Patent Publication Number: US-11660201-B2

Title: Systems, apparatuses, and methods for correcting a bone defect

Description:
FIELD 
     This disclosure relates generally to medical devices, and more specifically to implants for correcting bone deformity. 
     BACKGROUND 
     Tailor&#39;s bunion, or bunionette, is a condition of the human foot resulting in the inflammation of the fifth metatarsal bone at the base of the smallest toe. Tailor&#39;s bunions have proven to be difficult to repair due to the small size of the fifth metatarsal, especially at the distal metaphysis where many surgeons would prefer to make osteotomies. Further, the small cross-sectional area of the fifth metatarsal makes even the smallest screw difficult to place for a shifting head osteotomy (e.g., distal chevron, distal transverse cut), as the screws themselves take up a large portion of the remaining bone-on-bone contact. 
     SUMMARY 
     In some embodiments, an implant having a unitary body includes an intramedullary portion and an extramedullary portion. The intramedullary portion is sized and structured to be received within an intramedullary canal of a first bone and defines a longitudinal axis. The extramedullary portion includes a surface defining an axis that is disposed at an angle with respect to the longitudinal axis. An aperture defined along the extramedullary portion is sized and configured to receive a fastener therein for coupling the extramedullary portion of the implant to a second bone. 
     In some embodiments, the fastener is one of a locking fastener and a non-locking fastener. 
     In some embodiments, the extramedullary portion defining the aperture includes surface features permitting a fastener to be received at a plurality of angles relative to a central axis defined by the aperture. 
     In some embodiments, the surface features include a plurality of intermittent threads. 
     In some embodiments, the central axis defined by the aperture is positioned at an oblique angle with respect to the longitudinal axis defined by the intramedullary portion of the implant. 
     In some embodiments, the intramedullary portion has a circular cross-sectional geometry. 
     In some embodiments, a first end of the intramedullary portion of the implant tapers to a blunt end. 
     In some embodiments, a first end of the intramedullary portion of the implant tapers to a blade. 
     In some embodiments, the extramedullary portion of the implant is enlarged with respect to the intramedullary portion. 
     In some embodiments, the intramedullary portion of the implant includes one or more surface features disposed thereon for securing the implant within an intramedullary canal of a first bone. 
     In some embodiments, the surface features are selected from a group consisting of threads, splines, fins, and knurling. 
     In some embodiments, the first bone is a first bone fragment formed from a third bone, and the second bone is a second bone fragment formed from the third bone. 
     In some embodiments, the first bone and the second bone are two adjacent bones of a joint. 
     In some embodiments, a system includes an implant and a fastener. The implant has a unitary body including an intramedullary portion and an extramedullary portion. The intramedullary portion is sized and structured to be received within an intramedullary canal of a first bone and defines a longitudinal axis. The extramedullary portion is structured to be coupled to a second bone. An aperture defined by the extramedullary portion includes a surface defining an axis that is disposed at an angle with respect to the longitudinal axis. The fastener is sized and structured to be received within the aperture defined by the extramedullary portion of the implant. 
     In some embodiments, a central axis defined by the aperture is positioned at an oblique angle with respect to the longitudinal axis defined by the intramedullary portion of the implant. 
     In some embodiments, the surface of the extramedullary portion of the implant includes a planar surface. 
     In some embodiments, the fastener is one of a locking screw and a non-locking screw. 
     In some embodiments, the system includes an inserter having a body extending from a first end to a second end. At least one of the first end and the second end defines a pocket that is interconnected with a hole. 
     In some embodiments, the pocket is sized, dimensioned, and structured to receive at least a portion of the extramedullary portion therein such that, when the extramedullary portion of the implant is received within the pocket, the hole defined by the inserter aligns with the aperture defined by the implant. 
     In some embodiments, the system includes a guide having a body extending from a first end to a second end. A hole extends through the body from the first end to the second end, and at least one of the first end and the second end is at least partially threaded for engaging a thread defined by the aperture defined by the implant. 
     In some embodiments, a treatment method includes forming a longitudinal hole in a first bone; inserting an intramedullary portion of an implant into the longitudinal hole; forming a hole in a second bone based on a position of an aperture defined by an extramedullary portion of the implant relative to the second bone; and inserting a fastener through the aperture and into the second bone to couple the extramedullary portion of the implant to the second bone. The intramedullary portion of the implant defines a first longitudinal axis, and the extramedullary portion has a surface defining an axis that is disposed at an angle with respect to the longitudinal axis defined by the intramedullary portion. 
     In some embodiments, forming the hole in the second bone includes inserting a cutting tool into a guide hole defined by a guide, and further inserting the cutting tool into the guide hole until the cutting tool engages the second bone. The guide is coupled to the implant such that the guide hole is aligned with the aperture defined by the implant. 
     In some embodiments, the method includes disengaging the guide from the implant prior to inserting the fastener through the aperture. 
