Abstract:
A medical implant for osteosynthesis wherein the implant has a first configuration when it is releasably attached to a delivery instrument and a second configuration when it is released from the delivery instrument. The implant has non-symmetrical means for fixation to bone segments and when the implant is released following insertion into the bone segments the fixation means prevent or minimizes rotation or other movement of the bone segments relative to one another. The fixation means also have means to prevent pullout from bone. The means for fixation may be adapted to compress, distract or control spacial orientation of the bone segments relative to one another. The implant may be packaged in a kit with tools to facilitate implant surgery.

Description:
BACKGROUND OF THE INVENTION 
       [0001]    Field of the Invention 
         [0002]    The present invention is in the technical field of medical devices. More particularly, the present invention is in the technical field of bone fixation or arthrodesis or deformity correction. The invention relates to a fixation system for bones of all types utilizing an implant. Such systems are used in osteosynthesis (bone fusion), wherein the implant bridges the fracture generating a force (typically compression) across the bone members. The force is generated by either the properties of the implant, the different configurations of the implant, the surgical technique or placement of the implant or a combination thereof. For example, the implant may have a first configuration when in free-state and a second configuration required for insertion. It may be desirable for optimal implant placement and function to be able to pre-assemble or attach the implant to an inserter to facilitate placement of the implant on or in the bone. Once implanted, it is desirable to prevent or minimize rotation or other movement of the bone segments relative to one another. The implant may be indicated for the various bones of the entire skeleton. 
         [0003]    The Related Art 
         [0004]    The present invention seeks to remedy the problems of the prior art. The invention produces a system that allows placement of an implant in its final required position with or without additional manipulation. In addition, the present invention will provide resistance to pullout and/or rotation once implanted. The implant features may be particularly beneficial in a compression implant. The current invention may or may not rely on additional implant positioning once positioned in the bone. Also, the current invention may incorporate other necessary features for delivery of the implant into the bone. 
       SUMMARY OF THE INVENTION 
       [0005]    The present invention includes an implant or other bone fastening device. The implant may be a bone staple, bone plate, modular staple, or the like. The implant has elastic properties or other material properties that allow the device to have at least two configurations or configurable to various positions when placed on or in the bone. The free-state or implanted-state of the device provides a force, typically compression, across two or more bone members. An inserter is used to hold the implant or other fastening device in a configuration that is different than the free-state or implanted-state configuration. This first configuration may be useful in placement of the implant onto or into bone members. Fastening device and implant are used interchangeably in this application and are not intended to be limiting in nature. 
         [0006]    The present invention may have implant legs that once inserted into bone provide a dynamic compression and prevent pullout and/or rotation of the adjoining bone segment. The implant also has features for releasably engaging an implant inserter. The present invention includes an implant or portion of an implant that is made of an elastic material or a material that may allow the implant to have multiple configurations. The ability of the implant to have multiple configurations may be achieved by the material properties that have shape memory or super elastic properties or it may be achieved by manipulation (mechanical, physical, chemical, temperature, electrical or otherwise) of the implant to create a second configuration. The implant is held in one configuration during insertion or removal and returns to or is placed in another configuration in its free-state or implanted-state. The implant may have multiple configurations, for example one for inserting into the bone and at least a second configuration for compressing, distracting, controlling spatial orientation or the like of one or more bone segments. 
         [0007]    The implant has features for engaging the bone. These features may include bone screws, leg members, pins or other features for attaching the implant to bone. The implant may have one or more bridge members. The implant may have leg members for engaging the bone. The implant may have modular members for engaging bone, such as bone screws or pegs. To those skilled in the art, based on the description of the invention herein, it will be evident that multiple options exist for connecting an implant to bone. The connecting members or features may not necessarily be of the same material as the bridge component. The deformability aspect of the current invention may be in the bridge member(s), the connecting member(s) or another member(s) of the implant or fixation device. The leg member(s) may be configured to receive members from the inserter to hold the implant in its first configuration or to allow manipulation of the implant to another configuration. The leg members also have features or geometry to prevent relative movement between two adjoining bone segments. For example, these features may include fins, projections, non-circular geometries or the like that may prevent rotation of the leg within each bone segment thereby preventing rotation between the adjoining bone segments. 
