Abstract:
A novel anchor is disclosed in a system for fixing fragments of bone together. The anchor includes a first modular fracture plate and an intercalary member configured to engage a second fracture plate at variable distances from the first fracture plate.

Description:
[0001]    This application is a division of U.S. patent application Ser. No. 13/998,567 filed Nov. 12, 2013. It is a nonprovisional application which claims the filing dates of its parent application as well as of the same inventor&#39;s provisional application, Ser. No. 61/796,662, filed in the United States Patent and Trademark Office on Nov. 19, 2012. 
     
    
       [0002]    This invention relates to repairing and reconstructing injured ligaments and tendons. More particularly, it relates to novel devices, instruments and methods for repairing and reconstructing an injured intra-articular, extra-articular ligament or a tendon to a bone. It also relates to novel implants, instruments and methods for realigning the axis of a bone and for fixing fragments of a bone together. 
         [0003]    Except for the provisional application just referred to and the parent application Ser. No. 13/998,567 identified above, there are no patent applications related to this one. None of these applications is subject to any federally sponsored research or development or to any joint research agreement. 
       BACKGROUND OF THE INVENTION 
       [0004]    Orthopaedic surgeons frequently perform reconstructive and reparative surgery for injured ligaments and tendons of the musculoskeletal system. When a patient traumatically injures a ligament in a joint, he may suffer from instability of that joint and require surgery to restore the function of the ligament and of the joint. Many ligament injuries cannot be directly repaired but rather require reconstructive surgery to make a new ligament by replacing the injured ligament with tendon graft. Likewise, when a patient traumatically ruptures a tendon of a muscle, he requires surgery to repair the tendon in order to restore the function of the muscle. Both the reconstruction of ligaments and repair of tendons involve mechanically connecting a soft-tissue tendon to the bone until the tendon can biologically reattach to the bone. 
         [0005]    Orthopaedic surgeons also perform surgery to realign bones for patients who suffer from malalignment of bones and joints due to developmental and acquired disorders. The surgery, known as osteotomy, entails cutting a bone and realigning it along the cut, osteotomy, to change the alignment of the bone and adjacent joints. 
         [0006]    Orthopaedic surgeons also perform surgery to repair fractures of bones, reconnecting the broken members so that they can heal in proper relationship. Repairing fractures of bones typically involves mechanically connecting the separated bone fragments, often with a properly sized and shaped bone fracture repair plate and screws. 
       BRIEF SUMMARY OF THE INVENTION 
       [0007]    The present invention discloses a new method, instruments and implants for reconstructing or replacing a damaged ligament of a joint or repairing a torn tendon by reattaching the bundle of soft-tissue directly to the cortical surface of a bone. The present invention also discloses a new manner of realigning a bone by performing an osteotomy and altering the relative position of the bone fragments. A novel implant utilizing an adjustable length bone fixation plate for repairing a fracture of a bone is also disclosed. 
         [0008]    Accordingly, an object of this invention is to provide an improved means to restore a damaged ligament or tendon attached to a bone, thereby better restoring the normal anatomy of the joint and its normal structural relationships. 
         [0009]    Another object of this invention is to better restore the anatomy of a joint by attaching a soft-tissue graft to the cortical surface of the ligament attachment site on the bone. 
         [0010]    Another object of this invention is to avoid the surgical morbidity associated with drilling a large tunnel in a bone to reattach a ligament graft or torn tendon. 
         [0011]    Another object of this invention is to avoid destruction of bone, creation of bone drilling debris, late tunnel widening, bone deficiency and similar drawbacks which complicate surgery. 
         [0012]    Another object of this invention is to improve the functional outcomes of surgery because of an improved anatomic positioning of the graft and decreased surgical morbidity. 
         [0013]    Another object of this invention is to provide for an osteotomy in a bone along a plane with a controlling relationship to an adjacent joint and its direction of movement. 
         [0014]    Another object of this invention is to maximize the bony contact area across an osteotomy site to provide maximum stability and area of the bone healing surface. 
         [0015]    Another object of this invention is to minimize changes to the longitudinal length of a bone following an osteotomy. 
         [0016]    Another object of this invention is to minimize the distance between the joint and an osteotomy site while creating the osteotomy and realigning the bone at a position that maintains the relative length and function of the ligaments and tendons surrounding the joint. 
         [0017]    Other objects and advantages of this invention will be apparent to orthopaedic surgeons and other persons who are skilled in the art of ligament and tendon repair and reconstruction, osteotomy, and bone fixation, particularly after reviewing the following description of the preferred embodiments of the present invention and the accompanying drawings. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0018]      FIG. 1A  is a perspective view of a joint with two bones and an undamaged ligament connecting the bones at their bone attachment sites. 
