Patent Publication Number: US-11642121-B2

Title: Tensionable knotless anchors and methods of tissue repair

Description:
RELATED APPLICATION 
     This is a divisional of U.S. application Ser. No. 15/352,246, filed on Nov. 15, 2016, which is a continuation-in-part of U.S. application Ser. No. 15/004,154, filed on Jan. 22, 2016, now U.S. Pat. No. 10,172,606, the subject matter of which are herein incorporated by reference in their entireties. 
    
    
     BACKGROUND 
     The present disclosure relates to surgical devices and methods and, more particularly, to surgical devices and methods for use in tissue repair. 
     SUMMARY 
     Surgical assemblies, systems and techniques for knotless soft tissue repair and fixation, such as fixation of soft tissue (ligament, tendon, graft, etc.) to bone, are disclosed. Surgical assemblies comprise tensionable knotless fixation devices that are inserted into bone. A tensionable knotless fixation device is provided with a tensioning construct (formed of a tensioning strand, a tensionable, adjustable, knotless, self-cinching loop, and a splice adjacent the loop) pre-loaded onto a fixation device. A flexible material (for example, suture or suture tape) may be attached to a fixation device. A flexible material may be threaded through an eyelet of a fixation device. 
     Methods of soft tissue repair which do not require tying of knots and allow adjustment of both tension of suture and location of tissue with respect to bone are also disclosed. 
     An exemplary method includes the steps of providing a first fixation device preloaded with a tensionable construct; providing a second fixation device with a non-pre-looped tensionable construct; anchoring the first and second fixation devices in bone such that the first and second fixation devices are arranged in a medial row; passing the pre-loaded tensionable construct of the first fixation device and the non-pre-looped tensionable construct of the second fixation device through tissue; threading a free end of a flexible strand of the non-pre-looped tensionable construct through a tensionable loop of the pre-looped tensionable construct and then subsequently passing the free end of the non-pre-looped tensionable construct through an eyelet of a passing device coupled with the flexible strand of the non-pre-looped tensionable construct; and pulling on a tail end of the passing device to thread the free end of the flexible strand of the first fixation device through a splice in itself, thereby forming two interlocking loops outside of the tissue. This exemplary method may also include the steps of preloading the first and second fixation devices with first and second flexible materials, respectively; passing first and second limbs of the first and second flexible materials through the tissue proximal to the pre-looped tensionable and non-pre-looped tensionable constructs; tightening or tensioning the two interlocking loops by pulling on a free end of the pre-looped tensionable construct and the free end of the non-pre-looped tensionable construct; and securing the first and second ends of the first and second flexible material to bone with additional fixation devices. 
     Other objects, advantages and salient features of the invention will become apparent from the following detailed description, which, taken in conjunction with the annexed drawings, discloses preferred embodiments of the present invention. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIGS.  1  and  2    illustrate an exemplary embodiment of a fixation device loaded onto a driver. 
         FIGS.  3  and  4    illustrate an exemplary embodiment of an anchor tip loaded with a tensioning construct. 
         FIGS.  5 - 8    illustrate an exemplary embodiment of an anchor tip. 
         FIGS.  9 - 11    illustrate another exemplary embodiment of an anchor tip (a 3.5 mm round eyelet). 
         FIGS.  12 - 14    illustrate another exemplary embodiment of an anchor tip (a 4 mm round eyelet). 
         FIGS.  15 - 18    illustrate another exemplary embodiment of an anchor tip (an elongated open eyelet, curved). 
         FIGS.  19 A- 19 D  illustrate an exemplary embodiment of a surgical assembly. 
         FIGS.  20 - 30    illustrate an exemplary method of tissue repair with the fixation device of  FIG.  1   . 
         FIGS.  31 A-B  illustrate pre-looped and non-pre-looped tensionable fixation devices in accordance with an exemplary embodiment of the present invention. 
         FIGS.  32 A- 32 D  illustrate exemplary method of tissue repair using the fixation devices of  FIGS.  31 A- 31 B . 
         FIGS.  33 A- 33 C  illustrate another exemplary method of tissue repair using the fixation devices of  FIGS.  31 A- 31 B . 
         FIGS.  34 A and  34 B  illustrate a further exemplary method of tissue repair with the tensionable fixation device of  FIGS.  31 A- 31 B . 
         FIG.  35    illustrates a driver and anchor assembly. 
         FIGS.  36 A and  36 B  illustrates a pre-looped tensionable loop assembly and a non-pre-looped tensionable loop assembly, respectively. 
         FIGS.  37 A and  37 B , and  FIGS.  37 C and  37 D , illustrate an anchor construct as a pre-looped tensionable loop construct, depicted after the anchor has been inserted into the bone, and an anchor construct that is non-pre-looped tensionable loop construct, depicted after the anchor has been inserted into the bone, respectively. 
     
    
    
     DETAILED DESCRIPTION 
     Surgical assemblies, systems and techniques for knotless soft tissue repair and fixation, such as fixation of soft tissue (ligament, tendon, graft, etc.) to bone, are disclosed. Surgical assemblies comprise tensionable knotless fixation devices that are inserted into bone. Tensionable knotless fixation devices are provided with a tensioning construct (formed of a tensioning strand, a tensionable, adjustable, knotless self-cinching loop, and a splice adjacent the loop) pre-loaded onto the fixation device. A flexible material (for example, suture or suture tape) may be attached to the fixation device, for example, by being threaded through an eyelet of the fixation device. 
     As detailed below, the surgical assemblies and devices disclosed allow for knotless fixation of tissue using an eyelet suture of a fixation device (for example, a suture anchor with an eyelet or a SwiveLock® anchor). A mechanism inside the suture eyelet is similar to the knotless tensionable construct of the SutureTak®, except that there is no post or similar device within the anchor body to allow suture to wrap around. The knotless tensionable construct passes the anchor body of modified SwiveLock® anchors. In this manner, the surgical assemblies and devices detailed below combine two technologies to provide a strong knotless repair, as well as a backup knotless repair separate from a first repair. 
