Patent Publication Number: US-7713300-B2

Title: Apparatus and method for manipulating a flexible strand and soft tissue replacement during surgery

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation-in-part of U.S. patent application Ser. No. 10/066,519 filed on Jan. 31, 2002. The disclosure of the above application is incorporated herein by reference. 
    
    
     FIELD 
     The present teachings relate to endoscopic soft tissue replacement fixation. More particularly, the present teachings relate to an apparatus and a method to reconstruct an anterior cruciate ligament with soft tissue replacements within a femoral tunnel. 
     BACKGROUND 
     The knee joint is frequently the object of injury and is often repaired using arthroscopic surgical procedures. An example of such arthroscopic surgical procedure is the replacement of anterior cruciate ligaments of the knee. The tearing of these ligaments is common in sports activities such as football or skiing. 
     Various natural and synthetic tissue replacements are used. The replacements can be xenograft, allograft or autograft. For example, fascia lata soft tissue replacements are flexible strands which are affixed to a threaded stud and turned into the femoral tunnel. Hamstring soft tissue replacements are also currently fixed over a screw in the tibial tunnel and fixed on the lateral femur. This technique requires the femoral tunnel to completely penetrate the femur. In addition, according to present procedures, fixation of the soft tissue replacement on the femoral side requires a large incision. 
     Further, various other graft portions, such as a patellar tendon graft, which can include a bone tendon bone graft can be used. The graft can be harvested from between patella and the selected bone to which the tendon is anchored. This allows for creation of a bone-tendon-bone graft where the tendon is already anchored to bone portions and only the bone portions are fixed relative to the implant site in the bone. Further examples include a quadriceps tendon graft as various examples of autografts. All grafts from similar sites of selected individuals can also be used in a patient requiring a graft. Further, xenograft materials can be harvested from compatible animals for implantation to selected patients. Also, synthetic materials, such as those that are biologically compatible and include appropriate physical properties can be used. One skilled in the art is generally aware of the various types of graft materials that can be provided for performing a grafting procedure. 
     It has been difficult to insert and fasten a soft tissue replacement in a blind hole or tunnel. Attempts have been made to thread the soft tissue replacement through the tunnel and over an anchor, but with some difficulty. Thus far, the prior art has not developed a quick and efficient way to implant a soft tissue replacement over an implanted anchoring system. 
     While offering certain improvements in arthroscopic surgery to repair ligaments, the prior art may still be improved upon to overcome the limitations on the endoscopic hamstring soft tissue replacement fixation due, in many instances, to the weakness of the flexible strand used to span the gap between the tendon soft tissue replacement and the fixation post. 
     Other techniques attempt to use biological fixation to augment or replace mechanical fixation. While increasing fixation strength these techniques require time to fully realize their fixation potential. Additionally the techniques may take additional surgical time and resources that a purely mechanical fixation technique may not require. 
     SUMMARY 
     An apparatus including a member that acts as a flexible strand insertion and guide rod is used to increase the simplicity and effectiveness of a soft tissue implant procedure. The member inserts a flexible strand, which has been preloaded onto the insertion rod, into a blind tunnel formed in a bone structure and provides a guide for a drill point or bit. Thus the member may be removed with the flexible strand already positioned in place to move an implant into the blind tunnel over the drill point. A cross or set pin can then be moved after the drill point into the drill hole to lock the implant in place. 
     The apparatus according to various embodiments allows a method of performing an implant procedure. A method of surgically implanting a soft tissue replacement for attaching two bone members comprises inserting an insertion rod having a flexible strand pre-loaded on the insertion rod into a first tunnel. A second tunnel can be formed transverse and through the first tunnel and the insertion rod with a tool bit. A flexible strand can be reached within the first tunnel. The method also includes removing the insertion rod from the first tunnel. 
     According to various embodiments an apparatus to assist in positioning a graft in a tunnel, having a diameter, formed in a bone while performing a surgery is disclosed. The apparatus can includes a guide member extending along a first axis and having a first end and second end. A guide portion can extend from the first end and generally along the first axis. An implant alignment member positionable relative to the guide portion can also be provided. Also, an engaging member can remove a portion of the alignment member from the tunnel. The alignment member is operable to align an implant and operable to hold the graft in the tunnel. 
     According to various embodiments a system for positioning a soft tissue graft in a bore formed in a bony portion of an anatomy is disclosed. The system can include a guide member positionable in a portion of the bore. An implant can hold the soft tissue graft in a portion of the bore. A positioning member can interconnect with the implant to align the implant with the bore. Also, an assisting member can interact with the positioning member to assist in positioning the positioning member relative to the soft tissue graft prior to positioning the implant. 
     According to various embodiments a method of surgically attaching a soft tissue graft to at least one bone member is disclosed. The method can include inserting an insertion rod having a guide portion into a first tunnel of the bone member. An engaging member can be positioned on the guide portion. A tunnel forming device can be positioned relative to the guide portion. A second tunnel can be formed transverse and through the first tunnel and relative to the guide portion. An implant aligning member can be passed through the second tunnel and through the guide section. An alignment suture member can be interconnected with the implant aligning member. 
