Patent Publication Number: US-2020275956-A1

Title: Inserter And Method For Securing An Implant To A Spinal Process With A Flexible Fastening System

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of U.S. patent application Ser. No. 15/980,956, filed May 16, 2018, which is a divisional of U.S. patent application Ser. No. 15/258,123, now U.S. Pat. No. 9,999,450, filed Sep. 7, 2016, which is a continuation of U.S. patent application Ser. No. 14/644,428, now U.S. Pat. No. 9,757,167, filed Mar. 11, 2015. The entire contents of each of the above applications are hereby incorporated by reference. 
    
    
     BACKGROUND 
     1. Technical Field 
     The present disclosure relates to implants and, more specifically, to methods, flexible implant systems, and instruments for securing an implant to a bony element. 
     2. Discussion of Related Art 
     The spine is made up of a superposition of vertebrae, that are normally aligned along a vertebral axis, extending from the lumbar vertebrae to the cervical vertebrae, with each vertebra presenting a posterior wall from which a spinous process projects and two side edges having walls from which the ribs and/or transverse processes projects. When an individual&#39;s spine presents abnormal curvature, the vertebrae are inclined relative to one another and relative to said vertebral axis. The lateral edges of the vertebrae situated on one side are thus closer to one another and form a concave curve, while the lateral edges on the other side appear spaced apart from one another and form a convex curve. In order to straighten the spinal column, the lateral edges of the vertebrae on the concave side are spaced apart from one another and are taken relative to one another to a distance that is substantially equivalent to the distance between the lateral edges on the other side. Thereafter, in order to keep the vertebrae in that position relative to one another, known devices are used that have screws for insertion into the vertebrae or hooks for inserting along the inside wall of the spinal canal, associated with rods for interconnecting the screws or the hooks. 
     The hooks are generally inserted in pairs in each vertebra and on either side close to the pedicles, the heads of the hooks projecting from the posterior wall of a vertebra, one on either side of the spinous process. The heads may be tulip-shaped to receive a rod that is secured by means of a set screw inserted in the head and bearing against the rod. Rows constituted by the heads of the hooks situated on either side of the spinous processes are interconnected and held in fixed position by two rods that are parallel to each other and to the axis of the spine. 
     The screws have tulip-shaped heads and are inserted in pairs in the posterior walls of vertebrae in the pedicles on either side of the spinous processes. The screws constitute fastening points in the vertebrae for holding them relative to one another. The screws are inserted into the pedicles of the vertebrae, and under certain circumstances, the pedicles may be damaged. 
     Therefore, a continuing need exists for an implant that can address the anatomy correction, including large deformity reductions and translations needed, and still maintain the safety of the patient. In addition, there is a need for instruments and methods for securing such an implant to a bony element of a patient. 
     SUMMARY 
     In an aspect of the present disclosure, a surgical instrument includes a body, a securement arm, a clamp lock, and a tensioning assembly. The body defines a longitudinal axis and has proximal and distal portions. The distal portion defines a recess. The securement arm is coupled to the body and is translatable along the body in a direction parallel to the longitudinal axis between first and second positions. The clamp lock is pivotally coupled to the distal portion of the body. The clamp lock is pivotable between secured and unsecured configurations. The tensioning assembly is translatable in a direction that is parallel to the longitudinal axis between proximal and distal positions. The tensioning assembly is configured to draw a flexible band to tension the flexible band about a bony element. 
     In aspects, the surgical instrument includes a securement screw that passes through a securement opening defined in the proximal portion of the body. The securement screw may be rotatably coupled to a distal end of the securement arm and may be configured to translate the securement arm between its first and second positions. The securement screw may include a threaded body and the walls that define the securement opening may include threads. The threaded body of the securement screw may engage the threads of the securement opening such that the securement arm translates in a direction that is parallel to the longitudinal axis in response to rotation of the securement screw. The securement arm may include securement fingers that define a passage therebetween. The distal portion of the body may be positioned within the passage. 
     In some aspects, the clamp lock includes a securement tab that is positioned on one end and defines a lock cam opening on the other end. The clamp lock may define a pivot pin opening positioned between the securement tab and the lock cam opening. The pivot pin opening may receive a pivot pin that is fixed to the distal portion of the body such that the clamp lock is pivotable about the pivot pin. The securement tab may be configured to engage a notch defined by a clamp received within the recess defined in the distal portion of the body to secure the clamp within the recess. The lock cam opening may receive a lock cam pin. The securement arm may include securement fingers where each securement finger defines a lock cam channel. The lock cam pin may be disposed within the lock cam channel of each of the securement fingers. In the proximal position of the securement arm, the walls defining the lock cam channels may engage the lock cam pin to secure the clamp lock in its secured configuration. In the distal position of the securement arm, the walls defining the lock cam channels may engage the lock cam pin to pivot the clamp lock to its unsecured position. The securement arm may have an intermediate position between its first and second position such that the clamp lock is pivotable between its secured and unsecured positions. The clamp lock may be biased towards the secured configuration. 
     In particular aspects, the surgical instrument includes a tensioning screw that passes through a tensioning opening defined in the proximal portion of the body. The tensioning screw may pass through a tensioning body of the tensioning assembly and may be configured to translate the tensioning assembly between the proximal and distal positions. The distal portion of the body may include a tensioning screw support arm that extends perpendicular to the longitudinal axis and defines a tensioning screw securement opening that rotatably receives a distal end of the tensioning screw. 
     In certain aspects, the tensioning assembly includes a button that defines a tensioning screw passage which receives a threaded body of the tensioning screw therein. The tensioning screw passage may be defined by a first wall that has a smooth surface and a second wall that includes threads. The button may have a disengaged position in which the second wall is engaged with the threaded body of the tensioning screw such that the tensioning assembly translates in a direction that is parallel to the longitudinal axis in response to rotation of the tensioning screw. The button may have a depressed position in which the second wall is disengaged from the threaded body of the tensioning screw such that the tensioning assembly is freely translatable over the threaded body parallel to the longitudinal axis irrespective of rotation of the tensioning screw. The tensioning assembly may include a button biasing member that is positioned to urge the button towards the disengaged position. 
