Abstract:
Components and associated methods of manufacture for bone and joint stabilization devices or systems are described in which medical devices are provided that include a rotatable foot as a distal anchor. The devices are tensioned during a medical procedure after applying a proximal anchor or anchoring head and remain active under tension for continued compression of the anatomy to be treated.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims the benefit of and priority to U.S. Provisional Application No. 62/318,037, filed Apr. 4, 2016, which is incorporated by reference herein in its entirety for all purposes. 
     
    
     FIELD 
       [0002]    The embodiments described herein are related in the field of surgery and, more particularly, for use in bone fusion, joint stabilization and/or fracture fixation surgery. 
       BACKGROUND 
       [0003]    Various devices have been employed in orthopedic surgery for bone fusion and/or joint stabilization. Bone screws, staples and plates have served as a set of rigid options. Per U.S. Pat. Nos. 4,959,064; 6,656,184; 7,833,256; 7,985,222; 8,048,134; 8,449,574 and 8,491,583 and U.S. Patent Publ. Nos. 2006/0264954 some screw-type devices have incorporated tensioning springs or members. Button-and-suture type devices have provided a more flexible set of options. U.S. Pat. Nos. 7,235,091, 7,875,057 and 8,348,960 offer examples of such device and suitable applications therefor. The subject embodiments address many shortcomings of existing products as may be appreciated by those with skill in the art. 
       SUMMARY 
       [0004]    Bone and/or joint stabilization devices are described that are advantageously tensioned during a medical procedure to remain active in maintaining compression of the subject anatomy during use. In the subject embodiments, an orthopedic surgery device or system comprises an elongate member or body, optionally comprising a spring pattern defined by a plurality of beams, each including a lateral component free to deflect when stretching the elongate body axially. An anchoring head typically receives the elongate body and may secure it with a one-way (e.g., ratcheting) interface at one end. A deployable foot is used to anchor an opposite end of the elongate body. 
         [0005]    The anchor or anchoring foot may comprise a body with an oval, race-track or rectangular planform shape. Generally, the height, length and width of the foot will be minimized, while still maintaining adequate surface area and strength for load bearing. 
         [0006]    Embodiments hereof are focused on features associated with this anchoring foot and optionally associated components. Optional features of the elongate body and/or anchoring heads that may be employed in the subject devices or systems are disclosed in U.S. patent application Ser. No. 15/002,022 and PCT Patent Appl. No. PCT/US16/14125 each commonly assigned, field Jan. 20, 2016 and incorporated by reference in their entireties for such description and/or any other purpose. 
         [0007]    The foot is secured to the elongate body by one or more strand(s) of material (e.g., multi-filament suture or cord). With the strand(s) received through an aperture adjacent to a distal end of the elongate body, sections or portions of the strand are looped over proximal and distal ends of the foot to secure its position. So-connected or affixed to the elongate member, it can rotate from a position aligned with the elongate body to a position transverse (or at least angled, typically upwards of about 45 or about 60 degrees up to 90 degrees) to the elongate body for anchoring the overall device during a medical procedure. 
         [0008]    Lateral and longitudinal movement of the foot relative to the elongate body is controlled (i.e., minimized or effectively eliminated) by virtue of sections of the strand(s) located on each side of the elongate body and optionally received within grooves in the foot. When the strands are tightened during assembly and so-fixed, the relative positioning of elements constrains other degrees of freedom, except for rotation of the foot about a horizontal axis defined by the distal end of the elongate body. 
         [0009]    Such construction requires no pivot hinge in defining a stable rotatable interface between the elements. The interaction between the elongate body and foot with the strand portions do so instead. Nevertheless, other complicating features (such as providing a bias towards a/the transverse position by an integral or a supplemental spring to aid transition from the foot&#39;s axial delivery configuration to its implanted position) may be provided. Alternatively, one or more pull wires or cords may be employed to accomplish or assist with such rotation. 
