Patent Publication Number: US-11382677-B2

Title: Charco-resis implant, alignment instrument, system and method of use

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     This application is a continuation of U.S. application Ser. No. 14/379,361 filed Aug. 18, 2014 and entitled Charco-Resis Implant, Alignment Instrument, System and Method of Use, which will issue as U.S. Pat. No. 10,524,845 on Jan. 7, 2020, which is a National Stage application based on International Application No. PCT/US2013/026397 filed Feb. 15, 2013, and published as WO 2013/123366 on Aug. 22, 2013 and entitled Charco-Resis Implant, Alignment Instrument, System and Method of Use, which claims priority benefit under 35 U.S.C. § 119(e) of U.S. provisional application No. 61/599,604 filed Feb. 16, 2012 and entitled Orthopedic Implant for correction and stabilization of the foot and/or ankle, which are incorporated herein by reference in their entireties. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates generally to correction of a flat foot or rocker-bottom deformity, such as Charcot foot. More specifically, but not exclusively, the present invention concerns bone and elongate member implants and alignment guides for inserting the implants to correct a flat foot or rocker-bottom deformity. 
     SUMMARY OF THE INVENTION 
     Aspects of the present invention provide elongate member implants, bone implants, an alignment guide for inserting the elongate member and bone implants, and method for correcting a flat foot or rocker-bottom deformity. 
     In one aspect, provided herein is an implant system including a bone implant and an elongate member. The bone implant includes a proximal end, a distal end, a hole along a longitudinal axis, and at least one opening intersecting the hole. The elongate member includes a first end with a head portion, a second end with a coupling mechanism, and an opening along a longitudinal axis. The coupling mechanism of the elongate member engages the at least one opening to couple the bone implant to the elongate member. 
     In another aspect, provided herein is a bone fusion system. The system may include an implantable device, a rod, and an alignment guide. The implantable device includes a proximal end, a distal end, a longitudinal opening, and at least one hole extending into the longitudinal opening. The rod includes a first end with a head portion, a second end with an engagement member, and a hole extending along a longitudinal axis. An alignment guide including a first end and a second end, the first end of the alignment guide is configured to engage the proximal end of the implantable device and the second end of the alignment guide is configured to insert the rod into the patient&#39;s bones to engage the implantable device. 
     In yet another aspect, provided herein is a surgical method for fixing a patient&#39;s joint including selecting a fixation implant and a compression shaft. The method also includes determining a trajectory for the compression shaft and inserting the fixation implant into the patient&#39;s joint. The method may further include assembling an alignment guide. The alignment guide may include a drive tube, a driver, an alignment body, a sleeve, a first guide, and a second guide. The drive tube may include a longitudinal hole and may couple to the fixation implant at one end. The driver may be inserted into the longitudinal hole of the drive tube and may also couple to the proximal end of the fixation implant. The alignment body includes a first end, a second end, and a carriage. The carriage is configured to slidingly engage the first end of the alignment body and the second end of the alignment body engages the driver and may couple to the drive tube. The sleeve includes a longitudinal opening and may mate with the alignment body. The first guide includes a longitudinal hole and the first guide may be configured to engage the longitudinal opening in the sleeve. The second guide includes a longitudinal hole and is configured to engage the longitudinal hole of the first guide. The method may also include positioning the carriage and the sleeve relative to the fixation implant. The method may further include securing the carriage to the alignment body to maintain the sleeve position. The method may also include inserting a first guide and a second guide into the sleeve. The method also may include inserting a guide pin through the second guide and the patient&#39;s joint to intersect the fixation implant. The method may also include removing the second guide from the sleeve and inserting a drill over the guide pin to ream an opening in the patient&#39;s joint. The method may further include removing the drill and first guide from the sleeve. In addition, the method may include inserting the compression shaft over the guide pin, through the sleeve, and into the patient&#39;s joint. The method may further include removing the guide pin and inserting the compression shaft into the patient&#39;s joint. In addition, the method may include disassembling the alignment guide. 