     In aspects, the surgical instrument includes a band locking mechanism that is positioned on the tensioning assembly. The band locking mechanism may be configured to fix a flexible band to the tensioning assembly. The tensioning assembly may include first and second support arms. Each of the first and second support arms may define a pin opening that receives an end of the flexible band lock pivot pin. The band locking mechanism may include a locking lever that is pivotally supported about the flexible band lock pivot pin. The band locking mechanism may include an inner locking member and an outer locking member. The inner locking member may be pivotally coupled to a tensioning body of the tensioning assembly and may include an inner locking surface that faces the outer locking member. The outer locking member may include tabs that are connected by a connector. Each of the tabs may define a flexible band pin lock opening that slidably receives the band locking pin. The tabs may define opposing camming recesses that are configured to receive cam bosses defined on the locking lever. The locking lever may be pivotable between unlocked and locked configurations. As the locking lever is pivoted towards the locked configuration, the cam bosses may engage the tabs to move an outer locking surface, that is disposed on the outer locking member, towards the inner locking surface. The inner and outer locking surfaces may define a band passage therebetween and may be configured to fix a flexible band within the band passage when the locking lever is in its locked configuration. 
     In some aspects, the recess defined by the distal portion of the body is configured to receive a clamp. The securement arm may be configured to secure a rod within a clamp that is received in the recess defined by the distal portion of the body. In the secured configuration of the clamp lock, the clamp lock may be configured to secure a clamp within the recess defined by the distal portion of the body. The tensioning assembly may be configured to draw the flexible band through a clamp that is secured in the recess of the distal portion defining by the distal portion of the body. 
     In another aspect of the present disclosure, a method of surgery includes positioning a clamp within a recess defined in a distal portion of a body of a surgical instrument, positioning a rod within a rod cavity defined by the clamp, rotating a securement screw of the surgical instrument to translate a securement arm of the surgical instrument distally, passing ends of a flexible band that is positioned about a bony element through a slot of the clamp and through a band passage defined by a band locking mechanism of the surgical instrument, rotating a band locking lever of the band locking mechanism to a locked configuration to fix the flexible band within the band passage, rotating a tensioning screw to translate the locking mechanism proximally over the tensioning screw parallel to the longitudinal axis to tension the flexible band about the bony element, securing the clamp to the rod, securing the clamp to the flexible band, and releasing the clamp from the recess of the distal portion of the surgical interment. The body of the surgical instrument defines a longitudinal axis. The securement fingers of the securement arm may secure the rod within the rod cavity of the clamp when the securement arm is translated distally. 
     In aspects, positioning the clamp within the recess includes urging a clamp lock towards an unsecured configuration with the clamp as the clamp is positioned within the recess. The clamp lock may engage the clamp to secure the clamp within the recess when the clamp is positioned within the recess. Positioning the clamp within the recess may include rotating the securement screw to translate the securement arm to a fully proximal position. The securement arm may define lock cam channels that each have walls which engage a lock cam pin to pivot a clamp lock to an unsecured configuration. Rotating the securement screw may include pivoting the clamp lock to a secured configuration to secure the clamp within the clamp recess in response to distal translation of the securement arm. During subsequent distal translation of the securement arm, the wall defining the lock cam channel may engage the lock cam pin to fix the clamp lock in the secured configuration. 
     In some aspects, the method includes inserting a tool through an opening in the distal portion to engage a rod set screw to the clamp and rotating the tool such that the rod set screw is rotated to partially secure the rod within the rod cavity of the clamp after rotating the securement screw of the surgical instrument to translate the securement arm of the surgical instrument and before passing ends of the flexible band through the slot of the clamp. Securing the clamp to the rod may include inserting a tool through an opening in the distal portion to engage a rod set screw of the clamp and rotating the tool such that the rod set screw is rotated to secure the rod within the rod cavity of the clamp. 
     In particular aspects, the method includes depressing a button of a tensioning assembly and translating the tensioning assembly proximally over the tensioning screw to a distal position before rotating the band locking lever of the band locking member to the locked configuration. The method may include rotating the tensioning screw to translate the locking mechanism to a distal position before pivoting the band locking lever of the band locking member to the locked configuration. 
     In certain aspects, rotating the band locking lever includes engaging an outer locking member with camming bosses of the band locking lever to move the outer locking member towards an inner locking member. The band passage may be defined between locking surfaces of the inner and outer locking members. Securing the clamp to the flexible band may include inserting a tool through an opening in the distal portion to engage a band set screw of the clamp and rotating the tool such that the band set screw is rotated to secure the flexible band within the rod cavity of the clamp. Releasing the clamp may include rotating the securement screw to translate the securement arm to a fully proximal position. The securement arm may define lock cam channels that have walls which engage a lock cam pin to pivot a clamp lock to an unsecured configuration. The method may include trimming the flexible band to length adjacent the clamp after securing the flexible band to the clamp. 
