Patent Publication Number: US-2021169473-A1

Title: Implant inserters

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     The present application is a continuation application of U.S. patent application Ser. No. 16/031,980, filed Jul. 10, 2018, entitled IMPLANT INSERTERS, which is a continuation-in-part of International Patent Application No. PCT/US2018/016994, filed Feb. 6, 2018, entitled IMPLANT INSERTER, which claims priority to U.S. Provisional Application No. 62/455,361, filed Feb. 6, 2017, entitled IMPLANT INSERTER. The foregoing is incorporated by reference as though set forth herein in their entirety. 
    
    
     TECHNICAL FIELD 
     The present disclosure relates to Inserters for dynamic implants. More specifically, the present disclosure relates to inserters that engage a dynamic implant bridge. 
     BACKGROUND 
     A dynamic implant has a free state, or relaxed state, which is its shape when no external forces are acting upon the implant, other than gravity perhaps. In the free state, the implant is not elastically or plastically deflected or deformed. The implant may experience loads that are below a threshold for elastic or plastic deflection or deformation. In the free state, the implant legs may converge at their distal tips. The implant may be made from high elasticity materials such as nitinol and/or polyetheretherketone (PEEK) so that the implant may be elastically deformed by an external force, and then resume the free state when the external force is removed. 
     The inserter securely and releasably couples to the implant. When actuated, the inserter urges the implant out of the free state into a continuum of elastically deformed states in which the implant legs may a) progressively approach a parallel condition, b) achieve a parallel condition, or c) progressively diverge at their distal tips. When the inserter is uncoupled from the implant, the implant resumes the free state, or attempts to do so. When the implant is implanted in bone, then the implant may only be able to partially relax toward the free state due to the resistance of the bone. 
     SUMMARY 
     The various systems and methods of the present technology have been developed in response to the present state of the art, and in particular, in response to the problems and needs in the art that have not yet been fully solved by currently available inserters. 
     To achieve the foregoing, and in accordance with the technology as embodied and broadly described herein, in an aspect of the technology, an inserter for a dynamic implant having an elongated bridge and first and second connecting means extending from first and second ends of the bridge, wherein the bridge has a proximal surface, wherein the bridge and the first and second connecting means each have a distal surface, the inserter including: first and second hooks, wherein the first and second hooks face each other across an alcove, wherein the first and second hooks each have a proximal surface, wherein the alcove has a proximal surface that is proximal to the proximal surfaces of the first and second hooks; and a ram head having a distal surface, wherein the ram head is movable relative to the first and second hooks between a proximal position and a distal position, wherein in the proximal position, the distal surface of the ram head is proximal to the proximal surface of the alcove, wherein in the distal position, the distal surface of the ram head is distal to the proximal surface of the alcove; wherein when the inserter is connected to the implant, the first and second hooks receive the first and second connecting means, the proximal surfaces of the first and second hooks contact the distal surfaces of the first and second connecting means, the alcove receives the bridge, and the distal surface of the ram head faces the proximal surface of the bridge; wherein when the inserter is connected to the implant and the ram head is in the proximal position, the implant is in a relaxed state in which the bridge is undeformed; wherein when the inserter is connected to the implant and the ram head is in the distal position, the implant is in an elastically deformed state in which the bridge is elastically deformed. 
     Embodiments of this aspect of the technology may include one or more of the following attributes. When the ram head moves between the proximal and distal positions, the ram head does not rotate relative to the first and second hooks. The inserter includes a ram, wherein the ram includes the ram head and a ram shaft extending proximally from, and integrally formed with, the ram head, wherein a proximal portion of the ram shaft is threaded. The inserter includes a body and a knob, wherein the knob is captive to the body. distal portion of the body includes the first and second hooks, wherein the ram shaft is received in the body, wherein the knob includes a threaded hole, wherein the proximal portion of the ram shaft threads into the knob hole, wherein the knob is captive within a slot in a proximal portion of the body. When the inserter is connected to the implant, the distal surface of the ram head contacts the proximal surface of the bridge. 
