Devices and methods for treating the vertebral body

• US 8,556,978 B2
• Filed: 11/15/2011
• Issued: 10/15/2013
• 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): Truong, Kevin T.
• Assistant Examiner(s): BECCIA, CHRISTOPHER J
• Application Number:
  US13/296,841
• Publication Number:
  US 20120059482A1
• Time in Patent Office: 700 Days
• Field of Search: 606/86.A, 606/90, 623 7111- 1716, 623 111- 17167
• US Class Current: 623/17.16
• 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 for prostheses A61F2210/0014
• 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

The present invention relates to methods of separating, supporting or both separating and supporting layers of tissue in the human spine. Such methods generally comprise inserting at least one member between layers of tissue in the human spine and changing the configuration of the member to define a support structure between the tissue layers.

Claims

1. A device for treating a vertebral body, comprising:

a generally elongated intravertebral implant having a passageway extending longitudinally through the elongated implant and a plurality of slots spaced apart along the elongated implant; and

the elongated implant being movable between a generally linear insertion configuration for insertion into an interior region of the vertebral body and a generally helical implanted configuration including a plurality of vertically adjacent windings with at least one of the windings contacting an immediately adjacent winding, the at least one and immediately adjacent windings being configured for contact that assists in maintaining the elongated implant in the helical configuration.

2. The device of claim 1 in which the at least one and immediately adjacent windings are configured for contact that resists lateral shifting of such windings relative to each other.

3. The device of claim 1 in which the contact between the at least one and immediately adjacent windings includes interfering surfaces between the windings.

4. The device of claim 1 in which the at least one and immediately adjacent windings have engaging shoulders that resist lateral displacement of such windings relative to one another.

5. The device of claim 1 in which the at least one and immediately adjacent windings having engaging convex and concave surfaces that assist in maintaining the implant in a helical configuration.

6. The device of claim 1 in which each of the at least one and immediately adjacent windings has an upper surface and a lower surface configured so that the upper surface of one winding contacts the lower surface the adjacent winding in the helical configuration to resist relative lateral displacement.

7. The device of claim 6 in which one of the upper and lower surfaces include convex portions and the other of the upper and lower surfaces includes cooperating concave portions.

8. The device of claim 6 wherein the upper surface of one of such windings includes an elongated rib extending therealong and the lower surface of the other of such windings includes an elongated slot for receiving the rib, contact between the rib and slot resisting lateral displacement of one winding relative to the other.

9. The device of claim 1 in which the implant has a double round cross-sectional shape.

10. The device of claim 1 in which the implant has a cross-sectional shape including a square profile portion and round profile portion.

11. The device of claim 1 wherein immediately adjacent windings are locked together to resist relative lateral shifting.

12. The device of claim 1 in which the implant, relative to the implanted helical configuration, includes a top surface, a bottom surface, a radially inner facing surface and a radially outer facing surface, the slots extending through at least the radially inner facing surface, and being in flow communication with the passageway, whereby flowable bone filling material may be flowed through the passageway and slots and into a region radially inwardly of the helical structure.

13. The device of claim 12 in which the flowable material includes a bone filler material.

14. The device of claim 12 wherein the bone filler material is bone cement, allograph material, autograph material, a therapeutic drug or agent or other biocompatible material.

15. A method for treating a vertebral body having an interior region defined by a generally annular cortical wall and upper and lower endplates, the method comprising:

introducing a generally elongated intravertebral implant in a generally linear insertion configuration through the cortical wall and into the interior region of the vertebral body, the generally elongated implant having a passageway extending longitudinally through the elongated implant and a plurality of slots spaced apart along the elongated implant; and

changing the configuration of the elongated implant to form a generally vertically extending helical configuration within the interior region of the vertebral body, the helical configuration extent sufficient to separate, support or separate and support the upper and lower endplates and including a plurality of vertically adjacent windings with at least one of the windings contacting an immediately adjacent winding, the at least one winding and immediately adjacent winding being configured to for contact that assists in maintaining the elongated implant in the helical configuration.

16. The method of claim 15 in which the at least one and immediately adjacent windings are configured for contact that resists lateral shifting of such windings relative to each other.

17. The method of claim 15 in which the contact between the at least one and immediately adjacent windings includes interfering surfaces between the windings.

18. The method of claim 15 in which the at least one and immediately adjacent windings have engaging shoulders that resist lateral displacement of such windings relative to one another.

19. The method of claim 15 in which, the at least one and immediately adjacent windings have engaging convex and concave surfaces that assist in maintaining the implant in a helical configuration.

20. The method of claim 15 in which each of the at least one and immediately adjacent windings has an upper surface and a lower surface configured so that the upper surface of one winding contacts the lower surface the adjacent winding in the helical configuration to resist relative lateral displacement.

21. The method of claim 20 in which one of the upper and lower surfaces include convex portions and the other of the upper and lower surfaces includes cooperating concave portions.

22. The method of claim 20 wherein the upper surface of one of such windings includes an elongated rib extending therealong and the lower surface of the other of such windings includes an elongated slot for receiving the rib, contact between the rib and slot resisting lateral displacement of one winding relative to the other.

23. The method of claim 15 in which the implant has a double round cross-sectional shape.

24. The method of claim 15 in which the implant has a cross-sectional shape including a square profile portion and round profile portion.

25. The method of claim 15 wherein immediately adjacent windings are locked together to resist relative lateral shifting.

26. A vertebral body implant comprising:

a generally elongated member including a passageway extending longitudinally through at least a portion thereof and a plurality of slots spaced apart along the elongated implant;

the elongated member being flexible between a generally linear insertion configuration for insertion into an interior region of a vertebral body and a generally helical implanted configuration including a plurality of vertically adjacent windings;

each winding in the helical configuration including an upper surface, a lower surface, a radially inward facing surface and a radially outward facing surface;

the slots extending through the upper and lower surfaces and the radially inward facing surface, and the longitudinal passageway being in fluid communication with a plurality of the slots;

the upper and lower surfaces of each winding being configured such that the upper surface of each winding provides interfering contact with the lower surface of an immediately adjacent winding, which contact resists lateral movement of such windings relative to one another.

27. The device of claim 26 in which the at least one and immediately adjacent windings have engaging shoulders that resist lateral displacement of such windings relative to one another.

28. The device of claim 26 in which the at least one and immediately adjacent windings having engaging convex and concave surfaces that assist in maintaining the implant in a helical configuration.

29. The device of claim 26 in which one of the upper and lower surfaces include convex portions and the other of the upper and lower surfaces includes cooperating concave portions.

30. The device of claim 26 wherein the upper surface of one of such windings includes an elongated rib extending therealong and the lower surface of the other of such windings includes an elongated slot for receiving the rib, contact between the rib and slot resisting lateral displacement of one winding relative to the other.

31. The device of claim 26 in which the implant has a double round cross-sectional shape.

32. The device of claim 26 in which the implant has a cross-sectional shape including a square profile portion and round profile portion.

33. The device of claim 26 wherein immediately adjacent windings are locked together to resist relative lateral shifting.

34. The device of claim 26 in which the implant, relative to the implanted helical configuration, includes a top surface, a bottom surface, a radially inner facing surface and a radially outer facing surface, the slots extending through at least the radially inner facing surface, and being in flow communication with the passageway, whereby flowable bone filling material may be flowed through the passageway and slots and into a region radially inwardly of the helical structure.

35. The device of claim 34 in which the flowable material includes a bone filler material.

36. The device of claim 34 wherein the bone filler material is bone cement, allograph material, autograph material, a therapeutic drug or agent or other biocompatible material.