     Further areas of applicability of the present teachings will become apparent from the detailed description provided hereinafter. It should be understood that the detailed description and specific examples, while indicating the various embodiments are intended for purposes of illustration only and are not intended to limit the scope of the teachings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The present teachings will become more fully understood from the detailed description and the accompanying drawings, wherein: 
         FIG. 1  is a perspective view of the bone insertion rod affixed to a U-Guide; 
         FIG. 2  is a perspective view of bone insertion rod not affixed to the U-Guide; 
         FIG. 2A  is a detail perspective view of a guide portion of an insertion rod according to various embodiments; 
         FIG. 3  is an exemplary view of a knee prepared for insertion of the insertion rod; 
         FIG. 4  is a perspective view of the insertion rod and U-Guide inserted into the tibia and femur tunnels with the flexible strand in place; 
         FIG. 5  is a view of the U-Guide and insertion rod in place with a K-Wire Drill Point forming a transverse tunnel; 
         FIG. 6  is perspective view of the K-Wire Drill Point with the flexible strand affixed to a soft tissue replacement and draped over the K-Wire Drill Point; 
         FIG. 7  is a perspective view of the soft tissue replacement pulled over the K-Wire and out through the tibial tunnel; 
         FIG. 8  is a perspective view of the soft tissue replacement in place and the ACL Cross Pin set in place in the transverse tunnel in the femur; 
         FIG. 9  is a deep view of the knee with an ACL replacement having its free ends affixed to the tibia and the femoral end affixed over the ACL Cross Pin; 
         FIG. 10  is an environmental perspective view of an apparatus according to various embodiments positioned relative to a knee with a measuring device; 
         FIG. 11  is an environmental perspective view of an apparatus according to various embodiments positioned relative to a knee with a drill point through the femur; 
         FIG. 12  is an environmental perspective view of an apparatus according to various embodiments positioned relative to a knee with a pin alignment suture through the femur; 
         FIG. 13  is an environmental perspective view of an apparatus according to various embodiments positioned relative to a knee with a pin alignment suture through the femur and a graft pusher in a first position relative to the femur; 
         FIG. 14  is an environmental perspective view of an apparatus according to various embodiments positioned relative to a knee with a pin alignment suture through the femur and a graft pusher in a second position relative to the femur; 
         FIG. 15  is an environmental perspective view of an apparatus according to various embodiments positioned relative to a knee with a pin alignment suture through the femur and the graft in a position relative to the femur; 
         FIG. 16  is an environmental perspective view of an apparatus according to various embodiments positioned relative to a knee with a pin alignment suture through the femur and the graft in a position relative to the femur and aligning an implant according to various embodiments; and 
         FIG. 17  is an environmental perspective view of an apparatus according to various embodiments positioned relative to a knee with a pin alignment suture through the femur and the graft in a position relative to the femur and fixing an implant according to various embodiments; 
     
    
    
     DETAILED DESCRIPTION OF VARIOUS EMBODIMENTS 
     The following description of various embodiments is merely exemplary in nature and is in no way intended to limit the teachings, its application, or uses. Moreover, while the present teachings are directed in detail below with regard to ACL reconstruction, those skilled in the art will recognize the other types of soft tissue fixation may employ the present teachings. 
     Referring to  FIG. 1 , a generally guide apparatus  10  which may be generally a U-shaped guide or a U-Guide generally includes an L-shaped retaining bar or L-guide  12  which includes two portions or legs, a first portion  14  and a second portion  16 , that is substantially perpendicular to the first portion  14 . The first portion  14  defines a guide section  18 , having a guide section ledge  18   a , formed transversely through the first portion  14 . The guide section may be a passage through or transverse to the first portion  14  such as a bore wherein the guide section ledge would be a bore ledge. A set screw  20  can be provided to create a locking mechanism for the guide section  18 . The second portion  16  defines a bore  22  formed transversely through the second portion  16 . Also, a flexible strand notch or flexible strand retaining member  23  is formed near the bore  22  on the second portion  16 . A second set screw  24  is also provided to create a locking mechanism for the bore  22 . The L-guide  12  is shown in an L-shape, however, it will be understood the L-guide  12  may be any appropriate form. Generally, however, the axes defining the guide section  18  and the bore  22  are orthogonal. Therefore, the first axis A of the guide section  18  should intersect the second axis B of the bore  22  at a right angle at a position. 
     An insertion or guide rod  26  is adjustably held in the bore  22  and locked in place with the second set screw  24 . With continuing reference to  FIG. 1  and further reference to  FIG. 2 , the insertion rod  26  includes a body portion  28 . The body portion  28  is substantially cylindrical and formed around a longitudinal axis C. The body portion  28 , which is generally a solid, may also taper towards the guide portion  36  (described herein). Also, the body portion  28  may include depth indicia  29  to give a visual indication of the depth of the insertion rod  26  into a patient. 
