The present invention relates to a bone implant, in particular, a condylar plate for fixation of a small bone fracture. In one embodiment of the present invention, the condylar plate of the present invention includes two or more tines connected to a plate having one or more apertures configured to receive a fastener. In one embodiment, the tines of the condylar plate are configured to be fixed to the condyle portion of a small bone.
In another embodiment of the present invention, the condylar plate includes scalloped edges adjacent each of said apertures.
In yet another embodiment of the present invention, the tines on the condylar plate are normal to the plate. In another embodiment, all or a portion of the tines are removable. In another embodiment, the tines are flexible. In an embodiment of the invention, the tines are flexible from about 0 to about 90 degrees. In another embodiment, the tines are flexible from about 0 to 45 degrees.
In an embodiment of the invention, a method of fitting a condylar plate to a small bone in a patient is disclosed. In one embodiment, the method includes molding a pliable condylar plate template to the small bone of a patient, drilling holes in the bone through apertures in the template at the location where the tines will be fixated to the bone, and conforming (e.g., bending) the condylar plate to a configuration that corresponds to the template configuration. In one embodiment, the template is substantially identical to the condylar plate, except that it has apertures where the tines would be located.
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:
The present invention is related to bone plates, in particular, a condylar plate and methods for fitting and using bone plates.
Referring to
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In an embodiment of the invention, condylar plate 40 is a low-profile plate. Referring to
In an embodiment of the present invention, condylar plate 40 includes two or more tines 10 configured to be fixed to the condyle portion of a small bone. One advantage to using at least two tines is that optimal stability is increased. In an embodiment of the present invention, tines 10 are substantially normal to longitudinal portion 70 of condylar plate 40 according to the present invention. In an embodiment of the invention, tines 10 have a beveled edge 90 for facilitating insertion of tine 10 into a condyle of a bone. Referring to
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In an embodiment of the invention, tines 10 are fully or partially removable. That is, tines 10 can be clipped (e.g., with side cutter pliers or other appropriate cutting device) to a particular length to fit an individual bone, as shown in
In an embodiment of the present invention, condylar plate 40 has two tines 10 that are spaced from about 3 to about 9 millimeters apart. In another embodiment, tines 10 are spaced about 3.5 to about 8.5 millimeters apart. In another embodiment, tines 10 are spaced about 4 to about 6.4 millimeters apart.
In an embodiment of the invention, the thickness (j) of each of tines 10 present on condylar plate 40 is about 0.5 millimeter to about 2 millimeters. In another embodiment, the thickness (j) of each of tines 10 is about 0.7 to about 1.5 millimeters. In another embodiment, the thickness (j) of each of tines 10 is about 1 to about 1.3 millimeters.
In an embodiment of the present invention, longitudinal section 70 of condylar plate 40 is flat. In another embodiment, condylar plate 40, including tines 10, is flexible. That is, plate 40 can be conformed (e.g., by bending) to a configuration that corresponds to and fits the anatomy (e.g., to the contour of a bone or bones on which it is placed). In another embodiment, plate 40 is conformed to achieve optimal fixation. Referring to
In an embodiment of the invention, longitudinal section 70 of plate 40 transitions from a flat to a radiused cross-section. Referring to
In another embodiment of the invention, condylar plate 40 includes two or more apertures 20, 30 configured to receive a fastener. In an embodiment of the invention, apertures 20 are substantially rounded and cup-shaped, and are defined by a Gage Ball having a specific diameter. In an embodiment of the invention, apertures 20 are defined by a Gage Ball having a diameter of from about 2.0 millimeters to about 5 millimeters. In another embodiment, the Gage Ball diameter is from about 2.3 millimeters to about 4.5 millimeters. In another embodiment, the Gage Ball diameter is about 2.6 millimeters.
In an embodiment of the invention, apertures 20, 30 are tapered from top profile 50 of plate 40 to bottom profile 60 of plate 40, such that upon insertion of a fastener, the fastener head will be substantially flush with top profile 50 of plate 40. One advantage of having the fasteners flush or substantially flush with top profile 50 of plate 40 is that it plays a role in minimizing soft tissue irritation.
