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 AND METHOD FOR POSTERIOR HORN MEDIAL MENISCUS ROOT REPAIR

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 AND METHOD FOR POSTERIOR HORN MEDIAL MENISCUS ROOT REPAIR

FIELD OF THE INVENTION:

The present invention relates to an apparatus and method for posterior horn medial meniscus root repair. Particularly it relates to an apparatus and method for posterior horn medial meniscus root repair with suture anchor such as tibial tunnel not occupied after surgery.

BACKGROUND OF THE INVENTION:

The meniscus is an essential anatomical structure situated inside the knee. Their main functions include the absorption and distribution of loads throughout the joint, enhancing the contact area between the femur and the tibia. Each of the menisci has bony fixations in their anterior and posterior extremities, known as meniscal roots, which anchor them securely to the tibial plateau in the medial and lateral compartments. Injuries of the meniscal roots represent potential damage to the maintenance of joint homeostasis by increasing the contact pressure on loading areas, which can extend to premature wear of the cartilage of the femoral condyles and tibial plateau.

Meniscal root avulsions are the most challenging injuries causing meniscal extrusion and loss of hoop stress distribution, which can lead to the development of knee arthritis. Fastening the meniscus in a small bone socket has proven to be an effective means to restore hoop stresses and improve outcomes.

Meniscal root tears are characterized as soft tissue or bony root avulsion injuries or radial tears located within 1 cm of the meniscus root attachment. They can be either a tear that disconnects the root area completely from the body of the meniscus or a disruption of the meniscus attachment directly from the bone that can cause the whole meniscus to lose its capacity to safeguard the underlying cartilage.

Meniscal root tears are one of the most common injuries to the knee joint. They occur in younger patients as a result of high-energy trauma, but most cases occur in individuals above the age of 40 years following a minor traumatic event due to degeneration of the meniscus with age. A torn meniscus causes pain, swelling, stiffness, and a catching or locking sensation in your knee making you unable to move your knee through its complete range of motion.

Meniscus root repair is a surgery performed to repair a torn meniscus root. Meniscal repair may be performed either by open surgery under direct vision or minimally invasively using an arthroscope that can be inserted into the knee through a very small key-hole incision to locate and repair the damaged meniscus.

Presently, treatment alternatives for root repair include conservative management, meniscectomy, and meniscal root repair (MRR). In any case, it is paramount to assess the patient’s lower limb alignment, since coronal plane deformities could deteriorate clinical results. When pointed, tibial or femoral osteotomy must be performed to correct the mechanical axis, whether associated or not with the root repair. Some of the prior art documents disclose such types of root repair surgery methods and apparatus.

The prior art document CN101961264A discloses a repair method and apparatus for meniscal tissue and provides the method and apparatus that is used to repair the breach in the meniscus. The pair of the fixed component has the pre-formation structure that connects with the stitching line segment separately and makes and with the described stitching line segment of crossing over described breach described fixed component is placed on the described meniscal tissue, the described structure is made and is formed the grappling knot by expansion, and described stitching line segment is shortened with the described breach of closure.
The prior art document US20130085512A1 discloses an assembly for meniscal repair including a first tissue fixation member configured to secure a meniscal tissue, a suture anchor having a proximal end, a distal end, a central axis defined therethrough, an eyelet on the proximal end of the suture anchor, and a textured outer surface, and a first suture configured to be coupled to the first tissue fixation member and configured to be received through the eyelet of the suture anchor.

The prior art document US20120283750A1 discloses a method for repairing a meniscus, particularly a torn meniscus. The method of repairing a meniscus may include using a suture passer to pass a suturing element from the region between the superior surface of the meniscus and the femoral condyle, through the meniscus tissue, into the region between the inferior surface of the meniscus and the tibial plateau, across the inferior surface of the meniscus, and back to the superior surface of the meniscus, without deeply penetrating the posterior capsular region of the knee. Equivalently, the suture element can be passed from the inferior surface of the meniscus to the superior surface and back to the inferior surface.

The problem associated with the conventional method is the tibial tunnel is occupied restricting the option of performing anterior cruciate ligament (ACL), posterior cruciate ligament (PCL), and high tibial osteotomy (HTO) along with root repair. Inventors of the present invention have surprisingly found the solution to all the above-mentioned problems by developing apparatus and methods for posterior horn medial meniscus root repair.

