Adjustable multi-loop fastening device

Abstract

The present invention discloses a device for tissue repair and reconstruction of the anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL). The device further comprises a fixation plate having an upper side and a lower side, the upper side comprising a plurality of circular through-holes, an oval groove with paired openings connected by a bridge, and a stepped hole extending from the upper side to the lower side. In an embodiment, the device further comprises a strand, the strand comprising a knot. The knot divides the strand into a tension end and a leading end.

Description

[Technical Field]

[0001] The present subject matter relates generally to the field of medical devices. More particularly, the present subject matter relates to tissue repair and reconstruction techniques, such as surgical reconstruction of the anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL), and related fixation and reconstruction devices. [Background technology]

[0002] Ligaments are pieces of fibrous tissue that connect bones. Ligaments are often damaged (e.g., avulsed, separated, or torn) due to injury or accident. Damaged ligaments can prevent proper joint movement and cause significant pain. One of the most common such injuries is a rupture of the anterior cruciate ligament (ACL). The ACL connects the femur and tibia at the center of the knee joint. ACL injury can cause knee joint instability, leading to significant pain and arthritis. Surgical techniques have been developed to restore these soft tissues and reattach them to the associated bones.

[0003] Reconstructive surgery, particularly anterior cruciate ligament (ACL) reconstruction, is well known in the field. It is generally accepted in orthopedic surgery that the ACL does not heal spontaneously after injury. Initial attempts to repair this ligament almost uniformly failed to stabilize the knee joint. Over the past few decades, specialists have turned to ligament reconstruction techniques to restore knee joint stability and normal knee kinematics. Cortical fixation may be preferred by surgeons who primarily use soft tissue grafts. Sutures and various fixation devices (e.g., buttons, anchors, etc.) are commonly used in orthopedic surgery to perform joint stabilization, tissue repair, tissue restoration, fracture repair, and other similar surgical procedures. These procedures often involve fixating damaged tissue or aligning bones to restore joint function.

[0004] In ACL surgery, a thin, elongated element, often called a button, fits into the anterolateral cortex of the femur, where it is attached to the graft with sutures or tape through a femoral tunnel. A particularly critical issue in graft surgery is securing the graft within the bone tunnel with the required tension. Incorrect graft tensioning can affect the success of the procedure. While tensioning devices are sometimes used, the surgeon must tie the sutures after achieving the required tension. Tying the knot can lead to errors, leading to suture stretching and improper graft tension. Adjustable loops, due to their high locking tension, can stretch under the graft tension and gradually slip the end suture (tensioning / adjusting suture) under the sling lock. Adjustable suture loops require a strong pull to retract, which can sometimes injure the surgeon or damage the surgeon's gloves. Solutions such as wrapping the suture multiple times around instruments like forceps or using reinforced gloves have been attempted, but they have not fully met the industry's needs.

[0005] Thus, prior art devices have not allowed for the convenient attachment of tendons or ligaments to the fixation device using suturing techniques to achieve the necessary force and maximum fixation strength. Summary of the Invention

[0006] SUMMARY OF THE INVENTION The embodiments of the present disclosure provide technical improvements as solutions to one or more of the above-mentioned technical problems identified by the inventors in conventional systems.

[0007] In one embodiment, a device for tissue repair and reconstruction of the anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) is disclosed. The device further comprises a fixation plate having an upper side and a lower side, the upper side comprising a plurality of circular through-holes, an oval groove with paired openings connected by a bridge, and a stepped hole extending from the upper side to the lower side. In one embodiment, the device further comprises a strand, the strand comprising a knot. The knot divides the strand into a tension end and a leading end. The tension end is threaded from the lower side to the upper side through the hole in the fixation plate and from the upper side to the lower side through one of the paired openings, forming a first adjustable fixation loop. The tension end of the strand further passes from the lower side to the upper side through the opening, forming a first small loop. The tension end of the strand passes from the lower side to the upper side through the hole, forming a second adjustable fixation loop with the tension end and the leading end extending away from the upper side. The tension end of the strand then passes from the top to the bottom through the opening to form a second small loop. The tension end of the strand then passes from the bottom to the top through the hole to form a third adjustable locking loop. The tension end of the strand is threaded through the first small loop to lock the adjustable loop, and the leading end of the strand is pulled through the hole and the lower guideway, then pulled out through the second through hole at the top.

