Granted Patent B2

US 12,226,320 · App. 18/167,462 · Granted Feb 18, 2025

Inventors: Christian Karl Schultz (Hoboken, NJ); Bryan D. Milz (Florida, NY); Zinoviy Sosnov (Fair Lawn, NJ)

Assignee: K2M, INC.

A61F2/447A61B17/1757A61F2/30749A61F2/442A61F2/4611B60R19/023A61F2002/3049A61F2002/30593A61F2002/30784A61F2310/00023

Abstract

Claims (82)

1. A spine implant for an ALIF procedure, the spine implant comprising:

a cage having an anterior surface and a posterior surface, the cage defining:

a first angled bore in a first lateral side of the anterior surface, the first angled bore extending from proximate a first surface to and through a second surface;

a second angled bore in a second lateral side of the anterior surface, the second angled bore extending from proximate the first surface to and through the second surface;

a third angled bore between the first angled bore and the second angled bore, the third angled bore extending from proximate the second surface to and through the first surface;

a first opening disposed between the first angled bore and the third angled bore; and

a second opening disposed between the second angled bore and the third angled bore;

wherein each of the first angled bore, the second angled bore, and the third angled bore is sized and configured to receive a respective fastener in a manner to direct a tip of each respective fastener into an adjacent vertebral body;

wherein the first opening is sized and configured to receive a first locking element, and

wherein the second opening is sized and configured to receive a second locking element.

2. The spine implant of claim 1 , further comprising:

a first fastener including a first head and a first shaft extending from the first head that terminates at a first tip, the first shaft sized and configured to be received in the first angled bore;

a second fastener including a second head and a second shaft extending from the second head that terminates at a second tip, the second shaft sized and configured to be received in the second angled bore; and

a third fastener including a third head and a third shaft extending from the third head that terminates at a third tip, the third shaft sized and configured to be received in the third angled bore.

3. The spine implant of claim 2 , further comprising the first locking element and the second locking element.

4. The spine implant of claim 3 , wherein:

the first locking element is configured to engage the first head of the first fastener and the third head of the third fastener when the first shaft is received within the first angled bore and the third shaft is received in the third angled bore; and

the second locking element is configured to engage the second head of the second fastener and the third head of the third fastener when the second shaft is received within the second angled bore and the third shaft is received in the third angled bore.

5. The spine implant of claim 4 , wherein the first locking element is configured to rotate when disposed in the first opening, and wherein the second locking element is configured to rotate when disposed in the second opening.

6. The spine implant of claim 5 , wherein the cage includes titanium.

7. The spine implant of claim 5 , wherein at least one of the first angled bore, the second angled bore, and the third angled bore is sized and configured to receive an arm of an insertion tool.

8. The spine implant of claim 5 , wherein:

the first locking element includes a first oblong head having a diameter that is greater than a diameter of a shaft extending from the first oblong head, and

the second locking element includes a second oblong head having a diameter that is greater than a diameter of a shaft extending from the second oblong head.

9. The spine implant of claim 8 , wherein each shaft of the first locking element and the second locking element includes at least two prongs separated by at least one slit, each prong of the at least two prongs including a radial ridge extending outwardly from the prong.

10. The spine implant of claim 9 , wherein each prong is biased such that the at least two prongs are urged toward each other when the first locking element is inserted into the first opening and when the second locking element is inserted into the second opening.

11. The spine implant of claim 8 , wherein each of the first locking element and the second locking element includes a flexible base having a main portion and a flexible bar.

12. The spine implant of claim 11 , wherein the flexible base of the first locking element is disposed between the first oblong head and the shaft of the first locking element, and wherein the flexible base of the second locking element is disposed between the second oblong head and the shaft of the second locking element.

13. The spine implant of claim 12 , wherein the flexible bars of the first locking element and the second locking element are configured to provide at least one of a tactile feedback and an audible feedback when the first locking element and the second locking element are disposed in a locked position such that the first oblong head of the first locking element engages at least one of the first head of the first fastener and the third head of the third fastener and the second oblong head of the second locking element engages at least one of the second head of the second fastener and the third head of the third fastener.

14. A system, comprising:

an intervertebral implant including:

a first lateral side surface;

a second lateral side surface;

a posterior surface extending between the first lateral side surface and the second lateral side surface; and

an anterior surface disposed opposite the posterior surface and extending between the first lateral side surface and the second lateral side surface, the anterior surface defining a plurality of openings each of which at least partially extend toward the posterior surface;

a first surface extending between the first lateral side surface and the second lateral side surface and between the posterior surface and the anterior surface;

a second surface extending between the first lateral side surface and the second lateral side surface and between the posterior surface and the anterior surface;

a first opening of the plurality of openings extending from proximate the first surface to and through the second surface;

a second opening of the plurality of openings extending from proximate the first surface to and through the second surface;

a third opening of the plurality of openings disposed between the first opening and the second opening, the third opening extending from proximate the second surface to and through the first surface;

a first locking element at least partially disposed within a fourth opening of the plurality of openings, the fourth opening disposed between the first opening and the third opening, the first locking element including a first oblong head and a shaft extending from the first oblong head; and

a second locking element at least partially disposed within a fifth opening of the plurality of openings, the fifth opening disposed between the second opening and the third opening, the second locking element including a second oblong head and a shaft extending from the second oblong head,

wherein the first locking element is configured to rotate within the fourth opening such that the first oblong head is configured to move from an unlocked position to a locked position; and

wherein the second locking element is configured to rotate within the fifth opening such that the second oblong head is configured to move from an unlocked position to a locked position.

