Patent Abstract:
A method and construct for joint repair in which attachment of a double bundle graft ligament approximates anatomic orientation using interference fixation in a single bone tunnel. The double bundle graft features separable strands. A threaded screw is inserted between the separable strands and provides interference fixation of the graft against radially opposing walls defining the bone tunnel. Attachment of the graft using separated strands more closely approximate the configuration of the native ligament. The resulting reconstruction exhibits mechanical functionality that more accurately mimics that of the intact joint, with a minimum of associated tissue morbidity.

Full Description:
[0001]    This application is a continuation of Ser. No. 10/975,087, filed Oct. 28, 2004, now U.S. Pat. No. 7,326,247, which claims the benefit of U.S. Provisional Application Ser. No. 60/515,429, filed Oct. 30, 2003. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the Invention 
         [0003]    The present invention relates to cruciate ligament reconstruction, and more specifically to anatomically accurate cruciate ligament reconstruction using double-bundle ligament grafts in single bone tunnels. 
         [0004]    2. Description of the Related Art 
         [0005]    Cruciate ligament reconstruction is routinely performed by creating femoral and tibial tunnels, and various graft types are used to replace the native cruciate ligament. Most reconstructions are performed using a single-bundle ligament graft made of autograft or allograft material. 
         [0006]    Biomechanical studies have shown that an anatomic double-bundle cruciate ligament reconstruction can be superior in restoring normal knee laxity compared with conventional single-bundle isometric reconstructions. Double-bundle reconstructions, as compared to single-bundle reconstructions, more closely approximate the structure and configuration of the native tendon, and better accommodate the knee&#39;s “screw-home” mechanism. 
         [0007]    Double-bundle reconstructions currently involve individual fixation for each strand of the graft. The need to individually fixate each strand of the double-bundle graft adds to the complexity and cost of the procedure. Double-bundle reconstructions also are performed as shown in U.S. Pat. No. 6,623,524 to Schmieding, the disclosure of which is incorporated herein by reference. Methods for repairing torn cruciate ligaments using double-bundle grafts that are simpler to complete and more closely approximate the native ligament development would enhance reconstruction results. 
       SUMMARY OF THE INVENTION 
       [0008]    The present invention provides methods and apparatus for fixing a double bundle ligament in single bone tunnels during knee ligament reconstruction. The techniques produce a more anatomically correct ligament reconstruction, particularly as in the case of the anteromedial and posterolateral bundles of the anterior cruciate ligament (ACL). 
         [0009]    In order to reestablish native anatomical biomechanics of the damaged ligament, the fixation method of the present invention provides a double bundle configuration of the ligament using a single tunnel at each of the femoral and tibial attachment sites. 
         [0010]    A double, triple, or quadruple graft is prepared, and a femoral socket and a tibial tunnel, in the form of axially elongate openings, are created for ligament reconstruction in the standard fashion. Reference is made to examples of standard ligament reconstruction techniques disclosed in U.S. Pat. No. 5,320,626 to Schmieding and U.S. Pat. No. 5,350,383 to Schmieding et al., the disclosures of which are incorporated herein by reference. 
         [0011]    A notcher, burr or rasp is used to remove material from the tunnel walls to notch or widen the tunnel openings. The notches accommodate graft strands that are forced against the tunnel walls and into the notches by a fixation implant inserted between strands of the replacement graft, as described further below. 
         [0012]    The notches are oriented such that strands of a ligament graft fixed in the tunnel achieve an orientation that more closely approximates that of the native ligament bundles. A fixation implant installed between strands of the graft spread the strands to approximate the anatomical attachment and functionality of the ligament being replaced. In a preferred embodiment, fixation is achieved using an interference implant, preferably in the form of a threaded screw. The technique provides simultaneous anatomical spreading and fixation in each tunnel. 
         [0013]    An exemplary application of the technique to reconstruction of the anterior cruciate ligament in the human knee features positioning a threaded interference screw between the anteromedial and posterolateral bundles of the ACL in each of the preformed tibial tunnel and femoral socket. Installation of the tibial and femoral screws preferably is made in a retrograde fashion, reference being made to examples of retrograde interference fixation described in U.S. Pat. No. 6,461,373 to Wyman et al., the disclosure of which is incorporated herein by reference. 
