Abstract:
A system and method for making an orthopedic repair by fixing a soft tissue graft to bone, utilizes an implant including a body wedge having first and second outwardly expandable wedge portions, a wing portion having outwardly expandable wings, and a deployment member which is movable distally into the implant to deploy the wedge portions and the wings into an expanded deployed orientation.

Description:
[0001]    This application is a divisional under 35 U.S.C. 120 of commonly assigned U.S. application Ser. No. 14/055,758, filed on Oct. 16, 2013 and entitled Methods and Systems for Material Fixation, now allowed, which in turn claims the benefit under 35 U.S.C. 119(e) of the filing date of Provisional U.S. Application Ser. No. 61/717,569, entitled Methods and Systems for Material Fixation, filed on Oct. 23, 2012, which applications are each herein expressly incorporated herein by reference, in their entirety. 
         [0002]    This application is also related to commonly assigned U.S. Pat. Nos. 7,879,094 and 8,206,446, both herein also expressly incorporated by reference in their entirety. 
     
    
     BACKGROUND OF THE INVENTION 
       [0003]    The present invention relates generally to devices, systems and methods for material fixation. More particularly, the invention relates to a new and novel tendon-to-bone fixation system. 
         [0004]    One of the most common needs in orthopedic surgery is the fixation of tendon to bone. The fixation of diseased tendons into a modified position is called tenodesis and is commonly required in patients with injury to the long head of the biceps tendon in the shoulder. In addition, tendons which are torn from their insertion site into bone also frequently require repair. This includes distal biceps tendon tears, rotator cuff tears, and torn flexor tendons in the hand. Tendons are also frequently used in the reconstruction of unstable joints. Common examples include anterior cruciate ligament and collateral ligament reconstructions of the knee, medial and lateral elbow collateral ligament reconstructions, ankle collateral ligament reconstruction, finger and hand collateral ligament reconstructions and the like. The commonly assigned U.S. Pat. Nos. 7,879,094 and 8,206,446, already incorporated by reference herein, describe devices and techniques for performing these types of procedures, utilizing, for example, the AperFix® femoral implant. 
         [0005]    Currently, two different sources are utilized for the tissue that replaces the injured native Anterior Cruciate Ligament (ACL). When the new tissue comes from the patient&#39;s own body, the new graft is referred to as an “autograft”, and when cadaveric tissue is used, the new graft is referred to as an “allograft”. The most common autograft ACL reconstruction performed currently is the bone-patellar tendon-bone (BTB) graft. The BTB graft fixed with an interference screw is used more often because it more accurately replicates the native ACL due to its aperture compression at the femoral tunnel aperture. However, BTB reconstructions result in an increased rate of anterior knee pain post-surgically for periods of up to three years after reconstruction. Additionally, the harvest procedure for the BTB autograft is invasive, and can be difficult to perform. Alternatively, the hamstring tendon autograft ACL reconstruction technique does not result in any significant post-surgical pain, and the harvest procedure is minimally invasive compared to the BTB graft harvest. The reason that the hamstring tendon autograft procedure is not used more frequently in ACL reconstructions is that the fixation of the hamstring tendons to the femur and tibia are not as strong as the fixation of the BTB autografts. 
         [0006]    Many systems have addressed some of the problems associated with ACL reconstruction using hamstring tendons, but there is not one system that addresses them all. The EndoButton by Smith &amp; Nephew is easy to use and does not need additional drill holes. However, it does require additional accessories and additional people to perform the procedure, and does not replicate the native ACL due to a lack of tendon-to-bone compression at the aperture as well as additional length of tendon between fixation points. The EndoButton is an example of a cortical-only hamstring fixation device that yields a longer graft construct, resulting in a graft that is less stiff than the native ACL. Peer-reviewed journal data show that existing soft tissue fixation systems with long graft lengths between fixation points have as much as a 56% reduction in graft stiffness when compared to the native ACL. 
