Patent Abstract:
An implant for osteosynthesis which can be used to repair fractures and or fuse joints. The implant comprises one or more through holes for the passage of one or more sutures therethrough and or one or more sutures may be an integral part of the implant. The one or more sutures may be used to pull bone segments together and create compression therebetween and or to affix soft tissue to a bone segment.

Full Description:
BACKGROUND OF THE INVENTION 
     Field of the Invention 
       [0001]    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 that is placed within all or part of a bony structure. Such systems are used in osteosynthesis, wherein the implant bridges a fracture or joint to provide rigidity and aid in healing of the fracture or fusion site. The implant devices of the present invention may be placed in an intramedullary canal or within a bone either completely or partially. The implant may primarily be used for fixation or for aiding in creating a fusion across more than one bone or within a single bone or bone segment. The implant may be constructed of a biologic material, a synthetic material, and or a resorbable material which may be biologic or synthetic. The implant may have material properties or other means for promoting bone growth (osteoinductive) and or for providing a structure for promoting bone growth (osteoconductive). The implant may be provided in a sterile kit and may be preassembled to an instrument for means of insertion. In addition, the present invention provides resistance to pull-out and or rotation and/or pistoning once implanted. Furthermore, the implant includes a means for attaching a suture for additional tissue fixation. The implant may be indicated for the various bones of the entire skeleton. A “fixation device” or the 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. 
       SUMMARY OF THE INVENTION 
       [0002]    The present invention includes an implant or other bone fastening device. The implant may be placed fully or partially within a bone&#39;s intramedullary canal or within the bone itself. The implant is used for fixation or for aiding in the creating a fusion across more than one bone or within a single bone or bone segment. The implant may be constructed from a number of biocompatible materials including but not limited to a biologic material, a synthetic material, and or a resorbable material which may be biologic or synthetic. The implant may have material properties or other means for promoting bone growth (osteoinductive) and or for providing a structure for bone growth (osteoconductive). The implant may be provided in a sterile kit and may be preassembled to an instrument for means of insertion. The implant of the present invention can be inserted in an axial direction by simply pushing it into the bone. It does not have to be screwed in. It may optionally be rotated when it is pushed in, but rotation usually is not necessary. In addition, the implant devices of the present invention provide resistance to pull-out and or rotation and or pistoning once implanted. Furthermore, the implant includes a means for attaching a suture for additional tissue fixation. 
         [0003]    The devices of the present invention may be of one piece construction or of more than one piece. The embodiments described herein are of one piece construction but it will be apparent to those skilled in the art how to make them from more than one piece based upon the disclosures herein. The preferred embodiment may have a tapered geometry for better purchase in the bone in order to resist pull-out and may provide tissue fixation. The implant also has features for engaging bone in a manner to resist pull-out and or rotation and or pistoning. The present invention has a means for attaching a suture that may be utilized for soft or hard tissue attachment. 
         [0004]    The terms “implant”, “implant device”, “fixation device” and “device” are used interchangeably herein to refer to the devices of the present invention. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0005]      FIG. 1  is a perspective view of a first embodiment of the invention. 
           [0006]      FIG. 2  is a side view of a first embodiment of the invention. 
           [0007]      FIG. 3  is a top view of a first embodiment of the invention. 
           [0008]      FIG. 4  is an end view of a first embodiment of the invention. 
           [0009]      FIG. 5  is a top view of a first embodiment of the invention. 
           [0010]      FIG. 5A  is the section view A-A of  FIG. 5 . 
           [0011]      FIG. 6  is a perspective view of a second embodiment of the invention. 
           [0012]      FIG. 7  is a side view of a second embodiment of the invention. 
           [0013]      FIG. 8  is a top view of a second embodiment of the invention. 
           [0014]      FIG. 8A  is the section view A-A of  FIG. 8 . 
           [0015]      FIG. 9  is a perspective view of a third embodiment of the invention. 
           [0016]      FIG. 10  is a side view of a third embodiment of the invention. 
           [0017]      FIG. 11  is an end view of a third embodiment of the invention. 
           [0018]      FIG. 12  is a top view of a third embodiment of the invention. 
           [0019]      FIG. 12A  is the section view A-A of  FIG. 12 . 
           [0020]      FIG. 13  is a perspective view of on an exemplary embodiment of the invention shown assembled to an insertion device. 
           [0021]      FIG. 14  is a top view of a surgical kit describing the implant and instruments of the invention. 
           [0022]      FIG. 15  is a side view of one exemplary embodiment of the invention in one potential application showing the implant not fully inserted into the bone with a suture. 
           [0023]      FIG. 16  is a side view of one exemplary embodiment of the invention in one potential application showing the implant in fully inserted into the bone with a suture extending from the implant and the bone for soft tissue attachment. 
           [0024]      FIG. 17  is a top view of a fourth embodiment of the invention with a section line A-A showing a double suture integral to the implant. 
           [0025]      FIG. 17A  is the section view of the fourth embodiment shown in  FIG. 17 . 
           [0026]      FIG. 18  is a top view of a fifth embodiment of the invention with a section line A-A showing a single suture integral to the implant. 
           [0027]      FIG. 18A  is the section view of the fifth embodiment shown in  FIG. 18 . 
           [0028]      FIG. 19  is a side view showing the detail of an embodiment of the bone engaging features of the invention. 
           [0029]      FIG. 20  is a perspective view of multiple possible alternate embodiments of the bone engaging features of the invention. 
           [0030]      FIG. 21  is a side view of a sixth embodiment depicting a hole in either end of the implant. 
