Patent Publication Number: US-9839464-B2

Title: Device and method for use during ligament reconstruction

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This application claims priority to U.S. patent application Ser. No. 13/050,520, filed Mar. 17, 2011 which claims the benefit of U.S. Patent Application Ser. No. 61/315,228, filed Mar. 18, 2010, the disclosure of which is incorporated herein in its entirety. 
    
    
     BACKGROUND 
     Field of Technology 
     The present disclosure relates to ligament reconstruction surgery, and more specifically, a device and method for determining lengths during reconstruction surgery. 
     Related Art 
     The creation of reconstruction tunnels in the femur for ligament reconstruction surgery is required for the attachment of a soft tissue graft, such as a semitendinosis tendon. The length of the femoral tunnel needs to be determined and calculations need to be made to, among other things, determine the appropriate lengths for the implants that are used to fixate the grafts in the tunnels. Currently, manual calculations are used. These manual calculations are often inaccurate and time consuming. Therefore, a device and method for more accurately making these calculations are needed. 
     SUMMARY 
     In one aspect, the present disclosure relates to a device for use during ligament reconstruction surgery. The device includes a handle and a shaft coupled to the handle, the handle including a first channel for housing of an insert, a second channel, a third channel for housing of the shaft, a first window, a second window, and a groove. 
     In an embodiment, the device further includes the insert, the insert including a first set of numbers for display through the first window, a second set of numbers for display through the second window, and a knob assembly disposed within the groove. In another embodiment, the insert further includes a nipple extending from an end of the insert. 
     In another aspect, the present disclosure relates to a method for use during ligament reconstruction surgery. The method includes placing a guide wire through a tibia and a femur; providing a device comprising a handle and a shaft coupled to the handle, the handle including a first channel housing an insert, a second channel, a third channel housing the shaft, a first window, and a second window; placing the device over an end of the guide wire; viewing a first set of numbers on the insert through the first window to determine a femoral tunnel length; viewing a second set of numbers on the insert through the second window to determine a femoral socket depth; creating a femoral socket; creating a through hole in the femur, the through hole extending from the femoral socket, the femoral socket and the through hole together creating the femoral tunnel; and placing a soft tissue graft within the femoral tunnel. 
     In an embodiment, the method further includes creating a tibial tunnel prior to placing the guide wire through the tibia and the femur. In another embodiment, the soft tissue graft is placed within both the femoral tunnel and the tibial tunnel. In yet another embodiment, placing the guide wire through the tibia and the femur includes aligning a laser ring on the guide wire with an end of the femur. In a further embodiment, placing the device over the guide wire includes contacting an end of the shaft with the femur. In yet a further embodiment, a number on the second set of numbers represents a length of a closed loop suture. 
     In an embodiment, viewing a second set of numbers on the insert through the second window to determine a femoral socket depth includes finding a number on a first set of numbers on the handle that corresponds with the number of the second set of numbers on the insert that represents the length of the closed loop suture. In another embodiment, the number on the first set of numbers on the handle represents a drill depth for the soft tissue graft. In another embodiment, the method further includes finding a number on a second set numbers on the handle that corresponds with the soft tissue graft drill depth number. In yet another embodiment, the number on the second set of numbers represents a drill depth for the femoral socket. 
