Abstract:
A device for positioning a femoral tunnel during ACL reconstruction, the device comprising: a shaft having a lumen, the lumen defining a longitudinal axis; and a distal offset projection, at least a portion of the distal offset projection extending distally from the elongated shaft; and a single lateral reference member configured to reference a portion of a patient&#39;s anatomy, e.g., a PCL or a portion of the femoral notch, the lateral reference member located on one of the left or the right side of the device, wherein, on a second one of the left or the right side of the device, the device defines a void. Two devices may be employed to provide a set.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a continuation-in part of, and claims the benefit of priority to, U.S. patent application Ser. No. 12/366,967, filed Feb. 6, 2009, entitled “Guide for Creating a Femoral Tunnel During an ACL Reconstruction,” and U.S. Provisional Patent Application Ser. No. 61/066,575, filed Feb. 21, 2008, entitled “Guide for Creating a Femoral Tunnel During an ACL Reconstruction,” the disclosures of each being incorporated herein by reference in their entirety. In addition, this application is related to U.S. Provisional Patent Application Ser. No. 61/066,572, filed Feb. 21, 2008, entitled “Device for Orienting the Tibial Tunnel Position During an ACL Reconstruction” and U.S. patent application Ser. No. 12/367,007, filed Feb. 6, 2009, entitled “Device for Orienting the Tibial Tunnel Position During an ACL Reconstruction,” the disclosures of each also being incorporated herein by reference in their entirety. 
     
    
     BACKGROUND 
       [0002]    1. Technical Field 
         [0003]    This invention relates to surgical apparatus and procedures in general, and more particularly to surgical apparatus and procedures for reconstructing a ligament. 
         [0004]    2. Background of Related Art 
         [0005]    A ligament is a piece of fibrous tissue which connects one bone to another. Ligaments are frequently damaged (e.g., detached or torn or ruptured, etc.) as the result of injury and/or accident. A damaged ligament can cause instability, impede proper motion of a joint and cause pain. Various procedures have been developed to repair or replace a damaged ligament. The specific procedure used depends on the particular ligament which is to be restored and on the extent of the damage. 
         [0006]    One ligament which is frequently damaged as the result of injury and/or accident is the anterior cruciate ligament (i.e., the ACL). Looking first at  FIGS. 1 and 2 , it will be seen that the ACL  5  extends between the top of the tibia  10  and the bottom of the femur  15 . A damaged ACL can cause instability of the knee joint and cause substantial pain and arthritis. For this reason, ACL reconstruction is a common procedure with more than 100,000 cases being performed in the United States annually. 
         [0007]    Various procedures have been developed to restore and/or reconstruct a damaged ACL through a graft ligament replacement. Traditionally, this procedure is performed utilizing a trans-tibial approach. In this approach, a tibial tunnel or bone tunnel  20  is created in tibia  20  by drilling up through tibia  10 . Bone tunnel  20  is then used to access an inner surface of femur  15  to drill a bone tunnel  25  up into femur  15 . More particularly, once tibial tunnel  20  is created, a conventional femoral guide, often referred to as an “over-the-top” guide ( FIG. 4 ), is used to accurately locate the femoral tunnel  25 . More specifically, the “over-the-top” guide is placed through the tibial tunnel, across the joint, through the femoral notch, and then into position so that the distal finger of the guide is positioned against the backside of the femur. ( FIG. 5 ). Proper placement of the femoral tunnel is imperative in order for the ACL graft to be properly positioned on the femur. However, as a result of using the aforementioned trans-tibial technique and the aforementioned conventional “over-the-top” femoral guide, the position of the femoral tunnel is effectively dictated by the position of the first-drilled tibial tunnel. This often results in a femoral tunnel position, and thus, an ACL reconstruction (i.e., graft orientation, etc.) that is less than optimal. 
         [0008]    In an attempt to better position the femoral tunnel, surgeons have recently begun utilizing the so-called “medial portal technique” to drill and create the femoral tunnel. By drilling the femoral tunnel through the medial portal or an accessory portal, the femoral and tibial tunnels may be drilled independently of one another and, therefore, in a more appropriate anatomical position. 