           [0031]      FIG. 22  is a side view of a seventh embodiment depicting an implant releaseably attached to an inserter/driver. 
           [0032]      FIG. 23  is a close-up view of the connection means of the embodiment shown in  FIG. 22 . 
           [0033]      FIG. 24  is a top view of an eighth embodiment depicting a design of the invention with a core member. 
           [0034]      FIG. 24A  is the section view A-A of  FIG. 24 . 
           [0035]      FIG. 25  is a top view of a ninth embodiment depicting a design of the invention with a core member extending completely through the implant. 
           [0036]      FIG. 25A  is the section view A-A of  FIG. 25 . 
           [0037]      FIG. 26  is a side view of a tenth embodiment of the invention depicting an implant with extended ends. 
           [0038]      FIG. 27  is an exploded view of an alternate embodiment of a kit of the invention with the implant pre-assembled to an inserter in a sterile package. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0039]    The present invention includes an implant for spanning and or fixating at least two bone segments of different bones or the same bone. Exemplary embodiments of the current invention are discussed in the figures below. The implant may have bone engaging features and fixation features which are used for tissue attachment. The fixation features provide a means for generating compression across the bone segments to further aid in the healing of the bone. The present invention may have an apparatus or instrument for inserting the implant that is pre-assembled or affixed to the implant. The embodiments described herein may be constructed of any suitable biocompatible material which may be biologic or synthetic. The implant of the current invention may be packaged as an implant kit with the associated instruments needed to complete the implantation. 
         [0040]      FIG. 1  is a perspective view of an implant  100  having a first end  110  and a second end  120 . First end  110  may be placed into a first bone segment and second end  120  may be placed into a second bone segment or second end  120  may be placed into a first bone segment and first end  110  may be placed into a second bone segment. The bone segments may be adjacent, opposing bones or the same bone across a fracture or osteotomy site. First end  110  has features  140  that may be rings or barbs for engaging bone. The number of bone engaging features may vary by implant size and geometry. The style of the bone engaging features  140  may also vary to include barbs of various styles, threads, rings, bumps, teeth or the like. The bone engaging features  140  may or may not be circular in cross-section. First end  110  also includes a through hole  150  that may be used with a suture or the like for tissue fixation. The suture and through hole  150  may be used to generate compression between the bone segments that are engaged with implant ends  110  and  120 . The compression may be generated by having the second end  120  engaged in bone, while the bone in which first end  110  may be engaged is pulled towards the second end  120  by passing the suture through the hole  150  then through the bone attached to the first end  110  and tightening the suture such that the bones segments are brought together. In this figure, the implant  100  may also act as a tissue anchor and as an aid in fusing or compressing the two bone segments. The use of the suture with through hole  150  also provides a means for resisting rotation and or pistoning of the implant relative to the bone. An alternate embodiment may have the suture pre-assembled to the implant either temporarily or permanently. The suture may or may not be packaged with the implant, pre-threaded through the suture hole, tied to the suture hole, and or injection molded into the implant. The suture may be integral with the implant which may eliminate the through hole  150 , but still provide a means for anchoring, generating compression or controlling orientation as described herein. End  110  may also have a surface  155  that may be relatively flat for resisting rotation of the implant  100  in the bone. Hole  150  may have a feature  152  at the transition of the hole  150  to the surface  155  that may prevent tearing or breaking of the suture. End  110  may have a surface  151  that may be tapered for facilitating insertion into the bone. Surface  151  may also be of geometry to prevent stress risers in the bone at the end of the implant. The implant  100  has an end  120  for engaging a bone or segment of bone. As illustrated, end  120  has bone engaging features  160  that may be rings or barbs for engaging bone. The number of bone engaging features  160  may vary by implant size and geometry. The style of the bone engaging features  160  may also vary to include barbs of various styles, threads, rings, bumps, teeth or the like. The bone engaging features  160  may or may not be circular in cross-section. The bone engaging features  160  may or may not be similar to the bone engaging features  140 . The type of bone engaging feature may also vary within the same implant. For example bone engaging features  160  may alternate between circular barbs and non-circular rings. End  120  may have surface  125  that may be tapered for facilitating insertion into the bone. Surface  125  may also be of geometry to prevent stress risers in the bone at the end  120 . Implant  100  has a cannulation  105  that may extend through the entire length of the implant  100 . First end  110  and second end  120  may have feature  130  interposed between them. Feature  130  may serve as a stop to prevent first end  110  or second end  120  from extending too far into a bone segment. Feature  130  may have faces  135  that create a non-circular cross-section and minimize the amount of implant material that may be between two opposing bone segments. 
