Apparatus for restoration of the spine and methods of use thereof

• US 9,579,130 B2
• Filed: 04/02/2009
• Issued: 02/28/2017
• Est. Priority Date: 04/08/2008
• Status: Active Grant

• Current Assignee: Stryker European Operations Limited (Stryker Corporation)
• Original Assignee: Vexim SAS
• Inventors: Vienney, Ccile, Oglaza, Jean-Franois
• Primary Examiner(s): Merene, Jan Christopher
• Assistant Examiner(s): MAHMUD, ATIYA S
• Application Number:
  US12/417,565
• Publication Number:
  US 20090281628A1
• Time in Patent Office: 2,889 Days
• Field of Search: 606/68, 606/90, 606/105, 606246-249, 606/313, 606/320, 606326-327, 606/79, 623/17.11, 623/17.13, 623/17.15, 623/17.12, 623/17.14, 623/17.16
• US Class Current: 1/1
• 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: A61F 2/446 having a circular or elliptical cross-section substantially parallel to the axis of the spine, e.g. cylinders or frustocones
• CPC Class Codes: A61F 2002/30411 having two threaded end parts connected by a threaded central part with opposite threads at its opposite ends, i.e. for adjusting the distance between both end parts by rotating the central part
• CPC Class Codes: A61F 2002/30462 retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2002/30471 connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2002/3055 for adjusting length
• CPC Class Codes: A61F 2002/30579 with mechanically expandable devices, e.g. fixation devices
• CPC Class Codes: A61F 2002/30583 filled with hardenable fluid, e.g. curable in-situ
• 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 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 2220/0091 connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2310/00023 Titanium or titanium-based alloys, e.g. Ti-Ni alloys

Abstract

The subject disclosure are directed to systems, apparatuses, devices and methods for vertebral and spinal correction. In some embodiments, an expansible implant is provided which may be inserted between two vertebrae, for instance, for maintenance and/or restoration of the distance/space between vertebrae. The implant may include first and second opposed plates that are intended to move away from one another, and which engage portions of vertebrae via a recess provided for on a bearing surface of the plates. The implant may additionally include at least first and second opposed end members, where at least one of the end members includes an aperture configured for receiving at least a portion of a retaining element adapted for retaining the implant in an expanded configuration once the implant is 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. An intervertebral expansible implant, comprising:

a plane of expansion intrinsic to the implant, wherein the implant includes a first length corresponding to a contracted configuration and a second length shorter than the first length corresponding to an expanded configuration;

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

at least first and second implant end members monolithically integral with each of the opposed plates, wherein the opposed plates move away from one another as the end members are brought towards one another;

at least a first support and a second support, wherein each support is connected to respective first or second end members, and is disposed between the respective first or second end members and the first or second opposed plates, wherein each support is separated from a winged portion of at least one of the first and second opposed plates by a transverse slot extending over a length of each support; and

a retaining element configured to be retained by the implant after expansion to retain the implant, once expanded, in the expanded configuration, wherein;

the retaining element comprises a shaft integral with a head portion, wherein the head portion is larger than the shaft, the head portion including a top-surface,

the first end member including an end-surface and a head-recess in the end-surface arranged adjacent to at least one aperture provided in the first end member, the at least one aperture configured for receiving one end of the retaining element,

the at least one aperture is sized to receive and pass the shaft of the retaining element, and

the head-recess is sized to receive and retain the head portion of the retaining element, such that when the head portion of the retaining element is fully received into the head-recess, a top surface of the head portion sits flush with or below the end-surface.

2. The expansible implant according to claim 1, wherein the first end member is located at a proximal end of the implant, and the second member is located at a distal end of the implant;

a first aperture is provided in the second end member positioned distally on the implant;

the at least one aperture is a second aperture provided in the first end member;

the retaining element includes at least an abutment provided on a proximal end of the retaining element;

the first aperture is configured for receiving a distal portion of the retaining element, at least the distal end of the retaining element includes a mating area corresponding to a mating area of the first aperture;

the second aperture is configured for receiving a proximal portion of the retaining element such that when the mating area of the distal end of the retaining element mates with the mating area of the first aperture, the abutment is positioned proximate an exterior side of the proximal end member of the implant, thereby enabling the retaining element to retain the implant in the expanded configuration.