[0008] In one embodiment, a method for attaching a graft includes the steps of: providing a device comprising a fixation plate having an upper side and a lower side; and a flexible single strand having a knot dividing the strand into a tension end and a leading end, the upper side having a plurality of circular through-holes, an oval groove having paired openings connected by a bridge, and a stepped hole extending from the upper side to the lower side; threading the tension end of the strand from the lower side to the upper side through the hole in the fixation plate and then from the upper side to the lower side through one of the paired openings to form a first adjustable fixation loop; threading the tension end of the strand from the lower side to the upper side through the opening to form a first small loop; and threading the tension end of the strand from the lower side to the upper side through the hole to form a second adjustable locking loop with the tension end and leading end extending away from the upper side. forming a small adjustable fixation loop; threading the tension end of the strand from top to bottom through the opening to form a second small loop; threading the tension end of the strand from bottom to top through the hole to form a third adjustable fixation loop; threading the tension end of the strand through the first small loop to lock the adjustable loop, pulling the leading end of the strand through the hole and the lower guideway, and withdrawing the leading end at the top through the second through-hole; attaching a graft to the first, second, and third adjustable fixation loops of the fixation device; and applying tension to the tension end of the strand to shorten the adjustable loop and transfer the load to the graft, thereby achieving fixation of the graft and minimizing slip / creep of the strand within the loop.

[0009] It will be understood that features of the present disclosure can be combined in various combinations without departing from the scope of the present disclosure, which is defined by the following detailed description and drawings. [Brief explanation of the drawings]

[0010] The above summary, and the following detailed description of exemplary embodiments, will be better understood when read in conjunction with the accompanying drawings. For the purpose of illustrating the disclosure, exemplary structures of the disclosure are shown in the drawings. However, the disclosure is not limited to the particular methods and apparatus disclosed herein. Furthermore, those skilled in the art will appreciate that the drawings are not drawn to scale. Wherever possible, similar elements are designated by the same numerals.

[0011] Embodiments of the present disclosure will now be described, by way of example only, with reference to the following figures:

[0012] FIG. 1 illustrates a perspective view of a fixation device according to an exemplary embodiment of the present disclosure.

[0013] 2(a)-2(d) show side perspective views of a fixation plate and a single braided medical strand element combined to form a fixation device according to an exemplary embodiment of the present disclosure.

[0014] 3(a)-3(j) illustrate steps for constructing an embodiment of a fixation device according to an exemplary embodiment of the present disclosure.

[0015] 4(a)-4(c) show an implant coupled to an adjustable fixation loop of a fixation device according to an exemplary embodiment of the present disclosure.

[0016] In the accompanying drawings, numerals refer to items identified by a line connecting the numeral and the item. Where a numeral is accompanied by an associated arrow, the numeral is used to identify the general item to which the arrow is pointing.

[0017] Moreover, the figures depict various embodiments of the present subject matter for purposes of illustration only. Those skilled in the art will readily recognize from the following discussion that alternative embodiments of the structures and methods illustrated herein may be employed without departing from the principles of the present subject matter described herein. DETAILED DESCRIPTION OF THE INVENTION

[0018] The following detailed description illustrates embodiments of the present disclosure and the manner in which they may be practiced. The words "comprising," "having," "containing," and "including," as well as other forms thereof, are intended to be equivalent in meaning and open-ended, in that the item or items following any one of these words are not meant to be an exhaustive list of such items or items, nor are they limited to only the listed items or items. It should also be noted that as used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise.

[0019] Those skilled in the art will recognize many variations, alternatives, and modifications of the embodiments of the present disclosure. It should be understood that the present subject matter is not limited to the particular methodology, protocols, etc. described herein, as such may vary. The terminology used herein is for the purpose of describing embodiments only and is not intended to limit the scope of the present subject matter, which is defined solely by the claims.

[0020] As mentioned above, orthopedic medicine, which specializes in the diagnosis, treatment, and prevention of disorders related to bones, joints, and ligaments, plays a vital role in ensuring that people can move freely and painlessly. One of the focuses of this field of medicine is the treatment and management of ligament injuries. Ligaments are flexible yet tough connective tissues that connect bones and are crucial for ensuring joint stability and smooth movement.