     In some embodiments, the method includes disengaging an insertion tool from the implant prior to inserting the fastener through the aperture. 
     In some embodiments, the longitudinal hole is formed using a broach. 
     In some embodiments, the first bone is a first bone segment formed from a third bone, the second bone is a second bone segment formed from the third bone, and the method includes performing an osteotomy on the third bone to form the first bone segment and the second bone segment. 
     In some embodiments, the third bone is a fifth metatarsal. 
     In some embodiments, the angle between the axis defined by the surface and the longitudinal axis is a right angle. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG.  1    is a plan view of one example of an implant in accordance with some embodiments; 
         FIG.  2    is a side view of the implant illustrated in  FIG.  1    in accordance with some embodiments; 
         FIG.  3    is a detail view of the enlarged head of an extramedullary portion of the implant illustrated in  FIG.  1    in accordance with some embodiments; 
         FIG.  4    is a plan view of another example of an implant in accordance with some embodiments; 
         FIG.  5    is a side view of the implant illustrated in  FIG.  4    in accordance with some embodiments; 
         FIG.  6    is a bottom-side plan view of one example of an inserter in accordance with some embodiments; 
         FIG.  7    is a side view of the inserter illustrated in  FIG.  6    in accordance with some embodiments; 
         FIG.  8    is a top-side plan view of the inserter illustrated in  FIG.  6    in accordance with some embodiments; 
         FIG.  9    is a detailed view of the engagement end of an inserter, taken along line  9 - 9  in  FIG.  7   , in accordance with some embodiments; 
         FIG.  10    is a cross-sectional view, taken along line  10 - 10  in  FIG.  8   , in accordance with some embodiments; 
         FIG.  11    is a side view of one example of a guide tool in accordance with some embodiments; 
         FIG.  12    is a front side plan view of the guide tool illustrated in  FIG.  11    in accordance with some embodiments; 
         FIG.  13    is a sectional view of the guide tool illustrated in  FIG.  11   , taken along line  13 - 13  in  FIG.  12   , in accordance with some embodiments; 
         FIG.  14    is a top-side plan view of one example of a broach in accordance with some embodiments; 
         FIG.  15    is a side view of the broach illustrated in  FIG.  14    in accordance with some embodiments; 
         FIG.  16    is a bottom-side plan view of the broach illustrated in  FIG.  14    in accordance with some embodiments; 
         FIG.  17    is a side view of one example of a broach insert for a broach in accordance with some embodiments; 
         FIG.  18    is a top-side plan view of the broach insert shown in  FIG.  17    in accordance with some embodiments; 
         FIG.  19    is an isometric view of an assembly of an implant, an inserter, and a guide in accordance with some embodiments; 
         FIG.  20    is a flow diagram of one example of a method of treatment in accordance with some embodiments; 
         FIGS.  20 A- 20 H  illustrate various stages of the method of treatment in accordance with  FIG.  20   ; and 
         FIG.  21    illustrates one example of an implant joining two bone segments, sections, or fragments in accordance with some embodiments. 
     
    
    
     DESCRIPTION 
     This description of the exemplary embodiments is to be read in connection with the accompanying drawings, which are to be considered part of the entire written description. In the description, relative terms such as “lower,” “upper,” “horizontal,” “vertical,”, “above,” “below,” “up,” “down,” “top” and “bottom” as well as derivative thereof (e.g., “horizontally,” “downwardly,” “upwardly,” etc.) should be construed to refer to the orientation as then described or as shown in the drawing under discussion. These relative terms are for convenience of description and do not require that the apparatus be constructed or operated in a particular orientation. Terms concerning attachments, coupling and the like, such as “connected” and “interconnected,” refer to a relationship wherein structures are secured or attached to one another either directly or indirectly through intervening structures, as well as both movable or rigid attachments or relationships, unless expressly described otherwise. In the various drawings, like reference numerals indicate like items, unless expressly stated otherwise. 
     This disclosure provides implants, systems for installing the implants, and treatment methods for minimally invasive correction of Tailor&#39;s bunion (or of an analogous deformity in another joint). Although the drawings show application of the implant, inserter, and guide for treating a fifth metatarsal for the correction of Tailor&#39;s bunion, the implant, systems, and methods can be sized, configured, and tailored to treat other bones. For example, while the implants, systems, and methods may be described as being used to couple together first and second fragments or segments formed from a single bone, it should be understood that the implants, systems and methods may be used to extend across a joint thereby coupling together two adjacent and/or distinct bones (e.g., a metatarsal and a phalange). As such, the terms “first bone” and “second bone” may refer to two naturally distinct bones (e.g., a metatarsal and a phalange) and/or to two sections, portions, or fragments operatively formed from a single bone (e.g., a distal fragment and a proximal fragment formed from a metatarsal). 
