阅读说明：本技术 无结不稳定锚 (Knotless unstable anchor ) 是由 朱塞佩·隆巴尔多 格雷迪·布雷斯利希 彼得·米勒 艾德里安·博斯沃思 于 2018-11-15 设计创作，主要内容包括：一种无结不稳定锚,所述无结不稳定锚具有锚,所述锚具有第一侧和第二侧的锚,缝线材料从所述第一侧到所述第二侧穿过所述锚。所述缝线材料具有从所述锚的所述第一侧延伸的可调节环以及从所述锚的所述第二侧延伸的第一分支和第二分支。在所述第一分支的第一端部与所述锚之间的所述第一分支中形成接头。在所述第一端部与所述接头之间的所述第一分支中形成自塌缩环。所述第二分支延伸穿过所述第一分支中的所述接头。(A knotless unstable anchor having an anchor with a first side and a second side through which suture material is passed 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 branches extending from the second side of the anchor. A joint is formed in the first branch between a first end of the first branch and the anchor. A self-collapsing ring is formed in the first branch between the first end and the joint. The second branch extends through the joint in the first branch.)

1. A knotless unstable anchor comprising:

an anchor having a first side and a second side, suture material passing through the anchor from the first side to the second side,

wherein the suture material has an adjustable loop extending from the first side of the anchor and first and second branches extending from the second side of the anchor;

A joint formed in the first branch between a first end of the first branch and the anchor;

a self-collapsing ring formed in the first branch between the first end and the joint; and is

Wherein the second branch extends through the joint in the first branch.

2. The anchor of claim 1, wherein the self-collapsing loop is formed in the first branch by passing the second end of the second branch through an aperture in the first branch.

3. Anchor according to claim 1, in which the suture material is one continuous suture strand.

4. The anchor of claim 1 wherein the suture material passes through the anchor at more than one pass-through location.

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

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

7. The anchor of claim 1, further comprising a pass-through branch releasably connected to the adjustable ring.

8. The anchor of claim 1, further comprising a segment between the linker and the self-collapsing ring in the first branch, the segment increasing in length as the circumference of the self-collapsing ring decreases.

9. The anchor of claim 1, further comprising a driver on which the knotless unstable anchor is loaded.

10. The anchor of claim 1, wherein the first branch is configured to pass through the adjustable ring and the self-collapsing ring.

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

12. A method of securing a first body in position relative to a bone hole, the method comprising the steps of:

providing a knotless unstable anchor, said knotless unstable anchor comprising: an anchor having a first side and a second side through which suture material passes from the first side to the second side, wherein the suture material has an adjustable loop extending from the first side of the anchor and first and second branches extending from the second side of the anchor; a joint formed in the first branch between a first end of the first branch and the anchor; and a self-collapsing ring formed in the first branch between the first end and the joint;

passing the second branch through the junction in the first branch;

Attaching the passing branch to the adjustable ring via a releasable connection;

implanting the anchor into a bone hole;

passing the first branch over at least a portion of the first body to an opposite side of the first body; and

pulling the first leg through the adjustable ring on the opposite side of the first body.

13. The method of claim 12, further comprising the steps of: pulling the first branch through the self-collapsing ring on the first branch.

14. The method of claim 13, further comprising the steps of: pulling the second branch to reduce the circumference of the adjustable ring to a second size that is less than the first size.

15. The method of claim 14, further comprising the steps of: pulling the first leg to reduce a circumference of the self-collapsing ring to a second size that is smaller than the first size.

16. The method of claim 15, wherein decreasing the perimeter of the self-collapsing ring increases the length of a fragment between the linker and the self-collapsing ring.

17. The method of claim 15, wherein reducing the circumference of the self-collapsing ring rotates the self-collapsing ring to an opposite side of the first body.

18. The method of claim 12, further comprising the steps of: loading the knotless unstable anchor onto a drive.

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.

Technical Field

The present disclosure relates generally to suture anchor devices for soft tissue to bone repair procedures, and more particularly, to a knotless unstable anchor having a sliding configuration for tissue tensioning and a joint to fix tissue in place relative to bone.

Background

Suture anchors are commonly used in surgery to repair soft tissue to bone. Typically, they are inserted into preformed holes and then sutures are passed through the tissue to be repaired. In many cases, the sliding knot allows for better control of tissue tensioning as the surgeon manipulates the sliding knot to appose the tissue to the bone. In doing so, the tissue is naturally brought back to the origin of the suture and stops moving directly over the preformed hole or guide hole. To secure the sliding knot, the surgeon will complete the procedure by tying one or more alternate knot ties. The act of tying a knot presents a number of challenges to the surgeon, particularly when performing the act with an arthroscope. Furthermore, in some cases, knots are considered a source of post-operative pain caused by irritation from the knot pile.

Various types of suture anchors have been deployed that secure sutures in place without requiring the surgeon 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 the driver to be engaged with the anchor while the suture is tensioned to appose the tissue to the bone. Since the driver is still engaged in the guide hole, the tissue is prevented from being able to be tensioned so that the tissue is located directly above the guide hole (the origin of the suture), thereby giving a less than ideal tissue position and hindering adjustment of the suture tension.

