Double-row collapsible suture structure

Abstract

This invention is entitled "Double-row Collapsible Suture Construction". The invention provides a tissue fixation and repair construction and a repair method using the tissue fixation and repair construction. An exemplary tissue fixation and repair construction may include a first implantable anchor connected to a suture having a fixation tail and a tensioning tail. The fixation tail may include: a reverse knot positioned distally adjacent to a finger catcher such that the reverse knot substantially abuts the finger catcher when adjacent to it; a fixation stop knot configured to prevent further movement of the fixation tail through the second implantable anchor when the second implantable anchor is placed on the suture; and a finger catcher. The tensioning tail may pass through the finger catcher and the reverse knot and can be used to adjust the tension of the tissue fixation and repair construction when the first and second implantable anchors are inserted into the bone.

Description

Technical Field

[0001] This disclosure relates in general to double-row collapsible suture structures. Background Technology

[0002] Many injuries and conditions require soft tissue repair or reattachment of soft tissue to bone and / or surrounding tissues. For example, once healthy tissue is torn from bone, such as a partial or complete tear of the rotator cuff tendon from the humerus (rotator cuff tear), surgical reattachment of the tissue to the bone is often necessary to allow healing and natural reattachment to occur. Several devices and methods have been developed to perform these surgical repairs. Some of the more successful methods involve the use of suture fixation components such as suture anchors, which typically include an anchor body having one or more suture attachment features and include tissue or bone engagement features for retaining the suture anchor within or adjacent to tissue or bone. Depending on the specific injury, repair may be performed using one or more suture anchors connected to or interconnected with one or more suture segments.

[0003] Surgical intervention may also be necessary when tears occur within a single type of tissue. Sutures can also be used in conjunction with one or more suture anchors to repair such tissue tears. Sutures can be secured to the suture anchors and tissue using knots tied by the surgeon during the repair procedure or by using "knotless" devices and methods, in which one or more anchors and one or more sutures can be connected and tensioned without the surgeon needing to tie knots during the procedure. Knotless anchoring is particularly useful in minimally invasive surgeries such as endoscopic or arthroscopic repairs, where the surgeon remotely manipulates the sutures at the surgical site using tools inserted through a small-diameter cannula or endoscope, which can make knotting difficult and cumbersome.

[0004] However, current techniques for dual-row fixation require setting suture tension during anchor insertion, which can make it difficult to reliably set the appropriate tension. Furthermore, current techniques require multiple anchors for both the medial and lateral rows. Additionally, using current techniques and fixation device designs, suture retention for lateral row anchors is relatively low because the sutures are typically compressed between the bone and the anchor.

[0005] Therefore, there is still a need for improved tissue repair devices, systems, and methods. Summary of the Invention

[0006] In one aspect, a tissue repair construct is provided, which may include a first implantable anchor and a flexible member. The first implantable anchor may include a joining member and at least one bone-jointing feature located on a lateral wall of the first implantable anchor. The flexible member may include an intermediate portion connected to the joining member and a first tail and a second tail extending from the intermediate portion. Each of the first tail and the second tail may include a terminal. A portion of the first tail may extend through an internal collapsible channel and a first knot formed in a portion of the second tail, the first knot being formed in the second tail adjacent to the hollow portion. The second tail may include a fixation knot located between the terminals of the first knot and the second tail.

[0007] In some embodiments, the intermediate portion is slidably coupled to the connecting member. In other embodiments, the tissue repair structure may include a second implantable anchor configured to be coupled to the second tail. In such embodiments, the second implantable anchor may be disposed adjacent to the fixation knot. In other embodiments, the terminal of the first tail may be configured to be coupled to the second tail. In other embodiments, the terminal of the first tail is configured to be separate from the second tail. In some embodiments, the distance between the fixation knot and the first knot may be set at a distance from the fixation knot that is approximately 3 mm to 5 mm longer than the length of the first implantable anchor. In other embodiments, the internal collapsible channel may be configured to be located outside the bone when the first implantable anchor is disposed within the bone.

[0008] In another aspect, a method is provided. The method may include inserting a tissue repair structure into a first bone hole, the tissue repair structure including a first implantable anchor and a flexible member, the first implantable anchor having an engagement member and at least one bone engagement feature located on a lateral wall of the first implantable anchor, the flexible member being coupled to the engagement member and at least one tail extending from the flexible member, wherein the flexible member is self-joined to form a collar located 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 at least a portion of the flexible member and the second implantable anchor into a second bone hole; and tensioning the flexible member after inserting the second implantable anchor into the second bone hole to apply and set a desired amount of tension in the repair structure.