         [0007]    The Arthrex TightRope DB is also a cortical fixation device that also incorporates a wedge that is pulled between the tendon bundles. This separates the bundles, but the wedge doesn&#39;t expand. 
         [0008]    The Rigid Fix by Mitek is a cross-pin device that requires multiple drill holes, additional instruments, and assistance from other people in the operating room to complete the repair. Also, there is only passive compression of tendon-to-bone, not direct, active compression. 
         [0009]    The Stratis ST by Scandius attempts to more accurately replicate the native ACL by adding material to take up space in the femoral tunnel, resulting in more intimate contact between the tendon and the bone. However, to insert the device into the femoral tunnel, the cross-sectional area must be less than the cross-sectional area of the hole. Therefore, there is no real compression of tendon to bone. The Stratis ST also requires additional drill holes, accessories, and people to perform the procedure. 
         [0010]    EZLoc, by Arthrotek gives high strength and attempts to more accurately replicate the native ACL in the same fashion as the Stratis ST by taking up the space in the tunnel. This does create more intimate contact between the tendon and bone, but does not offer real compression at the aperture. 
         [0011]    The Mitek Femoral IntraFix is an interference screw device that incorporates a sheath to protect the graft during screw insertion. Since it is a compression device, there is no active engagement of the implant with the tunnel wall. 
         [0012]    Interference screws such as the RCI screw by Smith &amp; Nephew and RetroScrew by Arthrex are easy to use and provide compression of tendon to bone at the femoral tunnel aperture. However, the pull-out strength and stiffness of the repair are significantly lower than in the preceding systems. 
       SUMMARY OF THE INVENTION 
       [0013]    The invention seeks to improve the tendon-bone fixation of hamstring autografts as well as other soft tissue ACL reconstruction techniques. The device is easy to use, provides high fixation of tendon-bone and active tendon-bone compression, requires no additional accessories, uses only one drill hole, and can be implanted by one person. The device replicates the native ACL by compressing the tendons against the bone at the aperture of the femoral tunnel, effectively shortening the length of the graft, which leads to a shorter graft and increased graft stiffness as compared to cortical-only hamstring fixation devices. It also provides strength greater than 1,000 N (Newtons), which is desirable for ACL reconstruction systems. 
         [0014]    The device of the present invention is indented for use in tenodesis procedures with soft tissue grafts, utilizing either arthroscopic or open techniques during ACL, Posterior Cruciate Ligament (PCL), Medial Collateral Ligament (MCL), Lateral Collateral Ligament (LCL), and Medial Patellofemoral Ligament (MPFL) reconstruction. During a ligament reconstruction procedure, soft tissue grafts are attached to the femur utilizing the device. Soft tissue grafts are typically harvested from the patient&#39;s ipsilateral leg, but cadaveric tissue is also acceptable. The device also provides active compression of the tendons at the aperture of the bone tunnel. 
         [0015]    Minimizing the removal of bone and providing a device that is able to be used in tunnels under 25 mm are important in tenodesis procedures. The device of the present invention is a shorter version of the AperFix® Femoral implant, commercially available from the assignee and disclosed in prior U.S. Pat. No. 7,879,094. 
         [0016]    More particularly, there is provided an implant for affixing soft tissue to bone, which comprises a body wedge having first and second outwardly expandable wedge portions, a wing portion having outwardly expandable wings, which is connected to a distal end of the body wedge, and a deployment member which is movable distally into the implant to deploy the wedge portions and the wings into an expanded deployed orientation. When the wings are in their expanded deployed orientation, portions of the wings extend proximally over distal portions of the body wedge. Advantageously, a breakaway connection is provided between two of the outwardly expandable wings to hold them together in an undeployed retracted orientation, until the deployment member advances distally a sufficient distance to break the connection deploy the wings outwardly. The breakaway connection, in the disclosed embodiments, comprises a wing breakaway tab. 
