Bone plates are commonly used to assist in the healing of broken and fractured bones, especially in situations where casts cannot be applied to the injured area (e.g., fractures occurring to facial areas such as the nose, jaw or eye sockets). A fractured or broken bone may first need to be reset into its proper position before the fracture site is held in place by a bone plate secured to the bone with a screw or other type of fastener.
Some bone plates have a locking mechanism to lock the fastener to the bone plate: e.g., those described in U.S. Pat. No. 5,601,553 to Trebling et al., U.S. Pat. No. 6,206,881 to Frigg, et al., and U.S. Pat. No. 6,974,461 to Wolter, each of which is hereby incorporated by reference in its entirety. The '553 and '881 patents describe a locking mechanism where threads on a screw head and threads on the plate match and are interlocked as the screw head is engaged. The '461 patent describes a method whereby a threaded screw head engages a non-threaded bone plate, such that the threads of the screw head tap a hole in the unthreaded plate.
However, both of these locking mechanisms have drawbacks. A disadvantage of the mechanism described in the '553 and '881 patents is the inability to induce compression (lag) across a fracture plane. In order to confer the benefit of an accelerated healing process and reduced recovery time, the bone plate not only needs to secure the break or fracture site in place, but also needs to maintain the break or fracture under some slight pressure for a sufficient length of time. In the mechanism taught in the '461 patent, the thread on the head of the screw is limited in its ability to engage the plate and is also associated with an increased risk of gauling (cold welding) of the screw to the bone plate. The potential for gauling of the screw to the plate may be minimized by requiring the material of the plate and that of the screw used to be of sufficiently different hardness. However, such a requirement imposes needless plate design constraints and leads to increased manufacturing costs.
Thus, there exists a need for a bone plate with an improved locking mechanism that desirably enables locking of the fastener therein and reliably provides sustained compression across a break or a fracture plane.
The present invention relates generally to a fixation device for fixing two bones together, where the fixation system has locking fixation. The present invention also relates to a fixation system whereby at least one fixation element (e.g., a bone screw, a nail, or other fastener) engages a fixation device. The present invention includes a fixation device comprising a first outer surface, a second outer surface, and an aperture defined at least in part by an aperture wall. In one embodiment, the aperture extends from the first outer surface to the second outer surface. In one embodiment, the tabs protrude from the aperture wall into the aperture, and each of the tabs is configured to form a locking securement with a fixation element disposed within the aperture.
In one embodiment, the fixation element engages the fixation device at an angle. In one embodiment, the fixation element is configured to reduce interference upon the fixation device. In one embodiment, the fixation element is configured to engage the tabs of a fixation device and lock into place.
In one embodiment, the fixation device includes an angular surface. In another embodiment, the fixation device includes an angular surface and a substantially flat surface. In one embodiment, the fixation device includes at least one angular tab cut to facilitate insertion of a fixation element. In one embodiment, the fixation device is configured to lock the fixation element into place.
The present invention also relates to a fixation element having threading that includes a radiused profile. In one embodiment, the threading for the fixation elements includes a superior angular thread profile. In one embodiment, the treading for the fixation elements includes an inferior radiused thread profile. In another embodiment, the threading for the fixation elements includes both a superior angular and an inferior radiused thread profile.
The present invention also relates to an instrument useful in inducing compression, or lag, across a fracture plane. In one embodiment, the instrument is configured to advance a fixation element into a fracture plane without the head of the fixation element coming into contact with the fixation device until a desired compression is achieved across the fracture site being repaired.
The present invention also relates to a method for inducing compression including partially advancing a fully threaded or partially threaded locking fixation element into an aperture of a fixation device, placing the lag tool between the fixation element head and the fixation device, turning the fixation element until the desired amount of compression is achieved across a fracture site being repaired, removing the lag tool, and then locking the fixation element into the fixation device.
The foregoing summary, as well as the following detailed description of various embodiments of the invention, will be better understood when read in conjunction with the appended drawings. Drawings are provided for the purpose of illustrating certain embodiments of the invention. It should be understood, however, that the invention is not limited to the precise arrangements and instrumentalities shown, including the recited dimensions. In the drawings:
a and 2b illustrate a tab configuration in the aperture of a fixation device in accordance with an embodiment of the present invention.
a and 3b are respectively an isometric and a cross-sectional view of a locking fixation system in accordance with one embodiment of the present invention.
a and 4b are cross-sectional views of a fixation element engaging the aperture and tab of a fixation device in accordance with an embodiment of the present invention.
a, 9b, and 9c are isometric illustrations of a lag tool according to the present invention.
The present invention is described more fully hereinafter with reference to the accompanying drawings, which form a part hereof, and which show, by way of illustration, specific exemplary embodiments by which the invention may be practiced. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. Moreover, the present invention may be embodied as methods or devices. Accordingly, the present invention may take the form of an entirely mechanical device embodiment, an entirely method embodiment or an embodiment combining method and mechanical device aspects. The following detailed description is, therefore, not to be taken in a limiting sense.
Locking Fixation System
The present invention relates to a locking fixation system for repairing bone fractures. In certain embodiments, the locking fixation system lockingly engages a fixation element (i.e., a “fastener”) to a fixation device (e.g., a bone plate). Moreover, in certain embodiments, the fixation element head is configured to engage a fixation device at several different angles. Angular fixation improves stability of the fixation device over time and in the face of pressure and stresses on the particular bone or bones being fixed.