     Methods of soft tissue repair which do not require tying of knots and allow adjustment of both the tension of the suture and the location of the tissue with respect to the bone are also disclosed. 
     A surgical assembly can include (i) a fixation device; (ii) a tensionable construct pre-loaded on the fixation device; and (iii) a flexible material (for example, suture or suture tape) attached to the fixation device. A flexible material may be also pre-loaded on the fixation device, and may be releasably attached to the fixation device, or securely fixed to it. The fixation device can include an anchor body insertable over an anchor tip, the anchor tip including a shaft attached to an anchor tip body, the anchor tip body being provided with first and second apertures or openings (for example, an eyelet oriented in a first direction and a through-hole or passage oriented in a second direction, which may be different from the first direction). A tensionable construct may be pre-loaded on the fixation device. The tensionable construct may consist of a flexible strand with a knot and a free end, a splice and an adjustable, tensionable, self-cinching, knotless, closed loop having an adjustable perimeter, located adjacent the splice. The tensionable construct passes through the anchor tip and extends through at least a portion of the anchor body of the fixation device. 
     The fixation device may be a SwiveLock® anchor as disclosed and described, for example, 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, with or without a modified eyelet in the anchor tip, and as detailed below. 
     The flexible material (suture construct) can be any suture strand or 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. However, the fixation devices detailed below can be used with any type of flexible material or suture known in the art. 
     The tensionable construct may use a mechanism similar to that of knotless SutureTak® but provides variations and improvements in the design of the tensioning construct. Details of the formation of an exemplary tensioning construct employed in the embodiments of the present invention detailed below are set forth in U.S. Pat. No. 9,107,653 issued Aug. 18, 2015; US 2013/0165972, entitled “Tensionable Knotless Anchor Systems and Methods of Tissue Repair;” and US 2013/0345750, entitled “Tensionable Knotless Labral Anchor and Methods of Tissue Repair,” the disclosures of all of which are incorporated by reference in their entirety herein. 
     The tensionable construct may be formed of a flexible strand or flexible material that is easily spliced through itself to form a splice and a knotless, self-cinching, adjustable, closed loop with an adjustable perimeter. The flexible strand or material may be made of any known suture material, such as ultrahigh molecular weight poly ethylene (UHMWPE) or FiberWire® suture (disclosed in U.S. Pat. No. 6,716,234 the disclosure of which is herein incorporated by reference in its entirety), and can be braided or multi-filament. For example, the suture can be UHWMPE suture without a core to permit ease of splicing. 
       FIG.  1    illustrates an exemplary embodiment of a fixation device  10  (tensionable knotless fixation device  10 ) seated on a driver  91 . Tensionable knotless fixation device  10  comprises an anchor body  20  and an anchor tip  30 , the anchor body  20  being insertable over the anchor tip  30 . A tensionable construct  50  (also referred to as “tensioning construct  50 ”) and a flexible material  70  are pre-loaded on the fixation device  10  to form surgical assembly  1 . Tensionable knotless fixation device  10  is seated on driver  91 . Driver  91  has a thin cannulated rod  92 , where anchor tip  30  is seated at the proximal end  94  of the thin cannulated rod  92 . Anchor body  20  is cannulated and is fully seated around thin cannulated rod  92 . 
     Tensionable construct  50  is pre-loaded onto the fixation device  10 , and extends through at least a portion of the fixation device. Flexible material  70  may be also pre-loaded onto the fixation device  10 . 
     Anchor tip  30  includes anchor tip body  31  attached to a cannulated shaft  36  (not shown in  FIG.  1   ), wherein the cannulated shaft  36  is at least partially disposed within thin cannulated rod  92  of driver  91 . Anchor tip body  31  is also provided with first and second through-holes, openings, or passages  32 ,  34 . In an exemplary embodiment, one of the first and second through-holes, openings, or passages is an eyelet  32  having a first orientation relative to a longitudinal axis of the anchor tip, and the other of the first and second-through holes, openings, or passages is a flexible material hole or passage  34  (a transverse opening  34 ) having a second orientation relative to a longitudinal axis of the anchor tip. In an exemplary embodiment, the first orientation is different from the second orientation. In another exemplary embodiment, the first orientation is about perpendicular to the second orientation. Eyelet  32  accommodates and houses tensionable construct  50 . Hole, opening, or passage  34  accommodates and houses flexible material  70 . 
       FIG.  2    illustrates another view of tensionable knotless fixation device  10  pre-loaded with tensionable construct  50  but without flexible material  70 . 
     During installation of fixation device  10 , anchor body  20  is assembled onto the operational end of the driver  91 . Anchor tip  30  is threaded or otherwise attached onto the tip of thin cannulated rod  92 . Anchor tip  30  is then placed within a prepared bone hole or tunnel until anchor tip  30  reaches the bottom of the bone hole or tunnel, or reaches the desired depth. At this point, anchor body  20  is still outside of the bone hole or tunnel. Anchor body  20  is then reduced down thin cannulated rod  92  (advanced down the cannulated rod to be insertable over the anchor tip  30 ) by holding a thumb pad (not pictured) as the inserter handle (not pictured) of the driver  91  is turned clockwise. When anchor body  20  is fully seated, cannulated shaft  36  of anchor tip  30  is fully engaged by cannulated anchor body  20 , creating a stable swivel construct of the fixation device  10  wherein anchor tip  30  is rotatably secured to anchor body  20 . 
     In an exemplary embodiment, anchor body  20  is cannulated and has a proximal end  22  and a distal end  24 , wherein proximal end  22  is the end closest to anchor tip  30 . The exterior  26  of anchor body  20  can be threaded, for example like a screw, or can be any suitable means for securing in a bone hole or tunnel, for example, in the form of circumferential ridges extending radially. The exterior  26  of anchor body  20  is responsible for both securing fixation device  10  in the bone hole or tunnel, as well as securing, by friction or interference fit, suture construct  70  against the bone wall and exterior  26  of anchor body  20 . 
