FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENT RULES, 2003
COMPLETE SPECIFICATION
(See Section 10 and Rule 13)
An Adjustable Loop Fixation Device BIORAD MEDISYS PRIVATE LIMITED
AN INDIAN COMPANY REGISTERED UNDER THE COMPANIES ACT
WITH ADDRESS: SURVEY NO. 48, 3 & 48 7, PASHAN – SUS ROAD, SUS, PUNE,
MAHARASHTRA 411021
THE FOLLOWING SPECIFICATION PARTICULARLY DESCRIBES THE SUBJECT MATTER.

FIELD OF THE INVENTION
[0001] The present invention relates generally to surgical procedures and devices for the repair and reconstruction of soft tissue injuries. More particularly, the invention relates to the surgical reconstruction of Anterior Cruciate Ligament (ACL) and Posterior Cruciate Ligament (PCL) using an adjustable loop fixation device..
BACKGROUND
[0002] Joint injuries may commonly result in the complete or partial detachment of ligaments, tendons, and soft tissues from bone. Tissue detachment may occur in many ways, e.g., as the result of an accident such as a fall, overexertion during a work related activity, during the course of an athletic event, or in any one of many other situations and/or activities. These types of injuries are generally the result of excess stress or extraordinary forces being placed upon the tissues. If, however, the ligament or tendon is completely detached from its attachment site on an associated bone or bones, or if it is severed as the result of a traumatic injury, surgical intervention may be necessary to restore full function to the injured joint. A number of conventional surgical procedures exist for re-attaching such tendons and ligaments to bone.
[0003] An increasing number of surgical techniques are now performed arthroscopically. One such procedure involves forming aligned femoral and tibial tunnels in a knee to repair a damaged anterior cruciate ligament (“ACL”). In one ACL repair procedure, a ligament graft is associated with a surgical implant and secured to the femur. A common ACL femoral fixation means includes an elongate “button,” sometimes referred to as a cortical button. The cortical button is attached to a strand loop that is sized to allow an adequate length of a soft tissue graft to lie within the femoral tunnel while providing secure extra-cortical fixation.

[0004] Existing devices and methods can be limited because they do not always provide the desired strength. In some instances, one or more knots tied to help maintain a location of the strand loop with respect to a cortical button, and thus the graft associated therewith, can loosen or slip. Knots tied on, around or through the button are used to hold the graft and the button in place. However, knots are known for reducing the strength of the fixation. Thus, even if a ligament graft is disposed at a desired location during a procedure, post-operatively the circumference of the loop can increase, causing the graft to move away from the desired location. Further, it can be desirable to limit the number of knots used in conjunction with such devices, because of the potential for the knots loosening and because the additional surface area knots can increase the risk of trauma. More recently, adjustable loop cortical suspension devices have been introduced, and have gained popularity for ACL reconstruction. These allow for adjusting the length of the suspension loop after insertion. Still further, existing devices and methods also lack adjustability in many instances. For example, sometimes it requires over-drilling of the femoral socket to allow for it to flip at lateral femoral cortex. As a result of this over-drilling, some part of the socket is not filled by the graft, hence leaving scope for graft motion within the tunnel, which can hamper graft incorporation and cause tunnel widening. Sometimes, there is no proper locking of the adjustable suspension loops. Furthermore, the fixation devices comprises of different sutures probably a main suture which pulls the device from the tunnel and a tension suture to adjust and give the desired strength to the device during ACL reconstruction.
[0005] This invention is therefore directed towards providing an improved a method and device, which is relatively simple in design and structure, and is highly effective for its intended purpose.

