Patent Description:
The present disclosure is directed generally to surgical devices for repair and reconstruction of soft tissue injuries and, more particularly, to devices for fixation of a soft tissue graft at a surgical site.

Many common surgical procedures involve the repair and reconstruction of torn or damaged soft tissue. For example, in common arthroscopic surgical procedures, a replacement graft ligament is secured at the site of the original, now damaged, ligament. The repair and reconstruction of torn or damaged soft tissues is a common surgical procedure. For example, replacement graft ligaments may be secured at the site of the original ligament. The procedure generally involves drilling bone tunnels into adjacent bones at the site of the original ligament and securing a graft ligament within these bone tunnels. In many applications, such as in the knee joint, such procedures may be performed arthroscopically. The graft ligament may be an autograft, an allograft, a xenograft, or it may be totally artificial and synthetic. Common types of anterior cruciate ligament (ACL) grafts, for example, include ones which may be autologous or allograft bone-patellar tendon-bone or soft tissue (such as semitendinosus and gracilis tendons), both types harvested by techniques well known to those skilled in the art.

The graft ligaments may be secured within the bone tunnels in a variety of ways. Of prime importance is the degree to which they can withstand pullout forces prior to complete healing. For example, it is known to use interference screws inserted parallel to the tunnel axis to compress the ends of the graft ligament against the wall of the bone tunnel to secure the graft ligament and promote tissue in-growth.

Suspensory graft fixation devices have been developed to secure a graft ligament in a bone tunnel. One such device is described in <CIT>), entitled Graft Fixation Implant, assigned to the assignee hereof. Suspensory graft fixation devices work by lying transversely across the opening of a bone tunnel and generally take the form of an elongated anchor member which suspends a graft retaining loop from a fixation point on the surface of a bone to which the graft is to be attached (in this case, a femur). The elongated member has an axis and a pair of suture receiving apertures symmetrically situated on the axis on opposite sides of the center of the elongated member. In ACL procedures the elongated member, often called a button, is adapted to be situated transversely across the exit opening of the bone tunnel on the lateral femoral cortex so that a supporting loop, generally made of suture material, can be suspended from the button and can extend into the bone tunnel from the suture receiving apertures of the button. The suture loop supports one end of a graft ligament passed through the loop.

The term "suture" as used herein may be any type of filamentous material such as a biocompatible or bioabsorbable filament, ribbon, tape, woven or non-woven material capable of providing the loop support and the frictional resistance required by the device described herein. In arthroscopic procedures, such as an ACL reconstruction, the elongated anchor member is initially aligned with the axis of the bone tunnel, and pulled through the tunnel to the exit at the distal end on the lateral femur. For such suspensory graft fixation devices to be able to support a graft ligament and to be properly transversely situated at the exit of the bone tunnel, the suture loop and the bone tunnel must both be long enough to enable the elongated member to "flip" from an axially aligned orientation to a transverse orientation when it exits the bone tunnel.

Since the supporting loop of such a suspensory device is most often of a fixed length, graft fixation requires preparation of a graft ligament of predetermined length. Furthermore, because conventional art suspensory graft fixation devices have fixed loop lengths they are produced in multiple sizes (ranging, for example, from loop lengths of <NUM> to <NUM> in <NUM> increments in the case of XO Button® implants made by ConMed Corporation, Largo, Fla. ) in order to accommodate various graft and tunnel lengths that may be encountered during a surgical procedure. The fixed graft length and variations in tunnel and loop lengths can make conventional suspensory ligament fixation challenging.

Recently, suspensory devices have been made with adjustable loop lengths. See, for example, <CIT> and entitled Integrated Adjustable Button-Suture-Graft Construct with Two Fixation Devices. It has been found that the adjustability of the loop length of a suspensory graft fixation device may be achieved in a manner considerably less complex than that described in the aforementioned publication.

At times surgeons may encounter situations where they cannot produce a bone tunnel of adequate length to receive a ligament graft suitable for suspensory fixation. A predetermined length of graft ligament is required to engage a predetermined portion of the bone tunnel for proper healing. For example, a so-called short tunnel ACL reconstruction may present a relatively small (narrow) femur which does not enable formation of an adequately long bone tunnel which means, in turn, the suspensory anchor member cannot be advanced far enough out of the tunnel to flip yet keep enough contact between the graft and the bone tunnel wall. Use of an adjustable loop in such situations could nevertheless enable the surgeon to proceed with a suspensory-type repair.