           [0019]      FIG. 1B  is a perspective view of the joint in  FIG. 1A  illustrating the ligament in a damaged condition. 
           [0020]      FIG. 1C  is a perspective view of a joint similar to the joint in  FIG. 1B  with a ligament graft replacing the damaged ligament and fixed to the two bones within either a blind ended or complete bony tunnel in accordance with traditional techniques prior to the present invention. 
           [0021]      FIGS. 2A ,  2 B,  2 C and  2 D are perspective views of the joint in  FIG. 1B  with alternative forms of a ligament graft replacing the damaged ligament and fixed to the two bones at the cortical surfaces of the bone attachment sites in accordance with the present invention. 
           [0022]      FIGS. 3A ,  3 B, and  3 C are perspective views of the joint in  FIG. 1B  with a folded ligament graft replacing the damaged ligament and fixed to the two bones at the cortical surfaces of the bone attachment sites in accordance with the present invention. 
           [0023]      FIGS. 4A ,  4 B,  4 C,  4 D, and  4 E are perspective views of the joint in  FIG. 1B  with alternative forms of a ligament graft replacing the damaged ligament and fixed to the two bones at the cortical surfaces of the bone attachment sites in accordance with the present invention. 
           [0024]      FIGS. 5A ,  5 B, and  5 C are perspective views of the joint in  FIG. 1A  with alternative forms of a folded ligament graft replacing the damaged ligament and fixed to the two bones at the cortical surfaces of the bone attachment sites in accordance with the present invention. 
           [0025]      FIG. 6  is a perspective view of the joint in  FIG. 1B  with a graft augmented by a mechanical bridging material replacing the damaged ligament and fixed to the two bones at the cortical surfaces of the bone attachment sites in accordance with the present invention. Ideally these augmenting mechanical bridges anatomically follow the course of the native ligament and its bundles, attached to the bones at the native ligament attachment points. 
           [0026]      FIGS. 7A and 7B  are perspective views of the joint in  FIG. 1B  with alternative forms of a graft augmented by a fixation device which captures the free ends of the graft replacing the damaged ligament and fixed to the two bones at the cortical surfaces of the bone attachment sites in accordance with the present invention. 
           [0027]      FIGS. 8A ,  8 B,  8 C,  8 D, and  8 E are perspective views of the joint in  FIG. 1B  with alternative forms of a graft replacing the damaged ligament and fixed to the bones at the cortical surfaces of the bone attachment sites in accordance with the present invention. 
           [0028]      FIG. 9  is a perspective view of a tendon attached to the cortical surface of a bone in accordance with the present invention. 
           [0029]      FIG. 10  is a perspective view of a novel curved bone cutting guide which is utilized in the invention described herein. 
           [0030]      FIG. 11A  is a perspective view of the bone cutting guide shown in  FIG. 10  aligned on a bone using a novel hinged external jig arranged across a joint for determining the plane of terminal flexion and extension of the joint in which the bone is a member. 
           [0031]      FIG. 11B  is a perspective view of the hinged external jig shown in  FIG. 11A . 
           [0032]      FIG. 12  is a perspective view of a bone being cut utilizing the curved bone cutting guide shown in  FIG. 10 . 
           [0033]      FIG. 13  is a perspective view of a bone which has been cut using the curved bone cutting guide of  FIG. 10  disposed for realignment in accordance with the present invention. 
           [0034]      FIG. 14  is a perspective view of a fractured bone repaired with a traditional plate and screws. 
           [0035]      FIG. 15  is a perspective view of a fractured bone with a novel adjustable-length compression fracture plate placed across the fracture in the bone in accordance with the present invention. 
           [0036]      FIG. 16  is a perspective view of a number of intercalary segments having various cross sectional configurations which may be used with the fracture plate shown in  FIG. 15 . 
           [0037]      FIG. 17A  is a perspective view of a novel double locking screw arranged for engagement with the fracture plate of  FIG. 15   
           [0038]      FIG. 17B  is a perspective view of a conventional screw arranged for engagement with the fracture plate of  FIG. 15 . 
           [0039]      FIG. 18  is a sectional view of the fracture plate in  FIG. 15  applied to the bone taken along the line  1 - 1  in  FIG. 15 . 
