IP Library Granted Patent US 11,045,327
Granted Patent B2
US 11,045,327 · App. 16/401,852 · Granted Jun 29, 2021

Adjustable interbody fusion devices and methods of use

Inventors: Ross R. Nichols (North Webster, IN); Daniel Refai (Atlanta, GA); Brian G. Emerick (Columbia City, IN); Heidi Stamets (Monroeville, IN)
Assignee: BIOSPINE, LLC
A61F2/4455A61F2/30767A61F2/442A61F2/447A61F2/4425A61F2/4611A61F2002/2835A61F2002/3039A61F2002/30064A61F2002/3084A61F2002/3093A61F2002/30266A61F2002/30383A61F2002/30433A61F2002/30495A61F2002/30525A61F2002/30538A61F2002/30556A61F2002/30593A61F2002/30601A61F2002/30624A61F2002/30632A61F2002/30828A61F2002/4628A61F2002/4629
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Quick Facts
Patent No.
US 11,045,327
App. No.
16/401,852
Granted
Jun 29, 2021
Kind
B2
Abstract

Interbody fusion devices, insertion tools, methods for assembling an interbody fusion device, and methods for inserting a medical device between two vertebral bodies are disclosed. The interbody fusion device includes a base member, a top member, and at least one movement mechanism. The base member includes at least one of a pivotal cylinder and a hinge channel. The top member includes at least one of a pivot cylinder and a hinge channel. The at least one pivot cylinder of the base member engages the at least one hinge channel of the top member and the at least one pivot cylinder of the top member engages the at least one hinge channel of the base member. The at least one movement mechanism engages the top member and the base member. Also disclosed are a vertebral spacer device and an interbody spacer system including an insertion tool and an interbody fusion device.

Claims (61)

1. An interbody system, comprising:

a device tool, comprising:

a handle;

a device end;

a housing connecting the handle and the device end;

a securement mechanism coupled to the handle, extending through the housing and protruding from the device end;

at least one adjustment mechanism coupled to the handle, extending through the housing and protruding from the device end;

a first knob for actuating the securement mechanism; and

at least one second knob for actuating the at least one adjustment mechanism; and

an interbody device, comprising:

a first member comprising an interior surface, an outer surface configured to engage a first vertebral body;

a second member pivotably coupled with the first member by a hinge, the second member comprising an interior surface, an outer surface configured to engage a second vertebral body, a tool attachment opening for receiving the securement mechanism of the device tool, and at least one adjustment opening adjacent the tool attachment opening configured to receive the at least one adjustment mechanism; and

at least one movement mechanism extending between the interior surfaces of the first and second members configured to selectively adjust the relative orientation of the first and second members,

wherein the at least one adjustment mechanism of the device tool is configured to actuate the at least one movement mechanism of the interbody device by operation of the at least one second knob when the at least one adjustment mechanism is positioned within the at least one adjustment opening and operatively coupled with the at least one movement mechanism; and

wherein the at least one movement mechanism is configured such that actuation of the at least one movement mechanism by the at least one adjustment mechanism by operation of the at least one second knob adjusts a height of the at least one movement mechanism.

2. The system of claim 1 , wherein the second member further comprises an alignment opening, and wherein the device tool further comprises an alignment protrusion extending from the device end, the alignment protrusion being configured to mate within the alignment opening.

3. The system of claim 2 , wherein the alignment opening and the alignment protrusion define corresponding non-circular cross-sectional shapes.

4. The system of claim 2 , wherein the tool attachment opening extends from the alignment opening, and wherein securement mechanism extends through and from the alignment protrusion.

5. The system of claim 4 , wherein the tool attachment opening comprises internal threads, and the securement mechanism comprises external threads configured to threadably engage with the internal threads of the tool attachment opening by operation of the first knob when the alignment protrusion is mated within the alignment opening to selectively secure the interbody device to the device end of the device tool.

6. The system of claim 1 , wherein the tool attachment opening comprises internal threads, and the securement mechanism comprises external threads configured to threadably engage with the internal threads of the tool attachment opening by operation of the first knob to selectively secure the interbody device to the device end of the device tool.

7. The interbody system of claim 1 , wherein the at least one adjustment mechanism of the device tool comprises two adjustment mechanisms actuated by the at least one second knob.

8. The interbody system of claim 7 , wherein the securement mechanism is positioned between the two adjustment mechanisms at the device end of the device tool.

9. The interbody system of claim 7 , wherein the at least one adjustment opening of the second member of the interbody device comprises two adjustment openings, and the at least one movement mechanism comprises two movement mechanisms, and wherein a first adjustment mechanism of the two adjustment mechanisms is configured to actuate a first movement mechanism of the two movement mechanisms by operation of the at least one second knob when the first adjustment mechanism is positioned within a first adjustment opening of the two adjustment openings and operatively coupled with the first movement mechanism, and a second adjustment mechanism of the two adjustment mechanisms is configured to actuate a second movement mechanism of the two movement mechanisms by operation of the at least one second knob when the second adjustment mechanism is positioned within a second adjustment opening of the two adjustment openings and operatively coupled with the second movement mechanism.

10. The interbody system of claim 9 , wherein the at least one second knob comprises a singular second knob.

11. The interbody system of claim 1 , wherein the hinge comprises at least one of a pivot cylinder and a hinge channel of the first member and at least one of a pivot cylinder and a hinge channel of the second member, wherein the at least one pivot cylinder or hinge channel of the first member engages the at least one hinge channel or pivot cylinder, respectively, of the second member.

