Patent Publication Number: US-2015080897-A1

Title: Cortical, anti-migration, facet dowel for fusion of facet joints in the spine and devices for setting the same in place

Description:
RELATED APPLICATIONS 
     This application is a divisional of U.S. patent application Ser. No. 13/051,488, filed Mar. 18, 2011, which claims the benefit of U.S. Patent Application No. 61/315,071, filed Mar. 18, 2010. U.S. patent application Ser. No. 13/051,488 is herein incorporated by reference. 
    
    
     FIELD OF THE INVENTION 
     Facet dowel allografts and devices for emplacement of the same, more specifically, for emplacement of a facet dowel allograft for fusion of facet joints in the open surgery of the spine. 
     BACKGROUND OF THE INVENTION 
     Millions of Americans suffer from lower back pain. For facet joint disorders, often the source of lower back pain, the most commonly used procedure for alleviating the pain is facet fusion. 
     It is one objective in a facet spinal fusion procedure to reduce a patient&#39;s post-operative pain, blood loss, and rehab time. An important consideration in achieving these foregoing objectives is an allograft that ensures vertebrae stability and is resistant to graft migration. 
     OBJECTS OF THE INVENTION 
     It is an one of the objects of this invention to provide for a facet dowel allograft that is stable and helps prevent allograft migration after implanting. 
     It is another object of the present invention to provide for a set of instruments that will help prepare the adjacent facets for receipt of the novel dowel and to emplace the novel dowel in an open surgical operation between the adjacent facets. 
     SUMMARY OF THE INVENTION 
     A novel allograft is provided for insertion into a prepared site between adjacent facets, the allograft or facet dowel typically comprised of three portions, a partially spherical body defining a spherical segment, a nose portion, and a tail portion, all aligned along a longitudinal axis. In addition, a set of instruments is provided for the excavation of an allograft and placement site between the two facets. The set of instruments includes a T-spade drill which will, in conjunction with a normal drill, excavate a site for the emplacement of the allograft. A novel method of using the instruments and the allograft is also provided. 
     The novel facet dowel is typically comprised of 100% cortical bone, but may, in an alternate embodiment, be comprised of cancellus bone. The facet dowel typically is comprised of three portions in an integrated body having a long axis: a partially spherical body defining a spherical segment, a nose portion along the long axis thereof and a tail portion extending along the long axis thereof. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIGS. 1A and 1B  illustrate a facet dowel allograft. 
         FIGS. 1C and 1D  illustrate alternate embodiments of the implant. 
         FIGS. 2A ,  2 B,  2 C, and  2 D are views of various instruments used in the placement of the novel dowel illustrated in  FIGS. 1A   01 D in a facet fusion procedure. 
         FIGS. 3A and 3B  illustrate side and end views of the prep-drill for use in the facet fusion procedure. 
         FIGS. 4A ,  4 B, and  4 C illustrate side, top, and end views of the T-spade drill of Applicants&#39; present device. 
         FIGS. 5A ,  5 B, and  5 B 1  illustrate top (cutaway), side, and removed end views of the working channel of Applicants&#39; present device. 
         FIG. 5C  is an elevational view of the tip portion of the working channel. 
         FIGS. 5D and 5E  are cutaway cross-sectional longitudinal views of the tip and removed end of the working channel. 
         FIGS. 6A and 6B  illustrate cross-sectional side and detailed end views of the inserter of Applicants&#39; present device. 
         FIG. 7  illustrates a side elevational view of a tamp driver for use with Applicant&#39;s present invention. 
         FIGS. 8A and 8B  illustrate side and top views of a joint finder for use with Applicant&#39;s devices. 
         FIGS. 9 and 9A  illustrate a channel set for use with Applicant&#39;s present device. 
         FIGS. 10A ,  10 B,  10 B 1 ,  10 C,  10 D,  10 D 1 ,  10 D 2 ,  10 D 3 ,  10 E, and  10 F illustrate perspective views of the novel instruments in use, in “step by step” fashion. 
         FIGS. 10   a ′,  10   b ′,  10   c ′,  10   d ′,  10   e ′, and  10   f ′ illustrate respective exploded view of  FIGS. 10   a ,  10   b ,  10   c ,  10   d ,  10   e , and  10   f , showing the interaction of the instruments with the facet joint. 
         FIG. 11  illustrates an allograft implanted in a facet joint. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
     Dimensions in the drawings are in inches and millimeters. The dimensions illustrated on all the sheets are in mm (inches bracketed) nominal, approximate, and may vary. 
       FIGS. 1A and 1B  illustrate a facet dowel allograft  10  in side view and rear view. Facet dowel allograft  10  is seen to comprise, typically, three portions. A body portion  12  is partially spherical or a spherical segment. A nose portion  14  and a tail portion  16  extend along a longitudinal axis L, which longitudinal axis L extends through a spherical center point C of the body portion. Body portion  12  is partially spherical and the sphere is truncated by parallel planes with a nose portion  14  extending in a first direction along a longitudinal axis L and a tail portion  16  extending opposite in a second direction along the same longitudinal axis L. 
     Nose portion  14  is seen to include a least some tapered walls  14   a,  which define a rounded, cap-like or core-like structure, which may have a tip portion  14   b.  Nose portion is typically partly cylindrical with a larger diameter D N  where it joins body portion  12  and a smaller diameter D NT  at a tip portion  14   b  thereof. 
     Tail portion  16  may be at least party cylindrical and may have a diameter of D T . D T  is usually equal to or approximately equal to D N . D N  and D T  are typically smaller than diameter D S , which is the diameter of the body portion or spherical segment  12  of the implant or allograft  10 . 
       FIG. 1C  illustrates an alternate embodiment of Applicants&#39; allograft or implant  10   a  that omits the nose portion. In other words, spherical body  12   a  continues in its spherical shape where, in the prior embodiments, there was a nose portion. 
       FIG. 1D  illustrates an alternate preferred embodiment of Applicants&#39; allograft or implant  10   b,  wherein the nose portion  14  does not have a cap shape to it, instead is truncated with a flat nose tip  14   b.    
     
