Abstract:
Apparatus and methods for fixation of bone to bone, or soft tissue to bone. The apparatus comprises two fixation devices (for example, two buttons) joined by a biologic material (for example, a graft or tendon). Each fixation device is provided with at least one opening that allows the passage of the flexible material attached to the biologic material. The button may be formed, for example, of metal, PEEK or PLLA.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims the benefit of U.S. Provisional Application No. 61/115,425, filed Nov. 17, 2008, the entire disclosure of which is incorporated by reference herein. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates to the field of surgery and, more particularly, to a joint or ligament reconstruction technique and associated fixation and reconstruction device. 
     BACKGROUND OF THE INVENTION 
     Acromioclavicular (“AC”) joint dislocations are characterized by severe upward displacement of the lateral end of the clavicle relative to the acromium of the scapula. Surgery is recommended to reduce and internally fix the displacement, which could otherwise lead to a painful deformity and loss of function. 
     BRIEF SUMMARY OF THE INVENTION 
     The present invention provides a technique and reconstruction system for repairing AC joint dislocations. The reconstruction system of the present invention comprises two fixation devices (for example, a button and a washer) joined by a biologic component (for example, a graft such as an allograft or autograft). 
     The present invention also provides a method of addressing both acute and chronic AC joint indications. The method of the present invention comprises the steps of: (i) providing a surgical construct including at least two fixation devices joined by a biologic component (for example, a graft such as an allograft or autograft); and (ii) engaging the surgical construct in or on the clavicle, and in or on the coracoid. 
     Other features and advantages of the present invention will become apparent from the following description of the invention which refers to the accompanying drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  illustrates a fully assembled view of a surgical construct of the present invention, with three strands of flexible material attached to two fixation devices (such as a button and a washer). 
         FIG. 2(   a ) illustrates a top view of the button of the surgical construct of  FIG. 1 . 
         FIG. 2(   b ) illustrates a side, cross-sectional view of the button of the surgical construct of  FIG. 1 . 
         FIG. 2(   c ) illustrates a bottom view of the button of the surgical construct of  FIG. 1 . 
         FIG. 2(   d ) illustrates a perspective view of the button of the surgical construct of  FIG. 1 . 
         FIG. 3(   a ) illustrates a cross-sectional view of the washer of the surgical construct of  FIG. 1  (taken along line B-B of  FIG. 3(   b )). 
         FIG. 3(   b ) illustrates a top view of the washer of the surgical construct of  FIG. 1 . 
         FIG. 3(   c ) illustrates a perspective, isometric view of the washer of the surgical construct of  FIG. 1 . 
         FIG. 3(   d ) illustrates a cross-sectional view of the washer of the surgical construct of  FIG. 1 , taken along line A-A of  FIG. 3(   b ). 
         FIG. 3(   e ) illustrates a side view of the washer of the surgical construct of  FIG. 3(   c ). 
         FIG. 3(   f ) illustrates an enlarged view of the detail A of the washer of  FIG. 3(   d ). 
         FIGS. 4(   a )-( d ) illustrate subsequent steps of threading three strands of flexible material through the surgical construct of  FIG. 1 . 
         FIGS. 5-15  illustrate subsequent steps of a method of AC joint reconstruction according to an embodiment of the present invention, employing the surgical construct of  FIG. 1  and with a biologic component (for example, a graft) attached therein. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     The present invention provides a surgical construct and technique for AC joint dislocation surgical repairs. The surgical construct comprises two fixation devices (for example, a button and a washer, or two buttons have the same or different configuration) joined by a biologic component (for example, a graft such as an allograft or autograft) and at least a strand of flexible material (for example, a high strength suture such as FiberWire® suture, sold by Arthrex, Inc. of Naples, Fla., which is disclosed and claimed in U.S. Pat. No. 6,716,234, the entire disclosure of which is incorporated herein by reference). 
     Referring now to the drawings, where like elements are designated by like reference numerals,  FIGS. 1-4  illustrate various structural elements of surgical construct  100  of the present invention provided with two fixation devices (for example, a button and a washer) and at least one strand of flexible material.  FIGS. 5-15  illustrate subsequent steps of an exemplary method of AC joint reconstruction according to an embodiment of the present invention, employing graft system  200  of the present invention that includes the surgical construct  100  of  FIGS. 1-4  and a biologic component  50  (for example, a graft) attached to the surgical construct  100 . 
