IP Library › Granted Patent US 12,144,742
Granted Patent B2
US 12,144,742 · App. 18/328,876 · Granted Nov 19, 2024

Implant system and methods of use

Inventors: Randal R. Betz (Bradenton, FL); Dale E. Whipple (Nashua, NH); Charlie Barfield (Hernando, MS); Dimitri K. Protopsaltis (Memphis, TN); Michael Sherman (Memphis, TN); Marc Burel (Perkasie, PA)
Assignee: FOUNDATION SURGICAL GROUP, INC.
A61F2/4425A61F2002/30405A61F2002/443
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Quick Facts
Patent No.
US 12,144,742
App. No.
18/328,876
Granted
Nov 19, 2024
Kind
B2
Abstract

An implant system comprising a staple and a cage is disclosed. The implant system is secured to the bone by moving the staple rotationally and longitudinally whereby tines of the staple and opposing tines frictionally and mechanically engage or embed themselves in the bone side walls. For vertebral applications, the cage defines an upper surface plane, a lower surface plane and a cage surface angle between these two planes whereby the cage surface angle may alter an endplate surface plane of one or more vertebral body when the cage is implanted in a vertebral body. Implant systems may be configured for use as an interbody or intrabody implant system. The implant system may also be configured for use in arthrodesis procedures with other joints within the body. The implant system may further comprise an anchor frame or plate to further secure the cage and staple to the anatomy.

Claims (118)

1. An orthopedic implant device configured to be implanted across a vertebral body of a vertebrae, the orthopedic implant device comprising:

a cage;

an anchor frame pivotally coupled to the cage;

a staple comprising a staple head and a staple shaft;

the staple shaft configured to rotate the staple head from an extended position extended from the cage to a deployed position;

the staple shaft configured to rotate relative to the cage about a shaft longitudinal axis;

the anchor frame configured to pivot about an axis that is a different axis than the shaft longitudinal axis;

wherein the orthopedic implant device is configured to be implanted across the vertebral body of the vertebrae;

the cage further comprising at least one cage stop;

the at least one cage stop comprises a radially grooved surface;

the staple shaft having an engagement portion configured to mate with an engagement tool whereby when the engagement tool is rotated, the staple shaft is rotated;

the staple shaft coupled to a key;

the key comprising a radially grooved washer shaped to be coupled to and mate with the engagement portion of the staple shaft; and

the radially grooved washer having a radially grooved surface configured to mesh with the radially grooved surface of the at least one cage stop whereby when the staple head is retracted to a stabilized position, the staple shaft is rotationally locked in a radial position relative to the cage.

2. The orthopedic implant device of claim 1 wherein:

a longitudinal axis of the cage is configured to extend laterally across the vertebral body of the vertebrae; and

the orthopedic implant device is configured to be implanted from a lateral direction relative to the vertebral body and the staple head is configured to secure the orthopedic implant device to a distal lateral sidewall of the vertebral body.

3. The orthopedic implant device of claim 1 wherein:

the orthopedic implant device is configured to be implanted from one of an anterior or an oblique direction relative to the vertebral body and the staple head is configured to secure the orthopedic implant device to a distal lateral sidewall of the vertebral body.

4. The orthopedic implant device of claim 1 wherein:

the staple shaft is received in a through bore of the cage; and

the through bore of the cage extends along a longitudinal axis of the cage from a first lateral side of the cage to a second lateral side of the cage.

5. The orthopedic implant device of claim 1 wherein:

the extended position comprises a neutral alignment of the staple head and an extended location of the staple head extended a distance away from the cage; and

the deployed position comprises a non-neutral alignment of the staple head and the extended location of the staple head away from the cage.

6. The orthopedic implant device of claim 1 wherein the staple shaft is further configured to move the staple head from an insertion position to the extended position.

7. The orthopedic implant device of claim 6 wherein:

the insertion position comprises a neutral alignment of the staple head and a non-extended location relative to the cage; and

the extended position comprises the neutral alignment of the staple head and an extended location of the staple head away from the cage.

8. The orthopedic implant device of claim 1 wherein the staple shaft is further configured to move the staple head from the deployed position to the stabilized position.

9. The orthopedic implant device of claim 8 wherein:

the deployed position comprises a non-neutral alignment of the staple head and an extended location of the staple head away from the cage; and

the stabilized position comprises the non-neutral alignment of the staple head and a retracted location of the staple head retracted towards the cage.

