Patent Abstract:
The present disclosure describes a suture passer device that includes a handle, a shaft extending from the handle, a suture carrier secured to the handle and extending through the shaft, and a suturing head extending from the shaft and configured to retain tissue. The handle is operable to advance the suture carrier through the suturing head to pass a suture through tissue retained in the suturing head. According to one aspect of the present disclosure, the suture passer device includes a quick-connect mechanism releasably connecting the shaft to the handle. According to another aspect of the present disclosure, the shaft includes a first shaft and a second shaft pivotally coupled to the first shaft, and the first shaft defines a first channel for receiving the second shaft. Methods of disassembling the suture passer device are also described.

Full Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     The present disclosure is related to U.S. patent application Ser. No. 14/137,277, entitled “Suture Passer with Tissue Reinforcement Positioner”, filed Dec. 20, 2013. The entire disclosure of the application referenced above is incorporated herein by reference. 
     FIELD 
     The present disclosure relates to a suture passer with tissue reinforcement positioner. 
     BACKGROUND 
     This section provides background information related to the present disclosure which is not necessarily prior art. 
     Various devices and methods are known for suturing soft tissue in connection with arthroscopic, endoscopic, or other surgical procedures. These and other small-incision or less invasive surgical procedures generally require that suturing and the associated manipulation of suturing are performed in confined areas which are not easily accessible. 
     Although the existing devices can be satisfactory for their intended purposes, there is still a need for procedures and devices that provide greater control in the passage of sutures, greater control in the passage of delicate sutures, and increased flexibility in the types and thicknesses of tissues that can be sutured in ordinary and in less invasive procedures. 
     SUMMARY 
     This section provides a general summary of the disclosure, and is not a comprehensive disclosure of its full scope or all of its features. 
     The present disclosure describes a suture passer device that includes a handle, a shaft extending from the handle, a suture carrier secured to the handle and extending through the shaft, and a suturing head extending from the shaft and configured to retain tissue. The handle is operable to advance the suture carrier through the suturing head to pass a suture through tissue retained in the suturing head. According to one aspect of the present disclosure, the suture passer device includes a quick-connect mechanism releasably connecting the shaft to the handle. According to another aspect of the present disclosure, the shaft includes a first shaft and a second shaft pivotally coupled to the first shaft, and the first shaft defines a first channel for receiving the second shaft. Methods of disassembling a suture passer device are also described. 
     Further areas of applicability will become apparent from the description provided herein. The description and specific examples in this summary are intended for purposes of illustration only and are not intended to limit the scope of the present disclosure. 
    
    
     
       DRAWINGS 
       The drawings described herein are for illustrative purposes only of selected embodiments and not all possible implementations, and are not intended to limit the scope of the present disclosure. 
         FIG. 1  is a side view of a suture passer device according to the principles of the present disclosure; 
         FIG. 2  is an exploded isometric view of the suture passer device shown in  FIG. 1 ; 
         FIG. 3A  is an isometric view of a suturing head of the suture passer device with an upper jaw in an open position and a suture carrier in a retracted position; 
         FIG. 3B  is a section view taken along line  3 B shown in  FIG. 3A ; 
         FIG. 4A  is an isometric view of the suturing head with the upper jaw in a closed position and the suture carrier in an extended position; 
         FIG. 4B  is a section view taken along line  4 B shown in  FIG. 4A ; 
         FIG. 5  is an isometric view of a handle assembly of the suture passer device with a trigger and a rear handle in released positions; 
         FIG. 6  is a side view of the handle assembly with the trigger and the rear handle in applied positions; 
         FIG. 7  is an isometric view of a proximal end of a shaft assembly of the suture passer device disconnected from a distal end of the handle assembly; 
         FIG. 8  is a side view of the proximal end of the shaft assembly connected to the distal end of the handle assembly; 
         FIG. 9  is a side view of an alternative embodiment of the shaft assembly and the handle assembly with a proximal end of the shaft assembly disconnected from a distal end of the handle assembly; 
         FIG. 10  is a side view of the alternative embodiment of the shaft assembly and the handle assembly with the proximal end of the shaft assembly connected to the distal end of the handle assembly; 
         FIG. 11  is an isometric view of the proximal end of the shaft assembly with an inner shaft inserted into an outer shaft; 
         FIG. 12  is an isometric view of a proximal end of a shaft assembly with the inner shaft removed from the outer shaft; 
         FIG. 13  is an isometric view of the suturing head with the upper jaw in the open position and positioning a tissue reinforcement construct, the suture carrier in the retracted position, a suture extending through a lower jaw, and soft tissue disposed between the lower jaw and the upper jaw; 
         FIG. 14  is an isometric view of the suturing head in the closed position, the soft tissue being held between the upper and lower jaws, and the suture carrier in the extended position and passing a portion of the suture through the soft tissue and the tissue reinforcement construct; 
         FIG. 15A  is an end view of the suturing head passing two portions of a suture through soft tissue and the tissue reinforcement construct, the suture extending through a suture anchor secured in a hole in bone; 
         FIG. 15B  is an end view of the two portions of the suture tied in a knot to form an adjustable loop that secures the soft tissue to the bone; 
         FIG. 16A  is an end view of the suturing head passing adjustable loops of a suture construct through soft tissue and the tissue reinforcement construct, the suture construct extending through a suture anchor secured in a hole in bone, and a locking member position adjacent to the loops; 
         FIG. 16B  is an end view of the locking member extending through the loops and preventing the loops from being pulled through the soft tissue and the tissue reinforcement member as the loops are tightened; 
         FIG. 17A  is an isometric view of the suturing head with the upper jaw in the open position and positioning a tissue reinforcement construct, the suture carrier in the retracted position, and a first end of a flexible suture anchor of a suture construct extending through the lower jaw; 
         FIG. 17B  is an isometric view of the suturing head in the closed position, the soft tissue being held between the upper and lower jaws, and the suture carrier in the extended position and passing the first end of the flexible suture anchor through the soft tissue and the tissue reinforcement construct; 
         FIG. 17C  is an isometric view of a plurality of suture constructs extending through soft tissue and the tissue reinforcement construct, with the suturing head passing a portion of one of the suture constructs through the soft tissue and the tissue reinforcement construct as illustrated in  FIG. 17B ; 
         FIG. 18A  is an isometric view similar to that shown in  FIG. 13  but illustrating an alternative embodiment of a suturing head having teeth for positioning the tissue reinforcement construct instead of a slot; and 
         FIG. 18B  is a side view similar to that shown in  FIG. 14  but illustrating the alternative embodiment of the suturing head. 