     These, and other objects, features and advantages of this invention will become apparent from the following detailed description of the various aspects of the invention taken in conjunction with the accompanying drawings. 
    
    
     
       BRIEF DESCRIPTION OF DRAWINGS 
       The accompanying drawings, which are incorporated in and constitute a part of the specification, illustrate embodiments of the invention and together with the detailed description herein, serve to explain the principles of the invention. The drawings are only for purposes of illustrating preferred embodiments and are not to be construed as limiting the invention. 
         FIG. 1  is a top perspective view of an alignment guide, in accordance with an aspect of the present invention; 
         FIG. 2  is a top perspective view of the alignment guide of  FIG. 1  attached to a bone implant and an elongate member, in accordance with an aspect of the present invention; 
         FIG. 3  is a bottom perspective view of the alignment guide, bone implant, and elongate member of  FIG. 2 , in accordance with an aspect of the present invention; 
         FIG. 4  is an exploded view of the alignment guide, bone implant, and elongate member of  FIG. 2 , in accordance with an aspect of the present invention; 
         FIG. 5  is an exploded distal end view of the drive tube, bone implant, and split bushing of  FIG. 4 , in accordance with an aspect of the present invention; 
         FIG. 6  is an exploded proximal end view of the drive tube, bone implant, and split bushing of  FIG. 4 , in accordance with an aspect of the present invention; 
         FIG. 7  is a perspective view of the bone implant of  FIG. 2 , in accordance with an aspect of the present invention; 
         FIG. 8  is a perspective view of another embodiment of the bone implant, in accordance with an aspect of the present invention; 
         FIG. 9  is a perspective view of yet another embodiment of the bone implant, in accordance with an aspect of the present invention; 
         FIG. 10  is an exploded perspective view of a further embodiment of the bone implant and a bushing, in accordance with an aspect of the present invention; 
         FIG. 11  is a top view of the bone implant of  FIG. 10 , in accordance with an aspect of the present invention; 
         FIG. 12  is a cross-sectional view of the bone implant of  FIG. 11  as viewed along line  12 - 12  in  FIG. 11 , in accordance with an aspect of the present invention; 
         FIG. 13  is a perspective view of the elongate member of  FIG. 2 , in accordance with an aspect of the present invention; 
         FIG. 14  is a perspective view of another embodiment of the compression screw, in accordance with an aspect of the present invention; 
         FIG. 15  is a perspective view of the bone implant of  FIG. 10  engaging the drive tube and driver of the alignment guide of  FIG. 1  while being inserted into a patient&#39;s foot, in accordance with an aspect of the present invention; 
         FIG. 16  is a perspective view of the alignment body of the alignment guide of  FIG. 1  engaging the drive tube and driver of  FIG. 15 , in accordance with an aspect of the present invention; 
         FIG. 17  is a perspective view of the alignment guide of  FIG. 1  engaging the bone implant of  FIG. 10  inserted into a patient&#39;s foot, in accordance with an aspect of the present invention; 
         FIG. 18  is a perspective view of the alignment guide of  FIG. 1  configured to insert the elongate member of  FIG. 13  and engaging the bone implant of  FIG. 10 , in accordance with an aspect of the present invention; 
         FIG. 19  is a perspective view of the bone implant of  FIG. 10  and the elongate member of  FIG. 13  implanted into a patient&#39;s foot, in accordance with an aspect of the present invention; 
         FIG. 20  depicts one embodiment of a surgical method for implanting the bone implant and elongate member into a patient&#39;s body, in accordance with an aspect of the present invention. 
     
    
    
     DETAILED DESCRIPTION FOR CARRYING OUT THE INVENTION 
     Generally stated, disclosed herein is an alignment guide for inserting an elongate member relative to a bone implant. A number of embodiments of bone implants are disclosed herein, as well as several embodiments of the elongate member. The terms “bone implant,” “subtalar implant,” “implantable device” and “fixation implant” may be used interchangeably as they essentially describe the same type of device. In addition, the terms “elongate member,” “compression beam,” “rod,” and “compression shaft” may be used interchangeably as they essentially describe the same type of device. Further, a surgical method for implanting an implant including the subtalar implant and compression beam using the alignment guide is discussed. 