         [0008]    A “bone fixation device” or implant may include any of a variety of devices that secure an object to a bone, including but not limited to staples, bone plates, modular staples, bone screws, pins, blades, suture anchors, and the like. The terms “inserter,” “implant inserter,” “insertion device,” and “delivery instrument” are used herein interchangeably. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0009]      FIG. 1  is a perspective view of a first embodiment of the present invention. 
           [0010]      FIG. 2  is a front view of a first embodiment of the present invention further showing the location of section A-A. 
           [0011]      FIG. 3  is the section view A-A of the leg of the first embodiment shown in  FIG. 2 . 
           [0012]      FIG. 4  is a front view of a second embodiment of the present invention showing alternate leg geometry and a section B-B. 
           [0013]      FIG. 5  is the section view B-B of the second embodiment shown in  FIG. 4 . 
           [0014]      FIG. 6  depicts other possible cross sections for other embodiments of the staple legs. 
           [0015]      FIG. 7  is a perspective view of a third embodiment of the current invention. 
           [0016]      FIG. 8  is a perspective view of a fourth embodiment of the current invention. 
           [0017]      FIG. 9  is a top view of an implant kit that may be provided for inserting the implant of the current invention into bone segments. 
           [0018]      FIG. 10 a    shows a section view of two bones with an exemplary embodiment of the current invention partially inserted into the bones. 
           [0019]      FIG. 10 b    shows a section view of two bones with an exemplary embodiment of the current invention fully inserted into the bones. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0020]    The present invention includes an implant for spanning and/or fixating at least two bone segments. The exemplary embodiments of the current invention are discussed in the description of the figures below. The implant may be of a configuration similar to a bone staple as discussed below. The present invention includes an apparatus or instrument for inserting the device that may be pre-assembled or affixed to the implant. The implant or implants could be held in a particular configuration prior to use that facilitates insertion into the bone segments. The embodiments described herein may be used in connection with any type of inserter or fixation device that is compatible with the description and objectives stated herein, including but not limited to various bone staples, bone plates, etc. that may have more than one implant configuration and may generate a force, typically a compressive force, across bone segments. 
         [0021]      FIG. 1  shows a bone implant  100  consisting of a bridge  110  and legs  120 . The implant  100  shown in  FIG. 1  may have legs  120  converging or in a compressed state. This may be the free-state or implanted state of the implant  100 . Bridge member  110  may be of uniform cross section or of a varying cross section as depicted in  FIG. 1 . In this particular embodiment bridge member  110  consist of an arched geometry. Legs  120  may have a tapered tip  125  that may facilitate insertion into the bone. Legs  120  may also have barbs  130  that may minimize or prevent pullout and/or rotation. In this exemplary embodiment, legs  120  have barbs  130  on either side of groove  122 . This interrupted barb geometry may further resist rotation of the leg  120  in a bone. The barbs  130  are shown on the internal surface of this embodiment, but may also be present on an external surface of the legs  120 . The implant  100  has fin like projections  140  to resist rotation of the legs  120  within the bone thereby resisting rotation between the bone segments in which the legs  120  are implanted. In this embodiment the fin  140  is shown on one external surface of the implant leg  120 . The fin  140  may also be on more than one surface of leg  120  and not necessarily on the surface directly opposed to the barbs  130 . Implant  100  has opening  150  for attachment to an inserter or to allow manufacturing of the non-symmetrical legs  120  and particularly groove  122 . As shown in  FIG. 1 , staple legs  120  may have a groove  122  that is defined by the shape of the opening  150  and the outer geometry of the legs  120 . The non-circular geometry of the legs  120  when inserted into the bone provides an interference type fit with the bone such that the non-circular geometry will not rotate within the bone. Leg  120  should not rotate within the bone because the non-circular and/or non-symmetrical geometry does not match the prepared hole in the bone. An interference fit within the bone may be generated by using a drill that has a smaller diameter than the circumscribed outer diameter of the implant leg  120  or the prepared hole is of a different geometry than the implant leg  120 . Leg  120  may not rotate within the bone because the non-circular and/or non-symmetrical geometry may create a “keyed” interlock with the bone in which the leg is inserted. This keyed geometry may be the negative of the implant leg geometry. 
