Patent Application
20200214689
The present invention relates to an all-suture anchor construct for fixation in a bone hole or tunnel and, more particularly, to an all-suture anchor construct having an expandable portion with a length of a suture or filament positioned in contacting relation therewith upon deployment, and which may also include a flat section of woven suture tape, braid or fibrous construct with the length of suture woven or positioned therethrough.
Many orthopedic surgical and medical procedures require the fixation of one body to another body. Such bodies may include bone, soft tissue, and prosthetics. One body can be fixed in a position relative to another using connector devices, such as screws and suture anchors (e.g., cannulated knotless suture anchors and soft all-suture anchors). For example, various orthopedic surgeries (such as the reattachment of soft tissue to bone) require the insertion and fixation of a suture anchor within a bone hole (e.g., at a desired tissue reattachment location). Suture anchors can include “hard” suture anchors, and “soft” all-suture anchors.
As described in U.S. Pat. No. 8,409,252, 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 bioabsorbable 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.
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 U.S. Pat. No. 9,173,652) and a suture or filament portion. Another example of a “soft” all-suture anchor is the Y-Knot® device. See, e.g., U.S. Pat. No. 9,826,971. Such soft all-suture anchors are often preferred by some orthopedic surgeons over the hard suture anchors because of their relative softness and usually excellent pull-outs strength among other reasons which should be understood by a person of ordinary skill in the art. In a traditional Y-Knot device, a suture filament is pierced entirely through a braid material a number of times, such that the suture passes through a “front” surface and a “back” surface.
There are at least two general, conventional methods for inserting a suture anchor within a bone. In one method, a bone hole is created and prepared using a drill bit. The drill bit is typically advanced through a drill guide to create the bone hole and then, a suture anchor is passed through or down the drill guide with an anchor inserter/installation device into the bone hole for deployment.
In a second method, the drilling step is eliminated in an attempt to avoid the aforementioned misalignment issue. A self-punching suture anchor, such as the Y-Knot® RC suture anchor, for example, is designed with an inserter that allows the anchor in the inserter to be directly positioned on the bone at the desired location. When the anchor in the inserter is positioned at the desired location, the inserter can be hammered, forcing the anchor directly into the bone.
Conventional methods and devices for inserting/deploying such all-suture anchors are known, examples of which are disclosed in U.S. Pat. No. 9,173,652.
In order to deploy correctly, conventional all-suture type anchors must expand diametrically and thus rely on the compressive failure of the sub-cortical cancellous bone at the implantation site. If however, the subcortical bone is extremely hard and dense, such as is found in the load bearing region of the acetabular rim of the hip joint, compressive failure of the bone may not occur, thus resulting in poor pull-out strength of the anchor.
Therefore, there is a need for a soft all-suture anchor construct that can be structured and composed of materials sufficient to greatly increase anchor pull-out strength in hard bone.
Description of the Related Art Section Disclaimer: To the extent that specific patents/publications/applications/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/applications/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).
Embodiments of the present invention recognize that there are potential problems and/or disadvantages with conventional soft all-suture anchors (as discussed herein and above). Various embodiments of the present invention may be advantageous in that they may solve or reduce one or more of the potential problems and/or disadvantages discussed herein.
The present disclosure is directed to an inventive configuration, structure, and resulting function of a soft all-suture anchor that utilizes a hybrid combination of soft implantable materials. 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.
In one embodiment, an all-suture anchor is disclosed and 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; 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 may 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.
According to another embodiment, the all-suture anchor briefly described above in conjunction with an installation device is provided. The installation device can include, but is not limited to, a handle and a distal deployment end, which can be fork-shaped or other appropriate shape to sufficiently hold during deployment and to deploy the all-suture anchor within a bone hole.
According to yet another embodiment, a method of deploying the all-suture anchor briefly described above in a preformed bone hole (already drilled) can include, but is not limited to, the steps of: (i) providing the all-suture anchor briefly described above; and (ii) using the installation device to deploy the all-suture anchor into the preformed bone hole (preferably into cancellous bone below the cortex) by tensioning the free ends of the filament (applying a force on the free ends of the filament in a direction away from the bone hole). In brief, the tensile force applied to the suture tails causes the flat tape/fibrous construct to “form a clump” and “ball-up” underneath the cortical layer and thus provide fixation for the anchor. In an embodiment that includes an expandable portion (with or without the fibrous construct), an activator can be applied to cause expansion of the expandable member to deploy the anchor.