         [0009]    As shown in  FIG. 6 , when drilling the femoral tunnel through the medial portal, surgeons typically still use the same “over-the-top” femoral guide used during the aforementioned trans-tibial approach. However, because the “over-the-top” femoral guide is designed for use in a trans-tibial approach, the “over-the-top” femoral guide is not ideal for use in a medial portal approach. These “over-the-top” femoral guides generally have narrow-shaped distal tip geometries to aid in their ability to pass through the tibial tunnel. In addition, such femoral guides have an offset spatula design to hook the posterior femoral notch, thereby aiding in positioning of the guide. Aside from this spatula design, these femoral guides have no other specific referencing geometries for properly positioning the femoral tunnel. 
         [0010]    Traditionally, surgeons utilize what is known as a “clock face” orientation in order to decide where to place the femoral tunnel within the notch of knee. This clock face orientation technique designates positions along the notch from 9 o&#39;clock to 3 o&#39;clock, depending on which knee is being reconstructed. This technique, while seemingly simplistic, is limited by a number of factors, one being that the positioning of the imaginary clock face along the notch is completely subjective and hence widely affected by the specific implementation of the surgeon. Therefore, it would be beneficial to have a femoral guide for use in medial approach ACL reconstruction surgery that is configured for more accurate femoral tunnel positioning. In addition, it would be beneficial if the femoral guide is designed in such a way that it might also be utilized during a trans-tibial approach. 
       SUMMARY 
       [0011]    A guide for positioning a guide wire on a femur to allow a tunnel to be formed in the femur along the guide wire is provided. The guide includes an elongated shaft having proximal and distal ends, and a distal tip formed on the distal end of the elongated shaft, the distal tip having a diameter substantially similar in size to the diameter of the desired resultant femoral tunnel, wherein the elongated shaft and the distal tip are cannulated to receive the guide wire. 
         [0012]    The distal tip further may further include at least one of opposed fingers and a distal projection. The opposed fingers or distal projection may be configured to reference a leading edge of the posterior cruciate ligament. The opposed fingers or distal projections may further be configured to reference a posterior femoral cortex. The elongated shaft may be configured to extend across a knee joint, the length of a tibial tunnel, or out of a medial port. The distal end may include a substantially circular cross-section, a substantial semi-spherical cross-section, or an unroofed cross-section. 
         [0013]    Additionally, there is provided a method of positioning a femoral tunnel during an ACL reconstruction. The method includes the steps of providing a femoral guide including an elongated shaft having a distal end, the distal end including a diameter substantially similar in size to the diameter of the desired resultant femoral tunnel, wherein the elongated shaft and the distal end are cannulated to receive a guide wire therethrough, inserting the femoral guide into a knee joint, positioning the distal end of the guide against the femur, and inserting the guide wire through the femoral guide and into the femur. 
         [0014]    The femoral guide may include one of opposed fingers and a distal projection configured for referencing a posterior cruciate ligament. The method may further include the step of referencing a leading edge of a posterior cruciate ligament and/or the posterior femoral cortex. The method may also include the step of flexing the knee to 120 degrees. The femoral guide may be inserted into the knee joint using a medial portal approach or a trans-tibial approach. 
         [0015]    In accordance with various embodiments, the present invention may provide a device for positioning a femoral tunnel during ACL reconstruction, the device comprising: a shaft having a lumen, the lumen defining a longitudinal axis; and a distal offset projection, at least a portion of the distal offset projection extending distally from the elongated shaft; and a single lateral reference member configured to reference some portion of a patient&#39;s anatomy, e.g., a patient&#39;s PCL or a portion of the femoral notch, the lateral reference member located on one of the left or the right side of the device, wherein, on a second one of the left or the right side of the device, the device defines a void. The lumen may be configured to receive a guide wire therethrough. 
