All-suture anchor and deployment assembly

An all-suture anchor for attaching soft tissue to bone while creating an interference fit within a bone hole, and a deployment device for the all-suture anchor. The all-suture anchor includes an anchor body having first and second ends. The second end is folded toward the first end, creating a looped distal end of the anchor body, while the first and second ends of the anchor body form a proximal end. The anchor body is composed of a first material having a first density. A passing filament, of a second (different) density, is woven through the anchor body at passing locations such that a pair of free ends of the passing filament extends from the proximal end of the anchor body. The all-suture anchor additionally includes a binding filament bound axially at the proximal end of the anchor body around the first end and the second end of the anchor body.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention is directed generally to an all-suture anchor and, more particularly, to a multi-density all-suture anchor and deployment device.

2. Description of Related Art

Current rigid body expanding anchors used in arthroscopy to attach soft tissue to bone are typically larger in size as compared to soft, all-suture anchors. In contrast, the all-suture anchors are typically smaller in size, yet oftentimes do not provide the fixation strength of larger, rigid body anchors when used in soft bone. Furthermore, the current rigid body expanding anchors consist of two rigid body members that must be actuated until an internal mechanism controlled by distance is reached. When used in hard bone, there exists instances where the interference fit between anchor and bone is so great after insertion, that an anchor expansion mechanism fails to deploy.

Hand set deployment of arthroscopic all-suture anchors pull out of hard and soft bone more readily than all-suture anchors deployed by a driver/inserter mechanism. A typical driver/inserter mechanism consists of a method for deploying an all-suture anchor against a rigid body within the hole prepared in bone by the surgeon. Currently, all-suture anchors that are used to re-attach soft tissue to bone consist of a single material and contain a uniform density. This homogenous suture anchor structure is relatively smooth and soft in nature, allowing it to more easily be pulled out of uniform densities of hard and soft bone where no sub-cortical bone shelf exists.

Therefore, there is a need for a soft suture anchor that can have an interference fit within a bone hole, and a deployment device therefor that does not need to reach a particular deployment distance.

Description of the Related Art Section Disclaimer: To the extent that specific patents/publications/products are discussed above in this Description of the Related Art Section or elsewhere in this disclosure, these discussions should not be taken as an admission that the discussed patents/publications/products are prior art for patent law purposes. For example, some or all of the discussed patents/publications/products may not be sufficiently early in time, may not reflect subject matter developed early enough in time and/or may not be sufficiently enabling so as to amount to prior art for patent law purposes. To the extent that specific patents/publications/products are discussed above in this Description of the Related Art Section and/or throughout the application, the descriptions/disclosures of which are all hereby incorporated by reference into this document in their respective entirety(ies).

SUMMARY OF THE INVENTION

The present invention is directed to an all-suture anchor for attaching soft tissue to bone while creating an interference fit within a bone hole, and a deployment device for the all-suture anchor. According to one aspect, the all-suture anchor includes an anchor body having a first end and a second end. The second end is folded toward the first end, creating a looped distal end of the anchor body. The first end and the second end of the anchor body form a proximal end of the anchor body. The anchor body is composed of a first material having a first density. The all-suture anchor also includes a passing filament having a pair of free ends. The passing filament is woven through the anchor body at a plurality of passing locations such that the pair of free ends extends from the proximal end of the anchor body. The passing filament is composed of a second material having a second density, and the second density is different than the first density. The all-suture anchor additionally includes a binding filament bound axially at the proximal end of the anchor body around the first end and the second end of the anchor body.

According to another aspect, the all-suture anchor includes an anchor body having a first end and a second end. The second end is folded toward the first end, creating a first limb extending to the first end and a second limb extending to the second end. The anchor body is composed of a first material having a first density. The all-suture anchor also includes a first piercing (or hole) in the second limb and the first limb extends through the first piercing. The all-suture anchor additionally includes a passing filament having a pair of free ends. The passing filament is woven through the anchor body at a plurality of passing locations such that one of the pair of free ends extends from the first end of the anchor body and the other of the pair of free ends extends from the second end of the anchor body. The passing filament is composed of a second material having a second density, and the second density is different than the first density.

According to another aspect, the present invention is a suture anchor deployment assembly. The assembly includes: (i) a suture anchor deployment device having a tube with a channel extending therethrough and (ii) a suture anchor. The suture anchor includes an anchor body having a proximal end and a distal end. The anchor body composed of a first material having a first density. The suture anchor also includes a passing filament having a pair of free ends. The passing filament is woven through the anchor body at a plurality of passing locations such that the pair of free ends extends from the proximal end of the anchor body. The passing filament is composed of a second material having a second density, and the second density is different than the first density. The anchor body is positioned within the tube of the suture anchor deployment device such that the pair of free ends of the passing filament extends proximally from the tube. In an undeployed state, the tube has a first diameter and in a deployed state, the tube has a second diameter which is greater than the first diameter.

