Knotless unstable anchor

Abstract

To provide a suture anchor used alone and formed of a soft material promoting an ability of fixing a suture without necessity of forming a knot, and adjusting, maintaining, and positioning a tissue to a desired position of a pilot hole during attachment of the anchor.SOLUTION: A knotless unstable anchor 10 includes an anchor having a first side surface and a second side surface, in which a suture material passes from the first side surface to the second side surface. The suture material includes: an adjustable loop 30 extending from the first side surface of the anchor; and a first rim 24 and a second rim 26 extending from the second side surface of the anchor. A splice 28 is formed in a first rim between a first end of the first rim and the anchor. A self folding loop 22 is formed in the first rim between the first end and the splice. The second rim extends so as to pass the splice of the first rim.SELECTED DRAWING: Figure 4

Description

[Technical Field]

[0001] This application claims priority to U.S. Provisional Patent Application No. 62 / 586,383, filed November 15, 2017.

[0002] FIELD OF THE INVENTION The present disclosure relates generally to suture anchor devices for use in soft tissue in bone repair procedures, and more particularly to knotless unstable anchors that include a sliding construct for tensioning the tissue and a splice for securing the tissue in position relative to the bone. [Background technology]

[0003] 2. Description of Related Art Suture anchors are commonly used in surgical procedures to repair soft tissue to bone. They are typically inserted into pre-formed holes, after which the suture is threaded through the tissue to be repaired. A sliding knot is often tied, allowing the surgeon to manipulate the knot to better tension the tissue as the tissue and bone are apposed. This allows the tissue to naturally return to the origin of the suture, resting directly over the pre-formed hole or pilot hole. To secure the sliding knot, the surgeon completes the procedure by tying one or more alternating half-knots. Tying knots can be challenging for surgeons, especially when performed arthroscopically. Furthermore, knots are sometimes implicated in postoperative pain due to irritation caused by overlapping knots.

[0004] Various types of suture anchors have been deployed to secure sutures in place without the surgeon having to tie a knot. Some designs capture the suture between two anchor components, while others utilize an interference fit between the anchor and the bone tunnel. Many designs using these fixation methods require a driver to be engaged with the anchor while tensioning the suture to appose the tissue and bone. Because the driver is directly engaged with the pilot hole, the driver prevents the tissue from being tensioned so that it rests directly over the pilot hole (suture start point), creating a non-ideal position and preventing adjustment of the suture tension.

[0005] A conventional method for solving the tissue position problem involves implementing an adjustable loop formed around the tissue to be repaired. In this case, an anchor is attached to the bone and a driver is removed. One limb of the suture is free to pass through the tissue and enter a loading filament that returns through the suture limb, creating a unidirectional loop. This requires that the raised end of the suture remain fixed so that when the suture is tensioned, it acts as a finger trap, thereby preventing the loop from loosening. This method also requires that the longitudinal length of the suture be passed through or around the tissue before the loop can become too small and cause tissue damage through adhesion. Furthermore, the fixed end must be deep in the hole and not move, limiting tension. Finally, this type of device is made of a rigid material that could damage tissue if pulled out of the hole during healing.

[0006] Therefore, there is a need for a single-use suture anchor that secures the suture without the need to tie knots and is constructed of a soft material that facilitates the ability to adjust, maintain, and position tissue in the desired location of the pilot hole during anchor installation.

[0007] Disclaimer in the Related Technology section explains: To the extent that specific patents / publications / products are discussed in this Related Art section description or elsewhere in this disclosure, these discussions should not be taken as an admission that the discussed patents / publications / products are prior art for purposes of patent law. For example, some or all of the patents / publications / products discussed may not be sufficiently early in time, may not reflect subject matter that developed early enough in time, and / or may not be sufficiently valid to be prior art for purposes of patent law. To the extent that a specific patent / publication / product is discussed above in this Related Art section description and / or throughout the application, that description / disclosure is incorporated herein by reference in its entirety. Summary of the Invention

[0008] Embodiments of the present invention recognize that conventional knotted or knotless suture structures have potential problems and / or drawbacks. For example, knotted and knotless constructs can be large and stiff enough to cause irritation and require constant engagement by a driver during installation, which can result in tissue being positioned in a less-than-ideal location over the bone hole (as discussed above). Therefore, there is a need for a single-use suture anchor constructed of a soft material that secures the suture without the need to tie a knot and facilitates the ability to adjust, maintain, and position the tissue in a desired location over the pilot hole during anchor installation. Various embodiments of the present invention may be advantageous in that they may solve or reduce one or more of the potential problems and / or drawbacks described herein.

[0009] The present disclosure relates to an inventive configuration, structure, and resulting function of a knotless instability anchor, and a method for securing a first body in position relative to a bone hole. The knotless instability anchor includes an anchor having a first side and a second side, with a suture material passing from the first side to the second side. The suture material has an adjustable loop extending from the first side of the anchor and first and second limbs extending from the second side of the anchor. A splice is formed in the first limb between a first end of the first limb and the anchor. A self-folding loop is formed in the first limb between the first end and the splice. The second limb extends through the splice in the first limb.

[0010] According to another aspect, a method of securing a first body in a relative position to a bone hole includes, but is not limited to, the steps of: (i) providing a knotless unstable anchor including an anchor having a first side and a second side, with a suture material passing from the first side to the second side, the suture material having an adjustable loop extending from the first side of the anchor, a first limb and a second limb extending from the second side of the anchor, a splice formed in the first limb between a first end of the first limb and the anchor, and a self-folding loop formed in the first limb between the first end and the splice; (ii) passing the second limb through the splice of the first limb; (iii) attaching the passing limb to the adjustable loop via a releasable connection; (v) embedding the anchor in the bone hole; (vi) passing the first limb over at least a portion of the first body to an opposite side of the first body; and (vii) pulling the first limb through the adjustable loop on the opposite side of the first body.

