Double-row folding suture structure

Abstract

To improve tissue repair devices, systems, and methods.SOLUTION: Tissue fixation and repair constructs and methods of repair using the same are provided. An exemplary tissue fixation and repair construct can include a first implantable anchor coupled to a suture having a fixed tail and a tensioning tail. The fixed tail can include an overhand knot located distally adjacent to a finger trap, such that the overhand knot substantially abuts the finger trap when adjacent thereto, a fixed stopper knot configured to prevent further movement of the fixed tail through a second implantable anchor when the second implantable anchor is placed onto the suture, and a finger trap. The tensioning tail can be passed through the finger trap and overhand knot, and can be used to adjust tension of the tissue fixation and repair construct when the first implantable anchor and the second implantable anchor are inserted into bone.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present disclosure relates generally to a double row collapsible suture structure. [Background technology]

[0002] Various injuries and conditions require the repair or reattachment of soft tissue to bone and / or surrounding tissue. When normally healthy tissue detaches from bone, such as when the rotator cuff tendon in the shoulder is partially or completely torn from the humerus (rotator cuff tear), surgery is often required to reattach the tissue to bone to allow healing and natural reattachment to occur. Numerous devices and methods have been developed to perform these surgical repairs. Some of the more successful methods involve the use of suture fixation devices, such as suture anchors, which typically have an anchor body with one or more suture attachment mechanisms and a tissue or bone engaging mechanism for holding the suture anchor in or adjacent to tissue or bone. Depending on the particular injury, one or more suture anchors coupled with or interconnected by one or more segments of suture may be used to perform the repair.

[0003] Surgery may also be necessary when tears occur in the substance of a single type of tissue. Sutures may also be used with one or more suture anchors to repair such tissue tears. The sutures may be fastened to the suture anchors and tissue using knots tied by the surgeon during the repair procedure, or using "knotless" devices and methods in which one or more anchors and one or more sutures may be connected and tensioned without the surgeon having to tie knots during surgery. Knotless fastening is particularly useful in minimally invasive surgical procedures, such as endoscopic or arthroscopic repair, in which the surgeon must remotely manipulate the sutures at the surgical site using instruments inserted through small-diameter cannulas or endoscopic tubes, which can make the tying process difficult and time-consuming.

[0004] However, current techniques for double-row fixation require setting suture tension while the anchors are being inserted, which can make it difficult to reliably set the correct amount of tension. In addition, current techniques require the use of multiple anchors for both the medial and lateral rows. Furthermore, current techniques and fixation device designs result in relatively poor suture retention for the lateral row anchors because the sutures are often compressed between the bone and the anchors. Summary of the Invention [Problem to be solved by the invention]

[0005] Thus, there remains a need for improved tissue repair devices, systems, and methods. [Means for solving the problem]

[0006] In one aspect, a tissue repair structure is provided and may include a first implantable anchor and a flexible member. The first implantable anchor may include an engagement member and at least one bone-engaging feature on an outer sidewall of the first implantable anchor. The flexible member may include an intermediate portion coupled to the engagement member and first and second tails extending from the intermediate portion. Each of the first and second tails may include a terminal end. A portion of the first tail may extend through an internal collapsible passage formed within a portion of the second tail and a first knot formed in the second tail adjacent to the hollow portion. The second tail may include a knot secured intermediate the first knot and the terminal end of the second tail.

[0007] In some embodiments, the intermediate portion can be slidably coupled to the engaging member. In other embodiments, the tissue repair structure can include a second implantable anchor configured to be coupled to the second tail. In such embodiments, the second implantable anchor can be disposed proximate to the fixation knot. In yet other embodiments, the terminal end of the first tail can be configured to be coupled to the second tail. In still other embodiments, the terminal end of the first tail can be configured to be separated from the second tail. In some embodiments, the distance between the fixation knot and the first knot can be disposed at a distance from the fixation knot approximately equal to 3-5 mm greater than the length of the first implantable anchor. In other embodiments, the internal collapsible channel can be configured to be disposed outside the bone when the first implantable anchor is disposed within the bone.

[0008] In another aspect, a method is provided that may include inserting a tissue repair structure into a first bone hole, the tissue repair structure including a first implantable anchor having an engaging member and at least one bone-engaging feature on an outer sidewall of the first implantable anchor, and a flexible member coupled to the engaging member, the flexible member having at least one tail extending from the flexible member, the flexible member joining itself to form a loop proximal to the first implantable anchor, passing at least a portion of the flexible member through or around soft tissue, coupling the flexible member to a second implantable anchor, inserting the second implantable anchor and at least a portion of the flexible member into the second bone hole, and tensioning the flexible member to apply and set a desired amount of tension in the repair structure after the second implantable anchor is inserted into the second bone hole.