     As illustrated in  FIGS. 1-4 , surgical construct  100  of the present invention comprises two fixation devices  10 ,  20  connected by at least one strand of flexible material. In an exemplary embodiment only, the two fixation devices include (i) a first fixation device  10  having a first body provided with a first plurality of apertures and an attachment device (such as a handle) extending about perpendicular to a main surface of the first body; and (ii) a second fixation device  20  having a second body provided with a second plurality of apertures, the second body having a curved orientation relative to the longitudinal axis of the second body. 
     The first fixation device  10  is illustrated in more details in  FIG. 2 . As shown in the drawings, and according to an exemplary embodiment only, the first fixation device  10  is a button that comprises a first body  12  provided with a first plurality of apertures  13  and an attachment device (a handle)  15  extending about perpendicular to a main surface of the first body  12 . The first plurality of apertures  13  allow at least one flexible strand (for example, suture strands  31 ,  32 ,  33  of  FIG. 1 ) to be passed and threaded therethrough (as shown, for example, in  FIG. 1  and in the exemplary steps of  FIG. 4 ). Handle  15  of the first fixation device forms opening or aperture  15   a  ( FIG. 2(   d )) with body  12  and is configured to allow a biologic construct (for example, a graft such as an allograft or autograft) to be passed therethrough and securely attached to the handle, for further manipulation and insertion through the coracoid and the clavicle. 
     The second fixation device  20  is illustrated in more detail in  FIG. 3 . As shown in the drawings, and according to an exemplary embodiment only, the second fixation device  20  is a washer that comprises a second body  22  provided with a second plurality of apertures  23 . The second plurality of apertures  23  allow at least one flexible strand (for example, suture strands  31 ,  32 ,  33  of  FIG. 1 ) to be passed and threaded therethrough (as shown, for example, in  FIG. 1  and in the exemplary steps of  FIG. 4 ). 
       FIGS. 5-15  illustrate subsequent steps of an exemplary method of AC joint reconstruction (stabilization of AC joint dislocation) according to an embodiment of the present invention, employing graft system  200  that includes the surgical construct  100  of  FIGS. 1-4  and a biologic component  50  (for example, a graft) attached to the surgical construct  100 . The exemplary steps of the AC joint repair illustrated in  FIGS. 5-15  will be detailed below with reference to the following description: 
     The system  200  of the present invention combines strength, simplicity, and a biologic component to address both chronic and acute acromioclavicular joint indications. With system  200  of the present invention, an allograft or autograft is easily secured to the coracoid button  10 , and the unique cortical washer  20  allows for fixation of the graft to the clavicle (for example, by screw fixation). The metal clavicle washer  20  and coracoid button  10  are joined by a continuous loop of flexible strand (for example, a #5 FiberWire®), providing fixation during the healing phase. This technique can be completed arthroscopically or open. 
     Intended Use 
     The system  200  of the present invention is intended for chronic and acute Grade IV-VI AC separations, as well as Type III separations per surgeon&#39;s discretion. 
     Biologic Compound (Graft) Preparation 
     A graft  50  (such as an autograft or allograft semitendinosis, gracilis or tibialis) is cleaned and prepared. The graft length is approximately 12-15 cm, to allow the folded graft (as detailed below) to pass through a 4.5-5.5 mm sizing block. Preferably, the graft is whipstitched on each of the free ends, and this can be simplified with a FiberLoop® or TigerLoop™, which is disclosed in U.S. Patent Publication No. 2008/0027485, incorporated by reference herein. In order for there to be whipstitching inside the clavicle tunnel, it is important to begin stitching approximately 30 mm from the graft center point. When doubled over, the graft with whipstitching should easily pass through a 6 mm sizing block. 
     An exemplary arthroscopic surgical technique employing graft system  200  of the present invention (that includes the surgical construct  100  of  FIGS. 1-4  and a biologic component  50  (for example, a graft) attached to the surgical construct  100 ) is detailed below with reference to  FIGS. 5-15 . An open surgical technique employing the graft system  200  of the present invention will be detailed following the description of the arthroscopic surgical technique. 
     Arthroscopic Surgical Technique 
     The patient is placed in the lateral or beach chair position under a general anesthesia. The arthroscope is introduced into the glenohumeral joint via a standard posterior portal. An anterior portal is created with an outside/in technique using a spinal needle to verify position. A cannula is inserted through the anterior portal. A full radius shaver blade is introduced through the anterior cannula and through the rotator interval. The base of the coracoid is debrided until the coracoid can be visualized. The inferior border of the coracoid is fully exposed using a shaver and a probe. A 70° arthroscope may facilitate visualization and exposure of the coracoid base. 
     Reference is now made to  FIGS. 5-15  and to the following description: 
     