[0011] The suture material or suture as the term is used and described herein includes monofilament or multifilament sutures, as well as other metallic or non-metallic filament or wire-like materials suitable for performing the function of a suture, which may include both bioabsorbable and nonabsorbable materials. [Brief explanation of the drawings]

[0012] The present invention will be more fully understood and appreciated from a reading of the following detailed description in conjunction with the accompanying drawings, which illustrate only exemplary embodiments of the disclosed subject matter, and in which: Therefore, the disclosed subject matter may admit of other equally effective embodiments and should not be considered as limiting its scope.

[0013] Reference will now be made briefly to the accompanying drawings, in which:

[0014] [Figure 1] FIG. 1 is a schematic illustration of a perspective view of suture strands in a first step of creating a pre-deployment configuration of a knotless unstable anchor, according to an embodiment. [Figure 2] FIG. 2 is a schematic illustration of a perspective view of suture strands in a second step of creating a pre-deployment configuration of a knotless unstable anchor, according to an embodiment. [Figure 3] FIG. 3 is a schematic illustration of a perspective view of suture strands in a third step of creating a pre-deployment configuration of a knotless unstable anchor, according to an embodiment. [Figure 4] FIG. 4 is a schematic illustration of a perspective view of suture strands in a fourth step of creating a pre-deployment configuration of a knotless unstable anchor, according to an embodiment. [Figure 5] FIG. 5 is a schematic illustration of a perspective view of a suture strand with an attached pass-through limb, according to one embodiment. [Figure 6] FIG. 6 is a schematic illustration of a perspective view of a suture strand with an attached pass-through limb, according to an alternative embodiment. [Figure 7] FIG. 7 is a schematic illustration of a perspective view of a driver with a knotless unstable anchor loaded in a pre-deployment configuration, according to one embodiment. [Figure 8] FIG. 8 is a schematic illustration of a side view of a knotless unstable anchor in a post-deployment configuration, according to one embodiment. [Figure 9] FIG. 9 is a schematic illustration of a back view of a woven material according to an alternative embodiment. [Figure 10]FIG. 10 is a schematic diagram of a top view of the woven material of FIG. [Figure 11] FIG. 11 is a schematic illustration of a back view of a woven material according to an alternative embodiment. [Figure 12] FIG. 12 is a schematic diagram of a top view of the woven material of FIG. [Figure 13] FIG. 13 is a schematic illustration of a top view of a folded and stitched woven material according to one embodiment. [Figure 14] FIG. 14 is a schematic illustration of a top view of the woven material of FIG. 13 with an additional material covering. [Figure 15] FIG. 15 is a schematic illustration of a side view of one embodiment of a woven material in an undeployed state, according to an alternative embodiment. [Figure 16] 16 is a side schematic view of the woven material of FIG. 15 in a deployed state, shortened and expanded, according to an alternative embodiment. [Figure 17] FIG. 17 is a schematic illustration of a top view of a woven material according to an alternative embodiment. [Figure 18] FIG. 18 is a schematic diagram of a side view of the woven material of FIG. [Figure 19] FIG. 19 is a schematic illustration of a top view of a woven material with a central eyelet according to an alternative embodiment. [Figure 20] FIG. 20 is a schematic representation of a top view of the woven material of FIG. 19 with a length of suture passing through the central eyelet. [Figure 21] FIG. 21 is a schematic illustration of a top view of a woven material loaded with two lengths of suture, according to an alternative embodiment. [Figure 22] FIG. 22 is a schematic illustration of a top view of a woven material loaded with two lengths of suture, according to an alternative embodiment. [Figure 23] FIG. 23 is a schematic illustration of a top view of a woven material having an additional single filament according to an alternative embodiment. [Figure 24] FIG. 24 is a schematic diagram of a side view of the woven material of FIG. 23 loaded into an inserter (driver). [Figure 25]FIG. 25 is a digital photograph of a perspective view of a woven material in an unloaded (not loaded into a fixture or inserter) pre-deployment configuration according to an alternative embodiment. [Figure 26] FIG. 26 is a schematic illustration of a side view of the embodiment of the fabric material of FIG. 25 connected to an attachment device or inserter in a pre-deployment configuration. [Figure 27] 27 is a schematic illustration of a side view of one embodiment of the woven material of FIG. 25 in a deployed configuration positioned in a bone hole. [Figure 28] FIG. 28 is a digital photograph of a side view of one embodiment of the woven material of FIG. 25 in a deployed configuration positioned in a bone hole. [Figure 29] FIG. 29 is a digital photograph of a perspective view of a woven material in an unloaded (not loaded into a fixture or inserter) pre-deployment configuration according to an alternative embodiment. [Figure 30] FIG. 30 is a schematic illustration of a side view of the embodiment of the woven material of FIG. 29 connected to an attachment device or driver in a pre-deployment configuration. [Figure 31] 31 is a schematic illustration of a side view of one embodiment of the woven material of FIG. 29 in a deployed configuration positioned in a bone hole. [Figure 32] FIG. 32 is a schematic illustration of a side view of a portion of a woven material according to an alternative embodiment. [Figure 33] FIG. 33 is a digital photograph of a side view of the woven material embodiment of FIG. 29 in a deployed configuration after an activator has been added. [Figure 34] FIG. 34 is a schematic illustration of a side view of a knotless unstable anchor in a deployed configuration, according to one embodiment. [Figure 35] FIG. 35 is a schematic illustration of a side view of a knotless unstable anchor in a deployed configuration, according to one embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0015] Aspects of the present invention and specific features, advantages, and details thereof will be more fully described with reference to non-limiting examples illustrated in the accompanying drawings. Descriptions of well-known structures are omitted so as not to unnecessarily obscure the invention. It should be understood, however, that the detailed description and specific non-limiting examples, while illustrating aspects of the present invention, are given by way of illustration only and not limitation. Various substitutions, modifications, additions, and / or arrangements within the spirit and / or scope of the central concept of the present invention will be apparent to those skilled in the art from this disclosure.