[0009] In some embodiments, the flexible member may have an intermediate portion coupled to a connecting member and a first tail and a second tail extending from the intermediate portion, each of the first tail and the second tail having a terminal, and wherein the flexible member is spliced ​​by passing the first tail through a portion of the second tail. In this embodiment, the method may include, after the passing step, separating the terminal of the first tail from the second tail; and coupling the flexible member to the second anchor by inserting the terminal of the second tail into the second implantable anchor. In other embodiments, the distal end of the flexible member may be coupled to the first implantable anchor, and the second anchor may be coupled to the second implantable anchor by coupling a collar in the flexible member to a connecting suture attached to the second implantable anchor. Attached Figure Description

[0010] The invention will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings, in which:

[0011] Figure 1 This is a schematic diagram of an implementation scheme for the fixation and repair of structures;

[0012] Figure 2a During the initial steps of surgical procedures Figure 1 A side sectional view of a tissue fixation and repair structure, in which a first implantable anchor is inserted into a hole formed in the bone;

[0013] Figure 2b During the subsequent steps of surgical procedures Figure 1 A side cross-sectional view of a structure used for tissue fixation and repair, in which a portion of the structure passes through soft tissue;

[0014] Figure 2c During the subsequent steps of surgical procedures Figure 1 A side sectional view of the tissue fixation and repair structure, in which a second hole is formed in the bone;

[0015] Figure 2d During the subsequent steps of surgical procedures Figure 1 A side sectional view of the structure for fixing and repairing the organization, in which the tensioning tail of the flexible member is separated from the fixing tail of the tensioning member;

[0016] Figure 2e During the subsequent steps of surgical procedures Figure 1 A side sectional view of the tissue fixation and repair structure, in which the fixation tail is connected to the second anchor to be implanted in the second hole;

[0017] Figure 2f During the subsequent steps of surgical procedures Figure 1A side sectional view of the structure for fixing and repairing tissues, in which the second anchor is inserted into the second hole;

[0018] Figure 2g During the subsequent steps of surgical procedures Figure 1 A side sectional view of a tissue fixation and repair structure, in which the tensioned tail is tensioned to bring the soft tissue closer to the bone;

[0019] Figure 3 It is used to Figure 1 A side cross-sectional schematic diagram of an exemplary technique for connecting a flexible component of an organization fixing and repairing structure to a second anchor.

[0020] Figure 4 It is a side sectional view of an additional embodiment of a tissue fixation and repair structure having multiple flexible components connected to implantable anchors;

[0021] Figure 5 It is a side sectional view of one embodiment of the organization for fixing and repairing structures;

[0022] Figure 6a During the initial steps of surgical procedures Figure 5 A side sectional view of a tissue fixation and repair structure, in which a first implantable anchor is inserted into a hole formed in the bone;

[0023] Figure 6b During the subsequent steps of surgical procedures Figure 5 A side cross-sectional view of a structure used for tissue fixation and repair, in which a portion of the structure passes through soft tissue;

[0024] Figure 6c During the subsequent steps of surgical procedures Figure 5 A side sectional view of the tissue fixation and repair structure, in which a second hole is formed in the bone;

[0025] Figure 6d During the subsequent steps of surgical procedures Figure 5 A side sectional view of the structure for tissue fixation and repair, in which the second anchor is inserted into the second hole; and

[0026] Figure 7 This is a top view schematic diagram of an exemplary embodiment of a double-row rotator cuff repair according to the technology disclosed herein. Detailed Implementation

[0027] Certain exemplary embodiments will now be described to provide a comprehensive understanding of the principles of the structure, function, manufacture, and use of the apparatuses 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 apparatuses and methods specifically described herein and illustrated in the drawings are non-limiting exemplary embodiments, and the scope of this disclosure is defined only by the claims. Features shown or described in conjunction with one exemplary embodiment may be combined with features of other embodiments. Such modifications and variations are intended to be included within the scope of the invention.

[0028] Furthermore, in this disclosure, components with similar names in various embodiments generally have similar features; therefore, in specific embodiments, not every feature of every component with a similar name is necessarily fully described. Additionally, the extent to which linear or circular dimensions are used in the description of the disclosed systems, devices, and methods is 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 of such linear and circular dimensions can be readily determined for any geometry. The size and shape of systems and devices and their components may depend at least on the anatomy of the patient in which the system and device will be used, the size and shape of the components with which the system and device will be used, and the method and procedure in which the system and device will be used.

[0029] The accompanying drawings provided herein are not necessarily drawn to scale. Furthermore, the arrows used to describe the direction of tensionable or pulling components are exemplary and in no way limit the direction in which individual components can be tensioned or pulled. Those skilled in the art will recognize other manner and directions used to generate the desired tension or movement. Similarly, although in some embodiments the movement of a component is described relative to another component, those skilled in the art will recognize that other movements are possible. Additionally, while terms such as “first” and “second” are used to describe aspects of components, such as a first end and a second end, such use does not indicate that one component precedes another. Terms of this nature can be used to distinguish two similar components or features, and such first and second components are generally used interchangeably. Furthermore, many terms may be used interchangeably in this disclosure, but those skilled in the art will understand.

