DESC: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:
MULTI-STRUCTURE MITRAL 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 a medical implant. More particularly, the present disclosure relates to a multi-structure mitral implant.
BACKGROUND OF INVENTION
[2] Mitral valves located between the left atrium and the left ventricle are responsible for blood flow therebetween. Medical conditions such as for example, mitral valve prolapse, may cause the mitral valve to slip backward due to abnormal size and/or damage to the valve tissues. This may lead to conditions such as mitral regurgitation where the leaflets of the mitral valves do not close properly therefore resulting in an abnormal backflow of the blood from the left ventricle to the left atrium leading to persisting chest pain, weakening of heart muscles, shortness of breath, congestion in heart and/or ultimately heart attack.
[3] Most commonly, some of the prior techniques used to treat such conditions include stitching the portions of the native mitral valve leaflets directly to each other, valve replacement or valve repairing. The repairing process includes leaflet and annulus remodeling.
[4] Generally, a leaflet ring is used to connect all the leaflets inside the annulus and reduce the gap between the leaflets. The leaflet ring is attached to the annulus and the gaps are closed. Conventionally available leaflet rings may provide relief to the patients to some extent for a limited span of time but over a period of time, the leaflet ring may loosen in the valve annulus, which in turn may lead to migration of the leaflet ring into the blood vessel. Also, the leaflet ring may be unable to seal the valve properly therefore, leading to leaking of the blood.
[5] The conventional ring requires an open-heart surgery for implantation in an individual which is a long procedure and causes increased loss of blood in the patient. Yet another problem faced with conventionally available leaflet rings is that they are generally rigid in nature. Hence, once placed in the targeted site, they may lead to damage of the blood vessels of the heart.
[6] Thus, there arises a need for an implant that overcomes the problems associated with the conventional leaflet rings.
SUMMARY OF INVENTION
[7] 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.
[8] The present disclosure relates to an implant. The implant includes a first structure having a first end and a second end defining a length therebetween. The first structure includes multiple slots and a plurality of first anchors provided along its length. Each subsequent first anchor of the plurality of first anchors is provided after a predefined number of slots of the multiple slots from a previous first anchor, the plurality of first anchors being pivotably adjustable to form an angle A with an elongated body of the first structure .
[9] The first structure of the implant includes a locking mechanism. A male portion of the locking mechanism is provided at the first end which has a first cavity . A female portion is provided at the second end which includes a flap. The male portion mates with the female portion thereby locking the first structure .
[10] In an embodiment, the implant includes a second structure and/or a third structure. The second structure has a tubular body made by braiding one or more wires. The second structure encloses the first structure. The first anchors protrude out from the second structure. The third structure is a layered knitted fabric wrapped around the second structure. The third structure includes a plurality of holes to accommodate the first anchors and/or second anchors.
BRIEF DESCRIPTION OF DRAWINGS
[11] 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.
[12] Fig. 1 depicts the placement of an implant 100 inside a native annulus, according to an embodiment of the present disclosure.
[13] Fig. 2A depicts a first structure 200 of the implant 100, according to an embodiment of the present disclosure.
[14] Fig. 2B depicts the first structure 200 in an open configuration, according to an embodiment of the present disclosure.
[15] Fig. 2C depicts the first structure 200 in a closed configuration, according to an embodiment of the present disclosure.
[16] Fig. 3 depicts the implant 100 having a second structure 300, according to an embodiment of the present disclosure.
[17] Fig. 4 depicts the implant 100 having the second structure 300 with second anchors 320, according to an embodiment of the present disclosure.
[18] Fig. 5A depicts the implant 100 having a third structure 500, according to an embodiment of the present disclosure.
[19] Fig. 5B depicts the implant 100 in a closed configuration, according to an embodiment of the present disclosure.
[20] Fig. 6 depicts a method 600 of manufacturing the implant 100, according to an embodiment of the present disclosure.
[21] Fig. 7A depicts a method 700 for deployment of the implant 100, according to an embodiment of the present disclosure.
[22] Figs. 7B-7C depict various steps of a process for implantation of the implant 100 inside the native annulus, according to an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE DRAWINGS
[23] 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.
[24] 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.
[25] 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.
[26] 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.
[27] The present disclosure relates to an implant. In an embodiment, the implant is placed at the opening of the mitral valve of the heart. The implant includes multiple structures, each of a predefined configuration, and formed of a different material. For instance, the implant includes a first structure that acts as a leaflet ring and includes a plurality of anchors which prevent migration of the first structure at the target site. Over the first structure, the implant includes a second structure. The second structure is braided, on which a layer of fabric is provided. The implant is thus covered and this configuration of the implant helps tissue growth on the implant.
[28] Further, once the implant is deployed, an artificial heart valve such as a bioprosthetic heart valve, a mechanical heart valve, an artificial tissue engineered valve etc. can be secured to the implant to treat conditions such as mitral prolapse. The implant is capable of reducing one or more gaps between the leaflets of the mitral valve which ultimately helps in reducing mitral regurgitation. The implant of the present disclosure forms a ring once deployed in the native annulus (or the target site), allowing a secure placement of an artificial heart valve at the target site and reduces the gap between the native mitral valve and the wall of the target site. Thus, the implant remodels the native mitral valve and helps to support/hold the artificial heart valve implant in place. Further, the implant of the present disclosure is implanted by a transcatheter technique thereby eliminating an open-heart surgery.
