Patent Publication Number: US-11660126-B1

Title: Iliac anchor system

Description:
RELATED APPLICATIONS 
     This patent application claims the benefit of U.S. Provisional Application No. 62/868,751, filed Jun. 28, 2019, and of U.S. Provisional Patent Application No. 62/884,469, filed Aug. 8, 2019, the disclosures of which are hereby incorporated by reference herein in their entireties. 
    
    
     FIELD OF THE DISCLOSURE 
     This patent application is directed generally to spinal support systems and more specifically to anchoring of spinal support systems. 
     BACKGROUND 
     Implementation of various spinal surgical techniques often require the use of spinal support rods that are anchored to the vertebrae with pedicle screws to provide stabilization of the spine during treatment of spinal disorders. Examples include application of a coercive force to the spine for corrective purposes (e.g., correction of scoliosis). Another example is maintaining adjacent vertebrae stationary so that bone growth tissue can bridge the vertebrae in a spinal fusion process. Such spinal support systems may be subject to substantial anchoring forces to accomplish the prescribed support or corrective action. An orthopedic anchoring system having enhanced strength characteristics to maintain the integrity of the spinal support system while enabling greater forces to be exerted thereon would be welcomed. 
     SUMMARY OF THE DISCLOSURE 
     Various embodiments of the disclosure provide an orthopedic anchoring system with structural and mounting characteristics that enhances strength and integrity by several factors and resulting in reduced failure rates relative to conventional anchoring systems, The orthopedic anchoring system is mounted to the ilium proximate the iliac crest, where there are fewer ligaments and nerves relative to other regions of the lower spine, thereby providing for a safer and less problematic implant. The implant may be performed either as an alternative to or in addition to standard pedicle screw mounts at the L5 or S1 vertebrae. The implantation may be performed using minimally invasive techniques in a matter of a few minutes, with attendant faster recuperation rates. 
     Conventional spinal support systems include spinal support rod is anchored to the lower portions of the spine, such as at the L5 or S1 vertebrae, with pedicle screw anchors. Certain applications require substantial forces, for example for fusion of multiple vertebrae. The forces that pedicle screws can accommodate can be limiting. Most failures of such conventional spinal support systems result from failure of the pedicle screw anchor. Some spinal support systems attempt to enhance the anchoring strength by increasing the length of the anchoring pedicle screw anchor. But lengthening the pedicle screw anchor provides limited benefit, and the the increased length can be difficult or risky to implement in the regions at the base of the spine, where nerves and ligaments are ubiquitous. Furthermore, there are instances where the base of the spine of a given patient is not suitable to accommodate a pedicle screw anchor, for example where the lower portions of the spine have been subjected to trauma. 
     The disclosed anchoring system addresses these limitations and shortcomings of conventional spinal support systems. Structurally, an anchoring system for a spinal support assembly is disclosed, comprising an orthopedic fastener including a proximal end portion, a mid-portion, and a threaded distal end portion arranged along a central axis. A mounting receiver is configured to engage the threaded distal end portion along a receiver axis, the central axis and the receiver axis being concentric when the orthopedic fastener and the mounting receiver are engaged. A support rod receptacle is coupled to the standoff of the mounting receiver, the support rod receptacle extending radially outward from the receiver axis. In some embodiments, a standoff extends radially outward from the receiver axis, the support rod receptacle being coupled to the standoff, and may include a ball pivot, the support rod receptacle being configured to receive the ball pivot to define a polyaxial connection. In some embodiments, the mounting receiver and the support rod receptacle are unitary. In some embodiments, the mounting receiver defines a wedge shape. In some embodiments, the mounting receiver defines a concave face for seating the mounting receiver against a bone, for example, by defining opposed lateral edges that seat the mounting receiver. 
     In some embodiments, the proximal end portion of the orthopedic fastener includes a head portion, which may include a flange having a distal face that includes a radiused shoulder, a bottom-tapped hole accessible from a proximal face of the head portion, and/or wherein the proximal end portion defines a first polygonal socket that extends distal to and is accessible from bottom tapped hole. Some embodiments include a profiled washer that surrounds the proximal end portion of the orthopedic fastener, and may also include a head portion at the proximal end portion, the head portion being configured to engage a concave face of the profiled washer. In some embodiments, the concave face of the profiled washer defines a spherical profile, and the head portion defines a convex spherical profile that interfaces with the concave spherical profile of the profiled washer. Some embodiments comprise a guide tower frangibly connected to the support rod receptacle. 
     In various embodiments of the disclosure, a method for anchoring a spinal support system in a patient is disclosed, comprising providing a kit including an orthopedic anchoring system, the orthopedic anchoring system including an orthopedic fastener, a mounting receiver, and a support rod receptacle and providing instructions for implanting the orthopedic anchoring system. The instructions include: positioning the mounting receiver on an ilium and proximate an iliac crest of a patient; passing the orthopedic fastener through the ilium; and coupling the orthopedic fastener to the mounting receiver. In some embodiments, the kit additionally includes one or more of a guide tower, a tool, a driver assembly, a pilot hole drill, and a guide wire. In some embodiments, the instructions provide that the step of passing the orthopedic fastener through the ilium comprises passing the orthopedic fastener through the ilium from one of a lateral approach and a posterolateral approach. In some embodiments, the instructions provide that the step of positioning the mounting receiver on the ilium in the instructions provided in the step of providing instructions comprises positioning the mounting receiver on the ilium from a superior posterior approach. 
