/0025 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• 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 2230/0019 : rectangular
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2230/0084 : cubical
• CPC Class Codes: A61F 2230/0091 : helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/0067 : Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2310/00293 : containing a phosphorus-containing compound, e.g. apatite

Abstract

Methods of separating and/or supporting layers of tissue in the human spine. Such methods generally comprise inserting at least a distal end portion of a guide member between layers of tissue in the human spine wherein the distal end portion defines a predetermined shape. A distraction device is advanced over at least the distal end portion of the guide member so that the distraction device substantially assumes the predetermined shape of the distal end portion of the guide member to form a support structure between the tissue layers that separates and/or supports the tissue layers.

Claims

1. A method of treating the human spine, comprising:

inserting a flexible elongated guide between tissue layers of the human spine;

inserting a flexible one-piece elongated member along and constrained by the guide between tissue layers of the human spine, said one-piece elongated member being inserted in a first generally linear configuration between the tissue layers;

curving the elongated member into a second helical configuration in which the elongated member defines a plurality of windings coiled around a vertical axis extending generally in the longitudinal direction of the spine and defining an inner space, the elongated member in the helical configuration separating and/or supporting the tissue layers; and

introducing flowable material including bone cement into the inner space of the helical configuration.

2. The method of claim 1 in which introducing flowable material comprises introducing flowable material directly into the inner space.

3. The method of claim 1 in which the flowable material is introduced into the inner space through a passageway extending within the elongated member.

4. The method of claim 1 in which the elongated member is biased to curve into the second helical configuration.

5. The method of claim 1 wherein the elongated member is made of shape memory material.

6. The method of claim 1 wherein the elongated member is made of polymer material.

7. A method for treating a vertebral body having an upper endplate and a lower endplate, the method comprising:

introducing a flexible elongated guide into a vertebral body;

introducing an elongated flexible implant into the vertebral body along and constrained by guide, the implant being introduced in a first generally linear shape;

curving the elongated implant as it advances in the vertebral body so that it extends more than 360 degrees about an axis that intersects the upper and lower endplates of the vertebral body to define a second shape within the vertebral body that is generally helical and comprises a plurality of windings about the axis, the helical implant separating and/or supporting the endplates of the vertebral body; and

introducing flowable material comprising bone cement into the vertebral body.

8. The method of claim 7 in which the implant extends fully around the axis a plurality of times between the endplates.

9. The method of claim 7 in which the implant includes a longitudinal passageway, and the method including introducing the flowable material through the passageway and into the vertebral body.

10. The method of claim 7 in which the implant includes a longitudinal passageway and the method includes introducing the flowable material through the passageway and into the helical shape.

11. The method of claim 7 in which the implant includes a longitudinal passageway communicating with at least one outlet of the implant positioned within the vertebral body, which at least one outlet is oriented to direct the flowable material in a preferential direction, and the method includes introducing the flowable material through the passageway and at least one outlet and in the preferential direction.

12. The method of claim 11 in which the preferential direction is away from a posterior portion of the vertebral body.

13. The method of claim 7 in which the implant defines an area within the helical shape and the method includes directing the flowable material into the area.

14. The method of claim 7 in which the implant defines a barrier to direct or limit the flow of flowable material within the vertebral body.

15. The method of claim 7 wherein the implant is advanced such that the helical shape contacts the endplates of the vertebral body so as to support and/or separate the endplates.

16. The method of claim 7 including diffusing a material from the implant into the vertebral body.

17. A method for treating a vertebral body having an upper endplate and a lower endplate, the method comprising:

introducing a flexible elongated guide into a vertebral body;

introducing an elongated flexible implant into the vertebral body along and constrained by guide, the implant being introduced in a first generally linear shape;

curving the elongated implant as it advances in the vertebral body so that it extends more than 360 degrees about an axis that intersects the upper and lower endplates of the vertebral body to define a second shape within the vertebral body that is generally helical and comprises a plurality of windings about the axis, the helical implant separating and/or supporting the endplates of the vertebral body, and the implant including surfaces that resist lateral shifting between adjacent windings; and

introducing flowable material comprising bone cement into an area containing cancellous bone.

18. The method of claim 17 in which the adjacent windings include interfering surfaces to resist lateral shifting between adjacent windings.

19. The method of claim 17 in which the implant comprises an upper surface including a first abutment surface and a lower surface including a second abutment surface, and wherein the first and second abutment surfaces of adjacent windings are engageable in the helical shape to resist lateral deformation.

20. The method of claim 19 in which the first and second abutment surfaces comprise elongated shoulders.

21. The method of claim 17 in which the adjacent windings of the implant are substantially adjacent so as to define a helical shape that is substantially incompressible along its axis.

22. A method for treating a vertebral body having an upper endplate and a lower endplate, the method comprising:

introducing a flexible elongated guide into a vertebral body;

introducing an elongated flexible implant into the vertebral body along and constrained by guide, the implant being introduced in a first generally linear shape;

curving the elongated implant as it advances in the vertebral body so that it extends more than 360 degrees about axis that intersects the upper and lower endplates of the vertebral body to define a second shape within the vertebral body that is generally helical and comprises a plurality of windings about the axis, the helical implant separating and/or supporting the endplates of the vertebral body, and the implant including surfaces that resist lateral shifting between adjacent windings; and

introducing flowable material comprising bone cement into the vertebral body.

23. The method of claim 22 in which the implant is made of polymeric material.

24. The method of claim 22 in which the implant includes a longitudinal passageway, and the method including introducing the flowable material through the passageway and into the vertebral body.

25. The method of claim 22 in which the implant includes a longitudinal passageway and the method includes introducing the flowable material through the passageway and into the helical shape.

26. The method of claim 22 in which the implant includes a longitudinal passageway communicating with at least one outlet of the implant positioned within the vertebral body, which at least one outlet is oriented to direct the flowable material in a preferential direction, and the method includes introducing the flowable material through the passageway and at least one outlet and in the preferential direction.

27. The method of claim 26 in which the preferential direction is away from a posterior portion of the vertebral body.

28. The method of claim 22 in which the implant defines an area within the helical shape and the method includes directing the flowable material into the area.

29. The method of claim 22 in which the implant defines a barrier to direct or limit the flow of flowable material within the vertebral body.

30. The method of claim 22 wherein the implant is advanced such that the helical shape contacts the endplates of the vertebral body so as to support and/or separate the endplates.

31. The method of claim 22 including diffusing a material from the implant into the vertebral body.

32. The method of claim 22 in which the adjacent windings include interfering surfaces to resist lateral shifting between adjacent windings.

33. The method of claim 22 in which the implant comprises an upper surface including a first abutment surface and a lower surface including a second abutment surface, and wherein the first and second abutment surfaces of adjacent windings are engageable in the helical shape to resist relative lateral shifting.

34. The method of claim 33 in which the first and second abutment surfaces comprise elongated shoulders.

35. The method of claim 22 in which the adjacent windings of the implant are substantially adjacent so as to define a helical shape that is substantially incompressible along its axis.