Patent Description:
The present disclosure is directed generally to an all-suture anchor and, more particularly, to an all-suture anchor composed of materials of varying densities.

Currently, all-suture anchors used to re-attach soft tissue to bone are generally composed of a single material having a uniform density. <FIG> shows an example of a conventional all-suture anchor <NUM>. The all-suture anchor <NUM> includes a braid <NUM> composed of a single material with a passing suture <NUM> woven therethrough for deployment. This homogenous all-suture anchor structure is relatively smooth and soft in nature. As a result, current all-suture anchors rely on expansion that is controlled by the density of the bone in addition to the mechanics of the anchor when it is deployed.

Many conventional arthroscopic all-suture anchors are set or deployed by hand. These hand-set all-suture anchors pull out of hard and soft bone more readily than all-suture anchors deployed by a driver/inserter mechanism (although, some anchors deployed by a driver/inserter mechanism pull out after being set).

Therefore, there is a need for a suture anchor made of a material(s) that is optimal for generating bone compression and increased interference fixation post-installation.

An all-suture anchor with the features in the pre-characterizing portion of Claim <NUM> is disclosed in <CIT>. Further anchoring elements related to the present invention are disclosed in <CIT>, <CIT> and <CIT>.

The present invention is directed to an all-suture anchor composed of a material(s) with a density (or densities) that is optimal for generating bone compression and increasing interference fixation post-installation. The all-suture anchor of the present invention is defined in Claim <NUM>. Further advantageous features are set out in the dependent claims.

A method for deploying an all-suture anchor is disclosed, which is not forming part of the invention. The method includes the steps of: (i) providing an all-suture anchor having a fibrous construct movable between a pre-deployment configuration and a deployed configuration, the fibrous construct having a first density and a monofilament woven therethrough, the monofilament having a second density which is different than the first density; (ii) weaving a passing suture through the all-suture anchor; (iii) loading the all-suture anchor in a pre-deployment configuration onto a driver; and (iv) driving the all-suture anchor into a bone hole using the driver. The monofilament is preferably fixed with respect to the fibrous construct after it is woven through the fibrous construct, as opposed to a passing suture that can move through the fibrous construct (at least in the pre-deployment configuration).

Suture material or sutures, as the terms are used and described herein, can include monofilament or multi-filament suture as well as any other metallic or non-metallic filamentary or wire-like material suitable for performing the function of a suture. This material can include both bio absorbable and non-absorbable materials.

Suture anchors, as the term is used herein, can include soft suture anchors and rigid suture anchors. Soft suture anchors are formed from filaments of suture material which are retained within pre-formed bone holes by being deformable to increase their diameter to a size greater than that of the bone hole, to thereby reside within the cancellous bone and under the bone cortex. One such suture anchor is disclosed in <CIT> assigned to the assignee hereof. Since soft anchors are commonly made entirely of suture materials, they are sometimes called "all-suture" anchors, and generally include a fibrous construct anchor body portion (or fibrous, braided or woven fabric-type structure such as a flexible web, as described in <CIT>) and a suture or filament portion. Methods and devices for inserting/deploying such all-suture anchors are known, examples of which are disclosed in <CIT>.

As described in <CIT>, for example, "non-soft," "hard" or "rigid" suture anchors generally include a "hard" anchor body portion (that may or may not include inner and outer members) and a suture/filament portion. The anchor body of such suture anchors may be formed of a biocompatible and/or bio absorbable material. These materials may be of such composition that they are reabsorbed by the body, e.g., during the healing process of the bone. Exemplary materials that are suitable for use in the inner and outer members include, but are not limited to, polyetheretherketone ("PEEK"), polylactic acid/beta-tricalcium phosphate ("PLA/Beta-TCP") composites, ultra-high molecular weight polyethylene ("UHMWPE"), as well as other metallic, non-metallic, and polymeric materials.

It should also be appreciated that terminology explicitly employed herein that also may appear in any disclosure cited should be accorded a meaning most consistent with the particular concepts disclosed herein.

One or more aspects of the present invention are particularly pointed out and distinctly claimed as examples in the claims at the conclusion of the specification. The foregoing and other objects, features, and advantages of the invention are apparent from the following description taken in conjunction with the accompanying drawings in which:.

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

Referring now to the figures, wherein like reference numerals refer to like parts throughout, <FIG> shows a top perspective view schematic representation of an all-suture anchor <NUM>, according to an embodiment. In the depicted embodiment, the all-suture anchor <NUM> comprises a fibrous construct <NUM> and a monofilament <NUM> woven therethrough. The fibrous construct <NUM> can be any fibrous, braided (e.g., uniform or non-uniform braid) or woven fabric-type structure having a first density.