         [0016]    In accordance with various embodiments, the present invention may also provide a set of devices for positioning a femoral tunnel during ACL reconstruction, the set comprising: a first device comprising a shaft having a lumen, a distal offset projection, at least a portion of the distal offset projection extending distally from the elongated shaft, and a left lateral reference member configured to reference some portion of a patient&#39;s anatomy, e.g., a patient&#39;s PCL or a portion of the femoral notch, when the first device is in position in a patient&#39;s left knee; and a second device comprising a shaft having a lumen, a distal offset projection, at least a portion of the distal offset projection extending distally from the elongated shaft, and a right lateral reference member configured to reference some portion of a patient&#39;s anatomy, e.g., a patient&#39;s PCL or a portion of the femoral notch, when the second device is in position in a patient&#39;s right knee. The lumen of each one of the first and second devices may be configured to receive a guide wire therethrough. The first and second devices may be connectable to each other such that, when connected, they together form a femoral tunnel positioning device that is configured to be used in a medial portal technique. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0017]    The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the disclosure and, together with a general description of the disclosure given above, and the detailed description of the embodiment(s) given below, serve to explain the principles of the disclosure, wherein: 
           [0018]      FIG. 1  is a perspective view of a knee joint showing an ACL; 
           [0019]      FIG. 2  is an alternate perspective view of the knee joint of  FIG. 1 ; 
           [0020]      FIG. 3  is a perspective view of a knee joint including tibial and femoral tunnels (shown in phantom) and a ligament graft; 
           [0021]      FIG. 4  is a side view of a conventional “over-the-top” femoral guide; 
           [0022]      FIG. 5  is side view of a knee joint including the “over-the-top” femoral guide of  FIG. 4  accessing the femur using the trans-tibial approach; 
           [0023]      FIG. 6  is a side view of a knee joint including the “over-the-top” femoral guide of  FIG. 4  access the femur using the medial portal approach; 
           [0024]      FIGS. 7A-7C  are side views of the distal end of various embodiments of a femoral guide according to the present disclosure; 
           [0025]      FIGS. 8A-8C  are end views of the distal end of the embodiments of  FIGS. 7A-7C , respectively; 
           [0026]      FIGS. 9A-9C  are end views of the distal end of alternative embodiments of a femoral guide according to the present disclosure; 
           [0027]      FIG. 10A  is a side view of a distal end of a femoral guide according to another embodiment of the present disclosure; 
           [0028]      FIG. 10B  is an end view of the distal end of the femoral guide of  FIG. 10A ; 
           [0029]      FIG. 10  C is a side view of the femoral guide of  FIGS. 10A and 10B ; 
           [0030]      FIG. 10  D is an end view of the femoral guide of  FIGS. 10A-10C ; 
           [0031]      FIG. 10  E is top view of the distal end of the femoral guide of  FIGS. 10A-10D ; 
           [0032]      FIG. 11  is a partial cut-away view of a femoral guide according to an embodiment of the present disclosure being used in a medial portal approach; 
           [0033]      FIG. 12  is a partial cut-away view of a femoral guide according to an embodiment of the present disclosure being used in a trans-tibial approach; 
           [0034]      FIG. 13  is a side view of the proximal end of a femoral guide according to an embodiment of the present disclosure. 
           [0035]      FIG. 14  is a top view of a femoral tunnel positioning guide, according to an example embodiment of the present invention; 
           [0036]      FIG. 15  is a top view of a femoral tunnel positioning guide for the right knee, according to another example embodiment of the present invention; and 
           [0037]      FIG. 16  is a top view of a femoral tunnel positioning guide for the left knee, according to another example embodiment of the present invention. 
       
    
    
     DETAILED DESCRIPTION OF THE EMBODIMENTS 
       [0038]    The femoral guide of the present disclosure is designed to be used in determining the position of a femoral tunnel guide wire which facilitates the positioning of a femoral tunnel during an ACL reconstruction. As with conventional femoral guides, the femoral guide of the present disclosure may reference an “over-the-top” position with an offset spatula; however, it can also be designed and utilized without such an offset spatula. This includes having no spatula, or instead having one or multiple spike projections or other similar projections to hold the spatula in position on the bone. 
