Abstract:
A method of loading an implant inserter with an implant tab and an intramedullary orthopedic implant includes placing the intramedullary orthopedic implant engaged with the implant tab in an implant tab press tool. The implant tab press tool closes the implant tab, which is then moved to a locked position. The implant press tool opens, and the implant tab coupled with the intramedullary orthopedic implant is removed therefrom. The implant tab coupled with the intramedullary orthopedic implant and the implant inserter are placed in an inserter press tool. The inserter press tool closes the implant inserter, which is then moved to a locked position. The inserter press tool opens, and the implant inserter loaded with the implant tab and the intramedullary orthopedic implant coupled therewith is removed from the inserter press tool.

Description:
BACKGROUND OF THE INVENTION 
       [0001]    1. Field of the Invention 
         [0002]    The present invention relate generally to an intramedullary implant for use in one or more bones to provide internal fixation during surgery, instrumentation for using the intramedullary implant, packaging for the intramedullary implant and the instrumentation, and also a method of implanting the intramedullary implant. 
         [0003]    2. Description of the Related Art 
         [0004]    Corrective surgery involving bones can include the use of external fixation devices or internal fixation devices. Internal fixation devices can be located inside the bone or outside the bone. Implants located inside bones can be referred to as intramedullary implants. Intramedullary implants can be made of metal, shape memory materials, artificial bone, or bioresorbable materials. Intramedullary implants that use shape memory materials are typically composed of shape memory materials such as Nitinol. 
         [0005]    Intramedullary implants that are composed of Nitinol typically operate using a temperature dependent property of Nitinol called shape memory. Shape memory allows the intramedullary implants the ability to undergo deformation at one temperature and then recover their original, undeformed shape upon heating above their “transformation temperature”. In practice this is frequently accomplished by using preoperative freezing to deform the intramedullary implants from a first final shape into a second shape. After insertion the intramedullary implants recover their undeformed shape due to heating by the body above their transformation temperature. However, preoperative freezing can be a logistical challenge both to health care facilities as well as a surgeon, who has a limited amount of time to work with the implant before it warms to room temperature. 
         [0006]    Intramedullary implants can also be designed to utilize the superelastic properties of a material such as Nitinol. In this instance, the implant deforms during implantation, but uses superelastic behavior to flex and engage the bone. A difficulty in designing a superelastic intramedullary implant is allowing the surgeon access to both sides of the implant. While it is simple to insert one side of the implant into a first bone, it becomes difficult to insert the second side into a second bone. 
         [0007]    In designing a proper intramedullary implant that affixes one or more bones, it is also difficult to achieve proper position within the bones. In particular, when the intramedullary implant is inserted into one or more bones, one of the bones is typically less resistive to motion than the other bone due to different anatomy or bone quality. As such, when the bones are reduced or pressed together, the intramedullary implant tends to migrate in the direction of the bone that is less resistive, thereby resulting in an improper final placement of the intramedullary implant. Furthermore, once the implant is positioned inside the bone, and the bones are fully reduced so that they are touching, it is difficult to reposition the implant because there is no access to the intramedullary space. 
         [0008]    Accordingly, an intramedullary implant design that does not require preoperative freezing and maintains the intramedullary implant in the proper position within the bones would be beneficial. 
       SUMMARY OF THE INVENTION 
       [0009]    In accordance with the present invention, an intramedullary orthopedic implant includes at least a first body section having a first end and a second end. The first body section further includes first and second wings extending away from the first end of the first body section towards the second end of the first body section. The intramedullary orthopedic implant may include a second body section having a first end located at the second end of the first body section and a second end. The second body section includes first and second wings extending away from the first end of the second body section towards the second end. The intramedullary orthopedic implant further includes first and second legs located at the second end of either the first body section or the second body section. The first and second wings of the first body section may lie in a first plane and the first and second wings of the second body section may lie in a second plane. 
         [0010]    The first and second wings of the first body section begin in a first open insertion shape and during insertion into an intramedullary canal in a first bone flex towards the first body section to conform with the shape of the intramedullary canal. The first and second wings of the first body section accordingly move to a second implanted shape that creates an anchoring force between the first and second wings and the first bone, thereby anchoring the first and second wings within the intramedullary canal in the first bone. Likewise, the first and second wings of the second body section begin in a first open insertion shape and during insertion into the intramedullary canal in a first bone flex towards the second body section to conform with the shape of the intramedullary canal. The first and second wings of the second body section accordingly move to a second implanted shape that creates an anchoring force between the first and second wings and the first bone, thereby anchoring the first and second wings within the intramedullary canal in the first bone. 
         [0011]    The first and second legs begin in a first implanted shape, are movable to a second insertion shape, and remain in the second insertion shape as long as the first and second legs are mechanically constrained. The first and second legs each include a bend with a transition section extending from the second end of either the first body section or the second body section, a bow adjacent the bend, and a tip adjacent the bow, wherein mechanically constraining the first and second legs results in the transition sections moving in are toward one another until the tips are adjacent. After insertion of the first and second legs into an intramedullary canal in a second bone and the removal of the mechanical constraint, the first and second legs move from the second insertion shape to the first implanted shape. The movement of the first and second legs from the second insertion shape to the first implanted shape creates an anchoring force between the first and second legs and the second bone, thereby anchoring the first and second legs within the intramedullary canal in the second bone. 
         [0012]    When implanting the intramedullary orthopedic implant, the first body section inserts head first into the intramedullary canal in the first bone until the first body section, the second body section, and the transition sections reside within the intramedullary canal in the first bone. After insertion of the first and second legs into the intramedullary canal in the second bone and the removal of the mechanical constraint, the transition sections move in are away from one another such that the first and second legs return to their first implanted shape. The return of the first and second legs to their first implanted shape creates an anchoring force between the first and second legs and the second bone, thereby anchoring the first and second legs within the intramedullary canal in the second bone. The anchoring forces of the first and second wings of the first and second body sections oppose the anchoring force of the first and second legs, thereby compressing the first bone with the second bone. 
         [0013]    The intramedullary orthopedic implant may be implanted using an implant tab and an implant inserter. The implant tab engages and constrains the first and second legs in the second insertion shape. The implant inserter engages the first and second legs in the second insertion shape and is used to insert the first and second body sections into the intramedullary canal in the first bone. After insertion of the first and second body sections into the intramedullary canal in the first bone and the disengagement of the implant inserter from the first and second legs, the implant tab is grasped to maintain the first and second body sections in the intramedullary canal in the first bone and further to allow the insertion of the first and second legs in the second insertion shape into the intramedullary canal in the second bone. The disengagement of the implant tab from the first and second legs releases the first and second legs to move from the second insertion shape to the first implanted shape. The movement of the first and second legs to move from the second insertion shape to the first implanted shape creates an anchoring force between the first and second legs and the second bone, thereby anchoring the first and second legs within the intramedullary canal in the second bone. 
         [0014]    The implant inserter and implant tab loaded with the intramedullary orthopedic implant may be sterilely packaged. An intramedullary implant package receives therein the implant inserter and implant tab loaded with the intramedullary orthopedic implant. After packaging of the implant inserter and implant tab loaded with the intramedullary orthopedic implant, the implant package is sealed and the implant inserter and implant tab loaded with the intramedullary orthopedic implant sterilized. The implant package maintains the implant inserter and implant tab loaded with the intramedullary orthopedic implant sterile after sterilization. 
         [0015]    The intramedullary orthopedic implant may be utilized to fixate a first bone and a second bone. Intramedullary canals are prepared in the first bone and the second bone. The first body section inserts into the intramedullary canal in the first bone, resulting in the wings flexing towards the first body section to conform with the shape of the intramedullary canal in the first bone. The flexing of the wings of the first body section creates an anchoring force between the wings and the first bone, thereby anchoring the wings within the intramedullary canal in the first bone. The first and second legs insert into the intramedullary canal in the second bone. The mechanical constraint is removed such that the first and second legs move from the second insertion shape to the first implanted shape. The movement of the first and second legs from the second insertion shape to the first implanted shape creates an anchoring force between the first and second legs and the second bone, thereby anchoring the first and second legs within the intramedullary canal in the second bone such that the first bone compresses with the second bone. 
         [0016]    The implant inserter and implant tab loaded with the intramedullary orthopedic implant are used as follows to fixate a first bone and a second bone. Intramedullary canals are prepared in the first bone and the second bone. The implant inserter is used to insert the first body section into the intramedullary canal in the first bone such that the wings flex towards the body section to conform with the shape of the intramedullary canal in the first bone. The flexing of the wings of the first body section creates an anchoring force between the wings and the first bone, thereby anchoring the wings within the intramedullary canal in the first bone. The implant inserter is disengaged from the first and second legs, and the implant tab grasped to maintain the body section in the intramedullary canal in the first bone. The first and second legs are inserted into the intramedullary canal in the second bone. The implant tab is disengaged from the first and second legs such that the first and second legs move from the second insertion shape to the first implanted shape. The movement of the first and second legs from the second insertion shape to the first implanted shape creates an anchoring force between the first and second legs and the second bone, thereby anchoring the first and second legs within the intramedullary canal in the second such that the first bone compresses with the second bone. 