       FIG. 5 
     
     The coracoid button  10  and the white FiberWire® suture labeled “Graft” are removed from the package. The midpoint of 12-15 cm allograft or autograft  50  is placed over the “basket handle”  15  of button  10 . The graft suture is tied over the graft  50 , making sure to tie sufficient half-hitches. The suture is cut leaving a 2 mm tail. The whipstitched sutures and graft limbs are pulled through the clavicle washer  20  to obtain graft/surgical construct  200 . Preferably, the graft/construct  200  is kept moist until implanted. The entire construct  200  must pass easily through a 6 mm sizing block. 
     
       FIG. 6 
     
     A 2.4 mm unicortical hole is drilled in clavicle  101  at the desired location, which is typically about 35 mm from the distal clavicle  101 . The drill hole may be placed in the center of the clavicle  101  in the anterior to posterior plane. The pin is left in place. A 6 mm hole is reamed unicortical over the pin. Both pin and reamer are removed. The hole serves as a pilot hole for AC guide placement. 
     
       FIG. 7 
     
     A drill guide  60  is positioned in the previously drilled clavicle pilot hole. The coracoid target is placed on the inferior border of the base of the coracoid  102 . The ideal location on the inferior coracoid is close to the base where it projects off of the glenoid. Sufficient bone bridges must be ensured, both anteriorly and posteriorly to the 6 mm reamed tunnel. 
     
       FIG. 8 
     
     A pin  61  is drilled through the inferior cortex of the clavicle  101  and through the coracoid  102 . The pin  61  is left in position. 
     
       FIG. 9 
     
     The drill sleeve is removed and the drill guide is repositioned under the pin  61  to keep it from advancing while reaming. Alternatively, the guide can be removed and a curette or open window of a shaver blade can be used to accomplish this step. A 6 mm cannulated reamer is placed over the pin for slow reaming through the clavicle  101  and coracoid  102 . The reamer is left, but the inner guide pin is removed. 
     
       FIG. 10 
     
     The lasso wire is passed through the reamer, making sure to keep the loop end up. A grasper is used to pull the lasso out of the anterior portal. The cannulated reamer is removed and an end of “Traction” (TigerWire) suture of the GraftRope construct is loaded into the loop (e.g., the lasso loop). The lasso loop is used to draw “Traction” suture through the clavicle  101  and the coracoid  102 , and out the anterior portal. 
     
       FIG. 11 
     
     The “Traction” suture is pulled to deliver the coracoid button  10  through the clavicle  20 . A forked probe, suture retriever, or knot pusher may be used to leverage the suture beneath the coracoid  102 , while pulling on the suture from outside the anterior portal. This facilitates delivery of the coracoid button  10  and graft  50  through the coracoid  102 . Once the button  10  is through the coracoid  102 , a probe may be used to maneuver the button  10  into the desired position at the coracoid base  102 . 
     
       FIG. 12 
     
     The clavicle is reduced. While the clavicle is maintained reduced, the #5 blue FiberWire is tightened. The index finger may be used to “walk” the clavicle washer  20  to the clavicle  101 . The washer  20  is tied down making sure to throw multiple half-hitches. The suture is cut leaving adequate suture tails. 
     
       FIG. 13 
     
     The limbs of the graft  50  are separated, and both limbs are pull tight. A flexible strand (such as a 1.1 mm Nitinol wire) is placed through both cortices of the clavicle tunnel to act as a guide. An interference device (for example, a 5.5 mm Tenodesis Screw) and a driver (for example, a Tenodesis driver) are placed over the guide wire and the screw is inserted until flush. 
     