[0030] This invention provides soft tissue fixation and repair constructs, methods for soft tissue repair using these constructs, and kits including the soft tissue fixation and repair constructs. These constructs are particularly useful for dual-row fixation repairs, such as rotator cuff repairs, and include implantable anchors with connected collapsible collars. After the anchors are implanted in the bone (e.g., on the medial side) and a flexible member passes through or surrounds the soft tissue, the flexible member can be coupled to a second implantable anchor, such as a knotless anchor for the lateral row, which is also implanted in the bone. One advantage of the constructs described herein is that tension can be applied to the flexible member to tension the flexible collar using a knotless technique and compress the soft tissue into the bone after the anchors are inserted into the bone. A disadvantage of many current techniques is that tension can only be applied when the second anchor is inserted, making tension difficult to control. The soft tissue fixation and repair constructs and methods described herein provide stronger lateral row fixation through a more convenient and less time-consuming procedure. Another advantage of the structures and techniques disclosed herein is that the same type of anchor can be used for both the inner and outer rows, which is not usually the case in current practice.

[0031] Figure 1 One embodiment of a tissue fixation and repair structure 10 is shown, configured for implantation into a patient's body to facilitate soft tissue repair. The tissue fixation and repair structure 10 includes a first implantable anchor 12, such as a medial anchor, configured to be inserted into a hole formed in bone, wherein a flexible member 14 is coupled to the first implantable anchor. In an exemplary embodiment, the first implantable anchor 12 has at least one bone-engaging feature 16 located on the lateral wall of the first implantable anchor. Additionally, in some specific embodiments, the first implantable anchor 12 is hollow, having a lumen 18 extending through it, wherein a first flexible member engagement feature 20 crosses 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 can be a tensioning tail, which the surgeon can use to adjust the overall tension of the flexible member 14 during tissue fixation and installation of the repair structure 10. The second tail 24 can be a fixing tail, on which various features can be formed, such as a reverse hand knot 28, a fixing stop knot 30, and a finger catcher 32, each of which is discussed in further detail below. The first tail 22 and the second tail 24 may optionally be joined together by an end connector 34.

[0032] like Figures 1 to 2gAs shown, the tissue fixation and repair structure includes a first implantable anchor 12 configured to be securely implanted into bone. In such structures, the implantable anchor is configured to attach to a suture and is used in tissue repair procedures, such as soft tissue reattachment or repair at joints (such as the hip, knee, or shoulder), and specifically for rotator cuff repair procedures.

[0033] Those skilled in the art will understand that various types of suture anchors can be used in conjunction with the constructions provided herein, including both rigid and soft anchors, and screw-type anchors, and this disclosure is not intended to limit the design of the anchors provided herein. Some exemplary embodiments of anchors that can be used in conjunction with the constructions and related teachings provided herein include Healix Ti TM Anchoring components, Healix Advance TM Anchoring components, Healix Advance TM Knotless anchorage, Versalok TM Anchoring components and Gryphon TM Anchoring devices, each of which is commercially available from DePuy Mitek Inc. (325 Paramount Drive, Raynham, Mass. 02767), and U.S. Patent 9,345,567 entitled “Systems, Devices, and Methods for Securing Tissue Using Snare Assemblies and Soft Anchors” and U.S. Patent 9,763,655 entitled “Systems, Devices, and Methods for Securing Tissue Using Hard Anchors,” the contents of each of which are incorporated herein by reference in their entirety. Those skilled in the art will also understand that implantable anchoring devices can be made from a variety of well-known materials, including absorbable and non-absorbable materials. Furthermore, implantable anchoring devices can be available in any of a variety of sizes suitable for use in specific anatomical locations and for specific patients.

[0034] The suture anchors described herein are configured to maintain engagement with flexible components such as suture materials. Figures 1 to 2gAs shown, for example, the first implantable anchor 12 has a proximal end 12p and a distal end 12d disposed opposite to the proximal end 12p. The distal end 12d of the first implantable anchor 12 is configured to be inserted into a hole (such as a first bone hole 36) formed in the bone. The first implantable anchor is hollow and therefore has a lumen 18 extending from the proximal end through the first implantable anchor to the distal end. As shown, the lumen 18 is cylindrical in shape; however, various lumen shapes are possible. The first implantable anchor 12 may also include a flexible member engagement feature 20 that spans the lumen 18 at the distal end 12d and is configured to retain a portion of the flexible member 14 engaged with the suture anchor and disposed within the lumen 18. Alternatively, the anchor 12 may not have a lumen 18, but may have a flexible engagement feature 20 at the proximal end 12p, or it may include a proximal eyelet for engagement with the flexible member 14. Exemplary embodiments of this anchoring element that can be used in conjunction with the constructions and related teachings provided herein include the Spiralok anchoring element, which is commercially available from DePuy Mitek, Inc.