15. The system of claim 14 , further comprising:

a first fastener including a first head and a first shaft extending from the first head and terminating at a first tip, the first shaft sized and configured to be received in the first opening of the plurality of openings;

a second fastener including a second head and a second shaft extending from the second head and terminating at a second tip, the second shaft sized and configured to be received in the second opening of the plurality of openings; and

a third fastener including a third head and a third shaft extending from the third head and terminating at a third tip, the third shaft sized and configured to be received in the third opening of the plurality of openings.

16. The system of claim 15 , wherein the first oblong head of the first locking member engages the first head of the first fastener when the first fastener is disposed within the first opening of the plurality of openings and the first oblong head of the first locking member is in the locked position.

17. The system of claim 16 , wherein the first oblong head of the first locking member engages the third head of the third fastener when the third fastener is disposed within the third opening of the plurality of openings and the first oblong head of the first locking member is in the locked position.

18. The system of claim 16 , wherein the second oblong head of the second locking member engages the second head of the second fastener when the second fastener is disposed within the second opening of the plurality of openings and the second oblong head of the second locking member is in the locked position.

19. The system of claim 18 , wherein the second oblong head of the second locking member engages the third head of the third fastener when the third fastener is disposed within the third opening of the plurality openings and the second oblong head of the second locking member is in the locked position.

20. The system of claim 15 , wherein the intervertebral implant defines a window extending from the first surface to the second surface, the window sized and configured to receive a graft therein.

21. The system of claim 15 , further comprising an insertion tool including a handle and at least one flexible arm sized and configured to be received in at least one of the plurality of openings.

22. The system of claim 21 , wherein the at least one flexible arm includes a pair of flexible arms.

23. The system of claim 22 , wherein the insertion tool includes a first engagement feature extending longitudinally along a distal portion, the first engagement feature including a pair of slots disposed on opposite sides of the insertion tool.

24. The system of claim 14 , wherein the shaft of the first locking element includes at least two prongs separated by at least one slit, each prong being biased such that the at least two prongs are configured to be urged toward one another when the first locking element is inserted into the fourth opening.

25. The system of claim 24 , wherein the first locking element includes a flexible base having a main portion and a flexible bar, the flexible base disposed between the first oblong head and the shaft of the first locking element.

26. The spine implant of claim 25 , wherein the flexible bars of the first locking element is configured to provide at least one of a tactile feedback and an audible feedback when the first locking element is moved into the locked position.

27. The system of claim 14 , wherein the first surface is an inferior surface.

28. A spine implant, comprising:

a cage having a first surface and an opposed second surface, the cage defining:

a first angled bore in the first surface, the first angle bore extending from proximate a third surface to and through a fourth surface, the third surface and the fourth surface being disposed between the first surface and the second surface, and the fourth surface being disposed opposite the third surface such that the third surface is spaced apart from the fourth surface;

a second angled bore in the first surface, the second angled bore extending from proximate the fourth surface to and through the third surface; and

a first opening disposed between the first angled bore and the second angled bore,

wherein each of the first angled bore and the second angled bore is sized and configured to receive a respective fastener in a manner to direct a tip of each fastener into an adjacent vertebral body, and

wherein the first opening is disposed between the first angled bore and the second angled bore and is sized and configured to receive a first locking element.

29. The spine implant of claim 28 , further comprising:

a first fastener including a first head and a first shaft extending from the first head and terminating at a first tip, the first shaft sized and configured to be received in the first angled bore; and

a second fastener including a second head and a second shaft extending from the second head and terminating at a second tip, the second shaft sized and configured to be received in the second angled bore.

30. The spine implant of claim 29 , further comprising the first locking element disposed in the first opening.

31. The spine implant of claim 30 , wherein the first locking element is configured to rotate between a first position and a second position.

32. The spine implant of claim 31 , wherein the first locking element includes a first oblong head having a diameter that is greater than a diameter of a shaft extending from the first oblong head.

33. The spine implant of claim 31 , wherein the first locking element is configured to block, at least partially, the first angled bore and the second angled bore when the first locking element is in the first position.

34. The spine implant of claim 33 , wherein the first position is a locked position, and the second position an unlocked position.

35. The spine implant of claim 33 , wherein the first locking element is configured to block the first fastener from backing out of the first angled bore and block the second fastener from backing out of the second angled bore when the first shaft is disposed within the first angled bore, the second shaft is disposed in the second angled bore, and the first locking element is in the first position.

36. The spine implant of claim 30 , wherein the cage defines:

a third angled bore in the first surface, the third angled bore extending from proximal the third surface to and through the fourth surface; and

a second opening disposed between the second angled bore and the third angled bore.

37. The spine implant of claim 36 , further comprising:

a third fastener including a third head and a third shaft extending from the third head that terminates at a third tip, the third shaft sized and configured to be received in the third angled bore; and

a second locking element sized and configured to be disposed in the second opening.

Assignments (4)

Continuity (5)

References Cited (235)