     In various embodiments of the disclosure, a system for securing a mounting receiver assembly to an ilium bone is disclosed, comprising: an orthopedic fastener defining a central rotational axis and having a proximal end portion, a mid-portion, and a distal end portion that are concentric about the central rotational axis, the orthopedic fastener defining a central through-passage concentric about the central rotational axis that passes through the proximal end portion, the mid-portion, and the distal end portion; a mounting receiver defining a mounting aperture for coupling to the distal end portion of the orthopedic fastener, the mounting aperture defining and extending along a mounting axis; and a draw rod disposed in the central through-passage. In this embodiment: the mounting aperture of the mounting receiver includes female threads; the distal end portion of the orthopedic fastener includes a male threaded section configured to engage the female threads of the mounting aperture, the distal end portion defining at least one axially extending slot that radially and tangentially bifurcates the male threaded section so that the male threaded section defines a plurality of axially extending segments; the mid-portion includes external bone-engaging threads configured to engage bone tissue; and the draw rod includes a mandrel portion at a distal end, the mandrel portion being distal to the distal end portion of the orthopedic fastener when the orthopedic fastener and the mounting receiver assembly are in an unlocked configuration, the mandrel portion being disposed at least partially within the plurality of axially extending segments when the orthopedic fastener and the mounting receiver assembly are in a locked configuration. In some embodiments, the draw rod includes male threads, and the central through-passage of the orthopedic fastener includes female threads, the male threads of the draw rod being configured to threadably engage with the female threads of the central through-passage. The male threads of the draw rod may be proximate a proximal end thereof, and the female threads of the central through-passage are at the proximal end portion of the orthopedic fastener. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG.  1    is a lateral view of a lower spine and ilium with an orthopedic anchoring system implanted therein according to an embodiment of the disclosure 
         FIG.  2    is a partial superior posterior view of the implanted orthopedic anchoring system of  FIG.  1    parallel to plane according to an embodiment of the disclosure; 
         FIG.  3    is an axial, sectional view of the implanted orthopedic anchoring system of  FIG.  1    orthogonal to plane according to an embodiment of the disclosure; 
         FIG.  4    is a side view of an iliac anchoring system according to an embodiment of the disclosure; 
         FIG.  5    is a side view of an iliac anchoring system according to an embodiment of the disclosure; 
         FIG.  6    is an elevational view of a mounting receiver for the anchoring systems of  FIGS.  4  and  5    according to embodiments of the disclosure; 
         FIG.  7    is an enlarged perspective view of a distal end portion of an orthopedic fastener having a plurality of axially extending segments according to an embodiment of the disclosure; 
         FIG.  8    is an enlarged side view of the distal end portion of  FIG.  7    with a draw rod installed according to an embodiment of the disclosure; 
         FIG.  8 A  is a sectional view along plane A-A of  FIG.  8    according to an embodiment of the disclosure; 
         FIG.  9    is a partial perspective view of a receiver and tulip in a polyaxial arrangement according to an embodiment of the disclosure; 
         FIG.  10    is an exploded view of the receiver and tulip arrangement of  FIG.  11    according to an embodiment of the disclosure; 
         FIG.  11    is a first side elevational view of a receiver and tulip combination according to an embodiment of the disclosure; 
         FIG.  12    is a second side elevational cutaway view of the receiver and tulip combination of  FIG.  9    according to an embodiment of the disclosure; 
         FIG.  13    is an exploded view of alternative anchoring systems according to embodiments of the disclosure; 
         FIG.  14    is a perspective view of an orthopedic fastener for the anchoring system of  FIG.  13    according to an embodiment of the disclosure; 
         FIG.  14 A  is a perspective, partial cutaway view of the orthopedic fastener of  FIG.  14    according to an embodiment of the disclosure; 
         FIG.  14 B  is a sectional view of the orthopedic fastener of  FIG.  14    according to an embodiment of the disclosure; 
         FIG.  15    is a perspective, partial cutaway view of an alternative orthopedic fastener for use with the anchoring system of  FIG.  13    according to an embodiment of the disclosure; 
         FIG.  16    is a perspective, partial view of an alternative orthopedic fastener with a profiled washer for use with the anchoring system of  FIG.  13    according to an embodiment of the disclosure; 
         FIG.  17    is an enlarged, partial perspective view of a driver assembly for driving the orthopedic fasteners of  FIGS.  14  through  16    according to an embodiment of the disclosure; 
         FIG.  18    is a perspective view of a mounting receiver for an anchoring system of  FIG.  13    according to an embodiment of the disclosure; 
         FIG.  18 A  is a sectional view of the mounting receiver of  FIG.  18    according to an embodiment of the disclosure; 
         FIG.  19    is an elevational view of a mounting receiver for an anchoring system of  FIG.  13    according to an embodiment of the disclosure; 
         FIG.  19 A  is a sectional view of the mounting receiver at plane XIXA-XIXA of  FIG.  19    according to an embodiment of the disclosure; 
         FIG.  20    is a perspective view of a ball retainer for the anchoring system of  FIG.  13    according to an embodiment of the disclosure; 
         FIG.  20 A  is a sectional view of the ball retainer of  FIG.  20    according to an embodiment of the disclosure; 
         FIG.  21    is an enlarged, partial sectional view of an anchoring system of  FIG.  13    assembled with a tool for orienting the receiver according to an embodiment of the disclosure; 
         FIGS.  22  and  23    are partial sectional views of an implantation of an anchoring system of  FIG.  13    according to an embodiment of the disclosure; 
         FIG.  24    is an axial, sectional view of an implanted orthopedic anchoring system according to an embodiment of the disclosure; 
         FIG.  25    is an exploded view of an anchoring system according to an embodiment of the disclosure; 
         FIG.  26    is an enlarged, partial perspective view of a guide tower and tulip of the anchoring system of  FIG.  25    according to an embodiment of the disclosure; and 
         FIGS.  27  and  28    are partial sectional views of an implantation of the anchoring system of  FIG.  25    according to an embodiment of the disclosure. 
