Patent Application
20150127049
A recent trend in tissue anchor and suture anchor devices is the “soft” device, also referred to as a “filamentary” fixation device, in which the device itself is constructed of a filamentary material, such as suture or the like. Such filamentary fixation devices can replace traditional metal or hard polymer devices in numerous orthopedic surgical procedures, including soft tissue repair and replacement surgical procedures. Such filamentary fixation devices may provide solutions to various problems encountered with traditional metal or hard polymer devices. In many instances, such traditional devices tend to be large in diameter, and must include sufficient material, or other additional structures, to withstand the forces pulling against the device, whether via a suture or directly against the device itself. The size of such devices may limit the possible implantation locations in the body, as sufficient bone mass is required to accommodate the device. Moreover, a large hole must be drilled into the bone to allow for passage of the device through the cortical layer and into the cancellous bone. The larger drill holes may be too invasive resulting in excessive loss of healthy bone, or creation of a large repair site. Such filamentary fixation devices can alleviate many of these problems associated with traditional anchors.
Despite the many benefits these filamentary fixation devices provide, instances of, for example, poor bone quality and the like can increase the chances of lower pullout strength and overall effectiveness of the repair. For example, if the bone is too soft, the bone may not provide sufficient resistance to the device which could result in lower pull-out strength of the device.
Therefore, in light of such issues, there is a need in the art for an improved filamentary fixation device capable of having improved pullout strength in all types of bone, including bone of poor quality.
Generally, the present invention relates to filamentary fixation devices, kits, methods for manufacture or assembly, and methods of use, for example, in soft tissue repair, particularly where soft tissue must be reattached to bone. In such repairs, the filamentary fixation device can be implanted in a prepared bone hole to secure a length of filament to the bone. The filament can then be used to secure the soft tissue to bone. Further, while the majority of embodiments disclosed herein relate to the use of the filamentary fixation device of the present invention as a “suture anchor” for placement in bone, and to attach, reattach or otherwise secure soft tissue thereto, other uses of the filamentary device are also envisioned.
In one embodiment, the present invention includes a fixation device including a cannulated body having a length and a pathway along at least a portion of the length and formed of a filamentary material, the body including at least one projection along its length.
In one variation, the fixation device may include the at least one projection being positioned on an inner surface of the body such that the projection extends into the pathway. The at least one projection may include two or more projections. Further, the two or more projections can be spaced from one another along the length of the body, circumferentially along the inner surface, or both. Alternatively, where the body includes two or more projections, at least one of the projections can be positioned on the inner surface and at least one of the projections can be positioned on an outer surface of the body such that the at least one projection extends away from the outer surface of the body.
In another variation, the at least one projection may be positioned on an outer surface of the body such that the projection extends away from the outer surface of the body. Further, the at least one projection can include two or more projections, and moreover, the two or more projections can be spaced from one another along the length of the body, circumferentially along the outer surface, or both. Alternatively, the body can include two or more projections, wherein at least one of the projections can be positioned on the outer surface and at least one of the projections can be positioned on an inner surface of the body such that the at least one projection extends into the pathway.
In another embodiment, the present invention includes a fixation device including a body formed of filamentary material having a length and a pathway along a longitudinal axis, an outer surface on an exterior of the body and an inner surface defining the pathway, and an at least one projection extending from the body, and a filament having a length, a portion of the length positioned through the pathway.
In yet another embodiment, the present invention is a method of securing a filamentary fixation device in a bone hole including the steps of inserting the filamentary fixation device into the bone hole, the filamentary fixation device including a body formed of filamentary material having a length and a pathway along at least a portion of the length and along a longitudinal axis, an outer surface on an exterior of the body and an inner surface defining the pathway, and an at least one projection extending from the body, the body being folded on itself, and a filament positioned through the pathway; and tensioning the filament in a direction away from the bone hole to compress the filamentary fixation device within the bone hole such that the at least one projection engages an interior surface of the bone hole, wherein the engagement of the bone hole with the at least one projection restricts movement of the filamentary fixation device in the direction of tension.
In still another embodiment, the present invention includes a method of securing a filament to bone, including the steps of inserting at least a portion of the filament into a hole in the bone, the portion of filament having a filamentary fixation device positioned thereon, the device including a body having a length, a pathway and an at least one projection extending from an outer surface of the body, such that the portion of filament passes through the pathway; and tensioning the filament in a direction away from the bone such that the at least one projection of the device engages the bone and restricts movement of the device and the portion of the filament in the direction of tensioning.