[0009] In some embodiments, the flexible member can have an intermediate portion coupled to the engaging member, the flexible member having first and second tails extending from the intermediate portion, the first and second tails each having a terminal end, and the flexible member being joined by passing the first tail through a portion of the second tail. In such embodiments, the method can include, after the passing step, separating the terminal end of the first tail from the second tail and coupling the flexible member to the second anchor by inserting the terminal end of the second tail into the second implantable anchor. In other embodiments, the distal end of the flexible member can be coupled to the first implantable anchor, and the second anchor can be coupled to the second implantable anchor by coupling a loop in the flexible member to a connecting suture attached to the second implantable anchor. [Brief explanation of the drawings]

[0010] The present invention will be more fully understood from the following detailed description when read in conjunction with the accompanying drawings, in which: [Figure 1]1 is a schematic diagram of one embodiment of a tissue fixation and repair construct. [Figure 2a] 2 is a schematic side cross-sectional view of the tissue fixation and repair construct of FIG. 1 during an initial step of a surgical procedure in which a first implantable anchor is inserted into a hole formed in bone. [Figure 2b] 2 is a schematic cross-sectional side view of the tissue fixation and repair construct of FIG. 1 during a subsequent step in a surgical procedure in which a portion of the construct passes through soft tissue. [Figure 2c] 2 is a side cross-sectional schematic view of the tissue fixation and repair construct of FIG. 1 during a subsequent step in the surgical procedure in which a second hole is formed in the bone. [Figure 2d] 2 is a side cross-sectional schematic view of the tissue fixation and repair construct of FIG. 1 during a subsequent step in a surgical procedure, in which the tensioning tail of the flexible member is separated from the fixation tail of the tensioning member. [Figure 2e] 2 is a side cross-sectional schematic view of the tissue fixation and repair construct of FIG. 1 during a subsequent step in the surgical procedure, in which the fixation tail is coupled with a second anchor implanted in a second hole. [Figure 2f] 2 is a side cross-sectional schematic view of the tissue fixation and repair construct of FIG. 1 during a subsequent step in the surgical procedure in which a second anchor is implanted within the second hole. [Figure 2g] 2 is a side cross-sectional schematic view of the tissue fixation and repair construct of FIG. 1 during a subsequent step in a surgical procedure in which the tensioning tails are tensioned to approximate soft tissue to bone. [Figure 3] 2 is a side cross-sectional schematic illustration of an exemplary technique for connecting flexible members of the tissue fixation and repair construct of FIG. 1 using a second anchor. [Figure 4] 10A-10C are side cross-sectional schematic views of additional embodiments of tissue fixation and repair constructs having multiple flexible members coupled to implantable anchors. [Figure 5] 1 is a side cross-sectional schematic view of one embodiment of a tissue fixation and repair construct. [Figure 6a]6 is a schematic cross-sectional side view of the tissue fixation and repair construct of FIG. 5 during an initial step of a surgical procedure in which a first implantable anchor is inserted into a hole formed in the bone. [Figure 6b] 6 is a side cross-sectional schematic view of the tissue fixation and repair construct of FIG. 5 during a subsequent step in a surgical procedure in which a portion of the construct passes through soft tissue. [Figure 6c] 6 is a side cross-sectional schematic view of the tissue fixation and repair construct of FIG. 5 during a subsequent step in the surgical procedure in which a second hole is formed in the bone. [Figure 6d] 6 is a side cross-sectional schematic view of the tissue fixation and repair construct of FIG. 5 during a subsequent step in the surgical procedure in which a second anchor is implanted within the second hole. [Figure 7] 1 is a schematic overhead view of an exemplary embodiment of a dual row rotator cuff repair in accordance with the technology disclosed herein. DETAILED DESCRIPTION OF THE INVENTION

[0011] Certain exemplary embodiments will now be described to provide a thorough understanding of the principles of the structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments, and that the scope of the present invention is defined solely by the claims. Features illustrated or described in connection with one exemplary embodiment may be combined with features of other embodiments. Such modifications and variations are intended to be within the scope of the present invention.

[0012] Furthermore, in this disclosure, like-named components of embodiments generally have similar characteristics, and therefore, in particular embodiments, every feature of each like-named component will not necessarily be described in full detail. Additionally, to the extent linear or circular dimensions are used in describing the disclosed systems, devices, and methods, such dimensions are not intended to limit the types of shapes that can be used in conjunction with such systems, devices, and methods. Those skilled in the art will recognize that equivalent dimensions for such linear and circular dimensions can be readily determined for any geometric shape. The size and shape of the systems and devices and their components may depend, at least, on the anatomical structure of the subject within which the systems and devices are to be used, the size and shape of the components with which the systems and devices are to be used, and the method and procedure for which the systems and devices are to be used.

[0013] The drawings provided herein are not necessarily drawn to scale. Additionally, to the extent that arrows are used to describe directions in which components can be tensioned or pulled, these arrows are illustrative and do not in any way limit the directions in which individual components can be tensioned or pulled. Those skilled in the art will recognize other methods and directions for achieving the desired tension or movement. Similarly, while in some embodiments, movement of one component is described relative to another component, those skilled in the art will recognize that other movement is possible. Furthermore, terms such as "first" and "second" are used to describe various aspects of components, such as a first end and a second end, and do not indicate that one component is located before the other. The use of such terms can be used to distinguish between two similar components or features, and such first component and second component can often be used interchangeably. Furthermore, many terms may be used interchangeably throughout this disclosure, as would be understood by those skilled in the art.

