Patent Document

CROSS REFERENCE 
       [0001]    This Application claims the benefit of priority under 35 U.S.C. §119 of U.S. Provisional Application Ser. No. 61/339,869, filed on Mar. 10, 2010, herein fully incorporated by reference. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention relates to an orthopedic plate for use in osteotomies, or surgical procedures, which involve a surgical resection to correct the alignment of a bone or joint. In particular, the plate is designed for wedge opening osteotomies, which involve surgical removal of bone to allow for an opening or widening of a section which permits the desired realignment. The invention includes a contoured plate portion having holes that receive fixation means (i.e. screws), and a centrally located osteotomy support that maintains the opening between bone segments at a spaced relationship. The support can be integral to the plate, or can be modular, i.e. a separate and adjustable segment, which can be changed to accommodate the desired geometry of the osteotomy site and moved to aid in reduction of the bones at the site. 
       BACKGROUND OF THE INVENTION 
       [0003]    An osteotomy is a surgical procedure involving the surgical resecting of bone to correct a misalignment that can be a result of trauma, stress induced deformation, or congenital issues that manifest as misalignment. Hallus vagus, (which involves a bunion at the base of the great toe) is a typical example of a deformity, which may be surgically corrected by an osteotomy procedure and for which the present invention may be used. The surgery involves realignment of the bones of the metatarsophalangeal joint and can include removing bone from either side of the joint area, and opening a wedge shaped area to realign the bones of the great toe with the metatarsal bones of the foot. 
         [0004]    Examples of other surgical procedures for which the present invention might be useful include Cotton osteotomy, Evans osteotomy, lapidus bunionenctomy, calcaneolocuboid fusion, talonavicular fusion, MTP fusion, cuboid fracture, metarsocunieform fusion, chevron osteotomy, Naviculocuneioform fusion, Dwyer osteotomy, isolated TMT fusion, Navicular fracture, and Lisfranc fracture, radial corrections revisiting wrist fusions, tibial osteotomies, and even pediatric femoral and hip surgeries. 
       SUMMARY OF THE INVENTION 
       [0005]    In accordance with the present invention an orthopedic plate is provided that is specifically configured for use in opening osteotomies, and more specifically is configured for use on a variety of small bones. The plate has a bilateral double tabbed footprint (i.e., the outline looking down at the top of the plate). The footprint is symmetrical about the short axis in the x-y direction looking down on the plate, and includes on either side of that axis a larger extension, tab, or wing, and a smaller extension, tab, or wing, each extension including an opening (i.e., a screw hole). The opening optionally includes locking means, such as internal threads, which can accommodate fixed angle locking means or variable locking means that enable the captured screw to be placed with its axis at a variable angle with respect to the opening, and subsequently to be locked at that angle. The plate resembles the shape of a butterfly with a longer set of wings flanking a shorter set of wings. 
         [0006]    It is preferred that the plate is curved in the z-direction (i.e., the plane of the paper looking down on the outline of the plate) such that there is a radius of curvature on the bottom (i.e. the bone-facing) side of the plate. Thus, the plate can form a portion of a cylinder. More preferred for certain indication, the long axis of the plate (i.e., the axis which divides the larger set of extensions from the smaller set of extensions) is also curved or bent in the z direction, so that the plate forms a more complex geometry, such as a section of a torroid or a portion of a cylinder that is bent along the long axis (in the wall of the cylinder). The curve in the plate in the medial direction causes the screws in the openings on either side of the medial axis (perpendicular to the long axis) to be aligned so that their respective axes converge toward each other. The fact that the holes are located at different distances from the medial axis, which is enabled by the relative sizes of the larger extension, and the smaller extension, causes the same side screw axes to converge on the bottom side of the plate, but not to intersect such that impingement of the screws is inhibited, while pullout strength and bone support is improved by the convergent angle. 