         FIG. 19A  is an isometric view similar to that shown in  FIG. 13  but illustrating a second alternative embodiment of a suturing head for positioning the tissue reinforcement construct instead of a slot; and 
         FIG. 19B  is a side view similar to that shown in  FIG. 14  but illustrating a second alternative embodiment of the suturing head. 
         FIG. 20A  is an isometric view similar to that shown in  FIG. 13  but illustrating a third alternative embodiment of a suturing head having teeth for positioning the tissue reinforcement construct instead of a slot; and 
         FIG. 20B  is a side view similar to that shown in  FIG. 14  but illustrating a third alternative embodiment of the suturing head. 
     
    
    
     Corresponding reference numerals indicate corresponding parts throughout the several views of the drawings. 
     DETAILED DESCRIPTION 
     Example embodiments will now be described more fully with reference to the accompanying drawings. 
     Referring now to  FIGS. 1, 2, 3A, 3B, 4A, and 4B , a suture passer device  10  includes a handle assembly  12 , a suture carrier  14 , a shaft assembly  16 , and a suturing head  18 . The handle assembly  12  includes a front handle  20 , a rear handle  22 , a trigger  24 , and a handle spring  26 . The shaft assembly  16  includes an outer shaft  28 , an inner shaft  30 , a shaft spring  32 , and a washer  34 . The spring  32  and the washer  34  can be welded to the inner shaft  30 . The suturing head  18  includes an upper jaw  36  and a lower jaw  38 . The handle assembly  12  is operable to actuate the upper jaw  36  of the suturing head  18  from an open position ( FIG. 3 ) to a closed position ( FIG. 4 ) in order to clamp or engage soft tissue between the upper and lower jaws  36 ,  38 . The handle assembly  12  is also operable to actuate the suture carrier  14  from a retracted position ( FIG. 3 ) to an extended position ( FIG. 4 ) to pass a suture  40  through soft tissue that is clamped or held between the upper and lower jaws  36 ,  38 . 
     The suture carrier  14  includes a proximal body  42  having a round plinth, disk, or hockey puck shape, a cylindrical body  44 , and a flat, elongate body  45 . The proximal body  42  is disposed at the proximal end of the suture carrier  14  and is configured to be retained within a pocket  46  in the rear handle  22 . The cylindrical body  44  is attached to the proximal body  42  and extends from the proximal body  42  to the elongate body  45 . The elongate body  45  is attached to the cylindrical body  44  using, for example, a weld  47 , and extends from the cylindrical body  44  to the distal end of the suture carrier  14 . The elongate body  45  has a notch  48  adjacent to its distal end for holding the suture  40  and a pointed tip  50  at its distal end for piercing a hole in soft tissue so that the suture carrier  14  and the suture  40  can be passed through the tissue. The proximal body  42  can be made from plastic, and the cylindrical and elongate bodies  44 ,  45  can be made from a flexible material such as Nitinol or a flexible polymer. 
     With particular reference to  FIGS. 3A, 3B, 4A, and 4B , the upper jaw  36  of the suturing head  18  includes teeth  52 , a tissue reinforcement member holder  54 , a suture carrier receptacle  56 , and a suture retaining mechanism  58 . The teeth  52  are configured to bite into or grip soft tissue when the upper jaw  36  is in the closed position. The tissue reinforcement member holder  54  is configured to position a tissue reinforcement member  60  ( FIGS. 13 and 14 ) so that the suture carrier  14  and the suture  40  pass through the tissue reinforcement member  60  after passing through soft tissue held between the upper and lower jaws  36 ,  38 . In various implementations, the tissue reinforcement member holder  54  can also or alternatively be included in the lower jaw  38 . 
     The tissue reinforcement member holder  54  can be a slot  61  having open lateral sides  61   a ,  61   b , an open distal end  61   c , and a closed proximal end  61   d . The tissue reinforcement member  60  can be inserted into the slot  61 . In turn, the slot  61  can hold the tissue reinforcement member  60  while allowing the tissue reinforcement member  60  to be slidably adjustable in a lateral direction through the open sides  61   a ,  61   b.    
     The tissue reinforcement member  60  can be made from a flexible material such as woven, knitted, or braided polyester tape or a non-woven or non-braided material (such as felt), collagen fiber, or other reinforcement member. The tissue reinforcement member  60  is configured to increase the strength of a repair by reinforcing soft tissue. For example, a portion of the suture  40  may be passed through soft tissue and tied in a knot, and the tissue reinforcement member  60  may increase the force required to pull the knot through the soft tissue. The tissue reinforcement member  60  can be one of the example locking members described in U.S. Pat. Pub. No. 2011/0208240 (see, e.g., FIGS. 4 through 9), the disclosure of which is incorporated herein by reference in its entirety. The tissue reinforcement member  60  can be a mesh such as a SportMesh™ Soft Tissue Reinforcement, available from Arthrotek®, a Biomet® company of Warsaw, Ind. 
     The suture carrier receptacle  56  can be an opening in the upper jaw  36 . The suture carrier receptacle  56  can extend through portions of the upper jaw  36  disposed above and below the slot  61 . The suture carrier  14  and the suture  40  can be passed through the suture carrier receptacle  56  after passing through soft tissue held between the upper and lower jaws  36 ,  38 . 