In one or more embodiments briefly described above (and further described below), the first and second densities can be the same or similar.

Embodiments of the all-suture anchors described herein can include a fibrous construct anchor body portion (or fibrous, braided or woven fabric-type structure such as a flexible web), and a suture or filament portion having a first end and a second end. The anchor body can be hollow, cored, tubular or nontubular, and/or flat. The suture can pass through the anchor body in a number of ways (including woven, pass through a column, pierced through top and bottom, etc., as should be understood by a person of ordinary skill in the art in conjunction with a review of this disclosure). The anchor body can include a first state in which the anchor body is uncompressed and extends along the longitudinal axis of the suture when in an unfolded and pre-deployed condition; and a second state in which the flat anchor body is compressed and expanded in a direction perpendicular to longitudinal axis of the suture in a deployed condition (as discussed herein).

DETAILED DESCRIPTION OF THE INVENTION

Referring now to the figures, wherein like reference numerals refer to like parts throughout,FIG. 1shows a side view schematic representation of a dual density all-suture anchor10in the undeployed state, according to an embodiment. The anchor10comprises a braided anchor body100, which is folded to form a proximal or first end102and a looped distal or second end104. In the depicted embodiment, the braided anchor body100is a length of suture braid with a first end or limb106and a second end or limb108. The second end108has been folded to the first end106, creating a loop110in the braided anchor body100. In an embodiment, the anchor body100is composed of an ultra-high-molecular-weight polyethylene (UHMWPE) braid. Nevertheless, the anchor body100has a first density. The anchor body100can be flat, tubular, hollow tubular, or of any other known geometry.

Turning now toFIG. 2, there is shown a top view schematic representation of the dual density all-suture anchor100in the undeployed state, according to an embodiment. As shown inFIG. 2, the anchor10additionally comprises a passing filament12woven through the anchor body100at a plurality of passing locations112. The passing filament12is woven through the anchor body100such that free ends14,16of the passing filament12extend from the proximal end102of the anchor body100. The passing filament12may be woven through the anchor body100prior to or after folding the second end108to the first end106. In addition, the passing filament12is woven such that one or more passing sections112of the passing filament12are exposed on an outer surface114of the anchor body100, as shown inFIG. 2.

Still referring toFIG. 2, the passing filament12is composed of a material having a second density. The second density of the passing filament12is different from the first density of the anchor body100. Thus, the passing filament12adds irregularity to the anchor body100and creates an additional form of fixation by creating irregularity against/within a bone hole surface. Additional anchor locking occurs through interdigitation of the passing filament12and anchor body100and the creation of rigid mechanism “barbs” on the exterior surface114of the anchor body100.

As shown inFIGS. 1 and 2, the anchor body100is bound axially at the proximal end102with multiple passes of a binding filament18(e.g., monofilament) through the proximal end102of the anchor body100. The binding filament18is passed around and/or through the proximal end102of the anchor body100, simulating a binding sleeve around the proximal end102. In the depicted embodiment, the proximal end102is bound such that the first and second ends106,108of the anchor body100extend proximally from the binding filament18. The proximal end102can be bound by other biocompatable material, which can include tape and other like materials (as should be understood by a person of ordinary skill in the art in conjunction with a review of this disclosure).

The addition of the binding filament18to the anchor100inFIGS. 1 and 2provides an interference fit with surface of the bone hole because the binding filament18acts as a rigid body at the proximal end102of the anchor100. This allows the distal end104of the anchor body100to have a semi-rigid shoulder to expand against when the anchor10is deployed. The addition of binding filament12at the proximal end102of the anchor body100also provides a semi-rigid body that occludes the prepared anchor hole (i.e., bone hole), allowing the distal end104of the anchor body100to expand and gain additional purchase in hard and soft bone compared to single material/density all suture anchors.

From the undeployed state shown inFIGS. 1 and 2, the anchor10is inserted into a bone hole for deployment. Once the anchor10is placed within the bone hole (not shown), the user (e.g., surgeon) deploys the anchor10by tensioning the free ends14,16of the passing filament12. The anchor10can be deployed with the aid of an inserter (not shown) or any other known device used to deploy all-suture anchors, e.g., U.S. Pat. No. 9,173,652 (as should be understood by a person of ordinary skill in the art in conjunction with a review of this disclosure). When the passing filament12is tensioned, the anchor body100expands to the deployed state, shown inFIG. 3. The free ends14,16of the passing filament12can then be used to secure soft tissue in apposition to the bone comprising the bone hole. In particular, the free ends14,16of the passing filament12can be used to secure the soft tissue in apposition to the bone with one or more knots.

