Soft anchors for anatomical fixation and related systems and methods

Abstract

A tissue repair assembly is convertible from an insertion configuration to an anchoring configuration and includes an anchoring body, an actuator, and a "serpentine" member. The body and actuator include sutures. The body defines a ring whose length and width decrease and increase, respectively, during the conversion to the anchoring configuration. The actuator defines a first actuating portion and a second actuating portion, the former defining a locking mechanism having a knotted loop within a distal internal channel of the body. The serpentine member has a serpentine portion and a first tail and a second tail. In the insertion configuration: the serpentine portion extends through the knotted loop; the second actuating portion and the tail are located outside the body. Tensioning the second actuating portion and / or the tail converts the assembly to the anchoring configuration. The first tail can engage the second actuating portion and pull it through the channel, wherein the second actuating portion is slidable through the knotted loop and defines an external abutment ring.

Description

[0001] Cross-references to related applications This application claims the benefit of U.S. Provisional Patent Application No. 63 / 600,355, filed November 17, 2023, § 35U.SC 119(e), the entire contents of which are incorporated herein by reference. Technical Field

[0002] The present invention relates generally to apparatus, systems and methods for approaching damaged tissue, and more particularly to apparatus, systems and methods for anchoring a tissue repair component to a first anatomical structure and connecting the tissue repair component to a second anatomical structure so that the second anatomical structure approaches the first anatomical structure. Background Technology

[0003] When tissues (such as cartilage, skin, muscle, bone, tendons, and ligaments) are injured, surgical intervention is often required to repair the damage and promote healing. Surgical repair of tissue damage is typically performed using sutures attached to one or more anchoring devices implanted in or adjacent to the damaged tissue. Sutures can also be used to secure the repair by passing through or around the tissue, depending on a variety of surgical techniques. Sutures can also interconnect two or more anchors used to perform the repair. Suture anchors have been manufactured with a body formed of a variety of materials, including non-absorbable materials (such as metals and durable polymers) and bioabsorbable materials (such as absorbable polymers, bioceramics, absorbable composites, and treated bone). Anchors that are entirely or at least substantially composed of suture material are called “fully sutured anchors” or simply “sutured anchors,” and such anchors may be particularly advantageous in certain types of tissue repair. Furthermore, anchors that are entirely or at least substantially composed of textile suture material are called “soft anchors.” Soft anchors have shown advantages in fixation within bone material because the relatively soft and flexible nature of textile sutures allows them to fit into relatively small pre-drilled holes in the bone, thus reducing the amount of bone that must be removed before anchor insertion compared to other types of bone anchors. Summary of the Invention

[0004] According to embodiments of this disclosure, an assembly for anatomical approximation is configured to transition from an insertion configuration to an anchoring configuration, and includes an anchor body, an actuating member, and a serpentine member. The anchor body is formed of sutures defining an anchor loop and has a length along a first direction and a width along a second direction substantially perpendicular to the first direction. The anchor body is configured such that the length decreases and the width increases when the assembly transitions from an insertion configuration to an anchoring configuration. The actuating member is formed of sutures and defines a first actuating portion and a second actuating portion. The first actuating portion defines a locking mechanism within an internal channel defined by a distal portion of the anchor body. The locking mechanism includes a plurality of loops. The serpentine member has a first serpentine portion and a first serpentine tail and a second serpentine tail. When the component is in the insertion configuration: a first serpentine portion extends along the internal channel and passes through the plurality of loops; a second actuating portion and the first and second serpentine tails are located outside the anchor body; and at least one of the second actuating portion and the first and second serpentine tails is configured to receive a tensile force for changing the component from the insertion configuration to the anchor configuration. The free end region of the second serpentine tail is configured to connect with the free end region of the second actuating portion, such that the free end region of the first serpentine tail is configured to be pulled to draw the free end region of the second actuating portion into and through the internal channel of the anchor body, such that when the component is in the third configuration, the second actuating portion: 1) is held by and can slide relative to the plurality of loops within the internal channel, and 2) defines an abutment ring located outside the anchor body for abutting tissue.

[0005] According to another embodiment of this disclosure, an instrument assembly for delivering a tissue repair component to a target site of an anatomical structure includes an insertion instrument and a tissue repair component carried by the insertion instrument in an insertion configuration when carried. The insertion instrument has a proximal end and a distal end spaced apart from each other in a longitudinal direction. The insertion instrument also has a handle portion at the proximal end and a fork at the distal end. The tissue repair component includes an anchor body, an actuating member, and a serpentine member. The anchor body is formed of sutures and defines an anchor loop. The distal portion of the anchor body is capable of attaching to the fork between a pair of fork teeth. The anchor body defines a length in a longitudinal direction and a width in a lateral direction substantially perpendicular to the longitudinal direction. The anchor body is configured such that the length decreases and the width increases when the anchor body changes from the insertion configuration to the anchor configuration of the tissue repair component. The actuating member is formed of sutures and defines a locking mechanism and at least one actuating tail extending away from the locking mechanism. The locking mechanism includes a plurality of loops disposed within an internal channel on the distal portion of the anchor body. The serpentine member has a first serpentine portion and a first serpentine tail and a second serpentine tail. When the tissue repair assembly is in an insertion configuration: the first serpentine portion extends through the plurality of loops; the at least one actuating tail, the first serpentine tail, and the second serpentine tail are located outside the anchor body and extend into one or more suture clamping grooves on the handle portion; and one or more of the at least one actuating tail, the first serpentine tail, and the second serpentine tail are configured to receive tensile forces for changing the tissue repair assembly from an insertion configuration to an anchor configuration. A second serpentine tail is configured to engage with the at least one actuating tail and pull the at least one actuating tail into the internal channel and through the plurality of loops, such that a portion of the at least one actuating tail defines an applicator ring located outside the anchor body for applicating tissue.

[0006] According to an additional embodiment of this disclosure, a method for approximating a second anatomical structure relative to a first anatomical structure includes inserting an anchor body of a tissue repair assembly into a target location of the first anatomical structure. The anchor body is formed of sutures and defines an anchor loop. During the insertion step, an actuating member and a serpentine member are coupled to a distal portion of the anchor body and extend away from the anchor body. The actuating member defines a locking mechanism coupled to the distal portion of the anchor body. The locking mechanism includes a plurality of loops disposed within an internal channel in the distal portion of the anchor body. The method includes tensioning at least one of the actuating member and the serpentine member in a manner that reduces the length of the anchor body and increases the width of the anchor body; and coupling a free end region of the actuating member to a free end region of the serpentine member such that the coupled actuating member and the serpentine member form a loop through which at least a portion of the second anatomical structure extends. The method includes pulling a second free end region of the serpentine member in a direction away from the anchor body, thereby pulling the connected free end region of the actuating member through the plurality of loops, such that the actuating member itself forms a closing ring, through which at least a portion of the second anatomical structure extends. The method also includes pulling the free end region of the actuating member away from the plurality of loops, thereby reducing the circumference of the closing ring. Attached Figure Description

[0007] The foregoing description of the invention and the following detailed description of exemplary embodiments of the present application will be better understood when read in conjunction with the accompanying drawings. Exemplary embodiments are shown in the drawings to illustrate the characteristic features of the present application. However, it should be understood that the present application is not limited to the precise arrangements and means shown. In the drawings: Figure 1A This is a front plan view of a tissue repair assembly shown in an insert configuration according to an embodiment of the present disclosure. The tissue repair assembly includes an anchor body and further includes an operable or "actuating" member and a utility or "serpentine" member coupled to and extending from the anchor body. The portions of the anchor body, the utility member, and the serpentine member extending along the anchor body are made of textile stitching material and together define a "soft anchor" of the tissue repair assembly. Figure 1B It is shown in the anchored configuration Figure 1A The front view of the soft anchor shown in the figure; Figure 1C It is shown in a close-up configuration. Figure 1A The front view of the tissue repair component illustrated in the figure; Figures 2A to 2B yes Figures 1A to 1B The enlarged front view of the soft anchor illustrated in the figure shows, in particular, the insert configuration ( Figure 2A ) and in anchored configuration ( Figure 2B ) soft anchoring components; Figures 3A to 3C yes Figure 2A The anchor body of the soft anchor illustrated in the figure ( Figure 3A )(along Figure 2A (Cut off by section line 3A–3A), actuating component ( Figure 3B ) and serpentine components ( Figure 3C The corresponding axial sectional view of the anchor body, the actuating member and the serpentine member is cut along the corresponding plane orthogonal to the central axis of the anchor body, the actuating member and the serpentine member; Figure 4A and Figure 4B They are Figure 2A The front and rear view diagrams of the soft anchors illustrated in the figure; Figure 4C yes Figure 4A An enlarged partial sectional view of the distal portion of the soft anchor illustrated in the figure; Figure 4D It is set in Figure 4C An enlarged view of the one-way locking mechanism within the distal portion of the soft anchor illustrated in the figure; Figure 4E yes Figure 1A Another front view of the tissue repair component illustrated herein; Figures 5A to 5E and Figures 5G to 5H It is based on the implementation scheme of this disclosure. Figure 1A The front view of the tissue repair assembly illustrated herein shows the tissue repair assembly at various stages of the process for approximating tissue. Figure 5F Is in Figure 5E An enlarged view of the one-way locking mechanism of the stage illustrated in the figure; Figures 6A to 6M It is based on the implementation scheme of this disclosure. Figure 1A The corresponding plan view of the tissue repair component illustrated in the figure shows the various stages of constructing the tissue repair component and its soft anchors; Figure 7A The embodiment of this disclosure is constructed for using Figure 1A A planar component view of a surgical instrument assembly in which a tissue repair component is deployed to the patient's treatment site, as illustrated in the figure. Figure 7B yes Figure 7A A side plan view of the inserter fork of the surgical instrument assembly illustrated in the figure; Figure 7C From Figure 7A A frontal plan view of the distal region of the distal portion of the insertion member of the surgical instrument assembly illustrated herein, showing the distal region of the inserter fork. Figure 7D and Figure 7E They are Figure 7B The side and front views of the distal region of the inserter fork are illustrated in the figure. Figure 7F and Figure 7G These are the front and side view diagrams of the distal region of the inserter fork, shown as a load-bearing... Figure 2A The soft anchor illustrated in; Figures 8A to 8Q It is based on the embodiments of this disclosure and is used in the adoption Figure 1A The surgical approach for labral repair of the labrum, illustrated in the diagram, shows the various stages of the surgical system components. Figure 9A This is a front plan view of a tissue repair assembly according to another embodiment of the present disclosure, shown in an insert configuration; Figure 9B and Figure 9C yes Figure 9A The front view of the soft anchor of the tissue repair component illustrated herein, the soft anchor being in an insertion configuration ( Figure 9B ) and anchored configuration ( Figure 9C (This is shown in the image.) Figures 9D to 9G It is based on the implementation scheme of this disclosure. Figure 9A The diagram illustrates a front view of a tissue repair assembly, which is shown at various stages of the process for approximating tissue. Figure 10A This is a front view of a tissue repair assembly with a cannula-type actuating member according to another embodiment of this disclosure; Figure 10B yes Figure 10A The image shows a front view of the cannulated actuating component of the tissue repair assembly illustrated in the figure, which is shown in a neutral configuration. Figures 10C to 10D It is based on the implementation scheme of this disclosure. Figure 10B Enlarged perspective partial sectional end view of an alternative configuration of the end portion of the cannulated actuator illustrated in the figure; Figures 10E to 10I It is based on the implementation scheme of this disclosure. Figure 10A The diagram illustrates a front view of a tissue repair assembly, which is shown at various stages of the process for approximating tissue. Figures 11A to 11C It is similar to the additional embodiments of this disclosure. Figure 10A The front view of the additional tissue repair component of the tissue repair component illustrated in the figure shows an alternative arrangement of the anchor body and / or the cannula-type actuation component; Figure 12This is a front view of an alternative design of an intubation-type actuation member for a tissue repair assembly according to another embodiment of this disclosure, the intubation-type actuation member being shown in a neutral configuration; Figure 13A This is a front view of a tissue repair assembly having a cannula-type actuating member and an alternative anchor body according to another embodiment of this disclosure; Figure 13B yes Figure 13A The top plan view of the anchor body illustrated in the figure shows the anchor body in a neutral configuration; Figure 14 This is a front view of a tissue repair assembly with a cannula-type actuating member according to another embodiment of this disclosure, wherein the tail of the cannula-type actuating member is spliced ​​with the anchor body; Figure 15A This is a front plan view of a tissue repair assembly according to another embodiment of the present disclosure, the tissue repair assembly having a tubular actuating member partially disposed in the axial core space of the anchor body; and Figures 15B to 15E It is based on the implementation scheme of this disclosure. Figure 15A The diagram illustrates a front view of a tissue repair component, which is shown at various stages of the process for approximating tissue. Detailed Implementation

[0008] This disclosure will be more readily understood with reference to the following detailed description, taken in conjunction with the accompanying drawings and examples that form a part of this disclosure. It should be understood that this disclosure is not limited to the specific apparatus, methods, applications, conditions, or parameters described and / or shown herein, and that the terminology used herein is for the purpose of describing particular embodiments by way of example only and is not intended to limit the scope of this disclosure. Furthermore, unless the context clearly indicates otherwise, as used in this specification (including the appended claims), the singular forms “a” and “the” include the plural, and references to a particular numerical value include at least that particular value.

[0009] As used herein, the term "multiple" means more than one. When referring to a range of values, another embodiment includes from one specific value and / or to other specific values. Similarly, when a value is expressed as an approximation using "about," it should be understood that the specific value of that value constitutes another embodiment. All ranges include end values ​​and are composable.

[0010] As used herein, the terms “about” and “substantially” with respect to dimensions, angles, ratios, and other geometries take into account manufacturing tolerances. Furthermore, the terms “about” and “substantially” can include being greater than or less than 10% of the stated dimension, ratio, or angle. Additionally, the terms “about” and “substantially” can be applied equivalently to the specific values ​​stated.

[0011] As used herein, when referring to anatomical repair, the terms “approach,” “approaching,” “approaching,” and their derivatives refer to actions that reduce the distance between corresponding anatomical structures. It should be understood that, unless explicitly stated otherwise, these terms and their derivatives as used herein do not infer which particular anatomical structure moved relative to other anatomical structures. For example, as used herein, the exemplary phrase “the second anatomical structure is approached relative to the first anatomical structure” does not inherently mean that the second anatomical structure moves while the first anatomical structure remains stationary; while the exemplary phrase does cover the foregoing, it can also cover actions where the first anatomical structure moves while the second anatomical structure remains stationary, and it can also cover actions where both the first and second anatomical structures move (e.g., move closer to each other).

[0012] It should be understood that although terms involving numerical prepositions (e.g., "first," "second," "third") may be used herein to describe various features, these features should not be limited by these terms. These terms are used to distinguish one feature from another. For example, in another context, a first element may be referred to as a second element or a third element, and similarly, a second element may be referred to as a first element or a third element, without departing from the scope of the embodiments disclosed herein.

[0013] The embodiments disclosed herein relate to soft anchors for tissue repair components, particularly for tissue approximation. The soft anchors disclosed herein offer numerous advantages over many prior art soft anchors. For example, the soft anchors disclosed herein can be configured to have a narrow profile when in an insertion configuration (such as when loaded onto an insertion device), the narrow profile comprising a tapered distal geometry, and this narrow profile reduces friction with bone material when the anchor is inserted into a pre-formed bone tunnel or bone hole. The soft anchors disclosed herein also transition from their narrow insertion configuration to an "anchoring" (i.e., approximation) configuration, wherein the maximum width of the soft anchor is significantly increased, which facilitates firm attachment to bone. Furthermore, when in its anchoring configuration, the soft anchors disclosed herein exhibit a wide proximal side at or near its proximal end, which, combined with its increased maximum width, further ensures attachment to bone and prevents pull-out. The soft anchors disclosed herein also provide a proximal barrier-like structure for each anchor, which mechanically interferes with or otherwise prevents the locking mechanism or other distal portions of the anchor from migrating proximally from the remainder of the anchor. Furthermore, this mechanical interference has been observed to hinder or at least reduce the likelihood of adverse effects caused by proximal migration, such as protrusion or tension of the anchor at the bone's outer surface, and / or slack in the abutment ring connected to the anchor. Some of the soft anchors disclosed herein are also configured such that when they transition to their anchoring configuration, they collapse longitudinally (i.e., along the direction in which they are inserted), starting from their distal end and collapsing proximally, in a smooth, rapid longitudinal anchor collapse sequence that terminates when the collapsed portion of the anchor encounters mechanical interference with the barrier-like proximal portion of the anchor. This provides a sudden stop to the longitudinal collapse sequence, thereby providing the user with enhanced tactile feedback indicating that the soft anchor has been successfully anchored within the bone.