       FIGS.  1 - 3    show a first example of the implant  100 .  FIG.  1    is a plan view of the implant  100 , and  FIG.  2    is a medial (or lateral) side view of the implant  100  of  FIG.  1   . 
     Referring to  FIGS.  1 - 3   , the implant  100  is illustrated having a unitary body including an intramedullary portion  110  connected to an extramedullary portion  130 . The unitary body of implant  100  is configured to attach a first bone section, segment, or fragment to a second bone segment, section, or fragment. For example, implant  100  may be used to attach a proximal bone segment or fragment PF to a distal bone segment or fragment DF as best seen in  FIG.  21   . It should be understood that the implant  100  can be used on either left or right foot. 
     The intramedullary portion  110  defines a first longitudinal axis  120 , which can be a central axis. The intramedullary portion  110  is configured for insertion into the first bone section (e.g., proximal fragment PF shown in  FIG.  21   ). As best seen in  FIGS.  1  and  2   , intramedullary portion  110  may have a cylindrical geometric configuration with a one or more tapers or bevels  104  at first end (e.g., distal or insertion end)  102  to facilitate insertion of the intramedullary portion  110  into an intramedullary canal formed in a bone segment or fragment as will be discussed in greater detail herein. In some embodiments, the taper or bevel  104  terminates in a blunted tip  106 . Although the cross-sectional geometry of intramedullary portion  110  is shown as being cylindrical, one of ordinary skill in the art will understand that the cross-sectional geometry of intramedullary portion  110  may be polygonal (e.g., triangular, rectangular, pentagonal, etc.) and/or include one or more protrusions or flat surfaces formed thereon to resist rotation of the implant  110  relative to the first bone segment or fragment. In some embodiments, the intramedullary portion  110  may be completely or partially threaded. In some embodiments, the intramedullary portion  110  may include one or more fins or protrusions extending outwardly therefrom to resist rotation of the implant  100  relative to the bone segment, section, or fragment. 
     The extramedullary portion  130  includes a bone contacting side or face  132  configured to abut a surface of a second bone section (e.g., a distal fragment DF as shown in  FIG.  21   ). As best seen in  FIG.  1   , extramedullary portion  130  includes an enlarged head  134  defining a fastener aperture  136 . In some embodiments, the enlarged head  134  has a circular geometry, although one of ordinary skill in the art will understand that enlarged head  134  may have other shapes. The at least one fastener aperture  136  defined by enlarged head  134  of extramedullary portion  130  defines an aperture axis  138  as best seen in  FIG.  2   . Fastener aperture  136  is sized and configured to receive a bone fastener (e.g., an “Ortholoc® 3Di™” locking screw sold by Wright Medical Technology, Inc. of Memphis, Tenn.), which may be used to secure the extramedullary portion  130  to the second bone section. For example, in some embodiments, the fastener aperture  136  includes a number of intermittent threads  137  that are formed by first tapping the aperture  136  and then transversely cutting through the threads to form the thread segments or intermittent threads  137  as best seen in  FIGS.  1  and  3   . In some embodiments, six transverse cuts are made to form the intermittent threads  137 ; however, one of ordinary skill in the art will understand that fewer or more transverse cuts can be made. 
     In some embodiments, the aperture axis  138  is oriented obliquely relative to the first longitudinal axis  120  as best seen in  FIG.  2   . In other embodiments (not shown), the aperture axis  138  is from about 90 degrees to about 180 degrees from the first longitudinal axis  120 . For example, in some embodiments, the aperture axis  138  is oriented orthogonal to the first longitudinal axis  120 . 
     The bone fastener may be disposed transversely or obliquely, relative to the fastener aperture  136 . In some embodiments, polyaxial screws can be inserted at an angle of 0.0 to about 15 degrees with respect to the transverse axis of the fastener aperture  136 . In some embodiments, polyaxial screws such as 3Di locking screws or non-locking screws sold by Wright Medical Technology, Inc. of Memphis, Tenn. may be utilized. As will be understood by a person of ordinary skill in the art, polyaxial screws may be inserted parallel to aperture axis  138  or at an angle (e.g., up to 15 degrees) relative to aperture axis  138 . 
     As best seen in  FIG.  2   , a flat surface  140  is formed along a face of extramedullary portion  130  that is disposed opposite bone contacting side or face  132  and extends along at least a portion of the length of intramedullary portion  110 . In some embodiments, flat surface  140  is disposed parallel to bone contacting side or face, which is disposed at an angle with respect longitudinal axis  120  defined by intramedullary portion  110 . Put another way, in some embodiments, bone contacting side or face  132  and flat surface  140  are not arranged orthogonal or parallel to longitudinal axis  120 , although one of ordinary skill in the art will understand that such arrangements in which bone contacting side or face  132  and flat surface  140  are positioned parallel to longitudinal axis are contemplated. In some embodiments, the bone contacting side or face is positioned at an angle of 15 degrees (or 165 degrees) relative to longitudinal axis  120  for correcting the valgus of the fifth metatarsal (metatarsus quintus valgus) at the level of the metatarsal head. In some embodiments, flat surface  140  includes first and second portions, which themselves may be disposed at angles relative to one another (i.e., the first and second portions are not co-planar). 
