Patent Publication Number: US-2018035998-A1

Title: Filamentary fixation device and assembly and method of assembly, manufacture and use

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     The present application is a continuation of U.S. patent application Ser. No. 13/792,982, filed on Mar. 11, 2013, the disclosure of which is incorporated herein by reference 
    
    
     BACKGROUND OF THE INVENTION 
     Suture anchors are devices useful for fixing damaged soft tissue, such as tendons and ligaments, to bone. Presently, certain of these devices may be secured to bone either through a solid-body anchor having threaded mechanism or interference fit. Generally, these devices are constructed from metal, polymer, or bioresorbable material. Consequently, these suture anchor devices tend to be rigid structures that require a minimum amount of material to provide the strength needed to prevent catastrophic failure. This minimum amount of material dictates the volume of bone that must be removed for implantation to occur, which may be significant. 
     Further, current suture anchors typically include an eyelet at one end containing the suture designated for anchoring. This configuration commonly requires the suture anchor to be inserted into bone first, at which point the suture is passed through the target tissue where it is tensioned and tied-off with a surgical knot. Unfortunately, these knots may loosen or come undone compromising the procedure. Additionally, setting the proper tension may prove difficult as the operator may not be aware of the final tension of the suture until the surgical knot is set. 
     Thus, there is a need for an all filament anchor that provides for less bone removal during pilot hole creation without compromising pullout strength and provides flexibility in setting the optimum suture tension without the need for a complex surgical knot. 
     BRIEF SUMMARY OF THE INVENTION 
     Generally, the present invention includes devices, assemblies, systems, kits and methods of manufacture, assembly and use for the repair of soft tissue. Specifically, in one embodiment, the present invention includes a filamentary fixation device having a filamentary sleeve, loading member, and retriever member. In another embodiment of the present invention, the filamentary fixation device may have the filamentary sleeve, loading member, and a working suture. The filamentary fixation device can be used to anchor damaged soft tissue to bone. 
     According to a first embodiment of the present invention, a method of assembling a filamentary fixation assembly, including obtaining a filamentary sleeve having a pathway therethrough, a loading member positioned through at least a portion of the pathway, and a retriever member positioned through at least a portion of the pathway. The method also includes engaging a working suture with the retriever member. Additionally, the method includes positioning at least a portion of the working suture in the pathway using the retriever member. Further included in the method is the step of engaging the working suture with the loading member. 
     Further, the positioning step may include tensioning the retriever member such that at least a portion of the working suture may be disposed within the pathway and the working tails may pass through the pathway. Additionally, the step of engaging the working suture with the loading member may include tying the working tails into a sliding knot around the loading member. Further, the method may thus include the additional step of tensioning the loading member such that the sliding knot passes into the pathway. 
     Continuing with this embodiment, the retriever member may include a first end and a second end with the first end including a first loop configuration. The loading member may also include a first end and a second end, with the first end including a second loop configuration. Further, the filamentary sleeve may include a first end and a second end. The retriever member may be positioned through the pathway of the filamentary sleeve such that the first loop configuration may extend from the first end of the filamentary sleeve and the second end may extend from the second end of the filamentary sleeve. Similarly, the loading member may be positioned through the pathway of the filamentary sleeve such that the second loop configuration may extend from the second end of the filamentary sleeve and the first end may extend from the first end of the filamentary sleeve. As such, the engaging the retriever member with the working suture may include passing the working tails through the loop configuration. Further, the step of positioning at least a portion of the working suture in the pathway using the retriever member can include tensioning of the retriever member by pulling on the second end of the retriever member to pull the working suture into the pathway. Additionally, the aforementioned tying step may include tying the working tails through the second loop configuration of the loading member. Further, tensioning of the loading member may include pulling the second end of the loading member to pull the sliding knot into the pathway. 
     In another embodiment of the present invention, a filamentary fixation assembly includes a filamentary sleeve constructed entirely of filamentary material and having a pathway extending therethrough. Further included in the assembly is a loading member, which includes a first loop and at least one loading tail that is at least partially disposed within the pathway. Additionally, a working suture, which includes at least a first working tail, is included in the assembly. 
     The assembly can further include a retriever member. The retriever member may be at least partially disposed within the pathway and include a second loop and at least one retriever tail. The second loop may be positioned opposite the first loop, and the at least one retriever tail may be positioned adjacent the first loop. 
