Patent Publication Number: US-2023139487-A1

Title: Anchors and anchoring systems

Description:
FIELD 
     The present invention relates generally to anchors, anchoring systems, and methods for using the same for anchoring soft tissue to bone. 
     BACKGROUND 
     The complete or partial detachment of ligaments, tendons, and/or other soft tissues from their associated bones within the body are relatively commonplace injuries, particularly among athletes. Such injuries are generally the result of excessive stresses being placed on these tissues. By way of example, tissue detachment may occur as the result of an accident such as a fall, overexertion during a work-related activity, during the course of an athletic event, or in any one of many other situations and/or activities. 
     In the case of a partial detachment, the injury will frequently heal itself, if given sufficient time and if care is taken not to expose the injury to further undue stress. In the case of complete detachment, however, surgery may be needed to re-attach the soft tissue to its associated bone or bones. Numerous suture anchors are currently available to re-attach soft tissue to bone. Examples of such currently-available devices include screws, staples, suture anchors, and tacks. 
     In soft tissue re-attachment procedures utilizing suture anchors, such as push in style anchors, an anchor-receiving hole is generally first drilled in the bone at the desired point of tissue re-attachment. A suture anchor is then attached to soft tissue and then deployed in the hole using an appropriate installation tool. However, inserting the end of soft tissue (e.g., a tendon) into a blind hole can be a challenge as the soft tissue end has a tendency to interface with and catch on the hole (e.g., an edge of the hole) while the suture anchor is being deployed in the hole. Further, with current push in style anchors, when tying the soft tissue to the suture anchor, the distal end of the soft tissue can be pulled against the suture anchor in such a way to cause the soft tissue to flower out and create a bulbous end. As a result, the soft tissue can slide away from the suture anchor while the suture anchor is being inserted into the hole. Once the suture anchor has been driven into bone, the suture and the soft tissue cannot be adjusted to adjust the position of the soft tissue relative to the bone because the driven suture anchor holds the suture and soft tissue in place. 
     Accordingly, there remains a need for improved anchors and anchoring systems for attaching soft tissue to bone. 
     SUMMARY 
     Anchors for anchoring soft tissue to bone are provided. In one exemplary embodiment, an anchor can include a non-threaded, asymmetric anchor body having a distal nose and a spine extending proximally from one side of the distal nose, and a deflectable clip extending proximally from a side of the nose opposite the spine. The spine defines a back surface of the anchor body. The spine has an outer bone engaging surface, an inner tissue seating surface opposite the outer bone engaging surface, and opposed lateral sides. The deflectable clip and a portion of the spine defines a guide region configured to accommodate and shield a leading end of a soft tissue to be attached to bone. 
     The distal nose can have a variety of configurations. In some embodiments, a distal tip of the distal nose can have at least two suture holes extending longitudinally therethrough. In such embodiments, the at least two suture holes can be positioned laterally adjacent to each other. In other such embodiments, the at least two suture holes can be configured to receive an operative suture to maintain the leading end of the soft tissue at a distal end of the guide region. 
     In some embodiments, the anchor can include a plurality of pairs of deflectable wings extending from the lateral sides of the spine, in which each pair can be spaced longitudinally along the spine with each wing having a portion that extends above and beyond the tissue seating surface of the spine to define a soft tissue encompassing side surface. In such embodiments, the anchor can include at least one pair of suture recesses positioned proximally adjacent to at least one pair of deflectable wing. Each suture recess can be configured to at least partially house a suture, and each suture recess can extend through a lateral side of the anchor body such that a suture seated within the suture recess does not interfere with the deflection of the deflectable wings. In such embodiments, each suture recess can extend through the lateral side of the anchor body along a path that is at least partially arcuate. 
     In some embodiments, the anchor can include at least one bone engaging barb formed on the outer bone engaging surface. 
     The anchor body can have a variety of configurations. In some embodiments, the anchor body can have at least one bore formed at a proximal end of the anchor body and extending distally into the anchor body. The bore can be configured to receive a distal end of an inserter instrument. 
     In some embodiments, the anchor can include at least one deflectable back wing extending from the outer bone engaging surface. 
     In some embodiments, the anchor can include a pair of orientation tabs extending laterally from a proximal end of the lateral sides of the spine. The pair of orientation tabs can be configured to restrict lateral movement of the anchor when it is inserted into bone. 
     Soft tissue anchoring systems are also provided. In one exemplary embodiment, a system can include a non-threaded, asymmetric anchor being configured to be inserted into bone and an inserter instrument that is configured to removably couple to and push the anchor into bone. The anchor includes a distal nose with a longitudinal axis extending therethrough, a spine extending proximally from one side of the distal nose, and a flexible flange extending proximally from a side of the distal nose opposite the spine. The spine is offset from the longitudinal axis and the spine and the distal nose define a length of the anchor. The flexible flange and a portion of the spine defines a tissue receiving recess proximate and adjacent to the distal nose, and the flexible flange being effective to capture a soft tissue segment within the recess during insertion. The inserter instrument has a handle and an elongated shaft extending from the handle. The handle has a proximal end and a distal end, in which the proximal end has a shape that is representative of a portion of anatomy to which the anchor is to be inserted. 
     In some embodiments, the portion of the anatomy can be the humerus bone. 
     The elongated shaft can have a variety of configurations. In some embodiments, the elongated shaft can have an inserter prong at a distal end thereof. The inserter prong can be configured to be received within a bore extending into a proximal end of the anchor to removably couple to the anchor. In some embodiments, the elongated shaft can include at least one marking that is indicative of an insertion depth of the anchor when the anchor is being inserted into bone. 
     The handle can have a variety of configurations. In certain embodiments, the proximal end of the handle can be wider than the distal end of the handle. 
     The flexible flange has a variety of configurations. In some embodiments, the flexible flange has a length that can be less than the length of the anchor. 
     Methods for inserting an anchor into bone are also provided. In one exemplary embodiment, a method can include coupling a non-threaded anchor to an inserter instrument, the anchor having a distal nose and a spine extending proximally from one side of the distal nose, connecting a soft tissue to the anchor with a leading end of the soft tissue positioned within a guide region of the anchor, the guide region being formed, in part, by a deflectable clip extending proximally from the distal nose, the soft tissue being connected to the anchor with an operative suture that extends through the distal nose, and pushing the anchor with the soft tissue connected thereto into a bone socket to attach the soft tissue to bone. 