         [0041]      FIG. 2  is a side view of the embodiment of  FIG. 1 . The first end  110  of the implant  100  has bone engaging features with a major diameter of  195  and a minor diameter of  196 . In this figure, the bone engaging features  140  are of uniform size. Other embodiments are possible that may have bone engaging features that are of varying sizes and configurations. The first end  110  may be further defined as having a length  102 . Through hole  150  may pass through surface  155  and may extend through certain bone engaging features  140 . Through hole  150  may be configured at any location or angle to the long axis of the implant  100 . Furthermore, through hole  150  is intended to allow passage of a secondary element (i.e., a suture or insertion instrument) both into and out of the implant  100 . Through hole  150  is shown passing from one side of the implant  100  and out of the opposite side, an alternate embodiment may have a passage hole that enters and exits on the same side of the implant  100 . Still another embodiment may have a passage hole or suture that enters and exists from the top to bottom of the implant  100 . Second end  120  of the implant  100  has bone engaging features with a major diameter of  190  and a minor diameter of  191 . In this figure, the bone engaging features  160  are of uniform size. Other embodiments are possible that may have bone engaging features that are of varying sizes and configurations. The second end  120  may be further defined as having a length  101 . In this figure, second end  120  is shown not having a through hole  150 . (See also  FIG. 21  which has through holes  403  and  404 .) In an alternate embodiment, second end  120  may have a through hole  150  that may be used with the suture or the like for tissue fixation. The suture and through hole  150  may be used to generate compression between the bone segments that are engaged with the implant ends  110  and  120 . The compression may be generated by having the first end  110  engaged in bone, while the bone in which second end  120  may be engaged is pulled towards the first end  110  by passing the suture through the hole  150  then through the bone attached to the second end  120  and tightening the suture such that the bone segments are brought together. In this figure, the implant  100  may also act as a tissue anchor and as an aid in fusing or compressing the two bone segments. In yet other embodiments, both ends  110  and  120  may have through holes  150 . Yet further, alternate embodiments may have the suture pre-assembled to the both ends of the implant either temporarily or permanently. The suture may be simply packaged with or without the implant, pre-threaded through the suture holes, tied to the suture hole, and or injection molded into the implant. The suture may be integral with the implant in multiple locations or positions which may eliminate the through holes  150 , but still provide multiple means for anchoring, generating compression or controlling orientation as described herein.  FIG. 2  shows feature  130  having an effective diameter  136  and a length  103 . Some embodiments may require feature  130  to be as small as possible so as not to reduce the bone to bone apposition between the two bone segments. 
         [0042]      FIG. 3  is a top view of the embodiment described in  FIGS. 1 and 2 . This figure shows first end  110  having two flats  155  and  156  that may be present. These flats  155  and  156  are used to resist rotation of the implant  100  relative to bone.  FIG. 3  shows first end  110  and second end  120  both having a circular cross-section. Alternate embodiments may have a combination of a circular and non-circular ends where first end  110  may be non-circular and second end  120  may be circular or visa versa. The implant is depicted has having a first end  110  and a second end  120  with different lengths  101  and  102 . Alternate embodiments may have length  101  and  102  that may or may not be of equal length. The implant is depicted as having a first end  110  and a second end  120  with similar effective outer diameters  190  and  195 . Alternate embodiments may have effective outer diameters or dimensions  190  and  195  that may or may not be of equal value. The implant is depicted as having a first end  110  with a centerline  111  and a second end  120  with a collinear centerline  121 . Alternate embodiments may have first end  110  with a centerline  111  and second end  120  with a centerline  121  that may or may not be collinear and or parallel. 
         [0043]      FIG. 4  is an end view of implant  100  that has a cannulation  105  that may extend the entire length of the implant  100 .  FIG. 4  shows feature  130  having a non-circular cross-section. In an alternate embodiment, feature  130  may or may not have a circular cross-section. The cannulation may be used to facilitate implantation or may be used to accommodate another means of additional fixation. 
         [0044]      FIG. 5  is a side view of implant  100  and  FIG. 5A  is a section view A-A of the implant  100 . The section view A-A shows the cannulation  105  extending through the length of the implant  100 . It further shows the through hole  150  intersecting the cannulation and in this embodiment the through hole  150  may extend through the entire width of the implant. Alternate embodiments may or may not include the cannulation  105 . 
         [0045]      FIG. 6  is a perspective view of implant  300 , a second embodiment of the invention. Implant  300  has a first end  310  and a second end  320 . First end  310  may be placed into a first bone segment and second end  320  may be placed into a second bone segment. The bone segments may be opposing bones or the same bone across a fracture or osteotomy site. First end  310  has features  340  that may be rings or barbs for engaging bone. The number of bone engaging features may vary by implant size and geometry. The style of the bone engaging features  340  may also vary to include barbs of various styles, threads, rings, bumps, teeth or the like. The bone engaging features  340  may or may not be circular in cross-section. First end  310  may also include a through hole  350  that may be used with a suture or the like for tissue fixation or for insertion of the implant into a surgical site. The suture and through hole  350  may be used to generate compression between the bone segments that are engaged with implant ends  310  and  320 . The compression may be generated by having the second end  320  engaged in bone, while the bone in which first end  310  is engaged is pulled towards the second end  320  by passing the suture through the hole  350  then through the bone attached to the first end  310  and tightening the suture such that the bones segments are brought together. In this embodiment, the implant  300  may also act as a tissue anchor and as an aid in compressing or fusing the two bone segments. The use of the suture with through hole  350  may also provide a means for resisting rotation and or pistoning of the implant relative to the bone. An alternate embodiment may have the suture pre-assembled to the implant either temporarily or permanently. The suture may be simply packaged with or without the implant, pre-threaded through the suture hole, tied to the suture hole, and or injection molded into the implant. The suture may be integral with the implant, as shown in  FIGS. 17 a , 17 b , 18 a , and 18 b   , which may eliminate the through hole  350 , but still provide a means for anchoring, generating compression or controlling orientation as described herein. End  310  may also have a surface  355  that may be relatively flat for resisting rotation of the implant  300  in the bone. Hole  350  may have a feature(s)  352  at the transition of the hole  350  to the surface  355  that may prevent tearing or breaking of the suture. End  310  may have a surface  351  that may be tapered for facilitating insertion into the bone. Surface  351  may also be of a geometry to prevent stress risers in the bone at the end of the implant. Implant  300  may have an end  320  for engaging a bone or segment of bone. End  320  may have bone engaging features  360  that may be rings or barbs for engaging bone. The number of bone engaging features  360  may vary by implant size and geometry. The style of the bone engaging features  360  may also vary to include barbs of various styles, threads, rings, bumps, teeth or the like. The bone engaging features  360  may or may not be circular in cross-section. The bone engaging features  360  may or may not be similar to the bone engaging features  340 . The type of bone engaging feature may also vary within the same implant. For example bone engaging features  360  may alternate between circular barbs and non-circular rings. End  320  may have surface  325  that may be tapered for facilitating insertion into the bone. Surface  325  may also be of geometry to prevent stress risers in the bone at the end of the implant. Implant  300  may be solid without the previously described cannulation  105 . First end  310  and second end  320  may have feature  330  interposed between them. Feature  330  may serve as a stop to prevent first end  310  or second end  320  from extending too far into a bone segment. Feature  330  may have faces  335  that create a non-circular cross-section and minimize the amount of implant material that may be between two opposing bone segments. 