[0014] Soft tissue fixation and repair constructs and methods of soft tissue repair using the same, as well as kits containing the same, are provided. These constructs are particularly useful in dual-row fixation repair, for example, for rotator cuff repair, and include an implantable anchor coupled to a collapsible loop. After the anchor is implanted into bone, such as the medial aspect, and a flexible member is passed through or around the soft tissue, the flexible element can be coupled to a second implantable anchor, such as a knotless anchor in the lateral row, which is implanted into the bone. Among the advantages of the constructs described herein is the fact that tension can be applied to the flexible member to tighten the flexible loop through a knotless technique, compressing the soft tissue against the bone after the anchor is inserted into the bone. A disadvantage of many current techniques is that tension can only be applied while the second anchor is being inserted, making it difficult to control the tension. The soft tissue fixation and repair constructs and methods of soft tissue repair described herein provide stronger lateral row fixation through a more convenient and less time-consuming procedure. A further advantage of the structures and techniques disclosed herein is the ability to use the same type of anchor for both the medial and lateral rows, which is typically not the case in current practice.

[0015] FIG. 1 illustrates one embodiment of a tissue fixation and repair construct 10 configured to be implanted within a patient's body to facilitate soft tissue repair. The tissue fixation and repair construct 10 includes a first implantable anchor 12, such as an internal anchor configured to be inserted into a hole formed in bone, with a flexible member 14 coupled to the anchor 12. In the exemplary embodiment, the first implantable anchor 12 has at least one bone-engaging feature 16 located on its outer sidewall. Furthermore, in some embodiments, the first implantable anchor 12 is cannulated with a lumen 18 extending therethrough, and a first flexible member-engaging feature 20 spans the lumen 18 at a distal end 12d of the implantable anchor 12. The flexible member may include a first tail 22, a second tail 24, and an intermediate portion 26 disposed between the first tail 22 and the second tail 24. The first tail 22 may be a tensioning tail that can be used by a surgeon to adjust the overall tension of the flexible member 14 during placement of the tissue fixation and repair construct 10. The second tail 24 may be a fixation tail on which various features may be formed, such as a single knot 28, a fixation stop knot 30, and a finger loop 32, each of which is discussed in further detail below. The first tail 22 and the second tail 24 may optionally be connected together by a terminal joint 34.

[0016] 1-2g, a tissue fixation and repair construct includes a first implantable anchor 12 configured to be implanted in a fixed manner into bone. In such a construct, the implantable anchor is configured to couple to a suture and to be used in a tissue repair procedure, for example, for soft tissue reattachment or repair in a joint such as the hip, knee, or shoulder, particularly for a rotator cuff repair procedure.

[0017] Those skilled in the art will appreciate that a variety of suture anchor types, including both hard and soft anchors and including screw-type anchors, can be used with the structures provided herein, and that the present disclosure is not intended to be limited to the anchor designs provided herein. Some exemplary embodiments of anchors that can be used with the structures and related teachings provided herein include Healix Ti™ anchors, Healix Advance™ anchors, Healix Advance™ Knotless anchors, Versalok™ anchors, and Gryphon™ anchors (each commercially available from DePuy Mitek Inc., 325 Paramount Drive, Raynham, Mass. 02767), as well as anchors described in U.S. Pat. No. 9,345,567, entitled "Systems, Devices, and Methods for Securing Tissue Using Snare Assemblies and Soft Anchors," and U.S. Pat. No. 9,763,655, entitled "Systems, Devices, and Methods for Securing Tissue Using Hard Anchors," the contents of which are incorporated herein by reference in their entireties. Those skilled in the art will further appreciate that implantable anchors can be made from a variety of well-known materials, including absorbable and non-absorbable materials. Additionally, the implantable anchors can have any of a variety of sizes, for example, suitable for use in a particular anatomical location and for use with a particular patient.

[0018] The suture anchors described herein are configured to maintain engagement with a flexible member, such as a suture material. As shown in FIGS. 1-2g, for example, a first implantable anchor 12 has a proximal end 12p and a distal end 12d disposed opposite the proximal end 12p. The distal end 12d of the first implantable anchor 12 is configured to be inserted into a hole formed in a bone, such as a first bone hole 36. The first implantable anchor is cannulated and thus has a lumen 18 extending therethrough from the proximal end to the distal end. As shown, the lumen 18 is cylindrical, although various lumen shapes are possible. The first implantable anchor 12 may also include a flexible member engagement mechanism 20 at the distal end 12d that extends across the lumen 18 and is configured to engage the suture anchor and retain a portion of the flexible member 14 disposed within the lumen 18. Alternatively, anchor 12 need not have lumen 18, but may have a flexible engagement mechanism 20 at proximal end 12p, or may include a proximal eyelet to engage flexible member 14. Exemplary embodiments of such anchors that can be used in conjunction with the structures and related teachings provided herein include the Spiralok anchor, commercially available from DePuy Mitek, Inc.

[0019] The suture anchor also includes at least one feature for facilitating secure engagement in bone. By way of example, first implantable anchor 12 includes bone-engaging feature 16 formed on its outer sidewall and configured to engage first bone hole 36, thereby securing first implantable anchor 12 in place. As shown in FIG. 1 , in some embodiments, bone-engaging feature 16 may comprise a plurality of protrusions extending from outer sidewall 12o of first implantable anchor 12. The protrusions may be in the form of barbs and / or threads, or any similar structure that allows the anchor to gain grip with and remain securely attached to bone.

