# Patent

## Title
Extended tab bone screw system

## Abstract

A bone screw system is presented. The bone screw system has a fixation element, a receiving element, coupling element, and a compression element. In one aspect, the system also has a pair of leg extensions extending upwardly therefrom the receiving element.

## Background
CONTINUITY
This application claims the benefit of U.S. Patent Application 61/577,247 entitled “Bone Screw System” filed on Dec. 19, 2011, which is incorporated herein in its entirety by reference.


FIELD OF THE INVENTION
Presented herein is a bone screw system. More specifically, a bone screw for use in spinal surgery is presented.
BACKGROUND OF THE INVENTION
Spinal surgeons often treat spinal disorders with spinal fusion augmented with elongated spinal rods connected to the spine with pedicle screws. Such “rod assemblies” generally comprise one or two spinal rods and a plurality of screws inserted through the pedicles and into their respective vertebral bodies. The screws are provided with connectors, for coupling the spinal rods to the screws. The spinal rods extend along the longitudinal axis of the spine, coupling to the plurality of screws via their connectors. The aligning influence of the rods forces the patient's spine to conform to a more appropriate shape.
SUMMARY
Presented herein is a bone screw system that comprises a fixation element, a receiving element, coupling element, and a compression element. The fixation element can be a screw. The receiving element defines an internal bore sized to receive the shank portion of the fixation element and a seat adapted to support the head portion of the fixation element. The seat of the receiving element is shaped to substantially conform to an exterior portion of the head portion of the fixation element.
The receiving element is further adapted to receive a stabilizer rod. As such, in one aspect, the receiving element comprises a pair of opposed legs separated by a rod-receiving channel. In another aspect, the bone screw system also comprises a pair of leg extensions. Each leg extension has a first end and a second end, where the second end is coupled to a respective opposed leg of the receiving element.
The compression element is engagable with the receiving element. In one aspect, the compression element is adapted to move downward into the compression element receiving chamber to translate a force to the stabilizer rod and translate a force onto the head portion of the fixation element and substantially fix the position of the fixation element with respect to the receiving element.
Other aspects and embodiments of the bone screw system are described herein. This description is meant to fully describe the bone screw system, but not limit its design, function, or application.



BRIEF DESCRIPTION OF THE DRAWINGS
These and other features of the preferred embodiments of the present invention will become more apparent in the detailed description in which reference is made to the appended drawings wherein:
FIG. 1 is a perspective view of one aspect of a bone screw system;
FIG. 2 is a top plan view of the bone screw system of FIG. 1, showing a portion of the stabilizer rod:
FIG. 3 is a front elevational view of the bone screw system of FIG. 1;
FIG. 4 is a cut-away right side elevation view of the bone screw system of FIG. 1, cut along line 4-4 of FIG. 3;
FIG. 5 is an exploded cut-away front elevational view of Section 5 of FIG. 4 of the bone screw system of FIG. 1
FIG. 6 is a right side elevational view of the bone screw system of FIG. 1;
FIG. 7 a cut-away front elevational view of the bone screw system of FIG. 1, cut along line 7-7 of FIG. 6;
FIG. 8 is an exploded cut-away front elevational view of Section 8 of FIG. 7 of the bone screw system of FIG. 1;
FIG. 9 is an exploded front perspective view of the bone screw system of FIG. 1;
FIG. 10 is an exploded rear perspective view of the bone screw system of FIG. 1;
FIG. 11 is a perspective view of one aspect of a receiving element for use in a bone screw system;
FIG. 12 is a perspective view of one aspect of a coupling element coupled thereto a head portion of a fixation element of for use with a bone screw system;
FIG. 13 is a side elevational view of one aspect of a fixation element for use with a bone screw system;
FIG. 14 is a front elevational view of one aspect of a bone screw system, showing a pair of leg extensions and a connector;
FIG. 15 is a side elevational view of the bone screw system of FIG. 14;
FIG. 16 is a perspective view of the bone screw system of FIG. 14;
FIG. 17 is a perspective view of a bone screw system, showing a top saddle having a rod trough;
FIG. 18 A is a perspective view of a compression element and a top saddle with a rod trough;
FIG. 18B is a perspective view of the compression element and top saddle of FIG. 18A;
FIG. 19 is a perspective view of an insertion tool, inserting a stabilizer rod into a bone screw system with leg extensions;
FIG. 20 is a perspective view of the insertion tool of FIG. 19, showing the insertion tool using the connector as a fulcrum to maneuver the stabilizer rod into position; and
FIG. 21 is a perspective view of the insertion tool of FIG. 19, showing the insertion too using the connector as a fulcrum to further maneuver the stabilizer rod into position.



