Patent Publication Number: US-2020281712-A1

Title: Two-Way Adjustable Loop Suspensory Device

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims priority to U.S. Provisional Patent Application Ser. No. 62/555,081, filed on Sep. 7, 2017 and entitled “2-Way Adjustable Loop Suspensory Device.” 
    
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The present disclosure is directed generally to surgical devices for repair and reconstruction of soft tissue injuries and, more particularly, to devices and methods for fixation of a soft tissue graft at a surgical site. 
     2. Description of Related Art 
     Many common surgical procedures involve the repair and reconstruction of torn or damaged soft tissue. For example, in common arthroscopic surgical procedures, a replacement graft ligament is secured at the site of the original, now damaged, ligament. The repair and reconstruction of torn or damaged soft tissues is a common surgical procedure. For example, replacement graft ligaments may be secured at the site of the original ligament. The procedure generally involves drilling bone tunnels into adjacent bones at the site of the original ligament and securing a graft ligament within these bone tunnels. In many applications, such as in the knee joint, such procedures may be performed arthroscopically. The graft ligament may be an autograft, an allograft, a xenograft, or it may be totally artificial and synthetic. Common types of anterior cruciate ligament (ACL) grafts, for example, include ones which may be autologous or allograft bone-patellar tendon-bone or soft tissue (such as semitendinosus and gracilis tendons), both types harvested by techniques well known to those skilled in the art. 
     The graft ligaments may be secured within the bone tunnels in a variety of ways. Of prime importance is the degree to which they can withstand pullout forces prior to complete healing. For example, it is known to use interference screws inserted parallel to the tunnel axis to compress the ends of the graft ligament against the wall of the bone tunnel to secure the graft ligament and promote tissue in-growth. 
     Suspensory graft fixation devices have been developed to secure a graft ligament in a bone tunnel. One such device is described in U.S. Pat. No. 8,852,250 (Lombardo et al.), entitled Graft Fixation Implant, assigned to the assignee hereof and incorporated by reference herein. Suspensory graft fixation devices work by lying transversely across the opening of a bone tunnel and generally take the form of an elongated anchor member which suspends a graft retaining loop from a fixation point on the surface of a bone to which the graft is to be attached (in this case, a femur). The elongated member has an axis and a pair of suture receiving apertures symmetrically situated on the axis on opposite sides of the center of the elongated member. In ACL procedures the elongated member, often called a button, is adapted to be situated transversely across the exit opening of the bone tunnel on the lateral femoral cortex so that a supporting loop, generally made of suture material, can be suspended from the button and can extend into the bone tunnel from the suture receiving apertures of the button. The suture loop supports one end of a graft ligament passed through the loop. 
     The term “suture” as used herein may be any type of filamentous material such as a biocompatible or bioabsorbable filament, ribbon, tape, woven or non-woven material capable of providing the loop support and the frictional resistance required by the device described herein. In arthroscopic procedures, such as an ACL reconstruction, the elongated anchor member is initially aligned with the axis of the bone tunnel, and pulled through the tunnel to the exit at the distal end on the lateral femur. For such suspensory graft fixation devices to be able to support a graft ligament and to be properly transversely situated at the exit of the bone tunnel, the suture loop and the bone tunnel must both be long enough to enable the elongated member to “flip” from an axially aligned orientation to a transverse orientation when it exits the bone tunnel. 
     Since the supporting loop of such a suspensory device is most often of a fixed length, graft fixation requires preparation of a graft ligament of predetermined length. Furthermore, because conventional art suspensory graft fixation devices have fixed loop lengths they are produced in multiple sizes (ranging, for example, from loop lengths of 15 mm to 60 mm in 5 mm increments in the case of XO Button® implants made by ConMed Corporation, Largo, Fla.) in order to accommodate various graft and tunnel lengths that may be encountered during a surgical procedure. The fixed graft length and variations in tunnel and loop lengths can make conventional suspensory ligament fixation challenging. 
