Devices and methods for vertebral bone realignment

• US 10,548,740 B1
• Filed: 03/12/2018
• Issued: 02/04/2020
• Est. Priority Date: 10/25/2016
• Status: Active Grant

• Current Assignee: Samy Abdou Md
• Original Assignee: Samy Abdou Md
• Inventors: Abdou, Samy
• Primary Examiner(s): Summitt, Lynnsy M
• Assistant Examiner(s): Carter, Tara Rose E
• Application Number:
  US15/919,099
• Time in Patent Office: 694 Days
• CPC Class Codes: A61F 2/4425 made of articulated components
• 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 2/447 substantially parallelepipedal, e.g. having a rectangular or trapezoidal cross-section
• CPC Class Codes: A61F 2/4611 of spinal prostheses

Abstract

Methods and apparatus for providing correction of one or more maladies or conditions of the spinal column of a living being. In one embodiment, the apparatus includes an implantable device configured to be selectively adjustable in one or more portions thereof so as to permit correction of asymmetries or irregularities of the spinal column via insertion into one or more affected intervertebral disc spaces. In one variant, the implantable device includes upper and lower host elements which are hinged or can pivot relative to one another, and an insertable distraction mechanism which is adjustable to enable one side or the other of the implantable device to alter height. In another variant, both sides of the implantable device can be adjusted for height via the host elements and one or more pivots or hinges. In one implementation, the distraction mechanism is adjustable from multiple approaches into the disc space.

Claims

1. An implantable device configured for implantation within an intervertebral disc space, the intervertebral disc space disposed between a superior vertebral bone and an inferior vertebral bone, the implantable device comprising:

a first member, the first member comprising;

a first top surface configured to at least partially abut the superior vertebral bone;

a first bottom surface movably coupled to the first top surface, the first bottom surface configured to at least partially abut the inferior vertebral bone;

a first side surface;

a second side surface opposing the first side surface;

a receiving segment configured to reversibly couple with at least a segment of a second member, the second member comprising at least a second top surface, a second bottom surface, and an intervening distraction mechanism at least partially disposed between the second top surface and the second bottom surface, the at least segment of the second member comprising at least a segment of one of the second top surface or the second bottom surface, the distraction mechanism of the second member configured to be selectively actuatable to increase of a first distance between the second top surface and the second bottom surface of the second member, and thereby cause increase of a second distance between at least a portion of the first top surface and the first bottom surface; and

a selectively actuatable locking mechanism, the selectively actuatable locking mechanism (i) being a separate structure relative to the second member, and (ii) being configured to immobilize the first top surface relative to the first bottom surface after actuation of the distraction mechanism;

wherein the receiving segment of the first member is further configured to, after actuation of the locking mechanism and immobilization of the first top surface relative to the first bottom surface, (i) uncouple from the at least segment of one of the second top surface or the second bottom surface, and (ii) enable removal of the second top surface and the second bottom surface of the second member from the first member while the first top surface remains immobilized relative to the first bottom surface.

2. The implantable device of claim 1, wherein the first member further comprises a hinge segment disposed at the second side surface;

and

wherein the actuation of the distraction mechanism of the second member is further configured to cause at least partial rotation of the first top surface relative to the first bottom surface around an axis of the hinge segment.

3. The implantable device of claim 1, wherein the receiving segment at least in part comprises an aperture in at least one of the first top surface and the first bottom surface of the first member, the aperture configured to receive the at least segment of one of the second top surface or the second bottom surface of the second member, the received at least segment of the one of the second top surface or the second bottom surface of the second member configured to (i) extend through the aperture, and (ii) abut a segment of one of the superior vertebral bone or the inferior vertebral bone.

4. The implantable device of claim 1, wherein the receiving segment is configured to receive the second member at least partially within the first member, such that the second member is disposed at least partially between the first top surface and the first bottom surface.

5. The implantable device of claim 1, wherein the first top surface of the first member is configured to rotate relative to the first bottom surface, the first member configured to assume a wedge-shaped configuration after the actuation of the distraction mechanism of the second member.