       FIGS.  4 - 5    illustrate another example of an implant  200  in accordance with some embodiments.  FIG.  4    is a plan view of the implant  200 , and  FIG.  5    is a medial (or lateral) side view of the implant  200  of  FIG.  4   . 
     Like implant  100 , implant  200  may have a unitary body including an intramedullary portion  210  that transitions into an extramedullary portion  230 . Implant  200  is configured to attach a first bone section to a second bone section and can be used on either the left or the right foot. 
     The intramedullary portion  210  defines a first longitudinal axis  220 , which can be a central axis, extending from first end (e.g., an insertion end)  206  and continuing to extramedullary portion  230 . Intramedullary portion  210  may have a cylindrical geometric configuration with a one or more tapers or bevels  204  at first end  202  to facilitate insertion of the intramedullary portion  210  into bone segment as will be discussed in greater detail herein. In some embodiments taper or bevel terminates at a blade tip  206  that is more narrow and pointed than blunted tip  106 . Although the cross-sectional geometry of intramedullary portion  210  is shown as being cylindrical, one of ordinary skill in the art will understand that the cross-sectional geometry of intramedullary portion  210  may be polygonal and/or include one or more protrusions, extensions, flat surfaces, or other anti-rotation features formed thereon to resist rotation of the implant  210  relative to a bone when implanted. Further, as discussed above with respect to implant  100 , intramedullary portion  210  may be completely or partially threaded, or the intramedullary may including one or more fins or other protrusions extending from an external longitudinal surface thereof to engage the surrounding bone once implanted to resist rotation, improve fixation, and/or improve bone purchase. 
     Extramedullary portion  230  includes a bone contacting side or face  232  configured to abut a surface of the second bone section. As best seen in  FIG.  4   , extramedullary portion  230  includes an enlarged head  234  defining a fastener aperture  236  therethrough. Enlarged head  234  is shown with a circular geometry; however, one of ordinary skill in the art will understand that enlarged head  234  may have other geometrical shapes. The at least one fastener aperture  236  defines an aperture axis  238 , as best seen in  FIG.  5   , which is oriented obliquely relative to the first longitudinal axis  220 . 
     Fastener aperture  236  is sized and configured to receive a bone fastener, such as an “Ortholoc® 3Di™” locking screw sold by Wright Medical Technology, Inc. of Memphis, which may be used to secure the extramedullary portion  230  to a bone section. In some embodiments, the aperture axis  238  is aligned obliquely with the longitudinal axis  220  as shown in  FIG.  2   . In other embodiments (not shown), the aperture axis  238  is from about 90 degrees to about 180 degrees from the first longitudinal axis  220 . For example, in some embodiments, the aperture axis  238  is oriented orthogonal to the first longitudinal axis  220 . The bone fastener may be disposed transversely or obliquely, relative to the fastener aperture  236  and aperture axis  238 . For example, in some embodiments, polyaxial screws can be inserted with an angle of 0.0 to about 15 degrees from the aperture axis  238 . 
     As best seen in  FIG.  5   , a flat surface  240  is formed along a face of extramedullary portion  230  that is located on the opposite side of implant  200  as the contacting side or face  232 . Flat or planar surface  240  extends across extramedullary portion  230  and at least a portion of intramedullary portion  210 . In some embodiments, flat or planar surface  240  is disposed parallel to bone contacting side or face  232 , which is positioned at an angle with respect longitudinal axis  220  such that contacting side or face  232  and flat surface  240  are not arranged orthogonal or parallel to longitudinal axis  220 . In some embodiments, the contacting side or face  232  and flat surface  240  are positioned at an angle of 15 degrees (or 165 degrees) relative to longitudinal axis  220 ; however, a person of ordinary skill in the art will understand that contacting side or face  232  and flat or planar surface  240  may be disposed at other angles (e.g., 5 degrees, 10 degrees, 20 degrees, etc.) relative to longitudinal axis  220  defined by intramedullary portion. 
     Implants  100 ,  200  can comprise a metal, such as titanium, stainless steel, or CoCr. In some embodiments, the implants  100 ,  200  can comprise a metal substrate coated with or having an additional layer of hydroxyapatite (HA), titanium plasma spray (TPS)/vacuum plasma spray (VPS), roughened surface of resorbable blast media (RBM), a bioactive glass, an antimicrobial or antibiotic, or strontium. Alternatively, the implants  100 ,  200  can comprise a metal substrate with a composite coating or composite layer including HA on plasma, beads, an irregular sintered coating or TPS on an RBM-prepared substrate. In other embodiments, the metal substrate can have a porous coating. such as spherical bead, asymmetrical powder, or an irregular particle coating. 
