Plastically deformable inter-osseous device

• US 8,920,507 B2
• Filed: 12/24/2013
• Issued: 12/30/2014
• Est. Priority Date: 07/15/2010
• Status: Active Grant

• Current Assignee: Spine Wave Incorporated
• Original Assignee: Spine Wave Incorporated
• Inventors: Malandain, Hugues
• Primary Examiner(s): Hammond, Ellen C
• Assistant Examiner(s): JOHANAS, JACQUELINE T
• Application Number:
  US14/140,017
• Publication Number:
  US 20140114422A1
• Time in Patent Office: 371 Days
• Field of Search: 623 1711- 1716, 623/16.11, 623/11.11
• US Class Current: 623/17.16
• CPC Class Codes: A61B 17/8852 capable of being assembled or enlarged, or changing shape, inside the bone or disc
• 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 2002/30014 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2002/30016 differing in hardness, e.g. Vickers, Shore, Brinell
• CPC Class Codes: A61F 2002/30367 with additional means for preventing said rotation
• CPC Class Codes: A61F 2002/30579 with mechanically expandable devices, e.g. fixation devices
• CPC Class Codes: A61F 2002/30593 hollow
• 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 2002/4631 the prosthesis being specially adapted for being cemented
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• 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 2310/00131 Tantalum or Ta-based alloys
• CPC Class Codes: A61F 2310/00137 Tungsten or W-based alloys
• CPC Class Codes: A61F 2310/00161 Carbon; Graphite
• CPC Class Codes: A61F 2310/00167 Diamond or diamond-like carbon
• CPC Class Codes: A61F 2310/00203 containing alumina or aluminium oxide

Abstract

Described here are deformable monolithic, stabilization devices, or implants, suitable for use within bone and between bones, for instance, to fuse vertebral bodies, to repair herniated discs, or to repair spinal compression fractures. The implants are introduced into a chose site at a first, smaller height and then plastically deformed to achieve a second, but unique, pre-selected, larger height. Variations of the device provide one or more specific larger heights. The devices are particularly suitable as intervertebral spinal fusion implants for the immobilization of adjacent vertebral bodies. Methods of deploying the implants are also described as are instruments for such deployment.

Claims

1. An orthopedic stabilizing device for placement in an interosseous space defined by adjacent bony surfaces, comprising a plastically deformable monolithic body having a longitudinal axis, a lateral axis, and

a.) expandable along a height axis between a first smaller height to a second larger expanded height by plastic deformation of the monolithic body, said monolithic body having an upper bone contact structure and a lower bone contact structure, said monolithic body being operative to contact said adjacent bony surfaces when expanded, said body having a first locator arm, a second locator arm spaced from said first locator arm along the longitudinal axis, and an engagement surface, each locator arm being joined to the respective upper bone contact structure and the lower bone contact structure by a plastically deformable joint;

and

b.) having a formable load-bearing column that is not formed at the first height and is operative at the second height to form a supporting load-bearing column along the height axis that spans the distance between said upper bone contact structure and said lower bone contact structure, said formable column comprising a column portion supported by and projecting inwardly of said body and another column portion supported by and projecting inwardly of said body generally toward said column portion, said engagement surface being on said another column portion and including a latching structure, said latching structure of said engagement surface of said body not being in engagement with said column portion at said first height, said column portion being operative to directly engage and latch said latching structure of engagement surface at said second height to form said load-bearing column.

2. The device of claim 1, wherein said body has a proximal end and a distal end, said first locator arm being more proximate one of said proximal end or said distal end.

3. The device of claim 1, wherein said column portion includes latching structure to directly interact and latch with the latching structure on the engagement surface of said another column.

4. The device of claim 3, wherein said another column portion is supported by a center section of said body disposed between said upper bone contact structure and said lower bone contact structure.

5. The device of claim 4, wherein said center section is translatably movable in a direction transverse to said height axis.

6. The device of claim 1, wherein said body includes openings to allow osteogenic materials to flow into and through said monolithic body to said adjacent bony surfaces.

7. The device of claim 1, wherein each of the upper bone contact structure and the lower bone contact structure of the monolithic body comprises a bone contact region operative to contact an adjacent bony surface when the monolithic body is expanded.

8. The device of claim 1, wherein the upper bone contact structure and the lower bone contact structure are not substantially parallel when the monolithic body is expanded.

9. The device of claim 1, wherein said formable load-bearing column is disposed between said first locator arm and said second locator arm.

10. The device of claim 1, wherein said monolithic body comprises a metal or alloy.

11. The device of claim 1, wherein said monolithic body comprises at least one polymer.

12. A set of the devices of claim 1, comprising multiple devices wherein the difference between the first and second height is of equal value for each such device and the second height for each such device is different from each other device in the set.

13. A set of the devices of claim 1, comprising multiple devices wherein the second height for each such device is the same as each other device in the set and the difference between the first and second height for each such device is different from each other device in the set.