     In another aspect of the technology, a system for implant elastic deformation and insertion, includes: an implant movable between a relaxed state and an elastically deformed state, wherein the implant includes an elongated bridge and first and second connecting means, wherein the bridge extends between opposite first and second ends and has a distal surface and an opposite proximal surface, wherein the first connecting means extends from the first end of the bridge, wherein the second connecting means extends from the second end of the bridge, wherein each of the first and second connecting means has a distal surface, wherein when the implant is in the relaxed state, the bridge is undeformed; wherein when the implant is in the elastically deformed state, the bridge is elastically deformed; and an inserter including a ram for engaging the bridge and first and second hooks for engaging the connecting means, wherein the ram has a distal surface, wherein each of the first and second hooks has a proximal surface, wherein the first and second hooks are movable together relative to the ram between a distal position and a proximal position, wherein in the distal position, the proximal surfaces of the first and second hooks are distal to the distal surface of the ram by a first distance, wherein in the proximal position, the proximal surfaces of the first and second hooks are distal to the distal surface of the ram by a second distance, wherein the second distance is less than the first distance; wherein when the inserter is connected to the implant, the first and second hooks receive the first and second connecting means, the proximal surfaces of the first and second hooks contact the distal surfaces of the first and second connecting means, and the distal surface of the ram faces the proximal surface of the bridge; wherein when the inserter is connected to the implant and the first and second hooks are in the distal position, the implant is in the relaxed state; wherein when the inserter is connected to the implant and the first and second hooks are in the proximal position, the implant is in the elastically deformed state. 
     Embodiments of this aspect of the technology may include one or more of the following attributes. The ram does not rotate relative to the first and second hooks. The ram includes a proximal threaded ram shaft, wherein the distal surface of the ram is integrally formed with the ram shaft. The inserter includes a body and a knob, wherein the knob is captive to the body. A distal portion of the body includes the first and second hooks, wherein the ram shaft is received in the body, wherein the knob includes a threaded hole, wherein the ram shaft threads into the knob hole, wherein the knob is captive within a slot in a proximal portion of the body. When the inserter is connected to the implant, the distal surface of the ram contacts the proximal surface of the bridge. 
     These and other features and advantages of the present technology will become more fully apparent from the following description and appended claims, or may be learned by the practice of the technology as set forth hereinafter. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Exemplary embodiments of the technology will become more fully apparent from the following description and appended claims, taken in conjunction with the accompanying drawings. Understanding that these drawings depict only exemplary embodiments and are, therefore, not to be considered limiting of the scope of the technology, the exemplary embodiments will be described with additional specificity and detail through use of the accompanying drawings in which: 
         FIG. 1  is a perspective view of an implant inserter; 
         FIG. 2  is another perspective view of the implant inserter of  FIG. 1  from a different direction; 
         FIG. 3  is an exploded perspective view of the implant inserter of  FIG. 1 ; 
         FIG. 4  is another exploded perspective view of the implant inserter of  FIG. 1  from a different direction; 
         FIG. 5  is a top view of the implant inserter of  FIG. 1 ; 
         FIG. 6  is a cross-sectional view of the implant inserter of  FIG. 1 , taken along section line  6 - 6  of  FIG. 5 ; 
         FIG. 7  is a perspective view of another implant inserter; 
         FIG. 8  is another perspective view of the implant inserter of  FIG. 7  from a different direction; 
         FIG. 9  is an exploded perspective view of the implant inserter of  FIG. 7 ; 
         FIG. 10  is another exploded perspective view of the implant inserter of  FIG. 7  from a different direction; 
         FIG. 11  is a front view of the implant inserter of  FIG. 7 ; 
         FIG. 12  is a right view of the implant inserter of  FIG. 7 ; 
         FIG. 13  is a cross-sectional view of the implant inserter of  FIG. 7 , taken along section line  13 - 13  of  FIG. 12 ; 
         FIG. 14  is a cross-sectional view of the implant inserter of  FIG. 7 , taken along section line  14 - 14  of  FIG. 11 ; 
         FIG. 15  is a perspective view of an implant and yet another implant inserter; 
         FIG. 16  is another perspective view of the implant and implant inserter of  FIG. 15  from a different direction; 
         FIG. 17  is a perspective exploded view of the implant and implant inserter of  FIG. 15 ; 
         FIG. 18  is another perspective exploded view of the implant and implant inserter of  FIG. 15  from a different direction; 
         FIG. 19  is a front view of the implant and implant inserter of  FIG. 15 ; 
         FIG. 20  is a right view of the implant and implant inserter of  FIG. 15 ; 
         FIG. 21  is a cross-sectional view of the implant and implant inserter of  FIG. 15 , taken along section line  21 - 21  of  FIG. 20 ; and 
         FIG. 22  is a cross-sectional view of the implant and implant inserter of  FIG. 15 , taken along section line  22 - 22  of  FIG. 19 . 