[0020] The flexible member 14 of the tissue fixation and repair construct 10 may be a filament or suture material, such as a suture and / or suture tape. Those skilled in the art will appreciate that the filament or suture material may be any type and material typically used as a filament, such as cannulated filaments, braided filaments, and monofilaments. The type and strength of the filament may depend, at least in part, on other components used with the construct, such as suture anchors, the tissue through which the filament is passed or joined, and the type of procedure for which the filament is used. In some embodiments, the filament may have a size between approximately a No. 5 filament (about 20 gauge to about 21 gauge) and approximately a No. 5-0 filament (about 35 gauge to about 38 gauge); in one exemplary embodiment, the filament is a No. 2 filament (about 22 gauge to about 24 gauge), such as Orthocord™ filament available from DePuy Mitek, Inc., or Ethibond™ filament available from Ethicon, Inc. (Route 22 West, Somerville, NJ 08876). Flexible member 14 can be any type of suture and can be made from a variety of well-known materials, including natural and synthetic materials. Examples of flexible member materials include polymers such as polyglycolide, polypropylene, polyethylene terephthalate (PET), and polydioxanone, as well as fabrics such as nylon and silk. The flexible member 14 may be bioabsorbable, partially bioabsorbable, or non-absorbable, and may have a circular cross-section or another cross-section such as a square or rectangular shape. The flexible member 14 may also be hollow.

[0021] The thickness of the filament must provide connection strength while minimizing trauma caused to the tissue through which it passes. In some embodiments, different portions of the tissue fixation and repair construct 10 can have different thicknesses, based, at least in part, on the purpose of the portion, the thickness of the rest of the construct, the components or tissues through which the portion may pass, and the type of procedure in which the construct will be used. Orthocord™ sutures are approximately 55-65 percent PDS™ polydioxanone, which is bioabsorbable, with the remaining 35-45 percent being ultra-high molecular weight polyethylene, while Ethibond™ sutures are primarily high-strength polyester. The amount and type of bioabsorbable material, if any, utilized in the filaments of the present disclosure is primarily a matter of surgeon preference for the particular surgical procedure being performed.

[0022] The flexible member 14 may be formed from a single thread or multiple threads. Multiple threads may be linked together in any of a variety of ways, such as by braiding them together, to define a flexible member strand. In exemplary embodiments, the thread(s) forming the flexible member 14 are sufficiently flexible to allow the suture to be flexible. The threads forming the flexible member 14 may be made from different materials (e.g., the first several threads may be nylon and the second several threads may be PET), or all of the threads of the flexible member 14 may be made from the same material. In some embodiments, a flexible member 14 formed from multiple threads may include a core around which the threads are disposed, such as by braiding. The core may provide strength to the suture to help prevent the suture from breaking, cutting, etc. The suture may have any of a variety of sizes, such as within the approximate range of sizes #5 to #5-0.

[0023] When applied to form construct 10, as shown in Figures 1-2g, the flexible member has a first tail 22, a second tail 24, and an intermediate portion 26 disposed between the first and second tails. First tail 22 can be a tensioning tail that can be used to adjust the tension of the suture during placement of the construct in a surgical procedure. Second tail 24 is a fixation tail that can include features such as a single knot, a fixation stop knot, and a finger loop, which are described in further detail below.

[0024] 1-2g, second tail 24 of flexible member 14 has a single knot 28 formed thereon that is located adjacent finger bar 32 and distal to first implantable anchor 12 such that single knot 28 substantially abuts finger bar 32. Single knot 28 is configured to help maintain the integrity of finger bar 32 and to allow first tail 22 to pass through single knot 28 in a manner that allows first tail 22 to slidably move through single knot 28 in response to tension applied by a surgeon. Those skilled in the art will understand that although there may be a small gap between single knot 28 and finger bar 32 such that single knot 28 does not abut finger bar 32 in direct contact therewith, single knot 28 can still be considered to substantially abut finger bar 32 due to any number of factors, such as manufacturing tolerances. Although the simple knot 28 is shown and described as a simple knot, which can be beneficial in surgical procedures due to its low profile, any type of knot known to those skilled in the art that can accomplish the functions described herein may also be used in place of the simple knot, such as a claw knot. The simple knot 28 is formed by the flexible member 14 itself. In other embodiments, the simple knot 28 may be formed by attaching another flexible member to the flexible member 14 (e.g., tying it around the flexible member 14 and forming the simple knot 28 thereon).

[0025] The second tail 24 of the flexible member 14 also has a locking stop knot 30 formed thereon. As described in more detail below, the locking stop knot 30 is configured to maintain engagement between the flexible member 14 and, in particular, the second tail 24, thus preventing the second tail 24 from migrating through the second implantable anchor 38 (shown in FIGS. 2e-2g). The second implantable anchor 38, described in more detail below, can be the same type of suture anchor as the first implantable anchor 12 and, therefore, can have the same structure and mechanism as the first implantable anchor 12. By way of example, the second implantable anchor 38 may be used in the outer row of a dual-row repair construct. Securing the second implantable anchor 38 to the flexible member 14 is described in more detail below in connection with a discussion of a method of using the construct 10. In any event, to maintain engagement between second tail 24 and second implantable anchor 38, the diameter of fixation stop knot 30 must be larger than the space between flexible member engagement feature 40 of second implantable anchor 38 and the wall of lumen 42 of second implantable anchor 38. This structure prevents fixation stop knot 30 from entering completely into second lumen 42, and therefore second tail 24 remains connected to second implantable anchor 38.

[0026] The locking stop knot 30 is positioned on the second tail 24 at a specific location sufficiently spaced from the finger loop 32 and the single knot 28 so that manipulation of the finger loop 32 is not impeded and so that the finger loop remains spaced from the bone hole into which the second implantable anchor 38 is to be placed. Those skilled in the art will appreciate that this predetermined distance will vary depending on various factors, including the size of the anchor used, as well as the procedure and anatomy involved. Typically, the predetermined distance is about 5-15 mm, typically about 10 mm, greater than the length of the second implantable anchor 38.

[0027] The finger traps 32 useful in the structures 10 disclosed herein can take a variety of forms, so long as they allow the tensioning tail 22 to pass therethrough. Generally, the finger trap 32 is a hollow region of the flexible member 14 through which the flexible member 14 passes. For example, the first tail 22 can slide in one direction (D1) through the finger trap 32 when under tension, and is locked from sliding in the other, opposite direction (D2) through the finger trap 32 because the tension causes the finger trap 32 to collapse over the portion of the first tail 22 of the suture passing within the finger trap 32. Exemplary finger traps are described in detail in U.S. patent application Ser. No. 15 / 622,360, filed June 14, 2017, entitled "Finger Traps for Collapsible Suture Loops," the disclosure of which is incorporated herein by reference in its entirety.

[0028] Flexible member 14 of construct 10 defines an adjustable loop 44 that includes a partial portion of each of first tail 22 and second tail 24 and the entire intermediate portion 26. As previously mentioned, flexible member 14 can be tensioned by a surgeon by pulling on first tail 22 to slide a portion of flexible member 14 through finger loop 32. This tensioning collapses adjustable loop 44, reducing the distance between finger loop 32 and first implantable anchor 12.

[0029] An exemplary method of using tissue fixation and repair construct 10 to fixate soft tissue, such as tendon 46, will be described with reference to FIGS. 2a-2g. The method illustrated in FIGS. 2a-2g is performed, for example, arthroscopically in a minimally invasive manner through a cannula, such as cannula 48, which may be placed through the patient's skin using techniques known to those skilled in the art. In the illustrated embodiment, the cannula is substantially aligned with the location where the procedure will be performed and serves as a working channel through which tissue fixation and repair construct 10 and various tools needed to perform the procedure are passed. Those skilled in the art will recognize other methods by which the procedures described herein may be performed, including procedures using three or more cannulas, a single cannula, or no cannula at all. Additionally, other types of procedures, such as open procedures, may be used with the present disclosure, which may not require a cannula, such as cannula 48.

[0030] FIG. 2a shows the tissue fixation and repair construct of FIG. 1 with the first implantable anchor 12 inserted into a first bone hole 36 formed in a portion of bone 50. The first bone hole 36 can be formed using a variety of commonly known tools and methods, such as a drill. The bone first hole 36 can be disposed in a location proximate to where the tendon 46 will be attached to the bone 50. After the first bone hole 36 is formed, the tissue fixation and repair construct 10 can then be implanted into the first bone hole 36 using conventional techniques, for example, by passing a cannula through the construct 10 and screwing or tapping the anchor into place using a screwdriver. As shown, the first tail 22 is connected to the second tail 24 via the terminal joint 34 during insertion. While the anchor and an intermediate portion of the flexible member are disposed within the bone hole and the subject's body, the remainder of the construct 10 extends out of the subject's body and out of the cannula 48.

[0031] 2b illustrates the tissue fixation and repair construct of FIG. 1 with a portion of the flexible member 14 passed through the tendon 46 after the first implantable anchor 12 has been inserted into the first bone hole 36. When the end of the first tail 22 is connected to the second tail 24 via the terminal junction 34, the number of separate tails passing through or around the tendon 46 and cannula 48 may be reduced, thus simplifying the passage of the flexible member 14 through the tendon 46. While many techniques known to those skilled in the art can be used to pass the first tail 22 and the second tail 24 through tissue such as the tendon 46, in some embodiments, the cannula 46 may be manipulated to pass the first tail 22 and the second tail 24 through the tendon 46 with a suture passing device (e.g., an EXPRESSEW II flexible suture passer available from DePuy Mitek, LLC).

[0032] Thereafter, as shown in FIG. 2c, a second bone hole 52 is formed in a portion of the bone 50 adjacent to the first bone hole 36. This can be accomplished using tools and methods similar or the same as those used to form the first bone hole 36. As described in further detail below, the second bone hole 52 is configured to receive a second implantable anchor 38, which can be coupled to the tissue fixation and repair construct 10. The second implantable anchor 38 can be the same type as or similar to the first implantable anchor, as shown in FIG. 2e. After the portion of the flexible member 14 has passed through the tendon 46, the end of the first tail 22 is separated from the second tail 24, as shown in FIG. 2d.