     In this detailed description and the following claims, the words proximal, distal, anterior, posterior, medial, lateral, superior and inferior are defined by their standard usage for indicating a particular part of a bone or implant according to the relative disposition of the natural bone or directional terms of reference. For example, “proximal” means the portion of an implant nearest the torso, while “distal” indicates the portion of the implant farthest from the torso. As for directional terms, “anterior” is a direction towards the front side of the body, “posterior” means a direction towards the back side of the body, “medial” means towards the midline of the body, “lateral” is a direction towards the sides or away from the midline of the body, “superior” means a direction above and “inferior” means a direction below another object or structure. In addition, for the purposes of this disclosure when referencing the implants, the term “proximal” will mean the portion of the implant closest or nearest the alignment guide. The term “distal” shall mean the portion of the implant farthest away from the alignment guide. 
     Referring to the drawings, wherein like reference numerals are used to indicate like or analogous components throughout the several views, and with particular reference to  FIGS. 1-4 , there is illustrated an exemplary embodiment alignment guide  10  for aligning a compression beam  130  with a subtalar implant  20 . The alignment guide  10  may include an alignment body  12 , a drive tube  40 , a driver  50 , a knob  60 , a sleeve  100 , a first guide  110 , and a second guide  120 . The alignment body  12  may include a support arm  70 , an alignment arm  80 , and a carriage  90 . The driver  50  may couple to the knob  60  on a first end and engage the drive tube  40  on a second end. A first end of the support arm  70  may engage the driver  50  between the knob  60  and drive tube  40 . The drive tube  40  may also couple to the support arm  70  on a first end and a subtalar implant  20  on a second end (See  FIGS. 2 and 3 ). The support arm  70  may also couple with the alignment arm  80  on a second end. The carriage  90  may slidingly couple to the alignment arm  80  and the sleeve  100  may engage the carriage  90  relatively perpendicular to the alignment arm  80 . The carriage  90  aligns the sleeve  100  into a desired position for inserting the compression beam  130  to engage the implanted subtalar implant  20  (See  FIGS. 2 and 3 ). The second guide  120  may engage the sleeve  100  or the first guide  110  and the first guide  110  may engage the sleeve  100 . 
     As shown in the exploded views of  FIGS. 4-6 , the drive tube  40  may include a through hole  42  along the longitudinal axis of the drive tube  40 . The drive tube  40  may also include a coupling protrusion  44  on a first end and an implant engagement protrusion  46  on a second end opposite the first end. The implant engagement protrusion  46  of the drive tube  40  may engage the engagement cavity  30 , seen in  FIGS. 6-10 , of the subtalar implant  20 . The implant engagement protrusion  46  and the engagement cavity  30  may have corresponding shapes, which may have, for example, polygonal or multi-lobed shapes. The coupling protrusion  44  may be configured to couple the drive tube  40  to an engagement opening  76  of the support arm  70 . The driver  50  may pass through the hole  42  of the drive tube  40  to engage the longitudinal through hole  26  of the subtalar implant  20 . The driver  50  may include a longitudinal opening  52  and an engagement end  54  at the inferior end of the driver  50  for mating with a subtalar implant  20 . The engagement end  54  may also include a channel  56 . The proximal end of the driver  50  may couple with the engagement opening  62  of the knob  60  for insertion of the subtalar implant  20  into a patient, as seen in  FIG. 15 . 
