Description:FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENTS RULES, 2003
COMPLETE SPECIFICATION
(Section 10 and Rule 13)

1. TITLE OF THE INVENTION: ANNULOPLASTY IMPLANT
2. APPLICANT:
Meril Corporation (I) Private Limited, an Indian company of the address Survey No. 135/139, Muktanand Marg, Bilakhia House, Pardi, Vapi, Valsad-396191 Gujarat, India.

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

FIELD OF INVENTION
[1] The present disclosure relates to bio-medical implant. More particularly, the present disclosure relates to an annuloplasty implant.
BACKGROUND OF INVENTION
[2] Mitral regurgitation is a condition where the valve between the left heart chamber does not close properly. Mitral valves located between the left atrium and the left ventricle are responsible for blood flow the therebetween. Some medical conditions may lead to misfunctioning of the mitral valve leading to leakage of blood backwards from the left ventricle to the left atrium.
[3] Medical conditions such as endocarditis, rheumatic fever, valve prolapse, abnormality of heart muscles or damaged tissue cord may lead to the condition of mitral regurgitation in an individual over a period of time. As a result, an individual suffering from mitral regurgitation may face symptoms such as shortness of breath, pulmonary edema, orthopnea, paroxysmal nocturnal dyspnea and congestive heart failure.
[4] Treating mitral regurgitation may involve a valve replacement or valve remodeling technique where the valve leaflets of the native mitral valves are repaired and reshaped by replacing the supportive cords and removing excessive valve tissues to ensure the gaps in the valve are tightly closed to avoid the blood backflow.
[5] Conventional methods to treat mitral regurgitation involve invasive procedures such as open-heart surgeries and transcatheter based approaches such as using an artificial annuloplasty ring with annulus, clipping the annulus to close the leaflets. Sometimes regurgitation is also reduced by drugs to treat the mild leakage and improve the functioning of the heart. These conventional techniques may provide relief to some extent for a limited span of time.
[6] Implants for preventing mitral regurgitation are also known. However, the conventional implants suffer from many drawbacks. For example, they may lead to a lot of complications such as loosening of the implant and migration of the implant into the blood vessel. Further, actuating these implants is time consuming, which leads to loss of blood in the patient. Moreover, these implants are bulky and have a complex design, which may require long implantation procedures and may be damaging to the blood vessels, causing trauma to the nearby tissues.
[7] Hence, there arises a need of an implant which overcomes the problems related to conventionally available implants.
SUMMARY OF INVENTION
[8] Particular embodiments of the present disclosure are described herein below with reference to the accompanying drawings; however, it is to be understood that the disclosed embodiments are mere examples of the disclosure, which may be embodied in various forms. Well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail. Therefore, specific structural and functional 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 disclosure in virtually any appropriately detailed structure.
[9] The present disclosure relates to an implant. In an embodiment, the implant includes an actuating member, a first collar, a plurality of legs and a second collar. The actuating member includes a body having a non-threaded portion and a threaded portion. The threaded portion has a plurality of threads. The first collar is coupled to the non-threaded portion of the body. Each leg of the plurality of legs includes a first portion, a second portion and a third portion. The first portion is situated towards a proximal end of the leg and the third portion is situated towards a distal end of the leg. The first portion is coupled to the first collar. The second collar includes a cavity with internal threads configured to engage with the plurality of threads of the actuating member. The second collar includes a plurality of slots extending from a proximal face of the second collar to a distal face of the second collar. Each slot of the plurality of slots is configured to receive a part of the second portion of a corresponding leg. The second collar is slidable over the second portion of the plurality of legs. In response to the rotation of the actuating member in a pre-defined direction, the second collar is configured to move longitudinally in a distal direction, causing the plurality of legs to move radially inward.
BRIEF DESCRIPTION OF DRAWINGS
[10] The summary above, as well as the following detailed description of illustrative embodiments, is better understood when read in conjunction with the apportioned drawings. For the purpose of illustrating the present disclosure, exemplary constructions of the disclosure are shown in the drawings. However, the disclosure is not limited to specific methods and instrumentality disclosed herein. Moreover, those in the art will understand that the drawings are not to scale.
[11] Fig. 1A depicts an isometric view of an implant 100, according to an embodiment of the present disclosure.