In a further embodiment, the present invention includes a method of securing a filament to bone, including the steps of inserting at least a portion of the filament into a hole in the bone, the portion of filament having a filamentary fixation device positioned thereon, the device including a body having a length, a pathway and an at least one projection being positioned on an inner surface of the body such that the projection extends into the pathway, such that the portion of filament passes through the pathway; and tensioning the filament in a direction away from the bone to secure the device in bone. Furthermore, the at least one projection of the device can engage the filament and restrict movement of the filament through the pathway in at least one direction.
In another embodiment, the present invention includes a method of securing soft tissue to bone, including the steps of engaging the soft tissue with a first end of a filament, the filament having a length between the first end and a second end and having a filamentary fixation device positioned along a portion of the length, the device including a body having a length, a pathway and an at least one projection being positioned on an inner surface of the body such that the projection extends into the pathway, such that the portion of filament passes through the pathway; positioning the device within a hole in bone and securing the device therein; and tensioning the filament from the second end to draw the tissue towards the device, wherein the at least one projection of the device engages the filament and restricts movement of the filament through the pathway in a direction opposite the direction of tensioning.
a and 5b illustrate various steps of implanting the device of
The filamentary fixation devices, kits, methods for manufacture or assembly and methods of use of the present invention are intended for use in the repair, reattachment, replacement or otherwise securement of tissue, including both hard tissue (i.e., bone or the like) and soft tissue. Soft tissue may be, for example, meniscus, cartilage, capsule, ligaments and tendons, replacement grafts of any of these soft tissues, or the like. While many of the exemplary methods of use disclosed herein are directed towards the use of the filamentary fixation devices and kit as a suture anchor for implantation into a bone hole, other uses are also envisioned. As used herein, “proximal” or “proximally” means closer to or towards an operator, e.g., surgeon, while “distal” or “distally” means further from or away from the operator.
As used herein, the term “filament” or “filamentary” is defined as a suture or other thread-like material. Such filament may be constructed of synthetic material (e.g., PLGA, UHMWPE (ultra high molecular weight polyethylene), polyester, PEEK, Nylon, polypropylene, aramids (for example, Kevlar®-based fibers) or the like, or blends thereof), organic material (silk, animal tendon, or the like or blends thereof), or blends of both one or more organic materials and one or more synthetic materials. Alternatively, filaments may include thin metal wires. While any of these materials may be used, it is preferable, and is disclosed herein, that the various filaments or filamentary aspects of the present invention be constructed out of suture, such as UHMWPE, polyester or blends thereof.
In one embodiment, illustrated in detail in
The body 11 includes a generally cylindrical shape along a longitudinal axis, defined by the first end 18 and the second end 19, and the hollow pathway 14 extends along the longitudinal axis. The first end 18 and the second end 19 may be perpendicular to the longitudinal axis or they may be at a transverse angle to the longitudinal axis. The device 10 is illustrated with the body 11 folded on itself to form a U-shape, which is the preferred shape for insertion of the device 10 into a bone hole, for example. While this device 10 is one embodiment, it is envisioned that alternative configurations of the device 10 may also be used, and such alternative configurations may include alternative shapes, sizes, or features as desired. Generally speaking, many features of filamentary fixation device 10, and associated instrumentation and implant features, may be similar to those disclosed in U.S. Provisional Application No. 61/679,336, filed Aug. 3, 2012, U.S. application Ser. No. 13/303,849, filed Nov. 23, 2011, Ser. No. 13/588,586, filed Aug. 17, 2012, Ser. No. 13/588,592, filed Aug. 17, 2012, Ser. No. 13/783,804, filed Mar. 4, 2013, and Ser. No. 13/792,982, filed Mar. 11, 2013, and U.S. Pat. Nos. 5,989,252 and 6,511,498, the entireties of which are incorporated by reference herein as if fully set forth herein and all of which are assigned to the same entity as the present application. Another exemplary filamentary fixation device for use in the present invention is the ICONIX™ line of filamentary fixation products (Howmedical Osteonics, Mahwah, N.J.). Other alternative configurations are also envisioned.
Returning to the embodiment of
The shape of each projection 15a, 15b, as illustrated, is curved, though again, the shape may differ as desired, such that at least one of the projections can be curved, or a different shape, such as chevron-shaped or V-shaped, square-shaped, triangular-shaped, or the like.