     In some embodiments, the metal substrate of implants  100 ,  200  comprises a degradable (resorbable) material, such as a magnesium alloy, which may contain lithium, aluminum, rare earth metals (e.g., neodymium or cerium), manganese, zinc or other metals. In other embodiments, the resorbable material can include, but are not limited to polymer materials including a polylactide, polyglycolide, polycaprolactone, polyvalerolactone, polycarbonates, polyhydroxy butyrates, poly ortho esters, polyurethanes, polyanhydrides, and combinations and copolymers thereof, for example. In some embodiments, implants  100 ,  200  comprise a non-absorbable polymer, such as polyethereetherketone (PEEK), or an absorbable polymer composite, such as polylactic-acid (PLLA), a PLLA-beta-tricalcium-phosphate (β-TCP) blend, to list only a few possibilities. 
     In some embodiments, the implants  100 ,  200  comprise a biologic material. The biologic material can be a combination of Medical grade β-TCP granules and rhPDGF-BB solution, such as “AUGMENT®” bone graft material sold by Wright Medical Technology, Inc. of Memphis, Tenn. The biologic material can be applied, sprayed, or inserted at the wound site for bone in-growth, or can be provided as a coating on the implants or any or all portions of the implant system. In some embodiments, the biologic material is a coating containing osteoinductive or osteoconductive biological components. In some embodiments, the biologic material can include bone morphogenetic factors, i.e., growth factors whose activity are specific to bone tissue including, but not limited to, demineralized bone matrix (DBM), bone protein (BP), bone morphogenetic protein (BMP), and mixtures and combinations thereof. Additionally, formulations for promoting the attachment of endogenous bone may comprise bone marrow aspirate, bone marrow concentrate, and mixtures and combinations thereof. 
     The configuration of the implants  100 ,  200  advantageously provide an enhanced fixation of the distal fragment of the fifth metatarsal compared to the conventional buttressing k-wire technique. Further, the ability to use locking screws help prevent dorsal subluxation of the distal fragment as compared to the buttressing k-wire technique. 
     Inserter 
     In some embodiments, an inserter  300  may be provided for aiding a surgeon or other individual in implanting one of the implants  100 ,  200  in a patient. Such an inserter may be provided in a system or kit in accordance with some embodiments. One example of an inserter  300  is illustrated in the various views provided in  FIGS.  6 - 10   . Referring first to  FIGS.  6 - 8   , inserter  300  has a body  302  extending from a first end  304  to a second end  306  and defining a longitudinal axis  308 . In some embodiments, end  304  is an impacting or handle end and end  306  is an engagement end as described below. 
     As best seen in  FIGS.  6  and  7   , impacting end includes a flange  310  that extends in a perpendicular direction with respect to the longitudinal axis  308  defined by inserter  300 . Flange  310  includes an impacting surface  312 , which is sized and structured to be impacted by a hand, mallet, hammer, or other impacting tool as will be understood by one of ordinary skill in the art. In some embodiments, flange  310  is supported or reinforced by one or more reinforcing ribs  314 . Reinforcing rib(s)  314  may have triangular geometry as shown in  FIG.  7   , although other geometric configurations also are possible. 
     As best seen in  FIGS.  6  and  8   , one or more indents  316  may be provided along the length of the body  302 . Indents  316  may be provided to enhance the ability of a surgeon or other user to grasp and manipulate inserter  300 . In some embodiments, indents  316  have a rounded or curved configuration to provide for enhanced ergonomics. 
     Engagement end  306  is structured to engage an implant  100 ,  200  and defines a hole  318  ( FIGS.  6 ,  8 , and  9   ) and a pocket or channel  320  ( FIGS.  6 ,  9 , and  10   ). In some embodiments, hole  318  is dimensioned to provide clearance for receiving a mating end of a drill guide as discussed in greater detail herein. Pocket  320  is shaped and dimensioned to receive the enlarged head  134 ,  234  of extramedullary portion  130 ,  230  therein such that, when the enlarged head  124 ,  234  is received within pocket  320 , the wall(s)  322  defining pocket  320  snugly engages the outer surface of enlarged head  134 ,  234  of implant  100 ,  200  to resist rotation of the implant  100 ,  200  relative to inserter  300 . 
     As best seen in  FIGS.  7  and  10   , engagement end  306  may be angled relative to the longitudinal axis  308  of inserter  300 . In some embodiments, the angle of engagement end  306  corresponds to the angle of the extramedullary portion  130 ,  230  of the implant  100 ,  200 . Further, hole  318  defines an axis  324  that is arrange on body  302  of inserter  300  such that, when implant  100 ,  200  is engaged by engagement end  306  of inserter  300 , the axis  324  is aligned with aperture axis  138 ,  238 . 