     Recently, suspensory devices have been made with adjustable loop lengths. See, for example, U.S. patent application 2010/0256677, (Albertorio et al.) published Oct. 7, 2010 and entitled Integrated Adjustable Button-Suture-Graft Construct with Two Fixation Devices. It has been found that the adjustability of the loop length of a suspensory graft fixation device may be achieved in a manner considerably less complex than that described in the aforementioned publication. 
     At times surgeons may encounter situations where they cannot produce a bone tunnel of adequate length to receive a ligament graft suitable for suspensory fixation. A predetermined length of graft ligament is required to engage a predetermined portion of the bone tunnel for proper healing. For example, a so-called short tunnel ACL reconstruction may present a relatively small (narrow) femur which does not enable formation of an adequately long bone tunnel which means, in turn, the suspensory anchor member cannot be advanced far enough out of the tunnel to flip yet keep enough contact between the graft and the bone tunnel wall. Use of an adjustable loop in such situations could nevertheless enable the surgeon to proceed with a suspensory-type repair. 
     In instances in which soft tissue is to be pulled into a bone tunnel, such as ACL reconstruction, it is desired to have an adjustable loop to simplify the procedure and maximize the bone to soft tissue interface. 
     Description of the Related Art Section Disclaimer: To the extent that specific patents/publications/applications/products are discussed above in this Description of the Related Art Section or elsewhere in this disclosure, these discussions should not be taken as an admission that the discussed patents/publications/products are prior art for patent law purposes. For example, some or all of the discussed patents/publications/products may not be sufficiently early in time, may not reflect subject matter developed early enough in time and/or may not be sufficiently enabling so as to amount to prior art for patent law purposes. To the extent that specific patents/publications/applications/products are discussed above in this Description of the Related Art Section and/or throughout the application, the descriptions/disclosures of which are all hereby incorporated by reference into this document in their respective entirety(ies). 
     SUMMARY OF THE INVENTION 
     Embodiments of the present invention recognize that there are potential problems and/or disadvantages with conventional suspensory graft fixation devices (as discussed herein and above). Various embodiments of the present invention may be advantageous in that they may solve or reduce one or more of the potential problems and/or disadvantages discussed herein. 
     The present disclosure is directed to devices and methods for fixation of a soft tissue graft at a surgical site. It is an object of this invention to produce a suspensory graft ligament repair system suitable for short tunnel repairs. 
     It is another object of this invention to produce a suspensory graft fixation device adapted to lock the size and position of the graft supporting loop after it has been set at a desired length. 
     It is also an object of this invention to automatically lock the graft supporting loop by pulling it in one direction relative to the anchor member, and to vary the length of the graft supporting loop, to resize it, by pulling it in the opposite direction. 
     It is yet another object of this invention to correct for instances of over-tensioning of the graft or if the graft has been advanced too far into the bone tunnel. 
     In one aspect, a suspensory graft fixation device for securing a replacement graft ligament in a bone tunnel is provided. The suspensory graft fixation device includes an elongated anchor member with top and bottom surfaces, and adjacent first and second suture receiving apertures extending from the top surface to the bottom surface thereof. A graft supporting loop element is attached to the anchor member and is formed of a suture having first and second limbs. The suture is threaded through the first and second suture receiving apertures such that first and second loops are formed in the suture. The first and second loops extend from the bottom surface, while the first and second limbs extend from the top surface. A splice is formed in the second limb extending from the top surface and the first limb extends through the splice. 
     According to another aspect, the suspensory graft fixation device includes an elongated anchor member having a top surface and a bottom surface extending between a first end and a second end. A plurality of apertures extend from the top surface to the bottom surface of the elongated anchor member. At least two of the plurality of apertures are adjacent first and second suture receiving apertures. The device also includes a graft supporting loop element attached to the anchor member. The graft supporting loop element is formed of a suture having a first limb and a second limb. The suture is threaded through the first and second suture receiving apertures such that first and second loops are formed in the suture and extend from the bottom surface of the elongated anchor member, while the first and second limbs extend from the top surface. A splice is formed in the second limb of suture extending from the top surface of the elongated anchor member and the first limb extends through the splice. Tensioning the first loop pulls the first limb through the splice, lengthening the first loop, and tensioning the second loop pulls the splice over the first suture receiving aperture. 
