Implants for spinal fixation and or fusion

Patent metadata

Field	Value
Publication number	US-11234830-B2
Application number	US-202016874149-A
Country	US
Kind code	B2
Filing date	May 14, 2020
Priority date	Feb 14, 2019
Publication date	Feb 1, 2022
Grant date	Feb 1, 2022

Abstract

Bone implants, including methods of use and assembly. The bone implants, which are optionally composite implants, generally include a distal anchoring region and a growth region that is proximal to the distal anchoring region. The distal anchoring region can have one or more distal surface features that adapt the distal anchoring region for anchoring into iliac bone. The growth region can have one or more growth features that adapt the growth region to facilitate at least one of bony on-growth, in-growth, or through-growth. The implants may be positioned along a posterior sacral alar-iliac (“SAI”) trajectory. The implants may be coupled to one or more bone stabilizing constructs, such as rod elements thereof.

First claim

The invention claimed is:

1. A composite implant for use in at least one of bone fusion or stabilizing a plurality of bones, comprising:
an inner shank having a distal end region with one or more shank threads sized, positioned and configured for anchoring into iliac bone;
a sleeve including a tapered distal end that includes one or more sleeve outer threads, the sleeve sized and configured to be positioned over at least a portion of the inner shank to form the composite implant with the one or more shank threads interfacing with one or more sleeve inner threads disposed within the tapered distal end so as to resist relative motion between the sleeve and the inner shank in at least one direction, wherein the one or more shank threads, the one or more outer sleeve threads, and the one or more sleeve inner threads have the same thread direction,
the composite implant having a distal anchoring region that includes the one or more shank threads and the one or more sleeve outer threads in the tapered distal end, and a growth region that is proximal to the distal anchoring region, the one or more shank threads and the one or more sleeve outer threads in the tapered distal end configured to better adapt the distal anchoring region for anchoring into iliac bone than the growth region, and the growth region having one or more growth features that better adapt the growth region to facilitate at least one of bony on-growth, in-growth, or through-growth than the anchoring region.

2. The composite implant of claim 1 , wherein in a region between a sleeve distal end and a sleeve proximal end, the inner shank is more resistant to fatigue than the sleeve.

3. The composite implant of claim 2 , wherein the sleeve is made of a different material than the inner shank.

4. The composite implant of claim 3 , wherein the inner shank is made of one or more of titanium or stainless steel.

5. The composite implant of claim 1 , wherein the one or more sleeve outer threads comprise a dual lead thread region.

6. The composite implant of claim 1 , wherein the inner shank includes a smooth shank region proximal to the distal anchoring region, the sleeve disposed about at least a portion of the smooth shank region.

7. The composite implant of claim 1 , further comprising an inner shank interface feature is disposed in a proximal region of the inner shank.

8. The composite implant of claim 7 , further comprising a sleeve interface feature disposed in a sleeve proximal region.

9. The composite implant of claim 7 , wherein the inner shank interface feature comprises an annular groove sunk into the inner shank.

10. The composite implant of claim 7 , further comprising an inner shank interface feature that comprises a smooth surface.

11. The composite implant of claim 1 , wherein the one or more sleeve inner threads and the one or more shank threads resist motion via an interference fit.

12. The composite implant of claim 11 , wherein the one or more shank threads includes a flattened crest, the flattened crest having a length that increases in a proximal direction.

13. The composite implant of claim 1 , wherein the distal end region of the inner shank is tapered.

14. The composite implant of claim 1 , wherein the inner shank further comprises a thread barb with a surface depression configured to act as a stop to prevent the sleeve from advancing distally.

15. The composite implant of claim 1 , wherein inner shank includes a proximal end that has a surface configured to securely interface with a tulip.

16. The composite implant of claim 1 , wherein the inner shank further comprises a proximal thread region in a proximal end region of the inner shank, the proximal thread region axially spaced apart from and proximal to the distal end region.

17. The composite implant of claim 16 , wherein the one or more shank threads in the distal end region and the proximal thread region are multi-lead.

18. The composite implant of claim 1 , wherein the sleeve includes a plurality of fenestrations extending through the sleeve.

19. The composite implant of claim 18 , wherein at least half of the plurality of fenestrations are disposed axially in between one or more sleeve thread crests.

20. The composite implant of claim 19 , wherein each of the plurality of fenestrations are disposed axially in between the one or more sleeve thread crests.

21. The composite implant of claim 18 , wherein a subset of the plurality of fenestrations are disposed in an at least partial helical configuration.

22. The composite implant of claim 21 , wherein a second subset of the plurality of fenestrations are disposed in an at least partial helical configuration.

23. The composite implant of claim 18 , wherein one or more of the plurality of fenestrations are tapered and have an outer dimension that is larger than an inner dimension.

24. The composite implant of claim 1 , wherein the growth surface features include a plurality of lattice sections extending through at least an outer surface of the sleeve wherein each of the plurality of lattice section includes pores having dimensions smaller than each of a plurality of sleeve fenestrations, wherein a set of lattice sections are disposed in a partial helical configuration along the composite implant.

25. The composite implant of claim 24 , wherein a first group of the plurality of lattice sections extend all the way through a thickness of the sleeve, and a second group of the plurality of lattice sections only extend through an outer surface of the sleeve and not all the way through the thickness of the sleeve.

26. The composite implant of claim 25 , wherein each of the second group are disposed within fluted sections of the sleeve.

27. The composite implant of claim 1 , wherein the sleeve includes a plurality of lattice sections, at least a subset of the plurality of lattice sections do not extend all the way through a thickness of the sleeve.

28. The composite implant of claim 27 , wherein the subset of the plurality of lattice sections are disposed inside of a sleeve flute.

29. The composite implant of claim 27 , wherein a second subset of the plurality of lattice sections extend all the way through the sleeve.

30. The composite implant of claim 29 , wherein the second subset are disposed in a sleeve proximal region that is a multi-lead threaded region.

31. The composite implant of claim 27 , wherein the plurality of lattice sections are disposed axially adjacent at least one sleeve thread.

32. The composite implant of claim 27 , wherein a subset of the plurality of lattice sections are disposed in an at least partial helical configuration.

33. The composite implant of claim 1 , wherein the sleeve includes a central thread region that is single thread, wherein the central thread region is in the growth region.

34. The composite implant of claim 33 , wherein the sleeve further includes a proximal thread region that is multi-lead.

35. The composite implant of claim 1 , where the sleeve does not extend as far proximally as the inner shank.

36. The composite implant of claim 1 , wherein the inner shank includes a lumen that extends between an inner shank proximal end and an inner shank distal end.

37. The composite

Assignees

• Si Bone Inc

Inventors

• Mesiwala Ali H
• Reiley Mark A
• Sand Paul M
• Schneider Bret W
• Yerby Scott A
• Shaffrey Christopher I
• Eastlack Robert K
• Uribe Juan S
• Lieberman Isador H
• Phillips Frank M
• Polly David W
• Singer Phillip J
• Phelps Jeffrey B
• Lindsey Derek P
• Kahn Patrick
• Kerr Nikolas F
• Follini Francois

Classifications

• A61F2002/30738

  Sleeves · CPC title

• A61F2002/30851

  Multiple threadings · CPC title

• A61F2002/30841

  Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes · CPC title

• A61F2002/30149

  pentagonal · CPC title

• A61F2002/30593

  hollow · CPC title