     
    
    
     DETAILED DESCRIPTION OF THE DRAWINGS 
     Referring to  FIGS.  1  through  3   , an orthopedic anchoring system  30  implanted in an ilium for anchoring a spinal support assembly  29  is depicted according to an embodiment of the disclosure. The orthopedic anchoring system  30  includes an orthopedic fastener  32  coupled to a receiver assembly  33 . The receiver assembly  33  includes a mounting receiver  34  coupled to a support rod receptacle or “tulip”  31  for receiving a spinal support rod  35 . The “tulip” moniker is recognized in the spinal support arts as the support rod receptacle. Structural aspects of the tulip  31  are detailed, for example, at U.S. Pat. No. 10,646,260 to Abbasi, owned by the owner of the present application, the content of which is hereby incorporated by reference herein in its entirety except for express definitions and patent claims contained therein. The orthopedic anchoring system is coupled to the implanted spinal support assembly  29  via the spinal support rod  35 , acting as an anchor for maintaining therapeutic forces on the assembly  29 . For the depicted embodiment, the orthopedic fastener  32  is mounted to the ilium proximate the iliac crest, and the receiver assembly  33  oriented on a superior posterior plane III-III 
     Referring to  FIGS.  4  through  12   , orthopedic anchoring systems  30   a  and  30   b  are depicted according to an embodiment of the disclosure. Herein, the orthopedic anchoring systems, tulips, orthopedic fasteners, receiver assemblies, and mounting receivers are referred to generically or collectively with reference characters  30 ,  31 ,  32 ,  33 , and  34 , respectively, and specific or individual orthopedic anchoring systems and associated components are designated with a letter suffix (e.g., “orthopedic anchoring system  30   c  including orthopedic fastener  32   d  and receiver assembly  33   c  with mounting receiver  34   c  with tulip  31   b ”). In view of this disclosure, an artisan of ordinary skill will recognize that the tulips  31 , orthopedic fasteners  32 , and mounting receivers  34  are generally interchangeable, so that hybrid anchoring systems  30  and receiver assemblies  33  may be configured that are not specifically depicted herein. Such hybrid anchoring systems  30  and receiver assemblies  33  are within the scope of this disclosure. That is, the orthopedic anchoring systems  30  and receiver assemblies  33  depicted herein are not limiting. 
     Each orthopedic fastener  32  defines a central rotational axis  36  about which the fastener  32  is rotated and includes a proximal end portion  42 , a mid-portion  44 , and a distal end portion  46  that are concentric about the axis  36 . The mid-portion  44  of the orthopedic fasteners  32   a  and  32   b  includes external threads  48  configured to engage bone tissue. The distal end portion  46  of the orthopedic fasteners  32   a  and  32   b  includes a male threaded section  52  and may include self-tapping features, such as depicted at  FIG.  14   . In some embodiments, a diameter of the external threads  48  is greater than a diameter of the threads of the male threaded section  52 . 
     Each mounting receiver  34  includes a receiver body  72 , a standoff  73 , and the tulip  31 . The standoff  73  extends radially outward from a receiver or mounting axis  64  along a standoff axis  74 . For receiver assemblies  33   a  and  33   b  and associated mounting receivers  34   a  and  34   b , the receiver body  72  is a flange  75 . The receiver body  72  defines a mounting aperture  62  concentric about the mounting axis  64  for coupling to the distal end portion  46  of the orthopedic fastener  32 , the mounting aperture  62  defining and extending along the mounting axis  64 . In some embodiments, the mounting aperture  62  includes female threads  66 . The female threads  66  of the mounting receiver  34  are configured to threadably engage the male threaded section  52  at the distal end portion  46  of the orthopedic fastener  32 . 
     The tulip  31  includes female threads  76  concentric about a tulip axis  78 , the tulip  31  defining an outer radius RO about the tulip axis  78 . In some embodiments, the receiver assembly  33  includes a removable guide tower  84  ( FIG.  11   ) that extends from the tulip  31  for guiding a set screw  86  along the tulip axis  78  and into the tulip  31 . The guide tower  84  may be configured to slidingly guide the set screw  86  toward the tulip  31 , to threadably guide the set screw  86  toward the tulip  31 , or a combination of slidingly and threadably guiding the set screw  86  toward the tulip  31 . The guide tower  84  may be coupled to the tulip  31  with a frangible connection  88  (i.e., a connection that is easily broken). For the orthopedic anchoring system  30   a , the standoff  73  is rigidly attached to a tulip  31   a . For the orthopedic anchoring system  30   b , the standoff  73  includes a ball pivot  82  for polyaxial connection to a tulip  31   b.    
