Spinal fixation devices and methods of use

• US 10,575,961 B1
• Filed: 02/23/2018
• Issued: 03/03/2020
• 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 W
• Application Number:
  US15/904,057
• Time in Patent Office: 739 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 impanation 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. A device assembly configured for use in treatment of a spinal segment, the spinal segment comprising a superior vertebral bone, an inferior vertebral bone and an intervertebral disc space positioned therebetween, the device assembly comprising:

a first implantable member, the first implantable member comprising a superior surface configured to abut the superior vertebral bone and an inferior surface configured to abut the inferior vertebral bone;

a second implantable member, the second implantable member separately formed from the first implantable member, the second implantable member comprising;

a first extension comprising a first aperture, the first aperture configured to receive a first fastener, the first fastener configured to be at least partially advanced through the first aperture and into a first of the superior vertebral bone or the inferior vertebral bone; and

a second aperture; and

a placement instrument configured to deliver the first implantable member and the second implantable member to the spinal segment, the placement instrument comprising;

a proximal segment comprising a handle extended along a longitudinal axis;

a distal segment configured to engage the first implantable member;

an intermediate segment disposed between the proximal segment and the distal segment, the intermediate segment comprising an intermediate coupler configured to engage the second implantable member; and

a retention apparatus configured to;

(i) extend through the second aperture of the second implantable member, and (ii) engage with the first implantable member, the retention apparatus comprising a member having a distal end, the member further having a length greater than a width thereof, the member configured to align with the longitudinal axis.

2. The device assembly of claim 1, wherein said first implantable member further comprises a cavity configured to receive at least one bone forming material.

3. The device assembly of claim 1, wherein the first implantable member further comprises a proximal side surface and an opposing distal side surface, the proximal side surface connecting the superior surface and the inferior surface and configured to:

(i) engage with the distal end of the retention apparatus, and (ii) after the engagement with the distal end of the member of the retention apparatus, be positioned to face the second implantable member.

4. The device assembly of claim 3, wherein the proximal side surface of the first implantable member is further configured to receive the distal end of the member of the retention apparatus.

5. The device assembly of claim 3, wherein the second implantable member further comprises a distal side surface, an opposing proximal side surface, the distal side surface of the second implantable member configured to, after the engagement of the intermediate coupler to the second implantable member, face the proximal side surface of the first implantable member.

6. The device assembly of claim 5, wherein the opposing proximal side surface of the second implantable member is configured to engage with the intermediate coupler.

7. The device assembly of claim 5, wherein:

the second implantable member further comprises a first side surface and an opposing second side surface; and

the intermediate coupler comprises at least a proximal portion of a first prong, the proximal portion of the first prong configured to engage with one of the first side surface or the opposing second side surface of the second implantable member.

8. The device assembly of claim 7, wherein the distal segment at least in part comprises a distal portion of the first prong.

9. The device assembly of claim 1, wherein the second implantable member further comprises a second extension, the second extension comprising a third aperture that is configured to receive a second fastener, the second fastener configured to be at least partially advanced through the third aperture and into a second of the superior vertebral bone or the inferior vertebral bone.

10. The device assembly of claim 9, wherein the second aperture of the second implantable member is positioned between the first extension and the second extension.

11. The device assembly of claim 10, wherein said second implantable member further comprises a locking feature, said locking feature configured to limit back-out of each of the first fastener from the first of the superior vertebral bone or the inferior vertebral bone and the second fastener from the second of the superior vertebral bone or the inferior vertebral bone.

12. The device assembly of claim 11, wherein the second aperture of the second member is configured to receive at least a portion of the locking feature.

13. The device assembly of claim 1, further configured such that when the first implantable member is engaged with the distal segment of the placement instrument, and the second implantable member is engaged with the intermediate coupler of the intermediate segment, a cavity is formed between the first implantable member and the second implantable member, the cavity configured to receive at least a bone forming material.

14. The device assembly of claim 1, wherein the proximal segment of the placement instrument further comprises a channel aligned with the longitudinal axis, the retention apparatus configured to be inserted through the channel in order to enable the engagement of the retention apparatus with the first implantable member.

