# Patent

## Title
Large diameter bone anchor assembly

## Abstract

A bone anchor assembly is described having a large diameter for fixing a spinal connection element to bone. The assembly includes a receiver member for receiving the spinal connection element, a bone-engaging shank for engaging bone and a first and second insert for retaining the head of the shank within the receiver member.

## Background
CONTINUING DATA
This application claims the benefit of U.S. Provisional Patent Application Ser. No. 60/796,019, entitled “Large Diameter Bone Anchor Assembly”, filed Apr. 28, 2006, which is hereby incorporated by reference.


BACKGROUND
Spinal connection systems may be used in orthopedic surgery to align and/or fix a desired relationship between adjacent vertebrae. Such systems typically include a spinal connection element, such as a relatively rigid fixation rod or plate or a dynamic connector, that is coupled to adjacent vertebrae by attaching the element to various anchoring devices, such as hooks, bolts, wires, or screws. The spinal connection element can have a predetermined contour that has been designed according to the properties of the target implantation site, and once installed, the spinal connection element holds the vertebrae in a desired spatial relationship, either until desired healing or spinal fusion has taken place, or for some longer period of time.
Spinal connection elements can be anchored to specific portions of the vertebra. Since each vertebra varies in shape and size, a variety of anchoring devices have been developed to facilitate engagement of a particular portion of the bone. Pedicle screw assemblies, for example, have a shape and size that is configured to engage pedicle bone. Such screws typically include a threaded shank that is adapted to be threaded into a vertebra, and a head portion having a spinal connection element receiving portion, which, in spinal rod applications, is usually in the form of a U-shaped slot formed in the head for receiving the rod. A set-screw, plug, cap or similar type of closure mechanism, may be used to lock the connection element into the connection element receiving portion of the pedicle screw. In use, the shank portion of each screw may be threaded into a vertebra, and once properly positioned, a connection element may be seated through the spinal connection element receiving portion of each screw and the connection element is locked in place by tightening a cap or similar type of closure mechanism to securely interconnect each screw and the connection element. Other anchoring devices also include hooks and other types of bone screws.
In certain procedures, such as those in the lumbar or sacral spine, it may be necessary to use a larger diameter pedicle screw capable of carrying large loads or engaging large pedicles. A difficulty in using a larger diameter screw comes from the corresponding increase in the size of the receiver head to accommodate the larger diameter screw shank, since the shank is usually assembled from the top through the opening at the proximal end of the receiver head. The increased size of the receiver head can interfere with the bony anatomy and can limit the polyaxial range of motion of the screw head. Another problem associated with manufacturing large diameter top-loading screws is that the opening in the receiver head has to be larger to accept the larger diameter screw shank, which creates the need for a larger closure mechanism. It is desirable to maintain the same size opening in the receiver head such that the same size closure mechanisms can be used. Accordingly, a larger diameter polyaxial screw is needed which is not top-loading.
SUMMARY
Disclosed herein are embodiments of a bottom-loading bone anchor assembly having a large diameter bone-engaging shank. In one embodiment, the bone anchor assembly includes a receiver member having an opening at the proximal end for receiving the connection element and a bore having a diameter greater than the opening; a bone-engaging shank having a head at a proximal end, the head sized to fit through the bore of the receiver member; and an insert having a slot extending through a portion of the insert, sized to fit within the receiver member wherein the insert retains the head of the shank within the receiver member. The assembly may further include a closure mechanism having a diameter smaller than the diameter of the head of the shank and/or the major diameter of the bone-engaging shank.
Also disclosed herein are methods of assembling a large diameter bone anchor assembly by positioning an insert having a slot extending from a distal end into a receiver member having an opening at a proximal end for receiving a spinal connection element and a bore at a distal end; inserting a bone-engaging shank having a head at a proximal end in a proximal direction through the bore of the receiver member; aligning the insert with the head of the bone-engaging shank; and swaging a side of the receiver member inward to retain the insert and the head of the shank.