     Further, to the extent consistent, any of the aspects described herein may be used in conjunction with any or all of the other aspects described herein. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Various aspects of the present disclosure are described hereinbelow with reference to the drawings, which are incorporated in and constitute a part of this specification, wherein: 
         FIG. 1  is a perspective view of an inserter provided in accordance with the present disclosure; 
         FIG. 2  is an exploded perspective view, with parts separated, of the inserter of  FIG. 1 ; 
         FIG. 3  is an enlarged view, with parts separated, of the indicated area of detail of  FIG. 2 ; 
         FIG. 4  is a rear perspective view, with parts separated, of the tensioning assembly of  FIG. 3 ; 
         FIG. 5  is a side view of the inserter of  FIG. 1  in with a securement arm of the inserter in an intermediate position and an clamp positioned below a clamp recess of the inserter; 
         FIG. 6  is a side view of the inserter of  FIG. 1  with the clamp positioned within the clamp of the inserter and the securement arm of the inserter in a proximal position such that a clamp lock is in an unsecured configuration; 
         FIG. 7  is a side view of the inserter of  FIG. 6  with a flexible band drawn through the clamp, the securement arm of the inserter in the intermediate position, and the clamp lock in a secured configuration; 
         FIG. 8  is a side view of the inserter of  FIG. 7  with a rod received in the clamp; 
         FIG. 9  is a side view of the inserter of  FIG. 8  in with the securement arm in a distal position; 
         FIG. 10  is a side view of the inserter of  FIG. 9  with a tool inserted through the inserter to partially secure the clamp to the rod; 
         FIG. 11  is a side view of the inserter of  FIG. 9  with the flexible band drawn through a band passage of a band locking mechanism which is in an unlocked configuration and a tensioning assembly in a proximal position; 
         FIG. 12  is a side view of the inserter of  FIG. 11  with the tensioning assembly in a distal position; 
         FIG. 13  is a side view of the inserter of  FIG. 12  with the band locking mechanism in a locked configuration; 
         FIG. 14  is a side view of the inserter of  FIG. 13  with the tensioning assembly translated to the proximal position with the flexible band fixed to the tensioning assembly; 
         FIG. 15  is a side view of the inserter of  FIG. 14  with a tool inserted through the inserter to fix the flexible band to the clamp; and 
         FIG. 16  is a side view of the inserter of  FIG. 15  released from the clamp and the flexible band trimmed to length. 
     
    
    
     DETAILED DESCRIPTION 
     Embodiments of the present disclosure are now described in detail with reference to the drawings in which like reference numerals designate identical or corresponding elements in each of the several views. As commonly known, the term “clinician” refers to a doctor, a nurse or any other care provider and may include support personnel. Additionally, the term “proximal” refers to the portion of the device or component thereof that is closer to the clinician and the term “distal” refers to the portion of the device or component thereof that is farther from the clinician. In addition, the term “cephalad” is known to indicate a direction toward a patient&#39;s head, whereas the term “caudal” indicates a direction toward the patient&#39;s feet. Further still, the term “lateral” is understood to indicate a direction toward a side of the body of the patient, i.e., away from the middle of the body of the patient. The term “posterior” indicates a direction toward the patient&#39;s back, and the term “anterior” indicates a direction toward the patient&#39;s front. Additionally, terms such as front, rear, upper, lower, top, bottom, and similar directional terms are used simply for convenience of description and are not intended to limit the disclosure. In the following description, well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail. 
     This disclosure relates generally to an instrument and method for securing a flexible implant system to a bony element of a patient. The flexible implant system includes a clamp and a flexible band that wraps around a bony element. The instrument secures to the clamp such that a clinician may draw the flexible band through the clamp and secure the clamp to a rod. Then, the clinician uses the instrument to tension the flexible band about the bony element and to fix the flexible band to the clamp. For a detailed description of a suitable implant or clamp, reference may be made to commonly owned U.S. Patent Application Publication No. 2014/0257397, the entire contents of this application are hereby incorporated by reference. 
     Referring now to  FIGS. 1 and 2 , a surgical instrument or inserter  10  is provided in accordance with the present disclosure and includes a body  20 , a securement arm  40 , a clamp lock  50 , a tensioning assembly  60 , a securement screw  80 , and a tensioning screw  90 . The body  20  includes a proximal portion  22 , a central portion  24  extending from the proximal portion  22 , and a distal portion  30  extending from the central portion  24 . The central portion  24  defines a longitudinal axis A-A. The proximal portion  22  is substantially rectangular in cross-section and is orthogonal to the longitudinal axis A-A with first and second ends extending beyond the central portion  24 . The first end defines a securement screw opening  88  that extends parallel to the longitudinal axis A-A and that is threaded to cooperate with threads of the securement screw  80  as detailed below. The second end defines a tensioner screw opening  98  that extends parallel to the longitudinal axis A-A and that is dimensioned to allow the tensioning screw  90  to freely rotate relative to the proximal portion  22 . The central portion  24  includes central arm guides  26  and the distal portion  30  includes distal arm guides  28  positioned on opposite sides of the body  20  parallel to the longitudinal axis A-A. 
     The distal portion  30  receives and secures an implant or clamp  12  ( FIG. 5 ) to the inserter  10 . The distal portion  30  defines a clamp receiver  32  that is dimensioned and shaped to receive the clamp  12 . The distal portion  30  includes an alignment tab  36  for engaging a corresponding alignment notch  14  defined by the clamp  12  to align the clamp  12  with the clamp receiver  32 . The distal portion  30  also defines tool openings  34   a ,  34   b  that extend through the distal portion  30  and into the clamp receiver  32  ( FIG. 5 ). The tool openings  34   a ,  34   b  extend parallel to one another and are offset from the longitudinal axis A-A by an angle θ ( FIG. 10 ) to provide clearance for a tool as detailed below. The angle θ may be in a range of about 15° to about 45° (e.g., about 30°). The tool openings  34   a ,  34   b  are sized to receive tools for manipulating the clamp  12  secured in the clamp receiver  32  as detailed below. 
     The securement arm  40  is slidable relative to the body  20  to lock the clamp  12  within the clamp receiver  32  and retain a rod  19  ( FIG. 8 ) within the clamp  12  as detailed below. The securement arm  40  includes a proximal end portion  42 , an arm body  44 , and distal securement fingers  46 . The proximal end portion  42  defines a securement screw opening  43  that receives a distal retainer  86  of the securement screw  80  as detailed below. The arm body  44  extends from the proximal end portion  42  parallel to the longitudinal axis A-A. The proximal end portion  42  and the arm body  44  define a guide channel  45  that slidably receives central and distal arm guides  26 ,  28  of the body  20 . The securement fingers  46  extend from the arm body  44  and define a passage  49  therebetween. The securement fingers  46  are positioned on either side of the distal portion  30  of the body  20  such that the distal portion  30  is positioned within the passage  49 . Each of the securement fingers  46  also defines a guide shelf  47  that slides along surfaces of the distal guides  28  of the distal portion  30 . Each retention arm  46  also defines a lock cam channel  48  that receives a lock cam pin  54 . As discussed in greater detail below, the lock cam channel  48  engages the lock cam pin  54  as the securement arm  40  is translated to pivot the clamp lock  50  such that the clamp  12  is within the clamp receiver  32  of the distal portion  30 . 