     Extending from a first end of the body portion  28  is an L-Guide engaging portion  30  which includes a notch or projection  32  that is received in the second portion  16  of the L-Guide  12  to ensure proper orientation of the insertion rod  26  to the L-Guide  12 . The notch  32  on the insertion rod  26  is keyed to be received on to a portion of the second portion  16 . The insertion rod  26  further includes a collar  34 , having a first shoulder  34   a  and a second shoulder  34   b , to ensure that the insertion rod  26  is held at a predetermined depth in the L-Guide  12  and to further ensure proper orientation of the insertion rod  26  relative to the L-Guide  12 . 
     A guide portion  36  extends from a second end of the body portion  28 . The guide portion  36  includes two generally parallel legs  38  and  40  and a shoulder  41 . Each leg  38 ,  40  extends from the body portion  28  along axis C, though offset therefrom. The two legs  38 ,  40  define a slot  42 , where the slot  42  extends substantially the distance of the two legs  38 ,  40  and has a slot ledge  42   a  where the two legs  38 ,  40  meet at the shoulder  41 . 
     Also formed in each of the legs  38 ,  40  is a flexible strand groove  44 . The flexible strand groove  44  may be any appropriate depth, but exemplary is substantially equal in depth to the diameter of a cord or flexible strand thread to be used with the apparatus  10 . The flexible strand groove  44  extends, along the outside of each leg  38 ,  40 , substantially the length of the legs  38 ,  40  and also over the distal end of the legs  38 ,  40 . The flexible strand groove  44  also extends generally along axis C, though offset therefrom, and also over the terminal end of each leg  38 ,  40 . The plane defined by the slot  42  is substantially orthogonal to the plane defined by the flexible strand groove may lie on any relative plane as long as the two planes intersect within the area defined by the guide portion  36 . As described herein, a tool may be placed through the slot  42  while a cord is placed over the slot  42  by being positioned in the flexible strand groove  44 . 
     The insertion rod  26  may be any desired length. Preferably, however, the distance between the second collar shoulder  34   b  and the slot ledge  42   a  is equal to the distance between a first end of the first portion  14 , generally represented by line D, and the guide section ledge  18   a . In this way, the guide section ledge  18   a  and the slot ledge  42   a  are generally equidistant from the second portion  16 . Therefore, any instrument received through the guide section  18  would remain substantially parallel to the second portion  16  when it passed through the slot  42 . 
     The flexible strand groove  44  can be placed orthogonally to the slot  42  so that a cord, such as a flexible strand, may be placed in the flexible strand groove  44  to form an enclosed passage for any device that may be placed through the slot  42 . In this way, a device, such as a K-Wire (described herein), when inserted through the slot  42   a  has a flexible strand looped over the device. It will be understood, however, that the flexible strand groove  44  may be formed at any orientation relative to the slot  42  as long as a flexible strand placed in the flexible strand groove  44  will overlay the slot  42 . 
     The notch  32  ensures that the insertion rod  26  is properly oriented with the L-Guide member  12  of the U-guide apparatus  10 . In particular, the slot  42  is preferably aligned with the guide section  18 . The set screw  24  tightens against the L-Guide engaging portion  30  to ensure that the insertion rod  26  does not move during a surgical procedure. Also, this ensures the proper keyed fit of the notch  32  into the second portion  16  so that the guide section  18  and the slot  42  are properly aligned. This ensures that the instrument received through the apparatus  10  is aligned. It will be understood, however, that any appropriate means may be used to secure the insertion rod  26  to the L-Guide member  12  of the apparatus  10 . 
     Returning briefly to  FIG. 2A , the insertion or guide rod  26  can include a guide portion  36   a . The guide portion  36   a  can be similar to the guide portion  36 . For example, the guide portion  36   a  can include a first leg  38   a  and a second leg  40   a  and a slot  44   a  similar to the slot  44 . The guide portion  36   a  can also include a bore  45   a  that extends as a passage  43   a  through the leg  40   a . The guide portion  36   a  can further include a second bore  45   b  that extends as a passage  43   b  through the leg  38   a . Therefore, rather than the flexible strand  62  being placed in the slot  44 , the flexible strand  62  can pass through the passages  43   a ,  43   b  and through the bores  45   a ,  45   b  to be securely held relative to the guide portion  36   a . The slot  44   a  could be provided to allow movement of the guide portion  36   a  through a tunnel without impinging the flexible strand  62 . It will be understood that the guide portion  36   a  can be formed in any appropriate manner, such as the guide portion  36   a , the guide portion  36 , or any appropriate guide portion. The inclusion of the passages  43   a ,  43   b , however, can assist in holding the flexible strand  62  at a selected position relative to the guide portion  36   a d  using insertion of the member  26 . 
     Referring to the remaining  FIGS. 3-9 , an exemplary method for using the apparatus  10 , including the insertion rod  26  is described. It will be understood that although the apparatus  10  is described in the use of an Anterior Cruciate Ligament (ACL) replacement, any appropriate surgery may be performed with the apparatus  10  which would require its attributes. 