There are conventional solutions to the tissue location problem achieved by implementing an adjustable ring formed around the tissue to be repaired. In this case, the anchor is installed in the bone and the driver is removed. One branch of the suture is free and passes through the tissue and then into a loading filament which passes the tissue back through the suture branch, which forms a unidirectional loop. This requires that the upright end of the suture remain fixed so that it acts as a finger trap when tensioning the loop, preventing the loop from loosening. This method also requires that long lengths of suture be passed through or around the tissue before the loop is reduced, which can cause tissue damage due to abrasion. Furthermore, the fixed end must be located deep in the hole and must not migrate or be strained. Finally, devices of this type are constructed of rigid materials that can damage tissue if pulled out of the hole during healing.

Accordingly, there is a need for an easy to use suture anchor constructed of soft materials that secures sutures without the need for tying knots and facilitates the ability to adjust, maintain and position tissue in the desired location of the guide hole during anchor installation.

Disclosure of Invention

Embodiments of the present invention recognize potential problems and/or disadvantages associated with conventional knotted or knotless suture constructions. For example, knotted and unstructured constructs can be large and rigid enough to cause irritation, and require constant engagement of the driver during installation, which results in less than ideal positioning of the tissue over the bone hole (as described above). Accordingly, there is a need for an easy to use suture anchor constructed of soft materials that secures sutures without the need for tying knots and facilitates the ability to adjust, maintain and position tissue in the desired location of the guide hole during anchor installation. Various embodiments of the present invention may be advantageous in that they may address or reduce one or more of the potential problems and/or disadvantages discussed herein.

The present disclosure relates to inventive configurations, structures, and resulting functions of knotless unstable anchors and methods for securing a first body in place relative to a bone hole. The knotless unstable anchor comprises an anchor having a first side and a second side through which suture material is passed from the first side to the second side. The suture material has an adjustable loop extending from a first side of the anchor and first and second branches extending from a second side of the anchor. A joint is formed in the first branch between the first end of the first branch and the anchor. A self-collapsing ring is formed in the first branch between the first end and the joint. The second branch extends through the joint in the first branch.

According to another aspect, a method of securing a first body in position relative to a bone hole includes (but is not limited to) the steps of: (i) providing a knotless unstable anchor, said knotless unstable anchor comprising: an anchor having a first side and a second side through which suture material passes from the first side to the second side, wherein the suture material has an adjustable loop extending from the first side of the anchor and first and second branches extending from the second side of the anchor; a joint formed in the first branch between the first end of the first branch and the anchor; and a self-collapsing ring formed in a first branch between the first end and the joint; (ii) passing the second branch through the junction in the first branch; (iii) attaching the passing branch to the adjustable ring via a releasable connection; (v) implanting an anchor into a bone hole; (vi) passing the first leg over at least a portion of the first body to an opposite side of the first body; and (vii) pulling the first leg through the adjustable ring on an opposite side of the first body.

The term "suture material" or "suture" as used and described herein includes single or multi-filament sutures as well as any other metallic or non-metallic wire-like or thread-like material suitable for performing the function of suturing. Such materials may include bioabsorbable and non-absorbable materials.

Drawings

The invention will be more fully understood and appreciated from a reading of the following detailed description in conjunction with the drawings. The drawings illustrate only typical embodiments of the disclosed subject matter and are therefore not to be considered limiting of its scope, for the disclosed subject matter may admit to other equally effective embodiments.

Referring now briefly to the drawings, wherein:

fig. 1 is a perspective schematic view of a suture strand at a first step of forming a pre-deployment configuration of a knotless unstable anchor, according to an embodiment;

fig. 2 is a perspective schematic view of a suture strand at a second step of forming a pre-deployment configuration of a knotless unstable anchor, according to an embodiment;

fig. 3 is a perspective schematic view of a suture strand at a third step of forming a pre-deployment configuration of a knotless unstable anchor, according to an embodiment;

fig. 4 is a perspective schematic view of a suture strand at a fourth step of forming a pre-deployment configuration of a knotless unstable anchor, in accordance with an embodiment;

FIG. 5 is a perspective schematic view with suture strands attached through branches according to an embodiment;

FIG. 6 is a perspective schematic view of a suture strand with a pass-through branch attached according to an alternative embodiment;

fig. 7 is a perspective schematic view of a driver loaded with knotless unstable anchors in a pre-deployment configuration, according to an embodiment;

fig. 8 is a side view schematic illustration of a knotless unstable anchor in a post-deployment configuration, according to an embodiment;

FIG. 9 is a schematic rear view of a woven material according to an alternative embodiment;

FIG. 10 is a schematic top view of the woven material of FIG. 9;

FIG. 11 is a schematic rear view of a woven material according to an alternative embodiment;

FIG. 12 is a schematic top view of the woven material of FIG. 11;

FIG. 13 is a schematic top view of a folded and stitched woven material according to an embodiment;

FIG. 14 is a schematic top view of the woven material of FIG. 13 with an additional material covering;

fig. 15 is a side view schematic diagram of an embodiment of a woven material in an undeployed state according to an alternative embodiment;

FIG. 16 is a schematic side view of the woven material of FIG. 15 foreshortened and expanded in a deployed state, according to an alternative embodiment;

FIG. 17 is a schematic top view of a woven material according to an alternative embodiment;

FIG. 18 is a schematic side view of the woven material of FIG. 17;

FIG. 19 is a schematic top view of a woven material having a central aperture according to an alternative embodiment;

FIG. 20 is a schematic top view of the woven material of FIG. 19 with a length of suture passing through the central eyelet;

FIG. 21 is a schematic top view of a woven material loaded with two lengths of suture according to an alternative embodiment;