     The inserter instrument can have a variety of configurations. In some embodiments, the inserter instrument includes a handle having a proximal end and a distal end. The proximal end of the handle can have a shape that is representative of a portion of anatomy having the bone socket formed therein. 
     In some embodiments, coupling the anchor to the inserter instrument includes threading a removable stay suture through at least one hole extending through the anchor and cleating free ends of the stay suture to the handle. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       This invention will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings, in which: 
         FIG.  1    is back view of an exemplary embodiment of an anchor; 
         FIG.  2    is a side view of the anchor of  FIG.  1   ; 
         FIG.  3    is a front view of the anchor of  FIG.  1   ; 
         FIG.  4    is a front perspective view of the anchor of  FIG.  1   ; 
         FIG.  5    is a top-down view of the anchor of  FIG.  1   ; 
         FIG.  6    is a bottom-up view of the anchor of  FIG.  1   ; 
         FIG.  7    is a front perspective view of an exemplary embodiment of an inserter instrument having a handle and an elongated shaft extending from the handle; 
         FIG.  8    is a schematic illustrating a portion of the inserter instrument positioned next to a portion of a shoulder, showing the anatomical similarities between the handle and the portion of the shoulder; 
         FIG.  9    is a magnified front perspective view of a top portion of the inserter instrument of  FIG.  7   ; 
         FIG.  10 A  is a back perspective view of an exemplary embodiment of a soft anchoring system with the anchor of  FIG.  1    coupled to the inserter instrument of  FIG.  7   ; 
         FIG.  10 B  is a magnified view of a distal portion of the soft anchoring system of  FIG.  10 A ; 
         FIG.  11    is a front perspective view of an exemplary embodiment of a soft anchoring system with the anchor of  FIG.  1    coupled to an inserter instrument; 
         FIG.  12    is a front perspective view of an exemplary embodiment of a soft anchoring system with the anchor of  FIG.  1    coupled to an inserter instrument, the system having a stay suture and a fixation suture; 
         FIG.  13 A  is a magnified side view of a distal portion of the soft anchoring system of  FIG.  12    with the stay suture removed, showing a loop of the fixation suture and a soft tissue segment connected to the anchor; 
         FIG.  13 B  is the distal portion of the soft anchoring system of  FIG.  13 A , showing the loop passed over the anchor and connected soft tissue segment; 
         FIG.  13 C  is the distal portion of the soft anchoring system of  FIG.  13 B , showing the loop in a tightened configuration; 
         FIG.  14    is a schematic illustrating an end of a bicep tendon that is released from a glenoid attachment of a shoulder being threaded to the anchor of the soft anchoring system of  FIG.  10 A ; 
         FIG.  15    is a schematic illustrating a magnified view of the end of the bicep tendon being knotted to the anchor of the soft anchoring system of  FIG.  10 A ; 
         FIG.  16    is a schematic illustrating the anchor with the secured bicep tendon coupled thereto being docketed into a bone socket created within the shoulder of  FIG.  14   ; and 
         FIG.  17    is a schematic cross-sectional view of a portion of the shoulder of  FIG.  14   , showing the anchor and the secured bicep tendon fully inserted into the bone socket. 
     
    
    
     DETAILED DESCRIPTION 
     Certain exemplary embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the anchors, anchoring systems, and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will understand that the anchors, anchoring systems, and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments and that the scope of the present invention is defined solely by the claims. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present invention. 
     In general, non-threaded anchors (e.g., push in style anchors), soft tissue anchoring systems, and methods of using the same are provided. In one exemplary embodiment, the non-threaded anchor includes an anchor body having a guide region that is formed, in part, by a deflectable clip (e.g., a flexible flange). The guide region is configured to accommodate and shield a leading end of a soft tissue to be attached to bone. That is, during use, the non-threaded anchor is designed to provide better control of the soft tissue, e.g., during insertion into bone. It will be appreciated that absent such deflectable clip, the soft tissue can peel back and away from the non-threaded anchor as the non-threaded anchor is inserted into bone. This is at least because when attaching the soft tissue to the non-threaded anchor, the soft tissue is pulled towards the distal face of the non-threaded anchor causing the leading end of the soft tissue to flower out (e.g., sliding outward and away from the anchor) and create a bulbous end. Beneficially, with the incorporation of this deflectable clip, the form of the leading end of the soft tissue can be controlled, e.g., while being threaded and knotted to the non-threaded anchor and inserted into bone. As such, constraining the soft tissue within the guide region of the non-threaded anchor can reduce the risk of the soft tissue catching on bone (e.g., the edge of the aperture of a bone socket) during insertion. Additionally, this can increase visualization of the aperture of the bone socket and reduce wrapping of the soft tissue around the sides (e.g., including deflectable side wings, if present) of the non-threaded anchor. 
     Further, in exemplary embodiments, a soft tissue anchoring system can include a non-threaded anchor and an inserter instrument that is configured to removably couple to and push the non-threaded anchor into bone. The non-threaded anchor can have any configuration, such as the configurations described herein, that is suitable for being inserted into bone. The inserted instrument includes a handle having a proximal end and a distal end, and an elongated shaft extending from the handle. 
     The non-threaded anchors described herein can be asymmetrical. In such instances, this creates a desired insertion orientation, and therefore, a visual or tactile indicator could be employed on the inserter instrument to help demonstrate to the user the insertion orientation of the non-threaded anchor during use. For example, in some embodiments, the proximal end of the handle of the inserter instrument has a shape that is representative of a portion of anatomy to which the non-threaded anchor is to be inserted. The term “representative” can adopt its ordinary and usual meaning as understood by a person skilled in the art. For example, a structure (e.g., the handle of the inserted instrument) that is representative of a portion of anatomy can have one or more dimensions and surfaces (e.g., one or more outer surfaces) that are the same or approximately the same as that of a predetermined anatomy, within manufacturing tolerances and generally understood anatomical variations. Beneficially, this handle configuration can provide to the user (e.g., medical practitioner) a more intuitive indicator as to the orientation of the non-threaded anchor coupled thereto. By way of example, the handle can be made into a stylized bone shape modeled after the bone the anchor will be implanted into. 
     The portion of the anatomy can have a variety of configurations. For example, in some embodiments, the portion of the anatomy is the humerus bone. In such embodiments, landmarks on the humerus bone (e.g., bicipital groove) can be used as a primary indicator of non-threaded anchor orientation. In such instances, the desired orientation can be arranged such the handle form “aligns” to the anatomy (e.g., approximate rotation about the longitudinal axis of the inserter instrument relative to the longitudinal axis of the bone). Other exemplary suitable portions of the anatomy can include joints, hip, femur, tibia, patella, ankle, elbow, etc.. 