     With particular reference to  FIG. 3 , a knee  50  generally includes at least a tibia  52  and a femur  54  surrounded by soft tissue  55 . The knee  50  is initially prepared by forming a tibial tunnel  56  and a femoral tunnel  58  which are substantially in line with one another such that a straight and solid object could engage both the tibial tunnel  56  and the femoral tunnel  58  without a substantial amount of stress when the knee is placed in flexion between about 30 degrees and 110 degrees. It is understood that incisions must first be made in the soft tissue  55  surrounding the tibia  52  such that a tool may engage the tibia  52  and the femur  54  to form the tibial tunnel  56  and the femoral tunnel  58 . Any suitable tool may produce the respective tunnels  56 ,  58  such as a pneumatic or electric drill or reamer. It is also understood that the femoral tunnel  58  is a blind tunnel. A blind tunnel is a tunnel which includes an entrance but no discernable exit, rather a blind tunnel terminates below the surface of the femur  54 . 
     The size of the tibial tunnel  56  and the femoral tunnel  58  depends upon the size of the soft tissue replacement (described further herein) to be implanted into the patient. The larger the replacement needed, the larger the diameter of the tibial tunnel  56  and the femoral tunnel  58 . The tibial tunnel  56  and femoral tunnel  58  may be of any required diameter, but are generally between about 5 and 18 millimeters. It would be understood, however, that if a larger diameter replacement is necessary, then larger diameter tunnels  56 ,  58  may be produced in the tibia  52  and femur  54  to receive the implant. Additionally, smaller tunnels  56 ,  58  may be used if only a smaller implant is necessary. In addition, the largest area of the insertion rod  26  will have a diameter substantially equal to the diameter of the tibial tunnel  56  and femoral tunnel  58 . For example, if the insertion rod  26  was produced so that the guide portion  36 , in particular the shoulder  41 , form the largest diameter of the insertion rod  26 , then the outside diameter of the guide portion  36  would be substantially equal to diameter of the tibial tunnel  56  and the femoral tunnel  58 . Also, the body portion  28  may have a lesser diameter, or a taper towards the shoulder  41 , to ease insertion and removal of the insertion rod  26 . This ensures that the insertion rod  26 , and particularly the slot  42 , are substantially centered in the femoral tunnel  58  for the remaining procedure. 
     A flexible strand  62 , having a trailing end  62   a  and a leading end  62   b , is placed or pre-loaded into the flexible strand groove  44  and then the insertion rod  26  is inserted through the tibial tunnel  56  and into the femoral tunnel  58 , as best shown in  FIG. 4  (see also  FIGS. 1 and 2 ). The flexible strand  62  may be any generally known strand suitable to the purpose such as a mono- or poly-filament suture, a flexible wire, or cord made of any suitable material. The flexible strand groove  44  allows the flexible strand  62  to be inserted through the tunnels  56 ,  58  without engaging the walls of the tunnels  56 ,  58 . Generally the depth of the flexible strand groove  44  is at least equal to the diameter of the flexible strand  62 . The flexible strand  62  is placed so that it reaches substantially to the end of the femoral tunnel  58  and the slot  42  creates an opening through the center of the femoral tunnel  58  through which an instrument may pass, while not interrupting the flexible strand  62  which has been inserted into the femoral tunnel  58  by the insertion rod  26 . The flexible strand  62  is caught in the flexible strand notch  23 . The flexible strand  62  is held in position during the insertion of the insertion rod  26  into the tunnels  56 ,  58  and during the remaining surgical procedure by the flexible strand notch  23 . Any suitable means may be used to hold the flexible strand  62  in place relative to the L-Guide member  12  of the apparatus  10 . The flexible strand notch  23 , which holds the flexible strand  62  with friction, is merely exemplary of one appropriate means to hold the flexible strand  62  in place. 
     Once the insertion rod  26  has been inserted into the femoral tunnel  58 , so that the flexible strand  62  is positioned properly, a device, such as a drill bit or point  70  is used to produce a transverse tunnel  72  in the femur  54 . The transverse tunnel  72  is formed transversely to the femoral tunnel  58 . The transverse tunnel  72  will include an insertion point  72   a  and an exit point  72   b . It will be understood that an incision must first be made in the soft tissue  55  surrounding the femur  54 , so that the drill bit or point  70  may engage the femur  54  to form the transverse tunnel  72 . The drill point  70  may be powered by any appropriate device known in the art such as an electric or pneumatic drill. Furthermore, additional guide units or bullets  74 , such as the U-Guide bullet produced by Arthotek, Inc. of Warsaw, Ind., may be used to ensure the proper orientation and depth of the drill point  70 . The guide bullet  74  is inserted into the guide section  18  and held in place with the set screw  20  to ensure the drill point  70  is properly aligned with the slot  42  when producing the transverse tunnel  72 . The transverse tunnel  72  is produced through the entire width of the femur  54  so that the drill point  70  exits the femur  54  producing the exit point  72   b . This allows the drill point  70  to be removed through the exit point  72   b  at the appropriate time. While the apparatus  10  is still in place, a cannulated reamer (not shown) enlarges a portion of the transverse tunnel  72 . The reamed tunnel  73  receives the pin  84  (described herein). The reamed tunnel  73  does not extend the length of the transverse tunnel  72 . 
