Patent Publication Number: US-2019175170-A1

Title: Knotless closure suture and technique

Description:
BACKGROUND 
     The present disclosure relates to the field of surgery and, more particularly, to improved sutures and methods of tissue fixation. 
     SUMMARY 
     Suturing constructs and methods for fixation of soft tissue are disclosed. A suturing construct includes a suture with a very small loop on a distal end, and a splice terminating into a tapered portion/region at a proximal end. 
     The splice portion is provided with multiple laser cuts in one side near the loop at the distal end of the suture. A loader is pre-passed through the loop to load the suture tail back through the loop after passing it through the soft tissue. Once the suture is passed through the soft tissue, the tail is passed through the loop using the loader by folding the tapered end and shuttling it through the loop. The suture is then pulled through until it tightens all the way down. As it tightens, the laser cut roughened portion that is thicker pulls into the loop and prevents the suture from backing up. 
     Fixation of soft tissue is achieved by using the suture construct passed around or through soft tissue without the need of nitinol wire loops or similar devices. The tapered portion/region of the construct allows the suture construct to be retrieved after being passed through the tissue. After the formation of a cinch stitch and locking with the laser-cut portion near the loop, the suture construct may be secured into bone with additional fixation devices (such as one or more suture anchors). The construct may be employed with knotless or knotted fixation devices. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  illustrates an exemplary suturing construct. 
         FIGS. 2-5  illustrate a method of forming another exemplary suturing construct. 
         FIGS. 6-8  illustrate subsequent steps of an exemplary method of knotless labral repair with the suturing construct of  FIG. 1 . 
     
    
    
     DETAILED DESCRIPTION 
     The present disclosure provides methods and suturing constructs for fixation of tissue, for example, soft tissue. 
     A suturing construct includes a flexible strand with a small loop at its distal end, a tapered proximal end (tapered tail), and a splice region that is obtained from the loop creation and is provided between the small loop and the tapered proximal end. The splice region is provided with multiple laser cuts in one side near the loop at the distal end of the suture. The small loop is formed by splicing but it could be also formed by other methods known in the art, for example, braiding, weaving or gluing. 
     A shuttling device is pre-loaded onto the loop to load the tapered suture tail back through the loop after passing it through the soft tissue. The flexible strand may be suture, tape, wire, or any flexible material known in the art. The shuttling device may be a suture passing instrument, a suture passer, a shuttle/pull device, a loader, a shuttling wire or any passing instrument, such as FiberLink™ or a Nitinol loop. 
     Once the flexible strand is passed through the soft tissue, the tapered tail is passed through a loop of the shuttling device by folding the tapered end and shuttling it through the loop. The flexible strand is then pulled through until it tightens all the way down. As it tightens, the laser-cut roughened portion that is thicker pulls into the loop and prevents the flexible strand from backing up. 
     The flexible strand may be a standard braided coreless suture, may be tapered, and may include three exemplary varying widths throughout its length, with laser cuts in the thickened portion of the suture to create ridges or bumps or barbs. The suture is provided with a small loop to allow the suture to be pulled through until the ridges/bumps/barbs/protuberances engage and lock the suture under tension. 
     The loop is large enough to allow the tapered end and part of the splice region to pass through it and then lock to the loop, to create a cinch stitch around soft tissue. The flexible strand may be coreless or, in certain applications, may have a core. The loop is formed by splicing but it could be also formed by other methods known in the art, for example, braiding, weaving or gluing. 
     Fixation of tissue to bone is achieved by using the suturing construct passed around tissue without the need of nitinol wire loops or similar devices. The longer tapered portion/region of the construct allows the suturing construct to be retrieved after being passed through the same portal. After the formation of the cinch stitch and locking of the laser cuts into the loop, the suturing construct may be secured into bone with one or more fixation devices (such as one or two suture anchors). The suturing construct may be used with knotless or knotted fixation devices. 