Turning now toFIGS. 4-7, there is shown various views schematic representations of an all-suture anchor10, according to an alternative embodiment. The all-suture anchor10inFIGS. 4-7is comprised of uniform density material that is pierced upon itself one or more times to achieve contrasting densities in strategic locations. For example,FIG. 4shows a side view schematic representation of a round anchor body100, in the undeployed state, which has been pierced and passed through itself. In the embodiment shown inFIG. 4, the anchor body100has a first end102and a second end104, and has been folded at some point therebetween, creating a first limb106extending to the first end102and a second limb108extending to the second end104.

The first limb106comprises at least one piercing110(or hole) and/or the second limb108comprises at least one piercing110. In the embodiment depicted inFIG. 4, the second limb108comprises two piercings110along its length. The first limb106is then passed through both piercings110in the second limb108, creating the “figure 8” shape in the anchor body100, as shown inFIG. 4. In an alternative embodiment, inFIG. 5, there is shown a side view schematic representation of a flat anchor body100in the undeployed state. In the depicted embodiment, the second limb108of the anchor body100comprises one piercing110and the first limb106is passed through the one piercing110in the second limb108.

In both of the exemplary embodiments shown inFIGS. 4 and 5, a passing filament12is passed through the anchor body100after the first or second limbs106,108have been passed through the each other as described above. The passing filament12is woven through multiple passing locations112along the anchor body100. InFIGS. 4 and 5, the passing filament12is woven through the first end102and then the second limb108and a distal loop114of the anchor body100before it is woven through passing locations112along the first limb106and the second end104. Ultimately, the passing filament12is woven through the anchor body100in a “U-shaped” pattern such that free ends14,16of the passing filament12extend proximally from a proximal end102of the anchor body100. The free ends14,16of the passing filament are used to secure soft tissue in apposition to the bone comprising the bone hole after the anchor10is deployed in the bone hole.

Referring now toFIGS. 6 and 7, there are shown various views schematic representations of the all-suture anchor10in the deployed state, according to an alternative embodiment. From the undeployed state shown inFIGS. 4 and 5, the anchor10is inserted into a bone hole (not shown) for deployment. Once the anchor10is placed within the bone hole, the user (e.g., surgeon) deploys the anchor10by tensioning the free ends14,16of the passing filament12. The anchor10can be deployed with the aid of an inserter (not shown) or any other known device used to deploy conventional suture anchors (see reference above). When the passing filament12is tensioned, the anchor body100expands to the deployed state, shown inFIGS. 6 and 7. The free ends14,16of the passing filament12can then be used to secure soft tissue in apposition to the bone comprising the bone hole. In particular, the free ends14,16of the passing filament12can be used to secure the soft tissue to the bone with one or more knots.

The passing filament12and particular “piercing” configuration anchor body100of inFIGS. 4-7creates contrasting densities with single uniformed material based anchor body100. This all-suture anchor10generates compression against bone in the pierced, high material density locations (i.e., where there are piercings110), and anchor expansion in the low material density locations (i.e., where there are no piercings110). This creates intended, segmented areas of expansion (or alternating zones of press-fit fixation and anchor expansion) as if a chain of anchors were deployed in sequence. Further, the all-suture anchor10generates interference fixation in bone prior to anchor deployment that is not achieved by current commercialized all-suture anchors that can, under certain circumstances, pull out of a bone hole while being deployed.

Turning now toFIG. 8, there is shown a perspective view schematic representation of a suture deployment device120in a pre-deployment configuration, according to an embodiment. The suture deployment device120comprises a tube118with a channel122extending therethrough. The tube118can be composed of a polymer, such as PEEK, bio composite, or the like. Preferably, the tube118is thin such that it expands easily when pressure is applied the inside surface by an expanding anchor positioned therein upon deployment.

Still referring toFIG. 8, the channel122is sized and configured to contain an anchor10therein. The anchor10can be the all-suture anchors10shown inFIGS. 1-7. The anchor10may also be any known anchor, such as a rigid body anchor, a soft anchor, or an all-suture anchor, for example. The anchor10, in an undeployed state, is inserted into the channel122of the suture deployment device120. Sutures or other passing filaments12connected to the anchor10remain outside the suture deployment device120, as shown. With the anchor10in the undeployed state and loaded in the suture deployment device120, the suture deployment device120is inserted (e.g., tapped) into a bone hole for deployment.