         [0039]      FIGS. 7A-10E  show various embodiments of a femoral guide  100  formed in accordance with the present disclosure. Femoral guide  100  generally includes a distal tip  105  and a shaft  110  extending proximally therefrom. Distal tip  105  of femoral guide  100  may be dimensioned and configured to have the same geometry and circumference as the desired resulting femoral tunnel. In this manner, distal tip  105  acts as a visual aid to assist the surgeon in determining proper tunnel placement by providing a direct visual confirmation of where the resulting femoral tunnel will be located. Alternatively, distal tip  105  may be formed with a semi-hemispherical cross-section ( FIGS. 7B ,  8 B and  9 B), or with an “unroofed” cross-section ( FIGS. 7C ,  8 C,  9 C and  10 A-E) to aid in visualization. 
         [0040]    Shaft  110  of femoral guide  100  is configured to be of such a length so as to at least extend (i) across the knee joint, (ii) across the length of the tibial tunnel and/or (iii) out of the medial portal. Shaft  110  and distal tip  105  are cannulated so as to accept (and thereby aim) a guidewire of an appropriate circumference, length and width. 
         [0041]    In addition, the geometry of distal end  105  of femoral guide  100  may include (i) diametrically-opposed fingers  115  ( FIGS. 9A-9C ), and/or (ii) a distal projection  120  ( FIGS. 10A-10E ). Fingers  115  and/or projection  120  serve to reference the leading edge of the posterior cruciate ligament (PCL) and the posterior femoral cortex. Using the PCL as an anatomical reference enables a surgeon to set the femoral guide wire, and therefore the resulting femoral tunnel, in a position that better avoids any impingement of the PCL after the graft ligament has been placed in position. Such ACL/PCL impingement occurs when the femoral tunnel has been improperly positioned. In this manner, femoral guide  100  is configured to avoid any such ACL/PCL impingement, by using the PCL as an anatomical reference during formation of the femoral tunnel. 
         [0042]    As shown in  FIG. 11 , femoral guide  100  may be used in a medial portal approach with the knee in hyper-flexion, at approximately 120 degrees. However, it should be appreciated that femoral guide  100  may also be used with any ACL reconstruction approach, and with any angle of knee flexion. See, for example,  FIG. 12 , where femoral guide  100  is used during a traditional trans-tibial approach. Because of the size and/or configuration of distal end  105  of femoral guide  100 , for use in the trans-tibial approach, femoral guide  100  may be halved, with one half for use with the right knee and the other half for use with the left knee. 
         [0043]    Once the location of femoral tunnel  25  is identified by the surgeon with distal end  105  of femoral guide  100 , guide wire  30  ( FIG. 11 ) is extended through the cannulated shaft of elongated shaft  110  and into femur  15 . Once guide wires  30  has been inserted into femur  15  to a desired depth, femoral guide  100  is then removed from about guide wire  30  and from the medial portal into the knee. A cannulated drill bit (not shown) is then received about guide wire  30  and through the medial portal to drill femoral tunnel  25 . 
         [0044]    Looking next at  FIG. 13 , the proximal (or “butt”) end  125  of femoral guide  100  is preferably provided with a docking port  130  to mate with a handle  135  to aid the surgeon in aiming the guide more easily and accurately. Handle  135  may be configured in any desired geometry so as to be ergonomically comfortable and/or to facilitate in the placement or holding of distal tip  105  in a particular position. 
         [0045]    Femoral guide  100  provides surgeons with several significant improvements over prior art femoral guides. First, the distal portion of femoral guide  100  is configured (both in shape and diameter), to mirror that of the resulting tunnel and, therefore, the resulting graft. This gives the surgeon a visual “preview” or reference of the femoral tunnel prior to actually drilling the femoral tunnel. In addition, the distal shape of the femoral guide references the leading edge of the PCL&#39;s insertion onto the femur (i.e., the location where the PCL attaches to the femur) and places the resulting femoral tunnel in a position which avoids graft ACL/PCL impingement. 
