Abstract:
A device for positioning a tibial tunnel during ACL reconstruction, the device that includes an elongated body having proximal and distal ends; and a distal arm extending from the distal end of the elongated body, a distal portion of the distal arm being configured for insertion into a pre-formed opening in a femur. The distal arm and the body are not aligned relative to each other when viewed from above. A pair of such devices, providing tunnel positioning for right and left knee surgeries, maybe provided in a set.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation-in part of, and claims the benefit of priority to, 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” and 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,” 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. 61/066,575, filed Feb. 21, 2008, entitled “Guide for Creating a Femoral Tunnel During an ACL Reconstruction” and U.S. patent application Ser. No. 12/366,967, filed Feb. 6, 2009, entitled “Guide for Creating a Femoral Tunnel During an ACL Reconstruction,” the disclosures of each also being incorporated herein by reference in their entirety. 
    
    
     BACKGROUND 
     1. Technical Field 
     This invention relates to surgical apparatus and procedures in general, and more particularly to surgical apparatus and procedures for reconstructing a ligament. 
     2. Background of Related Art 
     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. 
     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. 
     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 bone tunnel  20  ( FIG. 3 ) is first drilled up through tibia  10 . Tibial tunnel  20  is then used to access the interior of the knee joint, and it is from tibial tunnel  20  that the position of a femoral tunnel  25  is determined. In this respect, it should be appreciated that the proper positioning of femoral tunnel  25  is important and that numerous guides have been designed to ensure that tibial tunnel  20  is correctly positioned in order to properly position the resulting femoral tunnel  25 . 
     Looking next at  FIGS. 4 ,  5  and  6 , simple tibial tunnel positioning guides generally consist of a hooked tip that may be positioned along the ACL footprint on the tibia at a position chosen by the surgeon. Other tibial tunnel positioning guides are more constraining, in order to attempt to obtain a more reliable and reproducible position for the tibial tunnel. As shown in  FIG. 7 , some other tibial tunnel positioning guides reference the tibial base of the posterior cruciate ligament (“PCL”) (U.S. Pat. No. 5,409,494 to Morgan et al.). 
     Looking next at  FIG. 8 , still another guide references the roof of the intercondylar notch, as well as orienting the guide&#39;s position relative to the plane of the tibial plateau (U.S. Pat. No. 6,254,605, by Howell et al.). This referencing is done in an attempt to avoid impingement of the femoral roof by the graft ligament. 
     All of these prior art tibial tunnel positioning guides, while utilizing different referencing points and methods, still share the same overall approach: each of these guides is used to orient the tibial tunnel first, but in a position deemed appropriate for the femoral tunnel, which is thereafter drilled through that tibial tunnel. The limitations of such an approach is that the position of the tibial tunnel is often compromised in order to later drill an appropriate femoral tunnel. This often results in the tibial tunnel being placed in a position which is more posterior and more vertical than is anatomically desired. 
     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, 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. 
     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. An embodiment of a femoral drill guide for use in medial portal techniques is described in commonly owned patent application Ser. No. 12/366,967, the contents of which are incorporated by reference in its entirety, and is shown generally as femoral guide  100  in  FIG. 4 . 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. While the medial portal approach greatly improves the ability of the surgeon to more accurately position the femoral tunnel, the older, simple trans-tibial guides are still used by the surgeon to position the tibial tunnel. 
     Therefore, it would be beneficial to have a device and method for orienting the position of a second-drilled tibial tunnel based on a first-drilled femoral tunnel. It would further be beneficial to have a device and method for positioning a tibial tunnel utilizing the medial portal approach prior to drilling a femoral tunnel. 
     SUMMARY 
     A device for positioning a tibial tunnel during ACL reconstruction is provided. The device includes a portion insertable into a pre-formed opening in the femur. The device may further include an elongated body having proximal and distal ends and an arm extending at an angle from the distal end of the elongated body, the arm being configured for insertion through a medial portal. The portion insertable into a pre-formed opening in the femur may include a tip formed on a distal end of the arm. 