     Further, the loading member may be constructed from a single line of filament. Further, the first loop may be formed by folding the single line of filament along its length, and the at least one loading tail may be two loading tails. Alternatively, the first loop may be a pre-formed loop, and the at least one loading tail may extend from the first loop. 
     Moreover, the retriever member may be constructed from a single line of filament. Further, the second loop may be formed by folding the single line of filament along its length, and the at least one retriever tail may be two retriever tails. Alternatively, the second loop may be a pre-formed loop, and the at least one retriever tail may extend from the second loop. Optionally, the retriever member may be constructed from memory metal. In another alternative, the filamentary sleeve may have a sidewall defined by the pathway, the sidewall having a plurality of pass-throughs disposed along one side of the filamentary sleeve. 
     In a further embodiment of the present invention, a method of anchoring tissue to bone using a filamentary sleeve is disclosed herein. The filamentary sleeve includes a pathway therethrough and a retriever member and loading member at least partially disposed within the pathway. The method includes engaging the retriever member with working tails of a working suture connected to the tissue, tensioning the retriever member such that at least a portion of the working suture is disposed within the pathway and the working tails pass through the pathway, inserting the filamentary sleeve into a bore hole in bone such that the loading member and working suture extend from the bore hole, tying the working tails into a sliding knot around the loading member and tensioning the loading member such that the sliding knot passes into the pathway, thereby fixedly securing the filamentary sleeve within the bore hole. 
     Optionally, the sliding knot may be a half-hitch knot. Further, the step inserting of the sleeve into the bore hole may occur prior to the tying step. Optionally, the step inserting of the sleeve into the bore hole may occur prior to the step of engaging the retriever member with the working tails. 
     Continuing with this embodiment, the method may further include the step of pulling on either or both the loading member and working suture to deploy the filamentary sleeve within the bore hole. Additionally, the filamentary sleeve can be constructed entirely of filamentary material and includes a sidewall defined by the pathway. The sidewall may optionally include a plurality of pass-throughs disposed along one side of the filamentary sleeve. 
     Continuing with this embodiment, the retriever member may include a first end and a second end. The first end may include a first loop configuration. The loading member may also include a first end and a second end where this first end may have a second loop configuration. Also, the filamentary sleeve may include a first end and a second end. The retriever member may be positioned through the pathway of the filamentary sleeve such that the first loop configuration extends from the first end of the filamentary sleeve and the second end may extend from the second end of the filamentary sleeve. Also, the loading member may be positioned through the pathway of the filamentary sleeve such that the second loop configuration may extend from the second end of the filamentary sleeve and the first end may extend from the first end of the filamentary sleeve. 
     Further, the step of engaging may include passing the working tails through the loop configuration, and the step of tensioning of the retriever member may include pulling on the second end of the retriever member to pull the working suture into the pathway. 
     Moreover, continuing with this embodiment, the step of tying may include tying the working tails through the second loop configuration of the loading member, and the step of tensioning of the loading member may include pulling the second end of the loading member to pull the sliding knot into the pathway. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       These and other features, aspects, and advantages of the present invention will become better understood with regard to the following description, appended claims, and accompanying drawings where: 
         FIG. 1A  shows a perspective view of an embodiment of a filamentary fixation device having a first embodiment of a filamentary sleeve. 
         FIG. 1B  shows a perspective view of the filamentary fixation device of  FIG. 1A  having a second embodiment of the filamentary sleeve. 
         FIGS. 2-8  show subsequent steps of an exemplary method of use and assembly illustrated using the filamentary fixation device of  FIG. 1A . 
     
    
    
     DETAILED DESCRIPTION 
       FIG. 1A  depicts an embodiment of a filamentary fixation assembly  10 , which includes a filamentary sleeve  30 , a retriever member  40 , and a loading member  20 . The filamentary sleeve  30  may be cylindrical in shape and include a pathway  33  extending therethrough and a wall thickness  36  defined between the pathway  33  and an outer surface of the sleeve  30 . 