Suture material, sutures, or filaments 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 bioabsorbable and non-absorbable materials, and can be round, flat, or braided.
The present invention will be more fully understood and appreciated by reading the following Detailed Description in conjunction with the accompanying drawings. The accompanying 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. Reference is now made briefly to the accompanying drawings, in which:
in accordance with an embodiment of the present invention, the hybrid all-suture anchor can be formed from an expanding portion (as described below and illustrated by the accompanying figures), and any filament/suture and/or fibrous construct (as should be understood by a person of skill in the art in conjunction with a review of this disclosure). For example, the all-suture anchor as shown and described in U.S. Pat. No. 9,826,971, including the filament and the fibrous construct and installation device, can form part of embodiments of the present invention. In addition, the all-suture anchor shown and described in U.S. patent application Ser. No. 16/033,616, including the filament and the fibrous construct and installation device, can form part of embodiments of the present invention. An expanding portion, which can include any sponge-like material including, but not limited to, a cellulose fiber sponge material (or other biocompatible material), can be combined with any all-suture anchor (including, but not limited to, examples discussed herein and in U.S. Pat. No. 9,826,971 and U.S. patent application Ser. No. 16/033,616 as should be understood by those of ordinary skill in the art in conjunction with a review of this disclosure) to form an embodiment of the hybrid all-suture anchor of the present invention. In an alternative embodiment, the fibrous construct can be eliminated and the filament and expandable portion can act as a hybrid all-suture anchor.
Set forth below are example descriptions related to the structure and functionality of, and to a method associated therewith, a hybrid all-suture anchor of an embodiment of the present invention. Advantages of the invention are illustrated by the example descriptions set forth herein. However, the particular conditions and details are to be interpreted to apply broadly in the art and should not be construed to unduly restrict or limit embodiments of the invention in any way.
Referring now to the drawings, wherein like reference numerals refer to like parts throughout, there is seen in
Still referring to
In an embodiment, the filament 2 is free to slide through the fibrous construct 4 (and the expandable portion 3 when attached thereto) such that the filament 2 can be removed from the fibrous construct 4 from the first end 4A of the fibrous construct 4 and/or the second end 4B of the fibrous construct 4. In accordance with an alternative embodiment, the filament is locked and not slidable through the fibrous construct 4 and/or the expandable portion 3 (when attached to the expandable portion 3).
Turning now to
As shown in
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In other words, the anchor body/fibrous construct 4 has two primary functions. First, it becomes a base for the suture 2 to slide within (within the column/lumen 6). Second, when compressed and/or pleated during deployment, the anchor body 4 becomes 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 body 4 change in shape to increase its overall width, thickness or diameter is a useful characteristic which may be used advantageously to secure the anchor 100 in a hole 400 or against a bony or soft tissue. It is this combination of the expanding anchor body 4 coupled with the suture 2 remaining slidable (in some embodiments; and non-slidable in others, at least at a particular position or point in use) in relation to the anchor body 204 that 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 to
Turning to
Similarly with respect to the filament 2 and fibrous construct 4 described above and the embodiments shown in
While embodiments of the present invention has been particularly shown and described with reference to certain exemplary embodiments, it will be understood by one skilled in the art that various changes in detail may be effected therein without departing from the spirit and scope of the invention as defined by claims that can be supported by the written description and drawings. Further, where exemplary embodiments are described with reference to a certain number of elements it will be understood that the exemplary embodiments can be practiced utilizing either less than or more than the certain number of elements.
The present application claims priority to and the benefit of U.S. Provisional Patent Application No. 62/543,516 filed on Aug. 10, 2017.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US18/45957 | 8/9/2018 | WO | 00 |
| Number | Date | Country | |
|---|---|---|---|
| 62543516 | Aug 2017 | US |