     In yet another aspect, a method of suspensory fixation of a replacement graft ligament in a bone tunnel is provided. The method includes the steps of: (i) providing an elongated anchor member having a top surface and a bottom surface, and adjacent first and second suture receiving apertures extending from the top surface to the bottom surface thereof; (ii) providing a suture having a first limb and a second limb with a central biting portion therebetween; (iii) passing the first limb through the first suture receiving aperture from the top surface to the bottom surface and thereafter, passing the first limb through the second suture receiving aperture from the bottom surface to the top surface, creating a first loop in the first limb; (iv) passing the second limb through the second suture receiving aperture from the top surface to the bottom surface and thereafter, passing the second limb through the first suture receiving aperture from the bottom surface to the top surface, creating a second loop in the second limb; (v) creating a splice in the second limb extending from the top surface from the first suture receiving aperture; and (vi) passing the first limb through the splice in the second limb. 
     It should be appreciated that all combinations of the foregoing concepts and additional concepts discussed in greater detail below (provided such concepts are not mutually inconsistent) are contemplated as being part of the inventive subject matter disclosed herein. In particular, all combinations of claimed subject matter appearing at the end of this disclosure are contemplated as being part of the inventive subject matter disclosed herein. It should also be appreciated that terminology explicitly employed herein that also may appear in any disclosure incorporated by reference should be accorded a meaning most consistent with the particular concepts disclosed herein. 
     These and other aspects of the invention will be apparent from and elucidated with reference to the embodiment(s) described hereinafter. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       One or more aspects of the present invention are particularly pointed out and distinctly claimed as examples in the claims at the conclusion of the specification. The foregoing and other objects, features, and advantages of the invention are apparent from the following description taken in conjunction with the accompanying drawings in which: 
         FIG. 1  is a perspective view schematic representation of a suspensory fixation device, according to an embodiment; 
         FIG. 2  is a top perspective view schematic representation of the anchor member of the suspensory fixation device, according to an embodiment; 
         FIG. 3  is a cross-sectional side view schematic representation of the suspensory fixation device, according to an embodiment; 
         FIG. 4  is a close-up perspective view schematic representation of a suspensory fixation device, according to an embodiment; and 
         FIG. 5  is a top view schematic representation of a suspensory fixation device, according to an embodiment; 
         FIG. 6  is a side view schematic representation of a suspensory fixation device in a bone tunnel, according to an embodiment; 
         FIG. 7  is a side view schematic representation of a suspensory fixation device in a first configuration attached to a graft and extending from a distal end of a bone tunnel, according to an embodiment; and 
         FIG. 8  is a side view schematic representation of a suspensory fixation device in a second configuration attached to a graft and extending from a distal end of a bone tunnel, according to an embodiment. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Aspects of the present invention and certain features, advantages, and details thereof, are explained more fully below with reference to the non-limiting examples illustrated in the accompanying drawings. Descriptions of well-known structures are omitted so as not to unnecessarily obscure the invention in detail. It should be understood, however, that the detailed description and the specific non-limiting examples, while indicating aspects of the invention, are given by way of illustration only, and are not by way of limitation. Various substitutions, modifications, additions, and/or arrangements, within the spirit and/or scope of the underlying inventive concepts will be apparent to those skilled in the art from this disclosure. 
     Referring now to the figures, wherein like reference numerals refer to like parts throughout,  FIG. 1  shows a side perspective view schematic representation of a suspensory graft fixation device  100 , according to an embodiment. The device  100  comprises an elongated anchor member  102  and a length of suture  104 . In the depicted embodiment, the suture  104  is in the form of a filamentous strand composed of high strength, filamentous material such as ultra-high molecular weight polyethylene. The anchor member  102  can be composed of metal, such as implantable grade titanium, or any other suitable bioabsorbable or biocompatible material (as should be understood by a person of ordinary skill in the art in conjunction with a review of this disclosure). In embodiments, the length of anchor member  102  may range from 12 mm to 20 mm. 
