Apparatus for bone restoration of the spine and methods of use

• US 8,986,386 B2
• Filed: 03/12/2009
• Issued: 03/24/2015
• Est. Priority Date: 03/12/2009
• Status: Active Grant

• Current Assignee: Stryker European Operations Limited (Stryker Corporation)
• Original Assignee: Vexim SAS
• Inventors: Oglaza, Jean-Franois, Banouskou, Ezzine, Vienney, Ccile
• Primary Examiner(s): Yang, Andrew
• Application Number:
  US13/256,090
• Publication Number:
  US 20120071977A1
• Time in Patent Office: 2,203 Days
• Field of Search: 623/17.11, 623/17.15, 623/17.16, 606 92- 94, 606/105
• US Class Current: 623/17.15
• CPC Class Codes: A61B 17/7065 Devices with changeable shape, e.g. collapsible or having retractable arms to aid implantation; Tools therefor
• CPC Class Codes: A61B 17/8858 laterally or radially expansible inflatable A61B17/8855
• CPC Class Codes: A61B 2017/0256 for the spine
• 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 2002/30235 tubular, e.g. sleeves
• CPC Class Codes: A61F 2002/30579 with mechanically expandable devices, e.g. fixation devices
• CPC Class Codes: A61F 2002/30581 having a pocket filled with fluid, e.g. liquid
• 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 2002/30624 Hinged joint, e.g. with transverse axle restricting the movement
• CPC Class Codes: A61F 2002/3097 using laser
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2310/00023 Titanium or titanium-based alloys, e.g. Ti-Ni alloys

Abstract

The subject disclosure is directed to systems, apparatuses, devices and methods for vertebral and spinal correction. In some embodiments, an expandable implant is provided which may be inserted inside the vertebral body and/or between two vertebrae, for instance, for maintenance and/or restoration of a space therein or there between. In certain embodiments, the implant includes a mechanical resistance that prevents the expandable implant from contracting once it has been expanded. Methods of treatment and methods of use of such implants for the alleviation of back pain (for example) are also provided herein.

Claims

1. A vertebral expandable implant, comprising:

first and second bearing surfaces intended to evenly move away from one another according to a plane of expansion during expansion of the implant;

at least first and second opposed ends of the implant associated with each of the bearing surfaces; and

a retaining element for retaining the implant in an expanded configuration,

at least one support extending linearly between one of the at least first and second opposed ends of the implant and an underneath side of one of the first and second bearing surfaces, wherein;

the retaining element comprises a deformable portion, a first end associated with the first end of the implant and a second end associated with the second end of the implant,

a first engagement element provided proximate the second end of the retaining element for engagement with a second engagement element provided on the second end of the implant, and

engagement between the first and second engagement element and deformation of the deformable portion of the retaining element substantially prevents the second end of the implant from moving away from the first end of the implant.

2. The expandable implant according to claim 1, wherein the first engagement element comprises one or more protruding ridges that extend outward away from an outer surface of the retaining element, and wherein the second engagement element comprises one or more recesses that extend inward away from an outer surface of the end of the implant, wherein upon expansion of the implant, at least a portion of at least one of the ridges abuts a portion of and/or is received by at least a portion of one or more recesses.

3. The expandable implant according to claim 2, wherein the one or more ridges at least partially circumscribe the outer surface of the retaining element.

4. The expandable implant according to claim 3, wherein the one or more ridges completely circumscribes a circumference of the outer surface of the retaining element.

5. The expandable implant according to claim 1, wherein the one or more deformation portions is configured as a circle, triangle, square, rectangle, oval, u-shape, or oblong.

6. The expandable implant according to claim 1, wherein the second engagement element comprises one or more protruding ridges that extend outward away from an outer surface of the end of the implant, and wherein the first engagement element comprises one or more recesses that extend inward away from an outer surface of the retaining element, wherein upon expansion of the implant, at least a portion of at least one of the ridges abuts a portion of and/or is received by at least a portion of one or more recesses.

7. The expandable implant according to claim 6, wherein the retaining element is tubular and the one or more recesses at least partially circumscribe the outer surface of the retaining element.

8. The expandable implant according to claim 6, wherein the one or more recesses comprise notches.

9. The expandable implant according to claim 1, wherein the retaining element is tubular and comprises a lumen configured for allowing the passage of a flowable material there through.

10. The expandable implant according to claim 9, wherein the retaining element further comprises an aperture configured for allowing the egress of the flowable material from the lumen of the tubular retaining element.

11. The expandable implant according to claim 1, wherein at least one of the ends of the implant is configured for association with an implant expander.

12. The expandable implant according to claim 11, wherein the implant expander comprises a proximal portion and a distal portion, wherein the distal portion is configured for association with at least one of the ends of the implant.

13. The expandable implant according to claim 12, wherein the proximal portion of the implant expander is configured for being coupled to an injection member of an injection system.

14. The expandable implant according to claim 13, wherein the proximal portion comprises a luer lock, threaded, or bayonet configuration.

15. The expandable implant according to claim 1, wherein expansion of the implant comprises movement of at least one of the ends of the implant relative to the retaining element.