[0035] The suture anchor also includes at least one feature to facilitate secure engagement with the bone. By way of example, the first implantable anchor 12 includes a bone engagement feature 16 formed on the outer wall of the first implantable anchor and configured to engage with a first bone hole 36, thereby securing the first implantable anchor 12 in place. Figure 1 As shown, in some specific embodiments, the bone engagement feature 16 may include a plurality of protrusions extending from the outer sidewall 12o of the first implantable anchor 12. The protrusions may be in the form of barbs and / or threads or any similar structure that enables the anchor to achieve a grip with the bone and remain firmly attached to the bone.

[0036] The flexible member 14 of the tissue fixation and repair structure 10 can be a filament or suture material, such as sutures and / or suture tape. Those skilled in the art will understand that the filament or suture material can be any type and material commonly used as a filament, including hollow filaments, braided filaments, and monofilaments. The type and strength of the filament may depend at least in part on other components used with the structure, such as suture anchors, the tissue through which the filament will pass or connect, and the type of surgery in which the filament will be used. In some embodiments, the filament may have a size between about #5 filaments (about 20 gauge to about 21 gauge) and about #5-0 filaments (about 35 gauge to about 38 gauge), and in one exemplary embodiment, the filament is a #2 filament (about 22 gauge to about 24 gauge), such as Orthocord, commercially available from DePuy Mitek, Inc. TMThe filaments or ethibonds may be available from Ethicon, Inc. (Route 22 West, Somerville, NJ 08876). TM The 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 materials used for the flexible member include polymers such as polyethylene glycol, polypropylene, polyethylene terephthalate (PET), and polydioxanone, as well as fabrics such as nylon and silk. The flexible member 14 can be bioabsorbable, partially bioabsorbable, or nonabsorbable, and can have a circular cross-section or another cross-section, such as a square or rectangular one. The flexible member 14 can also be hollow.

[0037] The thickness of the filament should provide strength in the connection, but at the same time minimize trauma to the tissue it passes through. In some embodiments, different portions of the tissue fixation and repair structure 10 may have different thicknesses, wherein the thickness is at least in part based on the purpose of the portion, the thickness of other portions of the structure, the components or tissues that the portion can pass through, and the type of surgery using the structure. Orthocord TM Approximately 55% to 65% of the sutures are bioabsorbable PDS. TM Polydioxane, and the remaining 35% to 45% is ultra-high molecular weight polyethylene, while Ethibond TM The sutures are primarily high-strength polyester. The amount and type of bioabsorbable material (if any) used in the filaments of this disclosure depend primarily on the surgeon's preference for the specific surgical procedure being performed.

[0038] The flexible member 14 may be formed from a single thread or multiple threads. These multiple threads may be joined together in any of a variety of ways to define strands of the flexible member, such as by braiding. In an exemplary embodiment, the thread forming the flexible member 14 has sufficient flexibility to allow the suture to be flexible. The thread forming the flexible member 14 may be made of different materials, for example, a first number of threads may be nylon and a second number of threads may be PET, or all the threads of the flexible member 14 may be made of the same material. In some embodiments, the flexible member 14 formed from multiple threads may include a core around which the threads are arranged, such as by braiding. The core may provide strength to the suture to help prevent breakage, buckling, etc. The suture may have any of a variety of sizes, such as those in the range of approximately size #5 to #5-0.

[0039] When applied to form structure 10, and as Figures 1 to 2gAs shown, the flexible member has a first tail 22, a second tail 24, and an intermediate portion 26 disposed between the first tail and the second tail. The first tail 22 may be a tensioning tail, which can be used to adjust the tension of the suture during the installation of the structure in surgical procedures. The second tail 24 is a fixing tail, which may include features such as a reverse knot, a fixing stop knot, and a finger catcher, as described in further detail below.

[0040] Continue to refer to Figures 1 to 2g The second tail 24 of the flexible member 14 has a reverse knot 28 formed thereon, which is located distal to the finger catcher 32 relative to the first implantable anchor 12, such that the reverse knot 28 is substantially adjacent to the finger catcher 32. The reverse knot 28 is configured to help maintain the integrity of the finger catcher 32 and to allow the first tail 22 to pass through the reverse knot 28 in such a way that the first tail 22 can slide through the reverse knot 28 in response to tension applied by the surgeon. Those skilled in the art will understand that although a small gap may exist between the reverse knot 28 and the finger catcher 32, such that the reverse knot 28 does not abut against the finger catcher 32 to make direct contact with it, it can still be considered that the reverse knot 28 is substantially adjacent to the finger catcher 32 due to any number of facts, such as manufacturing tolerances. Although the overhand knot 28 is shown and described as an overhand knot, which can be advantageous in surgical procedures due to its small size, any type of knot known to those skilled in the art capable of achieving the function described herein can be used in place of the overhand knot, such as a hitch knot. The overhand knot 28 is formed by the flexible member 14 itself. However, in other embodiments, another flexible member may be attached to the flexible member 14 to form the overhand knot 28 (e.g., tied around the flexible member 14 to form the overhand knot 28 thereon).