In the embodiment depicted in <FIG>, the fibrous construct <NUM> is a flat length of suture having and extending between a first end <NUM> and a second end <NUM>. In alternative embodiments, the fibrous construct <NUM> can also be a tube braid or cored suture (as should be understood by a person of ordinary skill in the art in conjunction with a review of this disclosure). The fibrous construct <NUM> is movable between a pre-deployment configuration, as shown in <FIG>, and a deployed configuration, as shown in <FIG>. The fibrous construct <NUM> may be composed of any traditional suture material, such as polyethylene (e.g., UHMWPE). The fibrous construct <NUM> can be, for example, <NUM> - <NUM> in width,. <NUM> in depth, and at least <NUM>,<NUM> (<NUM> inches) long. In an embodiment, the fibrous construct <NUM> has, for example, a width of <NUM> and a depth of. The fibrous construct <NUM> can also have, for example, an average USP knot pull strength ≥ <NUM>,45N (<NUM> LBF), with no individual value < <NUM>,65N (<NUM> LBF).

Still referring to <FIG>, the monofilament <NUM> has a second density which is different (higher or lower) from the first density (i.e., density of the fibrous construct <NUM>). In an embodiment, the monofilament <NUM> can be, for example, USP #<NUM>/<NUM> suture and is at least <NUM>,<NUM> (<NUM> inches) in length. The monofilament <NUM> can be composed of any traditional suture material, such as nylon, for example. The monofilament <NUM> can have, for example, an average USP knot pull strength ≥ <NUM>,79N (<NUM> LBF), with no individual value < <NUM>,<NUM> N (<NUM> LBF). The monofilament <NUM> is a segmented suture of multiple densities and may, e.g., be a suture with a fourth density etc. in addition to its different second and third densities. The monofilament <NUM> is woven a length of one or more sutures having contrasting (e.g., third, fourth. ) densities. The monofilament <NUM> is woven through the fibrous construct <NUM> from the first end <NUM> to the second end <NUM> (although, it does not have to stretch all the way to both ends, it can exist as it is woven through between both ends). As shown in <FIG>, the monofilament <NUM> can be woven through the fibrous construct <NUM> using a needle <NUM>.

In an embodiment, the monofilament <NUM> is threaded through the needle <NUM> and the needle <NUM> is used to pull the monofilament <NUM> through the fibrous construct <NUM> to create a "baseball" stitch, for example, as shown in <FIG>. In an embodiment, the monofilament <NUM>, for example, is woven through the fibrous construct <NUM> using a whip stitching technique to achieve the baseball stitch configuration. The fibrous construct <NUM> is tensioned and the monofilament <NUM>, formed in a continuous loop, is threaded onto the needle <NUM>. The loop of monofilament <NUM> is placed around the fibrous construct <NUM> such that the fibrous construct <NUM> is extending through the loop of monofilament <NUM>.

Then, the needle <NUM> is used to puncture a first surface <NUM> of the fibrous construct <NUM> along a central longitudinal y - y axis extending through the fibrous construct <NUM> from the first end <NUM> to the second end <NUM>. The needle <NUM> is pulled through the fibrous construct <NUM> to a second surface (not shown) and the monofilament <NUM> is pulled tight such that the monofilament <NUM> is snug on the first surface <NUM> of the fibrous construct <NUM>. As a result, the first stitch <NUM> includes a first portion <NUM> of monofilament <NUM> extending from a first side <NUM> of the fibrous construct <NUM> to a first central passing location <NUM> (meaning a location near or along the central longitudinal y - y axis) and a second portion <NUM> of monofilament <NUM> extending from a second side <NUM> of the fibrous construct <NUM> to the first central passing location <NUM>, as shown in <FIG>.

After the first stitch <NUM> is placed, the loop of monofilament <NUM> extends from the bottom surface (not shown) of the fibrous construct <NUM>. To place additional stitches <NUM>, the loop of monofilament <NUM> is pulled back around the fibrous construct <NUM>. Stated differently, the fibrous construct <NUM> is pulled or extended through the loop of monofilament <NUM> again. Thereafter, the needle <NUM> is passed through a subsequent second central passing location <NUM>, spaced from the first central passing location <NUM>. The monofilament <NUM> is pulled tight, securing a second stitch <NUM>. The method is repeated to place as many stitches <NUM> as desired along the length of the fibrous construct <NUM> to create added texture or irregularities in the all-suture anchor <NUM>. Preferably, there are <NUM> - <NUM> central passing locations along the length of the fibrous construct <NUM> and at least <NUM> inches of the fibrous construct <NUM> contains woven monofilament <NUM>. In an embodiment, the first and second ends <NUM>, <NUM> of the fibrous construct <NUM> are left unstitched with monofilament <NUM>.