     The securement screw  80  is rotatable to translate the securement arm  40  parallel to the longitudinal axis A-A of the inserter  10  between a first or proximal position ( FIG. 6 ), an intermediate position ( FIG. 8 ), and a second or distal position ( FIG. 9 ). The securement screw  80  includes a head  81 , a threaded body  84 , and a distal retainer  86 . The head  81  includes a tool engagement portion  82  proximal to a finger engagement portion  83 . The tool engagement portion  82  is dimensioned and shaped to be engaged by a tool (not explicitly shown) to rotate the securement screw  80 . For example, the tool engagement portion  82  may define a recess that is engagable with a torx or star-shaped screwdriver. Additionally or alternatively, the tool engagement portion  82  may have a hexagonal outer surface that is engagable with a wrench or a socket. The finger engagement portion  83  is sized and shaped to be engaged by fingers of a clinician to rotate the securement screw  80 . For example, the finger engagement portion  83  may include a knurled outer surface. Additionally or alternatively, the outer surface of the finger engagement portion  83  may include a plurality of raised surfaces with grooves between the raised surfaces to provide a gripping surface for fingers of a clinician. 
     The threaded body  84  of the securement screw  80  extends distally from the head  81  parallel to the longitudinal axis A-A. The distal retainer  86  is spaced apart from the threaded body  84  to define a retention recess  85  between the threaded body  84  and the distal retainer  86 . The threaded body  84  passes through and cooperates with threads on the inner surface of the securement screw opening  88  defined in the proximal portion  22  of the body  20 . A portion of the head  81  (e.g., finger engagement portion  83 ) is larger than the threaded body  84  to prevent the securement screw  80  from passing entirely through the securement screw opening  88 . The distal retainer  86  passes through the securement screw opening  43  defined in the proximal end portion  42  of the securement arm  40 . The proximal end portion  42  defines openings  41   a  that receive retention pins  41 . Each of the retention pins  41  pass through the retention recess  85  of the securement screw  80  such that the securement screw  80  passing between the retention pins  41  to rotatably receive and longitudinally fix the distal retainer  86  of the securement screw within the proximal end portion  42  of the securement arm  40 . Thus, allowing the securement screw  80  to rotate relative to the securement arm  40  such that as the securement screw  80  is rotated, the securement screw  80  translates the securement arm  40  between its proximal and distal positions as detailed below. 
     With continued reference to  FIG. 2 , the clamp lock  50  engages the clamp  12  to secure the clamp  12  ( FIG. 6 ) in the clamp receiver  32  of the distal portion  30 . A proximal end of the clamp lock  50  defines a lock cam opening  55  and a distal end of the clamp lock  50  includes a locking tab  59  facing the clamp receiver  32 . The clamp lock  50  defines a pivot pin opening  57  between the lock cam opening  55  and the locking tab  59 . The distal portion  30  defines a pivot pin passage  58  that receives a pivot pin  56  which passes through the pivot pin opening  57  of the clamp lock  50  to pivotally secure the clamp lock  50  to the distal portion  30  of the body  20 . 
     The clamp lock  50  is pivotable between a secured configuration ( FIG. 5 ) and an unsecured configuration ( FIG. 6 ). In the secured configuration, the locking tab  59  of the clamp lock  50  is positioned to engage a notch  16  of the clamp  12  to secure the clamp  12  within the clamp receiver  32 . In the unsecured configuration, the locking tab  59  is positioned away from the clamp  12  such that the clamp  12  is moveable into or out of the clamp receiver  32 . The clamp lock  50  may include a lock biasing member  51  positioned between the distal portion  30  and the clamp lock  50  that engages the clamp lock  50  between the pivot pin opening  57  and the lock cam opening  55  to urge the clamp lock  50  towards the secured position. The clamp lock  50  may define a recess for receiving an end of the lock biasing member  51 . The distal portion  30  may also define a cam notch  35  that receives the cam pin  54  when the clamp lock  50  is in the unsecured position. 
     With additional reference to  FIG. 3 , the tensioning assembly  60  is secured to a flexible band  18  ( FIG. 11 ) to tension the flexible band  18  about a bony element as the tensioning screw  90  is rotated as detailed below. The tensioning assembly  60  includes a tensioning body  62 , a button  64 , and a band locking mechanism  70 . The tensioning body  62  defines a tensioning screw channel  142  that passes through the tensioning body  62  parallel to the longitudinal axis A-A when the inserter  10  is assembled. A surface  62   c  of the tensioning body  62  facing the central portion  22  of the body  20  of the inserter  10  includes a guide nub  148  that is slidably received within a tensioner guide channel  27  ( FIG. 1 ) defined in a surface of the central portion  22  of the body  20  facing the tensioning assembly  60 . The tensioning body  62  also defines a button well  146  in one side surface  65   a  that passes through the majority of the tensioning body  62  orthogonal to and through the tensioning screw channel  142  that is sized to receive the button  64 . A button ring  144  may extend from this side surface  62   a  of the tensioning body  62  around the outer perimeter of the button well  146 . As shown in  FIG. 4 , the opposite side surface  62   b  of the tensioning body  62  may define an extension opening  155  that is axially aligned with the button well  146 . 
     With continued reference to  FIG. 3 , the button  64  has a substantially cylindrical body  151  and includes a button extension  154  that extends from one end of the cylindrical body  151 . The button extension  154  has a diameter that is less than the diameter of the cylindrical body  151 . The other end of the cylindrical body  151  includes defines an engagement surface  156 . The cylindrical body  151  defines a tensioning screw passage  152  that passes through the cylindrical body  151  at a location between the button extension  154  and the engagement surface  156 . The tensioning screw passage  152  defines an oblong shape and is larger than the tensioning screw  90  ( FIG. 2 ). The tensioning screw passage  152  is defined by a first wall or clearance  153   a  that has a substantially smooth surface and a second wall  153   b  that is threaded to engage threads of the tensioning screw  90  as detailed below. The first wall  153   a  is positioned adjacent the engagement surface  156  of the button  64  and the second wall  153   b  is positioned adjacent the button extension  154 . As shown, each of the first and second walls  153   a ,  153   b  define half of the tensioning screw passage  152 ; however, it is contemplated that one of the first or second walls  153   a ,  153   b  may define more than half (e.g., 75%) of the tensioner screw passage  152  with the other one of the first or second walls  153   a ,  153   b  defining the remainder (e.g., 25%) of the tensioning screw passage  152 . 