SUMMARY
[0006] Embodiment of the present disclosure present technological improvements as solutions to one or more of the above-mentioned technical problems recognized by the inventor(s) in conventional systems.
[0007] An object of the present invention is to provide an improved and novel construction of a fixation device which overcome the aforementioned disadvantages of the known existing devices for ACL reconstruction.
[0008] Another object of the present invention is to eliminate the use of two different sutures or threads and provide a single strand which acts as a lead and tension end of the strand.
[0009] Yet another object of the invention is to provide a device with the adjustable fixation loops working on a pulley mechanism to fix the graft in the bone tunnel.
[0010] In an aspect of the present disclosure, a fixation device comprising a fixation plate and a strand is disclosed. In order to make a fixation device,the strand and fixation plate is assembled by making the strand pass through the holes, twin apertures inside the elliptical groove and counterbore eventually pulling out the lead end of the strand through a through hole placed at the corner of the fixation plate via a guide way. The strand and fixation device is assembled outside the body of the patient. The graft is attached to the adjustable fixation loops of the fixation device. The fixation device is pulled out through the bone tunnel during surgery and the tension end of the strand is pulled to adjust the tension of the graft into the bone tunnel by shortening the first and second adjustable fixation loops. The present invention particularly works on a pulley mechanism for shortening of the adjustable fixation loops.

[0011] Additional aspects, advantages, features and objects of the present disclosure would be made apparent from the drawings and the detailed description of the illustrative embodiment.
[0012] It will be appreciated that features of the present disclosure are susceptible to being combined in various combinations without departing from the scope of the present disclosure as defined by the below mentioned detailed description and drawings.
BRIEF DESCRIPTION OF THE FIGURES
[0013] The summary above, as well as the following detailed description of illustrative embodiment, is better understood when read in conjunction with the appended drawings. For the purpose of illustrating the present disclosure, example constructions of the disclosure are shown in the drawings. However, the present disclosure is not limited to specific methods and instrumentalities disclosed herein. Moreover, those in the art will understand that the drawings are not to scale. Wherever possible, like elements have been indicated by identical numbers.
[0014] Embodiment of the present disclosure will now be described, by way of example only, with reference to the following diagrams wherein:
[0015] Fig 1. Illustrates a perspective view of the fixation device in accordance with an exemplary embodiment of the present disclosure;
[0016] Fig. 2(a), 2(b) and 2(c) illustrates a perspective view of upper and lower side of fixation plate and a single strand element respectively combined together to form a fixation device 100 in accordance with an exemplary embodiment of the present disclosure;

[0017] Fig. 3(a) - 3(h) illustrates the steps of building the embodiment of fixation device with an exemplary embodiment of the present disclosure;
[0018] Fig.4(a)-4(c) illustrates a graft connected to the adjustable fixation loops of the fixation device with an exemplary embodiment of the present disclosure.
[0019] In the above accompanying drawings, a number relates to an item identified by a line linking the number to the item. When a number is accompanied by an associated arrow, the number is used to identify a general item at which the arrow is pointing.
[0020] Further the figures depict various embodiment of the present subject matter for purposes of illustration only. One skilled in the art will readily recognize from the following discussion that alternative embodiment 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 EMBODIMENTS
[0021] The following detailed description illustrates embodiment of the present disclosure and manners by which they can be implemented. The words "comprising," "having," "containing," and "including," and other forms thereof, are intended to be equivalent in meaning and be open ended in that an item or items following any one of these words is not meant to be an exhaustive listing of such item or items, or meant to be limited to only the listed item or items. It must also be noted that as used herein and in the appended claims, the singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise.

[0022] The person skilled in the art will recognize many variations, alternatives, and modifications of the embodiment of the present disclosure. It should be understood that this invention is not limited to the particular methodology, protocols, and the like, described herein and as such may vary. The terminology used herein is for the purpose of describing particular embodiment only and is not intended to limit the scope of the present invention, which is defined solely by the claims.
[0023] Referring now to the drawings, Figures. 1-4 illustrate a fixation device 100 according to present invention. It should be noted that Figure 1-4 are merely examples. A person skilled in the art will recognize many variations, alternatives, and modifications of the embodiments of the present disclosure. The fixation device 100 may be any of various types of geometrical shapes like circular , rectangular, trapezoidal and the like according to various embodiments of the present disclosure.
[0024] In an aspect of the present disclosure, a fixation device comprising a fixation plate and a flexible single strand with a plurality of adjustable fixation loops and a method of building the strand with the fixation plate is disclosed.
[0025] Referring now to the drawings, Fig. 1 illustrates a fixation device 100 comprising a fixation plate 102 and a flexible single strand 104 together forming the fixation device for ACL reconstruction.
[0026] Now referring to Fig. 2(a), the flexible single strand 104 comprises a knot 202 which divides the strand 104 into two parts namely, tension end 104a and lead end 104b. The placement of the knot 202 decides the length of the lead end 104b of the flexible strand.