     Referring now to the drawings, where like elements are designated by like reference numerals,  FIG. 1  illustrates exemplary suturing construct  100  (surgical suture  100 ; side-to-side knotless suture  100 ; suture construct  100 ; knotless closure suture  100 ) in the form of a flexible strand  10  provided with a small closed loop  15  at one end  11  (for example, distal end) and with a tapered elongated portion/region  25  at other end  12  (for example, proximal end). A splice  52  in splice region  51  is located between the closed loop  15  and the tapered portion  25  and adjacent the closed loop  15 . Flexible strand  10  is spliced into itself to form small loop  15  (or a double loop) and splice  52 . Small loop  15  is integral to the coreless suture  10 . Flexible strand  10  is an exemplary suture that is coreless in the preferred embodiment, but that can also be a suture provided with a core. The tapered portion/region  25  may be stiffened and/or coated/impregnated with a material such as plastic, for example. Tapered portion/region  25  allows for easy locking of the construct. 
     Suturing construct  100  is also provided with shuttling device  60  which may be a suture passing instrument, loader, shuttling wire or passing instrument, such as FiberLink™  60  or a Nitinol loop  60  with closed loop or eyelet  61  attached to the flexible strand  50 . As shown in  FIG. 1 , shuttling device  60  is pre-loaded onto closed loop  15  (threaded through the closed loop  15 ). In particular and exemplary-only embodiments, the flexible strand  10  is a suture strand  10  and the shuttling device  60  is a suture passing device  60 . The shuttling device  60  is configured to allow the tapered portion  25  of the flexible strand  50  to pass through eyelet or loop  61  of the shuttling device  60  and through the small loop  15 , to form a knotless closed adjustable loop  55  having an adjustable length and perimeter. 
     Suturing construct  100  also includes a plurality of laser cuts  66  in one side near the loop  15  at the distal end  11  of the flexible strand  10 , i.e., on or around portion  60 . The laser cuts create bumps and/or barbs and/or ridges that roughen the flexible strand  10  (suture  10 ) for knotless locking. The laser cuts  66  may have a depth of 0.5-1 mm and may be formed at any angle with the surface of portion  60 , for example, at a 45 degree angle with the tangent to surface of portion  60 . Laser cuts  66  may be also provided as a plurality of various cuts, each of the plurality being formed at various angles and/or depths relative to top surface of portion  60 . 
     As detailed above, once the flexible strand  10  is passed through the soft tissue, the tail  25  is passed through the loop  61  using the loader  60  by folding the tapered end  25  and shuttling it through the loop  15 . The flexible strand  10  is then pulled through until it tightens all the way down. As it tightens, the thicker laser-cut roughened portion  60  with laser cuts  66  pulls into the loop  15  and prevents the flexible strand  10  from backing up. In this manner, flexible closed adjustable loop  55  is locked by the engagement of laser cuts  66  with inner surface of loop  15 . 
     In an exemplary embodiment, the loop  15  has a very small length and/or perimeter to allow the tail  25  to pass through the loop and form a closed, knotless, adjustable loop  55 . Loop  15  may have a length of about 10 mm. The tapered portion/region  25  has a length of about 2-3 inches. The overall length of the suture construct may be about 3 to 10 inches, preferably about 5 inches (for exemplary rotator cuff repairs involving attachment of labrum to glenoid). The loop portion  15  is formed by splicing (in the preferred embodiment) but it could be also formed by other methods known in the art, for example, by braiding, weaving or gluing. The loop  15  may be flexible, collapsible and with a fixed perimeter of about 10 mm. 
     The loop  15  may be also a racking hitch loop. For example,  FIGS. 2-5  illustrate a method of forming racking hitch loop  115  of exemplary suturing construct  200  (surgical suture  200 ; side-to-side knotless suture  200 ; suture construct  200 ; knotless closure suture  200 ) which is similar to the suturing construct  100  of  FIG. 1 , but differs in that the loop  115  is a racking hitch. Tail  25  ( FIG. 2 ) is passed/loaded through small loop  11  of flexible strand  10 , as shown in  FIG. 3 . The tail is pulled through until a small opening is left ( FIG. 4 ). A suture loader  60  is added, as shown in  FIG. 5 , to pull the tail through the racking hitch after it is passed through the tissue. 