In instances in which soft tissue is to be pulled into a bone tunnel, such as ACL reconstruction, it is desired to have an adjustable loop to simplify the procedure and maximize the bone to soft tissue interface.

<CIT> discloses a replacement ligament fixation device with two free strands and two loops which are locked by respective sheaths on the loop side of an anchor. A similar device is disclosed in <CIT>. A suture provided with a splice and forming an adjustable and self-locking loop is disclosed in <CIT>. <CIT> belongs to the prior art according to Art. <NUM>(<NUM>) EPC and discloses a graft fixation device for securing a replacement graft ligament in a bone tunnel comprising an anchor member and a graft supporting loop element formed of a suture threaded through the apertures of the anchor member, the suture forming first and second loops and a splice extending from the bottom surface of the anchor member in the bone tunnel, while the first and second limbs of the suture extend from the top surface of the anchor member.

Embodiments of the present invention recognize that there are potential problems and/or disadvantages with conventional suspensory graft fixation devices (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 devices for fixation of a soft tissue graft at a surgical site. It is an object of this invention to produce a suspensory graft ligament repair system suitable for short tunnel repairs.

It is another object of this invention to produce a suspensory graft fixation device adapted to lock the size and position of the graft supporting loop after it has been set at a desired length.

It is also an object of this invention to automatically lock the graft supporting loop by pulling it in one direction relative to the anchor member, and to vary the length of the graft supporting loop, to resize it, by pulling it in the opposite direction.

It is yet another object of this invention to correct for instances of over-tensioning of the graft or if the graft has been advanced too far into the bone tunnel.

Further advantageous features are set out in the dependent claims. In one aspect, a suspensory graft fixation device for securing a replacement graft ligament in a bone tunnel is provided. The suspensory graft fixation device includes an elongated anchor member with top and bottom surfaces, and adjacent first and second suture receiving apertures extending from the top surface to the bottom surface thereof. A graft supporting loop element is attached to the anchor member and is formed of a suture having first and second limbs. The suture is threaded through the first and second suture receiving apertures such that first and second loops are formed.

The first and second loops extend from the bottom surface, while the first and second limbs extend from the top surface. A splice is formed in the second limb extending from the top surface and the first limb extends through the splice.

According to another aspect, the suspensory graft fixation device includes an elongated anchor member having a top surface and a bottom surface extending between a first end and a second end. A plurality of apertures extend from the top surface to the bottom surface of the elongated anchor member. At least two of the plurality of apertures are adjacent first and second suture receiving apertures. The device also includes a graft supporting loop element attached to the anchor member. The graft supporting loop element is formed of a suture having a first limb and a second limb. The suture is threaded through the first and second suture receiving apertures such that first and second loops are formed in the suture and extend from the bottom surface of the elongated anchor member, while the first and second limbs extend from the top surface. A splice is formed in the second limb of suture extending from the top surface of the elongated anchor member and the first limb extends through the splice. Tensioning the first loop pulls the first limb through the splice, lengthening the first loop, and tensioning the second loop pulls the splice over the first suture receiving aperture.

In yet another aspect, a method of assembling a suspensory graft fixation device for securing a replacement graft ligament in a bone tunnel is provided. The method includes the steps of: (i) providing an elongated anchor member having a top surface and a bottom surface, and adjacent first and second suture receiving apertures extending from the top surface to the bottom surface thereof; (ii) providing a suture having a first limb and a second limb with a central bight portion therebetween; (iii) passing the first limb through the first suture receiving aperture from the top surface to the bottom surface and thereafter, passing the first limb through the second suture receiving aperture from the bottom surface to the top surface, creating a first loop in the first limb; (iv) passing the second limb through the second suture receiving aperture from the top surface to the bottom surface and thereafter, passing the second limb through the first suture receiving aperture from the bottom surface to the top surface, creating a second loop in the second limb; (v) creating a splice in the second limb extending from the top surface from the first suture receiving aperture; and (vi) passing the first limb through the splice in the second limb.