[0027] Referring to Fig. 2(b) and 2(c) the fixation plate 102 have an upper side 102(a) and a lower side 102(b) with curved edges to easily pull the graft into a tunnel without damaging a bone. The upper side 102a of the fixation plate has a plurality of circular holes 204 and 206 respectively extending from the upper side 102(a) to the lower side 102(b) of the fixation plate 102, an elliptical groove 208 placed at an angle with twin apertures 210 and 212 extending from the upper side 102(a) to the lower side 102(b) of the fixation plate 102, a counterbore 214 extending from the upper side 102(a) to the lower side 102(b) of the fixation plate 102 opens into a bracket 216 at the lower side 102(b) of the fixation plate 102 which acts as a stabilising member.
[0028] The circular holes i.e. a first hole 204 and a second hole 206 are placed at the extreme left and right corners on the upper side 102(a) of the fixation plate 102 respectively.The first hole 204 may be an optional hole for a flipping strand which the surgeon may require sometimes to adjust the fixation device for the desired strength once the fixation device is pulled out of a bone tunnel. The counterbore 214 arrests the knot 202 during the operation ensuring that the flexible strand 104 does not gets completely pulled out through the counterbore 214. The second hole 206 is connected to the counterbore 214 via a guide way 218 at the lower side 102(b) of the fixation plate 102.
[0029] Fig. 2(a) - 2(c) are mere examples. A person skilled in the art will recognize many variations, alternatives, and modifications of the embodiment of the present disclosure. The present invention is not limited to the five holes and the number of holes can be more or less than five according to the requirement of the thickness of the fixation plate and the strength to reconstruct the graft to be achieved. The shape of the through holes is not limited to circular and can be of any geometrical shape like triangle, elliptical, rectangle and the like according to the need for the strength during the time of the surgery. The placement of the knot in the strand is not limited to the embodiment of the invention and can be placed in the middle of the strand if required. The material used for the strand is not limited to Ultra High Molecular

Weight polyethylene (UHMWPE) material and can be made out of polythene or similar material. Furthermore, the strand can be of different shapes like flat or circular. Moreover, the fixation plate may be made from plastic also is not limited to the metals having high tensile strength,toughness, corrosion resistance and light in weight like titanium alloy, steels and the like.
[0030] Fig. 3(a) - 3(h) illustrates the engagement of the flexible strand 104 with the fixation plate 102 through the plurality of holes 204, 206, twin apertures 210,212 and counterbore 214. The following steps are conducted to engage the flexible strand 104 to the fixation plate 102 as shown in the Fig 3(a) - 3(h). As shown in Fig. 3(a), pass the tension end 104a of the strand 104 into the counterbore 214 from the upper side 102a of the fixation plate until the knot 220 gets arrested. Now put the tension end 104(a) of the flexible strand 104 from the lower side 102(b) of the fixation plate 102 into the aperture 210 to form a first adjustable fixation loop 302. (Ref. Fig. 3(b)). The tension strand 104a of the flexible strand 104 is not limited to the aperture 208 and can be put in either of the apertures 210 or 212 from the lower side 102b of the fixation plate 102.
[0031] Now put the tension strand 104a of the flexible strand 104 from the upper side 102a of the fixation plate 102 through the aperture 212 leaving a small loop 304 [Explained in later steps] (Ref. Fig 3(c)).
[0032] Pass the tension strand 104(a) of the flexible strand 104 from the lower side 102(b) of the fixation plate 102 back through the counterbore 214 forming a second adjustable fixation loop 306 wherein both the tension strand 104(a) and lead strand 104(b) extends away from the upper side 102(a) of the fixation plate 102. (Ref. Fig. 3(d)).
[0033] Now, pass the tension strand 104(a) of the flexible strand 104 through the small loop 304 in order to make a sling lock arrangement 308 when tension is applied. (Ref. Fig. 3(e))