     In a substitute embodiment of the filamentary sleeve  30 , the filamentary sleeve  30  may be provided with an alternative configuration as illustrated in  FIG. 1B . In such embodiment, the filamentary sleeve  30 ′ may be generally cylindrical with a plurality of pass-throughs  31 . A set of these pass-throughs  31  may provide filamentary material positioned within pathway  33 , such as retriever member  40 , loading member  20 , and working suture  50 , to instead have an alternative configuration relative to sleeve  30 ′. For example, the filamentary material (e.g., member  40 , member  20 , suture  50 ) extends through a portion of the pathway, exits the pathway  33  by traversing wall thickness  36  at a pass-through  31 , where it travels externally along apportion of the length of the filamentary sleeve  30 ′, then re-enters the pathway  33  at another pass-through  31  where it continues through another portion of the pathway  33 . These pass-throughs  31  may be symmetrically disposed along one side of the filamentary sleeve  30 ′. The symmetrical arrangement is such that when the filamentary sleeve  30 ′ is folded in half at least one pass-through  31  will face an opposing pass-through  31 . These pass-throughs  31  may also facilitate folding and compressing of the filamentary sleeve  30 ′ by drawing together discrete portions of the filamentary sleeve that are disposed between the pass-throughs as the filamentary material disposed within and through the pass-throughs are tensioned.). Moreover, such pass-throughs may result in greater fixation strength with a bore hole to be prepared in the bone (if used in this manner, as described further below). Further, these pass-throughs  31  may facilitate a solid anchoring position where the filamentary sleeve  30 ′ is folded and inserted into a bore hole  81  in bone  80 . As such, a pulling force, typically originating from the filamentary material passing through the filamentary sleeve  30 ′, creates a deploying friction between the filamentary sleeve  30 ′ and bore hole  81  (if present, as in  FIGS. 4 and 5 ). This friction buckles the filamentary sleeve  30 ′ material between the pass-throughs  30 ′ causing them to expand outwardly against the bore hole  81 , thereby significantly increasing the friction against the bone, which provides for a very strong anchor. In one example, the filamentary sleeve  31 ′ can be the Iconix® all suture anchor system (Howmedica Osteonics, Mahwah, N.J.). Additional example are disclosed in U.S. Provisional Application No. 61/679,336, filed Aug. 3, 2012, U.S. application Ser. No. 13/303,849, filed Nov. 23, 2011, Ser. No. 13/588,586, filed Aug. 17, 2012, and Ser. No. 13/588,592, filed Aug. 17, 2012, and U.S. Pat. Nos. 5,989,252 and 6,511,498, the entireties of which are incorporated by reference herein as if fully set forth herein and all of which are assigned to the same entity as the present application. As described in certain of these references, the pass-throughs can alternatively be positioned elsewhere on the sleeve such that they may or may not be symmetrical. Moreover, in another alternative, the sleeve could include a set of pass-throughs in the middle of the sleeve, along or in addition to one or more other sets of pass-throughs. Such a set of pass-through in the middle of the sleeve could also make folding the sleeve over an insertion instrument (not shown) easier, and thus also result in a more condensed structure on such an instrument, which thereby could necessitate a smaller bore hole in bone. While any of these sleeves (including sleeves  30  and  30 ′) could be used in the present invention, sleeve  30  is illustrated throughout the various disclosed embodiments for reasons of clarity and simplicity. 
     In one embodiment of the retriever member  40 , the retriever member  40  may include a retriever loop  41  that is a pre-formed loop and one retriever tail  42  extending therefrom, as illustrated in  FIGS. 1A and 1B . Alternatively, the retriever member  40  could have a plurality of retriever tails (not shown) extending from the retriever loop  41 . In one such configuration, the retriever member  40  may be constructed from a single line of filament wherein the retriever loop  41  and tail  42  are formed by a locking Brummel splice, as is known in the art. However, the locking Brummel splice is merely an example of the various approaches known in the art for forming a retriever loop  41  and a single retriever tail  42  or a plurality of retriever tails (not shown) extending therefrom. Another example of the above mentioned configuration is a suture shuttle constructed from memory metal materials, such as nitinol, an example of which is disclosed in U.S. Provisional Application No. 61/755,654, filed Jan. 1, 2013 the entirety of which is incorporated by reference herein as if fully set forth herein and which is assigned to the same entity as the present application. Other alternative examples are illustrated in the above applications incorporated by reference, specifically the &#39;336, &#39;586 and &#39;592 applications. 