Referring now toFIG. 9, there is shown a perspective view schematic representation of the suture deployment device120in a deployed configuration, according to an embodiment. Once the suture deployment device120is placed within the bone hole (not shown), the user (e.g., surgeon) deploys the anchor10by actuating an inserter (not shown) or any other similar device (as referenced above). The act of deployment causes the anchor body100of the anchor10to be drawn distally, shortening in length while expanding radially. Specifically, the expansion of the anchor body100causes the tube118to expand against the walls of the bone hole. In other words, the tube118has a first diameter in the undeployed state and a second diameter in the deployed state due to the expansion of the anchor body100positioned therein. The deployed anchor body100is locked into the expanded tube118via internal features, such as ribs or threads in the tube118. This allows the expansion mechanism to deploy without the need of a minimum travel distance as in the case of predicate two-piece rigid body expanding anchors. Ribs, threads, teeth or other surface features can be included on the outside surface of the tube118to assist with locking the deployed deployment device120in place.

Although the suture deployment device120inFIGS. 8 and 9can be used to with the expanding soft suture anchors10inFIGS. 1-7, the suture deployment device120can also be used with any expanding soft suture anchor, including any of the following expanding soft suture anchors (as should be understood by a person of ordinary skill in the art in conjunction with a review of this disclosure).

Turning now toFIGS. 10-35, there are shown various views schematic representations of a woven material (or soft anchor)100, according to a multitude of embodiments, which can be used in conjunction with the suture deployment device120described herein above. Generally, the following described and illustrated alternative all-suture anchor designs are configured to work with and be deployed (and expand in a deployed state) by the suture deployment device120described herein in the same manner as the woven material100and other all-suture anchors, described and illustrated herein. These alternative all-suture anchor design embodiments, and related functionalities are described separately below.

FIG. 10shows a perspective view schematic representation of a knotless instability anchor10in a pre-deployment configuration, according to another embodiment. The knotless instability anchor10includes a woven material (anchor)100and a strand of suture (or “suture strand”)12. To achieve the anchor10inFIG. 10, a pierce (or aperture)16is first formed at or near a first end18of the suture strand12. A second end20of the suture strand12is passed through the pierce16, creating a self-collapsing loop22with a first limb24and a second limb26of the suture strand12extending therefrom. The second end20is pulled through the pierce16and away from the first end18. A splice28is then created in the second limb26of the suture strand12. As also shown inFIG. 10, the second end20of the suture strand12is pulled through the splice28, creating an adjustable loop30in the second limb26of the suture strand12. As shown inFIG. 10, the adjustable loop30is pulled through a woven material100which functions as a soft all-suture anchor (e.g., Y-Knot anchor). The anchor10inFIG. 10is deployed using the adjustable loop30and the self-collapsing loop22, as shown and described in PCT Patent Application No. PCT/US18/61168 (as should be understood by a person of ordinary skill in the art in conjunction with a review of this disclosure).

Referring briefly toFIGS. 11-14, there are shown front and back views schematic representations of a woven material100, according to an embodiment. InFIGS. 11-14, the woven material100is an all-suture anchor braid.FIG. 11shows a back view of an all-suture anchor100, whileFIG. 12shows the front view. As shown, the length of suture12passing into and out of the woven material (i.e., anchor braid/fibrous construct)100only passes through one (e.g., “front”) surface110of the anchor braid100(FIG. 12). Similarly,FIGS. 13-14also show a back view (FIG. 14) and front view (FIG. 13) where the suture102passing only through one (e.g., “front”) surface110of the anchor braid100(FIG. 14). When the all-suture anchor100has suture12passing only through one (e.g., “front”) surface110, the anchor braid100protects the suture12from abrasion on the opposing (e.g., “back”) surface108(FIGS. 11 and 13) when loaded onto a driver (e.g., driver40as shown inFIG. 17) (as should be understood by a person of ordinary skill in the art in conjunction with a review of this disclosure). InFIGS. 11-14, the suture12is passed through the anchor braid100at numerous passing locations. In an embodiment, the number of passing locations is eight passing locations, while the number of passing locations for some alternative all-suture anchors100is six passing locations. The number of passing locations can vary depending on the composition and size of the suture12and/or anchor braid100. The number of passing locations can be optimized by balancing input parameters, such as anchor braid length, anchor braid width, anchor braid pick density, suture diameter, and others, to yield output parameters, such as manufacturability, anchor creep under load, and pullout strength.

Turning now toFIGS. 15-16, there are shown top views schematic representations of an alternative embodiment of a woven material100. InFIGS. 15-16the woven material100is an anchor braid100with an additional material112. One of ordinary skill in the art should recognize and appreciate potential embodiments of a Y-Knot® anchor with additional material, such as monofilament polymers, to add strength. Additional material112can be applied to the all-suture anchor100. As shown inFIG. 15, the anchor braid100is folded in half. A monofilament112is used to stitch together each (i.e., two) side edge104,106of the anchor braid100to create an enclosed area114with the length of suture12inside, as shown inFIG. 16. In addition to improved strength, this will prevent the anchor braid100from rolling over on itself during insertion and exposing the suture12to the bone, causing abrasion. Additionally, the described twisting of the anchor braid100, in combination with a more dense material running in the axis of the anchor braid100can result in a threaded all-suture anchor100.