     The elongated body of the positioning device may be arced. The arm may be configured to point to the position of the resulting tibial tunnel on a tibial plateau when the distal tip is disposed in a femoral tunnel. The arm may include a pointed elbow configured to point to the position of the resulting tibial tunnel on the tibial plateau/ACL footprint. The arm may be configured to orient the angle of the resulting graft in the sagittal plane. The arm may extend from elongated body at an angle from about fifty degrees (50°) to about sixty degrees (60°). The angle between the elongated body and the arm may be adjustable. The arm may include a lateral projection. The proximal end of the elongated body may be configured for connection to an outrigger. The outrigger may be configured to direct a guide wire through the tibial. Also provided is a method for positioning a tibial tunnel during ACL reconstruction. The method includes the steps of forming an opening in a femur bone, inserting a portion of a device into the opening, and using the device to position an opening in a tibia bone. The step of creating an opening in a femur bone may performed using a medial portal approach. The device may include an elongated body, an arm extending at an angle from a distal end of the elongated body, and a tip formed on a distal end of the arm, the tip being configured for insertion into the femoral tunnel. The method may further include the step of positioning the device by referencing at least one of a lateral wall of the femoral notch and one or more tibial spines. 
     The device may further include a lateral projection for referencing the femoral notch. The method may further include the step of adjusting the coronal medial/lateral orientation angle of the arm of the device in a way that mimics an intact ACL. The arm of the device may be configured for insertion through a medial portal. The method may further include the step of flexing the knee through a range of motion to check for resultant graft impingement. A proximal end of the arm may include an elbow for engaging the tibia. 
     Additionally provided is a method for positioning a tibial tunnel during ACL reconstruction. The method includes the steps of providing a tibial guide including an elongated body, an arm extending at an angle from a distal end of the elongated body, and a tip formed on a distal end of the arm, the tip including a point for engaging a femur, inserting the distal end of the elongated body into a knee joint using a medial portal approach, engaging the pointed tip with the femur in a position corresponding to that of a desired femoral tunnel, and positioning the tibial guide by referencing at least one of a lateral wall of the femoral notch and one or more tibial spines. 
     In accordance with various embodiments, the present invention may provide a device for positioning a tibial tunnel during ACL reconstruction, the device comprising: an elongated body having proximal and distal ends; and a distal arm extending from the distal end of the elongated body, a distal portion of the distal arm being configured for insertion into a pre-formed opening in a femur, wherein the distal arm and the body are not aligned relative to each other when viewed from above. The distal arm and the body may be misaligned relative to each other when viewed from above so as to provide the tunnel position for one of a left or a right knee of a patient. A portion of the distal arm may be configured to be engaged by a guide wire. 
     In accordance with various embodiments, the present invention may also provide a set of devices for positioning a tibial tunnel during ACL reconstruction, the set comprising: a first device comprising an elongated body having proximal and distal ends, and a distal arm extending from the distal end of the elongated body, a distal portion of the distal arm being configured for insertion into a pre-formed opening in a femur, wherein the distal arm and the body are not aligned relative to each other when viewed from above; and a second device comprising an elongated body having proximal and distal ends, and a distal arm extending from the distal end of the elongated body, a distal portion of the distal arm being configured for insertion into a pre-formed opening in a femur, wherein the distal arm and the body are not aligned relative to each other when viewed from above, wherein the misalignment of the first device is a mirror image of the misalignment of the second device. The first device may be configured to position a tibial tunnel when positioned in a patient&#39;s right knee, and the second device may be configured to position a tibial tunnel when positioned in a patient&#39;s left knee. When the first device is in position in a patient&#39;s right knee and the distal portion is inserted into a pre-formed opening in the patient&#39;s right femur, the distal arm and the body may be configured to arrange a tunnel position in the right tibia that provides a sagittal angle of about 53° and a coronal angle that is in the range from about 60° to about 65°. When the second device is in position in a patient&#39;s left knee and the distal portion is inserted into a pre-formed opening in the patient&#39;s left femur, the distal arm and the body may be configured to arrange a tunnel position in the left tibia that provides a sagittal angle of about 53° and a coronal angle that is in the range from about 60° to about 65°. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a perspective view of a knee joint showing an ACL; 
         FIG. 2  is an alternate perspective view of the knee joint of  FIG. 1 ; 
         FIG. 3  is a perspective view of a knee joint including tibial and femoral tunnels (shown in phantom) and a ligament graft; 
         FIGS. 4-8  are views of various prior art embodiments of tibial tunnel positioning guides; 
         FIG. 9  is a femoral guide for use in ACL reconstruction utilizing the medial portal approach. 