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 illustrated 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.

Referring now to the figures, wherein like reference numerals refer to like parts throughout, <FIG> shows a side perspective view schematic representation of a suspensory graft fixation device <NUM>, according to an embodiment. The device <NUM> comprises an elongated anchor member <NUM> and a length of suture <NUM>. In the depicted embodiment, the suture <NUM> is in the form of a filamentous strand composed of high strength, filamentous material such as ultrahigh molecular weight polyethylene. The anchor member <NUM> can be composed of metal, such as implantable grade titanium, or any other suitable bioabsorbable or biocompatible material (as should be understood by a person of ordinary skill in the art in conjunction with a review of this disclosure). In embodiments, the length of anchor member <NUM> may range from <NUM> to <NUM>.

Turning briefly to <FIG>, there is a top perspective view schematic representation of the anchor member <NUM> of the suspensory fixation device <NUM>, according to an embodiment. The anchor member <NUM> extends along a central longitudinal y - y axis between its first end <NUM> and second end <NUM>. The anchor member <NUM> also has a pair of central suture receiving apertures <NUM>, <NUM>, which are sized or otherwise configured to receive suture <NUM> that will form loops. For example, the diameters of suture receiving apertures <NUM>, <NUM> may be on the order of <NUM>, while the diameter of the suture <NUM> may be on the order of <NUM> or USP size #<NUM>. In an embodiment according to <FIG>, the anchor member <NUM> is oblong in geometry. In particular, as shown, a length L of the anchor member <NUM> is greater than a width w of the anchor member <NUM>. The oblong geometry of the anchor member <NUM> allows the anchor member <NUM> to pass through narrow bone tunnels.

Referring back to <FIG>, the anchor member <NUM> has a top surface <NUM> and a bottom surface <NUM> (best seen in <FIG>). The bottom surface <NUM> is sometimes referred to as the proximal surface and is intended to be placed adjacent a bone tunnel exit. As used herein, the term "proximal" refers to the side of the bone containing the bone tunnel (i.e., extending inwardly away from the surface of the lateral femur in an ACL procedure), and the term "distal" refers to the side of the bone against which the transverse anchor member <NUM> rests (i.e., extending outwardly away from the surface on the lateral femur).

Still referring to <FIG>, the suture receiving apertures <NUM>, <NUM> are situated on opposite sides of a central bridge portion <NUM> extending between them. The anchor member <NUM> may also optionally have one or more placement apertures <NUM> extending between the top and bottom surfaces <NUM>, <NUM>. In the depicted embodiment, there is a placement aperture <NUM> at the first end <NUM> of the anchor member <NUM> and a placement aperture <NUM> at the second end <NUM> of the anchor member <NUM>. The placement apertures <NUM> are sized or otherwise configured to receive a placement suture <NUM> (or another filamentous strand) to facilitate placement of the device <NUM> at a bone tunnel exit. For example, a placement suture <NUM> is attached to a placement aperture <NUM> and pulled through the bone tunnel, facilitating orienting the elongated anchor member <NUM> parallel to the bone tunnel axis.

As shown in <FIG>, the suspensory fixation device <NUM> is designed to have the anchor member <NUM> operate with a filamentous strand <NUM> suitable for following a tortuous path through the suture receiving apertures <NUM>, <NUM> of anchor member <NUM>. In an embodiment, the filamentous strand <NUM> is a single length of appropriately sized suture. The term "suture" as used herein may be used interchangeably with "filamentous material" and, as described above, will be understood to mean any biocompatible or bioabsorbable strand of material which can, when combined with anchor member <NUM>, operate to support a replacement graft in the manner described below. As will be understood below, the combination of filamentous strand <NUM> with the features of anchor member <NUM> can perform different functions along the path of the suture <NUM> through the suture receiving apertures <NUM>, <NUM> of the anchor member <NUM>.