[0034] Now referring to Fig. 3(f) - 3(h), pass the lead strand 104(b) of the flexible strand 104 through the through hole 214 into the guide way 218 at the lower side 102b of the fixation plate 102 and eventually pulling out the lead strand 104b through the second hole 206 at the upper side 102 (a) of the fixation plate 102.
[0035] Fig. 3(a)-3(h) are merely examples. A person skilled in the art will recognize many variations, alternatives, and modifications of the embodiment of the present disclosure.
[0036] During surgery, as shown in fig 4(a), a graft 402 is attached to the first and second adjustable fixation loops 302 and 306 respectively of the fixation device 100 wherein the lead strand 104(b) is pulled in order to bring the whole graft 402 into a bone tunnel 404. The curved edges of the fixation plate 102 ensures the smooth pulling of the fixation plate 102 through the tunnel 404 without damaging the bone 406. As shown in fig 4(b), once the fixation plate 102 is pulled out of the bone tunnel 406, the fixation plate 102 sits comfortably at the end of the bone tunnel 406 with the help of the stabilizing member 216. Now, the graft 402 is fixed onto the cortex of the femur at the proximal end of the femoral tunnel. When tensioning end 104(a) of flexible strand 104 is pulled away from the graft 402, the flexible strand 104 passing under the sling lock 308 straightens and opens it . As a result, the knot 202 resting in the counterbore gets lifted due to friction in the direction of tensioning end 104(a) of flexible strand 104. This disables the primary locking i.e. sling lock arrangement 308 and secondary locking of counterbore. As the flexible strand 104 travels in the pull direction, the first loop 302, which is the extension of tensioning end 104(a) of flexible strand 104 get shortens.This shortening increases the tension of the graft 402 and a counter tension is developed in the other arm of the same loop 302. This pulls the flexible strand 104 from one arm of second loop 306 through sliding in slot 1 which acts as a pulley. The other arm of second adjustable loop 306 is locked in the counterbore 214 of the fixation plate 102 via knot 202. As a result, second adjustable loop 306 also get shortens and this goes on synchronisation until both adjustable loop get shorten and the graft 402 is securely suspended in the bone tunnel 404. The extra length above the

upper side of the fixation plate 102 of both the adjustable fixation loops 302 and 306 can be cutoff and removed.
[0037] It is observed that the use of multiple sutures or threads for the surgery has been completely eliminated.
[0038] It is further observed that along with the elimination of the multiple sutures, the single strand along with the fixation plate has provided the much needed strength to the graft which avoids any further post-surgery problems. Along with these advantages , there is a cost reduction, as well as elimination of time consuming surgery as described in the present invention
[0039] The present invention has both technical as well as economic significance with respect to the conventional devices for fixation or the like.
[0040] While a particular embodiment of the invention has been illustrated and described, modifications thereof will readily occur to those skilled in the art. It is understood that the various embodiment, details and constructions of the fixation device and their features described above and illustrated in the attached Figures may be interchanged among the various embodiment while remaining within the scope of the invention. Additionally, it is understood that various modifications could be made to any of the fixation device and/or elements described herein above while remaining within the scope of the invention.