     In an exemplary embodiment, the flexible strand  10  of suturing construct  100 ,  200  is suture formed essentially of a braid such as a FiberWire® CL braid, which is a coreless braid with ultrahigh molecular weight polyethylene (UHMWPE). In another exemplary embodiment, the flexible strand  10  is a suture formed essentially of polyester or similar material. For example, the flexible strand  10  may be formed of polyester yarns (twisted yarns of polyester) or a polyester suture in the form of a coreless braid or sheath which may be a multifilament, braided, knitted, or woven polyester construct, wherein the polyester is provided alone or in combination with any other known suture materials. In an exemplary-only embodiment, the flexible strand  10  is a braided coreless suture with about 100% polyester. 
     At least one or all of suture sections of suturing construct  100 ,  200  may be coated (partially or totally) with wax (beeswax, petroleum wax, polyethylene wax, or others), silicone (Dow Corning silicone fluid  202 A or others), silicone rubbers (Nusil Med 2245, Nusil Med 2174 with a bonding catalyst, or others) PTFE (Teflon, Hostaflon, or others), PBA (polybutylate acid), ethyl cellulose (Filodel) or other coatings, to improve lubricity of the final suture construct, knot security, pliability, handleability or abrasion resistance, for example. 
     The elongated tapered region  25  of the surgical constructs of the present disclosure allows the flexible strand/suture to be pushed through small and very small diameter tubes and cannulations (such as Lasso instruments, for example) yet fix securely with existing fixation devices (such as knotless suture anchors like PushLock® anchors). 
     Surgical suturing construct  100 ,  200  may have cross-sections of various forms and geometries, including round, oval, rectangular, or flat, among others, or combination of such forms and geometries. The diameter of construct  100 ,  200  may be constant or may vary. Tapered region  25  may include a plurality of adjacent tapered regions, each of the regions having a diameter different from those of the adjacent regions. In an exemplary-only embodiment, region  25  may comprise three adjacent regions, each having a taper different from the adjacent regions. 
     At least a part of the fibers of suturing construct  100 ,  200  may contain strands of a high strength suture material, such as Arthrex FiberWire® suture disclosed in U.S. Pat. No. 6,716,234, the disclosure of which is incorporated in its entirety by reference herein, with optional colored strands to assist surgeons in distinguishing between various suture lengths. 
     Surgical suturing construct  100 ,  200  has applicability to suture applications that may be employed in surgical procedures such as rotator cuff repair, Achilles tendon repair, patellar tendon repair, ACUPCL reconstruction, hip and shoulder reconstruction procedures, and applications for suture used in or with suture anchors. In exemplary embodiments only, the suturing construct  100 ,  200  may be employed in suture applications that do not involve knot tying, for example, for use with suture anchors (such as PushLock® and/or SwiveLock® suture anchors) or for knotless arthroscopic suture repairs (such as knotless single row rotator cuff repair, or SpeedBridge™ repair using no knots and only suture passing steps), among many others, but with simplified steps as no nitinol wires or similar structures are required. 
     In an exemplary-only embodiment, construct  100 ,  200  is employed to bring together a first tissue portion (for example, a first soft tissue) to a second tissue portion (for example, a second soft tissue) in a side-to-side closure repair. The construct is first passed through the first tissue portion. The tail (tapered region  25 ) is passed through or around the second tissue portion, and then passed through the loop using the shuttling device (loader) by folding the tapered end  25  and shuttling it through the loop. Flexible strand  10  (suture  10 ) is then pulled until it tightens and achieves the desired tension on closed adjustable loop  55 . As the flexible strand  10  tightens, the laser-cut roughened portion  60  of the construct  100 ,  200  (that is thicker) pulls into the loop  15 ,  115  and locks cuts  66  to the inner surface of loop  15 ,  115  (to the flexible strand  10 ) to prevent the flexible strand  10  from backing up. In an exemplary embodiment, the laser cuts  66  form a plurality of ridges/bumps/barbs/protuberances that engage and lock the suture  10  under tension. The flexible strand may be a standard braided suture that is tapered and that has three varying widths throughout its length. 