     In some embodiments and as best seen in  FIGS.  6 ,  8 ,  9 , and  10   , inserter  300  defines a hole or slot  330  along its length. The hole or slot  330  is sized and structured to receive a k-wire therein to temporarily fixate a distal fragment to another bone, e.g., the fourth metatarsal, as described in greater detail below. In some embodiments, an axis defined by hole or slot  330  is parallel to the axis  324  defined by hole  318 . However, one of ordinary skill in the art will understand that hole or slot  330  may be oriented at other angles relative to the axis  324  defined by hole  318 . 
     Inserter  300  may be provided in a wide variety of materials, including metal and/or plastic. In some embodiments, inserter  300  is formed from a material that may be sterilized such that the inserter may be provided in a sterilized package along with one or more implants and/or other devices described herein. 
     Guide Tool 
       FIGS.  11 - 13    illustrate one example of a guide tool  400  in accordance with some embodiments. Referring to  FIG.  11   , guide  400  includes a body  402  that extends from a coupling end  404  to a second end  406 . In some embodiments, the body  402  of guide  400  includes one or more shoulders  410 - 1 ,  410 - 2  due to the body  402  including one or more segments having a reduced diameter relative to an adjacent segment. As shown in  FIG.  11   , the guide  400  is provided with three body segments  402 - 1 ,  402 - 2 , and  402 - 3 , with a shoulder  410 - 1  provided at the interface between body segments  402 - 1  and  402 - 2  and a shoulder  410 - 2  provided at the interface between body segments  402 - 2  and  402 - 3 . One of ordinary skill in the art will understand that drill guide  400  may be provided with fewer segments and/or shoulders. 
     In some embodiments, distal segment  402 - 3  at coupling end  404  is at least partially threaded. For example and as illustrated in  FIG.  11   , threads  408  may extend partially or entirely along segment  402 - 3 . Body segment  402 - 2 , which is disposed between body segment  402 - 1  and body segment  402 - 3 , may be provided with a smooth external surface. In some embodiments, body segment  402 - 3  has a cross-sectional diameter that is sized to be received within hole  318  of inserter  300  and has a thickness or width of segment  402 - 3  (e.g., the distance between shoulder  410 - 2  and end  404 ) dimensioned relative to the depth of hole  318  defined by inserter  300  (e.g., the distance D 1  in  FIG.  10   ) such that shoulder  410 - 2  is approximately planar with wall  328  of inserter  300  when the partially threaded portion of distal segment  402 - 3  is tightened onto the threaded aperture  136 ,  236 . 
     Body segment  402 - 1 , which in some embodiments has the greatest cross-sectional diameter, may include a surface texture formed on an external surface thereof to facilitate manipulate by a user. For example, the external surface  402 - 1  may include knurling, ridges, grooves, or any other suitable surface texturing as will be understood by one of ordinary skill in the art. 
     As best seen in  FIGS.  12  and  13   , drill guide  400  defines a central guide hole  412  that extends through the entirety of body  402 . Guide hole  412  is sized and dimensioned to guide a suitable drill or other drilling or cutting tool for creating a pilot hole in a bone as discussed in greater detail below. 
     Broach 
       FIGS.  14 - 18    illustrate one example of a broach  500  including a handle  502  and a blade insert  504 , in accordance with some embodiments. The handle  502  includes a body  506  extending from a first end  510  to a second end  512  substantially along a central longitudinal axis  514 . The handle  502  defines at least one aperture  516  along its length extending from a first (e.g., upper) surface  518  to the second (e.g., lower or bottom) surface  520 . In some embodiments, the handle  502  defines a slot or channel (not shown) inwardly extending from a first end  512  into the body  506  sized and configured to receive a portion of an insert  504  therein. In some embodiments, the channel is sized and configured to receive a portion of an insert  504  such that the aperture  516  is aligned with apertures formed in the insert  504  (as described in greater detail below) when the insert  504  is inserted into the channel. In some embodiments, the insert  504  is over-molded by handle  502 . 
     End  510  of body  502  includes a flange  520  that extends perpendicularly with respect to the longitudinal axis  514  defined by body  502 . Flange  520  includes an impacting surface  522 . Impacting surface  522  is sized and structured to be impacted by a hand, mallet, hammer, or other impacting tool as will be understood by one of ordinary skill in the art. In some embodiments, flange  522  is supported or reinforced by one or more reinforcing ribs  524 . Reinforcing rib(s)  524  may have triangular geometry as illustrated in  FIG.  15   , although a person of ordinary skill in the art will understand that other geometric configurations also are possible. 
     As best seen in  FIGS.  14  and  16   , one or more indents  526  may be provided along the length of the body  502 . Indents  526  may be provided to enhance the ability of a surgeon or other user to grasp and manipulate inserter broach  500 . In some embodiments, indents  526  have a rounded or curved configuration to provide for enhanced ergonomics. 