Turning now toFIGS. 17-18, there are shown side view schematic representations of an embodiment of an alternative embodiment of a woven material100in the pre-deployment and post-deployment configurations. In the depicted embodiment, the woven material100is a soft all-suture anchor, such as the Y-Knot® anchor. One such suture anchor is disclosed in U.S. Pat. No. 9,826,971 assigned to the assignee hereof and incorporated by reference herein in its entirety.

An embodiment of the Y-Knot® anchor (or soft anchor or “all-suture” anchor)100is illustrated in detail inFIGS. 17-18. The Y-Knot® anchor100, as shown inFIGS. 17-18, contains at least two sections: at least one suture12, which is a suture to be anchored; and an anchor body100(e.g., fibrous construct, as should be understood by those of ordinary skill in the art in conjunction with a review of this disclosure), which is to form a portion of the anchor100that can increase in width, thickness and/or diameter and shrink in length as part of deployment. SeeFIG. 17, showing the anchor body100in the pre-deployment configuration; andFIG. 18, showing the anchor body100“shortened” and “expanded” in the post-deployment configuration, which is additive to the increase due to the pleats. This soft anchor embodiment also takes advantage of Poisson's ratio, which captures the following cause/effect relationship: compressing a material in a first direction causes the material to expand in direction perpendicular to the first direction (i.e., if compressed in the x-direction, the material will expand in the y-direction and/or z-direction), and stretching/lengthening a material in a first direction causes the material to contract in directions perpendicular to the first direction. Although, it is the anchor body100that increases in width, thickness and/or diameter at deployment, it should be understood that the suture12can also play a role in the deployment of the anchor100even though the suture12may remain free (in some embodiments) to slide, and non-slidable in others (at least at a particular position or point in use) in relation to the anchor body100. The suture12helps to position, align and support the anchor body100, such that if the suture12were to be removed from the anchor body100after deployment of the anchor100, the anchor body100may be free to spill (i.e., release), allowing the anchor body100to collapse and shrink in size, allowing for easy (and potentially undesirable) removal.

In other words, the anchor body100has two primary functions. First, it becomes a base for the suture12to slide within. Second, when compressed and/or pleated during deployment, the anchor body100becomes more compact in one direction thereby expanding outwardly and increasing its overall width, thickness or diameter to create a retention capacity. This action of having the anchor body100change in shape to increase its overall width, thickness or diameter is a useful characteristic which may be used advantageously to secure the anchor100in a hole116or against a bony or soft tissue118. It is this combination of the expanding anchor body100coupled with the suture12remaining slidable (in some embodiments; and non-slidable in others, at least at a particular position or point in use) in relation to the anchor body100that render embodiments of the present invention ideal for the reattachment of soft tissue to bone118or soft tissue to soft tissue where it is desirable to pass sliding knots to secure a repair.

Turning briefly toFIGS. 19-20, there are shown top and side views schematic representations of a woven material100, according to an alternative embodiment. InFIGS. 19-20the woven material100is an all-suture anchor braid. As shown inFIGS. 19-20, the length of suture12passes through an approximate center120of the anchor braid100. In the depicted embodiment, the length of suture12enters the anchor braid100through one (e.g., “front”) surface110and exits through the opposing (e.g., “back”) surface108of the anchor braid100. With the length of suture12positioned on both sides of the anchor braid100, the anchor braid100can be loaded onto the driver40(seeFIG. 17) such that anchor braid100can be positioned against a bone, while the lengths of suture12are along the driver40.

Referring now toFIGS. 21-22, there are shown top views schematic representations of a woven material100, according an additional alternative embodiment. InFIGS. 21-22, the woven material100is an all-suture inverted anchor braid100. To create an inverted anchor braid100, a threader with a threader loop is first passed through the anchor braid100. Then, in an end of the anchor braid100is pulled through the threader loop. Finally, the threader loop is pulled back through the anchor braid100, creating a central eyelet105, as shown inFIG. 21. A length of suture12can be loaded onto the inverted anchor braid100by passing the length of suture12through the anchor braid100, as described in conjunction with any of the embodiments herein, and passing through the central eyelet105, as shown inFIG. 22.