     In some embodiments, the non-threaded anchors and soft tissue anchoring systems described herein can be used in a biceps repair procedure in which a biceps tendon is attached to bone. In other embodiments, the non-threaded anchors and soft tissue anchoring systems described herein can be used in other types of surgical procedures, such as collateral ligament reconstructions in the knee, in which a hamstring tendon graft is attached to bone using a non-threaded anchor, and in other tenodesis procedures in which a tendon or other soft tissue is attached to bone using a non-threaded anchor. A person skilled in the art will appreciate that the non-threaded anchors, inserter instruments, and methods disclosed herein can be used with a variety of surgical devices, including measuring devices, drills, and mallets, etc. 
       FIGS.  1 - 6    illustrate an exemplary embodiment of a non-threaded anchor  100 . The non-threaded anchor  100  is asymmetrical and is configured to provide control over the form of attached soft tissue so as to reduce the risk of the soft tissue from adversely interfering with the opening created within the bone as the anchor is being inserted therein. For sake of simplicity, while soft tissue is attached to the non-threaded anchor  100  prior to insertion (e.g., via one or more sutures, e.g., tendon suture  504  in  FIGS.  11 - 14   ), as described in more detail below, soft tissue is omitted from  FIGS.  1 - 6   . The non-threaded anchor  100  includes an anchor body  102  and a deflectable clip  104 . 
     The one or more sutures can be any type of suture and can be made from any of a variety of materials, including natural materials and synthetic materials. Non-limiting examples of suitable materials for the one or more sutures include polymers, such as polyglycolide, polypropylene, polyethylene terephthalate (PET), and polydioxanone, and fabrics, such as nylon and silk. The one or more sutures can be bioabsorbable, partially bioabsorbable, or nonabsorbable, and can have a circular cross section or another cross section. 
     The anchor body  102  can have a variety of configurations. For example, as shown in  FIGS.  1 - 6   , the anchor body  102  includes a distal nose  106  and a spine  108 . While the distal nose  106  can have a variety of shapes and sizes, in this illustrated embodiment, the distal nose  106  has a bullet-shape configuration. As further shown, the distal nose  106  has a distal tip  107  that has two suture holes  110   a ,  110   b  defined therein that are configured to be used to fixate soft tissue to the non-threaded anchor  100 . The two suture holes  110   a ,  110   b  can also help prevent over tensioning the soft tissue toward the distal tip  107 . The two suture holes  110   a ,  110   b  can be arranged within the distal nose  106  in various locations and can extend in various directions relative to longitudinal axis of the distal nose  106 . 
     In this illustrated embodiment, the two suture holes  110   a ,  110   b  are positioned laterally adjacent to each other and each extend longitudinally through the distal nose  106  (e.g., extending along the longitudinal axis L of the distal nose  106  ( FIG.  1   )). Further, in this illustrated embodiment, the two suture holes  110   a ,  110   b  are distal facing. While two suture holes  110   a ,  110   b  are illustrated in  FIGS.  1 - 6   , a person skilled in the art will appreciate that any number of suture holes can be defined within the distal nose and extend through the distal nose in different directions, and therefore the number and extension direction of the suture holes are not limited to what is illustrated in the figures. 
     The anchor body  102  also includes a spine  108  that extends proximally from one side  106   a  of the distal nose  106  and is offset from the longitudinal axis L of the distal nose  106 . The spine and the distal nose define a length L A  of the non-threaded anchor  100 . As shown, the spine  108  defines a back surface  102   a  of the anchor body  102  (see  FIGS.  3 - 5   ). The spine  108  can have a variety of configurations. For example, in some embodiments, the spine  108  includes an outer bone engaging surface  112 , an inner tissue seating surface  113  that is opposite the outer bone engaging surface  112 , and opposed first and second lateral sides  114 ,  115 . 
     While the surfaces and sides of the spine  108  can have a variety of shapes, in this illustrated embodiment, the outer bone engaging surface  112  has a generally curved shape, and the inner tissue seating surface  113  has a generally planar shape (e.g., generally flat or linear). Further, the first lateral side  114  has a first segment  114   a  that has a generally planar shape (e.g., generally linear) and a second segment  114   b  that has a generally tapered shape. Similarly, the second lateral side  115  has a first segment  115   a  that has a generally planar shape (e.g., generally linear) and a second segment  115   b  that has a generally tapered shape. 
     In some embodiments, the spine  108  can include at least one auxiliary suture hole that is configured to augment the attachment of a soft tissue to the non-threaded anchor  100 , provide better control of the orientation of soft tissue attached to the non-threaded anchor  100 , or a combination thereof. Further, the at least one auxiliary suture hole can be configured to limit toggling post implantation. While the number of auxiliary suture holes can vary, in this illustrated embodiment, two axially suture holes  117   a ,  117   b  are defined within the spine  108 . As shown in  FIGS.  1 ,  3  and  4   , the two auxiliary suture holes  117   a ,  117   b  are positioned longitudinally adjacent to each other and each extend laterally through the spine  108  (e.g., extending laterally relative to the longitudinal axis Ls of the spine  108  ( FIG.  1   )). While two auxiliary suture holes  117   a ,  117   b  are illustrated, a person skilled in the art will appreciate that any number of auxiliary suture holes can be defined within the spine and extend through the spine in different directions, and therefore the number and extension direction of the auxiliary suture holes are not limited to what is illustrated in the figures. 
     In some embodiments, as shown in  FIG.  5   , the anchor body  102  has at least one bore  119  that is configured to receive a distal end of an inserter instrument (e.g., inserter instrument  200  in  FIGS.  7 - 9   ). For example, in certain embodiments, the bore  119  can have a complementary shape relative to the shape of the distal end of the inserted instrument. In this embodiment, the bore  119  has a generally cylindrical shape. In other embodiments, the bore  119  can have other suitable shapes (e.g., generally rectangular). In use, as described in more detail below, once the distal end of the inserter instrument is inserted into the bore  119 , the bore  119  helps maintain the position thereof within the non-threaded anchor  100 , and thus the resulting impact surface. In certain embodiments, the inserter instrument and non-threaded anchor interface can permit rotation within the body of the patient. 