[0021] Unfortunately, these vital structures are susceptible to injury. When it comes to ligament injuries, a ruptured anterior cruciate ligament (ACL) in the knee is one of the most common and serious. Such injuries not only make the knee unstable, but can also lead to chronic pain, arthritis, and other after-effects. Because the knee is the center of most movement, any problems with its function can significantly impair daily life.

[0022] Historically, attempts to repair an ACL tear have been fraught with difficulties. First, the ACL is a stubborn ligament. Unlike other tissues in the body, the ACL does not have the ability to repair itself or regenerate. If an ACL tear is left untreated, the knee will remain permanently unstable. As a result, orthopedic surgeons have continually sought innovative techniques to effectively repair this ligament and restore knee function.

[0023] Traditionally, the torn ligament was simply stitched back together. However, the results were less than ideal. The repaired ligament often did not provide the necessary stability, making the surgery less effective. Realizing the shortcomings of this approach, medical professionals turned to other conventional techniques and methodologies. Their efforts led to the emergence of reconstructive surgery, which essentially uses a graft (from the patient's own body or a donor) to replace the damaged ligament.

[0024] To securely fasten these grafts, surgeons use a variety of traditional tools and materials, from surgical buttons to complex sutures. The goal is clear: to ensure that the newly installed graft mimics the strength and functionality of a natural, healthy ACL. However, traditional techniques can be challenging, especially when it comes to properly adjusting tension.

[0025] Ensuring proper tension in the implant is essential for optimal knee stability. However, this is easier said than done. Many existing prior art techniques present various challenges. Applying the proper tension is physically demanding for the surgeon. The required force is not only exhausting, but can also pose risks, such as damaging surgical gloves and potentially compromising the sterile environment.

[0026] Some surgeons have tried to address these issues by wrapping sutures around the instruments or wearing reinforced gloves, but these solutions are band-aids that provide temporary relief without addressing the underlying cause.

[0027] Accordingly, one objective of the present subject matter is to devise a device that allows the graft to remain taut like a natural ligament, without imposing undue strain on the surgeon or compromising the sterility of the procedure. Achieving this could revolutionize ACL surgery, making the procedure more effective and ensuring better outcomes for countless patients worldwide. Accordingly, further present subject matter is directed to providing improved methods and devices that are relatively simple in design and construction, yet highly effective for their intended purposes.

[0028] Another object of the present subject matter is to provide a device and method for fixation of ligaments or tendons, such as the ACL, that can withstand the necessary tension without compromising the integrity of the graft or the convenience of the surgeon. Thus, the present subject matter will not only increase the success rate of ACL surgery, but will also significantly improve postoperative outcomes for patients.

[0029] It is an object of the present subject matter to provide an improved, novel structured fixation device designed to overcome the shortcomings of known existing devices for ACL reconstruction, thereby minimizing slip / creep of the interwoven braided medical strands within the loops.

[0030] Another object of the present subject matter is to provide an improved method for restoring ligaments by using adjustable loops that simplify the procedure and maximize the bone-to-soft tissue interface.

[0031] Yet another object of the present subject matter is to provide a fixation device and method for attaching to the adjustable fixation loops of a braided medical strand without compromising the graft or requiring additional materials to complete the repair.

[0032] The present subject matter provides techniques and reconstruction systems for bone-to-bone or soft tissue-to-bone fixation. The subject reconstruction systems disclose fixation devices that include a fixation plate and a single length of flexible and adjustable braided medical strand, and methods for assembling and connecting them to tissue. In one aspect of the present disclosure, to create a fixation device,

[0033] The braided medical strand and fixation plate are assembled by following a tortuous path through various openings in the fixation plate. To achieve this, the tension side of the braided medical strand is passed multiple times through pairs of openings connected by bridges extending between them within the oval groove, and then through stepped holes connected to the first opening via a channel, finally leading the leading end of the braided medical strand through guideways on the underside of the fixation plate and out through through-holes located at the corners of the fixation plate. The braided medical strand and fixation device are assembled outside the patient's body. The graft is attached to the three adjustable fixation loops of the fixation device. The fixation device is pulled through the bone tunnel during surgery by pulling the leading end of the braided medical strand. Meanwhile, the tension end of the braided medical strand is pulled to adjust the tension of the graft into the bone tunnel by shortening the three adjustable fixation loops, thereby achieving maximum fixation and minimizing slippage / creep of the braided medical strand within the loops. The present subject matter specifically operates on a pulley-like principle to shorten adjustable fixation loops and transfer loads to the implant.