     The suture retaining mechanism  58  prevents unintentional movement of the suture  40  out of the upper jaw  36  by maintaining the suture  40  at or near the suturing head  18 . In one embodiment, the suture retaining mechanism  58  can be a flap  62  that fits over the suture carrier receptacle  56 . The flap  62  can be made of a resilient and flexible material, such as spring steel, Nitinol, or a flexible polymer. The suture carrier  14  can be passed into the receptacle  56 , temporarily disrupting a suture engaging portion  64  of the flap  62  from a closed position in contact with the upper jaw  36  to an open position spaced apart from the upper jaw  36 . In turn, the flap  62  can pull the suture  40  through soft tissue held between the upper and lower jaws  36 ,  38 . The suture carrier  14  can then be retracted through the suture carrier receptacle  56 , allowing the suture engaging portion  64  to return to the closed position. In turn, the flap  62  biases the suture  40  against the receptacle  56  to prevent the suture  40  from being pulled back through the receptacle  56 . 
     The upper jaw  36  can be rotatably or pivotally coupled to the outer shaft  28  of the shaft assembly  16  using a pin  80 , and the lower jaw  38  of the suturing head  18  can be integrally formed with the outer shaft  28 . The shaft assembly  16  and the suturing head  18  can be made from metal. The lower jaw  38  can include a suture carrier channel  82  and a suture receptacle  84 . The suture carrier channel  82  can guide the suture carrier  14  as the suture carrier  14  is advanced and retracted through the lower jaw  38 . The suture carrier channel  82  includes a ramped portion  86  that directs the suture carrier  14  through the suture carrier receptacle  56  in the upper jaw  36 . The suture receptacle  84  can be an opening or slot formed into the lower jaw  38 . The suture  40  can be passed through the receptacle  84  before being received in the notch  48  in the suture carrier  14 . 
     With particular reference to  FIGS. 3B and 4B , the inner shaft  30  can also be rotatably or pivotally coupled to the outer shaft  28  using the pin  80 . The inner shaft  30  can define an elongate slot  88 , and the pin  80  can extend through the slot  88 . The slot  88  allows the inner shaft  30  to move distally or proximally relative to the outer shaft  28 . The length of the slot  88  can correspond to the amount of longitudinal movement of the inner shaft  30  required to actuate the upper jaw  36  between the open position and the closed position. 
     The upper jaw  36  can be rotatably or pivotally coupled to the inner shaft  30  using a pin  90 . Thus, as the inner shaft  30  axially moves distally relative to the outer shaft  28 , the upper jaw  36  rotates or pivots from the open position to the closed position. In this regard, the connections at the pins  80 ,  90  convert linear movement of the inner shaft  30  into rotational movement of the upper jaw  36 . 
     Referring now to  FIGS. 5 and 6 , the trigger  24  of the handle assembly  12  can be actuated from a released position ( FIG. 5 ) to an applied position ( FIG. 6 ) in order to actuate the upper jaw  36  from the open position to the closed position. In this regard, the trigger  24  can be rotatably or pivotally coupled to the front handle  20  using a pin  100 , and the trigger  24  can include a hammer portion  102  that is received within a slot  104  ( FIG. 2 ) in the inner shaft  30 . As the trigger  24  is actuated from the released position to the applied position, the hammer portion  102  pushes the inner shaft  30  distally relative to the outer shaft  28 . Then, as discussed above, the distal movement of the inner shaft  30  causes the upper jaw  36  to rotate or pivot from the open position to the closed position. 
     The shaft spring  32  can be captured between a proximal end  106  of the outer shaft  28  and the washer  34 . The washer  34  can define a slot  108  ( FIG. 2 ) configured to receive the inner shaft  30 . The width of the slot  108  can be less than the width of the inner shaft  30  to yield a press fit between the washer  34  and the inner shaft  30  that fixes the washer  34  onto the inner shaft  30 . Thus, when the trigger  24  is released, the biasing force of the shaft spring  32  acting on the washer  34  axially moves the inner shaft  30  proximally. Since the hammer portion  102  of the trigger  24  is received within the slot  104  in the inner shaft  30 , the proximal movement of the inner shaft  30  moves the hammer portion  102  proximally and returns the trigger  24  to the released position. 
     The rear handle  22  can be actuated from a released position ( FIG. 5 ) to an applied position ( FIG. 6 ) in order to actuate the suture carrier  14  from the retracted position to the extended position. In this regard, the rear handle  22  can be rotatably or pivotally coupled to the front handle  20  using a pin  110 , and the handle spring  26  can bias the rear handle  22  toward the released position. As the rear handle  22  is actuated from the released position to the applied position, the engagement between the proximal body  42  of the suture carrier  14  and the rear handle  22  moves the suture carrier  14  from the retracted position to the extended position. 
     The handle spring  26  can be a leaf spring and the shaft spring  32  can be a coil spring, as shown. Alternatively, both the handle spring  26  and the shaft spring  32  can be coil springs. In various embodiments, the spring rate of the handle spring  26  is less than the spring rate of the shaft spring  32 . Thus, if the rear handle  22  and the trigger  24  are applied at the same time, the upper jaw  36  rotates or pivots to the closed position before the suture carrier  14  advances to the extended position. This facilitates clamping soft tissue between the upper and lower jaws  36 ,  38  before passing the suture carrier  14  and the suture  40  through the soft tissue. 
     Referring again to  FIGS. 1 and 2 , a proximal end  112  of the shaft assembly  16  can be easily disconnected from a distal end  114  of the handle assembly  12 , and the outer shaft  28  can be rotated or pivoted away from the inner shaft  30 . This facilitates cleaning, disinfecting, and sterilizing the suture passer device  10 . In various implementations, the front handle  20 , the rear handle  22 , and the trigger  24  can be made from plastic. In these implementations, after a surgery, the shaft assembly  16  can be disconnected from the handle assembly  12 , and the handle assembly  12  can be discarded. 
