Patent Document

[0001]    This application claims the benefit of U.S. Provisional Application Serial No. 60/037,610, filed Feb. 12, 1997. 
     
    
     
       BACKGROUND OF THE INVENTION  
         [0002]    1. Field of the Invention  
           [0003]    The present invention relates to reconstruction of the anterior cruciate ligament (ACL), and, more specifically, to surgical graft fixation using semitendinosus and gracilis tendon autografts.  
           [0004]    2. Description of the Related Art  
           [0005]    When a ligament or tendon becomes detached from associated bone, surgery usually is required to re-secure the ligament or tendon. Often, a substitute ligament, or graft, is attached to the bone to facilitate re-growth and permanent attachment. Various methods of ligament graft attachment are known, including staples, suture over buttons, and interference screw fixation.  
           [0006]    Various problems exist with the known fixation methods. Staples and suture buttons are disadvantageous because they often do not provide fixation sufficient to withstand the normal tensile loads. With suture button fixation, for example, a strand of suture couples the button and the substitute ligament. This strand becomes the “weakest link in the chain,” and if the strand breaks, the ligament detaches.  
           [0007]    A stronger graft attachment can be obtained by interference screw fixation, whereby an interference screw is used to wedge a graft bone block to the wall of a graft tunnel. See, e.g., U.S. Pat. Nos. 5,211,647, and 5,603,716, incorporated herein by reference.  
           [0008]    Although interference screw attachment is more secure than using staples or suture buttons, it is sometimes neither possible nor desirable to provide such fixation, particularly in the femoral tunnel. In revision situations, for example, where a previous reconstruction has been performed, placing a second femoral tunnel placed close to the previous tunnel may not be indicated.  
           [0009]    In other cases, a semitendinosus graft must be used because the previous reconstruction used the mid third patellar tendon. Although a bone-semitendinosus graft-bone construct may be prepared using a workstation as disclosed in U.S. Pat. No. 5,397,357, such a procedure is time consuming, and may be undesirable for other reasons.  
           [0010]    A fixation technique which provides strong attachment of a semitendinosus graft in the femoral tunnel, using a transverse implant, is disclosed in U.S. Pat. No. 5,601,562, of common assignment with the present application, and incorporated herein by reference. The transverse implant is inserted through a loop in a tendon graft. A threaded portion of the implant screws into the bone as the implant is advanced with rotation into the repair site. The technique is disadvantageous, however, because the graft can become wrapped around the implant as it is rotated. An improved bone implant is the subject of U.S. Pat. No. 5,895,425.  
           [0011]    In addition, the prior art technique noted above requires a forked insertion tool, and a large femoral tunnel is needed to accommodate the forked insertion tool. As a result, the large femoral tunnel undesirably allows the graft to slide laterally, or “wipe” back and forth, along the fixation implant. Moreover, the diameter of the implant necessarily is limited by the size of the opening in the forked insertion tool.  
           [0012]    As a further disadvantage, the technique also requires the extra steps of forming and wedging a bone plug into the femoral tunnel after insertion of the ligament. Moreover, the technique does not accommodate a closed-loop graft construct, since the graft must have a free end in order to be inserted with the forked insertion tool. Further, the technique may not be indicated in revision procedures.  
           [0013]    Various endoscopic techniques and instruments relating to graft fixation are known in the prior art and can be used in the practice of the present invention. U.S. Pat. No. 5,320,636 to Schmieding discusses an endoscopic drill guide for graft tunnel location. U.S. Pat. No. Des. 378,780 illustrates a cannulated headed reamer as can be used in femoral socket formation. U.S. Pat. Nos. 5,269,786 and 5,350,383 disclose drill guides for location of bone tunnels.  
           [0014]    The need exists for fixation techniques that utilize narrower femoral/tibial tunnels, to prevent wiping, and that do not require the insertion of bone plugs. Also, the need exists for graft ligament loading techniques that can accommodate closed-looped grafts, that do not require specialized insertion tools to load the graft into the knee, and that can be indicated in certain revision procedures.  
         SUMMARY OF THE INVENTION  
         [0015]    The present invention overcomes the problems of the prior art and fulfills needs such as those noted above by providing a surgical method for loading tendon grafts into a joint and fixating the grafts using a transverse, intraosseous implant. The inventive technique advantageously uses narrow tibial and femoral tunnels, and eliminates the use of sutures, tapes, or extra-osseous metal fixation devices. The procedure also is indicated for revisions that would otherwise be jeopardized by secondary femoral tunnel creation. In addition, the technique can be implemented using a transverse implant that is advanced by impaction into the bone.  