Referring now to <FIG>, there is a cross-sectional side view schematic representation of the suspensory fixation device <NUM>, according to an embodiment. To load the anchor member <NUM> shown in <FIG>, the filamentous strand <NUM> is passed or wrapped through the suture receiving apertures <NUM>, <NUM>. Specifically, as shown in <FIG>, the filamentous strand <NUM> is first folded on itself to form a central bight portion <NUM>, thus creating two limbs <NUM>, <NUM> extending from the central bight portion <NUM>. Each limb <NUM>, <NUM> has a length extending from the central bight portion <NUM> to the free, unattached ends <NUM>, <NUM> of the limbs <NUM>, <NUM>.

Still referring to <FIG>, the first limb <NUM> is passed through a first suture receiving aperture <NUM> and the second limb <NUM> is passed through a second suture receiving aperture <NUM> (in the downward direction as shown in <FIG>). The first and second limbs <NUM>, <NUM> extend through the suture receiving apertures <NUM>, <NUM> from the top surface <NUM> of the anchor member <NUM> to the bottom surface <NUM> of the anchor member <NUM>. The second limb <NUM> is then passed up through the first suture receiving aperture <NUM> from the bottom surface <NUM> of the anchor member <NUM> to the top surface <NUM> of the anchor member <NUM>. Similarly, the first limb <NUM> is passed up through the second suture receiving aperture <NUM> from the bottom surface <NUM> of the anchor member <NUM> to the top surface <NUM> of the anchor member <NUM>. As shown in <FIG>, the central bight portion <NUM> extends over the central bridge portion <NUM> on the top surface <NUM> of the anchor member <NUM>, while two adjustable loops <NUM>, <NUM> extend from the suture receiving apertures <NUM>, <NUM> through the bottom surface <NUM> of the anchor member <NUM>, as shown in <FIG>.

With the free, unattached ends <NUM>, <NUM> extending from the top surface <NUM> of the anchor member <NUM>, a splice <NUM> is created in the second limb <NUM>, as shown in <FIG>. The first limb <NUM> is passed through the splice <NUM>, forming a jacket around the first limb <NUM>. In the depicted embodiment, the splice <NUM> is adjacent and above (distal to) the central bight portion <NUM>. With the filamentous strand <NUM> wrapped through the suture receiving apertures <NUM>, <NUM>, creating adjustable loops <NUM>, <NUM> extending from the bottom surface <NUM> of the anchor member <NUM>, and the splice <NUM> extending from the top surface <NUM> of the anchor member <NUM>, the device <NUM> can be used to adjustably apply and release tension on a graft at a bone tunnel exit.

While the suture path of an embodiment of device <NUM> is as shown in <FIG>, alternate embodiments are feasible. Thus, while the suture path through the anchor member <NUM> results in device <NUM> comprising a graft supporting element in the form of two adjustable loops <NUM>, <NUM>, there can be different loop constructions than that described above. For example, the adjustable loops <NUM>, <NUM> are formed from a single length of suture <NUM> (or other filamentous material) but in an alternate embodiment, the adjustable loops <NUM>, <NUM> could be formed by a plurality of individual lengths of suture <NUM> which together form the adjustable loops <NUM>, <NUM>.

Turning now to <FIG>, there are shown side views schematic representations of the device <NUM> at various configurations during deployment. First, the device <NUM> shown in <FIG> is attached to a graft <NUM> (<FIG>). In an embodiment, the graft <NUM> (<FIG>) is attached to the second loop <NUM> and a placement suture <NUM> is threaded through a placement aperture <NUM> of the anchor member <NUM>. The placement suture <NUM> is inserted through the proximal end <NUM> of the bone tunnel <NUM> and pulled toward the distal end <NUM> of the bone tunnel <NUM>. <FIG> shows a side view schematic representation of the device <NUM> in a bone tunnel <NUM>, according to an embodiment. As shown, the placement suture <NUM> is pulled or otherwise tensioned toward the distal end <NUM> of the bone tunnel <NUM>. In the depicted embodiment, the placement suture <NUM> is pulled through the bone tunnel <NUM>, facilitating orienting the elongated anchor member <NUM> substantially parallel to the bone tunnel axis z - z.

