Abstract:
A three-dimensional (3-D) femur orthopedic drill guide device (FIG.  1  and FIG.  2 ) is disclosed. The device guides a drill to make a hole in femoral bone. A tissue repair device is used to replace injured anterior cruciate ligament (ACL). The tissue replace device is assembled in the femur bone hole.

Description:
BACKGROUND 
       [0001]    1. Field 
         [0002]    USPTO CLASS 606/96, INTERNATIONAL CLASS A61 F 2002/0841 
         [0003]    This application relates to an orthopedic drill guide device for accommodating a bone drill. 
         [0004]    2. Background 
         [0005]    Surgery is necessary to replace injured ACL with a tissue repair device. The tissue repair device material can be synthetic or biological. The tissue repair device is implanted through pre-drilled holes in the tibia and femur bones. The tissue repair device is then pulled and secured to bones with screws, staples, sutures, or a combination thereof. 
         [0006]    The through hole in the proximal end of the tibia is typically drilled in an outside-in configuration. In the outside-in configuration, the drill enters the anteromedial side of the tibia and exits at the ACL&#39;s anatomic attachment site on the tibial plateau. 
         [0007]    The through hole in the distal end of the femur can be drilled in either an outside-in or inside-out configuration. The typical outside-in configuration consists of a through hole drilled from the lateral femoral epicondylar area and emerging at the origin of the ACL on the posteromedial aspect of the lateral femoral condyle. To perform the outside-in drilling the patient knee is positioned in flexion. The inside-out configuration is performed in the opposite direction of the outside-in configuration. To perform the inside-out drilling the patient knee is positioned in hyperflexion. Many complications arise when drilling the distal femur tunnel using present orthopedic drill guides. 
       Problem Description 
       [0008]    When drilling the femur following an outside-in configuration, the drill exit needs to avoid contact with adjacent soft tissue. If the drill is not properly oriented it may damage soft tissue including the femoral condyle cartilage, lateral/collateral ligaments, and/or popliteus tendon. Drill guides used for the outside-in configuration are c-clamps and outside guides. These guides are characterized to be planar or two dimensional. Planar guides do not provide the correct three-dimensional (3-D) directional direction required to prevent soft tissue damage. To obtain the appropriate direction the surgeon has to maneuver the drill guide. This process does not guaranty that soft tissue will not be damaged. In order to avoid soft tissue damage the tunnel should exit at the lateral femoral condyle flare. 
         [0009]    Planar guides also present the problem that the drilled tunnel length is not precisely controlled. A short tunnel of less than 20 mm reduces contact surface between the tissue repair device and the bone. The reduced contact surface negatively impacts the tissue repair device biological integration and increases its stress concentration. These problems may cause rupture of the tissue repair device. Current guides cannot predict tunnel length accurately which may result in short tunnel length. 
         [0010]    The other type of femoral guide is an inside-out instrument. To use these instruments the surgeon needs to reposition the patient from knee flexion to hyperflexion to position orthopedic guide and drill the femur. Additional positioning steps compromises surgeon&#39;s vision which may result in medial femoral condyle injury. Another problem of the inside-out configuration is that the resultant tunnel is short in length. Short length tunnel may rupture the tissue repair device. 
         [0011]    The resultant orientation of the tissue repair device must avoid its rupture. The tissue repair device direction should imitate the anatomical orientation of the ACL to improve its function. 
       SUMMARY ON THE INVENTION 
       [0012]    In accordance with one embodiment a three dimensional outside-in femoral orthopedic drill guide device ( FIG. 1 ,  FIG. 2 , and  FIG. 3 ) for anterior cruciate ligament reconstruction is disclosed. The guide forms a directional vector for the drill that avoids damage to soft tissue, provides proper tunnel length to promote biological integration of the tissue repair device, avoids leg repositioning to drill the tunnel which allows the surgeon to complete the surgery in one position: knee flexion, provides an anatomical similitude to the biological direction of the anterior cruciate ligament reducing its overstress, and eliminates the need to reposition the orthopedic drill guide device to obtain a proper tunnel directional vector. In addition, the orthopedic drill guide device avoids contact between the orthopedic drill guide device with the patella bone and/or the thigh. 
     
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING 
         [0013]      FIG. 1  shows 3-D orthopedic femoral guide exploded assembly. (A) Front View, (B) Right View 
           [0014]      FIG. 2  shows 3-D orthopedic femoral guide assembly. (A) Front View, (B) Right View 
           [0015]      FIG. 3  illustrates an alternate shape of a 3-D orthopedic femoral guide device. 
           [0016]      FIG. 4  depicts the view when facing the axial plane and rotating about the center femoral ACL origin the coronal plane should rotate ALPHA angle between 10 and 80 degrees clockwise for a right femur, and counter clockwise for a left femur. 
           [0017]      FIG. 5  depicts the view when facing the Sagittal Plane you should rotate BETA degrees about the Coronal Plane with center of rotation in the femoral ACL origin BETA angle between 10 and 80 degrees clockwise in right femur, and counter-clock wise in left femur. 
       
