IP Library Granted Patent US 12,396,758
Granted Patent B2
US 12,396,758 · App. 18/062,605 · Granted Aug 26, 2025

Polyaxial bone fixation element

Inventors: Christopher Ramsay (West Wareham, MA); John Di Vincenzo (Braintree, MA)
Assignee: Medos International Sarl
A61B17/7001A61B17/7037A61B17/7038A61B17/8605A61B17/8685
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Quick Facts
Patent No.
US 12,396,758
App. No.
18/062,605
Granted
Aug 26, 2025
Kind
B2
Abstract

A fastener device includes an anchor body that defines a through hole. The anchor body further includes an inner surface that defines a least a portion of the through hole. The fastener includes a head, a threaded shaft that extends out with respect to the head in a distal direction, and a neck between the head and threaded shaft. The head includes an outer surface configured to articulate along the inner surface when the fastener head is inserted in the through hole. At least a portion of the outer surface is convex and defines a portion of a sphere that defines a first diameter. The neck defines a second diameter and the fastener defines a ratio of the first diameter to the second diameter in a range between about 2 to 1 and about 3 to 1.

Claims (34)

1. A fastener device configured to secure a spinal rod relative to a bone, the fastener device comprising:

an anchor body including an anchor body housing, the anchor body defining a through hole that extends through the anchor body housing, the anchor body further defining a rod-receiving channel that is configured to receive the spinal rod and that is offset with respect to the through hole, the anchor body further including an upper end, a lower end, and an inner surface, the inner surface defining a least a portion of the through hole; and

a fastener including a head, a threaded shaft that extends out with respect to the head in a distal direction, and a neck that extends between the head and the threaded shaft, the head including an outer surface configured to articulate relative to the inner surface when the head is inserted in the through hole, at least a portion of the outer surface being convex and defining a portion of a sphere, the sphere defining a first diameter, and the fastener including a concave surface that extends along both the head and the neck, the neck defining a second diameter measured: 1) in a direction perpendicular to the distal direction, and 2) at a location spaced in the distal direction of an entirety of the concave surface,

wherein the fastener defines a ratio of the first diameter to the second diameter in a range between about 2 to 1 and about 3 to 1.

2. The fastener device of claim 1 , wherein:

the fastener is elongate along a central axis that is parallel to the distal direction;

the portion of the outer surface includes a first point that is located in the distal direction with respect to all other points of the portion of the outer surface;

the concave surface includes a second point that is located in a proximal direction, which is opposite the distal direction, with respect to all other points of the concave surface; and

the first point is spaced from the central axis a first distance measured in a direction perpendicular to the distal direction, the second point is spaced from the central axis a second distance measured in a direction perpendicular to the distal direction, and the first distance is greater than the second distance.

3. The fastener device of claim 1 , wherein the location is a first location, the through hole extends away from the upper end and toward the lower end in a longitudinal direction, and the inner surface defines a minimum inner diameter that is both: 1) measured at a second location that is on the inner surface, and 2) measured in a direction perpendicular to the longitudinal direction, the second location is closer to the lower end as measured along the longitudinal direction, than the second location is to the upper end as measured along the longitudinal direction.

4. The fastener device of claim 3 , wherein the lower end defines a lower opening where the through hole exits the anchor body housing, the anchor body defines a plane that includes an entirety of the lower opening, the head of the fastener defines a third location such that the fastener is devoid of any locations positioned in a proximal direction, which is opposite the distal direction, from the third location, and the fastener device defines a configuration in which the third location is positioned a first distance from the upper end, the lower end is positioned a second distance from the upper end, the first distance and the second distance each measured along the longitudinal direction, and the first distance is greater than the second distance.

5. The fastener device of claim 3 , wherein the first diameter is larger than the minimum inner diameter.

6. The fastener device of claim 5 , wherein the upper end defines an upper opening where the through hole exits the anchor body housing, the upper opening defines an inner diameter measured in the direction perpendicular to the longitudinal direction, and the inner diameter is greater than both the first diameter and the minimum inner diameter.

7. The fastener device of claim 1 , wherein all lines that: 1) lie entirely within a plane parallel to the distal direction, and 2) are tangent to the portion of the outer surface are noncollinear with all lines that: 1) lie entirely within the plane, and 2) are tangent to the concave surface.

8. The fastener device of claim 1 , further comprising a stabilization mechanism configured to be positioned in the through hole such that when the fastener is inserted in the through hole such that the outer surface contacts the inner surface the stabilization mechanism exerts a force on the fastener that resists relative movement of the fastener and the anchor body.

9. The fastener device of claim 8 , wherein the stabilization mechanism includes a biasing member configured to expand as the head of the fastener contacts the biasing member, such that the expanded biasing member exerts the force on the outer surface of the fastener.

10. The fastener device of claim 9 , wherein the anchor body defines a recess configured to receive the biasing member such that the biasing member is captured within the recess.

11. The fastener device of claim 1 , wherein the inner surface defines a recess is configured to face radially inwardly toward a widest portion of the head of the fastener as measured along a second direction that is perpendicular to the first direction.

12. The fastener device of claim 11 , wherein the widest portion of the head forms a portion of the outer surface and an entirety of the widest portion of the head is configured to be radially aligned with the recess when the widest portion of the head defines a plane that is perpendicular to the first direction.

13. A fastener device configured to secure a spinal rod relative to a bone, the fastener device comprising:

an anchor body including an anchor body housing and a central axis, the anchor body defining a through hole that extends through the anchor body housing along the central axis, the anchor body further defining a rod-receiving channel that is configured to receive the spinal rod, the anchor body further including an upper end, a lower end spaced from the upper end in a first direction, and an inner surface that defines at least a portion of the through hole, the inner surface including: 1) a first portion that has a first cross-sectional dimension, 2) a second portion that defines a second cross-sectional dimension that is equal to or greater than the first cross-sectional dimension, and 3) a third portion that defines a recess that defines a third cross-sectional dimension that is greater than both the first cross-sectional dimension and the second cross-sectional dimension, wherein the first portion terminates at a first end of the recess in a direction that is opposite the first direction, and the third portion is disposed between the first portion and the second portion with respect to the first direction; and

a fastener including a head and a threaded shaft that extends out with respect to the head, the head including an outer surface configured to articulate relative to the first portion of the inner surface when the head is inserted in the through hole, wherein a part of the outer surface of the head is configured to be disposed beyond the first end of the recess along the direction that is opposite the first direction when the head is inserted in the through hole,

wherein the recess is configured to face radially inwardly toward a widest portion of the head of the fastener as measured along a second direction that is perpendicular to the first direction, the widest portion of the head forms a portion of the outer surface, and an entirety of the widest portion of the head is configured to be radially aligned with the recess when the widest portion of the head defines a plane that is perpendicular to the first direction.

14. The fastener device of claim 13 , further comprising a biasing member configured to be inserted into the through hole and positioned such that the biasing member is aligned with the third portion along a second direction that is perpendicular to the first direction.

15. The fastener device of claim 14 , wherein the biasing member is a split ring that includes an inner surface that faces the central axis when the split ring is inserted in the through hole, the split ring defines a fourth cross-sectional dimension measured from a first point on the inner surface, through the central axis, to a second point on the inner surface in the second direction, and when the split ring is in an unbiased state the fourth cross-sectional dimension is less than each of the first cross-sectional dimension, the second cross-sectional dimension, and the third cross-sectional dimension.

16. The fastener device of claim 14 , wherein the biasing member is configured to contact the outer surface of the head of the fastener.

17. The fastener device of claim 13 , wherein the first portion defines a portion of a first sphere that has the first cross-sectional dimension, the threaded shaft extends out with respect to the head in a distal direction, the fastener includes a neck that extends between the head and the threaded shaft, at least a portion of the outer surface is convex and defines a portion of a second sphere, the second sphere defining a first fastener diameter, the fastener includes a concave surface that extends along both the head and the neck, the neck defines a second fastener diameter measured: 1) in a direction perpendicular to the distal direction, and 2) at a location spaced in the distal direction of an entirety of the concave surface, and the fastener defines a ratio of the first fastener diameter to the second fastener diameter in a range between about 2 to 1 and about 3 to 1.

18. The fastener device of claim 17 , wherein:

the fastener is elongate along a central axis that is parallel to the distal direction;

the portion of the outer surface includes a first point that is located in the distal direction with respect to all other points of the portion of the outer surface;

the concave surface includes a second point that is located in a proximal direction which is opposite the distal direction, with respect to all other points of the concave surface; and

the first point is spaced from the central axis a first distance measured in a direction perpendicular to the distal direction, the second point is spaced from the central axis a second distance measured in a direction perpendicular to the distal direction, and the first distance is greater than the second distance.

19. The fastener device of claim 18 , wherein the location is a first location, the through hole extends away from the upper end and toward the lower end in a longitudinal direction, and the inner surface defines a minimum inner diameter that is both: 1) measured at a second location that is on the inner surface, and 2) measured in a direction perpendicular to the longitudinal direction, the second location is closer to the lower end as measured along the longitudinal direction, than the second location is to the upper end as measured along the longitudinal direction.

20. The fastener device of claim 13 , wherein the recess faces toward the head of the fastener when the fastener is in a first configuration in which the outer surface is in contact with a portion of a sphere defined by the first portion.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 10, 2023
From: RAMSAY, CHRISTOPHER; DI VINCENZO, JOHN
To: DEPUY SYNTHES PRODUCTS, INC.
Reel/Frame 062327/0356 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 10, 2023
From: DEPUY SYNTHES PRODUCTS, INC.
To: MEDOS INTERNATIONAL SARL
Reel/Frame 062327/0476 →
Continuity (4)
Continuation 16871085 · May 11, 2020
Continuation 15441326 · Feb 24, 2017
Provisional Application 62300456 · Feb 26, 2016
Related Publication 20230102605A1 · Mar 30, 2023
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