In an embodiment of the invention, the locking fixation system includes a fixation device and at least one fixation element, both of which are more fully described below. Any size fracture on any size bone may be fixed using the fixation system of the present invention. In an embodiment of the invention, one advantage of the fixation system of the present invention is the capability for angular stability. In an embodiment of the invention, angular stability minimizes the risk of a mal-union or a non-union, particularly with respect to articular or sub-articular fractures.
A. Fixation Device
A fixation device in accordance with the present invention and drawings is described herein. As used herein, the term “fixation device” means a device that fixes two or more parts together to create a union of such parts. In an embodiment of the present invention, the fixation device is a bone plate. In an embodiment of the invention, the bone plate is a regular shape. In an embodiment of the invention, the bone plate is a shape selected from the group consisting of a Y-shape, a T-shape, an L-shape, a straight plate, or a curved plate. In another embodiment, the bone plate is an irregularly shaped plate. In another embodiment, the bone plate is any shape useful in fixing bone fragments.
In an embodiment of the invention, and with reference to
In an embodiment of the invention, fixation device 10 includes at least one tab slot 19 defined by adjacent tabs 20. In an embodiment of the invention, tab slot 19 has a substantially flat profile. In another embodiment, tab slot 19 has an angular profile. In an embodiment, and with reference to
In an embodiment of the present invention, fixation device 10 includes at least one tab 20. In an embodiment of the invention, there is a minimum of one tab. In another embodiment, there are 2 tabs; in another embodiment there are 3 tabs; in another embodiment there are 4 tabs; in another embodiment there are 5 tabs; in another embodiment there are 6 tabs; in another embodiment there are 7 tabs; in another embodiment there are 8 tabs; in another embodiment there are 9 tabs; in another embodiment there are 10 tabs; in another embodiment there are 11 tabs; in another embodiment there are 12 tabs; in another embodiment there are 13 tabs; in another embodiment there are 14 tabs. In an embodiment of the invention, tabs 20 form a “flower” pattern as shown, for example, in
With reference to
In an embodiment of the invention, the ratio of the thickness of tab 20 to the pitch of threads 5 is from about 1:1 to about 1:4. In another embodiment, the ration is from about 1:1.5 to about 1:3. In another embodiment, the ratio is from about 1:2 to about 1:2.5. In another embodiment, the ratio is about 1:2 (see
In an embodiment of the invention, fixation device 10 and fixation element 1 are manufactured from the same material. In another embodiment, they are manufactured from different material. In an embodiment of the invention, tabs 20 are manufactured of the same or different material than fixation device 10. In an embodiment of the invention, tabs 20 are manufactured from stainless steel or other alloys or titanium or titanium alloys, or any other biocompatible material.
In an embodiment of the present invention, and with reference to
In an embodiment of the invention, and with reference to
In an embodiment of the present invention, and with reference to
B. Fixation Element
In an embodiment of the invention, at least one fixation element, i.e., a fastener, is used with the fixation device. Referring to
a, 3b, and 4a illustrate the interface between tabs 20 and threads 5. In an embodiment of the invention, fixation element 1 is inserted into aperture 21 at an angle of up to 20 degrees relative to the fixation device. In another embodiment, fixation element 1 is inserted into aperture 21 at an angle of about 15 degrees relative to the fixation device.
The present invention also relates to a fixation element 1, having a particular thread design to maximize the functionality, design, and usefulness of such a fixation element with a fixation device 10 according to the present invention. In an embodiment of the invention, threads 5 are designed to deflect in any direction tabs 20 of fixation device 10 according to the present invention. In another embodiment of the invention, and with reference to
In an embodiment of the present invention, and with reference to
In an embodiment of the present invention, and with reference to
One advantage of the present invention over the prior art is that no threads are left in the fixation device 10 upon removal of a fixation element 1. In the prior art device and method, threads remain in the plate upon removal of a fixation element (see e.g., U.S. Pat. No. 6,974,461, which is herein incorporated by reference). Use of deflecting tabs 20 to engage threads 5 is also an advantage over the prior art, which uses deforming plate material to engage fixation element threads 5.
C. Fixation Lag Tool
The present invention also relates to a tool that allows for induction of compression, or lag, across a fracture plane, and a method for inducing compression. In an embodiment of the invention, as shown in
In an embodiment of the invention, the method for inducing compression includes partially advancing a fully threaded or partially threaded locking fixation element 1 into an aperture 21 of fixation device 10; placing the lag tool 40 between fixation element head 2 and the fixation device 10; turning the fixation element 1 until the desired amount of compression is achieved across a fracture site being repaired; removing tool 40 and locking fixation element 1 into fixation device 10 as described above.
The present invention also relates to a locking fixation kit. The kit comprises a fixation lag tool 40 for inducing compression across a fracture plane, fixation device 10, and fixation element 1 according to the present invention.
It will be apparent to those skilled in the art that various modifications and variations can be made in the device of the present invention without departing from the scope of the invention. Thus, it is intended that the present invention cover the modifications and variations of the present invention. Any and all publications, patents, and patent applications are herein incorporated by reference in their entirety.
This application claims the benefit of U.S. Provisional Application Nos. 60/875,689 filed on Dec. 19, 2006, and 60/975,936 filed on Sep. 28, 2007, the contents of which are hereby incorporated by reference in their entirety.
Number | Date | Country | |
---|---|---|---|
60875689 | Dec 2006 | US | |
60975936 | Sep 2007 | US |