DETAILED DESCRIPTION OF THE INVENTION
The present systems and apparatuses and methods are understood more readily by reference to the following detailed description, examples, drawing, and claims, and their previous and following description. However, before the present devices, systems, and/or methods are disclosed and described, it is to be understood that this invention is not limited to the specific devices, systems, and/or methods disclosed unless otherwise specified, as such can, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular aspects only and is not intended to be limiting.
The following description of the invention is provided as an enabling teaching of the invention in its best, currently known embodiment. To this end, those skilled in the relevant art will recognize and appreciate that many changes can be made to the various aspects of the invention described herein, while still obtaining the beneficial results of the present invention. It will also be apparent that some of the desired benefits of the present invention can be obtained by selecting some of the features of the present invention without utilizing other features. Accordingly, those who work in the art will recognize that many modifications and adaptations to the present invention are possible and can even be desirable in certain circumstances and are a part of the present invention. Thus, the following description is provided as illustrative of the principles of the present invention and not in limitation thereof.
As used throughout, the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to “a screw” can include two or more such screws unless the context indicates otherwise.
Ranges can be expressed herein as from “about” one particular value, and/or to “about” another particular value. When such a range is expressed, another aspect includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent “about,” it will be understood that the particular value forms another aspect. It will be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independently of the other endpoint.
As used herein, the terms “optional” or “optionally” mean that the subsequently described event or circumstance may or may not occur, and that the description includes instances where said event or circumstance occurs and instances where it does not.
Presented herein is a bone screw system 10 that comprises a fixation element 100, a receiving element 200, coupling element 300, and a compression element 400. In one aspect, the fixation element 100 is adapted to engage a bone and has a head portion 110 and a threaded shank portion 120. The fixation element can be a screw. In an exemplified aspect, the head portion is substantially spherical, or substantially semispherical, although other shapes are contemplated. As one skilled in the art can appreciate, the fixation element can comprise a pedicle screw, such as a standard fast-pitch, double-lead pedicle screw. As such, the head portion 110 can be configured to engage the particular insertion tool designed for the system 10. In one aspect, the head portion of the fixation element defines a screw tool bore 130 configured for engagement with the insertion tool. As illustrated in FIG. 9, the screw tool bore 130 can be a hex shaped bore or other shape that mates with a corresponding insertion tool or driver.
The receiving element 200, as illustrated in FIG. 11, defines an internal bore 210 sized to receive the shank portion 120 of the fixation element 100 and a seat 220 adapted to support the head portion of the fixation element. The seat 220 of the receiving element is shaped to substantially conform to an exterior portion 112 of the head portion of the fixation element. The receiving element can be configured in various ways, as those skilled in the art can appreciate.
The receiving element is further adapted to receive a stabilizer rod 500. As such, in one aspect, the receiving element 200 comprises a pair of opposed legs 240 separated by a rod-receiving channel 250. As illustrated in FIG. 9, the rod 500 receiving channel 250 is sized for complementary engagement with a portion of the stabilizer rod. The compression element 400, as discussed below, is configured to work with the receiving element to compress the stabilizer rod onto the coupling element 300, although the system can work without the use of a coupling element. The compression of the stabilizer rod into the receiving element can be accomplished in several manners, including but not limited to, externally threading the two legs 240 for engagement with an internally threaded nut, or internally threading the two legs for engagement with an externally threaded set screw. As such, in this aspect, the pair of opposed legs 240 defines a compression element receiving chamber 260. In one exemplified aspect, the threads of the opposed legs and complimentary threads of compression element can comprise square threads. As one skilled in the art can appreciate, other thread patterns, such as but not limited to, inwardly tilted threads, dove tail threads, and the like, may be used.
In one exemplified aspect, the coupling element is positioned in the receiving element below the stabilizer rod when the stabilizer rod is in the receiving element. In one aspect, a top portion 310 of the coupling element is substantially saddle-shaped to substantially conform to the shape of the stabilizer rod to maximize contact surface area between the coupling element 300 and the stabilizer rod. The coupling element provides additional surface area of contact between the stabilizer rod and the head of the fixation element, so when the compression element is in place, the force of the compression element maintains the orientation of the fixation element.
The compression element is engagable with the receiving element 200, as discussed herein. In one aspect, the compression element 400 is adapted to move downward into the compression element receiving chamber 260 to translate a force to the stabilizer rod 500 and place it into contact with the coupling element, which translates a force onto the head portion of the fixation element and substantially fixes the position of the fixation element with respect to the receiving element. If the system is without a coupling element, the stabilizer rod can exert the force onto the head portion of the fixation element directly.