FIG. 22 is a schematic top view of a woven material loaded with two lengths of suture according to an alternative embodiment;

FIG. 23 is a schematic top view of a woven material with additional monofilaments in accordance with an alternative embodiment;

FIG. 24 is a schematic side view of the woven material of FIG. 23 loaded on an inserter (or driver);

fig. 25 is a perspective digital photograph of a woven material in an unloaded (not loaded onto a mounting device or inserter), pre-deployment configuration, in accordance with an alternative embodiment;

FIG. 26 is a side schematic view of the embodiment of the woven material of FIG. 25 connected to a mounting device or inserter in a pre-deployment configuration;

FIG. 27 is a side schematic view of an embodiment of the woven material of FIG. 25 positioned in a bone hole in a post-deployment configuration;

FIG. 28 is a side view digital photograph of the embodiment of the woven material of FIG. 25 positioned in a bone hole in a post-deployment configuration;

Fig. 29 is a perspective digital photograph of a woven material in an unloaded (not loaded onto a mounting device or inserter), pre-deployment configuration, in accordance with an alternative embodiment;

FIG. 30 is a side schematic view of the embodiment of the woven material of FIG. 29 connected to a mounting device or inserter in a pre-deployment configuration;

FIG. 31 is a side schematic view of an embodiment of the woven material of FIG. 29 positioned in a bone hole in a post-deployment configuration;

FIG. 32 is a schematic side view of a portion of a woven material according to an alternative embodiment;

FIG. 33 is a side view digital photograph of the embodiment of the woven material of FIG. 29 in a post-deployment configuration after addition of an activator;

fig. 34 is a side view schematic illustration of a knotless unstable anchor in a post-deployment configuration, under an embodiment; and

fig. 35 is a side view schematic illustration of a knotless unstable anchor in a post-deployment configuration, under an embodiment.

Detailed Description

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

By way of brief background, the term suture anchor, as used herein, may include a soft suture anchor. Soft suture anchors are formed from filaments of suture material that are retained within a preformed bone hole by being deformable to increase their diameter to a size larger than the bone hole so as to reside within cancellous bone and below cortical bone. One such suture anchor is disclosed in U.S. patent No. 9826971. Since soft anchors are often made entirely of suture material, they are sometimes referred to as "full suture" anchors and typically include a fibrous construct anchor body portion (or a fibrous, braided or woven fabric-type structure, such as a flexible mesh, as described in U.S. patent No. 9173652, the contents of which are incorporated herein by reference in their entirety) and a suture or filament portion. Some methods and devices for inserting/deploying such full suture anchors are known, examples of which are disclosed in U.S. patent No. 9173652.

Referring now to the drawings, wherein like reference numerals refer to like parts throughout, embodiments of the present invention include a knotless unstable anchor 10 comprising a woven material (anchor) 100, a strand of suture (or "suture strand") 12, and a passing filament (or "passing branch") 14 (fig. 4-6). Fig. 1-2 show perspective schematic views of suture strands 12 at first and second steps of forming a pre-deployment configuration of knotless unstable anchor 10, according to an embodiment. To prepare the suture strand 12 for use, as shown in fig. 1, a perforation (or aperture) 16 is formed at or near a first end 18 of the suture strand 12. In one embodiment, the perforations 16 are about 1/3 the length of the suture strands 12 from the first end 18. The second end 20 of the suture strand 12 is rotated proximally (or counterclockwise) through the suture strand 12 along the central longitudinal y-y axis. As shown in fig. 2, the second end 20 is passed through the perforation 16, which forms a self-collapsing loop 22 from which first and second branches 24, 26 of the suture strand 12 extend. As also shown in fig. 2, the second end 20 is pulled through the perforation 16 and away from the first end 18.

Turning now to fig. 3, a perspective schematic view of the suture strand 12 in a third step of forming a pre-deployment configuration of a knotless unstable anchor is shown, according to an embodiment. As shown in fig. 3, a splice 28 is formed in the second branch 26 of the suture strand 12. In one embodiment, the connector 28 is an eye connector having a length of about 3mm to 6 mm. In embodiments, the joint 28 is 2mm to 5mm proximal of the second end 20 of the suture strand 12. As also shown in fig. 3, the second ends 20 of the suture strands 12 are threaded through the joint 28. The second end 20 is pulled through the joint 28, which forms an adjustable loop 30 in the second branch 26 of the suture strand 12.

Referring now to fig. 4, a perspective schematic view of suture strands 12 in a fourth step of forming a pre-deployment configuration of a knotless unstable anchor is shown, according to an embodiment. At a fourth step, as shown in fig. 4, adjustable loop 30 is pulled through woven material 100, which woven material 100 acts as a soft, full suture anchor (e.g., a Y-tie anchor). In the depicted embodiment, the woven material 100 is a flat, flexible woven material, such as a denim. In the depicted embodiment, the woven material 100 has six pass-through locations 102 in which the adjustable loops 30 (suture strands 12) enter or exit the woven material 100. In a preferred embodiment, woven material 100 has eight pass-through locations 102 (alternatively, there can be any number of multiple pass-through locations).