Referring to
In an embodiment of the invention, the top profile inner diameter 74 is from about 2.5 millimeters to about 5.5 millimeters. In another embodiment, top profile inner diameter 74 is from about 3 millimeters to about 4.725 millimeters.
In another embodiment of the invention, the bottom profile diameter 76 (identified as o in
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In another embodiment of the invention, at least one aperture 30 is configured to provide up to 1 millimeter of movement during placement, such movement being in at least a one-axis direction to ensure optimal alignment of condylar plate 40 with a bone. Referring to
In an embodiment of the invention, aperture 30 has two radii, a left radius, closer to tines 10, and a right radius, closer to the other apertures, which radii can be the same or different, as shown in
In an embodiment of the invention, the edges 25 of plate 40 are sculpted, for example, scalloped. One advantage of sculpting edges 25 of plate 40 is that it simplifies the contouring of plate 40, and also reduces the aperture stress concentration, thus apertures 20, 30 better resist fatigue. Another advantage of sculpting edges 25 of plate 40 is that it aids in optimizing vascularization around plate 40, which is important to the healing process. Another advantage is that sculpted edges 25 of plate 40 improve the fit of plate 40, thereby optimizing stability of plate 40 after implantation, and protection of soft tissue. Referring to
In an embodiment of the invention, fasteners useful to secure or attach plate 40 to a bone include, for example, screws, k-wires, rivets, pins, and combinations thereof. In certain embodiments, plate 40 includes one or more apertures 20, 30 to receive or accommodate the selected fastener (e.g., screws, k-wires, rivets, and/or pins). In an embodiment of the invention, condylar plate 40 is configured to accommodate 1.5 millimeter bone screws. In another embodiment, condylar plate 40 is configured to accommodate 2.0 millimeter bone screws. In another embodiment, condylar plate 40 is configured to accommodate 2.4 millimeter bone screws.
In an embodiment of the invention, plate 40 is constructed from a medical grade biocompatible material (e.g., metal, alloy, polymer, cobalt-chrome alloys, for example MP35N, BioDurâ„¢, and 22-13-5). In one embodiment, the metal is stainless steel (e.g., polished stainless steel). In an embodiment of the invention, the stainless steel is cold-worked. In one embodiment, the cold-worked stainless steel provides added strength to the plate over titanium or other alloys. One advantage of using stainless steel is that it reduces tendon adhesion in dorsal plating and does not appear to cause a severe inflammatory response. In another embodiment, the plate is constructed from titanium. In another embodiment, the plate is constructed from TAV titanium alloy.
Referring again to
The present invention also discloses a method for fitting a condylar plate to a bone.
In an embodiment of the invention, condylar plate 40 is fitted to a bone using a template. In one embodiment, the template is substantially identical in size and shape to condylar plate 40, except that no tines are present. Instead, the template includes small apertures in a location substantially identical to where tines are present on the condylar plate. The apertures on the template are used to drill holes in the bone where the tines will be fixed.
In an embodiment of the invention, the template is constructed from titanium. One advantage of titanium is that it can be color-coded. In an embodiment of the invention, the template includes apertures for k-wires. In an embodiment of the invention, the template is constructed of a pliable material. In an embodiment of the invention, the template is temporarily fixed to the bone using a k-wire. In another embodiment, the template is temporarily fixed to the bone using a clamp. Once fixed, the template is molded around the bone at a position where the condylar plate will be fixed. Holes are drilled into the bone through the small apertures on the template at the location where the tines on the condylar plate will be fixed to the bone. The template is then removed, and the condylar plate is bent into shape with, for example, bending pliers, to conform the plate to the shape of the template. One advantage of using a template is that it avoids the surgeon having to return to the fracture site multiple times to ensure the correct fit for the plate.