         [0022]      FIG. 2  is a front view of implant  100  showing bridge component  110 , legs  120 , fins  140  and barbs  130 . Bridge member  110  is shown with an arched geometry of varying thickness. Bridge member  110  has a center thickness  160  and two outer thicknesses  170  and  180  at the connection region of the bridge  110  to the legs  120 . This connection region may be further defined by joint  190  which may be arched, gusseted or some other suitable geometry. In this embodiment, thickness  160  is less than thickness  170  and  180 . Thickness  170  and  180  are shown as being equivalent in this particular embodiment. Thickness  160  may be more or less than thickness  170  and thickness  180 . Thickness  170  may be more or less than thickness  180 . The combination of geometries  160 ,  170 ,  180  and  190  are such that the stresses seen by the bridge member  110  and connection region of the bridge member  110  and legs  120  are sufficient to withstand the loading environment of the implant. The legs  120  are shown to have barbs  130 . The barbs may have peaks  131  and valleys  132 . The barbs  130  may have multiple geometries and configurations. The barbs may or may not be present or needed in a particular embodiment. The merits of the current invention are still viable in the absence of the barbs  130 . The number of barbs  130  may vary depending on the length of the leg  120 . As shown in this embodiment, the barb peaks  131  are proud to surface  123 . The barb valleys  132  are relatively equal to the surface  123 . In an alternate embodiment the barb peaks  131  may be below surface  123  or at the level of surface  123 . Still further in an alternate embodiment, barb valleys  132  may be below surface  123  or above surface  123 . Any combination of the location of the barb peaks  131  and barb valleys  132  relative to surface  123  may be possible. The fin  140  is located on the external leg surface  124 . The fin  140  may be proud or extend beyond surface  124 . Fin  140  may include a lead-in surface  145  to facilitate insertion into a bone segment. Fin  140  may also include a surface  146  that may sit below a bone surface to prevent or resist pullout of the staple leg  120 . Fin  140  may include barbs similar to the barb  130 . Fin  140  is of a geometry that creates a non-circular and/or non-symmetrical staple leg such that the geometry of the staple leg  120  will resist rotation within a bone segment. The geometry of the staple leg  120  in combination with the fin  140  and groove  122  may not match the geometry of the prepared hole in the bone for which the staple leg  120  will be inserted. This may create an interference fit between the staple leg  120  and the prepared hole. The implant  100  may be inserted into a bone without preparing a hole in the bone segment. The geometry of the staple leg  120  in combination with the fin  140  and groove  122  may create an interlock between the bone geometry and the implant leg geometry  120  in an unprepared bone segment. 
         [0023]      FIG. 2  includes dashed lines  200  and  201  to represent opening  150  as also illustrated in  FIG. 1 . Opening  150  is used for attachment to a delivery instrument or inserter. Opening  150  may be used to create groove  122 . As shown in  FIG. 2 , opening  150  is positioned such that the opening extends through the top of the bridge  110  to the bottom of the staple legs  120 . The opening  150  opens toward the inside of the staple leg  120  creating the groove  122 . In an alternate embodiment, groove  122  may open toward the outside of the legs. 