BRIEF DESCRIPTION OF THE FIGURES
These and other features and advantages of the bone anchor assembly and methods disclosed herein will be more fully understood by reference to the following detailed description in conjunction with the attached drawings in which like reference numerals refer to like elements through the different views. The drawings illustrate principles of the bone anchor assembly and methods disclosed herein and, although not to scale, show relative dimensions.
FIG. 1A illustrates an exploded view of a large diameter bone anchor assembly.
FIG. 1B illustrates a top view of the bone anchor assembly shown in FIG. 1A.
FIG. 1C illustrates a side view of the bone anchor assembly shown in FIG. 1A.
FIG. 1D illustrates another side view of the bone anchor assembly shown in FIG. 1A.
FIG. 2A illustrates a top view of the inserts of the bone anchor assembly shown in FIG. 1A.
FIGS. 2B,2C illustrate side views of the inserts of the bone anchor assembly shown in FIG. 1A.
FIG. 2D illustrates a bottom view of the inserts of the bone anchor assembly shown in FIG. 1A.
FIG. 3A illustrates a perspective view of the receiver member, inserts, and bone-engaging shank of the bone anchor assembly shown in FIG. 1A.
FIG. 3B illustrates a top view of the receiver member, inserts and bone-engaging shank of the bone anchor assembly shown in FIG. 3A.
FIG. 3C illustrates a perspective view of the receiver member and inserts of the bone anchor assembly shown in FIG. 3A.
FIG. 4A shows a top view of the receiver member of the bone anchor assembly shown in FIG. 1A.
FIG. 4B shows a cross-section of the receiver member shown in FIG. 4A.