       FIGS. 6-8  illustrate an exemplary method of soft tissue repair  300  ( FIG. 8 ) with suturing construct  100 .  FIG. 6  illustrates a schematic view of a surgical site undergoing a method of fixation of soft tissue to bone (or of soft tissue to soft tissue) by the methods of the present disclosure. In an exemplary embodiment only, the surgical site is the shoulder and the tissue is labrum  80  to be attached to glenoid  90  with exemplary surgical construct  100 . 
     Fixation of soft tissue to bone, such as fixation of labrum to glenoid, typically involves the formation of an incision to access the surgical site and then reattachment of the soft tissue. When soft tissue is attached to bone, the surgeon drills a cavity in the bone and inserts a fixation device such as a bone anchor. Typically, the bone anchor is formed of metal, composite, plastic or bioabsorbable material, and is held in place by threads or by barbs. If an anchor is employed, the anchor typically includes an eyelet through which construct  100  is then threaded/passed. 
     Fixation of tissue to bone is achieved by using the suturing construct  100  passed around tissue  80  without the need of nitinol wire loops or similar devices. The tapered elongated portion/region  25  allows the suturing construct  100  to be retrieved (with instrument  82  in  FIG. 6 , for example) after being passed through the same portal. After the formation of cinch stitch  55  ( FIG. 7 ) and the locking of the construct with laser cuts  66  penetrating inner surface area of loop  15 , the suturing construct  100  may be secured into bone  90  with one or more fixation devices (such as one or more suture anchors like anchor  70  of  FIG. 8 ) by passing tapered end region  25  through eyelet  77  and then securing the knotless fixation device  70  with suturing construct  100  in bone, to obtain final repair  300  ( FIG. 8 ). 
       FIG. 8  also illustrates an exemplary knotless fixation device  70  with an eyelet  77  that allows ends of flexible strand  10  (suture  10  of suturing construct  100 ) to pass therethrough and additionally aid in the fixation of the labrum  80  to the glenoid  90 . The flexible strands may be also secured by employing any number of fixation devices, knotless or otherwise, for example two fixation devices such as two knotless fixation devices  70  with two eyelets  77 , in lieu of the one fixation device. The technique may be repeated multiple times at different locations in the bone (i.e., multiple cinch stitches at different locations around the labrum). 
     A method of fixation of a first tissue to a second tissue with suturing construct  100 ,  200  comprises inter alia the steps of: (i) passing a suturing construct  100 ,  200  through or around the first tissue, the suturing construct consisting of a length of a flexible strand  10  having a first end and a second end, a small closed loop  15 ,  115  formed at the first end and having a fixed perimeter, a tapered region  25  formed at the second end, a splice  51  in a splice region  52  located adjacent the first end and the closed loop  15 ,  115  wherein the splice region (or a region adjacent the loop  115 ) includes a plurality of laser cuts  66  that prevent the flexible strand  10  from backing up, and a shuttling device  60  with a shuttling loop  61  attached to the flexible strand  10 ; (ii) passing the tapered end  25  of the flexible strand through shuttling loop  61 ; and (iii) pulling the shuttling device to allow the flexible strand to form a cinching loop  55  around tissue  80  and to lock laser cuts  66  to an inner surface of loop  15 ,  115 . The method may further comprise the steps of (iv) attaching the suturing construct  100 ,  200  to a knotless fixation device  70  by threading the tapered end  25  of the suturing construct  100 ,  200  through an eyelet  77  of the knotless fixation device; and (v) placing the knotless fixation device  70  with the attached suturing construct  100 ,  200  into a second tissue. 