     After the reamed tunnel  73  is produced, the apparatus  10 , is removed as particularly shown in  FIG. 6 . Once the apparatus  10  has been removed, the drill point  70  remains in the transverse tunnel  72 . A soft tissue replacement  80  is affixed to the trailing end  62   a  of the flexible strand  62 . The soft tissue replacement may be any suitable replacement such as a hamstring portion, an allograft tissue replacement, a xenograft tissue replacement, or an artificial soft tissue replacement which may be produced from materials such as polymers or metal. After the soft tissue replacement  80  has been affixed to the trailing end  62   a , the leading end  62   b  of the flexible strand  62  is pulled drawing the soft tissue replacement  80  first through the tibial tunnel  56  and then through the femoral tunnel  58  over the drill point  70  and back down the femoral tunnel  58  and out through the tibial tunnel  56 . This produces a loop of the soft tissue replacement  80  over the drill point  70  inside of the femoral tunnel  58 . After being looped over the drill point  70 , the two free ends  80   a  and  80   b  of the soft tissue replacement  80  extend from the tibial tunnel  56  adjacent to the tibia  52 . 
     After the soft tissue replacement  80  has been looped over the drill point  70 , an ACL cross pin or pin  84  is pulled into place in the reamed tunnel  73 . The drill point  70  generally includes an eyelet  86  which will allow the attachment of the pin  84  to the drill point  70 . Generally, the pin  84  is attached to the eyelet  86  through a second flexible strand  88  or other appropriate means. After the pin  84  is attached to the eyelet  86 , the drill point  70  is pulled through the transverse tunnel  72 , through the loop of the soft tissue replacement  80  and out the exit point  72   b . This pulls the pin  84  into position and fixes it within the transverse tunnel  72 , as particularly shown in  FIG. 8 . Once the pin  84  has been fixed in place in the transverse tunnel  72 , the attached flexible strand  88  may be cut or otherwise disengaged from between the eyelet  86  and the pin  84 . The drill point  70  is then freely removed from the transverse tunnel  72 . This leaves the pin  84  lodged into the transverse tunnel  72  which may be locked in place with either portions of the pin  84  or through any other appropriate locking means. Although any appropriate means may be used to hold pin  84  in the reamed tunnel  73 , the pin  84  may include a square end to hold pin  84  in place. The pin  84  may also be threaded such as the device described in U.S. Pat. No. 5,674,224 entitled “Bone Mulch Screw Assembly For Industrial Fixation of Soft Tissue Soft tissue replacements And Method For Using Same” to Stephen M. Howell et al. incorporated herein by reference. 
     Because the pin  84  has been lodged in the transverse tunnel  72 , and the soft tissue replacement  80  is looped over the pin  84 , only the free ends  80   a  and  80   b  need to be secured to the tibia  52  to complete the implantation. A staple  90  is used to affix the free ends  80   a  and  80   b  of the soft tissue replacement  80  to the tibia  52 , as best shown in  FIG. 9 . It will be understood, however, that any appropriate means may be used to affix the free ends  80   a ,  80   b  to the tibia  52  such as The Washer-Loc™ tibial fixation device sold by Arthrotek, Inc., of Indiana, U.S.A.; U.S. Pat. No. 6,280,472 B1 entitled “Apparatus And Method For Tibial Fixation Of Soft Tissue” to James A. Boucher et al.; and U.S. Pat. No. 5,931,869 entitled “Apparatus And Method For Tibial Fixation Of Soft Tissue” to James A. Boucher et al. each incorporated herein by reference. Once the free ends  80   a  and  80   b  of the soft tissue replacement  80  are affixed to the tibia  52 , the soft tissue replacement  80  securely attaches the tibia  52  and the femur  54  substantially as a natural ACL would. 
     It will be understood that any appropriate means may be used to affix the soft tissue replacement  80  in the femoral tunnel  58 . The pin  84  is merely exemplary of any appropriate device to affix the soft tissue replacement  80  in the femoral tunnel  58 . Any commonly known screw or other fixation device may be used to fix the soft tissue replacement  80  in the femoral tunnel  58 . It will also be understood that the soft tissue replacement  80  may be pulled over the pin  84  after the pin  84  has been lodged in the transverse tunnel  72 . In particular, if the pin  84  is smooth, the soft tissue replacement  80  may be pulled over the pin  84  without damaging the soft tissue replacement  80  itself. The drill point  70  is simply removed from the transverse tunnel  72  before the soft tissue replacement  80  is pulled into the femoral tunnel  58 . 
     It will also be understood that the method for performing the described procedure may be altered but remain within the scope of the presently claimed invention. For example the flexible strand  62  may looped over the insertion rod  26  such that the two free ends  62   a  and  62   b  are on one side and a loop of the flexible strand is formed on the other side of the insertion rod  26 . Thus the soft tissue replacement  80  may be affixed to both free ends  62   a  and  62   b  or placed through the loop and then pulled over the insertion rod  26 . 