    
    
     DETAILED DESCRIPTION 
       [0018]    To drill a femoral through hole, a three dimensional orthopedic drill guide device is used. The three dimensional orthopedic drill guide device ( FIG. 1  and  FIG. 2 ) is comprised of an arm ( 10 ), a hollow sleeve ( 20 ), a removable hollow bullet-shaped pilot ( 50 ), and a support base ( 30 ). The arm ( 10 ) has two ends where the first end is attached to the hollow sleeve ( 20 ). The second end of the arm ( 10 ) is attached to the support base ( 30 ). The arm ( 10 ) function is to connect the hollow sleeve ( 20 ) and support base ( 30 ). The arm ( 10 ) shape avoids the contact with the patella and the thigh when the orthopedic drill guide device is installed in the femur ( 40 ). The offset distance of the arm ( 10 ) is between 20 mm or larger moving away from the knee in the inferior direction to avoid contact with the patella, and a distance between 20 mm or larger in the lateral direction to avoid contact with the thigh. The arm ( 30 ) also serves as a means for the surgeon to grasp, position, and maneuver the orthopedic drill guide device during its installation to the femur ( 40 ). 
         [0019]    The shape combination of the arm ( 10 ), hollow sleeve ( 20 ), and support base ( 30 ) or other additional components allow the three dimensional direction of the guide to properly direct the drill ( 60 ). For example, the arm ( 10 ) can be made of one piece that mimics the shape of an offset femoral condyle ( FIG. 1  and  FIG. 2 ), or be made of more than one piece that are combined ( FIG. 3 ) to obtain the proper directional vector ( 70 ) for the orthopedic drill guide device. 
         [0020]    The hollow sleeve ( 20 ) is of constant diameter for its full length, this diameter is intended to fit the outside diameter of a removable hollow bullet-shaped pilot ( 50 ). This removable hollow bullet-shaped pilot ( 50 ) will have a constant inside diameter to fit and accommodate a particular drill size ( 60 ). The hollow bullet shape pilot ( 50 ) is used to secure the 3-D orthopedic drill guide device to the femoral bone ( 40 ) from the lateral femoral epicondylar area ( 42 ) where the drill ( 60 ) enters the femur ( 40 ). The hollow bullet shaped pilot ( 50 ) may incorporate a knurled knob ( 52 ) at one end to facilitate insertion and removal into the hollow sleeve ( 20 ). The removable hollow bullet shaped pilot ( 50 ) has a least one bone engaging tooth ( 54 ) at the other end to keep orthopedic drill guide in place when assembled. The hollow bullet-shape pilot ( 50 ) inside diameter accurately accommodates a particular drill ( 60 ) size and it can be inserted and removed from the hollow sleeve ( 20 ) to allow changing the hollow bullet shape pilot ( 50 ) of different inside diameters. The hollow bullet shape pilot ( 50 ) may be retained within the hollow sleeve ( 20 ) during use of a threads or any other suitable means that prevents the hollow bullet-shape pilot ( 50 ) to turn with the drill ( 60 ) during drilling; 
         [0021]    The support base ( 30 ) is attached to the second end of the arm ( 10 ). The support base ( 3 ) is positioned by the surgeon to the original anatomical ACL&#39;s femoral insertion center ( 44 ). The hollow bullet shape pilot ( 50 ) is then pressed and locked to the femur ( 40 ) allowing assembly of the orthopedic guide device. Once the orthopedic guide device is locked into position the surgeon proceeds to drill ( 60 ) the femur ( 40 ) entering from the lateral femoral condyle flare ( 42 ) and emerging at the origin of the ACL ( 44 ) on the posteromedial aspect of the lateral femoral condyle where the support base ( 30 ) is located. 
         [0022]    The orientation of the drill is predetermined by the 3-D orthopedic drill guide. The directional vector ( 70 ) of the 3-D orthopedic drill guide is achieved by rotating degrees ( FIG. 4 ) measured from the coronal plane ( 80 ) when facing the axial plane ( 90 ), and rotating BETA degrees ( FIG. 5 ) about the coronal plane ( 110 ) when facing the sagittal plane ( 100 ). The 3-D orthopedic guide angle ALPHA is between 10 and 80 degrees measured clockwise for a right femur ( 40 ) and counter clockwise for a left femur ( 40 ), and angle BETA is between 10 and 80 degrees measured clockwise for a right femur ( 40 ) and counter clockwise for a left femur ( 40 ). Other geometrical references and notations may be used to obtain the same directional vector ( 70 ). 
         [0023]    The 3-D orthopedic drill guide needs a set of right and left instruments to obtain the ALPHA and BETA angles. The 3-D orthopedic drill guide can be machined and/or formed from non-corrosive metals. 
         [0024]    Novel features of the 3-D orthopedic drill guide device include the following
   1. The guide provides the correct directional vector for the drill that avoids damage to soft tissue. The surgeon does not have to maneuver the drill guide to obtain the correct drill direction.   2. Surgery is completely performed at a 90 degree flexion. This avoids repositioning the patient to perform the surgery. Repositioning the patient may interrupt surgeons&#39; vision to drill the bone tunnel.   3. The installed tissue repair device is completely inside the tunnel with a safe, predictable, and reproducible tunnel length of more than 20 mm. A tunnel length larger than 20 mm minimizes stress concentration and promotes biological integration of the tissue repair device. This minimizes rupture of the tissue repair device during its use.   4. Bone-Tendon-Bone tunnel mismatch can be accommodated optimizing fixation.   5. Direction of tunnel reduces tension applied to the graft.   6. Predictable tunnel length.   7. Safe and reproducible tunnel placement.   8. Biological integration is favored through a longer tunnel   9. It avoids contact between the orthopedic drill guide device with the patella bone and/or the thigh.   10. 3-D orthopedic drill guide arm can be used to grasp guide into position when drilling. This allows for better support and direction of the drill.   
 
         [0035]    While this drill guide device is intended primarily for use in the implantation of ACL tissue repair device, its convenience to drill bone enable it to be used in other applications.