[0034] In one embodiment, a device for tissue repair and reconstruction of the anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) is disclosed. In one advantage, the device is an adjustable multi-loop fixation device. The device further comprises a fixation plate having an upper side and a lower side, the upper side comprising a plurality of circular through-holes, an oval groove with paired openings connected by a bridge, and a stepped hole from the upper side to the lower side. Furthermore, in one example, the fixation plate is made from a material selected from the group consisting of plastic, titanium alloy, and steel.

[0035] In one embodiment, the fixation plate has curved edges to facilitate smooth pulling of the fixation device through the bone holes during surgery. Additionally, circular through-holes are located at the corners of the fixation plate, and bridges connecting pairs of openings form a winding path for the strands.

[0036] In an embodiment, the device further comprises a strand. In one example, the strand is flexible, single-braided, medical-grade, and has a circular cross-sectional shape. In yet another example, the strand is made of ultra-high molecular weight polyethylene (UHMWPE) or a biocompatible material. The strand includes a knot. The knot divides the strand into a tension end and a leading end. A step in the hole is configured to secure the knot in the strand and prevent slippage during tensioning.

[0037] The tension end of the strand is threaded from bottom to top through the hole in the fixation plate and then from top to bottom through one of the pair of openings to form a first adjustable fixation loop. The tension end of the strand is then threaded from bottom to top through the opening to form a first small loop. The tension end of the strand is then threaded from bottom to top through the hole to form a second adjustable fixation loop with the tension end and leading end extending away from the top. The tension end of the strand is then threaded from top to bottom through the opening to form a second small loop. The tension end of the strand is then threaded from bottom to top through the hole to form a third adjustable fixation loop. The tension end of the strand is threaded through the first small loop to lock the adjustable loop, and the leading end of the strand is pulled through the hole and the lower guideway and then pulled out at the top through the second through hole.

[0038] In embodiments, the device comprises a graft connected to first, second and third adjustable fixation loops, wherein tension applied to the tension ends of the strands shortens the adjustable loops, achieving fixation of the graft and minimizing slip / creep of the strands within the loops.

[0039] In embodiments, the tension ends of the strands are slidably adjustable within the pair of openings to achieve a desired tension in the graft.

[0040] In this embodiment, the tension ends of the strands are pulled to shorten the adjustable loops, distributing the load on the graft and achieving the desired fixation.

[0041] In another embodiment, a method for attaching an implant includes the steps of providing a device including a fixation plate having an upper side and a lower side, and a single flexible strand having a knot dividing the strand into a tension end and a leading end, the upper side having a plurality of circular through-holes, an oval groove with paired openings connected by a bridge, and a hole with a step from the top to the bottom, threading the tension end of the strand from the bottom to the top through the hole in the fixation plate and then from the top to the bottom through one of the paired openings to form a first adjustable fixation loop, threading the tension end of the strand from the bottom to the top through the opening to form a first small loop, and threading the tension end of the strand from the bottom to the top through the hole to form a second adjustable fixation loop with the tension end and leading end extending away from the top side. threading the tension end of the strand from top to bottom through the opening to form a second small loop; threading the tension end of the strand from bottom to top through the hole to form a third adjustable fixation loop; threading the tension end of the strand through the first small loop to lock the adjustable loop, pulling the leading end of the strand through the hole and the lower guideway, and then pulling the leading end at the top through the second through-hole; attaching a graft to the first, second, and third adjustable fixation loops of the fixation device; and achieving fixation of the graft by applying tension to the tension end of the strand, shortening the adjustable loop, and transferring the load to the graft, and minimizing slip / creep of the strand within the loop.

[0042] These and other features and advantages of the present subject matter will become apparent from the following description of the subject matter, which is provided in conjunction with the accompanying drawings and illustrated embodiments of the subject matter.