     Turning briefly to  FIG. 2 , there is a top perspective view schematic representation of the anchor member  102  of the suspensory fixation device  100 , according to an embodiment. The anchor member  102  extends along a central longitudinal y-y axis between its first end  106  and second end  108 . The anchor member  102  also has a pair of central suture receiving apertures  110 ,  112 , which are sized or otherwise configured to receive suture  104  that will form loops. For example, the diameters of suture receiving apertures  110 ,  112  may be on the order of 1 mm, while the diameter of the suture  104  may be on the order of 1 mm or USP size #5. In an embodiment according to  FIG. 5 , the anchor member  102  is oblong in geometry. In particular, as shown, a length L of the anchor member  102  is greater than a width w of the anchor member  102 . The oblong geometry of the anchor member  102  allows the anchor member  102  to pass through narrow bone tunnels. 
     Referring back to  FIG. 2 , the anchor member  102  has a top surface  114  and a bottom surface  116  (best seen in  FIGS. 3-4 ). The bottom surface  116  is sometimes referred to as the proximal surface and is intended to be placed adjacent a bone tunnel exit. As used herein, the term “proximal” refers to the side of the bone containing the bone tunnel (i.e., extending inwardly away from the surface of the lateral femur in an ACL procedure), and the term “distal” refers to the side of the bone against which the transverse anchor member  102  rests (i.e., extending outwardly away from the surface on the lateral femur). 
     Still referring to  FIG. 2 , the suture receiving apertures  110 ,  112  are situated on opposite sides of a central bridge portion  118  extending between them. The anchor member  102  may also optionally have one or more placement apertures  120  extending between the top and bottom surfaces  114 ,  116 . In the depicted embodiment, there is a placement aperture  120  at the first end  106  of the anchor member  102  and a placement aperture  120  at the second end  108  of the anchor member  102 . The placement apertures  120  are sized or otherwise configured to receive a placement suture  140  (or another filamentous strand) to facilitate placement of the device  100  at a bone tunnel exit. For example, a placement suture  140  is attached to a placement aperture  120  and pulled through the bone tunnel, facilitating orienting the elongated anchor member  102  parallel to the bone tunnel axis. 
     As shown in  FIG. 1 , the suspensory fixation device  100  is designed to have the anchor member  102  operate with a filamentous strand  104  suitable for following a tortuous path through the suture receiving apertures  110 ,  112  of anchor member  102 . In an embodiment, the filamentous strand  104  is a single length of appropriately sized suture. The term “suture” as used herein may be used interchangeably with “filamentous material” and, as described above, will be understood to mean any biocompatible or bioabsorbable strand of material which can, when combined with anchor member  102 , operate to support a replacement graft in the manner described below. As will be understood below, the combination of filamentous strand  104  with the features of anchor member  102  can perform different functions along the path of the suture  104  through the suture receiving apertures  110 ,  112  of the anchor member  102 . 
     Referring now to  FIG. 3 , there is a cross-sectional side view schematic representation of the suspensory fixation device  100 , according to an embodiment. To load the anchor member  102  shown in  FIG. 2 , the filamentous strand  104  is passed or wrapped through the suture receiving apertures  110 ,  112 . Specifically, as shown in  FIG. 3 , the filamentous strand  104  is first folded on itself to form a central bight portion  122 , thus creating two limbs  124 ,  126  extending from the central bight portion  122 . Each limb  124 ,  126  has a length extending from the central bight portion  122  to the free, unattached ends  128 ,  130  of the limbs  124 ,  126 . 