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 and method for posterior horn medial meniscus root repair.

Another object of the present invention is to provide an apparatus and method for posterior horn medial meniscus root repair through which the tibial tunnel remains unoccupied.

Another object of the present invention is to provide an apparatus and method for posterior horn medial meniscus root repair in which fixation is quite robust, being close to the root avulsion.

Another object of the present invention is to provide an apparatus and method for posterior horn medial meniscus root repair which helps in preventing the occurrence of osteoarthritis in patients.

Another object of the present invention is to provide an apparatus and method for posterior horn medial meniscus root repair in which no metal parts are used in the anchor.

Another object of the present invention is to provide an apparatus and method for posterior horn medial meniscus root repair through which making the fixation in the root very low profile and also the knots on the meniscus are low profile.

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 key or 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 and method for posterior horn medial meniscus root repair.

The main aspect of the present invention is to provide an apparatus for posterior horn medial meniscus root repair comprising a guiding clamp being placed on the anterior part of the tibia having a V-shape rigid handle and a movable drill guiding
handle, a locking knob located on the top end of said drill guiding handle, a hollow rod removably connected at the bottom end of said drill guiding handle, a drilling rod having a lesser diameter than said hollow rod being capable to drill in the tibia to form a tunnel, a cannulated sleeve having a needle cut empty point at the one end, a loop in fiber and a cross wire suture shuttle device to shuttle said loop in fiber, a suture anchor extendedly connected with suture strands along with a flexible leading fiber being capable to lead said suture anchor inside the tibia tunnel, a suture passing device to pass the suture from a medial meniscus root avulsion, a knot pusher being capable to lock the suture strands, wherein said posterior horn medial meniscus root repair such as the tibial tunnel being not occupied after the fastening of said suture strands with said medial meniscus root avulsion.

Another aspect of the present invention is to provide an apparatus for posterior horn medial meniscus root repair in which the suture anchor is made with ultra-high molecular weight polyethylene fiber wire.

Another aspect of the present invention is to provide a method for posterior horn medial meniscus root repair, said method comprising the following steps:
a. making a medial accessory portal viz. Anteromedial to the tibial tunnel;
b. debriding of tibial cartilage with meniscus curette;
c. preparing the bed through the exposure of subchondral bone;
d. placing said guiding clamp on the anterior part of the tibia;
e. locking said drilling handle at the position of the drill with said locking knob;
f. drilling tibial tunnel with said drilling rod which is guided by said hollow rod;
g. placing said cannulated sleeve inside the tibial tunnel through said hollow rod such as it passes through the whole tunnel;
h. fastening the suture shuttling device with said cannulated sleeve and passing the suture shuttling device through said tibial tunnel by pulling said cannulated sleeve;
i. passing loop in fiber through said suture shuttling device from said tibial tunnel;
j. passing suture anchor and flexible leading fiber in said tibial tunnel;
k. withdrawing flexible leading fiber from the accessory medial portal with the help of said loop in fiber;
l. anchoring said suture anchor and pulling the strands to check pull-out strength;
m. directing said first suture strand and second suture strand with the suture passing device through the detached meniscus;
n. passing said first suture strand and second suture strand into the meniscus stump;
o. tying and locking both suture strands over said meniscus;
p. cutting the remaining extra suture strands with a suture cutter leaving a low profile knot over said meniscus.

Yet another aspect of the present invention is to provide a method for posterior horn medial meniscus root repair through which the tibial tunnel remains free allowing to do the combined surgery of anterior cruciate ligament (ACL), posterior cruciate ligament (PCL), and high tibial osteotomy (HTO) along with the root repair.

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 placement of the guiding clamp on the tibia as disclosed in the present invention.
FIG. 2 represents the drilling inside the tibia to form a tibial tunnel as disclosed in the present invention.
FIG. 3 represents the cannulated sleeve as disclosed in the present invention.
FIG. 4 represents the placement of cannulated sleeve through a hollow rod as disclosed in the present invention.
FIG. 5 represents the placement of a suture shuttling device through the cannulated sleeve in the tibial tunnel as disclosed in the present invention.
FIG. 6 represents the side view of the placement of the suture shuttle device inside the cannulated sleeve as disclosed in the present invention.
FIG. 7 represents the removal of the guiding lamp as disclosed in the present invention.
FIG. 8 represents the insertion of the loop in fiber inside the suture shuttle device as disclosed in the present invention.
Fig. 9 represents the insertion of the flexible leading fiber inside the tibial tunnel as disclosed in the present invention.
Fig. 10 and Fig. 11 represent the placement of the suture anchor inside the tibial tunnel as disclosed in the present invention.
Fig. 12 represents the suture passing device as disclosed in the present invention.

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 and methods for root repair. 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 tibia known as shinbone or shankbone is the larger, stronger, and anterior of the two bones in the leg below the knee in vertebrates, and it connects the knee with the ankle bones.

Throughout the specification, the term “meniscus” is a C-shaped piece of tough, rubbery cartilage that acts as a shock absorber between the shinbone and the thighbone.

Throughout the specification, the term “subchondral bone” refers to the biological bed for healing, with the help of meniscus curette.

Throughout the specification, the term “medial meniscus” is an important structure that provides stability, dissipates force, and assists to provide normal kinematics of the knee.

The main embodiment of the present invention is to provide an apparatus for posterior horn medial meniscus root repair along with the method for the same through which after the surgery the tibial tunnel (100c) is not occupied and is free for further surgeries.

As per detail embodiment of the present invention is to provide an apparatus for posterior horn medial meniscus root repair comprising;
a guiding clamp (100) being placed on the anterior part of the tibia (100a) having a V-shape rigid handle (101) and a movable drill guiding handle (102), a locking knob (103) located on the top end of said drill guiding handle (102), a hollow rod (104) removably connected at the bottom end of said drill guiding handle (102);
a drilling rod (200) having a lesser diameter than said hollow rod (104) being capable to drill in the tibia (100a) to form a tibial tunnel (100c);
a cannulated sleeve (300) having a needle cut empty point (301) at the one end;
a loop in fiber (400) and a cross wire suture shuttle device (500) to shuttle said loop in fiber (400);
a suture anchor (600) extendedly connected with suture strands (601) along with a flexible leading fiber (602) being capable to lead said suture anchor (600) inside the tibia tunnel (100c);
a suture passing device (700) to pass the suture strands (601) from a medial meniscus root avulsion (100b);
a knot pusher being capable to lock the suture strands (601);
wherein,
said posterior horn medial meniscus root repaired such as the tibial tunnel (100c) being not occupied after the fastening of said suture strands (601) with said medial meniscus root avulsion (100b).

As per detailed embodiment of the present invention, the tibial tunnel (100c) made into the tibia (100a) with the help of the drilling rod (200). To fix the drilling point on the tibia (100c), the movable drill guiding handle (102) used. Said movable drill guiding handle (102) being capable to slide on said rigid handle (101) to adjust the point to drill onto said anterior part of said tibia (100a). Said locking knob (103) being provided to lock the movable drill guiding handle (102) at the desired position.

As per detailed embodiment of the present invention, said suture anchor (600) made with ultra-high molecular weight polyethylene fiber wire. Said suture anchor (600) made without use of any metal.

As per detailed embodiment of the present invention, said hollow rod (104) is located at the end of the movable drill guiding handle (102) is detachable. Said hollow rod (104) having the cavity which guiding the drill drilling rod (200) and cannulated sleeve (300) inside the tibial tunnel (100c).

As per another embodiment of the present invention, said suture anchor (600) is said suture strands (601) are 2.3mm rootfix all suture anchors. Said flexible leading fiber (602) is made of usp # 5 flexible introducer. Said anchor strands (601) are made of usp # 0 fiber.

As per the detailed embodiment of the present invention, the method for posterior horn medial meniscus root repair said method comprising the following steps:
a. making a medial accessory portal viz. Anteromedial to the tibial tunnel;
b. debriding of tibial cartilage with meniscus curette;
c. preparing the bed through the exposure of subchondral bone;
d. placing said guiding clamp (100) on the anterior part of the tibia (100a);
e. locking said drilling handle (102) at the position of the drill with said locking knob (103);
f. drilling in the tibia (100a) to form a tibial tunnel (100c) with said drilling rod (200) which is guided by said hollow rod (104);
g. placing said cannulated sleeve (300) inside the tibial tunnel (100c) through said hollow rod (104) such as it passes through the whole tibial tunnel (100c);
h. fastening the suture shuttling device (500) with said cannulated sleeve (300) and passing the suture shuttling device (500) through said tibial tunnel (100c) by pulling said cannulated sleeve (300);
i. passing loop in fiber (400) through said suture shuttling device (500) from the said tibial tunnel (100c);
j. passing suture anchor (600) and flexible leading fiber (602) in said tibial tunnel (100c);
k. withdrawing flexible leading fiber (602) from the accessory medial portal with the help of said loop in fiber (602);
l. anchoring said suture anchor (600) and pulling the suture strands (601) to check pull-out strength;
m. directing said first suture strand (601a) and second suture strand (601b) with the suture passing device (700) through the detached meniscus;
n. passing said first suture strand (601a) and second suture strand (601b) into the meniscus stump;
o. tying and locking both suture strands (601a, 601b) over said meniscus;
p. cutting the remaining extra suture strands (601a, 601b) with a suture cutter leaving a low profile knot over said meniscus.

As per detailed embodiment of the present invention, through said method, the tibial tunnel (100c) remains free allowing to do the combined surgery of anterior cruciate ligament (ACL), posterior cruciate ligament (PCL), and high tibial osteotomy (HTO) along with the root repair.

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

According to Fig. 1 of the present invention, the guiding clamp (100) being placed on the anterior part of the tibia (100a). The guiding clamp (100) being made of a V-shape rigid handle (101) and a movable drill guiding handle (102). To lock the movable drill guiding handle (102), the locking knob (103) provided which is located on the top end of said drill guiding handle (102). The hollow rod (104) removably connected at the bottom end of said drill guiding handle (102). The hollow rod (104) helps to guide the drilling rod (200) and cannulated sleeve (300) inside the tibia (100a).

Fig. 2 of the present invention, shows the forming of the tibial tunnel (100c) inside the tibia (100a) with the use of the drilling rod (200) as disclosed in step f. The drilling rod (200) being passed through the hollow rod (104) and make a tunnel (100c) inside the tibia (100a).

As shown in Fig. 3 and Fig. 4 of the present invention, the cannulated sleeve (300) having a needle cut empty point (301) at the one end passed through the tibial tunnel (301) from the opening end of the tunnel (100c) to the other end as disclosed in the step g. The needle cut empty point (301) came out from the tunnel (100c) at the other end.

As shown in Fig. 5 and Fig. 6 of the present invention, the cross wire suture shuttle device (500) passed through said cannulated sleeve (300) as the hook-like portion of said suture shuttle device (500) came out at the other end of the tibial tunnel (100c) as disclosed in the step h.

As shown in Fig. 7 of the present invention, after inserting the suture shuttle device (500), said guiding clamp (100) needs to be removed from the tibia (100a).

As shown in Fig. 8 of the present invention, the loop in fiber (400) inserted into the hook-like structure of the suture shuttle device (500) as disclosed in step i. The suture shuttle device (500) guides said loop-in fiber into the tibial tunnel (100c).

As shown in Fig. 9, Fig. 10, and Fig. 11 of the present invention, passing suture anchor (600) and flexible leading fiber (602) in said tibial tunnel (100c) as disclosed in the step j. This results in, said suture anchor (600) being placed inside the tibial tunnel (100c) and after that withdrawing flexible leading fiber (602) from the accessory medial portal with the help of said loop in fiber (602).

As shown in Fig. 12 of the present invention, the suture passing device (700) is shown to pass the suture strands (601) from a medial meniscus root avulsion (100b).

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:

• In the above-mentioned method, the fixation is quite robust, being close to the root avulsion.
• In the above-mentioned method, there is no chance of tunnel collision as there is in the traditional technique. Hence, it is apt for multi-ligament surgeries.
• This method helps in preventing the occurrence of osteoarthritis in patients

LIST OF REFERENCE NUMERALS:

Guiding clamp (100)
Tibia (100a)
Medial meniscus root avulsion (100b)
Tibial tunnel (101c)
Rigid handle (101)
Drill guiding handle (102)
Locking knob (103)
Hollow rod (104)
Drilling rod (200)
Cannulated sleeve (300)
Needle cut empty point (301)
Loop in fiber (400)
Suture shuttle device (500)
Suture anchor (600)
Suture strands (601)
First suture strand (601a)
Second suture strand (601b)
Flexible leading fiber (602)
Suture passing device (700)
, Claims:CLAIMS:-
We Claim:

1. An apparatus for posterior horn medial meniscus root repair comprising;
a guiding clamp (100) being placed on the anterior part of the tibia (100a) having a V-shape rigid handle (101) and a movable drill guiding handle (102), a locking knob (103) located on the top end of said drill guiding handle (102), a hollow rod (104) removably connected at the bottom end of said drill guiding handle (102);
a drilling rod (200) having a lesser diameter than said hollow rod (104) being capable to drill in the tibia to form a tunnel;
a cannulated sleeve (300) having a needle cut empty point (301) at the one end;
a loop in fiber (400) and a cross wire suture shuttle device (500) to shuttle said loop in fiber (400);
a suture anchor (600) extendedly connected with suture strands (601) along with a flexible leading fiber (602) being capable to lead said suture anchor (600) inside the tibia tunnel;
a suture passing device (700) to pass the suture strands (601) from a medial meniscus root avulsion (100b);
a knot pusher being capable to lock the suture strands (601);
wherein,
said posterior horn medial meniscus root repaired such as the tibial tunnel (100c) being not occupied after the fastening of said suture strands (601) with said medial meniscus root avulsion (100b).

2. The apparatus for posterior horn medial meniscus root repair as claimed in claim 1, wherein said movable drill guiding handle (102) being capable to slide on said rigid handle (101) to adjust the point to drill onto said anterior part of said tibia (100a).

3. The apparatus for posterior horn medial meniscus root repair as claimed in claim 1, wherein said locking knob (103) being capable to lock said drill guiding handle (102) on the desired position of drill.

4. The apparatus for posterior horn medial meniscus root repair as claimed in claim 1, wherein said suture anchor (600) made with ultra-high molecular weight polyethylene fiber wire.

5. A method for posterior horn medial meniscus root repair, said method comprising the following steps:
a. making a medial accessory portal viz. Anteromedial to the tibial tunnel;
b. debriding of tibial cartilage with meniscus curette;
c. preparing the bed through the exposure of subchondral bone;
d. placing said guiding clamp (100) on the anterior part of the tibia (100a);
e. locking said drilling handle (102) at the position of the drill with said locking knob (103);
f. drilling in the tibia (100a) to form a tibial tunnel (100c) with said drilling rod (200) which is guided by said hollow rod (104);
g. placing said cannulated sleeve (300) inside the tibial tunnel (100c) through said hollow rod (104) such as it passes through the whole tibial tunnel (100c);
h. fastening the suture shuttling device (500) with said cannulated sleeve (300) and passing the suture shuttling device (500) through said tibial tunnel (100c) by pulling said cannulated sleeve (300);
i. passing loop in fiber (400) through said suture shuttling device (500) from said tibial tunnel (100c);
j. passing suture anchor (600) and flexible leading fiber (602) in said tibial tunnel (100c);
k. withdrawing flexible leading fiber (602) from the accessory medial portal with the help of said loop in fiber (602);
l. anchoring said suture anchor (600) and pulling the suture strands (601) to check pull-out strength;
m. directing said first suture strand (601a) and second suture strand (601b) with the suture passing device (700) through the detached meniscus;
n. passing said first suture strand (601a) and second suture strand (601b) into the meniscus stump;
o. tying and locking both suture strands (601a, 601b) over said meniscus;
p. cutting the remaining extra suture strands (601a, 601b) with suture cutter leaving a low profile knot over said meniscus.

6. The method for posterior horn medial meniscus root repair as claimed in claim 5, wherein through said method medial meniscus root is fastened to its tibial bed.

7. The method for posterior horn medial meniscus root repair as claimed in claim 5, wherein through said method the tibial tunnel (100c) remains free allowing to do the combined surgery of anterior cruciate ligament (ACL) , posterior cruciate ligament (PCL) and high tibial osteotomy (HTO) along with the root repair.

Dated this 29 Jul, 2022