[0041] The second tail portion 24 of the flexible member 14 also has a fixing stop knot 30 formed thereon. As explained in further detail below, the fixing stop knot 30 is configured to maintain the engagement between the flexible member 14 and specifically the second tail portion 24, and thus prevent the second tail portion 24 from moving through the second implantable anchor 38 (e.g., Figures 2e to 2g(As shown). As described in more detail below, the second implantable anchor 38 may be a suture anchor of the same type as the first implantable anchor 12, and therefore has the same structure and features as the first implantable anchor 12. By way of example, the second implantable anchor 38 may be used in the outer row of a double-row repair structure. The attachment of the second implantable anchor 38 to the flexible member 14 is described in more detail below in conjunction with a discussion of the method of using the structure 10. In any case, in order to maintain the engagement between the second tail 24 and the second implantable anchor 38, the diameter of the fixing stop knot 30 should be greater than the space between the flexible member engagement feature 40 of the second implantable anchor 38 and the wall of the lumen 42 of the second implantable anchor 38. This structure prevents the fixing stop knot 30 from fully entering the second lumen 42, and thus the second tail 24 remains connected to the second implantable anchor 38.

[0042] The fixation knot 30 is positioned on the second tail 24 at a specific location sufficiently spaced from the finger catcher 32 and the reverse knot 28, so that the operation of the finger catcher 32 is unimpeded and the finger catcher remains spaced from the bone hole where the second implantable anchor 38 is to be placed. Those skilled in the art will understand that this predetermined distance will vary depending on a variety of factors, including the size of the anchor used and the surgical and anatomical structures involved. Typically, the predetermined distance is about 5 mm to 15 mm, and usually about 10 mm, greater than the length of the second implantable anchor 38.

[0043] The finger catcher 32 that can be used in the construction 10 disclosed herein can take many forms, as long as it allows the tensioned tail 22 to pass through it. Generally, the finger catcher 32 is a hollow region of the flexible member 14, through which the flexible member passes itself. For example, when under tension, the first tail 22 can slide unidirectionally through the finger catcher 32 in a first direction D1 and is locked in place so that it cannot slide through the finger catcher 32 in the opposite direction D2, because the tension causes the finger catcher 32 on a portion of the first tail 22 of the suture to collapse, that portion passing through the finger catcher. An exemplary finger catcher is described in detail in U.S. Patent Application 15 / 622,360, filed June 14, 2017, entitled “Finger Traps for Collapsible SutureLoops,” the entire disclosure of which is incorporated herein by reference.

[0044] The flexible member 14 of the structure 10 defines an adjustable collar 44, which includes a portion of each of a first tail 22 and a second tail 24, as well as the entire intermediate portion 26. As previously described, the surgeon can tension the flexible member 14 by pulling on the first tail 22, causing a portion of the flexible member 14 to slide through the finger catcher 32. This tension causes the adjustable collar 44 to collapse and reduces the distance between the finger catcher 32 and the first implantable anchor 12.

[0045] An exemplary method for fixing soft tissue (such as tendon 46) using tissue fixation and repair structure 10 is referenced. Figures 2a to 2g Describe it. Figures 2a to 2g The illustrated method is performed via a minimally invasive (e.g., arthroscopic) insertion of a cannula (such as cannula 48), which is inserted 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 site of the procedure and serves as a working channel through which the tissue fixation and repair structure 10 and various tools required for the procedure pass. Those skilled in the art will recognize other ways in which the procedures described herein can be performed, including with three or more cannulas, a single cannula, or no cannulas at all. Furthermore, other types of surgeries, such as open surgeries, may be used in conjunction with this disclosure, which may not require cannulas such as cannula 48.

[0046] Figure 2a It shows Figure 1 The tissue fixation and repair structure 10 is described, wherein a first implantable anchor 12 has been inserted into a first bone hole 36 formed in a portion of bone 50. A variety of commonly known tools and methods can be used to form the first bone hole 36, such as a drill. The first bone hole 36 may be located adjacent to the location where the tendon 46 attaches to the bone 50. After the first bone hole 36 has been formed, the tissue fixation and repair structure 10 can then be inserted through a cannula and into the first bone hole 36 using common techniques, such as screwing or tapping the anchor into place using a driver. As shown, a first tail 22 is connected to a second tail 24 via an end connector 34 during insertion. And while the intermediate portion of the anchor and flexible member is positioned within the bone hole and the patient's body, the remainder of the structure 10 extends out of the patient's body and out of the cannula 48.