Turning now to fig. 5, a perspective schematic view of a suture strand 12 with a pass-through branch 14 attached is shown according to an embodiment. As shown in fig. 5, the adjustable loop 30 has been pulled through the woven material 100 such that the suture strands 12 extend from either side 104, 106 of the woven material 100. In the depicted embodiment, the woven material 100 may be a flat suture strip. Fig. 5 also shows the pass-through branch 14 releasably connected to the adjustable ring 30 via a releasable connection 32. The releasable connection 32 may be any known type of connection that can be easily undone, such as, for example, a slip knot. Referring briefly now to fig. 6, a perspective schematic view of a suture strand 12 with a releasable passing branch 14 attached is shown according to an alternative embodiment. In the depicted embodiment, the woven material 100 may be a Y-tie anchor (as further described with respect to fig. 15 and 16).

Referring now to fig. 7, a perspective schematic view of a driver 40 loaded with knotless unstable anchors 10 in a pre-deployment configuration is shown, according to an embodiment. The driver 40 may be composed of any suitable material, such as stainless steel. The driver 40 may include a handle 34 at the proximal end 36 and a forked distal end 38. To use knotless unstable anchor 10, driver 40 is loaded with knotless unstable anchor 10 in the pre-deployment configuration. The surgical field is prepared prior to deployment of the knotless unstable anchor 10. Typically, an incision is made through the skin distal to the bone having the injury to be repaired. Next, a cannula is inserted through the incision and into the area surrounding the bone (e.g., joint space). The drill guide is then inserted through the cannula and placed in position against the bone. A drill bit is inserted through the drill guide to form a bone hole. Next, the drill bit is removed and driver 40, loaded with knotless unstable anchor 10, is inserted into the bone hole. Driver 40 then pushes woven material 100 of knotless unstable anchor 10 into the bone hole as shown in fig. 34.

Still referring to fig. 34, to place the separated tissue 1010 in a desired position relative to the bone, the pass through branch 14 and the first branch 24 are positioned around or on opposite sides of the separated tissue 1010, as shown. Next, as shown in fig. 8, the first branch 24 is passed through the adjustable ring 30 over the separated tissue 1010 (fig. 34-35). At the next step, the first branch 24 is pulled through the self-collapsing ring 22, as also shown in fig. 8. To adjust the positioning of the tissue 1010 (fig. 34) relative to the woven material 100, the second branch 26 is pulled. Pulling the second branch 26 in a direction away from the woven material 100 reduces the circumference of the adjustable loop 30 and brings the tissue 1010 and the woven material 100 (and bone) closer together. When the tissue 1010 is in a desired position relative to the woven material 100 (and bone), the first branch 24 is pulled to collapse the self-collapsing loops 22, which secures the tissue 1010 in position relative to the woven material 100 (and bone) (as will be understood by those of ordinary skill in the art in view of a review of this disclosure).

Pulling the first branch 24 and collapsing the self-collapsing ring 22 also causes a segment 1000 (fig. 8) in the first branch 24 between the junction 28 and the aperture 16 to elongate. The segment 1000 elongates by virtue of becoming smaller (in circumference) from the collapsed ring 22. As the self-collapsing ring 22 becomes smaller and the segment 1000 elongates, the self-collapsing ring 22 rotates around the tissue 1010 to the opposite side of the woven material 100 in the bone hole, as shown in fig. 34. As depicted in both fig. 34 and 35, the self-collapsing ring 22 is moved to a position adjacent the adjustable ring 30, while the segments 1000 extend over and around the tissue 1010. In the post-deployment configuration, as shown in fig. 34 and 35, the first and second branches 24, 26 extend from opposite sides of the knotless unstable anchor 10, the woven material 100, and the tissue 1010. Finally, the first end 18 and the second end 20 of the suture scaffold 12 may be trimmed.

Turning now to fig. 9-30, schematic illustrations of various views of a woven material (or soft anchor) 100 according to various embodiments that can be used in conjunction with the knotless unstable anchor 10 described herein are shown. In general, the alternative full suture anchor designs described and illustrated below are configured to work with and be deployed by the drivers 40 described herein in the same manner as the woven material 100 and other full suture anchors described and illustrated herein. Alternative embodiments of woven material 100 may include a fibrous construction anchor body portion (or a fibrous, braided or woven fabric-type structure, such as a flexible mesh) and a suture or filament portion having a first end and a second end. Sutures can be threaded through the anchor body in a variety of ways (including weaving, threading through a post, piercing the top and bottom, etc., as will be understood by those of ordinary skill in the art in view of this disclosure). The anchor body may comprise a first state in which the anchor body is uncompressed and extends along a longitudinal axis of the suture when in the deployed and pre-deployment condition; and a second state in which, in the deployed condition, the flat anchor body compresses and expands in a direction perpendicular to the longitudinal axis of risk (as discussed herein).

Referring briefly to fig. 9-12, front and back schematic views of a woven material 100 according to an embodiment are shown. In fig. 9-12, the woven material 100 is a full suture anchor braid. Fig. 9 shows a rear view of the full suture anchor 100, while fig. 10 shows a front view. As shown, the length of suture 12 into and out of the woven material (i.e., anchor braid/fiber construction 100) passes through only one (e.g., "front") surface 110 of the anchor braid 100 (fig. 10). Similarly, fig. 11-12 also show a posterior view (fig. 12) and an anterior view (fig. 11) in which the suture 102 is threaded through only one (e.g., "anterior") surface 110 (fig. 12) of the anchor braid 100. When a full suture anchor 100 has a suture 12 passing through only one (e.g., "front") surface 110, the anchor braid 100 protects the suture 12 from wear on the opposite (e.g., "back") surface 108 (fig. 9 and 11) when loaded onto the driver 40 (as will be understood by those of ordinary skill in the art in conjunction with a review of this disclosure). In fig. 9-12, suture 12 is threaded through anchor braid 100 at multiple pass-through locations. In an embodiment, the number of pass-through locations is eight pass-through locations, while the number of pass-through locations of some alternative full suture anchors 100 is six pass-through locations. The number of pass-through locations may vary depending on the composition and size of the suture 12 and/or 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 weft density, suture diameter, etc. to yield output parameters such as manufacturability, anchor creep under load, and pullout strength.

