Abstract:
A method and apparatus for coupling a soft tissue implant into a locking cavity formed within a bone. The method includes the following: implanting in bone a first anchor including a first suture construct connected to the first anchor; passing a first adjustable loop of the first suture construct at least one of over or through the soft tissue; coupling the first adjustable loop to one of a first locking feature of the first anchor or a second locking feature of a second anchor; adjusting the first adjustable loop by pulling a first end of the first suture construct; and securing the soft tissue against bone by pulling the first end of the first suture construct.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a divisional of U.S. patent application Ser. No. 12/196,405 filed on Aug. 22, 2008, which is a continuation-in-part application of: (1.) U.S. patent application Ser. No. 11/541,506 filed on Sep. 29, 2006, now U.S. Pat. No. 7,601,165 issued Oct. 13, 2009; (2.) U.S. patent application Ser. No. 12/014,399 filed on Jan. 15, 2008, now U.S. Pat. No. 7,909,851 issued Mar. 22, 2011; (3.) U.S. patent application Ser. No. 12/014,340 filed on Jan. 15, 2008, now U.S. Pat. No. 7,905,904 issued Mar. 15, 2011; (4.) U.S. patent application Ser. No. 11/935,681 filed on Nov. 6, 2007, now U.S. Pat. No. 7,905,903 issued Mar. 15, 2011; (5.) U.S. patent application Ser. No. 11/869,440 filed on Oct. 9, 2007, now U.S. Pat. No. 7,857,830 issued Dec. 28, 2010; (6.) U.S. patent application Ser. No. 11/784,821 filed on Apr. 10, 2007; (7.) U.S. patent application Ser. No. 11/347,661 filed on Feb. 3, 2006, now U.S. Pat. No. 7,749,250 issued Jul. 6, 2010; and (8.) U.S. patent application Ser. No. 11/347,662 filed on Feb. 3, 2006, now abandoned. The disclosures of the above applications are incorporated herein by reference. 
     
    
     FIELD 
       [0002]    The present disclosure relates to method of coupling soft tissue to bone and, more particularly, to a method and apparatus using a plurality of fasteners and suture cinch loop construction to couple soft tissue to a bone. 
       BACKGROUND 
       [0003]    The statements in this section merely provide background information related to the present disclosure and may not constitute prior art. 
         [0004]    It is commonplace in arthroscopic procedures to employ sutures and anchors to secure soft tissues to bone. Despite their widespread use, several improvements in the use of sutures and suture anchors may be made. For example, the procedure of tying knots may be very time consuming, thereby increasing the cost of the procedure and limiting the capacity of the surgeon. Furthermore, the strength of the repair may be limited by the strength of the knot. This latter drawback may be of particular significance if the knot is tied improperly as the strength of the knot in such situations may be significantly lower than the tensile strength of the suture material. 
         [0005]    To improve on these uses, sutures having a single preformed loop have been provided.  FIG. 1  represents a prior art suture construction. As shown, one end of the suture is passed through a passage defined in the suture itself. The application of tension to the ends of the suture pulls a portion of the suture through the passage, causing a loop formed in the suture to close. Relaxation of the system, however may allow a portion of the suture to translate back through the passage, thus relieving the desired tension. 
         [0006]    It is an object of the present teachings to provide an alternative device for anchoring sutures to bone and soft tissue. The device, which is relatively simple in design and structure, is highly effective for its intended purpose. 
         [0007]    The present teachings provide for a method for coupling soft tissue to bone. The method includes the following: implanting in bone a first anchor including a first suture construct connected to the first anchor; passing a first adjustable loop of the first suture construct at least one of over or through the soft tissue; coupling the first adjustable loop to one of a first locking feature of the first anchor or a second locking feature of a second anchor; adjusting the first adjustable loop by pulling a first end of the first suture construct; and securing the soft tissue against bone by pulling the first end of the first suture construct. 
