Granted Patent B2

US 12,245,795 · App. 17/379,361 · Granted Mar 11, 2025

Inventors: Daniel Spangler (Green Lane, PA); Jason Cianfrani (Conshohocken, PA); Michael Harper (Pottstown, PA); Milan George (Collegeville, PA); Katherine Manninen (Limerick, PA); John Perkins (Pottstown, PA)

Assignee: Globus Medical, Inc.

A61B17/7032A61B17/7035A61B17/7082A61B17/888A61B17/7056

Abstract

Claims (40)

1. A method of treating a spinal irregularity by attaining stability between spinal segments, said method comprising:

providing an orthopedic fixation device, wherein the orthopedic fixation device includes:

a coupling element, wherein the coupling element comprises a bore extending therethrough and an interior surface disposed about the bore;

a bone fastener, wherein the bone fastener comprises a head and an extension that extends from the head, wherein the head is configured for loading into the coupling element through the bottom of the bore, wherein an outer surface of the head is roughened;

a locking clamp assembly, wherein the locking clamp assembly includes:

a clamp element having a spherical outer surface, a spherical inner surface, a rim extending around the spherical outer surface and disposed between an upper end and a lower end of the clamp element, and a plurality of slits extending through the clamp element and the rim, wherein at least a portion of the outer surface is configured to engage the interior surface of the coupling element, and wherein at least a portion of the inner surface is configured to engage the head of the bone fastener, wherein the spherical inner surface is roughened to engage with the outer surface of the head; and

a wedge element, wherein the wedge element comprises a wedge bore configured to receive an upper portion of the clamp element and an inner wedge surface disposed around at least a lower portion of the wedge bore, wherein the inner wedge surface is configured to engage at least a portion of the outer surface of the clamp element,

implanting the bone fastener into a vertebrae;

positioning the coupling element to the bone fastener;

angulating the bone fastener relative to the coupling element; and

locking a position of the coupling element relative to the bone fastener.

2. The method of claim 1 , wherein the bone fastener is angled up to 41 degrees relative to the coupling element.

3. The method of claim 1 , wherein the clamp element is configured to angulate relative to the coupling element.

4. The method of claim 3 , wherein the clamp element is angled up to 9 degrees relative to the coupling element.

5. The method of claim 4 , wherein the bone fastener is angled up to 50 degrees relative to the coupling element.

6. The method of claim 1 , wherein the head of the bone fastener is spherical.

7. The method of claim 1 , wherein a lip on the spherical outer surface of the clamp element limits rotation of the clamp element within the coupling element.

8. The method of claim 7 , wherein the plurality of slits extend past the lip on the spherical outer surface of the clamp element.

9. The method of claim 1 , wherein a threaded locking cap is configured to be threadably received within the coupling element to lock an elongate rod and the bone fastener in position.

10. The method of claim 1 , further comprising securing an elongate rod in the coupling element.

11. A method of treating a spinal irregularity by attaining stability between spinal segments, said method comprising:

providing an orthopedic fixation device, wherein the orthopedic fixation device includes:

a coupling element having a bore extending from a first end to a second end;

a bone fastener having a spherical head and a shaft that extends from the head, wherein the head is configured for loading into the coupling element through the second end and the shaft is configured to be secured to bone, wherein an outer surface of the head is roughened;

an elongate rod configured to extend through a portion of the coupling element; and

a locking clamp assembly including a clamp element and a wedge element, the clamp element having a spherical outer surface, a spherical inner surface, a plurality of slits extending through the clamp element, and a rim extending around the spherical outer surface between an upper end and a lower end of the clamp element, wherein the rim is transverse to the plurality of slits which extend through the rim, wherein at least a portion of the outer surface is configured to engage an interior surface of the coupling element, and wherein at least a portion of the inner surface is configured to engage the spherical head of the bone fastener, and the wedge element comprises an upper portion in the form of a seat configured to receive the elongate rod and a lower portion configured to engage at least a portion of the spherical outer surface of the clamp element, wherein the spherical inner surface is roughened to engage with the outer surface of the head,

wherein the bone fastener is configured to angulate relative to the coupling element, and

wherein the rim is configured to limit rotational travel of the clamp element within the coupling element

implanting the bone fastener into a vertebrae;

positioning the coupling element to the bone fastener; and

locking a position of the coupling element relative to the bone fastener.

12. The method of claim 11 , wherein a threaded locking cap is configured to be threadably received within the first end of the coupling element to lock the elongate rod and the bone fastener in position.

13. The method of claim 11 , wherein the bone fastener is angled up to 50degrees relative to the coupling element.

14. The method of claim 11 , wherein the clamp element is configured to angulate relative to the coupling element.

15. The method of claim 14 , wherein the clamp element is angled up to 9degrees relative to the coupling element.

16. The method of claim 15 , wherein the bone fastener is angled up to 50degrees relative to the coupling element.

17. The method of claim 11 , wherein the plurality of slits extend past the rim on the spherical outer surface of the clamp element.

18. The method of claim 11 , wherein the bone fastener is angled up to 41degrees relative to the coupling element.

19. The method of claim 11 , further comprising angulating the bone fastener relative to the coupling element.

20. The method of claim 19 , further comprising securing the elongate rod to the coupling element.

Assignments (1)

Continuity (5)

References Cited (253)

Cited By (7)

US 12,419,668 US 12,427,028 US 12,433,733 US 12,453,563 US 12,616,587 US 12,661,239 US 12,708,415