US20160206307A1 - Tissue engaging member - Google Patents

Abstract

A system includes a flexible member and a tissue engaging member fixed to the flexible member. The tissue engaging member includes a barb preformed to extend rearward from a distal end of the flexible member at an acute angle relative to the flexible member.

Description

FIELD
• The present disclosure relates to tissue engaging members attached to flexible or elongate members configured to be inserted into tissue.
BACKGROUND
• This section provides background information related to the present disclosure which is not necessarily prior art.
• In tissue repairs such as rotator cuff repairs and anterior cruciate ligament (ACL) reconstructions, a suture is typically used to attach soft tissue to bone or to other soft tissue. The soft tissue can be a tendon, a ligament, or cartilage. The suture can be used to hold soft tissue by wrapping the suture around soft tissue or passing the suture through soft tissue. The suture can be attached to bone using a suture anchor. Using knots to attach the suture to soft tissue or to bone may add complexity and time to the procedure.
• Accordingly, the present disclosure describes a tissue engaging member that can be attached to a flexible member, such as a suture, or to an elongate member. The tissue engaging member alone can be used as a knotless suture anchor, or the tissue engaging member attached to the elongate member can be used as a knotless suture anchor. The tissue engaging member includes one or more barbs that deflect radially inward to allow insertion of the tissue engaging member into tissue and that deflect radially outward to prevent removal of the tissue engaging member from tissue.
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.
• A system includes a flexible member and a tissue engaging member fixed to the flexible member. The tissue engaging member includes a barb preformed to extend rearward from a distal end of the flexible member at an acute angle relative to the flexible member.
• 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 perspective view of a first tissue engaging member attached to a distal end of a flexible member;
• FIG. 2 is a perspective view of a second tissue engaging member attached to a distal end of a flexible member;
• FIG. 3 is a perspective view of a third tissue engaging member attached to a distal end of a flexible member;
• FIG. 4 is a perspective view of a fourth tissue engaging member attached to a distal end of a flexible member;
• FIG. 5 is a perspective view of a flexible member passing through a tissue engaging member;
• FIG. 6 is a perspective view of a flexible member entering a proximal surface of a tissue engaging member, passing through the tissue engaging member, and exiting the proximal surface of the tissue engaging member;
• FIG. 7 is a perspective view of a flexible member passing through a plurality of tissue engaging members;
• FIG. 8 is a planar view of a flexible member attached to proximal surfaces of a plurality of tissue engaging members;
• FIG. 9 is a planar view of a tissue engaging member attached to a distal end of a flexible member and inserted into tissue;
• FIG. 10 is a planar view of a tissue engaging member attached to a distal end of a flexible member and passed through a portion of tissue;
• FIG. 11 is a planar view of a tissue engaging member attached to a distal end of a flexible member and passed through several portions of tissue;
• FIG. 12 is a planar view of a tissue engaging member attached to a distal end of a flexible member, with one barb of the tissue engaging member inserted into one portion of tissue and another barb of the tissue engaging member inserted into another portion of tissue;
• FIG. 13 is a planar view of a tissue engaging member attached to a distal end of a flexible member, with the tissue engaging member deflected radially inward toward the flexible member as the flexible member is inserted into tissue;
• FIG. 14 is a planar view of a tissue engaging member attached to a distal end of a flexible member, with the tissue engaging member deflected radially outward away from the flexible member as a tension force is applied to the flexible member;
• FIG. 15 is a planar view of tissue engaging members attached to opposite ends of a flexible member;
• FIG. 16A is a perspective view of a tissue engaging member at a distal end of a flexible member and a self-locking loop at a proximal end of the flexible member, where the self-locking loop is passed through a suture anchor;
• FIG. 16B is a perspective view of a tissue engaging member at a distal end of a flexible member and a self-locking loop at the proximal end of the flexible member, where the self-locking loop is passed through a second tissue engaging member;
• FIG. 17 is a perspective view of a tissue engaging member attached to a distal end of a flexible member and a suture anchor attached to a proximal end of the flexible member;
• FIG. 18 is a perspective view of a plurality of flexible members having portions that are intertwined and distal ends to which tissue engaging members are attached;
• FIG. 19 is a perspective view of a tissue engaging member attached to a distal end of a flexible member and a tissue reinforcing material attached to a proximal end of the flexible member;
• FIG. 20 is a perspective view of a tissue engaging member attached to a distal end of a flexible member and a tissue adhering material attached to a proximal end of the flexible member;
• FIG. 21 is a planar view of a first elongate member including a plurality of tissue engaging members extending rearward from a distal end of an elongate body and a suture engaging feature at a proximal end of the elongate body;
• FIG. 22 is a planar view of a second elongate member including a plurality of tissue engaging members extending rearward from a distal end of an elongate body and a suture engaging feature at a proximal end of the elongate body;
• FIG. 23 is a planar view of a third elongate member including a plurality of tissue engaging members extending rearward from a distal end of an elongate body and a suture engaging feature at a proximal end of the elongate body;
• FIG. 24A is a section view of a fourth elongate member including an actuator coupled to a distal end of a suture and pivotally connected to a plurality of tissue engaging members;
• FIG. 24B is a section view of the fourth elongate member ofFIG. 24A, with the suture retracted to retract the actuator and thereby extend the tissue engaging members radially outward from the fourth elongate member;
• FIG. 25 is a planar view of a fifth elongate member including a plurality of tissue engaging members extending rearward from a distal end of an elongate body, where the tissue engaging members are absent from surfaces of the elongate body adjacent to a hole through which a suture is passed;
• FIG. 26A is a planar view of a sixth elongate member including a plurality of tissue engaging members extending rearward from a distal end of an elongate body and an suture engaging feature attached to the distal end of the elongate body;
• FIG. 26B is a section view of a first embodiment of the sixth elongate member ofFIG. 26A including an elongate body having a round shape.
• FIG. 26C is a section view of a second embodiment of the sixth elongate member ofFIG. 26B including an elongate body having a flat shape.
• FIG. 27 is a section view of a tissue engaging member attached to a distal end of a suture positioned within a suture delivery tube;
• FIG. 28 is a section view of a tissue engaging member attached to a distal end of a suture positioned within a suture delivery tube having a sharp distal end for piercing tissue;
• FIG. 29A is a section view of an elongate member mounted on a distal end of a first rod fixed to a first cannula, the elongate member including a plurality of tissue engaging members extending rearward from a distal end of an elongate body and a suture engaging feature through which a suture is passed;