     
    
    
     DETAILED DESCRIPTION 
     Exemplary embodiments of the technology will be best understood by reference to the drawings, wherein like parts are designated by like numerals throughout. It will be readily understood that the components of the technology, as generally described and illustrated in the figures herein, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description of the embodiments of the apparatus, system, and method is not intended to limit the scope of the invention, as claimed, but is merely representative of exemplary embodiments of the technology. 
     The phrases “connected to,” “coupled to” and “in communication with” refer to any form of interaction between two or more entities, including mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interaction. Two components may be functionally coupled to each other even though they are not in direct contact with each other. The term “abutting” refers to items that are in direct physical contact with each other, although the items may not necessarily be attached together. The phrase “fluid communication” refers to two features that are connected such that a fluid within one feature is able to pass into the other feature. 
     The word “exemplary” is used herein to mean “serving as an example, instance, or illustration.” Any embodiment described herein as “exemplary” is not necessarily to be construed as preferred or advantageous over other embodiments. While the various aspects of the embodiments are presented in drawings, the drawings are not necessarily drawn to scale unless specifically indicated. 
     Standard medical planes of reference and descriptive terminology are employed in this specification. While these terms are commonly used to refer to the human body, certain terms are applicable to physical objects in general. 
     A standard system of three mutually perpendicular reference planes is employed. A sagittal plane divides a body into right and left portions. A coronal plane divides a body into anterior and posterior portions. A transverse plane divides a body into superior and inferior portions. A mid-sagittal, mid-coronal, or mid-transverse plane divides a body into equal portions, which may be bilaterally symmetric. The intersection of the sagittal and coronal planes defines a superior-inferior or cephalad-caudal axis. The intersection of the sagittal and transverse planes defines an anterior-posterior axis. The intersection of the coronal and transverse planes defines a medial-lateral axis. The superior-inferior or cephalad-caudal axis, the anterior-posterior axis, and the medial-lateral axis are mutually perpendicular. 
     Anterior means toward the front of a body. Posterior means toward the back of a body. Superior or cephalad means toward the head. Inferior or caudal means toward the feet or tail. Medial means toward the midline of a body, particularly toward a plane of bilateral symmetry of the body. Lateral means away from the midline of a body or away from a plane of bilateral symmetry of the body. Axial means toward a central axis of a body. Abaxial means away from a central axis of a body. Ipsilateral means on the same side of the body. Contralateral means on the opposite side of the body. Proximal means toward the trunk of the body. Proximal may also mean toward a user or operator. Distal means away from the trunk. Distal may also mean away from a user or operator. Dorsal means toward the top of the foot. Plantar means toward the sole of the foot.  Varus  means deviation of the distal part of the leg below the knee inward, resulting in a bowlegged appearance. Valgus means deviation of the distal part of the leg below the knee outward, resulting in a knock-kneed appearance. 
     The implant inserters disclosed herein are adapted to engage dynamic implants having an elongated bridge, or body, with connection means extending from each end of the bridge along the longitudinal direction established by the bridge. Each dynamic implant has a free state, or a relaxed state, when no external forces act upon the implant (other than gravity), and an elastically deformed state, when the bridge is flexed against the resistance of the inserter supporting the connection means. An example implant  400  is shown in  FIGS. 15-22 . 
     Referring to  FIGS. 1-6 , an implant inserter  100  may include a body  102 , a carriage  104 , a lever  106 , a screw  108 , a lever pin  110 , and a carriage pin  112 . 
     The body  102  extends between a distal end  150  and a proximal end  152 . The body  102  is an elongated plate-like part. The distal end  150  includes an undercut rail  154  that extends across the distal aspect of the body  102  along a top-bottom direction. The rail  154  may be referred to as a ram or a ram head. The rail  154  may overhang, or extend past, the bottom side of the body  102 . The bottom-most aspect  166  of the rail  154  may be convex in a front view. The rail  154  is shown as a T-rail, but other undercut geometries are contemplated, such as a dovetail rail. The distal end  150  includes bilateral bosses  156 ,  158  which extend from the top side of the body  102  proximal to the rail  154 . The bosses  156 ,  158  are separated by a gap  160 . A transverse hole  162  extends through both bosses  156 ,  158  along a left-right direction. An internally threaded hole  164  extends through the body  102  proximal to the bosses  156 ,  158  along a top-bottom direction. 