[0047] Figure 2b It shows Figure 1The tissue fixation and repair structure, wherein a portion of the flexible member 14 has 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 coupled to the second tail 24 via the end connector 34, the number of individual tails passing through or around the tendon 46 and cannula 48 can be reduced, and thus the passage of the flexible member 14 through the tendon 46 is simplified. The first tail 22 and the second tail 24 can pass through or around tissues such as tendons 46 using a variety of techniques known to those skilled in the art. In some embodiments, a suture threading device (such as the EXPRESSEW II flexible suture threader from DePuy Mitek, LLC) can pass through the cannula 46 and be operated to allow the first tail 22 and the second tail 24 to pass through the tendon 46.

[0048] Subsequently, a second bone hole 52 is formed in a portion of the bone 50 adjacent to the first bone hole 36, as shown. Figure 2c As shown. This can be achieved using tools and methods similar to or the same as those used to form the first bone hole 36. As will be described in more 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 structure 10. The second implantable anchor 38 may have the same or similar type as the first implantable anchor, such as... Figure 2e As shown. After a 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. Figure 2d As shown.

[0049] The flexible member 14 is then coupled to the second implantable anchor 38 by inserting the second tail 24 into the second cavity 42 of the second implantable anchor 38, such that the second tail 24 extends toward the proximal end 38p of the second implantable anchor 38 into the distal end 38d of the second implantable anchor 38. In doing so, the securing knot 30 engages the flexible member engagement member 40 of the second implantable anchor 38, thereby allowing the terminal portion of the second tail 24 to pass through the proximal end 38p of the second implantable anchor 38, while preventing the securing knot 30 from passing through the proximal end of the second implantable anchor, as... Figure 2e As shown. Because the fixation stop knot 30 has a diameter larger than at least one channel of the second implantable anchor, the fixation stop knot 30 cannot pass through at least one channel of the second implantable anchor 38, thereby limiting the further extension of the suture along the proximal end 38p of the second implantable anchor 38. A beneficial effect of the fixation stop knot 30 is that the position of the fixation tail can be maintained relative to the second implantable anchor 38, which significantly simplifies the management of the flexible component as the second implantable anchor passes through the cannula 48 and reaches the insertion site at the second bone hole 52.

[0050] After attaching the flexible member 14 to the second implantable anchor 38, the second implantable anchor 38 is first inserted into the second bone hole 52 (distal end 38d), as follows. Figure 2f As shown. When the fixation stop knot 30 is restricted to passing proximally through the flexible member engagement feature 20 of the second implantable anchor 38, it will be held in position relative to the anchor. Thus, the flexible member retention is provided not only by compression between the bone and the anchor, but also by the anchoring provided by the fixation stop knot 30. Once the second implantable anchor 38 is positioned within the bone hole 52, the ends of the first tail 22 and the second tail 24 are positioned such that they extend through and out of the cannula 48, thereby making them accessible and manipulable by the surgeon.

[0051] like Figure 2g As shown, after the second implantable anchor has been inserted into the second bone hole 52, tension can be applied to the first tail 22 by the surgeon pulling the end of the first tail 22 in the direction of arrow F1. Due to the connection of the tensioning structure between the first implantable anchor 12 and the portion of the second implantable anchor 38, the sliding motion of the flexible member 14 through the finger catcher 32 causes the adjustable collar 44 to collapse and abut against the bone compression tendon 46. Since the reverse knot 28 is designed to reduce stress on the flexible member 14 and the finger catcher 32, the pulling direction of the finger catcher 32 on the first tail 22 is at an angle to the finger catcher 32 or in a direction other than direction D1 (e.g., Figure 1 The structure (as shown) is protected from damage. A particular advantage of the structure described herein is that it can be tensioned after the first and second anchors are implanted into the bone, thereby simplifying the procedure and allowing the desired amount of tension to be set (and maintained) after implantation. This advantage makes the structure described herein particularly suitable for knotless double-row repair structures and allows the same type of anchors to be used for both medial and lateral rows.

[0052] After tensioning, the cannula is removed, excess suture material is trimmed and removed, and the surgical wound is closed.

[0053] In some specific implementations, when the tissue fixation and repair structure 10 is assembled at the surgical site, the surgeon may use a suture device (such as...) Figure 3The suture 54 shown facilitates the insertion of the second tail 24 through the distal end 38d of the second implantable anchor 38. The suture 54 may include a connecting feature 56 at its distal end for engaging the first tail 22, and a handle 58 for gripping by a surgeon. In use, once the second implantable anchor 38 has been inserted through the cannula 48 using the slotted inserter 60, the surgeon may pull the handle 58 in the direction of arrow F2, thereby pulling the suture 54 through the slot 62 formed in the inserter 60, thereby bringing the securing knot 30 into contact with the flexible member engagement feature 40 of the second implantable anchor 38.

