Plastically deformable inter-osseous device

• US 9,398,961 B2
• Filed: 07/30/2015
• Issued: 07/26/2016
• 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 T
• Application Number:
  US14/813,310
• Publication Number:
  US 20150366673A1
• Time in Patent Office: 362 Days
• US Class Current: 1/1
• 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 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 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 deformable monolithic body having a distal end, a proximal 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 locator arm adjacent the distal end and a locator arm adjacent the proximal end, each locator arm being joined to a respective upper bone contact structure and a lower bone contact structure without discontinuity, said device being expandable along a height axis between a first unexpanded height to a second and third larger expanded height by deformation of the monolithic body, 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 one of said second larger height or said third larger height.

2. The device of claim 1, wherein said third height is greater than said second height, said second height defining an intermediate height of expansion and said third height defining a full height of expansion.

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

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

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

6. The device of claim 4, wherein said second partial column has a second latch and a third latch, said second latch being disposed on said second partial column closer to said upper bone contact structure than said third latch, said second latch being engageable with said first latch upon expansion of said device to form said load-bearing column at said intermediate height.

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

8. The device of claim 7, wherein said third latch is disposed at said apex of said second partial column, said third latch being engageable with said first latch upon expansion of said device to form said load-bearing column at said full height.

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

10. 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, a proximal end and a longitudinal axis extending through the distal and proximal ends, said device being expandable along a height axis between a first unexpanded height to a second and third larger expanded height by deformation of the monolithic body, said body including longitudinally separated first and second partial columns that are not engaged with each other at said first height and operative to move longitudinally and engage upon expansion and plastic deformation of said body to form a load-bearing column at one of said second larger height or said third larger height, said monolithic body having a lower bone contact structure and an upper bone contact structure spaced from each other along the height axis, said first partial column being supported by said lower bone contact structure and said second partial column being supported by said upper bone contact structure, a locator arm adjacent the distal end and a locator arm adjacent the proximal end, each partial column being disposed between said locator arms and each locator arm being joined to a respective upper bone contact structure and a lower bone contact structure without discontinuity by a plastically deformable joint, and wherein said third height is greater than said second height, said second height defining an intermediate height of expansion and said third height defining a full height of expansion.

11. The device of claim 10, wherein said first partial column has an apex directed toward said upper bone contact structure.

12. The device of claim 11, wherein said first partial column includes a first latch disposed at said apex of said first partial column.

13. The device of claim 12, wherein said first partial column includes a pair of teeth at said apex forming a portion of said first latch.

14. The device of claim 12, wherein said second partial column has a second latch and a third latch, said second latch being disposed on said second partial column closer to said upper bone contact structure than said third latch, said second latch being engageable with said first latch upon expansion of said device to form said load-bearing column at said intermediate height.

15. The device of claim 14, wherein said second partial column has an apex directed toward said lower bone contact structure.

16. The device of claim 15, wherein said third latch is disposed at said apex of said second partial column, said third latch being engageable with said first latch upon expansion of said device to form said load-bearing column at said full height.