     As shown in  FIGS.  1 - 6   , the deflectable clip  104  (e.g., a flexible flange) extends proximally from a side  106   b  of the distal nose  106  opposite the spine  108 . As a result, the deflectable clip  104  and a portion of the spine  108  define a guide region  116  (see  FIGS.  2  and  5   ) that is configured to accommodate and shield a leading end of a soft tissue to be attached to bone. For example, in use, while the soft tissue is being attached to the non-threaded anchor, the guide region  116  can reduce the tendency of the soft tissue to extrude out of the side of the non-threaded anchor. Further, the guide region  116  can also prevent the attached soft tissue from catching on bone (e.g., the edge of bone socket) while the non-threaded anchor  100  is being inserted into the bone socket. While the guide region  116  can be positioned at any various locations along the length L A  of the non-threaded anchor  100 , in this illustrated embodiment, the guide region  116  is proximate and adjacent to the distal nose  106 . The guide region  116  can also be referred to herein as a tissue receiving recess. In use, as described in more detail below, the at least two suture holes  110   a ,  110   b  are configured to receive an operative suture to maintain a leading end of a soft tissue at a distal end  116   a  of the guide region  116 . 
     The operative suture(s) can be any type of suture and can be made from any of a variety of materials, including natural materials and synthetic materials. Non-limiting examples of suitable materials for the operative suture(s) include polymers, such as polyglycolide, polypropylene, polyethylene terephthalate (PET), and polydioxanone, and fabrics, such as nylon and silk. The operative suture(s) can be bioabsorbable, partially bioabsorbable, or nonabsorbable, and can have a circular cross section or another cross section. 
     The deflectable clip has a length L F  that extends from a first end  104   a  to a second end  104   b  of the deflectable clip. As shown the first end  104   a  is distal to the distal nose  106 . The deflectable clip  104  can have any suitable length that is suitable for capturing and shielding a leading end of soft tissue that is attached to the non-threaded anchor. In this illustrated embodiment, the length L F  of the deflectable clip  104  is less that the length L A  of the non-threaded anchor  100 . The deflectable clip  104  is designed to be flexible. As a result, this can reduce the risk of fracture of the non-threaded anchor  100  (e.g., during non-threaded anchor insertion). In use, as described in more detail below, the deflectable clip  104  is effective to capture a soft tissue segment (e.g., at least a leading end of a soft tissue) within the guide region  116  during non-threaded anchor insertion. This can shield the leading end of the soft tissue segment from getting caught on bone. 
     While not illustrated, in some embodiments, the non-threaded anchor  100  can also include transverse suture hole(s) (e.g., suture hole(s) that extend laterally relative to the longitudinal axis L of the non-threaded anchor  100 ) that are positioned proximal to the distal end  116   a  of the guide region  116 . In use, when attaching a soft tissue segment to the non-threaded anchor  100  (e.g., while a suture attached to the soft tissue segment is being threaded and knotted), the transverse suture hole(s) can be used to limit the amount the user can distally advance the leading end of a soft tissue along the non-threaded anchor  100 . This can help further reduce the risk of flowering of the leading end. 
     As further shown in  FIGS.  1 - 6   , the non-threaded anchor  100  includes at least one pair of deflectable wings that extend from the lateral sides  114 ,  115  of the spine  108 . The deflectable wings are configured to engage bone to help secure the non-threaded anchor  100  within the bone socket. While the number of pairs can vary, in this illustrated embodiment, the non-threaded anchor  100  includes three pairs of deflectable wings  118   a ,  118   b ,  120   a ,  120   b ,  122   a ,  122   b , in which one wing  118   a ,  120   a ,  122   a  extends from first lateral side  114  of the spine  108  and the other wing  118   b ,  120   b ,  122   b  extends from the second lateral side  115  of the spine  108 . As shown in  FIGS.  1  and  3   , each deflectable wing  118   a ,  118   b ,  120   a ,  120   b ,  122   a ,  122   b  extends outward from the spine  108  in such a way that creates a respective space  119   a ,  119   b ,  121   a ,  121   b ,  123   a ,  123   b  therebetween. This allows the deflectable wings  118   a ,  118   b ,  120   a ,  120   b ,  122   a ,  122   b  to move (e.g., flex) inward and closer to the spine  108  when the non-threaded anchor  100  is inserted into a bone socket. Further, the deflectable wings  118   a ,  118   b ,  120   a ,  120   b ,  122   a ,  122   b  are resilient so that after they move inward they are biased to return to their original configurations (see  FIGS.  1  and  3   ), thereby increasing the friction between non-threaded anchor and the walls of the bone socket in which the non-threaded anchor  100  is inserted. This increased friction can help secure the non-threaded anchor  100  within the bone socket, and in certain instances, can also resist proximal movement of the non-threaded anchor post-insertion. 
     Further, the deflectable wings are configured to constrain soft tissue that is positioned against the back surface  102   a  of the non-threaded anchor  100  so as to prevent the soft tissue from wrapping around the anchor body  102  during insertion. For example, as shown in this illustrated embodiment, each pair of deflectable wings  118   a ,  118   b ,  120   a ,  120   b ,  122   a ,  122   b  is spaced longitudinally along the spine  108  with each wing having a portion that extends above and beyond the inner tissue seating surface  113  of the spine  108  to define a soft tissue encompassing side surface  124   a ,  124   b . That is, wings  118   a ,  120   a ,  122   b  define a first soft tissue encompassing side surface  124   a  and wings  118   b ,  120   b ,  122   b  define a second soft tissue encompassing side surface  124   b . It is also contemplated herein that in other embodiments, the at least one pair of deflectable wings can be omitted. 
     In some embodiments, the non-threaded anchor  100  can include additional bone engaging features. For example, as shown in  FIGS.  1  and  2   , the non-threaded anchor includes at least one bone engaging barb  132  that is formed on the outer bone engaging surface  112  of the spine  108  and at least one deflectable back wing  134  that extends from the outer bone engaging surface  112  of the spine  108 . While any number of bone engaging barbs and deflectable back wings can be employed, in this illustrated embodiment, there is one bone engaging barb  132  and one deflectable back wing  134 . It is also contemplated herein that in other embodiments, the at least one bone engaging barb  132  and/or the at least one deflectable back wing  134  can be omitted. 