     Turning now to  FIGS.  17  and  18   , one example of a blade or broach insert  504  is illustrated in accordance with some embodiments. Insert  504  includes a body  530  extending from a first end  532  to a second end  534  substantially along a central longitudinal axis  536 . The insert  504  includes a first portion  538  configured to be coupled to a handle  502  and a second portion  540  configured to be at least partially inserted into a cut formed in a bone, such as a metatarsal, including the fifth metatarsal. Aperture  542  is positioned along the length of body  530  and enables over-molding material to flow within aperture  542 . In some embodiments, one or more additional apertures  548  are defined by body  530  and are positioned along the body  530  of insert  504  such that, when the insert  504  is properly received within handle  502 , apertures  548  are aligned with holes  516 . The alignment of holes  516 ,  548  provides a passageway through broach  500  and enables a k-wire, pin, or other tool to be inserted through broach to provide some additional leverage for a user to dislodge broach from an intramedullary canal. 
     As shown in  FIGS.  14 - 16   , the insert  504  is configured to be coupled to the handle  502  to define a broach  500  configured to assist in the preparation of an intramedullary canal in a bone, such as a metatarsal, including a fifth metatarsal. As described in greater detail below, the second portion  540  of the insert  504  is configured to be inserted into a bone and leveraged to offset a first portion of a bone with a second portion of the bone to prepare an intramedullary canal. In some embodiments, a leading edge  550  of the insert  504  is configured to facilitate insertion into the bone. The leading edge  550  can be sharpened to define a cutting edge and/or include a thickness less than the thickness of the insert  504 . 
     In some embodiments, the broach handle  502  (or a portion thereof) can be formed by injection molding material such as polycarbonate (PC), polyamide (e.g., Nylon), polyarylamide (e.g., PARA, Ixef, etc.), acrylonitrile butadiene styrene (ABS), and/or any other suitable injection molding material. The injection molding can be formed over one or more structural features, such as ribs, lattice, etc. or surface features, such as knurling, plasma spray, etc., to provide increased strength and/or to withstand forces applied during insertion of the broach  500  and formation of an intramedullary canal in a bone. In some embodiments, the insert  504  (or a portion thereof) is formed of a metal material formed by any suitable process, such as by stamping, bending, drilling, milling, turning, etc. 
     Assembly/System/Kit 
     In some embodiments, the implant  100 ,  200 , inserter  300 , and guide  400  are provided in an assembled configuration, such as the configuration shown in  FIG.  19   . For example, the assembly  10  may be provided in sterilized package with each component having been sterilized after assemblage and packaging. As shown in  FIG.  19   , the extramedullary portion  130 ,  230  of implant  100 ,  200  is received within pocket  320  of inserter  300  such that intramedullary portion  110 ,  210  of implant is exposed by and extends away from end  306  of inserter  300 . 
     More particularly, to provide the assembly  10 , aperture hole  136 ,  236  of implant  100 ,  200  is aligned with hole  318  of inserter. Guide  400  is engaged with implant  100 ,  200  and inserter  300  by inserting body segment  402 - 3  into the aligned holes  136  (or  236 ) and  318  and then engaging the threads  408  of guide  400  with the thread segments  137  (or  237 ) of the implant. In some embodiments, threads  408  of guide  400  are engaged with thread segments  137  (or  237 ) by rotating guide body  402  relative to implant  100 ,  200  and inserter  300 . The rotation of guide body  402  and thread engagement causes body  402  to advance into aperture  136  (or  236 ) and hole  318  of inserter  318  until shoulder  410 - 2  contacts the surface  328  of inserter  300 . Once fully engaged, the relative positions of implant  100 ,  200 , inserter  300 , and guide are fixed in the assembled configuration  10  shown in  FIG.  19   . 
     In some embodiments, the various implants and/or tools are provided in a surgical kit in which each of the various components is individually placed within a sterilized package in a disassembled configuration and sterilized. For example, in some embodiments, one or more implants (of various sizes) may be provided in the kit with a correspondingly sized inserter, guide tool, and fastener(s). For example, the implant may be provided in 2 mm, 3 mm, 4 mm, 5 mm, and other cross-sectional diameters with inserters, guide tools, fasteners, and k-wire(s) configured for implanting these implants. Systems may also be provided in which one or more of the various components are separately packaged and then gathered at the time of surgery as will be understood by one of ordinary skill in the art. Various combinations of kits and/or individual components may be gathered together to provide a system. One of ordinary skill in the art will understand that there are numerous ways to provide a kit, system, and/or assembly and the foregoing examples are not limiting. 
     Method of Use/Treatment Method 
       FIG.  20    is a flow chart of one example of a treatment method  600  in accordance with some embodiments, with  FIGS.  20 A- 20 G  illustrating various steps performed of the method. At block  602 , a patient is placed in a supine position on an operating table, and the metaphysis of the fifth metatarsal (or other targeted bone or implant site) is identified. 