Turning now to fig. 13-14, schematic top views of alternative embodiments of woven materials 100 are shown. In fig. 13-14, the woven material 100 is an anchor braid 100 with additional material 112. One of ordinary skill in the art will recognize and appreciate possible embodiments of a Y-tie anchor having additional material (such as monofilament polymer) to increase strength. Additional material 112 may be applied to the full suture anchor 100. As shown in fig. 13, the anchor braid 100 is folded in half. Each (i.e., both) side edges 104, 106 of the anchor braid 100 are stitched together using a monofilament 112 to form an enclosed area 114 with the length of suture 12 inside, as shown in fig. 14. In addition to increasing strength, this will also prevent the anchor braid 100 from flipping over on itself during insertion and exposing the suture 12 to bone, causing wear. Additionally, the described twisting of the anchor braid 100 in combination with the denser material extending on the axis of the anchor braid 100 may result in a threaded full suture anchor 100.

Turning now to fig. 15-16, side-view schematic diagrams of embodiments of alternative embodiments of the woven material 100 in pre-and post-deployment configurations are shown. In the depicted embodiment, woven material 100 is a soft full suture anchor, such as And (6) an anchor. One such suture anchor is disclosed in U.S. patent No. 9826971, assigned to the assignee herein, which is incorporated herein by reference in its entirety.

An embodiment of an anchor (or soft or "full suture" anchor) 100 is shown in detail in fig. 15-16. As shown in figures 15-16 of the drawings, anchor 100 comprises at least two segments: at least one suture 12, which is the suture to be anchored; and an anchor body 100 (e.g., a fiber construct, as will be understood by those of ordinary skill in the art in light of this disclosure) that is to form a portion of the anchor 100 that may increase in width, thickness, and/or diameter and may contract in length as part of deployment. Referring to fig. 15, the anchor body 100 is shown in a pre-deployment configuration; and fig. 16, showing the anchor body 100 in a "shortened" and "expanded" configuration in a post-deployment configuration, as an additional result of the addition caused by the plication. The soft anchor embodiment also utilizes the poisson ratio, which captures the following cause/effect relationship: compressing the 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-direction and/or the z-direction), and stretching/elongating the material in the first direction causes the material to contract in a direction perpendicular to the first direction. Although the anchor body 100 increases in width, thickness, and/or diameter upon deployment, it should be understood that the suture 12 may also function in the deployment of the anchor 100 even though the suture 12 may remain free to slide (in some embodiments) and in other embodiments (at least at certain locations or points in use) is not slidable relative to the anchor body 100. The suture 12 helps position, align, and support the anchor body 100 so that if the suture 12 were to be removed from the anchor body 100 after deployment of the anchor 100, the anchor body 100 may be To freely spill (i.e., release) allowing anchor body 100 to collapse and shrink in size, allowing for easy (and potentially undesirable) removal.

In other words, the anchor body 100 has two primary functions. First, it becomes the basis in which the suture 12 slides. Second, the anchor body 100 becomes more compact in one direction when compressed and/or pleated during deployment, expanding outward and increasing its overall width, thickness, or diameter to create retention capability. This effect of reshaping the anchor body 100 to increase its overall width, thickness or diameter is a useful feature that may be advantageously used to secure the anchor 100 in the hole 116 or against bone or soft tissue 118. It is this combination of expanding the anchor body 100 to couple with the suture 12 that remains slidable relative to the anchor body 100 (in some embodiments; and in other embodiments, at least non-slidable relative to the anchor body at a particular location or point in use) that makes embodiments of the present invention ideal for soft tissue reattachment to the bone 118 or soft tissue reattachment to soft tissue, in which case it is desirable to deliver a sliding knot to secure the repair.

Turning briefly to fig. 17-18, schematic top and side views of a woven material 100 according to an alternative embodiment are shown. In fig. 17-18, the woven material 100 is a full suture anchor braid. As shown in fig. 17-18, the length of suture 12 is threaded through approximately the center 120 of the anchor braid 100. In the depicted embodiment, the length of suture 12 enters the anchor braid 100 through one (e.g., "front") surface 110 and exits through an opposite (e.g., "back") surface 108 of the anchor braid 100. With the length of suture 12 positioned on both sides of the anchor braid 100, the anchor braid 100 can be loaded onto the driver 40 so that the anchor braid 100 can be positioned against the bone with the lengths of suture 12 along the driver 40.

Referring now to fig. 19-20, schematic top views of a woven material 100 according to additional alternative embodiments are shown. In fig. 19-20, the woven material 100 is a full suture inverted anchor braid 100. To form the inverted anchor braid 100, a threader with a threader loop is first passed through the anchor braid 100. The end of the anchor braid 100 is then pulled through the threader loop. Finally, the threader loop is pulled back through the anchor braid 100, forming a central eyelet 105, as shown in fig. 19. The length of suture 12 may be loaded onto the inverted anchor braid 100 by passing the length of suture 12 through the anchor braid 100 (as described in connection with any of the embodiments herein) and through the central eyelet 105 (as shown in fig. 20).

