Spinal fixation devices and methods of use

• US 9,901,458 B1
• Filed: 05/18/2017
• Issued: 02/27/2018
• Est. Priority Date: 09/23/2011
• Status: Active Grant

• Current Assignee: Samy Abdou Md
• Original Assignee: Samy Abdou Md
• Inventors: Abdou, Samy
• Primary Examiner(s): Bates, David
• Application Number:
  US15/599,315
• Time in Patent Office: 285 Days
• CPC Class Codes: A61F 2/30744 End caps, e.g. for closing an endoprosthetic cavity
• 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 2/4601 for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
• CPC Class Codes: A61F 2/4603 for insertion or extraction of endoprosthetic joints or of accessories thereof
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2002/2835 Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30153 rectangular
• CPC Class Codes: A61F 2002/30433 using additional screws, bolts, dowels, rivets or washers e.g. connecting screws
• CPC Class Codes: A61F 2002/30578 having apertures, e.g. for receiving fixation screws
• CPC Class Codes: A61F 2002/30593 hollow
• CPC Class Codes: A61F 2002/30774 internally-threaded
• CPC Class Codes: A61F 2002/3093 for promoting ingrowth of bone tissue
• CPC Class Codes: A61F 2002/448 comprising multiple adjacent spinal implants within the same intervertebral space or within the same vertebra, e.g. comprising two adjacent spinal implants
• 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 2002/4629 connected to the endoprosthesis or implant via a threaded connection
• 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 2310/00179 : Ceramics or ceramic-like structures

Abstract

Placement apparatus and methods of use for implantation of spacers within an inter-vertebral disc space. In one embodiment, the load-bearing superstructure of the implant is subdivided and the bone forming material is positioned within an internal space of the placement instrument but external to the load bearing elements themselves. At least a portion of the bone graft material is freely contained within the disc space. A method of using the device is also described. In one embodiment, the placement device is used to place the implantable spacers at opposing ends of the disc space using a directly lateral surgical approach.

Claims

1. An orthopedic device assembly configured for delivery of a first implantable device and a second implantable device to an intervertebral disc space, said intervertebral disc space disposed between a superior vertebral bone and an inferior vertebral bone, the orthopedic device assembly comprising:

said first implantable device comprising;

(i) a first surface configured to abut said superior intervertebral bone, and (ii) a second surface configured to abut said inferior vertebral bone;

said second implantable device being a separate component from the first implantable device and comprising at least one member having a first aperture configured to receive a fastener, said fastener configured to be advanced at least partially through said first aperture and into one of said superior vertebral bone or said inferior vertebral bone; and

a non-implantable placement instrument comprising an intermediate segment, a proximal segment and a distal segment, said placement instrument extended along a longitudinal axis from a proximal end of said proximal segment to said distal segment;

wherein;

said proximal segment comprises a handle;

said distal segment comprises a first surface configured to engage with said first implantable device; and

said intermediate segment comprises a second surface configured to engage with said second implantable device; and

wherein said non-implantable placement instrument is configured such that, as measured along said longitudinal axis, a distance between said first surface and said proximal end is greater than a distance between said second surface and said proximal end.

2. The orthopedic device assembly of claim 1, wherein said first implantable device further comprises a cavity configured to house a bone forming material.

3. The orthopedic device assembly of claim 1, wherein said intermediate segment comprises at least a pair of extension elements configured to straddle at least a portion of said second implantable device, said second surface of said intermediate segment comprising a surface of at least one of said pair of extension elements that is configured to engage said second implantable device.

4. The orthopedic device assembly of claim 3, wherein:

said distal segment comprises a distal end of each of said pair of extension elements; and

said first surface of said distal segment comprises a first pair of engagement features, each of said first pair of engagement features being (i) disposed on one of said pair of extension elements and (ii) configured to engage with said first implantable device.

5. The orthopedic device assembly of claim 4, wherein said first implantable device further comprises a pair of outer side surfaces and a second pair of engagement features having a complementary configuration to said first pair of engagement features.

6. The orthopedic device assembly of claim 1, further comprising a second aperture formed within said second implantable device;

and

wherein said placement instrument further comprises a retention apparatus, said retention apparatus comprising at least one elongate member configured to enable coupling of a distal end of said retention apparatus to said first implantable device, said distal end of said retention apparatus configured to extend through said second aperture of said second implantable device to couple to said first implantable device.