     While the at least one bone engaging barb  132  can have a variety of configurations, in this illustrated embodiment, the at least one bone engaging barb  132  has a tapered configuration. Similarly, the at least one deflectable back wing  134  can have a variety of configurations. As shown, the at least one deflectable back wing  134  extends outward from the spine  108  in such a way that creates a space  135  therebetween. This allows the at least one deflectable back wing  134  to move (e.g., flex) inward and closer to the spine  108  when the non-threaded anchor  100  is inserted into a bone socket. Further, the at least one deflectable back wing  134  is resilient so that after it moves inward it is biased to return to its original configuration (see  FIGS.  1  and  2   ). This creates increased friction against the walls of the bone socket in which the non-threaded anchor  100  is inserted. In certain embodiments, the at least one bone engaging barb  132  is also resilient. Alternatively, or in addition, this increased friction between the at least one deflectable back wing  134  and the spine  108  and/or between the at least one bone engaging barb  132  and the spine  108  can also help resist proximal movement of the non-threaded anchor  100  post-insertion. Various embodiments of other bone engaging features are further described in U.S. Pat. Nos. 8,114,128 and 8,882,801, which are hereby incorporated by reference in their entireties. 
     Further, the non-threaded anchor  100  includes at least one pair of suture recesses positioned proximally adjacent to at least one pair of deflectable wings, in which each suture recess is configured to at least partially house a suture. This allows a “shoelace capture” or tie band around the soft tissue and non-threaded anchor. The at least one pair of suture recesses also creates a smaller diameter to retain position of the suture once the suture(s) are constricted around the soft tissue and non-threaded anchor at this location. Further, in some embodiments, a narrower section can be placed lateral to these suture recesses to aide retention during assembly of the soft tissue and non-threaded anchor. It is also contemplated herein that in other embodiments, the at least one pair of suture recesses can be omitted. 
     While the number of pairs of suture recesses can vary, in this illustrated embodiment, the non-threaded anchor  100  includes three pairs of suture recesses  126   a ,  126   b ,  128   a ,  128   b ,  130   a ,  130   b . As shown, the first pair of suture recesses  126   a ,  126   b  are positioned proximally adjacent to the first pair of deflectable wings  118   a ,  118   b , the second pair of suture recesses  128   a ,  128   b  are positioned proximally adjacent to the second pair of deflectable wings  120   a ,  120   b , and the third pair of suture recesses  130   a ,  130   b  are positioned proximally adjacent to the third pair of deflectable wings  122   a ,  122   b . Further, a narrower section  127  (see  FIG.  3   ) was placed lateral to each suture recess  126   a ,  126   b ,  128   a ,  128   b ,  130   a ,  130   b . 
     In this illustrated embodiment, each suture recess  126   a ,  126   b ,  128   a ,  128   b ,  130   a ,  130   b  extends through a lateral side of the anchor body  102 . As a result, in use, this prevents a suture that is seated within the suture recess from interfering with the deflection of the deflectable wings. Further, in some embodiments, as shown in  FIGS.  1  and  3   , each suture recess extends along a path that is at least partially arcuate. In other embodiments, the path can have other suitable shapes. In this illustrated embodiment, suture recesses  126   a ,  128   a ,  130   a  each extend through the first lateral side  114  of the spine  108  and suture recesses  126   b ,  128   b ,  130   b  each extend through the second lateral side  115  of the spine  108 . These suture recesses in combination with the suture(s) seated therein can limit toggling post implantation. Further, this combination can be configured to augment the attachment of a soft tissue to the non-threaded anchor  100 , provide better control of the orientation of soft tissue attached to the non-threaded anchor  100 , or a combination thereof. 
     As further shown in  FIGS.  1 - 4   , the non-threaded anchor  100  includes pair of orientation tabs  136   a ,  136   b  that are configured to restrict lateral movement of the non-threaded anchor  100  when the non-threaded anchor  100  is inserted into a bone socket. While the pair of orientation tabs can have a variety of configurations, in some embodiments, as illustrated, each tab  136   a ,  136  extends laterally from a proximal end of a respective lateral side of the spine  108 . More specifically, the first orientation tab  136   a  of the pair of orientation tabs extends laterally from the proximal end  114   c  of the first lateral side  114  of the spine  108 , and the second orientation tab  136   b  of the pair of orientation tabs extends laterally from the proximal end  115   c  of the second lateral side  115  of the spine  108 . 
     Alternatively, or in addition, a maximum outer diameter D of the distal end  101  of the non-threaded anchor  100  (see  FIGS.  2  and  5   ) can be sized in such a way that allows the non-threaded anchor  100  to pilot the center of a bone socket. As a result, this can reduce the positional freedom of the non-threaded anchor  100  within the bone socket and therefore help maintain axial alignment of the non-threaded anchor relative to the bone socket. That is, the maximum outer diameter D of the distal end  101  can help prevent positional deviation of the non-threaded anchor  100  with the respect to the central axis of the bone socket. In some embodiments, the maximum outer diameter D of the distal end  101  can be from about 3 mm to 12 mm or from about 5.4 mm to 9 mm, with a manufacturing tolerance from about 0 mm to 0.25 mm. A person skilled in the art will appreciate that the maximum outer diameter D of the distal end  101  depends at least upon the size and/or shape of the bone socket. The term “diameter” is a straight line distance through opposing sides of the distal end of the non-threaded anchor. For example, a straight line distance from an outer-bone engaging surface of the deflectable clip to an outer bone engaging surface of the segment of the spine that overlaps in length with the deflectable clip (see  FIGS.  2  and  5   ). A “diameter” as used herein is not limited to a structure with a circular or even rounded cross-section. 
     To attach soft tissue to bone, a bone socket (e.g., bore, hole, and the like) can be formed in bone of a patient, such as by using a drill, an awl, a punch instrument, etc., as will be appreciated by a person skilled in the art. A diameter of the bone socket can be slightly less than a maximum outer diameter of the non-threaded anchor to be disposed within the bone socket, and a length of the bone socket can be the same as or slightly greater than a length of the non-threaded anchor. The bone socket can extend fully through the cortical bone to allow the non-threaded anchor to be fully engaged through the thickness of the cortical bone. The bone socket can also extend into the cancellous bone depending on the length of the non-threaded anchor. 