         FIG. 10  is a side view of a tibial tunnel positioning guide according to an embodiment of the present disclosure; 
         FIG. 11  is a perspective view of a tibial tunnel positioning guide according to an alternative embodiment of the present disclosure; 
         FIG. 12  is a side view of a tibial tunnel positioning guide according to another embodiment of the present disclosure; 
         FIG. 13  is a side view of a tibial tunnel positioning guide according to yet another embodiment of the present disclosure; 
         FIG. 14  is an enlarged side view of the distal end of the tibial tunnel positioning guide of  FIG. 10 ; 
         FIG. 15  is a side view of the distal end of the tibial tunnel positioning guide of  FIG. 11 ; 
         FIG. 16  is an alternate side view of the distal end of the tibial tunnel positioning guide of  FIGS. 11 and 15 ; 
         FIG. 17  is an end view of the distal end of the tibial tunnel positioning guide of  FIGS. 11 ,  15  and  16 ; 
         FIG. 18  is a side view of the tibial tunnel positioning guide of FIGS.  11  and  15 - 17  secured to an outrigger; 
         FIG. 19  is partial cut away view of a knee joint including a tibial tunnel positioning guide and outrigger of  FIG. 18  positioning; 
         FIG. 20  is a partial cut-away side view of the knee joint of  FIG. 19  illustrating the path of a guide wire through the tibia; 
         FIG. 21  is an alternate partial cut-away side view of the knee joint of  FIGS. 19 and 20 ; 
         FIG. 22  is a perspective view of a knee joint including a tibial tunnel positioning guide according to still yet another embodiment of the present disclosure and further including an outrigger; 
         FIG. 23  is a bottom view of a distal end of a tibial tunnel positioning guide for a right knee, according to still yet another embodiment of the present disclosure; and 
         FIG. 24  is a bottom view of a distal end of a tibial tunnel positioning guide for a left knee, according to still yet another embodiment of the present disclosure. 
     
    
    
     DETAILED DESCRIPTION OF THE EMBODIMENTS 
     Looking now at  FIGS. 10-17 , there is shown a tibial tunnel positioning guide  200 . Tibial tunnel positioning device  200  generally includes a distal tip  205 , an arm  210  and an arced body  220 . Distal tip  205  is configured to reference a previously-drilled femoral tunnel (e.g., a femoral tunnel drilled using a medial portal approach). Distal tip  205  may be configured in any shape or size suitable to mate with the femoral tunnel. As shown, distal tip  205  is generally ball-tipped and includes a diameter of substantially the size of the previously-drilled femoral tunnel. Arm  210  extends proximally from distal tip  205  and connects distal tip  205  to arced body  220 . Arm  210  is configured to point to the position of the resulting tibial tunnel on the tibial plateau when distal tip  205  is disposed in femoral tunnel  25 . Arm  210  is further configured to orient the angle of the resulting graft in the sagittal plane. Studies have determined that, on average, an intact ACL exists in the sagittal plane at an angle of fifty-five degrees (55°) in reference to the perpendicular axis of the tibia (or the plane of the medial or lateral surface of the tibial plateau/joint surface). Accordingly, arm  210  is configured to connect distal tip  205  to body  220  at a pre-determined angle. Arm  210  may be configured to extend from body  220  at any predetermined angle, preferably from about fifty degrees (50°) to about sixty degrees (60°). This configuration allows a surgeon to choose a particularly-angled tibial tunnel positioning guide  200  based on MRI, X-ray or other imaging data. Alternatively, tibial tunnel positioning device  200  may be configured with an angle-adjustable arm (not shown) such that arm  210  may be adjusted to any angle required to meet the needs of the surgeon. 