[0033] The flexible member 14 is then coupled to the second implantable anchor 38 by inserting the second tail 24 into the second lumen 42 of the second implantable anchor 38 such that the second tail 24 extends from the distal end 38d of the second implantable anchor 38 toward the proximal end 38p of the second implantable anchor 38. In doing so, the fixation stop knot 30 engages the flexible member engaging member 40 of the second implantable anchor 38, allowing the terminal portion of the second tail 24 to pass through the proximal end 38p of the second implantable anchor 38 while preventing it from passing through the fixation stop knot 30, as shown in FIG. 2e. Because the fixation stop knot 30 has a larger diameter than the at least one passageway of the second implantable anchor, the fixation stop knot 30 cannot pass through the at least one passageway of the second implantable anchor 38, thus restraining the suture from extending further toward the proximal end 38p of the second implantable anchor 38. An advantage of the fixation stop knot 30 is that it can maintain the position of the fixation tails relative to the second implantable anchor 38, thereby significantly simplifying management of the flexible member as the second implantable anchor passes through the cannula 48 and to the insertion site of the second bone hole 52.

[0034] After attaching the flexible member 14 to the second implantable anchor 38, as shown in FIG. 2f, the second implantable anchor 38 is first inserted into the distal end 38d of the second bone hole 52, as shown in FIG. 2f. The locking stop knot 30 is restrained from passing proximally through the flexible member engagement feature 20 of the second implantable anchor 38, and is therefore maintained in position relative to the anchor. Thus, flexible member retention is provided not only by compression between the bone and the anchor, but also by the tethering provided by the locking stop knot 30. Once the second implantable anchor 38 is positioned within the bone hole 52, the terminal ends of the first and second tails 22, 24 are positioned to extend through and out of the cannula 48, thereby allowing the surgeon access and manipulation.

[0035] As shown in FIG. 2g, after the second implantable anchor is inserted into the second bone hole 52, the surgeon can apply tension to the first tail 22 by pulling on the terminal end of the first tail 22 in the direction of arrow F1. The action of the flexible member 14 sliding through the finger bar 32 collapses the adjustable loop 44, tensioning the portion of the structure connecting the first and second implantable anchors 12, 38 and thereby compressing the tendon 46 against the bone. Because the single knot 28 is designed to reduce stress on the flexible member 14 and the finger bar 32, the finger bar 32 is protected from damage when the direction of tension on the first tail 22 is at an oblique angle to the finger bar 32, as shown in FIG. 1, or in a direction other than direction D1 as shown in FIG. 1. One particular advantage of the constructs described herein is that the constructs can be tensioned after the first and second anchors are implanted in the bone, thus simplifying the procedure and allowing the desired amount of tension to be set (and maintained) after implantation. This advantage makes the constructs described herein particularly well-suited for use with knotless dual-row repair constructs, allowing the same type of anchor to be used for both the medial and lateral rows.

[0036] After tensioning, the cannula is removed, excess suture material is trimmed away, and the surgical wound is closed.

[0037] In some embodiments, a threader, such as threader 54 shown in FIG. 3 , can be utilized by a surgeon to facilitate insertion of second tail 24 through distal end 38d of second implantable anchor 38 when tissue fixation and repair construct 10 is being assembled at a surgical site. Threader 54 can include a coupling mechanism 56 at its distal end for engaging first tail 22 and a handle 58 for grasping by the surgeon. During use, when second implantable anchor 38 is inserted through cannula 48 via use of slotted inserter 60, surgeon pulls handle 58 in the direction of arrow F2, thereby pulling threader 54 through slot 62 formed in inserter 60, thereby bringing fixation stopper knot 30 into contact with flexible member engagement feature 40 of second implantable anchor 38.

[0038] While this method is described using a technique in which a first implantable anchor is attached with a single flexible member connecting to a single second implantable anchor, those skilled in the art will understand that the first implantable anchor may be attached with a single, double, or triple number of folding sutures, each of which may be connected to a second implantable anchor. FIG. 4 illustrates an exemplary embodiment of a tissue fixation and repair construct 10′ including a first implantable anchor 12′ having a first flexible member 14′ and a second flexible member 14″ attached thereto. As shown in this embodiment, the first flexible member 14′ and the second flexible member 14″ are structurally identical to the flexible member 14 described above and illustrated in FIGS. 1-2g, and the first implantable anchor 12′ is structurally identical to the first implantable anchor 12 (also described above and illustrated in FIGS. 1-2g). Flexible member 14 and second flexible member 14' are each coupled to a flexible member engagement mechanism 20' of first implantable anchor 12' and thereby held in engagement with first implantable anchor 12'.

