Patent Publication Number: US-10791007-B2

Title: Systems and methods for acromioclavicular stabilization

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This is a continuation of U.S. patent application Ser. No. 14/925,529, filed Oct. 28, 2015, the entire disclosure of which is incorporated by reference in its entirety herein. 
    
    
     BACKGROUND 
     The present disclosure relates to surgical methods and, more particularly, to surgical methods for acromioclavicular joint stabilization. 
     SUMMARY 
     Surgical methods for acromioclavicular joint stabilization are disclosed. Methods can comprise forming a first tunnel in a first bone of an acromioclavicular joint; forming a second tunnel in a second bone of the acromioclavicular joint; and securing a cannulated insert into at least one of the first and second tunnels. A method may further comprise passing a flexible construct through the first and second tunnels; positioning/placing an attachment device within or over at least one of the first and second tunnels; and affixing/securing a flexible construct to the attachment device. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  illustrates an exemplary embodiment of an acromioclavicular joint repair. 
         FIG. 2  illustrates another exemplary embodiment of an acromioclavicular joint repair. 
     
    
    
     DETAILED DESCRIPTION 
     Surgical methods for joint stabilization are disclosed. An exemplary method comprises inter alia the steps of: (i) forming a first tunnel in a first bone of a joint and forming a second tunnel in a second bone of the joint; (ii) securing (implanting or inserting) a cannulated insert into at least one of the first and second bone tunnels; and (iii) passing a flexible construct through the first and second bone tunnels. An exemplary method may further comprise (iv) positioning/inserting/placing an attachment device within or over at least one of the first and second bone tunnels; and (v) securing/fixating/affixing the flexible construct to the attachment device. In an exemplary embodiment, one of the first and second bones is the acromion, and the other of the first and second bones is the clavicle. 
     An exemplary method of acromioclavicular (AC) joint stabilization comprises inter alia the steps of: forming at least one clavicle tunnel through a clavicle; forming at least one acromion tunnel through an acromion; securing at least one cannulated insert into at least one of the clavicle and acromion tunnels; passing at least one flexible construct through each of the clavicle and acromion tunnels; placing at least one attachment device within or on at least one of the clavicle and acromion tunnels; and affixing the at least one flexible construct to the at least one attachment device. The at least one clavicle tunnel may be formed anteriorly or posteriorly through the clavicle, and the at least one acromion tunnel may be formed superiorly through the acromion. The at least one clavicle tunnel may be formed superiorly through the clavicle, and the at least one acromion tunnel may be formed superiorly through the acromion. 
     The flexible construct may be a suture, suture tape, suture chain, or any combination of suture, suture tape, and suture chain. The flexible construct may be a tensionable, knotless, adjustable, self-locking, construct formed of a length of flexible material with a knotless, adjustable, self-locking closed loop, a splice adjacent the closed loop, and a free end. The closed loop has an adjustable perimeter, or a fixed perimeter (i.e., an adjustable length or a fixed length of the loop). The flexible construct may be a suture strand such as FiberWire 
     The attachment device may be a fixation device that allows securement of a flexible strand to it, for example, a button, a washer, an anchor, a screw, a bolt, or a nail, among many others. The attachment device may be secured/positioned at one of the clavicle and/or acromion tunnels 
     The methods detailed below have applications to joint and ligament reconstruction and stabilization. Particular applications relate to AC joint stabilization, where the methods of the present invention provide simple, reproducible, minimally invasive techniques for AC joint stabilization. 
     Referring now to the drawings, where like elements are designated by like reference numerals,  FIGS. 1 and 2  illustrate AC joint stabilizations  100  and  200  (repairs  100 ,  200 ) according to different embodiments. 