     As discussed above, the guide apparatus  10  includes a plurality of components including the L-guide portion  12 , which includes a guide section  18  defining a guide ledge  18   a . The insertion or guide rod  26  can be interconnected with the L-guide  12  to form a portion of the guide apparatus  10 . Although the guide apparatus  10  can be used according to various embodiments, including that described above, various other methods and procedures can be performed with the similar apparatus. 
     It will be understood that the guide apparatus  10  can be used to perform a plurality of procedures, such as assisting in replacing an anterior cruciate ligament (ACL) in a knee joint between the femur  54  and the tibia  52 . It will be understood that various procedures can be performed, such as with initial reference to  FIGS. 3-5 . As described and illustrated above and briefly summarized below, a soft tissue replacement can be performed relative to the knee  50 . The tibial tunnel  56  and the femoral tunnel  58  can be formed in the tibia and the femur  54 , respectively. It will be understood that various and appropriately sized incisions can be made in the soft tissue  55  as necessary and any appropriate apparatus can be used to form the tunnels  56 ,  58 . 
     With reference to  FIG. 10 , the guide apparatus  10  can be positioned relative to the knee  50 . In particular, the guide rod  26  can be positioned in the tunnels  56 ,  58 . The guide rod  26  can be positioned in the tunnels  56 ,  58  either prior to or after being interconnected with the L-guide portion  12 . Further, as discussed above, the guide rod  26  can include an engaging member, such as a pre-loaded flexible strand  62 . Once the guide apparatus  10  is positioned relative to the tibia  52  and the femur  54  through the tunnels  56 ,  58 , a targeting bullet or sizing member  100  can be passed through the guide section  18 . The sizing member  100  can be passed through an incision made in the soft tissue  55  as will be understood by one skilled in the art. 
     The sizing member  100  which can be similar to or the same as the bullet  24 , can include a distal or bone engaging end  102  and a proximal end  104  interconnected by a body  106 . The body  106  can include one or a plurality of demarcations  108  that can be referenced relative to the L-guide portion  12 . The sizing member  100  can be used to select an appropriate implant, such as the graft fixation pin  84 . The graft fixation pin  84  can be selected based on various characteristics, such as the depth to the soft tissue  55 , the size of the femur  54  relative to the soft tissue  55 , the depth of the femur  54 , the positioning of the tunnel  58  within the femur  54 , or any other appropriate consideration. Regardless, the sizing member  100  may be used during the procedure to assist in selecting an appropriate graft fixation pin  84 . It will be understood, however, that the sizing member  100  is not necessary and any appropriate method can be used to select the graft fixation pin  84 . 
     After positioning the sizing member  100  relative to the guiding apparatus  10  and the femur  54 , the guide wire or drill point  70  can be positioned through the sizing member  100  and drilled through the femur  54  as illustrated in  FIG. 11 . This can be used to form a portion of the transverse tunnel  72  through the femur  54 . As discussed above, the drill point  72  can pass through the guide portion or the opening  42  in the guide rod  26 . The drill point  70  can be passed through the entire length or width of the femur  54 . The drill point  70  may extend out a side of the femur  54  so that a distal tip  70   a  of the drill point extends out of the femur along with a proximal end  70   b  of the drill point  70 . This may allow for either end of the drill point  70  to be operated for various purposes, such as those described herein. It will be understood, however, that the drill point  70  can be passed through the femur  54  in any appropriate manner with the use of the guide apparatus  10 , without the use of the guide apparatus  10 , or with or without the sizing member  100 . The drill point  70  can be powered by hand or with a power tool, or in any appropriate manner. It will be understood that the guiding apparatus, if used, can include portions that allow the drill guide  70  to be positioned relative to the femur  54  in any appropriate manner. 
     Once the drill point  70  is passed through the femur  54 , such as by drilling the drill point  70  through the femur, a portion of the transverse tunnel  72  can be enlarged. A drill bit  110  can be used to form the enlarged portion  73  of the transverse tunnel  72 . The drill bit  110  can also be powered in any appropriate manner such as with a power drill motor, a hand tool, or the like. Further, the drill bit  110  can be any appropriate member that is able to perform the enlargement of transverse tunnel  73 . For example, a reamer, a cannulated drill bit, or any other appropriate tool can be used to form the enlarged transverse tunnel  73 . 
     The drill bit  110  can be drilled over the drill point  70  to any appropriate depth in the femur  54 . For example, the drill bit  110  can be drilled into the femur  54  until it reaches or bottoms out on the guide rod  26 . Therefore, when the drill bit  110  reaches the guide rod  26 , it will be understood that the drill bit  110  has formed the enlarged tunnel  73  from an exterior of the femur  54  to at least a portion of the femoral tunnel  56 . The enlarged and tunnel portion  73  can be used for any appropriate portion, such as positioning the cross pin or bullet  84  into the femur  54 . 