     Referring now to  FIGS. 7 and 8 , the proximal end  112  of the shaft assembly  16  can be inserted into a cylindrical channel  120  in the front handle  20  and releasably connected to the handle assembly  12  using a quick-connect mechanism such as a bayonet mount. In this regard, the outer shaft  28  can define a pair of J-shaped slots  122  (only one shown) disposed on opposite sides of the outer shaft  28 , and the front handle  20  can include pins  124  extending into the cylindrical channel  120 . To connect the shaft assembly  16  to the handle assembly  12 , the open ends  126  of the J-shaped slots  122  can be aligned with the pins  124 . The proximal end  112  of the shaft assembly  16  can then be inserted into the cylindrical channel  120  until the pins  124  contact radial surfaces  128  of the J-shaped slots  122 . The shaft assembly  16  can then be rotated relative to the handle assembly  12  until the pins  124  contact closed ends  130  of the J-shaped slots  122 . 
     As discussed above, the shaft spring  32  may be captured between the proximal end  106  of the outer shaft  28  and the washer  34 . The biasing force of the shaft spring  32  may urge the outer shaft  28  distally, thereby engaging the pins  124  with the closed ends  130  of the J-shaped slots  122 . Thus, to disconnect the shaft assembly  16  from the handle assembly  12 , the outer shaft  28  can be moved by hand further into the cylindrical channel  120  to overcome the biasing force of the shaft spring  32  and disengage the pins  124  from the closed ends  130  of the J-shaped slots  122 . The shaft assembly  16  can then be rotated relative to the handle assembly  12  until the pins  124  contact longitudinal surfaces  132  of the J-shaped slots  122 . The proximal end  112  of the shaft assembly  16  can then be withdrawn from the cylindrical channel  120 . 
     Referring to  FIGS. 9 and 10 , an alternative embodiment of a releasable connection between the shaft assembly  16  and the handle assembly  12  is illustrated. In this embodiment, the proximal end  112  of the shaft assembly  16  includes pins  134  (only one shown) disposed on opposite sides thereof, and the distal end  114  of the handle assembly  12  defines L-shaped slots  136 . To connect the shaft assembly  16  to the handle assembly  12 , the pins  134  are aligned with open ends  138  of the L-shaped slots  136 . The proximal end  112  of the shaft assembly  16  can then be inserted into the cylindrical channel  120  until the pins  134  contact radial surfaces  140  of the L-shaped slots  136 . The shaft assembly  16  can then be rotated relative to the handle assembly  12  until the pins  134  contact closed ends  142  of the L-shaped slots  136 . Although not shown in  FIGS. 9 and 10 , the shaft spring  32  may bias the outer shaft  28  distally, thereby maintaining the engagement between the pins  134  and the closed ends  142  of the L-shaped slots  136 . 
     To disconnect the shaft assembly  16  from the handle assembly  12 , the shaft assembly  16  can be rotated relative to the handle assembly  12  until the pins  134  contact longitudinal surfaces  144  of the L-shaped slots  136 . The proximal end  112  of the shaft assembly  16  can then be withdrawn from the cylindrical channel  120  in the front handle  20 . Although not shown in  FIGS. 9 and 10 , the shaft spring  32  may bias the outer shaft  28  distally, thereby forcing the proximal end  112  of the shaft assembly  16  out of the cylindrical channel  120  in the front handle  20 . 
     Referring now to  FIGS. 11 and 12 , the proximal end  112  of the shaft assembly  16  is illustrated with the inner shaft  30  inserted into the outer shaft  28  ( FIG. 11 ) and the inner shaft  30  rotated or pivoted away from the outer shaft  28  ( FIG. 12 ). The embodiment shown in  FIGS. 11 and 12  is the same embodiment that is shown in  FIGS. 7 and 8  with the J-shaped slots  122  defined in the outer shaft  28  near the proximal end  112  of the shaft assembly  16 . The outer shaft  28  can also define a U-shaped channel  150  that is configured to receive the inner shaft  30 . The inner shaft  30  can also define a U-shaped channel  152 . When the inner shaft  30  is inserted into the U-shaped channel  150  in the outer shaft  28 , the U-shaped channels  150 ,  152  can cooperate to define a fully enclosed channel for guiding the suture carrier  14 . The ability to pivot the inner shaft  30  away from the outer shaft  28  exposes interior features, such as the U-shaped channels  150 ,  152 , and makes it easier to disassemble and assemble components of the shaft assembly  16 . In turn, the shaft assembly  16  can be easily cleaned, disinfected, and sterilized. 
     As discussed above, the shaft spring  32  may be captured between the proximal end  106  of the outer shaft  28  and the washer  34 . Thus, when the shaft assembly  16  is disconnected from the handle assembly  12 , the biasing force of the shaft spring  32  can hold the inner shaft  30  in the U-shaped channel  150  of the outer shaft  28 , as shown in  FIG. 11 . However, the proximal end  106  of the outer shaft  28  may be pulled upward by hand to rotate the outer shaft  28  away from the inner shaft  30 . When the outer shaft  28  is rotated away from the inner shaft  30 , as shown in  FIG. 12 , the shaft spring  32  is allowed to relax. Thus, before rotating the outer shaft  28  back toward the inner shaft  30 , the shaft spring  32  may be compressed by hand to avoid interference between the shaft spring  32  and the U-shaped channel  150  in the outer shaft  28 . 
     Referring now to  FIGS. 13 and 14 , the suture passer  10  is illustrated with the tissue reinforcement member  60  positioned or slidably received in the slot  61  in the upper jaw  36 , and soft tissue  160  positioned between the upper and lower jaws  36 ,  38 . The slot  61  in the upper jaw  36  of the suture passer  10  can aid in the positioning of the tissue reinforcement member  60  before, during, and after passing the suture  40  through the soft tissue  160 . The suture passer  10  can be used to pass the suture  40  through the soft tissue  160  and the tissue reinforcement member  60  substantially simultaneously. For example, using only one hand placed on the handle assembly  12 , the suture carrier  14  can be advanced to pass the suture  40  through the soft tissue  160  and the tissue reinforcement member  60  in a single, continuous operation or motion. In addition, using only the suture passer  10 , the tissue reinforcement member  60  can be positioned in the path of the suture carrier  14 , and the suture carrier  14  can be advanced to pass the suture  40  through the soft tissue  160  and the tissue reinforcement member  60 . Thus, a second instrument is not required to hold the tissue reinforcement member  60 . Since the suture passer  10  accomplishes the functions of multiple tools while requiring minimal space, the suture passer  10  can be used in an arthroscopic surgery or an open surgery. 