[0014] refer to Figure 1AAn exemplary tissue repair assembly 1 for anatomical approximation includes an anchor body 4, an operative or "actuating" member 6 attached to the anchor body 4, and a functional or "serpentine" member 8 temporarily attached to the anchor body 4. The distal portion of the repair assembly 1, particularly the anchor body 4 and corresponding portions of the actuating member 6 and the serpentine member 8 extending along the side and / or interior of the anchor body 4, defines an anchor unit 2 of the repair assembly 1. The anchor unit 2 may be simply referred to as "anchor" 2. Due to the construction of its constituent components (described in more detail below), the anchor 2 may be characterized as a "soft" anchor 2. In the exemplary embodiments disclosed herein, the repair assembly 1 is specifically configured for anatomical approximation (i.e., reducing the distance between the first anatomical structure 5 and the second anatomical structure 7). Specifically, the anchor body 4 is configured to attach the repair assembly 1 to a target location 3 of the first anatomical structure 5. The actuating member 6 extends from the anchor body 4 and is configured to connect the repair assembly 1 to the second anatomical structure 7, and the serpentine member 8 is configured to engage with the free end 6e of the actuating member 6 and to pass through the free end via a locking mechanism attached to the anchor body 4, thereby forming a convergence ring around the second anatomical structure 7. With the convergence ring in place, the actuating member 6 can be used to bring at least one of the first anatomical structure 5 and the second anatomical structure 7 toward the other. For this purpose, the soft anchor 2 of the repair assembly 1 is adapted to be in either the first configuration or the insertion configuration C1 (e.g., Figure 1A When (as shown), it is inserted into the target position 3 of the first anatomical structure 5. The repair component 1, especially its anchor 2, is also configured to change from the insertion configuration to the second configuration or anchor configuration C2, wherein the anchor body 4 is attached to the target position 3, as shown. Figure 1B As shown. Repair component 1 is also configured to transform into a third configuration or approximation configuration C3, in which the first and second anatomical structures 5 and 7 are approximated, as... Figure 1C As shown.

[0015] The first anatomical structure 5 and the second anatomical structure 7 may include bone and / or soft tissue (e.g., cartilage, ligaments, and / or tendons, as a non-limiting example). For example, as Figures 1A to 1CAs shown, the first anatomical structure 5 may include bone, the second anatomical structure 7 may include soft tissue, and the repair component 1 may be used to bring the soft tissue abutment to the bone. In one particular technique of this kind, the repair component 1 may be used to repair a torn labrum in the shoulder. In this particular example, the first anatomical structure 5 may be the glenoid 5 of the shoulder, and the second anatomical structure 7 may be the torn portion of the labrum 7. For example, an anchor body 4 may be inserted into and attached to a pre-drilled hole 3 formed in the glenoid 5, an actuating member 6 may be connected to the torn portion of the labrum 7, and a serpentine member 8 may be used to pull the free end 6e of the actuating member 6 through the anchor body 4 to bring the torn portion of the labrum 7 and the glenoid 5 abutment (i.e., reduce the distance between them). It should be understood that various other tissue repairs, such as ACL repair, ankle instability repair, Achilles tendon repair, rotator cuff repair, extra-articular knee ligament reconstruction / repair (e.g., MPFL, MCL, LCL, ALL), iliotibial band (ITB) tendon fixation, biceps tendon fixation, and knee meniscus repair, can be performed using the repair component 1 described herein, these are only additional, non-limiting examples. It should also be understood that the target location 3 of the first anatomical structure 5 need not be a hole formed therein. For example, the first target location 3 may be located near the outer surface of the first anatomical structure 5.

[0016] Now for reference Figure 2A The soft anchor 2 is shown in an insertion configuration C1. The anchor body 4 defines and extends along a central body axis X1 and is arranged in a specific shape. The central body axis X1 extends in an axial direction a1. In the illustrated embodiment, the anchor body 4 is ring-shaped, which may be referred to as the anchor ring 14, and this ring is preferably a closed loop defining an internal anchor eyelet 12. Therefore, in such embodiments, the central body axis X1 is also arranged in a ring (e.g., a closed loop). It should be understood that the anchor body 4 can be arranged in other shapes in the insertion configuration, such as V-shaped, U-shaped, horseshoe-shaped, and hourglass-shaped, these are only non-limiting examples, and such other shapes may, but do not necessarily, define an internal anchor eyelet.

[0017] The anchor body 4 has a rear or proximal end 16 and an anterior or distal end 18 spaced apart from each other along a longitudinal direction L, the longitudinal direction being oriented along the insertion axis X0 (also referred to herein as the "insertion axis" X0) inserted into the patient's anatomy. Specifically, the distal end 18 is spaced apart from the proximal end 16 along a distal direction D, the distal direction being oriented along the longitudinal direction L. The proximal end 16 is spaced apart from the distal end 18 along a proximal direction P, the proximal direction being opposite to the distal direction D, and also oriented along the longitudinal direction L. It should be understood that the proximal direction P and the distal direction D are unidirectional components of the longitudinal direction L, which is bidirectional. It should also be understood that, as used herein, the terms "longitudinal," "longitudinally," and their derivatives refer to the longitudinal direction L; the terms "proximal," "towards proximal," and their derivatives refer to the proximal direction P; and the terms "distal," "towards distal," and their derivatives refer to the distal direction D.

[0018] Anchor body 4 defines a proximal portion 4a and a distal portion 4b that are longitudinally spaced apart from each other. The proximal portion 4a extends distally from the proximal end 16 toward the distal portion 4b. The distal portion 4b extends proximally from the distal end 18 toward the proximal portion 4a. Anchor body 4 may also define an intermediate portion 4c located longitudinally between the proximal and distal portions 4a and 4b. Actuating member 6 is preferably connected to the distal portion 4b of anchor body 4. Additionally, serpentine member 8 is also preferably connected to the distal portion 4b of anchor body 4 in insertion configuration C1.

[0019] Now for reference Figures 2A to 2B The anchor body 4 is defined in length along the longitudinal direction L and in width along a lateral direction A that is substantially perpendicular to the longitudinal direction L. The anchor body 4 is also defined in thickness along a transverse direction T that is substantially perpendicular to both the longitudinal and lateral directions L and A. It should be understood that, as used herein, the terms “lateral,” “towards the side,” and their derivatives refer to the lateral direction A; the terms “transverse,” “laterally,” and their derivatives refer to the transverse direction T. As mentioned above, the anchor body 4 is configured such that when in the insertion configuration C1 ( Figure 2A When inserted into the target position 3 of the first anatomical structure 5, it is in the anchoring configuration ( Figure 2B When the anchor body 4 is attached to the target location 3, the repair component 1 is configured to change from the insertion configuration C1 to the anchoring configuration C2 in response to (i.e., as a response to, or caused by) a tensile force applied to one or more of the actuating member 6 and the serpentine member 8. In the illustrated embodiment, the change of the repair component 1 to the anchoring configuration C2 is preferably actuated by applying a tensile force generally in the proximal direction P to the free end 6e of the actuating member 6 and the opposite ends 8e1, 8e2 of the serpentine member 8 (these ends 6e, 8e1, 8e2 are as follows: Figure 1A(As shown). The approach configuration C3 will be discussed in more detail below. It should be understood that during and after the transformation of the repair component 1 to the approach configuration C3, the anchor body 4 remains anchored relative to the first anatomical structure 5. Therefore, the approach configuration C3 can be characterized as a later stage of the anchor configuration C2.

[0020] As the repair component 1 transitions from the insertion configuration C1 to the anchoring configuration C2, the anchor body 4 is specifically configured to converge, reducing its length and increasing its width. This results in a narrower width for the anchor body 4 in the insertion configuration, facilitating insertion of the anchor body 4 into the target location 3 (such as a hole 3 formed in the bone 5), followed by a transition to the wider anchoring configuration, which facilitates rigid fixation to anatomical structures (e.g., within the hole 3 in the bone 5). Specifically, in the insertion configuration ( Figure 2A In the anchoring configuration, the anchor body 4 defines a first maximum width W1 along the lateral direction A and a first maximum length L1 along the longitudinal direction L. Figure 2B In this design, the anchor body 4 defines a second maximum width W2 along the lateral direction A and a second maximum length L2 along the longitudinal direction L, wherein the second maximum width W2 is greater than the first maximum width W1, and the second maximum length L2 is less than the first maximum length L1. It has been observed that the anchor body 4 presents a wide proximal side 16a at or near its proximal end 16, which enhances anchorage within the bone and reduces the likelihood of pull-out, which is particularly advantageous when anchoring to harder cancellous bone materials. It should be understood that the first and second maximum widths W1 and W2 each refer to the total width of the anchor body 4 relative to the lateral direction A, and are not limited to the width measured between two opposite points on the anchor body 4 intersecting a single linear axis oriented along the lateral direction A. For example, those locations defining the maximum width of the anchor body 4 may be spaced apart from each other along the longitudinal direction L. It should be understood that, as used herein, the terms “converging,” “converging,” “gathering together,” “gathering together,” and their derivatives refer to an action in which at least a portion of the anchor body 4 is forced to expand in the lateral direction A in response to a shortening force in the longitudinal direction L. It should also be understood that, as the anchor body 4 changes from the insertion configuration C1 to the anchoring configuration C2, the maximum thickness of the anchor body 4 in the lateral direction T also preferably increases.

[0021] The anchor body 4 is preferably made of a sewing material, particularly a textile sewing material. Therefore, the anchor body 4 greatly contributes to the anchor 2 being characterized as a "soft anchor". Now refer to... Figure 3AIn such embodiments, the anchor body 4 includes a textile structure or "shroud" 15 defining an internal core space 17 that may be centrally located along the anchor body 4 such that a central body axis X1 extends along the core space 17. The sheath 15 is preferably composed of a plurality of stitching material fibers woven or otherwise woven or wound together in a manner that defines the sheath 15. In the illustrated embodiment, the plurality of stitching fibers are woven together in a circular weave pattern, which provides the sheath 15 with a generally circular cross-sectional profile. In other embodiments, the sheath 15 may have a flat or "ribbon-like" cross-sectional profile or other cross-sectional profiles, including those more fully described in U.S. Patent 11,666,320 ("'320 Reference"), issued June 6, 2023, by Johnson et al., the entire disclosure of which is hereby incorporated herein by reference. The textile stitching material of the sheath 15 may have a material composition including one or more of the following: polyethylene terephthalate (PET), such as ETHIBOND manufactured by Ethicon, Inc. of Bridgewater, New Jersey, USA. ® Branded polyester stitching thread, ultra-high molecular weight polyethylene (UHMWPE), polydioxanone (PDS), polypropylene (PP), and nylon. The sheath fiber can be single-stranded or multi-stranded and may or may not use colorants as needed. In the illustrated embodiment, the internal core space 17 of the anchor body 4 typically does not contain material of the anchor body 4; however, in other embodiments, the anchor body 4 may include a core member extending within and along the internal core space 17. It should be understood that such a core member may include expandable materials, such as those disclosed in '320 references.

[0022] Now for reference Figures 3B to 3CThe actuating member 6 and the serpentine member 8 are also preferably made of stitching material, particularly textile stitching material. In such embodiments, the actuating member 6 and the serpentine member 8 each have a corresponding textile structure or "shroud" 19, 25 defining corresponding internal core spaces 21, 27, which are respectively centered along the central actuating member axis X2 and the central serpentine member axis X3. The sheaths 19, 25 of the actuating member 6 and the serpentine member 8 are preferably made of multiple stitching material fibers woven or otherwise woven or wound together in a manner that defines the sheaths 19, 25. In the illustrated embodiment, the multiple stitching fibers are woven together in a circular weave pattern, which provides the sheaths 19, 25 with a generally circular cross-sectional profile. In other embodiments, the sheaths 19, 25 of one or both of the actuating member 6 and the serpentine member 8 may have a flat or "strip-like" cross-sectional profile or other cross-sectional profiles, including those more fully described in '320 references. The fibers of the textile stitching material of the sheaths 19, 25 of the actuating member 6 and the serpentine member 8 may have a material composition including those described above for the sheath 15 of the anchor body 4. In the illustrated embodiment, at least a majority of the internal core spaces 21, 27 of the actuating member 6 and the serpentine member 8 are free of material, which facilitates various manipulations, modifications, and constructions of one or more portions of the actuating member 6 and the serpentine member 8, such as splicing, as described in more detail below. However, in other embodiments, one or more portions of the actuating member 6 and / or the serpentine member 8 may include one or more core members extending within and along the internal core spaces 21, 27, and these core members may include expandable materials, such as those disclosed in '320 references.

[0023] In one non-limiting exemplary embodiment of the repair component 1, the anchor body 4 is made of a textile stitching material, including No. 5 UHMWPE woven with PET tracer yarn; the actuating member 6 is made of a textile stitching material, including No. 1 UHMWPE; and the serpentine member 8 is made of a textile stitching material, including No. 1 co-woven fabric of UHMWPE and PET. It should be understood that various other textile stitching material compositions, sizes, and constructions may be used for the anchor body 4, actuating member 6, and serpentine member 8.

[0024] Now for reference Figures 4A to 4COne or both of the actuating member 6 and the serpentine member 8 can be connected to the distal portion 4b via splicing with the distal portion 4b of the anchor body 4. For example, in the illustrated embodiment, both the actuating member 6 and the serpentine member 8 enter the internal channel 22 of the anchor body 4 at a first position 20a and exit the internal channel at a second position 20b of the anchor body 4. In the illustrated embodiment, the internal channel 22 includes the internal core space 17 of the anchor body 4. Specifically, as Figure 4C As shown, the actuating member 6 and the serpentine member 8 enter the internal channel 22 through a first through-hole 24a (which passes through the sheath 15 at the first position 20a), and extend side-by-side along the axial direction a1 of the anchor body 4 through a portion of the internal core space 17, then exit the internal channel 22 through a second through-hole 24b (which passes through the sheath 15 at the second position 20b). Therefore, in the illustrated embodiment, the first through-hole 24a is located at the first position 20a, and the second through-hole 24b is located at the second position 20b. Thus, it can be said that the actuating member 6 and the serpentine member 8 penetrate the sheath 15 at the first and second positions 20a, 20b. In this example, the internal channel 22 includes the first and second through-holes 24a, 24b and a portion of the internal core space 17 extending between them.

[0025] For the purposes of this disclosure, the distal portion 4b of the anchor body 4 is defined as the portion through which the actuating member 6 and the serpentine member 8 extend. Therefore, the distal portion 4b of the anchor body 4 can be described as the portion extending distally from the nearest of the first and second positions 20a, 20b to the distal end 18 of the anchor body 4. Preferably, the first and second positions 20a, 20b are equidistant from the distal end 18 of the anchor body 4 in the longitudinal direction L, which helps the anchor body 4 to form a predictable convergence pattern when transitioning to an anchoring configuration. However, in other embodiments, the first and second positions 20a, 20b may be spaced apart from each other in the longitudinal direction L (i.e., the first and second positions 20a, 20b may be non-equidistant from the distal end 18 of the anchor body 4 in the longitudinal direction).

[0026] Refer again Figure 2AThe distal portion 4b of the anchor body 4 defines a distal portion length L3 along the longitudinal direction L. The distal portion length L3 is preferably about 80% to about 5.0% of the first maximum length L1 of the anchor body 4, more specifically about 40% to about 20% of the first maximum length L1, and more specifically about 28% to about 32% of the first maximum length L1. In other words, the ratio of the distal portion length L3 to the first maximum length L1 (i.e., L3:L1) can be in the range of about 0.80:1 to about 0.05:1, more specifically in the range of about 0.40:1 to about 0.20:1, and more specifically in the range of about 0.32:1 to about 0.28:1.

[0027] Refer again Figure 4C The internal channel 22 has a channel length D1 (also referred to as the "joint length" D1 in this example) measured along the central body axis X1 between the first and second positions 20a, 20b. For measurement purposes, the first and second positions 20a, 20b can be defined as the locations where the corresponding reference axis X4 (extending from the geometric center of the first and second through holes 24a, 24b) intersects the central body axis X1 in a perpendicular manner. The channel length D1 can range from about 6.0 mm to about 16.0 mm, more specifically from about 11.0 mm to about 14.0 mm, and more specifically from about 12 mm to about 13 mm.

[0028] Refer again Figures 4A to 4C It should be understood that when the repair component 1 is in the insertion configuration C1: the actuating member 6 includes at least one first portion 6a residing within and extending along the internal channel 22 of the anchor body 4, and at least one second portion 6b located outside the anchor body 4; and the serpentine member 8 includes at least one first portion 8a residing within and extending along the internal channel 22 of the anchor body 4, and at least one second portion 8b located outside the anchor body 4. These first portions 6a and 8a of the actuating member 6 and the serpentine member 8 may be referred to as "first actuating portion" 6a and "first serpentine portion" 8a, respectively, and those second portions 6b and 8b of the actuating member 6 and the serpentine member 8 may be referred to as "second actuating portion" 6b and "second serpentine portion" 8b, respectively. The second actuating portion 6b and the second serpentine portion 8b each may include a pair of tails 6b, 8b, which may be referred to as "actuated tail" 6b and "serpentine tail" 8b, respectively, extending proximally from the distal portion 4b of the anchor body 4. The actuated tail 6b and serpentine tail 8b extend proximally from the first and second through holes 24a, 24b to corresponding proximally actuated tail ends (where at least one proximally actuated tail end defines a free end 6e) and corresponding first and second serpentine tail ends 8e1, 8e2, these components in… Figure 1A As shown in the figure, and will be described in more detail below.