         [0008]    The present teachings provide for another method for coupling soft tissue to bone. The method includes: implanting in bone a first anchor including a first suture construct connected to the first anchor, the first suture construct including a first end and a second end; passing a first adjustable loop of the first suture construct at least one of over or through the soft tissue; coupling the first adjustable loop to a first locking feature of a second anchor having a second suture construct with a second adjustable loop; adjusting the first adjustable loop by pulling the first end of the first suture construct, the first end passed through a first passage portion defined by the first suture construct; securing the soft tissue against the bone with the first adjustable loop by pulling the first end; implanting the second anchor in bone; passing the second adjustable loop at least one of over or through the soft tissue; coupling the second adjustable loop to a second locking feature of a third anchor; implanting the third anchor in bone; adjusting the second adjustable loop by pulling a third end of the second suture construct; and securing the soft tissue against the bone with the second adjustable loop by pulling the third end of the second suture construct. 
         [0009]    The present teachings also provide for a bone anchor for coupling soft tissue to bone. The bone anchor includes a bone coupling portion, a tissue coupling portion, and a suture construct. The bone coupling portion includes a plurality of bone locking features. The tissue coupling portion is adjacent to the bone coupling portion. The tissue coupling portion defines an aperture and a suture coupling feature. The suture construct is seated within the aperture. The suture construct includes a first adjustable loop. A first end of the suture construct is passed through the first passage portion defined by the suture construct. The suture construct defines a first aperture and a second aperture at opposite ends of the first passage portion. Pulling the first end of the suture construct decreases a length of the first adjustable loop. 
       SUMMARY 
       [0010]    To overcome the aforementioned deficiencies, a method for configuring a braided tubular suture and a suture configuration are disclosed. The method includes passing a first end of the suture through a first aperture into a passage defined by the suture and out a second aperture defined by the suture so as to place the first end outside of the passage. A second end of the suture is passed through the second aperture into the passage and out the first aperture so as to place the second end outside of the passage. 
         [0011]    A method of surgically implanting a suture construction in a bone is disclosed. A suture construction is formed by passing the suture through a bore defined by a locking member. A first end of the suture is passed through a first aperture within the suture into a passage defined by the suture and out a second aperture defined by the suture so as to place the first end outside of the passage and define a first loop. A second end of the suture is then passed through the second aperture into the passage and out the first aperture so as to place the second end outside of the passage, and define a second loop. A fastener is coupled to bone. Soft tissue is then passed through the first and second loops. The locking member is coupled to the fastener. Tension is applied onto the first and second ends to constrict the first and second loops about the soft tissue. 
         [0012]    In another embodiment, a method of surgically implanting a suture is disclosed. The suture is passed through a bore defined by a first fastener. A suture construction is formed by passing the suture through a bore defined by a locking member. A first end of the suture is passed through a first aperture within the suture into a passage defined by the suture and out a second aperture defined by the suture so as to place the first end outside of the passage and define a first loop. A second end of the suture is then passed through the second aperture into the passage and out the first aperture so as to place the second end outside of the passage, and define a second loop. A second fastener is coupled between the first and second loops. After the fastener is coupled to the patient, tension is applied onto the first and second ends to constrict at least one of the first and second loops about the soft tissue. 
         [0013]    Further areas of applicability will become apparent from the description provided herein. It should be understood that the description and specific examples are intended for purposes of illustration only and are not intended to limit the scope of the present disclosure. 
     
    
     
       DRAWINGS 
         [0014]    The drawings described herein are for illustration purposes only and are not intended to limit the scope of the present disclosure in any way. 
