Granted Patent B2

US 12,262,921 · App. 18/011,612 · Granted Apr 1, 2025

Inventors: Brittany Lang (Warrenton, VA); Michael Barrus (Redondo Beach, CA)

Assignee: K2M, Inc.

A61B17/7037A61B17/7032A61B2017/564

Abstract

Claims (35)

1. A spinal fixation device, comprising:

a bone screw including a head and a shank extending from the head;

a modular head assembly, comprising:

a housing having a proximal surface, a distal surface, and a throughhole formed through the housing from the proximal surface to the distal surface;

an anvil slidable within a portion of the throughhole;

a biasing member circumferentially surrounding the anvil to impart a distally directed force on the head of the bone screw;

an assembly cap secured to the housing, the assembly cap including an inner surface defining a cavity having a first portion and a second portion, the first portion having a first diameter and the second portion having a second diameter smaller than the first diameter, the anvil located entirely above the assembly cap;

a retaining ring positioned at least partially within the cavity of the assembly cap, the retaining ring transitionable between a first configuration in which the retaining ring is sized to receive the head of the bone screw and a second configuration in which the retaining ring is compressed about the bone screw,

wherein movement of the retaining ring from the first portion to the second portion compresses the retaining ring from the first configuration to the second configuration and secures the bone screw relative to the housing.

2. The spinal fixation device of claim 1 , wherein a distal portion of the housing defines a counterbore terminating at an annular face.

3. The spinal fixation device of claim 2 , wherein an inner surface of the housing defines at least one slot.

4. The spinal fixation device of claim 3 , wherein the anvil defines a proximal end, a distal end and a circumferential sidewall extending therebetween, the circumferential sidewall including at least one outwardly extending lug arranged to be slidably received within the at least one slot.

5. The spinal fixation device of claim 4 , wherein the at least one lug comprises two lugs diametrically opposed from one another about the circumferential sidewall of the anvil.

6. The spinal fixation device of claim 4 , wherein distal end of the anvil comprises an outwardly extending flange.

7. The spinal fixation device of claim 6 , wherein the biasing member is provided between the outwardly extending flange and the at least one outwardly extending lug.

8. The spinal fixation device of claim 7 , wherein the biasing member is biased between the outwardly extending flange of the anvil and the annular face of the counterbore.

9. The spinal fixation device according to claim 7 , wherein the biasing member is a wave spring.

10. The spinal fixation device of claim 2 , wherein the counterbore defines an internal threading and the assembly cap includes an external threading configured to threadably engage the internal threading of the counterbore.

11. The spinal fixation device of claim 1 , wherein the retaining ring defines a proximal end and a distal end, the proximal and distal ends defining a lumen therethrough.

12. The spinal fixation device of claim 11 , wherein the retaining ring is formed from a resilient material, and wherein an outer surface of the retaining ring defines a slit in communication with the lumen.

13. The spinal fixation device of claim 11 , wherein the proximal end of the retaining ring defines an outwardly extending shelf arranged to contact the anvil.

14. The spinal fixation device of claim 1 , wherein the inner surface of the assembly cap includes an inwardly extending ledge at a distal end of the assembly cap to limit distal movement of the retaining ring.

15. A method of assembling a spinal fixation device, comprising:

providing a modular head assembly, the modular head assembly including a housing having a throughhole formed through the housing from a proximal surface of the housing to a distal surface of the housing, an anvil slidable within a portion of the throughhole, a biasing member circumferentially surrounding the anvil, an assembly cap secured to the housing including an inner surface defining a cavity having a first portion with a first diameter and a second portion with a second diameter smaller than the first diameter, and a retaining ring positioned at least partially within the cavity of the assembly cap and transitionable between a first configuration in which the retaining ring is sized to receive a head of a bone screw and a second configuration in which the retaining ring is compressed about the bone screw, the anvil located entirely above the assembly cap;

securing the bone screw within bone;

positioning a bore defined through a distal surface of the assembly cap adjacent the head of the bone screw;

advancing the modular head assembly over the head of the bone screw such that the head of the bone screw is received within the bore;

moving the retaining ring from the second portion of the cavity to the first portion of the cavity;

inserting the head of the bone screw through a lumen defined through distal and proximal surfaces of the retaining ring; and

allowing the biasing member to apply a distally directed biasing force to the anvil which, in turn, applies a biasing force to the bone screw.

16. The method of claim 15 , wherein the securing step comprises rotating the assembly cap in a first direction to threadably engage a threading defined on an outer surface of the assembly cap with a threading defined on an inner surface of the housing.

17. The method according to claim 15 , wherein the inserting step comprises allowing the retaining ring to expand to an expanded state as the head of the bone screw is received within the lumen of the retaining ring and, thereafter, allowing the retaining ring to return to an unexpanded state after the head of the bone screw has passed through the lumen.

18. The method according to claim 15 , further comprising installing a spinal rod within a U-shaped slot defined through an outer surface of the housing and extending through the proximal surface thereof.

19. The method according to claim 18 , further comprising rotating a set screw in a first direction to threadably engage a threading defined on an outer surface of the set screw with a corresponding threading defined on an inner surface of the housing, wherein rotation of the set screw in the first direction causes the set screw to move in a distal direction which, in turn, causes a corresponding distal movement of the spinal rod, the anvil, and the retaining ring.

20. The method according to claim 19 , wherein the corresponding distal movement of the retaining ring translates the retaining ring from the first portion of the assembly cap to the second portion of the assembly cap and causes the retaining ring to transition from the first configuration to the second configuration and fix a rotational and angular position of the bone screw relative to the modular head assembly.

Assignments (2)

Continuity (2)

References Cited (312)

Cited By (2)

US 12,564,426 US 12,661,155