[0016] As a brief background, suture anchor, as used herein, can include soft suture anchors. Soft suture anchors are formed from filaments of suture material that are retained within a pre-formed bone hole by deforming the filament so that its diameter exceeds the size of the hole, thereby residing within the cancellous bone and subcortically. One such suture anchor is disclosed in U.S. Pat. No. 9,826,971. Because soft anchors are typically made entirely of suture material, they are sometimes referred to as "all-suture" anchors and generally include an anchor body portion of a fibrous construct (or a fibrous, braided, or woven-type structure, such as a flexible web, as described in U.S. Pat. No. 9,173,652, the entirety of which is incorporated herein by reference). Several methods and devices for inserting / deploying such all-suture anchors are known, examples of which are disclosed in U.S. Pat. No. 9,173,652. As described in U.S. Pat. No. 8,409,252, for example, a "non-soft," "hard," or "rigid" suture anchor generally includes a "hard" anchor body portion (which may or may not include an inner member and an outer member) and a suture / filament portion.

[0017] Referring now to the drawings, wherein like reference numerals refer to like parts throughout, an embodiment of the present invention includes a knotless unstable anchor 10 (FIGS. 4-6) including a woven material (anchor) 100, a suture strand (or "suture strand") 12, and a passing filament (or "rim") 14. FIGS. 1 and 2 show schematic diagrams of perspective views of the suture strand 12 in first and second steps to create a pre-deployment configuration of the knotless unstable anchor 10, according to an embodiment. To prepare the suture strand 12 for use, a penetration (or opening) 16 is formed at or near a first end 18 of the suture strand 12, as shown in FIG. 1. In one embodiment, In this configuration, the length of the penetration 16, from the first end 18, is approximately one-third the length of the suture strand 12. The second end 20 of the suture strand 12 is rotated proximally (or counterclockwise) along a central longitudinal yy axis through the suture strand 12. As shown in FIG. 2, the second end 20 passes through the penetration 16 to create a self-folding loop 22, with a first limb 24 and a second limb 26 of the suture strand 12 extending therefrom. Also shown in FIG. 2, the second end 20 is pulled through the penetration 16 and away from the first end 18.

[0018] Referring now to FIG. 3 , a schematic diagram of a perspective view of the suture strand 12 in a third step of creating a pre-deployment configuration of a knotless unstable anchor is shown, according to an embodiment. As shown in FIG. 3 , a splice 28 is created in the second limb 26 of the suture strand 12. In one embodiment, the splice 28 is an eye splice approximately 3 mm to 6 mm in length. In one embodiment, the splice 28 is 2 mm to 5 mm proximal from the second end 20 of the suture strand 12. As also shown in FIG. 3 , the second end 20 of the suture strand 12 passes through the splice 28. The second end 20 is pulled through the splice 28, creating an adjustable loop 30 in the second limb 26 of the suture strand 12.

[0019] Referring now to FIG. 4, a schematic diagram of a perspective view of the suture strands 12 in a fourth step of creating a pre-deployment configuration of a knotless unstable anchor is shown, according to an embodiment. In the fourth step, the adjustable loops 30 are pulled through a woven material 100, which functions as a soft all-suture anchor (e.g., a Y-Knot anchor), as shown in FIG. 4. In the illustrated embodiment, the woven material 100 is a flat, soft, woven material, such as Dyneema. In the illustrated embodiment, the woven material 100 has six pass-through locations 102 at which the adjustable loops 30 (suture strands 12) enter or exit the woven material 100. In a preferred embodiment, the woven material 100 has eight pass-through locations 102 (alternatively, any number of multiple pass-through locations may be used).

[0020] Referring now to FIG. 5, a schematic diagram of a perspective view of a suture strand 12 having a pass-through limb 14 attached thereto is shown, according to one embodiment. As shown in FIG. 5, an adjustable loop 30 is pulled through the woven material 100 so that the suture strand 12 extends from either side 104, 106 of the woven material 100. In the illustrated embodiment, the woven material 100 may be a flat suture tape. FIG. 5 also shows the limb 14 removably connected to the adjustable loop 30 via a removable connection 32. The removable connection 32 may be any well-known type of connection that can be easily untied, such as a slip knot. Referring now briefly to FIG. 6, a schematic diagram of a perspective view of a suture strand 12 having a removable pass-through limb 14 attached thereto is shown, according to an alternative embodiment. In the illustrated embodiment, the woven material 100 may be a Y-Knot anchor (further described with respect to FIGS. 15 and 16).

[0021] Referring now to FIG. 7 , a schematic diagram of a perspective view of a driver 40 loaded with a knotless unstable anchor 10 in a pre-deployment configuration is shown, according to an embodiment. The driver 40 may be constructed of any suitable material, such as stainless steel. The driver 40 may include a handle 34 at a proximal end 36 and a bifurcated distal end 38. To use the knotless unstable anchor 10, the driver 40 is loaded with the knotless unstable anchor 10 in a pre-deployment configuration. Prior to placing the knotless unstable anchor 10, the surgical field is prepared. Typically, an incision is made in the skin distal to the bone where the injury to be repaired is located. A cannula is then inserted through the incision into the area around the bone (e.g., the joint space). A drill guide is then inserted through the cannula and placed in position relative to the bone. A drill bit is inserted through the drill guide to create a bone hole. The drill bit is then removed, and the driver 40 loaded with the knotless unstable anchor 10 is inserted into the bone hole. Thereafter, as shown in FIG. 34, the driver 40 pushes the woven material 100 of the knotless unstable anchor 10 into the bone hole. Start leaking.