         [0007]    Preferably, the screw holes include locking means, which could, for example, include internal threads that mate with corresponding external threads on the head of the screw. Other fastening means, such as pegs, could also be used. It is further advantageous, if means are provided to allow for the use of variable locking means in the same screw holes. The present invention, advantageously contemplates the use of a variable locking means that fits mate with the locking screw holes of the plates, but present the option of either fixed angle locking or variable angle locking and even variable angle non-locking using a screw with an appropriately sized rounded or hemispherical head that rides on the threads of the locking screw hole, depending on the surgeon&#39;s preference for the individual indication. 
         [0008]    The bottom side of the screw also includes a centrally located osteotomy support means. In a first embodiment of the invention, the support is integral to the plate and preferably includes one or more flange members that extend from the plate in the z direction. When there are multiple flange members, and preferably, a pair, they are parallel so as to form a channel along the long axis, or the medial axis for the in-growth of bone, but to provide initial support for the bone edges following the surgery. The flanges can extend in the direction of the long axis or perpendicular to that direction along the medial axis. 
         [0009]    In a second embodiment, the osteotomy support can be modular. In this version of the invention, the support can be a separate piece that has a first member extending through a passageway (i.e., optionally a round opening or a slot with a keyhole) in the center of the plate. The first support member has a neck, which slides in the passageway, and a stop that is wider than the narrow portion of the passageway, but which can be inserted through the key of the passageway in order to allow for assembly. The first support member can be a screw with a round stop or can have a stop of a more complex shape, such as an ellipse, and is attached to the support means, which can be a block, a pair of flanges. The support means can be rotated by means of the first support member that extends beyond the top surface of the plate to cause distraction of bone members on either side of the osteotomy. Optionally, the first support means, particularly in the case of the elliptical shaped member may include a high friction surface about it&#39;s edge such as angled teeth, or ratcheting members that block the support from rotating back once it has been positioned to help maintain the position when the first member slides into the passage way when the support means is in the desired position. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0010]      FIG. 1  is a front side view of a first embodiment of the osteotomy plate of the present invention showing a modular support; 
           [0011]      FIG. 2  is a back view of the osteotomy plate shown in  FIG. 1 ; 
           [0012]      FIG. 3  is a back view of a modification of the embodiment of the osteotomy plate of  FIGS. 1 and 2  showing a keyhole for attachment of the support member; 
           [0013]      FIG. 4  is a further modification of the embodiment of the osteotomy plate of  FIGS. 1 and 2 ; 
           [0014]      FIG. 5  is a second embodiment of the osteotomy plate shown in  FIG. 1  having an integral support member which extends in the longitudinal direction; 
           [0015]      FIG. 6  is a modification of the osteotomy plate shown in  FIG. 5  having an integral support member that extends transverse to the longitudinal direction; 
           [0016]      FIG. 7  is a cross sectional view of the osteotomy plate of  FIG. 6  showing a bend along the longitudinal axis; and 
           [0017]      FIG. 8  is an illustration of a variable locking assembly that can be used with the present invention. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0018]      FIG. 1  shows a first embodiment of the osteotomy plate  10  in accordance with the invention, which has a plate member with a bilateral double tabbed footprint, with a first set of tabs  12  or wings flanking a second set of tabs  14  or wings with a slight incurve  16  between the tab members on either side of the medial axis  18 . Each tab includes an opening  20  for a screw or other fastening means, which could, for example, include a peg or wire. The openings  20  also include internal threads  24  or other means to enable a locking relation to the screw  22 , and optionally grooves  26  in the threads, which receive a drill guide (shown in  FIG. 3 ). The threads of the openings receive the external threads on locking screws that can be used with the osteotomy plate. The openings also can receive variable locking assembly  30  as is shown in  FIG. 8 . Advantageously, the variable locking assembly  30  includes an externally threaded locking insert  32 , which comprises a biocompatible material that is softer than the corresponding screw head  34  which is threaded into the locking insert at a desired angle so as to seat the screw  33  in the plate at a desired angle. 