In another alternative embodiment, shown in fig. 21-22, the woven material 100 is an anchor braid 100 loaded with multiple lengths of suture 12A, 12B. In the depicted embodiment, the anchor braid 100 is loaded with two segments of suture 12A, 12B. The length of suture 12A, 12B may extend through the anchor braid 100 along its opposite edges 122A, 122B (fig. 22), through two off-center locations 124A, 124B (fig. 21), or any conceivable combination thereof (including the length of suture 12A, 12B extending through approximately the center 120 of the anchor braid 100). Additionally, the multiple lengths of suture 12A, 12B may enter/exit the anchor braid 100 on the same surface (fig. 9-12) or on an opposite surface (fig. 17-18).

In yet another alternative embodiment, as shown in fig. 23-24, the woven material 100 is a full suture anchor consisting of a flat braid, a tubular braid, a cored suture, a multi-density segmented suture, or a suture having a contrasting density. The anchor 100 in fig. 23-24, for example, includes additional braided monofilaments 112. As shown in fig. 23, additional braided monofilaments 112 are woven around and through the anchor. The additional braided monofilaments 112 provide additional forms of fixation by creating irregularities in the bone surface, additional anchor "locking" between multiple suture densities (a hybrid of interdigitation of the monofilaments and locking/eversion of the UHMWPE braid) via the added monofilament braid 112, and/or forming rigid mechanical "barbs" on the outer surface of the anchor 100 that are deployed via the base density of the UHMWPE braid. As described above, multiple lengths of suture (not shown) may enter/exit anchor 100.

According to another embodiment, the woven material 100 has an open elongated post/lumen extending from a first end to a second end, and the suture 12 passes through the open post and is at least partially positioned therein. In an embodiment, the suture 12 is free to slide through the open post such that the suture 12 can be removed from the open post from the first end of the woven material 100 and the second end of the woven material 100. Embodiments of the woven material 100 may be tubular in addition to having open elongated posts/lumens. The suture 12 may be woven directly in situ onto the flat band/woven material 100 (e.g., a circular section suture braid) or with an open post into which the circular section suture braid may be inserted thereafter.

In particular, as shown in fig. 25, a perspective schematic view of a woven material 400 in an unloaded (not loaded onto a mounting device or inserter), pre-deployment configuration is shown, according to one embodiment. In the depicted embodiment, the woven material 400 is a soft full suture anchor. The full suture anchor 400 may include, but is not limited to, a flat fibrous configuration 4 having a first end 4A, a second end 4B, and an open elongate post/lumen 6 having a first end 6A and a second end 6B (each of the first end 6A and the second end 6B of the open elongate post/lumen 6 may extend between or beyond the first end 4A and the second end 4B of the flat fibrous configuration). The open elongated column/lumen 6 may be woven along an axis parallel to, or along the central axis of the planar 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 column/lumen is woven along a central axis.

Still referring to fig. 25, a filament 2 is shown having a first end 2A and a second end 2B and passing through and at least partially positioned in an open post 6. In an embodiment, the filament 2 is free to slide through the open column 6 such that the filament 2 may be removed from the open column 6 from the first end 2A of the fibrous construct 2 and the second end 2B of the fibrous construct 2. According to an alternative embodiment, the filament is locked and cannot slide through the open post 6.

Turning now to fig. 26 and 27, a side view schematic diagram of an embodiment of a full suture anchor 400 in pre-and post-deployment configurations is shown. As described above, the full 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 construction 4 having a first end 4A and a second end 4B, which is to form a portion of the anchor 400 that may increase in width, thickness and/or diameter and may contract in length as part of deployment, and an open elongate post/lumen 6 extending from the first end 6A to the second end 6B.

As shown in fig. 26, the mounting device (or driver 40 as described above) is provided in a pre-deployment configuration. The full suture anchor 400 is shown connected to a distal deployment end 804 of a mounting device 800 (which may be the driver 40 of the embodiments described herein) that also includes a handle 802. The distal deployment end 804 and the full suture anchor 100 are shown positioned in a bone hole 900 in cancellous bone 904 below cortical bone 902. To deploy the full suture anchor 400 (which may be connected to other tissue that needs to be apposed to the bone, as will be understood by those of ordinary skill in the art in light of this disclosure), the first end 2A and/or the second end 2B are pulled/tensioned in a direction away from the bone hole 400. Regardless of whether mounting device 800 is in place in bone hole 900, first end 2A and second end 2B may be pulled/tensioned in a direction away from bone hole 900 (if mounting device 800 is in place in bone hole 900, it may act as a reaction force to the tension pulled out of hole 900 to assist in the deployment of full suture anchor 400).

As shown in fig. 27, the anchor body/fibrous construct 4 is shown "shortened" and "expanded" and locked in the bone hole 900 in the post-deployment configuration, due to the added additional result of the folds formed by the fibrous construct 4 (which may also be part of the fibrous construct 4). See also fig. 28. The full suture anchor 400, and in particular the fibrous construct 4, utilizes a poisson ratio (as described above with respect to other anchors) that captures the following cause/effect relationship: compressing the 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-direction and/or the z-direction), and stretching/elongating the material in the first direction causes the material to contract in a direction perpendicular to the first direction. Although the anchor body/fiber construction 4 increases in width, thickness, and/or diameter upon deployment, it should be understood that the suture 2 may also function in the deployment of the anchor 400, even though the suture 2 may remain free to slide in some embodiments, and may not be slidable relative to the anchor body 4 in other embodiments (at least at particular locations or points in use). The suture 2 helps position, align, and support the anchor body 4 (as will be appreciated by those skilled in the art in light of this disclosure).