     Further areas of applicability of the present disclosure will become apparent from the detailed description provided hereinafter. It should be understood that the detailed description and specific examples, while indicating the preferred embodiment of the disclosure, are intended for purposes of illustration only and are not intended to limit the scope of the disclosure. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The accompanying drawings, which are incorporated in and form a part of the specification, illustrate the embodiments of the present disclosure and together with the written description serve to explain the principles, characteristics, and features of the disclosure. In the drawings: 
         FIG. 1  shows a front elevation of the handle and shaft of the device of the present disclosure; 
         FIG. 2  shows a side elevation of the handle and shaft of the device of the present disclosure; 
         FIG. 3  shows a side elevation of the insert of the device of the present disclosure; 
         FIG. 4  shows a front elevation of the insert of the device of the present disclosure 
         FIG. 5  shows markings visible from the side elevation of the insert; 
         FIG. 6  shows markings visible from the front elevation of the insert; 
         FIG. 7  shows markings visible from another side elevation; 
         FIG. 8  shows a cross section view of the device of the present disclosure; 
         FIG. 9  shows a groove receptive to a shaft of the device; 
         FIGS. 10 and 10   a  shows a guide wire insertable through the shaft of the device; 
         FIG. 11  shows the guidewire deployed at a surgical site; 
         FIG. 12  shows the guidewire deployed and aligned with the femoral notch; 
         FIG. 13  shows the guidewire deployed through the device at the surgical site; 
         FIG. 14  shows the guidewire at a determined drill depth; 
         FIG. 15  shows the guidewire used for guiding drilling of a through-hole; 
         FIGS. 16 and 16   a  show insertion of a suture strand via the guidewire; and 
         FIG. 17  shows coupling a graft via the suture strand. 
     
    
    
     DETAILED DESCRIPTION OF THE EMBODIMENTS 
     The following description of the preferred embodiment(s) is merely exemplary in nature and is in no way intended to limit the disclosure, its application, or uses. 
       FIGS. 1-9  show the device  10  of the present disclosure and/or its components. The device  10  includes a handle  11  and a shaft  11   k  coupled to the handle  11 . The handle  11  includes a first channel  11   a  having an opening  11   a ′, a second channel  11   b  having two openings  11   b ′, and a third channel  11   c . The second channel  11   b  is perpendicular to the first and third channels  11   a , 11   c . The handle  11  also includes a first window  11   d , a second window  11   e , and a groove  11   f . A first set of numbers  11   g  and a second set of numbers  11   h  are located on the outer surface  11   i  of the handle  11 . The second channel  11   b  has threads  11   j  located on an inner surface  11   b ″ of the second channel  11   b . A knob assembly  12  having a knob  12   a  and a shaft  12   b  coupled to the knob  12   a  is coupled to the handle  11  such that the shaft  12   b  is disposed within the second channel  11   b . The shaft  12   b  includes threads  12   c , which engage the threads  11   j  of the second channel  11   b  when the shaft  12   b  is disposed within the second channel  11   b . An insert  13 , as more clearly shown in  FIGS. 3 and 4 , is disposed within the first channel  11   a . The insert  13  includes a first set of numbers  13   a , a second set of numbers  13   b , a channel  13   c  having two openings  13   d  and threads  13   e  located on an inner surface  13   f  of the channel  13   c , and a nipple  13   g  extending from an end of the insert  13 . Coupled to the insert  13  is a knob assembly  14  having a knob  14   a  and a shaft  14   b  coupled to the knob  14   a  such that the shaft  14   b  is disposed within the channel  13   c . The shaft  14   b  includes threads  14   c , which engage the threads  13   e  of the channel  13   c  when the shaft  14   b  is disposed within the channel  13   c.    
     When the insert  13  is disposed within the first channel  11   a , the shaft  14   b  is disposed within the groove  11   f  ( FIG. 9 ), the first set of numbers  13   a  is shown through the first window  11   d , and the second set of numbers  13   b  is shown through the second window  11   e . As will be further described below, the first set of numbers  13   a  will indicate the required femoral tunnel length and the second set of numbers  13   b  will indicate the required length of the closed loop of suture that is used with the soft tissue graft. The first set of numbers  11   g  on the handle  11  serve to indicate the depth of the graft within the femoral bone tunnel, otherwise known as the amount of graft, lengthwise, located in the femoral tunnel, and the second set of numbers  11   h  serve to indicate the depth in which a surgeon will need to drill to create a femoral socket for the housing of the soft tissue graft. 