         [0024]    Opening  150  in  FIG. 2  is positioned such that the opening  150  spans the connecting region between bridge  110  and the leg  120  which may include radius  190  thereby opening to the internal region of the staple (i.e. towards the midline of the staple  100 ). The inner border,  201  of the opening  150  may extend into the bridge member  110 . The outer border  200  of opening  150  may extend through the entire length of the staple leg  120 . The position of the inner border  201  may be advantageous in creating groove  122  and the non-circular, non-symmetrical geometry of the staple leg  120 . The position of the inner border  201  may be advantageous in the manufacturing of the implant  100 , particularly the geometry of the leg  120 , which may include the groove  122 . This positioning of the inner border  201  of opening  150  may allow ease of manufacturing by providing a thinner section in the area of thickness  170  or  180  to, for example, provide a starter hole for a wire EDM process or laser cut process or machining process. The present invention may include the positioning of opening  150 . The positioning of opening  150  may be such that it extends through a thinner section of the implant, in this embodiment the thickness  170  of the implant bridge  110 . This may be particularly advantageous in the setup of the manufacturing process. Having the inner border  201  extending through the thinner section  170  may allow the manufacture a simplified more cost effective manufacturing process without having to create groove  122  entirely within the perimeter of the staple leg. The position of opening  150  relative to the staple leg  120  and/or the bridge member  110  and/or joint region  190  may provide a means for distributing the required stresses within the implant to achieve a desired compressive force. The position and geometry of opening  150  may be altered within the scope of this invention to manipulate the stress distribution to achieve the desired performance. Within the scope of this invention, the position and geometry of opening  150  may be altered in combination with the thicknesses  170 ,  160 ,  180  and/or joint  190  to manipulate the stress distribution to achieve the desired performance. The amount of desired force generated by the current invention may be accomplished by manipulating individual aspects of the implant geometry and their relative orientations to one another. The geometry and relative orientation of thicknesses  160 ,  170  and/or  180  may be altered to manipulate the stress distribution within the implant bridge  110  to achieve the desired performance. The geometry and relative orientation of thicknesses  160 ,  170  and/or  180  may be altered in combination with the joint region  190  geometry and relative orientation to manipulate the stress distribution within the implant bridge  110  and/or implant legs  120  to achieve the desired performance. The geometry and relative orientation of thicknesses  160 ,  170  and/or  180  may be altered in combination with the joint region  190  geometry and relative orientation and may be in combination with altering the geometry and relative orientation of opening  150  to manipulate the stress distribution within the implant bridge  110  and/or implant legs  120  to achieve the desired performance. The geometry and relative orientation of opening  150  may be altered to manipulate the stress distribution within the implant bridge  110  and/or implant legs  120  to achieve the desired stress distribution and/or performance. Furthermore, the implant width  175  as shown in  FIG. 3  may also be manipulated in geometry and/or orientation either as an independent variable or in combination with the previously described aspect or aspects of the implant to manipulate the stress distribution within the implant bridge  110  and/or implant legs  120  to achieve the desired performance or force generation. 
         [0025]      FIG. 3  shows the cross section view A-A as noted in  FIG. 2  illustrating that the cross section of the opening does not need to be uniform, although a uniform cross section can optionally be used. Opening  150  is further divided into openings  150   a  and  150   b . Opening  150   a  is represented by the vertical dashed lines in  FIG. 3  and may be bounded by the portion of opening  150  surrounded by the staple leg  120  and opening toward the midline of the implant  100 . This portion  150   a  of the opening  150  is analogous to the previously discussed groove  122 . Opening  150   b  is represented by the horizontal solid lines in  FIG. 3  and may be bounded by the portion of opening  150  contained in the staple bridge  110  and inside edge of the staple leg  120 . Combined, opening  150   a  and  150   b  make up opening  150 . Opening  150  may extend out of one particular side of a staple leg or may be contained completely within a staple leg or completely outside a staple leg. Opening  150  has an overall length  151  and may include an outside width  154  and an inside width  155 . Width  154  and  155  may or may not be equal in size. Length  151  is greater than lengths  154  and  155 . Width  155  may be more or less than width  154 . In this exemplary embodiment opening  150  may have an outer edge generated by a radius  152  and an inner edge generated by radius  153 . Radius  152  may or may not be the same as  153 . Radius  153  may be greater than or less than  152 . The outer borders of opening  150  may or may not be radii. Geometries, such as tear drops, squares, rectangles, ovals, slots, keyholes, etc. may be used to create opening  150 . Opening  150  is such that the geometry is more resistant to bending in the direction of the force generated by the implant. In this particular embodiment, space  150  is more resistant to bending in the direction of the compressive force. Space  150  is used to facilitate insertion of the implant or connection to an inserter for implantation. The geometry of space  150  would mimic that geometry of the corresponding insertion tool. The insertion tool would have a geometry similar to that of space  150 . 
         [0026]    As shown in the exemplary embodiment of  FIG. 3 , the interrupted staple leg geometry  120  may create a geometry that produces multiple fins or features to resist rotation. In this exemplary embodiment fin  140  exists on the outside perimeter of the staple leg  120 . In addition other fins may be created in the outer geometry of the staple leg  120  and the groove  122 , e.g. space  150   a . As shown in  FIG. 3  the combination of the staple leg geometry  120 , the opening  150  and/or groove  122  may be used to make an effective fin  210  and/or  220 . 