In accordance with other embodiments of the present invention, the stitch design does not have to look like what is shown in <FIG>. Whatever the look of the monofilament <NUM> being weaved through the fibrous construct <NUM>, it is preferable that a portion of the monofilament <NUM> extend from the outside surface of the fibrous construct <NUM> in order for an outside surface of the portion of the monofilament <NUM> to be able to grip to the surface of a bone hole upon deployment of the anchor. In addition, multiple monofilaments <NUM> of the same or different material with the same or different densities can be woven through a fibrous construct <NUM>, for added bone surface grip capability benefit.

In alternative embodiments, the all-suture anchor <NUM> comprises additional features for creating irregularity within the bone surface when the all-suture anchor <NUM> is deployed. For example, the fibrous construct <NUM> may comprise rigid, mechanical barbs (or other similar protrusions, as should be understood by a person of ordinary skill in the art in conjunction with a review of this disclosure) on an exterior surface of the fibrous construct <NUM>. In other examples, the monofilament <NUM> (or fibrous construct <NUM>) may comprise added texture or rigidity along its length (which can, but does not have to be, composed of a material of yet another different density), which creates greater interference for fixation, as shown in <FIG>.

Turning now to <FIG>, there are shown various views schematic representations of the all-suture anchor <NUM> loaded on a driver <NUM>. The driver <NUM> shown in <FIG>, for example, can be any standard anchor driver. In the depicted embodiment, the driver <NUM> has a pronged end <NUM> with spaced first and second arms <NUM>, <NUM> (<FIG>). To prepare the all-suture anchor <NUM> for deployment, a passing suture <NUM> is threaded through the all-suture anchor <NUM> in the pre-deployment configuration, as shown in <FIG>. A first end <NUM> of the passing suture <NUM> extends from the first end <NUM> of the all-suture anchor <NUM> and a second end <NUM> of the passing suture <NUM> extends from the second end <NUM> of the all-suture anchor <NUM>.

With the passing suture <NUM> extending through the all-suture anchor, the all-suture anchor <NUM> can be loaded onto the driver <NUM>. To load the all-suture anchor <NUM>, the all-suture anchor <NUM> is placed between the first and second arms <NUM>, <NUM> of the pronged end <NUM>. The all-suture anchor <NUM> is placed in the pronged end <NUM> such that a portion of the fibrous construct <NUM> between the first and second ends <NUM>, <NUM> is placed between the arms <NUM>, <NUM>, and the first and second ends <NUM>, <NUM> of the passing suture <NUM> extend on opposing sides of the driver <NUM>, as shown in <FIG>. In an embodiment, an approximately central portion <NUM> of the fibrous construct <NUM> is placed between the arms <NUM>, <NUM>.

Referring now to <FIG>, there is shown a side sectioned view schematic representation of an all-suture anchor <NUM> deployed in a bone hole <NUM>, according to an embodiment. With the all-suture anchor <NUM> in the pre-deployment configuration loaded on the driver <NUM>, as shown in <FIG>, the pronged end <NUM> of the driver <NUM> is pushed into the bone hole <NUM>. When the all-suture anchor <NUM> is within the bone hole <NUM>, the driver <NUM> can be removed. The passing suture <NUM> is tensioned to deploy the all-suture anchor <NUM>. The contrasting density (i.e., irregularities) of the fibrous construct <NUM> and the monofilament <NUM> woven therethrough generates bone compression and additional interference fixation. As a result, the all-suture anchor <NUM> has additional purchase in hard and soft bone as compared to all-suture anchors composed of a single material (or multiple materials) of one density. For example, the all-suture anchor <NUM> has more power in hard bone, such as in a hip, as compared to conventional all-suture anchors (of uniform density). With the all-suture anchor <NUM> in place, the passing suture <NUM> can be used to secure a soft tissue in a desired position relative to the bone hole <NUM>. In addition, the all suture anchor <NUM> can be deployed such that the thickness of the fibrous construct <NUM> is greater in the deployed state as compared to the thickness of the fibrous construct <NUM> in an un-deployed state.

All definitions, as defined and used herein, should be understood to control over dictionary definitions, definitions in cited documents, 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 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, 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.

It will be further understood that the terms "comprise" (and any form of comprise, such as "comprises" and "comprising"), "have" (and any form of have, such as, "has" and "having"), "include" (and any form of include, such as "includes" and "including"), and "contain" (any form of contain, such as "contains" and "containing") are open-ended linking verbs. As a result, a method or device that "comprises", "has", "includes" or "contains" one or more steps or elements. Likewise, a step of 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. Furthermore, a device or structure that is configured in a certain way is configured in at least that way, but may also be configured in ways that are not listed.

Claim 1:
An all-suture anchor (<NUM>), comprising:
a fibrous construct (<NUM>) movable between a pre-deployment configuration and a deployed configuration, the fibrous construct having a first density; and
a monofilament (<NUM>) woven through the fibrous construct, the monofilament having a second density, which is different than the first density;
characterized in that the monofilament comprises a segment of a third density.