     Any suitable inserter instrument can be used to drive a non-threaded anchor (e.g., non-threaded anchor  100 ) into bone (e.g., into the formed bone socket). In general, the inserter instrument (e.g., inserter instrument  200 ) includes a handle and an elongated shaft extending therethrough. In use, the non-threaded anchor is coupled to a distal end of the elongated shaft. For example, the distal end of the elongated shaft can be inserted into the non-threaded anchor (e.g., inserted into a bore  119  of non-threaded anchor  100  in  FIG.  5   ) and a removable stay suture (stay suture  402  in  FIGS.  10 A- 10 B ) can be threaded through holes of the non-threaded anchor (e.g., auxiliary suture holes  117   a ,  117   b  of non-threaded anchor  100  in  FIG.  1   ) and the free ends of the removable stay suture can be wrapped around one or more cleats (e.g., cleat  214  in  FIG.  7   ) of the handle. A soft tissue can then be connected (e.g., threaded and knotted or threaded and locked (e.g., via a lock loop device)) to the non-threaded anchor. Once the soft tissue is connected to the non-threaded anchor, the inserter instrument can then be used to insert and drive (e.g., push) the non-threaded anchor and connected soft tissue into a formed bone socket. Once the non-threaded anchor and connected soft tissue are driven to its desired position within the bone socket, the removable stay suture can be released from the one or more cleats and removed from the inserter instrument, followed by the removal of the inserter instrument from the non-threaded anchor. 
     The handle can have any suitable shape that is configured to facilitate grasping and manipulation of the inserter instrument. While the shape can vary, in some embodiments, the handle has a generally cylindrical. 
     In instances where there is a desired insertion orientation for an anchor (e.g., when the anchor is asymmetrical, e.g., non-threaded anchor  100  in  FIGS.  1 - 6   ), a visual or tactile indicator could be employed on the inserter instrument to help demonstrate to the user the insertion orientation of the non-threaded anchor during use. By way of example, as shown in  FIG.  7   , the handle of the inserter instrument can have a shape that is representative of a portion of anatomy to which the anchor is to be inserted. 
       FIGS.  7 - 9    illustrate an exemplary embodiment of inserter instrument  200  having a handle  202  and an elongated shaft  204  extending from the handle  202 . The elongated shaft  204  can be permanently or removably coupled to the handle  202 . In this illustrated embodiment, as will be described in more detail below, the handle extends from a proximal end  206  to a distal end  208 , and the proximal end  206  has a stylized bone shape that is modeled after a humerus bone  302  of a shoulder  300  (see  FIG.  8   ). While the inserter instrument  200  is designed for a biceps repair procedure in which a biceps tendon is attached to bone, a person skilled in the art would appreciate that the inserter instrument can be designed for other surgical procedures (e.g., medial patellofemoral ligament reconstruction from the patella to the femur, lateral ankle ligament reconstruction, elbow collateral ligament reconstruction, posterior tibialis tendon reattachment or reconstruction, distal biceps tendon reattachment, or any other soft tissue graft, ligament, or tendon bony attachment), and therefore, the stylized bone shape can be modeled after another bone or joint (e.g., the femur, tibia, patella, ankle, elbow, etc.) to be operated on during such other surgical procedure. 
     As shown in  FIGS.  7  and  8   , the proximal end  206  is wider than the distal end  208  of the handle  202  and has a generally similar shape to that of the humerus head  304  of the humerus bone  302 . Further, as shown in more detail in  FIG.  9   , , the proximal end  206  of the handle  202  includes at least one indicator feature  210 . This at least one indicator feature  210  generally correlates (e.g., in size, shape, and/or position) to a landmark  306  on the humerus bone  302 . In this illustrated embodiment, the landmark  306  is the bicipital groove of the humerus bone  302 . As such, the at least one indicator feature  210  is in the form of a groove that extends inward from the outer-most front surface  203  of the handle  202 . While the proximal end  206  of the handle  202  includes one indicator feature that is representative of the bicipital grove of the humerus bone, in other embodiments, the proximal end can include additional or different indicator features that are representative of other landmarks of the humerus bone. 
     Further, in some embodiments, the top surface  212  of the handle  202  can have a generally flat configuration, as illustrated in  FIGS.  7 - 9   . This configuration can help enhance the interface between the handle  202  and a driver instrument (e.g., a mallet). That is, the generally flat configuration of the top surface  212  can help maximize the contact between the handle  202  and the driver instrument while the driver instrument is tapping or otherwise pushing the handle  202  to thereby tap or push the coupled non-threaded anchor into a bone docket. 
     The handle  202  can include additional elements. For example, as shown in  FIGS.  7  and  8   , the handle  202  includes a cleat  214  that extends outward from the distal end  208  of the handle  202 . The cleat  214  is configured to allow free end(s) of a suture (e.g., a stay suture  402  in  FIGS.  10 A- 10 B ) to be wrapped about the cleat  214  to allow the suture to be selectively secured to the handle  202  (e.g., for purposes of removably securing the non-threaded anchor to the handle). The cleat  214  can have a variety of configurations. The cleat  214  includes a spool structure  214   a , In use, once the stay suture is threaded through the auxiliary suture holes (e.g., auxiliary suture holes  117   a ,  117   b  of non-threaded anchor  100  in  FIGS.  1 - 7   ), the stay suture is wrapped around the spool structure  214   a  and removably fixed to the cleat  214 . 
     In some embodiments, the handle  202  can include various features that can assist with gripping the handle  202  (e.g., during use of the inserter instrument  200 ). For example, the handle  202  can include gripping features, such as grooves  216 , that can assist with allowing the user to efficiently and effectively grasp the handle  202  for non-threaded anchor coupling, soft tissue threading, and/or non-threaded anchor insertion into bone. While the grooves  216  can be positioned at any location along the handle  202 , as shown in  FIGS.  7  and  8   , the grooves  216  are positioned proximal to the distal end  208  of the handle  202 . Alternatively, or in addition, at least a portion of the outer-most front surface  203  of the handle  202  can have a roughened finish that can increase friction between a user’s hand and the handle  202  during use, thereby enhancing the user’s grip about the handle  202 . 