           [0015]      FIG. 1  represents a prior art suture configuration; 
           [0016]      FIGS. 2A and 2B  represent suture constructions according to the teachings; 
           [0017]      FIG. 3  represents the formation of the suture configuration shown in  FIG. 4A ; 
           [0018]      FIGS. 4A and 4B  represent alternate suture configurations; 
           [0019]      FIGS. 5-7  represent further alternate suture configurations; 
           [0020]      FIG. 8  represents the suture construction according to  FIG. 5  coupled to a bone engaging fastener; 
           [0021]      FIGS. 9-11B  represent the coupling of the suture construction according to  FIG. 5  to a bone screw; 
           [0022]      FIGS. 12A-12E  represent the coupling of a soft tissue to an ACL replacement in a femoral/tibial reconstruction; 
           [0023]      FIGS. 13A-13D  represent a close-up view of the suture shown in  FIGS. 1-11C ; 
           [0024]      FIGS. 14A and 14B  represent side and top views of a suture construction used to couple soft tissue to bone; 
           [0025]      FIGS. 15A-15D  represent an alternate method of coupling soft tissue to bone; 
           [0026]      FIGS. 16A-16D  represent yet another method for coupling soft tissue to bone; 
           [0027]      FIG. 17  is an alternate method of coupling soft tissue to bone; 
           [0028]      FIGS. 18A-18B  represent an alternate mechanism for coupling soft tissue to bone; and 
           [0029]      FIGS. 19A-19C  represent another method of coupling soft tissue to bone. 
       
    
    
     DETAILED DESCRIPTION 
       [0030]    The following description is merely exemplary in nature and is not intended to limit the present disclosure, application, or uses. It should be understood that throughout the drawings, corresponding reference numerals indicate like or corresponding parts and features. 
         [0031]      FIG. 2A  represents a suture construction  20  according to the present teachings. Shown is a suture  22  having a first end  24  and a second end  26 . The suture  22  is formed of a braided body  28  that defines a longitudinally formed hollow passage  30  therein. First and second apertures  32  and  34  are defined in the braided body  28  at first and second locations of the longitudinally formed passage  30 . 
         [0032]    Briefly referring to  FIG. 3 , a first end  24  of the suture  22  is passed through the first aperture  32  and through longitudinal passage  30  formed by a passage portion and out the second aperture  34 . The second end  26  is passed through the second aperture  34 , through the passage  30  and out the first aperture  32 . This forms two structures or loops  46  and  46 ′. Structures defined herein can be loops, knots or tangles, each having unique properties. As seen in  FIG. 2B , the relationship of the first and second apertures  32  and  34  with respect to the first and second ends  24  and  26  can be modified so as to allow a bow-tie suture construction  36 . As described below, the longitudinal and parallel placement of first and second suture portions  38  and  40  of the suture  22  within the longitudinal passage  30  resists the reverse relative movement of the first and second portions  38  and  40  of the suture once it is tightened. 
         [0033]    The first and second apertures are formed during the braiding process as loose portions between pairs of fibers defining the suture. As further described below, the first and second ends  24  and  26  can be passed through the longitudinal passage  30  multiple times. It is envisioned that either a single or multiple apertures can be formed at the ends of the longitudinally formed passage. 
         [0034]    As best seen in  FIGS. 4A and 4B , a portion of the braided body  28  of the suture defining the longitudinal passage  30  can be braided so as to have a diameter larger than the diameter of the first and second ends  24  and  26 . Additionally shown are first through fourth apertures  32 ,  34 ,  42 , and  44 . These apertures can be formed in the braiding process or can be formed during the construction process. In this regard, the apertures  32 ,  34 ,  42 , and  44  are defined between adjacent fibers in the braided body  28 . As shown in  FIG. 4B , and described below, it is envisioned the sutures can be passed through other biomedically compatible structures. 
         [0035]      FIGS. 5-7  represent alternate constructions wherein a plurality of loops  46   a - d  are formed by passing the first and second ends  24  and  26  through the longitudinal passage  30  multiple times. The first and second ends  24  and  26  can be passed through multiple or single apertures defined at the ends of the longitudinal passage  30 . The tensioning of the ends  24  and  26  cause relative translation of the sides of the suture with respect to each other. 
         [0036]    Upon applying tension to the first and second ends  24  and  26  of the suture  22 , the size of the loops  46   a - d  is reduced to a desired size or load. At this point, additional tension causes the body of the suture defining the longitudinal passage  30  to constrict about the parallel portions of the suture within the longitudinal passage  30 . This constriction reduces the diameter of the longitudinal passage  30 , thus forming a mechanical interface between the exterior surfaces of the first and second parallel portions as well as the interior surface of the longitudinal passage  30 . 