We Claim:
1. A medical implant 100 for securing /fixing a ligament or tendon graft 402 in a desired
position/bone tunnel 404 comprising;
A fixation plate 102 having an upper side 102(a) and a lower side 102(b) wherein,
the said fixation plate 102 comprises a plurality of passages (204,206,210,212 and 214) extending from the said upper side 102(a) to the said lower side 102(b) of the said fixation plate 102 to receive a single strand 104 of flexible material having a tension end 104(a) and a lead end 104(b) wherein,
a knot 202 is positioned in between the said tension end 104(a) and the said lead end 104(b) acting as secondary stopper;
the said lead end 104(b) of the flexible strand 104 is pulled out from a passage 206 via a guide way 218 at the lower side 102(b) of the said fixation plate 102 connected to the said counterbore 216; and
the said flexible strand 104 is successively inserted into the said plurality of passages (204,206,210,212 and 214) to form a plurality of loops (302,306) having adjustable length formed on the lower side 102(b) of the said fixation plate 102 in such a way that when the tension is applied by pulling the tension end 104(a) of the strand 104 a sling lock 308 acting as a primary stopper is formed on the said upper side 102(a) of the said plate 102 eventually securing the said graft 402 in the bone tunnel 404;
2. The medical implant of claim 1, wherein the fixation plate 102 is made up of titanium alloy.
3. The medical implant of claim 1, wherein the fixation plate 102 has curved edges ensuring the smooth pulling of the fixation plate 102 through the tunnel 404 without damaging the bone 406.

4. The medical implant of claim 1, wherein the flexible strand is composed of Ultra-High Molecular Weight polyethylene (UHMWPE) material.
5. The medical implant of claim 1, wherein the fixation plate defines 5 passages that includes circular holes (204,206), elliptical shaped groove 208 comprising apertures 210,212 and a counterbore 214.
6. The medical implant of claim 1, wherein the length of the fixation plate 102 extending along the longitudinal axis is about 12-15 mm, width of the fixation plate 102 extending along the upper side 102(a) or the lower side 102(b) of the fixation plate 102 is in a range of about 2 mm to about 6 mm, and a thickness of the fixation plate 102 extending between the upper side 102(a) or the lower side 102(b) of the fixation plate 102 is in a range of about 1 mm to about 3 mm.
7. The medical implant of claim 1, wherein the said bracket 216 in the form of the dome adapted to be seated on the surface of the graft element extending downwardly from the lower side 102(b) defining a channel to pass a lead end 104(b) of the flexible strand 104 in the form of a guide way 218 which is in communication with the counterbore 214.
8. The medical implant of claim 1, wherein the length of the flexible strand is 1.5 metres.
9. A method for securing a ligament or tendon graft 402 in a bone tunnel 404 comprising;
a fixation plate 102 having an upper side 102(a) and a lower side 102(b) wherein, the said plate 102 comprises a plurality of strand receiving passages (204,206,210,212 and 214) extending from the said upper side 102(a) to the said lower side 102(b) of the said plate 102;
tying a flexible strand 104 comprising a tension end 104(a) and a lead end 104(b) to the said fixation plate 102 by passing the said tension end 104(a) successively through the said plurality of passages (204,206,210,212 and 214) to form a plurality of loops 302,306 on the said lower side 102(b) of the fixation plate 102

and a sling lock 308 is formed on the upper side 102(a) of the fixation plate 102 when the said tension end 102(a) is passed under a loop 304 and extended along the direction away from the upper side 102(a) of the fixation plate 102; shortening the length of the loops 302,306 by pulling the tension end 104(a) of the strand 104 in the direction away from the fixation plate 102 to advance the graft 402 and secure it to the bone by applying the appropriate tension.
10. The assembly of claim 7, wherein the tension end 104(a) of the flexible strand 104 is passed through the said aperture 210 from the lower side 102b of the fixation plate 102 to form a first adjustable fixation loop 302.
11. The assembly of claim 7, wherein tension strand 104a of the flexible strand 104 is passed from the lower side 102b of the fixation plate 102 back through the countersink 214 forming the second adjustable fixation loop 306.
12. The assembly of claim 7, wherein the length of the loops is about equal to the length of tibial tunnel.
13. The assembly of claim 7, wherein the fixation plate 102 defines 5 passages that includes circular holes (204,206), elliptical shaped groove 208 comprising apertures 210,212 and a counterbore 214.