         [0017]    The implant inserter may be loaded with the implant tab and the intramedullary orthopedic implant using a method incorporating mechanical assistance. The implant tab includes first and second tab legs and is movable between an unlocked and a locked position. In moving between the unlocked and the locked position, the first and second tab legs transition between a normally open and a closed position. The implant inserter includes first and second inserter arms that transition between a normally splayed position and an implant engagement position. Furthermore, the implant inserter is movable between an open and a locked position. 
         [0018]    The first and second legs of the intramedullary orthopedic implant in their first implanted shape engage the implant tab in its unlocked position. After the intramedullary orthopedic implant engages the implant tab, the intramedullary orthopedic implant and the implant tab are placed in an implant tab press tool. The implant tab press tool is activated to close the implant tab such that the implant tab is moved to its locked position and the first and second tab legs transition to their closed position. Furthermore, moving the implant tab to its locked position couples the intramedullary orthopedic implant with the implant tab such that the first and second legs of the intramedullary orthopedic implant are constrained in their second insertion shape. Once the intramedullary orthopedic implant couples with the implant tab, the implant press tool is deactivated and the implant tab loaded with the intramedullary orthopedic implant is removed from the implant tab press tool. 
         [0019]    The implant tab coupled with the intramedullary orthopedic implant is placed in an inserter press tool. The implant inserter having its first and second inserter arms in their normally splayed position is placed in the inserter press tool such that its first and second inserter arms surround a portion of the implant tab and the intramedullary orthopedic implant. The inserter press tool is activated to move the first and second inserter arms to their implant engagement position. In the implant engagement position implant engagement position, a portion of the first and second inserter arms grasps the implant tab and the first and second legs of the intramedullary orthopedic implant. The implant inserter is then moved to its locked position, wherein the implant inserter is loaded with the implant tab and the intramedullary orthopedic implant coupled therewith. The inserter press tool is deactivated and the implant inserter loaded with the implant tab and the intramedullary orthopedic implant coupled therewith is removed from the inserter press tool. 
     
    
     
       BRIEF DESCRIPTION OF DRAWINGS 
         [0020]      FIG. 1  is a perspective view illustrating an implant including wings in a first open insertion shape and legs in a first implanted shape. 
           [0021]      FIG. 2  is a top view illustrating the implant including the wings in the first open insertion shape and the legs in the first implanted shape. 
           [0022]      FIG. 3  is a side view illustrating the implant including the wings in the first open insertion shape and the legs in the first implanted shape. 
           [0023]      FIG. 4  is a front view illustrating the implant including the wings in the first open insertion shape. 
           [0024]      FIG. 5  is a rear view illustrating the implant including the wings in the first open insertion shape and the legs in the first implanted shape. 
           [0025]      FIG. 6  is a perspective view illustrating the implant including the wings in the first open insertion shape and the legs in an insertion shape. 
           [0026]      FIG. 7  is a top view illustrating the implant including the wings in the first open insertion shape and the legs in the insertion shape. 
           [0027]      FIG. 8  is a side view illustrating the implant including the wings in the first open insertion shape and the legs in the insertion shape. 
           [0028]      FIG. 9  is a perspective view illustrating an implant insertion device including an implant tab, an inserter tab, and an implant inserter in an engaged position. 
           [0029]      FIG. 10  is a perspective view illustrating the implant tab. 
           [0030]      FIG. 11  is a perspective illustrating the implant tab engaging the implant. 
           [0031]      FIG. 12  is a bottom view illustrating the implant tab engaging the implant. 
           [0032]      FIG. 13  is a perspective view illustrating the inserter tab. 
           [0033]      FIG. 14  is a rear perspective view illustrating the implant inserter in a disengaged position. 
           [0034]      FIG. 15  is a front perspective view illustrating the implant inserter in a disengaged position. 
           [0035]      FIG. 16  is a bottom view illustrating the implant insertion device loaded with the implant. 
           [0036]      FIG. 17  is a perspective view illustrating the implant insertion device loaded with the implant. 
           [0037]      FIG. 18  is a perspective view illustrating insertion of the implant into an intramedullary canal of a first bone. 
           [0038]      FIG. 19  is a side view illustrating insertion of the implant into the intramedullary canal of the first bone. 
           [0039]      FIG. 20  is a top view illustrating insertion of the implant into the intramedullary canal of the first bone. 
           [0040]      FIG. 21  is a perspective view illustrating the implant inserted into the intramedullary canal of the first bone. 
           [0041]      FIG. 22  is a perspective view illustrating removal of the implant inserter from the implant after insertion of the implant into the intramedullary canal of the first bone. 
           [0042]      FIG. 23  is a perspective view illustrating the implant inserted into an intramedullary canal of a second bone. 
           [0043]      FIG. 24  is a perspective view illustrating disengagement of the implant tab from the implant and insertion of the implant into the intramedullary canal of the second bone. 
           [0044]      FIG. 25  is a perspective view illustrating the implant inserted into the intramedullary canals of the first and second bones with the wings of the implant in their implanted shape and the legs of the implant in their insertion shape. 
           [0045]      FIG. 26  is a perspective view illustrating the implant inserted into the intramedullary canals of the first and second bones with the wings of the implant in their implanted shape and the legs of the implant in their first implanted shape. 
           [0046]      FIG. 27  is a side view illustrating the implant inserted into the intramedullary canals of the first and second bones with the wings of the implant in their implanted shape and the legs of the implant in their first implanted shape. 
           [0047]      FIG. 28  is a top view illustrating the implant inserted into the intramedullary canals of the first and second bones with the wings of the implant in their implanted shape and the legs of the implant in their first implanted shape. 
           [0048]      FIG. 29  is a perspective view illustrating a drill bit. 
           [0049]      FIG. 30  is a perspective view illustrating a drill bit stop. 
           [0050]      FIG. 31  is a side view illustrating the drill bit engaged with the drill bit stop. 
           [0051]      FIG. 32  is a perspective view illustrating a sizing tool used to select a proper implant. 
           [0052]      FIG. 33  is a perspective view illustrating a bone broach used to create a cavity in bone for an implant. 
           [0053]      FIG. 34  is a perspective view illustrating an implant inserter according to a second embodiment of an implant insertion device with a slider in its implant engagement position. 
           [0054]      FIG. 35  is a perspective view illustrating the second embodiment of the implant inserter with the slider in its implant disengagement position. 
           [0055]      FIG. 36  is a perspective view illustrating the second embodiment of the implant inserter with the slider in its implant disengagement position and arms of the implant inserter in their implant disengagement position. 
           [0056]      FIG. 37  is a front view illustrating the second embodiment of the implant inserter with the slider in its implant engagement position. 
           [0057]      FIG. 38  is a front view illustrating the second embodiment of the implant inserter with the slider in its implant disengagement position and the arms of the implant inserter in their splayed position. 
           [0058]      FIG. 39  is a perspective view illustrating an implant tab back piece with tab legs in their splayed position. 
           [0059]      FIG. 40  is a front perspective view illustrating an implant tab front piece. 
           [0060]      FIG. 41  is a rear perspective view illustrating the implant tab front piece. 
           [0061]      FIG. 42  is a perspective view illustrating an implant tab with tab legs in their implant engagement position. 
           [0062]      FIG. 43  is a perspective view illustrating the implant tab with the tab legs engaging the legs of an implant. 
           [0063]      FIG. 44  is a bottom view illustrating the implant tab with tab legs engaging the legs of the implant. 
           [0064]      FIG. 45  is a perspective view illustrating the implant being held by the implant tab and further being constrained by the second embodiment of the implant inserter with its slider in its implant engagement position. 
           [0065]      FIG. 46  is a perspective view illustrating the drill bit engaged with the drill bit stop and being used to drill a hole in a first bone. 
           [0066]      FIG. 47  is a side view illustrating the drill bit engaged with the drill bit stop and being used to drill a hole in a first bone. 
           [0067]      FIG. 48  is a perspective view illustrating the drill bit engaged with the drill bit stop being used to drill a hole in a second bone. 
           [0068]      FIG. 49  is a side view illustrating the drill bit engaged with the drill bit stop and being used to drill a hole in a second bone. 
           [0069]      FIG. 50  is a perspective view illustrating the sizing tool being used to measure the depth of the hole in the first bone. 
           [0070]      FIG. 51  is a perspective view illustrating the sizing tool being used to measure the depth of the hole in the second bone. 
           [0071]      FIG. 52  is a perspective view illustrating the bone broach being used to create a cavity in the first bone. 
           [0072]      FIG. 53  is a perspective view illustrating the bone broach being used to create a cavity in the second bone. 
           [0073]      FIG. 54  is a perspective view illustrating the implant inserter and the implant tab being used to insert an implant into a first bone. 