       
         
           
               
            
               
                   
               
               
                 RANGE/PREFERRED ALLOGRAFT DIMENSIONS 
               
            
           
           
               
               
               
            
               
                   
                 RANGE 
                 PREFERRED 
               
               
                   
                   
               
            
           
           
               
               
               
               
            
               
                   
                 L OA   
                 6.5 mm-10.5 mm 
                 8.5 mm 
               
            
           
           
               
               
               
               
               
            
               
                   
                 L N   
                 1-3 
                 mm 
                   2 mm 
               
               
                   
                 L S   
                 2.5-6.5 
                 mm 
                 4.5 mm 
               
               
                   
                 L T   
                 1-3 
                 mm 
                   2 mm 
               
               
                   
                 D N   
                 1.8-5.8 
                 mm 
                 3.8 mm 
               
               
                   
                 D S   
                 3.8-7.8 
                 mm 
                 5.8 mm 
               
               
                   
                 D T   
                 1.8-5.8 
                 mm 
                 3.8 mm 
               
               
                   
                 D NT   
                 .8-3.8 
                 mm 
                 1.8 mm 
               
               
                   
                   
               
            
           
         
       
     
       FIGS. 2A ,  2 B,  2 C, and  2 D will be referred to next. These figures help illustrate the structure, function, and use of the instruments for and placement of, the novel dowels illustrated in  FIGS. 1A-1D  in a facet fusion procedure. 
       FIGS. 2A-2D  all use a cylindrical hollow working channel  1  having two spaced apart legs  1   d / 1   e . In  FIG. 2A , working channel receives a prep-drill  2 , which prep-drill will drill out an inter-facet site for the allograft emplacement. Prep-drill  2  has a working shaft tip  2   a  of a diameter equal to about D N  (may be slightly smaller or slightly larger) and tapered to a point. The tapered end of drill may taper at about the same angle of the walls of the cap of the nose of allograft  10 . It engages a T-handle  18  (see  FIG. 10C ) at the removed end thereof and rotated. Tip or working portion is designated  2   a  and removed end  2   b.    
     After the allograft site is selected and drilled out in ways known in the art, the prep-drill is removed from the working channel  1  and a T-spade drill  3  is inserted. It is a function of T spade drill  3  to remove bone adjacent the inter-facet gap for receipt of allograft  10  therein. 
       FIG. 2B  illustrates the T spade drill  3  in working channel  1  in a first position, which may be referred to as the retracted and aligned position, and  FIG. 2C  illustrates the T spade drill in the same position, but the view being a side view. 
     When the T spade drill is moved to an extended position from that shown in FIGS.  10 D 1 - 10 D 3 , it may be rotated typically 180-360° in the inter-facet location that was previously drilled with the prep-drill to excavate space for the spherical segment of allograft  10 . By such rotation, bone is removed from the vertebrae located above and below to define a volume that is spherical with a shape substantially identical to body  12 , the volume with a diameter about equal to Ds (see  FIG. 1A ). 
       FIG. 2D  illustrates the facet or allograft  10 , mounted to the tip of inserter  5 , which inserter is then slipped into the working channel  1 . Then driver tamp shaft  6   a  is inserted into the hollow channel of inserter  5  as set forth below, to force the allograft  10  into the shaped (drilled and excavated) site. 
       FIG. 3  illustrates the details of Applicants&#39; prep-drill  2 . Prep-drill  2  is seen to have a tip portion  2   a,  a removed end  2   b,  and a body  2   c.  Tip  2   a  is a working portion of the drill and may have a diameter of about D N /D T . This diameter is seen to be slightly greater than D N  and D T , which may be about 3.8 mm, but slightly less than diameter D S , which is approximately 5.88 mm. 
       FIG. 3  also illustrates that removed end  2   b  may include a stop portion  2   d,  which will limit the extension of body  2   c  and tip  2   a  from the end of working channel as stop portion  2   d  has a diameter greater than the interior diameter of the working channel. Prep-drill  2  may also have a hex portion  2   e  at a removed end thereof for engagement with a hex driver which will rotate the prep-drill in a manner known in the art. The length of the working channel and tip to stop portion of prep-drill  2  will be sufficient for the tip  2   a  of the drill to clear a channel at least the length of the allograft  10 . 
       FIGS. 4A-4C  illustrate views of the T spade drill  3 ; a first view in  FIG. 4A  and a second view in  FIG. 4B , which second view represents a rotation of 90° from the first view of the elongated instrument. Reference to FIGS.  10 D 1 - 10 D 3  are also helpful. 
       FIGS. 4A and 4B  are views of T-spade drill  3 . T-spade drill  3  is seen to have a tip portion  3   a,  a body  3   b  and a removed end  3   c  thereof. Body  3   b  and tip portion  3   a  are dimensioned to slide within the inner channel of working channel  1  as set forth in  FIGS. 2B and 2C . 
     Turning now to the details of tip portion  3   a,  tip portion  3   a  is seen to have a nose portion  3   e,  which nose portion may have a perimeter  3   f  and which nose portion joins a body or flat portion  3   g.  The body or flat portion  3   g  joins the near end of body 3 b,  which body may include a tapered portion  3   h.  The diameter of the nose portion  3   e,  which is typically tapered, is about equal to the diameter of the working portion  3   a  of the drill, here about 4.09 mm (may be slightly more or slightly less). The diameter of the flat portion  3   g  is approximately equal to or slightly greater or slightly less than the diameter of the spherical or segmented portion  12  (D N ). This thickness of the flat portion is typically about 1.52 mm or about equal to or slightly more or less than an inter-facet gap at the drill site. The thickness can be seen in  FIG. 4A  to be less than the diameter of nose D N . Tapered portion  3   h  usually has a diameter where it meets the flat portion of about D N  (as seen in  FIG. 4B ). It is seen that, with respect to FIGS.  10 D- 10 D 3 , the T-spade drill may be inserted in the channel created by the prep-drill with the flat section aligned with the inter-facet gap (and aligned with legs  1   d / 1   e ) and, when rotated at least 180-360°, will scoop out a portion of first and second facets to define the inter-facet volume (see FIG.  10 D 3 ). This inter-facet volume is partially spherical, substantially similar to the shape of body  12  and having dimensions for the snug receipt of body portion  12  of allograft  10 . 
     Turning now to removed end  3   c,  it is seen to include a stop portion  3   i  which will limit the limit the longitudinal extension of the T-spade drill through the working channel as seen in  FIGS. 2B and 2C , as well as a orientation boss  3   j.  Orientation boss  3   j  will align with a longitudinal slot le in the removed end  1   c  of working channel  1  as seen in  FIGS. 5B and 5E , so that tip portion  3   a  may move from the position as seen in  FIG. 2B  (retracted) to the position as seen in FIGS.  10 D 1  and  10 D 3 , the extended and aligned position. The T-spade drill will not reach the extended position ( FIG. 10D ) or leave the extended position (i.e., retract) unless the boss  3   j  is aligned with slot  1   e.  This ensures that the flat portion  3   g  is aligned with the channel legs  1   d / 1   e  and therefore the gap, as well as aligned with the hole drilled out prior to insertion of the T-spade. A lasered mark  31  on the stop may be aligned with lasered mark  1   j  on working channel to demonstrate alignment of box  3   j  and slot  1   e . Hex portion  3   k  will allow the engagement of the T-spade drill  3  with a hex drive tool in ways known in the art. In an alternate preferred embodiment of the T-spade drill  3 , a T-shaped handle is integral with the removed end and no hex portion  3   k  is used. Note that the legs  1   d / 1   e  of the working channel and position of longitudinal slot  1   e  will help place tip  3   a  aligned in the inter facet gap. 
       FIGS. 5A-5E  illustrate details of working channel  1 . Working channel  1  is seen to include a tip portion  1   a,  a body portion  1   b,  and a removed end  1   c.  Working channel  1  will allow the receipt of the prep-drill, T-spade, inserter, and joint finder in ways described herein. 
     Tip  1   a  is seen to comprise the pair of legs  1   d  and  1   e,  which are spaced apart, as best seen in  FIG. 5E . Removed end  1   c  is seen to include the longitudinal slot  1   e  to run through inner walls of working channel walls to annular channel  1   f,  which is defined by shoulders  1   g  and  1   h.  Shoulders  1   g  and  1   h  will enclose boss  3   j  as the T-spade drill is rotated from the extended, aligned position as seen in  FIGS. 2B and 2C  to excavate the two facet joints for the receipt of spherical portion  12  of dowel  10 . Moreover, annular channel if will be spaced into working channel  1  such that tip  3   a  of the T-spade drill extends beyond end walls  1   i  and nose  3   e  typically beyond the ends of legs  1   d / 1   e.  of working channel  1 . 
       FIG. 5A  illustrates a joint finder alignment slot  1   j  on the inner walls of tip  1   a  of the working channel  1 . It may be seen in FIGS.  8 A and  10 B 1  that there is a boss  7   d  on the outer surface of the joint finder near tip  7   a.  When the joint finder locates the joint, the wedge-shaped tip will be properly situated in the joint. The working channel  1  is slid over the joint finder and down the joint finder so legs  1   d / 1   e  are next to the joint (the space between the upper and lower facets) until joint finder alignment slot  1   j  is aligned with boss  7   d.  When boss  7   d  and slot  1   j  are in alignment, then the flat of the tip  7   a  will be aligned with the two legs of the working channel and the working channel will be properly situated, rotationally-wise in the joint. FIG.  10 B 1  shows working channel  1  in proper alignment with the seated joint finder (bones have been omitted for clarity), with the working channel  1  in position to drive legs  1   d / 1   e  up to a final position that typically puts the legs adjacent the edges of tip  7   a  and in the joint between the facets. 
     Legs  1   d / 1   e  of the working channel extend about 8 mm beyond the end walls  1   i  of the working channel  1  and the drill stop  2   d  puts the tip  2   a  of the drill  2  about 3 mm beyond the ends of the legs, about the same distance for the T-spade  3 . That is to say, the nose of the drill  2  and the nose of the T-spade extend about 3 mm beyond the ends of the legs of the working channel when the either the drill or T-spade stop hits the end walls of the working channel. It may be seen with respect to  FIGS. 10F  that the driver tamp  5 , when fully seated in inserter  4  and channel  1 , is about 3-4 mm past the ends of the channel set  1 . 
       FIGS. 6A and 6B  illustrate inserter  4 , which functions to firmly engage facet dowel  10  at one end thereof and move, with the facet dowel thereon through the working channel, to the allograft site that has been drilled and shaped (with T-spade  3 ) as set forth herein.  FIGS. 6A and 6B  illustrate that inserter  4  includes a tip portion  4   a,  body portion  4   b,  and a removed end  4   c.  Details of tip portion  4   a  are seen in  FIG. 6B . Tip portion  4   a  includes a partially spherical volume  4   d  that is dimensioned to snugly engage spherical portion  12  of facet dowel  10 . A pair of opposed slots  4   e  allow some flexing of the inserter tip, so that dowel  10  may be partially inserted into tip  4   a  with nose portion pointed forward and outside of the tip area and with tail portion up in the channel as seen in  FIGS. 10E and 10F . A set of four annular holes  4   f  are provided for allowing the tip to flex and receive the implant or allograft. 
     With the working channel in place as seen in  FIGS. 10E and 10F  and with the legs  1   d  and  1   e  stabilizing and locating the working channel with respect to the inter-facet gap or space in ways known in the art, the inserter, with the allograft  10  (nose portion forward) may be inserted into the working channel and moved to the shaped site for inserting, typically by gentle tamping, therein. 
       FIG. 7  illustrates a driver tamp  5  for the uses set forth herein. Driver tamp  5  is seen to have a tip portion  5   a,  a cylindrically elongated body  5   b,  and a stop portion  5   c  at a removed end thereof. Tip  5   a  and body  5   b  are dimensioned for receipt within the inner channel of the inserter with a length between the near end of face walls of stop  5   c  and the removed end at tip  5   a,  here designated as about 165.84 mm. When inserter  4  is fully seated into working channel  1  (stop  4   c  flush with end walls of working channel), with the allograft in the proper position on the tip thereof, and when driver tamp  5  is fully inserted such that stop  5   c  is against stop  4   c,  removed tip  5   a  will have pushed tail  16  of the allograft to the position illustrated in  FIG. 10F , that is, fully inserted. 
       FIGS. 8A and 8B  illustrate joint finder  7  having a tip portion  7   a,  cylindrical elongated body portion  7   b,  and removed end  7   c.  Tip portion  7   a  is tabular with a wedge-shaped removed end as seen in  FIG. 8A  and the body portion is long enough to receive the working channel over it as seen in  FIG. 10B . Boss  7   d  is provided for alignment and engagement with slot  1   j  as seen in FIG.  10 B 1 . 
     Channel set  8  is seen to have a cylindrical, hollow channel  8   a  therein. Channel set  8  is further seen to have a nose portion  8   b  extending from a body portion  8   c,  both portions  8   a  and  8   b  being cylindrical and having inner walls which define hollow channel  8   a.  Body  8   c  is seen to have forward stop  8   d  between nose portion  8   b  and body portion  8   c.    
       FIGS. 10A-10G  help illustrate the structure and function of the foregoing instruments and allograft as used in a facet joint fusion operation. 
     A brief summary of the steps used to implant the allograft to assist in the fusion, which implanted allograft is illustrated in  FIG. 11 , is set forth as follows. After opening and preparing the surgical site in ways known in the art, the facet finder is tapped into position until minimal resistance is met as seen in  FIG. 10A . Next, the working channel is slid down the joint finder. Alignment pins (legs) are utilized for the placement of the working channel over the facet finder and tapped into place until seated on the facet. This is illustrated in  FIG. 10B . FIG.  10 B′ shows the alignment of the pins in the channel. Next, the drill is inserted into the working channel and the drilling is continued through the working channel until the drill hits the stop. This is illustrated in  FIG. 10C . 
       FIGS. 10D ,  10 D 1 ,  10 D 2 , and  10 D 3  illustrate the step in which the drilled-out channel is further excavated through the use of a T-spade. The T-spade drill is laser marked and the T-spade drill and the alignment are aligned in parallel to the facet joint as seen in FIG.  10 D 1 . The drill is rotated two or three times until no resistance (see FIG.  10 D 2 ), which illustrates the tip of the T-spade drill when it is rotated perpendicular to the aligned position or the parallel position as set forth in FIG.  10 D 1 . 
     FIG.  10 D 3  illustrates the excavated space and the T-spade drill in the aligned position, which will allow the withdrawal of the instrument from the working channel. 
     Next, the allograft  10  is loaded into inserter  4  and moved to the insertion site, which has been drilled and excavated. The inserter is then placed into the working channel, with the allograft on the tip until the inserter is flush with the channel instrument (see  FIG. 10E ). A tamp is placed through the central channel of the inserter until it touches the removed end of the tail of the allograft, at which point the allograft is tapped into a final position as illustrated in  FIG. 11  (see  FIG. 10F ). 
     In  FIG. 10A , a superior and inferior facet is seen and joint finder  7  is used to locate and, if necessary, separate slightly interior and inferior facet. The proper angle, depth, and spacing of the facets and how to manipulate the joint finder would be apparent to one skilled in the art. 
     After the site is located and prepared by the joint finder in ways known in the art, then the working channel  1  is slipped over the joint finder as is illustrated in  FIG. 10B . The working channel may be manipulated by rotating it slightly while urging it into the joint as located by the joint finder. The legs of the working channel will typically be parallel to and in the plane of the face of the wedge-shaped tip as best seen in  FIG. 10B . Channel set  8  may be slipped over the removed end of the joint finder and tapped so as to drive the legs and the working channel snugly into the inter-facet gap area and to locate the working channel at the allograft site location. 
       FIGS. 8A ,  10 B, and  10 B 1  also illustrate that a boss  7   d  may be provided for engaging a slot  1   j  at the end of channel  1  so the legs of the channel align with the flat of the wedge on the joint finder. The boss may be dimensioned so as to fit within the interior of the working channel. 
       FIG. 10C  illustrates the step of drilling the allograft site (following removal of the joint finder from the working channel). Moreover, it may be appreciated how the stop member on the prep-drill is used to limit the penetration of the drill tip beyond a selective limit past end walls  1   i  of working channel  1 . A T-handle  18  may be used to engage the hex end of the prep-drill in ways known in the art. 
     FIGS.  10 D- 10 D 3  illustrate the shaping step wherein the T-spade drill  3  is inserted into the working channel and extended with orientation boss  3   j  through longitudinal slot  1   e , which orientation of the boss in the slot will place the flat portion of parallel to the faces of the interior and superior facets, which are adjacent the inter-facet space. Moreover, it is seen that orientation slot  1   e  on the working channel is located aligned the legs  1   e  of the working channel  1 , which legs define the plane in which the flat portion  3   g  of the T-spade drill  3  is placed when the T-spade drill  3  is urged up to the annular ring. Rotation of 180° in either direction will then allow the spherical leading edge defining the outer perimeter of the flat portion  3   g  to shape the vertebrae bone above and below the drilled out channel in such a way as to provide a fit for the allograft as best seen in the detailed portion of  FIG. 10D . 
       FIG. 10E  illustrates the manner in which the allograft  10 , with its tail inserted in the tip portion  4   a  of inserter  4 , is urged so that the nose and typically a portion of spherical body  12  is protruding from end walls  1   i  as best seen in the detail in  FIG. 10E . When this position is reached, the stop portion  4   e  of the inserter  4  is typically up against the removed end of working channel  1  as seen in  FIG. 10F . 
     At this point, as illustrated in  FIG. 10F , the driver tamp  5  may be inserted in the inner channel of the inserter  4  until strikes the removed end of the tail of the allograft. At that point, it may be struck or otherwise pushed, while holding the channel set and such action will force the spherical body to spread the two facets slightly until the spherical body reaches the shaped interior of volume corresponding to the spherical shape excavated as illustrated in  FIG. 10D . At this point, the inferior and superior facet faces will, under compression, close around the spherical body in the manner illustrated in the detailed portion of  FIG. 10F . 
     Although the invention has been described in connection with the preferred embodiment, it is not intended to limit the invention&#39;s particular form set forth, but on the contrary, it is intended to cover such alterations, modifications, and equivalences that may be included in the spirit and scope of the invention as defined by the appended claims. For example, gas is considered to be a fluid, the device may operate with either a liquid or a gas.