In another alternative embodiment, as shown inFIGS. 23-24, the woven material100is an anchor braid100loaded with multiple lengths of suture12A,12B. In the depicted embodiment, the anchor braid100is loaded with two lengths of suture12A,12B. The lengths of suture12A,12B may extend through the anchor braid100along its opposing edges122A,122B (FIG. 24), through two off-center locations124A,124B (FIG. 23), or any conceivable combination thereof (including an extension of the length of suture12A,12B through the approximate center120of the anchor braid100). In addition, the lengths of suture12A,12B may enter/exit the anchor braid100on the same surface (FIGS. 11-14) or on opposing surfaces (FIGS. 19-20).

In yet another alternative embodiment, as shown inFIGS. 25-26, the woven material100is an all-suture anchor comprised of flat braid, tube braid, cored suture, segmented suture of multiple densities, or suture with a contrasting density. The anchor100inFIGS. 25-26includes an additional braided monofilament112, for example. The additional braided monofilament112is woven around and through the anchor, as shown inFIG. 25. The additional braided monofilament112provides an additional form of fixation by creating irregularity within the bone surface via the added monofilament braid112, additional anchor “locking” between the multi suture densities (interdigitation of monofilament co-mingled with UHMWPE braid locking/flipping) and/or the creation of rigid mechanical “barbs” on the exterior surface of the anchor100that are deployed via the base density of a UHMWPE braid. Lengths of suture (not shown) may enter/exit the anchor100as described above.

In accordance with another embodiment, the woven material100has an open elongated column/lumen extending from a first end to a second end; and the suture12passes through and is positioned at least partially in the open column. In an embodiment, the suture12is free to slide through the open column such that the suture12can be removed from the open column from the first end of the woven material100and the second end of the woven material100. An embodiment of the woven material100can also be tubular in addition to having an open elongated column/lumen. The suture12may either be woven in situ directly onto the flat tape/woven material100(e.g., a round section suture braid), or woven with an open column into which the round section suture braid may be later inserted.

In particular, as seen inFIG. 27, a perspective view schematic representation of a woven material400in an unloaded (not loaded onto an installation device or inserter), pre-deployment configuration, according to an embodiment. In the depicted embodiment, the woven material400is a soft all-suture anchor. The all-suture anchor400can include, but is not limited to, a flat fibrous construct4having a first end4A, a second end4B, and an open elongated column/lumen6having a first end6A and the second end6B (each of the first end6A and the second end6B of the open elongated column/lumen6can extend between or beyond the first4A and second4B ends of the flat fibrous construct). The open elongated column/lumen6can be woven along an axis that is parallel to or along a central axis of the flat fibrous construct4, or can be woven along a path that is not parallel to the central axis. As shown inFIG. 25, the open elongated column/lumen is woven along the central axis.

Still referring toFIG. 27, a filament2is shown having a first end2A and a second end2B, and passing through and at least partially positioned in the open column6. In an embodiment, the filament2is free to slide through the open column6such that the filament2can be removed from the open column6from the first end2A of the fibrous construct2and/or the second end2B of the fibrous construct2. In accordance with an alternative embodiment, the filament is locked and not slidable through the open column6.

Turning now toFIGS. 28 and 29, there are shown side view schematic representations of an embodiment of the all-suture anchor400in the pre-deployment and post-deployment configurations. As described above, the all-suture anchor400contains at least two sections: at least one suture2with a first end2A and a second end2B; and an anchor body/fibrous construct4with a first end4A and a second end4B, and an open elongated column/lumen6extending from a first end6A to a second end6B, which is to form a portion of the anchor400that can increase in width, thickness and/or diameter and shrink in length as part of deployment.

As shown inFIG. 28, the installation device (or driver40, as described herein above) in the pre-deployment configuration is provided. The all-suture anchor400is shown connected to the distal deployment end804of an installation device800(which can be a driver40of an embodiment described herein—seeFIG. 17), which also includes a handle802. The distal deployment end804and the all-suture anchor100are shown positioned in a bone hole900in cancellous bone904under the bone cortex902. In order to deploy the all-suture anchor400(which can be connected to other tissue that needs to be brought into apposition to the bone, as should be understood by a person of ordinary skill in the art in conjunction with a review of this disclosure), the first end2A and/or the second end2B are pulled/tensioned in a direction away from the bone hole400. The first end2A and the second end2B can be pulled/tensioned in a direction away from the bone hole900with or without the installation device800in place in the bone hole900(if installation device800is in place in the bone hole900, it can act as a counter force to the tension force out of the hole900to assist with the deployment of the all-suture anchor400).