     After insertion of the subtalar implant  20  into a patient, as shown in  FIGS. 1-3 and 16 , the driver  50  may be engage the support arm  70 . As shown in  FIG. 4 , the support arm  70  may include a base  68  with a first end and a second end. The first end of the base  68  includes an alignment end  72  with a through hole  74  and an engagement opening  76 , as seen in  FIG. 4 . The second end of the base  68  includes an engagement protrusion  78 , shown in  FIG. 4 . The driver  50  may be inserted into the through hole  74  of the support arm  70  by removing the knob  60 , sliding the support arm  70  onto the driver  50  and reattaching the knob  60 . As seen in  FIGS. 1 and 4 , the support arm  70  is slid onto the driver  50 , the engagement opening  76  of the alignment end  72  engages the coupling protrusion  44  of the drive tube  40 . The support arm  70  may couple with the alignment arm  80  on the second end of the base  68 , as shown in  FIGS. 1 and 2 . 
     As shown in  FIGS. 3 and 4 , the alignment arm  80  may include an engagement end  82  with an engagement opening  84  on a first end and a stop protrusion  86  on the second end. The first end and the second end of the alignment arm  80  may be connected by an arm member  88 . The support arm  70  may couple with the alignment arm  80  by inserting the engagement protrusion  78  of the support arm  70  into the engagement opening  84  of the alignment arm  80 . 
     As seen in  FIG. 1 , the carriage  90  may engage the arm member  88  of the alignment arm  80 . The carriage  90  may include a threaded through hole  92  and an engagement channel  94 , as shown in  FIG. 4 . The engagement channel  94  may be, for example, perpendicular to the through hole  92 . Opposite the engagement end  82  of the alignment arm  80 , the engagement channel  94  of the carriage  90  may be inserted onto the arm member  88  to slide along the alignment arm  80 . The arm member  88  may include a stop protrusion  86 , shown in  FIG. 3 , to prevent the carriage  90  from sliding off the end of the arm member  88  once attached to the alignment arm  80 . The channel  94  of the carriage  90  may move along the arm member  88  of the alignment arm  80  to allow for alignment of the compression beam  130  with the already implanted subtalar implant  20 . Once a desired trajectory is obtained, a locking mechanism  96  (See  FIGS. 1-2 and 4 ) may be used to secure the carriage  90  to the arm member  88 . The locking mechanism  96  may be, for example, a set screw. 
     As shown in  FIGS. 2-3 and 18 , the compression beam  130  may be aligned with the subtalar implant  20  by inserting the sleeve  100  into the threaded through hole  92  of the carriage  90 . The sleeve  100  may include an adjustment knob  102  for inserting the sleeve  100  into the threaded hole  92  of the carriage  90  and to adjust the position of the sleeve  100  relative to the subtalar implant  20 . The terms “screw sleeve” and “sleeve” may be used interchangeably as they essentially refer to the same device. The screw sleeve  100  may also include threads  106  longitudinally along the exterior of the screw sleeve  100  below the adjustment knob  102  for mating with the threaded hole  92  of the carriage  90 . In addition, the screw sleeve  100  may include a longitudinal opening  104  (See  FIG. 4 ) through the screw sleeve  100 . The longitudinal opening  104  of the screw sleeve  100  may be configured for insertion of a first guide  110  and/or a second guide  120 . 
     The second guide  120 , as shown in  FIG. 4 , may include a head  122  for engaging the adjustment knob  102  of the screw sleeve  100  or a head  112  of the first guide  110 . The second guide  120  may also include a longitudinal through hole  124  for insertion of a guide pin (not shown) into the patient&#39;s bones. The second guide  120  may be, for example, a k-wire guide. The guide pin may be, for example, a temporary fixation pin, a k-wire, or the like. The first guide  110 , as shown in  FIG. 4 , may include a head  112  and a longitudinal through hole  114 . The first guide  110  may be, for example, a drill guide. The second guide  120  may be inserted into the opening  104  of the screw sleeve  100  or into the through hole  114  of the first guide  110  to align the second guide  120  relative to the subtalar implant  20 . The longitudinal opening  114  of the first guide  110  may also be used for insertion of a drill (not shown), which may be used to drill over the guide pin for insertion of the compression beam  130  into the patient&#39;s bones. The opening  104  of the screw sleeve  100  may also allow for insertion of the compression beam  130  attached to an insertion tool (not shown) for correct alignment with the subtalar implant  20 . 