         [0014]    The reconstruction techniques according to the present invention provide a more anatomical reconstruction that maximizes graft stiffness with true joint line fixation, which reduces tunnel widening. In addition, with respect to knee reconstructions, the techniques substantially increase femoral and tibial graft fixation strength compared to standard interference screws. Further, the invention maintains graft tension during tibial screw fixation, and replaces the need for double tunnel surgery using reproducible transtibial techniques and instrumentation. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0015]    A more complete understanding of the invention will be gained by reference to the descriptions below when read in conjunction with the attached drawings listed as follows: 
           [0016]      FIG. 1  illustrates a graft ligament used in an exemplary method of anterior cruciate ligament reconstruction according to the present invention; 
           [0017]      FIG. 2  is a schematic anterior view of a human left knee shown during a step of notch formation in femoral and tibial tunnels in the method of anterior cruciate ligament reconstruction according an exemplary embodiment of the present invention; 
           [0018]      FIG. 3  illustrates the left knee with a ligament graft passed into the tunnels in preparation for femoral fixation in retrograde fashion according to the present invention; 
           [0019]      FIG. 4  illustrates alignment of a femoral retroscrew in the knee in a further step of the reconstruction method according to the present invention; 
           [0020]      FIG. 5  illustrates positioning of the femoral retroscrew with respect to the graft strands in the method of ligament reconstruction according to the present invention; 
           [0021]      FIG. 6  illustrates insertion of the femoral retroscrew according to the present invention; 
           [0022]      FIG. 7  illustrates the knee in preparation for insertion of a tibial retroscrew according to the present invention; 
           [0023]      FIG. 8  illustrates a step of delivering the tibial retroscrew into the knee joint according to the present invention; 
           [0024]      FIG. 9  illustrates alignment of the tibial retroscrew with the tibial tunnel according to the present invention; 
           [0025]      FIG. 10  illustrates insertion of the tibial retroscrew in the tibial tunnel according to the present invention; 
           [0026]      FIG. 11  illustrates a further step of the exemplary ligament reconstruction method according to the present invention; and 
           [0027]      FIG. 12  illustrates secondary screw fixation in the exemplary ligament reconstruction method according to the present invention. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0028]    An exemplary method of anterior cruciate ligament (ACL) reconstruction in a human knee according to the present invention is described below in conjunction with  FIGS. 1-12 . The teachings, methods, and techniques presented can be applied as well to other surgical applications, including without limitation posterior cruciate ligament (PCL) reconstruction in the human knee, for example, as well as reconstructions of other ligaments and joints in humans and skeletal creatures. Adaptations and adjustments to the exemplary technique of human ACL reconstruction described undoubtedly will be necessary in the other surgical applications. They will be well within the skill of the practitioner capable of understanding and undertaking the present teachings and techniques, however, and readily accomplished without undue experimentation. 
         [0029]    Referring initially to  FIG. 1 , a double hamstring autograft or tibialis tendon allograft  2  of a minimum length of 140 mm is preferred for the double bundle ACL technique. A midline  4  is marked and 20 mm whip-stitches  6 ,  8  of #2 FiberWire™ suture is placed on each side of the graft mid line  4 . (FiberWire™ suture is sold by Arthrex, Inc. of Naples, Fla., the assignee of the present application, and is described and claimed in U.S. Pat. No. 6,716,234, the disclosure of which is incorporated herein by reference). Suturing across the midline  4  is avoided to allow for folding of the graft during tunnel insertion, described in more detail below. Another pair of 20 mm whip-stitches  10 ,  12  is placed 50 mm from the proximal ends of the graft  2  to enhance tibial RetroScrew fixation, described further below. A #5 FiberWire™ graft passing suture  14  is looped around the midline  4 . Sutures  16 ,  18  are secured with whip-stitching to the ends of graft  2 . 
         [0030]    Referring to  FIG. 2 , a skeletal knee joint  20  is illustrated showing terminal portions of a femur  22  with femoral condyles  24  engaging medial and lateral menisci  26 ,  28  of a tibia  30 . A portion of a fibula  32  also is shown. Femoral socket  34  and tibial tunnel  36  are prepared in standard transtibial fashion. Femoral socket orifice  38  is notched at the 10:00 ( 40 ) and 4:00 ( 42 ) positions for left knee  20 , to accommodate anteromedial and posterolateral bundles of graft  2 , described below in further detail. The anterior and posterior tibial tunnel orifices are notched using a 5 mm wide Retro Tunnel notcher  44 , sold by Arthrex, Inc. of Naples, Fla. 
         [0031]    Referring to  FIG. 3 , graft  2 , folded at the midline  4  is passed into the femoral socket  40 . A #2 FiberStick™  46  (FiberStick™ is a length of FiberWire™ with a stiffened tip, disclosed in U.S. Patent Application Publication No. US 2003/0153948, incorporated herein by reference) is preloaded in a RetroScrew driver  48  with a 2 cm length extending from the tip of driver  48 . The driver  48  is inserted through the tibial tunnel  36  anterior the graft  2 . The extended end of FiberWire™  46  is retrieved and pulled out an anteromedial portal. The FiberStick™  46  is inserted to a head of a femoral retroscrew  50 . The FiberStick™  46  is knotted at the tip of the Femoral RetroScrew  50  with at least three half hitches. The Femoral RetroScrew  50  is then snapped into the end of a Shoehorn Cannula  52 , sold by Arthrex, Inc. of Naples, Fla. The cannula  52  is inserted into the anteromedial portal and a cannula obturator (not shown) is used to push the screw  50  into the joint. 