10. The orthopedic implant device of claim 1 wherein:

the staple shaft is received in a through bore of the cage; and

the staple shaft is rotatable within the through bore of the cage whereby the staple shaft is configured to move the staple head from the extended position to the deployed position relative to the cage.

11. The orthopedic implant device of claim 1 wherein:

the staple shaft is received in a through bore of the cage; and

the staple shaft is longitudinally slidable within the through bore of the cage whereby the staple shaft is configured to slidably move the staple head from an insertion position to the extended position extended away from the cage.

12. The orthopedic implant device of claim 1 wherein:

the staple shaft is received in a through bore of the cage; and

the staple shaft is longitudinally slidable within the through bore of the cage whereby the staple shaft is configured to slidably move the staple head from the deployed position to the stabilized position retracted towards the cage.

13. The orthopedic implant device of claim 1 wherein the orthopedic implant device further comprises a threaded nut.

14. The orthopedic implant device of claim 13 wherein:

the staple shaft having a threaded portion; and

the threaded nut configured to mate with the threaded portion of the staple shaft whereby when the threaded nut is rotated, the threaded nut engages the threaded portion of the staple shaft and the staple head is moved away from the cage.

15. The orthopedic implant device of claim 13 wherein:

the staple shaft having a threaded portion; and

the threaded nut configured to mate with the threaded portion of the staple shaft whereby when the threaded nut is rotated, the threaded nut engages the threaded portion of the staple shaft and the staple head is retracted towards the cage.

16. The orthopedic implant device of claim 13 wherein:

the staple shaft having a threaded portion;

the engagement portion of the staple shaft configured to be engaged by a shaft engagement portion of the engagement tool whereby the shaft engagement portion of the engagement tool is configured to rotate the staple shaft and move the staple head from the extended position to the deployed position;

the threaded nut configured to be engaged by a nut engagement portion of the engagement tool to rotate the threaded nut;

the threaded nut is configured to mate with the threaded portion of the staple shaft whereby when the threaded nut is rotated in a first direction, the threaded nut engages the threaded portion of the staple shaft and the staple head is extended away from the cage; and

the threaded nut is configured to mate with the threaded portion of the staple shaft whereby when the threaded nut is rotated in a second direction, the threaded nut engages the threaded portion of the staple shaft and the staple head is retracted towards the cage.

17. The orthopedic implant device of claim 13 wherein the threaded nut is received in a retaining channel of the cage whereby a longitudinal position of the threaded nut relative to the cage is constrained by the retaining channel.

18. The orthopedic implant device of claim 1 wherein the anchor frame pivots about the axis which is about ninety degrees to the shaft longitudinal axis.

19. The orthopedic implant device of claim 1 wherein the anchor frame pivots about the axis which is about ninety degrees to a longitudinal axis of the cage.

20. The orthopedic implant device of claim 1 wherein:

the radially grooved washer has a through hole shaped to be coupled to and mate with the engagement portion of the staple shaft.

21. The orthopedic implant device of claim 1 configured to alter an endplate surface plane of the vertebral body.

22. The orthopedic implant device of claim 1 wherein:

the staple shaft is received in a through bore of the cage;

the through bore of the cage extends from a first lateral side of the cage to a second lateral side of the cage;

the staple shaft is rotatable within the through bore of the cage whereby the staple shaft is configured to move the staple head from the extended position to the deployed position relative to the cage;

the staple shaft is longitudinally slidable within the through bore of the cage whereby the staple shaft is configured to slidably move the staple head from an insertion position to the extended position away from the cage;

the staple shaft is longitudinally slidable within the through bore of the cage whereby the staple shaft is configured to slidably move the staple head from the deployed position to the stabilized position when retracted towards the cage;

the orthopedic implant device further comprises a threaded nut configured to mate with a threaded portion of the staple shaft whereby when the threaded nut is rotated, the threaded nut engages the threaded portion of the staple shaft and the staple head is moved away from the cage;

and

the anchor frame further comprises at least one pivot connection configured to pivotally couple the anchor frame to the cage.

23. An orthopedic implant device configured to extend laterally across a vertebral body, the orthopedic implant device comprising:

a cage;

an anchor frame;

a staple;

the anchor frame pivotally coupled to the cage;

the anchor frame, the staple and the cage operably coupled;

whereby the anchor frame and the staple are configured to be secured to opposite lateral sidewalls of the vertebral body;

the staple configured to rotate relative to the cage about a staple rotation axis;

the anchor frame configured to pivot about an axis that is a different axis than the staple rotation axis;

whereby the cage is configured to be secured to extend laterally across the vertebral body;

the cage further comprising at least one cage stop;

the at least one cage stop comprises a radially grooved surface;

the staple comprising a staple shaft having an engagement portion configured to mate with an engagement tool whereby when the engagement tool is rotated, the staple shaft is rotated;

the staple shaft coupled to a key;

the key comprising a radially grooved washer shape to be coupled to and mate with the engagement portion of the staple shaft; and

the radially grooved washer having a radially grooved surface configured to mesh with the radially grooved surface of the at least one cage stop whereby when the staple is retracted to a stabilized position, the staple shaft is rotationally locked in a radial position relative to the cage.