     Referring now to  FIGS. 7-10 , a plurality of subtalar implants  20  are shown. The subtalar implants  20  may include a proximal end  22  and a distal end  24 . The subtalar implants  20  may also be, for example, tapered from the proximal end  22  to the distal end  24  creating, for example, a bullet or cone shape, as shown in  FIG. 12 . The subtalar implants  20  may also include a longitudinal hole or opening  26  from the proximal end  22  to the distal end  24 . The longitudinal hole or opening  26  may be, for example, a through hole. The terms “longitudinal hole,” “longitudinal opening” and “through hole” may be used interchangeably as they essentially refer to the same structure. Alternatively, the subtalar implant  20  may include a longitudinal hole  26  extending into the subtalar implant  20  from the proximal end  22 , which does not extend all the way to the distal end  24 . In addition, the subtalar implants  20  may include at least one opening  28  relatively perpendicular to and intersecting with the hole  26 , as seen in  FIG. 12 . The at least one opening  28  may be, for example, a blind hole. The at least one opening  28  of the subtalar implants  20  may be, for example, one opening along the longitudinal axis of the subtalar implants  20 , two openings spaced apart along the longitudinal axis of the subtalar implants  20  and positioned approximately 90 degrees or 180 degrees from each other, or three openings spaced apart along the longitudinal axis of the subtalar implants  20  and positioned approximately 120 degrees apart from each other. The subtalar implants  20  may also include an engagement cavity  30  at the proximal end  22  of the opening  26  for connecting with a driver  50  and drive tube  40  for insertion into a patient&#39;s bones. The subtalar implants  20  may have at least one bushing  34  (See  FIG. 4 ) in the at least one opening  28  for engaging the compression beam  130 . The bushing  34  (See  FIG. 10 ) may include a cavity  36  with threads  38  for engaging the threaded tip  142  (See  FIGS. 13-14 ) of the compression beam  130 . Alternatively, the at least one opening  28  may be threaded to engage the compression beam  130 . 
     The subtalar implants  20  may also include a plurality of grooves  32  which may be in various arrangements. Examples of these grooves  32  are shown in  FIGS. 6-10 . The plurality of grooves  32  may extend, for example, horizontally around the circumference of the implants  20 , at an angle around the circumference of the implants  20 , and both horizontally and at an angle around the circumference of the implants  20 . The plurality of grooves  32  may be horizontal relative to the longitudinal axis of the implants  20 , such that, the grooves  32  are substantially perpendicular to the longitudinal axis as they extend around the circumference of the implants  20 . The plurality of grooves  32  may include, for example, sharp edges, rounded edges or a combination of both sharp and rounded edges. In addition, the size and depths of the plurality of grooves  32  and the spacing (or pitch) between each groove of the plurality of grooves  32  may vary on the implants  20 . For example, as illustrated,  FIGS. 7 and 8  show the plurality of grooves  32  extending horizontally around the circumference of the implants  20  relative to the longitudinal axis of the implants  20 , however the plurality of grooves  32  shown in  FIG. 7  are larger and spaced farther apart than the plurality of grooves  32  shown in  FIG. 8 . The plurality of grooves  32  may, for example, extend horizontally around the circumference of the implant  20  relative to the longitudinal axis of the implant  20  on a first portion and extend at an angle around the circumference of the implant  20  on a second portion, as shown in  FIG. 9 , the proximal end  22  of the implant  20  includes the horizontal grooves  32  and the distal end  24  of the implant  20  includes the angled grooves  32 , although other arrangements of the plurality of grooves  32  are also contemplated. As shown in  FIG. 10 , the plurality of grooves  32  may, for example, extend both horizontally relative to the longitudinal axis and at an angle from the proximal end  22  to the distal end  24  in an overlapping pattern relative to each other. As shown in  FIG. 10 , the first portion and second portion of the implant  20  may overlap relative to each other. 