         [0010]    With a device setup having its foot in a body-aligned or stowed configuration, the foot and body can be inserted together through a minimum-diameter hole or channel spanning bone(s), joint space and/or a fracture. Then the system is secured or stabilized with the foot in a fully or partially transverse foot orientation, with the elongate body received in an anchoring head or otherwise clamped. 
         [0011]    The elongate body may be covered by a sheath prior to deployment. The sheath helps to prevent tissue ingrowth once implanted. Alternatively, a/the sheath may be used to support the elongate for advancement into place and/or hold distal anchor (i.e., foot) position. The sheath may be trimmed to desired length before or after any such activity, or it may be selected from a panel of different length pre-trimmed sheaths. It may be removed as part of an overall orthopedic injury treatment method along with the elongate member and head and foot anchors, after healing. Or the sheath may be left in place, serving the purpose of allowing removal of the elongate member as part of this or these method(s), or as a separate removal procedure method. 
         [0012]    In a method of manufacture, the foot is attached to the elongate body with one strand as detailed below or with a plurality of strands. The assembled parts may be provided in packaged combination in a kit to be acquired. They may be loaded in a sheath to preset foot position in alignment with the elongate body for implantation. In producing a final assembly (e.g., carried out by a physician in situ), the body may be received at a proximal end by an anchoring head. A tooth or multiple teeth in the anchoring head may be engaged with the elongate body and advanced relative to the body until it is stretched to a desired tension. Tooth engagement may be with through-holes in the elongate body. Finally, the elongate body may be trimmed to length with flush cutters or a customized unit—in either a method of use and/or manufacture of a final implant configuration. 
         [0013]    In sum, the subject device or systems, kits in which they are included (with or without assembly), methods of use (e.g., implantation, during treatment of a patient while mending and/or for system removal) and manufacture (including assembly of the various components—as applicable—in vivo or ex vivo) are all included within the scope of the present disclosure. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0014]    The details of the subject matter set forth herein, both as to its structure and operation, may be apparent by study of the accompanying figures, in which like reference numerals may refer to like parts. The components in the figures are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the subject matter. Moreover, all illustrations are intended to convey concepts, where relative sizes, shapes and other detailed attributes may be illustrated schematically rather than literally or precisely. Nevertheless, to-scale features (e.g., as from engineering drawings and/or photographs) may be relied upon as antecedent basis for claim support. 
           [0015]      FIGS. 1A and 1B  are front and side views of an elongate body optionally employed in the subject devices, systems and/or methods hereof. 
           [0016]      FIGS. 2A and 2B  are top and bottom perspective views of an anchoring foot for use with the elongate body in  FIGS. 1A and 1B  or another elongate member. 
           [0017]      FIGS. 3A-3C  are top, side-sectional and bottom views of an anchoring head that may be used with the elongate body in  FIGS. 1A and 1B . 
           [0018]      FIG. 4  is a side view of the subject foot secured to the elongate body with a looped strand of suture material. 
           [0019]      FIGS. 5A and 5B  are top and bottom views of the foot as attached in  FIG. 4  with the foot rotated into alignment with the elongate body. 
           [0020]      FIG. 6  is a perspective view of the device configuration shown in  FIGS. 5A and 5B , further including a delivery sheath. 
           [0021]      FIGS. 7A-7G  are construction views detailing suture splice and loop production as well as foot attachment to the elongate body. 
           [0022]      FIGS. 8A and 8B  are opposite-facing views of the subject device or system being deployed and after deployment in performing syndesmosis repair. 
       
    
    
     DETAILED DESCRIPTION 
       [0023]    Various example embodiments are shown in the figures and further described below. Reference is made to these examples in a non-limiting sense, as it should be noted that they are provided to illustrate more broadly applicable aspects of the devices, systems and/or methods. Various changes may be made to these embodiments and equivalents may be substituted without departing from the true spirit and scope of the various embodiments. In addition, many modifications may be made to adapt a particular situation, material, composition of matter, process, process act(s) or step(s) to the objective(s), spirit or scope of the present invention. All such modifications are intended to be within the scope of the claims that can be made herein. 