• FIG. 29B is a section view of the elongate member ofFIG. 29A mounted on the distal end of the first rod and inserted into a second cannula;
• FIG. 29C is a section view of the elongate member ofFIG. 29A mounted on a distal end of a second rod and inserted into the second cannula;
• FIG. 30 is a perspective view of a suture passer passing a suture having a distal end to which a tissue engaging member is attached;
• FIG. 31 is a perspective view of a plurality of sutures having distal ends fixed to tissue using a plurality of tissue engaging members, and proximal ends fixed in bone using a plurality of suture anchors;
• FIG. 32A is a perspective view of a plurality of sutures wrapped around tissue and inserted into tissue, with proximal ends of the plurality of sutures fixed to bone using a suture anchor and distal ends of the plurality of sutures fixed to tissue using a plurality of tissue engaging members;
• FIG. 32B is a perspective view of a plurality of sutures extending directly into tissue, with proximal ends of the plurality of sutures fixed to bone using a suture anchor and distal ends of the plurality of sutures fixed to tissue using a plurality of tissue engaging members;
• FIG. 33 is a perspective view of a plurality of sutures wrapped around and inserted into tissue, with proximal ends of the sutures attached to a ti screw suture anchor and distal ends of the plurality of sutures fixed in the tissue using tissue engaging members;
• FIG. 34 is a planar view of a tendon repair using a plurality of sutures having opposite ends to which tissue engaging members are attached;
• FIG. 35A is a perspective view of an anterior cruciate ligament (AOL) reconstruction in which tissue is fixed within a hole in a tibia using a plurality of sutures having proximal ends attached to a toggle anchor, and distal ends to which a plurality of tissue engaging members are attached;
• FIG. 35B is a perspective view of an ACL reconstruction in which a plurality of tissue engaging members attached to a suture are piercing through two portions of tissue and into a tibia to hold the two portions of tissue;
• FIG. 35C is a perspective view of an ACL reconstruction in which a plurality of tissue engaging members attached to a suture are piercing two portions of tissue to hold the two portions of tissue together;
• FIG. 36 is a planar view of an elongate member inserted into a hole in bone, the elongate member including a plurality of tissue engaging members engaging tissue and the bone to hold the tissue in the hole;
• FIG. 37 is a planar view of an elongate member inserted into a hole in bone, the elongate member including a plurality of tissue engaging members engaging a suture and the bone to hold the suture in the hole;
• FIG. 38 is a planar view of an elongate member being inserted into a proximal end of a cannulated suture anchor fixed in tissue, the elongate member including a plurality of tissue engaging members for engaging a suture within the cannulated suture anchor to fix the suture to the tissue;
• FIG. 39 is a planar view of an elongate member being inserted into a proximal end of a cannulated suture anchor fixed in tissue, a distal end of the elongate member including a suture engaging feature through which a suture is passed, the elongate member including a plurality of tissue engaging members for engaging the cannulated suture anchor to fix the suture to tissue; and
• FIG. 40 is a planar view of an elongate member being inserted through a proximal end of a cannulated suture anchor fixed in tissue, a distal end of the elongate member including a suture engaging feature through which a suture is passed, where the elongate member can be rotated to engage a bracket on the elongate member with a bracket on the cannulated suture anchor.
• Corresponding reference numerals indicate corresponding parts throughout the several views of the drawings.
DESCRIPTION OF VARIOUS EMBODIMENTS
• Example embodiments will now be described more fully with reference to the accompanying drawings.
• Referring now toFIG. 1, asystem10 includes a suture orflexible member12 and atissue engaging member14. Theflexible member12 can be monofilament, multifilament, and/or braided and can be coated with antimicrobials. Thetissue engaging member14 is fixed to adistal end16 of theflexible member12. Theflexible member12 and thetissue engaging member14 can be formed integrally as a single unit, such as by molding theflexible member12 and thetissue engaging member14 in a single operation, or theflexible member12 and thetissue engaging member14 can be formed separately and later joined together. Thetissue engaging member14 can be molded to theflexible member12, press fit to theflexible member12, or fixed to theflexible member12 using an adhesive or otherwise fixing or connecting structure.
• Thetissue engaging member14 includes afirst barb18 and asecond barb20 that are preformed to extend rearward from thedistal end16 of theflexible member12 at an acute angle θ relative to theflexible member12. The first andsecond barbs18,20 can be 0.5 to 2.0 millimeters (mm) in diameter and 2.0 to 6.0 mm in length. Thefirst barb18 has adistal end22, and thesecond barb20 has adistal end24. The distal ends22,24 of thetissue engaging member14 can be sharpened, as shown, or rounded. Theflexible member12 can be made from a first material, and thetissue engaging member14 can be made from a second material. The second material can be the same as the first material, or the second material can be different from and/or stiffer than the first material. The first material can be polyethylene, and the second material can be polyether ether ketone (PEEK) and/or metal.
• When thedistal end16 of theflexible member12 is inserted into tissue in a first direction, thebarbs18,20 may deflect radially inward toward theflexible member12 to reduce the effort required to insert theflexible member12 into the tissue. Once thedistal end16 of theflexible member12 is inserted into the tissue, thetissue engaging member14 maintains thedistal end16 of theflexible member12 in the tissue. If tension is applied to theflexible member12 in a second opposite direction, thebarbs18,20 may deflect radially outward from theflexible member12 and the distal ends22,24 of thebarbs18,20 pierce into tissue to prevent easy removal of theflexible member12 from the tissue. In this manner, thetissue engaging member14 attaches to and bites into the tissue. Thebarbs18,20 may deflect when theflexible member12 is inserted into or pulled from tissue such as bone, and thebarbs18,20 may not deflect when theflexible member12 is inserted into or pulled from tissue such as soft tissue.
• With continued reference toFIG. 1 and additional reference toFIGS. 2 through 4, a tissue engaging member according to the present disclosure can include one or more barbs having various shapes and sizes.FIG. 1 shows that thebarbs18,20 of thetissue engaging member14 are cylindrical, are opposed, and are joined together to form an arrow shape.FIG. 2 shows asystem26 including theflexible member12 and atissue engaging member28 includes abarb30 having a cylindrical shape and extending rearward from thedistal end16 of theflexible member12. Thebarb30 has a distal end32 that can be relatively flat, rounded, or sharpened.
• FIG. 3 shows asystem34 including theflexible member12 and atissue engaging member36. Thetissue engaging member36 includes abarb38 having a fish-scale shape and oval-shaped planar faces with only one axis of symmetry. Thebarb38 has adistal end40 including generally arcuate edges transitioning to generally straight edges that taper inward as they extend from thedistal end40 of thebarb38 to thedistal end16 of theflexible member12.