       FIG. 1  illustrates a top view of an exemplary embodiment of an AC joint stabilization  100  (repair  100 ). A first bone tunnel  12  is formed anteriorly/posteriorly in clavicle  10 , and a second bone tunnel  22  is formed superiorly in acromion  20 . At least one cannulated insert  14 ,  24  can be provided (for example, implanted, positioned, inserted, or secured) into one or both of bone tunnels  12  and  22 . The at least one cannulated insert can protect the bone from abrasions caused by flexible construct  30 . 
     Flexible construct  30  is passed through acromion tunnel  22  or acromion cannulated insert  24 , and then passed through clavicle bone tunnel  12  or clavicle cannulated insert  14 . Attachment device  16  may then be inserted on one side of clavicle bone tunnel  12 . Alternatively, attachment device  16  may be preloaded with flexible construct  30 . In that case, flexible construct  30  and attachment device  16  are inserted at the same time, and the flexible construct can pass through both tunnels before the ends of the strands are secured to attachment device  16 . 
     Flexible construct  30  can be affixed to attachment device  16  by means known in the art, for example by passing through one or more apertures in attachment device  16  and tying a knot. In the exemplary embodiment illustrated in  FIG. 1 , one end of flexible construct  30  is passed through acromion bone tunnel  22  or acromion cannulated insert  24 , then both ends are passed into clavicle bone tunnel  12  or clavicle cannulated insert  14  opposite of attachment device  16 . Both ends are then secured to attachment device  16 . 
     Bone tunnels  12  and  22  can be formed according to methods known in the art. For example, bone tunnels  12  and  22  can be formed by drilling through the target bone using a drill of the desired diameter. Alternatively, each bone tunnel can be formed by first drilling a drill guide wire through the target bone. A drill with the desired diameter is then guided over the drill wire guide to bore out each of the bone tunnels  12  and  22 . 
     At least one cannulated insert may be affixed/inserted/secured/positioned or implanted into at least one of bone tunnels  12  and  22 . In an embodiment, a clavicle cannulated insert  14  is implanted into clavicle tunnel  12 , and no insert is implanted into acromion tunnel  22 . In another embodiment, an acromion cannulated insert  24  is implanted into acromion tunnel  22 , and no insert is implanted into clavicle tunnel  12 . In another embodiment, a cannulated insert is implanted into both the clavicle tunnel  12  and acromion tunnel  22 . In yet another embodiment, no insert is implanted in any tunnel.  FIG. 1  illustrates an example embodiment having both a clavicle cannulated insert  14  implanted into clavicle tunnel  12 , and acromion cannulated insert  24  implanted into acromion tunnel  22 . 
     Cannulated inserts  14  and  24  can be any suitable cannulated inserts that can securely attach to bone and allow passage of flexible construct through a cannulated body. For example, cannulated inserts  14  and  24  can be cannulated screws having external bone fixation means to securely fix the screws in bone tunnels  12  and  22 . Additionally, cannulated inserts  14  and  24  can be designed or chosen such that cannulated inserts  14  and  24  do not have a head or other portion substantially extending from bone tunnels  12  and  22 . Cannulated inserts  14  and  24  can be implanted such that each end of cannulated inserts  14  and  24  is completely within bone tunnels  12  and  22 , even or nearly even with entrances of bone tunnels  12  and  22 , or extending insubstantially out from bone tunnels  12  and  22 .  FIG. 1  illustrates an exemplary embodiment having cannulated inserts  14  and  24  disposed completely within bone tunnels  12  and  22 . 
     Attachment device  16  may be positioned/inserted within or on/above the bone tunnel(s) before or after flexible construct  30  is passed through the bone tunnels or cannulated inserts. Alternatively, attachment device  16  may be preloaded with flexible construct  30 . 
     Attachment device  16  may be any suitable attachment or fixation device known in the art. For example, attachment device  16  may be a cortical button or washer, or a button in the shape of a “dog bone,” or an anchor, or any other fixation/attachment device known in the art. Attachment device  16  may be any button, washer, anchor, screw, bolt, or nail, or combination of these fixation devices. 