     Referring now to  FIGS. 13 and 14 , two embodiments of the compression beam  130  are shown. The compression beam  130  may include a first end  132 , a second end  134 , and a through hole  136  extending longitudinally from the first end  132  to the second end  134 . The terms “through hole,” “longitudinal hole,” and “longitudinal opening” may be used interchangeably as they essentially refer to the same structure. Alternatively, the hole  136  may not be a through hole, rather the hole  136  may extend into the compression beam  130  from the first end  132  but not extend all the way through to the second end  134 . The first end  132  of the compression beam  130  may include a head portion with an engagement opening  138  for engaging an insertion tool (not shown) and a coupling mechanism  140  including fixation threads for engagement with the patient&#39;s bone. The second end  134  of the compression beam  130  may include a threaded tip  142  for engaging the at least one bushing  34  of the subtalar implant  20 . The terms “second end,” “threaded tip,” “coupling mechanism” and “engagement member” may be used interchangeably as they essentially describe the same type of component. Alternatively, if the subtalar implant  20  does not include bushings  34 , the threaded tip  142  may be inserted directly into the at least one opening  28  of the subtalar implant  20  to couple the compression beam  130  to the subtalar implant  20 . The threaded tip  142  may be, for example, a machine thread. In an alternative embodiment, shown in  FIG. 14 , the second end  134  of the compression beam  130  may also include a compression engagement portion  144  adjacent to the threaded tip  142 . The compression engagement portion  144  may have a larger diameter than the diameter of the threaded tip  142  for engaging the patient&#39;s bone. The compression engagement portion  144  may also assist with compression of the patient&#39;s bones during insertion of the compression beam  130 . The compression beam  130  may be, for example, made of titanium, stainless steel, nitinol, or like metals. As depicted in  FIGS. 13 and 14 , the second end  134  is a threaded tip  142 , although alternative second ends  134  which are not threaded are also contemplated, for example, taper press fits, snap rings, and the like. 
     Referring now to  FIG. 20 , a surgical method for inserting an implant system that may include a subtalar implant  20  and compression beam  130  using the alignment guide  10  is shown. The surgical method may include the step  150  of using an x-ray template of the patient&#39;s joint to determine the size of the subtalar implant  20  and trajectory of the compression beam  130 . The next step  152  may include inserting the subtalar implant  20  into the patient&#39;s hind foot, for example, within the joint space of the talus bone  182  and calcaneous bone  190 . The drive tube  40  and driver  50  may be used to insert the subtalar implant  20  into the patient&#39;s hind foot at a set distance based on the x-ray template, as shown in  FIG. 15 . Next a physician may perform step  154  using an imaging technique, for example, fluoroscopy, of the patient&#39;s joint to check positioning of the subtalar implant  20 . Once the desired positioning of the subtalar implant  20  is confirmed, the alignment body  12  may be attached in step  156 , as shown in  FIG. 16 . The alignment body  12  may be attached by, for example, sliding the support arm  70  onto the driver  50  and coupling the support arm  70  to the drive tube  40 . The knob  60  may be removed and replaced in order to slide the support arm  70  onto the driver  50 . In addition, step  156  may include coupling the alignment arm  80  with a carriage  90  attached to the support arm  70 , as seen in  FIG. 16 . Alternatively, the carriage  90  may be inserted onto the alignment arm  80  after coupling it to the support arm  70 . 