         [0024]      FIGS. 1A and 1B  illustrate an example of an elongate body  10  to which the subject foot may be attached. In the front or plan view of  FIG. 1A , an optional stretchable or spring-type architecture is evident from the repetition of laterally deflectable beams  12 . The beams (or beam pairs) serve as leaf spring elements in series. As noted above, further details of such an elongate body or member  10  may be appreciated in reference to U.S. patent application Ser. No. 15/002,022 and PCT Patent Appl. No. PCT/US16/14125. 
         [0025]    As shown in  FIG. 1B , a proximal side or end  14  of elongate body  10  may be tapered to assist in loading an anchor head onto the elongate body  10 . The taper is optionally defined by matching angular grinds  16 ,  18  or produced by other means of material removal or omission during manufacture. 
         [0026]    The opposite, distal side  20  of the elongate body may be squared-off or (at least substantially) flat-edged as shown. Otherwise, this end may be rounded. In any case, distal end  20  provides a pivot axis  24  (roughly as indicated) about which the foot, when attached, can pivot or rotate as further described. 
         [0027]    One or more through holes or apertures are advantageously provided adjacent to the distal end  20  of elongate body  10  for use in foot attachment. In the embodiment of body  10  shown, aperture(s)  22  that may be so-used are integrated in the spring pattern. However, the aperture(s) provided for foot attachment may instead be provided by dedicated features (vs. multi-purpose features as in elongate body  10 ). 
         [0028]      FIGS. 2A and 2B  provide perspective views of an anchor or anchoring foot  100  for use with elongate body  10  or another elongate member. The distal end  20  of the elongate body is intended to (at least substantially) span a proximal side  120  or surface of the foot where indicated by the phantom-lines. This location is set between diametrically-opposed side grooves or channels  102  in the sides  104  of the foot, optionally at a midpoint of the foot. Stated otherwise, the proximal end  20  of body  10  can be positioned so that a midline  106  of the length “L” of the foot and axis  24  coincide. 
         [0029]    As illustrated and discussed further below, the grooves  102  (running or spanning the thickness “T” of the foot) receive one or more strands of material for holding or securing foot  100  to elongate body  10 . Half-cylinder grooves (with edges at the full width “W” of the part) are shown for this purpose. However, V- or rectangular-shaped grooves can be used. In any case, these features offer a stable seat or seating position for the strand(s) of material used to hold the foot onto the elongate body. 
         [0030]    The reverse (i.e., distal) side  122  of the foot may also include a recess in the form of a slot, channel or groove  108 . It too is configured to receive a part of the strand(s). In a preferred embodiment, a splice section of a single loop of suture material is received therein. This approach offers an extremely low-profile solution to construction. 
         [0031]    The distal side groove  108  may terminate adjacent to or in alignment with the position of side grooves  102 . The position of an inboard terminus  110  to groove  108  will typically be set in coordination with the tie-on approach employed with the strand(s). Examples of such construction are elaborated upon below. An outboard terminus  112  of groove  108  may be open and optionally radiused (as shown) or closed-off as indicated by dashed line section  114 . 
         [0032]    An anchor or anchoring head may be used to secure elongate body  10  opposite the anchor or anchoring foot  100  in use.  FIGS. 3A-3C  show views of a suitable head  200  with teeth  202  designed for one-way advancement over the body. The teeth interact with the apertures or windows  22  in the body (spring) pattern shown. As illustrated with included draft angles, the anchor is advantageously injection molded in biocompatible polyetheretherketone (PEEK) polymer material. Nevertheless, other anchor and/or coordinated body configurations or constructions may be employed in the subject devices or systems. 
         [0033]    A support rim or frame  204  of the anchor head may be round (as shown in  FIGS. 3A and 3C ), square or otherwise configured. Indeed, the support structure may be integrated in an orthopedic plate (e.g., as integrally formed or press-fit therein) or otherwise provided. 