     In an alternative embodiment of the retriever member  40  the retriever member  40  may be a single line of filament (not shown). In such an embodiment, the single line of filament may be folded along its length forming a retriever loop and a pair of retriever tails (not shown). An example of such an alternative is illustrated in U.S. application Ser. No. 13/783,804, filed Mar. 4, 2013, the entirety of which is incorporated by reference herein as if fully set forth herein and which is assigned to the same entity as the present application. 
     The loading member  20  may be similarly configured to that of the retriever member  40 , and thus may have any of the above arrangements as described above as to the retriever member  40 . In one embodiment, as illustrated in  FIGS. 1A and 1B , the loading member  20  may be constructed from a single line of filament that may be folded along its length to form a loading loop  22  and a pair of loading tails  21 . 
     In an alternate embodiment (not shown), the loading member  20  may include a loading loop that is a pre-formed loop and one loading tail, or a plurality of loading tails, extending from the loading loop. In one such configuration, the loading member  20  may be constructed from a single line of filament wherein the loading loop and tail are formed by a locking Brummel splice, as is known in the art. However, the locking Brummel splice configuration is merely an example of the various approaches known in the art for forming a single loop with a tail extending therefrom, any of which may be utilized. Thus, while  FIGS. 1A and 1B  (and throughout  FIGS. 2-8 ) illustrate a preferred embodiment of both the loading loop  20  and retriever member  40 , they may instead be present in a variety of other configurations, and may have similar or different configurations from one another as desired. 
     Continuing with the embodiment of the filamentary fixation assembly  10  as illustrated in  FIG. 1A , the retriever member  20  may be partially disposed within a pathway  33  of the filamentary sleeve  30  such that the retriever loop  41  extends out of one side  34  of the filamentary sleeve  30  and the retriever tail  42  extends from the from the other side  35  of the filamentary sleeve  30 . The loading loop  40  may also be partially disposed within the pathway  33  such that the loading loop  22  extends out of one side  35  of the filamentary sleeve  30  and the loading tails  21  extend out of the other side  34 . Generally, the loading loop  22  is positioned on the opposite side  35  of filamentary sleeve  30  as the retriever loop  41 , but on the same side  35  and adjacent to the retriever tail  42 . 
       FIG. 3  depicts another embodiment of the filamentary fixation assembly  10 ′, which may include the filamentary sleeve  30 , the loading member  20 , and a working suture  50 . The filamentary sleeve  30  and loading member  20  may be of any of the embodiments and configurations as described in the above embodiment of the filamentary fixation assembly  10 . 
     In one embodiment of the working suture  50 , the working suture may be constructed from a single line of filament that may be folded along its length to form a pair of working tails  51 . 
     In an alternate embodiment of the working suture  50 , the working suture  50  may include a pre-formed loop and at least one working tail extending from the pre-formed loop (not shown). In one such configuration, the working suture  50  may be constructed from a single line of filament wherein the pre-formed loop and working tail are formed by a locking Brummel splice, as is known in the art. However, the locking Brummel splice configuration is merely an example of the various approaches known in the art for forming a single loop with a tail extending therefrom, any of which may be utilized. An example of such a working suture can be found in the above, incorporated by reference, &#39;804 application, as well as U.S. application Ser. No. 13/441,290, filed Apr. 6, 2012, the entirety of which is incorporated by reference herein as if fully set forth herein and which is assigned to the same entity as the present application. Such working sutures may be secured to the tissue  60  by, for example, passing a free end around or through the tissue, and then through the pre-formed loop. The free end may then be tensioned to pull the loop against the tissue, similar to a “luggage tag” configuration. 
     As has been described in the prior embodiment of the filamentary fixation assembly  10 , the loading member  20  is partially disposed within the pathway  33  of the filamentary sleeve  30  such that the loading loop  22  extends out of one side  35  of the filamentary sleeve  30  and the loading tails  21  extend from the other side  34 . The working suture  50  also may be partially disposed within the pathway  33  such that the working tails  51  extend from the filamentary sleeve  30  on the same side  35  as and adjacent to the loading loop  22 . In some embodiments, the working tails  51  may be tied around the loading loop  22  in a sliding knot configuration, such as a half-hitch knot, as discussed further below. 