     Anchor body  20  (in the form of a cannulated fixation device  20  or cannulated screw  20 ) may be pre-loaded onto the shaft of the driver. The anchor tip  30  (implant  30 ) is designed to be releasably attached (by a snap fit, for example) to a distal end of the driver and to swivel relative to the anchor body  20  (cannulated fixation device  20 ). The anchor tip (implant) with attached suture is anchored into bone by rotating the driver to rotate and advance the anchor body  20  (cannulated fixation device  20 ) while keeping the anchor tip  30  (implant  30 ) stationary, thereby securing the suture and providing tissue fixation without tying knots in the suture. The driver with the cannulated rod (passing slidably and rotatably through a cannulated driver assembly of the driver) has a tip adapted to accept the anchor tip  30  (implant  30 ), to allow the anchor tip  30  to be loaded onto the rod and be fully seated on an end of the shaft of the driver. 
     The anchor tip  30  (implant  30 ) is rotatably received within the anchor body  20  upon advancement of the anchor body  20  over a shaft of the anchor tip  30 , the anchor tip  30  being configured to receive the tensionable construct and the flexible material. The anchor tip has a closed aperture or eyelet to receive the flexible material (suture or suture tape) to be attached to bone. The anchor tip  30  may be a metal tip or non-metal tip (e.g., plastic or polymer), and the anchor body  20  may have a cylindrical, screw-like configuration (for example, a cannulated interference screw). 
     Flexible material  70  can comprise any type of flexible material or suture known in the art, preferably suture tape such as Arthrex FiberTape®, or combination of suture and suture tape, among many others. Flexible material  70  can be configured to be pre-loaded or threaded through eyelet  32  of anchor tip  30 . A first limb  72   a  and a second limb  72   b  pass outside of anchor body  20  and are secured against the bone wall and exterior  26  by friction or interference fit. In an exemplary embodiment, first limb  72   a  and second limb  72   b  can terminate into a single suture passing limb  74  to simplify passing each of limbs  72   a  and  72   b  through tissue. In this manner, both limbs  72   a  and  72   b  can be passed at the same time. After passing limb  74  is passed through tissue, it can be cut and removed, leaving first limb  72   a  and second limb  72   b  separated and passed through tissue. 
     In another embodiment, first limb  72   a  and second limb  72   b  do not terminate into a single passing limb, and are passed through tissue separately. In this embodiment, flexible material  70  may or may not be pre-loaded through eyelet  32  of anchor tip  30 . In another embodiment, first limb  72   a  and second limb  72   b  do not terminate into a single suture passing limb, but both are loaded into a suture passer together and passed together. 
       FIG.  3    illustrates an exemplary embodiment of anchor tip  30  with tensionable construct  50  preloaded onto anchor tip  30 . Tensionable construct  50  comprises a tensioning strand  52 , a tensionable loop  54 , a splice  55 , and fixed loop strands  56   a  and  56   b  of stand  56  attached to loop  54 . Fixed loop strands  56   a  and  56   b  pass through tensionable loop  54  and can terminate into a single loop strand  56 . Loop strand  56  and tensioning strand  52  can then terminate into a single tensioning construct passing limb  58 . In another embodiment, loop strands  56   a  and  56   b  do not terminate into a single loop strand  56 , but instead terminate along with tensioning strand  52  into tensioning construct passing limb  58 . In this embodiment, three limbs teiminate into one limb at the same place. Tensioning construct passing limb  58  can be passed through tissue and then cut and removed. Loop strands  56   a  and  56   b  can then be discarded, leaving tensioning strand  52  and tensionable loop  54  passed through the tissue. Multiple tensionable loop strands may be provided attached to loop  54  (for example, passed through the loop  54 ). Loop  54  is a knotless, tensionable, adjustable, self-cinching loop having an adjustable perimeter. 
     Tensionable construct  50  can be pre-loaded onto anchor tip  30  by tying static knot  60  on the outside of hole  34 . Tensioning strand  52 , tensionable loop  54 , splice  55 , and loop strands  56   a  and  56   b  pass through cannulated shaft  36  of anchor tip  30  and then through cannulated anchor body  20 , exiting fixation device  10  at distal end  24  of anchor body  20 .  FIG.  4    illustrates loop strands  56   a ,  56   b  terminating into loop strand  56 , and then loop strand  56  and tensioning strand  52  terminating into tensioning construct passing limb  58 . 
       FIGS.  5 - 18    illustrate various exemplary embodiments  30   a - 30   d  of anchor tip  30 . 
       FIGS.  5 - 8    illustrate exemplary embodiment  30   a  of anchor tip  30 . Anchor tip  30   a  can include eyelet  32   a , hole  34   a , and cannulated shaft  36   a . Hole  34   a  is positioned at the proximal tip of anchor tip  30   a . Cannulated shaft  36   a  can have an outer width  37   a  and an inner width  38   a , where inner width  38   a  represents how wide the hollow portion of cannulated shaft  36   a  is. In an exemplary embodiment, hole  34   a  can be wider than the inner width  38   a . In another exemplary embodiment, hole  34   a  and inner width  38   a  can be approximately the same width. In another exemplary embodiment, hole  34   a  can be narrower than inner width  38   a . Additionally, tip body  31   a  can be wider than outer width  37   a  of cannulated shaft  36   a . Proximal end  33   a  of anchor tip  30   a  can be wider than, about as wide as, or narrower than, outer width  37   a  of cannulated shaft  36   a . The size and shape of eyelet  32   a  can be any suitable size and shape. In the exemplary embodiment of  FIGS.  5 - 8   , eyelet  32   a  has two rounded ends, wherein first rounded end  40   a , located near proximal end  33   a  of anchor tip  30   a , is smaller than second rounded end  41   a  located near cannulated shaft  36   a.    