     The carriage  104  extends between a bottom end  118  and a top end  120 . The carriage  104  may have a rectangular overall shape in a top or bottom view ( FIG. 5 ). In a front or back view, the top portion of the carriage  104  may be rectangular, while the bottom portion may flare outwardly toward the bottom end  118 . The bottom-most aspect of the carriage  104  may include two jaws or hooks  122 ,  124  that face each other across a shallow alcove  126  with a top surface  142  that faces down (bottom). The hooks  122 ,  124  include top surfaces  128 ,  130 , respectively. The hooks  122 ,  124  include back walls  132 ,  134 , respectively. Thus, the hooks  122 ,  124  are suitable for front loading an implant. However, one wall  132 ,  134  may optionally be a front wall, similar to the arrangement of walls  222 ,  224  discussed below, or both walls  132 ,  134  may be front walls, similar to walls  332 ,  334  discussed below. An undercut channel  136  extends from a central portion of the alcove  126  across the back side of the carriage toward the top end  120 . The undercut channel  136  may terminate before reaching the top end  120 . The undercut channel  136  is shown as a T-slot, but other undercut geometries are contemplated, such as a dovetail slot. A window  138  extends through the carriage  104  between the front and back sides. The window  138  may be centered in the left-right width of the carriage and may intersect the top portion of the undercut channel  136 . A transverse hole  140  extends left-right through the carriage and intersects the undercut channel  136  near the middle of the window  138 . 
     The lever  106  extends between a distal end  170  and a proximal end  172 . The lever  106  may be an elongated plate-like part with a bend  174  seen best in a left or right side view ( FIG. 6 ). An elongated slot  176  may extend through the lever  106  along a left-right direction near the distal end  170 . The slot  176  may be oval as shown, or another elongated shape. A transverse hole  178  may extend through the lever  106  along the left-right direction near the bend  174 . Distally-facing shoulders  180 ,  182  may be formed around each end of the hole  178 . A slot or notch  184  may extend distally into the proximal end  172 , dividing the proximal end  172  into prongs  186 ,  188 . 
     The screw  108  includes a head  190  and an externally threaded shaft  192  extending from the head. 
     The inserter  100  may be operatively assembled by inserting the lever  106  into the gap  160  between the bosses  156 ,  158  of the body  102  so that the convex side of the bend  174  faces the body  102  and the distal ends  150 ,  170  face the same direction; inserting the lever pin  110  through the holes  162 ,  178  of the body  102  and lever  106 ; passing the externally threaded shaft  192  of the screw  108  between the prongs  186 ,  188  of the lever  106  and threading the shaft  192  into the hole  164  of the body  102 ; inserting the distal end  170  of the lever  106  into the window  138  of the carriage  104 ; sliding the rail  154  of the body  102  into the bottom end of the channel  136  of the carriage  104 ; and inserting the carriage pin  112  through the hole  140  of the carriage  104  and the slot  176  of the lever  106 . 
     When the inserter  100  is operatively assembled, the carriage  104 , lever  106 , screw  108 , lever pin  110 , and carriage pin  112  are captive to the body  102 , although the screw  108  is readily removable. Turning the screw  108  clockwise and counterclockwise moves the proximal end  172  of the lever  106  closer to, or farther from, the body  102 . The lever  106  may be biased toward the head  190  of the screw  108  or toward the body  102 , for example with a spring element. Preferably, the lever  106  is biased toward the head  190  of the screw  108 . The distal end  170  of the lever  106  moves in the opposite direction as the proximal end  172  due to the hinge formed by the lever pin  110  in the holes  162 ,  178 . The carriage  104  moves with the distal end  170  of the lever  106  due to the pinned connection of the carriage pin  112  in the hole  140  and slot  176 . Thus, turning the screw  108  causes the carriage  104  to move relative to the body  102 . More specifically, turning the screw  108  causes the hooks  122 ,  124  to move along a bottom-top direction relative to the rail  154 . However, there is no relative rotation between the carriage  104  and the body  102 . 
     With brief reference to the clip  400  shown in  FIGS. 15-22  and discussed in detail below, the clip  400  and inserter  100  may be operatively assembled by turning the screw  108  to lower the hooks  122 ,  124  relative to the rail  154  so that the bottom aspect  166  of the rail  154  is within the channel  136  of the carriage  104 ; sliding the hooks  122 ,  124  into engagement with the connecting means  414 ,  416 ; and turning the screw  108  to raise the hooks  122 ,  124  relative to the rail  154  so that the bottom aspect  166  of the rail  154  contacts the bridge  406 . The connecting means  414 ,  416  may contact the back walls  132 ,  134 . 