• FIG. 4 shows asystem42 including theflexible member12 and atissue engaging member44. Thetissue engaging member44 includes a barb46 that is shaped similar to a claw or a prey-catching tooth. The barb46 has generally rounded major surfaces and generally arcuate edges. The barb46 includes a distal end48 that is pointed or sharp and can pierce into tissue. The generally arcuate edges of the barb46 taper outward from the distal end48 of the barb46 to the longitudinal center of the barb46, and taper inward from the longitudinal center of the barb46 to thedistal end16 of theflexible member12.
• With continued reference toFIG. 1 and additional reference toFIGS. 5 through 8, theflexible member12 can extend through or terminate at a tissue engaging member according to the principles of the present disclosure.FIG. 1 shows theflexible member12 terminating at thetissue engaging member14.FIG. 5 shows asystem50 including atissue engaging member52 through which theflexible member12 is passed. Thetissue engaging member52 includes afirst barb54 and asecond barb56 attached to theflexible member12. Thebarbs54,56 can be separate pieces or can be a single piece including a hole through which theflexible member12 is passed.
• FIG. 6 shows asystem58 including theflexible member12 and atissue engaging member60. Thetissue engaging member60 includes afirst barb62 and asecond barb64 that are joined together to form an arrow shape. Theflexible member12 enters thetissue engaging member60 at anentry position66 on thefirst barb62, and theflexible member12 exits thetissue engaging member60 at anexit position68 on thesecond barb64. Thetissue engaging member60 can include holes at the entry andexit positions66,68 through which theflexible member12 can be passed through. Theflexible member12 can be secured to thetissue engaging member60 or theflexible member12 can be allowed to move relative to thetissue engaging member60. Theflexible member12 includes afirst portion70 that extends in a first direction toward thetissue engaging member60, and asecond portion72 that extends in a second direction away from thetissue engaging member60. The second direction is generally opposite from the first direction.
• FIG. 7 shows asystem74 shaped similar to a wire or bristle brush and including theflexible member12 andtissue engaging members76,78,80. Thetissue engaging members76,78,80 each include two barbs that form an arrow shape and extend rearward from thedistal end16 of the flexible member12 (shown inFIG. 1). Thetissue engaging members76,78,80 can be randomly or uniformly attached to theflexible member12 along the length of and about theflexible member12, including at thedistal end16 of theflexible member12. Thetissue engaging members76,78,80 can include holes through which theflexible member12 extends, or the barbs forming thetissue engaging members76,78,80 can be separate from each other and attached to theflexible member12. Also thesystem74 can include different tissue engaging members along the length of theflexible member12, such as those shown inFIGS. 1 through 5, and/or tissue engaging members braided into theflexible member12.
• Thetissue engaging member78 can be rotated 90 degrees around the longitudinal axis of theflexible member12 relative to thetissue engaging members76,80. This ensures that thetissue engaging members76,78,80 extends in one of four radial directions from theflexible member12, rather than extending in only two radial directions from theflexible member12. In turn, the pullout force required to remove thetissue engaging members76,78,80 from tissue can be increased. In addition, thetissue engaging members76,80 can be used to fix a first set of tissue portions together, and thetissue engaging member78 can be used to fix a second set of tissue portions together. Multiple tissue engaging members can be oriented like thetissue engaging member78.
• FIG. 8 shows asystem82 that can be inserted into multiple openings in tissue. Thesystem82 includes theflexible member12 andtissue engaging members84,86,88 each having an arrow shape. Theflexible member12 extends toward an inner surface of each of thetissue engaging members84,86,88 in a first direction, is attached to the inner surface of thetissue engaging members84,86,88, and extends away from thetissue engaging members84,86,88 in a second direction that is generally opposite from the first direction. Theflexible member12 can be molded to thetissue engaging members84,86,88 or attached to thetissue engaging members84,86,88 using an adhesive. Additionally, theflexible member12 can enter and exit holes in each of thetissue engaging members84,86,88, as shown inFIG. 6.
• Referring now toFIGS. 9 through 14, methods of using thesystem10 will now be described. Although thesystem10 is shown and described inFIGS. 9 through 14, the methods of use for thesystem10 can apply to any of the flexible member systems shown or described in the present disclosure and to any combination thereof.FIG. 9 shows thedistal end16 of theflexible member12 and thetissue engaging member14 inserted into atissue90. Thetissue90 can be a soft tissue, such as a tendon, a ligament, or cartilage, and thetissue engaging member14 can be used to fix thetissue90 to other soft tissue or to bone. Thetissue engaging member14 enters thetissue90 in a first direction at thelocation92 and, without knots, prevents removal of thedistal end16 of theflexible member12 from thetissue90 in a second opposite direction. In this regard, thesystem10 is unidirectional.
• FIG. 10 shows thedistal end16 of theflexible member12 and thetissue engaging member14 entering thetissue90 at alocation94, passing through thetissue90, and exiting thetissue90 at alocation96. In this position, the distal ends22,24 of thetissue engaging member14 can engage thetissue90 when a removal or tension force is applied to theflexible member12. This engagement prevents removal of theflexible member12 and thetissue engaging member14 from thetissue90.
• FIG. 11 shows thedistal end16 of theflexible member12 and thetissue engaging member14 entering and exiting thetissue90 at several locations in a spiral, helical, or otherwise similar manner. In turn, several portions of theflexible member12 are embedded in thetissue90. Thedistal end16 of theflexible member12 and thetissue engaging member14 enter thetissue90 at alocation98, exit thetissue90 at alocation100, enter thetissue90 at alocation102, exit thetissue90 at alocation104, enter thetissue90 at alocation106, and exit thetissue90 at alocation108. Alternatively, thedistal end16 of theflexible member12 and thetissue engaging member14 can terminate in thetissue90, as shown inFIG. 9.
• Portions of theflexible member12 that are embedded in thetissue90 include aportion110, aportion112, and aportion114. Since multiple portions of theflexible member12 are embedded in thetissue90, the holding capacity of theflexible member12 can be increased so that a higher tension force can be applied to theflexible member12 without pulling theflexible member12 out of thetissue90. The pullout force of theflexible member12 can be increased even more by attaching a plurality of tissue engaging members to theflexible member12 along the length of theflexible member12, such as shown inFIG. 7.
• FIG. 12 shows thedistal end16 of theflexible member12 and thetissue engaging member14 inserted betweenadjacent tissue portions116,118. Thedistal end16 of theflexible member12 and thetissue engaging member14 are inserted between thetissue portions116,118 at alocation120. Thefirst barb18 of thetissue engaging member14 is engaging thetissue portion116, and thesecond barb20 of thetissue engaging member14 is engaging thesecond tissue portion118. This engagement holds thetissue portions116,118 together to, for example, close a tear between thetissue portions116,118.