3. The expansible implant according to claim 2, wherein the mating areas comprise corresponding screw threads.

4. The expansible implant according to claim 3, wherein the mating areas comprise corresponding screw threads, and wherein upon the abutment abutting with the head-recess, further threading of the screw threads corresponds to expansion of the implant.

5. The expansible implant according to claim 4, wherein the degree of expansion of the implant is controlled by the amount of threaded engagement of the corresponding screw threads.

6. The expansible implant according to claim 3, wherein the second aperture comprises screw threads and in place of or in addition to the abutment, the proximal end of the retaining element includes screw threads corresponding to the screw threads of the second aperture, and upon the corresponding screw threads of the second aperture and proximal end of the retaining element being engaged with one another, the retaining element retains the implant in the expanded configuration.

7. The expansible implant of claim 1, further comprising an expandable envelope member.

8. The expansible implant of claim 7, further comprising a material configured to aid in retaining the expanded configuration of the implant.

9. The expansible implant of claim 8, wherein the material comprises a bone cement.

10. The expansible implant of claim 7, wherein the expandable envelope member at least partially covers the implant.

11. The expansible implant according to claim 1, wherein the retaining element is selected from the group consisting of:

a screw, a rivet, a wire and combinations thereof.

12. The expansible implant according to claim 1, wherein a length of the retaining element corresponds to the first length of the implant.

13. A method for restoring an intervertebral space between two vertebral bones, comprising the steps of:

percutaneously inserting into a body an expansible implant, wherein the expansible implant includes a contracted and an expanded configuration, and wherein the implant includes a first length corresponding to contracted configuration and a second length shorter than the first length corresponding to the expanded configuration, the implant comprises;

first and second opposed plates, wherein each plate includes a recess configured for engaging a respective portion of the two vertebral bones during use of the implant, wherein the first and second plates are intended to move away from one another toward the respective vertebral bones as the implant is expanded;

first and second implant end members monolithically integral with each of the opposed plates, wherein the opposed plates move away from one another as the end members are brought towards one another;

at least a first support and a second support, wherein each support is connected to respective first or second end members, and is disposed between the respective first or second end members and the first or second opposed plates, wherein each support is separated from a winged portion of at least one of the first and second opposed plates by a transverse slot extending over a length of each support; and

a retaining element configured to be retained by the implant after expansion to retain the implant, once expanded, in the expanded configuration, wherein;

the retaining element comprises a shaft integral with a head portion, wherein the head portion is larger than the shaft, the head portion including a top-surface;

at least one aperture provided in the first end member, the at least one aperture configured for receiving one end of the retaining element;

the first end member including an end-surface and a head-recess in the end-surface arranged adjacent the aperture,

wherein the aperture is sized to receive and pass the shaft of the retaining element, and

the head-recess is sized to receive and retain the head portion of the retaining element, such that a top surface of the head portion sits flush with or below the end-surface;

positioning the implant between the vertebral bones; and

expanding the implant from the contracted configuration to the expanded configuration thereby restoring the intervertebral space. expanded, the retaining element retains the implant in the expanded configuration.

14. The method according to claim 13, wherein the positioning comprises aligning the recesses with respective vertebral bones such that when the implant is expanded the recesses engage a portion of the vertebral bones.

15. The method according to claim 14, wherein the positioning further includes rotating the implant so as to align the recesses with the vertebral bones.

16. The method according to claim 15, wherein the expansion or rotation of the implant causes the recesses to contact and engage a portion of the vertebral bones.

17. The method according to claim 16, wherein the portion of the vertebral bones fit within the recess of the implant.

18. The method according to claim 13, wherein the implant further comprises an envelope member.

19. The method according to claim 18, vherein the envelope member is expanded prior to or after expansion of the implant.

20. The method according to claim 19, wherein the envelope member is expanded via the expansion of the implant.

21. The method according to claim 18, wherein the envelope member is expanded by the addition of a fill material therein.

22. The method according to claim 13, wherein the implant is expanded to the expanded configuration by engagement of the retaining element.

23. The method according to claim 13, wherein once the implant is expanded, the retaining element retains the implant in the expanded configuration.

24. The method according to claim 13, wherein the implant is inserted in a collapsed configuration.