         [0046]      FIG. 7  is a side view of the embodiment of  FIG. 6 . The first end  310  of implant  300  is shown to have an angle  307  relative to second end  320 . The angle  307  may be useful in facilitating deformity correction or may help better correct the normal anatomy. In this figure, angle  307  is shown in one plane. Other embodiments may have more complex or compound angles. The first end  310  of the implant  300  may have bone engaging features with a major diameter of  395  and a minor diameter of  396 . This figure further shows the bone engaging features  340  are of uniform size. Other embodiments are possible that may have bone engaging features that are of varying sizes and configurations. The first end  310  may be further defined as having a length  302 . Through hole  350  may pass through surface  355  and may extend through certain bone engaging features  340 . Second end  320  of the implant  300  may have bone engaging features with a major diameter of  390  and a minor diameter of  391 . In this figure, the bone engaging features  360  are of uniform size. Other embodiments are possible that may have bone engaging features that are of varying sizes and configurations. The second end  320  may be further defined as having a length  301 . In this figure, second end  320  is shown not having a through hole  350 . In an alternate embodiment, second end  320  may have a through hole  350  that may be used with the suture or the like for tissue fixation. The suture and through hole  350  may be used to generate compression between the bone segments that are engaged with the implant ends  310  and  320 . The compression may be generated by having the first end  310  engaged in bone, while the bone in which second end  320  may be engaged is pulled towards the first end  310  by passing the suture through the hole  350  then through the bone attached to the second end  320  and tightening the suture such that the bones segments are brought together. This figure further shows that the implant  300  may also act as a tissue anchor and as an aid in compressing or fusing the two bone segments. In yet other embodiments both ends  310  and  320  may have through holes  350 . Yet further, alternate embodiments may have the suture pre-assembled to both ends of the implant either temporarily or permanently. The suture may be simply packaged with the implant, pre-threaded through the suture holes, tied to the suture hole, and or injection molded into the implant. The suture may be integral with the implant in multiple locations or positions which may eliminate the through holes  150 , but still provide multiple means for anchoring, generating compression or controlling orientation as described herein.  FIG. 7  shows feature  330  having an effective diameter  336  and a length  303 . Some embodiments may require feature  330  to be as small as possible so as not to reduce the bone to bone apposition between the two bone segments. 
         [0047]      FIG. 8  is a top view of the embodiment described in  FIGS. 6 &amp; 7 . This figure shows first end  310  having two flats  355  and  356  that may be present. These flats  355  and  356  may be used to resist rotation of the implant  300  relative to bone.  FIG. 8  shows first end  310  and second end  320  both having a circular cross-section. Alternate embodiments may have a combination of a circular and non-circular ends where first end  310  may be non-circular and second end  320  may be circular or visa versa. The implant is depicted as having a first end  310  and a second end  320  with different lengths  301  and  302 . Alternate embodiments may have length  301  and  302  that may or may not be of equal length. The implant is depicted has having a first end  310  and a second end  320  with different effective outer diameters  390  and  395 . In this figure, first end  310  has a larger effective diameter  395  than the effective diameter  390  of second end  320 . An alternate embodiment may have first end  310  with a smaller effective diameter  395  than the effective diameter  390  of second end  320 . Alternate embodiments may have effective outer diameters or dimensions  390  and  395  that may or may not be of equal value. The implant is depicted has having a first end  310  with a centerline  311  and a second end  320  with a non collinear centerline  321 . In this embodiment centerline  311  may have angle  307  relative to centerline  321 . Alternate embodiments may have first end  310  with a centerline  311  and second end  320  with a centerline  321  that may or may not be collinear and or parallel in multiple planes.  FIG. 8  is a side view of the implant  300  and  FIG. 8A  is a section view A-A of the implant  300 . The section view B-B shows the solid cross-section of the implant  300 . 