     Still referring to  FIG. 3 , the first limb  124  is passed through a first suture receiving aperture  110  and the second limb  126  is passed through a second suture receiving aperture  112  (in the downward direction as shown in  FIG. 3 ). The first and second limbs  124 ,  126  extend through the suture receiving apertures  110 ,  112  from the top surface  114  of the anchor member  102  to the bottom surface  116  of the anchor member  102 . The second limb  126  is then passed up through the first suture receiving aperture  110  from the bottom surface  116  of the anchor member  102  to the top surface  114  of the anchor member  102 . Similarly, the first limb  124  is passed up through the second suture receiving aperture  112  from the bottom surface  116  of the anchor member  102  to the top surface  114  of the anchor member  102 . As shown in  FIG. 3 , the central bight portion  122  extends over the central bridge portion  118  on the top surface  114  of the anchor member  102 , while two adjustable loops  132 ,  134  extend from the suture receiving apertures  110 ,  112  through the bottom surface  116  of the anchor member  102 , as shown in  FIG. 1 . 
     With the free, unattached ends  128 ,  130  extending from the top surface  114  of the anchor member  102 , a splice  136  is created in the second limb  126 , as shown in  FIG. 3 . The first limb  124  is passed through the splice  136 , forming a jacket around the first limb  124 . In the depicted embodiment, the splice  136  is adjacent and above (distal to) the central bight portion  122 . With the filamentous strand  104  wrapped through the suture receiving apertures  110 ,  112 , creating adjustable loops  132 ,  134  extending from the bottom surface  116  of the anchor member  102 , and the splice  136  extending from the top surface  114  of the anchor member  102 , the device  100  can be used to adjustably apply and release tension on a graft at a bone tunnel exit. 
     While the suture path of an embodiment of device  100  is as shown in  FIG. 3 , alternate embodiments are feasible. Thus, while the suture path through the anchor member  102  results in device  100  comprising a graft supporting element in the form of two adjustable loops  132 ,  134 , there can be different loop constructions than that described above. For example, the adjustable loops  132 ,  134  are formed from a single length of suture  104  (or other filamentous material) but in an alternate embodiment, the adjustable loops  132 ,  134  could be formed by a plurality of individual lengths of suture  104  which together form the adjustable loops  132 ,  134 . 
     Turning now to  FIGS. 6-8 , there are shown side views schematic representations of the device  100  at various configurations during deployment. First, the device  100  shown in  FIG. 1  is attached to a graft  148  ( FIGS. 7-8 ). In an embodiment, the graft  148  ( FIGS. 7-8 ) is attached to the second loop  134  and a placement suture  140  is threaded through a placement aperture  120  of the anchor member  102 . The placement suture  140  is inserted through the proximal end  144  of the bone tunnel  142  and pulled toward the distal end  146  of the bone tunnel  142 .  FIG. 6  shows a side view schematic representation of the device  100  in a bone tunnel  142 , according to an embodiment. As shown, the placement suture  140  is pulled or otherwise tensioned toward the distal end  146  of the bone tunnel  142 . In the depicted embodiment, the placement suture  140  is pulled through the bone tunnel  142 , facilitating orienting the elongated anchor member  102  substantially parallel to the bone tunnel axis z-z. 
     Referring now to  FIG. 7 , there is shown a side view schematic representation of the device  100  in a first configuration attached to a graft  148  and extending from the distal end  146  of the bone tunnel  142 . As shown in  FIG. 7 , the placement suture  140  is pulled until the anchor member  102  exits the distal end  146  of the bone tunnel  142  and the graft  148  remains within the bone tunnel  142 . When using the device  100  to secure the graft  148 , the two adjustable loops  132 ,  134  (also shown in  FIG. 1 ) serve different purposes. The first loop  132 , which is created from the first limb  124 , functions to resize the lengths of both adjustable loops  132 ,  134 . The second loop  134 , which is created from the second limb  126  and attached to the graft  148 , functions to lock the device  100  in place, thereby locking the graft  148  in position with respect to the bone tunnel exit (i.e., distal end  146  of the bone tunnel  142 ). 
     In use, tension is first applied to the first loop  132 , which causes an increase in size of both adjustable loops  132 ,  134 . In one embodiment, a tether  138  (e.g., rope, suture, or other filamentous strand) is attached to the first loop  132 , as shown in  FIG. 1 . When the tether  138  is pulled proximally or otherwise away from the splice  136 , slack is introduced into the adjustable loops  132 ,  134 , enlarging the adjustable loops  132 ,  134 . In some cases, the splice  136  is pulled toward the second suture receiving aperture  112  when the first loop  132  is tensioned. However, the splice  136  is too large relative to the second suture receiving aperture  112  and can thus not be pulled through the second suture receiving aperture  112  to the bottom surface  116  of the anchor member  102 . Accordingly, additional tension on the first loop  132 , pulls the first limb  124  (and the splice  136 ) proximally to the second suture receiving aperture  112  where the first limb  124  is, due to its size relative to the second suture receiving aperture  112 , pulled through the splice  136  and the second suture receiving aperture  112  to provide the extra slack in the adjustable loops  132 ,  134 . At the same time, tension on both adjustable loops  132 ,  134 , by the graft  148 , causes the anchor member  102  to rotate. As shown in  FIGS. 7-8 , the graft  148  (or filament (not shown) attached to the graft  148 ) can be tensioned or otherwise pulled proximally from the proximal end  144  of the bone tunnel  142 , which tensions the adjustable loops  132 ,  134 . The tension from the graft  148  the anchor member  102  to rotate from a first configuration substantially parallel to the bone tunnel axis z-z ( FIG. 7 ) to a second configuration substantially perpendicular to the bone tunnel axis z-z ( FIG. 8 ). When the anchor member  102  is perpendicular across the bone tunnel  142 , the anchor member  102  is locked in place by bringing the splice  136  against the first suture receiving aperture  110 . Again, the splice  136  is too large relative to the first suture receiving aperture  110  and can thus not be pulled through the first suture receiving aperture  110  to the bottom surface  116  of the anchor member  102 . As the splice  136  is created in the second limb  126 , the second limb  126  cannot be pulled through the first suture receiving aperture  110  to supply slack and instead locks the device  100 . 
     All definitions, as defined and used herein, should be understood to control over dictionary definitions, definitions in documents incorporated by reference, and/or ordinary meanings of the defined terms. 
     While various embodiments have been described and illustrated herein, those of ordinary skill in the art will readily envision a variety of other means and/or structures for performing the function and/or obtaining the results and/or one or more of the advantages described herein, and each of such variations and/or modifications is deemed to be within the scope of the embodiments described herein. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the teachings is/are used. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments described herein. It is, therefore, to be understood that the foregoing embodiments are presented by way of example only and that, within the scope of the appended claims and equivalents thereto, embodiments may be practiced otherwise than as specifically described and claimed. Embodiments of the present disclosure are directed to each individual feature, system, article, material, kit, and/or method described herein. In addition, any combination of two or more such features, systems, articles, materials, kits, and/or methods, if such features, systems, articles, materials, kits, and/or methods are not mutually inconsistent, is included within the scope of the present disclosure. 
     The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprise” (and any form of comprise, such as “comprises” and “comprising”), “have” (and any form of have, such as, “has” and “having”), “include” (and any form of include, such as “includes” and “including”), and “contain” (any form of contain, such as “contains” and “containing”) are open-ended linking verbs. As a result, a method or device that “comprises”, “has”, “includes” or “contains” one or more steps or elements. Likewise, a step of method or an element of a device that “comprises”, “has”, “includes” or “contains” one or more features possesses those one or more features, but is not limited to possessing only those one or more features. Furthermore, a device or structure that is configured in a certain way is configured in at least that way, but may also be configured in ways that are not listed. 
     The corresponding structures, materials, acts and equivalents of all means or step plus function elements in the claims below, if any, are intended to include any structure, material or act for performing the function in combination with other claimed elements as specifically claimed. The description of the present invention has been presented for purposes of illustration and description, but is not intended to be exhaustive or limited to the invention in the form disclosed. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the invention. The embodiment was chosen and described in order to best explain the principles of one or more aspects of the invention and the practical application, and to enable others of ordinary skill in the art to understand one or more aspects of the present invention for various embodiments with various modifications as are suited to the particular use contemplated.