     In some embodiments, the orthopedic fastener  32  defines a central through-passage  92  concentric about the central axis  36  that passes through the proximal end portion  42 , the mid-portion  44 , and the distal end portion  46  of the orthopedic fastener  32 . The distal end portion  46  may define at least one axially extending slot  94  that radially and tangentially bifurcates the male threaded section  52 , as depicted for the orthopedic fastener  32   b . Herein, “tangential” and its derivatives refer to a direction along the θ-coordinate of an r-θ-z coordinate system; “radial” or “lateral” refer to a direction along or parallel to the r-coordinate, and “axial” refers to a direction along or parallel to the z-coordinate. The bifurcation of the male threaded section  52  defines a plurality of axially extending segments  96 . In some embodiments, the plurality of segments  96  is four segments  96  (depicted). 
     In some embodiments, a draw rod  102  is disposed in the central through-passage  92 , such as depicted for the orthopedic anchoring system  30   b . The draw rod  102  may include a mandrel portion  104  at a distal end  106  thereof, the mandrel portion  104  being distal to the distal end portion  46  of the orthopedic fastener  32   b  when the orthopedic fastener  32   b  and the mounting receiver  34   b  are in an unlocked configuration  108 . In a locked configuration, the mandrel portion  104  is seated at least partially within the plurality of segments  96 . In some embodiments, the draw rod  102  includes male threads  112 , and the central through-passage  92  of the orthopedic fastener  32   b  includes female threads  114 , the male threads  112  of the draw rod  102  being configured to threadably engage with the female threads  114  of the central through-passage  92 . The male threads  112  of the draw rod  102  may be proximate a proximal end  116  of the draw rod  102 , with the female threads  114  of the central through-passage  92  being proximate the proximal end portion  42  of the orthopedic fastener  32   b.    
     In some embodiments, the orthopedic anchoring system  30  includes a nut  122  including female threads  124 , as depicted for the orthopedic anchoring system  30   a . The orthopedic fastener  32   a  includes male threads  126  at the proximal end portion  42  configured to threadably engage the female threads  124  of the nut  122 . In other embodiments, the orthopedic fastener  32  includes a head portion  128  at the proximal end portion  42 , such as depicted for orthopedic anchoring system  30   b . In some embodiments, the orthopedic anchoring system  30  includes a washer  132  against which the nut  122  or the head portion  128  register when the orthopedic anchoring system  30  is implanted. The proximal end portion  42  of the orthopedic fastener  32  may define a counter bore  134  for access to the proximal end  116  of the draw rod  102 , as depicted for the orthopedic fastener  32   b.    
     For operation of anchoring systems  30   a  and  30   b , as well as for anchoring systems  30  generally, a bore  138  is formed in the ilium ( FIG.  3   ). For orthopedic fasteners  32  that implement the self-tapping features, the bore  138  is formed with the orthopedic fastener  32 , without need for pre-drilling the bore  138 . The external threads  48  are screwed into the bone surrounding the bore  138 , which may be facilitated by the larger diameter of the external threads  48 . With the receiver assembly  33  held in place, the orthopedic fastener  32  is threaded through the ilium so that the male threaded section  52  of the distal end portion  46  protrudes through the ilium and into mounting aperture  62  of the mounting receiver  34 . The mounting receiver  34  is drawn against the ilium by the advancement of the orthopedic fastener  32  into the mounting receiver  34 . The orthopedic fastener  32  is drawn into tension, for example by the nut  122  of orthopedic fastener  32   a  ( FIG.  4   ) or the head portion  128  of orthopedic fastener  32   b  ( FIG.  5   ). 
     For the orthopedic anchoring system  30   b , after setting the orthopedic fastener  32   b  within the ilium and drawing the mounting receiver  34   b  tightly against the ilium, the draw rod  102  is drawn proximally through the orthopedic fastener  32   b , for example rotationally, utilizing the threads  112  and  114 . As the mandrel portion  104  of the draw rod  102  is proximally drawn into the orthopedic fastener  32   b , the axially extending segments  96  are splayed radially outward, which expands the male threaded section  52  radially outward to bind the male threads of the threaded section  52  within the female threads  66  of the mounting receiver  34   b . In this way, the mounting receiver  34   b  is rotationally fixed and locked with respect to the orthopedic fastener  32   b.    
     Referring to  FIG.  13   , orthopedic anchoring systems  30   c  and  30   d  are depicted according to embodiments of the disclosure. The orthopedic anchoring systems  30   c ,  30   d  include a receiver assembly  33   c  or  33   d  comprising the tulip  31   b  and one of a mounting receiver  34   c  or  34   d . As depicted, the orthopedic anchoring systems  30   c ,  30   d  include an orthopedic fastener  32   c ; however, any of the orthopedic fasteners  32   c ,  32   d , or  32   e  (detailed below) may be implemented with the orthopedic anchoring systems  30   c ,  30   d . In the depicted embodiment, the orthopedic anchoring systems  30   c ,  30   d  include the guide tower  84 , the set screw  86 , and the ball pivot  82  for polyaxial connection to the tulip  31   b . In addition, the orthopedic anchoring system  30   c  may include a ball retainer  152 . A portion of the spinal support rod  35  is also represented in line for insertion into the tulip  31   b.    
     Referring to  FIGS.  14  through  14 B , the orthopedic fastener  32   c  is depicted in greater detail according to an embodiment of the disclosure. The orthopedic fastener  32   c  may include some of the same components and attributes as orthopedic fasteners  32   a  and  32   b , some of which are indicated with same-labeled reference characters. The orthopedic fastener  32   c  includes the head portion  128  and a shaft portion  174  that extends distally from the head portion  128 . The head portion may include a flange  176  with a distal face  178  having a radiused shoulder  182 . In some embodiments, the head portion  128  defines a bottom-tapped hole  184  accessible from a proximal face  186 , the bottom-tapped hole  184  defining threads  185 . In some embodiments, a cavity  188  extends into the shaft portion  174  from a distal extremity  192  of the bottom-tapped hole  184 . The cavity  188  may define sequential sockets  194 , including a proximal socket  194   a  and a distal socket  194   b , each defining a unique polygonal shape. In the depicted embodiment, the proximal socket  194   a  defines a square-shaped polygon, and the distal socket  194   b  defines a hexagonal-shaped polygon. The orthopedic fastener  32 ,  32   c  may also define the central through-passage  92  that extends through the orthopedic fastener  32 ,  32   c , concentric about the central rotation axis  36 . 