         [0032]    Referring to  FIG. 4 , the retroscrew  50  is urged by drawing on FiberStick  46  until the RetroScrew  50  is in axial alignment with tibial tunnel  36 . The Femoral RetroScrew  50  is then mounted on the tip of driver  48 , care being taken to remove soft tissue from the driver/screw interface prior to seating the screw  50 . The RetroScrew  50  is fully inserted onto the driver when a laser line  54  is flush with the head of the screw. The FiberStick™ suture  46  is removed out the anteromedial portal. 
         [0033]    Referring next to  FIG. 5 , graft  2  is pulled distally to visualize the whip-stitching  6 ,  8  and to position the Femoral RetroScrew  50  between the two strands of the folded graft  2 . The graft  2  is pulled slowly so that it is seated fully in the femoral socket  40  while advancing the screw  50  into the femoral socket  40  between the graft strands. A probe (not shown) may be used to orient the two bundles of graft  2  anatomically into the respective notches of femoral tunnel  40 . The distal end of the whip-stitching  6 ,  8  should be flush with the opening of tunnel  40  prior to insertion of screw  50 . 
         [0034]    The graft  2  is tensioned in the femoral socket  40 , and graft strands are positioned into the notches of the femoral tunnel  40 . The Femoral RetroScrew  50 , is positioned between the graft strands and axially aligned with the tunnel  40  in 90° of knee flexion. The diameter of femoral RetroScrew  50  should be equal to or 1 mm larger than the diameter of the drilled femoral socket. The femoral RetroScrew  50  separates the folded graft  2  into two anatomical bundles. The concentrically-positioned screw  50 , under the looped graft  2 , substantially increases femoral pull-out strength of the graft  2  as compared to prior techniques. 
         [0035]    Referring to  FIG. 7 , the knee is cycled and the driver  48  is reloaded with a #2 FiberStick™  56  and reinserted up the tibial tunnel  36  anterior to the graft  2 . The proximal end of the FiberStick™  56  is retrieved and pulled out the anteromedial portal using a grasper  58 . 
         [0036]    Referring to  FIG. 8 , the end of FiberStick™  56  is passed through the tip of a Tibial RetroScrew  60  having a diameter appropriate to the tibial tunnel diameter. A Mulberry knot is tied behind the round head of the retroscrew  60 . The Tibial RetroScrew  60  is snapped into the end of the Shoehorn Cannula  52  and the cannula  52  inserted into the anteromedial portal. A cannula obturator is used to push the retroscrew  60  into the joint. 
         [0037]    Referring to  FIG. 9 , the knee is cycled and the driver  48  is reloaded with a #2 FiberStick™  62  and reinserted up the tibial tunnel  36  anterior to the graft  2 . The Tibial RetroScrew  60  is mounted onto the tip of driver  48  by pulling on the FiberStick™ suture  62 . Soft tissue is removed from the screw/driver interface prior to seating of the screw  60 . The screw  60  is fully inserted on the driver  48  when a laser line on the driver  48  is flush with the tip of the screw. The FiberStick™  62  is wrapped around handle posts on the driver  48  ( FIG. 10 ) to secure the screw  60  for retrograde insertion. 
         [0038]    While fully tensioning the graft  2  in approximately 20° of knee flexion, the Tibial RetroScrew  60  is inserted counter-clockwise, anterior to the graft  2  under full visual control. Insertion is completed when the round head of the screw  2  is slightly countersunk with respect to the tibial tunnel orifice. The FiberWire™  62  is released from the driver handle and withdrawn out the anteromedial portal by pulling from the knotted end using a grasper  58 , as shown in  FIG. 11 . 
         [0039]    Secondary screw fixation of the graft in the tibial tunnel may be performed by inserting a second Femoral RetroScrew  64  into the distal end of the tibial tunnel  36  (in an antegrade fashion). Such bi-cortical fixation of the graft  2  in the tibial tunnel  36  provides maximum graft fixation strength, creates a blood-rich healing environment in the tunnel  36  between the two screws  60 ,  64 , and reduces post-op soft tissue hematoma. 
         [0040]    Although the present invention has been described in connection with preferred embodiments, many modifications and variations will become apparent to those skilled in the art.

Technology Classification (CPC): 0