[0043] Referring now to the drawings, Figures 1, 2, 3, and 4 illustrate a fixation device 100 in accordance with the present subject matter. It should be noted that Figures 1, 2, 3, and 4 are merely exemplary. Those skilled in the art will recognize many variations, alternatives, and modifications of the disclosed embodiments. Fixation device 100 may be any of a variety of geometric shapes, such as circular, rectangular, trapezoidal, etc., according to various embodiments of the present disclosure.

[0044] In one aspect of the present disclosure, a fixation device and method for constructing strands (also called braided medical strands) using fixation plates is disclosed.

[0045] Referring now to the drawings, FIG. 1 shows a fixation device 100 comprising a fixation plate 102 and a single flexible braided medical strand 104 that together form a fixation device for ACL reconstruction.

[0046] 2(a), the flexible braided medical strand 104 is unitary in structure and includes a knot 202 that divides the braided medical strand 104 into two portions: a tension end 104a and a leading end 104b. The placement of the knot 202 determines the length of the leading end 104b of the braided medical strand. The braided medical strand is constructed from an ultra-high molecular weight polyethylene (UHMWPE) material or a biocompatible material.

[0047] 2(b), 2(c), and 2(d), the fixation plate 102 has upper and lower sides 102(a) and 102(b) with curved edges to facilitate drawing the graft into the bone tunnel without damaging the bone. The upper side 102a of the fixation plate has a plurality of circular through-holes 204, 206, an angularly arranged oval groove 208 with a bridge 214 extending between it and a pair of openings 210, 212, and a hole 216 through a dome-like structure 220 that functions as a stabilizing member and includes a step 218 extending from the upper side 102a to the lower side 102b of the fixation plate 102. The hole 216 is connected to the opening 210 via a channel 222.

[0048] The first through-hole 204 and the second through-hole 206 are located at the extreme left and right corners, respectively, of the upper side 102(a) of the fixation plate 102. The first through-hole 204 may be an optional through-hole for inverting a braided medical strand, which is sometimes required by surgeons to ensure fixation of the device after it has been withdrawn from the bone hole (described below). The hole 216 includes a step 218 for stopping the knot 202 to prevent it from slipping through the hole 216 during surgery. The second through-hole 206 is connected to the hole 216 via a guideway 224 on the lower side 102b of the fixation plate 102.

[0049] Figures 2(a), 2(b), 2(c), and 2(d) are merely examples. Those skilled in the art will recognize many variations, alternatives, and modifications of the embodiments of the present disclosure. The present subject matter is not limited to five holes; the number of holes may be greater or less than five depending on the thickness of the fixation plate and the strength required to restore the graft. The shape of the through-holes is not limited to circular; they may be any geometric shape, such as triangular, oval, or rectangular, depending on the strength required during surgery. Furthermore, the placement of knots in the braided medical strand is not limited to the embodiments of the present subject matter; they may be placed in the middle of the braided medical strand as needed. Furthermore, the material used for the braided medical strand is not limited to ultra-high molecular weight polyethylene (UHMWPE) or biocompatible materials; polyethylene or similar polymers may also be used. Furthermore, the braided medical strand may have different shapes, such as a flat or circular shape. Additionally, the fixation plate can be made from plastic or similar materials, and is not limited to metals such as titanium alloys, steel, and the like, which have high tensile strength, toughness, corrosion resistance, and light weight.

[0050] Figures 3(a), 3(b), 3(c), 3(d), 3(e), 3(f), 3(g), 3(h), 3(i), and 3(j) illustrate the winding path of the flexible braided medical strand 104 with the fixation plate 102 through the multiple holes 204, 206, the paired openings 210, 212, and the hole 216 having the step 218. As shown in Figures 3(a), 3(b), 3(c), 3(d), 3(e), 3(f), 3(g), 3(h), 3(i), and 3(j), the following steps are performed to engage the flexible braided medical strand 104 with the fixation plate 102.

[0051] As shown in FIG. 3(a), the tension end 104a of the braided medical strand 104 is inserted into the hole 216 from the upper side 102a of the fixation plate until the knot 202 stops at the step 218. Next, the tension end 104(a) of the flexible braided medical strand 104 is inserted into the opening 210 from the lower side 102b of the fixation plate 102 to form a first adjustable fixation loop 302 (see FIG. 3(b)). The tension end 104a of the flexible braided medical strand 104 is not limited to the opening 210, and can be inserted into either the opening 210 or 212 from the lower side 102b of the fixation plate 102.