     Arm  210  may further include a lateral projection  215 . Lateral projection  215  is configured to reference the lateral wall of the femoral notch to help position the resulting tibial tunnel to avoid lateral wall impingement once the graft ligament is positioned. Lateral projection  215  also aids the surgeon in orienting the medial-lateral position of tibial tunnel  20  and its orientation angle in the coronal plane. In this manner, the surgeon may set the coronal medial/lateral orientation angle of the resultant graft position in a way that mimics an intact ACL. Arm  210  may also include a pointed “elbow” which points to the resulting tibial tunnel&#39;s guide wire position on the tibial plateau/ACL footprint. 
     Arced body  220  extends proximally from arm  210  and is configured to facilitate insertion through the medial portal. The configuration of arced body  220  accounts for medial portal positioning to avoid the position of the portal influencing guide placement. More particularly, arm  210  of tibial tunnel positioning guide  200  may be sized and shaped to mirror the size and shape of the ligament graft to be positioned. This allows the surgeon a visual reference of what the resulting graft will look like when placed in the knee. It should be appreciated that forming arm  210  to mirror the form of the ligament graft also allows the surgeon to check for any impingement prior to drilling tibial tunnel  20 . For example, once tibial tunnel positioning guide  200  is docked into the pre-drilled femoral tunnel (i.e., by placing the distal ball tip in the femoral tunnel), the surgeon may bring the knee through a range of motion to check for resultant graft impingement before creating the tibial tunnel. 
     Arced body  220  may also be configured for connection to an outrigger  225 . ( FIG. 18 ). Outrigger  225  positions the guide wire to be drilled through starting point of the outer tibial cortex. Arced body  220  and outrigger  225  may join at a set angle, or an adjustable angle such that the resultant outer tibial cortex starting point is not positioned too far medially, and in the position desired by the surgeon. In other words, body  220  and/or arm  210  (and therefore distal tip  205 ) may be set off-angle or off-axis from outrigger  225  if desired. 
     Looking next at  FIGS. 19-21 , tibial tunnel positioning guide  200  is placed through a medial portal with distal ball tip  205  of tibial tunnel positioning guide  200  positioned in the pre-drilled femoral tunnel. The anterior/posterior position of the resulting tibial tunnel is determined by selecting the angle of tibial tunnel positioning guide  200 . The surgeon may do this in one of two ways: (i) by selecting an appropriately pre-angled guide, or (ii) by setting a desired angle on an angle-adjustable guide. The medial/lateral position of the guide (and therefore the resulting tibial tunnel) is determined by the lateral projection referencing the lateral wall of the notch. In addition, pointed elbow of arm  210  may also reference the tibial spines. In particular, the pointed elbow or arm  210  may reference the medial tibial spine to set the resultant graft in the proper anatomic coronal orientation. 
     Lastly, with an outrigger attached to tibial tunnel positioning guide  200 , the surgeon may move the starting point of the tibial tunnel on the outer cortex, (e.g., medially and away from the MCL), if desired. With the aforementioned positions and references set, tibial tunnel positioning guide  200  is now in place so that the surgeon can confidently drill the tibial tunnel. 
     Looking now at  FIG. 22 , tibial tunnel positioning guide  300  may also be used in an approach where the femoral tunnel has not yet been drilled. In this embodiment, distal tip  305  is configured with a sharp point rather than a ball-tipped end, and a medial projection  315  rather than a lateral projection. The point of distal tip  305  and medial projection  315  are positioned referencing the location of where the PCL is inserted on the femoral notch. Tibial tunnel positioning guide may also be positioned with the point placed at any other spot along the femoral notch, or other position according to the preferences of the surgeon. 