         [0017]    The deployment member comprises a screw, which comprises an enlarged head for deploying the wedge portions outwardly when the head advances distally to a position between the wedge portions. The screw further comprises a threaded shank distal to the head. A tendon eyelet is provided in the wedge body for receiving soft tissue therein. 
         [0018]    Outer keys are provided on the wing portion, and corresponding keyways are provided on the outer wedge body which are adapted to engage with one another to prevent the wings from rotating relative to the body wedge during implant deployment. Additionally, a wing deployment surface on the wing portion and a corresponding body wedge deployment surface on the body wedge are arranged so that, during deployment of the wings and body wedge portions, the wing deployment surface and the body wedge deployment surface slidably engage one another to cause the wings to bend around wing flex radii and thereby urge a bone engagement edge on the wing portion to start engaging radially into the bone. 
         [0019]    In another aspect of the invention, there is provided an implant for affixing soft tissue to bone, which comprises a body wedge having first and second outwardly expandable wedge portions, a wing portion having outwardly expandable wings, which is connected to a distal end of the body wedge, and a deployment member which is movable distally into the implant to deploy the wedge portions and the wings into an expanded deployed orientation. Advantageously, a breakaway connection is provided between two of the outwardly expandable wings to hold them together in an undeployed retracted orientation until the deployment member advances distally a sufficient distance to break the connection deploy the wings outwardly. The breakaway connection, in the disclosed embodiments, comprises a wing breakaway tab. 
         [0020]    The deployment member comprises a screw, which comprises an enlarged head for deploying the wedge portions outwardly when the head advances distally to a position between the wedge portions. The screw further comprises a threaded shank distal to the head. A tendon eyelet is provided in the wedge body for receiving soft tissue therein. 
         [0021]    Outer keys are provided on the wing portion, and corresponding keyways are provided on the outer wedge body which are adapted to engage with one another to prevent the wings from rotating relative to the body wedge during implant deployment. Additionally, a wing deployment surface on the wing portion and a corresponding body wedge deployment surface on the body wedge are arranged so that, during deployment of the wings and body wedge portions, the wing deployment surface and the body wedge deployment surface slidably engage one another to cause the wings to bend around wing flex radii and thereby urge a bone engagement edge on the wing portion to start engaging radially into the bone. 
         [0022]    In still another aspect of the invention, there is disclosed a method of making an orthopedic repair by fixing a soft tissue graft to bone, which comprises a step of placing a soft tissue graft on an implant. The implant comprises a body wedge having first and second outwardly expandable wedge portions, a wing portion having outwardly expandable wings which is connected to a distal end of the body wedge, and a deployment member which is movable distally into the implant to deploy the wedge portions and the wings into an expanded deployed orientation. The method further comprises steps of disposing the implant within a bone tunnel at a desired location, such that a plurality of ends of the soft tissue graft extend from the implant in a proximal direction through the bone tunnel, deploying the wedge portions of the implant outwardly to engage portions of the plurality of ends of the soft tissue graft and push the soft tissue graft ends into contact with adjacent bone, and deploying the wing portions outwardly so that wing portions engage adjacent bone to fix the implant in place within the bone tunnel, wherein the wing portions deploy proximally over portions of the body wedge. 
         [0023]    The deploying steps are performed by advancing a lead screw distally into the implant, in a disclosed embodiment. 
         [0024]    The wing portions deploying step is performed by advancing a deployment member distally into the implant and breaking a breakaway tab connecting the wing portions together in their undeployed orientation. The breakaway tab ensures that the wings do not deploy or partially deploy prematurely. 