[0052] Now, the tension end 104a of the flexible braided medical strand 104 is passed through the opening 212 from the upper side 102a of the fixation plate 102, leaving behind the first small loop 304 (described in a later step) (see FIG. 3(c)).

[0053] The tension end 104a of the flexible braided medical strand 104 is passed back through the hole 216 from the underside 102b of the fixation plate 102, with both the tension end 104a and the leading end 104b extending away from the upper side 102a of the fixation plate 102 to form a second adjustable fixation loop 306 (see FIG. 3(d)).

[0054] Next, the tension end 104a of the flexible braided medical strand 104 is threaded from the upper side 102a of the fixation plate 102 through the opening 210, leaving a second small loop 308, as shown in Figure 3(e). The tension end 104a of the flexible braided medical strand 104 is then threaded from the lower side 102b of the fixation plate 102 back through the hole 216 to form a third adjustable fixation loop 310 (see Figure 3(f)).

[0055] Here, the tension end 104a of the flexible braided medical strand 104 is threaded through the first small loop 304 to create a locking configuration, while the second small loop 308 fits into the channel 222 when the tension end 104(a) of the braided medical strand 104 is pulled, as shown in FIG. 3(g).

[0056] Next, referring to Figures 3(h) to 3(j), the leading end 104b of the flexible braided medical strand 104 is passed through the hole 216 via the guide path 224 on the lower side 102b of the fixing plate 102, and finally the leading end 104b is pulled out through the second through-hole 206 on the upper side 102a of the fixing plate 102.

[0057] Figures 3(a)-3(j) are merely examples. One of ordinary skill in the art would recognize many variations, alternatives, and modifications of the disclosed embodiments.

[0058] 4(a)-4(c), an implant 402 is attached to the first, second, and third adjustable fixation loops 302, 306, and 310, respectively, of the fixation device 100, and the leading side 104b is pulled so that the entire implant 402 enters the bone tunnel 404. The curved edges of the fixation plate 102 ensure smooth retraction of the fixation plate 102 through the bone tunnel 404 without damaging the bone (see FIG. 4(b)). As shown in FIG. 4(c), as the fixation plate 102 is retracted from the bone tunnel, the fixation plate 102 fits snugly against the end of the bone tunnel against the stabilizing member 220.

[0059] The present subject matter facilitates operation of the fixation device 100 by applying tension to the assembly in one direction to activate a loop length adjustment mechanism that operates essentially on the pulley principle to change the size of the graft supporting multiple adjustable loops, and by applying tension to the assembly in the opposite direction to activate an automatic loop locking mechanism.

[0060] During surgery, the tension end 104b of the braided medical strand 104 is pulled, which releases the locking structure and moves the knot ball 202, which was frictionally retained within the hole, upward, shortening the length of the third adjustable fixation loop 310. This shortening of the third adjustable fixation loop 310 transfers the entire load of the graft to this loop. As a result of the tension, the braided medical strand slides within the channel, moving the second adjustable fixation loop 306 through the hole 216 toward the upper side of the fixation plate, shortening the length of the second adjustable fixation loop 306, and then the third adjustable fixation loop 310 and the second adjustable fixation loop 306 share the load of the graft and readjust to the same length. This continuous sliding of the adjustable fixation loops is performed, in particular, based on the principle of a pulley mechanism, so that all three adjustable fixation loops are shortened equally at the same time. Once the graft 402 is securely suspended in the bone tunnel 404 and the desired strength is achieved, the surgeon releases the tensioned end of the braided medical strand and properly forms the locking configuration by fastening the knot ball 202 to the hole 216, pinching the braided medical strand, and fastening the adjustable loop to the bridge 214. Any excess length above the fixation plate 102 on both adjustable fixation loops 304 and 306 can be cut off and removed.

[0061] It has been confirmed that there is no longer a need to use multiple sutures or threads during surgery.

[0062] Furthermore, it is observed that the single braided medical strand together with the fixation plate provides the necessary strength to the graft while eliminating multiple sutures and minimizing slip / creep of the braided medical strand within the loop, avoiding further post-operative problems. In addition to these benefits, there are also other advantages such as cost savings and elimination of the time-consuming surgery mentioned in the prior art.