12. The interbody system of claim 1 , wherein the at least one second knob is positioned at a distal end of the handle that is distal to the housing, and the first knob is positioned at a proximal end of the handle that is proximal to the housing.

13. The interbody system of claim 1 , wherein the housing defines at least one tube through which the securement mechanism and the at least one adjustment mechanism extend, and wherein the at least one tube comprises a first tube through which the securement mechanism extends and at least one second tube through which the at least one adjustment mechanism extends.

14. The interbody system of claim 1 , wherein the tool attachment opening and the at least one adjustment opening are positioned in a lateral side of the second member that extends between the outer and interior surfaces thereof.

15. The interbody system of claim 1 , wherein the at least one movement mechanism comprises at least one expansion assembly and at least one drive rod that adjusts the height of the at least one expansion assembly by rotation thereof, the at least one drive rod comprising a drive head aligned with the at least one adjustment opening of the second member and configured to mate with the at least one adjustment mechanism such that operation of the at least one second knob rotates the at least one adjustment mechanism and the at least one drive rod.

16. The interbody system of claim 15 , wherein the at least one expansion assembly comprises a gear, a threaded rod engaged with the gear, and a load head engaged with the threaded rod, wherein the gear comprises a plurality of depressions in an exterior surface thereof and a plurality of threads on an interior surface, wherein the threaded rod comprises a plurality of threads on an exterior surface thereof that engage the plurality of threads on the interior surface of the gear and a pivot projection on a superior end, and wherein the load head comprises a top surface that engages the interior surface of the first member and a channel positioned on a bottom surface thereof that receives the pivot projection of the threaded rod therein and prevents rotation of the threaded rod.

17. The interbody system of claim 16 , wherein the at least one drive rod comprises external threads that engage the plurality of depressions of the gear of the at least one expansion assembly such that rotation of the at least one drive rod rotates the gear and, thereby, translates the threaded rod with respect to the gear.

18. The interbody system of claim 15 , wherein the at least one movement mechanism comprises two expansion assemblies and at least one drive rod that adjusts the total height of the two expansion assembles via assemblies by rotation thereof.

19. An interbody system, comprising:

a device tool, comprising:

a handle;

a device end;

a housing connecting the handle and the device end;

a securement mechanism coupled to the handle, extending through the housing and protruding from the device end;

at least one adjustment mechanism coupled to the handle, extending through the housing and protruding from the device end;

a first knob for actuating the securement mechanism; and

at least one second knob for actuating the at least one adjustment mechanism; and

an interbody device, comprising:

a first member comprising an interior surface, an outer surface configured to engage a first vertebral body;

a second member pivotably coupled with the first member by a hinge, the second member comprising an interior surface, an outer surface configured to engage a second vertebral body, a tool attachment opening for receiving the securement mechanism of the device tool, and at least one adjustment opening adjacent the tool attachment opening configured to receive the at least one adjustment mechanism; and

at least one movement mechanism extending between the interior surfaces of the first and second members configured to selectively adjust the relative orientation of the first and second members,

wherein the at least one adjustment mechanism of the device tool is configured to actuate the at least one movement mechanism of the interbody device by operation of the at least one second knob when the at least one adjustment mechanism is positioned within the at least one adjustment opening and operatively coupled with the at least one movement mechanism, and wherein the at least one adjustment mechanism of the device tool comprises two adjustment mechanisms actuated by the at least one second knob.

20. An interbody system, comprising:

a device tool, comprising:

a handle;

a device end;

a housing connecting the handle and the device end;

a securement mechanism coupled to the handle, extending through the housing and protruding from the device end;

at least one adjustment mechanism coupled to the handle, extending through the housing and protruding from the device end;

a first knob for actuating the securement mechanism; and

at least one second knob for actuating the at least one adjustment mechanism; and

an interbody device, comprising:

a first member comprising an interior surface, an outer surface configured to engage a first vertebral body;

a second member pivotably coupled with the first member by a hinge, the second member comprising an interior surface, an outer surface configured to engage a second vertebral body, a tool attachment opening for receiving the securement mechanism of the device tool, and at least one adjustment opening adjacent the tool attachment opening configured to receive the at least one adjustment mechanism; and

at least one movement mechanism extending between the interior surfaces of the first and second members configured to selectively adjust the relative orientation of the first and second members,

wherein the at least one adjustment mechanism of the device tool is configured to actuate the at least one movement mechanism of the interbody device by operation of the at least one second knob when the at least one adjustment mechanism is positioned within the at least one adjustment opening and operatively coupled with the at least one movement mechanism; and

wherein the housing defines at least one tube through which the securement mechanism and the at least one adjustment mechanism extend, and wherein the at least one tube is a first tube through which the securement mechanism extends and at least one second tube through which the at least one adjustment mechanism extends.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 12, 2024
From: BIOSPINE, LLC
To: EMERICK, BRIAN G.; REFAI, DANIEL
Reel/Frame 069567/0324 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 23, 2019
From: NICHOLS, ROSS R.; REFAI, DANIEL; EMERICK, BRIAN G.; STAMETS, HEIDI
To: BIOSPINE, LLC.
Reel/Frame 049268/0902 →
Continuity (4)
Continuation 15991460 · May 29, 2018
Continuation 14890837
Provisional Application 61822620 · May 13, 2013
Related Publication 20190254839A1 · Aug 22, 2019
Cited By (11)
US 12,239,544 US 12,295,865 US 12,318,308 US 12,364,529 US 12,414,863 US 12,440,349 US 12,485,019 US 12,521,252 US 12,533,241 US 12,544,236 US 12,635,998