     The shaft portion  174  of the orthopedic fastener  32   c  may include a proximal shank portion  212  and threaded distal portion  214 . In some embodiments, a crest  216  of the threaded distal portion  214  defines a maximum first diameter D 1  and the proximal shank portion  212  defines a second diameter D 2 , the maximum first diameter D 1  being greater than the second diameter D 2 . The threaded portion  214  may define male threads  217  at a tapered distal tip portion  218 . In some embodiments, one or more self-tapping flutes  222  are defined at the tapered distal tip portion  218 . 
     Referring to  FIG.  15   , an orthopedic fastener  32   d  is depicted according to an embodiment of the disclosure. The orthopedic fastener  32   d  includes many of the same components and attributes as orthopedic fastener  32   c , some of which are indicated by same-labeled reference characters. The orthopedic fastener  32   d  presents a flat  224  on the distal face  178  of the head portion  128 , the flat  224  being substantially orthogonal to the central rotation axis  36 . In some embodiments, the orthopedic fastener  32   d  includes a reduced diameter D 3  at the mid-portion  44 , the reduced diameter D 3  being reduced relative to the maximum first diameter D 1  and the second diameter D 2 . 
     Functionally, the flat  224  enables the orthopedic fastener  32   d  seat on cortical bone surface with limited disturbance to the opening of the bore  138  that is formed by the implantation. The flat  224  also enables various washers and washer assemblies (e.g., washer  132  of  FIG.  5   ) to be incorporated into the associated orthopedic anchoring system  30 . The reduced diameter D 3  can, in some embodiments, enable the orthopedic fastener  32   d  to rotate freely within the bore  138  formed by the fastener  32   d . The free rotation enables easier rotational orientation of the associated receiver assembly  33  about the axes  36 ,  64  of the orthopedic anchoring system  30  as the orthopedic fastener  32   d  and receiver assembly  33  are drawn together. The reduced diameter D 3  may also be implemented with orthopedic fastener  32   c.    
     Referring to  FIG.  16   , the proximal of an orthopedic fastener  32   e  with a profiled washer  228  is depicted according to an embodiment of the disclosure. The orthopedic fastener  32   e  includes many of the same components and attributes as orthopedic fastener  32   d , some of which are indicated by same-labeled reference characters. The distal face  178  of the head  128  of the orthopedic fastener  32   e  includes a convex surface  226 , presenting, for example a spherical profile  227 . The profiled washer  228  includes a concave surface  229 , presenting, for example a spherical profile  227 ′. The profiled washer  228  may define an oversized through-aperture  230  that is oversized with respect to the second diameter D 2  of the orthopedic fastener  32   e . When implanted, the profiled washer  228  is captured between the head  128  and the surface of the ilium and engages the convex surface  227  of the distal face  178 . 
     Functionally, the orthopedic fastener  32   e  and profiled washer  228  combination can accommodate seating on a bone (ilium) surface that is not orthogonal to axis of the bore  138 , thereby providing a more uniform seating on the bone surface. The alignment causes the profiled washer  228  to seat substantially normal to the surface of the cortical bone with limited disturbance to the opening of bore  138 . The profiled washer  228  may distribute the clamping force of the orthopedic anchoring system  30  more evenly and over a larger area than would the head  128 , and may prevent sliding (abrasive) contact on the bone surface as the orthopedic fastener  32  is rotationally threaded into place. 
     The oversized through-aperture  230  enables compliance over a range of angles. The convex and concave surfaces  227  and  229  may be configured to enable sliding contact therebetween as the orthopedic fastener  32   e  and profiled washer  228  are drawn together during implantation. The sliding engagement can enable the orthopedic fastener  32   e  and profiled washer  228  combination to comply with the angle between the surface of the bone and the axis of the bore  138 , as depicted at  FIG.  28   . The spherical profiles  227  and  227 ′ are examples of slideably engaging surfaces that enable alignment, but the convex and concave surfaces  227  and  229  are not limited thereto. Other combinations of surface profiles may enable compliance between the orthopedic fastener  32   e  and profiled washer  228 , and may include features (not depicted) that facilitate seating or gripping between the convex and concave surfaces  227  and  229 . 
     The orthopedic fastener  32   e  is depicted as having the reduced diameter D 3 , the functionality of which is included with the description attendant to  FIG.  15   . Optionally, the orthopedic fastener  32   e  may include a threaded mid-portion  44 , akin to fastener  32   c , instead of the reduced diameter D 3 . 
     Referring to  FIG.  17   , a driver assembly  202  for driving the orthopedic fastener  32   c  is depicted according to an embodiment of the disclosure. The driver assembly  202  includes a sleeve  204  through which a drive shaft  206  can be axially translated. A distal end of the drive shaft defines a polygonal drive bit  208  that is configured to mate with one or both of the sequential sockets  194  of the orthopedic fastener  32   c . In the depicted embodiment, the polygonal drive bit  208  is square-shaped, for mating with the proximal socket  194   a . In some embodiments, the sleeve  204  includes retention threads  210  configured to threadably engage the threads  185  of the bottom-tapped hole  184 . 