         [0034]    In the subject devices and/or systems, the foot  100  may be held to the elongate body with a strand  150  of suture material as shown in  FIG. 4 . In this example, the suture is passed and looped or wrapped over both ends  124 ,  126  of the foot and through aperture  22  in the elongate body  10  to provide such attachment. As such, strand  150  held in an inverted U-like or stirrup-type shape on each side of the foot. 
         [0035]    Position of the foot relative to the elongate body is stabilized laterally by the strand given its position within the respective side groves  102 . As shown, the grooves may be shaped and sized such that strand portions  152   a,    152   b  set in a side-by-side configuration fill the available space. The foot can pivot in either direction (e.g., about the distal end  20  of the elongate body  10 ) and indicated by the arrows. Other motion is limited or constrained. 
         [0036]    The nature of movement limitation or constraint is further appreciated in reference to  FIG. 5A . Lateral and longitudinal constraint of the foot is applied by virtue of the loop sections  154   a,    154   b  of the strand(s) received on each side of aperture  22 , along with the portions  152  in the side grooves  102 .  FIG. 5B  illustrates the matter further, showing how each loop portion  156   a,    156   b  is indeed tightly and symmetrically bound in the system. 
         [0037]    In the example pictured, a single loop of strand material is provided with one portion fed over each end  24 ,  26  of the length of the foot. Further, each end of the loop is secured (relative to the other) within a splice section  158 . The splice section is received within the distal side or face groove  108 . Splice  158  is shown adhered in place by adhesive  160  (e.g., 4014 LOCTITE). Gluing can also help insure integrity or strength of the splice against loosening and/or pull-out failure. 
         [0038]    Alternatively, no adhesive is used and the “tail” (in this case defined by the splice) is received and held by a press or friction fit in groove  108 . Regardless, the splice is typically trimmed (e.g., at dashed line  162 ) so that it does not extend beyond an end limit or boundary of the foot  100 . 
         [0039]    Such location for any tail features (i.e., within groove  108 ) and/or trimming will typically also occur even if no splice is present in the system. In which case (still using the side grooves  102 ), one or more knots may be used for securing one or more independent strands for tying the foot onto the elongate member. 
         [0040]    As shown in  FIG. 6 , the foot  100  can be releasably held or stabilized in an axial orientation for deployment in connection or association with a sleeve or sheath  170 . In these figures, a clear polyester (e.g., polyethylene terephthalate (PET)) sheath is shown. However, the sheath may be any other biocompatible material. Thin-walled plastic tubing may be preferred, however, as it can easily deform from round to provide a minimum form-fitting profile or coverage  172  to the body  10  and foot  100 . 
         [0041]    As referenced above, the foot is rotatably affixed, held or secured to the elongate body by a strand(s), filament(s) or cord(s) of material. As an example, braided FORCE FIBER (Teleflex Medical) suture produced with ultra high molecular weight polyethylene (UHMWPE) material may be used. At approximately 0.010 inch diameter, 3-0 size suture material offers 15+ pound force (lfb) tensile strength for construction. 
         [0042]    The elongate body advantageously comprises NiTi alloy that is superelastic in use at human body temperature (i.e., the material has an Af of about 37° C. or less). Otherwise, the NiTi alloy may be selected in order to use its potential shape-memory effect for tightening (or tighten further) once emplaced. Alternatively, the elongate member may comprise a high performance or so-called “engineering” polymer such as PEEK. Other materials (especially those with high reversible stain potential such as Beta titanium alloy) might be employed for elongate body  10  as well. 
         [0043]    The elongate body is advantageously substantially flat, with the foot rotatable around its end as variously shown and described. As such, the body may have an aspect ratio of width to thickness of between about 10 to 1 and about 30 to 1. Such a form factor also minimizes manufacturing complexity and cost in that the elongate member may then be cut (e.g., laser cut, water jet cut or etched) from flat wire, strip or plate. The cut part can be media blasted, pickled and/or electropolished for surface finish. 