16. The expandable implant according to claim 10, wherein the material comprises a mixture.

17. The expandable implant of claim 16, wherein the material comprises a bone cement or bone graft.

18. An expandable implant, comprising:

a first and second bearing surfaces, wherein the first and second surfaces are intended to evenly move away from one another according to plane of expansion during expansion of the implant;

at least first and second opposed end members associated with each of the bearing surfaces;

a retaining element; and

at least a pair of supports associated with at least one of the bearing surfaces, at least one of the bearing surfaces additionally associated with at least one of the end members, wherein

a first support of the pair including a first engagement element, said first support extending linearly between one of the at least first and second end members and an underneath side of one of the first and second bearing surfaces upon expansion of the implant,

a second support of the pair including a second engagement element, said second support extending linearly between the one of the at least first and second end members and the underneath side of the one of the first and second bearing surfaces upon expansion of the implant, and

upon expanding the implant a predetermined amount, at least a portion of the first engagement element engages with at least a portion of the second engagement element to prevent movement.

19. The expandable implant according to claim 18, wherein the first engagement element comprises one or more protruding ridges that extend outward away from an outer surface of the retaining element, and wherein the second engagement element comprises one or more recesses that extend inward away from an outer surface of the end of the implant, wherein upon expansion of the implant, at least a portion of at least one of the ridges abuts a portion of and/or is received by at least a portion of one or more recesses.

20. The expandable implant according to claim 19, wherein the one or more ridges comprise teeth and the one or more recesses comprise notches.

21. The expandable implant according to claim 19, wherein at least one of the first and second bearing surfaces correspond to a respective plate.

22. The expandable implant according to claim 18, wherein the retaining element is tubular and includes a lumen configured for allowing the passage of a material there through.

23. The expandable implant according to claim 18, wherein the retaining element further comprises an aperture configured for allowing the egress of the material from the lumen of the tubular retaining element.

24. A method for restoring a space between two surfaces, comprising the steps of:

inserting an expandable implant, wherein the expandable implant includes a contracted and an expanded configuration, and the implant comprises;

a first and second opposed plates each including a recess configured for engaging a portion of a respective vertebrae of two vertebrae adjacent each respective plate, wherein the first and second plates are intended to move away from one another according to a plane of expansion as the implant is expanded;

at least first and second opposed end members associated with each of the opposed plates, wherein at least one of the end members includes an aperture configured for receiving one end of a retaining element;

a retaining element; and

at least a pair of first and second supports associated with at least one of the first and second plates and additionally associated with at least one of the first and second end members, wherein at least one of the pair of the first and second supports comprises a first engagement element and a second engagement element for engagement with the first engagement element;

aligning the recesses with respective vertebral bones such that when the implant is expanded the recesses engage a portion of the vertebral bones; and

expanding the implant from the contracted configuration to the expanded configuration and thereby restoring the space.

25. The method according to claim 24, wherein at least one of the first and second supports of the expandable implant comprises the engagement element and another of the first and second supports comprises the engagement element receiving member, additionally wherein the engagement element and the receiving member are configured for associating with one another in such a manner so as to restrain the implant from contracting once expanded.

26. The method according to claim 24, wherein the engagement element is configured as a tooth element and the receiving member is configured as a notch element.

27. The method according to claim 24, wherein expansion of the implant comprises movement of at least one of the end members relative to the retaining element.

28. The method according to claim 24, comprising a plurality of engagement elements and a plurality of engagement element receiving members.

29. The method according to claim 24, wherein the retaining element retains the implant in the expanded configuration.

30. The method according to claim 24, wherein positioning further includes rotating the implant so as to align the recesses with the vertebral bones.

31. The method according to claim 24, wherein the implant is inserted in a collapsed configuration.

32. The method according to claim 24, wherein the space comprises a space between two separate vertebrae and the surfaces comprise a surface on two opposed vertebral bones.

33. The method according to claim 24, wherein the space comprises a space within a vertebral body and the surfaces comprise opposed surfaces within the vertebral body.

34. An expandable implant, comprising:

a first and second bearing surfaces, wherein;

the first and the second bearing surfaces remain substantially parallel to each other during expansion of the implant, and

the first and second surfaces are intended to evenly move away from one another according to plane of expansion during expansion of the implant;

at least first and second opposed end members associated with each of the bearing surfaces;

a retaining element; and

at least a pair of supports associated with at least one of the bearing surfaces, at least one of the bearing surfaces additionally associated with at least one of the end members, wherein

a first support of the pair including a first engagement element,

a second support of the pair including a second engagement element, and

upon expanding the implant a predetermined amount, at least a portion of the first engagement element engages with at least a portion of the second engagement element to prevent movement.

35. The expandable implant according to claim 34, wherein the first engagement element comprises one or more protruding ridges that extend outward away from an outer surface of the retaining element, and wherein the second engagement element comprises one or more recesses that extend inward away from an outer surface of the end of the implant, wherein upon expansion of the implant, at least a portion of at least one of the ridges abuts a portion of and/or is received by at least a portion of one or more recesses.

36. The expandable implant according to claim 35, wherein the one or more ridges comprise teeth and the one or more recesses comprise notches.

37. The expandable implant according to claim 35, wherein at least one of the first and second bearing surfaces correspond to a respective plate.

38. The expandable implant according to claim 34, wherein the retaining element is tubular and includes a lumen configured for allowing the passage of a material there through.

39. The expandable implant according to claim 34, wherein the retaining element further comprises an aperture configured for allowing the egress of the material from the lumen of the tubular retaining element.

40. The expandable implant according to claim 34, wherein the pair of supports are configured in a parallel arrangement.