     While the elongated shaft  204  can have a variety of configurations, in this illustrated embodiment, the elongated shaft  204  is generally cylindrical in shape along the majority of its length. As shown in  FIG.  7   , the distal end  218  of the elongated shaft  204  has a tapered configuration that terminates at a driving surface  219 . While not shown, the driving surface  219  has a generally rectangular shape. In other embodiments, the driving surface  219  can have any other suitable shape. Further, the distal end  218  includes an inserter prong  220 . The inserter prong  220  extends distally from the driving surface  219 . The inserter prong  220  is configured to be received within a bore (e.g., bore  199  in  FIG.  5   ) extending into a proximal end of a non-threaded anchor to removably couple to the non-threaded anchor (e.g., non-threaded anchor  100  in  FIGS.  1 - 7   ). While the inserter prong can have a variety of configurations, in this illustrated embodiment the inserter prong has a generally cylindrical shape. A person skilled in the art will appreciate that the structural configuration of the inserter prong depends at least upon the shape and size of the bore within the non-threaded anchor to be coupled the inserter instrument  200 . In certain embodiments, when the structurally configuration of the inserter prong  220  is not complementary to the bore of the non-threaded anchor, the elongated shaft  204  can be removed from the handle  202  (e.g., by pulling the elongated shaft  204  away from and relative to the handle  202  or vice versa) and another elongated shaft having an inserter prong of a different shape and/or size can be coupled to the handle for subsequent use. 
     In some embodiments, as shown in  FIG.  7   , the distal end  218  of the elongated shaft  204  includes at least one marking  222 . While the at least one marking can have a variety of configurations, in this illustrated embodiment, the at least one marking  222  is defined between a first border line  224   a  and a second border  224   b . Each of the first and second border lines  224   a ,  224   b  at least partially wrap about the elongated shaft  204 . The at least one marking  222  is configured to be associated with a desired insertion depth of a non-threaded anchor when the non-threaded anchor is being inserted into a bone socket. For example, the desired insertion depth can be below the cortical bone. As such, the at least one marking  222  can be positioned on the distal end  218  at a location that allows the user to determine when the non-threaded anchor is deployed below the cortical bone during the non-threaded anchor’s insertion into the bone socket. 
       FIG.  10 A  illustrates an exemplary embodiment of a soft tissue anchoring system  400  that includes the non-threaded anchor  100  ( FIGS.  1 - 6   ) coupled to the inserter instrument  200  ( FIGS.  7 - 9   ). The soft tissue anchoring system  400  also includes a stay suture  402  that is used to further removably affix the non-threaded anchor  100  to the inserter instrument  200 . The stay suture  402  is configured to maintain the fixation of the non-threaded anchor  100  to the inserter instrument  200  unassisted while a soft tissue segment (e.g., a tendon, ligament, or the like) is being connected to the non-threaded anchor  100  (see  FIG.  14   ). 
     As shown in  FIG.  10 A , and in more detail in  FIG.  10 B , the stay suture  402  is threaded through the auxiliary suture holes  117   a ,  117   b  of the non-threaded anchor  100  and the distal end  218  of the elongated shaft  204  is partially inserted into the non-threaded anchor  100  such that the inserter prong  220  (obstructed) is received within the bore  119  (obstructed) of the non-threaded anchor  100 . The non-threaded anchor  100  is positioned such that the guide region  116  (obstructed) is clocked to align with the cleat  214 . Further, the stay suture  402  is wrapped around the spool structure  214   a  and fixed in the cleat  214 . 
     As further shown in  FIGS.  10 A and  10 B , the soft tissue anchoring system  400  includes a threader tab  404  having at least one feeder wire coupled thereto. In this illustrated embodiment, two feeder wires  406 ,  408  are coupled to the threader tab  404  and each is threaded through the a respective one of the two suture holes  110   a ,  110   b  of the distal nose  106  of the non-threaded anchor  100 . This loads the threader tab  404  to the non-threaded anchor  100 . Further, the two feeder wires  406 ,  408  are each in a looped configuration. This allows free ends of a suture (e.g., tendon suture  504  in  FIGS.  14 - 16   ) attached to a soft tissue segment (e.g., biceps tendon  500  in  FIGS.  14 - 17   ) to be passed therethrough and couple to the threader tab  404 . In use, once the free ends of the suture are placed in respective feeder wires  406 ,  408 , the threader tab  404  is pulled away from the non-threaded anchor  100  to shuttle the suture through the two suture holes  110   a ,  110   b  of the non-threaded anchor  100 . 
       FIG.  11    illustrates another embodiment of a soft tissue anchoring system  700 . Aside from the differences described below, the soft tissue anchoring system  700  is similar to the soft tissue anchoring system  400  in  FIG.  10 A  and therefore common features are not described in detail herein. As shown, the soft tissue anchoring system  700  includes first and second cleats  706 ,  708  that extend outward from first and second lateral sides  704   a ,  704   b  of the handle  702 , respectively. Further, the handle  702  includes a lumen  705  that extends through the distal end  703  of the handle  702 . The lumen is configured to receive and allow the stay suture  710  to be passed therethrough. 
     The first and second cleats  706 ,  708  are each configured to allow a respective free end  710   a ,  710   b  of a stay suture  710  to be wrapped thereabout to allow the stay suture  710  to be selectively secured to the handle  702  (e.g., for purposes of removably securing the non-threaded anchor  100  to the handle  702 ). In use, the stay suture is threaded through the non-threaded anchor  100 , passed through the lumen  705  and wrapped about the first and second cleats  706 ,  708 . In other embodiments, both free ends  710   a ,  710   b  can be wrapped about the same cleat, for example, either the first cleat  706  or the second cleat  708 . The first and second cleats  706 ,  708  can have a variety of configurations. In this illustrated embodiment, the first and second cleats  706 ,  708  each include a respective spool structure  706   a ,  708   b . In use, once the stay suture is threaded through the auxiliary suture holes  117   a ,  117   b  (obstructed) of non-threaded anchor  100 , the free end  710   a  is wrapped around the spool structure  706   a  and removably fixed to the cleat  706 , and the free end  710   b  is wrapped around the spool structure  708   a  and removably fixed to the cleat  708 . 