• FIG. 13 shows the optional deflection of thetissue engaging member14 as thetissue engaging member14 is inserted into tissue. The arrow represents a first direction in which thetissue engaging member14 is inserted. The dashed lines represent thetissue engaging member14 before thetissue engaging member14 is inserted into tissue, and the solid lines represent thetissue engaging member14 after thetissue engaging member14 is inserted into tissue. As shown, thebarbs18,20 of thetissue engaging member14 deflect radially inward toward theflexible member12 as thetissue engaging member14 is inserted into tissue. Thetissue engaging member14 can be sufficiently flexible to deflect radially inward toward theflexible member12 to reduce the effort required to insert thedistal end16 of theflexible member12 into tissue.
• FIG. 14 shows the optional deflection of thetissue engaging member14 as a tension or removal force is applied to theflexible member12. The arrow represents a second direction in which the removal force is applied. The dashed lines represent thetissue engaging member14 before the removal force is applied, and the solid lines represent thetissue engaging member14 after the removal force is applied. As shown, thebarbs18,20 of thetissue engaging member14 deflect radially outward from theflexible member12 as the removal force is applied to theflexible member12. Thetissue engaging member14 can be sufficiently stiff to prevent further deflection of thebarbs18,20 and thereby prevent easy removal of thetissue engaging member14 from tissue. In addition, thebarbs18,20 can have sharp tips, as shown, that bite into the tissue.
• Referring now toFIGS. 15 through 20, a system including a tissue engaging member attached to a distal end of a flexible member can include various connections at a proximal end of the flexible member.FIG. 15 shows asystem122 including atissue engaging member124 attached to thedistal end16 of theflexible member12 and atissue engaging member126 attached to aproximal end127 of theflexible member12. Thetissue engaging member124 can be inserted into one portion of tissue and thetissue engaging member126 can be inserted into another portion of tissue to hold the two portions of tissue together. In addition, multiple systems such as thesystem122 can be used to hold two portions of tissue together. The two portions of tissue held together can be end-to-end, or the two portions of tissue can be overlapping layers of tissue.
• FIGS. 16A and 16B show systems that include atissue engaging member128 attached to aflexible member130 forming a self-locking loop. Theflexible member130 has afirst end132 and asecond end134. Theflexible member130 includes abraided body136 that defines alongitudinal passage138 extending between afirst aperture140 and asecond aperture142. Thefirst end132 of theflexible member130 is passed through thefirst aperture140, through thepassage138, and out thesecond aperture142. Thesecond end134 of theflexible member130 is passed through thesecond aperture142, through thepassage138, and out thefirst aperture140. In this manner, theflexible member130 forms twoloops144a,144bin a bowtie configuration. Reverse movement theflexible member130 through thepassage136 is resisted once theflexible member130 is tightened. In this regard, theloops144a,144bare self-locking and can be used in place of knots in theflexible member130.
• FIG. 16A shows asystem146 that includes theflexible member130 arranged in the bowtie configuration, thetissue engaging member128 attached to theloop144b, and asuture anchor148 connected to theloop144a. Theloop144acan be connected to asuture anchor148 by passing theloop144athrough apassage148ain thesuture anchor148. Thesystem146 can be used to fix soft tissue to bone. For example, thetissue engaging member128 can be inserted into soft tissue, thesuture anchor148 can be inserted into bone, and the first and second ends132,134 of theflexible member130 can be pulled to lock theloops144a,144b.
• FIG. 16B shows asystem150 including thetissue engaging member128 attached to theloop144band atissue engaging member151 connected to theloop144a. Thesystem150 can be used to fix soft tissue to soft tissue. For example, thetissue engaging member128 can be inserted into one portion of soft tissue, thetissue engaging member151 can be inserted into another portion of soft tissue, and tension can be applied to the first and second ends132,134 to pull the two portions of soft tissue together. Although theflexible member130 forms two self-locking loops in a bowtie configuration, theflexible member130 can form more or less loops in various configurations. Further discussion of self-locking loops can be found in commonly assigned U.S. patent application Ser. No. 11/541,505, now U.S. Pat. No. 7,658,751, and U.S. patent application Ser. No. 11/541,506, now U.S. Pat. No. 7,601,165, the disclosures of which are incorporated by reference herein in their entirety.
• FIG. 17 shows asystem152 including a suture orflexible member154 and atissue engaging member156 attached to adistal end158 of theflexible member154. A proximal end of theflexible member154 is connected to asuture anchor160 by, for example, fixing the proximal end of theflexible member154 within ahollow opening162 in thesuture anchor160. The proximal end of theflexible member154 can include a self-locking loop, such as the self-lockingloop136 ofFIGS. 16A and 16B, which loops around a shoulder or ledge on thesuture anchor160 within thehollow opening162 to hold the proximal end of theflexible member154 in place. Thesystem152 can be used to fix soft tissue to bone using thesuture anchor160.
• FIG. 18 shows braided sutures orflexible members166,168,170, andtissue engaging members172,174,176 attached todistal ends178,180,182 of theflexible members166,168,170 rather than a single tissue engaging member attached to the distal ends178,180,182. Theflexible members166,168,170 are connected to aconstruct184 including intertwinedportions186,188,190 of theflexible members166,168,170. Although theconstruct184 is shown as includingintertwined portions186,188,190 of theflexible members166,168,170, theconstruct184 can be a flexible member having a diameter that is larger than the diameters of theflexible members166,168,170, and theflexible members166,168,170 can extend from the larger-diameter flexible member forming theconstruct184.
• FIG. 19 shows asystem190 including a suture orflexible member192 and atissue engaging member194 attached to adistal end196 of theflexible member192. Aproximal end198 of theflexible member192 is connected to atissue reinforcing material200, such as an allograft patch or SportMesh™ from Biomet Sports Medicine of Warsaw, Ind. Thetissue reinforcing material200 can be placed on tissue such as skin, soft tissue, or bone, and the tissue can grow or thicken into thetissue reinforcing material200. Thetissue reinforcing material200 can be attached to the tissue using an adhesive, and thetissue reinforcing material200 can be used to hold portions of tissue together at a defect site. Thetissue engaging member194 can be used to tie soft tissue to the tissue on which thetissue reinforcing material200 is placed.
• FIG. 20 shows asystem202 that includes theflexible member192 and thetissue engaging member194 attached to thedistal end196 of theflexible member192. Theproximal end198 of theflexible member192 is attached to atissue adhering material204 such as an adhesive or blood. Thetissue adhering material204 can couple theproximal end198 of theflexible member192 to atissue205, and thetissue engaging member194 can couple thedistal end196 of theflexible member192 to another tissue (not shown). AlthoughFIGS. 16 through 20 depict tissue engaging members attached to distal ends of flexible members and other elements connected to proximal ends of the flexible members, the tissue engaging members can be attached to the proximal ends of the flexible members and the other elements can be connected to the distal ends of the flexible members. In addition, inFIGS. 1 through 20, any number of tissue engaging members having various shapes and sizes can be used with any of the embodiments in any combination.