       FIGS.  9 - 11    illustrate another exemplary embodiment  30   b  of anchor tip  30 . Anchor tip  30   b  can include eyelet  32   b , hole  34   b , and cannulated shaft  36   b . Hole  34   b  is positioned at positioned at the proximal tip of anchor tip  30   b . Anchor tip  30   b  can further have a second hole  35   b  located on the side of anchor tip body  31   b . Cannulated shaft  36   b  can have an outer width  37   b  and an inner width  38   b , where inner width  38   b  represents how wide the hollow portion of cannulated shaft  36   b  is. In an exemplary embodiment, hole  34   b  can be wider than the inner width  38   b . In another exemplary embodiment, hole  34   b  and inner width  38   b  can be approximately the same width. In another exemplary embodiment, hole  34   b  can be narrower than inner width  38   b . Additionally, tip body  31   b  can be wider than outer width  37   b  of cannulated shaft  36   b . Proximal end  33   b  of anchor tip  30   b  can be wider than, about as wide as, or narrower than outer width  37   b  of cannulated shaft  36   b . The size and shape of eyelet  32   b  can be any suitable size and shape. In the exemplary embodiment of  FIGS.  9 - 11   , eyelet  32   b  has two rounded ends, wherein first rounded end  40   b , located near proximal end  33   b  of anchor tip  30   b , is smaller than second rounded end  41   b  located near cannulated shaft  36   b.    
       FIGS.  12 - 14    illustrate another example embodiment  30   c  of anchor tip  30 . Anchor tip  30   c  can include eyelets  32   c , hole  34   c , and cannulated shaft  36   c . Hole  34   c  is positioned at positioned at the proximal tip of anchor tip  30   c . Cannulated shaft  36   c  can have an outer width  37   c  and an inner width  38   c , where inner width  38   c  represents how wide the hollow portion of cannulated shaft  36   c  is. In an exemplary embodiment, hole  34   c  can be wider than the inner width  38   c . In another exemplary embodiment, hole  34   c  and inner width  38   c  can be approximately the same width. In another exemplary embodiment, hole  34   c  can be narrower than inner width  38   c . Additionally, tip body  31   c  can be wider than outer width  37   c  of cannulated shaft  36   c . Proximal end  33   c  of anchor tip  30   c  can be wider than, about as wide as, or narrower than outer width  37   c  of cannulated shaft  36   c . The size and shape of eyelets  32   c  can be any suitable size and shape. In the exemplary embodiment of  FIGS.  12 - 14   , eyelets  32   c  each have an approximately rectangular shape. 
       FIGS.  15 - 18    illustrate another exemplary embodiment  30   d  of anchor tip  30 . Anchor tip  30   d  can include eyelet  32   d , hole  34   d , and cannulated shaft  36   d . Hole  34   d  can be located on the side of anchor tip body  31   d . Cannulated shaft  36   d  can have an outer width  37   d  and an inner width  38   d , where inner width  38   d  represents how wide the hollow portion of cannulated shaft  36   d  is. Tip body  31   d  can be wider than outer width  37   d  of cannulated shaft  36   d . Proximal end  33   d  of anchor tip  30   d  can be wider than, about as wide as, or narrower than outer width  37   d  of cannulated shaft  36   d . The size and shape of eyelet  32   d  can be any suitable size and shape. In the exemplary embodiment of  FIGS.  15 - 18   , eyelet  32   d  has two rounded ends, wherein first rounded end  40   d , located near proximal end  33   d  of anchor tip  30   d , is smaller than second rounded end  41   d  located near cannulated shaft  36   d.    
       FIGS.  19 A-D  illustrate simplified steps of an exemplary surgical tissue repair  100  with at least one exemplary fixation device described above. The exemplary surgical repair includes a medial row with first and second medial fixation devices  10   a  and  10   b , and a lateral row with first and second lateral fixation devices  10   c  and  10   d . First and second medial fixation devices  10   a  and  10   b  can be any embodiment of fixation device  10  described herein, and can comprise anchor body  20 , anchor tip  30 , tensionable construct  50 , and flexible material  70 . 
     First and second lateral fixation devices  10   c  and  10   d  can be any suitable knotless fixation devices known in the art. For example, first and second lateral fixation devices  10   c  and  10   d  can be any embodiment of fixation device  10  described herein, or any Arthrex SwiveLock® anchors (as disclosed and described 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) or any Arthrex PushLock™ anchors (as described in U.S. Pat. No. 7,329,272 issued Feb. 12, 2008, the disclosure of which is fully incorporated herein by reference), or any combination of these devices. 
     First and second lateral fixation devices  10   c  and  10   d  do not have a tensioning construct or suture construct pre-loaded. Instead, first and second lateral fixation devices  10   c  and  10   d  are secured to the surgical assembly by limbs  72   a ,  72   b ,  72   c , and  72   d  of flexible materials  70   a  and  70   b . A first limb  72   a  of flexible material  70   a  and a first limb  72   c  of flexible material  70   b  are passed through an eyelet (not pictured) of first lateral fixation device  10   c  before the eyelet is loaded into a prepared bone tunnel or hole. Tension can be adjusted if necessary prior to advancing anchor body (not pictured) of lateral fixation device  10   c  into the prepared bone tunnel or hole. A second limb  72   b  of flexible material  70   a  and a second limb  72   d  of flexible material  70   b  are similarly passed through an eyelet (not pictured) of second lateral fixation device  10   d  before the eyelet is loaded into a prepared bone tunnel or hole. Tension can be adjusted if necessary prior to advancing anchor body (not pictured) of lateral fixation device  10   d  into the prepared bone tunnel or hole. First and second limbs  72   a  and  72   b  of flexible material  70   a  pass through tensionable loop  54   a  and thus can be tensioned by pulling tensioning strand  52   a . Similarly, first and second limbs  72   c  and  72   d  of flexible material  70   b  pass through tensionable loop  54   b  and can be tensioned by pulling tensioning strand  52   b . Thus, the final surgical assembly of repair  100  ( FIG.  19 D ) having four fixation devices is secured by flexible materials  70   a  and  70   b , while tensioning constructs  50   a  and  50   b  provide additional tensioning capabilities in addition to providing a backup knotless repair separate from the repair by flexible materials  70   a  and  70   b.    