In other words, the anchor body/fiber construct 4 has two main functions. First, it becomes the basis in which the suture 2 slides (within the post/lumen 6). Second, the anchor body 4 becomes more compact in one direction when compressed and/or pleated during deployment, expanding outward and increasing its overall width, thickness, or diameter to create retention capability. This effect of reshaping the anchor body 4 to increase its overall width, thickness or diameter is a useful feature that may be advantageously used to secure the anchor 400 in the hole 900 or against bone or soft tissue. It is this combination of expanding the anchor body 4 to couple with the suture 2 that remains slidable relative to the anchor body 4 (in some embodiments; and in other embodiments, at least non-slidable relative to the anchor body at a particular location or point in use) that makes embodiments of the present invention ideal for soft tissue reattachment to bone or soft tissue reattachment to soft tissue, in which case it is desirable to deliver a sliding knot to secure the repair.

In one embodiment, inventive configurations, structures and resulting functions of a soft full suture anchor utilizing a hybrid combination of soft implantable materials are provided. The hybrid soft full suture anchor of the embodiments has superior pullout strength characteristics compared to conventional soft full suture anchors. Embodiments of the present invention provide better soft full suture anchors for use in hard bone due in part to the hybrid expansion member portion. These embodiments are also applicable in soft cancellous bone where a very thin or weak cortical layer is present. Hybrid full suture anchors may include, but are not limited to, an expandable member/portion configured to increase in size from a first pre-deployment condition to a second deployed condition upon application of an activator; and a filament having a first filament end and a second filament end and positioned in contacting relationship with the expandable member in a second deployed condition. The anchor may also include a flat fiber construction having a first end and a second end, and wherein the filament passes through the fiber construction. The planar fiber configuration comprises a first state in which the planar fiber configuration is uncompressed and extends along the longitudinal axis of the filament when in a deployed and pre-deployment condition; and a second state in which, in the deployed condition, the flat fiber configuration compresses and expands in a direction perpendicular to the longitudinal axis of the filament. The structure, configuration, and function of the expandable member and the fibrous construct (when part of an embodiment) help to position and retain the anchor in the bone hole in the post-deployment condition. The expandable portion/member may be part of a hybrid full suture anchor (as described herein) for use with only any filamentary portion. The expandable portion/member may also be part of a hybrid full suture anchor (as described herein) for use with any filament portion and any fibrous construct portion.

For example, referring to fig. 29, a perspective view of a hybrid soft all-suture anchor 500 in a pre-deployment configuration is shown, according to one embodiment. The hybrid full suture anchor 500 may include, but is not limited to, a flat fiber construction 4 having a first end 4A, a second end 4B. The filament 2 is shown having a first end 2A and a second end 2B and is woven, threaded or otherwise threaded through the fiber construction 4 at pass-through locations 25, 27 and 25, 28. For a further description of the structural aspects of filament and fiber construction, see us 9826971, which is part of this example of the invention (as will be understood by those of ordinary skill in the art in conjunction with a review of this disclosure).

In embodiments, the filament 2 is free to slide through the fibrous construct 4 (and the expansible 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 cannot slide through the fibrous construction 4 and/or the expandable portion 3 (when attached to the expandable portion 3).

Turning now to fig. 30 and 31, a side view schematic diagram of an embodiment of a full suture anchor 500 in pre-and post-deployment configurations is shown. As described above, the full suture anchor 500 includes at least two sections: at least one suture 2 having a first end 2A and a second end 2B; an anchor body/fiber construction 4 having a first end 4A and a second end 4B, the anchor body/fiber construction configured to form a portion of the anchor 500 that may increase in width, thickness, and/or diameter and may contract in length as part of deployment. The full suture anchor 500 also includes an expansible portion 3 configured to form a portion of the anchor 500 that may increase in size in a post-deployment configuration in response to an activator (as will be understood by those of ordinary skill in the art in light of a review of this disclosure).

As shown in fig. 30, a mounting device (or inserter as described above) is provided in a pre-deployment configuration. The full suture anchor 500 is shown connected to a distal deployment end 804 of a mounting device 800 (which may be an inserter as described above) that also includes a handle 802. The distal deployment end 804 and the full suture anchor 500 are shown positioned in a bone hole 900 in cancellous bone 904 below cortical bone 902. To deploy the full suture anchor 500 (which may be connected to other tissues that need to be apposed to the bone, as will be understood by those of ordinary skill in the art in light of this disclosure), the first end 2A and/or the second end 2B are pulled/tensioned in a direction away from the bone hole 400. Regardless of whether mounting device 800 is in place in bone hole 900, first end 2A and second end 2B may be pulled/tensioned in a direction away from bone hole 900 (if mounting device 800 is in place in bone hole 900, it may act as a reaction force to the tension pulled out of hole 900 to assist in the deployment of full suture anchor 500). Additionally, an activator can be added to the anchor to expand the expandable portion to a second size that is larger than the first pre-deployment size. In one embodiment, the activator is water.