     In some embodiments, alternatively or in addition, a soft tissue anchoring system can include a fixation suture, for example, as shown in  FIG.  12   , which is configured to help further fixate a soft tissue to the non-threaded anchor. Aside from the differences described below, the soft tissue anchoring system  800  illustrated in  FIG.  12    is similar to the soft tissue anchoring system  700  in  FIG.  11    and therefore common features are not described in detail herein. As shown, in addition to the stay suture  810 , the soft tissue anchoring system  800  also includes a fixation suture  812  that is threaded through auxiliary suture hole  117   a  of the non-threaded suture  100 . In use, as shown in  FIGS.  13 A- 13 C , the fixation suture  812  forms a loop  814  ( FIG.  13 A ), and once the soft tissue segment  801  is connected to the non-threaded anchor  100  (e.g., via knotting the free ends  816   a ,  816   b  of a tissue suture  816  (e.g., tendon suture) against the distal nose  106 ), the loop  814  of the fixation suture  812  is passed over the distal nose  106  and the soft tissue segment  801  ( FIG.  13 B ). The fixation suture  812  is then pulled (e.g., towards the proximal end  806  of the handle  802 ) and wrapped about the second cleat  808  to thereby tighten the loop  814  about the non-threaded anchor  100  and connected soft tissue segment  801  (see  FIGS.  12  and  13 C ). As a result, the soft tissue segment  801  is secured against the back surface  102   a  (see  FIG.  12   ) of the non-threaded anchor  100 . This securement helps to minimize toggling between the non-threaded anchor  100  and the connected soft tissue segment  801  (e.g., during insertion in a bone socket). After implantation of the non-threaded anchor  100  and connected soft tissue segment  801 , the fixation suture  812  can be removed. In certain embodiments, the fixation suture  812  can be cut and knotted, rather than cleated, to thereby secure the soft tissue segment  801  against the back surface  102  during and after insertion. Alternatively, or in addition, a free needle (not shown) can be used to pass the fixation suture  812  through the soft tissue segment  801  for additional fixation to the non-threaded suture  100 . 
       FIGS.  14 - 17    schematically illustrates an exemplary embodiment of using the soft tissue anchoring system  400  ( FIGS.  10 A- 10 B ) in a biceps tendon repair procedure. More specifically,  FIGS.  14 - 17    illustrate coupling a biceps tendon  500  to the non-threaded anchor  100  ( FIGS.  1 - 6  and  10 A- 10 B ) and inserting, via the inserter instrument  200  ( FIG.  7 - 10 B ), the non-threaded anchor  100  into a bone socket  502  formed within a humerus bone  600 . While not shown, the biceps tendon  500  is first released from the glenoid attachment and a portion of the biceps tendon  500  is pulled out of or otherwise externalized from the patient. The biceps tendon  500  is then sized and thereafter stitched via a tendon suture  504 . The bone socket  502  is then formed in the humerus bone  600  (e.g., by drilling). The two free ends  504   a ,  504   b  of the tendon suture  504  are placed within respective feeder wires  406 ,  408  and the threader tab  404  is pulled away from the non-threaded anchor  100  to cause the tendon suture  504  to be threaded through the two suture holes  110   a ,  110   b  of the distal nose  106  of the non-threaded anchor  100 . 
     Once the tendon suture  504  is threaded through the two suture holes  110   a ,  110   b , the non-threaded anchor  100  is advanced down the tendon suture  504  ( FIG.  14   ) until the leading end  501  of the biceps tendon  500  is positioned within the guide region  116  of the non-threaded anchor  100  ( FIG.  15   ). As shown in  FIG.  15   , the two free ends  504   a ,  504   b  are then knotted together to secure the leading end  501  within the guide region  116 , and consequently connect the biceps tendon  500  to the non-threaded anchor  100 . More specifically, the biceps tendon  500  is therefore secured between the deflectable clip  104  and the spine  108  of the non-threaded anchor  100 . In other embodiments, the tendon suture  504  can be attached to the non-threaded anchor  100 , for example, by a knot and keyhole opening, a locking loop (e.g., adjustable loop technology), or pulling the suture into a tight slot to pinch it. 
     Once secured and connected, the user introduces the non-threaded anchor  100  into the patient ( FIG.  16   ) and docks the non-threaded anchor  100  in the bone socket  502  using the inserter instrument  200 . While not shown, the non-threaded anchor  100  and connected biceps tendon  500  is then pushed into the bone socket  502  to a desired depth ( FIG.  17   ). The non-threaded anchor  100  and the connected biceps tendon  500  can be pushed into the bone socket  502  using a driver (e.g., a mallet). Alternatively, or in addition, a user can themselves apply a downward force to the handle  202  that is effective to advance the non-threaded anchor  100  and connected bicep tendon  500  through the bone socket  502 . Once the non-threaded anchor  100  is at its desired depth, the stay suture  402  can be released from the cleat  214  from the handle  202  and the inserter instrument  200  can be removed from the non-threaded anchor  100 , and thus the patient. The stay suture  402  can then be removed from the patient. 
     In the present disclosure, like-named components of the embodiments generally have similar features, and thus within a particular embodiment each feature of each like-named component is not necessarily fully elaborated upon. Additionally, to the extent that linear or circular dimensions are used in the description of the disclosed anchors, anchoring systems, and methods, such dimensions are not intended to limit the types of shapes that can be used in conjunction with such implants, implant systems, and methods. A person skilled in the art will recognize that an equivalent to such linear and circular dimensions can easily be determined for any geometric shape. Sizes and shapes of the anchors and anchoring systems, and the components thereof, can depend at least on the anatomy of the subject in which the anchors and anchoring systems will be used, the size and shape of components with which the anchors and anchoring systems will be used, and the methods and procedures in which the anchors and anchoring systems will be used. 
     Values or ranges may be expressed herein as “about” and/or from/of “about” one particular value to another particular value. When such values or ranges are expressed, other embodiments disclosed include the specific value recited and/or from/of the one particular value to another particular value. Similarly, when values are expressed as approximations, by the use of antecedent “about,” it will be understood that here are a number of values disclosed therein, and that the particular value forms another embodiment. It will be further understood that there are a number of values disclosed therein, and that each value is also herein disclosed as “about” that particular value in addition to the value itself. In embodiments, “about” can be used to mean, for example, within 10% of the recited value, within 5% of the recited value or within 2% of the recited value. 
     For purposes of describing and defining the present teachings, it is noted that unless indicated otherwise, the term “substantially” is utilized herein to represent the inherent degree of uncertainty that may be attributed to any quantitative comparison, value, measurement, or other representation. The term “substantially” is also utilized herein to represent the degree by which a quantitative representation may vary from a stated reference without resulting in a change in the basic function of the subject matter at issue. 
     One skilled in the art will appreciate further features and advantages of the invention based on the above-described embodiments. Accordingly, the invention is not to be limited by what has been particularly shown and described, except as indicated by the appended claims. All publications and references cited herein are expressly incorporated herein by reference in their entirety. Any patent, publication, or information, in whole or in part, that is said to be incorporated by reference herein is only to the extent that the incorporated material does not conflict with existing definitions, statements, or other disclosure material set forth in this document. As such the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference.