Description:
FORM 2
THE PATENTS ACT, 1970
(39 OF 1970)
&
The Patents Rules, 2003
COMPLETE SPECIFICATION
(See section 10; rule 13)

1. Title of the invention – AN APPARATUS FOR LIGAMENT RECONSTRUCTION WITH UNIDIRECTIONAL ADJUSTABLE LOOP

2. Applicant(s)

(a) NAME : OSTEOCARE MEDICAL PVT LTD
(b) NATIONALITY: INDIAN
(c) ADDRESS: A/ 701, Privilion, Behind Iscon Temple, Iscon cross road, Bopal Ambali Road, A'bad - 380054

3. PREAMBLE TO THE DESCRIPTION

The following specification particularly describes the invention and the manner in which it is to be performed.

AN APPARATUS FOR LIGAMENT RECONSTRUCTION WITH UNIDIRECTIONAL ADJUSTABLE LOOP

FIELD OF THE INVENTION:

The present invention relates to an apparatus for ligament reconstruction with unidirectional adjustable loop. Particularly, it relates to an apparatus for ligament reconstruction with unidirectional adjustable loop after tibial fixation.

BACKGROUND OF THE INVENTION:

There are primarily two types of medical procedures for ligament injury, one of them being non-surgical and the other one being surgical procedures. The procedure is decided on the severity of the injury. When the severity of the injury is high the recommended medical procedure is surgical procedure.

Ligament reconstruction is a commonly performed surgical procedure to repair or reconstruct damaged ligaments, primarily in the knee area. Ligaments are tough fibrous tissues that connect bones and provide stability to joints, particularly the femur and tibia bones. The procedure typically involves replacing the damaged ligament with a graft, which can be sourced from different areas of the patient's body known as an autograft, or from a donor known as an allograft.

Various factors can cause ligament injuries, including sports-related activities, trauma, repetitive stress, or degenerative conditions. When a ligament is torn or severely damaged, it can result in joint instability, pain, and a restricted range of motion. In such cases, ligament reconstruction is frequently considered an effective treatment option to restore stability and functionality to the joint.

One of the widely used apparatus for ligament reconstruction is the fixation implant. The fixation implant is used to place the graft into the tunnel of the affected knee joint to restore its functionality. The surgeon will delicately eliminate any remaining injured or torn ligament tissue. Subsequently, they will utilize the graft to generate a fresh ligament. The graft is inserted through tiny tunnels that have been created in the bones close to the joint. The surgeon will secure the graft in position using specific screws, sutures, or other fixation implants. Some of the prior art documents disclose such types of fixation implants.

The prior art document WO2016090104A1 titled Closed loop suture for anchoring tissue grafts, discloses a method and device for securing a tissue graft within a bone passage includes providing a graft fixation device that houses a closed loop having both braided and non-braided portions. A tissue graft is looped through the closed loop at the non-braided portion to attach the tissue graft to the graft fixation device. The graft fixation device is passed through the bone passage and seated against the surface of the bone to secure the tissue graft within the bone passage.

The prior art document US20130317544A1 titled Continuous Loop and Button Assembly, discloses fixation assemblies having a button captured by a continuous (i.e., closed) loop of thread, such as ultra-high molecular weight polyethylene (UHMWPE) fiber are disclosed herein. Preferred assemblies are constructed such that the intact button cannot be detached from the continuous loop without breaking or opening the loop of fiber. The closed fiber advantageously contains at least one or two stitched, or otherwise secured or reinforced, sections positioned on the loop.

The prior art document US2010324676A1 titled Bone-tendon-bone suture button constructs and methods of tissue fixation, discloses a continuous loop and button construct and technique for ligament repair and fixation, including bone to bone, or soft tissue to bone. The continuous loop, which is attached to the button, is formed of a flexible material and is provided with at least one joined region (a bridged, stitched, bonded or knotted region) to form a closed loop figure-8 construct with proximal and distal openings with respect to the fixation device. The figure-8 construct (either bridged, stitched, bonded or knotted) is adapted for attachment to a bone block of a BTB graft, for example, and used for ligament reconstruction.

The problem associated with the above mentioned prior art is lack of adjustability. There are chances of graft laxity after the surgical procedure, one of the reasons it can be caused is due to suboptimal positioning of the graft. Further, the drilling of the tunnel is wider and deeper to enable the flipping of the button. This causes a dead space between the graft and the bone at one end of the tunnel. Inventors of the present invention have surprisingly found the solution to all the above-mentioned problems by developing an apparatus for ligament reconstruction with unidirectional adjustable loop.

OBJECT OF THE INVENTION:

The principle object of the present invention is to overcome all the mentioned and existing drawbacks of the prior arts by providing an apparatus for ligament reconstruction with unidirectional adjustable loop.

Another object of the present invention is to provide an apparatus for ligament reconstruction with unidirectional adjustable loop being capable of adjustment after tibial fixation.

Another object of the present invention is to provide an apparatus for ligament reconstruction with unidirectional adjustable loop which is to reduce the possibility of graft laxity.

Another object of the present invention is to provide an apparatus for ligament reconstruction with unidirectional adjustable loop which has an interlocking mechanism to restrict the movement of the graft.

Another object of the present invention is to provide an apparatus for ligament reconstruction with unidirectional adjustable loop which has a button to restrict the movement of the graft.

Another object of the present invention is to provide an apparatus for ligament reconstruction with unidirectional adjustable loop which provides the advantages of a closed loop and provision for adjustment.

Another object of the present invention is to provide an apparatus for ligament reconstruction with unidirectional adjustable loop which uses biocompatible materials to prevent any infection to the user from the apparatus.

Another object of the present invention is to provide an apparatus for ligament reconstruction with unidirectional adjustable loop which assists in regaining the affected knee joints' functionality.

SUMMARY OF THE INVENTION:

This summary is provided to introduce a selection of concepts in a simplified form that is further disclosed in the detailed description of the invention. This summary is not intended to identify essential inventive concepts of the claimed subject matter, nor is it intended for determining the scope of the claimed subject matter.

The present invention is all about an apparatus for ligament reconstruction with unidirectional adjustable loop.

The main aspect of the present invention is to provide an apparatus for ligament reconstruction with unidirectional adjustable loop comprising a unidirectional loop, a leading fiber, a tensioning fiber, a flipping fiber, a loop handle, a button, an interlocking mechanism, a graft and a tunnel wherein the unidirectional loop being capable of adjustment even after tibial fixation for ligament reconstruction in the direction of the loop handle and restricting the unidirectional loop movement in the opposite direction as a result of the interlocking mechanism and the button.

Another aspect of the present invention is to provide an apparatus for ligament reconstruction with unidirectional adjustable loop, wherein said unidirectional loop being capable of adjustment by shortening the loop towards the loop handle.

Another aspect of the present invention is to provide an apparatus for ligament reconstruction with unidirectional adjustable loop, wherein said interlock mechanism being obtained through following method:
a) tensioning fiber is passed through the hole B from top to bottom side of the button;
b) making a small loop the tensioning fiber is again passed through the hole B from bottom to top side of the button;
c) tensioning fiber is passed through the hole C from top to bottom side of the button;
d) tensioning fiber is passed through the small loop made in step b, before passing it through the hole C from bottom to top side of the button;
e) braiding of the tensioning fiber is done such that it becomes a single fiber after step d.

Yet another aspect of the present invention is to provide an apparatus for ligament reconstruction with unidirectional adjustable loop to secure the graft in the tunnel to maintain the integrity of the knee joint.

BRIEF DESCRIPTION OF THE DRAWINGS:

The foregoing summary, as well as the following detailed description of the invention, is better understood when read in conjunction with the appended drawings. For the purpose of illustrating the invention, exemplary constructions of the invention are shown in the drawings.
FIG. 1 represents the apparatus for ligament reconstruction with unidirectional adjustable loop.
FIG. 2 represents the loop handle for pulling the graft.
FIG. 3 represents the graft along with the apparatus for ligament reconstruction with unidirectional adjustable loop with respect to the tunnel.
FIG. 4 represents the button after flipping it, making it perpendicular to the axis of the tunnel.

DETAILED DESCRIPTION OF THE INVENTION:

Detailed embodiments of the present invention are disclosed herein, however, it is to be understood that the disclosed embodiments are merely exemplary of the invention, which may be embodied in various forms. Therefore, specific functional and structural details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present invention in virtually any appropriately detailed structure.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention belongs.

The present invention overcomes the aforesaid drawbacks of conventional apparatus for ligament reconstruction. The objects, features, and advantages of the present invention will now be described in greater detail. Also, the following description includes various specific details and is to be regarded as merely exemplary. Accordingly, those of ordinary skill in the art will recognize that: without departing from the scope and spirit of the present disclosure and its various embodiments there may be any number of changes and modifications described herein.

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. Although any systems and methods similar or equivalent to those described herein can be used in the practice or testing of embodiments of the present invention, the preferred, systems are now described.

Throughout the specification, the term “ligament” is the ligaments present in and/or around the knee of the human body.

Throughout the specification, the term “tunnel” is a hollow cavity drilled through the femur and tibia bones.

Throughout the specification, the term “femur” is the thigh bone, which is the longest and strongest bone in the human body.

Throughout the specification, the term “tibia” is the shin bone, which is the second longest bone in the human body.

The main embodiment of the present invention is to provide an apparatus for ligament reconstruction with unidirectional adjustable loop (100) comprising; a unidirectional loop (1), a leading fiber (2), a tensioning fiber (3), a flipping fiber (4), a loop handle (5), a button (6), an interlocking mechanism (7), a graft (8) and a tunnel (9) wherein the unidirectional loop (1) being capable of adjustment even after tibial fixation for ligament reconstruction in the direction of the loop handle (5) and restricting the unidirectional loop (1) movement in the opposite direction as a result of the interlocking mechanism (7) and the button (6). The adjustment allows to reduce the chances of graft laxity after the apparatus is fixed on the tibial bone.
As per detailed embodiment of the present invention is to provide, the unidirectional loop (1) which can be manufactured in a plurality of sizes, the most optimized sizes are 15mm, 20mm, and 25mm. After cinching of the unidirectional loop (1) with the tensioning fiber (3), the length can be reduced upto 5mm in the direction of the loop handle (5).

As per detailed embodiment of the present invention is to provide an apparatus for ligament reconstruction with unidirectional adjustable loop (100), wherein said unidirectional loop (1) being capable of adjustment by shortening the loop towards the loop handle (5). The hybrid arrangement of the loop has the advantages of both a closed loop as well as an adjustable loop. It provides the tensional rigidity of a closed loop while still offering adjustment like an adjustable loop.

As per detailed embodiment of the present invention is to provide an apparatus for ligament reconstruction with unidirectional adjustable loop (100), wherein the button (6) having a plurality of holes as a hole A (10), a hole B (11), a hole C (12) and a hole D (13) which being capable of restricting the movement of the unidirectional loop (1) and the graft (8) in its position, said button (6) being made of a single material preferably titanium. The tensioning fiber is made by braiding of the fibers. The tensioning fiber comprises of the unidirectional loop (1), the interlocking mechanism (7) and the loop handle (5). The braiding of the fibers splits at the appropriate places and merges again to form a single component.

As per detailed embodiment of the present invention is to provide an apparatus for ligament reconstruction with unidirectional adjustable loop (100) wherein the components are made up of biocompatible materials which are non-toxic to the human body.

As per detailed embodiment of the present invention is to provide an apparatus for ligament reconstruction with unidirectional adjustable loop (100), wherein the unidirectional loop (1) is made up of a single material preferably Ultra-High Molecular Weight Polyethylene (UHMWPE).

As per detailed embodiment of the present invention is to provide an apparatus for ligament reconstruction with unidirectional adjustable loop (100), wherein the leading fiber (2) being capable of pulling the graft (8) through the tunnel (9); said leading fiber (2) being made of a single material preferably Ultra-High Molecular Weight Polyethylene (UHMWPE); said leading fiber (2) being passed through the hole A (10) of the button (6). The leading fiber (2) is used to pull the graft across the tunnel (9) and it is placed at its predetermined location to replace the damaged ligament of the affected knee joint.

As per detailed embodiment of the present invention is to provide an apparatus for ligament reconstruction with unidirectional adjustable loop (100), wherein the tensioning fiber (3) being capable of transmitting tension to the graft (8) upon applied external force; said tensioning fiber (3) being made of a single material preferably UHMWPE. The tensioning fiber is used to apply appropriate tension to the graft after tibial fixation, the tension of the graft is essential to restore the functionality of the knee joint.

As per detailed embodiment of the present invention is to provide an apparatus for ligament reconstruction with unidirectional adjustable loop (100), wherein the flipping fiber (4) being capable of flipping the button (6) at outer cortex of the tunnel (9); said flipping fiber (4) being made of a single material preferably UHMWPE; said flipping fiber (4) being passed through the hole D (13) of the button (6). The flipping fiber (4) assists to hold the graft in place by flipping the button by approximately 90 degrees, such that the button is placed perpendicular to the axis of the tunnel (9).

As per detailed embodiment of the present invention is to provide an apparatus for ligament reconstruction with unidirectional adjustable loop (100), wherein the loop handle (5) being capable to assist in cinching of the unidirectional loop (1). The loop handle (5) further assists to pull the graft (8) into its predetermined place.

As per detail embodiment of the present invention is to provide an apparatus for ligament reconstruction with unidirectional adjustable loop (100), wherein said interlock mechanism (7) being obtained through following method:
a. tensioning fiber (3) is passed through the hole B (11) from top to bottom side of the button (6);
b. making a small loop the tensioning fiber (3) is again passed through the hole B (11) from bottom to top side of the button (6);
c. tensioning fiber (3) is passed through the hole C (12) from top to bottom side of the button (6);
d. tensioning fiber (3) is passed through the small loop made in step b, before passing it through the hole C (12) from bottom to top side of the button (6);
e. braiding of the tensioning fiber (3) is done such that it becomes a single fiber after step d.

As per detailed embodiment of the present invention is to provide an apparatus for ligament reconstruction with unidirectional adjustable loop (100), wherein the interlocking mechanism (7) in conjunction with the button (6) being capable of adjustment after tibial fixation of the graft (8).

The embodiments of the present invention are further illustrated with the help of the Figures.

According to Fig. 1 of the present invention, illustrates an embodiment of the unidirectional adjustable loop (100) having a unidirectional loop (1), a leading fiber (2), a tensioning fiber (3), a flipping fiber (4), a loop handle (5), a button (6), an interlocking mechanism (7), a graft (8) and a tunnel (9). The tensioning fiber (3) is manufactured by braiding, the braiding splits in certain sections of the structure, the various sections are the unidirectional loop (5), a loop handle (5), and an interlocking mechanism (7). The interlocking mechanism (7) restricts the movement of the graft (8) and allows adjustability in the direction of the loop handle (5). The tensioning fiber (3) being capable of transmitting tension to the graft (8) upon applied external force. The leading fiber (2) being capable of pulling graft (8) through the tunnel (9). The flipping fiber (4) being capable of flipping the button (6) at outer cortex of the tunnel (9). The button (6) having a plurality of holes as a hole A (10), a hole B (11), a hole C (12) and a hole D (13) which being capable of restricting the movement of the unidirectional loop (1) and the graft (8) in its position

According to Fig. 2 of the present invention, illustrates the loop handle (5) in the scenario where the unidirectional loop (1) is cinched and when the unidirectional loop (1) is under no pull force. The loop handle (5) assists the medical professionals in better cinching the graft (8) and induces appropriate tension.

According to Fig. 3 of the present invention, illustrates the tunnel (9) along with graft (8), which is secured by the apparatus for ligament reconstruction with unidirectional adjustable loop (100). The leading fiber (2), the tensioning fiber (3), the flipping fiber (4) and the button (6) along with the graft (8) secured is pulled through the tunnel (9) to replace the damaged ligament to retain the functionality of the affected knee joint.

According to Fig. 4 of the present invention, illustrates the button (6) after being flipped outside of the tunnel for securing the graft. After the graft (8) is placed in its predetermined position, the flipping fiber (4) is used to flip the button approximately up to 90 degrees, such that the button is perpendicular to the axis of the tunnel (9).

Without further description, it is believed that one ordinary skill in the art can, using the preceding description and the illustrative examples, make and utilize the present invention and practice the claimed methods. It should be understood that the foregoing discussion and examples merely present a detailed description of certain preferred embodiments. It will be apparent to those of ordinary skill in the art that various modifications and equivalents can be made without departing from the spirit and scope of the invention.

ADVANTAGES OF THE INVENTION:
• The apparatus provides the structural rigidity of a closed loop while having adjustability even after tibial fixation.
• It eliminates the dead space between the tunnel and the graft needed for flipping the button.
• Reduces chances of graft laxity in the ligament.

LIST OF REFERENCE NUMERALS:

An apparatus for ligament reconstruction with unidirectional adjustable loop (100)
Unidirectional loop (1)
Leading fiber (2)
Tensioning fiber (3)
Flipping fiber (4)
Loop handle (5)
Button (6)
Interlocking mechanism (7)
Graft (8)
Tunnel (9)
Hole A (10)
Hole B (11)
Hole C (12)
Hole D (13)
, Claims:CLAIMS:-
We Claim:

1. An apparatus for ligament reconstruction with unidirectional adjustable loop (100) comprising; a unidirectional loop (1), a leading fiber (2), a tensioning fiber (3), a flipping fiber (4), a loop handle (5), a button (6), an interlocking mechanism (7), a graft (8) and a tunnel (9); wherein, the unidirectional loop (1) being capable of adjustment even after tibial fixation for ligament reconstruction in the direction of the loop handle (5) and restricting the unidirectional loop (1) movement in the opposite direction as a result of the interlocking mechanism (7) and the button (6).

2. The apparatus for ligament reconstruction with unidirectional adjustable loop (100) as claimed in claim 1, wherein said unidirectional loop (1) being capable of adjustment by shortening the loop towards the loop handle (5).

3. The apparatus for ligament reconstruction with unidirectional adjustable loop (100) as claimed in claim 1, wherein the button (6) having a plurality of holes as a hole A (10), a hole B (11), a hole C (12) and a hole D (13) which being capable of restricting the movement of the unidirectional loop (1) and the graft (8) in its position, said button (6) being made of a single material preferably titanium.

4. The apparatus for ligament reconstruction with unidirectional adjustable loop (100) as claimed in claim 1, wherein the unidirectional loop (1) is made up of a single material preferably Ultra-High Molecular Weight Polyethylene (UHMWPE).

5. The apparatus for ligament reconstruction with unidirectional adjustable loop (100) as claimed in claim 1, wherein the leading fiber (2) being capable of pulling the graft (8) through the tunnel (9); said leading fiber (2) being made of a single material preferably Ultra-High Molecular Weight Polyethylene (UHMWPE); said leading fiber (2) being passed through the hole A (10) of the button (6).

6. The apparatus for ligament reconstruction with unidirectional adjustable loop (100) as claimed in claim 1, wherein the tensioning fiber (3) being capable of transmitting tension to the graft (8) upon applied external force; said tensioning fiber (3) being made of a single material preferably UHMWPE.

7. The apparatus for ligament reconstruction with unidirectional adjustable loop (100) as claimed in claim 1, wherein the flipping fiber (4) being capable of flipping the button (6) at outer cortex of the tunnel (9); said flipping fiber (4) being made of a single material preferably UHMWPE; said flipping fiber (4) being passed through the hole D (13) of the button (6).

8. The apparatus for ligament reconstruction with unidirectional adjustable loop (100) as claimed in claim 1, wherein the loop handle (5) being capable to assist in cinching of the unidirectional loop (1).

9. The apparatus for ligament reconstruction with unidirectional adjustable loop (100) as claimed in claim 1, wherein said interlock mechanism (7) being obtained through following method:
a. tensioning fiber (3) is passed through the hole B (11) from top to bottom side of the button (6);

b. making a small loop the tensioning fiber (3) is again passed through the hole B (11) from bottom to top side of the button (6);

c. tensioning fiber (3) is passed through the hole C (12) from top to bottom side of the button (6);

d. tensioning fiber (3) is passed through the small loop made in step b, before passing it through the hole C (12) from bottom to top side of the button (6);

e. braiding of the tensioning fiber (3) is done such that it becomes a single fiber after step d.

10. The apparatus for ligament reconstruction with unidirectional adjustable loop (100) as claimed in claim 1, wherein the interlocking mechanism (7) in conjunction with the button (6) being capable of adjustment after tibial fixation of the graft (8).

Dated this 28th June, 2023