     Methods of soft tissue repair utilizing the surgical assemblies and devices described above are also disclosed.  FIGS.  20 - 30    illustrate more detailed steps of an exemplary embodiment of a tissue repair method to achieve final repair  200  ( FIG.  30   ). 
       FIG.  20    illustrates target tissue  90  and bone  99  with two prepared medial bone holes  111  and  112 , with first tensionable knotless fixation device  10   a  implanted into prepared medial bone hole  111 . Fixation device  10   a  has an anchor tip and anchor body (not visible since they have been implanted into prepared medial bone hole  111 ), tensionable construct  50   a , and flexible material  70   a . Tensionable construct has tensioning strand  52   a , tensionable loop  54   a , splice  55   a , and loop strands  56   a  and  56   b . Not pictured is the termination of the limbs into a single tensioning construct passing limb. Flexible material  70   a  has first limb  72   a  and second limb  72   b . Not pictured is the termination of the limbs into a single flexible material passing limb. Tissue  90  may be soft tissue such as rotator cuff, for example. 
       FIG.  21    illustrates the step of passing tensionable construct  50   a  through tissue  90  (for example, tendon, ligament, graft, etc.). In an exemplary embodiment, tensioning strand  52   a  and loop strands  56   a  and  56   b  terminate into a single tensioning construct passing limb  58   a . Tensioning construct passing limb  58   a  is loaded into any suitable suture passer known in the art, for example the Arthrex Scorpion™ suture passer. Suture passer  120  is positioned in the desired location on the target tissue and tensioning construct passing limb  58   a  is passed through target tissue  90 . In embodiments where tensioning strand  52   a  and loop strands  56   a  and  56   b  do not terminate into a single tensioning construct passing limb, then each strand may be passed separately, or loaded into a suture passer capable of passing multiple strands simultaneously. 
       FIG.  22    illustrates tensioning construct passing limb  58   a  passed through target tissue  90 . Tensioning construct passing limb  58   a  is pulled through target tissue such that tensioning strand  52   a  and tensionable loop  54   a  also pass through target tissue  90 . 
       FIG.  23    illustrates the step of removing tensioning construct passing limb  58   a  from tensionable construct  50   a . Cutting tensioning construct passing limb  58   a  leaves three strands: loop strands  56   a ,  56   b , and tensioning strand  52   a . Loop strands  56   a  and  56   b  wrap around tensionable loop  54   a  and may be discarded.  FIG.  24    illustrates tensioning construct  50   a  with tensioning strand  52   a  and tensionable loop  54   a  passed through tissue  90 , and loop strands  56   a  and  56   b  having been discarded. First and second limbs  72   a  and  72   b  of flexible material  70   a  have not yet been passed through tissue  90 . 
       FIG.  25    illustrates the step of passing flexible material  70   a  through tissue  90 . In an exemplary embodiment, first and second limbs  72   a  and  72   b  of flexible material  70   a  can terminate into a single flexible material passing limb  74   a . Passing limb  74   a  is loaded into any suitable suture passer known in the art, for example the Arthrex Scorpion™ suture passer. Suture passer  120  is positioned at a location on the target tissue adjacent or near where tensioning construct  50   a  was passed, and passing limb  74   a  is passed through target tissue  90 . In embodiments where first and second limbs  72   a  and  72   b  do not terminate into a passing limb, then each limb may be passed separately, or loaded into a suture passer capable of passing multiple limbs simultaneously. 
       FIG.  26    illustrates tensioning strand  52   a , tensionable loop  54   a , and first and second limbs  72   a  and  72   b  all passed through tissue  90 . Passing limb  74   a  has been cut and removed, leaving first and second limbs  72   a  and  72   b  separated. 
       FIG.  27    illustrates the step of retrieving first and second limbs  72   a  and  72   b  through tensionable loop  54   a . First and second limbs  72   a  and  72   b  can be retrieved using any retriever known in the art, for example the Arthrex FiberTape® Retriever. After being loaded into retriever  130 , limbs  72   a  and  72   b  are pulled through tensionable loop  54   a.    
       FIG.  28    illustrates the previously described steps having been repeated and completed for a second medial fixation device  10   b . Second medial fixation device  10   b  has an anchor tip and anchor body (not visible since they have been implanted into prepared medial bone hole  112 ), tensionable construct  50   b , and flexible material  70   b . Tensionable construct has tensioning strand  52   b , tensionable loop  54   b , splice  55   b , and loop strands (not pictured since they have already been discarded). Flexible material  70   b  has first limb  72   c  and second limb  72   d.    
     Once first and second medial fixation devices  10   a  and  10   b  have been implanted, and tensioning strands  52   a  and  52   b , tensionable loops  54   a  and  54   b , splices  55   a  and  55   b , and limbs  72   a ,  72   b ,  72   c , and  72   d  have been passed through tissue  90 , lateral bone holes can be prepared for first and second lateral fixation devices  10   c  and  10   d . Lateral fixation devices  10   c  and  10   d  can be any suitable fixation devices, for example any embodiment of fixation device  10  described herein, or any Arthrex SwiveLock® anchors (as disclosed and described, for example, 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), or any Arthrex PushLock™ anchors (as described in U.S. Pat. No. 7,329,272 issued Feb. 12, 2008, the disclosure of which is fully incorporated herein by reference), or any screw-in or push-in type anchors, or any combination of these devices. 
     First and second lateral fixation devices  10   c  and  10   d  do not have a tensionable construct or flexible material (suture tape) pre-loaded. Instead, first and second lateral fixation devices  10   c  and  10   d  are secured to the surgical assembly by limbs  72   a ,  72   b ,  72   c , and  72   d  of flexible material  70   a  and  70   b . First limb  72   a  of flexible material  70   a  and a first limb  72   c  of flexible material  70   b  are passed through an eyelet (not pictured) of first lateral fixation device  10   c  before the eyelet is loaded into a prepared bone hole. Tension can be adjusted if necessary prior to advancing anchor body (not pictured) of lateral fixation device  10   c  into the prepared bone hole. Second limb  72   b  of flexible material  70   a  and a second limb  72   d  of flexible material  70   b  are similarly passed through an eyelet (not pictured) of the second lateral fixation device  10   d  before the eyelet is loaded into a prepared bone hole. Tension can be adjusted if necessary prior to advancing anchor body (not pictured) of lateral fixation device  10   d  into the prepared bone hole. 