     In operation, the retention threads  210  of the sleeve  204  are threaded into the bottom-tapped hole  184  and the polygonal drive bit  208  of the drive shaft  206  inserted into and mated with one or both of the sequential sockets  194  of the orthopedic fastener  32   c . The retention threads  210  assure that the orthopedic fastener  32   c  and the driver assembly  202  remain engaged during formation of the bore  138 . The seated drive bit enables rotation of the orthopedic fastener  32   c  in both rotational directions and without binding the retention threads  210  within the bottom-tapped hole  184 . 
     Referring to  FIGS.  18  and  18 A , the mounting receiver  34   c  is described in further detail according to an embodiment of the disclosure. In the depicted embodiment, the standoff  73  includes the ball pivot  82  is joined to the receiver body  72  via the standoff  73 . The standoff  73  extends from a first side  252  of the ball pivot  82 . A socket  248  may be defined at a second side  246  of the ball pivot  82 , the second side  246  being diametrically opposed to the first side  252  along the standoff axis  74 . The receiver body  72  defines the mounting aperture  62  and threads  66  concentric about the mounting axis  64 . The mounting axis  64  may be substantially orthogonal to the standoff axis  74 . The female threads  66  of the mounting aperture  62  may be tapered threads  262 , akin to a pipe tap or a STOVER nut. 
     The receiver body  72  includes a first lateral face  282  and a second lateral face  284 . In some embodiments, the receiver body  72  defines a wedge-shaped profile  286 , with the first lateral face  282  defining a first acute angle θ 1  relative to the standoff axis  74  and the second lateral face  284  defining a second acute angle θ 2  relative to the standoff axis  74 . In some embodiments, the wedge-shaped profile  286  is asymmetrical; that is, the first angle θ 1  may be different than the second angle θ 2 . In some embodiments, the first angle θ 1  is less than the second angle θ 2 . 
     Referring to  FIGS.  19  and  19 A , a mounting receiver  34   d  is depicted according to an embodiment of the disclosure. The mounting receiver  34   d  may be used as an alternative to the mounting receiver  34   c  for configuration of a receiver assembly  33   d , as depicted at  FIG.  13   , and includes some of the same components and attributes as the mounting receiver  34   c , some of which are indicated with same-labeled reference characters. The first lateral face  282  of the mounting receiver  34   d  defines a concavity  288  that extends between first and second opposed lateral edges  287  and  289 , the first lateral edge  287  being proximate the standoff  73 . A first radial offset distance R 1  is defined from the standoff axis  74  to the first lateral edge  287  at a mid-plane XIXA-XIXA, the mid-plane XIXA-XIXA being coplanar with the mounting axis  64 . A second radial offset distance R 2  is defined from the standoff axis  74  to the second lateral edge  289  at the mid-plane XIXA-XIXA, the second radial offset distance R 2  being greater than the first radial offset distance R 1 . The radial offset distance R 1  is greater than the outer radius RO of the tulip  31  ( FIG.  23   ). In the depicted embodiment, the second lateral face  284  defines a convex profile  285  at the mid-plane XIXA-XIXA. The shape of the receiver body  72  of the mounting receiver  34   d  may, in some instances, allow for more lead-in or female tapered threads  262  for engagement with the threaded portion  214  of the orthopedic fastener  32   c.    
     Referring to  FIGS.  20  and  20 A , the ball retainer  152  is depicted in greater detail according to an embodiment of the disclosure. The ball retainer  152  includes a plurality of petals  292  that extend from a flange  294 . Assembly and operation of the ball retainer  152  is described, for example, at U.S. Pat. No. 10,070,895 to Barra, et al., the contents of which are hereby incorporated by reference herein in its entirety except for patent claims and express definitions contained therein. The ball retainer  152  may include a threaded aperture  296  that passes through the center of the flange  294 . 
     Functionally, the tapered female threads  262  of the receiver body  72  receives the male threads  217  of the tapered distal tip portion  218  of the orthopedic fastener  32   c . The angled arrangement of the lateral faces  282  and  284  of mounting receiver  34   c  may conform approximately to the surfaces of the ilium and the sacrum, as depicted at  FIG.  24   . For mounting receiver  34   d , the concavity  288  may act to seat the opposed lateral edges  287  and  289  onto the bone. For some implantations, the concavity  288  may conform approximately to the local surface of the ilium in certain locations. 
     The tapered female threads  262  and the male threads  217  of the tapered distal tip portion  218  are deformed as the orthopedic fastener  32   c  is driven into the mounting aperture  62  of the mounting receiver  34   c ,  34   d . In some embodiments, the deformation may occur in one or more additional or alternative ways. For example, the pitch of the female threads  262  of the receiver body  72  differ from the pitch of the tapered distal tip portion  218  of the orthopedic fastener  32   c . In another example, the cross section of the female threads  66 ,  262  of the receiver body  72  may be non-circular (e.g., oblong or oval), thereby and causing an interference fit at the minor diameter thereof. In yet another example, the diameter of the female threads  262  of the receiver body  72  may be less than that of the male threads  217  so as to cause an interference fit diametrically. These examples are non-limiting, and may be used in combination. The deformation of the tapered female threads  262  and the male threads  217  lock the orthopedic fastener  32   c  and the mounting receiver  34   c ,  34   d  in a fixed relationship and maintains the orthopedic fastener  32   c  in tension to secure the orthopedic anchoring system  30   d  to the ilium. 