As shown inFIG. 29, the anchor body/fibrous construct4is shown “shortened” and “expanded” in the post-deployment configuration and locked in the bone hole900, which can be additive to the increase due to pleats formed by the fibrous construct4(which may also be part of the fibrous construct4). See alsoFIG. 30. The all-suture anchor400, and, in particular, the fibrous construct4takes advantage of Poisson's ratio (as described with respect to other anchors, above), which captures the following cause/effect relationship: compressing a material in a first direction causes the material to expand in direction perpendicular to the first direction (i.e., if compressed in the x-direction, the material will expand in the y-direction and/or z-direction), and stretching/lengthening a material in a first direction causes the material to contract in directions perpendicular to the first direction. Although, it is the anchor body/fibrous construct4that increases in width, thickness and/or diameter at deployment, it should be understood that the suture2can also play a role in the deployment of the anchor400even though the suture2may remain free to slide in some embodiments, and non-slidable in others (at least at a particular position or point in use) in relation to the anchor body4. The suture2helps to position, align and support the anchor body4(as should be understood by a person of skill in the art in conjunction with a review of this disclosure).

In other words, the anchor body/fibrous construct4has two primary functions. First, it becomes a base for the suture2to slide within (within the column/lumen6). Second, when compressed and/or pleated during deployment, the anchor body4becomes more compact in one direction thereby expanding outwardly and increasing its overall width, thickness or diameter to create a retention capacity. This action of having the anchor body4change in shape to increase its overall width, thickness or diameter is a useful characteristic which may be used advantageously to secure the anchor400in a hole900or against a bony or soft tissue. It is this combination of the expanding anchor body4coupled with the suture2remaining slidable (in some embodiments; and non-slidable in others, at least at a particular position or point in use) in relation to the anchor body4that render embodiments of the present invention ideal for the reattachment of soft tissue to bone or soft tissue to soft tissue where it is desirable to pass sliding knots to secure a repair.

In one embodiment, an inventive configuration, structure, and resulting function of a soft all-suture anchor that utilizes a hybrid combination of soft implantable materials is provided. A hybrid soft all-suture anchor of an embodiment includes superior pull-out strength properties as compared to conventional soft all suture anchors. Embodiments of the present invention provide a better soft all-suture anchor for use in hard bone, due in part to a hybrid expanding component portion. These embodiments are also suitable for use in soft cancellous bone where there is a very thin or weak cortical layer. The hybrid all-suture anchor can include, but is not limited to, an expandable member/portion configured to increase in size from a first pre-deployed condition to a second deployed condition upon the application of an activator; and a filament having a first filament end and a second filament end, and positioned in contacting relation to the expandable member in the second deployed condition. The anchor can also include a flat fibrous construct having a first end and a second end, and wherein the filament passes through the fibrous construct. The flat fibrous construct includes a first state in which the flat fibrous construct is uncompressed and extends along the longitudinal axis of the filament when in an unfolded and pre-deployed condition; and a second state in which the flat fibrous construct is compressed and expanded in a direction perpendicular to longitudinal axis of the filament in a deployed condition. The structure, configuration, and functionality of the expandable member, and of the fibrous construct (when part of an embodiment), help to set and hold the anchor in the bone hole in a post-deployment condition. The expandable portion/member can be part of a hybrid all-suture anchor used with any filament portion (as described herein) only. The expandable portion/member can also be part of a hybrid all-suture anchor used with any filament portion and any fibrous construct portion (as described herein).

For example, referring toFIG. 31, a perspective view of a hybrid soft all-suture anchor500in a pre-deployment configuration, according to an embodiment is shown. The hybrid all-suture anchor500can include, but is not limited to, a flat fibrous construct4having a first end4A, a second end4B. A filament2is shown having a first end2A and a second end2B, and woven, threaded, or otherwise passing through the fibrous construct4at passing locations25,27and25,28. See U.S. Pat. No. 9,826,971 for a further description of the structural aspects of the filament and fibrous construct, which is part of this example of the invention (as should be understood by a person of ordinary skill in the art in conjunction with a review of this disclosure).

In an embodiment, the filament2is free to slide through the fibrous construct4(and the expandable portion3when attached thereto) such that the filament2can be removed from the fibrous construct4from the first end4A of the fibrous construct4and/or the second end4B of the fibrous construct4. In accordance with an alternative embodiment, the filament is locked and not slidable through the fibrous construct4and/or the expandable portion3(when attached to the expandable portion3).

Turning now toFIGS. 32 and 33, there are shown side view schematic representations of an embodiment of the all-suture anchor500in the pre-deployment and post-deployment configurations. As described above, the all-suture anchor500contains at least two sections: at least one suture2with a first end2A and a second end2B; and an anchor body/fibrous construct4with a first end4A and a second end4B, which is configured to form a portion of the anchor500that can increase in width, thickness and/or diameter and shrink in length as part of deployment. The all-suture anchor500also includes an expandable portion3which is configured to form a portion of the anchor500that can increase in size in the post-deployment configuration in response to an activator (as should be understood by a person of ordinary skill in the art in conjunction with a review of this disclosure).