[0022] With further reference to FIG. 34, to position the separated tissue 1010 in a desired position relative to the bone, the passing limb 14 and first limb 24 are positioned around or on either side of the separated tissue 1010, as shown. Next, as shown in FIG. 8, the first limb 24 is passed through the adjustable loop 30 over the separated tissue 1010 (FIGS. 34 and 35). In a next step, also shown in FIG. 8, the first limb 24 is pulled through the self-folding loop 22. To adjust the position of the tissue 1010 (FIG. 34) relative to the woven material 100, the second limb 26 is pulled. By pulling the second limb 26 away from the woven material 100, the circumference of the adjustable loop 30 decreases, bringing the tissue 1010 and the woven material 100 (and bone) closer together. When the tissue 1010 is in the desired position relative to the woven material 100 (and bone), the first limb 24 is pulled to fold the self-folding loop 22, securing the tissue 1010 in a relative position to the woven material 100 (and bone) (as would be understood by one of ordinary skill in the art in conjunction with a review of this disclosure).

[0023] Pulling on first limb 24 collapses self-collapsing loop 22, also elongating segment 1000 (FIG. 8) of first limb 24 between splice 28 and opening 16. Segment 1000 elongates because self-collapsing loop 22 becomes smaller (in circumference). As shown in FIG. 34, as self-collapsing loop 22 becomes smaller and segment 1000 elongates, self-collapsing loop 22 rotates around tissue 1010 toward the opposite side of woven material 100 in the bone hole. As shown in both FIGS. 34 and 35, self-collapsing loop 22 moves into a position adjacent adjustable loop 30, while segment 1000 extends over and around tissue 1010. In the deployed configuration, as shown in Figures 34 and 35, the first and second limbs 24, 26 extend from opposite sides of the knotless unstable anchor 10, the woven material 100, and the tissue 1010. Finally, the first and second ends 18, 20 of the suture strand 12 are trimmed.

[0024] 9-30, various schematic views of a woven material (also known as a soft anchor) 100 according to numerous embodiments are shown, which may be used in conjunction with the knotless unstable anchor 10 described herein. Generally, all alternative suture anchor designs described and illustrated below are configured to operate with and be deployed by the driver 40 described herein in the same manner as the woven material 100 and other all suture anchors described and illustrated herein. Alternative embodiments of the woven material 100 may include an anchor body portion of a fibrous construction (or a fibrous, braided, or woven-type structure, such as a flexible web) and a suture or filament portion having a first end and a second end. The suture may be passed through the anchor body in numerous ways (e.g., woven, passed through struts, threaded through the top and bottom, etc., as should be understood by those skilled in the art in conjunction with a review of this disclosure). The anchor body may have a first state in which the anchor body is uncompressed and extends along the longitudinal axis of the suture when in an unfolded, pre-deployed state, and a second state in which the flat anchor body is compressed and expanded in a direction perpendicular to the longitudinal axis of the suture when in the deployed state.

[0025] Referring briefly to Figures 9-12, there are shown schematic front and back views of a woven material 100, according to an embodiment. In Figures 9-12, the woven material 100 is an entire suture anchor braid. Figure 9 shows a back view of the entire suture anchor 100, and Figure 10 shows a front view. As shown, the length of suture 12 passing into and out of the woven material (i.e., anchor braid / fibrous construct) 100 passes through only one (e.g., "front") surface 110 of the anchor braid 100 (Figure 10). Similarly, Figures 11 and 12 show a back view (Figure 12) and a front view (Figure 11) in which the suture 102 passes through only one (e.g., "front") surface 110 of the anchor braid 100 (Figure 12). If the entire suture anchor 100 has sutures 12 passing through only one (e.g., "front") surface 110, the anchor braid 100 protects the sutures 12 from abrasion on the opposing (e.g., "back") surface 108 (FIGS. 9 and 11) when loaded onto the driver 40 (e.g., as should be understood by one of ordinary skill in the art in conjunction with a discussion of this disclosure). In FIGS. 9-12, the sutures 12 pass through the anchor braid 100 at numerous pass locations. In embodiments, the number of pass locations is eight, and some alternative entire suture anchors 100 have six pass locations. The number of pass locations can vary depending on the composition and size of the sutures 12 and / or the anchor braid 100. The number of pass locations can be optimized by balancing input parameters such as anchor braid length, anchor braid width, anchor braid pick density, and suture diameter to obtain output parameters such as manufacturability, anchor creep under load, and tensile strength.

[0026] 13 and 14, top view schematics of an alternative embodiment of a woven material 100 are shown. In FIGS. 13-14, the woven material 100 is an anchor braid 100 having additional material 112. Those skilled in the art should recognize and understand potential embodiments of a Y-knot anchor using additional material for increased strength, such as a monofilament polymer. The additional material 112 can be applied to the entire suture anchor 100. As shown in FIG. 13, the anchor braid 100 is folded in half. The monofilament 112 is used to stitch together each of the two side edges 104, 106 of the anchor braid 100, creating a closed region 114 with the length of suture 12 inside, as shown in FIG. 14. In addition to improving strength, this prevents the anchor braid 100 from rolling on itself during insertion, exposing the suture 12 to bone and causing wear. Additionally, twisting the anchor braid 100 as described, in combination with a denser material running within the shaft of the anchor braid 100, can result in a fully threaded suture anchor 100.

[0027] 15 and 16, there are shown schematic side views of an alternative embodiment of a woven material 100 in pre-deployment and post-deployment configurations. In the illustrated embodiment, the woven material 100 is a soft suture anchor, such as a Y-Knot® anchor. One such suture anchor is disclosed in U.S. Patent No. 9,826,971, assigned to the assignee of the present application and incorporated herein by reference in its entirety.