     Flexible construct  30  may be any flexible strand or cord, or any length of a flexible material that can be passed through at least a portion of a bone tunnel or through-hole. For example, and as detailed below, the flexible construct may be at least one strand of suture, for example a high strength suture material such as FiberWire® suture, which is formed of an advanced, high-strength fiber material, namely ultrahigh molecular weight polyethylene (UHMWPE), or suture tape, suture chain, or any combination of suture, suture tape, and suture chain. Flexible construct  30  may be also any tensionable, knotless, adjustable, self-locking, construct formed of a length of flexible material (such as suture) with a knotless, adjustable, self-locking closed loop (having a fixed or adjustable perimeter), a splice adjacent the closed loop, and a free end. The knotless loop may be formed to encircle one bone (for example, one of the acromion or clavicle) with the free tensionable end exiting the other bone (for example, the other of the acromion or clavicle) to allow stabilization of the bones relative to each other and reduction in the distance between the two bones. 
     Flexible construct  30  is passed through acromion bone tunnel  22  and clavicle bone tunnel  12 , and is secured to attachment device  16 . 
       FIG. 2  illustrates an anterior view of another exemplary embodiment of an AC joint stabilization  200  (repair  200 ). Joint stabilization  200  differs from joint stabilization  100  in a number of ways, including how bone tunnel  12  is formed in clavicle  10 , where attachment device  16  is implanted, and how flexible construct  30  is passed. The exemplary embodiment consists of forming a first bone tunnel  12  superiorly in clavicle  10  (instead of anteriorly/posteriorly), and forming a second bone tunnel  22  superiorly in acromion  20 . At least one cannulated insert  14 ,  24  can be implanted into one or both of bone tunnels  12  and  22 .  FIG. 2  illustrates an exemplary embodiment having both a clavicle cannulated insert  14  implanted into clavicle bone tunnel  12 , and an acromion cannulated insert  24  implanted into acromion bone tunnel  22 , but it is understood that a cannulated insert may be implanted into clavicle bone tunnel  12  and not in acromion bone tunnel  22 , or vice versa. 
     Flexible construct  30  is passed through acromion tunnel  22  or acromion cannulated insert  24 , and then passed through clavicle bone tunnel  12  or clavicle cannulated insert  14 . Attachment device  16  may then be positioned on one side of clavicle bone tunnel  12 . Alternatively, attachment device  16  may be preloaded with flexible construct  30 . In that case, flexible construct  30  and attachment device  16  are positioned/inserted at the same time, and the flexible construct can pass through both tunnels before the ends of the strands are secured to attachment device  16 . 
     Flexible construct  30  can be secured/affixed to attachment device  16  by means known in the art, for example by passing through one or more apertures in attachment device  16  and tying a knot. In the exemplary embodiment illustrated by  FIG. 2 , one end of flexible construct  30  is passed through acromion bone tunnel  22  or acromion cannulated insert  24 , then each end is passed into clavicle bone tunnel  12  or clavicle cannulated insert  14  from opposite sides and secured to attachment device  16 . 
     An exemplary method of joint repair comprises the steps of: forming a first tunnel in a first bone of a joint; forming a second tunnel in a second bone of the joint; securing (for example, implanting) a cannulated insert into at least one of the first and second tunnels; passing a flexible construct through the first and second bone tunnels; providing (for example, inserting) an attachment device on one end of the first or second bone tunnel; and affixing the flexible construct to the attachment device. The first tunnel may be a clavicle tunnel formed anteriorly or posteriorly through a clavicle. The second tunnel may be an acromion tunnel formed superiorly through an acromion. The attachment device may be positioned at one end of the clavicle tunnel, and the method may further comprise: passing at least one end of the flexible construct through the acromion tunnel or acromion cannulated insert; and passing all ends of the flexible construct through an end of the clavicle tunnel opposite the attachment device. 
     The attachment device may be also inserted on one end of the acromion tunnel, and the method may comprise: passing at least one end of the flexible construct through the clavicle tunnel or clavicle cannulated insert; and passing all ends of the flexible construct through an end of the acromion tunnel opposite the attachment device. 