• Referring now toFIGS. 21 through 26, elongate members including tissue engaging members or barbs radially extending from elongate bodies will now be described. The barbs and the elongate bodies can be made from PEEK, polyethylene, and/or metal. The elongate bodies can be sufficiently stiff to enable insertion of the elongate bodies into tissue.
• FIG. 21 shows anelongate member206 including a taperedelongate body208 having adistal end210 that can be rounded, as shown, to guide theelongate member206 into a preformed hole in soft tissue, bone, or a suture anchor. Alternatively, thedistal end210 of theelongate body208 can be pointed to pierce into soft tissue. Theelongate body208 can be 3.5 to 10.0 mm in length and 1 to 3 mm in diameter. In addition, theelongate body208 can be rigid and therefore may not deflect when inserted into soft tissue or bone.
• Theelongate member206 includes a first row of tissue engaging members orbarbs212, a second row of tissue engaging members orbarbs214, and a third row of tissue engaging members orbarbs216. Thebarbs212,214,216 extend rearward from thedistal end210 of theelongate body208 at an angle other than parallel to a longitudinal axis of theelongate body208. Although not shown, theelongate body208 can include a fourth row of tissue engaging members or barbs on the hidden surface of theelongate body208 opposite from the second row ofbarbs214. In this regard, when viewing theelongate body208 in a direction toward thedistal end210 of theelongate body208, the first row ofbarbs212, the second row ofbarbs214, the third row ofbarbs216, and the fourth row of barbs can be axial paths spaced 90 degrees apart around the circumference of theelongate body208. In addition, theelongate member206 can include at least 6 to 12 barbs per mm of length of theelongate body208.
• Further, the distance between tips of the barbs can be greater than the distance between bases of the barbs so that tissue or suture is pinched between the barbs as the tissue or suture is forced between the barbs. The tissue or suture may be forced between the barbs when the barbs pierce the tissue or suture or when the barbs engage the tissue or suture without piercing the tissue or suture. In either case, pinching the tissue or suture between the barbs locks theelongate member206 in the tissue or suture.
• The barbs can be sufficiently flexible to deflect radially inward toward theelongate body208 when theelongate member206 is inserted into tissue in a first direction to reduce the effort required to insert theelongate member206 into tissue. In addition, the barbs can be sufficiently rigid and deflect radially outward from theelongate body208 when a removal force is applied to theelongate member206 in a second opposite direction to prevent removal of theelongate member206 from tissue, such as soft tissue or bone. Each of the barbs can include a hooked or pointedend218 that pierces into tissue to prevent removal of theelongate member206 from the tissue. Theelongate body208 can remain rigid as the barbs flex radially inward and outward.
• Theelongate member206 can also include asuture engaging feature220, such as an eyelet or a shoulder, which is separate from and attached to aproximal end221 of theelongate body208. Alternatively, theelongate body208 and thesuture engaging feature220 can be integrally formed. For example, theelongate body208 can define thesuture engaging feature220, which can be a hole formed in theelongate body208. Asuture222 can be passed through thesuture engaging feature220. The sutureengaging feature220 can be positioned at theproximal end221 of theelongate body208, at thedistal end210 of theelongate body208, or at a location between or beyond theends210,221 of theelongate body208.
• FIG. 22 shows anelongate member224 including anelongate body226 having adistal end228 and aproximal end230. Thedistal end228 of theelongate body226 can be sharpened, as shown, or rounded. Theelongate member224 includes multiple tissue engaging members or leaves232 extending rearward from thedistal end228 of theelongate body226. Theleaves232 can include layers of planar members randomly adhered to theelongate body226 along the length of and about theelongate body226. Theleaves232 can have multiple jagged protrusions orbarbs234 that pierce into tissue to prevent removal of theelongate member224 from tissue. Theleaves232 can lie relatively flat against theelongate body226 unless a removal force is applied to theelongate member224, in which case theleaves232 can deflect radially outward to prevent removal of theelongate member224. The sutureengaging feature220 can be attached to theproximal end230 of theelongate body226.
• FIG. 23 shows anelongate member236 including anelongate body238 having adistal end240 and aproximal end242. Theelongate body238 includes radially extending tissue engaging members or leaves244 stacked uniformly along the length of theelongate body238 to form a pine tree shape. Theleaves244 are flexible and include pointed protrusions orbarbs246 that pierce into tissue when a removal force is applied to theelongate member236 to prevent removal of theelongate member236. Thedistal end240 of theelongate body238 is pointed to enable theelongate member236 to pierce into tissue.
• FIG. 24A illustrates anelongate member248 that includes anelongate body250 having adistal end252 and aproximal end254. Thedistal end252 of theelongate body250 is a pointed or sharp tip that enables theelongate member248 to pierce into tissue. Theelongate body250 defines afirst channel256 adjacent to theproximal end254 of theelongate body250 and asecond channel258 adjacent to thedistal end252 of theelongate body250. Thechannels256,258 of theelongate body250 receive anactuator260 such as a cannulated rod having a closeddistal end261.
• Asuture262 can be attached to theactuator260 such as by press fitting thesuture262 within theactuator260. Theactuator260 can includemultiple sockets264, and multiple tissue engaging members orbarbs266 can extend throughholes268 in theelongate body250 and can be pivotally mounted in thesockets264 of theactuator260. When theelongate member248 is inserted into tissue, thebarbs266 can rotate radially inward toward theelongate body250 until thebarbs266 contact proximal sides of theholes268. At that point, thebarbs266 can deflect radially inward toward theelongate body250. The rotation and/or deflection of thebarbs266 decreases the effort required to insert theelongate member248 into tissue in a first direction.
• FIG. 24B illustrates theelongate member248 with theactuator260 retracted to extend thebarbs266 radially outward from theelongate body250 to prevent removal of theelongate member248 from tissue in a second direction. To retract theactuator260, a tension force can be applied to the proximal end of thesuture262, as represented by the larger arrow269-1. The dashed lines represent theproximal-most barbs266 and thedistal end261 of theactuator260 before theactuator260 is retracted. After theactuator260 is retracted, thebarbs266 rotate radially outward from theelongate body250 in the direction indicated by the smaller arrows269-2 until thebarbs266 contact the distal sides of theholes268 and theelongate body250. In this position, thebarbs266 prevent removal of theelongate member248 when theelongate member248 is inserted into tissue.
• FIG. 25 shows anelongate member270 including a taperedelongate body272 having adistal end274 and aproximal end276. Theelongate body272 can include a first row of radially extending tissue engaging members orbarbs278 and a second opposed row of radially extending tissue engaging members orbarbs280 extending rearward from thedistal end274 of theelongate body272. The distance between tips of thebarbs278,280 can be greater than the distance between bases of thebarbs278,280.