     The socket  248  of the ball pivot  82  enables control of the rotational position of the mounting receiver  34   c ,  34   d  during implantation. The socket  248  is configured to accept a driver  232 , such as a hex driver (depicted). The sequential sockets  194  enables the orthopedic fastener  32   c  to be driven with two different drivers (not depicted)—a square driver or a hex driver. The ball retainer  152  grips and retains the ball pivot  82  within the tulip  31   b . The threaded aperture  294  may provide utility during assembly with the tulip  31   b , and can also be used with a male threaded member (not depicted) for disassembly by pushing the ball pivot  82  from the tulip  31   b  with the male threaded member. The central through-passage  92  enables the orthopedic fastener  32   c  to be positioned with a guide wire  324 . The self-tapping flutes  222  enable the orthopedic fastener  72  to bore through the ilium without need for pre-drilling. The radiused shoulder  182  of the distal face  178  of the head portion  128  of the orthopedic fastener  32   c  augments dilation of soft tissue as the head portion  128  passes therethrough. 
     Referring to  FIGS.  21  through  23   , implantation of the orthopedic anchoring system  30   c  is depicted according to an embodiment of the disclosure. Though the specific orthopedic fastener  32   c  is represented in  FIGS.  27  and  28   , orthopedic fasteners  32   d  or  32   e  may also be implemented in the implantation. To implant the orthopedic anchoring system  30   c , a posterior incision is made that extends over the iliac crest. A tool  322  (e.g., a hex wrench) is inserted through the guide tower  84 , the ball retainer  152 , and into the socket  248 , and the assembly inserted into the posterior incision so that the lateral face  282  is proximate the surface of the ilium. A lateral incision is made that enables alignment of the orthopedic fastener  32   c  along the mounting axis  64  through the iliac crest. Using standard visualization techniques (e.g., x-ray imaging), a pilot hole is formed with a pilot hole drill (not depicted) that is passed through the ilium, for example a JAMSHIDI™ needle. Though the mounting receiver  34   d  of  FIGS.  19  and  19 A  is depicted in  FIGS.  21  through  23   , the mounting receiver  34   c  of  FIGS.  18  and  18 A  may also be implemented. 
     The guide wire  324  is inserted through the pilot hole and into the mounting aperture  62  of the mounting receiver  34   c ,  34   d . The orthopedic fastener  32   c  is driven into the iliac crest with driver assembly  202 . Using the tool  322  to maintain the orientation of the mounting receiver  34   c ,  34   d , the orthopedic fastener  32   c  is bored through the ilium and into the mounting aperture  62  of the mounting receiver  34   c ,  34   d  to engage the tapered female threads  262 . The orthopedic fastener  32   c  can be rotated within the bore  138  formed through the wing of the ilium by the orthopedic fastener  32   c , drawing the receiver  34   c ,  34   d  into place, seated against the ilium. The deformation of the tapered female threads  262  and the male threads  217  of the tapered distal tip portion  218  locks the orthopedic fastener  32   c  and the mounting receiver  34   c ,  34   d  together and maintains the orthopedic fastener  32   c  in tension to secure the orthopedic anchoring system  30   d  to the ilium. The tool  322  may be withdrawn and the spinal support rod  35  clamped against the ball pivot  82  with the set screw  86  to set the tulip  31   b  in a desired orientation on the ball pivot  82  ( FIG.  23   ). 
     Referring to  FIG.  24   , the orthopedic anchoring system  30   c  is depicted in an implanted configuration  330  according to an embodiment of the disclosure. Methods and procedures for implementing the implanted configuration  330  may be the same as depicted and described attendant to  FIGS.  22  and  23    for the orthopedic anchoring system  30   c , mutatis mutandas for the wedge-shaped profile  286  of the receiver body  72  of the mounting receiver  34   c  and the posterolateral approach to achieve the orientation depicted in  FIG.  24   . The implanted configuration  330  depicts the utility of the wedge-shaped profile  286  of the receiver body  72  for the mounting receiver  34   c . The angled arrangement of the lateral faces  282  and  284  of the wedge-shaped profile  286  can conform approximately to the surfaces of the ilium and the sacrum, and may also enable passage of the mounting receiver  34   c  to the implant site with less trauma to surrounding tissue and ligaments. 
     Referring to  FIG.  25   , an orthopedic anchoring system  30   d  is depicted according to an embodiment of the disclosure. The orthopedic anchoring system  30   d  includes a receiver assembly  33   e  comprising a tulip  31   c  and a mounting receiver  34   e . As depicted in  FIG.  25   , the orthopedic anchoring system  30   d  includes the orthopedic fastener  32   c ; however, any of the orthopedic fasteners  32   c ,  32   d , or  32   e  as depicted and described herein may be implemented with the orthopedic anchoring system  30   e . In the depicted embodiment, the orthopedic anchoring system  30   d  includes the guide tower  84  and the set screw  86 . The spinal support rod  35  is also represented in line for insertion into the tulip  31   c.    