           [0040]      FIG. 19  is a sectional view taken along the same line  1 - 1  in  FIG. 18  of the fracture plate in  FIG. 15  applied to a bone and utilizing a double locking screw as shown in  FIG. 17A . 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0041]    An undamaged joint  10  is illustrated in  FIG. 1A  which includes a first bone  4  and a second bone  5  connected by a ligament  1 . Such ligaments  1  may consist of multiple separate bundles such as ligament bundles  2 , 3  which connect to the bone attachment sites  7  on the cortical surfaces  6  on the bones  4 , 5 . 
         [0042]    Ligaments of a joint can be torn from injury, as shown in  FIG. 1B . Primary repair of the torn ligaments  11  themselves is usually unsuccessful and orthopaedic surgeons typically replace them by drilling either a blind ended tunnel  22  or a tunnel completely through the bone such as tunnel  23  at the ligament attachment sites  7  and place a biologic soft-tissue graft such as the graft  21  in the tunnels  22 ,  23  to replace the spanning ligament  1 . That construction is shown at  FIG. 1C . 
         [0043]    Drilling tunnels in a bone creates injury, does not allow for anatomic attachment of a graft to the cortical surface, and sometimes leads to other surgically related complications. 
         [0044]    The novel method, technique and implant of the present invention reconstructs a ligament such as ligament  1  by connecting a biologic soft-tissue graft  21  to the cortical surfaces  6  at the ligament attachment sites  7  located on the bones  4  and  5  of a joint  10 . Various forms which the graft  21  may take are shown in  FIGS. 2 through 9 . 
         [0045]    At the time of ligament reconstructive surgery, with or without arthroscopic, fluoroscopic, robotic, or computer navigational assistance, cortical loops  32  are placed along a cortical surface  6  at a ligament bundle attachment site  7  capturing the soft-tissue graft  21 . The cortical surface of the bone may be prepared to stimulate a healing response at that site. The cortical loops  32 , which may be called fixation devices, may be of a fixed length or adjustable length and composed of permanent, biologic, composite, or resorbable biocompatible material, and they can be of varying diameter or width. Each loop  32  engages the bone at two separate sites  34  with intervening cortical bone surface between. Multiple cortical loop fixation devices  32  and multiple biologic soft-tissue grafts  21  can be used to in a multitude of configurations to restore the multiple bundle  2 , 3  anatomy of the original ligament  1  across the bones  4 ,  5 ,  8  proximate to a joint  10 . Additional mechanical reinforcements  41  can be used to bridge the bones  4 , 5  to mechanically reinforce graft  21  until it heals to bones  4  and  5 , and mechanical graft locks  51  can be added to fix loose ends of the graft back upon itself to create a closed loop as shown in  FIGS. 7A and 7B . Grasping suture or other mechanical devices  33  placed at either or both of the loop and free ends of a soft-tissue graft or the ends of the graft themselves can be anchored to the bone  4  at a distant site to augment the overall fixation strength of ligament reconstruction construct ( FIG. 8A ) 
         [0046]    Cortical fixation loops  32  can also be used in multiple configurations to fix torn tendons  24  of muscles  25  back to a cortical surface  6  of a bone  4 , as shown in  FIG. 9 , for example. 
         [0047]    Bone realignment procedures are also sometimes needed in conjunction with ligament reconstructive procedures. In the present invention, the following novel bone realignment procedures may be utilized. A hinged external jig  61  and bone cutting guide  71  may be created using patient-specific three-dimensional anatomic data from preoperative imaging modalities and computer software, including but not limited to computed tomographic scans, magnetic resonance imagining and plain radiography. The hinged external jig  61  can be applied to a joint  80  with fasteners  63 ,  64  that help position the jig  61  along bones  81 ,  82  of the joint  80 , thereby positioning the hinge  62  with its two connecting arm  65 ,  66  at the center of rotation of the joint  80  as shown in  FIG. 11A . Fasteners  63 ,  64  may be applied to the bones  81 ,  82  but surrounding soft-tissue or similar bone fixation devices around the joint  80  may be used instead. The hinged external fixation jig  61  may be unilateral (single hinge  62  and arms  65 ,  66 ) or bilateral (two hinges  62  and two sets of arms  65 ,  66 ). 
         [0048]    The bone cutting guide  71  is removably attached to the hinged external jig  61  through the jig connector  67 . The joint  80  is moved to demonstrate the plane of bending motion, as shown in  FIG. 11A . Also, the jig connector  67  allows cranial-caudal and rotational adjustment of the cutting guide position. A longitudinal alignment rod  90  can be removably attached to the cutting guide  71  to help adjust the longitudinal alignment in the coronal and sagittal planes. When the cutting guide is arranged in proper position, i.e., height, rotation, slope (tilt), and perpendicular to the plane of flexion of the joint  80 , it is fixed to the bone  82  with bone fixation devices  110  and the external hinged jig  61  is removed as shown in  FIG. 12 . 