[0029] like Figures 4A to 4B As shown, a pair of actuated tails 6b include a first actuated tail 6b1 and a second actuated tail 6b2; and a pair of serpentine tails 8b include a first serpentine tail 8b1 and a second serpentine tail 8b2. In the illustrated embodiment, the first actuated tail 6b1 and the first serpentine tail 8b1 extend proximally from the first through-hole 24a; and the second actuated tail 6b2 and the second serpentine tail 8b2 extend proximally from the second through-hole 24b. It should be understood that the first and second actuated tails 6b1, 6b2 and the first and second serpentine tails 8b extend proximally from the first and second through-holes 24a, 24b and are located within the anchor eye 12 (or at least within the contour of the anchor eye 12 in a reference plane extending in the longitudinal and lateral directions L, A (this reference plane may be referred to as the LA reference plane). From the anchor eyelet 12 (or at least from its outline), the first and second actuating tails 6b1, 6b2 and the second serpentine tail 8b2 pass through the proximal portion 4a of the anchor body 4, and the first serpentine tail 8b1 passes along the proximal portion 4a of the anchor body 4. In the illustrated embodiment, the first and second actuating tails 6b1, 6b2 pass through a first proximal penetrating hole 23a on the proximal portion 4a of the anchor body 4; the second serpentine tail 8b2 passes through a second proximal penetrating hole 23b on the proximal portion 4a of the anchor body 4; and the first serpentine tail 8b1 passes along the proximal portion 4a of the anchor body 4. In this embodiment, the first and second proximal penetrating holes 23a, 23b are located laterally opposite to each other on both sides of the insertion axis X0. Preferably, the first and second proximal through holes 23a, 23b are substantially equidistant from the insertion axis X0 in the lateral direction A; alternatively, the first and second proximal through holes 23a, 23b need not be equidistantly spaced laterally from the insertion axis X0. Furthermore, in the illustrated embodiment, the first serpentine tail 8b1 passes along the proximal portion 4a of the anchor body 4 at a position substantially adjacent to the first proximal through hole 23a. In other embodiments, the first serpentine tail 8b1 may pass through the first proximal through hole 23a together with the actuating tails 6b1, 6b2. In other embodiments, the second serpentine tail 8b2 may pass along the proximal portion 4a of the anchor body 4 (instead of passing through the through hole in the proximal portion 4a). In yet another embodiment, two or more, up to all, of the actuating tails 6b1, 6b2 and the serpentine tails 8b1, 8b2 may pass along the proximal portion 4a of the anchor body 4.

[0030] Continue to refer to Figures 4A to 4BThe actuating tails 6b can be coupled together to provide an engaged actuating tail 6d, which extends to the free end 6e of the actuating member 6. In the illustrated embodiment, the actuating tail 6b is connected via a first or distal engagement position 6c1 to a second or proximal engagement position 6c2 (e.g., Figure 4E As shown, the actuating tails 6b1 and 6b2 are spliced ​​together. For example, one of the actuating tails 6b1 and 6b2 can be bury spliced ​​into the other of the actuating tails 6b2 and 6b1, thereby providing a spliced ​​actuating portion 6g that extends from the first engagement position 6c1 (see...). Figure 4A (i.e., the splicing insertion point) extends proximally to the second joint position 6c2 (see...) Figure 4E (i.e., the end of the splice). Therefore, the first joining position 6c1 may be referred to as the "splice insertion point" 6c1, and the second joining position 6c2 may also be referred to as the "splice end" 6c2. It should also be understood that, as used herein, the term "embedded splice" and its derivatives (e.g., "embedded splice" and "embedded in splice") refer to a suture structure in which a first suture segment penetrates the sheath of a second suture segment and extends longitudinally along the interior of the second suture segment in a substantially parallel arrangement, wherein the first suture segment terminates within the interior of the second suture segment. The substantially parallel arrangement of the aforementioned embedded splice may include coaxial alignment of the first and second suture segments (such as when the first suture segment extends within and along the core space of the second suture segment). In the illustrated embodiment, the first actuating tail 6b1 penetrates the sheath 19 of the second actuating tail 6b2 at the splice insertion point 6c1. Therefore, along the splicing actuation portion 6g, the sheath 19 of the first actuation tail 6b1 resides inside the sheath 19 of the second actuation tail 6b2 (such as within the core space 21 of the second actuation tail 6b2). Thus, along the splicing actuation portion 6g, the sheaths 19 of the first and second actuation tails 6b1 can be referred to as the "inner" and "outer" sheaths 19, respectively. It should be understood that, in the illustrated embodiment, the end of the first actuation tail 6b1 defines the splicing end 6c2.

[0031] When in the insertion configuration C1, the first engagement position 6c1 (i.e., the splicing insertion point) of the actuating member 6 is preferably located within the anchor hole 12 (or at least within the outline of the anchor hole 12) relative to the longitudinal and lateral directions L, A. Preferably, the first engagement position 6c1 is located substantially at the longitudinal midpoint of the anchor body 4 (i.e., at approximately half of the first maximum length L1, or at a location of ½ L1). The first engagement position 6c1 is also preferably laterally biased toward the first snake tail (also referred to as the "first snake tail" 8b1) of the snake tails 8b2 and away from the second snake tail (also referred to as the "second snake tail" 8b2) of the snake tails 8b2. In other words, the first engagement position 6c1 is preferably close to the first snake tail 8b1 and away from the second snake tail 8b2. This allows the engaged actuating tail 6d to extend along the first serpentine tail 8b1 in the proximal direction P, which may be advantageous when the repair assembly 1 is loaded onto the insertion device, as described in more detail below. The splicing end 6c2 of the actuating member 6 is preferably located distal to the free end 6e of the actuating member 6 (see [link to original text]). Figure 4E (as described in more detail below).

[0032] Now for reference Figures 4A to 4D The repair assembly 1 includes a retaining or "locking" mechanism 26, which is configured to retain the actuating member 6 in place relative to the anchor body 4 when in the approach configuration C3, thereby maintaining the approach positioning of the second anatomical structure 7 relative to the first anatomical structure 5. In this embodiment, the locking mechanism 26 is disposed within the anchor body 4, particularly within the distal portion 4b of the anchor body. Furthermore, the locking mechanism 26 of this embodiment is defined by the actuating member 6, particularly by the first actuating portion 6a, and is configured to engage with the first serpentine portion 8a when the repair assembly 1 is in the insertion configuration C1, such as... Figures 4C to 4DAs shown. The locking mechanism 26 is specifically configured such that when a closing loop is formed around (or through) the second anatomical structure 7, the serpentine member 8 can guide the free end 6e of the actuating member 6 to engage with the locking mechanism 26. For this purpose, the locking mechanism 26 is configured to facilitate unidirectional axial sliding of the serpentine member 8 and the subsequently engaged actuating tail 6d relative to the locking mechanism 26 when the repair assembly 1 changes from the anchoring configuration C2 to the closing configuration C3. Therefore, the locking mechanism 26 can also be referred to as a "one-way" locking mechanism 26. In the illustrated embodiment, the locking mechanism 26 is specifically configured to allow the serpentine member 8 and the subsequently engaged actuating tail 6d to slide relative to the locking mechanism 26 along the central serpentine member axis X3 in a first axial serpentine direction dX3-1 (towards the first serpentine tail end 8e1), but subsequently prevents (or at least significantly prevents) the engaged actuating tail 6d from sliding relative to the locking mechanism 26 along the central serpentine member axis X3 in a second axial serpentine direction dX3-2 (opposite to the first axial serpentine direction dX3-1, i.e., the second axial serpentine direction dX3-2 towards the second serpentine tail end 8e2). Therefore, the "one-way" sliding direction provided by the locking mechanism 26 of this embodiment is... Figure 4C The first axial serpentine direction dX3-1 is shown.

[0033] In the illustrated embodiment, the locking mechanism 26 includes one or more loops 28 defined by the first actuating member 6. For example, the locking mechanism 26 may include first and second loops 28 defined by corresponding portions of the first actuating portion 6a, these portions being bent or otherwise manipulated into loops 28, which fold back and pass through the first actuating portion 6a at first and second through holes 30. In the insertion configuration C1, the first serpentine portion 8a extends through the eyelet defined by the loop 28. Subsequently, in the approach configuration C3, the second actuating portion 6b (e.g., the engaged actuating tail 6d) extends through the eyelet of the loop 28 (see [link to previous embodiment]). Figure 5F This occurs after the free end 6e of the actuating member 6 is pulled through the loop 28 by the serpentine member 8, as described in more detail below. It has been observed that the configuration of the loop 28 disclosed herein provides unidirectional sliding of the actuated tail 6d discussed above. The locking mechanism 26 of the illustrated embodiment defines a loop spacing distance D3, measured along the central body axis X1 between the geometric center points of the first and second loops 28. The loop spacing distance D3 may range from about 1.0 mm to about 12 mm, more specifically from about 2.0 mm to about 7.0 mm, and more specifically from about 3.5 mm to about 4.5 mm. In other embodiments, the locking mechanism 26 may consist of a single loop 28 or may include two or more loops 28. In still other embodiments, the locking mechanism 26 may employ other clamping structures to provide unidirectional sliding for the engaged actuated tail 6d.

[0034] Now for reference Figure 4E The second serpentine tail 8e2 defines a connecting structure for engagement with the proximal portion 6h of the actuating member 6, thereby allowing the serpentine member 8 to guide the actuating member 6 through to engage with the locking mechanism 26 to form a closing ring. Preferably, the connecting structure of the second serpentine tail 8b2 is defined along its free end region (i.e., the region extending to the second serpentine tail 8e2). In the illustrated embodiment, the connecting structure is a ring 8f, which may be referred to as a "serpentine ring" 8f, and is configured to receive the free end region of the actuating member 6 (i.e., the region extending to the free end 6e). Specifically, when the free end 6e of the engaged actuating tail 6e passes through the serpentine ring 8f, the first serpentine tail 8e1 is configured to be pulled to pass the free end region of the engaged actuating tail 6d through the internal channel 22 of the anchor body 4, so that in the closing configuration, the engaged actuating tail 6d defines a closing ring located outside the anchor body 4 for closing the organization, as described in more detail below. The serpentine ring 8f has a length D2, which is preferably sized to facilitate engagement with the engaged actuating tail 6d.

[0035] The serpentine ring 8f is preferably configured as an eyelet, through which a portion of the serpentine member 8 folds back and splices into a portion of the second serpentine tail 8e2 and optionally along a portion of the first serpentine tail 8b2. In the illustrated embodiment, the eyelet providing the serpentine ring 8f extends from the splice insertion point 8g1 to the splice end 8g2. In this way, the serpentine member 8 has a spliced ​​serpentine portion 8g extending from the splice insertion point 8g1 to the splice end 8g2. It should be understood that the splice insertion point 8g1 defines the distal end of the serpentine ring 8f. The spliced ​​serpentine portion 8g has a first or "spliced" serpentine thickness T1, which is greater than a second or "non-spliced" serpentine thickness T2 of the remainder of the serpentine member 8, the remainder including the portion defining the second serpentine tail 8b2 of the serpentine ring 8f, and a narrow portion 8h of the serpentine member 8 extending from the splice end 8g2 to the first serpentine tail 8e1. The thickness T1 of the spliced ​​serpentine can be about twice (2×) the thickness T2 of the non-spliced ​​serpentine, because the spliced ​​serpentine area 8g contains two (2) serpentine sheaths 25, while the narrow serpentine portion 8h contains one (1) serpentine sheath 25.

[0036] The proximal portion 6h of the actuating member 6 (which may also be referred to as the "proximal actuating portion" 6h) extends from the splicing end 6c2 to the free end 6e of the actuating member 6 and is configured to pass through the serpentine ring 8f for engagement, thereby allowing the serpentine member 8 to guide the actuating member 6 through the knot 28 of the locking mechanism 26. In the illustrated embodiment, the engaged actuating tail 6d comprises both the splicing actuating portion 6g and the proximal actuating portion 6h. In other words, in the illustrated embodiment, the splicing actuating portion 6g and the proximal actuating portion 6h are components of the engaged actuating tail 6d. The splicing actuating portion 6g has a first or "spliced" actuating thickness T3, which is greater than the second or "non-spliced" actuating thickness T4 of the proximal actuating portion 6h. The splicing actuation thickness T3 can be about twice (2×) the non-splicing actuation thickness T4 because the splicing actuation part 6g has two (2) actuation sheaths 19 (inner and outer sheaths 19), while the proximal actuation part 6h has one (1) actuation sheath 19.

[0037] It should be understood that the splicing ends 6c2 and 8g2 of the actuating member 6 and the serpentine member 8 can be positioned respectively to facilitate the smooth passage of the actuating member 6 through the loop 28 of the locking mechanism 26. For example, the position of the splicing end 8g2 of the serpentine member 8 can be adjusted to set preferred initial conditions in the loop 28. In the illustrated embodiment, the splicing end 8g2 of the serpentine member 8 is located on the other side of the locking mechanism 26, opposite the splicing insertion point 8g1, such that when in the insertion configuration C1, the splicing serpentine portion 8g extends through the loop 28. Therefore, when the repair assembly 1 is in the insertion configuration C1, the size of the loop 28 can be adjusted (i.e., reduced) to the splicing serpentine thickness T1, which is greater than the non-splicing serpentine thickness T2. In other words, when in the insertion configuration C1, the inner diameter of the loop 28 can be substantially equal to the splicing serpentine thickness T1. When the thickness of the spliced ​​serpentine section T1 is approximately twice (2×) the thickness of the non-spliced ​​serpentine section T2 (i.e., when T1 ≈ 2×T2), the spliced ​​serpentine region 8g will result in the inner diameter of the initial loop 28 being approximately twice (2×) its value when the loop 28 is assembled around the narrow serpentine section 8h. The aforementioned dimensional difference between T1 and T2 (i.e., T1>T2) reduces the mechanical resistance of the serpentine loop 8f as it passes through the loop 28 to guide the actuating member 6.

[0038] Additionally, the splice end 6c2 of the actuating member 6 can be positioned to maximize the performance of the tissue repair component 1. For example, the splice end 6c2 of the actuating member 6 is preferably positioned away from the free end 6e so as to be positioned along the actuating column during and after tissue approach. Furthermore, the splice end 6c2 of the actuating member 6 is preferably located sufficiently far from the free end 6e such that when the serpentine ring 8f pulls the proximal actuating portion 6h toward the junction 28, the proximal actuating portion 6h can pass through the serpentine ring 8f and fold back onto itself (see [link to relevant documentation]). Figure 5DThe dimensional difference between the spliced ​​actuation thickness T3 and the non-spliced ​​actuation thickness T4 (i.e., T3>T4) further reduces the mechanical resistance when the serpentine ring 8f guides the proximal actuation portion 6g through the junction ring 28. The dimensional difference of T3 being greater than T4 provides a significant advantage to the repair assembly 1 because when the proximal actuation portion 6h passes through the serpentine ring 8f and folds back on itself, the connecting structure (i.e., the folded-back proximal actuation portion 6h and the serpentine ring 8f) has a local maximum thickness at the second serpentine end 8e2, which can be approximately twice the non-spliced ​​serpentine thickness T2 (2×) and twice the non-spliced ​​actuation thickness T4 (2×) (i.e., local maximum thickness ≈ (2×T2) + (2×T4)). When thicknesses T2 and T4 are less than T1 and T3, respectively, the connecting structure encounters less resistance when guiding through the junction ring 28, thus requiring a relatively lower guiding force. For example, when T2 is approximately ½ T1 and T4 is approximately ½ T3, the maximum local thickness of the connection structure can be approximately ¼ (approximately 25%) of its thickness if there were no thickness difference between T1 and T2 and between T3 and T4, respectively. Therefore, the splicing serpentine portion 8g and the splicing actuating portion 6g significantly reduce the resistance encountered by the actuating member 6 when it passes through the loop 28, thus requiring a lower threading force. In this way, the presence of the splicing serpentine portion 8g and the splicing actuating portion 6g facilitates a smooth transition during threading as the serpentine member 8 pulls the actuating member 6 into the internal channel 22 of the anchor body 4 and through the loop 28.

[0039] Another benefit of the presence of the splice actuation portion 6g and the position of the splice end 6c2 is that its embedding into the splice extends the local thickness to T3, which also increases the warp and weft density of the splice actuation portion 6g (i.e., the number of fibers on a suture of a given length). The extended thickness T3 and the increased warp and weft density of the splice actuation portion 6g enhance the locking force provided by the locking mechanism 26 when the splice actuation portion 6g passes through the knot loop 28. It should be understood that a trade-off can be made between increasing the initial size of the knot loop 28 (e.g., to reduce the required threading force) and increasing the extent to which the knot loop 28 must contract to fit the coupled actuation tail 6d, with sufficient force to perform unidirectional locking during and after tissue agglutination. It should also be understood that the thickness of one or more of the serpentine members 8 (e.g., T1 and T2) and the actuating members 6 (e.g., T3 and T4) may be locally varied to provide the conditions required for the intended application. These conditions may include initial conditions (e.g., in the insertion configuration C1), anchoring conditions (e.g., during and after the transition to the anchoring configuration C2), threading conditions, and approaching conditions (e.g., during and after the transition to the approaching configuration C3).

[0040] Now for reference Figures 5A to 5H The following describes how the repair component 1 can be applied to the collapsing tissue, based on the exemplary technology.

[0041] like Figure 5A As shown, in insertion configuration C1, the anchor body 4 is inserted along the insertion axis X0 into the target position 3 of the first anatomical structure 5. In this example, the first anatomical structure 5 is bone, and the target position 3 is a pre-drilled hole 3 in the bone 5. The engaged actuating tail 6d and the first and second serpentine tails 8b1, 8b2 extend generally proximally from the anchor body 4. Figure 5B As shown, the repair assembly 1 is actuated into the anchoring configuration C2 by simultaneously applying tensile force to the engaged actuating tail 6d and the first and second serpentine tails 8b1 and 8b2, thereby bringing the anchor body 4 together and attaching it to the bone along the side of the hole 3.