           [0016]    As applied in the knee, the method includes the use of standard techniques to drill a longitudinal tunnel in the tibia. Subsequently, a femoral socket is formed, preferably in the lateral femoral condyle. According to the present invention, forming the socket is preferred to forming a tunnel through the lateral femoral cortex. Advantageously, the diameters of the tibial tunnel and femoral socket are made just large enough to accommodate the graft in a snug fit.  
           [0017]    A tunnel hook, mounted on a cross-pin drill guide, is inserted through the tibial tunnel and into the femoral socket. A drill pin directed by the drill guide is drilled through the femur to intersect the femoral socket. The drill pin passes through the capture slot of the tunnel hook.  
           [0018]    A hole then is formed in the femur, preferably using a cannulated drill placed over the guide pin, to accommodate a threaded section of the transtibial implant. A channel is formed in the lateral femoral cortex to accommodate the remainder of the implant, preferably using a dilator placed over the guide pin.  
           [0019]    Next, a flexible strand, preferably a wire formed of nitinol, is attached to the guide pin and pulled through the femur. Equal lengths of the strand protrude from the medial and lateral sides of the femoral shaft, and are secured to prevent accidental pull-out. The tunnel hook is withdrawn, the strand being captured in the slot of the hook.  
           [0020]    The hook is retracted completely, through the femoral socket and out of the tibial tunnel, such that a loop of the flexible strand protrudes from the entrance to the tunnel. Free ends of the strand remain exposed on either side of the femoral shaft.  
           [0021]    The graft is passed through the diverted loop of the flexible strand. The loop is retracted into the femoral socket by pulling evenly on the medial and lateral ends of the strand. As a result, the graft is drawn into the socket.  
           [0022]    The cannulated implant is placed over the wire and driven into the femur. The implant preferably is formed with back-biting threads. Accordingly, the implant easily can be impact driven into the repair site, and yet can be removed if necessary by rotation. The cannulated implant passes over the strand and under the tendon, thus securing the graft in the femoral socket.  
           [0023]    Tibial fixation of the graft can be performed by various known methods, including interference screw fixation, which provides the most secure post-operative result; distal fixation with a cancellous screw using a post and washer technique; and a belt buckle staple technique utilizing a pair of ligament staples.  
           [0024]    An alternative method of tendon loading is also provided for a closed-loop graft reconstruction. According to the alternative method, a flexible line is joined to one end of the strand. A strand/line loop is formed so as to protrude from the entrance to the tibial tunnel and present the junction between the strand and the line. The strand and the line are dejoined, opening the strand/line loop to accept the graft. The strand and line are rejoined so as to capture the graft, and the procedure continues substantially as set forth above.  
           [0025]    Other features and advantages of the present invention will become apparent from the following description of the invention which refers to the accompanying drawings. For example, although the description herein relates to ACL grafts and forming femoral tunnels in the knee, it will become apparent that expanded indications for the inventive method include other joints and replacement of other ligament or tendon structures using various types of graft constructs. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0026]    [0026]FIG. 1 is an elevation of a tunnel hook according to the present invention.  
         [0027]    [0027]FIG. 2 is a distal end view of the tunnel hook of FIG. 1.  
         [0028]    [0028]FIG. 3 is an elevation of a drill pin according to the present invention.  
         [0029]    [0029]FIG. 4 is an enlarged view of the distal tip of the drill pin of FIG. 3.  
         [0030]    [0030]FIG. 5 is a distal end view of the drill pin of FIGS. 3 and 4.  
         [0031]    [0031]FIG. 6 is an elevation of a tunnel dilator according to the present invention.  
         [0032]    [0032]FIG. 7 illustrates a graft-passing wire according to the present invention.  
         [0033]    [0033]FIG. 8 illustrates a transverse implant having back-biting threads according to the present invention.  
         [0034]    [0034]FIG. 9 is an enlarged detail view of the back-biting threads of the transverse implant illustrated in FIG. 8.  
         [0035]    [0035]FIG. 10 is a schematic view of a hook and a drill pin mounted on a drill guide and disposed within the femoral socket according to the present invention.  
         [0036]    [0036]FIG. 11 is a schematic view of a tunnel dilator being used to form a femoral channel for the transverse implant according to the present invention.  
         [0037]    [0037]FIG. 12 illustrates a flexible strand attached to the drill pin and being pulled through the femur according to the present invention.  
