Patent Publication Number: US-2011071574-A1

Title: Plastic Implant for Osteosynthesis

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of U.S. patent application Ser. No. 10/314,406, filed Dec. 9, 2002, which is a continuation of International Application No. PCT/CH00/00315, filed Jun. 9, 2000, all of which are incorporated herein by reference in their entirety. 
    
    
     FIELD OF THE INVENTION 
     The invention relates to a bone fixation system for osteosynthesis that includes an implant and longitudinal fixation elements, which may be in the form of wires, nails, pins, or screws, that are received by the implant for anchoring in bone. 
     The implant can be formed as a hone plate or an intramedullary nail. In its plate-like embodiment it can act as an internal fixation means for osteosynthesis, for example, to the proximal humerus or other areas near the joint of tubular bones. 
     BACKGROUND OF THE INVENTION 
     From U.S. Pat. No. 5,476,467 BENOIST, a guiding template that has shafts in the manner of a fan is known for guiding Kirschner wires. The disadvantages of this arrangement consist of the fact that the fixation elements (Kirschner wires) can only be guided parallel to one another through the guiding template. Due to the shaft structure of the template, it does not lie directly on the bone so that the length of the wires to be introduced is unnecessarily extended. 
     SUMMARY OF THE INVENTION 
     Here the invention aims to provide a remedy. The objective of the invention is to provide an osteosynthetic implant which has no penetrating holes to receive longitudinal fixation elements to be anchored in the bone, but rather only a number of indentations in its surface that serve as an aid to positioning and guiding to introduce the fixation elements, at diverging angles and crossing one another, first through the implant and then into the bone. 
     The implant permits the introduction of fixation elements, at diverging angles and crossing one another, into the bone so that primarily a migration of the fixation elements running intramedullarily or in the spongiosa is preventing proximally as well as distally. 
     The invention realizes the objective with an implant that has surface indentations that do not penetrate completely through the implant, but rather serve as an aid to positioning and guiding the fixation elements there through as well as with a fixation device that includes this implant and at least one fixation element for fastening the implant in or on a bone. 
     The indentations, preferably formed conically or cylindrically, in the upper side of the implant serve as centering elements for the penetrating holes of the guiding plate, for example, with Kirschner wires. The Kirschner wires have, on their front part, a drill bit whose length corresponds preferably to at least the thickness of the plate-like implant or to the diameter of the implant in the form of an intramedullary nail. Furthermore, the Kirschner wires have an outer thread that serves to secure against axial displacement in the implant so that a migration of the Kirschner wires in the implant is prevented. The Kirschner wires can be drilled into the implant at angles to its surface that can be freely chosen by the surgeon, preferably in directions skewed relative to one another in order to achieve an optimal fracture fixation. The position and angle of the Kirschner wires can thus be chosen according to the fracture to be cared for. 
     Thus the advantage can be achieved that a minimally invasive operation technology can be applied, with implant material to be inserted minimally. The implant according to the invention is suitable in particular, due to the possibility of arranging the fixation elements in three dimensions, to osteosynthesis of bones that are osteoporotic or weakened by disease. The stability of the osteosynthesis is thus produced primarily by the bolts/wires and their crosswise positioning in the bone. Due to the fact that the implant lies directly on the bone, the free length of the wires to be introduced is reduced to a minimum. Thereby an early load of the fracture site is possible, and thus an earlier utilization of the affected connective masses and, in the ideal case, quicker healing. 
     A preferred extension consists of the case wherein the implant consists of a bioresorbing or biodegradable plastic that is preferably chosen from the group of polylactates. The indentations are expediently disposed in a regular grid on the upper side of the implant. 
     In a development as a bone plate or as plate-like guiding bodies, the implant preferably has an approximately circular upper side with indentations disposed in concentric circles. The number of indentations is between 3 and 100, preferably between 7 and 40. Typically 10 indentations are provided. Expediently the indentations expand conically toward the upper side. The conical indentations advantageously have a conical angle ranging from 30° to 120°, preferably from 40° to 100°. The indentations have on the upper side a diameter ranging from 1.0 to 3.0 mm, preferably between 1.5 to 2.2 mm (typically 2 mm). The depth of the indentations is in the 0.6 to 1.5 mm range, preferably between 0.8 to 1.2 mm (typically 1 mm). 
     In the preferred embodiment as plate-like implant, its upper side is preferably formed convexly in order to achieve a better conformity to the surface of the bone. Its thickness is in the 2 to 6 mm range, preferably between 2.5 to 4.0 mm. The upper side expediently has a surface area ranging from 3 to 15 cm 2 , preferably between 4 to 10 cm 2  (typically 4.5 cm 2 ). 
     In a preferred form of embodiment, the fixation element used as implant has a drill bit with a length from 4 to 10 mm, preferably from 5 to 8 mm. The drill bit should preferably correspond at least to the thickness of the implant. 
     The fixation element is expediently provided with an outer thread, preferably over a length from 30 to 80 mm. It preferably has no head at its back end and has a uniform diameter, seen over its entire length, preferably in the 1 to 6 mm range (typically in the 2 to 5 mm range). 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The invention and extensions of the invention are explained in more detail in the following with the aid of the partially schematic representations of an embodiment example. Shown are: 
         FIG. 1  a perspective representation of a plate-like implant formed as a guiding body; 
         FIG. 1A  is a top view of an alternate plate-like implant; 
         FIG. 2  is a cross-section through the implant along the line II-II in  FIG. 1  in the area of two indentations; 
         FIG. 3  is a view of a fixation element in the form of a Kirschner wire; and 
         FIG. 4  is a view of a fractured humerus with an implant that is fastened to the bone with a plurality of Kirschner wires drilled therein. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     The implant  1  represented in  FIGS. 1 and 2  consists of a 3-mm-thick, arched plate of a biodegradable plastic, in particular a polylactate, suitable for implantation in the human body. The implant  1  has a convex upper side  3  and a concave lower side  4  intended for contact with the bone. In the upper side  3  a plurality of indentations  2  in the form of funnels expanding conically toward the upper side  3  are introduced. 
     The lower side  4  of the implant  1  is preferably made to conform to the bone surface to be applied in order to achieve as good and broad a bone contact surface as possible. 
     Represented in  FIG. 3 , the fixation element  10  in the form of a customary Kirschner wire has no head at its back end  13  so that it has a uniform diameter over its entire length. At its front end the fixation element  10  has a drill bit  11  as well as an outer thread  12 . 
     The implant  1  can be introduced through a minimal incision in the body, for example, in the area of the proximal humerus  20  ( FIG. 4 ) to which it can be fastened with the fixation means  10 . In so doing, the additional use of bone cement is not ruled out. Since the plate-like implant  1  has sufficient indentations  2 , they can serve to fasten bands to bone fragments of the humerus  20 . In so doing, the three-dimensional, skewed arrangement of the fixation means  10  prevents their loosening so that on the whole a greatly improved stability of fixation results.