DETAIL DESCRIPTION OF EXEMPLARY EMBODIMENTS
Certain exemplary embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the large diameter piece bone anchor assembly and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those of ordinary skill in the art will understand that the large diameter bone anchor assembly and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments and that the scope of the present invention is defined solely by the claims. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present invention.
The articles “a” and “an” are used herein to refer to one or to more than one (i.e. to at least one) of the grammatical object of the article. By way of example, “an element” means one element or more than one element.
The terms “comprise,” “include,” and “have,” and the derivatives thereof, are used herein interchangeably as comprehensive, open-ended terms. For example, use of “comprising,” “including,” or “having” means that whatever element is comprised, had, or included, is not the only element encompassed by the subject of the clause that contains the verb.
FIGS. 1-4 illustrate an exemplary embodiment of a bottom-loading large diameter bone anchor assembly. The exemplary bone anchor assembly 10 may be employed to engage one or more spinal connection elements to bone. For example, bone anchor assembly 10 may be employed to connect a spinal plate, rod (rigid or dynamic), and/or cable to a vertebra of the spine. Although the exemplary bone anchor assembly 10 described below is designed primarily for use in spinal applications, one skilled in the art will appreciate that the structure, features, and principles of the exemplary bone anchor assembly 10, as well as the other exemplary embodiments described below, may be employed to couple any type of orthopedic implant to any type of bone or tissue. Non-limiting examples of applications of the bone anchor assembly 10 described herein include long bone fracture fixation/stabilization, small bone stabilization, lumbar spine as well as thoracic stabilization/fusion, cervical spine compression/fixation, dynamic, non-fusion applications including facet replacement and dynamic posterior systems as well as skull fracture/reconstruction plating.
The illustrated exemplary bone anchor assembly 10 shown in FIGS. 1A-D includes a bone-engaging shank 40 configured for engaging bone, a receiver member 60 for receiving a spinal connection element, and an insert 20 for retaining the shank 40 within the receiver member 60. The bone-engaging shank 40 extends from a proximal end 46 to a distal end 48 along a longitudinal axis. An outer surface 44 of the bone-engaging shank 40 extends between the proximal end 46 and the distal end 48. The outer surface 44 of the bone-engaging shank 40 may include one or more bone engagement mechanisms to facilitate gripping engagement of the bone anchor assembly 10 to bone. In the illustrated exemplary embodiment, for example, the bone-engaging shank 40 includes an external thread 56. The external thread 56 may extend along at least a portion of the bone-engaging shank 40. For example, in the illustrated exemplary embodiment, the external thread 56 extends from the distal end 48 to the proximal end 46 of the bone-engaging shank 40. One skilled in the art will appreciate that bone engagement mechanisms other than external thread 56 may be employed, including, for example, one or more annular ridges, multiple threads, dual lead threads, variable pitched threads, and/or any other conventional bone engagement mechanism. In the illustrated exemplary embodiment, the shank diameter 30 of bone-engaging shank 40 may be defined by the major diameter of external thread 56.
The proximal end 46 of the exemplary bone-engaging shank 40 has a head 42 configured to fit within the receiver member 60 and to facilitate adjustment of the shank 40 relative to the receiver member 60. For example, the head 42 may be generally spherical in shape to permit pivoting of the bone-engaging shank 40 relative to the receiver member 60. In the illustrated exemplary embodiment, for example, the head 42 may be in the shape of a truncated sphere having a generally planar proximal surface 57 and a generally hemispherically shaped distal surface 58. The head 42 of the shank 40 may have surface texturing, knurling, and/or ridges. A drive feature 54 may be located internally or externally on the head 42 of the shank 40.
Referring to FIGS. 4A-B, the receiver member 60 of the exemplary bone anchor assembly 10 includes a proximal end 62 having a cylindrical opening leading to recess 68, and a distal end 70 having a bore 64 forming a seat portion 72. The receiver member 60, in certain exemplary embodiments, may be configured to receive a spinal connection element and couple the spinal connection element to the bone anchor assembly. In the exemplary embodiment, for example, the recess 68 of the receiver member 60 may be sized and shaped to receive a spinal rod 80, as illustrated in FIG. 1A. For example, the receiver member 60 has a generally U-shaped cross-section defined by two legs 76A and 76B separated by recess 68. Each leg 76A, 76B is free at the proximal end 62 of the receiver member 60. In the exemplary embodiment, for example, the inner surfaces 104 of the legs 76A, 76B are threaded to mate with a corresponding thread on the closure mechanism shown as a setscrew 100. The exemplary spinal rod 80 may be seated within the recess 68 by aligning the spinal rod 80 and the recess 68 and advancing the spinal rod 80 between the legs 76A, 76B into the recess 68. The configuration of recess 68 of the receiver member 60 may be varied to accommodate the type, size and shape of spinal connection element employed.
In the exemplary embodiment, the bore 64 of the receiver member 60 is sized to receive at least a portion of a bone anchor assembly, such as the head 42 of the shank 40. For example, the head 42 of the shank 40 may be inserted in the proximal direction through the bore 64 of the receiver member 60, as illustrated in FIG. 1A. In the exemplary embodiment, the diameter of the bore 64 may be greater than the diameter of the opening 67 of the receiver member 60 at the proximal end 62. In the exemplary embodiment, the major diameter 30 of the shank 40 may be greater than the diameter of the closure mechanism 100 and the opening 67 of the receiver member 60. In other exemplary embodiments, the diameter of the bore 64 may be equal to or less than the diameter of the opening 67 and the major diameter 30 may be less than or equal to the diameter of the closure mechanism 100 and the opening 67 of the receiver member 60.
The distal end 70 of the receiver member 60 may be sized and shaped to accommodate the head 42 of the shank 40. For example, the distal end 70 may define a seat portion 72 for accommodating the head 42 of the shank 40 allowing the bone-engaging shank 40 to pivot relative to the receiver member 60. In some exemplary embodiments, the seat portion 72 may be generally spherical in shape to permit pivoting of the bone-engaging shank 40 relative to the receiver member 60. In the illustrated exemplary embodiment, the seat portion 72 may be generally hemispherical in shape and may have a curvature analogous to the distal surface 58 of the head 42 of the core shank 40. In other exemplary embodiments, the seat portion 72 may be tapered or may have any other shape that allows adjustment of the head 42 of the shank 40 relative to the receiver member 60. In the exemplary embodiment, the bone anchor assembly 10 is a polyaxial bone anchor assembly. The bone-engaging shank 40 when assembled with the insert 20 within the receiver member 60 may be pivoted to one or more angles relative to the receiver member 60.
Referring to FIG. 1A, first and second inserts 20 of the bone anchor assembly 10 are positionable between the inner surface of the receiver member 60 and the outer surface of the head 42 of the shank 40. The inserts 20 are positioned about the head 42 and cooperate to retain the head 42 of the shank 40 within the receiver member 60. In the exemplary embodiment shown in FIGS. 2A-D, the first and second inserts 20 may have a proximal surface 22 shaped for engaging the spinal rod or a spinal connection element. The insert 20 may have an inner surface 26 contoured with a semi-spherical shape for engaging the head 42 of the shank 40 and an outer surface 28 having a semi-circular shape and tapered for engaging a portion of the seat 72 of the receiver member 60. The inner surface 26 of the insert 20 may be textured for better gripping of the head 42 of the shank 40. Examples of texturing include knurling, blasting, or ridges. The insert 20 extends from a proximal end 12 to a distal end 14. In the exemplary embodiment, the insert 20 may taper from the proximal end 12 to the distal end 14. A slot 24 extends proximally from the distal end 14 of the insert providing flexibility to the insert. The proximal corners 16 of the insert may be contoured. The insert 20 has a generally semi-circular shape when viewed from the top as shown in FIG. 2A. One skilled in the art will recognize that any number of inserts 20 may be used in the bone anchor assembly to retain the head 43 of the shank 40 within the receiver member 60.
The exemplary bone anchor assembly 10 may include a closure mechanism 100 that secures the spinal connection element to the bone anchor assembly. Referring to FIGS. 1A-D, the closure mechanism 100 secures the exemplary spinal rod 80 within the recess 68 of the receiver member 60. The closure mechanism 100 may engage the proximal end 62 of the receiver member 60 or, in other exemplary embodiments, may engage other portion(s) of the receiver member 60. The exemplary closure mechanism 100 is an internal setscrew that engages an inner surface of the proximal end 62 of the receiver member 60. For example, the closure mechanism 100 may have external threads 102 that engage internal threads 104 provided on the proximal end 62 of the receiver member 60. Distal advancement of the closure mechanism 100 into engagement of the spinal rod 80, seats the spinal rod 80 in the proximal surface 22 of the insert 20. The insert 20 then is advanced into the seat portion 72 of the receiver member 60 causing the insert 20 to move distally against the inner surface of the receiver member and compress or flex inwardly against the head 42 of the shank 40 thereby fixing the relative movement of the head 42 in relation to the receiver member 60. In one embodiment, the major diameter 30 of the bone-engaging shank 40 may be greater than the diameter of the closure mechanism 100 and the opening 67 of the receiver member 60.
One skilled in the art will appreciate that other types of closure mechanisms may be employed. For example, an external closure mechanism positionable around the outer surface of the legs 76A, 76B of the receiving member 60 may be employed. In other exemplary embodiments, the closure mechanism may comprise an external and an internal closure mechanism, a non-threaded twist-in cap, and/or any other conventional closure mechanism.
The components of the bone anchor assembly may be manufactured from any biocompatible material, including, for example, metals and metal alloys such as titanium and stainless steel, polymers, and/or ceramics. The components may be manufactured of the same or different materials. In one exemplary method of manufacturing, the bone-engaging shank 40, the insert 20 and the receiver member 60 are separately constructed and assembled prior to implantation. The first and second inserts 20 in one exemplary method may be inserted within the receiver member 60 either through the bore 64 at the distal end or the opening 67 at the proximal end 62 extending into the recess 68. The shank 40 may be coupled to the receiver member 60 by positioning the head 42 of the shank 40 through the bore 64 at the distal end 70 of the receiver member 60. The inserts 20 are advanced into the receiver member 60 until the head 42 of the shank 40 expands the slot 24 of the insert 20 around the head 42 seating the head 42 against inner surface of the insert 20 such that the distal end 48 of the shank 40 extends through the bore 64. While maintaining the alignment of the insert 20 and the head 42 of the shank 40, the outer side surfaces of the receiver member 60 may be swaged inwardly to retain the insert 20 in place with the head 42 of the shank 40 within the receiver member 60. The swaged protrusion 78 extends between the contoured corners 28 of the insert 20 to prevent the insert 20 from moving in the proximal direction.
While the large diameter bone anchor assembly and methods of the present invention have been particularly shown and described with reference to the exemplary embodiments thereof, those of ordinary skill in the art will understand that various changes may be made in the form and details herein without departing from the spirit and scope of the present invention. Those of ordinary skill in the art will recognize or be able to ascertain many equivalents to the exemplary embodiments described specifically herein by using no more than routine experimentation. Such equivalents are intended to be encompassed by the scope of the present invention and the appended claims.