[0054] Although the method is described using a technique in which a first implantable anchor is loaded with a single flexible member that will be connected to a single second implantable anchor, those skilled in the art will understand that the first implantable anchor may be loaded with one, two, or three times the number of collapsible sutures, each of which may be connected to a second implantable anchor. Figure 4 An exemplary embodiment of a tissue fixation and repair structure 10' is shown, the structure including a first implantable anchor 12' loaded with a first flexible member 14' and a second flexible member 14'". As shown in this embodiment, the first flexible member 14' and the second flexible member 14' are structurally similar to those described above and Figures 1 to 2g The flexible member 14 shown is identical, and the first implantable anchor 12' is structurally identical to the first implantable anchor 12 (also described above and Figures 1 to 2g (As shown) The same. Flexible member 14 and the second flexible member 14' are each connected to the flexible member engagement feature 20' of the first implantable anchor 12', thereby maintaining engagement with the first implantable anchor 12'.

[0055] It can also be used for double-row fixation repair. Figures 5 to 6dIn another embodiment shown, the tissue fixation and repair structure 110 includes a first implantable anchor 112 and a pre-jointed suture loop 114 attached to the first implantable anchor. 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 a lumen 18, and an engagement feature 120 that may be the same as or similar to a first flexible member engagement feature 20. The pre-jointed suture loop 114 may be attached to the first implantable anchor 112 at its distal end 114d. By way of example, the distal end 112d may have a fixation stop knot 130 similar to a fixation stop knot 30 to maintain engagement between the pre-jointed suture loop 114 (and specifically its distal end 114d) and the first implantable anchor 112, and thus prevent the distal end 114d from moving through the lumen 118. The pre-sewed suture loop 114 may include a splicing region 132 through which the pre-sewed suture loop 114 passes and through itself, thereby forming a loop 144. The loop 144 can be adjusted (i.e., closed) by pulling on the proximal end 114p of the pre-sewed suture loop 114 in the direction of arrow F3. The flexible member 114 may also include a reverse knot 128 formed thereon, which is located distal to the adjacent splicing region 132 relative to the first implantable anchor 112, such that the reverse knot 28 is substantially adjacent to the splicing region 132. The reverse knot 128 is configured to help maintain the integrity of the splicing region 132 and to allow a portion of the flexible member 114 to pass through the reverse knot 128 in such a way that the portion can slidably move through the reverse knot 128 in response to tension applied by the surgeon in the direction of arrow F3. Those skilled in the art will understand that while a small gap may exist between the overhand knot 128 and the splicing area 132, such that the overhand knot 128 does not adjoin the splicing area 132 to make direct contact with it, the overhand knot 128 can be considered substantially adjacent to the splicing area 132 due to any number of facts, such as manufacturing tolerances. Although the overhand knot 128 is shown and described as an overhand knot, which can be advantageous in surgical procedures due to its small size, any type of knot known to those of ordinary skill in the art capable of achieving the functions described herein can also be used in place of the overhand knot, such as a tying knot. The overhand knot 128 is formed by the flexible member 114 itself. However, in other embodiments, another flexible member may be attached to the flexible member 114 to form the overhand knot 128 (e.g., tied around the flexible member 114 to form the overhand knot 128 thereon).

[0056] An exemplary method for fixing soft tissue (such as tendon 146) using tissue fixation and repair structure 110 is referenced. Figures 6a to 6d To describe. Similar to what was described above and Figures 2a to 2g The method shown, Figures 6a to 6dThe method shown can be performed minimally invasively (e.g., arthroscopically) by inserting a cannula (not shown) through the patient's skin. Those skilled in the art will recognize other ways in which the procedures described herein can be performed, including with three or more cannulas, a single cannula, or no cannulas at all. Furthermore, other types of surgeries, such as open laparotomy, can be used in conjunction with this disclosure, which may not require intubation.

[0057] Figure 6a A tissue fixation and repair structure 110 is shown, wherein a first implantable anchor 112 has been inserted into a first bone hole 136 formed in a portion of bone 150. When the first implantable anchor 112 and a portion of a pre-splicing suture loop 114 are positioned within the bone hole 136 and the patient's body, the remainder of the pre-splicing suture loop 114 extends through a cannula (not shown) and out of the patient's body. After the first implantable anchor 112 has been inserted into the first bone hole 136, a portion of the pre-splicing suture loop 114 passes through or surrounds a tendon 146, as shown. Figure 6b As shown. Subsequently, a second bone hole 152 is formed in a portion of the bone 150 adjacent to the first bone hole 136, as shown. Figure 6c As shown. Then, the collar 144 of the pre-splicing suture collar 114 is attached to the connecting suture 138a of the implantable anchor assembly 138. The connecting suture 138a is attached to the second implantable anchor 138b at an eyelet 138c located at the proximal end 138p of the second implantable anchor 138b and at a first fork 138e located at the distal end 138d. After being attached to the collar 144, the second implantable anchor 138b is then inserted into the second bone hole 152, as shown. Figure 6d As shown. The pre-splicing suture loop 114 is then tensioned by pulling on the proximal end 114p of the pre-splicing suture loop 114, causing the loop 144 to collapse and tension the connecting suture 138a. When the connecting suture 138a is tensioned, the second implantable anchor 138b rotates within the second bone hole 152, causing the first fork arm 138e to engage the wall of the second bone hole 152 to lock the second implantable anchor 138b within the second bone hole 152, thereby anchoring the tendon 146 in place. Exemplary embodiments of this second implantable anchor, which can be used in conjunction with the constructions and related teachings provided herein, include the Bioknotless RC Suture Anchor, commercially available from DePuy Mitek, Inc.