         [0048]      FIG. 9  is s a perspective view of implant  500 , a third embodiment of the invention. Implant  500  has a first end  510  and a second end  520 . First end  510  may be placed into a first bone segment and second end  520  may be placed into a second bone segment. The bone segments may be opposing bones or the same bone across a fracture or osteotomy site. First end  510  has features  540  that may be rings or barbs for engaging bone. The number of bone engaging features may vary by implant size and geometry. The style of the bone engaging features  540  may also vary to include barbs of various styles, threads, rings, bumps, teeth or the like. The bone engaging features  540  may or may not be circular in cross-section. First end  510  may also include a through hole  550  that may be used with a suture or the like for tissue fixation. The suture and through hole  550  may be used to generate compression between the bone segments that are engaged with the implant ends  510  and  520 . The compression may be generated by having the second end  520  engaged in bone, while the bone in which first end  510  may be engaged is pulled towards the second end  520  by passing the suture through the hole  550  and then through the bone attached to the first end  510  and then tightening the suture such that the bones segments are brought together. The order/steps of passing the suture through the hole can vary. It can be placed through the implant first then the bone. Or it can be placed through the bone first then the implant. The order of steps isn&#39;t critical, as long as the suture passes through the implant. In this figure, the implant  500  may also act as a tissue anchor and as an aid in compressing or fusing the two bone segments. The use of the suture with through hole  550  may also provide a means for resisting rotation and or pistoning of the implant relative to the bone. End  510  may also have a surface  555  that may be relatively flat for resisting rotation of the implant  500  in the bone. Hole  550  may have a feature  552  at the transition of the hole  550  to the surface  555  that may prevent tearing or breaking of the suture. End  510  may have a surface  551  that may be tapered for facilitating insertion into the bone. Surface  551  may also be of a geometry to prevent stress risers in the bone at the end of the implant. Implant  500  may have an end  520  for engaging a bone or segment of bone. End  520  may have bone engaging features  560  that may be rings or barbs for engaging bone. The number of bone engaging features  560  may vary by implant size and geometry. The style of the bone engaging features  560  may also vary to include barbs of various styles, threads, rings, bumps, teeth or the like. The bone engaging features  560  may or may not be circular in cross-section. The bone engaging features  560  may or may not be similar to the bone engaging features  540 . The type of bone engaging feature may also vary within the same implant. For example bone engaging features  560  may alternate between circular barbs and non-circular rings. End  520  may have surface  525  that may be tapered. This tapered region  525  may facilitate insertion into the bone and may optimize the engagement with the bone segment. Surface  525  may also be of a geometry to prevent stress risers in the bone at the end of the implant. First end  510  and second end  520  may have feature  530  interposed between them. Feature  530  may serve as a stop to prevent first end  510  or second end  520  from extending too far into a bone segment. Feature  530  may have faces means  535  that create a non-circular cross-section and minimize the amount of implant material that may be between two opposing bone segments. Means  535  may also act as features that key into one or more bone segments. Means  535  may resist rotation of the implant  500  relative to the bone segment(s). Means  535  may also serve to maintain a relative orientation between the implant and bone segments. 
         [0049]      FIG. 10  is a side view of the embodiment of  FIG. 9 . The first end  510  of the implant  500  may have bone engaging features with a major diameter of  595  and a minor diameter of  596 . In this figure, the bone engaging features  540  are of uniform size. Other embodiments are possible that may have bone engaging features that are of varying sizes and configurations. The first end  510  may be further defined as having a length  502 . Through hole  550  may pass through surface  555  and may extend through certain bone engaging features  540 . Second end  520  of the implant  500  may have bone engaging features with a major diameter of  590  and a minor diameter of  591 . In this figure, the bone engaging features  560  vary along the length  501 . The minor diameter  591  may be equivalent for bone engaging features  560  while the major or outer diameters  590 ,  592  and  593  vary in size along the length  501 . The varying diameters  590 ,  592 , and  593  may be a result of taper geometry  525 . Based on the description herein, those skilled in the art will understand that other embodiments are possible that may have bone engaging features that are of varying sizes and configurations. The second end  520  may be further defined as having a length  501 . In this figure, second end  520  is shown not having a through hole  550 . In an alternate embodiment, second end  520  may have a through hole  550  that may be used with the suture or the like for tissue fixation or for insertion of the implant into a surgical site. The suture and through hole  550  may be used to generate compression between the bone segments that are engaged with the implant ends  510  and  520 . The compression may be generated by having the first end  510  engaged in bone, while the bone in which second end  520  may be engaged is pulled towards the first end  510  by passing the suture through the hole  550  then through the bone attached to the second end  520  and tightening the suture such that the bones segments are brought together. In this figure, the implant  500  may also act as a tissue anchor and as an aid in compressing the two bone segments. In yet other embodiments both ends  510  and  520  may have through holes  550 .  FIG. 10  is a side view showing feature  530  having an effective diameter  536 , a length  503  and a feature  535 . Some embodiments may require feature  530  to be as small as possible so as not to reduce the bone to bone apposition between the two bone segments. 
         [0050]      FIG. 11  is an end view of the implant  500 . This view shows the feature  530  having a relatively circular cross-section with means  535  that may be equally positioned on opposite sides of the implant  500 . Alternate embodiments are possible that may have one or more means  535  that may or may not be equally spaced. In an alternate embodiment, feature  530  may or may not have a circular cross-section. 
         [0051]      FIG. 12  is a top view and a section view of the third embodiment. This figure shows first end  510  having two flats  555  and  556  that may be present. These flats  555  and  556  may be used to resist rotation of the implant  500  relative to bone.  FIG. 12  shows first end  510  and second end  520  both having substantially circular cross-sections. Alternate embodiments may have a combination of circular and non-circular ends where first end  510  may be non-circular and second end  520  may be circular or visa versa. The implant is depicted has having a first end  510  and a second end  520  with different lengths  501  and  502 . Alternate embodiments may have lengths  501  and  502  that may or may not be of equal length. The implant is depicted has having a first end  510  with a centerline  511  and a second end  520  with a collinear centerline  521 . Alternate embodiments may have first end  510  with a centerline  511  and second end  520  with a centerline  521  that may or may not be collinear and or parallel. The section view C-C of  FIG. 12  shows the implant  500  with a solid cross-section. It further shows the through hole  550  intersecting the centerline  511  which may also be off centerline. 