[0028] An embodiment of a Y-Knot® anchor (or soft anchor or “all-suture” anchor) 100 is illustrated in detail in FIGS. 15 and 16. As shown in FIGS. 15 and 16, the Y-Knot anchor 100 includes at least two sections: at least one suture 12, which is the suture to be secured; and an anchor body 100 (e.g., a fibrous construct, as should be understood by those skilled in the art in conjunction with a review of this disclosure) that forms a portion of the anchor 100 that can increase in width, thickness, and / or diameter and contract in length as part of deployment. Looking at FIG. 15, the anchor body 100 is shown in a pre-deployment configuration, while looking at FIG. 16, the anchor body 100 is shown in a “shortened” and “expanded” post-deployment configuration, which is in addition to the increase due to the pleats. This soft anchor embodiment also utilizes Poisson's ratio, which captures the following cause and effect relationship: That is, compressing a material in a first direction causes the material to expand in a direction perpendicular to the first direction (i.e., when compressed in the x-direction, the material expands in the y- and / or z-directions), and stretching / stretching a material in a first direction causes the material to contract in a direction perpendicular to the first direction. It should be understood that while it is the anchor body 100 that increases in width, thickness, and / or diameter upon deployment, the suture 12 also plays a role in the deployment of the anchor 100, albeit with the suture 12 being free to slide (in some embodiments) and unable to slide (at least at certain locations or points) with respect to the anchor body 100 in other embodiments. The suture 12 may also be removed from the anchor body 100 after deployment of the anchor 100. - The body 100 is free to spill (i.e., release), helping to position, align and support the anchor body 100 so that it collapses and shrinks in size, allowing for easy (and potentially undesirable) removal.

[0029] Thus, anchor body 100 has two primary functions. First, it provides a base for the suture 12 to slide within. Second, when compressed and / or crimped during deployment, anchor body 100 becomes more compact in one direction, thereby expanding outward, increasing its overall width, thickness, or diameter and creating holding capacity. This effect of changing the shape of anchor body 100 and increasing its overall width, thickness, or diameter is a useful feature that can be advantageously used to secure anchor 100 within hole 116 or relative to bone or soft tissue 118. It is this combination of an expanding anchor body 100 coupled with a suture 12 that remains slidable (in some embodiments, and at least at certain locations or points during use, in other embodiments non-slidable) relative to anchor body 100 that makes embodiments of the present invention ideal for soft tissue to bone 118 reattachment or soft tissue to soft tissue reattachment when threading a sliding knot is desired to secure the repair.

[0030] 17 and 18, schematic top and side views of a woven material 100 according to an alternative embodiment are shown. In FIGS. 17 and 18, the woven material 100 is an all-suture anchor braid. As shown in FIGS. 17 and 18, a length of suture 12 passes through approximately the center 120 of the anchor braid 100. In the illustrated embodiment, the length of suture 12 enters the anchor braid 100 through one (e.g., "front") surface 110 and exits through the opposing (e.g., "back") surface 108 of the anchor braid 100. With lengths of suture 12 positioned on either side of the anchor braid 100, the anchor braid 100 can be positioned against the bone while the anchor braid 100 can be loaded onto the driver 40 such that the length of suture 12 is aligned with the driver 40.

[0031] 19 and 20, a top view schematic of a woven material 100 is shown according to an additional alternative embodiment. In FIGS. 19 and 20, the woven material 100 is a fully sutured inverted anchor braid 100. To create the inverted anchor braid 100, a threader with a threading loop is first threaded through the anchor braid 100. It is then pulled through the threading loop at the end of the anchor braid 100. Finally, as shown in FIG. 19, the threading loop is pulled back through the anchor braid 100, creating a central eyelet 105. A length of suture 12 can be loaded onto the inverted anchor braid 100 by passing the length of suture 12 through the anchor braid 100 and, as shown in FIG. 20, passing it through the central eyelet 105, as described in connection with any of the embodiments shown herein.

[0032] In another alternative embodiment, as shown in FIGS. 21 and 22, the woven material 100 is loaded with multiple lengths of sutures 12A, 12B. In the illustrated embodiment, the anchor braid 100 is loaded with two lengths of sutures 12A, 12B. The lengths of sutures 12A, 12B may extend through the anchor braid 100 along its opposing edges 122A, 122B (FIG. 22), through two off-center locations 124A, 124B (FIG. 21), or any conceivable combination thereof (including an extension of the lengths of sutures 12A, 12B through approximately the center 120 of the anchor braid 100). Furthermore, the lengths of sutures 12A, 12B may enter / exit the anchor braid 100 on the same plane (FIGS. 9-12) or on opposing planes (FIGS. 17-18).

[0033] In yet another alternative embodiment, as shown in Figures 23 and 24, the woven material 100 may be a flat braid, a tubular braid, a central suture, multiple density split sutures, or a dense braid. 23 and 24, for example, includes an additional braided monofilament 112. The additional braided monofilament 112 is woven around and through the anchor, as shown in FIG. 23. The additional braided monofilament 112 provides additional anchoring features by creating irregularities in the bone surface via the additional monofilament braid 112, additional anchor "locking" between multiple suture densities (monofilament interdigitation mixed with UHMWPE braid locking / flipping), and / or creating stiff mechanical "barbs" on the exterior surface of the anchor 100 disposed via the base density of the UHMWPE braid. Lengths of suture (not shown) can enter and exit the anchor 100, as described above.

[0034] According to the anchor embodiment, the woven material 100 has open elongated struts / lumens extending from the first end to the second end, and the suture 12 passes at least partially through and is positioned within the open struts. In one embodiment, the suture 12 slides freely through the open struts so that the suture 12 can be removed from the first end of the woven material 100 and the second end of the woven material 100. Embodiments of the woven material 100 can also be tubular in addition to having open elongated struts / lumens. The suture 12 can be woven in situ directly onto a flat tape / woven material 100 (e.g., a rounded section suture braid) or woven with open struts into which a rounded section suture braid can be inserted later.

[0035] In particular, as shown in FIG. 25, a perspective view of a woven material 400 in an unloaded (not loaded into an insertion device or inserter) pre-deployment configuration is shown, according to an embodiment. In the illustrated embodiment, the woven material 400 is a soft suture anchor. The entire suture anchor 400 includes, but is not limited to, a flat fibrous structure 4 having a first end 4A and a second end 4B, and open elongated struts / lumens 6 having a first end 6A and a second end 6B (the first end 6A and second end 6B of the open elongated struts / lumens 6 may extend between or behind the first end 4A and second end 4B of the flat fibrous structure). The open elongated struts / lumens 6 may be woven along or along an axis parallel to the central axis of the flat fibrous structure 4, or may be woven along a path that is not parallel to the central axis. As shown in FIG. 25, the open elongated struts / lumens are woven along the central axis.