         [0019]    The plate further includes a support member generally at  40 , which can be integral to the plate member as is shown in the second embodiment, or can be modular as is illustrated in the first embodiment of the invention. In the modular version, the plate  10  includes a central opening  42  that receives a necked portion  44  of the support member  40 . The necked portion is joined to a stop  46  that has at least a width that is wider than the central opening  42  so as to hold the support relative to the plate member  10 . The stop can be a simple screw having a circular or round head  48  as is shown in  FIGS. 1-3 , or can be a more complex shape such as the ratcheting ellipse version  50  shown with an elliptical slot  51  in  FIG. 4 . 
         [0020]    In the modification shown in  FIG. 3 , the central opening is a keyhole  43 . In this version; the necked portion  44  of the support member  40  has a width that is smaller than the keyhole  43 , and the stop  46  has a width that is greater than the slot  45 , but which is smaller than the slot portion  45  of the keyhole  43  to enable the first support member to movably engage the plate and the stop  46  is smaller than the enlarged opening  47  in the keyhole  43  to allow the stop to be inserted through this area. 
         [0021]    In the ratcheting version of the present invention shown in  FIG. 4 , the stop is an round shape  50  that includes inverted teeth  52  which enable the elliptical support  54  to be used for distraction of the bone and to stop the backward rotation of the support when the stop  50  is engaged in a circular area  55  within the elliptical central opening  56 . 
         [0022]    In a second embodiment, the plate  110  has the same bilateral double tabbed footprint as the first embodiment, with a first set of tabs  112  or wings flanking a second set of tabs  114  or wings with a slight incurve  116  between the tab members on either side of the medial axis  118 . Again, each tab includes an opening  120  for a screw or other fastening means and the openings  120  also include internal threads  124  which can selectably receive a fixed angle locking screw, a variable angle locking screw or a variable angle non-locking screw. In this embodiment, the bottom side of the plate  110  includes fixed support means  140  that are advantageously, a pair of flange members  142  that can extend parallel in the direction of either the long axis  144  or the medial axis  146  of the plate. The flanges define a channel  148 , which allows for bone in-growth. 
         [0023]      FIG. 7  illustrates the plate in cross-section along the longitudinal axis. As can be seen the plate has a generally uniform thickness between the inward surface  27  which opposes and optimally, but not necessarily engages the bones, and the outward surface  29 . The inward surface  27  of the plate  10  includes a generally uniform radius of curvature  34 ,  36  along both the longitudinal axis in the transverse direction but in an advantageous modification of the invention, the plate includes a bend in the direction of the longitudinal axis in the area of the support member, and extending outward in either direction from there along the longitudinal axis, the axis is again straight. The amount of bend will depend on the length of this section of the plate. If this section is 1 mm, the bend is from about 1° to about 6°, and preferably about 2° to about 3°, with 3 mm being from about 4° to about 10°, and 5 mm being from about 5° to about 12.5°, and 7 mm being from about 6 to about 15°. 
         [0024]    The screws useful with the plate of the present invention are self-starting, self-tapping screws including the option of partial or full cannulation. The screws include a cutting end having multiple flutes, and preferably 2 or 3 flutes about a conical recess. The screws further include a partial taper of the inner diameter in the proximal end over the first several thread turns, for example over 2-8, and preferably over 3-5 turns in order to increase the fatigue life of the screw as well as providing potential physiological advantages in use. The screws further include a torque driving recess. 
         [0025]    The plate is formed of a biocompatible material, and preferably a metal such as surgical grade stainless steel, titanium or a titanium alloy. Preferably, the plate has a thickness of between about 1.0 and 2.0 millimeters, more preferably between about 1.25 and 1.75 millimeters, and most preferably between about 1.4 and 1.6 millimeters. The plate includes a continuous rounded outer edge  41 , which is defined between the top and the bottom surface. In addition, the plate  10  can include a one or more small through holes sized to receive a K-wire or other similar guide wire. 
         [0026]    While in accordance with the patent statutes the best mode and preferred embodiment have been set forth, the scope of the invention is not limited thereto, but rather by the scope of the attached claims.

Technology Category: 1