The 1.5 millimeter condylar plate 40 is configured with five apertures 20, 30, all of which are configured to receive a 1.5 millimeter bone screw. Four of apertures 20 are substantially rounded and cup-shaped, each having a diameter defined by a Gage Ball having about a 2.60 millimeter diameter. Apertures 20, 30 are situated along longitudinal axis 70 in a substantially straight line as follows: There is a substantially round aperture 20 located at the top of plate 40 between tines 10 which is bendable to optimize fixation of plate 40 to the bone. Aperture 30 is located just below tines 10 and is oval shaped and has a length along longitudinal axis 70 of plate 40 of about 3.000 millimeters. Aperture 30 is configured to receive the 1.5 millimeter screw, but allows for about 1 millimeter of movement in longitudinal axis 70 of plate 40 to optimize the fixation of plate 40 on the bone. There are three substantially round apertures 20 that follow the oval-shaped aperture 30, which are spaced substantially equally apart at a distance of about 4,000 millimeters from center point to center point of each aperture 20.
Plate 40 is about 23,396 millimeters long and about 0.575 millimeters thick. Tines 10 are about 12.5 millimeters long, taking into account the thickness of plate 40. Tines 10 are about 0.57 millimeters thick. Each of tines 10 is beveled at a 60 degree angle, and each bevel 90 is about 0.869 millimeters in depth.
The 2.0 millimeter condylar plate 40 is configured with five apertures 20, 30, all of which are configured to receive a 2.0 millimeter bone screw. Four of apertures 20 are substantially rounded and cup-shaped, each having a diameter defined by a Gage Ball having about a 4.10 millimeter diameter. Apertures 20, 30 are situated along longitudinal axis 70 in a substantially straight line as follows: There is a substantially round aperture 20 located at the top of plate 40 between tines 10 which is bendable to optimize fixation of plate 40 to the bone. Aperture 30 is located just below tines 10 and is oval shaped and has a length along longitudinal axis 70 of plate 40 of about 4.325 millimeters. Aperture 30 is configured to receive the 2.0 millimeter screw, but allows for about 1 millimeter of movement in longitudinal axis 70 of plate 40 to optimize the fixation of plate 40 on the bone. There are three substantially round apertures 20 that follow the oval-shaped aperture 30, which are spaced substantially equally apart at a distance of about 6.5 millimeters from center point to center point of each aperture 20.
Plate 40 is about 35.880 millimeters long and about 1.0 millimeter thick. Tines 10 are about 13.0 millimeters long, taking into account the thickness of plate 40. Tines 10 are about 1.0 millimeter thick. Each of tines 10 is beveled at a 60 degree angle, and each bevel 90 is about 0.774 millimeters in depth.
The 2.4 millimeter condylar plate 40 is configured with five apertures 20, 30, all of which are configured to receive a 2.4 millimeter bone screw. Four of the apertures 20 are substantially rounded and cup-shaped, each having a diameter defined by a Gage Ball having about a 4.50 millimeter diameter. Apertures 20, 30 are situated along longitudinal axis 70 in a substantially straight line as follows: There is a substantially round aperture 20 located at the top of plate 40 between tines 10 which is bendable to optimize fixation of plate 40 to the bone. Aperture 30 is located just below tines 10 and is oval shaped and has a length along longitudinal axis 70 of plate 40 of about 4.725 millimeters. Aperture 30 is configured to receive the 2.4 millimeter screw, but allows for about 1 millimeter of movement in longitudinal axis 70 of plate 40 to optimize the fixation of plate 40 on the bone. There are three substantially round apertures 20 that follow the oval-shaped aperture 30, which are spaced substantially equally apart at a distance of about 6.500 millimeters from center point to center point of each aperture 20.
Plate 40 is about 37.616 millimeters long and about 1.00 millimeter thick. Tines 10 are about 17.0 millimeters long, taking into account the thickness of plate 40. Tines 10 are about 1.0 millimeter thick. Each of tines 10 is beveled at a 60 degree angle, and each bevel 90 is about 0.764 millimeter in depth.
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 provided they come within the scope of the appended claims and their equivalents.
This application claims priority to U.S. Provisional Patent Application No. 60/718,136, filed on Sep. 16, 2005, which is herein incorporated by reference in its entirety.
Number | Date | Country | |
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60718136 | Sep 2005 | US |