     The button  64  is positioned within the button well  146  of the tensioning body  62  with a button biasing member  66  positioned about the button extension  154  between the cylindrical body  151  and the side surface  62   b  of the body  62  such that the button  64  is biased out of the button well  146 . As shown, the button biasing member  66  is in the form of a series of stacked Belleville washers; however, other biasing members are also contemplated including, but not limited to, coil springs. As discussed in detail below, the tensioning screw  90  passes through the tensioning screw channel  142  of the tensioning body  62  and the tensioning screw passage  152  of the button  64  to retain the button  64  within the button well  146 . 
     The button  64  has a disengaged position ( FIG. 1 ) and a depressed position ( FIG. 12 ). In the disengaged position, the button biasing member  66  urges the threads of the second wall  153   b  into engagement with a threaded body  94  of the tensioning screw  90 . In the depressed position, the button  64  is depressed against the button biasing member  66  such that the threads of the second wall  153   b  are disengaged from the threaded body  94  of the tensioning screw  90 . In the depressed position, the button extension  154  may be positioned within the extension opening  155  to provide enough clearance for the second wall  153   b  to disengage the threaded body  94 . Further, in the depressed position, the first wall  153   a  may abut the threaded body  94  of the tensioning screw  90 . 
     The tensioning screw  90  includes a head  91 , the threaded body  94 , and a distal retainer  96 . The head  91  includes a tool engagement portion  92  proximal to a finger engagement portion  93 . The tool engagement portion  92  is dimensioned and shaped to be engaged by a tool (not explicitly shown) to rotate the tensioning screw  90 . For example, the tool engagement portion  92  may define a recess that is engagable with a torx or star-shaped screwdriver. Additionally or alternatively, the tool engagement portion  92  may have a hexagonal outer surface that is engagable with a wrench or a socket. The finger engagement portion  93  is sized and shaped to be engaged by fingers of a clinician to rotate the tensioning screw  90 . For example, the finger engagement portion  93  may include a knurled outer surface. Additionally or alternatively, the outer surface of the finger engagement portion  93  may include a plurality of raised surfaces with grooves between the raised surfaces to provide a gripping surface for fingers of a clinician. 
     The threaded body  94  of the tensioning screw  90  extends distally from the head  91  parallel to the longitudinal axis A-A ( FIG. 2 ). The distal retainer  96  is spaced apart from the threaded body  94  to define a retention recess  95  between the threaded body  94  and the distal retainer  96 . The threaded body  94  passes through the tensioning screw opening  98  defined in the proximal portion  22  of the body  20 . The tensioning screw opening  98  is sized to permit the threaded body  94  of the tensioning screw  90  to rotate freely. A portion of the head  91  (e.g., finger engagement portion  93 ) is larger than the threaded body  94  to prevent the tensioning screw  90  from passing entirely through the tensioning screw opening  98 . 
     Referring briefly back to  FIG. 2 , the distal portion  30  includes a tensioning screw securement arm  37  that extends orthogonal to the longitudinal axis A-A ( FIG. 2 ). The tensioning screw securement arm  37  also defines a tensioning screw securement opening  39  that is aligned with the tensioning screw opening  98  defined in the proximal portion  20 . The distal retainer  96  of the tensioning screw  90  passes through the tensioning screw securement opening  39  defined in the tensioning screw securement arm  37  of the distal portion  30 . Each of the retention pins  61  pass through the retention recess  95  of the tensioning screw  90  such that the tensioning screw  90  passes between the retention pins  61  to rotatably receive and longitudinally fix the distal retainer  96  of the tensioning screw  90  within the tensioning screw securement arm  37  of the distal portion  30 . Thus, allowing the tensioning screw  90  to rotate relative to the tensioning screw securement arm  37 . As detailed below as the tensioning screw  90  is rotated, the tensioning screw  90  translates the tensioning assembly  60  parallel to the longitudinal axis A-A ( FIG. 2 ) between a proximal position ( FIG. 14 ) and a distal position ( FIG. 12 ). 
     With reference to  FIGS. 3 and 4 , the band locking mechanism  70  secures a flexible band  18  ( FIG. 7 ) to the tensioning assembly  60  such that the tensioning assembly  60  may draw the flexible band  18  through the clamp  12  to tension the flexible band  18  about a bony element as detailed below. The band locking mechanism  70  includes band locking lever  74 , an outer locking member  76 , and an inner locking member  78 . First and second support arms  160   a ,  160   b  support the band locking lever  74  and the outer locking member  76  to the tensioning body  62 . The first support arm  160   a  is fixed to the side surface  62   b  of the tensioning body  62  opposite the side surface  62   a  that defines the button well  146 . The first support arm  160   a  extends past a surface  62   d  of the tensioning body  62  and away from the surface  62   c  of the tensioning body  62 , which includes the guide nub  148 , such that the first support arm  160   a  extends away from the body  20  of the inserter  10 . The first support arm  160   a  extends orthogonal to the body  20  of the inserter  10 . The second support arm  160   b  is spaced apart from the first support arm  160   a  and is supported by a bridge  163  that extends from the first support arm  160   a . The second support arm  160   b  and the bridge  163  define a band passage  168  with a surface of the tensioning body  62  opposite the guide nub  148 . The first support arm  160   a  may act as a back stop to the band passage  168  as detailed below. 