As shown inFIG. 32, the installation device (or inserter, as described herein above) in the pre-deployment configuration is provided. The all-suture anchor500is shown connected to the distal deployment end804of an installation device800(which can be an inserter, as described herein above), which also includes a handle802. The distal deployment end804and the all-suture anchor500are shown positioned in a bone hole900in cancellous bone904under the bone cortex902. In order to deploy the all-suture anchor500(which can be connected to other tissue that needs to be brought into apposition to the bone, as should be understood by a person of ordinary skill in the art in conjunction with a review of this disclosure), the first end2A and/or the second end2B are pulled/tensioned in a direction away from the bone hole400. The first end2A and the second end2B can be pulled/tensioned in a direction away from the bone hole900with or without the installation device800in place in the bone hole900(if installation device800is in place in the bone hole900, it can act as a counter force to the tension force out of the hole900to assist with the deployment of the all-suture anchor500). In addition, an activator can be added to the anchor to cause the expandable portion to expand to a second size greater than the first pre-deployment size. In one embodiment, the activator is water.

As shown inFIG. 33, the anchor body/fibrous construct4is shown “shortened” and “expanded” in the post-deployment configuration and locked in the bone hole900, which can be additive to the increase due to pleats formed by the fibrous construct4(which may also be part of the fibrous construct4). The all-suture anchor500, and, in particular, the fibrous construct4takes advantage of Poisson's ratio (similarly, as discussed above), which captures the following cause/effect relationship: compressing a material in a first direction causes the material to expand in direction perpendicular to the first direction (i.e., if compressed in the x-direction, the material will expand in the y-direction and/or z-direction), and stretching/lengthening a material in a first direction causes the material to contract in directions perpendicular to the first direction. Although, it is the anchor body/fibrous construct4that increases in width, thickness and/or diameter at deployment, it should be understood that the suture2can also play a role in the deployment of the anchor500even though the suture2may remain free to slide in some embodiments, and non-slidable in others (at least at a particular position or point in use) in relation to the anchor body4. The suture2helps to position, align and support the anchor body4(as should be understood by a person of skill in the art in conjunction with a review of this disclosure).

In other words, the anchor body/fibrous construct4has two primary functions. First, it becomes a base for the suture2to slide within (within the column/lumen6). Second, when compressed and/or pleated during deployment, the anchor body4becomes more compact in one direction thereby expanding outwardly and increasing its overall width, thickness or diameter to create a retention capacity. This action of having the anchor body4change in shape to increase its overall width, thickness or diameter is a useful characteristic which may be used advantageously to secure the anchor500in a hole900or against a bony or soft tissue. It is this combination of the expanding anchor body4coupled with the suture2remaining slidable (in some embodiments; and non-slidable in others, at least at a particular position or point in use) in relation to the anchor body804that render embodiments of the present invention ideal for the reattachment of soft tissue to bone or soft tissue to soft tissue where it is desirable to pass sliding knots to secure a repair.

Still referring toFIG. 33, the expandable portion3is shown in the expanded second size, greater than the first smaller pre-deployment size, after exposure to the activator. The expandable portion expands greatly in volume when exposed to the activator, causing it to wedge in the bone hole900and lock the anchor500in place. In accordance with an embodiment, in order to tension the filament2to reattach soft tissue (not shown), the filament2can freely slide backward and forward through the fibrous construct4and through the expandable portion3(as may be necessary when connected to the expandable portion3). In certain situations without the presence of fibrous construct4, the free sliding filament2could potentially cut through the expandable portion3resulting in a less than optimum deployment of the all-suture anchor500. As such, in some embodiments of the all-suture anchor500with or without the fibrous construct4, a second short length of suture2-1could be wrapped or looped around the filament2(seeFIG. 34) to prevent sawing/cutting through the expandable portion3by the filament2when in contacting relation with the expandable portion3.

Turning toFIG. 35, a side view digital photograph of an embodiment of the all-suture anchor ofFIG. 31in a post-deployment configuration after addition of an activator according to an embodiment is shown. As shown, the expandable portion3has increased in size to a second deployed structural condition (bone hole is not shown to illustrate the extent of expansion of expandable portion3), and the filament2is positioned through and/or in otherwise contacting relation with the expandable portion3.

Similarly with respect to the filament2and fibrous construct4described above and the embodiments shown inFIGS. 32-34, the expandable portion3can be a part of any all-suture anchor described herein or otherwise including the all-suture anchor shown and described in U.S. patent application Ser. No. 16/033,616. The same structure and functionality of the expandable portion3described above and shown inFIGS. 32-34can apply to these embodiments of an all-suture anchor (with and without the fibrous construct).