     Once the enlarged portion  73  of the transverse tunnel is formed, a transverse pin alignment suture or flexible member  112  can be interconnected with an eyelet  70   c  formed on the drill point  70 , as illustrated in  FIG. 12 . The transverse pin alignment suture  112  can then be drawn through the transverse tunnel  72  by withdrawing the drill point  70  therefrom. An external portion of the suture  112  can be clamped or held in place with any appropriate mechanism such as with a clamp  114 . 
     Once the pin alignment suture  112  is drawn through the transverse tunnel  72 , the guide apparatus  10  can be substantially removed from the knee  50 . The flexible member  60  that is initially loaded on the guide rod  26  can be used to withdraw a portion of the pin alignment suture  112  out of the tibial tunnel  56 . The portion of the suture  112  drawn out of the tibula tunnel  56  can be clipped to any appropriate portion or held in a relative location such as being clipped with a clip  116  to a drape  118 , as illustrated in  FIG. 13 . It will be understood, however, that the pin alignment suture  112  can be held in any appropriate manner exterior to the tibia  52 . Although it has been disclosed above that the flexible member can be used to withdraw a portion of the pin alignment suture  112  from the tibial tunnel  56 , it will be understood that any appropriate enlargement mechanism can be provided. For example, a releasable member, such as a finger or a clip, can be formed on the guide rod  26  that can be used to withdraw the pin alignment suture  112 . Therefore, it will be understood, that the flexible member  60  is merely exemplary of a mechanism or instrument to withdraw a portion of the pin alignment suture  112 . 
     Once the pin alignment suture  112  has been held in a selected position, such as with the clip  116 , a soft tissue graft  120  can be interconnected with a positioning tool  124 , as illustrated in  FIG. 14 . The soft tissue graft  120  can include any appropriate soft tissue, such as an allograft, a xenograft, an autograft, or combinations thereof. The soft tissue graft  120  can be formed or prepared in any appropriate manner. For example, ends of the soft tissue graft can be intertwined or sutured together with a graft suture  126 . The intertwined end  128  of the soft tissue graft  120  are thereby held relative to one another for implantation of the soft tissue graft  120 . 
     The positioning instrument  124  can include any appropriate mechanism to assist in positioning the soft tissue graft  120  in the tunnels  56 ,  58 . For example, the positioning instrument  124  can include a positioning arm  128  and a T bar or handle  130 . The positioning arm  128  can include a distal fork or graft engaging portion  132 . The handle  130  can include any appropriate configuration to allow for interconnecting the sutures  126  therewith. Interconnecting the sutures  126  with the handle  130  can assist in holding the soft tissue  120  relative to the positioning instrument  124  for a selected period of time. It will be understood, however, that the fork  132  can be any appropriate portion and a fork is merely exemplary. 
     The soft tissue graft  120  can be sized in any appropriate manner. For example, the soft tissue graft  120  can include a dimension, a volume, a diameter, or the like that can substantially fill at least a portion of the femoral tunnel  58  or the tibial tunnel  56 . It will be understood, however, that the soft tissue graft  120  can be formed in any appropriate size for achieving a selected result. The positioning instrument  124  allows the graft  120  to be positioned into the tunnel, such as allowing it to be substantially seated in the tibial tunnel  58  without the assistance of any other mechanisms. The graft positioning member  124  allows the graft  120  to be passed through the tunnels  56 ,  58  with ease by a user, such as a physician. The positioning member  124  also enables a size specific graft that is sized to fill the diameter of the tunnels  56 ,  58  to be moved into the tunnels. The tunnels  56 ,  58  can be formed to substantially match a dimension of the graft for various purposes such as initial fixation and bone ingrowth. 
     As discussed above, the positioning instrument  124  allows for pushing the soft tissue graft  120  into the tunnels  56 ,  58 . Because the soft tissue graft  120  is pushed into the tunnels  56 ,  58 , the soft tissue graft can be formed to substantially fill the tunnels so that a substantial force can be used push the soft tissue graft  120  into the tunnels  56 ,  58 . It will be understood that the force used may not cut or otherwise deteriorate the graft  120 , but the force may be substantial due to the positioning instrument  154 . 
     Further, the tunnel is formed in the anatomy, such as the femoral tunnel  58  can be sized such that the tibia tunnel extends a selected distance past the transverse tunnel  72 . The transverse tunnel  72  can be formed relative to the femoral tunnel  58  such that there is a head room or distance that is formed by the femoral tunnel  58  that is past or extends past the transverse tunnel  72 . As discussed above, the guide bit  70  generally assists in positioning the implant  130  relative to the soft tissue graft  120  after the soft tissue graft  120  is in position in the femoral tunnel  56 . Therefore, the soft tissue graft  120  can be pushed into the femoral tunnel  56  such a distance that the implant  120  does not substantially interact with or contact the soft tissue graft  120  as it is passed through the transverse tunnel  72  as discussed further herein. This can be provided for various reasons such as easing the positioning of the implant  130  relative to the soft tissue graft  120  and the femoral tunnel  56 . Because the soft tissue graft  120  is substantially pushed past the transverse tunnel  72 , the implant  130  can be easily and efficiently moved past and/or through the femoral tunnel  56  without substantially contacting the soft tissue graft  120  while moving the implant  130 . 