     As will be described in greater detail below, assembly  10 ′ can be assembled from assembly  10  using retriever member  40 , or a similar device suitable to pass the tails  51  of working suture  50  through sleeve  30 . 
     The filamentary sleeve  30 , retriever member  40 , loading member  20  and working suture  50  may be constructed from filamentary material, such as homogenous or heterogeneous materials including, but not limited to, polyester, polyethylene (including ultra-high molecular weight polyethylene (UHMWPE)), polytetrafluorethylene (including expanded polytetrafluorethylene), nylon, polypropylene, aramids (such as Kevlar-based materials), polydioxanone, polygycolic acid, and organic material (silk, animal tendon, or the like). Further, the retriever member  40  may be constructed from memory metal material such as nitinol, and the filamentary sleeve  30  may be entirely constructed from filamentary material. Therefore, the filamentary fixation device  10 ,  10 ′ may be, and is preferably, constructed entirely from filamentary material. 
     The filamentary fixation device  10 ,  10 ′ may be provided to the user in any number of arrangements. In one arrangement, the end user may be provided the embodiment of the filamentary fixation assembly  10  that includes the loading member  20  and retriever member  40  disposed within the pathway  33  of the filamentary sleeve  30 . However, in another arrangement, the user may be provided this embodiment of the filamentary fixation device  10  along with the working suture  50  disassembled from the filamentary fixation device  10 . In such a circumstance, the user may convert this embodiment into the other embodiment of the filamentary fixation device  10 ′ that includes the loading loop  20  and working suture  50  disposed within the pathway  33  of the filamentary sleeve  30 . However, in another arrangement, the user may only be provided the filamentary fixation assembly  10 ′. 
     In another arrangement, a kit may be provided with a filamentary sleeve  30 , loading member  20 , retriever member  40 , and working suture  50  either in assembled form or unassembled leaving it to the user to arrange the device as he or she desires for a particular application. If the device comes to the user unassembled, the kit may further include a suture passing device, such as any of the variations of retriever member  40  and loading member  20  described above. Preferably, if included, such a suture passer would be manufactured from metal wire to provide adequate rigidity in passing the various filaments through the sleeve  30 . Alternatively, the working suture  50 , retriever member, and/or loading member may be provided affixed to a needle (not shown) to provide the adequate rigidity for passing through sleeve  30 . Any kit of the present invention may include a plurality of any or all of the sleeve  30 , member  20 , member  40  and/or suture  50 . 
     The present invention also includes a method of assembly of one embodiment of the filamentary fixation device  10 , including a filamentary sleeve  30 , loading member  20 , and retriever member  40 , is now described. In this embodiment, the filamentary sleeve  30 , retriever member  40 , and loading member  20  may be obtained unassembled and preferably constructed from filamentary material. The loading member  20  is positioned into the pathway  33  of the filamentary sleeve  30  such that the loading loop  22  and loading tails  21  extend from the filamentary sleeve  30  at opposing sides as shown in  FIG. 1 . The retriever member  40  may then be positioned within the pathway  33  such that the retriever loop  41  extends from the same side  34  of the filamentary sleeve  30  as that of the loading tails  21 , and the retriever tail  42  extends from the same side  35  as the loading loop  22 . While the loading member  20  is described herein as being positioned within the pathway  33  prior to the retriever member  40 , the retriever member  40  may be positioned within the pathway  33  first. It is envisioned that a method may also entail the use of a suture passer, as described above. 
     In another embodiment of the filamentary fixation device  10 ′, the working suture  50  and filamentary sleeve  30  may be obtained, wherein the filamentary sleeve  30  includes the loading member  20  and retriever member  40  disposed within the pathway  33  of the filamentary sleeve  30 , such that the loading loop  20  and retriever tails  42  extend from one side of the filamentary sleeve  30  and the retriever loop  41  and loading tails  21  extend from the other. The working suture  50  may be placed into an engagement configuration with the retriever member  40 . This engagement configuration could include simply passing the working tails  42  through the retriever loop  41  or tying the working tails  42  to the retriever loop  41 . The retriever member  40  is then tensioned at the retriever tail  42  such that a portion of the working suture  50  enters into the pathway  33  of filamentary sleeve  30 , and preferably such that the working tails  51  extend from the same side  35  of the filamentary sleeve  30  as the loading loop  22 . The working tails  51  may then be tied to the loading loop  22  in a sliding knot configuration, preferably a half-hitch knot  52 , as shown in  FIG. 5 . Tension may then be applied to the working tails  51  and a working loop  52  located opposite the working tails  51  in an opposite direction. Simultaneously, tension may be applied to the loading tails  21  such that the half-hitch knot  52  enters into the pathway  33  of the filamentary sleeve  30 . In this fashion, the working suture  50  may be fixedly secured to the sleeve  30 . 