         [0027]      FIG. 4  shows an embodiment of the current invention of a staple  300  having a staple bridge  310  and staple legs  320 . In this particular embodiment the staple legs  320  are shown parallel relative to each other. Staple bridge  310  may be relatively flat across the top and may have a varying thickness represented by thickness  360 ,  370  and  380 . Bridge member  310  has a center thickness  360  and two outer thicknesses  370  and  380 . In this embodiment, thickness  360  is less than thickness  370  and  380 . Thickness  370  and  380  are shown as being equivalent in this particular embodiment. Thickness  360  may be more or less than thickness  370  and thickness  380 . Thickness  370  may be more or less than thickness  380 . The connection region between the staple leg  320  and the staple bridge  310  has geometry  350 . This geometry  350  may be used to facilitate insertion of the implant  300  or connection to an inserter for implantation. This geometry  350  may be arched, gusseted or some other suitable geometry. The combination of geometries  360 ,  370 ,  380  and  350  are such that the stresses seen by the bridge member  310  and connection region of the bridge member  310  and legs  320  are sufficient to withstand the loading environment of the implant. The position of geometry  350  relative to the staple leg  320  and/or the bridge member  310  may provide a means for distributing the required stresses with the implant to achieve a desired compressive force. The position and geometry of  350  may be altered within the scope of this invention to manipulate the stress distribution to achieve the desired performance. Within the scope of this invention, the position and geometry of undercut  350  may be altered in combination with the thicknesses  370 ,  360 , and/or to manipulate the stress distribution to achieve the desired performance. The amount of desired force generated by the current invention may be accomplished by manipulating individual aspects of the implant geometry and their relative orientations to one another. The geometry and relative orientation of thicknesses  360 ,  370  and/or  380  may be altered to manipulate the stress distribution within the implant bridge  310  to achieve the desired performance. The geometry and relative orientation of thicknesses  360 ,  370  and/or  380  may be altered in combination with the joint region  350  geometry and relative orientation to manipulate the stress distribution within the implant bridge  310  and/or implant legs  320  to achieve the desired performance. The geometry and relative orientation of geometry  350  may be altered to manipulate the stress distribution within the implant bridge  310  and/or implant legs  320  to achieve the desired stress distribution and/or performance. Furthermore, the implant width  390  as shown in  FIG. 5  may also be manipulated in geometry and/or orientation either as an independent variable or in combination with the previously described aspect or aspects of the implant to manipulate the stress distribution within the implant bridge  310  and/or implant legs  320  to achieve the desired performance or force generation. 
         [0028]    The legs  320  are shown to have barbs  330 . The barbs may have peaks  331  and valleys  332 . The barbs  330  may have multiple geometries and configurations. The barbs may or may not be present or needed in a particular embodiment. The merits of the current invention are still viable in the absence of the barbs  330 . The number of barbs  330  may vary depending on the length of the leg  320 . As shown in this embodiment, the barb peaks  331  are co-linear with the surface  323 . The barb valleys  132  are below the surface  323 . In an alternate embodiment the barb peaks  331  may be below surface  323  or above the level of surface  323 . Still further in an alternate embodiment, barb valleys  332  may be below surface  323  or above surface  323 . Any combination of the location of the barb peaks  331  and barb valleys  332  relative to surface  323  may be possible. The fin  340  is located on the external leg surface  324 . The fin  340  may be proud or extend beyond surface  324 . Fin  340  may include lead-in surface  345  to facilitate insertion into a bone segment. Fin  340  may also include a surface  346  that may sit below a bone surface to prevent or resist pullout of the staple leg  320 . Fin  340  may include barbs similar to the barb  330 . Fin  340  is of a geometry that creates a non-circular and/or non-symmetrical staple leg  320  such that the geometry of the staple leg  320  will resist rotation within a bone segment. The geometry of the staple leg  320  in combination with the fin  340  may not match the geometry of the prepared hole in the bone for which the staple leg  320  will be inserted. This may create an interference fit between the staple leg  320  and the prepared hole. The implant  300  may be inserted into a bone without preparing a hole in the bone segment. The geometry of the staple leg  320  in combination with the fin  340  may create an interlock between the bone geometry and the implant leg geometry  320  in an unprepared bone segment. 