     After first and second lateral fixation devices  10   c  and  10   d  have been fixated/inserted/implanted, the resulting surgical assembly is shown in  FIG.  28   . Any remainder of limbs  72   a ,  72   b ,  72   c , and  72   d  extending out from lateral fixation devices  10   c  and  10   d  may be cut off using any suitable suture cutter, for example the Arthrex FiberWire® cutter.  FIG.  28    also illustrates the step of pulling tensioning strand  52   a  to tighten tensionable loop  54   a  in order to apply tension to first and second limbs  72   a  and  72   b.    
       FIG.  29    illustrates the step of pulling tensioning strand  52   b  to tighten tensionable loop  54   b  in order to apply tension to first and second limbs  72   c  and  72   d  of suture construct  70   b.    
       FIG.  30    illustrates the final surgical repair  200 . Tensionable loops  54   a  and  54   b  have been tensioned, and tensioning strands  52   a  and  52   b  have been cut to remove them from the final assembly. Tensioning strands  52   a  and  52   b  can be cut using any suitable suture cutter, for example the Arthrex FiberWire® cutter. 
     An exemplary method of tissue repair comprises inter alia the steps of: (i) inserting into bone a surgical assembly comprising a fixation device; a tensionable construct pre-loaded on the fixation device, the tensionable construct including a tensioning strand, a knotless, adjustable, self-cinching, tensionable loop having an adjustable perimeter, and a splice adjacent the loop; and a flexible material (for example, suture tape) attached to the fixation device; and (ii) passing the tensionable construct and limbs of the flexible material around or through tissue to be fixated (or reattached) to bone, so that the tensionable loop is positioned over the tissue, and then passing limbs of the flexible material through the tensionable loop. The method may further comprise the step of securing the limbs of the flexible material into bone. The limbs may be secured with at least another fixation device that is inserted into bone. The method may further comprise the step of pulling on the tensioning strand to appropriate tissue to bone. The tissue may be soft tissue such as tendon, ligament, or graft. 
     Another exemplary method of soft tissue repair comprises inter alia the steps of: (i) inserting into bone a surgical assembly comprising a fixation device; a tensionable construct pre-loaded on the fixation device, the tensionable construct including a tensioning strand, a knotless, adjustable, self-cinching, tensionable loop having an adjustable perimeter, and a splice adjacent the loop; and a flexible material (for example, suture tape) attached to the fixation device; (ii) passing the tensionable construct and limbs of the flexible material around or through tissue to be fixated (or reattached) to bone so that the tensionable loop is positioned above and over the soft tissue, and above and over the bone; (iii) subsequently, passing limbs of the flexible material through the tensionable loop; and (iv) passing the limbs of the flexible material over the tissue and securing the limbs with additional fixation devices into bone, to form a mattress stich repair. 
     Another exemplary method of soft tissue repair comprises inter alia the steps of: (i) inserting into bone a plurality of surgical assemblies, each surgical assembly comprising a fixation device; a tensionable construct pre-loaded on the fixation device, the tensionable construct including a tensioning strand, a knotless, adjustable, self-cinching, closed, tensionable loop having an adjustable perimeter, and a splice adjacent the loop; and a flexible material (for example, suture or suture tape) attached to the fixation device; (ii) passing the tensionable construct and limbs of the flexible material—of each surgical assembly—around or through tissue to be fixated (or reattached) to bone, so that the tensionable loop of each surgical assembly is positioned over and above the soft tissue, and over and above the bone; (iii) subsequently, passing limbs of the flexible material of each surgical assembly through the corresponding tensionable loop; and (iv) passing the limbs of each surgical assembly over the tissue, and securing the limbs with a plurality of fixation devices into bone, to form a mattress stich repair. 
     The flexible strands and materials described above may be formed of strands of high strength suture material with surgically-useful qualities, including knot tie down characteristics and handling, such as Arthrex FiberWire® suture disclosed in U.S. Pat. No. 6,716,234, the disclosure of which is 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) fibers, braided with at least one other fiber, natural or synthetic, to form lengths of suture material. The flexible strand may be a high-strength suture, such as an ultrahigh molecular weight polyethylene (UHMWPE) suture which is the preferred material as this material allows easy splicing. 
     The suture constructs may be formed of optional colored strands, such as black or blue, to assist surgeons in distinguishing between suture lengths with the trace and suture lengths without the trace. Preferably, each of the limbs may be provided in different colors to assist surgeons in retrieving one limb from each of the knotless fixation devices and then loading them through another knotless fixation device, during the formation of the criss-cross suturing pattern. 
     Suture constructs 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. 
     Suture constructs 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. 
     The surgical assembly and methods of the present invention have applicability to tissue repairs such as rotator cuff repair, Achilles tendon repair, patellar tendon repair, knee repairs such as ACL and/or PCL reconstruction, hip and shoulder reconstruction procedures, and applications involving repairing soft tissue to bone. 
       FIG.  31 A  illustrates a tensionable fixation device  102  with a pre-loaded tensionable loop (pre-looped tensionable fixation devices), and  FIG.  31 B  illustrates another type of tensionable fixation device without a pre-loaded tensionable loop (non-pre-looped tensionable fixation device)  202  used in methods of tissue repair illustrated in  FIGS.  32 A- 32 D ,  FIGS.  33 A- 33 C , and  FIGS.  34 A and  34 B , in accordance with various exemplary embodiments as disclosed. The methods of  FIGS.  32 A- 32 D,  33 A- 33 C, and  34 A and  34 B  are more secure than conventional knot repairs, are faster than conventional repairs thus saving time and money in the OR, eliminate the potential of knots impinging against adjacent structures and causing irritation or damage, and eliminate any knot failures of the repair. 