     The suturing construct  100 ,  200  may be employed in surgical procedures such as rotator cuffrepair, Achilles tendon repair, and patellar tendon repair, among many others. Although the invention has been described with reference to a particular application (i.e., fixation of labrum to glenoid in a shoulder repair), it must be understood that the suture construct of the present invention has applicability to any type of repairs (any repair in addition to a shoulder repair) and, thus, the invention is not limited by this exemplary-only embodiment. 
     In an exemplary embodiment only, the fixation device  70  is a knotless suture anchor such as the two-piece Arthrex PushLock® anchor, disclosed in U.S. Pat. No. 7,329,272, or an Arthrex SwiveLock® anchor, disclosed in U.S. Pat. No. 8,012,174 issued Sep. 6, 2011, U.S. Pat. No. 9,005,246 issued Apr. 14, 2015, and US 2013/0296936 published Nov. 7, 2013, the disclosures of all of which are fully incorporated by reference in their entirety herein. 
     The suturing construct  100 ,  200  may be also employed with knotted fixation devices, for example, knotted anchors. Thus, the disclosure is not limited to the use of suturing construct  100 ,  200  with knotless fixation devices such as fixation device  70 , and the disclosure contemplates the use of suturing construct  100 ,  200  with any type of fixation device, knotless or knotted or combination of knotless and knotted fixation devices. The exemplary constructs of the present disclosure may be employed in various tissue repairs such as knotless rotator cuff repair with the SpeedBridge™ and SpeedFix™ repair techniques, or similar reattachment techniques of soft tissue to bone employing knotless fixation devices for the formation of single, double or multiple row constructs in arthroscopic rotator cuff repairs, or high demand applications like AC joint reconstruction and other areas where tissue pull-through may be a concern. 
     Flexible strands  10 ,  60  may be made of any known suture construct, such as multifilament, braided, knitted, woven suture, or including fibers of ultrahigh molecular weight polyethylene (UHMWPE) or the FiberWire® suture (disclosed in U.S. Pat. No. 6,716,234, the disclosure of which is hereby incorporated by reference in its entirety herein). 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 preferred FiberWire® suture includes a core within a hollow braided construct, the core being a twisted yarn of UHMWPE. Flexible strands  10 ,  60  may be also formed of 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, the disclosure of which is incorporated by reference in its entirety herein. Surgical construct  100 ,  200  can be used with any type of flexible material or suture known in the art. 
     The strands may be also formed of a stiff material, or combination of stiff and flexible materials, depending on the intended application. The strands may be also coated and/or provided in different colors. The strands may be also provided with tinted tracing strands, or otherwise contrast visually with the remaining elements of the construct, which could be a plain, solid color, or display a different tracing pattern, for example. Various structural elements of surgical construct  100 ,  200  may be visually coded, making identification and handling of the suture legs simpler. Easy identification of suture in situ is advantageous in surgical procedures, particularly during arthroscopic surgeries, such as endoscopy and laparoscopy. 
     Surgical construct  100 ,  200  may include surgical sutures or similar materials that may be coated (partially or totally) with wax (beeswax, petroleum wax, polyethylene wax, or others), silicone (Dow Corning silicone fluid  202 A or others), silicone rubbers (Nusil Med 2245, Nusil Med 2174 with a bonding catalyst, or others) 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. 
     Preferably, elongated tapered end  25  may have a very fine end that is coated, impregnated, or stiffened with a material such as plastic, for example. 
     The term “high strength suture” is defined as any elongated flexible member, the choice of material and size being dependent upon the particular application. For the purposes of illustration and without limitation, the term “suture” as used herein may be a cable, filament, thread, wire, fabric, or any other flexible member suitable for tissue fixation in the body.