[0042] like Figure 5C As shown, the second serpentine tail 8b2 and the engaged actuating tail 6d are positioned on opposite sides of the second anatomical structure 7. Starting from this positioning, the free end 6e of the engaged actuating tail 6d is positioned proximally around the second anatomical structure 7, and the proximal actuating portion 6h passes through and engages with the serpentine ring 8f, such that the second anatomical structure 7 is captured by the engaged actuating tail 6d and the second serpentine tail 8b2. At this stage, the actuating member 6 and the serpentine member 8 combine to form a closed penetrating ring 31 around the second anatomical structure 7. Specifically, the penetrating ring 31 includes a first serpentine portion 8a (which, as shown...) Figure 4D The loop 28 passing through the locking mechanism 26 is shown, along with the second serpentine tail 8b2 and the actuating tail 6d connected thereto (via the serpentine loop 8f). The guide ring 31 facilitates the formation of the approach ring 32, which will be defined by the actuating member 6 extending around the second anatomical structure 7 and passing through the locking mechanism 26, as described in more detail below. Therefore, the guide ring 31 can be characterized as a precursor to the approach ring 32.

[0043] like Figure 5D As shown, tension is applied to the first serpentine tail 8b1 in the first axial serpentine direction dX3-1. This causes the serpentine ring 8f to pull the engaged actuating tail 6d in the first axial serpentine direction dX3-1, thereby guiding the engaged actuating tail 6d through the locking mechanism 26 in the anchor 2. During this guiding process, the free end 6e of the engaged actuating tail 6d can optionally be secured by a tool 135 (such as a gripper) to prevent the engaged actuating tail 6d from disengaging from the serpentine ring 8f. As described above, securing the free end 6e of the engaged actuating tail 6d also allows the proximal actuating portion 6h to fold back within itself on the serpentine ring 8f during the guiding process. Figures 5E to 5FAs shown, the threading continues, causing the proximal actuating portion 6h of the engaged actuating tail 6d to be pulled by the serpentine ring 8f, and to enter, pass through, and be pulled out of the opposite side of the locking mechanism 26 along the first axial serpentine direction dX3-1. Specifically, this threading causes the splicing actuating portion 6g of the engaged actuating tail 6d to pass through the knot ring 28 of the locking mechanism 26, as... Figure 5F As shown. At this stage, the serpentine member 8 has exited the anchor body 4 and no longer extends through the loop 28 of the locking mechanism 26, so the serpentine ring 8f can disengage from the engaged actuating tail 6d.

[0044] like Figure 5E As shown, the engaged actuating tail 6d defines a closing ring 32 at this stage, which extends around the second anatomical structure 7 from the locking mechanism 26 in the anchor body 4 and folds back into the locking mechanism 26. Specifically, the splicing actuating portion 6g of the engaged actuating tail 6d defines the closing ring 32. Additionally, at this stage, the engaged actuating tail 6d also has a free portion 35 extending from the locking mechanism 26 to the free end 6e of the engaged actuating tail 6d. The free portion 35 may also be referred to herein as the “actuating post” 35 of the actuating member 6, and is used to pull the actuating member 6 in a manner that reduces the circumference of the actuating ring 32, thereby bringing the second anatomical structure closer to the first anatomical structure, as... Figure 5G As shown. Specifically, in order to reduce the circumference of the approaching ring 32 to bring the second anatomical structure 7 closer together, the actuating post 35 is pulled away from the anchor body 4 at the free end 6e of the post 35 in the first axial actuation direction dX2-1. During the approach, the splicing actuating portion 6g slides through the knot 28 of the locking mechanism 26, which engages with the woven outer sheath 19 of the splicing actuating portion 6g in a manner that allows unidirectional sliding through it (i.e., along the first axial actuation direction dX2-1) but prevents (or at least substantially resists) sliding in the opposite direction, as described above.

[0045] like Figure 5H As shown, when the second anatomical structure 7 is satisfactorily approximated relative to the first anatomical structure 5, the free end 6e of the post 35 is preferably trimmed to remove excess suture material at the treatment site. It should be understood that the locking mechanism 26 essentially locks the approximation ring 32 into a fully approximated configuration, thereby eliminating the need for further ligation of the free portion of the actuating tail 6d. Optionally, the post 35 may be ligated as shown to provide a secondary locking structure to the approximation ring 32. It should be understood that numerous additional and / or alternative steps may be performed to facilitate the aforementioned exemplary techniques for approximating tissue.

[0046] refer to Figure 6A Referring to Figure 6N, an exemplary method for constructing repair component 1 will be described, which may also be referred to as a method for preparing repair component 1 for use. Therefore, in Figure 6A The repair component 1 discussed in Figure 6P can be characterized as being in various stages of configuration preparation.

[0047] like Figure 6A As shown, a serpentine loop 8f is formed at the second serpentine tail end 8e2, preferably by forming an eye joint, through which a portion of the end region of the serpentine member 8 folds back and splices into and extends along another portion of the end region, thereby defining the spliced ​​serpentine portion 8g of the serpentine member 8, as referenced above. Figure 4E As described. A splicing serpentine portion 8g of the serpentine ring 8f extends from a splicing insertion point 8g1 defining the distal end of the serpentine ring 8f to a splicing end 8g2 spaced apart from the splicing insertion point 8g1 in a first axial serpentine direction dX3-1. The splicing serpentine portion 8g can be formed, for example, by embedding the end region of the serpentine member 8 from the splicing insertion point 8g1 into itself to splice to the splicing end 8g2. The splicing serpentine portion 8g has a splicing length D4 measured from the splicing insertion point 8g1 to the splicing end 8g2. Preferably, the splicing length D4 is greater than half (1 / 2) of the total length of the serpentine member 8, which facilitates the subsequent positioning of the splicing serpentine portion 8g2 in the insertion configuration C1 as a loop 28 passing through the locking mechanism 26, as referenced above. Figure 4E The steps in question will be discussed in more detail below.

[0048] like Figure 6B As shown, the locking mechanism 26 of the actuating member 6 begins to form by passing the second end 6e2 of the actuating member 6 (opposite to its first end 6e1) through the central portion 6f of the actuating member 6 at the first through hole 30. This forms a first loop 28, which is collapsible so as to subsequently tighten around the serpentine member 8. Preferably, the second end 6e2 of the actuating member 6 passes substantially perpendicularly through the central actuation axis X2 of the actuating member 6 at the first through hole 30. Figure 6C As shown, the second serpentine tail end 8e2 and the serpentine loop 8f pass through the first knot 28 in the second axial serpentine direction dX3-2. Subsequently, as... Figure 6D As shown, the first loop 28 collapses and tightly encloses the portion of the serpentine member 8 that passes through it; in the illustrated embodiment, this portion is the spliced ​​serpentine portion 8g. For example... Figure 6EAs shown, the locking mechanism 26 continues to be formed: a second loop 28 is formed by passing the second end 6e2 of the actuating member 6 through the central portion 6f of the actuating member 6 at the second through hole 30. This second loop is collapsible. Similar to the first through hole, the second end 6e2 of the actuating member 6 passes substantially perpendicularly through the central actuation axis X2 of the actuating member 6 at the second through hole 30. The second through hole 30 is spaced apart from the first through hole 30 by the loop spacing distance D3 discussed above. Subsequently, the second serpentine tail end 8e2 and the serpentine ring 8f pass through the second loop 28 in the second axial serpentine direction dX3-2, and as... Figure 6F As shown, the second loop 28 collapses and wraps tightly around the portion of the serpentine member 8 that passes through it (i.e., the spliced ​​serpentine portion 8g). At this stage, a locking mechanism 26 is formed, which has loops 28 capable of adhering to and thus clamping the serpentine member 8. (Refer to the above text.) Figure 4E The part of the serpentine component 8 that is held by the loop 28 at this stage is described as the spliced ​​serpentine part 8g.

[0049] like Figure 6G As shown, the actuating member 6 and the serpentine member 8 are connected to the anchor body 4, particularly by splicing them together. Specifically, the first end 6e1 and the first serpentine tail 8e1 of the actuating member 6 pierce the sheath 15 of the anchor body 4 at the second penetration hole 24b (located at the second position 20b), from which the first end 6e1 and the first serpentine tail 8e1 enter the internal channel 22 of the anchor body 4. From there, the first end 6e1 and the first serpentine tail 8e1 are pulled in and extend along the core space 17 of the anchor body 4, and pierce the anchor body 4 to exit from the anchor body at the first penetration hole 24a (located at the first position 20a). Preferably, the first end 6e1 and the first serpentine tail 8e1 of the actuating member 6 are simultaneously pulled into, through, and out of the internal channel 22 of the anchor body 4. This ensures that the actuating member 6 and the serpentine member 8 enter the anchor body 4 together at the same location (i.e., the second penetration hole 24b) and exit the anchor body 4 together at the same location (i.e., the first penetration hole 24a). It should be understood that in order to pierce the sheath 15 of the anchor body 4 at the first and second penetration holes 24a, 24b, both the first end 6e1 and the first serpentine tail 8e1 of the actuating member 6 can be connected to a piercing tool (such as a needle) that pierces the sheath 15 at the first and second penetration holes 24a, 24b and pulls the actuating member 6 and the serpentine member 8 through them. Further pulling of the first end 6e1 and the first serpentine tail 8e1 of the actuating member 6 continues until the locking mechanism 26 is positioned within the internal channel 22 between the first and second penetration holes 24a, 24b of the anchor body 4, as... Figure 6HAs shown. Preferably, the locking mechanism 26 is laterally centered between the first and second through holes 24a, 24b. It should be understood that when the anchor body 4 is further prepared and arranged in the insertion configuration C1, the portion of the anchor body 4 extending between the first and second through holes 24a, 24b will become the distal portion 4b of the anchor body 4. In the preparation configuration, such as Figures 6G to 6H Those shown, the portions of the anchor body 4 extending in opposite directions away from the distal portion 4b, can be referred to as the anchor body tail 4d. As the locking mechanism 26 is positioned as desired within the internal channel 22 of the anchor body 4, tension is applied to the anchor tail 4b (such as at its end 4e) to cause the sheath 15 to collapse and tightly enclose the locking mechanism 26 in a close-fitting manner, as... Figure 6H As shown. At this stage, the actuating member 6 and the serpentine member 8 located outside the anchor body 4 are as described above. Figures 4A to 4C The corresponding actuated tail 6b and serpentine tail 8b are described.

[0050] like Figure 6I As shown, the process of arranging the anchor body 4 into the anchor ring 14 includes joining the anchor body tails 4d together. For example, at least one anchor body tail of the anchor body 4d may be spliced ​​into another anchor body tail of the anchor body 4d. In the illustrated example, each anchor body tail of the anchor body 4d is spliced ​​with the opposite anchor body tail 4d, starting at a splicing insertion point 4f, extending from there along the splicing area 4h of the corresponding opposite anchor body tail 4d, and exiting from the corresponding opposite anchor body tail at a splicing exit point 4g. The splicing exit point 4g of each anchor body tail 4d may be adjacent to a locking mechanism 26 embedded in the distal portion 4b of the anchor body 4. Each of the splicing areas 4h of the anchor body tail 4d has a splicing length D5 measured between the splicing insertion point 4f and the splicing exit point 4g, which can range from about 3.0 mm to about 30 mm, more specifically from about 8.0 mm to about 16.0 mm, and more specifically from about 11.5 mm to about 13.5 mm. In the currently depicted construction phase, the actuating tail 6b and the serpentine tail 8b preferably bypass the unspliced ​​portion 4i of the anchor body tail 4d opposite the distal portion 4b of the anchor body 4 on the same side of the unspliced ​​portion 4i. In other words, in the depicted construction phase, the actuating tail 6b and the serpentine tail 8b preferably do not extend through the opening or gap between the unspliced ​​portions 4i of the anchor body tail 4d.

[0051] like Figure 6JAs shown, the end 4e of the anchor body tail 4d is tensioned to pull the anchor body tail 4d through the splicing area 4h and pull the splicing insertion points 4f toward each other, preferably until the splicing insertion points 4f are substantially pulled together (i.e., substantially co-located). Subsequently, as... Figure 6K As shown, the anchor body 4 can be tensioned to stretch the outer braided layer of the sheath 15 of the anchor body 4 until the outer sheath 15 tightly adheres to the inner anchor body tail 4d. The portion of the anchor body tail 4d extending outward from the anchor ring 14 can be trimmed (e.g., cut off) at the trimming position 4k. Subsequently, the circumference of the anchor ring 14 can be slightly increased such that the trimmed end of the anchor body tail 4d is pulled into the sheath 15 of the anchor body 4, thereby producing... Figure 6L The structure shown.

[0052] like Figure 6M As shown, the actuating tails 6b are connected together, for example by embedding one actuating tail 6b into the splicing to the other actuating tail 6b within the interval from the splicing insertion point 6c1 to the splicing end 6c2, as referenced above. Figures 4A to 4B and Figure 4E As described above, this provides, as... Figure 4E The diagram shows an engaged actuating tail 6d extending from the splice insertion point 6c1 to the free end 6e of the actuating member 6. A step to eliminate excess slack in the engaged actuating tail 6d may include pushing the sheath 19 of the outer actuating tail 6b2 proximally towards the free end 6e, starting from the splice insertion point 6c1. This effectively tensions the braided layers of the outer sheath 19 along its length until the outer sheath 19 is tightly fitted against the sheath 19 of the inner actuating tail 6b1, thereby synchronizing the braided structures of the outer and inner sheaths 19. Figure 6M As shown, and as referenced above Figures 4A to 4B As described, one or both of the engaged actuating tail 6d and the snake tails 8b1, 8b2 can pierce the proximal portion 4a of the anchor body 4. In the illustrated embodiment, the engaged actuating tail 6d and the second snake tail 8b2 pierce the proximal portion 4a of the anchor body 4 at corresponding proximal penetration holes 23a, 23b, which are located on opposite lateral sides of the insertion axis X0. It should be understood that the positions of the proximal penetration holes 23a, 23b can be selected to be substantially aligned with the distal penetration holes 24a, 24b along the longitudinal direction L, respectively. After piercing the proximal portion 4a of the anchor body 4, the engaged actuating tail 6d and the second snake tail 8b2 are preferably tensioned to eliminate any slack in their respective sheaths 19, 25 within the anchor eyelet 12. At this stage, the repair assembly 1 is constructed and ready to be loaded onto the assertion device.

[0053] It should be understood that the aforementioned exemplary technology used to construct the repair component 1 of the illustrated embodiment provides the anchoring element 2 with a design particularly advantageous for anchoring within pre-drilled holes in the bone. (Refer again) Figure 6M Now, some of these advantages will be described. One such advantage is that, when in the insertion configuration C1, the elongated and elliptical profile of the anchoring ring 14 provides a tapered profile (particularly a tapering towards the distal end) for the distal portion 4b, which facilitates its insertion into the bore. This tapered profile can be further emphasized when the anchoring member 2 is mounted on an insertion device (such as an insertion fork), as described in more detail below. Another advantage is that, when in the anchoring configuration C2 (see... Figure 2B When the anchor body 4 is positioned, it has been observed that the anchor body 4 presents a wide proximal side 16a at or near the proximal end 16, which, combined with the increased second maximum width W2, enhances attachment within the bone and reduces the likelihood of pull-out. The proximal portion 4a of the anchor body 4 also provides a proximal barrier structure that mechanically interferes with and thus prevents the locking mechanism 26 from migrating away from the anchor body 4 (such as during anchoring and / or tissue approximation), thereby also preventing tension effects that may result from such migration and undesirable loosening in the approximation ring 32.

[0054] Another advantage is that as the soft anchor 2 transitions from the insertion configuration C1 to the anchoring configuration C2, the soft anchor 2 undergoes an actuation sequence (i.e., a convergence sequence) that provides enhanced tactile feedback to the user (e.g., a surgeon, physician, technician, or other medical professional). Since the maximum length of the anchor body 4 along the longitudinal direction L decreases from L1 to L2 during the actuation to the anchoring configuration, the longitudinal aspect of this actuation sequence may also be referred to herein as the "longitudinal anchor collapse sequence." Various aspects of the longitudinal anchor collapse sequence will be described with reference to the longitudinal reference positions Z0-Z4 of the soft anchor 2 in the insertion configuration C1 shown in Figure 6N. In these longitudinal reference positions: position Z0 is aligned with the distal end 18 of the anchor body 4; position Z1 is aligned with the locking mechanism 26, particularly where the first serpentine portion 8a passes through the knot 28; position Z2 is aligned with the first and second positions 20a, 20b described above; position Z3 is aligned with the boundary between the middle portion 4c and the proximal portion 4b of the anchor body 4; and position Z4 is aligned with the proximal end 16 of the anchor body 4.