     While some of the particular embodiments shown hereinabove have the body  220  and the arm  210  being aligned relative to each other when viewed from above, it should be recognized that the present invention may also include other embodiments in which the body  220  and the arm  210  are not aligned relative to each other when viewed from above. For example, various embodiments of the present invention may include an arrangement in which the body  220  and the arm  210  are misaligned relative to each other when viewed from above.  FIGS. 23 and 24  illustrate top views of example embodiments of tibial tunnel positioning devices  300  and  400 , respectively, that have a distal arm  210  and a body  220  that are not aligned relative to each other when viewed from above. The tibial tunnel positioning device  300  shown in  FIG. 23  may advantageously be employed to position a tibial tunnel during a surgical procedure that involves a patient&#39;s right knee. The tibial tunnel positioning device  300  includes most of the same features of the above-described tibial tunnel positioning devices, e.g., a distal arm  210 , a body  220  configured to be attached to an outrigger, a distal tip  205  that is configured to be inserted into a pre-drilled opening in a patient&#39;s femur, etc. In this embodiment, the distal arm  210  and the body  220  are not aligned relative to each other when viewed from above, but rather have a pre-formed angle relative to each other. In this manner, when the device  300  is in position in a patient&#39;s right knee and the distal tip  205  is inserted into a pre-drilled opening in the patient&#39;s right femur, the distal arm  210  and the body  220  are configured to arrange a tunnel position that provides a sagittal angle of approximately, e.g., 53°, and a coronal angle that is in the range from, e.g., about 60° to about 65°. 
     Similarly, the tibial tunnel positioning device  400  shown in  FIG. 24  may advantageously be employed to position a tibial tunnel during a surgical procedure that involves a patient&#39;s left knee. Again, the tibial tunnel positioning device  400  includes most of the same features of the above-described tibial tunnel positioning devices, e.g., a distal arm  210 , a body  220  configured to be attached to an outrigger, a distal tip  205  that is configured to be inserted into a pre-drilled opening in a patient&#39;s femur, etc. In this embodiment, the distal arm  210  and the body  220  are not aligned relative to each other when viewed from above, but rather have a pre-formed angle relative to each other. In this manner, when the device  300  is in position in a patient&#39;s left knee and the distal tip  205  is inserted into a pre-drilled opening in the patient&#39;s left femur, the distal arm  210  and the body  220  are configured to arrange a tunnel position that provides a sagittal angle of approximately, e.g., 53°, and a coronal angle that is in the range from, e.g., about 60° to about 65°. 
     By providing that the distal arm  210  and the body  220  are not aligned relative to each other when viewed from above, the tibial tunnel positioning devices  300 ,  400  may provide improved tibial tunnel positioning as compared to other devices in which the distal arm  210  and the body  220  are aligned relative to each other when viewed from above. Specifically, when a surgeon utilizes a convention tibial tunnel positioning guide, e.g., in which the distal arm  210  and the body  220  are aligned relative to each other when viewed from above, the surgeon must change the position of the device during the surgical procedure to account for whether he or she is performing the procedure on the patient&#39;s right knee or the left knee. In contrast, by providing that the distal arm  210  and the body  220  are not aligned relative to each other when viewed from above, the tibial tunnel positioning devices  300 ,  400 , the surgeon need not change the position of the device during the surgical procedure to account for whether he or she is performing the procedure on the patient&#39;s right knee or the left knee, but rather may select the tibial tunnel positioning devices  300 ,  400  that matches the specific knee being worked on. Of course, it should be recognized that, in accordance with the present invention, the tibial tunnel positioning devices  300 ,  400  may be provided as a set. 
     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 invention, may be made by those skilled in the art while still remaining within the principles and scope of the invention.