15. The device assembly of claim 14, wherein the retention apparatus is configured to rotate within the channel in order to enable the engagement of the retention apparatus with the first implantable member.

16. A delivery device and implant assembly comprising:

a first implantable member, the first implantable member comprising a superior surface configured to abut a superior vertebral bone of a spinal segment and an inferior surface configured to abut an inferior vertebral bone of the spinal segment;

a second implantable member, the second implantable member separable from the first implantable member and comprising at least a first extension, the first extension comprising a first aperture configured to receive a first fastener, the first fastener sized to be at least partially advanced through the first aperture and into one of the superior vertebral bone or the inferior vertebral bone; and

a placement instrument configured to deliver the first implantable member and the second implantable member to the spinal segment, the placement instrument comprising;

a proximal segment comprising a handle, the handle having a longitudinal axis and being greater in length than width, the length measured along the longitudinal axis;

a first prong comprising;

a distal segment comprising a first surface configured to engage the first implantable member;

an intermediate segment disposed between the proximal segment and the distal segment and comprising a second surface configured to engage with the second implantable member; and

a retention apparatus comprising an elongate member, the elongate member configured to (i) be aligned with the longitudinal axis of the handle, and (ii) engage the first implantable member;

wherein the placement instrument is extended from a proximal end of the proximal segment to a distal end of the distal segment; and

wherein the first surface of the distal segment is positioned a greater distance from the proximal end than the second surface of the intermediate segment, as measured along the longitudinal axis.

17. The delivery device and implant assembly of claim 16, wherein the first implantable member further comprises a proximal side surface and an opposing distal side surface, the proximal side surface connecting the superior surface and the inferior surface of the first implantable member and configured to engage with a distal portion of the retention apparatus so as to be oriented toward the second implantable member.

18. The delivery device and implant assembly of claim 17, wherein the proximal side surface is further configured to receive the distal portion of the retention apparatus.

19. The delivery device and implant of claim 17, wherein the second implantable member further comprises a distal side surface, an opposing proximal side surface, the distal side surface of the second implantable member configured to, after the engagement of the second surface of the intermediate segment of the first prong with the second implantable member, face the proximal side surface of the first implantable member.

20. The delivery device and implant of claim 19, wherein the second surface of the intermediate segment is configured to engage with one of a first side surface or an opposing second side surface of the second implantable member, the first and opposing second side surfaces of the second implantable member each comprise a different surface than either the proximal side surface or the opposing distal side surface.

21. The delivery device and implant of claim 16, wherein the first implantable member further comprises a first side surface and an opposing second side surface, the first side surface connecting the superior surface and the inferior surface of the first implantable member, and configured to engage with the first surface of the distal segment.

22. The delivery device and implant of claim 16, wherein the second implantable member further comprises a second extension, the second extension comprising a second aperture that is configured to receive a second fastener, the second fastener sized to be at least partially advanced through the second aperture and into one of the superior vertebral bone or the inferior vertebral bone into which the first fastener is not advanced.

23. The delivery device and implant of claim 16, wherein a third aperture of the second implantable member is positioned between the first extension and the second extension.

24. The delivery device and implant of claim 23, wherein the second implantable member further comprises a locking feature, the locking feature configured to restrict unwanted retraction of each of the first and second fastener from a respective one of the superior vertebral bone or the inferior vertebral bone.

25. The delivery device and implant of claim 24, wherein the third aperture of the second implantable member is configured to receive at least a portion of the locking feature.

26. The delivery device and implant of claim 16, wherein the proximal segment further comprises a channel aligned with the longitudinal axis, the retention apparatus configured to be inserted through the channel in order to enable the engagement of the retention apparatus with the first implantable member.

27. The delivery device and implant of claim 26, wherein the retention apparatus is configured to rotate within the channel in order to enable the engagement of the retention apparatus with the first implantable member.