Referring now to <FIG>, there is shown a side view schematic representation of the device <NUM> in a first configuration attached to a graft <NUM> and extending from the distal end <NUM> of the bone tunnel <NUM>. As shown in <FIG>, the placement suture <NUM> is pulled until the anchor member <NUM> exits the distal end <NUM> of the bone tunnel <NUM> and the graft <NUM> remains within the bone tunnel <NUM>. When using the device <NUM> to secure the graft <NUM>, the two adjustable loops <NUM>, <NUM> (also shown in <FIG>) serve different purposes. The first loop <NUM>, which is created from the first limb <NUM>, functions to resize the lengths of both adjustable loops <NUM>, <NUM>. The second loop <NUM>, which is created from the second limb <NUM> and attached to the graft <NUM>, functions to lock the device <NUM> in place, thereby locking the graft <NUM> in position with respect to the bone tunnel exit (i.e., distal end <NUM> of the bone tunnel <NUM>).

In use, tension is first applied to the first loop <NUM>, which causes an increase in size of both adjustable loops <NUM>, <NUM>. In one embodiment, a tether <NUM> (e.g., rope, suture, or other filamentous strand) is attached to the first loop <NUM>, as shown in <FIG>. When the tether <NUM> is pulled proximally or otherwise away from the splice <NUM>, slack is introduced into the adjustable loops <NUM>, <NUM>, enlarging the adjustable loops <NUM>, <NUM>. In some cases, the splice <NUM> is pulled toward the second suture receiving aperture <NUM> when the first loop <NUM> is tensioned. However, the splice <NUM> is too large relative to the second suture receiving aperture <NUM> and can thus not be pulled through the second suture receiving aperture <NUM> to the bottom surface <NUM> of the anchor member <NUM>. Accordingly, additional tension on the first loop <NUM>, pulls the first limb <NUM> (and the splice <NUM>) proximally to the second suture receiving aperture <NUM> where the first limb <NUM> is, due to its size relative to the second suture receiving aperture <NUM>, pulled through the splice <NUM> and the second suture receiving aperture <NUM> to provide the extra slack in the adjustable loops <NUM>, <NUM>. At the same time, tension on both adjustable loops <NUM>, <NUM>, by the graft <NUM>, causes the anchor member <NUM> to rotate. As shown in <FIG>, the graft <NUM> (or filament (not shown) attached to the graft <NUM>) can be tensioned or otherwise pulled proximally from the proximal end <NUM> of the bone tunnel <NUM>, which tensions the adjustable loops <NUM>, <NUM>. The tension from the graft <NUM> the anchor member <NUM> to rotate from a first configuration substantially parallel to the bone tunnel axis z - z (<FIG>) to a second configuration substantially perpendicular to the bone tunnel axis z - z (<FIG>). When the anchor member <NUM> is perpendicular across the bone tunnel <NUM>, the anchor member <NUM> is locked in place by bringing the splice <NUM> against the first suture receiving aperture <NUM>. Again, the splice <NUM> is too large relative to the first suture receiving aperture <NUM> and can thus not be pulled through the first suture receiving aperture <NUM> to the bottom surface <NUM> of the anchor member <NUM>. As the splice <NUM> is created in the second limb <NUM>, the second limb <NUM> cannot be pulled through the first suture receiving aperture <NUM> to supply slack and instead locks the device <NUM>.

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 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.

Claim 1:
A suspensory graft fixation device for securing a replacement graft ligament in a bone tunnel, comprising:
an elongated anchor member (<NUM>) comprising a top surface (<NUM>) and a bottom surface (<NUM>), and adjacent first and second suture receiving apertures (<NUM>, <NUM>) extending from the top surface to the bottom surface thereof;
a graft supporting loop element attached to the anchor member, the graft supporting loop element formed of a suture (<NUM>) comprising a first limb (<NUM>) and a second limb (<NUM>);
wherein the suture is threaded through the first and second suture receiving apertures forming first and second loops (<NUM>, <NUM>) extending from the bottom surface of the elongated anchor member, while the first and second limbs extend from the top surface,
characterized in that it comprises a splice (<NUM>) formed in the second limb of suture extending from the top surface of the elongated anchor member, wherein the first limb extends through the splice and wherein the splice is too large relative to the first and second suture receiving apertures and cannot be pulled through to the bottom surface of the elongated anchor member.