       FIG. 14 
     
     For final construct ( FIGS. 14 and 15 ), the graft limbs are cut at screw level. Alternatively, or additionally, the limbs are run to the AC joint and are secured to the capsule with FiberWire, or to the anterior and posterior acromion with fixation devices (such as 3 mm SutureTaks). 
     Open Surgical Technique 
     Incision and Exposure 
     An incision of about 4 cm is performed beginning approximately 3.5 cm proximal to the AC joint and is cut inferiorly toward the coracoid. The deltotrapezial fascia is split longitudinally over the distal clavicle. The deltoid fibers are split inferiorly toward the coracoid. The superior surface of the coracoid is exposed. 
     Clavicle/Coracoid Tunnel Preparation 
     A 2.4 mm guide pin is drilled through both cortices of the clavicle, approximately 35 mm proximal to the AC joint. The guide pin is overreamed with a 6 mm reamer to create a bicortical clavicle hole. The guide pin and reamer are removed from the clavicle. Further exposure of the superior surface of the coracoid is conducted. The medial and lateral borders at the base of the projection of the coracoid are defined. Under direct visualization, a 2.4 mm guide pin is drilled through the midpoint of the base of the coracoid. Sufficient bone bridges both medially and laterally to the coracoid tunnel must be left. A bicortical coracoid hole is created with a 6 mm reamer. To protect from advancing the guide pin distally, a retractor is placed under the coracoid. The guide pin and reamer are removed from the coracoid. 
     Positioning of the Passing Wire 
     A wire (for example, a SutureLasso™ Wire) is fed through the coracoid graft passing instrument (right or left) which in turn is used to pass the wire through the coracoid tunnel. The wire is retrieved lateral to the conjoined tendon and inferior to the coracoacromial ligament. The coracoid graft passing instrument is removed and the portion of the wire above the coracoid is passed retrograde through the clavicle tunnel. 
     GraftRope Positioning/Implantation 
     The end of “Traction” (TigerWire®) suture of the surgical construct  100  is loaded into the lasso loop. The lasso loop is used to draw “Traction” suture through the clavicle and coracoid and inferior to the coracoacromial ligament. The “Traction” suture is pulled to deliver the coracoid button through the clavicle. It may be necessary to use a suture retriever or knot pusher to leverage the “Traction” suture beneath the coracoid, while pulling on the suture. This may facilitate delivery of the coracoid button and graft through the coracoid. Once the button is through the coracoid, a finger may be used to maneuver the button into the desired position at the coracoid base. The clavicle is reduced. While the clavicle is maintained reduced, the #5 blue FiberWire® is tightened. The index finger may be used to “walk” the clavicle washer to the clavicle. The washer is tied down making sure to throw multiple half-hitches and leaving adequate suture tails. The limbs of the graft are separated, and both limbs are pulled tight. A wire (for example, a 1.1 mm Nitinol wire) is pulled through both cortices of the clavicle tunnel to act as a guide. An interference device (for example, a 5.5 mm Tenodesis Screw) and a driver (for example, a Tenodesis driver) are placed over the guide wire and the screw is inserted until flush. For final construct, the graft limbs are cut at screw level, or the limbs may be run to the AC joint and secured to the capsule with FiberWire®, or to the anterior and posterior acromion with fastening devices such as 3 mm SutureTaks®. 
     If desired, the graft can be passed beneath/around the coracoid instead of tied to the coracoid button. In this case, it is possible to drill a 4 m tunnel to pass the button alone and the graft limbs can be passed through the clavicle tunnel and clavicle washer. 
     Although the present invention has been described above with reference to a specific embodiment with FiberWire® suture, the invention contemplates any flexible material including hollow braided constructs, or filaments of various colors, among many others. 
     While the present invention is described herein with reference to illustrative embodiments for particular applications, it should be understood that the invention is not limited thereto. Those having ordinary skill in the art and access to the teachings provided herein will recognize additional modifications, applications, embodiments and substitution of equivalents all fall within the scope of the invention. Accordingly, the invention is not to be considered as limited by the foregoing description.