14. An orthopedic stabilizing device for placement in an interosseous space defined by adjacent bony surfaces, comprising:

a plastically deformable monolithic body having a distal end and a proximal end, an upper bone contact structure and a lower bone contact structure, a locator arm more proximate the distal end and a locator arm more proximate the proximal end, each locator arm being joined to the respective upper bone contact structure and the lower bone contact structure by a plastically deformable joint, each of said locator arms being substantially inflexible from, and having no other deformable joint between, the deformable joint at the upper bone contact structure to the deformable joint at the lower bone contact structure and rotatable about said deformable joints, said upper bone contact structure being movable relative to said lower bone contact surface about said deformable joints, a load-bearing column formable between said locator arms, at least a portion of said formable column projecting in a fixed direction from one of said upper bone contact structure or said lower bone contact structure, said body being expandable along a height axis between a first smaller height to a second larger expanded height by the differential movement between said upper bone contact structure and said lower bone contact structure, said column not being formed at the first height and said column being operative at the second height to form said load-bearing column along the height axis that spans the distance between said upper bone contact structure and said lower bone contact structure.

15. The device of claim 14, wherein said load-bearing column is disposed between said locator arms.

16. The device of claim 15, wherein said upper bone contact structure and said lower bone contact structure are substantially inflexible and translatably movable relative to each other.

17. The device of claim 16, wherein each of said upper bone contact structure and said lower bone contact structure has openings to allow osteogenic materials to flow into and through said monolithic body between adjacent bone surfaces.

18. The device of claim 14, wherein said formable column comprises a column portion projecting inwardly from one of said upper bone contact structure or said lower bone contact structure, said column portion comprising a latch for latching upon expansion, with another latch supported by said body generally opposite said latch on said column portion.

19. The device of claim 18, wherein said formable column includes another column portion projecting inwardly within said body and wherein said another latch is supported on said another column portion.

20. The device of claim 19, wherein said another column portion is supported by the other of said upper bone contact structure or said lower bone contact structure.

21. The device of claim 14, wherein said plastically deformable joint comprises a structural component of reduced cross-sectional area.

22. An orthopedic stabilizing device for placement in an interosseous space defined by adjacent bony surfaces, comprising:

a deformable monolithic body having a distal end and a proximal end, an upper bone contact structure and a lower bone contact structure, a locator arm adjacent the proximal end, a locator arm adjacent the distal end, a center section having a distal end and a proximal end extending between said upper bone contact structure and said lower bone contact structure, each locator arm being joined to said upper bone contact structure, said lower bone contact structure and said center portion at the respective distal and proximal ends by a deformation joint thereat, a first partial column on said upper bone contact structure projecting toward said center section, a second partial column on said lower bone contact structure projecting toward said center section, said center section including a third partial column projecting toward said upper bone contact structure and a fourth partial column projecting toward said lower bone contact structure, said body being expandable along a height axis between a first smaller height to a second larger expanded height, said center section being movable in a direction transverse to said expanded height, said partial columns not being engaged with each other at said first height and operative to form upon expansion a load-bearing column along the height axis by the direct engagement of said first partial column with said third partial column and the second partial column with said fourth partial column, said load-bearing column spanning the distance between said upper bone contact structure and said lower bone contact structure.

23. The device of claim 22, wherein each of said first, second, third and fourth partial columns includes latching structure that is operative to directly interact at the expanded height to maintain the monolithic body at the expanded height.

24. The device of claim 22, wherein each of said upper bone contact structure and said lower bone contact structure has openings to allow osteogenic materials to flow into and through said monolithic body between adjacent bone surfaces.

25. The device of claim 24, wherein the locator arm adjacent one of the proximal end or said distal end is longer than the locator arm adjacent the other of said proximal end or said distal end.

26. The device of claim 22, wherein said center section is movable in said direction transverse to said expanded height as said locator arms are deformed about said deformation joints.

27. The device of claim 22, wherein a deformation joint is configured to be plastically deformable.

28. An orthopedic stabilizing device for placement in an interosseous space defined by adjacent bony surfaces, comprising:

a deformable monolithic body having a distal end and a proximal end, an upper bone contact structure and a lower bone contact structure, a locator arm adjacent the proximal end, a locator arm adjacent the distal end, a center section having a distal end and a proximal end extending between said upper bone contact structure and said lower bone contact structure, each locator arm being joined to said upper bone contact structure, said lower bone contact structure and said center portion at the respective distal and proximal ends by a deformation joint thereat, a first partial column on one of said upper bone contact structure or said center section, a first engagement surface on the other of said upper bone contact structure or said center section, a second partial column on one of said lower bone contact structure or said center section, a second engagement surface on the other of said lower bone contact structure or said center section, said body being expandable along a height axis between a first smaller height to a second larger expanded height, said center section being movable in a direction transverse to said expanded height, said first and said second partial columns not being engaged with said respective first and second engagement surfaces at said first height and operative to form upon expansion a load-bearing column along the height axis by the direct engagement of said first partial column with said first engagement surface and the second partial column with said second engagement surface, said load-bearing column spanning the distance between said upper bone contact structure and said lower bone contact structure.