     In an example method of using the suture passer  10 , the reinforcement member  60  is slidably inserted into the slot  61  in the upper jaw  36 , and the suture  40  is inserted into the suture receptacle  84  in the lower jaw  38 , as shown in  FIG. 13 . The upper jaw  36  is then closed to clamp and retain the soft tissue  160  between the upper and lower jaws  36 ,  38  while simultaneously positioning the tissue reinforcement member  60 . The suture carrier  14  is then advanced through the suture carrier channel  82  in the lower jaw  38  and the receptacle  56  in the upper jaw  36 . As the suture carrier  14  advances through the lower jaw  38 , the notch  48  in the suture carrier  14  catches the suture  40 . Thus, as the suture carrier  14  advances through the receptacle  56  in the upper jaw  36 , the suture carrier  14  passes the suture  40  through both the soft tissue  160  and the tissue reinforcement member  60  substantially simultaneously, as shown in  FIG. 14 . The suture carrier  14  passes the suture  40  from a first side  160   a  of the soft tissue  160  to a second side  160   b  of the soft tissue  160 . As the suture carrier  14  retracts through the receptacle  56  in the upper jaw  36 , the suture retention mechanism  58  prevents the suture  40  from retracting with the suture carrier  14  and maintains the suture  40  on the second side  160   b  of the soft tissue  160 . 
     Referring now to  FIGS. 15A and 15B , an example method of using the suture passer  10  and the suture  40  to attach the soft tissue  160  to bone  162  is illustrated. First, a suture anchor  164  can be secured within a hole  166  formed in the bone  162 . The suture anchor  164  can be a hard, rigid anchor or a soft, deformable anchor. The hole  166  can be pre-formed or formed by external threads  168  on the anchor  164 . The suture  40  can be passed through a hole  170  in the anchor  164  before or after the anchor  164  is secured to the bone  162 . 
     The tissue reinforcement member  60  can then be inserted into the slot  61  in the upper jaw  36  of the suture passer  10 , and a first end  172  of the suture  40  can be inserted into the suture receptacle  84  in the lower jaw  38 . The upper jaw  36  can then be closed to clamp or retain the soft tissue  160  between the upper and lower jaws  36 ,  38 . The suture carrier  14  can then be advanced to pass the first end  172  of the suture  40  through both the soft tissue  160  and the tissue reinforcement member  60  substantially simultaneously. The suture carrier  14  can then be retracted. 
     The suture passer  10  can then be moved along the length of tissue reinforcement member  60  in a direction X without removing the member  60  from the slot  61  in the upper jaw  36  since the slot  61  has the open sides  61   a ,  61   b . The suture passer  10  can then be used to pass a second end  174  of the suture  40  through the soft tissue  160  and the tissue reinforcement member  60 . After the first and second ends  172 ,  174  of the suture  40  are passed through the soft tissue  160  and the tissue reinforcement member  60 , the first and second ends  172 ,  174  can be tied in a slip knot  176  to form an adjustable loop  178 . The size of the loop  178  can be decreased to bring the soft tissue  160  closer to the bone  162 . The tissue reinforcement member  60  prevents the knot  176  and the suture  40  from being pulled through the soft tissue  160  while the suture  40  is under tension. 
     Referring now to  FIGS. 16A and 16B , an example method of using the suture passer  10  and a suture construct  180  to attach the soft tissue  160  to bone  162  is illustrated. First, the suture construct  180  can be passed through the hole  170  in the suture anchor  164 , and the anchor  164  can be secured within the hole  166  in the bone  162 . The suture construct  180  can be formed of a monofilament, a braided fiber or strand, or other flexible material. The suture construct  180  can include a first end  182 , a second end  184 , a first adjustable loop  186 , a second adjustable loop  188 , and a braided body  200 . The braided body  200  of the suture construct  180  can define a longitudinal passage  202  extending between a first opening  204  and a second opening  206 . 
     The first and second ends  182 ,  184  and the braided body  200  can be integrally formed as a single braided construct using a braiding process for braiding fibers composed of a biocompatible material. The openings  204 ,  206  can be created during the braiding process as loose portions between pairs of fibers. The longitudinal passage  202  can be a portion of a longitudinal passage that extends along the entire length of the suture construct  180 . 
     Before forming the adjustable loops  186 ,  188 , the braided body  200  can be positioned within the hole  170  in the anchor  164 . The first adjustable loop  186  can then be formed by passing the first end  182  through the longitudinal passage  202  in the direction from the second opening  206  to the first opening  204 . Similarly, the second adjustable loop  188  can be formed by passing the second end  184  through the longitudinal passage  202  in the direction from the first opening  204  to the second opening  206 . 
     A second suture anchor  164 ′ can also be secured within a hole  166 ′ in the bone  162 , and a suture construct  180 ′ can be passed through a hole  170 ′ in the anchor  164 ′ and arranged to form two adjustable loops  186 ′,  188 ′ as described above. The suture passer  10  can then be used to pass the adjustable loops  186 ,  188 ,  186 ′,  188 ′ through the soft tissue  160  and the single, elongated tissue reinforcement member  60  as shown in  FIG. 16A . The suture passer  10  can be moved along the length of the tissue reinforcement member  60  in the direction X without removing the member  60  from the slot  61  in the upper jaw  36  since the slot  61  has the open sides  61   a ,  61   b . To this end, the suture passer  10  can be slid axially along the length of the tissue reinforcement member  60  as the member  60  passes through the open sides  61   a ,  61   b  of the slot  61 . 