[0039] 5-6d, which is also useful in dual-row fixation repair, a tissue fixation and repair construct 110 includes a first implantable anchor 112 and a pre-attached suture loop 114 attached thereto. The first implantable anchor 112 may be the same as or similar to the first implantable anchor 12 described above and, therefore, may include a lumen 118 that may be the same as or similar to lumen 18 and an engagement mechanism 120 that may be the same as or similar to first flexible member engagement mechanism 20. The pre-attached suture loop 114 may be attached to the first implantable anchor 112 at its distal end 114d. By way of example, distal end 112d may have a locking stop knot 130 similar to locking stop knot 30 to maintain engagement between pre-secured suture loop 114, particularly its distal end 114d, and first implantable anchor 112, thus preventing movement of distal end 114d through lumen 118. Pre-secured suture loop 114 may include a bonded region 132 through which pre-secured suture loop 114 is threaded, thereby forming loop 144. Loop 144 may be adjusted (i.e., closed) by pulling proximal end 114p of pre-secured suture loop 114 in the direction of arrow F3. Flexible member 114 may also include a simple knot 128 formed thereon, located distal to first implantable anchor 112 adjacent bonded region 132, such that simple knot 28 substantially abuts bonded region 132. The single knot 128 helps to maintain the integrity of the joined region 132 and is configured to allow a portion of the flexible member 114 to pass through the single knot 128 in such a way that the portion of the flexible member 114 can slidably move through the single knot 128 in response to tension applied by the surgeon in the direction of arrow F3.Those skilled in the art will understand that although there may be a small gap between the single knot 128 and the joined region 132 such that the single knot 128 does not abut the joined region 132 so as to be in direct contact with the joined region 132, the single knot 128 can still be considered to be substantially abutting the joined region 132 due to any number of factors, such as manufacturing tolerances. While the single knot 128 is shown and described as a single knot and may be beneficial in surgical procedures due to its low profile, any type of knot known to those skilled in the art that can achieve the functions described herein may also be used in place of the single knot, such as a claw knot. The single knot 128 is formed by the flexible member 114 itself. In other embodiments, another flexible member may be attached to the flexible member 114 to form the single knot 128 (e.g., tied around the flexible member 114 and forming the single knot 128 thereon).

[0040] An exemplary method of using the tissue fixation and repair construct 110 to fixate soft tissue, such as a tendon 146, is described with reference to Figures 6a-6d. Similar to the method described above and illustrated in Figures 2a-2g, the method illustrated in Figures 6a-6d can be performed in a minimally invasive manner, e.g., arthroscopically, through a cannula (not shown) that can be placed through the patient's skin. Those skilled in the art will recognize other ways in which the procedures described herein can be performed, including procedures through three or more cannulas, a single cannula, or no cannula. Additionally, other types of procedures, such as open procedures, which may not require a cannula, can be used with the present disclosure.

[0041] FIG. 6a shows the tissue fixation and repair construct 110 with a first implantable anchor 112 inserted into a first bone hole 136 formed in a portion of bone 150. The first implantable anchor 112 and a portion of a pre-cemented suture loop 114 are disposed within the bone hole 136 and the subject's body, while the remaining portion of the pre-cemented suture loop 114 extends out of the subject's body through a cannula (not shown). As shown in FIG. 6b, after the first implantable anchor 112 is inserted into the first bone hole 136, the portion of the pre-cemented suture loop 114 is passed through or around a tendon 146. Thereafter, as shown in FIG. 6c, a second bone hole 152 is formed in a portion of the bone 150 adjacent to the first bone hole 136. Loop 144 of pre-secured suture loop 114 is then coupled to connecting suture 138a of implantable anchor assembly 138. Connecting suture 138a is coupled to second implantable anchor 138b at eyelet 138c located at proximal end 138p of second implantable anchor 138b and at first prong 138e at distal end 138d. After being coupled to loop 144, second implantable anchor 138b is then inserted into second bone hole 152, as shown in FIG. 6d. Pre-secured suture loop 114 is then tensioned by pulling proximal end 114p of pre-secured suture loop 114, which folds loop 144 and tensions connecting suture 138a. As connecting suture 138a is tensioned, second implantable anchor 138b rotates within second bone hole 152 and first prong 138e engages the wall of second bone hole 152 to lock second implantable anchor 138b within second bone hole 152, thereby anchoring tendon 146 in place. An exemplary embodiment of such a second implantable anchor that can be used in conjunction with the structures and related teachings provided herein includes a Bioknotless RC suture anchor commercially available from DePuy Mitek, Inc.

[0042] Each of these configurations can be used to tension the tissue fixation and repair construct 10, 110 after both the first implantable anchor 12, 112 and the second implantable anchor 38, 138b are fully inserted into their corresponding bone holes.

[0043] While the structures and fixation methods described above are shown with respect to a tissue fixation and repair structure having two implantable anchors and at least one flexible member, other configurations feature additional implantable fixations using methods similar to those described above with respect to the embodiments of Figures 1-2g and 5-6d. For example, Figure 7 illustrates a dual-row repair in which four implantable anchors (two inner and two outer rows) and four flexible members are used to secure tendon 700. As shown in Figure 7, first and second inner implantable anchors 701, 702 and first and second outer implantable anchors 703, 704 are provided, each of which may be substantially similar to first and second implantable anchors 12, 38. However, it will be understood that different anchor types, such as the anchors shown in Figures 5-6d, may be used in the outer rows compared to the inner rows. First, second, third, and fourth flexible members 705-708 are also provided, each of which may be substantially similar to flexible member 14 (or 114), each of which has the same structural features as flexible member 14 (or 114) described above, and each of which may be inserted into a bone hole formed in a portion of bone 711 in a manner similar to first and second implantable anchors 12, 38. As shown, first and second flexible members 705, 706 are coupled to first inner implantable anchor 701 to form a first dual structure 709, and third and fourth flexible members 707, 708 are coupled to second inner implantable anchor 702 to form a second dual structure 710. The first and second inner implantable anchors 701, 702 can be placed in the bone 705 in a manner similar to the first implantable anchor 12 and flexible member 14, as described above. The flexible members 705-708 can then be passed through the tendon 700 in a manner similar to that described above with respect to the flexible member 14.The first outer implantable anchor 703 can be mounted on the first and fourth flexible members 705, 708, and the second outer implantable anchor 704 can be mounted on the second and third flexible members 706, 707. This mounting results in a cross-shaped flexible member pattern that provides enhanced support and fixation. The first and second outer implantable anchors 703, 704 can then be placed into the bone 705 opposite the first and second inner implantable anchors 701, 702, respectively, and the first through fourth flexible members 705-708 can be tensioned in a manner similar to that of the flexible anchor 14, thereby securing the tissue in place.