24. The orthopedic implant device of claim 23 wherein:

the staple comprises a staple head and the staple shaft;

the cage comprises a through bore extending longitudinally through the cage; and

the staple shaft received in the through bore of the cage to operably couple the cage and the staple.

25. The orthopedic implant device of claim 23 wherein:

the staple comprises a staple head and the staple shaft;

the orthopedic implant device further comprises a coupling element; and

the coupling element configured to engage the staple shaft and operably couple the staple to the cage whereby the coupling element adjusts a positional relationship of the staple head and the anchor frame whereby the staple head and the anchor frame are configured to be secured to the opposite lateral sidewalls of the vertebral body by a compression force.

26. The orthopedic implant device of claim 25 wherein:

the coupling element comprises a threaded nut configured to engage a threaded portion of the staple shaft whereby the coupling element adjusts the positional relationship of the staple head and the anchor frame.

27. A method to secure a first bone portion to a second bone portion, the method comprising:

providing an orthopedic implant device comprising:

a cage,

a staple,

an anchor frame,

the cage coupled to the staple,

the anchor frame pivotally coupled to the cage about a pivot axis,

the staple comprising a staple head and a staple shaft,

the staple shaft configured to rotate the staple head from an extended position extended from the cage to a deployed position,

the staple shaft configured to rotate relative to the cage about a shaft longitudinal axis,

the anchor frame configured to pivot about the pivot axis that is a different axis than the shaft longitudinal axis,

wherein the orthopedic implant device is configured to be implanted across the first bone portion and the second bone portion,

the cage further comprising at least one cage stop,

the at least one cage stop comprises a radially grooved surface,

the staple shaft having an engagement portion configured to mate with an engagement tool whereby when the engagement tool is rotated, the staple shaft is rotated,

the staple shaft coupled to a key,

the key comprising a radially grooved washer shaped to be coupled to and mate with the engagement portion of the staple shaft, and

the radially grooved washer having a radially grooved surface configured to mesh with the radially grooved surface of the at least one cage stop whereby when the staple head is retracted to a stabilized position, the staple shaft is rotationally locked in a radial position relative to the cage;

inserting the cage and the staple into an opening between the first bone portion and the second bone portion;

positioning the staple head in the deployed position by rotating the staple head about the shaft longitudinal axis; and

securing the anchor frame to the first bone portion and the second bone portion by retracting the staple head towards the cage and/or the anchor frame.

28. The method of claim 27 further comprising positioning the staple head in the stabilized position to secure the staple to the first bone portion and the second bone portion whereby the staple further secures the cage to the first and the second bone portions.

Assignments (3)
CHANGE OF NAME Recorded Aug 4, 2023
From: NOFUSCO CORPORATION
To: FOUNDATION SURGICAL GROUP, INC.
Reel/Frame 064502/0748 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 23, 2023
From: BARFIELD, CHARLIE; PROTOPSALTIS, DIMITRI K.; SHERMAN, MICHAEL
To: MB INNOVATIONS, INC.
Reel/Frame 064348/0823 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 17, 2023
From: MB INNOVATIONS, INC.; BETZ, RANDAL R.; WHIPPLE, DALE E.; BUREL, MARC
To: NOFUSCO CORPORATION
Reel/Frame 064281/0470 →
Continuity (11)
Continuation In Part 18051732 · Nov 1, 2022
Continuation In Part 17676609 · Feb 21, 2022
Continuation 17347492 · Jun 14, 2021
Continuation In Part 17934874 · Sep 23, 2022
Continuation In Part 17676609 · Feb 21, 2022
Provisional Application 63478620 · Jan 5, 2023
Provisional Application 63369330 · Jul 25, 2022
Provisional Application 63039242 · Jun 15, 2020
Provisional Application 63349136 · Jun 5, 2022
Provisional Application 63247345 · Sep 23, 2021
Related Publication 20230310169A1 · Oct 5, 2023
Cited By (1)
US 12,491,078