     The filamentary fixation assembly  10 ,  10 ′ may be used in soft tissue repair procedures to fix soft tissue to bone as illustrated in  FIGS. 2-8 , for example. Such soft tissue repair can be performed in any soft tissue, include such tissue in the foot, ankle, hand, wrist, elbow, hip and shoulder, and in particular soft tissue repair of the rotator cuff and labrum in the hip and shoulder.  FIGS. 2-8  illustrate one embodiment of such a method of repair, as performed specifically in the reattachment of the labrum to the glenoid, though this method may be useful and be performed in other soft tissues of the body. 
     Initially in this embodiment, as illustrated in  FIG. 2 , the working suture  50  may be passed around or through the tissue  60  designated for repair. Where the working suture  50  is a single line of filament, one end of the filament may be passed through the tissue  60 , as seen in  FIG. 2 , using a suture passer, as is known in the art, or other techniques that are known in the art. In other instances, the single line of filament many be folded along its length forming a looped-end  52  and a pair of working tails  51 , in which case the looped-end  52  is passed through the tissue and the working tails  51  are passed through the looped-end  52  around a portion of the tissue in a “luggage-tag” configuration (not shown). This “luggage-tag” configuration may also be utilized where the working suture  50  includes the pre-formed loop and single working tail extending from the pre-formed loop as described above, or where the working suture  50  is provided pre-assembled with the filamentary sleeve  30 , also described above, in which case the entire filamentary fixation assembly  10 ′ would be passed through the looped end (not shown). It is noted that where the working suture  50  is provided already assembled to the filamentary sleeve  30  in conjunction with the loading loop  20 , the following steps utilizing the retriever loop  40  may be skipped. 
     Continuing with this embodiment, and with reference to  FIG. 2 , the filamentary fixation assembly  10  may be introduced to the surgical repair site where the working tails  51  engage the retriever loop  41  of the retriever member  40 . This engagement can be as simple as threading the working tails  51  through the retriever loop  41 . The retriever member  40  is then tensioned at the retriever tail  42  as demonstrated by arrow  30 . This tension passes the retriever loop  41  through the pathway  33  of the filamentary sleeve such that the working suture  50  is partially disposed within the filamentary sleeve  30  and the working tails  51  extend from the pathway  33  and reside adjacent the loading loop  22 , as shown in  FIG. 3 . 
     With the loading member  20  and working suture  50  now disposed within the filamentary sleeve  30  as shown in  FIG. 3 , the filamentary sleeve  30  may be folded and inserted into a bore hole  81  that has been formed in bone  80  such that both ends of the loading member  20  and working suture  50  extend from the bore hole  81  as shown in  FIG. 4A . The bore hole  81  is generally formed in cancelleous bone  82  through cortical bone  83 , and the filamentary sleeve  30  is generally inserted into the cancellous region of the bore hole  81 , as shown. Once the filamentary sleeve  30  is inserted in the bore hole  81 , either or both the loading member  20  and working suture  50  may be tensioned to deploy sleeve  30  and firmly seat the sleeve  30  within the bore hole  81 . Such deployment is described in many of the above-incorporated applications. Due to the relatively thin nature of the filamentary sleeve  30  and filamentary material located therein, the bore hole  81  may generally be very small as compared to the bore hole  81  necessary to accommodate a current rigid suture anchor, thereby preserving native bone. For example, the sleeve  30  may be constructed of #5 suture, and working suture  50  and loading member  20  may both be constructed of #2 suture. Thus, in a preferred embodiment, bore hole  81  may have a diameter of about 2.3 mm. 