In still another aspect, the compression element can further comprise a top saddle 410 rotatingly positioned on its bottom face 420. It can, for example, be mounted to the bottom face 420 of the compression element. Alternately, as illustrated in FIG. 9, the top saddle 410 can comprise a male protrusion 412 designed to penetrate the compression element 400 and be retained thereby. In this aspect, the top saddle self-aligns into secure engagement with the stabilizer rod 500 as the top saddle moves downward toward the stabilizer rod. This design maximizes the contact surface area between the compression element 400 and the stabilizer rod. The top saddle 410 shown in FIG. 10 shows a top saddle 410 comprising a rod trough 414 substantially conformable to the surface of the stabilizer rod. In one exemplified aspect, the top saddle comprises a proximal end 416 and a distal end 418, where at least one of the two ends extends out of the compression element receiving chamber substantially along the longitudinal axis AR of the rod-receiving channel. In this fashion, the orientation of the top saddle is maintained to keep the rod trough 414 in substantially co-linear relation to the longitudinal axis of the rod-receiving channel and is prevented from rotating with the compression element by the two legs of the receiving element. In one aspect, the proximal end 416 extends further than the radius of the compression element receiving chamber. In another aspect, the distal end 418 extends further than the radius of the compression element receiving chamber. In yet another aspect, both ends extend further than the radius of the compression element receiving chamber.
The compression element 400 is designed to be driven into the compression element receiving chamber. In one aspect, the top face 430 of the compression element defines a set screw tool bore 440 configured for engagement with an insertion tool. The set screw tool bore 440 can be, but is not necessarily, configured to engage the same insertion tool as the screw tool bore discussed above.
Some practitioners may desire to position the bone screw system with the aid of one or more guide wires. In this case, the practitioner can place a guide wire into the desired target location. In this aspect, the system defines a coaxial aperture along the longitudinal axis AL. Therefore, in this aspect, the compression element 400, the coupling element 300, and the fixation element each define a coaxial guide wire aperture 510. Where there is a top saddle present in the system, the top saddle also defines a coaxial guide wire aperture 510.
In another aspect, the bone screw system also comprises a pair of leg extensions 242. Each leg extension has a first end 244 and a second end 246, where the second end 246 is coupled to a respective opposed leg 240 of the receiving element 200. The pair of leg extensions define a first insertion tool pathway 270 therebetween one another and a second insertion tool pathway 280 therebetween one another.
In one aspect, the cross-sectional shape of the leg extensions are substantially similar to the cross-sectional shape of the leg to which it is coupled, each leg extension having the same outer cross sectional shape as the leg to which it is coupled. As can be appreciated, the cross-sectional dimensions of the leg extensions can also be substantially the same as the crosssectional dimensions of the legs to which they are coupled, although it is contemplated that the leg extensions can vary in shape and dimension from the legs to which they are coupled. The length of each leg extension can vary, but in any event, the first end of each of the leg extensions extends outside of the patient when the fixation element is positioned within the spine of the patient.
In an exemplified aspect, the two leg extensions are coupled to each respective leg at or near the leg extension's second end 246 in a manner such that the leg extension can be removed from the leg if desired. In one aspect, the leg and the leg extension can be integral, with a reduced thickness portion 248 at or near the point of coupling. In this aspect, sufficient radial pressure exerted near the reduced thickness portion will fracture the reduced thickness portion 248, thereby separating the leg extension from the leg. The reduced thickness portion can be interior, exterior, or both. Interior, in this instance, refers to the side of the leg extension or leg that faces the compression element receiving chamber.
The interior face 247 of each of the leg extensions need not be threaded like the legs of the receiving element. This configuration permits the compression element to slide between the leg extensions and into the compression element receiving chamber until it reaches the threaded portion. In one aspect, the interior face 247 of the leg extensions is threaded toward the second end 246.
In another aspect, the two leg extensions are connected via a connector 249 positioned at a point spaced therefrom the first end of the leg extension and spanning the first insertion tool pathway 270. In one aspect, the connector is positioned substantially perpendicular to the longitudinal axis A.sub.L. Positioning the connector 249 a predetermined distance spaced from in near proximity to the first end provides a fulcrum point from which a rod insertion tool can rotate traversing both the first and second insertion tool pathways to allow the stabilizing rod and the insertion tool to pass to push a stabilizer rod into position within the receiving chamber, and wherein the second insertion tool pathway is open from the first end through the second end of the leg extensions to the rod receiving channel and wherein the leg extensions and the legs are integral, and wherein at a coupling point between the legs and leg extensions there is a reduced thickness. As seen in FIG. 19, the stabilizer rod is positioned between the leg extensions with the insertion tool. As the stabilizer rod is positioned lower and toward the second end of the leg extensions, the insertion tool is partially positioned between the leg extensions. At this point, the handle of the insertion tool can be lifted, using the connector as a fulcrum to push the stabilizer rod into position within the rod receiving channel.
As can be appreciated by one skilled in the art, the materials of construction can vary. The materials of construction are generally biocompatible materials for use in surgery. For example, the bone screw system 10 can comprise Titanium or a Titanium alloy, such as Ti 6-4 ELI. The system can also be bead blasted to increase frictional forces and to add stability to the system.
Although several embodiments of the invention have been disclosed in the foregoing specification, it is understood by those skilled in the art that many modifications and other embodiments of the invention will come to mind to which the invention pertains, having the benefit of the teaching presented in the foregoing description and associated drawings. It is thus understood that the invention is not limited to the specific embodiments disclosed herein above, and that many modifications and other embodiments are intended to be included within the scope of the appended claims. Moreover, although specific terms are employed herein, as well as in the claims which follow, they are used only in a generic and descriptive sense, and not for the purposes of limiting the described invention, nor the claims which follow.