[0036] 25 , filament 2 has a first end 2A and a second end 2B and is shown positioned at least partially through open strut 6. In one embodiment, filament 2 slides freely through open strut 6 such that filament 2 can be removed from first end 2A of fibrous construct 2 and / or second end 2B of fibrous construct 2 and from open strut 6. According to an alternative embodiment, filament 2 is locked and not slidable through open strut 6.

[0037] 26 and 27, there are shown schematic side views of an embodiment of a whole suture anchor 400 in pre-deployment and post-deployment configurations. As discussed above, the whole suture anchor 400 includes at least two sections: at least one suture 2 having a first end 2A and a second end 2B; an anchor body / fiber construct 4 having a first end 4A and a second end 4B; and an open elongate strut / lumen 6 extending to the first end 6A and the second end 6B, which form a portion of the anchor 400 that can increase in width, thickness, and / or diameter and can decrease in length as part of deployment.

[0038] As shown in FIG. 26, the attachment device (or driver 40 as described herein) is provided in a pre-deployment configuration. The entire suture anchor 400 is shown connected to the distal deployment end 804 of the attachment device 800 (which may be the driver 40 of an embodiment described herein). 8A, which may be inserted into the bone hole 900. The distal deployment end 804 and entire suture anchor 100 are shown positioned within a bone hole 900 in cancellous bone 904 below the bone cortex 902. To deploy the entire suture anchor 400 (which may be connected to other tissue that needs to be brought into apposition to the bone, as should be understood by those skilled in the art in conjunction with a discussion of this disclosure), the first end 2A and / or the second end 2B are pulled away from the bone hole 900 under tension. The first end 2A and the second end 2B can be pulled away from the bone hole 900 with or without the insertion device 800 in place within the bone hole 900 (which, when in place within the bone hole 900, acts as a counter force to the pulling force from the hole 900, assisting in the deployment of the entire suture anchor 400).

[0039] As shown in FIG. 27, the anchor body / fiber construct 4 "shortens" and "expands" in a deployed configuration, shown locked in the bone hole 900, which may be in addition to the augmentation due to pleats formed by the fibrous construct 4 (which may be part of the fibrous construct 4). See also FIG. 28. The entire suture anchor 400, and in particular the fibrous construct 4, also utilizes Poisson's ratio (as described above for other anchors), which captures the following cause and effect relationship: compressing a material in a first direction causes the material to expand in a direction perpendicular to the first direction (i.e., if compressed in the x-direction, the material will expand in the y- and / or z-directions), and stretching / stretching the material in the first direction causes the material to contract in a direction perpendicular to the first direction. It should be understood that while it is the anchor body / fibrous construct 4 that increases in width, thickness, and / or diameter upon deployment, the suture 2 also plays a role in the deployment of the anchor 400, albeit with the suture 2 freely sliding (in some embodiments) and not being able to slide (at least in certain locations or points) in other embodiments relative to the anchor body 4. The suture 2 helps to position, align, and support the anchor body 4 (as should be understood by one of ordinary skill in the art in conjunction with a discussion of this disclosure).

[0040] Thus, the anchor body / fibrous construct 4 has two primary functions. First, it provides a base for the suture 2 to slide within (within the strut / lumen 6). Second, when compressed and / or pleated during deployment, the anchor body 4 becomes more compact in one direction, thereby expanding outward, increasing its overall width, thickness, or diameter and creating retention capabilities. This effect of changing the shape of the anchor body 4 and increasing its overall width, thickness, or diameter is a useful feature that can be advantageously used to secure the anchor 400 within the hole 900 or to bone or soft tissue. It is this combination of an expanding anchor body 4 coupled with a suture 2 that remains slidable (in some embodiments, and at least at certain locations or points during use; in other embodiments, non-slidable) relative to the anchor body 4 that makes embodiments of the present invention ideal for soft tissue to bone reattachment or soft tissue to soft tissue reattachment when threading a sliding knot is desired to secure the repair.

[0041] In one embodiment, an inventive design, structure, and resulting function of a soft all-suture anchor utilizing a hybrid combination of soft implantable materials is provided. The hybrid soft all-suture anchor of one embodiment includes superior pullout strength characteristics compared to conventional soft all-suture anchors. Embodiments of the present invention provide a soft all-suture anchor that is better suited for use in hard bone, in part, due to the hybrid expandable component portion. These embodiments are also suitable for use in soft, cancellous bone with a very thin or weak cortical layer. The hybrid all-suture anchor may include, but is not limited to, an expandable member / portion configured to increase in size from a first pre-deployed state to a second deployed state upon application of an activator, and a filament having a first filament and a second filament positioned in contact with the expandable member in the second deployed state. The anchor may also include a flat fibrous construct having a first end and a second end, with the filament passing through the fibrous construct. The flat fibrous construct is uncompressed and stretched along the longitudinal axis of the filaments when the flat fibrous construct is in an unfolded, pre-deployed state. The suture anchor may have a first state in which it extends along the length of the filament, and a second state in which it is compressed and expanded in a direction perpendicular to the longitudinal axis of the filament in a deployed state with the flattened filamentous construct. The structure, configuration, and functionality (as some embodiments) of the expandable member and the filamentous construct serve to set and retain the anchor in the bone hole in the deployed state. The expandable portion / member can be part of a hybrid all-suture anchor used with only any filament portion (as described herein). The expandable portion / member can also be part of a hybrid all-suture anchor used with any filament portion and any filamentous construct portion (as described herein).