         [0049]    The cutting guide  71  includes cutting holes  75 , a slot  74 , stabilizing arms or tabs  73  and holes  72  for bone fixation devices  110  (see  FIGS. 10 and 12 ). With the cutting guide  71  fixed in position on bone  82 , pins of fixed length  120  may be inserted into the bone through holes  75  in the cutting guide  71 . Each pin can possess a slightly larger cutting diameter at its leading tip which allows the pin to cut through a first cortex of a bone  82  and pass with relatively little tactile resistance through the central cancellous portion of bone  82  until pin  120  reaches the second cortex and meets resistance again. By placing several fixed length pins  120  in this fashion, the thickness of the bone  82  and the required depth of the cut can be determined. Then a cutting blade  100  can be advanced through cutting slot  74  to a depth which matches depth mark  130  on the cutting blade  100  corresponding to the length of pins  120  until the mark  130  on the blade  100  reaches the trailing end of the fixed length pins  120  as shown in  FIG. 12 . 
         [0050]    When the bone  82  is cut, and the cutting guide  71  is removed, any adjacent supporting bone such as bone  84  is also cut, and bones  82  and  84  are realigned along their respective osteotomies  140 ,  150 . There they are fixed in position as shown in  FIG. 13 . 
         [0051]    The present invention includes fixation of bone  201  fragments  202 ,  203  from osteotomies  140  or fracture  204 . After percutaneous or open exposure of a bone  201  with a fracture  204 , a conventional plate  205  and screws  250  can be applied as shown in  FIG. 14 . In the present invention, as shown in  FIG. 15 , after a similar exposure novel modular fracture plate ends  220  are connected with single or multiple intercalary segments  240  to assemble the locking adjustable-length compression fracture plate  200 . That plate is applied to the bone  201 , centered over the fracture  204 . Proper length and size intercalary segments  240  can be inserted into the intercalary segment channels  221  of the fracture plate ends  220 . Modular fracture plate ends  220 , intercalary segments  240 , and locking screws  230  can be made in various sizes in order to fix different sized bones. Intercalary segments  240  can also be made in different cross sectional shapes, stiffness, longitudinal shape, bending properties, materials (including radiolucent, biologic, resorbable) and lengths such as  240   a,    240   b  and  240   c  (see  FIG. 16 ). 
         [0052]    After the adjustable length plate  200  is applied to the reduced fracture  204 , locking screws  230  or non-locking screws  250  are inserted through the regular screw single-locking and non-locking locking holes  226  in the fracture plate ends  220  to connect the fracture plate ends  220  to the bone  201 . Optionally, a locking compression-reduction clamp (not shown) can be used to grasp each of the fracture plate ends  220  by their respective compression device attachment points  229  and apply compression and reduction forces across fracture  204 . Then, with the compression clamp in place, double locking screws  230  can be inserted into the combination screw locking and intercalary segment locking holes  222  for locking engagement between the fracture plate ends  220  and the intercalary segment  240  as shown in  FIGS. 18 and 19 . 
         [0053]    Locking engagement connects the double locking screw  230  at a fixed position, depth and angle relative to the fracture plate ends  220  and also compresses the intercalary segment  240  within the intercalary segment channel  221  of the fracture plate ends  220  so as to prevent any longitudinal or rotational movement between the fracture plate ends  220  and the intercalary segment  240  along the axis of the intercalary segment  240 . This locking engagement can be reversed with removal of the locking screw  230 . The double locking screws  230  can have combined or separate plate and intercalary segment engaging sections  233 ,  232  and a threaded bone engaging section  231  as shown in  FIG. 17A . The plate and intercalary segment engaging sections  233 ,  232  of the double locking screw  230  reversibly engage plate engaging section  224  and intercalary segment-plate engaging section  223 . These interacting sections of the holes  222  and screws  230  may refer to physically separate segments or overlapping segments, or to the same segments of the holes  222  and screw  230 , depending upon which engaging mechanisms are incorporated. The intercalary channels  221  may be completely enclosed or partially enclosed within the fracture plate ends  220 . 
         [0054]    From the foregoing it will be evident that, although particular forms of the present invention have been illustrated and described, nevertheless various modifications can be made without departing from the true spirit and scope of the invention. Accordingly, no limitations are intended by the foregoing description and the accompanying drawings, and the true spirit and scope of the invention are intended to be expressed in the following claims.