         [0029]      FIG. 5  is the section view B-B as depicted in  FIG. 4 . The staple leg  320  may be of solid construction without a groove. The staple leg  320  may have fin  340  protruding from a surface of the staple leg creating a non-symmetrical and/or non-circular geometry. Staple leg  320  may have a width  345  and a height  346 . In this particular embodiment the staple leg height  346  is represented as being relatively equivalent to the staple bridge height  390 . In other embodiments, staple leg height  346  may be more or less than staple bridge height  390 .  FIG. 5  represents an embodiment that does not include and opening passing through the staple bridge  310  or the staple leg  320 . 
         [0030]      FIG. 6  shows other possible cross-section geometries that may be used for staple legs  120  and/or  320 . The embodiments shown in  FIG. 6  have various faces that create a geometry that is non-circular and/or non-symmetrical in at least one plane. The geometry of the staple legs in combination with a fin and/or a groove may not match the geometry of the prepared hole in the bone for which the staple leg will be inserted. This may create an interference fit between the staple leg and the prepared hole. The implant may be inserted into a bone without preparing a receiving hole in the bone segment. The geometry of the staple leg in combination with the fin and/or groove may create an interlock between the bone geometry and the implant leg geometry in an unprepared bone segment. With the current invention, it is also possible to create a broached hole in a bone segment that may match the non-circular and/or non-symmetrical geometry of a staple leg. The combination of the non-circular and/or non-symmetrical leg with a broach of similar geometry would resist rotation of the staple leg in the bone segment. 
         [0031]      FIG. 7  shows yet another embodiment of the current invention of staple  400  having a bridge  410  and legs  420 . In this embodiment the width  405  of the legs  420  is different than the width  406  of the staple bridge  410 . Opening  450  is present and extends into the bridge  410 . This embodiment shows groove  422  extending the length of the staple leg  420 . The combination of the geometry of the staple leg  420 , the opening  450 , the position of the opening  450  relative to the staple bridge  410  and the groove  422  creates effective fins  441  and  442 . 
         [0032]      FIG. 8  is yet another embodiment of the current invention, staple  480 . Staple  480  has a bridge  481  and legs  482 . The opening  483  is present but may not extend into the bridge  481 . Opening  483  may open to the outside of the staple leg  482  creating groove  484 . The combination of the geometry of the staple leg  482 , the opening  483 , the position of the opening  483  relative to the border of the staple leg and the groove  484  creates effective fins  485  and  486 . 
         [0033]    The implant of the current invention may be packaged as an implant kit with the associated instruments needed for a successful implantation. Such a kit may include the implant or implants, the necessary drills, reamers or broaches for preparing the bone for receiving the implant, any necessary drill guides and an inserter for facilitating implantation of the implant into the bone. This kit may be provided sterile packaged for single use.  FIG. 9  shows one embodiment of an implant kit  1000  that may be used to provide the end user with the necessary associated instruments for successfully implanting an implant of the current invention. Such a kit may include one or more implants  1100  similar to the embodiments described herein. The kit may also include a drill  1200 , a drill guide  1300  and a provisional fixation pin  1400 . The kit may also include an insertion tool or inserter  1500  for facilitating insertion of the implant  1100  into a bone segment. One embodiment of the kit may have the implant  1100  preassembled to the insertion tool  1500 . The components of this kit may be assembled in a tray  1600  constructed of appropriate materials. Once the end user opens the kit, the surgical technique may include the following steps. After exposure of the operative site, the osteotomy or fracture may be reduced and held in place. The drill guide or reamer guide may be placed across the fusion site with both guide tubes against the bone. The first hole is drilled to final depth by advancing the drill, reamer or broach until the depth stop hits the top of the guide. A provisional fixation pin may be placed in the prepared hole to help maintain reduction while the second hole is prepared. Once both holes have been prepared, the legs of the implant, which has been assembled or loaded to the inserter tool, may be inserted into the prepared holes in the bone. Since an interference fit may be used, light tapping on the end of the inserter tool may be helpful in advancing the implant into the bone. The implant should be fully inserted until flush against the surface of the bone. The implant may then be released from the inserter tool. Alternatively, the holes in the bone may not be prepared for receiving the legs of the staple. As described herein, certain features of the current invention may be used or beneficial in a technique that does not require preparation of holes in the bone prior to insertion of the implant. 
