Plastically deformable inter-osseous device

• US 10,117,756 B2
• Filed: 07/18/2016
• Issued: 11/06/2018
• 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): Johanas, Jacqueline
• Application Number:
  US15/212,373
• Publication Number:
  US 20160324659A1
• Time in Patent Office: 841 Days
• 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 implants suitable for use within bone and between bones to fuse vertebral bodies, to repair herniated discs, or to repair spinal compression fractures. The implants are introduced into a chosen 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 suitable as intervertebral spinal fusion implants for the immobilization of adjacent vertebral bodies. Methods of and instruments for deployment of the implants are also described. Also described are variations of the device suitable as sizing instruments.

Claims

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

a deformable monolithic body having a distal anterior end, a proximal posterior end and a longitudinal axis extending through the distal and proximal ends, an upper bone contact structure and a lower bone contact structure spaced from each other, a first locator arm adjacent the anterior distal end and a second locator arm adjacent the proximal posterior end, each locator arm being joined to a respective upper bone contact structure and a lower bone contact structure without discontinuity by a deformable joint and having a length between said upper bone contact structure and said lower bone contact structure, the length of said first locator arm being greater than the length of said second locator arm, said upper bone contact structure being movable relative to said lower bone contact surface about said deformable joints, said device being expandable along a height axis between a first unexpanded height to a second expanded height upon deformation of the monolithic body by differential movement between said upper bone contact structure and said lower bone contact structure, wherein the height of said body at said distal anterior end is greater than the height at said proximal posterior end at the expanded second height, said body including a first partial column between said locator arms projecting from said upper bone contact structure toward said lower bone contact structure, and a second matchable partial column between said locator arms projecting from said lower bone contact structure toward said upper bone contact structure, said first and second partial columns being longitudinally spaced and not engaged with each other at said first height and operative to move longitudinally and engage upon expansion to form a load-bearing column at said second expanded height along the height axis that spans the distance between said upper bone contact structure and said lower bone contact structure.

2. The device of claim 1, wherein said first partial column has an apex directed toward said upper bone contact structure.

3. The device of claim 2, wherein said first partial column includes a first latch disposed at said apex of said first partial column.

4. The device of claim 3, wherein said first partial column includes a pair of teeth at said apex forming a portion of said first latch.

5. The device of claim 3, wherein said second partial column has a second latch disposed on said second partial column, said second latch being engageable with said first latch upon expansion of said device to form said load-bearing column.

6. The device of claim 5, wherein said second partial column has an apex directed toward said lower bone contact structure.

7. The device of claim 1, wherein said deformable body is plastically deformable upon expansion.

8. The device of claim 7, wherein each of said locator arms is substantially inflexible from, and has no deformable joint between, the joint at the upper bone contact structure to the joint at the lower bone contact structure, said locator arms being rotatable about said joints.

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

a deformable monolithic body having a distal anterior end and a proximal posterior end, an upper bone contact structure and a lower bone contact structure, a first locator arm more proximate the distal anterior end and a second locator arm more proximate the proximal posterior end, each locator arm being joined to a respective upper bone contact structure and a lower bone contact structure without discontinuity by a deformable joint and having a length between said upper bone contact structure and said lower bone contact structure, the length of said first locator arm being greater than the length of said second locator arm, said upper bone contact structure being movable relative to said lower bone contact surface about said deformable joints, said device being expandable along a height axis between a first unexpanded height to a second expanded height by deformation of the monolithic body, wherein the height of said body at said distal anterior end is greater than the height at said proximal posterior end at the expanded second height, a load-bearing column formable between said locator arms, at least a first column portion of said load-bearing column projecting inwardly within said body in a fixed direction from one of said upper bone contact structure or said lower bone contact structure and a second column portion of said load-bearing column projecting inwardly within said body in a fixed direction facing said first column portion, said second column portion being supported by a center section of said body disposed between said upper bone contact structure and said lower bone contact structure, said load-bearing column not being formed at the first height and said first column portion and said second column portion being operative at the second expanded 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.

10. The device of claim 9, wherein said load-bearing column is disposed between said locator arms.

11. The device of claim 10, wherein said upper bone contact structure and said lower bone contact structure are substantially inflexible and translatably movable relative to each other.

12. The device of claim 9, 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.

13. The device of claim 9, wherein said first column portion comprises a latch for latching upon expansion with another latch supported by said body generally opposite said latch on said first column portion.

14. The device of claim 13, wherein said another latch is supported on said second column portion.

15. The device of claim 9, wherein said center section is translatably movable in a direction transverse to said height axis.

16. The device of claim 9, wherein each locator arm is rotatable about said deformable joints.

17. The device of claim 9, wherein at least one of said deformable joints is plastically deformable upon expansion.

18. The device of claim 17, wherein said plastically deformable joint comprises a structural component of reduced cross-sectional area.

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

a deformable monolithic body having a distal anterior end and a proximal posterior end, an upper bone contact structure and a lower bone contact structure, a first locator arm adjacent the distal anterior end and a second locator arm adjacent the proximal posterior end, and a center section supported by said body and translatable between said upper bone contact structure and said lower bone contact structure, each locator arm being joined to a respective upper bone contact structure and a lower bone contact structure without discontinuity by a deformable joint and having a length between said upper bone contact structure and said lower bone contact structure, the length of said first locator arm being greater than the length of said second locator arm, said upper bone contact structure being movable relative to said lower bone contact surface about said deformable joints, said device being expandable along a height axis between a first unexpanded height to a second expanded height by deformation of the monolithic body, wherein the height of said body at said distal anterior end is greater than the height at said proximal posterior end at the expanded second height, 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 first and second partial column portions and said first and second engagement surfaces being disposed between said first and second locator arms, 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 at said second expanded height.

20. The device of claim 19, wherein each of said first and second partial columns includes latching structure that is operative to directly interact at the second expanded height to maintain the monolithic body at the expanded height.

21. The device of claim 19, 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.

22. The device of claim 19, wherein said center section is movable in said direction transverse to said expanded height as said locator arms are deformed about said deformation joints.

23. The device of claim 19, wherein a deformation joint is configured to be plastically deformable.

24. The device of claim 19, wherein said center portion is joined to said locator arms at the respective distal and proximal ends.