     When the clip  400  and inserter  100  are operatively assembled, clockwise and counterclockwise rotation of the screw  108  causes the bridge  406  to move between an elastically deformed state and a relaxed state, or free state. In the elastically deformed state, the bottom aspect  166  of the rail  154  presses against the proximal surface  408  of the bridge  406 , flattening the bridge against the resistance of the connecting means  414 ,  416  in the hooks  122 ,  124  and spreading apart the free ends  436 ,  440  of the bone engaging members  402 ,  404 . In the relaxed state, the bottom aspect  166  of the rail  154  may be spaced apart from the proximal surface  408  of the bridge  406 , or may contact the proximal surface  408  so lightly that the bridge remains undeformed. 
     Referring to  FIGS. 7-14 , another implant inserter  200  may include a body  202 , a ram  204 , a ram pin  206 , and a knob  208 . 
     The body  202  extends between a distal end  218  and a proximal end  220 . The body  202  may be a generally plate-like part that is wider at the distal end  218  and narrower at the proximal end  220 . The distal-most aspect of the body  202  may include two jaws or hooks  222 ,  224  that face each other across a shallow alcove  226  with a proximal surface  240  that faces distally. Two proximal surfaces  240 ,  244  are shown; they may be coplanar. The hooks  222 ,  224  include proximal surfaces  228 ,  230 , respectively. The hook  222  includes a front wall  232  and the hook  224  includes a back wall  234 . Thus, the hooks  222 ,  224  are suitable for pivotably loading an implant. However, both walls  232 ,  234  may optionally be on the same side, front or back, similar to the walls  122 ,  124  discussed above or the walls  322 ,  324  discussed below. A notch  236  extends proximally from a central portion of the alcove  226 . A central longitudinal slot  238  or window extends between the front and back sides of the body  202  proximal to the notch  236 . A central longitudinal hole  242  extends proximally through the body  202  between the distal and proximal ends  218 ,  220 . A transverse window  246  extends between the front and back sides of the body  202  near the proximal end  220 , and may intersect the hole  242 . The window  246  may have a proximal surface  248  which faces distally. 
     The ram or shaft  204  extends between a distal end  250  and a proximal end  252 . The ram  204  includes a distal head  254 , which may be generally rectangular as shown. As seen best in  FIGS. 11 and 13 , the distal-most aspect  270  of the head  254  may be convex in a front or back view. A shaft  256  extends proximally from the head  254 . The shaft  256  may have a circular cross section as shown. The outer diameter of the shaft  256  may be greater than the thickness of the head  254  in a front-back direction, and may be less than the width of the head in a left-right direction, as seen best in  FIGS. 13 and 14 . A transverse hole  258  extends through the shaft  256  proximal to the head  254 . The proximal end  252  of the ram  204  may include external threads  259 . 
     The knob  208  may include a generally cylindrical body  262 . A central longitudinal internally threaded hole  260  may extend through the knob  208  along a proximal-distal direction. The knob  208  may include a first boss  264  extending distally from the body  262  concentric with the hole  260 , and a second boss  266  extending proximally from the body concentric with the hole. The second boss  266  may have a proximal surface  268  which faces proximally. 
     The inserter  200  may be operatively assembled by inserting the knob  208  in the window  246  of the body  202 , inserting the proximal end  252  of the ram  204  into the distal end  218  of the hole  242 , threading the proximal external threads  259  into the internally threaded hole  260  to draw the ram  204  proximally so that the hole  258  is exposed in the slot  238 , and inserting the pin  206  through the slot  238  and hole  258 . 
     When the inserter  200  is operatively assembled, the ram  204 , pin  206 , and knob  208  are captive to the body  202 . Clockwise and counterclockwise rotation of the knob  208  causes the ram  204  to translate along the proximal-distal direction. The pin  206  in the slot  238  prevents the ram  204  from rotating and limits the proximal and distal travel of the ram. 
     The clip  400  and inserter  200  may be operatively assembled by turning the knob  208  to move the ram  204  proximally so that the distal aspect  270  of the head  254  is within the notch  236 ; sliding the hooks  222 ,  224  over the connecting means  414 ,  416 ; and turning the knob  208  to move the ram  204  distally so that the distal aspect  270  of the head  254  contacts the bridge  406 . Sliding the hooks  222 ,  224  into engagement with the connecting means  414 ,  416  may involve pivoting or rotating the hooks relative to the connecting means, or vice versa. The connecting means  414 ,  416  may contact the front and back walls  232 ,  234 . 