• Theelongate body272 can also include asuture engaging portion281 from which no barbs extend, and theelongate body272 can define ahole282 adjacent to thesuture engaging portion281 and thedistal end274 of theelongate body272. Asuture284 can be routed past theproximal end276 of theelongate body272, alongside thesuture engaging portion281 of theelongate body272, and through thehole282 in theelongate body272. Since thesuture engaging portion281 of theelongate body272 does not have barbs extending therefrom, thesuture284 is allowed to pass freely alongside theelongate body272. Thesuture engaging portion281 of theelongate body272 can be recessed to ensure that thesuture284 stays within thesuture engaging portion281.
• FIG. 26A shows anelongate member286 including a taperedelongate body288 having adistal end290 and aproximal end292. Theelongate body288 includes a first row of tissue engaging members orbarbs294, a second row of tissue engaging members orbarbs296, a third row of tissue engaging members orbarbs298, a fourth row of tissue engaging members orbarbs300, and a fifth row of tissue engaging members orbarbs302. Theelongate body288 can also include additional rows of tissue engaging members or barbs that are not visible inFIG. 26A but are shown inFIGS. 26B and 26C. The barbs extend rearward from thedistal end290 of theelongate body288, and the barbs are positioned around the circumference of theelongate body288 along the length of theelongate body288. The distance between tips of the barbs can be greater than the distance between bases of the barbs.
• Asuture engaging feature304, such as an eyelet, can be positioned distal to thedistal end290 of theelongate body288, and asuture306 can be passed through thesuture engaging feature304. Theelongate body288 can have a bullet or round shape, as shown inFIG. 26B, or theelongate body288 can have a flat shape, as shown inFIG. 26C. Similarly, the elongate bodies shown inFIGS. 21 through 23 and 25 can also have a flat or round shape. In bothFIGS. 26B and 260, theelongate body288 includes rows of tissue engaging members or barbs that are opposite from and symmetric to the second, third and fourth rows ofbarbs296,298,300.
• Referring now toFIGS. 27 through 30, various methods of delivering a tissue engaging member and/or an elongate member according to the principles of the present disclosure will now be described.FIG. 27 depicts delivery of thesystem10 ofFIG. 1 through atube308. Thetube308 has adistal end310 that is open to allow delivery of theflexible member12 and thetissue engaging member14 through thedistal end310. Thetube308 can provide structural support for theflexible member12 to enable insertion of theflexible member12 and thetissue engaging member14 into tissue. Although thebarbs18,20 are shown extending radially outward from theflexible member12, the inner diameter of thetube308 can be approximately equal to or only slightly greater than the outer diameter of theflexible member12, which would force thebarbs18,20 radially inward toward theflexible member12 and minimize the opening in the tissue required to insert thetube308. Thetissue engaging member14 can be pushed into the tissue using a fork or a tube (not shown) inserted between thebarbs18,20 and theflexible member20.
• FIG. 28 illustrates atube312 having adistal end314 that is open to allow delivery of theflexible member12 and thetissue engaging member14 through thedistal end314. Thetube312 can provide structural support for theflexible member12 to enable insertion of theflexible member12 and thetissue engaging member14 into tissue. In addition, thedistal end314 of thetube312 has a pointed or sharp tip that enables thetube312 to pierce into tissue.
• FIG. 29A shows adelivery inserter316 that includes acannula318aand arod320aextending through thecannula318aand having adistal end322a. Anelongate member324 can be placed over thedistal end322aof thedelivery inserter316. Theelongate member324 includes anelongate body325 and multiple tissue engaging members orbarbs326 extending radially outward from theelongate body325 and rearward from adistal end327 of theelongate body325. Theelongate body325 defines ahole328 that extends through aproximal end329 of theelongate body325 and at least partially through theelongate body325. Thedistal end322aof therod320ais tapered, and thehole328 in theelongate member324 is tapered to match the taper of thedistal end322a. Asuture330 can be trapped between theelongate member324 and thedistal end322aof therod320aas theelongate member324 is slid onto thedistal end322a. Alternatively, thesuture330 can be connected to theelongate member324 before theelongate member324 is placed onto thedistal end322aof therod320a, such as by looping thesuture330 through or around a suture engaging feature on theelongate member324.
• In operation, a surgeon can hold thecannula318aand position theelongate member324 at a desired location within tissue. Once theelongate member324 is positioned as desired, the surgeon can pull on thecannula318aand thereby remove theelongate member324 from thedistal end322aof therod320a. When the surgeon pulls on thecannula318ato retract thedelivery inserter316, thebarbs326 engage tissue to prevent removal of theelongate member324 and the distal end of thesuture330 from the tissue.
• FIG. 29B shows a delivery inserter that is similar to the deliverinserter316 ofFIG. 29A except that thecannula318ais replaced with acannula318b, which is sized to receive both therod320aand theelongate member324. In operation, theelongate member324 is placed onto thedistal end322aof therod320a, and therod320ais inserted into thecannula318b. Thecannula318ais then inserted into tissue, such as soft tissue, to deliver theelongate member324 through the tissue without engaging theelongate member324 and the tissue. Therod320ais then used to push theelongate member324 into tissue, such as soft tissue or bone. Thecannula318band therod320aare then removed from the tissue, leaving theelongate member324 in the tissue.
• FIG. 29C shows a delivery inserter that is similar to the deliver inserter ofFIG. 29B except that therod320ais replaced with arod320b, which includes adistal end322band ashoulder331 at a transition to adistal end322b. In operation, theelongate member324 is slid onto the distal end322 of therod320auntil theelongate member324 abuts theshoulder331 on therod320b, and therod320ais inserted into thecannula318b. Then, theelongate member324 is delivered through tissue using thecannula318a, theelongate member324 is pushed into tissue using therod320b, and thecannula318band therod320bare removed from the tissue, as described above.
• FIG. 30 shows asuture passer332 including aneedle334 that can be extended to insert a suture system into tissue. For illustrations purposes, thesuture passer332 is shown passing thesystem10 ofFIG. 1. Theneedle334 can be sufficiently flexible to pass through thesuture passer332 and sufficiently rigid to guide thesystem10 and/or pierce into tissue. Thesuture passer332 can include cuttingedges336 that can be used to pierce a hole in tissue before passing a suture system into the tissue. Further discussion of suture passers and methods of delivering sutures into tissue using suture passers can be found in commonly assigned U.S. patent application Ser. No. 11/346,540, U.S. patent application Ser. No. 11/386,074, now U.S. Pat. No. 7,572,265, and U.S. patent application Ser. No. 11/501,171, the disclosures of which are incorporated by reference herein in their entirety. Thesuture passer332 is shown for illustration purposes and can be replaced with other suture passers, or combinations thereof, disclosed in the aforementioned patent applications.