         [0037]    As seen in  FIGS. 8-11B , the suture construction can be coupled to various biocompatible hardware. In this regard, the suture construction  20  can be coupled to an aperture  52  of the bone engaging fastener  54 . Additionally, it is envisioned that soft tissue or bone engaging members  56  can be fastened to one or two loops  46 . After fixing the bone engaging fastener  54 , the members  56  can be used to repair, for instance, a meniscal tear. The first and second ends  24 ,  26  are then pulled, setting the tension on the loops  46 , thus pulling the meniscus into place. Additionally, upon application of tension, the longitudinal passage  30  is constricted, thus preventing the relaxation of the tension caused by relative movement of the first and second parallel portions  38 ,  40 , within the longitudinal passage  30 . 
         [0038]    As seen in  FIGS. 9-11B , the loops  46  can be used to fasten the suture construction  20  to multiple types of prosthetic devices. As described further below, the suture  22  can further be used to repair and couple soft tissues in an anatomically desired position. Further, retraction of the first and second ends allows a physician to adjust the tension on the loops between the prosthetic devices. 
         [0039]      FIG. 11   b  represents the coupling of the suture construction according to  FIG. 2B  with a bone fastening member. Coupled to a pair of loops  46  and  46 ′ are tissue fastening members  56 . The application of tension to either the first or second end  24  or  26  will tighten the loops  46  or  46 ′ separately. 
         [0040]      FIGS. 12A-12E  represent potential uses of the suture constructions  20  in  FIGS. 2A-7  in an ACL repair. As can be seen in  FIG. 12A , the longitudinal passage portion  30  of suture construction  20  can be first coupled to a fixation member  60 . The member  60  can have a first profile which allows insertion of the member  60  through the tunnel and a second profile which allows engagement with a positive locking surface upon rotation. The longitudinal passage portion  30  of the suture construction  20 , member  60 , loops  46  and ends  24 ,  26  can then be passed through a femoral and tibial tunnel  62 . The fixation member  60  is positioned or coupled to the femur. At this point, a natural or artificial ACL  64  can be passed through a loop or loops  46  formed in the suture construction  20 . Tensioning of the first and second ends  24  and  26  applies tension to the loops  46 , thus pulling the ACL  64  into the tunnel. In this regard, the first and second ends are pulled through the femoral and tibial tunnel, thus constricting the loops  46  about the ACL  64  (see  FIG. 12B ). 
         [0041]    As shown, the suture construction  20  allows for the application of force along an axis  61  defining the femoral tunnel. Specifically, the orientation of the suture construction  20  and, more specifically, the orientation of the longitudinal passage portion  30 , the loops  46 , and ends  24 ,  26  allow for tension to be applied to the construction  20  without applying non-seating forces to the fixation member  60 . As an example, should the loops  24 ,  26  be positioned at the member  60 , application of forces to the ends  24 ,  26  may reduce the seating force applied by the member  60  onto the bone. 
         [0042]    As best seen in  FIG. 12C , the body portion  28  and parallel portions  38 ,  40  of the suture construction  20  remain disposed within to the fixation member  60 . Further tension of the first ends draws the ACL  64  up through the tibial component into the femoral component. In this way, suture ends can be used to apply appropriate tension onto the ACL  64  component. The ACL  64  would be fixed to the tibial component using a plug or screw as is known. 
         [0043]    After feeding the ACL  64  through the loops  46 , tensioning of the ends allows engagement of the ACL with bearing surfaces defined on the loops. The tensioning pulls the ACL  64  through a femoral and tibial tunnel. The ACL  64  could be further coupled to the femur using a transverse pin or plug. As shown in  FIG. 12E , once the ACL is fastened to the tibia, further tensioning can be applied to the first and second ends  24 ,  26  placing a desired predetermined load on the ACL. This tension can be measured using a force gauge. This load is maintained by the suture configuration. It is equally envisioned that the fixation member  60  can be placed on the tibial component  66  and the ACL pulled into the tunnel through the femur. Further, it is envisioned that bone cement or biological materials may be inserted into the tunnel  62 . 