7. The orthopedic device assembly of claim 1, further comprising a second aperture centrally formed within said second implantable device;

and

wherein said second aperture is configured to receive a locking feature, said locking feature configured to limit backing out of said fastener after said fastener is received within said first aperture.

8. An orthopedic device assembly configured for delivery of a first implantable device and a second implantable device to an intervertebral disc space, said intervertebral disc space disposed at least partly between a superior vertebral bone and an inferior vertebral bone, the orthopedic device assembly comprising:

said first implantable device comprising;

(i) a first surface configured to abut said superior intervertebral bone, and (ii) a second surface configured to abut said inferior vertebral bone;

said second implantable device being non-integrally formed with said first implantable device and comprising;

(i) a first aperture, and (ii) at least one side member disposed adjacent to said first aperture, said at least one side member having a second aperture configured to receive a fastener that is sized to be at least partially advanced through said second aperture and into one of said superior vertebral bone or said inferior vertebral bone; and

a non-implantable placement instrument configured to position said first implantable device and said second implantable device, said placement instrument extending along a longitudinal axis from a proximal end to a distal segment and comprising;

a proximal segment comprising a handle;

said distal segment configured to engage said first implantable device;

an intermediate segment positioned at least partially between said proximal segment and said distal segment, said intermediate segment comprising a second surface configured to engage said second implantable device; and

a retention apparatus comprising at least one elongated member capable of alignment with said longitudinal axis of said placement instrument, a distal end of said retention apparatus configured to extend through said first aperture of said second implantable device and couple to said first implantable device.

9. The orthopedic device assembly of claim 8, wherein said distal end of said retention apparatus is configured to threadedly couple with said first implantable device.

10. The orthopedic device assembly of claim 8, wherein said non-implantable placement instrument is configured such that a distance between said first surface and said proximal end is greater than a distance between said second surface and said proximal end, as measured along said longitudinal axis.

11. The orthopedic device assembly of claim 8, wherein the at least one elongated member of the retention apparatus is sized to be at least partially seated within an internal channel of said handle.

12. The orthopedic device assembly of claim 8, wherein said intermediate segment comprises at least a pair of extension elements configured to straddle at least a portion of said second implantable device.

13. The orthopedic device assembly of claim 8, wherein said first aperture of said second implantable device is configured to receive a locking feature;

and

said locking feature is configured to limit back-out of said fastener from a seated position within said second aperture of said second implantable device.

14. The orthopedic device assembly of claim 8, wherein said first implantable device further comprises a cavity configured to seat a bone forming material.

15. An orthopedic device assembly configured for delivery of implants to an intervertebral disc space, said intervertebral disc space disposed between a superior vertebral bone and an inferior vertebral bone, the orthopedic device assembly comprising:

a first implantable device comprising (i) a first surface configured to abut said superior intervertebral bone and (ii) a second surface configured to abut said inferior vertebral bone;

a second implantable device separately formed from the first implantable segment and comprising (i) a pair of outer side surfaces and (ii) at least one segment having a first aperture configured to receive a fastener, said fastener configured to be advanced at least partially through said first aperture and into one of said superior vertebral bone or said inferior vertebral bone; and

a non-implantable placement instrument configured to position said first implantable device and said second implantable device, said placement instrument comprising;

a proximal segment comprising a handle;

a distal segment comprising a first surface, said first surface configured to engage with said first implantable device;

an intermediate segment comprising at least a pair of extension elements configured to straddle at least a portion of said second implantable device, at least one of said pair of side extension elements comprising a second surface configured to engage with one of said pair of outer side surfaces of said second member;

wherein said non-implantable placement instrument is extended from a proximal end of said proximal segment to said distal segment along a longitudinal axis; and

wherein, said non-implantable placement instrument is configured such that said first surface of the distal segment is a greater distance from said proximal end, as measured along said longitudinal axis, than said second surface of the intermediate segment.

16. The orthopedic device assembly of claim 15, wherein said first implantable device further comprises a cavity configured to house a bone forming material.

17. The orthopedic device assembly of claim 15, wherein said first implantable device is sized so as to be at least partially inserted within said intervertebral disc space.