• Referring now toFIGS. 31 through 35, various methods of repairing a defect in tissue using a tissue engaging member according to the principles of the present disclosure will now be described.FIG. 31 shows a tissue repair, such as a rotator cuff repair, in which atissue338, such as a tendon or rotator cuff, is attached to abone340, such as a humerus, usingsuture systems342. Thesuture systems342 each include asuture anchor344 coupled to ends ofmultiple sutures346, and tissue engaging members orbarbs348 coupled to the opposite ends of thesutures346. Thesutures346 extend into thetissue338 and hold thetissue338 onto thebone340. Although twosuture systems342 are shown, more or less suture systems including more or less sutures and tissue engaging members can be used to attach thetissue338 to thebone340.
• FIGS. 32A and 32B show only one of thesuture systems342 holding thetissue338 onto thebone340. InFIG. 32A, thesutures346 extend from thesuture anchor344 and wrap around thetissue338 before entering a top surface of thetissue338. InFIG. 32B, thesutures346 extend directly from thesuture anchor344 into a bottom surface of thetissue338. In both figures, thebarbs348 are pushed deeper into thetissue338 to tension thesutures346.
• FIG. 33 is similar toFIG. 32A except that thesuture anchor344 has been replaced with asuture anchor350 such as a Ti Screw Suture Anchor from Biomet Sports Medicine of Warsaw, Ind. Thesuture anchor350 has a major diameter and a minor diameter that is less than the major diameter. Although only one suture anchor is shown, one or more suture anchors can be coupled to one or more suture and tissue engaging member arrangements to attach thetissue338 to thebone340.
• FIG. 34 illustrates a tendon repair using thesystem122 ofFIG. 15.Tissue portions352,354 are positioned end-to-end, and thesystem122 is used to hold the ends of thetissue portions352,354 together. Thetissue portions352,354 can be two portions of one torn tendon, two separate tendons, or a tendon and a bone. Thetendon portions352,354 can be part of an anterior cruciate ligament (ACL) or a posterior cruciate ligament (PCL). AlthoughFIG. 34 shows three duplicates of thesystem122 being used to attach the ends of thetendon portions352,354, more or less duplicates of thesystem122 can be used to attach the ends of thetendon portions352,354. The firsttissue engaging member124 of thesystem122 is inserted into and engages thetendon portion352, and the secondtissue engaging member126 of thesystem122 is inserted into and engages thetendon portion354. Tension is applied to thesuture12 by pushing the tissue engaging members deeper into thetendon portions352,354.
• FIGS. 35A through 35C illustrate a method of performing an ACL reconstruction using a tissue engaging member according to the principles of the present disclosure. In the ACL reconstruction, atissue356, such as graft, is inserted into ahole358 in atibia360. Asystem362 includes atoggle anchor364 positioned at the lower end of thehole358 and coupled to ends ofmultiple sutures366, and tissue engaging members orbarbs368 attached to the opposite ends of thesutures366. Thetissue engaging members368 engage thetissue356 to hold thetissue356 within thehole358 in thetibia360. AlthoughFIGS. 35A through 350 shows the ACL reconstruction on the tibia side, the ACL reconstruction on the femoral side can be performed in a similar manner using thesystem362.
• FIGS. 35B and 35C showtissue portions370,372 held together by thesystem74 ofFIG. 7. One of the barbs in each of thetissue engaging members76,78,80 is engaging thetissue portion370, and the other one of the barbs in thetissue engaging members76,78,80 is engaging thetissue portion372. InFIG. 35B, the barbs of thetissue engaging members76,78,80 extend downward through thetissue portions370,372 and into thetibia360. InFIG. 350, the barbs of thetissue engaging members76,78,80 extend upward into thetissue portions370,372 without penetrating thetibia360. In this regard, thesystem74 can be used to attach thetissue portions370,372 together. In addition, although only two tissue portions are shown, thetissue portions370,372 can be a four bundle graft, and thesystem74 can be used in place of a whip stitch to secure the four bundle graft together.
• Referring now toFIGS. 36 through 40, various methods of repairing defects in tissue using an elongate member according to the principles of the present disclosure will now be described.FIG. 36 shows anelongate member374 holding atissue376 within ahole378 in abone380. Theelongate member374 can be used without a suture to hold thetissue376 within thehole378 in thebone380. Theelongate member374 includes a taperedelongate body382 having adistal end384 and aproximal end386, and multiple tissue engaging members or barbs388 extending rearward from thedistal end384 of theelongate body382. The barbs388 engage thetissue376 and thebone380 to hold thetissue376 within thehole378 in thebone380.
• FIG. 37 shows theelongate member374 engaging asuture390 to anchor thesuture390 within thehole378 in thebone380. The barbs388 of theelongate member374 can pierce through thesuture390 and into thebone380 to hold thesuture390 within thehole378 in thebone380. Alternatively, theelongate member374 can trap thesuture390 within thehole378 in thebone380 even when the barbs388 do not pierce into thesuture390. In either case, theelongate member374 can function as a suture anchor.
• FIG. 38 shows anelongate member392 shaped similar to a pipe cleaner and being inserted into ahole394 in asuture anchor396 fixed in abone400 to trap asuture398 within thehole394. Theelongate member392 includes anelongate body402 and tissue engaging members orbarbs404 extending radially from theelongate body402. Thebarbs404 can be attached around the circumference of theelongate body402 in uniform, straight axial lines or in a random fashion. Thebarbs404 engage thesuture398 and thesuture anchor396 to hold thesuture398 within thehole394 in thesuture anchor396. When theelongate member392 is inserted within thehole394, thebarbs404 can extend rearward from the distal end of the elongate body402 (FIG. 39).
• FIG. 39 shows theelongate member392 inserted into thehole394 in thesuture anchor396.FIG. 39 is similar toFIG. 38 except that theelongate body402 defines ahole406 extending longitudinally through theelongate body402 and thesuture398 is passed through thehole406 and around one side of theelongate member406. When theelongate member392 is inserted into thehole394 in thesuture anchor396, thebarbs404 engage thesuture anchor396 and thesuture398 to anchor thesuture398 to thebone400. Although thesuture engaging feature406 is shown at the proximal end of theelongate member392, thesuture engaging feature406 can be positioned at the distal end of theelongate member392 or at any other suitable location along the length of theelongate member392.
• FIG. 40 is similar toFIG. 39 except that asuture engaging feature407, such as an eyelet, is attached to the proximal end of the elongate member and asuture398 is passed through thesuture engaging feature407. Additionally, abracket408 is attached to theelongate body402 of theelongate member392, and a bracket410 is attached to thesuture anchor396 within thehole394 in thesuture anchor396. Before theelongate member392 is inserted into thehole394 in thesuture anchor396, theelongate member392 can be oriented so that thebracket408 does interfere with the bracket410. Once theelongate member392 is completely inserted into thehole394, theelongate member392 can be rotated to engage thebrackets408,410 in order to prevent removal of theelongate member392 from thehole394 in thesuture anchor396.
• The methods for using elongate members discussed above can apply to other elongate members discussed above, or variations thereof, where appropriate. For example, theelongate member206 ofFIG. 21 can be used in a similar manner as theelongate member392 ofFIG. 39. In addition, various features of the elongate members discussed above can be interchangeable. For example, thebarbs212,214,216 can extend perpendicular to the longitudinal axis of theelongate body208 ofFIG. 21 just as thebarbs404 extend perpendicular to the longitudinal axis of theelongate body402 ofFIG. 39.
• 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 can 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.