         [0052]    Based on the description herein, those skilled in the art will understand that multiple variations of implant geometries are possible that are within the scope of the current invention. The descriptions herein discuss embodiments that may or may not include a pre-assembled suture or the like. A pre-assembled suture may be attached to the implant either temporarily or permanently. The suture may or may not be packaged with the implant, pre-threaded through the suture hole, tied to the suture hole or injection molded into the implant. The inclusion or exclusion of the suture for the descriptions herein is not intended to be limiting in scope. The foregoing embodiments and the embodiments described below may be manufactured from a number of materials including titanium, nitinol, stainless steels, PEEK, polymers, biologics, grafts, and/or resorbable materials. The exemplary embodiments described herein are not intended to be limiting. 
         [0053]      FIG. 13  is one possible embodiment of an instrument for means of insertion of an implant of the invention into the surgical site. The instrument for means of insertion, e.g. the inserter  700  may or may not be preassembled to the implant  750 . Inserter  700  has a handle region  720  to facilitate insertion and manipulation of the implant during insertion. The inserter  700  may have a connecting end  730  that may be customized for a particular implant embodiment. In this figure, connecting end  730  has a connecting member  710  that engages the through hole  760  of an implant  750 . The implant may or may not be preassembled to the inserter. 
         [0054]      FIG. 14  is one possible embodiment of a kit  1000 . Kit  1000  may be provided sterile or non-sterile and may include necessary instruments for completing a surgical procedure. This kit  1000  consists of a tray  1100  that may include an inserter/driver  1150  that may or may not be preassembled to the implant, a first drill/reamer  1160 , a second drill/reamer  1170 , and a k-wire or a suture passer  1180 . This embodiment includes implants  1200  and  1300 . The Implants  1200  and  1300  may be included in various sizes or may not be included in the kit. The implants  1200  and  1300  may be provided as individually packaged items or may be included as a component of kit  1000 . The drill/reamer  1160  and or  1170  may be included in a number of varying diameters. The reamers  1160  and  1170  may or may not be the same diameter. It may be advantageous for reamers  1160  and  1170  to be different diameters. The kit  1000  may include any number for reamers of the same diameter or different diameters. The size diameter used for drill/reamer  1160  and or  1170  may depend on the tightness of fit between the implant and bone as desired by the end user. The amount of pressfit or tightness of fit between the implant and bone may vary by user and may vary depending on surgeon preference, bone quality, bone geometry, etc. The drill/reamers  1160  and  1170  may include markings or indications  1175  that may be used to provide a reference for appropriate reaming or drilling depth. The reamers/drills  1160  and  1170  may have one or more markings  1175 . The markings  1175  may be in multiple locations or configurations. The indications or markings  1175  may provide a visual or physical calibration for indicating depth or some other predetermined measurement. The configuration of the implant kit  1000  is not intended to be limiting. Based on the description herein, those skilled in the art will agree multiple kit configurations may be possible. 
         [0055]    The kit  1000  or a similar kit embodiment may be used to prepare a bone for implantation. For exemplary purposes, a possible hammertoe or PIP fusion technique is described. An implant template and the patient&#39;s radiographs may be used to approximate the appropriate sized implant to be used. The profile of the implant must fit within the internal boundary of the cortical shell of the phalanges under surgical consideration. The planned amount of bone resection should be taken into account when evaluating implant position and size. Correct implant sizing is critical. The final sizing and fit of the implant must be evaluated with the actual implant to ensure proper fit within the bone. The surgeon should create an appropriate incision over the dorsal aspect of the PIP joint. A transverse capsulotomy with release of the collateral ligaments off the head of the proximal phalanx should be performed. The joint dissection and access should provide complete visualization of the articular surfaces of the middle and proximal phalanges. The appropriate bone cuts should be made perpendicular to the long axis of the phalanges. The final toe orientation is achieved by the angle of the bone resection. If the implant is angled, the bone resection should approximate the angle of the implant. The distal head of the proximal phalanx just posterior to the head of the phalange may be resected. The appropriate sized implant is selected. The appropriately sized reamer may be used to verify implant sizing. The appropriate implant reamer may be sterile packaged with the implant kit. A smaller diameter drill or reamer may be used to create an initial pilot hole if desired. The tip of the reamer may be inserted into the proximal phalanx along its central axis while verifying the correct position of the reamer with dorsal-plantar and medial-lateral fluoroscopy views. After the reamer location has been verified, the reamer may be advanced to the minimum required depth as indicated on the reamer, ensuring no to pierce the proximal cortex of the proximal phalanx. Correct trajectory of the implant is critical. Implants that are misaligned may prevent proper bone apposition and subsequent healing of the fusion site. If the reamer is not fully seated to the indicated mark(s)  1175 , the hole may not be drilled to the correct depth. With insufficient reamer depth in the bone, final seating of the implant in the phalanx may be difficult or not possible. The tip of the implant reamer may be inserted into the middle phalanx along its central axis verifying the correct position of the reamer with dorsal-plantar and medial-lateral fluoroscopy views. The implant which may be preloaded onto the instrument for means of insertion, e.g. the inserter, is selected and driven into the proximal phalanx by pushing the implant into the proximal phalanx until the inserter bottoms out on the resected bone surface. Slight tapping may be needed to fully seat the implant in the proximal phalanx then the inserter is removed leaving the middle barbed portion exposed. 