         [0044]      FIGS. 13A-13D  represent a close-up of a portion of the suture  20 . As can be seen, the portion of the suture defining the longitudinal passage  30  has a diameter d 1  which is larger than the diameter d 2  of the ends  24  and  26 . The first aperture  32  is formed between a pair of fiber members. As can be seen, the apertures  32 ,  34  can be formed between two adjacent fiber pairs  68 ,  70 . Further, various shapes can be braided onto a surface of the longitudinal passage  30 . 
         [0045]    The sutures are typically braided of from 8 to 16 fibers. These fibers are made of nylon or other biocompatible material. It is envisioned that the suture  22  can be formed of multiple type of biocompatible fibers having multiple coefficients of friction or size. Further, the braiding can be accomplished so that different portions of the exterior surface of the suture can have different coefficients of friction or mechanical properties. The placement of a carrier fiber having a particular surface property can be modified along the length of the suture so as to place it at varying locations within the braided constructions. 
         [0046]      FIGS. 14A and 14B  represent the coupling of soft tissue to a bone. Shown is a plurality of bone engaging fasteners  60  coupled to suture constructions  22  shown in  FIG. 2A  or  FIG. 4 . Each fastener  60  is coupled to a bone by being pressed into or threaded into an aperture formed within the bone. Adjoining fasteners are coupled together using loops  46  from an adjacent suture construction  22 . 
         [0047]    The fasteners  60  define a locking feature  92  which is used to couple the fastener  60  to the bone. Disposed on a first end of the fastener  60  is an aperture  94  configured to hold the suture construction  22 . Additionally, in the fastener  60  is a locking feature  100  configured to engage with one of the first or second loops  46  or  47  of an adjacent suture construction  22 . Returning briefly to  FIG. 14A , a suture end  26  and first loop  46  can be passed around or through an aperture  84  in soft tissue. 
         [0048]    The first loop  46  is then fed around or through a second aperture  84 ′ formed in the soft tissue  80 . After passing through the aperture  84 ′, the first loop  46  is coupled to the coupling feature  100  in an adjacent bone coupling fastener  60 . At this point, the first and second ends  24 ,  26  of the suture  22  are pulled tight, tightening the suture loop  46  about the soft tissue  80 . This pulls the soft tissue  80  against a surface of the bone. This can be used to couple soft tissue in an anatomy such in the repair of a rotator cuff. 
         [0049]    It is envisioned that a plurality of fasteners  60  can have associated suture constructions  22  which can similarly be coupled to adjacent fasteners  60 . Alternatively, the loops  46 ,  47  can looped around or passed through the soft tissue  80  and then can be coupled to the coupling feature  100  of its fastener  60 . 
         [0050]      FIGS. 15A-15D  represent an alternate method of coupling soft tissue  80  to a bone. As shown in  FIG. 15A , a first bone coupling fastener  60  is coupled to an aperture  63  formed in the bone. The bone coupling fastener  60  defines a fastener accepting bore  96 . The bore  96  may be a through bore or may terminate within the fastener  96 . The fastener accepting bore  96  is configured to accept a suture bearing fastener  98 . The first loop  46  can be coupled to the second loop  47  to fix the soft tissue  80 . 
         [0051]    The suture bearing fastener  98  defines an aperture  104  configured to accept the suture construction  22  according to any of the present teachings. As described below, the fastener  98  can also have a concave suture locking feature  100 . Disposed at a proximal end  102  of the fastener  96  can be soft tissue piercing feature  105  which can be an acute angle. Additionally, the suture bearing fastener  98  can have locking features to facilitate the coupling to the bore  96  of the bone coupling fastener  60 . 
         [0052]    As seen in  FIG. 15B , the suture construction of  FIGS. 1-7  can be coupled to the suture bearing fastener  98  through the suture bearing aperture  104  using a knot. After the suture bearing fastener  98  is pressed through or adjacent to the soft tissue  80 , the suture construction  22  can be looped over the soft tissue  80  and engaged with the concave locking feature  100 . The suture bearing fastener  98  can be pressed into the fastener  60  to lock the suture  22  into place. Tension can then be applied to the suture  22  construction to constrict the loop  46  or loops  46  and  47  about the soft tissue  80 . 