         [0025]    The invention, together with additional features and advantages thereof, may best be understood by reference to the following description taken in conjunction with the accompanying illustrative drawing. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0026]      FIG. 1  is an elevational view of an embodiment of an implant constructed in accordance with the principles of the present invention, in an undeployed state; 
           [0027]      FIG. 2  is a rotated view of the implant of  FIG. 1 ; 
           [0028]      FIG. 3  is a view similar to  FIG. 1 , with the implant in a deployed state; 
           [0029]      FIG. 4  is a rotated view of the implant of  FIG. 3 ; 
           [0030]      FIG. 5  is an elevational view of the implant of  FIG. 1 , in an undeployed state and showing greater detail; 
           [0031]      FIG. 5A  is an enlarged view of the portion of  FIG. 5  denoted by the identified circle; 
           [0032]      FIG. 6  is a cross-sectional view of  FIG. 5 , taken along lines  6 - 6 ; 
           [0033]      FIG. 7  is an elevational view similar to  FIG. 5 , with the implant in a rotated orientation; 
           [0034]      FIG. 8  is a cross-sectional view of  FIG. 7 , taken along lines  8 - 8 ; 
           [0035]      FIG. 9  is an elevational view of the implant of  FIG. 5 , showing hidden elements in phantom lines; 
           [0036]      FIG. 10  is an elevational view similar to  FIG. 9 , wherein the implant is rotated approximately one-quarter turn; 
           [0037]      FIG. 11  is a top view of the implant of  FIG. 9 ; 
           [0038]      FIG. 12  is an elevational view of the wings portion of the implant of the present invention, shown in an undeployed state and in isolation; 
           [0039]      FIG. 13  is a cross-sectional view of  FIG. 12 , taken along lines  13 - 13 ; 
           [0040]      FIG. 14  is a top view of the wings shown in  FIG. 12 ; 
           [0041]      FIG. 15  is an elevational view similar to  FIG. 12 , with the wings being rotated about one-quarter turn; 
           [0042]      FIG. 16  is a cross-sectional view of the implant of  FIG. 15 , taken along lines  16 - 16 ; 
           [0043]      FIG. 17  is a bottom view of the wings of  FIG. 12 ; 
           [0044]      FIG. 17A  is an enlarged view of  FIG. 17 ; 
           [0045]      FIGS. 18-25  are isometric views, in varying orientations, of; the wings portion of the present invention; 
           [0046]      FIG. 26  is an elevational view, in isolation, of the body wedge portion of the inventive implant; 
           [0047]      FIG. 27  is an elevational view of the body wedge of  FIG. 26  rotated about one-quarter turn; 
           [0048]      FIG. 28  is a top view of the body wedge of  FIG. 26 ; 
           [0049]      FIGS. 29-36  are isometric views, in varying orientations, of the body wedge portion of the present invention; and 
           [0050]      FIGS. 37-40  are isometric views, in varying orientations, of the quad-lead screw portion of the present invention. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0051]    Referring now more particularly to the drawings, an implant  10  constructed in accordance with the principles of the present invention, having a body  12  comprising three separate major components. These components comprise a quad lead screw  14 , wings  16 , and a body wedge  18 . Tendon eyelets  20  are provided for the loading of tendons thereinto prior to insertion of the implant  10  into a bone tunnel. When the implant  10  is placed into a bone tunnel, the screw  14  is rotated clockwise until a head  22  of the screw  14  slides between portions  24 ,  26  of the body wedge  18 . This expands the base of the implant by forcing the wedge portions  24 ,  26  outwardly, thereby acting to compress the tendon against the bone tunnel walls. As the screw  14  continues to rotate, the wings  16  slide apart over the body wedge  18  and engage with the walls of the bone tunnel to anchor the implant  10  in place within the tunnel. The engagement of the wings  16  into the bone is what gives the implant the majority of its pullout strength.  FIGS. 1 and 2  illustrate the implant  10  in its undeployed state, while  FIGS. 3 and 4  illustrate the implant in its deployed state. 
         [0052]      FIGS. 5 and 7  illustrate the inventive implant  10  in its undeployed state, with  FIG. 7  being rotated about 90 degrees relative to  FIG. 5 .  FIGS. 6 and 8  are cross-sectional views taken along lines  6 - 6  of  FIG. 5 and 8-8  of  FIG. 7 , respectively.  FIGS. 9 and 10  are rotated views of the implant  10 , showing internal components in phantom, while  FIG. 11  is a top view of the implant shown in  FIG. 9 . 