     The first bone tunnel may be also a clavicle tunnel formed superiorly through a clavicle. The second bone tunnel may be an acromion tunnel formed superiorly through an acromion. The attachment device may be inserted on one end of the clavicle tunnel, and the method may further comprise: passing at least one end of the flexible construct through the acromion tunnel or acromion cannulated insert; and passing at least one end of the flexible construct through opposite ends of the clavicle tunnel. The attachment device may be positioned at one end of the acromion tunnel, and the method may further comprise: passing at least one end of the flexible construct through the clavicle tunnel or clavicle cannulated insert; and passing at least one end of the flexible construct through opposite ends of the acromion tunnel. 
     The present invention can include numerous variations to the exemplary embodiments described above. For example, the exemplary embodiments described above can be modified to include forming two or more bone tunnels in clavicle  10 , acromion  20 , or both. A cannulated insert can be implanted into any or all of the additional bone tunnels. If additional bone tunnels are formed, then flexible construct may be passed in a crossed or bridged configuration. Furthermore, additional flexible constructs may be used. 
     In any embodiment, more than one attachment device  16  may be used. In example embodiments having one clavicle bone tunnel  12 , an attachment device may be positioned at both ends of clavicle bone tunnel  12 . If two or more bone tunnels are formed in clavicle  10 , then an attachment device can be affixed to any end of any clavicle bone tunnel, so long as at least one attachment device is used. 
     Attachment device  16  may alternatively be positioned at one end of acromion bone tunnel  22  instead of clavicle tunnel  12 . In this embodiment, flexible construct  30  can be passed through clavicle bone tunnel  12  or clavicle cannulated insert  14  first, and then through acromion bone tunnel  22  or acromion cannulated insert  24  prior to being secured to attachment device  16 . Furthermore, an attachment device may be positioned at each end of acromion bone tunnel  22 . If two or more bone tunnels are formed in acromion  20 , then an attachment device can be affixed to any end of any acromion bone tunnel, so long as at least one attachment device is used. 
     Attachment device  16  detailed above may be any suitable fixation device known in the art. For example, attachment device  16  may be a cortical button or washer, or a button in the shape of a “dog bone,” such as the button disclosed and described in U.S. Pat. No. 9,421,007, issued Aug. 23, 2016, the disclosure of which is fully incorporated by reference in its entirety herein. Attachment device  16  may also be a cortical button or washer, such as those disclosed and described in U.S. Pat. No. 8,876,900, issued Nov. 4, 2014; U.S. Pat. No. 8,162,997, issued Apr. 24, 2012; U.S. Pat. No. 9,005,245, issued Apr. 14, 2015; and U.S. Pat. No. 9,072,510, issued Jul. 7, 2015, the disclosures of all of which are fully incorporated by reference in their entirety herein. Attachment device  16  may be a cannulated anchor, such as the anchor disclosed and described in U.S. Pat. No. 9,332,979, issued May 10, 2016, the disclosure of which is fully incorporated by reference in its entirety herein. In an embodiment using such an anchor, a cannulated insert may not be necessary in the bone tunnel receiving the anchor. However, depending on the depth of the bone tunnel and the anchor, a cannulated insert may still be wanted or needed. 
     Attachment device  16  may be circular, oblong, or any other suitable geometry. Attachment device  16  may be formed, for example, of metals such as titanium, titanium alloys or stainless steel, PEEK or PLLA, or other biocompatible and/or bioabsorbable materials known in the art. Attachment device  16  may comprise at least one aperture through which one or more end of flexible construct  30  may pass or secure to. 