     As seen in  FIG.  31 A , the pre-looped tensionable suture anchor fixation device  102  that preferably includes an anchor body  120  that receives an anchor tip  130 . The anchor tip  130  preferably includes an eyelet body  132  having an eyelet  160  sized to receive a flexible member  170  ( FIG.  33 A ). The tensionable pre-looped suture anchor fixation device  102  supports a tensionable construct  150  in a shaft  136  of the anchor body  120 . The tensionable pre-looped suture  150  may include a flexible strand  152  and a pre-looped tensionable loop  154  spliced through a flexible strand  152 . The flexible strand  152  may have a knotted end  156  that engages the eyelet body  132  of the anchor tip  130  to prevent the strand  152  from pulling through the anchor body  120 , and a free end  158  opposite the knotted end  156 . Both the free end  158  and at least a portion of the tensionable loop  154  extend outside of the fixation device  102 . 
     As seen in  FIG.  31 B , the non-pre-looped tensionable suture anchor fixation device  202  may include an anchor body  220  and an anchor tip  230  (having an anchor tip body  232  and knotted end  256 ), similar to pre-looped tensionable fixation device  102 . The anchor tip  230  may include an eyelet body  232  having an eyelet  160  sized to receive a flexible member  172  ( FIG.  33 A ). The non-pre-looped tensionable suture anchor fixation device  202  supports a non-pre-looped tensionable construct  250  in a shaft  236  within the anchor body  220 . The -non-pre-looped tensionable suture construct  250  may include a flexible strand  252  that has a knotted end  256  engaging the eyelet body  232  of the anchor tip  230 , and an opposite free end  258 . The flexible strand  252  is preferably coupled with a passer device  260 . The passer device  260  may be any known suture shuttling or puller that includes an eyelet  262  and a tail end  264  opposite the eyelet  262 . The passer device  260  may be threaded through a splice in the flexible strand  252 . The free end  258  of the flexible strand  252  and both the eyelet  262  and tail end  264  of the passer device  260  are outside of the anchor body  220 . 
       FIGS.  32 A- 32 D  illustrate an exemplary method of tissue repair using the pre-looped and non-pre-looped tensionable fixation devices  102  and  202  of  FIGS.  31 A and  31 B , respectively. As seen in  FIG.  32 A , the pre-looped and non-pre-looped tensionable fixation devices  102  and  202  are preferably pre-loaded with constructs  150  and  250 , respectively, and are anchored in bone  99 , preferably in a medial row. The tensionable construct  150  of the pre-looped tensionable fixation device  102  is passed through a target area in the tissue  90  (soft tissue layer). The construct  250  of the non-pre-looped tensionable fixation device  202  is passed through another target area in the tissue  90 . Once passed through the tissue  90 , the pre-looped tensionable loop  154  (or a portion thereof) and the free end  158  of the pre-looped tensionable construct  150 , and the free end  258 , the passer device eyelet  262  and tail end  264  of the non-pre-looped tensionable construct  250 , are above or outside of the tissue  90 . A cannula  300  may be optionally provided to facilitate management of the constructs  150  and  250 . 
     Once the constructs  150  and  250  are passed through the tissue  90 , interlocking loops are formed by first threading the free end  258  of the non-pre-looped tensionable construct  250  through the tensionable loop  154  of the tensionable pre-threaded construct  150  and then threading the free end  258  back through the eyelet  262  of the passer device  260  of the non-pre-threaded tensionable construct  250 , as seen in  FIG.  32 B . The tail end  264  of the passer device  260  can then be pulled away from the repair to thread the free end  258  of the strand  252  through itself (as shown by arrows in  FIG.  32 B ), thereby forming two interlocking loops, as seen in  FIG.  32 C . Those loops may then be tightened by pulling on the free ends  158  and  258 , as seen in  FIG.  32 C , thereby providing a secure suture on the tissue repair. 
       FIG.  32 D  illustrates an optional step of further securing the free ends  158  and  258  of the constructs  120  and  250 , respectively, once tightened on the repair, by employing additional fixation devices  302  to fix the free ends  158  and  258  to bone  99 . The additional fixation devices  302  may be any known fixation device, such as SwivelLock C suture anchors. Cinch-loop sutures ( 90 ) may be placed and fixed to the lateral row anchor to eliminate dog ears. The fixation devices  302  are preferably arranged in a lateral row so that the free ends  158  and  258  of the constructs  120  and  250  may cross one another and be secured via fixation devices  302  to form a suture bridge that links the medial row of suture anchors to the lateral row of suture anchors. 
       FIGS.  33 A- 33 D  illustrate another exemplary method of tissue repair using the tensionable and non-tensionable fixation devices  102  and  202  of  FIG.  31    and incorporating flexible materials  170  and  172 . As seen in  FIG.  33 A , once the fixation devices  102  and  202  are anchored to bone  99  and the constructs  150  and  250  are passed through the tissue  90 , the limbs  170   a  and  170   b  of flexible material  170  may be passed through the tissue  90  proximal to the tensionable construct  150 , and the limbs  172   a  and  172   b  of flexible material  172  may be passed through the tissue  90  proximal to the non-tensionable construct  250 . As seen in  FIG.  33 B , two interlocking loops of the constructs  150  and  250  are formed in the same manner as disclosed above regarding the embodiment of  FIGS.  32 A- 32 D . The limbs  170   a ,  170   b  of flexible material  170  and limbs  172   a ,  172   b  of flexible material  172  may be passed through the tissue either before or after the interlocking loops of the constructs  150  and  250  are formed and are preferably passed through the tissue before the interlocking loops of the constructs  150  and  250  are fully tensioned or tightened. Once the interlocking loops of the constructs  150  and  250  are fully tensioned to form a load sharing rip-stop on the repair, the limbs  170   a ,  170   b  of flexible material  170  and limbs  172   a ,  172   b  of flexible material  172  may be pulled over the rip-stop of constructs  150  and  250  to be secured to additional fixation devices  302  anchored in bone  99 . In this embodiment, the flexible materials  170  and  172 , such as suture tape, act as the primary securing sutures for the tissue repair. The additional fixation devices  302  may be arranged in a lateral row in bone  99  and the limbs  170   a ,  170   b  of flexible material  170  and limbs  172   a ,  172   b  of flexible material  172  may cross one another to form a bridge to compress the underlying tissue against the bone. For example, the limb  170   a  and the limb  172   a  may be secured to one of the additional fixation devices  302  and the limb  170   b  and the limb  172   b  may be secured to the other of the additional fixation devices  302 , as seen in  FIG.  33 C . 