     As seen in  FIG. 17 , in the next step  158 , the carriage  90  may be positioned along the alignment arm  80  relative to the subtalar implant  20  to determine the trajectory of the compression beam  130 . The screw sleeve  100  may be inserted into the threaded hole  92  in the carriage  90 . Once a desired trajectory of the compression beam  130  is reached, step  160  may include locking the carriage  90  to the alignment arm  80  using a locking mechanism (not shown). The next step  162  may include inserting the first guide  110  into the opening  104  of the screw sleeve  100  and the second guide  120  into the opening  114  of the first guide  100 , as shown in  FIG. 17 . Next a physician may insert a guide pin through the through hole  124  of the second guide  120  and through the patient&#39;s bones to intersect with the subtalar implant  20  in step  164 . After insertion of the guide pin into the patient&#39;s bones, step  166  may include checking the alignment of the guide pin (not shown) using an imaging technique, for example, fluoroscopy. Once proper alignment of the guide pin is confirmed, if the second guide  120  has not already been removed, the second guide  120  may be removed in step  168 . Next, in step  170 , a drill (not shown) may be inserted into the opening  114  of the first guide  110  over the guide pin (not shown) and an opening drilled for insertion of the compression beam  130 . As shown in  FIG. 19 , the opening may be drilled into the patient&#39;s bones, for example, the first metatarsal  184 , the medial cuneiform  186 , the navicular  188 , and the talus  182  where it engages the subtalar implant  20 . Step  172  may include removing the drill and first guide  110  from the opening  104  of the screw sleeve  100 . 
     After the drill and first guide  110  are removed, as shown in  FIG. 18 , the compression beam  130  may be attached to a tool (not shown) and inserted over the guide pin and through the opening  104  of the screw sleeve  100  in step  174 . Once the compression beam  130  passes through the screw sleeve  100  and begins engaging the drilled opening in the patient&#39;s bones, the guide pin may be removed in step  182 . Alternatively, the guide pin may be removed prior to inserting the compression beam  130 . As shown in  FIG. 20 , the alternative method may include removing the guide pin after the drill and first guide are removed, and then the compression beam may be inserted into the patient as discussed below with reference to step  176 . Once the guide pin is removed, the compression beam  130  may be inserted through the patient&#39;s bones to engage the subtalar implant  20  in step  176 , as shown in  FIG. 18 . Specifically, the threaded tip  142  of the compression beam  130  engages the at least one opening  28  of the subtalar implant  20  or a cavity  36  (See  FIGS. 6  an  10 ) in the bushing  34  (See  FIGS. 4, 6 and 10 ) that is positioned in the at least one opening  28  of the subtalar implant  20  to secure the compression beam  130  to the subtalar implant  20 . The compression beam  130  is fully inserted into the patient&#39;s bones once it is within or flush with the bone. Next step  178  may include checking the fixation using at least one imaging technique, for example, fluoroscopy. After fixation is confirmed, the alignment guide  10  may be disconnected from the subtalar implant  20  and compression beam  130  in step  180 . The implanted subtalar implant  20  and connected compression beam  130  are shown in  FIG. 19  after final placement. 
     The above described method and alignment guide  10  may be used to insert the compression beam  130  through the base of the metatarsal to mate with the subtalar implant  20 , as shown in  FIGS. 15-19 . Alternatively, the above described method and alignment guide  10  may be used to insert the compression beam  130  through the head of the metatarsal to mate with the subtalar implant  20 . In an additional alternative embodiment, the above described method that uses the alignment guide  10  with an alternative alignment arm  80  may be used to insert the compression beam  130  through the lateral column of the patient&#39;s foot to mate with the subtalar implant  20 . 
     The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprise” (and any form of comprise, such as “comprises” and “comprising”), “have” (and any form of have, such as “has”, and “having”), “include” (and any form of include, such as “includes” and “including”), and “contain” (and any form of contain, such as “contains” and “containing”) are open-ended linking verbs. As a result, a method or device that “comprises,” “has,” “includes,” or “contains” one or more steps or elements possesses those one or more steps or elements, but is not limited to possessing only those one or more steps or elements. Likewise, a step of a method or an element of a device that “comprises,” “has,” “includes,” or “contains” one or more features possesses those one or more features, but is not limited to possessing only those one or more features. Furthermore, a device or structure that is configured in a certain way is configured in at least that way, but may also be configured in ways that are not listed. 
     The invention has been described with reference to the preferred embodiments. It will be understood that the architectural and operational embodiments described herein are exemplary of a plurality of possible arrangements to provide the same general features, characteristics, and general system operation. Modifications and alterations will occur to others upon a reading and understanding of the preceding detailed description. It is intended that the invention be construed as including all such modifications and alterations.