Patent Application
20200281712
The present disclosure is directed generally to surgical devices for repair and reconstruction of soft tissue injuries and, more particularly, to devices and methods 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 U.S. Pat. No. 8,852,250 (Lombardo et al.), entitled Graft Fixation Implant, assigned to the assignee hereof and incorporated by reference herein. 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 15 mm to 60 mm in 5 mm 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, U.S. patent application 2010/0256677, (Albertorio et al.) published Oct. 7, 2010 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.
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 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 and methods 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.
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 in the suture. 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 suspensory fixation of 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 biting 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.
It should be appreciated that all combinations of the foregoing concepts and additional concepts discussed in greater detail below (provided such concepts are not mutually inconsistent) are contemplated as being part of the inventive subject matter disclosed herein. In particular, all combinations of claimed subject matter appearing at the end of this disclosure are contemplated as being part of the inventive subject matter disclosed herein. It should also be appreciated that terminology explicitly employed herein that also may appear in any disclosure incorporated by reference should be accorded a meaning most consistent with the particular concepts disclosed herein.
These and other aspects of the invention will be apparent from and elucidated with reference to the embodiment(s) described hereinafter.
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. Various substitutions, modifications, additions, and/or arrangements, within the spirit and/or 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,
Turning briefly to
Referring back to
Still referring to
As shown in
Referring now to
Still referring to
With the free, unattached ends 128, 130 extending from the top surface 114 of the anchor member 102, a splice 136 is created in the second limb 126, as shown in
While the suture path of an embodiment of device 100 is as shown in
Turning now to
Referring now to
In use, tension is first applied to the first loop 132, which causes an increase in size of both adjustable loops 132, 134. In one embodiment, a tether 138 (e.g., rope, suture, or other filamentous strand) is attached to the first loop 132, as shown in
All definitions, as defined and used herein, should be understood to control over dictionary definitions, definitions in documents incorporated by reference, 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.
The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. 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.
The corresponding structures, materials, acts and equivalents of all means or step plus function elements in the claims below, if any, are intended to include any structure, material or act for performing the function in combination with other claimed elements as specifically claimed. The description of the present invention has been presented for purposes of illustration and description, but is not intended to be exhaustive or limited to the invention in the form disclosed. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the invention. The embodiment was chosen and described in order to best explain the principles of one or more aspects of the invention and the practical application, and to enable others of ordinary skill in the art to understand one or more aspects of the present invention for various embodiments with various modifications as are suited to the particular use contemplated.
This application claims priority to U.S. Provisional Patent Application Ser. No. 62/555,081, filed on Sep. 7, 2017 and entitled “2-Way Adjustable Loop Suspensory Device.”
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2018/049698 | 9/6/2018 | WO | 00 |
| Number | Date | Country | |
|---|---|---|---|
| 62555081 | Sep 2017 | US |