           [0074]      FIG. 55  is a side view illustrating the implant inserter and the implant tab being used to insert the implant into the first bone. 
           [0075]      FIG. 56  is a perspective view illustrating the implant inserter and the implant tab after the implant has been inserted into the first bone. 
           [0076]      FIG. 57  is a side view illustrating the implant inserter and the implant tab after the implant has been inserted into the first bone. 
           [0077]      FIG. 58  is a perspective view illustrating the implant inserter being removed from the implant tab after the implant has been inserted into the first bone. 
           [0078]      FIG. 59  is a side view illustrating the implant inserter being removed from the implant tab after the implant has been inserted into the first bone. 
           [0079]      FIG. 60  is a perspective view illustrating the implant inserted into the first bone and a second bone with the implant tab still constraining the legs of the implant. 
           [0080]      FIG. 61  is a side view illustrating the implant inserted into the first bone and a second bone with the implant tab still constraining the legs of the implant. 
           [0081]      FIG. 62  is a perspective view illustrating the disengagement of the implant tab from the implant once the implant is inserted into the first bone and the second bone. 
           [0082]      FIG. 63  is a side view illustrating the disengagement of the implant tab from the implant once the implant is inserted into the first bone and the second bone. 
           [0083]      FIG. 64  is a perspective view illustrating an implant tray containing an implant inserter, an implant, and an implant tab. 
           [0084]      FIG. 65  is a perspective view illustrating an instrument tray containing a drill bit, a drill bit stop, two bone broaches, and a sizing tool. 
           [0085]      FIG. 66  is a top view illustrating an implant tray containing an implant inserter, an implant, and an implant tab. 
           [0086]      FIG. 67  is a top view illustrating an instrument tray containing a drill bit, a drill bit stop, two bone broaches, and a sizing tool. 
           [0087]      FIG. 68  is a perspective view illustrating an implant tab press tool. 
           [0088]      FIG. 69  is a perspective view illustrating the implant tab with tab legs normally splayed apart and the implant in its first implanted shape. 
           [0089]      FIG. 70  is a perspective view illustrating the implant engaged by the implant tab. 
           [0090]      FIG. 71  is a front view illustrating the implant engaged by the implant tab. 
           [0091]      FIG. 72  is a perspective view illustrating the implant tab and the implant inserted within a loading surface of the implant tab press tool. 
           [0092]      FIG. 73  is a top view illustrating the implant tab and the implant inserted within a loading surface of the implant tab press tool. 
           [0093]      FIG. 74  is a perspective view illustrating a vice of the implant press tool engaging the implant tab. 
           [0094]      FIG. 75  is a top view illustrating the vice of the implant press tool engaging the implant tab. 
           [0095]      FIGS. 76 and 77  are cross sectional front views illustrating the vice of the implant press tool engaging the implant tab. 
           [0096]      FIG. 78  is a perspective view illustrating an inserter press tool. 
           [0097]      FIG. 79  is a perspective view illustrating the implant tab and the implant inserted within a loading surface of the inserter press tool. 
           [0098]      FIG. 80  is a perspective view illustrating an implant inserter inserted within a loading surface of the inserter press tool. 
           [0099]      FIG. 81  is a top view illustrating the implant inserter inserted within a loading surface of the inserter press tool. 
           [0100]      FIG. 82  is a perspective view illustrating a vice of the inserter press tool engaging the implant inserter. 
           [0101]      FIG. 83  is a top view illustrating the vice of the inserter press tool engaging the implant inserter. 
           [0102]      FIGS. 84 and 85  are cross sectional top views illustrating the vice of the inserter press tool engaging the inserter. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0103]    As required, detailed embodiments of the present invention are disclosed herein; however, it is to be understood that the disclosed embodiments are merely exemplary of the invention, which may be embodied in various forms. Figures are not necessarily to scale, and some features may be exaggerated to show details of particular components or steps. 
         [0104]      FIGS. 1-28  illustrate the preferred embodiment of an implant  10  and an implant insertion device  40 . The implant  10  includes wings  110 ,  111 ,  120 , and  121  and legs  130  and  131 . The implant insertion device  40  engages the implant  10  to allow a surgeon to insert the implant  10  into tissue or bone during surgery. After insertion, the wings  110 ,  111 ,  120 , and  121  and legs  130  and  131  allow the implant  10  to fixate the tissue or bone. 
         [0105]    The implant  10  is composed of a shape memory material such as Nitinol that allows the wings  110 ,  111 ,  120 , and  121  of the implant  10  to move between a first open insertion shape and an implanted shape. Likewise, a shape memory material such as Nitinol allows the legs  130  and  131  of the implant  10  to move between a first implanted shape and an insertion shape. 
         [0106]    Shape memory materials such as Nitinol include temperature dependent properties and temperature independent properties. Shape memory is a temperature dependent property that allows the shape memory material the ability to undergo deformation at one temperature and then recover its original, undeformed shape upon heating above its “transformation temperature”. Superelasticity is a temperature independent property that allows the shape memory material the ability to undergo a mechanical deformation due to an external force applied to the shape memory material, and then recover its original undeformed shape upon release of the external force. 
         [0107]    The implant  10  may incorporate either temperature dependent shape memory properties or temperature independent superelastic properties. However, the implant  10  according to the preferred embodiment is superelastic in that the implant  10  stores mechanical energy and is subject to elastic (recoverable) deformation when the stored mechanical energy is released. For example, the application of an external force to the implant  10  through insertion of the implant  10  into an intramedullary canal of a bone results in the mechanical deformation of the wings  110 ,  111 ,  120 , and  121  from their first open insertion shape to their implanted shape. Furthermore, the application of an external force to the implant  10  through the loading of the implant insertion device  40  with the implant  10  results in the mechanical deformation of the legs  130  and  131  from their first implanted shape to their insertion shape. 
         [0108]    The ability of the wings  110 ,  111 ,  120 , and  121  of the implant  10  to mechanically deform from their first open insertion shape to their implanted shape aids insertion into an intramedullary canal of a first bone. Likewise, the loading of the implant insertion device  40  with the implant  10  resulting in the mechanical deformation of the legs  130  and  131  from their first implanted shape to their insertion shape aids insertion into an intramedullary canal of a second bone. 
         [0109]    After insertion, the wings  110 ,  111 ,  120 , and  121  of the implant  10  in their implanted shape engage the intramedullary canal of the first bone due to the mechanical energy stored therein as a result of their elastic deformation. Furthermore, upon release from the implant insertion device  40 , the legs  130  and  131  of the implant  10  release their stored mechanical energy by elastically deforming to their first implanted shape. The stored mechanical energy of the wings  110 ,  111 ,  120 , and  121  and the released mechanical energy of the legs  130  and  131  secures the implant  10  in the tissue or bone and maintains the tissue or bone fixated together. In maintaining the tissue or bones fixated together, the implant  10  may aid in the healing process in that the implant  10  continuously applies force to the fixated tissue or bone as the wings  110 ,  111 ,  120 , and  121  transition from their first open insertion shape to their implanted shape and the legs  130  and  131  transition from their insertion shape to their first implanted shape. 
         [0110]    In the preferred embodiment of the implant  10 , the implant  10  incorporates temperature independent superelastic properties to load the implant insertion device  40  with the implant  10  and to fixate tissue or bone. However, those of ordinary skill in the art will recognize that the implant  10  can incorporate the temperature dependent properties of shape memory as well, without losing any of the implant design advantages. In such an embodiment, the wings  110 ,  111 ,  120 , and  121  during insertion of the implant  10  will again mechanically deform from their first open insertion shape into their implanted shape upon insertion into an intramedullary canal of a first bone. Likewise, the legs  130  and  131  of the implant  10  can again be mechanically constrained from their first implanted shape into their insertion shape. Upon warming to body temperature, the shape memory property will cause the wings  110 ,  111 ,  120 , and  121 , and legs  130  and  131  to transform to their expanded shape such that they engage bone. In both a superelastic and shape memory embodiment, the implant does not require pre-operative freezing and the end result of the implant fixating the two bones is the same. 
         [0111]      FIGS. 1-8  illustrate the implant  10 . In the preferred embodiment, the implant  10  is an intramedullary implant and includes a body section comprised of a first body section  150  and a second body section  151 , legs  130  and  131 , and a longitudinal axis  155  that bisects the first body section  150 , the second body section  151 , and the legs  130  and  131 . The design of the implant  10  including the first body section  150 , the second body section  151 , and the legs  130  and  131  allows the first and second body sections  150  and  151  and a portion of the legs  130  and  131  adjacent the second body section  151  to insert into an intramedullary canal of a first bone. In addition, the design of the implant  10  allows a distal portion of the legs  130  and  131  to insert into an intramedullary canal of a second bone, thereby fixating the first bone and second bone together. 