[0058] Using each of these configurations, the tissue fixation and repair structures 10, 110 can be tensioned after both the first implantable anchors 12, 112 and the second implantable anchors 38, 138b have been fully inserted into their respective bone holes.

[0059] Although the aforementioned structures and fixation methods are shown relative to tissue fixation and repair structures having two implantable anchors and at least one flexible member, other configurations are characterized by the use of similar structures as described above. Figures 1 to 2g as well as Figures 5 to 6d The implementation scheme can be further implanted with fixation methods described above. For example, Figure 7 A dual-row repair is shown, in which four implantable anchors (two medial rows and two lateral rows) and four flexible members are used to fix the tendon 700. (See diagram) Figure 7 As shown, a first inner implantable anchor 701 and a second inner implantable anchor 702, as well as a first outer implantable anchor 703 and a second outer implantable anchor 704, are provided. Each of these implantable anchors may be substantially the same as the first implantable anchor 12 and the second implantable anchor 38. However, it should be understood that different anchor types (such as...) are available compared to the inner row. Figures 5 to 6d The anchor shown can be used for the lateral side. A first flexible member, a second flexible member, a third flexible member, and a fourth flexible member 705 to 708 are also provided, each of which may be substantially identical to flexible member 14 (or 114), and each of which has the same structural features as flexible member 14 (or 114) described above, provided in a manner similar to the first implantable anchor 12 and the second implantable anchor 38, and can be inserted into a bone hole formed in a portion of bone 711. As shown, the first flexible member 705 and the second flexible member 706 are coupled to the first medial implantable anchor 701 to form a first dual structure 709, and the third flexible member 707 and the fourth flexible member 708 are coupled to the second medial implantable anchor 702 to form a second dual structure 710. The first medial implantable anchor 701 and the second medial implantable anchor 702 can be installed into bone 705 in a manner similar to that described above for the first implantable anchor 12 and the flexible member 14. The flexible members 705 to 708 can then pass through the tendon 700 in a manner similar to that described above with respect to flexible member 14. A first lateral implantable anchor 703 can be mounted onto the first flexible member 705 and the fourth flexible member 708, and a second lateral implantable anchor 704 can be mounted onto the second flexible member 706 and the third flexible member 707. This mounting creates a cross-shaped pattern of flexible members that provides enhanced support and fixation. The first lateral implantable anchor 703 and the second lateral implantable anchor 704 can then be respectively installed into the bone 705, each lateral implantable anchor intersecting with the first medial implantable anchor 701 and the second medial implantable anchor 702, and the first to fourth flexible members 705 can be tensioned in a manner similar to that of flexible anchor 14, thereby securing the tissue in place.

[0060] Based on the above embodiments, those skilled in the art will recognize further features and advantages of the present invention. Therefore, the present invention should not be limited to what has been specifically shown and described, unless indicated by the appended claims. All publications and references cited herein are expressly incorporated by reference in their entirety.

Claims

1. A tissue repair structure, comprising: A first implantable anchor has a connecting member and at least one bone-connecting feature on its lateral wall; as well as A flexible member having a middle portion connected to the engaging member and having a first tail and a second tail extending therefrom, each of the first tail and the second tail having a terminal. A portion of the first tail extends through an internal collapsible channel and a first knot, the internal collapsible channel being formed in a hollow portion of the second tail, and the first knot being formed in the second tail distally adjacent to the hollow portion relative to the first implantable anchor. The second tail portion includes a fixing knot, which is located between the end of the second tail portion and the first knot.

2. The tissue repair structure according to claim 1, wherein the intermediate portion is slidably connected to the joining member.

3. The tissue repair structure of claim 1, further comprising a second implantable anchor configured to be attached to the second tail portion.

4. The tissue repair structure of claim 3, wherein the second implantable anchor is disposed near the fixation knot.

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

6. The tissue repair structure of claim 1, wherein the terminal portion of the first tail is configured to be separate from the second tail portion.

7. The tissue repair structure according to claim 1, wherein the distance between the fixation knot and the first knot is set at a certain distance from the fixation knot, wherein the distance is 3-5 mm longer than the length of the first implantable anchor.

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

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