         [0056]    If the suture hole is to be used, prior to inserting the distal end of the implant into the middle phalanx, pass the desired suture though the hole in the implant. Prepare a small hole in the proximal dorsal aspect of the middle phalanx. The suture will be passed through this hole. The order/steps of passing the suture through the hole can vary. It can be placed through the implant first then the bone. Or it can be placed through the bone first then the implant. The order of steps isn&#39;t critical, as long as the suture passes through the implant. With the suture passed through the implant and the middle phalanx, insert the distal end of the implant into the middle phalanx by positioning inserting the end of the implant into the pre-drilled hole in the middle phalanx. Apply axial force by firmly compressing the joint until the implant is fully seated and the resected surfaces of the proximal and middle proximal phalanges come into contact. With the implant fully seated and the implant positioned and alignment verified, the surgeon may proceed with his preferred closure which may be used to provide additional compression or fixation by tightening the suture such that the bone segments are brought closer together. The final closure and ligament reattachment may be performed with the suture that has been passed through the implant suture hole. 
         [0057]      FIG. 15  is a side view of an implant  200  that may have been inserted into the proximal bone segment  210  with a technique similar to the one described here in. The implant  200  has a first end  201  that may be partially inserted into the bone  210  leaving a second end  202  of the implant  200  exposed. Suture  230  is shown passing through the implant suture hole  205 , but prior to full implantation.  FIG. 16  is a side view of the implant  200  fully implanted with the suture  230  passing through the suture hole  205  in the second end  202  of the implant  200 . The suture  230  may also pass through the second bone  220  for final closure and or tissue attachment. When the suture  230  is securely tightened to bone  220  it may provide additional compression between bones  210  and  220 . 
         [0058]      FIG. 17  is a top view of a fourth embodiment of the invention. Implant assembly  800  is illustrated with a section line A-A showing a double suture  810  integral to the implant  820 .  FIG. 17A  is the section view showing the connection area  830  between the implant  820  and double suture  810 . The implant  820  may be of any configuration of the current invention described herein. The double suture  810  may be connected or attached to implant  820  at a connection area  830 . The double suture  810  may be non resorbable or resorbable. The suture  810  may be of any appropriate size. The attachment  830  may be temporary or the attachment  830  may be permanent. The double suture  810  may be integral to the implant  820 . The double suture  810  may be connected or attached to the implant  820  by means of permanently attaching the suture  810  to the implant  820 . The attachment  830  may be made by injection molding, insert molding, adhering, tying or other attachment means known to those skilled in the art. 
         [0059]      FIG. 18  is a top view of a fifth embodiment of the invention. Implant assembly  850  is illustrated with a section line A-A showing a single suture  860  integral to the implant  870 .  FIG. 18A  is the section view showing the connection area  880  between the implant  870  and suture  860 . The implant  870  may be of any configuration of the invention described herein. The suture  860  may be connected or attached to implant  870  at a connection area  880 . The suture  860  may be non resorbable or resorbable. The suture  860  may be of any appropriate size. The attachment  880  may be temporary or the attachment  880  may be permanent. The suture  860  may be integral to the implant  870 . The suture  860  may be connected or attached to the implant  870  by means of permanently attaching the suture  860  to the implant  870 . The attachment  880  may be made by injection molding, insert molding, adhering, tying or other attachment means known to those skilled in the art. 
         [0060]      FIG. 19  is a side view showing the detail of one possible embodiment of the bone engaging features of the current invention. The implant  900  has bone engaging features  901  and  902 . Bone engaging features  901  and  902  may or may not be of the same geometry. In this embodiment bone engaging features  901  and  902  are mirror images and may allow improved purchase and prevent pullout of the implant  900  when the implant  900  is implanted into opposing bones. Bone engaging feature  901  has an angle  910  with a depth of  920  and a radius of  930 . Bone engaging feature  901  has a face  935  that is at an angle  940 . Bone engaging feature  902  has an angle  950  with a depth of  960  and a radius of  970 . Bone engaging feature  902  has a face  975  that is at an angle  980 . Angles  910  and  950  may or may not be of equal value or similar direction but the direction of the angle is critical to the implant locking into the canal of the bone. As shown in  FIG. 19 , angles  910  and  950  are angled toward the shoulder  530 . This orientation creates a sharp corner, angle  940  and  980 , that will tend to resistively engage the prepared bone canal when a force is applied in the reverse direction of insertion. This feature advantageously holds the middle and proximal phalanges in direct opposition. Depths  960  and  920  may or may not be of equal value, orientation or geometry. Radii  930  and  970  may or may not be of equal value or orientation. Faces  935  and  975  may or may not be of equal length or similar geometry. Faces  935  and  975  may or may not be collinear. 
         [0061]      FIG. 20  is a perspective view of multiple possible alternate embodiments of the bone engaging features of the current invention. Implant  2100  is shown with a first end  2120 . First end  2120  may have a plurality of bone engaging features  2150  that are barb like and may be spaced along the length of first end  2120  and around the perimeter of first end  2120 . First end  2120  may have areas  2151  that may be void of bone engaging features such as  2150 . Implant  2200  has a first end  2220 . First end  2220  may have bone engaging features  2250  that may be helical in nature. Implant  2300  has first end  2320 . First end  2320  may have bone engaging features  2350 . Bone engaging features  2350  may have features  2352  and a geometry that may be used to create features  2351 . Bone engaging features  2351  may vary in geometry and sharpness along the length of first end  2320 . Implant  2400  may have first end  2420 . First end  2420  may have bone engaging features  2450  and groove(s)  2451 . Bone engaging features  2450  may vary in size, sharpness and geometry along the length of first end  2420 . Implant  2500  may have a first end  2520 . First end  2520  may have bone engaging features  2550 . Bone engaging features  2550  may be interrupted by hole(s)  2552 . Bone engaging features may further be interrupted by slot  2551  that may cause the first end  2520  to expand or be expandable. As will be apparent to those skilled in the art based upon the disclosures herein, an implant of the invention may have one or multiple types of bone engaging features to optimize effectiveness of the implant for its intended purpose. 