       FIG. 10  shows a guide wire  20  having a first end portion  21  and a second end portion  22 . The second end portion  22  includes an opening  23  and the first end portion  21  includes grooves  24  for drilling. The guide wire  20  also includes a laser ring  25 , as shown in  FIG. 10A , located along a length of the guide wire  20  and a laser line  26  extending from the ring  25 . The laser ring  25  serves as a reference point for calculations that are taken in preparation for a ligament reconstruction procedure, as will be further described below. For the purposes of this disclosure, the laser ring  25  extends the entire diameter of the guide wire  10 . However, the shape and the number of laser marks may vary. It is within the scope of this disclosure to have only the ring  25  located on the wire  20  and not the line  26 . 
     During reconstruction surgery, the knee joint is viewed arthroscopically to determine proper positioning of the femoral and tibial tunnels. In addition, guide systems may be used to position a drill guide along the desired tunnel paths prior to drilling of the tunnels. An example of a guide system is described in U.S. Pat. No. 5,139,520, the disclosure of which is incorporated herein by reference in its entirety. In the present disclosure, after proper positioning of the tunnels has been determined, the tibial tunnel  41  is drilled. Subsequently, the second end  22  of the guide wire  20  is coupled to the drill and the drill is then operated to drill along the desired femoral tunnel path  51 , such that the first end  21  of the guide wire  20  extends through the femur  50 , as shown in  FIG. 11 . As mentioned above, the laser ring  25  serves as a reference point for subsequent calculations. Generally, the surgeon will drill through the femur  50  until the laser ring  25  is aligned with an end of the femur  50 , more formerly known as the femoral notch, as shown in  FIGS. 11 and 12 . The laser line  26  serves to let the surgeon know if the surgeon has drilled past the end of the femur  50 . 
     The device  10  is then placed over the first end  21  of the guide wire  20  such that an end  11   k ′ of the shaft  11   k  contacts the femur  50 , as shown in  FIG. 13 . Once the device  10  is placed over the first end  21 , the end  21  comes into contact with the nipple  13   g  and moves the insert  13  longitudinally within the handle  11 . The knob  12   a  is rotated so as to engage the shaft  12   b  with the guide wire  20  and further couple the device  10  to the guide wire  20 . Optionally, the knob  14   a  is rotated to engage the knob  14   a  and shaft  14   b  with the handle  11  and further couple the insert  13  to the handle  11 . 
     Next, the surgeon looks in the first window  11   d  to see what number on the first set of numbers  13   a  is identified by the hash mark  11   l . For instance,  FIG. 5  shows the number as being identified as  55 . The number identified by the hash mark  11   l  represents the length the femoral tunnel  54  will be. As will be further described below, the femoral tunnel  54  includes a femoral socket  52  and a through hole  53 . Once the femoral tunnel length is identified, the surgeon then chooses the length (L,  FIG. 17 ) for the closed suture loop that will be used and finds this number on the second set of numbers  13   b  shown through the second window  11   e . For the purposes of this disclosure, an Endobutton® Closed Loop (Endobutton® CL) is used to fixate a soft tissue graft within the femoral socket  52 . The Endobutton® CL is owned and sold by Smith and Nephew, Inc. and is more fully described within U.S. Pat. No. 6,533,802, which is incorporated herein by reference in its entirety. After the surgeon has chosen a length L for the closed loop suture, the surgeon finds the number on the handle first set of numbers  11   g  that corresponds with the number that represents the closed loop suture length to determine the graft depth. As stated above, the graft depth is known as the amount of graft, lengthwise, that will be located in the femoral tunnel  54 . For instance, as shown in  FIG. 6 , if the closed loop suture length is 30 mm, the graft depth will be 25 mm. 
     Subsequent to the determination of graft depth, the surgeon will match the number for the graft depth with its corresponding number on the handle second set of numbers  11   h  to determine the drill depth for the socket  52 . For instance, as shown in  FIG. 7 , if the graft depth is 25 mm, then the drill depth is 35 mm. Once the drill depth is determined, the socket  52  is drilled, as shown in  FIG. 14 , using the guide wire  20  as a guide. The drill may be marked so that the surgeon knows when the desired depth has been reached. 
     After drilling the socket  52 , the surgeon then uses a smaller diameter drill to drill a through hole  53 , as shown in  FIG. 15 . For the purposes of  FIG. 15 , the drill is not shown as extending through the femur  50 . However, in practice the drill will extend through the femur to create through hole  53 . The through hole  53  is created to allow for flipping of the Endobutton® device once it is pulled through the tunnel  54 , as is described further below. Additionally, the through hole  53  is used to house an amount or length of closed loop suture that extends between the Endobutton® device and the soft tissue graft when the soft tissue graft is housed within the femur  50 , as will be further described later. 
     Next, the soft tissue graft  60  is coupled to the a fixation device, such as an Endobutton® CL  70 , by placing one end of the graft  60  through the closed loop of suture  71  and passing other suture strands  72 , connected to the Endobutton® device  73  through the opening  23  of the guide wire  20 , as shown in  FIGS. 16 and 16A . The soft tissue graft  60  is pulled into the femoral socket  52  and the tibial tunnels  41  via use of the device  10  and the guide wire  20 . The suture strands  72  are then used to pull, usually by hand, the Endobutton® device  73  through the through hole  53  and out of the femur  50 . Once the Endobutton® device  73  has been pulled out of the femur  50 , the device  73  is flipped, such that the device  73  lays across the opening to the through hole  53  and against the femur  50 , as shown in  FIG. 17 . Once the graft  60  has been coupled to the femur  50 , the other end of the graft  60  may be coupled to the tibia  40  to finish the procedure, as also shown in  FIG. 17 . 
     The guide wire  20  includes a biocompatible metal material, such as stainless material or titanium alloy. The opening  23  may be made via a punch press or other process and the grooves  24  and ring  25 /line  26  may be made by a machining or engraving process. The components of the device  10  (handle  11 , shaft  11   k , insert  13 , and knob assemblies  12 , 14 ) may also include a biocompatible metal material, such as a stainless steel or titanium alloy, and may be made from a molding or machining process. The first and second set of markings  11   g , 11   h , 13   a , 13   b  may be made by a process, including, but not limited to, a machining or engraving process and the windows  11   d - 11   e /groove  11   f  may be made by a process, including, but not limited to, a punch press. It is also within the scope of this disclosure for the insert  13  to not have a nipple  13   g  extending from its end. During repair, the end  21  of the guide wire  20  would come into contact with the end of the insert  13 , rather than the nipple  13   g , and move the insert  13  longitudinally within the handle  11 . 
     The device  10  of the present disclosure allows for calculation of the femoral tunnel length, the drill depth of the femoral socket  52 , and the graft depth, thereby eliminating the need to perform manual calculations. In addition, the device can be used to safely remove the guide wire  20  from the tibial and femoral tunnels  41 , 54 . For the purposes of this disclosure, the femoral socket  52  is drilled first and the through hole  53  is drilled second. However, it is possible for the through hole  53  to be drilled first and the femoral socket  52  to be drilled second. Also for the purposes of this disclosure, the graft  60  is coupled to the tibia  40  in the manner shown in  FIG. 17 . However, other manners of coupling the graft  60  to the tibia  40  may be used. Additionally, for the purposes of this disclosure, the shaft  11   k  is coupled to the handle  11  via press-fitting the shaft  11   k  to the handle  11 . However, other methods may be used. 
     As various modifications could be made to the exemplary embodiments, as described above with reference to the corresponding illustrations, without departing from the scope of the disclosure, it is intended that all matter contained in the foregoing description and shown in the accompanying drawings shall be interpreted as illustrative rather than limiting. Thus, the breadth and scope of the present disclosure should not be limited by any of the above-described exemplary embodiments, but should be defined only in accordance with the following claims appended hereto and their equivalents.