     After the adjustable loops  186 ,  188 ,  186 ′,  188 ′ are passed through the soft tissue  160  and the tissue reinforcement member  60 , a locking member  208  can be passed through and positioned within the adjustable loops  186 ,  188 ,  186 ′,  188 ′. The locking member  208  can be one of the example locking members described in the U.S. Pat. Pub. No. 2011/0208240 (see, e.g., FIGS. 4 through 9), the disclosure of which is incorporated herein by reference in its entirety. The adjustable loops  186 ,  188 ,  186 ′,  188 ′ can be self-locking adjustable loops (e.g., self-locking adjustable loops that have no knots). Examples of self-locking adjustable loops are disclosed in U.S. Pat. No. 7,658,751 and U.S. Pat. No. 7,601,165, the disclosures of which are incorporated herein by reference in their entirety. 
     When the locking member  208  is positioned within the adjustable loops  186 ,  188 ,  186 ′,  188 ′, the ends  182 ,  184 ,  182 ′,  184 ′ can be pulled to decrease the sizes of the adjustable loops  186 ,  188 ,  186 ′,  188 ′, respectively, and thereby bring the soft tissue  160  closer to the bone  162 . The size of the adjustable loops  186 ,  188 ,  186 ′,  188 ′ can be decreased until the soft tissue  160  is in contact with the bone  162  as shown in  FIG. 16B . The tissue reinforcement member  60  and the locking member  208  prevent the adjustable loops  186 ,  188 ,  186 ′,  188 ′ from being pulled through the soft tissue  160  as the size of the adjustable loops  186 ,  188 ,  186 ′,  188 ′ is decreased and after the repair is made. 
     Referring now to  FIGS. 17A, 17B, and 17C , an example method of using the suture passer  10  and a flexible loop construct  210  to attach the soft tissue  160  to bone  162  is illustrated. The flexible loop construct  210  can include a first flexible anchor  212 , a second flexible anchor  214 , and a suture construct  216 . Examples of flexible anchors and suture constructs are disclosed in U.S. Pat. Pub. No. 2011/0098727, the disclosure of which is incorporated herein by reference in its entirety. The flexible anchors  212 ,  214  may be a JuggerKnot™ Soft Anchor, available from Biomet® of Warsaw, Ind. The first flexible anchor  212  has a first end  218 , a second end  220 , a first opening  222 , a second opening  224 , and a longitudinal passage  226  extending between the first and second openings  222 ,  224 . The first end  218  can be longer than the second end  220 . The second flexible anchor  214  has a first end  228 , a second end  230 , a first opening  232 , a second opening  234 , and a longitudinal passage  236  extending between the openings  232 ,  234 . 
     The suture construct  216  can include a first end  237 , a second end  238 , adjustable loops  240 ,  241 , and a braided body  242 . The braided body  242  can define a first opening  244 , a second opening  246 , and a longitudinal passage  248  extending between the first and second openings  244 ,  246 . The first and second ends  237 ,  238  and the braided body  242  can be integrally formed as a single braided construct using a braiding process for braiding fibers composed of a biocompatible material. The openings  244 ,  246  can be created during the braiding process as loose portions between pairs of fibers. The longitudinal passage  248  can be a portion of a longitudinal passage that extends along the entire length of the suture construct  216 . 
     To form the flexible loop construct  210 , the suture construct  216  can be inserted through the longitudinal passage  236  in the second flexible anchor  214  until the braided body  242  is positioned within the longitudinal passage  236 . To form the adjustable loop  240 , the first end  237  of the suture construct  216  can be inserted through the longitudinal passage  226  in the first flexible anchor  212  in the direction from the first opening  222  to the second opening  224 . The first end  237  can then be inserted through the longitudinal passage  248  in the braided body  242  in the direction from the second opening  246  to the first opening  244 . To form the adjustable loop  241 , the second end  238  of the suture construct  216  can be inserted through the longitudinal passage  226  in the first flexible anchor  212  in the direction from the second opening  224  to the first opening  222 . The first end  237  can then be inserted through the longitudinal passage  248  in the braided body  242  in the direction from the first opening  244  to the second opening  246 . 
     After the flexible loop construct  210  is formed, the first end or tail  218  of the first flexible anchor  212  can be inserted through the suture receptacle  84  in the lower jaw  38 , as shown in  FIG. 17A . The upper jaw  36  can then be closed, and the suture carrier  14  can be advanced using only one hand to pass the tail  218  of the first flexible anchor  212  through both the soft tissue  160  and the tissue reinforcement member  60  simultaneously, as shown in  FIG. 17B . An instrument such as forceps can then be used to grab the tail  218  and pull the remainder of the first flexible anchor  212  through the soft tissue  160  and the tissue reinforcement member  60 . 
     Before or after the first flexible anchor  212  is passed through the soft tissue  160  and the tissue reinforcement member  60 , the second flexible anchor  214  can be inserted into the hole  166  in the bone  162 . Tension can then be applied to the first and second ends  237 ,  238  of the suture construct  216  to decrease the size of the adjustable loops  240 ,  241  and thereby bring the soft tissue  160  closer to the bone  162 . As tension in the adjustable loops  240 ,  241  increases, the flexible anchors  212 ,  214  deform as shown in  FIG. 17C . This prevents the first flexible anchor  212  from being pulled through the tissue reinforcement member  60  and prevents the second flexible anchor  214  from being pulled out of the hole  166  in the bone  162 . 
     After the suture passer  10  is used to pass the first flexible anchor  212  through the soft tissue  160  and the tissue reinforcement member  60 , the suture passer  10  can be moved in a direction X without removing the member  60  from the slot  61  in the upper jaw  36 . The suture passer  10  can then be used to pass first flexible anchors  212 ′,  212 ″,  212 ′″ of flexible loop constructs  210 ′,  210 ″,  210 ′″ through the soft tissue  160  and the tissue reinforcement member  60  in the manner described above. The bone  162  may be a humerus, and  FIG. 17C  may illustrate a rotator cuff repair. The suture passer  10  can also be used to repair an Achilles tendon or to attach soft tissue to soft tissue. 