[0055] Partly because the tail 4d of the trimmed anchor body resides within the axial core space 17 adjacent to the first and second positions 20a, 20b of the anchor body 4, the soft anchor generally has more material in its lateral-lateral cross-section (i.e., the cross-section in the corresponding planes extending along the lateral direction A and the lateral direction T) in the longitudinal region between positions Z2 and Z4 than in the lateral-lateral cross-section of the soft anchor in the region between positions Z0 and Z2. In other words, the soft anchor 2 generally has more lateral-lateral cross-sectional volume in the proximal and intermediate longitudinal regions (between Z2 and Z4) compared to the distal region (between Z0 and Z2). Since the locking mechanism 26 is located at the distal ends of the actuating member 6 and the serpentine member 8, which are positioned within the distal portion 4b of the anchor body 4, and since the locking mechanism 26 is substantially laterally centered within the distal portion 4b of the anchor body 4, when the user applies an actuating tensile force to the free end 6e of the actuating member 6 and the ends 8e1, 8e2 of the serpentine tails 8b1, 8b2, respectively, these tensile forces are primarily transmitted to the locking mechanism 26 at position Z1 (i.e., the loop 28 and the first serpentine portion 8a extending therethrough). Therefore, the initial stage of the longitudinal anchor collapse sequence involves the locking mechanism 26 being pulled proximally, thereby pulling the distal portion 4b of the anchor body 4 (including the sheath 15 surrounding the locking mechanism 26) proximally toward position Z2. Thus, the locking mechanism 26 can be characterized as the dominant structure for longitudinal anchor collapse. Therefore, as the locking mechanism 26 moves proximally during the longitudinal anchor collapse sequence, the locking mechanism 26 carries with it an increasing volume (i.e., material) around the soft anchor 2.

[0056] As the locking mechanism 26 advances proximally from position Z2 to position Z3, the middle portion 4c of the anchor body 4 effectively folds inward onto itself and generally faces the locking mechanism 26. Subsequently, as the locking mechanism 26 retracts proximally from position Z3 to position Z4, it pulls the distal portion 4b of the anchor body 4 proximally, causing mechanical interference with the proximal portion 4a of the anchor body 4. In this way, the proximal portion 4a of the anchor body 4 effectively acts as a barrier, preventing the distal portion 4b of the anchor body 4 from advancing proximally beyond the proximal portion 4a. This mechanical interference with the proximal portion 4a of the anchor body 4 also effectively prevents the locking mechanism 26 from migrating proximally out of the internal channel 22 and away from the anchor body 4 during anchor actuation or subsequent tissue convergence. At the end of the longitudinal anchor collapse sequence, the soft anchor 2 is in the anchor configuration C2, which has as Figure 2BThe outline of the anchor is shown. Through testing, the inventors have observed that the soft anchor 2 of the illustrated embodiment exhibits a rapid and smooth longitudinal anchor collapse sequence that terminates with a relatively sudden and firm stop, which together provide the user with positive tactile feedback indicating that anchor actuation has occurred (i.e., the anchor configuration C2 has been achieved).

[0057] Now for reference Figures 7A to 7G An exemplary instrument component 100 for deploying repair component 1 will be described. For example... Figure 7A As shown, the instrument assembly 100 includes an entry member 40 and an insertion instrument or "insertter" 60 configured to carry the repair assembly 1 and push it through a cannula 45 passing through the entry member 40 to reach the target site 3 of the first anatomical structure 5. The instrument assembly 100 also preferably includes an opening member 90 (such as a drilling member 90) configured to create an opening, such as a hole, in the first anatomical structure 5. In this case, the opening (e.g., the hole) becomes the target site 3 for inserting the anchor body 4. The entry member 40, the inserter 60, and the opening member 90 each have corresponding proximal ends 42, 62, 92 and corresponding distal ends 44, 64, 94, which are spaced apart from each other along their respective longitudinal directions. It should be understood that since the respective longitudinal directions of the entry member 40, the inserter 60, and the opening member 90 are configured to align with each other and with the longitudinal direction L of the repair assembly 1 during operation, the longitudinal direction L is also used herein to refer to the respective longitudinal directions of the entry member 40, the inserter 60, and the opening member 90. Similarly, the lateral direction A and the proximal and distal directions P and D used above also apply to each of the entry member 40, the inserter 60, and the opening member 90. It should be understood that the opening member 90 may be configured to advance forward through the cannula 45 of the guide member 40 to create an opening 3 (e.g., a hole 3) and withdraw backward before the inserter 50 is passed through the cannula 45 and inserted into the target location 3. Thus, the entry member 40 can be a multi-purpose instrument, one purpose being to provide a passage from the opening member 60 to the first anatomical structure 5, and another purpose being to provide a passage from the repair assembly 1 mounted on the inserter 60 to the target site 3. As shown, the opening member 90 may be a drill with a drill tip 96 at the distal end 94. In other embodiments, the opening member may be an awl or other hole-making device.

[0058] The access member 40 includes a handle portion 46 (also referred to herein as the "access handle" 46) at a proximal end 42 and an elongated sleeve portion 48 (also referred to herein as the "sleeve" 48) extending from the access handle 46 to a distal end 44. A cannula 45 extends distally from the proximal end 44, through the access handle 46 and through the sleeve portion 48 to reach the distal end 44. The cannula 45 may have a funnel-shaped inlet portion at the proximal end 42. The distal end 44 of the access member 40 may be configured to achieve and maintain a firm engagement with the first anatomical structure 5. For example, the distal end 44 of the access member 40 may have a serrated configuration, a fish-mouth configuration, or other such configurations known in the art. The sleeve portion 48 may also include one or more viewing windows at or near the distal end 44 for providing the surgeon with a view during operation of instruments within the cannula 45 located at or near the distal end 44, such as the drill member 90 and / or the repair assembly 1. The sleeve portion 48 may be straight, as shown; however, alternatively, one or more regions of the sleeve portion 48 (such as the distal region extending to or near the distal end 44) ​​may extend along a curved path, which facilitates access to certain areas of the patient's anatomy.

[0059] Now for reference Figure 7B The inserter 60 has a handle portion 61 (also referred to herein as the "insertion handle" 61) at a proximal end 62, and an elongated portion 63 (also referred herein as the "insertion rod" 63) extending distally from the insertion handle 61 to the distal end 64. The proximal region 65 of the insertion rod 63 has an outer surface 75 that may have a generally circular cross-sectional profile in a plane perpendicular to the longitudinal axis X5 of the inserter 60. The proximal region 65 defines a cross-sectional dimension or width W3 that may be substantially constant along the length of the proximal region 65, or may taper or otherwise narrow as it extends distally. The distal region 66 of the insertion rod 63 extends to the distal end 64 and has a forked geometry configured to carry the anchor body 4 in the insertion configuration C1 during operation. Therefore, the distal region 66 may be referred to herein as the "fork" 66 and will be discussed in more detail below.

[0060] The insertion handle 61 preferably has a gripping structure to facilitate gripping and operation by the user during operation. The insertion handle 61 also preferably includes one or more retention structures 67a, 67b configured to hold one or more proximal portions of the repair assembly 1 in a desired configuration during operation when the anchor body 4 is mounted on the fork 66. As shown, the one or more retention structures may include a first retention recess or "wire clamping groove" 67a extending distally from the distal end 62 of the inserter 60, preferably centered along the longitudinal axis X5 of the inserter 60. The one or more retention structures may also include a pair of second retention recesses or wire clamping grooves 67b extending substantially proximally from the distal side of the insertion handle 61 toward the first wire clamping groove 67a. One or both of the first clamping groove 67a and the second clamping groove 67b may be used as needed before and during operation to maintain the engaged actuated tail 6d and serpentine tail 8b1, 8b2 in a manner that provides the desired tension level to the tails 6d, 8b1, 8b2 during operation when the anchor body 4 is mounted on the fork 66. The distal end 68 of the insertion handle 61 preferably defines a distally facing shoulder configured to abut against the associated structure of the entry handle 46 to provide a predetermined protrusion distance D6 when the insertion rod 63 is fully inserted through the insertion tube 45. The distal end 64 of the inserter 60 (and thus the anchor body 4 mounted on the fork 66) extends distally beyond the distal end 44 of the entry member 40 by this predetermined protrusion distance, as... Figure 7C As shown. It should be understood that the instrument assembly 100, including its entry member 40, inserter 60, and opening member 90, is generally based on VERSALOOP, distributed by DePuy Mitek, Inc. of Reynolds, Massachusetts, USA. TM The soft anchoring component is designed and constructed.

[0061] Now for reference Figures 7B to 7F Fork 66 is configured to securely support the anchor body 4 through the insertion tube 45 of the entry member 40. Figure 7AThe fork 66 is designed to reach the target site 3 (such as a hole 3 pre-drilled in the bone 5) and is also capable of disengaging from the anchor body 4 and cleanly withdrawing the cannula 45 proximally, such that the anchor body 4 remains at the target site 3 after withdrawal. To this end, the fork 66 described herein has various unique structural features that represent an advancement over previous fork designs, particularly to accommodate the soft anchor 2 described above. The fork 66 is configured to carry the anchor body 4 in the insertion configuration C1, specifically by extending the anchor ring 14 longitudinally on the fork 66 (e.g., being tensioned or stretched) to reduce the maximum width of the anchor body 4 as it is advanced distally through the cannula 45 and reaches / enters the target site 3. This also presents the tapered distal portion 4b of the anchor body 4 as the dominant anchoring structure during anchor insertion, which reduces friction at the bone interface during insertion into the pre-drilled hole 3, thereby facilitating smooth insertion of the anchor into the pre-drilled hole 3. To accommodate the soft anchor 2 in the insertion configuration C1, the fork 66 defines a fork length D7, measured longitudinally from the proximal fork end 69 to the distal end 64, preferably greater than a first maximum length L1 of the anchor body 4. The proximal fork end 69 may be located at the interface between the proximal region 65 and the fork 66. The fork 66 includes one or more fork teeth 70, such as a pair of fork teeth 70, which extend to and define the distal end 64 of the inserter 60. It should be understood that the distal end 64 of the inserter 60 may be synonymously referred to as the distal end of the insert rod 63, the fork 66, and / or the fork teeth 70. These fork teeth 70 also define a gap 71 between them, which defines a gap width W4 measured in the lateral direction A between the inner surfaces of the fork teeth 70. The gap 71 also has a gap depth D8, measured longitudinally from the distal end 64 to the proximal end face 72 defined by the fork 66. The dimensions of the gap width W4 and depth D8 are designed such that when the anchor body 4 passes through the insertion tube 45 and reaches the target location 3, the distal portion 4b of the anchor body 4 can be securely held within the gap 71, but when the anchor body 4 is held at the target location 3, it can also be disengaged from the anchor body 4 and cleanly withdrawn. According to a non-limiting example, the width W4 can be up to about 4.0 mm, and the gap depth D8 can be up to about 5.0 mm.

[0062] Furthermore, the fork 66 in the illustrated embodiment has lateral and transverse profiles that are configured to facilitate secure connection with and clean separation from the anchor body 4. For example, Figure 7DThe lateral profile of the fork 66 is shown, i.e., the profile of the fork 66 in a plane extending in the lateral direction T and the longitudinal direction L. As observed in this lateral profile, the fork 66 defines first and second outer surfaces 74, 76 that are laterally opposed to each other, wherein a proximal recess 78 and a distal recess 80 each extend laterally from the second outer surface 76 toward the first outer surface 74. The proximal recess 78 is configured to allow a portion of the proximal portion 4a of the anchor body 4 to reside therein when the anchor body 4 is loaded onto the fork 66. The proximal recess 78 has a proximal surface portion 78a and a distal surface portion 78b. The proximal surface portion 78a defines a first rear angle A1 relative to the longitudinal axis X5 of the inserter 60. The distal surface portion 78b defines a second rear angle A2 relative to the longitudinal axis X5. As shown, the second rear angle A2 may be larger than the first rear angle A1, which facilitates the proximal withdrawal and disengagement of the fork 66 from the anchor body 4 after the anchor body 4 is inserted into the target position 3. According to a non-limiting example, the first rear angle A1 may be in the range of about 70 degrees to about 135 degrees, and the second rear angle may be in the range of about 95 degrees to about 170 degrees. The distal recess 80 is configured to allow a portion of one or both of the actuating tails 6b to reside therein when the anchor body 4 is loaded onto the fork 66, particularly the portion of the actuating tail 6b extending proximally from the corresponding first or second position 20a, 20b to the first engagement position 6c1. As shown, the distal recess 80 may have an arcuate lateral profile. Figure 7D As shown, the distal recess 80 may have a shallower recess depth than the proximal recess 78. In the illustrated embodiment, the fork 66, measured along the lateral direction T between the first and second outer surfaces 74, 76, has a substantially constant lateral fork thickness T5, except at the proximal and distal recesses 78, 80. The lateral fork thickness T5 may be substantially equivalent to the width W3 of the insert rod 63 along its proximal portion 65, such that the insert rod 63 may have a substantially uniform lateral profile (except at the proximal and distal recesses 78, 80). It should be understood that in other embodiments, the fork 66 does not need to have a proximal recess 78 and / or a distal recess 80.

[0063] Now for reference Figure 7EThis illustrates the lateral profile of the fork 66, i.e., the profile of the fork 66 in a plane extending along the lateral and longitudinal directions A and L. As observed in this lateral profile, the fork 66 defines a third outer surface 82 and a fourth outer surface 84 that are laterally opposed to each other. It should be understood that the fork 66 may have a proximal fork portion 66a and a distal fork portion 66b that are longitudinally spaced apart from each other. The proximal fork portion may extend from the proximal fork end 69 to a shared boundary 85 with the distal fork portion 66b, and the distal fork portion 66b may extend from the shared boundary 85 to the distal end 64 of the fork 66. When the anchor body 4 is mounted on the fork 66, the shared boundary 85 is preferably positioned to substantially coincide with the boundary between the intermediate portion 4c and the distal portion 4d of the anchor body 4. Therefore, in the illustrated embodiment, the distal fork portion 66b is configured to receive the distal portion 4b of the anchor body 4, while the proximal fork portion 66a is configured to receive the middle and proximal portions 4c, 4b of the anchor body 4. Furthermore, one or both of the proximal and distal fork portions 66a, 66b preferably have a lateral profile greater than that of the fork 66. Figure 7D Narrower side profile Figure 7E In the illustrated embodiment, the proximal fork portion 66a defines a proximal fork width W5 along the lateral direction A, and the distal fork portion 66b defines a distal fork width W6 along the lateral direction A. It should be understood that the proximal fork width W5 and the distal fork width W6 are each measured laterally along the respective proximal and distal fork portions 66a, 66b between the third and fourth outer surfaces 82, 84. As shown, the proximal fork width W5 is narrower than the distal fork width W6, and both (W5 and W6) are narrower than the lateral fork thickness T5 and the width W3 of the proximal portion 65 of the insert rod 63. In this way, the third and fourth outer surfaces 82, 84 effectively define lateral cutouts or recesses inward from the outer surface 75, which allows the fork 66 to accommodate the anchor body 4 when it is mounted on the fork 66. Additionally, as... Figure 7D As shown, the distal fork portion 66b may include lateral recesses or grooves 86, which are positioned relative to the lateral direction A between the fork teeth 70 and extend inwardly toward each other from the third and fourth outer surfaces 82, 84, respectively. Although in Figure 7D Only one such groove 86 can be seen in the middle, but it should be understood that another such groove 86 may be positioned laterally opposite it on the distal fork portion 66b.

[0064] The aforementioned features of fork 66 provide fork 66 with a geometry specifically adapted to the geometry of repair component 1 (particularly along its anchor body 4). When the anchor body 4 is mounted on fork 66, this adapted fork geometry 66 helps to reduce the first maximum width W1 along the lateral direction A. Figure 7F ), and also helps to reduce the first maximum thickness T6 of the anchor body 4 in the lateral direction T ( Figure 7G This advantageously facilitates the insertion of the anchor body 4 through the insertion tube 45 of the entry member 40 and its arrival at the target location 3. It should be understood that various adjustments to the geometry of the fork 66 described above are within the scope of this disclosure.

[0065] See now Figures 8A to 8Q An exemplary method will be described for repairing the glenoid labrum of the shoulder joint (particularly a labral-glenoid repair) using instrument assembly 100 within a surgical system 200. In this exemplary method, the repair assembly 1 is used to bring a dislodged portion of the glenoid labrum toward the glenoid. Using the terminology set forth above, in this example, the glenoid refers to the first anatomical structure 5, and the glenoid labrum refers to the second anatomical structure 7. Although this exemplary method refers to operations or steps performed by a surgeon, it should be understood that one or more of these steps may be performed by a physician, technician, or other medical professional.

[0066] Now for reference Figure 8A The first cannula 102 and the second cannula 104 of the surgical system 200 pass through the soft tissue and are positioned along corresponding tracks extending toward the glenoid 5. The first cannula 102 may be positioned inferiorly to the second cannula 104, and thus the second cannula may be positioned superiorly to the first cannula 102.

[0067] like Figure 8B As shown, the sleeve 48 of the entry member 40 is inserted through the first sleeve 102 and advanced distally, such that the distal end 44 of the sleeve 48 is advanced toward the glenoid 5, preferably toward the glenoid edge 5a. The surgeon continues to advance the sleeve 48 until the distal end 44 achieves a firm engagement with the glenoid, particularly from the glenoid edge 5a, as shown. Figure 8C As shown. With the sleeve 44 firmly engaged in the glenoid 5, the surgeon inserts the opening member 90 through the cannula 45 into the member 40 and advances the opening member 90 distally, such that the drill tip 96 at the distal end 94 of the opening member 90 forms a hole 3 in the glenoid 5, as shown. Figures 8D to 8E As shown. Subsequently, the opening member 90 is withdrawn proximally from the insertion tube 45 of the member 40, thereby exposing the hole 3, as shown. Figure 8F As shown.