     The first and second support arms  160   a ,  160   b  define a lock channel  162  therebetween. The first and second support arms  160   a ,  160   b  each define a lock guide channel  164  in a surface opposing the other support arm  160   a ,  160   b  that is orthogonal to the band passage  168  and in communication with the lock channel  162 . Each of the first and second support arms  160   a ,  160   b  also defines a pin opening  166  that passes through the lock channel  162 . The pin openings  166  oppose ends that receive an end of a band lock pivot pin  72 . As detailed below, the band lock pivot pin  72  supports the band locking lever  74  and the outer locking member  76 . 
     The band locking lever  74  defines a pin opening  172  and includes a lever arm  170 , cam bosses  174 , and a camming surface  176 . The pin opening  172  is sized to rotatably receive the band lock pivot pin  72  therethrough to support the band locking lever  74 . The lever arm  170  extends from the pin opening  172 . The cam bosses  174  are positioned adjacent the pin opening  172  and extend parallel to an axis defined by the pin opening  172 . The camming surface  176  is disposed on an outer surface of the band locking lever  74  about the pin opening  172 . 
     The outer locking member  76  includes tabs  178  that are joined by a connector  183  and define a lever channel  179  therebetween. The tabs  178  extend parallel to one another and in the same direction from the connector  183 . Each of the tabs  178  defines a pin slot  182  that slidably receives the band locking pin  72  such that each tab  178  is positioned between the band locking lever  74  and a respective one of the first and second support arms  160   a ,  160   b . Each of the tabs  178  includes a slide  180  that is positioned along one side of the pin slot  182  and extends towards the respective one of the first and second support arms  160   a ,  160   b . Each slide  180  is slidably received in the lock guide channel  164  defined in the respective one of the first and second support arms  160   a ,  160   b . The slides  180  of the outer locking member  76  are slidable within the lock guide channels  164  such that the outer locking member  76  is slidable towards and away from the surface  62   d  of the tensioning body  62 . 
     The band locking lever  74  is rotatable about the band locking pin  72  to move the outer locking member  76  towards and away from the surface  62   d  of the tensioning body  62 . Each of the tabs  178  defines the band locking slot  182  that slidably receive the band locking pin  72 . Tabs  178  also define camming recesses  181  that oppose one another. The camming recesses  181  are in communication with the lever channel  179  and are defined in an inner surface of each of the tabs  178  opposite the slides  180 . Each of the camming recesses  181  receives one of the cam bosses  174  of the band locking lever  74  to move the outer locking member  76  towards and away from the tensioning body  62  in response to rotation of the band locking lever  74  as detailed below. Walls defining the camming recesses  181  may also limit the rotation of the band locking lever  74  about the band locking pin  72 . The connector  183  includes a textured locking surface  184  that faces the tensioning body  62  and that is positioned within the band passage  168 . The textured locking surface  184  may include a plurality of protrusions that engage a flexible band  18  ( FIG. 11 ) disposed within the band passage  168  as discussed in greater detail below. 
     With continued reference to  FIGS. 3 and 4 , the inner locking member  78  includes a textured locking surface  189  that is positioned within the band passage  168  and in opposition to the textured locking surface  184  of the outer locking member  78 . The textured locking surface  189  is substantially similar to the textured locking surface  184  of the outer locking member  76 . The inner locking member  78  is pivotally coupled to the tensioning body  62  by a protrusion  186  that extends from the textured locking surface  189  towards the tensioning body  62 . 
     The protrusion  186  defines a retention opening  188  that receives a retention screw  68  therethrough to fix the inner locking member  78  to the tensioning body  62 . The tensioning body  62  defines an opening  185  in the surface  62   d  that receives the protrusion  186  of the inner locking member  78 . With particular reference to  FIG. 4 , the tensioning body  62  defines a retention screw opening  149  that passes through the opening  185 . A portion of the retention screw opening  149  is threaded. The retention screw  68  is threaded through the retention screw opening  149  and passes through the retention opening  188  of the inner locking member  78  to secure the inner locking member  78  within the opening  185  of the tensioning body  62 . The retention screw opening  149  may also pass through the first support arm  160   a.    
     The locking mechanism  70  is moveable between an unlocked configuration ( FIG. 12 ) and a locked configuration ( FIG. 13 ). In the locked configuration, the lever arm  170  of the locking lever  74  is substantially parallel to the longitudinal axis A-A ( FIG. 2 ) such that the locking mechanism  70  engages a flexible band  18  disposed within the band passage  168  between the locking surfaces  184 ,  189  of the inner and outer locking members  76 ,  78 , respectively, to fix the flexible band  18  relative to the tensioning body  62 . In the unlocked configuration, the lever arm  170  of the locking lever  74  is substantially perpendicular to the longitudinal axis of the inerter  10  such that a flexible band  18  is slidable through the band passage  168  between the locking surfaces  184 ,  189  of the inner and outer locking members  76 ,  78 , respectively. As the band locking lever  74  is rotated about the band locking pin  72  towards the unlocked configuration, the cam bosses  174  of the band locking lever  74  engage the outer locking member  76  to move the outer locking member  76  away from the tensioning body  62  such that the locking surface  184  of the outer locking member  76  is moved away from the locking surface  189  of the inner locking member  78 . As the band locking lever  74  is rotated towards its locked configuration, the cam bosses  174  engage the outer locking member  76  to move the outer locking member  76  towards the tensioning body  62  such that the locking surface  184  of the outer locking member  76  is moved towards the locking surface  189  of the inner locking member  78 . Additionally, the camming surface  176  of the band locking lever  74  may engage the connector  183  of the outer locking member  76  as the band locking lever  74  is rotated towards its locked configuration to move the outer locking member  76  towards the tensioning body  62 . 
     Referring now to  FIGS. 5-16 , a method of securing a flexible implant system to a bony element with an inserter is disclosed in accordance with the present disclosure. Initially, with reference to  FIG. 5 , the inserter  10  is positioned over the clamp  12  of a flexible implant system such that the clamp  12  is adjacent the clamp receiver  32  of the distal portion  30  with the securement arm  40  in the intermediate position between the proximal and distal positions such that the clamp lock  50  is pivotable between its secured and unsecured configurations. The inserter  10  is aligned with the clamp  12  such that the upper surface of the clamp  12  is positioned towards the clamp receiver  32  which is sized and shaped to receive the upper surface of the clamp  12 . In such an unsecured position of the clamp lock  50 , the lock cam pin  54  is moveable within the lock cam channel  48  defined in each of the securement fingers  46  of the securement arms  40 . 