         [0053]    As seen in  FIGS. 15C and 15D , the soft tissue  80  can be threaded through the loops  46  and  47  prior to or after the coupling of the suture bearing fastener  98  to the bone engaging fastener  60 . A guide wire  99  can be coupled to the bone through the fastener bore  96 . The guide wire  99  is then used to align the suture bearing fastener  98  through the soft tissue  80  and into the bore  96  of fastener  60 . 
         [0054]    As shown in  FIG. 16A-16C , one loop  46  of the suture construction  22  can have a fastening element  112  coupled thereto. This fastener element  112  can take the form of a hook having an aperture which accepts the suture from a loop  47 . The loop  46  of the suture construction can be passed through the aperture  84  formed in the soft tissue  80 . 
         [0055]      FIG. 16D  shows the fastener element  112  can be coupled to the first loop  46 . After the first and second loops  46  and  47  are coupled together about the soft tissue  80 , tension can be applied to the ends of the construction to pull the soft tissue to the bone. 
         [0056]    As shown in  FIG. 17 , bone engaging fastener  60  can have a bore  96  defined therein. The bore  96  can have a defined fastening loop  114  which is used to couple a suture construction  22  to the fastener  60 . In this regard, it is envisioned the passage portion  30  of the suture construction can be fixed within the fastening loop. One or both loops  46  and  47  can then be passed through an aperture  84  defined in the soft tissue  80 . These loops of material can be hooked to a hook  116  defined within the bore  96 . The application of tension to the ends pulls the soft tissue to the bone without the use of knots or additional fasteners. 
         [0057]      FIGS. 18A and 18B  represent an alternate method of coupling soft tissue  80  to bone. Shown is a bone engaging fastener  60  defining an internal bore  96 . The internal bore  96  defines a locking mechanism such a through pin  120 . Disposed about the locking mechanism is a suture construction  22  having a single loop  46 . Disposed on the loop  46  is a locking hook  122 . 
         [0058]    As shown in  FIG. 18B , the locking hook  122  can be used to couple the fastener  60  to a suture loop  124  passed through an aperture  84  formed in soft tissue  80 . The application of tension to the ends  22  and  26  of the suture construction  22  pulls the locking hook  122  and suture  124  into the bore  96 , thus locking the soft tissue  80  to the bone. 
         [0059]    As seen in  FIGS. 19A-19C , the fastener  60  can have a pair of suture constructions  22  and  22 ′. The first suture  22  can have a coupling member  122 , while the second suture  22 ′ can have a loop  46  threaded through the soft tissue  80 . After the loop  46  is threaded through or around the soft tissue, the locking member  122  is coupled to the loop  46 . The application of tension to the ends  26  of the suture constructions  22  and  22 ′ pull the locking member  122  into a bore  96  formed by the fastener  60 . This locks the loop  46  into position. Tension on the end  26  of suture  22  then pulls the soft tissue to the bone. 
         [0060]    It should be noted that while the interior bore of the fasteners  60  is shown as being smooth, it is envisioned that the interior surface can have features such as barbs or locking tabs to facilitate the coupling of the suture engaging fastener  98  with the bone engaging fastener  60 . Additionally, the interior bores can define driving surfaces or features such as a hex head. 
         [0061]    The description of the invention is merely exemplary in nature and, thus, variations that do not depart from the gist of the invention are intended to be within the scope of the invention. For example, any of the above mentioned surgical procedures is applicable to repair of other body portions. For example, the procedures can be equally applied to the repair of wrists, elbows, ankles, and meniscal repair. The suture loops can be passed through bores formed in soft or hard tissue. It is equally envisioned that the loops can be passed through or formed around an aperture or apertures formed in prosthetic devices, e.g. humeral, femoral or tibial stems. Such variations are not to be regarded as a departure from the spirit and scope of the invention.