         [0046]    While some of the particular embodiments shown hereinabove have described an arrangement of a femoral tunnel positioning device that is particularly configured for use through a medial portal, it should be recognized that the present invention may also include other embodiments in which the arrangement of the femoral tunnel positioning device is particularly configured for use in either a medial portal technique or in a trans-tibial technique. For example, various embodiments of the present invention may include an arrangement in which the arrangement of the femoral tunnel positioning device is particularly configured to be inserted through a pre-drilled tibial tunnel.  FIGS. 15 and 16  illustrate top views of example embodiments of femoral tunnel positioning devices  300  and  400 , respectively, that have a decreased profile or footprint as compared to the profile or footprint of a conventional femoral tunnel positioning device (an example of which is shown in  FIG. 14 ). The femoral tunnel positioning device  300  shown in  FIG. 15  may advantageously be employed to position a femoral tunnel during a surgical procedure that involves a patient&#39;s right knee. The femoral tunnel positioning device  300  includes most of the same features of the above-described femoral tunnel positioning devices, e.g., a distal offset projection  210 , a cannulated shaft  220  having a lumen  225  extending longitudinally therethrough. The femoral tunnel positioning device  300  also includes a right lateral referencing guide  2210  which functions, when the device  300  is in position in a patient&#39;s right knee, to reference some portion of a patient&#39;s anatomy, e.g., a patient&#39;s PCL or a portion of the femoral notch. It should be noted that the femoral tunnel positioning device  300  eliminates any lateral referencing guide on its left side, having instead a void at that location. By eliminating any lateral referencing guide on its left side, the femoral tunnel positioning device  300  may have a reduced profile or footprint when viewed from above (as shown), and thus may have a reduced cross-sectional area, as compared to other above-described femoral tunnel positioning devices. 
         [0047]    Similarly, the femoral tunnel positioning device  400  shown in  FIG. 16  may advantageously be employed to position a femoral tunnel during a surgical procedure that involves a patient&#39;s left knee. Again, the femoral tunnel positioning device  400  includes most of the same features of the above-described femoral tunnel positioning devices, e.g., a distal offset projection  210  and a cannulated shaft  220  having a lumen  225  extending longitudinally therethrough. The femoral tunnel positioning device  400  also includes a left lateral referencing guide  2220  which functions, when the device  400  is in position in a patient&#39;s left knee, to reference some portion of a patient&#39;s anatomy, e.g., a patient&#39;s PCL or a portion of the femoral notch. It should be noted that the femoral tunnel positioning device  300  eliminates any lateral referencing guide on its right side, having instead a void at that location. By eliminating any lateral referencing guide on its right side, the femoral tunnel positioning device  300  may have a reduced profile or footprint when viewed from above (as shown), and thus may have a reduced cross-sectional area, as compared to other above-described femoral tunnel positioning devices. 
         [0048]    By reducing the profile or footprint of the device, and thereby also reducing the cross-sectional area of the device, as compared to conventional femoral tunnel positioning devices, the femoral tunnel positioning devices  300 ,  400  may be better configures to be inserted into a patient&#39;s knee through a pre-drilled tibial tunnel (a pre-drilled tibial tunnel typically being relatively small as compared to an entry point used during a medial portal technique). In this manner, the provision of left and right-type femoral tunnel positioning devices may give a surgeon the flexibility to use either the trans-tibial technique or the medial portal technique. 
         [0049]    While some of the particular embodiments shown hereinabove have described a set of femoral tunnel positioning devices  300 ,  400  that are used separately, e.g., the femoral tunnel positioning devices  300  being used for the right knee while the femoral tunnel positioning devices  400  being used for the left knee, it should be recognized that the present invention may also include other embodiments in which the set of femoral tunnel positioning devices  300 ,  400  may be connected to each other for use as a single device. For example, in a particular embodiment of the present invention, the femoral tunnel positioning devices  300 ,  400  may be configured to connect to each other, such that, when connected, they together have a footprint or profile that is similar to the conventional femoral tunnel positioning device shown in  FIG. 14 . In this manner, one of the two halves of the device may be used separately during a trans-tibial technique, or the two halves may be connected to each other and used together during a medial portal technique. 
         [0050]    It should be understood that many additional changes in the details, materials, steps and arrangements of parts, which have been herein described and illustrated in order to explain the nature of the present disclosure, may be made by those skilled in the art while still remaining within the principles and scope of the disclosure. 
         [0051]    What is claimed is: