Patent Document

CROSS-REFERENCE TO RELATED APPLICATION 
       [0001]    This application is a continuation application of a co-pending U.S. application Ser. No. 13/655,795, filed Oct. 19, 2012, which is a divisional application of U.S. application Ser. No. 12/474,991, filed May 29, 2009, which is now a U.S. Pat. No. 8,313,492 issued on Nov. 20, 2012, which claims the benefit under 35 U.S.C. §119(e) of U.S. Provisional Application Ser. No. 61/057,556, filed May 30, 2008, the disclosures of which are incorporated herein by reference in their entirety. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present disclosure relates to a method for repairing damaged or fractured bones in the foot. 
       BACKGROUND 
       [0003]    There has not been any drill alignment guide instrument for use in foot and ankle soft tissues and bone repair applications. Thus, there is a continuing need for a drill alignment guide instrument for use in foot and ankle soft tissues and bone repair applications. 
         [0004]    The mid-foot region or the medial column of the foot is comprised of many osseous components—distal phalanx, proximal phalanx, first metatarsal, medial cuneiform, intermediate cuneiform, lateral cuneiform, cuboid, navicular and talus. Bone fractures in the mid-foot regions are generally difficult to fixate because of the geometries of the bones involved. Thus, there is a need for a guiding instrument that can provide guidance for targeting, aligning, measuring and drilling of a hole for placement of a bone screw and then actual placement of the bone screw while holding or compressing the bones in reduction. 
       SUMMARY 
       [0005]    The orthopedic drill guide of the present disclosure provides accurate means for guiding the drilling through foot bones such as cuneiforms or metatarsals to install bone screws for repairing soft tissues and bone fractures. The drill guide of the present disclosure is also configured and adapted to provide compression of the bone pieces while alignment, guiding, measuring, drilling, and screw installation are performed. The drill guide can also be used for syndesmosis applications in the mid-foot and distal tibia. 
         [0006]    The drill guide assembly of the present disclosure comprises an elongated body having first and second ends, a first arm member extending from the first end of the elongated body and a second arm member extending from the elongated body and configured and adapted to be longitudinally movable along the elongated body. The second arm member can be moved along the elongated body in two directions, towards or away from the first arm member. The second arm member is provided with a guide housing at its outer end (the end away from the elongated body), the guide housing being configured and adapted to removably receive a sleeve that has a longitudinal bore for receiving a guide wire (such as Kirschner wire, also known as K-wire) or a drill bit. 
         [0007]    Present disclosure also includes a depth gage device for measuring the depth of a K-wire that has been drilled into a bone. The depth gage device comprises a cannulated elongated body having first and second ends and a bore longitudinally extending through the length of the elongated body. The bore is closed at the first end of the elongated body and open at the second end of the elongated body. The open second end is configured and adapted to receive an elongated member such as the K-wire. An elongated slot opening is provided in the elongated body extending longitudinally over a portion of the elongated body. A piston is provided within the bore and the piston is configured and adapted to travel in longitudinal direction within the bore. An elastically compressible member such as a coil spring is provided within the bore extending between the closed first end of the elongated body and the piston. On the outer surface of the elongated body, a graduated rule is provided along the elongated slot opening. An indicator connected to the piston through the elongated slot opening is also provided whereby when the elongated member such as a K-wire is inserted into the open second end of the elongated body, the elongated member urges the piston towards the closed first end of the elongated body compressing the elastically compressible member. As the piston moves along inside the bore, the indicator also moves along with the piston and indicates a value on the graduated rule. The elastically compressible member keeps the piston in contact with said elongated member. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0008]      FIG. 1  is a perspective view of a drill guide assembly according to an embodiment of the present disclosure. 
           [0009]      FIG. 1A  is a perspective view of an embodiment of a guide housing. 
           [0010]      FIG. 2  is a plan view of the drill guide assembly of  FIG. 1 . 
           [0011]      FIG. 3  is a side view of the drill guide assembly of  FIG. 1 . 
           [0012]      FIG. 4  is an end view of the drill guide assembly of  FIG. 1 . 
           [0013]      FIG. 4A  is a detailed view of the region B in  FIG. 4 . 
           [0014]      FIG. 5  is a perspective view of an example of a removable sleeve for use with the drill guide assembly of the present disclosure. 
           [0015]      FIG. 6  is a side view of the removable sleeve of  FIG. 5 . 
           [0016]      FIG. 7  is an end view of the removable sleeve of  FIG. 5 . 
           [0017]      FIG. 8  is a top view of the removable sleeve of  FIG. 5 . 
           [0018]      FIG. 9  is a cross-sectional view of the removable sleeve through the line A-A shown in  FIG. 8 . 
           [0019]      FIG. 10  is a side view of the drill guide assembly of  FIG. 1  with the removable sleeve of  FIG. 5  inserted into the guide housing of the drill guide assembly. 
           [0020]      FIG. 11  is a cross-sectional view of the guide housing and the removable sleeve assembly through the line A-A shown in  FIG. 10 . 
           [0021]      FIG. 12  is a cross-sectional view of the drill guide assembly of  FIG. 1 . 
           [0022]      FIG. 13  is a cross-sectional view of the drill guide assembly of  FIG. 1  through the line B-B shown in  FIG. 3 . 
           [0023]      FIG. 14A  is a perspective view of a depth gage device according to an aspect of the present disclosure. 
           [0024]      FIG. 14B  is a top view of the depth gage device of  FIG. 14A . 
           [0025]      FIG. 14C  is a cross-sectional view of the depth gage device taken through the line A-A shown in  FIG. 14B . 
           [0026]      FIG. 14D  is a detailed view of the area B identified in  FIG. 14C . 
           [0027]      FIG. 14E  is a perspective view of an elastically compressible member  70  of the depth gage device of  FIG. 14A . 
           [0028]      FIG. 14F  is a plan view of the depth gage device of  FIG. 14A  in use in conjunction with the drill guide assembly of  FIG. 1 . 
           [0029]      FIG. 14G  is a perspective view of another embodiment of the depth gage device. 
           [0030]      FIG. 15  is a perspective view of a blunt trocar that can be used in conjunction with the drill guide assembly of the present disclosure. 
           [0031]      FIG. 16  is a plan view of a drill guide assembly according to another embodiment of the present disclosure. 
           [0032]      FIG. 17  is a cross-sectional view through the line C-C shown in  FIG. 16 . 
           [0033]      FIG. 18  is a top view of the drill guide assembly of  FIG. 16 . 
           [0034]      FIG. 19  is a cross-sectional view through the line A-A shown in  FIG. 18 . 
           [0035]      FIG. 20  is a detailed view of the area B identified in  FIG. 19 . 
           [0036]      FIG. 21  is a perspective view of a handle for use in conjunction with the drill guide assembly of the present disclosure. 
           [0037]      FIG. 22  is a plan view of the handle of  FIG. 21 . 
           [0038]      FIGS. 23 and 24  are cross-sectional views taken through the lines A-A and B-B shown in  FIG. 22 , respectively. 
           [0039]      FIG. 25  is a side view of the clamp of  FIGS. 16 and 21  operably engaged with the drill guide assembly of the present disclosure. 
           [0040]      FIG. 26  is a flowchart of the method according to one embodiment of the present disclosure. 
           [0041]      FIGS. 27A-27F  are photographs illustrating the various interim steps of the method of  FIG. 26 . 
           [0042]      FIG. 28  is a schematic illustration of a surgical drill guide kit including the drill guide assembly of the present disclosure. 
       
    
    
       [0043]    The features shown in the above referenced drawings are illustrated schematically and are not intended to be drawn to scale nor are they intended to be shown in precise positional relationship. Like reference numbers indicate like elements. 
       DETAILED DESCRIPTION 
       [0044]    This description of the exemplary embodiments is intended to be read in connection with the accompanying drawings, which are to be considered part of the entire written description. In the description, relative terms such as “lower,” “upper,” “horizontal,” “vertical,”, “above,” “below,” “up,” “down,” “top” and “bottom” as well as derivative thereof (e.g., “horizontally,” “downwardly,” “upwardly,” etc.) should be construed to refer to the orientation as then described or as shown in the drawing under discussion. These relative terms are for convenience of description and do not require that the apparatus be constructed or operated in a particular orientation. Terms concerning attachments, coupling and the like, such as “connected” and “interconnected,” refer to a relationship wherein structures are secured or attached to one another either directly or indirectly through intervening structures, as well as both movable or rigid attachments or relationships, unless expressly described otherwise. 
         [0045]      FIGS. 1-4  illustrate a drill guide assembly  100  according to an embodiment. The drill guide assembly  100  comprises an elongated body  102  having a first end  103 A and a second end  103 B. A first arm member  106  extends from the first end  103 A of the elongated body  102 . A modular second arm member  110  extends from the elongated body  102  and is configured and adapted to be longitudinally movable along the elongated body in two directions, towards or away from the first arm member  106 . The second arm member  110  is referred to as being modular because it is formed from a piece separate from the elongated body  102 . The second arm member  110  is provided with a guide housing  116  at its outer end (the end away from the elongated body  102 ). The guide housing  116  has a sleeve-receiving hole or a bore  117  for removably receiving a sleeve  20  (see  FIGS. 5 and 10 ). 
         [0046]    The lengths of the first arm member  106  and the second arm member  110  are matched so that the guide housing  116  and the tip  108  of the first arm member  106  align as shown. This alignment allows a K-wire or a drill bit inserted through the removable sleeve  20  positioned in the guide housing  116  to contact the tip  108  when the K-wire or the drill bit is extended towards the first arm member  106 . This will be discussed further in connection with the various examples of surgical procedures for using the drill guide assembly. As shown in  FIG. 2 , an alignment notch  119  may be optionally provided on the tip  108  of the first arm member  106 . The location of the alignment notch  119  is such that the longitudinal axis A of the guide housing  116  aligns with the alignment notch  119 . 
         [0047]    According to another embodiment, the guide housing  116  can be provided on the first arm member  106  rather than on the second arm member. In that embodiment, the outer end of the second arm member  110  would look like the tip  108  of the first arm member  106  shown in  FIG. 1  and the alignment notch  119  would be provided on the second arm member  110 . 
         [0048]    The second arm member  110  has a base portion  112  that is configured and adapted to engage the elongated body  102  to allow the longitudinal movement of the second arm member  110  along the elongated body  102  towards and away from the first arm member  106 . In one preferred embodiment, the elongated body  102  is four-sided having a generally rectilinear cross-section. The base portion  112  is provided with a matching rectilinear shaped through-hole  114  for receiving the elongated body  102 . This arrangement prevents the second arm member  110  from rotating about the elongated body  102  and helps maintain the alignment between the first arm member  106  and the second arm member  110  discussed above. 
         [0049]    As shown in  FIGS. 3 and 4 , in one preferred embodiment, one corner of the elongated body  102  is provided with a chamfer  102 A so that the four-sided rectilinear cross-section of the elongated body  102  has a chamfered corner.  FIG. 4A  shows a detailed view of the region B in  FIG. 4  with the body  102  of the drill guide assembly removed from the rectilinear shaped through-hole  114  of the base portion  112 . The through-hole  114  is provided with a truncated corner  114 A for aligning with the chamfer  102 A of the body  102 . The chamfer  102 A provides the elongated body  102  with a lateral cross-sectional shape that is non-symmetric. This feature makes the assembly of the two modular components, the elongated body  102  and the second arm member  110 , orientation sensitive. This feature ensures that the second arm member  110  is always in the correct orientation when the second arm member  110  is assembled with the body  102 . The chamfer  102 A functions as an orientation key. The orientation function can also be achieved with a variety of cross-sectional shapes for the elongated body  102  with or without a chamfer as long as the cross-sectional shape is asymmetric, such as a trapezoid. In the illustrated example, the lateral cross-sectional shape of the elongated body  102  and the corresponding through-hole  114  of the base portion  112  have rectilinear shape. However, other variations in the cross-sectional shape of the elongated body  102  that would provide the non-symmetry without substantially altering the other functions of the drill guide assembly is within the scope of the present disclosure. 
         [0050]    The base portion  112  and the elongated body  102  are configured and adapted to operably engage each other so that the longitudinal movement of the second arm member  110  along the elongated body  102  is ratcheted. Ratchet teeth  104  are provided on one of the sides of the elongated body  102 . The base portion  112  comprises a spring-loaded mechanism that cooperates with the ratchet teeth  104  and allows the second arm member  110  to be moved along the elongated body  102  in one direction, towards the first arm member  106 , but prevents the second arm member  110  from backing out in the opposite direction, away from the first arm member  106 . To move the second arm member  110  away from the first arm member  106 , the spring-loaded mechanism must be unlocked. An example of the spring-loaded mechanism will be described in more detail in conjunction with  FIG. 18 . 
         [0051]    Because the drill guide assembly  100  is used to grasp a piece of bone or compress two or more pieces of soft tissues or bones between the two arm members in order to align and drill a hole for a bone screw, the guide housing  116  and the tip  108  of the first arm member  106  are configured and adapted to provide a good grip on the bone. In one embodiment, the tip  108  of the first arm member  106  terminates in a sharp point that can be used to penetrate the soft tissue covering the bone and also dig into the bone surface and help anchor the first arm member. The tip  108  can also be curved towards the second arm member  110  as shown in the embodiments of  FIGS. 1, 10 and 12 . This curvature allows the tip  108  to be wrapped around a bone if appropriate. On the guide housing  116 , one or more spikes  118  can be provided on the side of the guide housing  116  facing the first arm member  106 . The one or more spikes  118  extend longitudinally towards the first arm member  106  and terminate in a sharp point to dig into the bone surface and/or soft tissues. The length and number of the spikes  118  provided on a particular drill guide assembly can be varied to meet the requirements of the particular intended application. Preferably, the one or more spikes  118  are positioned on the guide housing  116  so that the spike(s) do not interfere with the K-wire or the drill bit that would be inserted through the guide housing  116 . 
         [0052]    Referring to  FIG. 1A , according to another embodiment, the guide housing  116  can be provided with one or more holes  116   a  for fixating the instrument to a bone using K-wires or screws. The holes  116   a  preferably extend through the guide housing  116  longitudinally. 
         [0053]    During actual use, an external imaging method will generally be used to verify the position and alignment of the drill guide assembly with respect to the bone. External imaging method can include currently available technologies such as X-ray radiography, fluoroscopy, etc. and yet to be developed external imaging technologies. To enable this verification by external imaging such as X-ray radiography and fluoroscopy, in one preferred embodiment, the elongated body  102  of the drill guide assembly is made from a radiolucent material. One example of such material suitable for this application is polyetheretherketone (PEEK) thermoplastic polymer. Glass filled PEEK and carbon filled PEEK are some examples. When such polymer is used for the body  102 , the body  102  must have appropriate thickness so that the body  102  has sufficient stiffness. Aluminum alloys can also be radiolucent if it is thin enough. The first arm member  106  can also be radiolucent but in one preferred embodiment, at least the tip portion  108  of the first arm member  106  is made to be radiopaque (i.e. made of metal) so that the tip  108 , the guide housing  116  and the K-wire, for example, are visible in X-ray radiography in order to properly verify and confirm the alignment of the K-wire and the position of the drill guide. In an embodiment where the first arm member  106  is made of a metal and the elongated body  102  is made of a radiolucent polymer, the first arm member  106  would be mechanically joined to the body. For example, in the embodiment shown in  FIG. 12 , the first arm member  106  is joined to the body  102  by a screw  109 . 
         [0054]      FIGS. 5-9  illustrate an example of the sleeve  20  for removably inserting into the guide housing  116  of the drill guide assembly  100 . The sleeve  20  has a generally cylindrical body  21  that is inserted into the sleeve-receiving hole  117 . The sleeve  20  has a central bore  23  longitudinally extending through the full length of the sleeve  20 . The bore  23  is centrally located in the sleeve  20  such that when the sleeve  20  is inserted into the guide housing  116 , the longitudinal or central axis of the bore  23  coincides with the longitudinal axis A of the guide housing  116 . If the sleeve  20  is a K-wire sleeve used to guide a K-wire, the diameter of the bore  23  is matched to that of the particular K-wire. If the sleeve  20  is a drill sleeve used to guide a drill bit, the diameter of the bore  23  is matched to that of the particular drill bit. In one preferred embodiment, the sleeve  20  is provided with a flared head portion  22  at the top end that can act as a stop when the sleeve  20  is inserted into the guide housing  116 . 
         [0055]    The sleeve  20  can also have a retention tab  24  extending downward from the flared head portion  22  that cooperates with the guide housing  116  for retaining the sleeve  20  in place and prevent the sleeve  20  from falling or sliding out of the guide housing  116 . As illustrated in  FIGS. 6, 8 and 9 , the retention tab  24  is provided with a spring-loaded detent  27  that protrudes from the inner surface  25  of the retention tab  24 . The spring-loaded detent  27  urges against the guide housing  116  and retains the sleeve in place. The detent  27  can be spring-loaded inside the retention tab  24  as shown in the detailed view of  FIG. 9 . The spring-loaded detent  27  and a compressible member  28  such as a coil spring and steel ball are held within a cavity  26  by a set screw  29 . 
         [0056]    In one preferred embodiment, an annular groove  115  is provided on the outer surface of the guide housing  116  to cooperate with the spring-loaded detent  27  as shown in  FIGS. 1 and 2 . The groove  115  is referred to as an annular groove because it forms a ring around the outer surface of the guide housing  116 . When the sleeve  20  is fully inserted into the guide housing  116 , the spring-loaded detent  27  is extended into the groove  115  and prevents the sleeve  20  from unintentionally falling out of the guide housing  116 . This arrangement is shown in the assembled views of  FIGS. 10 and 11 . The sleeve  20  can be removed by simply pulling it out using some force to compress the spring-loaded detent  27 . In other embodiments, the groove  115  can be replaced with other structures such as indentations that will provide the same function as the groove  115  of receiving the spring-loaded detent  27 . 
         [0057]    Referring to  FIGS. 12 and 13 , in another example, the guide housing  116  and the sleeve  20  can be configured and adapted to prevent the sleeve  20  from rotating within the guide housing  116 . The sleeve  20  can be provided with an alignment tab  32  on its outer surface of the sleeve body  21  and the guide housing  116  can be provided with corresponding grooves  132  running longitudinally along the inner surface of the sleeve-receiving hole  117 . 
         [0058]      FIG. 13  is an illustration of a cross-section taken through the ratchet engaging portion  113  of the base  112  of the second arm member  110  showing the details of an example of a ratcheting mechanism between the second arm member  110  and the elongated body  102 . The elongated body  102  of the drill guide  100  extends through the base  112  as shown. Inside the ratchet engaging portion  113 , a button  130  having a through hole  134  for accommodating the elongated body  102  is provided. The button  130  is configured to move up and down in perpendicular direction to the ratchet teeth  104  surface of the elongated body  102 . In this example, slots  133  in the button  130  cooperate with the button guide pins  170  to limit the up and down travel of the button within the ratchet engaging portion  113 . A top side  130 A of the button  130  is exposed and protrudes from the ratchet engaging portion  113 . The bottom side  130 B of the button resides within the ratchet engaging portion  113  and a coil spring  180  positioned between the button  130  and the ratchet engaging portion  113  urges against the bottom side  130 B of the button. This keeps the bottom surface (in the orientation shown in  FIG. 13 ) of the through hole  134  pushed up against the ratchet teeth  104  when in a resting position. The ratchet teeth  104  are oriented in one direction such that when the second arm member  110  is pushed towards the first arm member  106 , the button  130  will slide over the ratchet teeth  104  while preventing the second arm member  110  to be moved away from the first arm member  106 . To move the second arm member  110  away from the first arm member  106 , the button  130  has to be pressed down (in the orientation shown in  FIG. 13 ) thus disengaging the button  130  from the ratchet teeth  104 . The structure described herein is just one example of a ratcheting mechanism that can be implemented to engage the base  112  of the second arm member  110  to the elongated body  102  of the drill guide assembly. 
         [0059]    Referring to  FIGS. 14A-14F , a depth gage  60  for use in conjunction with the drill guide of the present disclosure will be described. The depth gage  60  is used to measure the depth of the K-wire  400  (see  FIG. 14F ) drilled into the bone to determine the proper length of the bone screw. After the K-wire  400  is drilled into the bone with the drill guide in place, the depth gage  60  is slid over the remaining portion of the K-wire  400  that is not drilled into the bone and the depth gage  60  readily tells the surgeon the depth of the K-wire&#39;s penetration into the bone. 
         [0060]    In one embodiment, the depth gage  60  comprises a hollow elongated body  61  having an opening at one end  63  for receiving an elongated member, the K-wire  400  having a length. A spring-loaded piston  72  is provided within the hollow elongated body  61  for urging against the K-wire  400  received in the opening at one end  63  of the hollow elongated body. When the K-wire  400  is received into the opening and pushes the spring-loaded piston  72  away from the opening, the distance traveled by the spring-loaded piston  72  provides an indication about the length of the K-wire  400 . Specifically, in the application described herein, by sliding the depth gage  60  over the K-wire until the leading end  63  of the depth gage  60  contacts the bone surface, the distance traveled by the spring-loaded piston  72  indicates the length of the portion of the K-wire  400  that is drilled into the bone. Thus the depth of the bone drilled by the K-wire  400  is measured. 
         [0061]    In another embodiment, the depth gage  60  comprises a cannulated elongated body  61  having a first end  62  and a second end  63  and a bore  64  longitudinally extending through the length of the elongated body  61 . The bore  64  is closed at the first end  62  of the elongated body and open at the second end  63  of the elongated body, the open second end  63  being configured and adapted to receive an elongated member such as a K-wire. A pair of elongated slot openings  66  are provided in the elongated body diametrically opposed from one another and extend longitudinally over a portion of the elongated body  61 .  FIG. 14A  shown one of the two through slots  66  on the near-side of the depth gage  60 . The other slot opening would be on the opposite side of the depth gage  60 , the side not visible in the  FIG. 14A  view. 
         [0062]    A piston  72  is provided within the bore  64  and is configured to travel in longitudinal direction within the bore. An elastically compressible member  70  is also provided within the bore  64  and extends between the closed first end  62  of the elongated body and the piston  72 . The piston  72  and the compressible member  70  can be attached to one another but this is not necessary. As shown in  FIG. 14E , the piston  72  can be provided with a pair of guide pins  73 . The guide pins  73  extend into the slot openings  66  for guiding the piston as it is slides longitudinally within the bore  64 . The guide pins  73  can be a single pin that is placed through the piston  72  as shown in  FIG. 14E . 
         [0063]    At the first end  62  of the depth gage, the bore  64  is closed off to prevent the elastically compressible member  70  from falling out through that end. The bore  64  can be closed off in a variety of possible ways. In one example shown in  FIGS. 14A-14C , a stopping pin  68  placed through the body  61  of the depth gage  60  blocks the first end  62 . 
         [0064]    A graduated rule  65  is provided on the outer surface of the elongated body along said elongated slot opening  66 . In the embodiment of the depth gage  60  shown in  FIG. 14A , the graduated rule  65  is provided on a flat surface of the elongate body  61 . 
         [0065]    A sliding indicator  67  is provided for reading the measurement from the graduated rule  65  which indicates the length of an elongated member such as a K-wire that is drilled into the bone. The sliding indicator  67  is configured and adapted to cooperate with the piston  72  to move along with the piston  72  as the piston  72  moves inside the bore  64 . The sliding indicator  67  can be connected to the piston  72  by the guide pins  73  as shown in  FIG. 14A . The guide pin  73  is fitted through holes in the sliding indicator  67 . The guide pin  73  extends from one side of the sliding indicator  67  through the slot openings  66  and the piston  72  and out to the other side of the sliding indicator  67 , thus, connecting the sliding indicator  67  to the piston  72  residing within the bore  64 . As the piston moves up and down within the bore  64 , the sliding indicator  67  follows along from the outside of the depth gage  60 . The sliding indicator  67  can be provided with at least one marker  67 B for indicating a reading along the graduated rule  65 . In the particular embodiment shown in  FIG. 14A , the sliding indicator  67  is provided with a window  67 A and a pair of markers  67 B are provided to indicate the measurement on the graduated rule  65  shown through the window  67 A. 
         [0066]    The bore  64  can be defined into two portions, a front portion  64 A and a back portion  64 B. The front portion  64 A is where an elongated member, such as a K-wire, is received for measurement and the inside diameter of the front portion  64 A is appropriately matched to the diameter of the intended elongated member. The back portion  64 B is where the elastically compressible member  70  and the piston  72  reside. Thus, the inside diameter of the back portion  64 B is appropriately matched to the diameter of the elastically compressible member  70  and the piston  72 . Where the diameter of the elastically compressible member  70  and the piston  72  are larger than the diameter of the front portion  64 A, the inside diameter of the back portion  64 B will be larger and there will be a transition portion  64 C where the diameters change. (See  FIG. 14D ). The transition portion  64 C can act as a stop for the piston  72  defining its resting position. 
         [0067]    As discussed above during the description of the surgical procedures, after a K-wire is drilled into a bone to a certain depth using the drill guide, the depth gage  60  can be used to measure the length of the K-wire that is inside the bone. This measurement is necessary to determine the proper length of a bone screw that will be used after the K-wire is removed and a hole is drilled into the bone. 
         [0068]    As shown in  FIG. 14F , to measure the depth of the K-wire  400  inside the bone pieces  501  and  502 , the open end of the depth gage  60  at the second end  63  is slid over the portion of the K-wire that is remaining outside the bone until the leading tip of the depth gage  60  contacts the bone. The K-wire  400  extends into the bore  64  contacts the piston  72  and pushes the piston  72  back until the depth gage  60  contacts the bone surface and cannot be advanced further. The elastically compressible member  70 , which can be a coil spring or some other suitable component, urges the piston  72  against the K-wire and helps the piston  72  constantly maintain the contact with the K-wire  400 . This feature allows the depth gage  60  to be used accurately and easily in any orientation. 
         [0069]    Because the overall length of the K-wire  400  is known and the distance from the leading tip of the depth gage  60  to the resting position of the piston  72  is also known, the graduated rule  65  can be calibrated to provide the length of the portion of the K-wire that is drilled into the bone. Alternatively, the graduated rule  65  can be calibrated to provide the length of the K-wire that is remaining outside the bone in which case the surgeon can subtract that figure from the known total length of the K-wire to determine the length of the K-wire that is drilled into the bone. 
         [0070]      FIG. 14G  shows a depth gage  160  according to another embodiment. The depth gage  160  functions the same way as the depth gage  60  shown in  FIG. 14A . The depth gage body  61  is provided with a longitudinally extending bore  64 . To measure the depth of a K-wire, the front end  63  of the depth gage is slipped over the K-wire portion that remains outside a bone. Inside the depth gage  60  is provided with the piston  72  and the elastically compressible member  70 . The piston&#39;s sliding movement within the depth gage  160  is guided by the slot opening  66 . The slot opening is oriented in longitudinal direction and a graduated rule  65  is provided along the slot opening  66 . But unlike in the depth gage  60 , in this embodiment, the slot opening  66  and the graduated rule  65  are on the same side of the body  61 . The sliding indicator  67  connected to the piston  72  via the guide pin  73  (not visible in  FIG. 14G ) moves along the graduated rule following the piston&#39;s movement and thus indicating a measurement that correlates with the length of the K-wire drilled into the bone pieces. 
         [0071]      FIG. 15  shows a blunt trocar  80  for use with the drill guide assembly. The blunt trocar  80  can be used in conjunction with the drill-guiding sleeve  20  to verify the entry point for the drill. The trocar  80  comprises a blunt tip  82  and a plurality of grooves  83  can be provided on the body of the trocar to enhance gripping by the user. After the drill guide assembly is secured into a desired position around a repair site, the blunt trocar  80  can be inserted into the drill-guiding sleeve  20  and advanced until the blunt tip  82  contacts the surface to be drilled. The point of contact represents the drill entry point. Then, X-ray can be used to verify that the location of the drill entry point is correct. Alternatively, the blunt trocar  80  can have a diameter that is same as the outer diameter of the sleeve  20  in which case, the blunt trocar  80  can fit directly into the guide housing  116  and can be used without the drill-guiding sleeve  20 . 
         [0072]      FIGS. 16-20  show a drill guide assembly  200  according to another embodiment. In this embodiment, the one or more spikes  118  are provided on a base member  220 , the base member  220  configured and adapted to rotatably engage the guide housing  116 .  FIG. 17  shows the detailed structure of the spike base member  220 . The base member  220  circumscribes the end of the guide housing  116  that is closer to the first arm member  106  and is rotatable about the longitudinal axis of the guide housing  116 . The base member  220  is rotated to adjust the location of the one or more spikes  118 . The base member  220  is provided with a hole  223  that aligns with the sleeve-receiving hole  117  of the guide housing  116 . The base member  220  is also provided with means for securing the base member onto the guide housing  116 . For example, in the embodiment shown in  FIG. 17 , one or more set screws  222  are tapped into the side of the base member  220  to hold the base member  220  in place. The guide housing  116  is provided with a groove or indentations to cooperate with the set screws  222 . The base member  220  can be locked in place by tightening the set screws  222 . Optionally, by adjusting the set screws  222 , the base member  220  can be allowed to freely rotate without disengaging from the guide housing  116 . In another example, spring-loaded detents and pins can be provided in place of the set screws  222 . The spring-loaded detents and pins would also allow the base member  220  to freely rotate without disengaging from the guide housing  116 . As shown in  FIG. 19 , the outer surface of the base member  220  can be provided with a plurality of tabs  224  to help with turning the base member  220 .  FIG. 20  shows the same ratcheting mechanism structure shown in  FIG. 13  and described in conjunction with the drill guide assembly  100 . 
         [0073]      FIGS. 21-25  show an example of a clamp  300  that can be used to assist in the bone reduction using the drill guide assemblies of the present disclosure. The clamp  300  is generally constructed like a pair of pliers and comprises handles  302  connected by a hinge  303 . The operable ends  305  of the clamp  300  are configured to engage the drill guide assemblies  100 ,  200  to assist compressing the first and second arm members  106  and  110  together for bone reduction. 
         [0074]    Referring to  FIGS. 3, 12 and 18 , the drill guide assemblies  100  and  200  are provided with clamp engaging holes  141 ,  142 . The first hole  141  is provided near the first end  103 A of the elongated body  102 . The second hole  142  is provided on the base  112  of the second arm member  110 . Each of the two operable ends  305  of the clamp  300  are provided with a pin  312 . The pins  312  are inserted into the holes  141  and  142  of the drill guide assembly as shown in  FIG. 25 . Closing the handles  302  will compress the second arm member  110  towards the first arm member  106 . 
         [0075]    In one preferred embodiment, the operable ends  305  are configured to have an articulated end  310  that pivots about the hinge  320 . The detailed cross-sectional views of the articulated ends  310  in  FIGS. 23 and 24  show that a spring loaded ball  340  can be provided between the articulated ends  310  and the operable ends  305  to register the articulated ends  310  into certain predefined positions. This can be helpful in inserting the pins  312  into the receiving holes  141 ,  142  by keeping the articulated joint somewhat rigid. A coil spring  330  and the ball  340  can be provided within a chamber  314  inside the articulated end  310 . The operable ends  305  can be provided with terminal ends  306  that engage the ball  340  to register the position of the articulated ends  310 . The terminal ends  306  can be configured with one or more indents to register ball  340  as the articulated ends  310  are pivoted. 
         [0076]    Referring to  FIG. 12 , each of the clamp engaging holes  141  and  142  can be provided with a locking ring  145  that will cooperate with grooves  312   a  (see  FIGS. 23 and 24 ) on the pins  312  to lock the clamp  300  into the holes  141  and  142  to prevent the clamp  300  from disengaging from the drill guide assembly unintentionally. 
         [0077]    Referring to  FIG. 28 , in another embodiment, the drill guide assembly  100  can be provided as part of a surgical drill guide kit  800  containing all necessary accessories and parts. One embodiment of a surgical drill guide kit comprises the drill guide assembly  100 , one or more sleeves  20  (some of which can comprise K-wire guiding sleeves for receiving various sizes of K-wires and drill-guiding sleeves for receiving various sizes of drill bits), one or more K-wires  400  of varying sizes, one or more bone screws  600  of varying sizes, a depth gage  60 , a blunt trocar  80 , and a clamp  300 . The surgical drill guide kit  800  can also include other implants such as one or more bone plates  700  of appropriate sizes and configurations. The components of the kit  800  are preferably arranged in a convenient format, such as a surgical tray or a case. However, the kit components do not have to be packaged or delivered together, provided that they are assembled or collected together in the operating room for use at the time of surgery. 
         [0078]    According to another aspect of the present disclosure, an example of a surgical procedure for using the disclosed drill guide assembly will be described. An example of such surgical procedure is aligning and drilling a hole for a bone screw to repair fractured bones or secure two adjacent bones to repair damaged soft tissues (e.g. ligaments) in the mid-foot region, such as a Lisfranc foot injury. 
         [0079]    An embodiment of the procedure for repairing a Lisfranc foot injury will be described referring to  FIG. 26  and  FIGS. 27A-27F .  FIG. 26  shows a flowchart  500  of the method described herein. [Exposure/Joint Preparation]—Depending on the degree of injury and instability, one or two dorsal longitudinal incisions are made to gain access to the injury site (see  FIG. 27A  and block  501  of  FIG. 26 ). The first incision is made between the first and second metatarsal bases ( FIG. 27A ) and the second incision is made parallel to the first between the third and fourth metatarsal bases. Care should be taken to protect the sensory branches of the superficial peroneal nerve. Typically a small avulsion fracture can be seen at the medial base of the second metatarsal where the Lisfranc ligament attaches. Any small free pieces of cartilage should be removed and joint surfaces debrided if arthrodesis is desired. 
         [0080]    [Reduction]—The drill guide assembly  100  is used to maintain the reduction between the second metatarsal and the medial cuneiform. The first and second arm members  106 ,  110  of the drill guide assembly are placed around the second metatarsal and the medial cuneiform. Specifically, the hook-shaped tip portion  108  of the first arm member  106  is placed between the second and third metatarsal base. The targeting area (drilling point) placement on the medial cuneiform is determined using the spike  118  component of the second arm member  110  before fully reducing the Lisfranc joint. The targeting of the drilling point is done by moving the second arm member  110  towards the first arm member  116  until the spike  118  is placed on the medial side of the medial cuneiform in the general location where the bone is to be drilled (see  FIG. 27B  and block  502  of  FIG. 26 ). Next, the placement of the drill guide assembly  100  can be optionally verified by using the blunt trocar  80  and an external imaging as described above and adjusted if necessary (see block  503  of  FIG. 26 ). Once the placement of the drill guide assembly  100  is finalized, the drill guide assembly  100  is used to reduce the Lisfranc joint by closing the two arm members  106 ,  110  together (see block  504  of  FIG. 26 ). Generally, this compression can be done by hand and the ratcheting mechanism of the second arm member  110  aids in achieving the desired reduction of the bones. If necessary, however, additional compression force may be gained by the use of the clamp  300 . 
         [0081]    [K-wire placement]—Next, a K-wire guiding sleeve  20  is inserted into the guide housing  116  and a 1.6 mm K-wire is inserted into the sleeve&#39;s bore  23  and drilled through the medial cuneiform and the second metatarsal until an external imaging shows the K-wire touching the tip  108  of the first arm member  106  on the lateral side of the second metatarsal (see  FIG. 27C  and block  505  of  FIG. 26 ). Preferably, the position of the K-wire is verified by an external imaging in AP and lateral views (see block  506  of  FIG. 26 ). 
         [0082]    [Screw length determination]—Next, with the K-wire in place, the K-wire guiding sleeve  20  is removed and a depth gage  60  is inserted through the guide housing  116  and over the K-wire to measure the depth of the K-wire inside the bone (see  FIG. 27D  and block  507  of  FIG. 26 ). The measured depth of the K-wire is the length of the bone screw to be used. 
         [0083]    [Hole preparation]—A drill-guiding sleeve  20  is then placed in the guide housing  116  and a cannulated drill is used to pre-drill over the K-wire for screw placement (see  FIG. 27E  and block  508  of  FIG. 26 ). As discussed before, the K-wire sleeve and the drill sleeve are essentially the same except that the drill sleeve has a larger diameter bore  23 . The drill should be of the appropriate diameter for the bone screw that will be used and the diameter of the bore  23  in the drill sleeve should be appropriate size for the drill to ensure proper centering of the drill. If a 3.7 mm screw is to be used, a 2.6 mm cannulated drill is used for the pre-drill. If a 4.5 mm screw is to be used, then a 3.2 mm cannulated drill is used. If arthrodesis or lagging of the screw is desired, the appropriate overdrill (3.7 mm or 4.5 mm) is required to the desired depth. If head countersinking is required, the head drill must be used after the depth gage measurement is made. With the drill bit in the bone, an external imaging can be used to verify that proper depth was drilled (see block  509  of  FIG. 26 ). 
         [0084]    [Screw placement]—Once the bone is drilled, the drill bit, the K-wire and the drill-guiding sleeve are removed. At this point, the drill guide assembly  100  is still keeping the bones in reduction and a bone screw of appropriate diameter is screwed or threaded into the bones through the hole  117  in the guide housing  116  until the bone screw is fully seated on the medial cuneiform (see  FIG. 27F  and block  510  of  FIG. 26 ). If the bone determined to be soft and additional stability is required for the head of the screw, a washer may be placed on the screw prior to insertion. The screw is inserted utilizing the 2.5 mm hex driver for the 3.7 mm screws and the 3.5 mm hex driver for the 4.5 mm screws. Once the bone screw is in place, the drill guide assembly  100  is removed by releasing the ratcheting mechanism (see block  511  of  FIG. 26 ). 
         [0085]    Although the drill guide assembly  100  of the present disclosure is configured and adapted to be well suited for the Lisfranc injury repair procedure described above, the drill guide assembly  100  can be used to reduce and install bone screws through fractured bone pieces generally. For example, the drill guide assembly  100  can be used in the repair of bone fractures in the ankle, wrist, etc. The dimensions of the various components of the drill guide assembly  100  can be appropriately varied to accommodate different sizes of the bones involved. 
         [0086]    Although the invention has been described in terms of exemplary embodiments, it is not limited thereto. Rather, the appended claims should be construed broadly, to include other variants and embodiments of the invention, which may be made by those skilled in the art without departing from the scope and range of equivalents of the invention. The scope of the invention disclosed herein is to be limited only by the following claims.

Technology Category: 1