[0042] For example, referring to Figure 29, a perspective view of a hybrid soft all suture anchor 500 in a pre-deployed configuration is shown, according to an embodiment. Hybrid all suture anchor 500 can include, but is not limited to, a flat fibrous construct 4 having a first end 4A and a second end 4B. Filament 2 has a first end 2A and a second end 2B and is shown woven, threaded, or otherwise passing through fibrous construct 4 at pass-through locations 25, 27 and 25, 28. For a further description of the structural aspects of the filaments and fibrous constructs that are part of this embodiment of the invention (and should be understood by those skilled in the art in conjunction with a discussion of this disclosure), see U.S. Patent No. 9,826,971.

[0043] In one embodiment, the filament 2 freely slides through the fibrous construct 4 (and the expandable portion 3 when attached thereto) such that the filament 2 can be removed from the fibrous construct 4 from the first end 4A of the fibrous construct 4 and / or the second end 4B of the fibrous construct 4. According to an alternative embodiment, the filament is locked and not slidable through the fibrous construct 4 and / or the expandable portion 3 (when attached to the expandable portion 3).

[0044] 30 and 31 , there are shown schematic side views of an embodiment of a whole suture anchor 500 in a pre-deployed and a post-deployed configuration. As discussed above, the whole suture anchor 500 includes at least two sections: at least one suture 2 having a first end 2A and a second end 2B; and an anchor body / fibrous construct 4 having a first end 4A and a second end 4B, configured to form a portion of the anchor 500 that can increase in width, thickness, and / or diameter and can decrease in length as part of deployment. The whole suture anchor 500 also includes an expandable portion 3 (as should be understood by one of ordinary skill in the art in conjunction with a discussion of this disclosure) configured to form a portion of the anchor 500 that can increase in size in the post-deployed configuration in response to an activator.

[0045] As shown in FIG. 30 , an attachment device (or inserter as described herein) is provided in a pre-deployment configuration. The entire suture anchor 500 is shown connected to the distal deployment end 804 of the attachment device 800, which may be an inserter, as described above in this specification, and also includes a handle 802. The distal deployment end 804 and entire suture anchor 500 are shown positioned within a bone hole 900 in cancellous bone 904 below the bone cortex 902. To deploy the entire suture anchor 500 (which may be connected to other tissue that needs to be brought into apposition to the bone, as should be understood by those skilled in the art in conjunction with the discussion of this disclosure), the first end 2A and / or the second end 2B are pulled away from the bone hole 400 under tension. The first and second ends 2A, 2B can be pulled and drawn away from the bone hole 900, with or without the insertion device 800 in place within the bone hole 900 (which, when the insertion device 800 is in place within the bone hole 900, acts as a counter force to the pulling force from the hole 900, aiding in the placement of the entire suture anchor 500). Additionally, an activator can be added to the anchor to expand the expandable portion to a second size that is greater than the first pre-deployment size. In one embodiment, the activator is water.

[0046] As shown in FIG. 31 , the anchor body / fiber construct 4 “shortens” and “expands” in its deployed configuration and is shown locked in the bone hole 900, which may be in addition to the augmentation due to pleats formed by the fibrous construct 4 (which may be a portion of the fibrous construct 4). The entire suture anchor 500, and in particular the fibrous construct 4, also utilizes Poisson's ratio (also as described above), which captures the following cause and effect relationship: compressing a material in a first direction causes the material to expand in directions perpendicular to the first direction (i.e., if compressed in the x-direction, the material will expand in the y- and / or z-directions), and stretching / stretching the material in a first direction causes the material to contract in directions perpendicular to the first direction. It should be understood that while it is the anchor body / fibrous construct 4 that increases in width, thickness, and / or diameter upon deployment, the suture 2 also plays a role in the deployment of the anchor 500, albeit with the suture 2 being free to slide (in some embodiments) and unable to slide (at least at certain locations or points) in other embodiments relative to the anchor body 4. The suture 2 helps to position, align, and support the anchor body 4 (as should be understood by one of ordinary skill in the art in conjunction with a discussion of this disclosure).

[0047] Thus, the anchor body / fibrous construct 4 has two primary functions. First, it provides a base for the suture 2 to slide within (within the strut / lumen 6). Second, when compressed and / or pleated during deployment, the anchor body 4 becomes more compact in one direction, thereby expanding outward, increasing its overall width, thickness, or diameter and creating retention capabilities. This effect of changing the shape of the anchor body 4 and increasing its overall width, thickness, or diameter is a useful feature that can be advantageously used to secure the anchor 500 within the hole 900 or relative to bone or soft tissue. It is this combination of an expanding anchor body 4 coupled with a suture 2 that remains slidable (in some embodiments, and at least at certain locations or points during use; in other embodiments, non-slidable) relative to the anchor body 804 that makes embodiments of the present invention ideal for soft tissue to bone reattachment or soft tissue to soft tissue reattachment when threading a sliding knot is desired to secure the repair.

[0048] 31 , the expandable portion 3 is shown at an expanded second size, larger than the first, smaller, pre-deployment size, after being exposed to an activator. The expandable portion expands in volume upon exposure to the activator and wedges in the bone hole 900, locking the anchor 500 in place. According to embodiments, the filament 2 may be freely slidable back and forth through the fibrous construct 4 and the expandable portion 3 (as may be required when connected to the expandable portion 3) to tension the filament 2 and reattach soft tissue (not shown). In certain situations where the fibrous construct 4 is not present, the slidable filament 2 may be cut through the expandable portion 3, thereby resulting in less than optimal deployment of the entire suture anchor 500. Therefore, in some embodiments of the entire suture anchor 500, with or without the fibrous construct 4, a short second length of suture 2-1 is wrapped or looped around the filament 2 (see FIG. 32) to prevent the filament 2 from sewing / cutting through the expandable portion 3 when it contacts the expandable portion 3.

[0049] 33, there is shown a digital photographic side view of the entire suture anchor embodiment of FIG. 29 in a deployed configuration after the addition of an activator, according to an embodiment. As shown, the expandable portion 3 has increased in size to a second deployed configuration state (the bone hole is not shown to illustrate the extent of expansion of the expandable portion 3), and the filament 2 is positioned through and / or otherwise contacting the expandable portion 3.