       FIGS.  34 A and  34 B  illustrate yet another exemplary method of tissue repair using two tensionable fixation devices  150 . Unlike the embodiments of  FIGS.  32 A- 32 D and  33 A- 33 C , the embodiment of  FIGS.  34 A and  34 B  do employ a tensionable fixation device. As seen in  FIG.  34 A , two of tensionable fixation devices  102  are preloaded with constructs  150  and anchored in bone  99  and the constructs  150  are passed through the tissue  90 . The tensionable loops  154  of each construct  150  are passed separately though two different target areas in the tissue  90  and then tied together with a knotted segment  304 . A cannula  300  may be used to facilitate management of the constructs  150  outside of the tissue  90 . Once the loops  154  are tied together, they are brought down or over the tissue  90  by pulling on the free ends  158  and  258  of the tensionable constructs  150 , as seen in  FIG.  34 B . The knotted segment  304  preferably remains in an open loop, thereby facilitating sliding of the interlinked loops  154  on each other as the loops are tensioned. 
       FIG.  35    illustrates a driver and anchor assembly construct. A thumb pad  302  is located below the handle  304  of the assembly construct. The assembly construct includes a reverse threaded sleeve  300 , which serves to drive an anchor body  120 , such as a screw-in anchor body (such as a SwiveLock anchor), into a solid surface, such as into a bone. Located on the eyelet body  180  is a hole  156 , through which a knotted suture  256  will exit. The knotted suture  256  functions to fix a distal end of a tensionable suture loop to the anchor body  120 . A tensionable suture loop as part of the assembly construct may be provided by including a pre-threaded tensionable suture loop, so as to provide a construct assembly having a “pre-looped” tensionable loop. Alternatively, a tensionable loop that is not pre-threaded may be included with the assembly construct, so as to provide a “non-pre-looped” tensionable loop version of the assembly construct. In the non-pre-looped tensionable loop construct assembly configuration, the tensionable loop will be formed after the anchor body  120  has been inserted into a surface, such as inserted into bone. The driver and anchor body assembly would take on the same general appearance in both the pre-looped and non-pre-looped tensionable loop construct assembly. A knotted suture end  256  exiting a hole  156  in the side of the eyelet body  180  of the tip  190 , serves to fix a distal strand of a tensionable loop (either pre-looped or non-pre-looped tensionable loop construct), to the anchor body  120 . An eyelet  160  is provided within the eyelet body  180  of the tip  190 . 
       FIG.  36 A  illustrates a pre-looped tensionable loop assembly  150  and  FIG.  36 B  illustrates a non-pre-looped tensionable loop assembly  250 . The pre-looped tensionable loop assembly  150  includes a tensionable loop  154  that has been pre-threaded through a splice region  155 . A knotted suture end  156  at the eyelet body  180  serves to fix the distal strand of the tensionable loop  154  within a suture anchor. 
       FIG.  36 B  illustrates the non-pre-looped tensionable loop assembly  250  that includes a looped end  262  of a passing strand  210  (passing strand may be a FiberLink passer strand or a Nitinol wire passer strand). The free end  264  of the passing strand  300  and the main fixation suture limb  258  are provided as part of the non-pre-looped tensionable loop assembly. The main fixation suture limb  258  will be threaded through a splice region  255  of the suture after passing the suture limb  258  through the soft tissue that is to be secured. A knotted suture end  256  at the eyelet body  180  serves to fix a distal end of the tensionable loop once formed 
       FIG.  37 A  illustrates the suture anchor and tensionable loop (pre-looped tensionable loop version) construct configuration after the suture anchor  150  has been inserted into a surface, such as into a bone.  FIG.  37 B  presents the eyelet body  130  that includes an eyelet  132 , through which a suture limb  170  is passed. Also depicted is the knotted suture end  156  present on the suture body  130 . 
       FIG.  37 C  illustrates the suture anchor and tensionable loop (non-pre-looped tensionable loop version) construct configuration  250  after the suture anchor  220  has been inserted into a surface, such as into a bone. The main fixation suture  258  will be threaded through the splice region  255  of the suture  252 , after the main fixation suture is passed through or around an adjacent or surrounding penetrable material, such as through or around a soft tissue. The free passing end  264  of the passing strand is shown extending out of the suture anchor shaft  350  of the suture anchor  220 . The looped end  262  of the passing strand is also shown extending out of the suture anchor shaft  350  of the suture anchor  220 . The passing strand may be of a FiberLink passer material or a nitinol wire passer material. An eyelet  232  is provided at a tip  190  provided as part of the construct configuration, and includes an eyelet body  230 . Located on the eyelet body  230  is a knotted suture end  256 .  FIG.  37 D —illustrates a detailed view of the tip  190 . The tip  190  is shown to include an eyelet body  230  and an eyelet  232 , through which a suture  172  may be passed. A knotted suture end  256  is shown at the eyelet body  230 . The knotted suture end  256  of the passing suture strand serves to fix the distal end of the tensionable loop, and to maintain a continued tension between the suture and suture anchor after the suture anchor is implanted. This continued tension serves to enhance the self-locking mechanism at the suture splice  255 . 
     A surgical kit is disclosed that may include one or more of the fixation devices  102  and  202  preloaded with the tensionable pre-looped and tensionable non-pre-looped constructs  150  and  152 , respectively. One or more of the additional fixation devices  302  may also be provided with the kit along with the optional cannula  300 . 
     While particular embodiments have been chosen to illustrate the invention, it will be understood by those skilled in the art that various changes and modifications can be made therein without departing from the scope of the invention as defined in the appended claims.