# Patent

## Title
Tibial guide for ACL repair having left/right docking configuration

## 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.

## Background
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'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's right knee, and the second device may be configured to position a tibial tunnel when positioned in a patient's left knee. When the first device is in position in a patient's right knee and the distal portion is inserted into a pre-formed opening in the patient'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's left knee and the distal portion is inserted into a pre-formed opening in the patient'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'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'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'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's right knee and the distal tip 205 is inserted into a pre-drilled opening in the patient'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'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'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's left knee and the distal tip 205 is inserted into a pre-drilled opening in the patient'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'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'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.

## Claims

1. A system for identifying a desired location of a tibial tunnel during ACL reconstruction, the system comprising:
an outrigger including a curved portion and a tibial drill guide, wherein the curved portion and the tibial drill guide define a plane; and
a positioning device including,
an elongated body having proximal and distal ends, the elongated body being fixed relative to the curved portion and extending within the plane defined by the curved portion and the tibial drill guide; and
a distal arm extending from the distal end of the elongated body at an angle relative to the plane defined by the curved portion and the tibial drill guide, a distal portion of the distal arm being configured for insertion into a pre-formed opening in a femur, wherein the distal arm is configured such that when the distal portion of the distal arm is received within the pre-formed opening in the femur, a proximal end of the distal arm being disposed along a central axis defined by the tibial drill guide, wherein a distal portion of the distal arm is spherically-shaped.

2. The system of claim 1, wherein the distal arm and the body are 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.

3. The system of claim 1, wherein a portion of the distal arm is configured to be engaged by a guide wire.

4. The system of claim 1, wherein the distal arm of the positioning device is configured such that when the distal portion of the distal arm is received within the pre-formed opening in the femur, a proximal portion of the distal arm points to the desired location of the tibial tunnel.

5. The system of claim 1, wherein the positioning device is configured to position a tibial tunnel when positioned in a patient's right knee, and a second positioning device is configured to position a tibial tunnel when positioned in a patient's left knee.

6. The system of claim 5, wherein, when the second positioning device is in position in a patient's left knee and a distal portion of the second positioning device is inserted into a pre-formed opening in the patient's left femur, a distal arm and a body of the second positioning device are 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°.

7. The system of claim 1, wherein, when the positioning device is in position in a patient's right knee and the distal portion is inserted into a pre-formed opening in the patient's right femur, the distal arm and the body are 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°.

8. The system of claim 1, wherein the entirety of the elongated body extends within the plane defined by the curved portion and the tibial drill guide.