         [0062]      FIG. 21  is a side view of an implant  400  similar to the embodiment shown in  FIGS. 9 and 10  but in addition to a through hole  404  in the distal end  402 , the implant  400  also has a through hole  403  in the proximal end  401 . Implant  400  may also include bone engaging features  406  and or a means  405  for determining orientation and or position in a bone. 
         [0063]      FIG. 22  shows a seventh embodiment  430  of the current invention. Device  430  has an implant  431  that is attached to a driver end  432 . Implant  431  may be releaseably attached to driver  432  such that after implantation the driver end  432  may be snapped or broken off. The implant  431  has a proximal end  433  and a distal end  434 . The implant  431  may have bone engaging features  435  and or a through hole  436  as previously described herein. As depicted in  FIG. 23 , implant  431  is attached at one end to a driver  432 . As shown, the attachment  437  is at the distal end  434  of implant  431  but may also be at the proximal end  433 . The attachment  437  will be of a geometry that will allow transfer of sufficient force and manipulation for insertion while allowing the driver end  432  to be removed by either breaking, snapping or cutting the connection attachment means  437 . This may be advantageous to allow the implant and inserter to be manufactured from the same material by conventional manufacturing processes such as machining or injection molding. This may reduce the cost of the device and may provide for additional recycling of the driver material. This may be further advantageous in reducing surgical complexity and or surgical time. 
         [0064]      FIG. 24  is a top view and section view of an eighth embodiment  450  of an implant having a core member  454 . Implant  450  has other features and advantages of the current invention as described herein. The core member  454  is shown in the proximal end  451  of the implant but may also extend into or be partially or entirely within the proximal end  452 . The core member  454  may provide additional strength to implant  450 . For example if the implant  450  is comprised of PEEK or another plastic or biocompatible material or a resorbable material or bone, it may be advantageous to have a core member  454  comprised of a stronger material such as nitinol, stainless steel, titanium or other biocompatible material. The core  454  would be relatively stronger than the surrounding implant material. This may be particularly advantageous for enhancing the strength of smaller implants and may provide a means for creating bone engaging features on implants of small size with enhanced core strength. The core may also provide the benefit of being radio-opaque. 
         [0065]      FIG. 25  is a top view and section view of a ninth embodiment of the invention, implant  470 . Implant  470  has a core member  474  and may have other features and advantages of the current invention as described herein. The core member  474  is shown extending completely through the implant  470  and incorporates the through hole  473 . The core member  474  may provide additional strength to implant  470 . For example, if the implant  470  is comprised of PEEK or another plastic or biocompatible material or a resorbable material or bone, it may be advantageous to have a core member  474  comprised of a stronger material such as nitinol, stainless steel, titanium or other biocompatible material. The core  474  would be relatively stronger than the surrounding implant material. The core may also provide the benefit of being radio-opaque. Having a core extend completely through the implant  470  would provide a driver end  476  that is releaseably attached to the implant  470 . Implant  470  may be releaseably attached to driver end  476  such that after implantation the driver end  476  may be snapped or broken off. The implant  470  has a proximal end  471  and a distal end  472 . The implant  470  may have bone engaging features  475  and or a through hole  473  as previously described herein. As depicted in  FIG. 25 , implant  470  has a core member  474  that is attached at one end to a driver  476 . As shown, the attachment  476  is at the distal end  472  of implant  470  but may also be at the proximal end  471  depending on the intended use of the device. The attachment means  477  will be of a geometry that will allow transfer of sufficient force and manipulation for insertion while allowing the driver end  476  to be removed by either breaking, snapping or cutting the connection attachment means  477 . This may be advantageous to allow the implant and inserter to be manufactured by low cost processes such as injection molding or over molding. This may reduce the cost of the device and may provide for additional recycling of the driver material. This may be further advantageous in reducing surgical complexity and or surgical time. 
         [0066]      FIG. 26  is a side view of implant  480 . Implant  480  may have a proximal end  481  and a distal end  482 . Implant  480  may also have bone engaging means  484  and or a through hole  483  as well as other features and advantages of the current invention as described herein. Implant  480  may also have an extended proximal end  485  and or an extended distal end  486 . Extended ends  485  and  486  may be trimmed at the time of use to create a specific size. The extended ends  485  and  486  may be smooth or may have other features as described herein. 
         [0067]      FIG. 27  is an exploded view of an implant kit  600  that may have an implant of the current invention as described herein pre-assembled to an insertion or driver device  602 . The assembly of the inserter/driver and implant may be contained in a clamshell or other holding device  601 . The assembly of the inserter/driver and implant may be sterile packaged. 
         [0068]    The descriptions of the implants, instruments, and surgical technique embodiment and configurations described herein are not limiting. Based on the description herein, those skilled in the art will understand that there are numerous configuration and or embodiments that will be within the scope of the current invention. The exemplary embodiments described herein are not intended to be limiting.

Technology Classification (CPC): 0