As shown in fig. 31, the anchor body/fibrous construct 4 is shown "shortened" and "expanded" and locked in the bone hole 900 in the post-deployment configuration, due to the added additional result of the folds formed by the fibrous construct 4 (which may also be part of the fibrous construct 4). The full suture anchor 500, and in particular the fibrous construct 4, utilizes a poisson ratio (similarly, as described above) that captures the following cause/effect relationship: compressing the 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-direction and/or the z-direction), and stretching/elongating the material in the first direction causes the material to contract in a direction perpendicular to the first direction. Although the anchor body/fiber construction 4 increases in width, thickness, and/or diameter upon deployment, it should be understood that the suture 2 may also function in the deployment of the anchor 500, even though the suture 2 may remain free to slide in some embodiments, and may not be slidable relative to the anchor body 4 in other embodiments (at least at particular locations or points in use). The suture 2 helps position, align, and support the anchor body 4 (as will be appreciated by those skilled in the art in light of this disclosure).

In other words, the anchor body/fiber construct 4 has two main functions. First, it becomes the basis in which the suture 2 slides (within the post/lumen 6). Second, the anchor body 4 becomes more compact in one direction when compressed and/or pleated during deployment, expanding outward and increasing its overall width, thickness, or diameter to create retention capability. This effect of reshaping the anchor body 4 to increase its overall width, thickness or diameter is a useful feature that may be advantageously used to secure the anchor 500 in the hole 900 or against bone or soft tissue. It is this combination of the expanded anchor body 4 being coupled with the suture 2 that remains slidable relative to the anchor body 804 (in some embodiments; and in other embodiments, at least non-slidable relative to the anchor body at a particular location or point in use) that makes embodiments of the present invention ideal for soft tissue reattachment to bone or soft tissue reattachment to soft tissue, in which case it is desirable to deliver a sliding knot to secure the repair.

Still referring to fig. 31, after exposure to the activation agent, the expansible portion 3 is shown expanded to a second dimension, greater than the first, smaller pre-deployment dimension. When exposed to an activator, the volume of the expansible portion expands greatly, causing it to wedge into bone hole 900 and lock anchor 500 in place. According to one embodiment, in order to tension the filaments 2 to reattach soft tissue (not shown), the filaments 2 may freely slide forward and backward through the fibrous construct 4 and through the expansible portion 3 (as may be required when connected to the expansible portion 3). In some cases where the fibrous construct 4 is not present, the free-sliding filament 2 may cut through the expansible portion 3, resulting in less than optimal deployment of the full suture anchor 500. Thus, in some embodiments of the full suture anchor 500 with or without the fibrous construct 4, the second short length of suture 2-1 may be wrapped or looped around the filament 2 (see fig. 32) to prevent sawing/cutting through the expansible portion 3 by the filament 2 when in contact with the expansible portion 3.

Turning to fig. 33, a side view digital photograph of the embodiment of the full suture anchor of fig. 29 in a post-deployment configuration after addition of an activator is shown, according to one embodiment. As shown, the expansible portion 3 is increased in size to a second, deployed configuration (bone holes not shown to illustrate the degree of expansion of the expansible portion 3), and the filaments 2 are positioned through the expansible portion 3 and/or otherwise in contacting relationship therewith.

Similarly with respect to the filament 2 and fiber construction 4 described above and the embodiment shown in fig. 30-32, the expansible portion 3 may be part of any of the full-suture anchors described herein, or otherwise include the full-suture anchor shown and described in U.S. patent application No. 16/033616. The same structures and functions of the expansible portion 3 described above and shown in fig. 30-32 are applicable to these embodiments of full-suture anchors (with and without a fibrous construct).

All definitions, as defined and used herein, should be understood to take precedence over dictionary definitions, definitions in documents incorporated by reference, and/or ordinary meanings of the defined terms.

While various embodiments have been described and illustrated herein, those of ordinary skill in the art will readily envision a variety of other means and/or structures for performing the function and/or obtaining the results and/or one or more of the advantages described herein, and each of such variations and/or modifications is deemed to be within the scope of the embodiments described herein. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the teachings of the present invention is/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. It is, therefore, to be understood that the foregoing embodiments are presented by way of example only and that, within the scope of the appended claims and equivalents thereto, the 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. In addition, any combination of two or more such features, systems, articles, materials, kits, and/or methods, if such features, systems, articles, materials, kits, and/or methods are not mutually inconsistent, is included within the scope of the present disclosure.

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 indicates otherwise. It should also be understood that the terms "comprises" (and any form of "comprising", such as "comprises" and "comprising)", "has" (and "has)", such as "has" and "has)", "contains" (and any form of "containing", such as "comprises" and "containing)", and "contains" (and "contains" and any form of "containing", such as "contains" and "contains" are open-ended verbs. Thus, a method or apparatus that "comprises," "has," "includes" or "contains" one or more steps or elements. Likewise, a step of a method or an element of a device that "comprises," "has," "includes" or "contains" one or more features possesses those one or more features, but is not limited to possessing only those one or more features. Further, a device or structure that is constructed in a certain manner is constructed in at least that manner, but may also be constructed in ways that are not listed.

The corresponding structures, materials, acts, and equivalents of all means or step plus function elements in the claims below, if any, are intended to include any structure, material, or act for performing the function in combination with other claimed elements as 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 will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the invention. The embodiments were chosen and described in order to best explain the principles of one or more aspects of the invention and the practical application, and to enable others of ordinary skill in the art to understand one or more aspects of the invention for various embodiments with various modifications as are suited to the particular use contemplated.