Preferably, the shape of the at least one projection 15a, 15b may be a chevron-shape which is prepared by flattening the body 11 and cutting from the edge of the flattened portion to a desired distance through the sleeve at an angle transverse to the longitudinal axis of the body. Alternatively, the curved shape, as illustrated, can be prepared by cutting the outer surface 12 of the body 11 at an angle transverse to the longitudinal axis of the body. Since the body 11 is generally cylindrical in shape, such an angled cut results in a projection having the curved-shape. In one further embodiment, the first end 18 and the second end 19 may be parallel to the transverse angled cuts.
The projections can be formed by any known means. Typically, the projections are formed by cutting the body at a desired location to form the projection. The cut(s) can extend through less than 180 degrees of the circumference of the outer surface of the body, whether the cut is perpendicular to the longitudinal axis of the body or at an angle transverse to this axis. Upon formation of the projection or projections, a hole may be formed through the body 11 from the outer surface 12 to an inner surface 17 and into the cannulation 14. The resulting hole is simply the byproduct of forming the projection as the cut passes completely through the thickness of the wall of the body, defined between the outer surface 12 and the inner surface 17. Such resulting hole may be beneficial in terms of tissue in-growth into the body.
For example, in one embodiment, a hot knife may be used to cut the body 11 along at least a portion of the outer surface 12 along its circumference. The hot knife may also melt or otherwise soften the body material, both the material now forming the projections as well as the adjacent material. Upon completion of the cut, the softened material will cool and may harden to be stiffer and less flexible than prior to the cut, though the hardened portions of material may still have a degree of flexibility. This hardening step can be particularly beneficial to the projections as the hardened projections may impart a stronger locking force upon engagement with bone (discussed below).
Alternatively, an automated process using a blade, laser or the like may be used in place of the hot knife process. In this example, the use of the laser may impart greater precision on the cutting technique, and additionally, the laser can more easily form unique or detailed cutting patterns to form projections having complex shapes.
Whether using the hot knife, laser or other instrument for forming the cuts, the projections may be formed all at once (e.g., by a series of hot knife “blades” which form the cuts all at once along the length of the body, or length of filament which is later cut into distinct, separate bodies) or individually along the length of the body or length of filament.
In still another embodiment of forming the cuts, the entirety of the body 11 (or length of filament later divided into separate bodies) can be heated to a temperature just below the glass transition temperature of the material used. The body may then be allowed to cool. Due to the elevated temperature, upon cooling the body remains flexible but is harder or stiffer than prior to the heating process. The cuts may then be formed using any technique desired. This process may result in a stiffer body, including stiffer projections (as discussed above relative to the hot knife embodiment).
In yet a further embodiment, an adhesive may be used to stiffen a portion of the body 11, such as the projections or the entire body. Such an adhesive would stiffen the material to which it was applied. One example of a suitable adhesive is Histoacryl® (Aesculap, Inc., Center Valley, Pa.). The adhesive may be applied before or after the cuts are made to form the projections.
Furthermore, following cutting the filament, whether to form the separate bodies or to form the projections, heat may be applied to any cut portion of the filament to harden the end portion of the filament and/or projection as well as to prevent fraying at the point of cutting.
In yet another alternative embodiment, the projections may be separate from the body 11 and applied to the body using an adhesive, a weaving step or the like. Such projections may be the same or different material than the filament. In one example, such projections may be a rigid or semi-rigid plastic which are applied to the filament using an adhesive.
Projections 15a, 15b are preferably positioned on the body 11 such that they can contact the surface of the bone hole. As illustrated in
For example, as in
Both the body 11 and the filament 50 are formed of filamentary material, whether the same material or different materials. While the material of the body 11 should be hollow, the filament 50 can either be a hollow filament or a solid filament (i.e., having a core). The filament 50, as it may be positioned through the cannulation, should have a diameter less than or equal to the diameter of the cannulation 14 of the body 11, and as such the body should have an outer diameter that is larger than the diameter of the filament. In one example, the body may be constructed of #5 suture while the filament may be constructed of #1 or #2 filament. In another example, the body may preferably have an outer diameter of about 2.3 mm.
In another embodiment, illustrated in
Continuing with
Moreover, in an even further alternative, the projections need not be only on opposing sides, and thus facing one another, as in
Such projections may be formed by any of the methods discussed above. Further, the body 111 and filament 150 may be formed of any filamentary material desired, as discussed above.
These inner projections 115a, 115a′, 115b, 115b′ may contact the filament 150 when the filament is positioned through the pathway 114 of body 111. As illustrated, the projections may be positioned at an angle transverse to the longitudinal axis of the pathway 114 such as to allow generally one-way travel of the filament 150 through the pathway. In one example, illustrated in
In one alternative embodiment, illustrated in
This embodiment as illustrated in
In another embodiment, the present invention includes a kit comprising at least one filament and a plurality of filamentary fixation devices. The devices may vary in size, number of projections, location of projections, or the like, or alternatively each of the devices in the kit can be identical to each other. Similarly, the filament may be suitable for use in any of the devices, or alternatively the kit can include a plurality of filaments of the same diameter and length or of various diameters and/or lengths. The kit can include the filaments and devices individually, or alternatively, at least one filament can be positioned through at least one device. The kit may further include additional elements such as insertion instruments, drills and/or reamers, or the like. Further, the kit could include a filament loading shuttle or device, for example, such as those described in U.S. Provisional Application No. 61/679,336, filed Aug. 3, 2012 and U.S. application Ser. No. 13/588,586, filed Aug. 17, 2012, Ser. No. 13/588,592, filed Aug. 17, 2012, Ser. No. 13/783,804, filed Mar. 4, 2013, and Ser. No. 13/792,982, filed Mar. 11, 2013, all of which were incorporated by reference above.
The various embodiments of the filamentary fixation devices of
In one embodiment, a method of securing a filamentary fixation device in a bone hole includes the steps of inserting the filamentary fixation device 10, 10′, 10″, 110, 110′, 210 into the bone hole, the device having a filament 50, 50′, 50″, 150, 150′, 250 positioned therethrough, and tensioning the filament in a direction away from the bone hole to compress the filamentary fixation device within the bone hole such that an at least one projection moves outward from the outer surface (represented as 12, 112, 212 in certain figures) of the body 11, 11′, 11″, 111, 111′, 211 and/or inward from the inner surface (represented as 17, 117, 217 in certain figures) of the body.
If the projection is intended to move outward, then the tensioning step would move the projection into engagement with an interior surface of the bone hole 91, wherein the engagement of the bone hole with the projection restricts movement of the filamentary fixation device in the direction of tension. However, if the projection is intended to move inward, then the tensioning step would move the projection into engagement with the filament, wherein the engagement of the projection with the filament restricts movement of the filament, within the body, in at least one direction, even upon release of the tension on the filament. Of course, if the device 210 is used in this method, upon tensioning the filament, at least one projection may engage the surface of the bone hole and at least one projection may engage the filament within the pathway in the body.
Once tension has been applied, and the body 11, 11′, 11″, 111, 111′, 211 has been deployed, the filament may be used to perform a surgical repair of tissue, such as, for example, reattaching soft tissue to bone, for example a rotator cuff, shoulder labrum, hip labrum, or the like. The body having the at least one projection, and preferably a plurality of projections (directed outward and/or inward), may provide additional pullout strength against tension applied to the filament by the soft tissue, or other mass attached thereto. For example, one end of the filament may be secured to the soft tissue to be repaired, and the other end of the filament may be tensioned to tension the soft tissue towards the body and its position in the bone. The filament may then be secured to maintain tension on the soft tissue. In one variation, where the body includes projections on the inside, as with
In another embodiment, a method of securing a filament to bone includes the steps of inserting the filamentary fixation device 10, 10′, 10″, 110, 110′, 210 into the bone hole, the device having a filament 50, 50′, 50″, 150, 150′, 250 positioned therethrough, and tensioning the filament in a direction away from the bone hole to compress the filamentary fixation device within the bone hole such that an at least one projection moves outward from the outer surface (represented as 12, 112, 212 in certain figures) of the body 11, 11′, 11″, 111, 111′, 211 or inward from the inner surface (represented as 17, 117, 217 in certain figures) of the body. Upon compression of the device within the bone hole, the filament is secured to the bone via the device. If the at least one projection of the device moves outward, the filament may still remain free to travel longitudinally through the compressed device such that the length of the individual filament ends, extending from the device, can be adjusted. However, if at least one of the projections moves inward, the filament may be prevented from travelling through the pathway in at least one direction. The filament may then be used to secure tissue, or other mass, to the bone.
Although the invention herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present invention. It is therefore to be understood that numerous modifications may be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present invention as defined by the appended claims.