     When the clip  400  and inserter  200  are operatively assembled, clockwise and counterclockwise rotation of the knob  208  causes the bridge  406  to move between an elastically deformed state and a relaxed state, or free state. In the elastically deformed state, the distal aspect  270  of the head  254  presses against the proximal surface  408  of the bridge  406 , flattening the bridge against the resistance of the connecting means  414 ,  416  in the hooks  222 ,  224  and spreading apart the free ends  436 ,  440  of the bone engaging members  402 ,  404 . The force of the head  254  against the bridge  406  may also be resisted by the proximal surface  268  of the second boss  266  of the knob  208  against the proximal surface  248  of the window  246  of the body  202 . In the relaxed state, the distal aspect  270  of the head  254  may be spaced apart from the proximal surface  408  of the bridge  406 , or may contact the proximal surface  408  so lightly that the bridge remains undeformed. 
     Referring to  FIGS. 15-22 , a clip  400  and yet another inserter  300  are shown operatively assembled, with the clip  400  in the free state, or relaxed state. 
     The clip  400  is shown with an optional integrated anti-torque plug  450 . Clip  400  may also be referred to as a fastener, staple, or implant. The clip  400  may be a compression bone staple. Anti-torque plug  450  may also be referred to as a tab, keel, post, or implant. One or more clips  400  may be implanted in a single procedure, for example to join two bone portions together. 
     Referring to  FIGS. 17 and 18 , the clip  400  includes bone engaging members  402  and  404  which may be integral to a clip bridge  406 , also referred to as a clip body. The bone engaging members  402  and  404  may be referred to as legs. In other embodiments within the scope of the disclosure, a clip may include more than two bone engaging members; or alternatively may include openings for one or more independent fasteners in lieu of the bone engaging members. In other embodiments of the disclosure, the implant  400  may be more similar to a plate. The bone engaging member  402  extends from a left end  430  of the clip bridge  406  and the bone engaging member  404  extends from an opposite right end  432  of the clip bridge  406 . Bone engaging member  402  has a proximal end  434  attached to the left end  430  of the clip bridge  406  and an opposite distal end  436  which is a free end. Bone engaging member  404  has a proximal end  438  attached to the right end  432  of the clip bridge  406  and an opposite distal end  440  which is a free end. Clip bridge  406  has at least one upper or proximal surface  408  and at least one lower or distal surface  410 . The lower surface  410  may be referred to as a bone facing surface. Bone engaging member  402  extends from the lower surface  410  beside bone engaging member  404 . Referring to  FIG. 18 , the bridge  406  may decrease in thickness toward the left and right ends  430 ,  432  and connecting means  414 ,  416 . The major front-back dimension of the bridge  406  may be 5 mm and the front-back dimension of the connecting means  414 ,  416  may be 2.7 mm. The bone engaging members  402  and  404  may have features  412  that may improve bone purchase or improve pull out strength of the clip  400  from bone or soft tissue. The features  412  may be referred to as teeth or serrations. The features  412  may be on facing sides of the bone engaging members  402 ,  404  or on any or all sides of the bone engaging members. The clip  400  may have projections or other connecting means  414  and  416  for connection with a means of insertion. The connecting means  414 ,  416  may be referred to as tabs, ears, protrusions, wings, retainers, or retaining members. The connecting means  414  and  416  are shown extending sideways outwardly from the left and right ends  430 ,  432  of the bridge  406 , respectively, along a longitudinal direction established by the bridge. In other embodiments, the connecting means may project perpendicularly with respect to the bridge. The connecting means  414  and  416  may have lower or distal surfaces  418  and  420  respectively that may releasably engage with a means of insertion that may allow an inserter or other means of insertion to be side loading, top loading or pivotably loaded. For example, an inserter for clip  400  may be side loading or pivotably loading. The lower surfaces  418 ,  420  may be referred to as bone facing surfaces. Referring to  FIG. 21 , the lower surfaces  418 ,  420  are proximally spaced apart from, or proximally offset from, from the lower surface  410 . The dashed extension lines  410 ′ and  410 ″ in  FIG. 21  show the level of the lower surface  410  versus the lower surfaces  418 ,  420 . 