     With reference to  FIG. 14 , once the graft  120  has been positioned in a selected location in the tibial tunnel  58 , the clip  116  holding the pin alignment suture  112  at a selected location exterior to the femur  54  can be released. The pin placement suture  112  forms a loop  112   a  that is clipped with a clip  116 . The loop  112   a  can be positioned relative to the soft tissue graft  120  such that the positioning suture  112  can be placed between the portions of the soft tissue graft  120 . 
     With reference to  FIG. 15 , the soft tissue graft  120  can include a first or anterior portion  120   a  and the second or posterior portion  120   b . The suture positioning loop  112   a  can be positioned between and/or below the two portions  120   a ,  120   b  of the soft tissue graft  120 . Once the loop  112   a  is positioned relative to, such as below, the portions of the soft tissue graft  120 , the positioning suture  112  can be held within the femoral tunnel  58  such as with the clamping member  114 . Regardless, the pin alignment suture  112  can be formed or made taut within the femoral tunnel by moving it generally in the direction of the arrow M. It will be understood that the graft positioning instrument  124  can be disconnected from the soft tissue graft  120  to allow for the loop  112   a  to be passed between the portions  120   a ,  120   b  of the soft tissue graft  120 . 
     The pin alignment suture  112  can be used to move the drill point  70  through at least a portion of the transverse femoral tunnel  72 . The drill point  70  can also act as an implant alignment or positioning mechanism. Therefore, the drill point  70  is generally pulled under the graft  120  such as between the two portions  120   a ,  120   b . The pin positioning suture  112  assists in pulling the drill point beneath the graft  120 . 
     With reference to  FIG. 16 , an implant  130  can be passed over the guide wire drill point  70 . The implant  130  may be similar to the implant  84  for holding the soft tissue graft  120  relative to the femur  54 . The implant  30 , however, can include other portions. For example, the implant  130  may be cannulated such that it is able to pass over the drill point  70 . Further, it may include a proximal threaded or bone engagement portion  132  and a distal tunnel engagement portion  134 . The implant  130  can include a tapered structure such that it is able to pass under the graft  120  in a non-binding manner. 
     The implant  130  may pass over the drill wire  70  in any appropriate manner such as with a tool, annularly or the like. Once the implant  130  is positioned relative to the femur  54 , it can be fixed relative to the femur  54  in any appropriate manner. For example, a driving tool  140  may engage a portion of the implant  130  such as a tool engaging portion of the implant  130 , as illustrated in  FIG. 17 . The tool engaging portion of the implant  130  can include an interior tool engaging portion such that the bone engaging portion  132  can extend substantially to an end of the implant  130 . The bone engaging portion  132  can include threads such that operation of the tool  140  acts to rotate the implant  130  so the threads are able to engage the femur  54 . 
     The implant  130  can include a main body portion that engages the enlarged transverse tunnel  73  while the distal portion  134  engages the unenlarged transverse tunnel  72 . It will be understood, however, that the implant  130  can be formed in any appropriate manner to engage the femur in any appropriate manner to allow fixation of the graft  120  thereto. 
     The tool  140  can include a measurement sleeve  142  that is able to assist in determining an appropriate driven distance of the implant  130 . The measuring sleeve  142  can include demarcations that allow it to be used to determine whether the implant  130  has been driven an appropriate distance into the femur  54 . The demarcations on the sleeve  142  can be referenced to the demarcations on the sizing member  100  to ensure that the implant  130  is positioned relative to the femoral tunnel  58  in any appropriate manner to hold the graft  120 . 
     Once the implant  130  has been positioned relative to the femur  54  through the transverse tunnel  72 ,  73 , the soft tissue graft  120  can be fixed to the tibia  52  in any appropriate manner such as that described above. For example, the implant  90  can be used to fix the proximal end of the soft tissue relative to the tibia  52 , as illustrated in  FIG. 9 . 
     It will be understood that any appropriate implants may be used for the various implants described herein. For example, the AXL™ cross pin produced by Arthrotek, Inc. of Warsaw, Ind. can be used by the implant  130 . Further, the tibial fixation implant can be any appropriate implant such as the Bone Mulch™ Screw or LactoSorb™ Cross Pin produced by Arthrotek, Inc. of Indiana, U.S.A. or the Trans Fix™ implant by Arthrex, Inc. 
     It will be understood that the method described herein can be used to position a soft tissue graft relative to any appropriate portion of the anatomy. Although replacement of a soft tissue portion in a femur  54  and a tibia  52  have been described, interconnection of any appropriate bone portions can be formed with the various instruments and methods taught herein. 
     The teachings herein are merely exemplary in nature and, thus, variations that do not depart from the gist thereof are intended to be within the scope of the teachings. Such variations are not to be regarded as a departure from the spirit and scope of the teachings.