         [0044]    The foot may comprise stainless steel, titanium or titanium alloy (including NiTi alloy) and be produced using standard machining or rapid-prototyping techniques. Alternatively, the foot may comprise a biocompatible polymer material such as PEEK or another suitable high-strength polymer. 
         [0045]    Such plastic bodies are advantageously produced by injection molding with draft angles readily applied to the part. Also, the foot shown includes no through-holes (e.g., for threading suture material there-though as with suture-button type device components) otherwise complicating mold tooling. Rather, the part has side groves or slots for receiving the strand(s) that secure the foot and locate its position relative to the elongate member to which it is connected. 
         [0046]      FIGS. 7A-7G  illustrate a method of manufacture employing such an approach. As shown in  FIG. 7A , a strand  150  comprising 6-to-8 filament hollow core suture material is opened over a splicing length  180  with a threaded needle  182 . Upon passing the needle through the opening  184 , a loop  156  including a splice section  158  is formed as shown in  FIG. 7B . 
         [0047]    Finished splice length may be between about 5 and 10 mm. An example of a coordinated size for the foot may be: a length of about 12.5 mm, a width of about 3 mm and a thickness of about 1.5 mm. The shape or form of foot  100  may be generically or generally regarded as oval and/or rectangular. The specific shape or form pictured is sometimes specifically referred to as a “racetrack” shape. 
         [0048]    Turning to  FIG. 7C , an end of the (straightened-out or elongated) loop  156  can be flattened (e.g., between fingers or with a tool). The flattened section  186  is then easily slipped through a low-profile aperture  22  of the body  10  (or another opening) as illustrated in  FIG. 7D . 
         [0049]      FIG. 7E  shows loop  156  with one end  156   a  passed over and around end  126  of the foot and another end  156   b  passed over end  124  of foot  100 . However, the overall loop  156  has not yet been tightened. This is evident in the figured from the location of the spice  158  and the offset position of the foot  100  relative to the body  10 . 
         [0050]    To tighten the loop  156 , portions of the loop strand are worked through the aperture  22  and along the foot side grooves  102  until loop sections  156   a  and  156   b  are tight and the splice  158  centrally located adjacent the distal surface  122  of the foot. 
         [0051]    Such a result in shown in  FIG. 7F . Here, the offset between the parts shown in  FIG. 7E  is eliminated and the parts (i.e., body  10 , foot  100  and strand  150  elements) are tightly held together. 
         [0052]    If the splice is located as shown in  FIG. 7F  (i.e., toward foot end  124  with the distal side groove  108  and foot end  126  to the right), the strand ends may be threaded through (an optionally larger) needle  182 ′ and the needle used to draw the splice “tail” underneath the adjacent strand loop section  156   a  so that it underlies the same. So-positioned, the tail is tucked into the groove as shown in  FIG. 7G , with the junction  188  of the strand sections within splice  158  neatly hidden. 
         [0053]    Note, however, the reverse arrangement of loops  156   a  and  156   b  in  FIG. 5B . Here, the splice  158  tail is originally located toward the side of groove  108  (i.e., without crossing under an adjacent strand section) facilitating omission of the acts or steps illustrated in  FIG. 7F . However accomplished, with the remaining end(s) of the suture strand  150  are typically set in groove  108  and trimmed as indicated by the dashed line  162  (as similarly shown in  FIG. 5B .) 
         [0054]    Finally, the strand material may be glued into place if adhesive use is desired. Alternatively, the suture (or other) strand material may be glued first and then trimmed. 
         [0055]    Further steps in preparing a useable device may include loading it into a sheath as shown in  FIG. 6 , followed by packaging, sterilizing, etc. To prepare the device or system for deployment, the foot is rotated into alignment with the elongate body. The foot  100  may be setup in axial alignment with body  10  so that either end  124  or  126  is leading or most distal. 
         [0056]    For use, the construct may be held axially aligned in such a position in connection with a releasable Beath-type needle. A simpler option is to utilize a sheath  170  as previously described in connection with  FIG. 6 . 