[0068] Subsequently, as Figures 8G to 8H As shown, with the repair assembly 1 connected to its fork 66, the insertion rod 63 of the inserter 60 is introduced and advanced through the cannula 45 of the entry member 40 until the anchor body 4 is inserted into the desired depth within the bore 3 of the glenoid 5. When the insertion handle 61 is fully engaged with the entry handle 46 (as shown), Figure 8H As shown), the desired anchoring depth within the hole (e.g.) Figure 8I(As shown) can be a function of a predetermined protrusion distance D6, which is referred to above. Figure 7C As described. After inserting the anchor body 4 into the hole 3 at the desired depth (or at least a sufficient depth), the surgeon disengages the serpentine tail 8b and the engaged actuating tail 6d from the clamping grooves 67a, 67b. Subsequently, the surgeon withdraws the insertion member 40 and inserter 60 proximally from the first sleeve 102, thereby positioning the anchor body 4 at the desired (or at least a sufficient) depth within the hole 3, and causing the serpentine tail 8b and the engaged actuating tail 6d to extend proximally through and outward from the first sleeve 102.

[0069] Now for reference Figure 8J The surgeon pulls the serpentine tail 8b and the engaged actuating tail 6d proximally to actuate the anchor body 4 into the anchoring configuration C2 (which is in...). Figure 1B , Figure 2B and Figure 5B (As shown in the image).

[0070] Now for reference Figure 8K The surgeon may use a second cannula 104 to pass the joined actuating tail 6d through the labrum 7 and exit the second cannula 104 proximally. Although a simple suture of the joined actuating tail 6d passing through the labrum 7 is shown, it should be understood that more complex sutures can also be formed. It should also be understood that various suture guides, threaders, and / or suture holders may be used to pass the joined actuating tail 6d through the labrum 7 and exit the second cannula 104 proximally.

[0071] Now for reference Figure 8L The surgeon retrieves the second serpentine tail 8b2 (with a serpentine loop 8f at its end) proximally through the second cannula 104. At this stage, the engaged actuating tail 6d and the second serpentine tail 8b2 extend proximally from the second cannula 104, while the first serpentine tail 8b1 extends proximally from the first cannula 102. The surgeon can then insert the free end 6e of the engaged actuating tail 6d through the serpentine loop 8f (e.g., in a manner similar to...). Figure 5C (As shown). With the engaged actuating tail 6d extending through the serpentine ring 8f, the surgeon can pull the first serpentine tail 8b1 proximally from the first cannula 102, thereby pulling the serpentine ring 8f distally back through the second cannula 104. This action is also as follows: Figure 8M (It is similar to) Figure 5D As shown, the engaged actuating tail 6d (which extends through the serpentine ring 8f) is guided distally through the second sleeve 104 and returned toward the anchor body 4. The surgeon continues to pull the first serpentine tail 8b proximally, causing the serpentine ring 8f to... Figure 8NThe actuating tail 6d is successively pulled into, through, and out of the anchor body 4, and pulled upwards and proximally into the first sleeve 102. During this step, as described above... Figures 5E to 5F The section of stitching discussed is held by the locking mechanism 26 within the internal channel 22 of the distal portion 4b of the anchored body 4, replacing the serpentine member 8.

[0072] Now for reference Figure 8O The surgeon continues to pull the serpentine member 8 until the engaged actuating tail 6d extends proximally from the first cannula 102. At this stage, the actuating member 6 has completely passed through the labrum and forms an adjustable abutment ring 32 around the labrum 7. Now refer to Figure 8P The surgeon pulls the actuating tail 6d proximally through the first sleeve 102, thereby reducing the circumference of the abutment ring 32, which in turn brings the captured portion of the labrum 7 closer to the glenoid 5 (this is also similar to...). Figure 5G (Now for reference) Figure 8Q After the labrum 7 is fully abutted as desired, the surgeon preferably trims the free portion of the abutment actuating tail 6d near the abutment ring 32. As described above, the locking mechanism 26 essentially locks the abutment ring 32 in the fully abutted configuration, thereby eliminating the need for further ligation of the free portion of the abutment actuating tail 6d, although for redundancy purposes the surgeon may selectively ligate the free portion of the abutment actuating tail 6d prior to trimming.

[0073] It should also be understood that the exemplary methods described above may include various additional and / or alternative steps. It should also be understood that these exemplary methods can be used to repair other parts of anatomy while remaining within the scope of this disclosure. A non-limiting example of such other anatomical repairs includes lateral ankle instability repair.

[0074] refer to Figures 9A to 15E This will describe additional implementation schemes for the tissue repair component.

[0075] refer to Figures 9A to 9G Another embodiment of the tissue repair component 201 for anatomical fixation (e.g., anatomical approximation) will now be described. The repair component 201 of this embodiment and the method of repairing tissue using it are generally similar to those described in the preceding references. Figure 1A Those described in Figure 6N are repair components 1. For example, the repair component 201 of this embodiment includes an anchor body 4 and an actuating member 6 and a serpentine member 8 connected to and extending from the anchor body 4. Furthermore, the portions of the anchor body 4 and the actuating member 6 and the serpentine member 8 connected to the anchor body define a soft anchor 202 for the repair component 201. Additionally, similar to the embodiments described above, the anchor 202 is adapted to be in the insertion configuration C1 (… Figures 9A to 9B When inserted into the target position 3 of the first anatomical structure 5, it is configured to change from the insertion configuration C1 to the anchoring configuration C2. Figures 9C to 9G ), and is further constructed into a convergent configuration C3 that can be transformed into a convergent configuration where the first anatomical structure 5 and the second anatomical structure 7 are brought together ( Figure 9G For the sake of brevity, the following discussion focuses primarily on the differences between repair component 201 and repair component 1 described above. In the following discussion, features having similar design and function to those described above may be referred to using the same reference numerals.

[0076] See now Figure 9B The anchor body 4 can be configured as an anchor ring 14, which can be a closed ring, similar to the embodiment described above. In this embodiment, the actuating member 6 and the serpentine member 8 can be coupled to each other in such a way that a clamping or “locking” mechanism 226 is defined at a position distal to the distal end 18 of the anchor body 4. The actuating member 6 can extend proximally from the locking mechanism 226 through a distal through-hole 224b (which passes through the anchor body 4), through the anchor eyelet 12, and through a proximal through-hole 224a, which passes through the anchor body 4. The serpentine member 8 can extend proximally from the locking mechanism 226 through a corresponding distal through-hole 225b (which passes through the anchor body 4), and from there through the anchor eyelet 12, and through a corresponding proximal through-hole 225a, which passes through the anchor body 4. Preferably, the proximal and distal through-holes 224a and 224b through which the actuating member 6 extends are coaxial with the insertion axis X0 of the anchor 2. Additionally, the proximal and distal through-holes 225a and 225b through which the serpentine member 8 extends are preferably equidistantly spaced laterally from the insertion axis X0. It should be understood that the proximal and distal through-holes 224a, 224b, 225a, and 225b pass through corresponding portions of the anchor body 4 (i.e., between opposite sides of the sheath 15) along corresponding paths, and these paths are substantially perpendicular to the central body axis X1 at their respective intersections. In other words, the corresponding actuating member axis X2 and the serpentine member axis X3 are substantially perpendicular to the central body axis X1 when they intersect it at the corresponding proximal and distal through-holes 224a, 224b, 225a, and 225b.

[0077] The locking mechanism 226 of the currently illustrated embodiment is constructed as a two-loop Prussian knot, wherein the actuating member 6 defines a “loop” or ring 228 around the serpentine member 8. As a two-loop Prussian knot, the actuating member 6 defines four (4) rings 228 around the serpentine member 8 at a position distal to the distal end 18 of the anchor body 4. Similar to the locking mechanism 26 described above, the locking mechanism 226 of this embodiment provides unidirectional axial sliding of the serpentine member 8 (and subsequently the actuating member 6) through the rings 228 when the repair assembly 201 changes from the anchor configuration C2 to the approach configuration C3, and can therefore be referred to as a “one-way locking mechanism” 226. It should be understood that the locking mechanism 226 may alternatively include any type of friction knot, such as a piling knot or a rolling knot, and can be extended to any number of loops. As a non-limiting example, the locking mechanism 226 may include a single Prussian knot (with two (2) loops 228), a three-loop Prussian knot (with six (6) loops 228) or a four-loop Prussian knot (with eight (8) loops 228).

[0078] In this embodiment, when in the insertion configuration C1, the portion of the serpentine member 8 extending through the ring 228 of the locking mechanism 226 may be referred to as the "first serpentine portion" 8a, while the portion of the serpentine member 8 extending away from the first serpentine portion 8a may be referred to as the "serpentine tail," for example, the first and second serpentine tails 8b1, 8b2. Similarly, the portion of the actuating member 6a defining the ring 228 of the locking mechanism 226 may be referred to as the "first actuating portion 6a," while the portion of the actuating member 6 extending away from the first actuating portion 6a may be referred to as the "actuated tail," for example, the first and second actuated tails 6b. The first and second actuated tails 6b preferably extend side-by-side through the same proximal and distal penetration holes 224a, 224b, which pass through the anchor body 4. The first and second actuating tails 6b can be joined together in a manner that defines the engaging actuating tails 6d, such as via an embedded splice extending proximally from the first engagement position 6c1 (i.e., the "splice insertion point" 6c1) to the second engagement position 6c2 (i.e., the "splice end" 6c2). In this embodiment, as Figure 9B As shown, the splicing insertion point 6c1 is preferably located near the proximal end 16 of the anchor body 4, and as... Figure 9A As shown, the splicing end 6c2 can be located at the free end 6e of the actuating member 6. Alternatively, the splicing insertion point 6c1 of this embodiment can be located within the eyelet 12 of the anchoring ring 14; and the splicing end 6c2 can be spaced distally from the free end 6e of the actuating member 6. When the repair assembly 201 changes to the approach configuration C3, the second serpentine tail 8b2 pulls the engaged actuating tail 6d through the ring 228 of the locking mechanism 226, as described in more detail below (and similar to the manner of the embodiment described above).

[0079] The serpentine member 8 of this embodiment preferably has a first diameter region 8m and a second decreasing diameter region 8n, which extend from the transition position 8o in opposite directions. The transition position 8o and the decreasing diameter region 8n are positioned along the second serpentine tail 8b2, specifically such that the decreasing diameter region 8n extends from the transition position 8o to the free end 8e2 of the second serpentine tail 8b2. Thus, the decreasing diameter region 8n can be characterized as the region of the second serpentine tail 8b2. In the illustrated embodiment, the first diameter region 8m extends from the transition position 8o to the free end 8e1 of the first serpentine tail 8b1. Alternatively, the first serpentine tail may also have a decreasing diameter region extending to its free end 8e1. The diameter difference between the first diameter region 8m and the decreasing diameter region 8n can be provided by providing material in the core space of the serpentine member 8 along the first diameter region 8m while leaving the core space along the decreasing diameter region 8n without material. Alternatively, the core space of the decreasing diameter region 8n may also contain material, but the thickness or diameter of this material is smaller than the thickness or diameter in the core space of the first diameter region 8m. In a non-limiting example, the serpentine component 8 (including the first diameter region and the decreasing diameter regions 8m, 8n) includes ETHIBOND 5. ® The sutures, and the first diameter region of 8m also includes the second ETHIBOND spliced ​​within its axial core space. ® Sutures.

[0080] As the repair component 201 is inserted from configuration C1 ( Figure 9B ) to anchor configuration C2 ( Figure 9C The anchor body 4 is specifically configured to converge, reducing its length and increasing its width, similar to the embodiment described above. In this embodiment, the anchor body 4 can be actuated to change to anchor configuration C2 by cooperatively pulling or otherwise cooperating in tensioning the first and second serpentine tails 8b1, 8b2, which can be optionally achieved by tensioning the actuating member 6 at different times. Additionally or alternatively, the anchor body 4 can be actuated by cooperatively pulling or otherwise cooperating in tensioning the actuating member 6 with the first and second serpentine tails 8b1, 8b2, similar to the embodiment described above. Figure 2B The soft anchor 2 shown is as described.

[0081] Refer again Figure 9AIn the repair assembly 201 of this embodiment, in order to initiate the formation of a guide loop 31 around the second anatomical structure 7, the proximal region of the actuating member 6 is joined to the proximal region 8i of the second serpentine tail 8b2, for example, by splicing together. Therefore, the joined proximal region 8i of the second serpentine tail 8b2 can be referred to as its “proximal splicing region” 8i. The proximal splicing region 8i of the second serpentine tail 8b2 is positioned along the decreasing diameter region 8n. It should be understood that the splicing distance 8i required for the serpentine member to pull the actuating tail through the assembly will depend on the free end 6e of the actuating member 6 and the construction of the decreasing diameter region 8n of the serpentine member, but will generally have a length in the range of about 10 mm to about 80.0 mm, more specifically about 40.0 mm to about 50.0 mm. To facilitate such splicing connections, component 201 may include a threading tool or "threader" 205 that can pierce the sheath of the second serpentine tail 8e2 at the first and second through holes 8k1, 8k2, and extend within the core space of the second serpentine tail 8b2 between the first and second through holes 8k1, 8k2. The threader 205 extends outward from the second through hole 8k2 and includes a gripper 207, such as an eyelet 207, at its end. The free end 6e of the engaged actuating tail 6d can pass through the gripper 207, which can then be used to pull the free end 6e of the actuating member 6 into the core space of the second serpentine tail 8b2.

[0082] like Figure 9D As shown, during the stage of forming the through-ring 31, the free end 6e of the actuating member 6 can be pulled through the core space of the second serpentine tail 8b2 to move from the second through-hole 8k2 to the first through-hole 8k1 in the first axial serpentine direction dX3-1, and can be pulled outward through the first through-hole 8k1 and extend distally beyond the first through-hole. Figure 9E As shown, in the subsequent stage of forming the approaching ring 32, the engaged actuating tail 6d can be retracted along the second axial serpentine direction dX3-2 until the free end 6e of the actuating member 6 is pulled back into the second serpentine tail 8b1 between the first and second through holes 8k1, 8k2. This provides a smoother transition from the reduced diameter portion 8n to the spliced ​​portion 8i. Additionally or alternatively, Figure 9D The portion of the engaged actuating tail 6d, shown as extending outward and distally from the first through-hole 8k1, can be trimmed before retraction, or as an alternative to retraction. It should be understood that the reduced-diameter portion 8n of the second serpentine tail 8b2 preferably allows the diameter of the proximal splicing region 8i to be substantially equal to the diameter of the first region 8m of the serpentine member 8. This helps reduce the resistance between the proximal splicing region 8i and the ring 228 of the locking mechanism 226 when the serpentine member 8 passes through the proximal splicing region 8i through the locking mechanism 226.

[0083] exist Figure 9E In the stage shown, the proximal regions of the engaged actuating tail 6d and the second serpentine tail 8b2 provide a closed guide ring 31 around the second anatomical structure 7. At this stage, the serpentine member 8 is prepared to guide the engaged actuating tail 6d into and through the locking mechanism 225. For this purpose, the surgeon pulls the first serpentine tail 8b1 in the first axial serpentine direction dX3-1, which in turn pulls the connected second serpentine tail 8b2 and the engaged actuating tail 6d towards, then into, and through, the locking mechanism 226 along the first axial serpentine direction dX3-1, such that the actuating member 6 defines an abutment ring 32 around the second anatomical structure 7 and also defines an actuating post 35, as... Figure 9F As shown. At this stage, the serpentine member 8 can be disengaged from the actuating member 6, or optionally remain connected to it. As... Figure 9G As shown, the actuating column 35 can be pulled in the first axial actuation direction dX2-1 to reduce the circumference of the abutment ring 32 and bring the second anatomical structure 7 abutmented relative to the first anatomical structure 5. When the second anatomical structure 7 is satisfactorily abutted relative to the first anatomical structure 5, the actuating column 35 can be trimmed to remove excess material at the treatment site. It should be understood that the locking mechanism 226 essentially locks the abutment ring 32 in a fully abutted configuration, thereby eliminating the need for further ligation of the column 35. Optionally, the column 35 can be ligated to provide a secondary locking structure to the abutment ring 32. It should be understood that numerous additional and / or alternative steps can be performed to facilitate the aforementioned exemplary techniques for abutting tissue.

[0084] It should be understood that Figures 9A to 9G The repair component 201 shown has many of the same advantages as the repair component 2 described above (see previous references). Figure 6M and Figure 2B (See the discussion). For example, when in anchored configuration C2 (see... Figure 9CWhen the anchor body 4 exhibits a wide proximal side, this, combined with the increased maximum anchor width, enhances the anchor attachment within the bone. Additionally, the proximal portion 4a of the anchor body 4 provides a barrier-like structure that mechanically interferes with and thus prevents the locking mechanism 226 from migrating away from the anchor body 4 (such as during anchoring and / or tissue approximation), thereby also preventing tension effects that might result from such migration and undesirable relaxation in the approximation ring 32. Furthermore, since the locking mechanism 226 of this embodiment is located distal to the distal end 18 of the anchor body 4 in the insertion configuration C1, the distal portion 4b of the anchor body 4 provides another additional barrier-like structure to prevent the locking mechanism 226 from migrating proximally. Furthermore, a particular advantage of this embodiment is that the near-side region of the second serpentine tail 8b2 and the actuating member 6 (i.e., the splicing portion 8i along the second serpentine tail 8b2) enhances the smooth entry and passage of the near-side region of the actuating member 6 into and through the locking mechanism 226 when forming the approaching ring 32.