6. A device assembly configured for at least a portion thereof to be at least partially within an intervertebral disc space of a spinal column, the device assembly comprising:

a first member comprising;

a first top element;

a first bottom element movably coupled to the first top element; and

a first distraction mechanism that is configured to be actuated; and

a second member, the second member configured to (i) at least partially receive the first member, and (ii) be separable from the first member, the second member comprising;

a second top element;

a second bottom element movably coupled to the second top element;

a coupling that is configured to reversibly couple with the first member;

wherein the first member is configured such that, when the coupling of the second member is uncoupled from the first member, actuation of the first distraction mechanism is configured to cause an increase of a first distance between at least a portion of the first top element and the first bottom element of the first member;

wherein the first member and the second member are configured such that, when the first member is coupled to the coupling of the second member, the actuation of the first distraction mechanism is configured to cause increase in a second distance between at least a portion of the second top element and the second bottom element of the second member; and

wherein at least a segment of one of the first top element or the first bottom element comprises a surface having one or more projections configured to abut and fixate onto a segment of a vertebral bone adjacent to the intervertebral disc space.

7. The device assembly of claim 6, wherein the coupling is at least partially disposed between the second top element and the second bottom element of the second member.

8. The device assembly of claim 6, wherein at least one of the second top element and the second bottom element of the second member comprises an aperture configured to receive the at least segment of one of the first top element or the first bottom element of the first member, the at least segment of one of the first top element or the first bottom element configured to extend through the aperture in order to abut the segment of the vertebral bone.

9. The device assembly of claim 6, wherein the second member further comprises a multi-position locking mechanism configured to immobilize the second top element relative to the second bottom element of the second member, the multi-position locking mechanism being a separate structure relative to the first member.

10. The device assembly of claim 9, wherein:

the first member is configured to reversibly uncouple from the coupling of the second member after (i) locking of the multi-position locking mechanism of the second member, and (ii) immobilization of the second top element relative to the second bottom element;

the first member is sized for removal from the intervertebral disc space after uncoupling from the coupling of the second member; and

the first bottom element of the first member comprises a rigid first bottom surface.

11. The device assembly of claim 6, wherein the second top element of the second member is configured to rotate relative to the second bottom element of the second member, the second member further configured to have a wedge-shaped configuration after actuation of the distraction mechanism of the first member when the first member is coupled to the coupling of the second member.

12. A kit for treatment of a spinal segment, the spinal segment comprising at least a superior vertebral bone, an inferior vertebral bone, and an intervertebral disc space disposed between the superior vertebral bone and the inferior vertebral bone, the kit comprising:

a distraction module, the distraction module comprising a first top side, a first bottom side opposing the first top side and movably coupled to the first top side, and a distraction mechanism, the distraction mechanism configured to (i) distract the first top side away from the first bottom side, and (ii) retain the first top side and the first bottom side in a distracted configuration;

at least one housing module, the at least one housing module configured for at least partial implantation into the intervertebral disc space, the at least one housing module comprising a second top side, a second bottom side opposing the second top side and movably coupled to the second top side, and a coupler, the coupler configured to reversibly couple with at least a segment of the distraction module; and

a non-implantable driver, the non-implantable driver configured to (i) at least partially couple with the distraction module, and (ii) actuate the distraction mechanism;

wherein the distraction module, when the at least segment of the distraction module is coupled to the coupler of the at least one housing module, is configured to form an assembly with the at least one housing module;

wherein the non-implantable driver is configured to actuate the distraction module in the assembly to produce concurrent (i) distraction of the first top side away from the first bottom side, and (ii) distraction of the second top side away from the second bottom side; and

wherein the at least one housing module is configured such that the non-implantable driver is incapable of producing distraction of the second top side away from the second bottom side when the at least segment of the distraction module is uncoupled from the at least one housing module.