         [0112]    The first body section  150  includes a head  100 , wings  110  and  111 , a first end  165 , and a second end  166 . The head  100  extends from the first end  165  of the first body section  150  and includes barbs  101 . The head  100  inserts into the intramedullary canal of the first bone, and the barbs  101  anchor the head  100  into the intramedullary canal of the first bone. One of ordinary skill in the art will recognize that the head  100  may include any number of barbs  101  depending on application and the barbs  101  may alternate or protrude coplanar in their orientation. 
         [0113]    The wings  110  and  111  include tips  112  and extend outward and away from the first end  165  of the first body section  150  in a direction towards the second end  166  of the first body section  150 . The tips  112  are oriented in a direction substantially parallel with the longitudinal axis  155  and include engagement barbs  113 . The barbs  113  secure the wings  110  and  111  and therefore the first body section  150  to the intramedullary canal of the first bone. 
         [0114]    The second body section  151  includes wings  120  and  121 , a first end  170 , and a second end  171 . The wings  120  and  121  include tips  122  and extend outward and away from the first end  170  of the second body section  151  in a direction towards the second end  171  of the second body section  151 . The tips  122  are oriented in a direction substantially parallel with the longitudinal axis  155  and include engagement barbs  123 . The barbs  123  secure the wings  120  and  121  and therefore the second body section  151  to the intramedullary canal of the first bone. 
         [0115]    The design of the wings  110  and  111  and the wings  120  and  121  of the implant  10  allow easier insertion into the intramedullary canal of the first bone. In particular, the wings  110  and  111  and the wings  120  and  121  are shaped in that they are narrow at the point of insertion and expand outward and away from the point of insertion. In addition, the wings  110  and  111  and the wings  120  and  121  incorporate the superelastic properties of the implant  10  such that the wings  110 ,  111 ,  120 , and  121  prior to insertion begin in a first open insertion shape and then during insertion move to an implanted shape. The wings  110  and  111  flex towards the first body section  150  and the wings  120  and  121  flex towards the second body section  151  during insertion into the intramedullary canal of the first bone, thereby moving the wings  110 ,  111 ,  120 , and  121  from their first open insertion shape to their implanted shape and creating an anchoring force between the wings  110 ,  111 ,  120 , and  121  and the first bone. After insertion into the intramedullary canal of the first bone, the wings  110 ,  111 ,  120 , and  121  apply the anchoring force against the intramedullary canal such that the wings  110 ,  111 ,  120 , and  121  secure and anchor the implant  10  within the intramedullary canal of the first bone. 
         [0116]    One of ordinary skill in the art will recognize the wings  110  and  111  and the wings  120  and  121  may include any number of barbs  113  and  123  respectively depending on application. In addition, the barbs  113  and  123  of the wings  110  and  111  and the wings  120  and  121  respectively may protrude in a variation of angles and directions depending on application. Furthermore, while the preferred embodiment discloses a first body section  150  with wings  110  and  111  and a second body section  151  with wings  120  and  121 , one of ordinary skill in the art will recognize that the implant  10  may include only a single body section and wings. 
         [0117]    The leg  130  includes a proximal end  132 , a distal end  133 , a bend  140  including a transition section  137 , a bow  141 , and a tip  145  including barbs  161 . Likewise, the leg  131  includes a proximal end  134 , a distal end  135 , a bend  142  including a transition section  138 , a bow  143 , and a tip  146  including barbs  162 . The legs  130  and  131  incorporate the superelastic properties of the implant  10  in that the legs  130  and  131  move from a first implanted shape to an insertion shape when an external force is applied thereto. 
         [0118]    In moving to the insertion shape, the transition sections  137  and  138  travel angularly toward the longitudinal axis  155  such that the tips  145  and  146  abut, the bows  141  and  143  are adjacent, and the bends  140  and  142  converge to define an aperture  149  therebetween. The legs  130  and  131  return from their insertion shape to their first implanted shape when the external force is removed. In moving to the first implanted shape, the legs  130  and  131  assume a splayed shape due to the transition sections  137  and  138  traveling angularly away from the longitudinal axis  155  such that the tips  145  and  146  and the bows  141  and  143  separate and the bends  140  and  142  diverge to open the aperture  149 . 
         [0119]      FIGS. 1-5  illustrate the wings  110 ,  111 ,  120 , and  121  in their first open insertion shape and the legs  130  and  131  in their first implanted shape. When the legs  130  and  131  are in their first implanted shape, the barbs  161  and  162  of the tips  145  and  146  engage the intramedullary canal of the second bone to secure and anchor the implant  10  within the intramedullary canal of the second bone.  FIGS. 6-8  illustrate the wings  110 ,  111 ,  120 , and  121  in their first open insertion shape and the legs  130  and  131  in their insertion shape. The legs  130  and  131  are moved to their insertion shape by an external force and held in their insertion shape through contact with the implant insertion device  40  at the bends  140  and  141 . Movement of the legs  130  and  131  to their insertion shape facilitates insertion the implant  10  into the intramedullary canal of the second bone. 
         [0120]    In order to fixate a first bone to a second bone, the legs  130  and  131  are moved to their insertion shape, which, in the preferred embodiment, entails applying an external force that moves the legs  130  and  131  to their insertion shape. After the legs  130  and  131  move to their insertion shape, the implant  10  loads onto the implant insertion device  40 , and the legs  130  and  131  are held in their insertion shape through contact with the implant insertion device  40  at the bends  140  and  141 . Once the implant  10  loads onto the implant insertion device  40 , the implant  10  is ready for insertion into the intramedullary canal of the first bone. 
         [0121]    As previously described, the wings  110 ,  111 ,  120 ,  121 , and the legs  130  and  131  incorporate the superelastic or shape memory properties of the implant  10 , and thus can adapt to the intramedullary canal of the first and second bone. The design of the wings  110 ,  111 ,  120 , and  121  allows the wings  110 ,  111 ,  120 , and  121  to begin in a first open insertion shape and then move to an implanted shape that conforms to the shape of the intramedullary canal of the first bone when inserted. The wings  110 ,  111 ,  120 , and  121  during insertion accordingly conform and assume various constrained positions depending on the anatomy. Moreover, the positioning of the wings  110  and  111  and the wings  120  and  121  with distal ends trailing the direction of insertion facilitates insertion of the implant  10  into the intramedullary canal of the first bone. The wings  110  and  111  and the wings  120  and  121  upon insertion begin to flex due to the force imparted into the wings  110 ,  111 ,  120 , and  121  by the reduced diameter of the intramedullary canal of the first bone. The wings  110  and  111  and the wings  120  and  121  constrain and conform to the shape of the intramedullary canal of the first bone due to the superelastic or shape memory properties of the implant  10 . In addition, the barbs  113  and  123  secure and anchor the wings  110  and  111  and the wings  120  and  121 , respectively, to the intramedullary canal of the first bone. After insertion, the anchoring force imparted to the wings  110 ,  111 ,  120 , and  121  due to their the superelastic properties allows the implant  10  to engage and anchor the implant  10  within the intramedullary canal of the first bone and resist any motion outward from the first bone. 
         [0122]    In order to facilitate insertion into the second bone, the legs  130  and  131  are held in their insertion shape by the implant insertion device  40 . The legs  130  and  131  insert into the intramedullary canal of the second bone and the implant insertion device  40  is removed. After insertion of the legs  130  and  131  of the implant  10  into the intramedullary canal of the second bone and removal of the implant insertion device  40 , the superelastic properties of the implant  10  return the legs  130  and  131  to their first implanted shape such that an anchoring force created between the legs  130  and  131  and the second bone anchors the legs  130  and  131  within the intramedullary canal in the second bone. Upon returning to their first implanted shape, the barbs  161  and  162  of the tips  145  and  146  engage and anchor the legs  130  and  131  and therefore the implant  10  to the intramedullary canal of the second bone. The anchoring force created by legs  130  and  131  within the second bone is opposite of the anchoring force of the wings  110 ,  111 ,  120 , and  121  within the first bone. The opposing anchoring forces between the legs  130  and  131  and the wings  110 ,  111 ,  120 ,  121  creates compression at the second body section  151 . The operation of the wings  110  and  111 , the wings  120  and  121 , and the legs  130  and  131  in securing the implant  10  into the intramedullary canal of the first and second bone will be explained in greater detail herein. 
         [0123]    In the preferred embodiment, the implant  10  includes wings  110  and  111 , wings  120  and  121 , and legs  130  and  131 , nevertheless, one of ordinary skill in the art will recognize that any number of wings and legs may be used to accomplish a particular objective. In addition, in the preferred embodiment, the wings  110  and  111  are perpendicular in orientation to the wings  120  and  121  and the legs  130  and  131 , however, one of ordinary skill in the art will recognize that the wings  110  and  111 , the wings  120  and  121 , and legs  130  and  131  may be coplanar, perpendicular, or any relative angle with each other. 
         [0124]      FIG. 9  illustrates the implant insertion device  40 , which includes an implant inserter  45 , an inserter tab  50 , and an implant tab  60 . The implant insertion device  40  moves between a disengaged position and an engaged position that secures the implant  10  and maintains the implant  10  in the second shape. In addition, the implant insertion device  40  allows a surgeon to manipulate the implant  10  and insert the implant  10  into tissue or bones that require fixation. The implant insertion device  40  can be made of any suitable material; however, in the preferred embodiment the implant insertion device  40  is made from plastic. 