     With particular reference to  FIG. 6 , the inserter  10  is moved onto the clamp  12  such that the upper surface of the clamp  12  is received within the clamp receiver  32  of the distal portion  30 . The securement screw  80  is rotated in a first direction to move the securement arm  40  to its proximal position such that the lock cam pin  54  is engaged by walls of the lock cam channel  48  to move the clamp lock  50  to its unsecured configuration. It is contemplated that the securement fingers  46  may include visual indicia (e.g., a groove  46   a  in an outer surface of the securement fingers  46 ) to indicate when the securement arm  40  is in the intermediate position. In the intermediate position, the lock cam pin  54  is engaged with walls defining the lock cam channel  48  such that subsequent proximal movement of the securement arm  40  will move the clamp lock  50  towards its unsecured configuration. In the unsecured configuration of the clamp lock  50 , the lock cam pin  54  is positioned within the cam notch  35  of the distal portion  30 . As the distal portion  30  engages the clamp  12 , the alignment tab  36  of the distal portion  30  engages an alignment notch  14  of the clamp  12  to align the clamp  12  with the distal portion  30 . 
     Referring now to  FIG. 7 , the securement screw  80  is rotated in a second direction opposite the first direction to move the securement arm  40  towards its secured position until the clamp lock  50  returns to the secured configuration such that the locking tab  59  of the clamp lock  50  engages the securement notch  16  of the clamp  12  to secure the clamp  12  in the clamp receiver  32  of the distal portion  30 . The locking tab  59  may provide audible indicia when it engages the securement notch  16 . 
     It is contemplated that the clamp  12  may be secured in the clamp receiver  32  without the securement arm  40  in the unsecured position. For example, with the securement arm  40  in the intermediate position as shown in  FIG. 5 , as the distal portion  30  engages the clamp  12 , the clamp  12  may engage the locking tab  59  of the clamp lock  50  to pivot the clamp lock  50  towards the unsecured configuration against the lock biasing member  51  ( FIG. 2 ) until the securement notch  16  of the clamp  12  is aligned with the locking tab  59 . When the securement notch  16  of the clamp  12  is aligned with the locking tab  59 , the lock biasing member  51  urges the locking tab  59  into the securement notch  16  to secure the clamp  12  within the clamp receiver  32  of the distal portion  30 . 
     With continued reference to  FIG. 7 , when the clamp  12  is secured to the inserter  10 , ends  18   a  of a flexible band  18 , that is wrapped about a bony element VB, are passed through a slot (not explicitly shown) of the clamp  12 . The ends  18   a  of the flexible band  18  are stacked on top of one another as the flexible band  18  is passed through the slot of the clamp  12 . 
     Referring to  FIG. 8 , with the flexible band  18  within the slot of the clamp  12 , the inserter  10  is used to position a rod  19  (e.g., a spinal rod) within a rod cavity  17  defined by the clamp  12 . The clamp  12  may provide audible indicia (e.g., a click) when the rod  19  is received within the rod cavity  17 . The ends  18   a  of the flexible band  18  may be held or pulled as the rod  19  is positioned within the rod cavity  17  to draw slack, excess material, of the flexible band  18  through the slot of the clamp  12 . 
     With reference to  FIG. 9 , with the rod  19  positioned within the rod cavity  17  of the clamp  12 , the securement screw  80  is rotated in the second direction to move the securement arm  40  towards its distal position. As the securement arm  40  moves towards its distal position, the securement fingers  46  engage the rod  19  to secure the rod  19  within the rod cavity  17  of the clamp  12  to prevent the rod  19  from moving out of the rod cavity  17  while allowing clamp  12  to slide over the rod  19  until the clamp is locked to the rod  19  as detailed below. Further, as the securement arm  40  moves towards its distal position, the lock cam channel  48  moves over the lock cam pin  54  such that the walls defining the lock cam channel  48  engage the lock cam pin  54  to prevent the clamp lock  50  from pivoting towards the unsecured configuration ( FIG. 6 ). As such, when the securement arm  40  is in its distal position, the clamp  12  is fully secured in the clamp cavity  32  of the distal portion  30  and the rod  19  is secured in the rod cavity  17  of the clamp  12 . 
     Referring to  FIG. 10 , with the securement arm  40  in its distal position, a tool  200  may be inserted through the tool opening  34   b  of the distal portion  30  to engage a rod set screw  13  of the clamp  12 . The tool  200  is rotated to rotate the rod set screw  13  into engagement with the rod  19  to partially secure the clamp  12  to the rod  19 . The rod set screw  13  is only partially tightened to permit the clamp  12  to move about the rod  19  (e.g., rotate) as the flexible band  18  is fully tensioned about the bony element VB as detailed below. Once the rod  19  is partially secured within the clamp  12 , the tool  200  is removed from the tool opening  34   b.    
     With reference to  FIGS. 11 and 12 , the flexible band  18  is positioned within the band passage  168  of the tensioning assembly  60 . To position the flexible band  18  within the band passage  168  of the tensioning assembly  60 , the band locking lever  74  is rotated to the unlocked configuration to move the outer locking member  76  away from the inner locking member  78 . With the band locking lever  74  in the unlocked configuration, the flexible band  18  is positioned in the band passage  168  and between the locking surfaces  184 ,  189  ( FIGS. 3 and 4 ) of the inner and outer locking members  76 ,  78 , respectively. The flexible band  18  may abut the first support arm  160   a  to backstop the flexible band  18  within the band passage  168 . The flexible band  18  may also be positioned in the band recess  38  of the tensioning screw securement arm  37  of the distal portion  30 . The flexible band  18  may be positioned within the band passage  168  with the tensioning assembly  60  positioned anywhere along the tensioning screw  90  between its proximal position ( FIG. 11 ) and its distal position ( FIG. 12 ). 