     A means of insertion may maintain the clip  400  in a first configuration thereby allowing a second configuration once an inserter is disassembled from the implant. The first configuration may be an elastically deformed state, for example an insertion state. The second configuration may be a free state or an implanted state, as seen in  FIG. 19 . The means of insertion may utilize features similar to connecting means  414  and  416  in combination with other surfaces such as top surface  408 . This combination of means of insertion may be used to maintain one or more features or arms or projections in a particular configuration. This combination of means of insertion may create a bending modality, such as a three point or four point bend, to maintain a specific clip device configuration or combination of configurations. A combination of surfaces and means of insertion, such as connecting means  414 , may be used on the entire clip or portions of a clip to create or maintain a particular configuration of a clip. For example, a tab such as  414  and top surface, such as  408  may be used to maintain one side of a clip or one leg of a clip in a particular configuration. When disassembled, that leg may have a configuration that is different from or the same as the configuration of the rest of the clip. 
     Referring to  FIG. 19 , the clip  400  is shown in the free state, or relaxed state, which is the shape of the clip  400  when no external forces are acting upon the clip  400 , other than gravity; the clip  400  experiences no elastic or plastic deflection or deformation. In the free state, the bone engaging members  402  and  404  converge as they extend away from the bridge  406  so that the distal ends  436 ,  440  are closer together than are the proximal ends  434 ,  438 . An angle  422  is formed between the converging bone engaging members  402  and  404  in the free state. The angle  422  opens toward the bridge  406 . The angle  422  may be referred to as a free state angle. 
     The inserter  300  may be used with the clip  400  and other implants. The inserter  300  may include a body  302 , a ram or shaft  304 , a pin  306 , and a knob  308 . The ram  304  and the ram pin  306  may be coupled together as a ram sub-assembly  314 . 
     The body  302  extends between a distal end  318  and a proximal end  320 . The body  302  may be a generally plate-like part that is wider at the distal and proximal ends  318 ,  320  and narrower in between. The distal-most aspect of the body  302  may include two jaws or hooks  322 ,  324  that face each other across a shallow alcove  326  with a proximal surface  340  that faces distally. Two proximal surfaces  340 ,  374  are shown; they may be coplanar. The hooks  322 ,  324  include proximal surfaces  328 ,  330 , respectively. The hooks  322 ,  324  include front walls  332 ,  334 , respectively. Thus, the hooks  322 ,  324  are suitable for back loading an implant. However, one wall  332 ,  334  may optionally be a back wall, similar to the arrangement of walls  222 ,  224  discussed above, or both walls  332 ,  334  may be back walls, similar to walls  132 ,  134  discussed above. A first notch  336  extends proximally from a central portion of the alcove  326 . A second notch  338  extends proximally from a central portion of the first notch  336 . The second notch  338  is narrower than the first notch  336 . A central longitudinal hole  342  extends proximally through the body  302  between the distal and proximal ends  318 ,  320 . The body  302  may be thickened in the vicinity of the hole  342  so as to adequately support the hole  342  under expected loads. A third notch  344  extends distally into a central portion of the proximal end  320  and intersects a transverse slot  346  that extends between the front and back sides of the body  302 . The transverse slot  346  may have a proximal surface  348  that faces distally. A second proximal surface  370  is also shown, which also faces distally and may be coplanar with the proximal surface  348 . 
     The ram or shaft  304  extends between a distal end  350  and a proximal end  352 . The ram  304  may be similar to, or identical to, the ram  204 . The ram  304  includes a distal head  354 , which may be generally rectangular as shown. As seen best in  FIGS. 19 and 21 , the distal-most aspect  372  of the head  354  may be convex in a front or back view. A shaft  356  extends proximally from the head  354 . The shaft  356  may have a circular cross section as shown. The outer diameter of the shaft  356  may be greater than the thickness of the head  354  in a front-back direction, and may be less than the width of the head in a left-right direction, as seen best in  FIGS. 21 and 22 . A transverse hole  358  extends through the shaft  356  proximal to the head  354 . The proximal end  352  of the ram  304  may include external threads  359 . 
     The ram  304  and the ram pin  306  may be coupled together to form the ram sub-assembly  314  by inserting the ram pin through the hole  358 . The ram pin  306  may be fixed within the hole  358  by a press fit, swaging operation, welding or brazing operation, or the like. 
     The knob  308  may include a generally rectangular body  362  which may be contoured to match the proximal end  320  of the body  302 . A central longitudinal internally threaded hole  360  may extend through the knob  308  along a proximal-distal direction. The knob  308  may include a first shaft portion  364  extending distally from the body  362  concentric with the hole  360 . The outer diameter of the first shaft portion  364  may be less than the outer dimensions of the body  362  in a front, back, left, or right view. A second shaft portion  366  may extend distally from the first shaft portion  364  concentric with the hole  360 . The outer diameter of the second shaft portion  366  may be greater than the outer diameter of the first shaft portion  364  so that the second shaft portion has a proximal surface  368  that faces proximally. 