[0044] Those skilled in the art will recognize further features and advantages of the present invention based on the above-described embodiments. Accordingly, the present invention is not to be limited by what has been particularly shown and described, except as indicated by the appended claims. All publications and documents cited herein are expressly incorporated by reference in their entirety.

[0045] [Embodiment] (1) A tissue repair construct, comprising: a first implantable anchor having an engaging member and at least one bone engaging feature on an outer sidewall of the first implantable anchor; a flexible member having an intermediate portion connected to the engaging member and having first and second tails extending from the intermediate portion, each of the first and second tails having a terminal end; a portion of the first tail extending through an internal collapsible passage formed within a hollow portion of the second tail and a first knot formed within the second tail adjacent to the hollow portion; The tissue repair structure, wherein the second tail includes a fixation knot intermediate the first knot and the terminal end of the second tail. (2) The tissue repair structure of embodiment 1, wherein the intermediate portion is slidably coupled to the engaging member. (3) The tissue repair structure of embodiment 1, further comprising a second implantable anchor configured to be coupled to the second tail. (4) The tissue repair structure described in embodiment 3, wherein the second implantable anchor is disposed adjacent to the fixation knot. (5) The tissue repair structure of embodiment 1, wherein the terminal end of the first tail is configured to be coupled to the second tail.

[0046] (6) The tissue repair structure of embodiment 1, wherein the terminal end of the first tail is configured to be separated from the second tail. (7) The tissue repair structure of embodiment 1, wherein the distance between the fixation knot and the first knot is approximately equal to 3 to 5 mm more than the length of the first implantable anchor from the fixation knot. (8) A tissue repair structure as described in embodiment 1, wherein the internal collapsible passage is configured to be disposed outside the bone when the first implantable anchor is disposed within the bone. (9) A method comprising: inserting a tissue repair structure into a first bone hole, the tissue repair structure including a first implantable anchor having an engaging member and at least one bone engaging feature on an outer sidewall of the first implantable anchor, and a flexible member coupled to the engaging member, the flexible member having at least one tail extending therefrom, the flexible member being joined to itself to form a loop proximal to the first implantable anchor; passing at least a portion of the flexible member through or around soft tissue; coupling the flexible member to a second implantable anchor; inserting the second implantable anchor and at least a portion of the flexible member into a second bone hole; tensioning the flexible member to apply and set a desired amount of tension in the repair construct after the second implantable anchor is inserted into the second bone hole. (10) The method of embodiment 9, wherein the flexible member has an intermediate portion connected to the engaging member, the flexible member has a first tail and a second tail extending from the intermediate portion, the first tail and the second tail each having a terminal end, and the flexible member is joined by passing the first tail through a portion of the second tail.

[0047] (11) After the passing step, Separating the terminal end of the first tail portion from the second tail portion; 11. The method of embodiment 10, further comprising: coupling the flexible member to the second implantable anchor by inserting the terminal end of the second tail into the second anchor. (12) The method of embodiment 9, wherein a distal end of the flexible member is coupled to the first implantable anchor, and the second anchor is coupled to the second implantable anchor by coupling the loop in the flexible member to a connecting suture attached to the second implantable anchor.

Claims

1. 1. A tissue repair construct comprising: a first implantable anchor having a first engaging member and at least one bone engaging feature on an outer sidewall of the first implantable anchor; a flexible member having an intermediate portion connected to the first engaging member and having a first tail and a second tail extending from the intermediate portion, each of the first tail and the second tail having a terminal end; a second implantable anchor having a lumen extending therethrough and a second engaging member extending across the lumen, the second implantable anchor configured to be coupled to the second tail by inserting the second tail into the lumen; a portion of the first tail extends through an internal collapsible passage formed within a hollow portion of the second tail and through a first knot formed within the second tail adjacent to the hollow portion; the second tail includes a locking knot intermediate the first knot and the terminal end of the second tail; the second implantable anchor is disposed adjacent to the fixation knot; The tissue repair structure, wherein engagement of the fixation knot with the second engagement member is configured to prevent the fixation knot from passing through the second implantable anchor.

2. The tissue repair structure of claim 1 , wherein the intermediate portion is slidably coupled to the first engaging member.

3. The tissue repair structure of claim 1 , wherein the terminal end of the first tail is configured to be coupled to the second tail.

4. The tissue repair structure of claim 1 , wherein the terminal end of the first tail is configured to be separated from the second tail.

5. The tissue repair structure of claim 1 , wherein the internal collapsible channel is configured to be disposed outside of a bone when the first implantable anchor is disposed within the bone.

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