     With the flexible band  18  positioned within the band passage  168 , the tensioning assembly  60  is moved to its distal position as shown in  FIG. 12 . The tensioning assembly  60  may be moved to its distal position by rotating the tensioning screw  90  until the tensioning assembly  60  abuts the tensioning screw securement arm  37 . Alternatively, the tensioning assembly  60  may be moved to its distal position by depressing the button  64  to the depressed position, as detailed above, to disengage the threads of the second wall  153   b  from the threads of the tensioning screw  90  and sliding the tensioning assembly  60  into abutment with the tensioning screw securement arm  37  before releasing the button  64 . When the button  64  is released, the button biasing member  66  urges the button  64  to the disengaged position such that the threads of the second wall  153   b  engage the threaded body  94  of the tensioning screw  90 . 
     Referring to  FIG. 13 , with the flexible band  18  positioned in the band passage  168  and the tensioning assembly  60  in its distal position, the band locking lever  74  is rotated to the locked configuration such that the outer locking member  76  is moved towards the inner locking member  78 . As the outer locking member  76  is moved towards the inner locking member  78 , the locking surfaces  184 ,  189  ( FIGS. 3 and 4 ) of the inner and outer locking members  76 ,  78 , respectively, engage the flexible band  18  to fix the flexible band  18  relative to the tensioning assembly  60 . The ends  18   a  of the flexible band  18  are pulled by hand until slack or excess material of the flexible band  18  is drawn through the slot of the clamp  12  before the band locking lever  74  is rotated to the locked configuration. Additionally, the ends  18   a  of the flexible band  18  may be pulled by hand to tension the flexible band  18  about the bony element VB before the band locking lever  74  is rotated to the locked configuration. 
     With reference to  FIG. 14 , with the flexible band  18  fixed within the band locking mechanism  70  of the tensioning assembly  60 , the tensioning screw  90  is rotated to translate the tensioning assembly  60  towards its proximal position. As the tensioning assembly  60  is translated towards its proximal position, the flexible band  18  is drawn through the slot of the clamp  12  and is tensioned about a bony element VB. The tensioning assembly  60  is translated until the flexible band  18  is reduced and fully tensioned about the bony element VB. 
     Referring to  FIG. 15 , it is contemplated that the flexible band  18  may need to be tensioned more than tension applied to the flexible band  18  by a single translation of the tensioning assembly  60  from its distal position to its proximal position such that multiple translations of the tensioning assembly  60  are required. In such instances, the tool  200  is inserted through the tool passage  34   a  of the distal portion  30  to engage a band set screw  15  of the clamp  12  when the tensioning assembly  60  is in its proximal position. The tool  200  is then rotated to rotate the band set screw  15  to at least partially fix the flexible band  18  within the slot of the clamp  12 . With the flexible band  18  at least partially fixed, the band locking lever  74  is rotated to the unlocked configuration and the tensioning assembly  60  is translated to its proximal position. As detailed above, the tensioning assembly  60  may be translated by rotating the tensioning screw  90  or by depressing the button  64 . With the tensioning assembly  60  in its distal position, the band locking lever  74  is rotated to the locked configuration to fix the flexible band  18  to the tensioning assembly  60 . With the flexible band  18  fixed to the tensioning assembly  60 , the tool  200  is rotated to rotate the band set screw  15  such that the flexible band  18  is free to slide within the slot of the clamp  12 . The tensioning screw  90  is then rotated again to translate the tensioning assembly  60  towards its proximal position to draw the flexible band  18  through the slot of the clamp to reduce and tension the flexible band  18  about the bony element VB. This process is repeated until the flexible band  18  is fully reduced and tensioned about the bony element VB with a desired amount of tension. 
     When the flexible band  18  is fully tensioned, the tool  200  is inserted through the tool opening  34   b  of the distal portion to engage the rod set screw  13  of the clamp  12  as shown in  FIG. 11 . The tool  200  is rotated to fully tighten the rod set screw  13  to the rod  19  to fix the clamp  12  to the rod  19 . The tool  200  is then removed from the tool opening  34   b  and inserted through the tool opening  34   a  to engage the band set screw  15 . The tool  200  is then rotated to fully tighten the band set screw  15  to fix the flexible band  18  within the slot of the clamp  12 . 
     Referring to  FIG. 16 , with the clamp  12  fixed to the rod  19  and the flexible band  18  fixed within the slot of the clamp  12 , the flexible band  18  is cut to length adjacent the clamp  12 . It is contemplated that the flexible band  18  is cut in a range of about 0.1 cm to about 2.0 cm from the clamp  12  (e.g., 1.0 cm). It is further contemplated that the band locking lever  74  may be rotated to the unlocked configuration and/or the tensioning assembly  60  may be moved towards its distal position, by rotation of the tensioning screw  90  and/or depressing the button  64  as detailed above, to remove tension from the flexible band  18  after the band set screw  15  fixes the flexible band  18  within the slot and before the flexible band  18  is cut to length. 
     When the flexible band  18  is cut to length, the securement screw  80  is rotated to translate the securement arm  40  to its proximal position such that the securement fingers  46  are withdrawn from over the rod recess  17  of the clamp  12 . As detailed above, as the securement arm  40  reaches its proximal position, the walls defining the lock cam channel  48  engage lock cam pin  54  to pivot the clamp lock  50  to the unsecured configuration. With the securement arm  40  in its proximal position, the clamp  12  is released from the clamp receiver  32  of the distal portion  30  of the inserter  10 . 
     While several embodiments of the disclosure have been shown in the drawings, it is not intended that the disclosure be limited thereto, as it is intended that the disclosure be as broad in scope as the art will allow and that the specification be read likewise. Any combination of the above embodiments is also envisioned and is within the scope of the appended claims. Therefore, the above description should not be construed as limiting, but merely as exemplifications of particular embodiments. Those skilled in the art will envision other modifications within the scope of the claims appended hereto.