18. The orthopedic device assembly of claim 15, wherein:

said second implantable device further comprises a second aperture; and

said placement instrument further comprises a retention apparatus, said retention apparatus comprising a distal portion configured to (i) extend through said second aperture and (ii) couple with said first implantable device.

19. The orthopedic device assembly of claim 18, wherein said first surface of said distal segment of the non-implantable placement instrument is at least partially comprised of an end segment of said distal portion of the retention member.

20. The orthopedic device assembly of claim 19, wherein said end segment of said distal portion of said retention member is configured to threadedly engage with said first implantable device.

21. The orthopedic device assembly of claim 18, wherein said distal portion of the retention member is configured to be positioned collinear with said longitudinal axis of said non-implantable placement instrument.

22. The orthopedic device assembly of claim 18, wherein said second aperture is configured to receive a locking feature;

and

said locking feature is configured to restrict unintended retraction of said fastener from the first aperture when the fastener is seated therein.

23. The orthopedic device assembly of claim 15, wherein:

(i) said distal segment of the non-implantable placement instrument comprises a distal end of at least one of said pair of extension elements; and

(ii) said first surface of said distal segment comprises an engagement feature that is disposed on said distal end of the at least one of said pair of extension elements and is configured to engage with said first member.

24. The orthopedic device assembly of claim 15, wherein said second implantable device further comprises a spacer segment that is sized to be inserted within said intervertebral disc space.

25. An orthopedic device assembly, comprising:

a first implantable device sized to be positioned at least partly within an intervertebral disc space that is disposed between a superior vertebral bone and an inferior vertebral bone, the first implantable device comprising;

(i) a superior surface configured to abut said superior intervertebral bone, and

(ii) an inferior surface configured to abut said inferior vertebral bone;

a second implantable device, separately formed from the first implantable device and configured to be positioned at least partly on an outer surface of one or more of said superior vertebral bone and said inferior vertebral bone, said second implantable device comprising;

(i) a first aperture configured to seat a first fastener, a shank portion of said first fastener configured to be at least partially advanced through said first aperture and into said superior vertebral bone when said first fastener is an a first seated position;

(ii) a second aperture configured to seat a second fastener, a shank portion of said second fastener configured to be at least partially advanced through said second aperture and into said inferior vertebral bone when said second fastener is a second seated position;

(iii) a third aperture disposed between said first aperture and said second aperture, said third aperture configured to seat a locking feature that is adapted to limit undesired back out of at least one of said first and second fasteners from a respective seated position within said first and second apertures; and

a non-implantable placement instrument configured to position said first implantable device and said second implantable device at said intervertebral disc space, said placement instrument comprising;

a proximal segment comprising a handle;

a distal segment comprising a first surface, said first surface configured to engage with said first implantable device; and

an intermediate segment between said proximal segment and said distal segment, said intermediate segment comprising a second surface configured to engage with said second implantable device;

wherein said non-implantable placement instrument extends from said proximal segment to said distal segment along a longitudinal axis; and

wherein, said non-implantable placement instrument and said first and second implantable devices are configured such that, when engaged, said first implantable device and said second implantable are consecutively arranged along said longitudinal axis.

26. The orthopedic device assembly of claim 25, wherein said intermediate segment of said non-implantable placement instrument comprises at least a pair of extensions configured to straddle said second implantable device, said second surface of said intermediate segment comprising an inner surface of each of said pair of extensions.

27. The orthopedic device assembly of claim 26, wherein:

said distal segment of the non-implantable placement instrument comprises a distal end of at least one of said pair of extension elements; and

said first surface of said distal segment comprises an engagement feature that is disposed on said distal end of said at least one of said pair of extension elements, said engagement feature configured to engage with said first member.

28. The orthopedic device assembly of claim 25, wherein said non-implantable placement instrument further comprises a retention apparatus, the retention apparatus comprising a distal end that is (i) sized to extend through said third aperture of the second implantable device and (ii) configured to couple to said first implantable device.

29. The orthopedic device assembly of claim 28, wherein said first surface of said distal segment of said non-implantable placement instrument is at least partially comprised of said distal end of said retention member.

30. The orthopedic device assembly of claim 25, wherein said second implantable device further comprises a spacer segment that is sized to be inserted within said intervertebral disc space.