13. The kit of claim 12, wherein the distraction module comprises unitary device.

14. The kit of claim 12, wherein the at least one housing module comprises two or more housing modules, the two or more housing modules each configured to differ from another of the two or more housing modules in at least one dimension thereof.

15. The kit of claim 14, wherein the at least segment of the distraction module is configured to be received in each of the two more housing modules.

16. The kit of claim 12, wherein the at least one housing module is configured to receive at least one other distraction module.

17. The kit of claim 12, wherein the at least one housing module further comprises a locking feature, the locking feature comprising a separate structure from the distraction mechanism.

18. The kit of claim 17, wherein:

the at least segment of the distraction module is configured to be uncoupled from coupler of the at least one housing module after distraction of the second top side away from the second bottom side into a distracted position; and

the locking feature is configured to retain the second top side and the second bottom side in the distracted position after the at least segment of the distraction module is uncoupled from the coupler of the at least one housing module.

19. The kit of claim 18, wherein the coupler of the at least one housing module is configured for removal of the at least segment of the distraction module after positing the assembly within the intervertebral disc space.

20. The kit of claim 12, wherein the at least one housing module is devoid of a distraction mechanism that is independent of the distraction module.

21. The kit of claim 12, further comprising one or more other non-implantable drivers.

22. The kit of claim 12, further comprising one or more other distraction modules.

23. The kit of claim 22, wherein the distraction module comprises a first distraction module and the one or more other distraction modules comprise at least a second distraction module, the first distraction module configured to produce a first maximum distraction distance between the first top side and the first bottom side, the second distraction module configured to produce a second maximum distraction distance between the first top side and the first bottom side, the first maximum distraction distance being greater than the second maximum distraction distance.

24. The kit of claim 12, wherein:

the at least one housing module further comprises a front side and a back side opposing the front side; and

the at least one housing module is configured such that actuation of the distraction module produces a greater change in a height of the front side than in a height of the back side.

25. A kit for treatment of a spinal segment, the spinal segment comprising at least a superior vertebral bone, an inferior vertebral bone and an intervertebral disc space disposed between the superior vertebral bone and the inferior vertebral bone, the kit comprising:

a distraction module comprising a first top side, a first bottom side opposing the first top side and movable relative to the first top side, a distraction mechanism, an actuation member configured to actuate the distraction mechanism, the distraction mechanism, upon the actuation thereof, configured to;

(i) distract the first top side away from the first bottom side, and (ii) retain the first top side and the first bottom side in a distracted configuration;

at least one housing module comprising a second top side, a second bottom side opposing the second top side and movable relative to the second top side, and a coupler configured to reversibly seat at least a segment of the distraction module, the at least one housing module configured for at least partial implantation into the intervertebral disc space; and

a non-implantable driver configured to couple with the actuation member of the distraction module in order to cause the actuation member to actuate the distraction mechanism;

wherein, when the at least segment of the distraction module is seated in the coupler of the at least one housing module, the distraction mechanism, upon the actuation thereof, is further configured to cause the distraction of the first top side away from the first bottom side as well as concurrent distraction of the second top side away from the second bottom side; and

wherein the distraction module and the at least one housing module are configured to form an assembly when the at least one segment of the distraction module is seated in the coupler of the at least one housing module.

26. The kit of claim 25, wherein the non-implantable driver and the at least one housing module are configured such that the non-implantable driver is incapable of causing distraction of the second top side away from the opposing second bottom side when the at least one segment of the distraction module is unseated from the coupler of the at least one housing module.

27. The kit of claim 25, wherein the at least one housing module further comprises a locking feature, the locking feature comprising a separate structure from the distraction module.

28. The kit of claim 27, wherein:

the at least segment of the distraction module is configured to be uncoupled from coupler of the at least one housing module after distraction of the second top side away from the second bottom side into a distracted position; and

the locking feature is configured to retain the second top side and the second bottom side in the distracted position after the at least segment of the distraction module is uncoupled from the coupler of the at least one housing module.

29. The kit of claim 25, wherein the at least one housing module is devoid of an additional distraction mechanism that is independent of the distraction module.