     Flexible construct  30  is passed through acromion bone tunnel  22  and clavicle bone tunnel  12 , and is secured to attachment device  16 . Flexible construct  30  may be formed of suture or suture-like material, for example a high strength suture material such as FiberWire® suture, sold by Arthrex, Inc. of Naples, Fla., and described in U.S. Pat. No. 6,716,234, issued Apr. 6, 2004, the disclosure of which is incorporated by reference in its entirety herein. The high strength suture may be available in various lengths. FiberWire® suture is formed of an advanced, high-strength fiber material, namely ultrahigh molecular weight polyethylene (UHMWPE), sold under the tradenames SPECTRA® (Honeywell) and DYNEEMA® (DSM), braided with at least one other fiber, natural or synthetic, to form lengths of suture material. The suture may optionally include filaments of various colors. The suture may be also formed of a plurality of suture strands configured to separate from a single strand to a plurality of strands and/or loops. 
     Flexible construct  30  may also be formed of a suture tape, for example, Arthrex FiberTape®, which is a high strength suture tape that is braided and rectangular-like in cross section and as disclosed in U.S. Pat. No. 7,892,256, issued Feb. 22, 2011, the disclosure of which is fully incorporated by reference in its entirety herein. However, the surgical methods can be used with any type of flexible material or suture known in the art. 
     Flexible construct  30  may be also in the form of a tensionable construct that can be attached to tissue (passed through or around tissue, for example, bone to be fixated/approximated to another bone). The tensionable construct may be in the form of a tensionable, knotless, adjustable, self-locking, construct formed of a length of flexible material (such as suture) with a knotless, adjustable, self-locking closed loop (having a fixed or adjustable perimeter), a splice adjacent the closed loop, and a free end. 
     Although the present invention has been described above with reference to a flexible construct comprising FiberWire® suture and/or FiberTape® suture tape, the invention contemplates any flexible material including hollow braided constructs, or filaments of various colors, among many others. Furthermore, the invention contemplates using a flexible construct such as the one described in U.S. Pat. No. 9,332,979, issued May 10, 2016, the disclosure of which is fully incorporated by reference in its entirety herein. The flexible construct described therein contains two suture splices that are self-cinching (similar to the suture splices used in adjustable suture button/loop construct described in U.S. Pat. No. 8,460,379, issued Jun. 11, 2013; and U.S. Pat. No. 8,439,976, issued May 14, 2013, both sold by Arthrex, Inc. under the tradename ACL TightRope®, the disclosure of both of which are incorporated by reference in their entirety herewith). The lead loops of the suture are weaved through a suture loop (e.g., an Arthrex FiberLink®). The remaining suture and splices are weaved on the opposite side of the suture loop. 
     U.S. Pat. No. 9,332,979 describes a flexible construct formed of suture together with loops and a shuttle/pull suture (for example, a FiberLink®) or a nitinol loop which is attached to the suture construct to allow shuttling of the flexible construct through the tunnels in the clavicle and acromion. The FiberLink® is attached to the two lead loops of the suture. Free suture ends can be exposed outside an attachment device to allow tensioning after implantation. The flexible construct comprises a knotless, adjustable, flexible loop which has an adjustable length and can be attached to an attachment device. Details and the formation of the suture splices of the knotless, self-locking, adjustable construct are set forth, for example, in U.S. Pat. No. 8,460,379, issued Jun. 11, 2013; and U.S. Pat. No. 8,439,976, issued May 14, 2013, the disclosure of both of which are incorporated by reference in their entirety herein. 
     The flexible construct may be coated (partially or totally) with wax (beeswax, petroleum wax, polyethylene wax, or others), silicone, silicone rubbers, PTFE (Teflon, Hostaflon, or others), PBA (polybutylate acid), ethyl cellulose (Filodel) or other coatings, to improve lubricity of the suture or tape, knot security, pliability, handleability, or abrasion resistance, for example. The flexible construct may also contain a bioabsorbable material, such as PLLA or one of the other polylactides, for example, and/or may be formed of twisted fibers having strands of a contrasting color added to the braided threads, to make the suture more visible during surgical procedures. The colored strands can be dyed filaments or strands, for example.