[12] Fig. 1B depicts an exploded view of the implant 100, according to an embodiment of the present disclosure.
[13] Fig. 2 depicts an actuating member 110 of the implant 100, according to an embodiment of the present disclosure.
[14] Fig. 3 depicts a first collar 120 of the implant 100, according to an embodiment of the present disclosure.
[15] Fig. 4A depicts a perspective view of a second collar 130 of the implant 100, according to an embodiment of the present disclosure.
[16] Fig. 4B depicts an exploded view of the second collar 130 of the implant 100, according to an embodiment of the present disclosure.
[17] Fig. 5A depicts a front view of a leg 140 of the implant 100, according to an embodiment of the present disclosure.
[18] Fig. 5B depicts a side view of the leg 140 of the implant 100, according to an embodiment of the present disclosure.
[19] Fig. 6 depicts various views of an anchor 150 of the implant 100, according to an embodiment of the present disclosure.
[20] Fig. 7A depicts the implant 100 anchored at a target site inside a patient’ body, according to an embodiment of the present disclosure.
[21] Fig. 7B depicts the implant 100 in an actuated state, according to an embodiment of the present disclosure.

DETAILED DESCRIPTION OF THE DRAWINGS
[22] Prior to describing the invention in detail, definitions of certain words or phrases used throughout this patent document will be defined: the terms "include" and "comprise", as well as derivatives thereof, mean inclusion without limitation; the term "or" is inclusive, meaning and/or; the phrases "coupled with" and "associated therewith", as well as derivatives thereof, may mean to include, be included within, interconnect with, contain, be contained within, connect to or with, couple to or with, be communicable with, cooperate with, interleave, juxtapose, be proximate to, be bound to or with, have a property of, or the like. Definitions of certain words and phrases are provided throughout this patent document, and those of ordinary skill in the art will understand that such definitions apply in many, if not most, instances to prior as well as future uses of such defined words and phrases.
[23] Reference throughout this specification to “one embodiment,” “an embodiment,” or similar language means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, appearances of the phrases “in one embodiment,” “in an embodiment,” and similar language throughout this specification may, but do not necessarily, all refer to the same embodiment, but mean “one or more but not all embodiments” unless expressly specified otherwise. The terms “including,” “comprising,” “having,” and variations thereof mean “including but not limited to” unless expressly specified otherwise. An enumerated listing of items does not imply that any or all of the items are mutually exclusive and/or mutually inclusive, unless expressly specified otherwise. The terms “a,” “an,” and “the” also refer to “one or more” unless expressly specified otherwise.
[24] Although the operations of exemplary embodiments of the disclosed method may be described in a particular, sequential order for convenient presentation, it should be understood that the disclosed embodiments can encompass an order of operations other than the particular, sequential order disclosed. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Further, descriptions and disclosures provided in association with one particular embodiment are not limited to that embodiment, and may be applied to any embodiment disclosed herein. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed system, method, and apparatus can be used in combination with other systems, methods, and apparatuses.
[25] Furthermore, the described features, advantages, and characteristics of the embodiments may be combined in any suitable manner. One skilled in the relevant art will recognize that the embodiments may be practiced without one or more of the specific features or advantages of a particular embodiment. In other instances, additional features and advantages may be recognized in certain embodiments that may not be present in all embodiments. These features and advantages of the embodiments will become more fully apparent from the following description and apportioned claims, or may be learned by the practice of embodiments as set forth hereinafter.
[26] The present disclosure relates to an annuloplasty implant. The implant prevents bicuspid valve (e.g., mitral valve) regurgitation. The implant of the present disclosure is implanted on the native annulus of a patient’s heart. In an embodiment, the implant may include an actuating member, a plurality of legs, a first collar, a second collar, and a plurality of anchors. The implant of the present disclosure is radially expandable. Though the application of the implant of the present disclosure is explained in reference to preventing a bicuspid valve regurgitation, it should be noted that the teachings of the present invention may also be extended to prevent a tricuspid valve regurgitation in a patient and the same is within the scope of the present disclosure.
[27] Now referring to figures, Fig. 1A depicts an assembled view and Fig. 1B depicts an exploded view of an implant 100 according to an embodiment of the present disclosure. The implant 100 has a proximal end 100a and a distal end 100b. The implant 100 includes an actuating member 110, a first collar 120, a second collar 130, a plurality of legs 140 and a plurality of anchors 150. The aforesaid components of the implant 100 mentioned above are designed to work together in a synchronized manner to repair the native mitral valve of a patient.
[28] Now referring to Fig. 2, an exemplary actuating member 110 is depicted. The actuating member 110 has a proximal end 110a and a distal end 110b. In the depicted embodiment, the actuating member 110 is a screw. The actuating member 110 includes a head 110c and a body 110d. In an embodiment, the actuating member 110 is capable of being rotated in a clockwise direction and an anti-clockwise direction. The clockwise and anticlockwise rotation of the actuating member 110 facilitates the radial expansion and compression of the implant 100. The head 110c is situated at the proximal end 110a of the actuating member 110. The head 110c is rotatable in a clockwise and anticlockwise direction, causing the rotation of the actuating member 110. The head 110c may have any suitable shape such as, without limitation, cylindrical, hexagonal, rectangular, etc. In an example implementation, the head 110c is hexagonal. The body 110d of the actuating member 110 includes a non-threaded portion 110g and a threaded portion 110i. The first collar 120 is coupled to the non-threaded portion 110g of the body 110d. The body 110d includes a first ridge 110e and a second ridge 110f. In an embodiment, the first collar 120 is coupled to the non-threaded portion 110g of the body 110d between the first ridge 110e and the second ridge 110f. The first ridge 110e and the second ridge 110f are situated towards the proximal end 110a and the distal end 110b of the non-threaded portion 110g. The first ridge 110e and the second ridge 110f are annular. The first ridge 110e has a tapered profile with an increasing diameter from the proximal end 110a towards the distal end 110b. The second ridge 110f has a tapered profile with an increasing diameter from the distal end 110b towards the proximal end 110a. The first ridge 110e and the second ridge 110f act a stopper for the first collar 120 during the operation of the implant 100. The length of a portion defined by the first ridge 110e and the second ridge 110f may be slightly more than the length of the first collar 120.
[29] The threaded portion 110i of the body 110d is provided with a plurality of threads 110h on its outer surface. The plurality of threads 110h are operatively coupled to the second collar 130 (explained later). The plurality of threads 110h facilitates the longitudinal movement of the second collar 130. The actuating member 110 may be made of a material such as, without limitation, stainless steel, Nitinol, Titanium, Cobalt-Chromium, etc. In an embodiment, the actuating member 110 is made of stainless steel.
[30] Fig. 3 depicts an exemplary first collar 120. In an embodiment, the first collar 120 is cylindrical, though the first collar 120 may have any other suitable shape. The first collar 120 has a cavity 120a provided centrally and extending for the length of the first collar 120. A cross-sectional profile of the cavity 120a corresponds to a cross-sectional shape of the non-threaded portion 110g. In an embodiment, the cavity 120a has a circular cross-section. The cavity 120a has a diameter corresponding to an outer diameter of the non-threaded portion 110g. In an embodiment, the first collar 120 is fixedly coupled to the actuating member 110 to avoid twisting of the implant 100. The first collar 120 may be coupled to the actuating member 110 via a technique such as, without limitation, welding, brazing, soldering, press-fit, etc. In an embodiment, the first collar 120 is welded to the actuating member 110. The first collar 120 may be provided with a plurality of slots 120n. The plurality of slots 120n may be arranged equidistantly from each other on the periphery of the first collar 120. The plurality of slots 120n extend at least partially into the width of the first collar 120. In an example implementation, the plurality of slots 120n extend partially into the width of the first collar 120 for a pre-defined depth (e.g., 50% of the width of the first collar 120). Each slot 120n of the plurality of slots 120n is configured to receive a portion of a corresponding leg 140 of the plurality of legs 140. The shape and dimensions of the plurality of slots 120n corresponds to the shape and dimensions of the plurality of legs 140. In an embodiment, the plurality of slots 120n have a rectangular shape. The first collar 120 may have a pre-defined inner diameter and an outer diameter ranging from 3 mm to 7 mm and 6 mm to 9 mm, respectively. In an embodiment, the inner diameter of the first collar 120 is 5 mm and the outer diameter of the first collar 120 is 8 mm. The first collar 120 may have a pre-defined height ranging from 3 mm to 7 mm. In an embodiment, the first collar 120 has a height of 5 mm. The first collar 120 may be made up of a material such as, without limitation, stainless steel, Nitinol, Titanium, Cobalt-Chromium, etc. In an embodiment, the first collar 120 is made of stainless steel.
[31] Now referring to Fig. 4A and 4B, an exemplary second collar 130 is depicted. The second collar 130 is configured to move longitudinally in a distal direction (i.e., downwards) in response to the rotation of the actuating member 110 in a pre-defined direction (e.g., clockwise) and move longitudinally in a proximal direction (i.e., upwards) in response to the rotation of the actuating member 110 in another pre-defined direction (e.g., anticlockwise). The second collar 130 includes a first member 132, a second member 134 and a third member 136. The second member 134 is disposed between the first member 132 and the third member 136. The first member 132, a second member 134 and a third member 136 are coupled to each other. In an embodiment, the first member 132 has a cylindrical shape. In an embodiment, the first member 132 is a nut. The first member 132 may have an inner diameter and an outer diameter ranging from 2mm to 5 mm and 3.5 mm to 5.5 mm, respectively. In an embodiment, the first member 132 has an inner diameter of 3 mm and an outer diameter of 4.5 mm. The first member 132 has a first cavity 132a. The first cavity 132a extends for the height of the first member 132. The first cavity 132a is configured to receive a portion of the threaded portion 110i of the actuating member 110. The first cavity 132a is provided with a plurality of internal threads 132n (or internal threads 132n). The plurality of internal threads 132n are complementary to the plurality of threads 110h of the actuating member 110. The plurality of internal threads 132n is configured to engage with the plurality of threads 110h of the actuating member 110. In an embodiment, the second collar 130 is configured to move longitudinally in response to the rotation of the actuating member 110. The direction of the longitudinal motion (upward or downward) of the second collar 130 depends upon the rotational direction of the actuating member 110. The threaded coupling between the first member 132 and the actuating member 110 facilitates the longitudinal movement of the second collar 130. The first member 132 may be made of a material such as, without limitation, stainless steel, Nitinol, Titanium, Cobalt-Chromium, etc. In an embodiment, the first member 132 is made of stainless steel.
[32] In an embodiment, the second member 134 has a cylindrical shape. The second member 134 reduces friction and facilitates longitudinal movement of the second collar 130. In an embodiment, the second member 134 is a bearing. The second member 134 has a second cavity 134a to receive the first member 132. The second member 134 may be coupled to the first member 132 using press fit, welding, adhesive, etc. In an example implementation, the second member 134 is coupled to the first member 132 using press fit. The second cavity 134a extends for the height of the second member 134. The second member 134 has an inner diameter corresponding to the outer diameter of the first member 132. The second member 134 may have an outer diameter ranging from 4 mm to 8 mm. In an embodiment, the second member 134 has an outer diameter of 6 mm. The second member 134 may be made of a material such as, without limitation, stainless steel, Nitinol, Titanium, Cobalt-Chromium, etc. In an embodiment, the second member 134 is made of stainless steel.
[33] In an embodiment, the third member 136 has a cylindrical shape. In an embodiment, the third member 136 is a cuff. The third member 136 has a third cavity 136a extending for the height of the third member 136. The third cavity 136a is provided to receive the second member 134. The third member 136 is coupled to the second member 134 using press fit, welding, adhesive, etc. In an example implementation, the third member 136 is coupled to the second member 134 using press fit. The third member 136 has an inner diameter corresponding to the outer diameter of the second member 134. The third member 136 may have an outer diameter ranging from 8.5 mm to 10.5 mm. In an embodiment, the outer diameter of the third member 136 is 9 mm. In an embodiment, the third member 136 is configured to receive a portion of the plurality of legs 140. The second collar 130 includes a plurality of slots 136n extending from a proximal face of the second collar 130 to a distal face of the second collar 130. In an embodiment, the third member 136 is provided with a plurality of slots 136n extending from a proximal face 136c of the third member 136 to a distal face (not shown) of the third member 136. Each slot 136n of the plurality of slots 136n is configured to receive a part of a corresponding leg 140 of the plurality of legs 140. The plurality of slots 136n may have a shape such as without limitation, rectangular, square, oval, etc. In an embodiment, the plurality of slots 136n is rectangular shaped.
[34] The second collar 130 may have a pre-defined height ranging from 3 mm to 7 mm. In an embodiment, the second collar 130 has a height of 5 mm. The second collar 130 may be made up of a material such as without limitation, stainless steel, Nitinol, Titanium, Cobalt, Chromium, etc. In an embodiment, the second collar 130 is made of stainless steel.
[35] In an embodiment, the plurality of legs 140 includes three or more legs. Preferably, the plurality of legs 140 include between three and six legs. In the depicted embodiment, the plurality of legs 140 include four legs. Fig. 5A and Fig. 5B depicts an exemplary leg 140 of the plurality of legs 140, according to an embodiment of the present disclosure. The leg 140 has a proximal end 140a and a distal end 140b. The leg 140 may be made up of a flexible material such as, without limitation, stainless steel, Nitinol, Titanium, Cobalt-Chromium, etc. In an embodiment, the leg 140 is made of Nitinol. The leg 140 may have a pre-defined length ranging from 22 mm to 45 mm. In an embodiment, the leg 140 has a length of 38 mm.
[36] The leg 140 includes a first portion 140c, a second portion 140d and a third portion 140e. The first portion 140c is situated towards the proximal end 140a. The first portion 140c may have a shape such as, without limitation, hook shaped, C shaped, semi oval shaped, etc. In an embodiment, the first portion 140c is C shaped (as shown in Fig. 5B). The C shape of the first portion 140c provides strength to the implant 100 and also facilitates equal distribution of radial strength post deployment. The leg 140 is coupled to the first collar 120 with the help of the first portion 140c. In an embodiment, a proximal portion of the first portion 140c fits in and is coupled to a corresponding slot 120n of the plurality of slots 120n of the first collar 120 using a technique such as, without limitation, press-fit, laser welding, soldering, brazing, etc. In an embodiment, the proximal portion of the first portion 140c is fitted with the corresponding slot 120n via laser welding technique.
[37] The second portion 140d has an elongated structure. The second portion 140d may be straight or curved. In an embodiment, the second portion 140d has a curved shape. The second portion 140d is coupled to the second collar 130 such that the second collar 130 is slidable over the second portion 140d longitudinally. In an embodiment, a part of the second portion 140d is disposed in a corresponding slot 136n of the plurality of slots 136n of the third member 136 of the second collar 130.
[38] The third portion 140e is situated towards the distal end 140b of the leg 140. In an embodiment, the third portion 140e is generally rectangular in shape with a slight curve towards the proximal end 140a, though the third portion 140e may have any other pre-defined shape such as, without limitation, oval, square, rectangular, hexagonal, octagonal, etc. The third portion 140e is positioned generally parallel to a central axis of the implant 100. The third portion 140e includes an opening 140f towards the proximal end 140a. The third portion 140e is provided with a plurality of holes 140g situated towards the distal end 140b. The plurality of holes 140g may be disposed alternatingly in a pre-defined pattern (e.g., a zig-zag pattern) as shown in Fig. 5B. The plurality of holes 140g are configured to receive a portion of one of the anchors 150.
[39] The plurality of legs 140 are configured to move radially in response to the longitudinal motion of the second collar 130. The direction of radial movement of the plurality of legs 140 depends upon the direction of the longitudinal motion of the second collar 130. For example, the plurality of legs 140 move radially inward and outward when the second collar 130 moves downward (i.e., longitudinally in a distal direction) and upward (e.g., longitudinally in a proximal direction), respectively. In an embodiment, when the second collar 130 moves downward, the second collar 130 slides over the second portion 140d. As a result, the second portion 140d and therefore, the third portion 140e move radially inward, thereby, causing the implant 100 to radially compress. The flexibility of the second portion 140d facilitates smooth and easy inward or outward movement of the second portion 140d.
[40] The plurality of anchors 150 are configured to anchor the implant 100 at an implantation site (e.g., the annulus of the mitral valve). In an embodiment, the plurality of anchors 150 includes three or more anchors. Preferably, the plurality of anchors 150 include between three and six anchors. In the depicted embodiment, the plurality of anchors 150 include four anchors. Fig. 6 depicts an exemplary anchor 150 of the plurality of anchors 150, according to an embodiment. The anchor 150 may be a resilient member such as a spring, spike, arrowhead, etc. In an embodiment, the anchor 150 is a spring. The anchor 150 is coupled to the third portion 140e of the corresponding leg 140. Each of the plurality of anchors 150 has a proximal end 150a and a distal end 150b. Each anchor 150 includes a head 150c and a body 150d. The head 150c is situated towards the proximal end 150a and the body 150d extends from the head 150c distally towards the distal end 150b of the anchor 150. The head 150c facilitates in gripping and manipulating the anchor 150 during actuation of the implant 100. The head 150c is disposed within the opening 140f of the third portion 140e of the corresponding leg 140. The body 150d includes a plurality of coils having a suitable profile such as, without limitation, spiral, zig-zag, helical, etc. In an embodiment, the plurality of coils has a spiral profile. The body 150d is coupled to the third portion 140e of the corresponding leg 140 such that the anchor 150 is substantially parallel to the central axis of the implant 100. In an embodiment, one or more coils of the plurality of coils of the plurality of coils pass through the plurality of holes 140g of the third portion 140e (as depicted in Fig. 1A). Passing the one or more coils through the plurality of holes 140g secures the anchor 150 with the third portion 140e while allowing a rotational motion of the anchor 150 freely. The anchor 150 has a tip 150e at the distal end 150b. The tip 150e has a pre-defined shape. In an embodiment, the tip 150e has a z-shape. The Z-shaped tip 150e facilitates easy anchoring and penetration of the anchor 150 inside the annulus tissue wall of the mitral valve. This ensures proper fixation of the implant 100 to the annuls of the bicuspid valve and prevents the implant 100 from migrating. Although, the anchor 150 is shown to have a z-shaped tip, the tip may have any other pre-defined shape such as, without limitation spiral, conical, needle shaped, etc.
[41] The plurality of anchors 150 may be made up of a material such as without limitation, stainless steel, Nitinol, Titanium, Cobalt-Chromium, etc. In an embodiment, the plurality of anchors 150 is made of stainless steel. During medical procedure, once when the implant 100 is placed at a desired position, each of the plurality of anchors 150 are twisted using a suitable actuator, for example, a spanner, to facilitate the penetration of the tip 150e of the anchor 150 into the annular wall, thereby anchoring the implant 100 on the annular wall.
[42] The implant 100 is delivered to the target location via a minimally invasive procedure such as a transcatheter technique. For example, a guide catheter is inserted into the body of a patient via an access site (e.g., the femoral vein) and advanced to the right atrium. In an embodiment, a steerable guide catheter is used to provide better control and positioning of a delivery system. A puncture is made on the septal wall via a transeptal technique to access the left atrium. The puncture may be made by using any suitable surgical instrument, for example, a specialized needle, under fluoroscopic and echocardiographic guidance. The guide catheter is advanced through the transseptal puncture into the left atrium. The implant 100 is loaded on a suitable delivery system, e.g., a delivery catheter. The delivery system is inserted into the body of the patient via the access site. The delivery system is navigated to the left atrium and further through the left atrium to the mitral valve. Techniques such as, real time echocardiography and fluoroscopic may be used for better navigation of the delivery apparatus inside the body. Once the delivery system reaches the targeted site, the implant 100 is carefully positioned above the mitral valve leaflet. The implant 100 is placed on the annular wall of the mitral valve. The plurality of anchors 150 are anchored on the annular wall of the mitral valve. Once the plurality of anchors 150 are anchored, the surgeon rotates each anchor 150 in a pre-defined direction (e.g., clockwise) using a spanner to fixate the anchor 150 on the annular wall. Fig. 7A illustrates the implant 100 after anchoring the plurality of anchors 150 on the annular wall of the mitral valve. The surgeon actuates the actuating member 110 using a suitable actuator, for example, a spanner. The spanner is coupled to the head 110c of the actuating member 110 and rotated in a pre-defined direction (e.g., in the clockwise) direction. When the actuating member 110 is rotated in the clockwise direction, the second collar 130 moves downward. This causes the plurality of legs 140 to compress radially. This decreases the effective diameter of the implant 100. Consequently, the leaflets of the mitral valve come close to each other as shown in Fig. 7B. Thus, the annular diameter of the mitral valve is reduced. This prevents mitral regurgitation.
[43] The implant 100 of the present disclosure has a simple design and is easy to actuate. This makes the actuation procedure more efficient and reduces the surgery time. Further, the implant 100 can be easily loaded inside a catheter and anchored at the target site. The implant 100 is retractable and repositionable. For example, if the implant is not placed properly at the target site, the implant can be retracted and repositioned correctly. The implant preserves the native anatomy of an individual, which helps improving the quality of life, maintaining breathing pattern and reduce hospitalization for the patient. Thus, the overall patient outcome is improved.
[44] The scope of the invention is only limited by the appended patent claims. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the teachings of the present invention is/are used. , Claims:WE CLAIM:
1. An implant (100) comprising:
a. An actuating member (110) comprising a body (110d) having a non-threaded portion (110g) and a threaded portion (110i), the threaded portion (110i) having a plurality of threads (110h);
b. a first collar (120) coupled to the non-threaded portion (110g) of the body (110d);
c. a plurality of legs (140), each leg (140) of the plurality of legs (140) comprising:
i. a first portion (140c) situated towards a proximal end (140a) of the leg (140) and coupled to the first collar (120);
ii. a second portion (140d); and
iii. a third portion (140e) situated towards a distal end (140b) of the leg (140); and
d. a second collar (130) comprising:
i. a first cavity (132a) having internal threads (132n) configured to engage with the plurality of threads (110h) of the actuating member (110); and
ii. a plurality of slots (136n) extending from a proximal face of the second collar (130) to a distal face of the second collar (130), each of the plurality of slots (136n) is configured to receive a part of the second portion (140d) of a corresponding leg (140), the second collar (130) is slidable over the second portions (140d) of the plurality of legs (140);
e. wherein, in response to the rotation of the actuating member (110) in a pre-defined direction, the second collar (130) is configured to move longitudinally in a distal direction, causing the plurality of legs (140) to move radially inward.
2. The implant (100) as claimed in claim 1, wherein the body (110d) of the actuating member (110) comprises a first ridge (110e) and a second ridge (110f), wherein the first collar (120) is fixedly coupled to non-threaded portion (110g) of the body (110d) between the first ridge (110e) and the second ridge (110f).
3. The implant (100) as claimed in claim 1, wherein the first collar (120) comprises a plurality of slots (120n), each slot (120n) of the plurality of slots (120n) is coupled to a proximal portion of the first portion (140c) of the corresponding leg (140).
4. The implant (100) as claimed in claim 1, wherein the implant (100) comprises a plurality of anchors (150) configured to anchor the implant (100) at an implantation site, each anchor (150) of the plurality of anchors (150) is coupled with the third portion (140e) of the corresponding leg (140) and comprise a tip (150e) having a pre-defined shape.
5. The implant (100) as claimed in claim 4, wherein the pre-defined shape comprises z-shape, spiral, conical, or needle-shape.
6. The implant (100) as claimed in claim 4, wherein each anchor (150) comprises:
a. a head (150c) disposed within an opening (140f) of the third portion (140e); and
b. a body (150d) comprising a plurality of coils, wherein one or more coils of the plurality of coils pass through a plurality of holes (140g) provided on the third portion (140e).
7. The implant (100) as claimed in claim 4, wherein each anchor (150) is a resilient member.
8. The implant (100) as claimed in claim 1, wherein the second collar (130) comprises:
a. a first member (132) comprising the cavity (132a);
b. a third member (136) comprising the plurality of slots (136n); and
c. a second member (134) disposed between and coupled to the first member (132) and the third member (136).
9. The implant (100) as claimed in claim 1, wherein the third portion (140e) of each leg (140) is positioned parallel to a central axis of the implant (100).
10. The implant (100) as claimed in claim 1, wherein the actuating member (110) comprises a head (110c) capable of being rotated, wherein the rotation of the head (110c) causes the actuating member (110) to rotate.