         [0057]    Such a device or system  300  is also shown in  FIG. 8A , together with a SAWBONES model  190 . For insertion through a hole  192  drilled through bone(s), the sheath adds little size to the necessary deployment hole diameter. After device  300  insertion and sheath  170  withdrawal (or partial withdrawal at least so far as to expose foot  100 ), the foot can be manipulated to catch and turn to its deployed position as shown in  FIG. 8B . Such manipulation may be accomplished by re-advancing the sheath  170  while gripping the proximal end  14  of the elongate body  10  or otherwise. 
         [0058]    After optional sheath removal or trimming if implantation as part of system  300 ′ is desired, an anchoring head  200  is applied to the elongate body  10 . The example head  200  shown in  FIG. 8B  is secured by one-way advancement over elongate body  10 , with the elongate body pulled through head  200  to set the body  10  to a desired tension. An equal amount of compression is thereby applied to the subject anatomy by the foot  100  and head  200  anchor members in the overall system. 
         [0059]    Note that the orientation of elongate body  10  may be set in the direction shown in  FIG. 8A  or as in  FIG. 8B , or otherwise. Naturally, the selection will determine the angular orientation of the foot  100  as well. In any case, foot  100  anchors the device against bone on one side of device  300 ′ and head  200  anchors it on the other side. 
         [0060]    Finally, a proximal end of the elongate body  10  is trimmed off (advantageously flush) as indicated by the dashed line  302 . This may be accomplished with flush-cut nippers or using a cutter that may be integrated in a custom tensioning and/or cutting tool. 
         [0061]    Variations 
         [0062]    In addition to the embodiments disclosed above, still more variations are within the scope of this description. Indeed, other methods of use applicable to the subject devices or systems are presented in  FIGS. 8-15  of the above-referenced patent applications already incorporated herein by reference. 
         [0063]    The subject methods, including methods of use and/or manufacture, may be carried out in any order of the events which is logically possible, as well as any recited order of events. Medical methods may include any of a hospital staffs activities associated with device provision, implant introduction, positioning and/or re-positioning, and surgical access and/or closure. 
         [0064]    Furthermore, where a range of values is provided, it is understood that every intervening value, between the upper and lower limit of that range and any other stated or intervening value in the stated range is encompassed within the invention. Also, it is contemplated that any optional feature of the inventive variations described may be set forth and claimed independently, or in combination with any one or more of the features described herein. Moreover, no limitations from the specification are intended to be read into any claims, unless those limitations are expressly included in the claims. 
         [0065]    As used herein and in the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the context clearly dictates otherwise. In other words, use of the articles allow for “at least one” of the subject items in the description above as well as the claims below. The claims may exclude any optional element. As such, this statement is intended to serve as antecedent basis for use of such exclusive terminology as “solely,” “only” and the like in connection with the recitation of claim elements, or use of a “negative” limitation. 
         [0066]    Without the use of such exclusive terminology, the term “comprising” in the claims shall allow for the inclusion of any additional element irrespective of whether a given number of elements are enumerated in the claim, or the addition of a feature could be regarded as transforming the nature of an element set forth in the claims. 
         [0067]    The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present disclosure is not entitled to antedate such publication by virtue of prior disclosure. Further, the dates of publication provided may be different from the actual publication dates which may need to be independently confirmed. 
         [0068]    The subject matter described herein and in the accompanying figures is done so with sufficient detail and clarity to permit the inclusion of claims, at any time, in means-plus-function format pursuant to 35 U.S.C. Section 112, Part (f). However, a claim is to be interpreted as invoking this means-plus-function format only if the phrase “means for” is explicitly recited in that claim. 
         [0069]    While the embodiments are susceptible to various modifications and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It should be understood, however, that these embodiments are not to be limited to the particular form disclosed, but to the contrary, these embodiments are to cover all modifications, equivalents, and alternatives falling within the spirit of the disclosure. Furthermore, any features, functions, acts, steps, or elements of the embodiments may be recited in or added to the claims, as well as negative limitations that define the inventive scope of the claims by features, functions, acts, steps, or elements that are not within that scope.