         [0125]    The implant tab  60  of the implant insertion device  40  engages the implant  10  to allow manipulation thereof. The implant tab  60  further functions as a stop to prevent over-insertion of the implant  10 . The inserter tab  50  of the implant insertion device  40  is designed for use during the movement of the implant insertion device  40  between its disengaged position and its engaged position. Both the implant tab  60  and the inserter tab  50  interface with the implant inserter  45  of the implant insertion device  40  to load and release the implant  10  from the implant inserter  45 . 
         [0126]      FIGS. 10-12  illustrate the implant tab  60 . The implant tab  60  includes a handle  600 , front  601 , back  602 , sides  603 , spacer  604 , and restraining members  605  and  606 . The handle  600  provides a gripping surface to allow a user to manipulate the implant tab  60  and the implant  10  once the implant tab  60  engages the implant  10 . The spacer  604  and the restraining members  605  and  606  work in concert to secure and maintain the legs  130  and  131  of the implant  10  in their insertion shape. 
         [0127]    In order for the implant tab  60  to engage the implant  10 , an external force applied to the implant  10  moves the legs  130  and  131  to their insertion shape. Specifically, in accordance with the preferred embodiment, the external force is applied to the legs  130  and  131  of the implant  10  to move the legs  130  and  131  from their first implanted shape to their insertion shape. More specifically, the applied external force moves the leg  130  at the transition section  137  and the leg  131  at the transition section  138  until the tip  145  of the leg  130  and the tip  146  of the leg  131  abut. The spacer  604  of the implant tab  60  inserts into the aperture  149  formed between the bends  140  and  142  of the legs  130  and  131 , and the restraining members  605  and  606  of the implant tab  60  clasp the bends  140  and  141  of the legs  130  and  131 , thereby maintaining the legs  130  and  131  in their insertion shape. In the preferred embodiment, the restraining members  605  and  606  of the implant tab  60  clasp the bends  140  and  141  of the legs  130  and  131  such that the transition sections  137  and  138  of the legs  130  and  131  remain exterior relative to the front  601  of the implant tab  60 . 
         [0128]      FIGS. 13-15  illustrate the inserter tab  50  and the implant inserter  45 . The inserter tab  50  includes a handle  501 , pins  502  and  503 , and a jaw interface  504 . The implant inserter  45  includes a body  400  and arms  401  and  402 . The body  400  of the implant inserter  45  includes a front  414 , a back  416 , and a handle  418 . The handle  418  provides a gripping surface on the front  414  and the back  416  of the body  400 . The gripping surface of the handle  418  allows a surgeon to manipulate the implant inserter  45  and therefore the implant  10 . The arms  401  and  402  are formed integral with the body  400  and include jaws  420  and  421 . The arms  401  and  402  move between a normally open position and a closed position. 
         [0129]    The jaw  420  includes a pinhole  422 , a key  423 , an implant tab interface  424 , an inserter tab interface  425 , and a key slot  430 . The jaw  421  includes a pinhole  426 , a key  427 , an implant tab interface  428 , an inserter tab interface  429 , and a key slot  431 . The jaws  420  and  421  move between an unlocked position and a locked position. The locked position allows the jaws  420  and  421  to secure to the implant  10 , the implant tab  60 , and the inserter tab  50  to facilitate the insertion of the implant  10  into tissue or bone. The unlocked position facilitates the removal of the implant  10  and the implant tab  60  from the jaw  420  and  421 . 
         [0130]    The key  423  of the jaw  420  engages the key slot  431  of the jaw  421  and the key  427  of the jaw  421  engages the key slot  430  of the jaw  420  when the jaws  420  and  421  move from their unlocked to their locked position. In addition, as illustrated in  FIG. 16 , the key  423  and the key slot  430  of the jaw  420  and the key  427  and the key slot  431  of the jaw  421  form an implant retention cavity  435  when the jaws  420  and  421  are in their locked position. Furthermore, the implant tab interface  424  of the jaw  420  and the implant tab interface  428  of the jaw  421  engage and secure the implant tab  60  to the implant inserter  45  when the jaws  420  and  421  move from their unlocked to their locked position. 
         [0131]    Once the jaws  420  and  421  reach their locked position, the implant retention cavity  435  secures the legs  130  and  131  of the implant  10  within the implant inserter  45 , and the implant tab interface  424  of the jaw  420  and the implant tab interface  428  of the jaw  421  engage and secure the implant tab  60  to the implant inserter  45 . In particular, after the implant  10  secures to the implant tab  60 , the implant tab  60  along with the secured implant  10  is ready to be loaded within the jaws  420  and  421  of the implant inserter  45 . The legs  130  and  131  of the implant  10  insert between the jaws  420  and  421  and align with the key  423  and the key slot  430  of the jaw  420  and the key  427  and the key slot  431  of the jaw  421 . As illustrated in  FIG. 16 , the jaws  420  and  421  are then moved to their locked position, thereby loading the implant  10  within the implant retention cavity  435  of the implant inserter  45 . Specifically, the bow  141  and the tip  145  of the leg  130  and the bow  143  and the tip  146  of the leg  131  reside and are secured within the implant retention cavity  435 . In addition, as the jaws  420  and  421  move to their locked position, the back  602  and sides  603  of the implant tab  60  interface with the implant tab interface  424  of the jaw  420  and the implant tab interface  428  of the jaw  421  thereby loading the implant inserter  45  with the implant tab  60 . 
         [0132]    After the implant insertion device  45  has been loaded with the implant tab  60  and implant  10 , the inserter tab  50  is ready to engage and secure to the implant insertion device  45 . The pinhole  422  and the inserter tab interface  425  of the jaw  420  as well the pinhole  426  and the inserter tab interface  428  of the jaw  421  engage the inserter tab  50 . In particular, the inserter tab  50  is designed to maintain the arms  401  and  402  of the implant inserter  45  in their closed position and the jaws  420  and  421  of the implant inserter  45  in their locked position. The handle  501  of the inserter tab  50  provides a gripping surface to allow a user to manipulate the inserter tab  50 . The pin  502  inserts within the pinhole  422  of the jaw  420  and the pin  503  inserts within the pinhole  426  of the jaw  421  until jaw interface  503  of the inserter tab  50  is flush with the inserter tab interface  425  of the jaw  420  and the inserter tab interface  429  of the jaw  421 . Once the jaw interface  504  of the inserter tab  50  is flush with the inserter tab interface  425  of the jaw  420  and the inserter tab inserter tab interface  429  of the jaw  421 , the inserter tab  50  maintains the arms  401  and  402  of the implant inserter  45  in their closed position and the jaws  420  and  421  of the implant inserter  45  in their locked position. Removal of the inserter tab  50  from the implant inserter  45  such that the pins  502  and  503  disengage respectively from the pinholes  422  and  426  releases the jaws  420  and  421 , thereby allowing movement of the arms  401  and  402  from their closed position to their normally open position and the jaws  420  and  421  from their locked to their unlocked position. 
         [0133]    As illustrated in  FIG. 17 , loading the implant inserter  45  with the implant  10  and the implant tab  60 , moving the jaws  420  and  421  from their unlocked to their locked position, and securing the inserter tab  50  to the implant inserter  45  places the implant insertion device  40  into the engaged position. With the implant insertion device  40  loaded with the implant  10  and placed in its engaged position, the implant  10  is ready for insertion into the intramedullary canal of the first bone. 
         [0134]    As illustrated in  FIGS. 18-20 , a surgeon orients the implant insertion device  40  and the loaded implant  10  such that the head  100  of the implant  10  aligns with the intramedullary canal of the first bone. As illustrated in  FIG. 21 , after the head  100  of the implant  10  aligns with the intramedullary canal of the first bone, the surgeon inserts the implant  10  within the intramedullary canal until the front  601  of the implant tab  60  abuts the first bone. Specifically, as the implant  10  inserts into the intramedullary canal, the wings  110  and  111  and the wings  120  and  121  of the implant  10  begin to flex due to the force imparted into the wings  110 ,  111 ,  120 , and  121  by the reduced diameter of the intramedullary canal of the first bone. More specifically, the wings  110  and  111  flex towards the first body section  150  and the wings  120  and  121  flex towards the second body section  151  during insertion into the intramedullary canal of the first bone, thereby imparting a force to the wings  110 ,  111 ,  120 , and  121 . Due to the superelastic properties of the implant  10 , the flexing of the wings  110 ,  111 ,  120 , and  121  causes the wings  110 ,  111 ,  120 , and  121  to move from their first open insertion shape to their implanted shape that conforms with the intramedullary canal of the first bone. After insertion into the intramedullary canal of the first bone, the wings  110 ,  111 ,  120  and  121  apply the anchoring force against the intramedullary canal such that the barbs  113  and  123  secure and anchor the wings  110  and  111  and the wings  120  and  121 , respectively, thereby resisting any motion outward from the first bone. Likewise, the barbs  101  anchor the head  100  to the intramedullary canal of the first bone, thereby resisting any motion outward from the first bone. 
         [0135]    After insertion of the implant  10  into the intramedullary canal of the first bone, the implant  10  and the implant tab  60  are ready to be removed from the implant inserter  45 . As illustrated in  FIG. 22 , the inserter tab  50  is removed from the implant inserter  45  such that the pins  502  and  503  disengage respectively from the pinhole  422  of the jaws  420  and the pinhole  426  of the jaws  421 . Removal of the inserter tab  50  from the implant inserter  45  releases the jaws  420  and  421 , thereby allowing movement of the arms  401  and  402  from their closed position to their normally open position and the jaws  420  and  421  from their locked to their unlocked position. 
         [0136]    Once the jaws  420  and  421  move to their unlocked position, the key  423  of the jaw  420  disengages the key slot  431  of the jaw  421  and the key  427  of the jaw  421  disengages the key slot  430  of the jaw  420 . The disengagement of the key  423  and key  427  and movement of the jaw  420  and  421  to the unlocked position releases the legs  130  and  131  of the implant  10  from the implant retention cavity  435  of the implant inserter  45 . In addition, the back  602  and the sides  603  of the implant tab  60  release from the implant tab interface  424  of the jaw  420  and the implant tab interface  428  of the jaw  421 . At this point, the inserter tab  50 , the implant tab  60 , and the implant  10  have been removed from the implant inserter  45 , and the implant  10  is now ready for insertion into the intramedullary canal of the second bone. 
         [0137]    As illustrated in  FIGS. 23 , the surgeon orients the second bone and the first bone with the inserted implant  10  such that the distal ends  133  of the legs  130  and  131  align with the intramedullary canal of the second bone. After the distal ends  133  of the legs  130  and  131  align with the intramedullary canal of the second bone, the surgeon inserts the legs  130  and  131  of the implant  10  within the intramedullary canal until the back  602  of the implant tab  60  abuts the second bone. The use of the implant tab  60  accordingly provides the advantage that the legs  130  and  131  remain constrained until after at least partial insertion into the intramedullary canal of the second bone. After insertion of the legs  130  and  131  into the intramedullary canal of the second bone, the implant tab  60  is ready to be removed from the implant  10  to allow full insertion of the implant  10  within the intramedullary canal of the second bone. 
         [0138]    The surgeon manipulates the handle  600  of the implant tab  60  to remove the implant tab  60  from the implant  10 . As illustrated in  FIG. 24 , the spacer  604  of the implant tab  60  is removed from the slot  149  formed between the bends  140  and  142  of the legs  130  and  131 , and the restraining members  605  and  606  of the implant tab  60  are released from the bends  140  and  141  of the legs  130  and  131 .  FIG. 25  illustrates the implant  10  once the implant tab  60  has been removed. After removal of the implant tab  60 , the surgeon presses the second bone together with the first bone to fully insert the legs  130  and  131  of the implant  10  within the intramedullary canal of the second bone. As the legs  130  and  131  of the implant  10  fully insert into the intramedullary canal of the second bone, the superelastic properties of the implant  10  returns the legs  130  and  131  to their first implanted shape. In particular, the transition sections  137  and  138  travel angularly away from the longitudinal axis  155  such that the tips  145  and  146 , the bows  141  and  143 , and the bends  140  and  142  diverge, thereby splaying the legs  130  and  131  and returning the legs  130  and  131  to their first implanted shape. Upon returning to their first implanted shape, the barbs  161  and  162  of the tips  145  and  146  engage and anchor the legs  130  and  131  and therefore the implant  10  to the intramedullary canal of the second bone. 
         [0139]      FIGS. 26-28  illustrate the implant  10  fully inserted within the intramedullary canals of the first and second bones. While the implant  10  may be designed to rest at varying locations between the first and second bones, the implant tab  60  according to the preferred embodiment engages the implant  10  such that the transition sections  137  and  138  of the legs  130  and  131  remain exterior to the front  601  of the implant tab  60 . Consequently, insertion of the implant  10  within the intramedullary canal until the front  601  of the implant tab  60  abuts the first bone inserts the transition sections  137  and  138  of the legs  130  and  131  within the intramedullary canal of the first bone. The legs  130  and  131  accordingly span the intramedullary canals of the first and second bone such that the opposing anchoring forces generated between the legs  130  and  131  and the wings  110 ,  111 ,  120 ,  121  creates compression at the second body section  151  of the implant  10 , thereby resulting in enhanced compression between the first and second bones as the transition sections  137  and  138  move the legs  130  and  131  to their first implanted positions. 
         [0140]    The implant  10  due to its superelastic properties requires no pre-operative freezing for implantation. The wings  110 ,  111 ,  120 , and  121  begin in a first open insertion shape and deform during insertion to a second shape that conforms with the intramedullary canal of the first bone, thereby anchoring the implant  10  within the first bone. The legs  130  and  131  are mechanically deformed and held in an insertion shape by an implant insertion device  40 . Once inserted into the intramedullary canal of the second bone, the legs  130  and  131  are released to return to their first implanted shape that anchors the implant  10  within the second bone and creates compression between the first and second bones. Although the preferred embodiment of the implant  10  incorporates superelastic properties, one of ordinary skill in the art will recognize that certain surgeries may require the implant  10  to incorporate shape memory properties. 
         [0141]      FIG. 29  illustrates a drill bit for making holes in a bone. The drill bit  700  includes a drill bit shank  705 , drill bit flutes  710 , a drill bit tip  715 , and a drill bit marker line  716 . The drill bit tip  715  is sharpened, such as a trocar, to prevent skiving of the drill bit  700  during surgical use. The drill bit shank  705  can be smooth, for use with a chuck or pin driver mechanism, or it could include features for quick disconnect. The flutes  710  can extend for any length of the drill bit  700 , depending on how deep the application requires. Finally, the drill bit marker line  716  can be located at any point on the drill bit  700  to provide a reference for drill depth. There can be one, or multiple, drill bit marker lines  716 . 
         [0142]      FIG. 30  illustrates a drill bit stop  720 . The drill bit stop  720  can be made of plastic or metal, and is designed to fit over a drill bit, such as the drill bit  700 , to limit the depth of drilling. A drill bit stop body  725  is solid and provides a barrier for drilling. Drill bit stop appendages  730 ,  731 ,  732 , and  733  provide a flexible friction connection between the drill bit stop  720  and the drill bit  700 . There can be any number of drill bit stop appendages, but in this embodiment there are four. Finally, a drill bit stop hole  735  is a through-hole with diameter slightly larger, slightly smaller, or the same as the diameter of the drill bit  700 , depending on the desired fit. 
         [0143]      FIG. 31  illustrates the drill bit  700  engaged with the drill bit stop  720 . The drill bit stop hole  735  fits over the drill bit flutes  710  and a portion of the drill bit shank  705 . The drill bit stop appendages  730 - 733  flex slightly as the drill bit stop  720  is placed on the drill bit  700 , allowing for a frictional fit to prevent the drill bit stop  720  from sliding off prematurely. The drill bit stop body  725  now presents a hard stop surface when a surgeon begins to drill a hole in bone. In this embodiment, the drill bit stop body  725  limits the drilling depth to the location of the drill bit marker line  716 . 
         [0144]      FIG. 32  illustrates a sizing tool  750 . The sizing tool  750  includes three parts: a sizing guide body  755 , a sizing guide slider  760 , and a sizing guide pin  765 . The sizing guide body  755  can be made of plastic or metal, and is designed to be comfortable when used by a surgeon. The sizing guide body  755  includes a sizing guide hole  756 , which is a through hole that will accommodate the diameter of the sizing guide pin  765 . The sizing guide pin  765  can be made of metal or plastic, and includes a pin line  766  for marking the location of the pin. The sizing guide pin  765  slides freely through the sizing guide hole  756 . The sizing guide pin  765  is free on one end and inserts into the sizing guide slider  760  on the other end. The sizing guide slider  760  fits within an aperture of the sizing guide body  755  and includes slots  761  and  762  that engage and slide along the sizing guide body  755 . The sizing tool  750  is used as follows. The surgeon inserts the sizing guide pin  765  into a hole in a bone, while holding the sizing guide body  755 . The surgeon then slides the sizing guide slider  762  to the location such that the sizing guide pin  765  reaches the bottom of the hole in the bone. The surgeon can then read the depth of the hole by using the pin line  766 . 
         [0145]      FIG. 33  illustrates a bone broach  780 . The bone broach  780  includes a body  782 , ergonomically shaped to fit in a surgeon&#39;s hand, and a cutting blade  785 . The body  782  can be made of plastic or metal, or any suitable material. The cutting blade  785  can also be made of any material, but most likely from metal. The cutting blade  785  contains serrations and a tapered shape, such that inserting the cutting blade  785  into a hole in a bone results in pieces of bone being scraped. In this way, the bone broach  780  can shape a cavity in bone, which then receives an implant therein. 
         [0146]      FIGS. 34-38  illustrate an implant inserter  800  according to a second embodiment. 
         [0147]    The implant inserter  800  moves between an open and a locked position and includes an inserter body  805  and an inserter slider  820 . The inserter body  805  and the inserter slider  820  function together as an assembly to hold and insert an intramedullary implant, such as the implant  10 . The inserter body  805  includes inserter arms  806  and  807 , grasping projections  808  and  809 , and implant engagement surfaces  814  and  815 . The inserter slider  820  includes a slider hole  821  and a grasping surface  822 . The slider hole  821  is configured for the grasping projections  808  and  809  to slide into the slider hole  821  such that the inserter arms  806  and  807  are held in an implant engagement position. In the second embodiment, the inserter slider  820  defines a slot at the grasping surface  822  that allows the inserter slider  820  to frictionally engage the inserter body  805  at the juncture of the inserter arms  806  and  807 . It should be understood however that any number of attachment methods including grooves, channels, or sliding surfaces may be employed to slidably engage the inserter slider  820  with the inserter body  805 . 
         [0148]      FIG. 34  illustrates the implant inserter  800  in the locked position and the inserter arms  806  and  807  in the implant engagement position, although the implant  10  is not shown in this Figure for clarity. It can be seen that the slider hole  820  encompasses the grasping projections  808  and  809  to maintain the grasping projections  808  and  809  held together, which further keeps the inserter arms  806  and  807  in the implant engagement position. When the inserter arms  806  and  807  are held together, the implant engagement surfaces  814  and  815  are held together as well in a position suitable for engaging an implant. 
         [0149]      FIG. 35  illustrates the implant inserter  800  in the open position and the inserter arms  806  and  807  in a normally splayed position. Moving the implant inserter  800  to the open position withdraws the grasping surface  822  on the inserter slider  820  away from the grasping projections  808  and  809 . As the slider hole  821  withdraws from the grasping projections  808  and  809 , the grasping projections  808  and  809  are free to separate as illustrated in  FIG. 36 . It should be understood by one of ordinary skill in the art that the inserter arms  806  and  807  according to the second embodiment are molded in the normally splayed position such that as soon as the slider hole  821  is withdrawn and disengaged from the grasping projections  808  and  809 , the inserter arms  806  and  807  are free to move to their normally splayed position. The implant engagement surfaces  814  and  815  are separated as well, although no implant is yet shown in these Figures.  FIGS. 37 and 38  depict top views of the implant inserter  800  and its function according to the second embodiment. 
         [0150]      FIG. 39  illustrates an implant tab back  850 . The implant tab back  850  is made of metal or plastic, and consists of a tab surface  851 , tab projections  861  and  863 , tab legs  853  and  855 , and tab engagement surfaces  857  and  859 . The tab legs  853  and  855  are moveable between a normally open position and a closed position. 
         [0151]      FIGS. 40 and 41  illustrate an implant tab front or lock  875 . This component can also be made of plastic or metal. The implant tab front or lock  875  includes a tab surface  876 , tab slots  877  and  878  which are sized to receive the tab projections  861  and  863 , and tab constraining flaps  879  and  880 . 
         [0152]    The functioning of an implant tab  900  which is formed through the engagement of the implant tab front  875  with the implant tab back  850  is illustrated in FIGS.  42  and  69 - 71 . To form the implant tab  900 , the implant tab front  875  mounts to the implant tab back  850 . Upon mounting the implant tab front  875  to the implant tab back  850 , the implant tab front  875  is movable between a disengaged and a engaged position. Moving the implant tab front  875  between the disengaged and the engaged position transitions the implant tab  900  between an unlocked and locked position. The tab projections  861  and  863  insert into the tab slots  877  and  878  to hold the implant tab front  875  in place against the implant tab back  850 . Once the implant tab front  875  resides against the implant tab back  850 , the implant tab front  875  will be in its engaged position and the implant tab  900  will be in its locked position. In the locked position, the tab constraining flaps  879  and  880  grasp around the tab legs  853  and  855 , holding the tab legs  853  and  855  in the closed position. In the closed position, the tab engagement surfaces  857  and  859  are close together such that the implant  10  fits between and is held in place by the tab legs  853  and  855 . It is also noted that if a user squeezes or pinches the tab surfaces  851  and  876  towards each other, then the implant tab front  875  will move to its disengaged position. Moving the implant tab front  875  to its disengaged position, allows transition of the implant tab  900  to its unlocked position. As the implant tab  900  transitions to its unlocked position, the constraining flaps  879  and  880  release the tab legs  853  and  855  which travel to their normal open position, thus allowing the tab engagement surfaces  857  and  859  to separate. 
         [0153]      FIGS. 43-44  and  69 - 71  illustrate the functioning of the implant tab  900 . The tab legs  853  and  855  surround a portion of the legs  130  and  131  of the implant  10 . With the implant tab front  875  in position, the tab legs  853  and  855 , and hence the tab engagement surfaces  857  and  859  are held together to constrain the legs  130  and  131  of the implant  10 . 
         [0154]      FIG. 45  illustrates the full utility of the implant inserter  800  and the implant tab  900  in engaging the implant  10 . The legs  130  and  131  of the implant  10  are held together and constrained by the implant tab  900 . The implant tab  900  is positioned at the ends of the inserter arms  806  and  807  of implant inserter  800 . The inserter arms  806  and  807  are moved to their implant engagement position whereby the end of each inserter arm  806  and  807  grasps a respective tab leg  853  and  855  to maintain the implant tab  900  engaged with the implant inserter  800 . When the implant tab  900  is engaged with the implant inserter  800 , the implant engagement surfaces  814  and  815  encompass and engage the ends of the legs  130  and  131  of the implant  10  to assist in maintaining the legs  130  in their insertion shape. The inserter slider  820  moves forward such that the slider hole  821  maintains contact with the grasping projections  808  and  809 . With the slider hole  821  engaged with the grasping projections  808  and  809 , the inserter arms  806  and  807  remain constrained in their implant engagement position. In this configuration, the inserter  800  is in the locked position and the implant  10  is ready for insertion into a bone. 
         [0155]      FIGS. 46-49  illustrate a method for drilling holes in two bones  950  and  951  to pre-determined depths. The drill bit  700  is equipped with the drill bit stop  720 , and positioned such that the drill bit tip  715  penetrates a bone in the proper location. The drill bit stop  720  limits the depth to a desired maximum. The drill bit  700  can now drill into the bones  950  or  951  to a maximum depth, or any depth short of the maximum. 
         [0156]      FIGS. 50-51  illustrate a method of determining the size of an implant that will fit in a bone. The sizing tool  750  is positioned such that the slider pin  765  extends into a hole in the bone  950  or  951 . The sizing tool slider  760  can be positioned to reach the maximum depth of the hole, and then the depth of the hole becomes evident such that a surgeon selects an implant that fits in the hole without being too large or too small. 
         [0157]      FIGS. 52-53  illustrate a method for shaping a cavity to receive an implant using the broach  780 . In these Figures, the bones  950  and  951  have holes already drilled by the drill bit  700 . The cutting blade  785  inserts into each hole and shaves and chips away bone as broach  780  is manipulated by the surgeon. 
         [0158]      FIGS. 54-55  illustrate a method for inserting an intramedullary implant  10  into the bones  950  and  951 . In  FIGS. 54-55 , the implant  10  is firmly held by the implant inserter  800  and the implant tab  900 . The implant  10  is not yet inserted into bone. It can be seen that the constraining forces of the implant inserter  800  and the implant tab  900  maintain the legs  130  and  131  of the implant  10  in the closed position. 
         [0159]    Now, in  FIGS. 56-57 , the surgeon has used the implant inserter  800  to push the first and second body sections  150  and  151  of the implant  10  into the bone  950 . The inserter slider  820  is still in the forward position, and as the surgeon pushes on the implant inserter  800 , forward pressure on the inserter slider  820  is maintained, thus keep the implant  10  firmly engaged. 
         [0160]      FIGS. 58-59  illustrate what happens when the surgeon retracts the inserter slider  820 . The slider hole  821  retracts from the projections  808  and  809 , freeing them along with the inserter arms  806  and  807 , which move to their normal splayed open position. In this way, the implant inserter  800  can be easily disengaged and removed from the implant tab  900  and the legs  130  and  131  of the implant  10 , thereby exposing the legs  130  and  131  of implant  10 . 
         [0161]      FIGS. 60 and 61  illustrate the bone  951  pulled over the legs  130  and  131  of the implant  10 . The implant tab  900  is still in place, constraining the legs  130  and  131  of the implant  10  to allow for easy insertion into the bone  951 . 
         [0162]      FIGS. 62 and 63  illustrate the final steps in inserting the implant  10  into the bones  950  and  951 . The tab surfaces  851  and  876  are squeezed, causing the tab constraining flaps  879  and  880  to release the tab legs  853  and  855 . Without constraint, the tab legs  853  and  855  spring to their open and normal shape, allowing the implant tab  900  to be removed from the implant  10 . At this time, the implant legs  130  and  131  are now able to move freely to engage the interior of the bone  951 . The bone  951  can now be pressed forward to mate against the bone  950  with the implant  10  now spanning in between the two bones  950  and  951  as illustrated in  FIGS. 26-28 . The implant  10  lies between the bones  950  and  951 , thereby fixating the two bones  950  and  951 . 
         [0163]      FIGS. 64-66  illustrate an arrangement for packaging the implant  10 , preloaded onto the implant inserter  800  with the implant tab  900  in place. The implant tray  980  is configured to hold these components. 
         [0164]      FIGS. 65-67  illustrate packaging for instruments needed to use the implant  10 . In these Figures, an instrument tray  990  is configured to hold the drill bit  700  without or preloaded with the drill bit stop  720 , the sizing tool  750 , and one or more broaches  780 . In this configuration, two broaches  780  are shown, so that the surgeon has a selection of how to size holes in bone. 
         [0165]    A system now consists of one or more implant trays  980 , with a single instrument tray  990 . In this way, a surgeon using multiple implants on the same patient does not have to waste instruments unnecessarily. 
         [0166]    It should be understood that the pre-loading and packaging of the implant inserter  800  with the implant tab  900  in place with the implant  10  allows for sterilizing of the implant inserter  800  with the implant tab  900  in place and the implant  10  by any common sterilization method such as gas, radiation, or another type as well as delivery of the implant insertion device  10  and the implant  10  in sterile condition. The packaged instruments may be sterilized similarly. 
         [0167]    While the implant inserter  800  and the implant tab  900  may be manually loaded with the implant  10 , a method incorporating mechanical assistance improves the loading process.  FIGS. 68-85  illustrate a method of loading the implant inserter  800  with implant tab  900  and the implant  10  incorporating mechanical assistance. The method includes first loading the implant tab  900  with the implant  10 , and then loading the implant inserter  800  with the implant tab  900  and the secured implant  10 . 
         [0168]      FIGS. 68-77  illustrate a method of loading the implant tab  900  with the implant  10 . The method includes an implant tab press tool  1100  to couple the implant  10  with the implant tab  900 . Each method step at any given time normally involves multiple implants  10  and multiple implant tabs  900 , however, for the sake of disclosure and in order to aid in the understanding of the present invention, the method described herein will included only one implant  10  and one implant tab  900 . 
         [0169]      FIG. 68  illustrates the implant tab press tool  1100  that includes a press tool base  1110  and a vice  1115 . The press tool base  1110  defines a loading surface  1111  including a tab retention slot  1112  and an implant retention slot  1113 . The vice  1115  defines press faces  1116  and  1117 . The implant tab press tool  1100  in the present method is a pneumatic press; however, one of ordinary skill in the art will recognize that any form of press tool may be implemented. 
         [0170]    To load the implant tab  900  with the implant  10 , the implant tab  900  first receives therein the implant  10  in its first implanted shape. In particular, as illustrated in  FIGS. 69-71 , the implant tab  900  with its tab legs  853  and  855  in the normally open position, surround a portion of the legs  130  and  131  of the implant  10 . Specifically, the tab engagement surfaces  857  and  859  contact a portion of the legs  130  and  131  of the implant  10  to hold the implant  10  engaged with the implant tab  900 . After the implant tab  900  engages the implant  10 , the implant tab  900  and the implant  10  insert within the loading surface  1111  of the implant tab press tool  1100 . 
         [0171]    In order to properly insert the implant tab  900  and the implant  10  within the loading surface  1111  of the implant tab press tool  1100 , the implant  10  is placed within the implant retention slot  1113  and the implant tab  900  is placed within the tab retention slot  1112 . After the implant  10  and the implant tab  900  are placed within the implant retention slot  1113  and tab retention slot  1112 , respectively, the vice  1115  is pneumatically activated to load the implant tab  900  with the implant  10 . Specifically, the press faces  1116  and  1117  of the vice  1115  contact a respective tab leg  853  and  855  and move the tab legs  853  and  855  of the implant tab  900  to the closed position. Moving the tab legs  853  and  855  to the closed position constrains the legs  130  and  131  of the implant  10  into their insertion shape thereby loading the implant tab  900  with the implant  10 . After the tab legs  853  and  855  move to the closed position, a press tool operator moves the implant tab  900  to its locked position. In particular, the implant tab front  875  is moved to its engaged position such that the tab constraining flaps  879  and  880  grasp the tab legs  853  and  855 . The grasping of the tab legs  853  and  855  by the tab constraining flaps  879  and  880  holds the tab legs  853  and  855  in the closed position thereby coupling the implant  10  to the implant tab  900 . After coupling the implant tab  900  with the implant  10 , the press tool operator deactivates the implant tab press tool  1100  releasing the implant tab  900  with the now coupled implant  10  from the implant tab press tool  1100 . The implant tab  900  with the now coupled implant  10  is prepared for engagement with the implant inserter  800 . 
         [0172]      FIGS. 78-85  illustrate a method of loading the implant inserter  800  with the implant tab  900  and its coupled implant  10  according to the present invention. The method includes an inserter press tool  1500  to load the implant inserter  800  with the implant tab  900  and its coupled implant  10 . Each method step of the preferred embodiment at any given time normally involves multiple implant tabs  900  (with coupled implants  10 ) and multiple implant inserters  800 , however, for the sake of disclosure and in order to aid in the understanding of the present invention, the method described herein will included only one implant tab  900 , one implant  10 , and one implant inserter  800 . 
         [0173]      FIGS. 78 ,  84 , and  85  illustrate the inserter press tool  1500  that includes a press tool base  1509 , a press tool body  1510 , and a vice  1515 . The press tool body  1510  defines a loading surface  1511  including an implant tab retention slot  1512 , an implant retention slot  1513 , and an inserter retention slot  1514 . The vice  1515  resides within the inserter retention slot  1514  and defines press faces  1516  and  1517 . The inserter press tool  1500  in the present invention is a pneumatic press; however, one of ordinary skill in the art will recognize that any form of inserter press tool may be implemented. 
         [0174]    To load the implant inserter  800  with the implant tab  900  and the implant  10 , the implant tab  900  with the coupled implant  10  inserts within the loading surface  1511  of the inserter press tool  1500 . In particular, the implant tab  900  inserts within the tab retention slot  1512 , the first and second body sections  150  and  151  of the implant  10  insert within the implant retention slot  1513 . In addition, the legs  130  and  131  extend into the inserter retention slot  1514 . After the implant tab  900  and the implant  10  insert within the tab retention slot  1512  and implant retention slot  1513 , respectively, the implant inserter  800  in its open position inserts within the inserter retention slot  1514 . Specifically, the inserter arms  806  and  807  in their normally splayed position insert within the inserter retention slot  1514 . Furthermore, once the implant inserter  800  inserts within the inserter retention slot  1514 , a portion of the inserter arms  806  and  807  reside within the tab retention slot  1512 . 
         [0175]    After the implant inserter  800  inserts within the inserter retention slot  1514 , the vice  1515  engages the implant inserter  800  to load the implant inserter  800  with the implant tab  900  and the implant  10 . Specifically, the press faces  1516  and  1517  of the vice  1515  contact a respective end of each inserter arm  806  and  807  and move the inserter arms  806  and  807  to their implant engagement position. In the implant engagement position, the inserter arms  806  and  807  grasps a respective tab leg  853  and  855  to maintain the implant tab  900  engaged with the implant inserter  800 . Furthermore, the implant engagement surfaces  814  and  815  of the inserter arms  806  and  807  encompass and engage the ends of the legs  130  and  131  of the implant  10  to assist in maintaining the legs  130  in their insertion shape. After the inserter arms  806  and  807  travel to their implant engagement position, the implant inserter  800  is moved to its locked position. In particular, a press tool operator moves the inserter slider  820  forward such that the slider hole  821  maintains contact with the grasping projections  808  and  809 . With the slider hole  821  engaged with the grasping projections  808  and  809 , the inserter arms  806  and  807  remain constrained in their implant engagement position. After the implant inserter  800  is moved to its locked position, the press tool operator deactivates the inserter press tool  1500  releasing the implant inserter  800  with the loaded implant tab  900  and the implant  10  from the inserter press tool  1500 . The implant  10  is now preloaded onto the implant inserter  800  with the implant tab  900  in place, and is ready for packaging or implantation into tissue or bone. 
         [0176]    Although the present invention has been described in terms of the foregoing preferred embodiments, such description has been for exemplary purposes only and, as will be apparent to those of ordinary skill in the art, many alternatives, equivalents, and variations of varying degrees will fall within the scope of the present invention. That scope, accordingly, is not to be limited in any respect by the foregoing detailed description; rather, it is defined only by the claims that follow.