     While the engagement of the working tails  51  to the retriever loop  41  is described as occurring prior to folding and inserting the filamentary sleeve  30  into the bore hole  81 , this is merely an illustrative order of performance, and indeed, has been presented in this manner for the sake of clarity of illustration. In a preferred embodiment, the filamentary sleeve  30  may be folded and inserted into the bore hole  81  prior to engaging the working tails  51  with the retriever loop  41 . As such, the configuration as in  FIG. 4B  would instead be achieved by first inserting and deploying sleeve  30  in bore hole  81 , followed by passing the tails  51  through retriever loop  41 . Then, in such an alternative, the working tails would be passed through the pathway  33 , as detailed above, while the filamentary sleeve  30  is folded and deployed within the bore hole  81 . 
     Referring to  FIG. 5 , the working tails  51  are then engaged with loading loop  22 . For example, as illustrated, the tails  51  may be tied through the loading loop  22  preferably in a simple half-hitch knot  52 . While a half-hitch knot  52  is shown, any sliding knot that can be locked from further sliding that is known in the art may be utilized. Further, the tying of the half-hitch knot  52  may be performed prior to inserting the filamentary sleeve  30  in the bore hole  81  or after. 
     Referring to  FIGS. 6 and 7 , with the half-hitch knot  52  tied through the loading loop  22 , the loading tails  21  are tensioned as demonstrated by arrow  71 . Contemporaneous with the tensioning of the loading tails  21 , the working tails  51  are tensioned as demonstrated by arrow  72 . The tension on the loading tails  21  pulls the half-hitch knot  52  resulting in the sliding of half-hitch  52  toward the bore hole  81  and filamentary sleeve  30  as illustrated by  FIG. 6 , while the tension on the working tails  51  allows the working suture  50 , and thus tissue  60 , to be tensioned. Further, tension on the tails  51  can allow the half-hitch  52  to slide along the working suture  50 , while suture  50  and tissue  60  are tensioned and drawn towards bone hole  81 , while preventing the working tails  51 , and half-hitch  52 , to prematurely move into the bore hole  81  and sleeve  30 . Further, the tension on the working tails  51  may contract the half-hitch knot  52  and allow the user to maintain appropriate tension on the working suture  50  and the tissue  60  while the half-hitch  52  is slid into the filamentary sleeve  30 , as seen in  FIG. 7 . 
     As the knot  52  enters into the pathway  33 , the knot  52  may become trapped by the fold  32  (or other material of sleeve  30 ), at which point further tension on the working tails  51  and loading tails  21  further contracts the half-hitch knot  52 , until the working suture  50  and sleeve  30  are fixedly secured with one another and the engagement is so tight that it is no longer capable of sliding, thereby effectively securing the tissue  60 . Further, as the half-hitch  52  contracts and tightens, the material forming the knot  52  may become localized at a point, which further expands the filamentary sleeve  30  against the bore hole  81 , providing added anchoring support. This mechanism may provide the user the ability to maintain the desired tension of the working suture  50  up until the half-hitch  52  is locked into position, thereby setting the desired tension into the working suture  50  and tissue  60 . The working tails  51  and loading member  20  are trimmed close to the surface of the bone  80  resulting in a configuration as shown in  FIG. 8  where the filamentary sleeve  30  is fixedly secured in the bore hole  81  and the half-hitch  52  fixedly secures the working suture  50 , sleeve  30  and tissue  60  to one another and to the bore hole  81 . Thus, as illustrated, a portion of the loading member  20  can remain within the filamentary sleeve  30 . 
     In another embodiment, the present invention includes a system for the repair of soft tissue including at least one filamentary fixation assembly (including or in addition to a working suture  50 ), at least one instrument for insertion of the filamentary fixation assembly, and a surgical procedure. The surgical procedure may include instructions or protocol for using the filamentary fixation assembly and instrument to repair soft tissue. The protocol may include aspects of any of the above-discussed embodiments, though other variations are also envisioned within the scope of the present invention. 
     In an associated embodiment, the present invention includes a method of providing instructions or information to practice any of the various methods of performing soft tissue repair described herein. For example, the method may include supplying a surgical protocol, or like document, to provide step-by-step instructions for performing any of the method embodiments of the present invention. 
     Although the invention herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present invention. It is therefore to be understood that numerous modifications may be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present invention as defined by the appended claims.