[0063] The object of the present invention has technical and economic significance over conventional fixing devices and the like.

[0064] While particular embodiments of the present subject matter have been shown and described, modifications thereof will readily occur to those skilled in the art. It is understood that the various embodiments, details and configurations of the fixation devices described above and illustrated in the accompanying figures, and their features, may be interchanged between various embodiments while remaining within the scope of the present subject matter. Furthermore, it is understood that various modifications may be made to any of the fixation devices and / or elements described hereinabove while remaining within the scope of the present subject matter.

Claims

1. 1. A device for tissue repair and reconstruction of the anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL), comprising: a fixation plate having an upper side and a lower side, the upper side having a plurality of circular through holes, an oval groove having pairs of openings connected by bridges, and a stepped hole extending from the upper side to the lower side; a strand; the strand has a knot dividing the strand into a tension end and a leading end, the tension end being threaded from bottom to top through the hole in the fixation plate and from top to bottom through one of a pair of openings to form a first adjustable fixation loop, the tension end of the strand being threaded further from bottom to top through the opening to form a first small loop, the tension end of the strand being threaded from bottom to top through the hole to form a second adjustable fixation loop with the tension end and leading end extending away from the top, the tension end of the strand being threaded further from top to bottom through the opening to form a second small loop, the tension end of the strand being threaded from bottom to top through the hole to form a third adjustable fixation loop, the tension end of the strand being threaded through the first small loop to lock the adjustable loop, and the leading end of the strand being pulled through the hole and the lower guideway and out at the upper side through the second through hole. Device.

2. 10. The device of claim 1, comprising a graft connected to first, second and third adjustable fixation loops, wherein tension applied to the tension ends of the strands shortens the adjustable loops, achieving fixation of the graft and minimizing slip / creep of the strands within the loops.

3. 10. The device of claim 1, wherein the fixation plate has curved edges to facilitate smooth pulling of the fixation device through the bone tunnel during surgery.

4. 2. The device of claim 1, wherein the circular through-holes are located at the corners of the fixing plate.

5. 10. The device of claim 1, wherein a bridge connecting the pair of openings defines a winding path for the strand.

6. 10. The device of claim 1, wherein the step in the hole is configured to stop the knot in the strand and prevent slippage during tensioning.

7. 10. The device of claim 1, wherein the tension ends of the strands are slidably adjustable within the pair of openings to achieve a desired tension in the graft.

8. 10. The device of claim 1, wherein the tension ends of the strands are pulled to shorten the adjustable loops, distributing the load on the graft and achieving the desired fixation.

9. 10. The device of claim 1, wherein the fixation plate is made from a material selected from the group consisting of plastic, titanium alloy, and steel, and the flexible single strand is made from ultra-high molecular weight polyethylene (UHMWPE) or a biocompatible material.

10. 10. The device of claim 1, wherein the strands are flexible, single-braided, medicated, and circular in cross-sectional shape.

11. 1. A method of attaching a graft, comprising: A device comprising a fixed plate having an upper side and a lower side, and a flexible single strand having a knot dividing the strand into a tension end and a leading end, the upper side having a plurality of circular through holes, an oval groove having pairs of openings connected by bridges, and a stepped hole extending from the upper side to the lower side; passing the tension end of the strand from bottom to top through the hole in the fixation plate and then from top to bottom through one of the pair of openings to form a first adjustable fixation loop; Passing the tension end of the strand through the opening from bottom to top to form a first small loop; threading the tension end of the strand through the hole from the bottom side to the top side to form a second adjustable securement loop with the tension end and the leading end extending away from the top side; Passing the tension end of the strand through the opening from top to bottom to form a second small loop; threading the tension end of the strand through the hole from bottom to top to form a third adjustable securement loop; threading the tension end of the strand through the first small loop to lock the adjustable loop, pulling the leading end of the strand through the hole and the lower guideway, and pulling the leading end out of the second through hole at the upper side; attaching the graft to the first, second and third adjustable fixation loops of the fixation device; Applying tension to the tension end of the strand, shortening the adjustable loop and transferring the load to the graft achieves fixation of the graft and minimizes slip / creep of the strand within the loop; method.

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