28. A device assembly configured to deliver a first implantable member and a second implantable member to a spinal segment, the spinal segment comprising a superior vertebral bone, an inferior vertebral bone and an intervertebral disc space disposed therebetween, the first implantable member comprising a superior surface configured to abut the superior vertebral bone and an inferior surface configured to abut the inferior vertebral bone, the second implantable member separately formed from the first implantable member and comprising a first side surface, a second opposing side surface, and at least one extension, the at least one extension comprising a first aperture configured to receive a fastener, the fastener sized to be at least partially advanced through the first aperture and into one of the superior vertebral bone and the inferior vertebral bone, the device assembly comprising:

a placement instrument configured to deliver the first implantable member and the second implantable member to the spinal segment, the placement instrument comprising;

a proximal segment comprising an elongate body extended along a longitudinal axis of the proximal segment, the elongate body comprising a channel aligned with the longitudinal axis;

a distal segment; and

an intermediate segment positioned at least partially between the proximal segment and the distal segment and comprising at least a first portion of a first extension element, the first portion of the first extension element configured to engage the first side surface of the second implantable member; and

a retention apparatus configured for use with the placement instrument, the retention apparatus comprising;

an elongate member configured to be aligned with the longitudinal axis of the proximal segment, and for insertion through the channel; and

a distal coupler, the distal coupler configured to threadedly engage the first implantable member.

29. The device assembly of claim 28, wherein the distal segment is configured to engage the first implantable member.

30. The device assembly of claim 29, wherein the distal segment comprises a second portion of the first extension element.

31. The device assembly of claim 28, wherein:

the first implantable member further comprises a proximal side surface and an opposing distal side surface, the proximal side surface connecting the superior surface and the inferior surface and configured to engage with a distal end of the retention apparatus so as to oriented toward the second implantable member; and

the distal end of the retention apparatus is configured to be received in the proximal side surface of the first implantable member.

32. The device assembly of claim 28, wherein the intermediate segment further comprises a first portion of a second extension element, the first portion of the second extension element configured to engage the second side surface of the second implantable member, the second side surface of the second implantable member opposing the first side surface.

33. A device assembly configured for use in treatment of a spinal segment, the spinal segment comprising a superior vertebral bone, an inferior vertebral bone and an intervertebral disc space positioned therebetween, the device assembly comprising:

a first implantable member, the first implantable member comprising a superior surface configured to abut the superior vertebral bone and an inferior surface configured to abut the inferior vertebral bone;

a second implantable member, the second implantable member independent of the first member and comprising at least one extension, the at least one extension comprising a first aperture configured to receive a fastener, the fastener sized to be at least partially advanced through the first aperture and into one of the superior vertebral bone or the inferior vertebral bone; and

a placement instrument configured to deliver the first and second implantable members to the spinal segment, the placement instrument extended from a proximal end to a distal end and comprising;

a proximal segment comprising an elongate member extended along a longitudinal axis;

a distal segment;

an intermediate segment positioned at least partially between the proximal segment and the distal segment and comprising at least a pair of extension elements configured to straddle at least a portion of the second implantable member; and

a retention apparatus comprising at least a distal portion configured to engage the first implantable member;

wherein the first implantable member and the second implantable member, when coupled to the placement instrument, are consecutively arranged along the longitudinal axis of the elongate member.

34. The device assembly of claim 33, wherein the distal segment comprises a distal coupler configured to engage the first implantable member.

35. The device assembly of claim 33, wherein the first implantable member further comprises a proximal side surface and an opposing distal side surface, the proximal side surface connecting the superior surface and the inferior surface and configured to (i) engage with the distal portion of the retention apparatus, and (ii), after then engagement with the distal portion of the retention apparatus, be positioned to face the second implantable member.

36. The device assembly of claim 35, wherein the proximal side surface is further configured to receive the distal end of the retention apparatus.

37. The device assembly of claim 33, wherein:

the proximal segment further comprises a channel aligned with the longitudinal axis; and

the retention apparatus is configured to be inserted through the channel in order to enable the engagement of the retention apparatus with the first implantable member.

38. The device assembly of claim 37, wherein the retention apparatus is configured to rotate within the channel.