## Claims

1. A bone screw system comprising:
an elongate fixation element adapted to engage a bone and having a head portion and a threaded shank portion;
a receiving element defining an internal bore sized to receive the shank portion of the fixation element and a seat adapted to support the head portion of the fixation element, the receiving element comprising a pair of opposed legs separated by a rod receiving channel sized for complimentary engagement with a stabilizer rod, wherein the pair of opposed legs defines a compression element receiving chamber;
a coupling element configured to be positioned in the receiving element below the stabilizer rod, the coupling element having a top portion having a saddle shape to conform to the shape of the stabilizer rod, the coupling element providing additional surface area of contact between the stabilizer rod and the head portion of the fixation element;
a compression element configured to engage a portion of the receiving element and be complimentarily received in the compression element receiving chamber, the compression element configured to compress the stabilizer rod into the receiving element to fix the position of the stabilizer rod with respect to the receiving element;
a pair of leg extensions, each leg extension having a first end and a second end, wherein the second end extends away from and is coupled to the respective opposed leg of the receiving element, each leg extension having the same outer cross sectional shape as the leg to which it is coupled, the pair of leg extensions thereby defining an extension of the compression element receiving chamber, wherein the pair of leg extensions define a first insertion tool pathway therebetween and a second insertion tool pathway therebetween on opposing sides of the extension of the receiving chamber, and wherein the pair of leg extensions is coupled by a connector spanning the first insertion tool pathway positioned at a point or predetermined distance spaced from and in near proximity to the first end to provide a fulcrum point against which an insertion tool holding the stabilizer rod can use the connector as a fulcrum from which the insertion tool can rotate traversing both the first and second insertion tool pathways to allow the stabilizing rod and the insertion tool to pass to push the stabilizer rod into position within the receiving chamber, and wherein the second insertion tool pathway is open from the first end through the second end of the leg extensions to the rod receiving channel and wherein the leg extensions and the legs are integral, and wherein at a coupling point between the legs and leg extensions there is a reduced thickness.

2. The bone screw system of claim 1, wherein the compression element is adapted to move downward into the compression element receiving chamber to force the stabilizer rod into contact with the coupling element and translate a force onto the head portion of the fixation element to substantially fix the position of the fixation element with respect to the receiving element.

3. The bone screw system of claim 1, wherein the compression element comprises external threads and an interior portion of the opposed legs comprises internal threads complimentary to the external threads.

4. The bone screw system of claim 3, wherein an interior portion of the leg extensions each have internal threads.

5. The bone screw system of claim 1, wherein the compression element, the coupling element and the fixation element each define a coaxial guide wire aperture.

6. The bone screw system of claim 1, wherein the leg extensions have a cross sectional shape and the opposed legs each have a cross-sectional shape, and wherein the cross-sectional shape of the leg extensions is substantially similar to the cross-sectional shape of the opposed legs.

7. The bone screw system of claim 1, wherein the leg extensions are removably coupled to the respective legs at the coupling point.