         [0038]    [0038]FIG. 13 illustrates a loop of the flexible strand being pulled by the hook and out through the femoral socket according to the present invention.  
         [0039]    [0039]FIG. 14 illustrates the flexible strand loop having been diverted through the tibial tunnel, capturing a ligament graft, and pulling the graft into the tibial tunnel according to the present invention.  
         [0040]    [0040]FIG. 15 illustrates the ligament graft, having been loaded through the longitudinal tibial tunnel and into the femoral socket, being fixated using a transverse implant according to the present invention.  
         [0041]    [0041]FIG. 16 illustrates a completed tendon graft repair including tibial fixation with an interference screw. 
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0042]    Referring initially to FIGS. 1 and 2, the present invention involves the use of a slim, longitudinal tunnel hook  2 , which includes a shaft having a distal end and a proximal end. The distal end of tunnel hook  2  is provided with a hook  4 , having a capture slot  6 .  
         [0043]    Various features of tunnel hook  2  are provided for ease of use in the inventive procedure of the present invention. The purpose of the following features will become more clear in light of the method described below. Angled opening  8  allows escape of a graft-passing wire from capture slot  6 . Channels  10  on either side of hook  4  accommodate portions of the graft-passing wire as it forms a loop through a femoral tunnel. The proximal end of tunnel hook  2  features a mounting flange  11  for engagement with a drill guide.  
         [0044]    Referring to FIGS. 3, 4, and  5 , the invention also involves the use of a drill pin  12 , which includes an elongated, narrow shaft having a pointed distal end and a proximal end. The distal end of drill pin  12  is provided with a sharp, trocar tip  14  and a fluted drilling region  16  disposed adjacent to and proximal the faces of trocar tip  14 . The proximal end of drill pin  12  includes a hook  18  having an angled opening into its capture slot for engaging the graft-passing wire, as described more fully below.  
         [0045]    Referring to FIG. 6, a tunnel dilator  20  is shown. Tunnel dilator  20  has a tapered distal end and a proximal end. Dilator  20  is cannulated to be received over drill pin  12 . The dilator has an initial taper  22  at the distal end for insertion into the bone where the drill pin enters. A cylindrical portion  24  forms a channel in the femur for receiving an implant shaft. An interim fluted portion  26  can be provided alternatively to form a hole for receiving threads of the implant, as described below. A depth stop  28  is formed proximally.  
         [0046]    Referring to FIG. 7, a nitinol graft-passing wire  30  is shown. Passing wire  30  includes a flexible portion  32  having a loop  34  formed on the distal end and a rounded proximal end  36 .  
         [0047]    [0047]FIGS. 8 and 9 illustrate a transverse implant  40 . Implant  40  has a threaded proximal end and a threaded distal ends. The implant is cannulated to be received over graft-passing wire  30 . The implant has a taper  42  formed toward the distal end. The proximal end includes back-biting, helical threads  44  and a drive socket  46 . As shown in detail in FIG. 9, threads  44  have a sloping distal face  48  and a proximal face  50  meeting at a radiused edge  52 . Distal face  48  forms an angle A of about 72° with a perpendicular to the central axis of the implant. Proximal face  50  forms an angle B of about 18° with the perpendicular. The implant can be driven by impaction into bone, and then, if necessary, can be subsequently removed by screw rotation as discussed below.  
         [0048]    The method of the present invention is described with reference to FIGS. 10 through 16. A longitudinal tibial tunnel  56  is formed using known techniques of drilling up through the tibia  58 . Reproducible tunnel placement is achieved using instruments that reference intra-articular anatomical constants. A cannulated drill, received over a guide, is used to drill the tibial tunnel. Depending on the size of the graft, tunnel diameters of 7, 8, 9, and 10 mm are can be used.  
         [0049]    Once the tibial tunnel is formed, a cannulated headed reamer is used to form a closed-ended socket  60  in the femur  62 . The socket is formed to a minimum depth of about 40 mm to accommodate the insertion depth of tunnel hook  2 . The knee should be placed in 90° of flexion when forming the tibial tunnel and femoral socket.  
         [0050]    The tunnel and socket can be modified in various ways using tunnel taps. For example, crenulations formed in the tibial tunnel provide additional friction and helps eliminate unwanted graft rotation during interference screw insertion. A spiral groove formed in the tunnel wall provides additional interference friction of the graft collagen against the compressed cancellous bone in the tunnel. A rasp may be used to create an oval-shaped tunnel and femoral socket to accommodate insertion of four tendon strands.  