Claims (22)

1. A system, comprising:

a flexible member; and

a tissue engaging member fixed to the flexible member, the tissue engaging member including a barb preformed to extend rearward from a distal end of the flexible member at an acute angle relative to the flexible member.

2. The system ofclaim 1, wherein the flexible member includes polyethylene.

3. The system ofclaim 1, wherein the flexible member is a monofilament suture.

4. The system ofclaim 1, wherein the flexible member is a braided multifilament suture.

5. The system ofclaim 1, wherein the tissue engaging member is fixed to the flexible member using one of a press fit, an adhesive, and molding.

6. The system ofclaim 1, wherein the tissue engaging member includes at least one of polyether ether ketone (PEEK) and metal.

7. The system ofclaim 1, wherein the barb includes a hook configured to pierce into tissue when a removal force is applied to the flexible member.

8. The system ofclaim 1, wherein the barb is cylindrical.

9. The system ofclaim 1, wherein the barb has an oval-shaped planar face with only one axis of symmetry.

10. The system ofclaim 1, wherein the barb is claw-shaped.

11. The system ofclaim 1, wherein the flexible member extends through the tissue engaging member.

12. The system ofclaim 1, wherein the flexible member terminates at the tissue engaging member.

13. The system ofclaim 1, wherein: the tissue engaging member has an arrow shape; a first portion of the flexible member extends in a first direction toward an inner surface of the arrow shape; a second portion of the flexible member extends in a second direction away from the inner surface of the arrow shape; and the second direction is generally opposite from the first direction.

14. The system ofclaim 1, wherein the tissue engaging member includes a plurality of tissue engaging members randomly attached along the length of and about the flexible member.

15. The system ofclaim 1, wherein the tissue engaging member includes a first tissue engaging member attached to the distal end of the flexible member and extending proximally, and a second tissue engaging member attached to a proximal end of the flexible member and extending distally such that the first and second tissue engaging members are opposed to each other.

16. The system ofclaim 1, further comprising a self-locking loop attached to a proximal end of the flexible member, wherein the tissue engaging member is attached to the distal end of the flexible member.

17. The system ofclaim 1, wherein the flexible member includes a plurality of flexible members having portions that are intertwined and distal ends that are untwined, and the tissue engaging member includes a plurality of tissue engaging members, at least one of the tissue engaging members connected to each one of the distal ends of the plurality of flexible members.

18. The system ofclaim 1, further comprising at least one of a tissue reinforcing material and a tissue adhering material attached to a proximal end of the flexible member, wherein the tissue engaging member is attached to the distal end of the flexible member.

19. A system, comprising:

a flexible member; and

a tissue engaging member attached to the flexible member, wherein the tissue engaging member is configured to deflect toward the flexible member as the flexible member is inserted into tissue to allow insertion of the flexible member into tissue, and the tissue engaging member is configured to deflect away from the flexible member as a removal force is applied to the flexible member to prevent removal of the flexible member from tissue.

20. The system ofclaim 19, wherein the tissue engaging member is movable relative to the flexible member.

21. A system, comprising:

a flexible member; and

a tissue engaging member connected to the flexible member, the tissue engaging member comprising:

a first barb configured to deflect toward the flexible member as the flexible member is inserted into tissue to allow insertion of the flexible member into tissue, and to deflect away from the flexible member as a removal force is applied to the flexible member to prevent removal of the flexible member from tissue; and

a second barb configured to deflect toward the flexible member as the flexible member is inserted into tissue to allow insertion of the flexible member into tissue, and to deflect away from the flexible member as a removal force is applied to the flexible member to prevent removal of the flexible member from tissue.

22. The system ofclaim 21, wherein the first and second barbs form an arrow shape.

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