         [0034]      FIG. 10 a    shows an implant  2100  of the current invention assembled to an inserter  2000  of the current invention partially inserted into bones  2200  and  2300 . The inserter  2000  may have an inserter body  2010 , an inserter plunger  2015  and an ejector pin  2020 . The inserter has means for engaging the implant that allow the implant to be positioned flush to bone. For example, this embodiment would have inserter legs of a geometry that would mimic the space  150  as depicted in  FIG. 3 . The inserter legs may be in a fixed orientation. In this embodiment the legs are in a fixed parallel orientation for insertion into the implant  2100 . As the inserter legs are placed into the staple  2100 , the staple legs are made parallel. The inserter plunger  2015  may push the ejector pin  2020  thereby releasing, ejecting or disengaging the implant  2100  from the inserter body  2010 .  FIG. 10 a    shows the implant  2100  having parallel legs partially inserted in bones  2200  and  2300  showing the fusion site  2150  having a gap. The legs of implant  2100  are made relatively parallel and are maintained relatively parallel by the inserter  2000  to facilitate insertion into the bones  2200  and  2300 . Once the implant  2100  is released from the inserter  2000  as shown in  FIG. 10 b    the legs may converge or compress drawing bones  2200  and  2300  toward one another causing the fusion site  2150  to compress with no gap. 
         [0035]    The previous description of the embodiments described herein may be manufactured from a number of materials including those with elastic properties, such as super elastic nitinol. However this description is not intended to be limited by the materials of construction. Those skilled in the art will understand, based on the description of the invention herein, that the same may be accomplished using a material for example with shape memory aspects, such as shape memory nitinol or other materials that currently exist or may exist that have desirable material properties that will achieve the intended function of the current invention, for example stainless steel and/or titanium or titanium alloys. The use of an inserter/holding device may or may not be optional. The specific details of the inserter may vary greatly depending of the chosen embodiment. The exemplary embodiments described herein describe a one-piece staple-like implant. Those skilled in the art will understand, based on the description of the invention herein that an implant of multiple components would still be within the scope of the current invention. Other embodiments may include two or more fixation means that may be of the same style (such as bone screws, bone pegs, blades, staple legs, etc.) or of varying styles or some combination thereof. For fixation means that are modular in nature, they may or may not be made of the same material as the implant described herein. The embodiments described herein contemplate that both staple legs will include the same features. However, it is within the scope of the current invention that staple legs within the same implant may vary in their geometry, fins, length, cross section, barbs, or other physical characteristics relative to each other. Furthermore, one or more of the staple legs may be of a circular or symmetrical geometry while one or more of the other staple legs may be within the scope of this invention. 
         [0036]    The exemplary embodiments described herein are not intended to be limiting. The embodiments described herein can be manufactured from a number of different materials or combinations of materials. In the exemplary embodiments described herein, the implant may be made of a material that may have elastic or spring properties or shape memory properties that may allow the implant to have more than one configuration. Nitinol, for example, possesses material properties, such as shape memory and/or super elasticity that may provide the inherent properties to allow an embodiment to have multiple configurations. Still other materials such as PEEK or other polymers may also possess material properties beneficial for the embodiments as described herein. A combination of materials may also be preferred. The scope of this invention would apply to staples or implants manufactured from a number of materials such as nitinol, stainless steel, titanium, PEEK, polymers, biologic or resorbable materials. Based on the description of the invention herein, those skilled in the art will realize the merits of the current invention are independent of material but may be more beneficial in some materials than others. For example, certain aspects of the invention may be more appealing in nitinol given its dynamic compressive abilities in bone staples and its difficulty in manufacturability. Based on the description of the invention herein, those skilled in the art will realize the benefits of the current invention and will appreciate that the intent of this invention may be realized in other embodiments.