         [0051]    After the tibial tunnel and femoral socket are complete, tunnel hook  2 , fitted onto a C-ring cross-pin drill guide  64 , is inserted through tibial tunnel  56  and into femoral socket  60 . Tunnel hook  2  will capture within slot  6  the graft-passing wire  12  used in loading the graft tendons into the femoral socket, as described below with respect to FIGS. 12 and 13.  
         [0052]    Referring again to FIG. 10, with tunnel hook  2  and drill guide  64  in place, a 2 mm drill pin sleeve  66  is advanced in the direction of arrow A up to the skin proximal to the femoral condyle to indicate an incision site. The drill guide is positioned to allow the pin to pass parallel to the coronal plane, without excessive posterior or anterior divergence. A 2-cm incision is made transversely at this site through the skin and fascia lata, and soft tissue is cleared down to the condyle. Drill pin sleeve  66  is advanced until it contacts bone. Over-tightening of the drill pin sleeve against the femoral cortex is avoided to prevent the drill pin from deviating and missing capture slot  6  of tunnel hook  2 . A depth indicator on the sleeve is used to gauge the length of implant  40  that will be required.  
         [0053]    With the sleeve in position against the cortical bone, drill pin  12 , 2 mm. in diameter, is chucked into a power drill  68 , and advanced with rotation through the femur until it exits the skin on the medial side  70 . To ensure that the drill pin passes within the capture slot  6  of tunnel hook  2 , torque on the drill guide and changes in knee flexion are avoided during drilling.  
         [0054]    Referring to FIG. 11, a cannulated drill is placed over the guide pin to drill a hole  71  to accommodate threaded section  44  of implant  40 . The drill is replaced with tunnel dilator  20 , which is used to form a channel in the femur for the remainder of implant  40 . Tunnel dilator  20  is mounted onto a driver/extractor  72  and driven with a mallet in the direction of arrow B up to the depth stop  28 .  
         [0055]    Referring to FIG. 12, once the channel has been formed, loop  34  of nitinol graft-passing wire  30  is hooked onto hook  18  on the proximal end of drill pin  12 . By pulling on the drill pin, the graft-passing wire is drawn through the femur until it is positioned with equal lengths at either end protruding from the medial and lateral sides of the femoral shaft. Hemostats  74  are clipped onto the ends of the wire to prevent them from being pulled into the transverse femoral tunnel  70 , as shown in FIG. 14.  
         [0056]    Referring to FIGS. 13 and 14, once the graft-passing wire has been drawn through the femur, tunnel hook  2  is retracted from femoral socket  60  and tibial tunnel  56 , pulling graft-passing wire  30  with it to form a loop that protrudes from the entrance of tibial tunnel  56  on the anterior tibial cortex. The semitendinosus and gracilis tendons  76  are placed evenly over the wire loop, and the loop containing the tendons is retracted in the direction of arrow C back through the tibial tunnel and into the femoral socket by pulling evenly on the medial and lateral ends of the graft-passing wire, as shown by arrows D and E, respectively. Twisting of the graft during insertion is avoided.  
         [0057]    Referring to FIG. 15, once the tendons  76  have been drawn completely into femoral socket  60 , implant  40  is inserted over the guide wire and advanced by hand until the threaded section  44  contacts the femur. An implant impactor  78  is chucked into driver/extractor  72  and placed over the wire  30 . The head of the implant  40  is engaged and a mallet is used to drive the implant into the femur until a depth stop  82  on the driver  78  contacts the cortical bone. Pulling on the tendons  76  is avoided during impaction of the implant  40 .  
         [0058]    The implant is advanced along the wire in the direction of arrow F. The implant passes under the loop formed in tendons  76 , toward the medial side of the femur, to provide cross-pin support of tendons  76 . If removal of the implant should become necessary, reverse cutting threads  44  facilitate removal by unscrewing the implant with a 3.5 mm hex head screwdriver.  
         [0059]    Referring to FIG. 16, the repair is completed by interference screw  84  fixation of graft  76  in tibial tunnel  56 . The femoral tunnel is narrow so that tendons  76  fit snugly within tibial tunnel  56  and femoral socket  60 , thus avoiding wiping of the tendons along the implant.  
         [0060]    Although the present invention has been described in relation to particular embodiments thereof, many other variations and modifications and other uses will become apparent to those skilled in the art. Therefore, the present invention is to be limited not by the specific disclosure herein, but only by the appended claims.

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