     Referring to  FIG.  26   , the tulip  31   c  and receiver assembly  33   e  are depicted in greater detail according to an embodiment of the disclosure. The receiver assembly  33   e  includes the mounting receiver  34   e  and tulip  31   c  as an integrated or unitary structure. The mounting aperture  62  of the mounting receiver  34   d  may include the same components and attributes as the mounting aperture  62  of the mounting receiver  34   c ,  34   d , some of which are indicated in with same-labeled reference characters. During implantation, the tapered female threads  262  mate with the male threads  217  of the tapered distal tip portion  218  of the orthopedic fasteners  32   c ,  32   d  as previously described. Though not depicted, it is also contemplated that the tulip  31   c  be configured to have the same profile characteristics as the wedge-shaped profile  286  of the mounting receiver  34   c  or the concavity  288  of the mounting receiver  34   d.    
     Referring to  FIGS.  27  and  28   , implantation of the orthopedic anchoring system  30   d  is depicted according to an embodiment of the disclosure. Though the orthopedic fastener  32   e  is represented in  FIGS.  27  and  28   , orthopedic fasteners  32   c  or  32   d  may also be implemented in the implantation. To implant the orthopedic anchoring system  30   d  as depicted, a posterior incision is made that extends over the iliac crest. The guide tower  84  and receiver assembly  33   d  are inserted into the posterior incision so that the tulip  31   c  is at the desired location adjacent the ilium. The mounting aperture  62  is oriented to receive the orthopedic fastener  32   d  through the ilium using the guide tower  84  to control the tulip  31   c . A lateral incision is made that enables alignment of the orthopedic fastener  32   d  along the mounting axis  64  through the ilium. Using standard visualization techniques (e.g., x-ray imaging), a pilot hole is formed with a pilot hole drill (not depicted) that is passed through the ilium, for example a JAMSHIDI™ needle. 
     The guide wire  324  is inserted through the pilot hole and into the mounting aperture  62  of the tulip  31   c . The orthopedic fastener  32   d  is driven into the ilium with the driver assembly  202 . Using the guide tower  84  to maintain the orientation of the tulip  31   c , the orthopedic fastener  32   d  is bored through the ilium and into the mounting aperture  62  of the tulip  31   c  to engage the tapered female threads  262 . After the bore  138  is formed, the orthopedic fastener  32   d  can be rotated within the bore  138 , thereby drawing the mounting receiver  34   e  into seating contact against the ilium. The deformation of the tapered female threads  262  and the male threads  217  of the tapered distal tip portion  218  locks the orthopedic fastener  32   d  and the mounting receiver  34   d  together. The tulip  31   c  may be positioned in an angular orientation about the rotation axis  36  in a monoaxial arrangement as the orthopedic fastener  32   d  is set within the tulip  31   c . The spinal support rod  35  clamped against the orthopedic fastener  32   d  with the set screw  86  ( FIG.  28   ) to set the tulip  31   c  in a desired orientation about the central rotation axis  36 . 
     In some embodiments, some or all of the components of the orthopedic anchoring systems  30  are provided as a kit  350  (depicted at  FIGS.  13  and  25   ), complete with instructions  352  for use. The instructions  352  are provided on a tangible, non-transitory medium, and may be physically included with the kit  350  such as on a printed document (depicted), compact disc, or flash drive. Non-limiting examples of a tangible, non-transitory medium include a paper document and computer-readable media including compact disc and magnetic storage devices (e.g., hard disk, flash drive, cartridge, floppy drive). The computer-readable media may be local or accessible over the internet. The instructions  352  may be complete on a single medium, or divided among two or more media. For example, some of the instructions  352  may be written on a paper document that instruct the user to access one or more of the steps of the method over the internet, the internet-accessible steps being stored on a computer-readable medium or media. The instructions  352  may embody the techniques and methods depicted or described herein using text, photos, videos, or a combination thereof to instruct and guide the user. The instructions may be in the form of written words, figures, photos, video presentations, or a combination thereof to instruct and guide the user. 
     Each of the additional figures and methods disclosed herein can be used separately, or in conjunction with other features and methods, to provide improved devices and methods for making and using the same. Therefore, combinations of features and methods disclosed herein may not be necessary to practice the disclosure in its broadest sense and are instead disclosed merely to particularly describe representative and preferred embodiments. 
     Various modifications to the embodiments may be apparent to one of skill in the art upon reading this disclosure. For example, persons of ordinary skill in the relevant arts will recognize that the various features described for the different embodiments can be suitably combined, un-combined, and re-combined with other features, alone, or in different combinations. Likewise, the various features described above should all be regarded as example embodiments, rather than limitations to the scope or spirit of the disclosure. 
     Persons of ordinary skill in the relevant arts will recognize that various embodiments can comprise fewer features than illustrated in any individual embodiment described above. The embodiments described herein are not meant to be an exhaustive presentation of the ways in which the various features may be combined. Accordingly, the embodiments are not mutually exclusive combinations of features; rather, the claims can comprise a combination of different individual features selected from different individual embodiments, as understood by persons of ordinary skill in the art. 
     Any incorporation by reference of documents above is limited such that no subject matter is incorporated that is contrary to the explicit disclosure herein. Any incorporation by reference of documents above is further limited such that no claims included in the documents are incorporated by reference herein. Any incorporation by reference of documents above is yet further limited such that any definitions provided in the documents are not incorporated by reference herein unless expressly included herein. 
     Unless indicated otherwise, references to “embodiment(s)”, “disclosure”, “present disclosure”, “embodiment(s) of the disclosure”, “disclosed embodiment(s)”, and the like contained herein refer to the specification (text, including the claims, and figures) of this patent application that are not admitted prior art. 
     For purposes of interpreting the claims, it is expressly intended that the provisions of 35 U.S.C. 112(f) are not to be invoked unless the specific terms “means for” or “step for” are recited in the respective claim.