     Referring now to  FIGS. 18A and 18B , a suturing head  250  is illustrated that is similar to the suturing head  18  except that the suturing head  250  includes an upper jaw  252  instead of the upper jaw  36 . The upper jaw  252  is similar to the upper jaw  36  except the upper jaw  252  includes a tissue reinforcement member holder  253  formed as teeth  254  on the underside of the upper jaw  252 . The teeth  254  are configured to bite into or grip the tissue reinforcement member  60  when the tissue reinforcement member  60  is positioned on the teeth  254  as shown in  FIG. 18A . Thereafter, the teeth  254  hold or retain the tissue reinforcement member  60  to fix the tissue reinforcement member  60  to the upper jaw  252 . The teeth  254  can have barbed or hooked ends that enable the teeth  254  to hold the tissue reinforcement member  60 . The teeth  254  can also be configured to bite into or grip the soft tissue  160  when the upper jaw  252  is closed while the soft tissue is position between the upper and lower jaws  252 ,  38 . For example, the length of the teeth  254  can be greater than the thickness of the tissue reinforcement member  60 . The teeth  254  can position or hold the tissue reinforcement member  60  in the path of the suture carrier  14  so that, when the upper jaw  252  is closed and the suture carrier  14  is advanced, the suture carrier  14  is passed through the tissue reinforcement member  60  as shown in  FIG. 18B . 
     Referring now to  FIGS. 19A and 19B , a suturing head  260  is illustrated that is similar to the suturing head  18  except that the suturing head  250  includes an upper jaw  262  instead of the upper jaw  36 . The upper jaw  262  includes teeth  264 , a suture carrier receptacle  266 , and a suture retaining mechanism  268 . The teeth  264  are configured to bite into or grip the soft tissue  160  when the upper jaw  262  is in its closed position. 
     In various implementations, the upper jaw  262  can also include a tissue reinforcement member holder  270 . The tissue reinforcement member holder  270  is configured to position the tissue reinforcement member  60  so that the suture carrier  14  and the suture  40  pass through the tissue reinforcement member  60  after passing through soft tissue held between the upper and lower jaws  262 ,  38 . The tissue reinforcement member holder  270  may be a slot  272 , as shown, which is similar to the slot  61  in the upper jaw  36  of the suturing head  18 . 
     The suture carrier receptacle  266  can be an opening in the upper jaw  36 . The suture carrier receptacle  266  can extend through portions of the upper jaw  262  disposed above and below the slot  272 . The suture carrier  14  and the suture  40  can be passed through the suture carrier receptacle  266  after passing through soft tissue held between the upper and lower jaws  262 ,  38 . 
     The suture retaining mechanism  268  prevents unintentional movement of the suture  40  out of the upper jaw  262  by maintaining the suture  40  at or near the suturing head  18 . The suture retaining mechanism  268  can be made of a resilient and flexible material, such as spring steel, Nitinol, or a flexible polymer. The suture retaining mechanism  268  can include a distal end  274 , a proximal end  276 , teeth  278 , a wide, substantially flat, rectangular body  280 , a narrow, substantially flat, rectangular body  282 , a first pin-receiving portion  284 , and a second pin-receiving portion  286 . The teeth  278  can be disposed at the distal end  274  and can be configured to engage the suture  40  to maintain the suture  40  at or near the suturing head  18 . 
     The suture carrier  14  can be passed into the receptacle  266 , temporarily disrupting the distal end  274  of the suture retaining mechanism  268  from a closed position ( FIG. 19A ) in contact with the upper jaw  262  to an open position ( FIG. 19B ) spaced apart from the upper jaw  262 . The suture carrier  14  can then be retracted through the receptacle  266 , allowing the distal end  274  to return to its closed position. In turn, the suture retaining mechanism  268  biases the suture  40  against the receptacle  266  to prevent the suture  40  from being pulled back through the receptacle  266 . The suture retaining mechanism  268  can include ears  288  extending from the rectangular body  280  and configured to engage stops  290  on the upper jaw  262  disposed on opposite sides of the receptacle  266  as the distal end  274  returns to its closed position. 
     The first pin-receiving portion  284  includes a first cylindrical portion  292  defining a first pin hole  294 , a neck portion  296  extending from the rectangular body  280  to the first cylindrical portion  292 , and a tail  298  extending from the first cylindrical portion  292 . The second pin-receiving portion  286  includes a second cylindrical portion  300  attached to the rectangular body  280  and defining a second pin hole  302 . A first pin  304  can be inserted into a first pin hole  306  in the upper jaw  262  and into the first pin hole  294  in the suture retaining mechanism  268  to couple the suture retaining mechanism  268  to the upper jaw  262  adjacent to the distal end  274  of the mechanism  268 . A second pin  308  can be inserted into a second pin hole  310  in the upper jaw  262  and into the second pin hole  302  in the suture retaining mechanism  268  to couple the proximal end  276  of the mechanism  268  to the upper jaw  262 . 
     Thus, the suture retaining mechanism  268  can be coupled to the upper jaw  262  using two pin connections disposed at or near the distal and proximal ends  274 ,  276  of the mechanism  268 . In turn, if the suture retaining mechanism  268  fractures at a location between the two pin connections, such as at the junction between the rectangular bodies  280 ,  282 , the two portions of the suture retaining mechanism  268  on opposite sides of the fracture remain coupled to the upper jaw  262 . Therefore, the design of the upper jaw  262  ensures that no portion of the suture retaining mechanism  268  is left inside of a patient in the event of a fracture. 