[0050] Similarly with respect to the filament 2 and fibrous construct 4 described above and the embodiment shown in Figures 30-32, the expandable portion 3 may be part of any overall suture anchor described herein. The expandable portion 3 may have a fibrous structure or may include an entire suture anchor as shown and described in U.S. Patent Application No. 16 / 033,616. The same structure and function of the expandable portion 3 described above and shown in Figures 30-32 are applicable to these embodiments of an entire suture anchor (with or without a fibrous structure).

[0051] Definitions and all definitions used herein should be understood to control for dictionary definitions, documents incorporated by reference, and / or ordinary meanings of the defined terms.

[0052] While various inventive embodiments have been described and illustrated herein, those skilled in the art will readily envision numerous other means and / or structures for performing the functions and / or obtaining one or more of the results and / or advantages described herein, and each such variation and / or modification is deemed to be within the scope of the inventive embodiments described herein. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are exemplary, and that the actual parameters, dimensions, materials, and / or configurations will depend on the specific application or applications for which the teachings are used. Those skilled in the art will recognize or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments described herein. Accordingly, the foregoing embodiments are presented merely as exemplary, and it will be understood that, within the scope of the appended claims and their equivalents, embodiments may be practiced otherwise than as specifically described and claimed. Embodiments of the present disclosure are directed to each individual feature, system, article, material, kit, and / or method described herein. Furthermore, any combination of two or more such features, systems, articles, materials, kits, and / or methods is within the scope of the present disclosure, provided that such features, systems, articles, materials, kits, and / or methods are not mutually inconsistent.

[0053] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly dictates otherwise. It will be further understood that the terms "comprise" (and any form of comprise, such as "comprises" or "comprising"), "have" (and any form of have, such as "has" or "having"), "include" (and any form of include, such as "includes" or "including"), and "contain" (and any form of contain, such as "contains" or "containing") are open-ended linking verbs. Consequently, a method or apparatus "comprises," "have," "include," or "contain" one or more steps or elements. Similarly, a method step or apparatus element that "comprises," "has," "includes," or "contains" one or more features has those one or more features, but is not limited to possessing only those features or features. Furthermore, an apparatus or structure that is configured in a particular way is configured in at least that way, but may also be configured in ways not listed.

[0054] The corresponding structure, material, acts, and equivalents of all means or step-plus-function elements in the following claims are intended to include the structure, material, or acts for performing the function, if any, in combination with the elements of other claims that are specifically claimed. The description of the present invention has been presented for purposes of illustration and description, but is not intended to be exhaustive or limited to the invention in the form disclosed. Many modifications and variations may be made without departing from the scope and spirit of the invention. The embodiments have been chosen and described in order to best explain the principles and practical applications of one or more aspects of the invention and to enable others skilled in the art to appreciate one or more aspects of the invention in various embodiments with various modifications suited to the particular uses contemplated.

Claims

1. A knotless unstable anchor, 1. An anchor having a first side and a second side, with suture material passing from the first side to the second side, an anchor, the suture material having an adjustable loop extending from the first side of the anchor and first and second limbs extending from the second side of the anchor; a splice formed in the first limb between a first end of the first limb and the anchor; a self-folding loop formed in the first limb between the first end and the splice, the second limb includes a self-folding loop extending through the splice of the first limb.

2. The anchor of claim 1 , wherein the self-folding loop is formed in the first limb by threading the second end of the second limb through an opening in the first limb.

3. The anchor of claim 1 , wherein the suture material is a single continuous strand of suture.

4. The anchor of claim 1 , wherein the suture material passes through the anchor at two or more pass locations.

5. The anchor of claim 1 , wherein the second limb is configured to be pulled to reduce a circumference of the adjustable loop from a first size to a second size that is smaller than the first size.

6. The anchor of claim 1 , wherein the anchor is selected from the group consisting of all suture anchors.

7. The anchor of claim 1 , further comprising a pass-through limb removably connected to the adjustable loop.

8. The anchor of claim 1 , further comprising a segment at the first limb between the splice and the self-folding loop that increases in length as the circumference of the self-folding loop decreases.

9. The anchor of claim 1 , wherein the knotless unstable anchor further comprises a driver loaded thereon.

10. The anchor of claim 1 , wherein the first limb is configured to pass through the adjustable loop and the self-folding loop.

11. The anchor of claim 10 , wherein the first limb is configured to be pulled to reduce the circumference of the self-collapsing loop from a first size to a second size that is smaller than the first size.

12. 1. A method of fixing a first body in a relative position to a bone hole, the method comprising: a first side and a second side, and a suture material is passed from the first side to the second side; providing a knotless unstable anchor including a pass-through anchor, the suture material having an adjustable loop extending from the first side of the anchor, first and second limbs extending from the second side of the anchor, a splice formed in the first limb between a first end of the first limb and the anchor, and a self-folding loop formed in the first limb between the first end and the splice; passing the second limb through the splice of the first limb; attaching a pass-through limb to the adjustable loop via a releasable connection; embedding the anchor into a bone hole; passing the first rim over at least a portion of the first body to an opposite side of the first body; and pulling the first limb through the adjustable loop on the opposite side of the first body.

13. The method of claim 12 further comprising pulling the first limb through the self-folding loop on the first limb.

14. 14. The method of claim 13, further comprising pulling on the second limb to reduce the circumference of the adjustable loop to a second size smaller than the first size.

15. 15. The method of claim 14, further comprising pulling the first limb to reduce the circumference of the self-collapsing loop to a second size smaller than the first size.

16. 16. The method of claim 15, further comprising increasing the length of the segment between the splice and the self-folding loop by decreasing the circumference of the self-folding loop.

17. 16. The method of claim 15, wherein the self-folding loop is rotated to the opposite side of the first body by decreasing the circumference of the self-folding loop.

18. The method of claim 12 further comprising loading the knotless unstable anchor onto a driver.

19. The method of claim 12 , wherein the first body is tissue.

20. The method of claim 12, wherein the anchor is a full suture anchor.

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