     The inserter  300  may be assembled by coupling the knob  308  to the body  302  so that the first shaft portion  364  is in the third notch  344  and the second shaft portion  366  is in the transverse slot  346 ; inserting the ram pin  306  into the hole  358  of the ram  304  to form the ram sub-assembly  314 ; inserting the proximal end  352  of the ram into the distal end of the hole  342  of the body  302 ; advancing the ram proximally until the proximal end  352  reaches the knob  308 ; and engaging the external and internal threads  359 ,  360  so that the head  354  is received in the first notch  336  and the pin  306  is received in the second notch  338 . 
     When the inserter  300  is assembled, the ram  304 , pin  306 , and knob  308  are captive to the body  302 . Clockwise and counterclockwise rotation of the knob  308  causes the ram  304  to translate along the proximal-distal direction. The pin  306  in the second notch  338  prevents the ram  304  from rotating and limits the proximal travel of the ram. However, there is no limit to the distal travel of the ram in this embodiment, so that the inserter  300  is readily disassembled for cleaning. 
     The clip  400  and inserter  300  may be operatively assembled by turning the knob  308  to move the ram  304  proximally so that the distal aspect  372  of the head  354  is within the first notch  336 ; sliding the hooks  322 ,  324  over the connecting means  414 ,  416 ; and turning the knob  308  to move the ram  304  distally so that the distal aspect  372  of the head  354  contacts the bridge  406 . The connecting means  414 ,  416  may contact the front walls  332 ,  334 . 
     When the clip  400  and inserter  300  are operatively assembled, clockwise and counterclockwise rotation of the knob  308  causes the bridge  406  to move between an elastically deformed state and a relaxed state, or free state. In the elastically deformed state, the distal aspect  372  of the head  354  presses against the proximal surface  408  of the bridge  406 , flattening the bridge against the resistance of the connecting means  414 ,  416  in the hooks  322 ,  324  and spreading apart the free ends  436 ,  440  of the bone engaging members  402 ,  404 . The force of the head  354  against the bridge  406  may also be resisted by the proximal surface  368  of the second shaft portion  366  of the knob  308  against the proximal surface(s)  348  and/or  370  of the transverse slot  346  of the body  302 . In the relaxed state, the distal aspect  372  of the head  354  may be spaced apart from the proximal surface  408  of the bridge  406 , or may contact the proximal surface  408  so lightly that the bridge remains undeformed. 
     Any methods disclosed herein includes one or more steps or actions for performing the described method. The method steps and/or actions may be interchanged with one another. In other words, unless a specific order of steps or actions is required for proper operation of the embodiment, the order and/or use of specific steps and/or actions may be modified. 
     Reference throughout this specification to “an embodiment” or “the embodiment” means that a particular feature, structure or characteristic described in connection with that embodiment is included in at least one embodiment. Thus, the quoted phrases, or variations thereof, as recited throughout this specification are not necessarily all referring to the same embodiment. 
     Similarly, it should be appreciated that in the above description of embodiments, various features are sometimes grouped together in a single embodiment, Figure, or description thereof for the purpose of streamlining the disclosure. This method of disclosure, however, is not to be interpreted as reflecting an intention that any claim require more features than those expressly recited in that claim. Rather, as the following claims reflect, inventive aspects lie in a combination of fewer than all features of any single foregoing disclosed embodiment. Thus, the claims following this Detailed Description are hereby expressly incorporated into this Detailed Description, with each claim standing on its own as a separate embodiment. This disclosure includes all permutations of the independent claims with their dependent claims. 
     Recitation in the claims of the term “first” with respect to a feature or element does not necessarily imply the existence of a second or additional such feature or element. Elements recited in means-plus-function format are intended to be construed in accordance with 35 U.S.C. § 112 Para. 6. It will be apparent to those having skill in the art that changes may be made to the details of the above-described embodiments without departing from the underlying principles of the technology. 
     While specific embodiments and applications of the present technology have been illustrated and described, it is to be understood that the technology is not limited to the precise configuration and components disclosed herein. Various modifications, changes, and variations which will be apparent to those skilled in the art may be made in the arrangement, operation, and details of the methods and systems of the present technology disclosed herein without departing from the spirit and scope of the technology.