         [0053]      FIGS. 12-17A  are several views, in cross-section, of the wings  16  of the inventive implant  10 , while  FIGS. 18-25  illustrate the wings  16  from a variety of orientations.  FIGS. 26-28  are views of the body wedge  18  from two sides and the top, while  FIGS. 29-36  are perspective views, from various orientations, of the body wedge  18 .  FIGS. 37-40  are isolation views, from various orientations, of the quad lead screw  14 . 
         [0054]    There are several key features that enable the implant  10  to deploy successfully into bone. A wing breakaway tab  28  ( FIG. 5A ) is a small web of material that connects both wings  16  together. This prevents the wings  16  from prematurely deploying or partially deploying into the bone tunnel if the implant  10  is inserted and removed from the tunnel during the procedure. The tab  28  breaks and the wings  16  separate once the screw  14  advances completely into the base of the body wedge  18 . At this point, the wings  16  may rotate about the body wedge  18 , which does not allow the wings  16  to deploy into surrounding bone. However, outer wing keys  30  ( FIG. 17A ) are engaged with outer body wedge keyways  32  ( FIG. 28 ), which prevent the wings  16  from rotating relative to the body wedge  18 . As the screw  14  continues to rotate clockwise, a wing deployment surface  34  ( FIGS. 13, 27 ) slides along a body wedge deployment surface  36  ( FIG. 32 ), and the wings  16  bend around wing flex radii  38  ( FIG. 9 ), urging a bone engagement edge  40  ( FIG. 22 ) to start engaging radially into the bone. Without the bone engagement edge  40 , created by a slight flare of the wings  16 , the wings would not deploy into harder bone. 
         [0055]    As the screw  14  continues to rotate counterclockwise, the outer wing keys  30  slide out of the outer body wedge keyways  32  and inner wing keys  42  ( FIG. 17A ) engage with inner body wedge keyways  44  ( FIG. 28 ). This continues to prevent the wings  16  from rotating around the body wedge  18 , and prevents incomplete deployment. As the screw  14  completes its final clockwise rotation, a wing thread boss  46  ( FIG. 17 ) is pulled into a body wedge counterbore  48  ( FIG. 28 ). The wing thread boss  46  allows the wings  16  to be as short as possible by providing enough thread internal to the wings to prevent stripping in hard bone. 
         [0056]      FIGS. 37-40  illustrate the quad lead screw  14  from various angles, which comprises the head  22  and a shank  50  having threads  52 . The body  12  of the implant  10  comprises a channel  54  for receiving the threaded shank  50  of the screw  14  as it is advanced into the implant  10 , as described above. 
         [0057]    Advantageously, in certain applications, the implant  10  of the present invention, which has a length of 24 mm rather than the 29 mm length of the present AperFix femoral implant offered by the assignee, is insertable through the anteromedial portal, which creates a shorter tunnel than the transtibial approach. As noted above, the implant  10  comprises three major components, namely, a body wedge  18 , one-piece wings  16 , and a central screw  14 . The prior AperFix implant comprises a body, a central screw, left and right arms, attached to the body with pins, and a distal wedge for actuating the wings outwardly. By eliminating the two arms and the wedge components of the prior AperFix implant, replacing it with a one-piece wings component, the substantially shorter length is achievable, and the pins for securing the arms are also eliminated. 
         [0058]    The present invention, as noted above, includes a breakaway tab to keep the wings together prior to deployment. Without the tab, the wings would prematurely engage the bone. The keys and keyways are an anti-rotation feature to prevent the wings from rotating during initial deployment. Without these features, the wings would not fully deploy. The wedge is now build into the body, causing the wings to flare open into the bone. 
         [0059]    Accordingly, although exemplary embodiments of the invention has been shown and described, it is to be understood that all the terms used herein are descriptive rather than limiting, and that many changes, modifications, and substitutions may be made by one having ordinary skill in the art without departing from the spirit and scope of the invention.