[0085] Now for reference Figures 10A to 10I Another embodiment of the tissue repair component 301 for anatomical fixation (e.g., anatomical approximation) will now be described. The repair component 301 of this embodiment, and the method of repairing tissue using it, may be substantially similar to those of the repair components 1, 201 described above. For example, now referring to... Figure 10A The repair assembly 301 of this embodiment includes an anchor body 304, and further includes a tubular actuating member 306 and a serpentine member 8 that are coupled to and extend from the anchor body 304 when in the insertion configuration C1. Furthermore, the portions of the anchor body 304 and the actuating member 306 and the serpentine member 8 coupled to the anchor body define a soft anchor 302 for the repair assembly 301. For the sake of brevity, the following discussion focuses primarily on the differences between the repair assembly 301 and the repair assemblies 1 and 201 described above. In the following discussion, features having similar design and function to those described above may be referred to using the same reference numerals.

[0086] Continue to refer to Figure 10AThe anchoring body 304 is arranged as an anchoring ring 314 and is constituted by a continuous weave of stitching material. In this respect, the anchoring body 304 may be configured as more fully described in U.S. Patent 9,284,668 (“'320 References”), issued March 15, 2016, by Johnson et al., the entire disclosure of which is incorporated herein by reference. The actuating member 306 is constituted by textile stitching material and has a first portion 306a and a pair of actuating tails 306b, the first portion defining a cannula 307, the pair of actuating tails extending away from the first portion 306a in opposite directions. Thus, the first portion 306a may be characterized as a “sleeve” 306a. When in a neutral configuration, the actuating tails 306b may each have a flat or “band”-shaped cross-sectional geometry, such as the band geometry described more fully in '320 References. In the insertion configuration C1, the serpentine member 8 extends through the insertion tube 307 of the sleeve 306a, wherein the first and second serpentine tails 8b1 and 8b2 extend outward from the opening 309 to the first and second serpentine ends 8e1 and 8e2, respectively. The second serpentine tail 8b2 defines a serpentine loop 8f at the second serpentine tail end 8e2, which can be configured similarly to the above reference. Figure 1A and Figure 6A The described serpentine ring 8f.

[0087] refer to Figure 10B The actuating member 306 is shown separately in a neutral configuration. The actuating tail portion 306b may each have a first tail portion 311 adjacent to the sleeve 306a and an end tail portion 313 distal to the sleeve 306a and defining a free end 306e of the respective actuating tail portion 306b. One or both of the end tail portions 313 may have a geometry different from that of the first tail portion 311 and facilitate the passage of one or both of the free ends 306e through a connecting structure, such as a serpentine loop 8f. For example, one or both of the end tail portions 313 may have a circular cross-sectional geometry, such as... Figure 10C As shown, or a conical flat geometry, such as Figure 10D As shown. The cannula 306a defines first and second openings 309a, 309b at its end and in communication with the cannula 307.

[0088] Refer again Figure 10AThe sleeve 306 is connected to the distal portion 304b of the anchor body 304. The sleeve 306 is bent such that the distal apex 315 of the sleeve 306a is located distal to the distal end 318 of the anchor body 304. Thus, in this embodiment, the distal apex 315 of the sleeve 306 defines the distal end of the soft anchor 302. A portion of the sleeve 306a may extend through a corresponding through-hole 325b (which passes through the distal portion 304b of the anchor body 304) and proximally towards the proximal end 316 of the anchor body 304 within the eyelet 312 of the anchor ring 314. As shown, these portions of the sleeve 306a may extend substantially parallel to each other through the anchor eyelet 312, although in other embodiments, these portions of the sleeve 306a may extend non-parallel through the anchor eyelet 312. In the illustrated embodiment, when in the insertion configuration C1, the openings 309a, 309b at the end of the insertion tube 306a are positioned within the anchor eye 312, although in other embodiments, when in the insertion configuration C1, one or both of the openings 309a, 309b may be positioned proximal to the anchor body 304.

[0089] refer to Figures 10E to 10I The above reference will now be used to describe the process. Figures 10A to 10D The described repair component 301 is an exemplary method for approximating tissue. For example... Figure 10E As shown, when in insertion configuration C1, the soft anchor 302 of the repair component 301 is inserted into the target location 3 of the first anatomical structure 5, such as a pre-drilled hole 3 in the bone 5. During this stage, the actuating tails 306b1, 306b2 and the serpentine tails 8b1, 8b2 extend generally proximally away from the target location 3. Figure 10F As shown, with the soft anchor 302 inserted at the target position 3, the surgeon can actuate the anchor 302 into the anchoring configuration C2 by coordinating the tensioning actuation tails 306b1 and 306b2. Figure 10G As shown, with the soft anchor 2 in place, the surgeon can allow the free end 6e1 of the first actuating tail 306b1 to bypass the second anatomical structure 7. Additionally, the surgeon passes the free end 6e1 of the first actuating tail 306b1 through the serpentine loop 8f at the end 8e2 of the second serpentine tail 8b2, thereby connecting the proximal regions of the first actuating tail 306b1 and the second serpentine tail 8b2 together in such a way that a guide loop 31 is formed around the second anatomical structure 7. With the guide loop 31 formed, the surgeon can pull the free end 8e1 of the first serpentine tail 8b1 to guide the free end 306e1 of the first actuating tail 306b1 into and through the cannula 306a, thereby causing the actuating member 306 to form a convergence ring 32 around the second anatomical structure 7, as... Figure 10HAs shown. With the approach ring 32 formed and the free end 306e1 of the first actuating tail 306b1 and the second end 8e2 of the second serpentine tail 8b2 outside the sleeve 306a, the serpentine member 8 can disengage from the first actuating tail 306b1. At this stage ( Figure 10H The portion of the first actuating tail 306b1 extending outward from the first opening 309a of the sleeve 306a forms a post 35, and is subsequently tensioned to bring the second anatomical structure 7 closer to the first anatomical structure 5. Now refer to Figure 10I The repair component 301 is shown in a close-fitting configuration C3, wherein the first and second actuation tails 306b1, 306b2 have been trimmed to remove excess material at the treatment site.

[0090] It should be understood that the corresponding configurations (e.g., their dimensions and shapes) of the first actuating tail 306b1 and the cannula 306a together form a locking mechanism that maintains the positioning of the first actuating tail 306b1 within the cannula 307 in the approach configuration C3, thereby attaching the approached second anatomical structure 7 relative to the anchor 302 (and therefore also relative to the first anatomical structure 5). Specifically, during tissue approach, the tension applied to the first actuating tail 306b1 is transmitted to the cannula 306a, which, due to the braided configuration of the cannula 306a, stretches in the length direction and contracts in the diameter direction. This tension-responsive elongation-contraction behavior provides unidirectional locking for the portion of the first actuating tail 306b1 within the cannula 307. Since the tension along the first actuation tail 306b1 and the cannula 306a is maintained after the second anatomical structure is satisfactorily brought into contact, the cannula 306a is locked against the first actuation tail 306b1 with sufficient force to maintain the close positioning of the second anatomical structure relative to the first anatomical structure 5.

[0091] It should be understood that the above references Figures 10A to 10I The soft anchor 302 discussed may have alternative arrangements and modifications, some of which are non-limiting examples. Figures 11A to 11C As shown in the figure, each figure shows its soft anchor in the insertion configuration C1.

[0092] like Figure 11A As shown, in another embodiment of the soft anchor 302', the sleeve 306a may be configured such that its openings 309a, 309b are located proximal to the proximal end 16 of the anchor body 304. In this embodiment, the end portion of the sleeve 306 may extend proximally through a corresponding through hole 325a (which passes through the proximal portion 304a of the anchor body 304). Figure 11BAs shown, in another embodiment of the soft anchor 302'', the sleeve 306a may be configured such that its proximal portions converge with each other, such that the lateral spacing between the openings 309a, 309b is smaller than the lateral spacing in other embodiments of the soft anchor 302. Figure 11C As shown, in another embodiment of the soft anchor 302''', the anchor body 304 may be arranged in an hourglass shape. In this embodiment, the sleeve 306a may extend at each of its lateral sides 304s through a pair of additional through holes 325c that pass through the anchor body 304. Additionally, in this embodiment, the proximal and distal ends 316, 318 of the anchor body 304 may be substantially straight.

[0093] It should be understood that many other variations and improvements to the design of the soft anchor 302 are within the scope of this disclosure.

[0094] For example, see now Figure 12 In an additional embodiment, the soft anchor may employ a cannulated actuating member 306' having a central sleeve 306a and a pair of actuating tails 306b extending therefrom in opposite directions. The exemplified example of the cannulated actuating member 306' is shown in a neutral configuration and can be arranged in various shapes relative to the anchor bodies 4, 204, 304 described above, including those described above. Figure 10A and Figures 11A to 11C The shapes shown are as described. A central sleeve 306a defines a cannula 307 extending through it. In this embodiment, each actuating tail 306b includes a strip-shaped portion 311 extending outwardly from the central sleeve 306, and an end portion 317 having a circular cross-section and extending from the strip-shaped portion 311 to a free end 306e of the actuating tail 306b. The circular cross-section of these end portions 317 is configured to lock within the central sleeve 306a when in a close-fitting configuration.

[0095] Now for reference Figures 13A to 13B In yet another embodiment, the tissue repair component 401 has a soft anchor 402, which may be an anchor body 404 of an alternative type having a cannula-type actuating member 306. In this embodiment, the anchor body 404 does not need to be arranged in a ring, but may be an elongated body, which may optionally be made of a felt material. When in a neutral configuration, the anchor body 404 may have a generally flat geometry, which in Figure 13BAs shown in the figure. The anchor body 404 may define holes 424 configured to receive an associated portion of the sleeve 306a of the actuating member 306. When in the neutral configuration, the anchor body 404 may have a basic shape similar to a dog bone, but it should be understood that various other basic shapes may be used to achieve various anchor designs and shapes when in the insertion configuration C1. In the illustrated embodiment, the anchor body 404 defines six (6) holes 424, which may promote a shape similar to the lower half of an hourglass when coupled to the sleeve 306a and in the insertion configuration C1, such as Figure 13A As shown. It should be understood that the anchor body 404 may be defined with fewer or more than six (6) holes, which may facilitate various other arrangements and shapes of the anchor body 404 when connected with the insert-type actuating member 306. It should also be understood that the soft anchor 402 is actuated into anchoring and approaching configurations, similar to the manner described above with reference to other embodiments.

[0096] Now for reference Figure 14 An exemplary embodiment of the tissue repair assembly 501 is shown, wherein, when in the insertion configuration C1, one of the actuating member tails 311b is anchored to the anchor body 504. The anchor body 504 may be similar to the anchor bodies 4, 304 described above. Furthermore, the anchor body 504, as well as the portions of the actuating member 306 and the serpentine member 8 connected to the anchor body, define a soft anchor 502 for the repair assembly 501. As shown, the anchor body 504 may be arranged to have a closed anchor loop 514 of an elliptical shape. The repair assembly 501 may have a cannulated actuating member 306 having strip-shaped first and second actuating tails 311a, 311b extending outward from opposite ends of the sleeve 306a, similar to those described above. Figures 10A to 10I The described cannula-type actuating member 306. When in insertion configuration C1, the serpentine member 8 extends through and outwards from the cannula 306a and is configured to guide the first actuating tail 311a into and through the cannula 306a to form an applicator ring 32 around the second anatomical structure 7, as described above in conjunction with other embodiments herein. Similarly, in embodiments described above, when the first actuating tail 311a extends within the cannula 306a and is tensioned to applicate tissue, the geometry and construction of the first actuating tail 311a and the cannula 306a work together to form a one-way locking mechanism.

[0097] In this embodiment, the distal bent portion of the sleeve 306a passes through a laterally opposed through-hole 524 (which passes through the sheath 515 of the anchor body 504) and enters its internal channel, which may include the axial core space of the anchor body 504. Additionally, the second actuating tail 311b of this embodiment folds back and extends through the sheath 515 and enters and is attached thereto in the axial core space 504 of the anchor body 504. For example, the second actuating tail 311b may be stitched into and along the braided layer of the sheath 515. The stitching of the second actuating tail 311b along the braided layer of the sheath 515 can be optionally reinforced, such as via a keyhole stitch. In this way, when tension is applied to the first actuating tail 311a during tissue approach, at least a portion of that tension is transmitted through the sleeve 306a and the second actuating tail 311b to a portion of the anchor body 504 attached thereto, which increases the locking force applied by the sleeve 306a to the first actuating tail 311a. Additionally, the attachment of the second actuating tail 311b to the anchor body 504 further secures the locking mechanism to the anchor body 504, thereby reducing the likelihood of the locking mechanism migrating from the anchor body 504 during or after tissue approach. It should be understood that various modifications and improvements can be applied to the repair component 501 of this embodiment, including many modifications and improvements in other embodiments described herein.

[0098] Now for reference Figures 15A to 15E Another embodiment of a tissue repair assembly 601 for anatomical fixation (e.g., anatomical approximation) will now be described. Repair assembly 601 includes an anchor body 604 for attachment to a first anatomical structure 5, an actuating member 611 for forming an approximation ring that interconnects the anchor body 604 with a second anatomical structure 7, and a locking mechanism 626 for locking the approximation ring relative to the anchor body 604 after the second anatomical structure has satisfactorily approximated relative to the first anatomical structure. The distal portion of repair assembly 601 (particularly along the anchor body 604) can be characterized as a soft anchor 602. The repair assembly 601 of this embodiment, and the method of repairing tissue using it, can be generally similar to those of repair assemblies 1, 201, 301, and 501 described above.

[0099] For example, now refer to Figure 15A The repair component 601 of this embodiment is shown in an insertion configuration C1, wherein the anchor body 604 is preferably arranged as a closed anchor ring 614 with an elliptical shape. The anchor ring 614 defines a central anchor eye 619. The anchor body 604 may be similar to the above, referring to Figures 1 to 6N respectively. Figures 9A to 9GThe anchor body 4, 204 is described. Therefore, the anchor body 604 may have a textile sheath 615 surrounding (and defining) an axial core space 617. The repair assembly 601 includes a cannulated actuating member 605, which may be similar to the one described above. Figures 10A to 11C , Figure 13A and Figure 14 The described cannulated actuating member 306. Actuating member 605 includes a sleeve 606 coupled to an anchor body 604 and defining a locking mechanism 626. The sleeve 606 defines a cannula 607 extending between first and second openings 609a, 609b at opposite ends 610a, 610b of the sleeve 606. The sleeve 606 is coupled to a distal portion 604b of the anchor body 604 and is located within its axial core space 617. The distal portion 604b of the anchor body 604 includes its distal end 618 and is longitudinally opposed to a proximal portion 604a of the anchor body, including its proximal end 616. The anchor body 604 may also define an intermediate portion 604c longitudinally located between the proximal and distal portions 604a, 604b. Preferably, the sleeve 606 is laterally centered in the distal portion 604b of the anchor body 604, such that the lateral midpoint of the sleeve 606 intersects the insertion axis X0 of the soft anchor 602, which in turn intersects the distal end 618 of the anchor body 604. In this way, the first opening 609a is positioned on the first lateral side 623a of the anchor body 604, while the second opening 609b is positioned on the second lateral side 623b of the anchor body 623b opposite to the first lateral side 623a. For the purposes of the following discussion, the first and second lateral sides 623a, 623b of the anchor body 604 refer to the entire corresponding portions of the anchor body 604 on opposite sides of the insertion axis X0.

[0100] The actuating member 605 of this embodiment includes an actuating tail 611 and a snake tail 612, which extend from opposite ends of the sleeve 606 to the actuating tail end 611e and the snake tail end 612e, respectively. The actuating tail 611 and the snake tail 612 may each have a corresponding strip-shaped cross-sectional geometry, a circular cross-sectional geometry, or a combination thereof (e.g., one or both of the actuating tail 611 and the snake tail 612 may have one or more axial portions with a strip-shaped cross-sectional geometry and one or more axial portions with a circular cross-sectional geometry). In this embodiment, the actuating member 605 is an integral structure, i.e., the sleeve 606, the actuating tail 611, and the snake tail 612 are each separate parts forming the integral structure of the actuating member 605.

[0101] An actuating tail 611 extends from the first end 610a of the sleeve 606 and exits the anchor body 604 through a first distal penetration hole 624a, which passes through a sheath 615 on the first lateral side 623a of the anchor body 604. From the first distal penetration hole 624a, the actuating tail 611 extends along and / or through the anchor eyelet 619, across the insertion axis X0, and extends proximally through a second proximal penetration hole 625b, which passes through the proximal portion 604a of the anchor body 604 at its second side 623b.