## Claims

1. A bone anchor assembly for engagement to a connection element comprising:
a receiver member having a proximal opening at the proximal end for receiving the connection element and a bore at the distal end, the bore terminating at a distal opening having a diameter greater than the proximal opening;
a bone-engaging shank having a head at a proximal end, the head sized to fit through the distal opening of the bore of the receiver member;
a semi-spherical shaped first insert;
a semi-spherical shaped second insert separate and unconnected to the first insert, the first insert and the second insert each sized to fit within the receiver member, the first insert and the second insert each having a proximal end shaped for engaging the connection element and an inner surface shaped to engage the head of the bone shank, the first insert and the second insert positioned about the head; and
a closure mechanism for securing the connection element to the bone anchor assembly, wherein distal advancement of the closure mechanism seats the connection element against the proximal end of the first insert and the proximal end of the second insert and seats the head of the bone shank against the inner surface of the first insert and the inner surface of second insert, the first insert and the second insert cooperating to retain the head of the shank within the receiver member.

2. The bone anchor assembly of claim 1, wherein the head of the shank has a generally spherical shape.

3. The bone anchor assembly of claim 1, wherein the first and second inserts have contoured corners.

4. The bone anchor assembly of claim 1, wherein the first and second inserts have a textured surface for engaging the head of the shank.

5. The bone anchor assembly of claim 1, wherein the first and second inserts have a slot extending through a portion thereof for providing flexibility to the inserts.

6. The bone anchor assembly of claim 1, wherein the shank has a major diameter that is greater than the diameter of the closure mechanism.

7. The bone anchor assembly of claim 1, wherein the shank has a major diameter that is greater than the diameter of the proximal opening of the receiver member.

8. The bone anchor assembly of claim 1, wherein the first insert and the second insert are sized to fit through the proximal opening of the receiver member.

9. The bone anchor assembly of claim 1, wherein the first insert and the second insert are retained within the receiver member by swage protrusions.

10. A method of assembling a large diameter bone anchor assembly comprising:
positioning a semi-spherically shaped first insert having a slot extending from a distal end into a receiver member having a proximal opening at a proximal end for receiving a spinal connection element and a bore at a distal end, the bore terminating at a distal opening;
positioning a semi-spherically shaped second insert having a slot extending from a distal end into the receiver member, the second insert being separate and unconnected to the first insert;
inserting a proximal head of a bone-engaging shank in a proximal direction through the distal opening of the bore of the receiver member;
positioning the first and second inserts about the head of the bone-engaging shank; and
swaging a side of the receiver member inward to retain the inserts and the shank.

11. The method of claim 10, wherein the insert is positioned into the opening of the receiver member at the proximal end.