     As the distal end  274  moves from its closed position to its open position, the first pin-receiving portion  284  rotates counterclockwise about the first pin  304 , the rectangular body  282  flexes downward, and the second pin-receiving portion  286  moves distally. The first pin-receiving portion  284  can rotate counterclockwise about the first pin  304  until the tail  298  on the first pin-receiving portion  284  contacts a ledge  312  on the upper jaw  262 . In this regard, the ledge  312  on the upper jaw  262  can act as a stop that limits counterclockwise rotation of the first pin-receiving portion  284 . Conversely, as the distal end  274  moves from its open position to its closed position, the first pin-receiving portion  284  rotates clockwise about the first pin  304 , the rectangular body  282  returns to its relaxed state, and the second pin-receiving portion  286  moves proximally. The second pin hole  310  can be a slot rather than a cylindrical hole such that the second pin  308  can move distally or proximally in the second pin hole  310  to allow the distal or proximal movement of the second pin-receiving portion  286 . 
     Referring now to  FIGS. 20A and 20B , a suturing head  320  is illustrated that is similar to the suturing head  18  except that the suturing head  320  includes an upper jaw  322  instead of the upper jaw  36 . The upper jaw  322  includes teeth  324 , a suture carrier receptacle  326 , and a suture retaining mechanism  328 . The teeth  324  are configured to bite into or grip soft tissue when the upper jaw  322  is in its closed position. 
     In various implementations, the upper jaw  322  can also include a tissue reinforcement member holder  330 . The tissue reinforcement member holder  330  is configured to position the tissue reinforcement member  60  so that the suture carrier  14  and the suture  40  pass through the tissue reinforcement member  60  after passing through soft tissue held between the upper and lower jaws  322 ,  38 . The tissue reinforcement member holder  330  may be a slot  332 , as shown, which is similar to the slot  61  in the upper jaw  36  of the suturing head  18 . 
     The suture carrier receptacle  326  can be an opening in the upper jaw  322 . The suture carrier receptacle  326  can extend through portions of the upper jaw  262  disposed above and below the slot  332 . The suture carrier  14  and the suture  40  can be passed through the suture carrier receptacle  326  after passing through soft tissue held between the upper and lower jaws  322 ,  38 . 
     The suture retaining mechanism  328  prevents unintentional movement of the suture  40  out of the upper jaw  322  by maintaining the suture  40  at or near the suturing head  18 . The suture retaining mechanism  268  can be made of a resilient and flexible material, such as spring steel, Nitinol, or a flexible polymer. The suture retaining mechanism  328  can include a distal end  334 , a proximal end  336 , teeth  338 , a flat rectangular body  340 , a first pin-receiving portion  342 , and a second pin-receiving portion  344 . The teeth  338  can be disposed at the distal end  334  and can be configured to engage the suture  40  to maintain the suture  40  at or near the suturing head  18 . 
     The suture carrier  14  can be passed into the receptacle  326 , temporarily disrupting the distal end  334  of the suture retaining mechanism  328  from a closed position ( FIG. 20A ) in contact with the upper jaw  322  to an open position ( FIG. 19B ) spaced apart from the upper jaw  322 . The suture carrier  14  can then be retracted through the receptacle  326 , allowing the distal end  334  to return to its closed position. In turn, the suture retaining mechanism  328  biases the suture  40  against the receptacle  326  to prevent the suture  40  from being pulled back through the receptacle  326 . The suture retaining mechanism  328  can include ears  346  extending from the rectangular body  340  and configured to engage stops  348  on the upper jaw  322  disposed on opposite sides of the receptacle  326  as the distal end  334  returns to its closed position. 
     The first pin-receiving portion  342  includes a first cylindrical portion  350  defining a first pin hole  352 , a distal fillet  354  extending between first cylindrical portion  350  and the rectangular body  340 , and a proximal fillet  356  extending between first cylindrical portion  350  and the rectangular body  340 . The second pin-receiving portion  344  includes a second cylindrical portion  358  defining a second pin hole  360 , and a curved spring portion  362  extending from the rectangular body  340  to the second cylindrical portion  358 . A first pin  364  can be inserted into a first pin hole  366  in the upper jaw  322  and into the first pin hole  352  in the suture retaining mechanism  328  to couple the mechanism  328  to the upper jaw  322  adjacent to the distal end  334  of the mechanism  328 . A second pin  368  can be inserted into a second pin hole  370  in the upper jaw  322  and into the second pin hole  360  in the suture retaining mechanism  328  to couple the proximal end  336  of the mechanism  328  to the upper jaw  322 . 
     Thus, the suture retaining mechanism  328  can be coupled to the upper jaw  322  using two pin connections. In turn, if the suture retaining mechanism  328  fractures at a location between the two pin connections, such as across the width of the spring portion  362 , the two portions of the mechanism  268  on opposite sides of the fracture remain coupled to the upper jaw  322 . Therefore, the design of the upper jaw  322  ensures that no portion of the suture retaining mechanism  328  is left inside of a patient in the event of a fracture. 
     As the distal end  334  moves from its closed position to its open position, the first pin-receiving portion  342  rotates counterclockwise about the first pin  364  and the spring portion  362  flexes downward through a bottom opening  372  in the upper jaw  322 . Conversely, as the distal end  274  moves from its open position to its closed position, the first pin-receiving portion  284  rotates clockwise about the first pin  364  and the spring portion  362  returns to its relaxed state. In various implementations, the spring portion  362  may be configured to flex downward without extending through the bottom opening  372  in the upper jaw  322  to avoid contact between the spring portion  362  and the soft tissue  160 . For example, the flexibility of the spring portion  362  can be adjusted by altering the geometry and/or material of the spring portion  362 . 
     The foregoing description of the embodiments has been provided for purposes of illustration and description. It is not intended to be exhaustive or to limit the disclosure. Individual elements or features of a particular embodiment are generally not limited to that particular embodiment, but, where applicable, are interchangeable and can be used in a selected embodiment, even if not specifically shown or described. The same may also be varied in many ways. Such variations are not to be regarded as a departure from the disclosure, and all such modifications are intended to be included within the scope of the disclosure.

Technology Classification (CPC): 0