[0102] The wiring path of the serpentine tail 612 relative to the anchor body 604 and the sleeve 606 is as follows: The serpentine tail 612 extends from the second end 610b of the insert 606 and extends through a first serpentine through-hole 621a to the outside of the anchor body 604, which passes through the sheath 615. The serpentine tail 612 passes through a second serpentine through-hole 621b (which passes through the sheath 615) and is folded back into the anchor body 604. Figure 15AAs depicted, the first and second serpentine penetration holes 621a and 621b are located on the rear side of the anchor body 604. From the second serpentine penetration hole 621b, the serpentine tail 612 is routed through the insertion tube 607 (from its second opening 609b to its first opening 609a), withdrawn from the insertion tube 607, and then exits from the anchor body 604 through the first distal penetration hole 624a. From the first distal penetration hole 624a, the serpentine tail 612 extends along and / or through the anchor eyelet 619, and extends proximally through the first proximal penetration hole 625a, which passes through the proximal portion 604a of the anchor body 604 at its first lateral side 623b. From the first proximal through-hole 625a, the serpentine tail 612 extends generally proximally away from the anchor body 604 and folds back toward the anchor body 604 via a proximal bend 612g in the serpentine tail 612. From the bend 612g, the serpentine tail 612 extends generally distally and folds back through the first proximal through-hole 625a of the anchor body 604. In this way, the double-stranded portion of the serpentine tail 612 extending proximally from the first proximal through-hole 625a to the bend 612g defines an elongated serpentine loop 612f for engagement with the actuating tail 611, which will be described in more detail below. The folded-back portion of the serpentine tail 612 extends distally from the first proximal through-hole 625a and extends through and / or along the anchor eyelet 619, folding back through the first distal through-hole 624a into the distal portion of the anchor body 604b. From the first distal penetration 624a, the serpentine tail 612 extends back through the cannula 607, in which case it extends from its first opening 609a to the second opening 609b and from there outwards. From the second opening 609b of the sleeve 606, the serpentine tail 612 extends back outwards from the anchor body 604 through the second distal penetration 624b on the second lateral side 623b. From the second distal penetration 624b, the serpentine tail 612 extends through and / or along the anchor eyelet 619, and extends proximally through the second proximal penetration 625b of the anchor body 604, and from there proximally extends to the serpentine tail end 612e. With the aforementioned wiring of the actuating tail 611 and the serpentine tail 612, the serpentine ring 612f extends proximally from the first side of the anchor body 604 toward side 623a, while the free portions of the actuating tail 611 and the serpentine tail 612 extend proximally from the second side of the anchor body 604 toward side 623b. It should be understood that various modifications and improvements can be made to the repair assembly 601 while remaining within the scope of this disclosure.

[0103] Now refer to Figures 15B to 15E describe Figure 15AThe repair component 601 shown is applicable to tissue approximation, particularly according to an exemplary method for approximating the second anatomical structure 7 relative to the first anatomical structure 5. For visualization purposes, the soft anchor 2 in these figures is shown in an insertion configuration C1 (i.e., the anchor is not actuated into an anchoring configuration); however, it should be understood that during tissue approximation, the anchor 602 will be actuated into an anchoring configuration in which the anchor 602 converges, thereby reducing the maximum length of the anchor 602 and increasing the maximum width of the anchor 602, which is generally similar to the embodiment described above.

[0104] Now for reference Figure 15B The actuating tail end 611e is made to bypass the second anatomical structure 7 and pass through the serpentine ring 612f, thereby capturing the captured portion 611c of the actuating tail 611 or otherwise connecting the captured portion to the serpentine ring 612f. This causes the serpentine ring 612f and the actuating tail 611 to form a guide loop 31 around the second anatomical structure 7.

[0105] Now for reference Figure 15C The captured actuated tail portion 611c is guided into the cannula 606 using the serpentine tail 612. Specifically, tensioning the serpentine tail end 612e pulls the serpentine ring 612f and the captured actuated tail portion 611c distally through the first proximal penetration hole 625a, and subsequently through the first distal penetration hole 624a and through the first opening 609a of the cannula 606 into the insertion cannula 607. During the guidance, the actuated tail end 611e can optionally be secured by the gripping tool 135 to prevent the actuated tail end 611e from disengaging from the serpentine ring 612f. After guidance, the actuated tail 611 forms an applicator ring 32 around the second anatomical structure 7. Similarly, after insertion, the actuating tail 611 is pulled into the cannula 607 (through the first opening 609a), captured by the serpentine ring 612f and folded back around the ring, and exits the cannula 607 through the first opening 609a, extending to the actuating tail 611e. In this way, the repair assembly 601 can be characterized as providing a “double-stuff” actuating tail 611 within the cannula 607, and thereby also providing a double-stuff locking mechanism 626.

[0106] Now for reference Figure 15DWhen the serpentine loop 612f is inside the cannula 607 and the serpentine tail 612e is secured (as shown, this can be optionally assisted by means such as the gripping tool 135), the serpentine loop 612f effectively forms a pulley mechanism that acts on the actuated tail portion 611c captured within the cannula 607. This pulley mechanism allows the surgeon to pull the actuated tail 611e to reduce the circumference of the approach ring 32, thereby bringing the second anatomical structure 7 closer to the first anatomical structure 5. During tissue approach, the tension applied to the actuated tail 611e is transmitted along the actuated tail 611 to the cannula 606, which tensions the cannula 606, thereby enabling it to perform a one-way locking on the portion of the actuated tail 611 folded through the cannula 307. Since the tension along the actuation tail 611 and the cannula 606 is maintained after the second anatomical structure is satisfactorily brought into contact, the cannula 606 is partially locked against the actuation tail 611 with sufficient force to maintain the close positioning of the second anatomical structure relative to the first anatomical structure 5.

[0107] Now for reference Figure 15E When the second anatomical structure 7 is fully approximated relative to the anchor body 4 (and thus also relative to the first anatomical structure 5), the free portions of the actuating tail 611 and the serpentine tail 612 can be trimmed. Optionally, one or both of the free portions of the actuating tail 611 and the serpentine tail 612 can be ligated to provide one or more secondary locking structures to the approximation ring 32 of this embodiment. It should be understood that many additional and / or alternative steps may be performed to facilitate the aforementioned exemplary techniques for approximating tissue using the repair component 601.

[0108] It should be understood that the various parameters of the tissue repair components 1, 201, 301, 401, 501, 601 and their constituent soft anchors 2, 202, 302, 402, 502, 602 described above are provided as exemplary features to adapt the tissue repair components to approximate tissue, providing the various benefits and advantages discussed above, such as (as non-limiting examples): using soft anchors with narrower profiles for use within narrower bone foramina; obtaining wider, more beneficial actuated anchor configurations (e.g., wider proximal anchoring surfaces, proximal barrier-like anchoring structures that prevent pull-out and proximal migration of the locking mechanism); and enhanced tactile feedback of the anchors, among other benefits and advantages. These parameters may be adjusted as needed without departing from the scope of this disclosure.

[0109] It should also be understood that the size parameters disclosed above can be scaled up or down according to the patient's treatment needs (such as patient species, age, and treatment anatomy / location).

[0110] It should also be understood that, in additional embodiments, the tissue repair components 1, 201, 301, 401, 501, and 601 described above may be included in a kit comprising multiple interchangeable tissue repair components and associated instruments, such as those referenced above. Figures 7A to 8Q The described instrument allows surgeons or other users to select specific repair components to bring specific tissues closer together, based on the patient's specific treatment needs.

[0111] Although this disclosure has been described in detail, it should be understood that various changes, substitutions, and modifications may be made herein without departing from the spirit and scope of the invention as defined by the appended claims. Furthermore, the scope of this disclosure is not intended to be limited to the specific embodiments described herein. Specifically, one or more features from the foregoing embodiments may be used in other embodiments herein. Those skilled in the art will readily appreciate that existing or future processes, machines, manufactures, material compositions, apparatuses, methods, or steps may be developed based on this disclosure to perform substantially the same function or achieve substantially the same results as the corresponding embodiments described herein.

Claims

1. An assembly for anatomical approximation, wherein, The component is configured to transition from an insertion configuration to an anchoring configuration, the component comprising: An anchor body, the anchor body being formed by a suture and defining an anchor ring, the anchor body defining a length along a first direction and a width along a second direction substantially perpendicular to the first direction, wherein the anchor body is configured such that as the assembly changes from the insertion configuration to the anchoring configuration, the length decreases and the width increases; An actuating member, comprising a suture and defining a first actuating portion and a second actuating portion, wherein the first actuating portion defines a locking mechanism within an internal channel defined by a distal portion of the anchor body, wherein the locking mechanism includes a plurality of loops; and The serpentine component has a first serpentine portion, a first serpentine tail, and a second serpentine tail. Wherein, when the component is in the insertion configuration: The first serpentine portion extends along the internal channel of the anchor body and passes through the plurality of loops. The second actuating portion, as well as the first and second serpentine tail portions, are located outside the anchor body. The second actuating portion and at least one of the first and second serpentine tails are configured to receive tensile force for changing the component from the insertion configuration to the anchoring configuration, and The free end region of the second serpentine tail is configured to connect with the free end region of the second actuating portion, such that the free end region of the first serpentine tail is configured to be pulled to draw the free end region of the second actuating portion into and through the internal channel of the anchor body, such that: When the component is in the third configuration, the second actuation part: 1) It is held by the plurality of knots within the internal channel and is slidable relative to the plurality of knots within the internal channel, and 2) A catch-up ring located outside the body of the anchor is defined for use in catching the organization.

2. The assembly of claim 1, wherein, The plurality of knots includes a first knot and a second knot.

3. The assembly of claim 2, wherein, The first and second knots are defined by corresponding portions of the first actuating portion, which are bent into loops that fold back and penetrate the first actuating portion.

4. The assembly of claim 2, wherein, The first and second knots are spaced apart from each other by a knot spacing distance measured along the central axis of the anchor body, and the knot spacing distance is in the range of about 2.0 mm to about 7.0 mm.

5. The assembly of claim 4, wherein, The distance between the knot rings is in the range of about 3.5 mm to about 4.5 mm.

6. The assembly of claim 1, wherein, The second actuation portion includes a first actuation tail and a second actuation tail extending from a first position and a second position of the anchor body to the outside of the anchor body, respectively, and the first actuation tail and the second actuation tail extend from a splicing insertion point to a splicing end point to splice together, wherein the splicing insertion point is located within the contour of the anchor ring relative to the first direction and the second direction.

7. The component according to claim 1, wherein, The actuating member enters the internal channel at a first position on the anchor body and exits the internal channel at a second position on the anchor body.

8. The component according to claim 7, wherein, The channel length measured along the central axis of the anchor body between the first and second positions is in the range of about 8.0 mm to about 16.0 mm.

9. The assembly of claim 8, wherein, The length of the channel is in the range of approximately 11.0 mm to approximately 14.0 mm.

10. The assembly of claim 7, wherein, The anchor body comprises stitch fibers woven together in a circular braided structure.

11. The assembly of claim 7, wherein, The actuating member penetrates the circular braided structure at the first and second positions.

12. The assembly of claim 7, wherein, When the component is in the insertion configuration, the serpentine member enters and exits the internal channel at the first position and the second position, respectively.

13. The assembly of claim 7, wherein, The distal portion of the anchor body extends from the nearest side of the first position and the second position to the distal end of the anchor body, and when the assembly is in the insertion configuration, the distal portion of the anchor body has a length along the first direction ranging from about 28% to about 32% of the length of the anchor body.

14. The assembly of claim 1, wherein, The serpentine component is made of sutures.

15. The assembly of claim 1, wherein, The free end region of the second serpentine tail defines a serpentine loop for receiving at least a portion of the free end region of the second actuation portion for connecting the free end region of the second serpentine tail to the free end region of the second actuation portion.

16. The assembly of claim 15, wherein, The serpentine loop is defined by the eye joints of the two portions of the second serpentine tail.

17. A device assembly for delivering a tissue repair component to a target site of an anatomical structure, the device assembly comprising: An insertion device having a proximal end and a distal end spaced apart from each other in a longitudinal direction, the insertion device having a handle portion at the proximal end and a fork at the distal end; A tissue repair assembly, carried by the insertion device, wherein the tissue repair assembly is in an insertion configuration when carried, the tissue repair assembly comprising: An anchor body comprising a suture and defining an anchor ring, wherein a distal portion of the anchor body is capable of being attached to the fork between a pair of fork teeth, the anchor body defining a length along the longitudinal direction and a width along a lateral direction substantially perpendicular to the longitudinal direction, wherein the anchor body is configured such that as the anchor body changes from the insertion configuration of the tissue repair assembly to the anchoring configuration, the length decreases and the width increases; An actuating member, comprising a suture and defining a locking mechanism and at least one actuating tail extending away from the locking mechanism, wherein the locking mechanism includes a plurality of loops disposed within an internal channel in a distal portion of the anchor body; and The serpentine component has a first serpentine portion, a first serpentine tail, and a second serpentine tail. Wherein, when the tissue repair component is in the insertion configuration: The first serpentine portion extends through the plurality of knots. The at least one actuating tail, as well as the first serpentine tail and the second serpentine tail, are located outside the anchor body and extend into one or more stitching grooves in the handle portion. The at least one actuating tail and one or more of the first serpentine tail and the second serpentine tail are configured to receive tensile forces for converting the tissue repair assembly from the insertion configuration to the anchoring configuration, and The second serpentine tail is configured to engage with the at least one actuating tail and pull the at least one actuating tail into the internal channel and through the plurality of loops, such that a portion of the at least one actuating tail defines an abutment ring located outside the anchor body for abutting tissue.

18. The instrument assembly of claim 17, wherein, The fork defines a first outer surface and a second outer surface opposite to each other in a transverse direction substantially perpendicular to the longitudinal direction and the lateral direction. The fork also defines a distal recess and a proximal recess, each extending from one of the first outer surface and the second outer surface toward the other. The proximal portion of the anchor body is configured to at least partially reside in the proximal recess, and at least a portion of the actuating tail is configured to reside in the distal recess.

19. The instrument assembly of claim 18, wherein, The fork defines a distal surface portion within the proximal recess, the distal surface portion being oriented at a rear angle ranging from approximately 110 degrees to approximately 160 degrees with respect to the longitudinal axis of the insertion device.

20. The instrument assembly of claim 18, wherein, The insertion device defines an elongated portion extending from the handle portion to the fork along the longitudinal direction, the elongated portion defining a width measured in the lateral direction, wherein the fork defines a first outer surface and a second outer surface spaced apart from each other along the lateral direction, wherein the width between the first outer surface and the second outer surface in the lateral direction is less than the width of the elongated portion.

21. The device assembly of claim 17, further comprising a guide sleeve configured to be inserted through patient tissue into a target location of a first anatomical structure, the guide sleeve defining a cannula, wherein a drill member is configured to advance through the cannula and extend distally beyond a distal end of the guide sleeve for pre-drilling a hole in the first anatomical structure, and wherein the fork is configured to carry the anchor body through the cannula and into the pre-drilled hole in the first anatomical structure after the drill member is withdrawn proximally from the cannula.

22. A method for bringing a second anatomical structure closer to a first anatomical structure, comprising: An anchor body of a tissue repair component is inserted into a target location of the first anatomical structure, wherein the anchor body is formed of sutures and defines an anchor ring, wherein an actuating member and a serpentine member are coupled to a distal portion of the anchor body and extend away from the anchor body during the insertion step, wherein the actuating member defines a locking mechanism coupled to the distal portion of the anchor body, wherein the locking mechanism includes a plurality of knots disposed within an internal channel of the distal portion of the anchor body; Tension at least one of the actuating member and the serpentine member in such a way that the length of the anchor body is reduced and the width of the anchor body is increased; The free end region of the actuating member is connected to the free end region of the serpentine member, such that the connected actuating member and the serpentine member form a loop, wherein at least a portion of the second anatomical structure extends through the loop; Pulling the second free end region of the serpentine member in a direction away from the anchor body pulls the connected free end region of the actuating member through the plurality of loops, causing the actuating member itself to form a closing loop, wherein at least a portion of the second anatomical structure extends through the closing loop; Pulling the free end region of the actuating member away from the plurality of knots reduces the circumference of the approaching ring.

23. The method of claim 22, wherein, The serpentine member includes a first serpentine portion and a first serpentine tail and a second serpentine tail extending away from the first serpentine portion, the first serpentine portion extending through the plurality of loops during the insertion step, the free end region of the serpentine member being defined by the second serpentine tail, and the second free end region of the serpentine member being defined by the first serpentine tail.

24. The method of claim 23, wherein, The tensioning step includes simultaneously pulling the free end region of the actuating member, as well as the first serpentine tail and the second serpentine tail, away from the anchor body, thereby reducing the length of the anchor body and increasing the width of the anchor body.

25. The method of claim 23, wherein, The plurality of loops includes a first loop and a second loop, wherein the first loop and the second loop are configured to provide unidirectional axial sliding of the serpentine member and subsequently the actuating member through the loops.

26. The method of claim 22, wherein, Connecting the free end region of the actuating member to the free end region of the serpentine member includes passing the free end of the actuating member through a loop defined by the free end region of the serpentine member.

27. The method of claim 22, further comprising: Before connecting the free end region of the actuating member to the free end region of the serpentine member, the free end region of the actuating member is made to surround or pass through the second anatomical structure.

28. The method of claim 22, further comprising: Before inserting the anchor body into the target location, a hole is pre-drilled in the first anatomical structure, wherein the first anatomical structure is bone, and the target location is within the hole.

29. The method of claim 28, wherein, The bone is the glenoid cavity of the shoulder, and the second anatomical structure is the labrum, which is at least partially detached from the glenoid cavity.

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