     At block  604 , a longitudinal incision is made proximal from the metaphysis of the fifth metatarsal head M, as shown in  FIG.  20 A , and extending distally. In some embodiments, the periosteum around the metaphysis is elevated using an elevator to allow for extracapsular osteotomy. 
     In situations where a large lateral prominence of the metatarsal head exists, the lateral eminence may be shaved down at block  606 . The lateral eminence may be shaved down using a wedge burr or other suitable cutting or grinding tool as will be understood by one of ordinary skill in the art. 
     At block  608 , an osteotomy is performed. In some embodiments, a transverse osteotomy is made using a Shannon burr B or saw at the level of the metaphysis. For example, the burr B may be plunged bi-cortically and then swept dorsally and plantarly to complete the cut. The plane of the cut may be perpendicular to the axis of the fifth metatarsal or to the axis of the fourth metatarsal at the osteotomy site. In some embodiments, a chevron osteotomy is performed instead of a transverse osteotomy.  FIG.  20 B  illustrates an osteotomy being performed using a burr B in accordance with some embodiments. 
     At block  610 , the intramedullary canal of the proximal fragment PF is broached. In some embodiments, an initial broaching of the intramedullary canal may be performed using an elevator E after having moved the distal fragment DF out of the way as shown in  FIG.  20 C .  FIGS.  20 D and  20 E  illustrate the broach  500  being used to broach the intramedullary canal of proximal fragment PF. In some embodiments, a mallet, hammer, or other impaction device (not shown) may be used to achieve the desired broaching as will be understood by one of ordinary skill in the art. The impaction device may be used to hit impact surface  522  of broach  500  until the distal end of the broach handle  512  nearly touches the distal end of the proximal fragment PF. AP and ML radiographs may be checked to determine if the size of the broach adequately fills the intramedullary canal. If the broach does adequately fill the intramedullary canal, then the broach is removed. If the broach does not adequately fill the intramedullary canal, then a larger broach may be selected and the steps at block  610  may be repeated. 
     At block  612 , the implant  100 ,  200  is inserted into the broached intramedullary canal. In some embodiments, the implant  100 ,  200  is pre-attached to inserter  300  and guide to provide the assembly  10  shown in  FIG.  19    and as described above. The inserter  300  is used to guide implant  100 ,  200  into the broached intramedullary canal with the insertion end  106 ,  206  being introduced into the canal first as shown in  FIG.  20 F . A mallet (not shown) may be used to seat the implant  100 ,  200  fully (or properly) within the broached intramedullary canal. For example, the mallet may be used to tap on the impact surface  312  of inserter  300  until the inserter nearly touches the distal end of the proximal fragment. 
     At optional block  614 , a k-wire may be inserted through the hole or slot defined along the length of the inserter  300 , through the distal fragment DF, and into a second bone, such as a fourth metatarsal.  FIG.  20 G  illustrates the k-wire K being inserted through a hole or slot formed in inserter  300  and passing through the distal fragment DF and into second bone B 2 . In some embodiments, a surgeon may pinch medially of the distal fragment to ensure that the distal fragment is properly aligned in the dorsal-plantar direction and that the distal fragment laterally contacts the implant  100 ,  200 . This pinching may be performed prior to k-wire insertion and/or as the k-wire is inserted. 
     At block  616 , drilling for placement of the distal fragment screw is performed. For example, the distal fragment is drilled bi-cortically through the drill guide  400  as shown in  FIG.  20 H . In some embodiments, the drill guide  400  may be threaded directly into the thread segments  137 ,  237  within the fastener aperture  136 ,  236  having removed the inserter  300 . However, in some embodiments, the drilling may be performed while the inserter  300  is still engaged with drill guide  400  and implant  100 ,  200  as shown in  FIG.  20 H . Once drilling is complete, the drill guide  400  may be removed from its engagement with the assembly  10  of the implant  100 ,  200  and inserter  300 . Additionally, the inserter  300  may be removed from its engagement with the implant  100 ,  200 . 
     At block  618 , a fastener  700  is selected and used to secure the implant  100 ,  200  to the distal bone fragment DF. For example, a surgeon may use a locking or non-locking screw and inserts the selected fastener through fastener aperture  136 ,  236  and into the pre-drilled bone fragment. The k-wire K, if used, and inserter  300 , if not yet removed, may then be removed. 
     At block  620 , the incision is closed. In some embodiments, the distal-lateral corner of the proximal fragment is smoothed, using a burr, rasp, or other appropriate surgical tool, prior to closing the incision to avoid a sharp prominence after closure. One or more stitches also may be used to close the incision. 
     Although the subject matter has been described in terms of exemplary embodiments, it is not limited thereto. Rather, the appended claims should be construed broadly, to include other variants and embodiments, which may be made by those skilled in the art.