[29] Fig. 1 depicts an implant 100 placed inside the native annulus. The implant 100 is implanted via an interventional procedure avoiding the need for an open-heart surgery. The implant 100 is locked in a cinched position post deployment. The unique locking mechanism of the implant 100 helps in better sealing of the native mitral valve, preventing the backflow of blood from the left ventricle to the left atrium therefore, reducing mitral regurgitation and repairing/replacing the native heart valve. The implant 100 facilitates tissue growth and firmly supports the outer wall of the leaflet.
[30] The implant 100 provides additional support to an artificial heart valve ‘A’ if implanted within the implant 100. Further, the implant 100 prevents migration of the artificial heart valve as the artificial heart valve is tightly seated in the implant 100.
[31] The implant 100 has a first end 100a and a second end 100b (as shown in Fig. 5). The implant 100 may be made of multiple structures, each of a predefined configuration. In an embodiment, the implant 100 is made of three structures i.e., a first structure 200, a second structure 300 and a third structure 500 respectively.
[32] The implant 100 can attain two configurations, i.e., an undeployed configuration and a deployed configuration. In the undeployed configuration, the implant 100 is introduced inside a body lumen in a linear elongated configuration such that the two ends - first end 100a and second end 100b are distant from each other. Once the implant 100 is delivered at the target site, the ends of the implant 100 are locked using a locking mechanism of the implant 100 (referred as deployed configuration). In this configuration, the implant 100 resembles a substantially circular ring-like structure having a central opening. The exact shape of the implant 100 in the deployed configuration may vary depending upon the shape of the native annulus of an individual.
[33] Now referring to Fig. 2A, which depicts the first structure 200 of the implant 100. The first structure 200 has a first end 200a and a second end 200b defining a length therebetween. The first structure 200 includes an elongated body, forming the core of the implant 100. The first structure 200 may have a slightly curved configuration defining an arc having an angle ranging from 30°_to 40°. Alternately, the first structure 200 may have a flat configuration. The first structure 200 defines the length of the implant 100.
[34] The first structure 200 may be manufactured using various techniques such as without limitation laser cut, etc. In an embodiment, to obtain the first structure 200, a material is sheared to form the elongated body followed by laser cutting the elongated body to introduce multiple slots 210n and first anchors 220 as described below. The first structure 200 may be made up of a material such as without limitation nitinol, cobalt chromium, elgiloy, etc. In an embodiment, the first structure 200 is made from a nitinol tube and is flat.
[35] As stated above, the first structure 200 is provided with multiple slots 210n. The multiple slots 210n (herein, referred to as slots 210n) are present at least along a portion of the elongated body. For example, the slots 210n are provided along the entire length of elongated body of the first structure 200 extending from the first end 200a to the second end 200b. The slots 210n may be defined in the first structure 200 at regular or sporadic intervals. The intervals may be pre-defined between two slots 210n. The pre-defined intervals may range from 0.1 mm to 0.5 mm. In an embodiment, the predefined interval is 0.3 mm. The slots 210n may have a pre-defined shape such as without limitation rectangular, oval, circular, cylindrical, triangular, square, and zig-zag. In an embodiment, the slots 210n are oval shaped and transverse to the longitudinal axis of the first structure 200. The slots 210n may be made using techniques such as without limitation laser cutting, etc. The slots 210n provide flexibility to the implant 100 and allow easy bending of the implant 100 to attain a ring shape post deployment. The slots 210n provide radial strength to the first structure 200. Further, the slots 210n help in maintaining the blood flow.
[36] In addition to slots 210n, the first structure 200 may be provided with a plurality of first anchors 220 along the length of the first structure 200. The first anchors 220 may include more than two anchors 220, say six. In an embodiment, the first anchor 220 protrudes from an outer surface of the elongated body such that the distal end of the anchor protrudes away from the first structure 200. The outer surface of the elongated body is the surface facing towards a wall of a native annulus. The plurality of first anchors 220 are provided such that each subsequent first anchor of the plurality of first anchors 220 is provided after a predefined number of slots 210n of the multiple slots 210n from a previous first anchor 220. For instance, the first anchors 220 may be equidistant from each other having same number of slots 210n in between or placed at uneven distances from each other having different number of slots 210n in between, from the distal end to the proximal end. The first anchors 220 function to hold the implant 100 inside the leaflet. This provides better positioning and alignment to implant 100 and prevents it from migration.
[37] The first anchor 220 may have a pre- defined length ranging from 1 mm to 10 mm. In an embodiment, the first anchor 220 has a length of 4 mm.
[38] The first anchors 220 may be pivotably or angularly adjustable. The first anchors 220 may either incline in response to positioning, supporting and/or holding of the implant 100 once inside the leaflet. The first anchor 220 may be inclined defining a pre-defined angle with the outer surface of the elongated body of the first structure 200. The first anchor 220 may define an angle A with the elongated body of the first structure 200. The angle A defined by the first anchor 220 may range from 30° to 50°. In an embodiment, the angle A is 45°.
[39] In an exemplary embodiment, the first anchor 220 includes a first portion 220a and a second portion 220b as depicted in Fig. 2C. The first portion 220a of the first anchor 220 may have a pre- defined shape such as without limitation a leaf, tapered from the proximal end, tapered from the distal end, circular, etc. In an embodiment, the first portion 220a of the first anchor 220 is leaf shaped. In an embodiment, the first anchor 220 is made by laser cutting the first structure 200. In an embodiment, the second portion 220b is a connecting bar. The first portion 220a and the second portion 220b of the first anchor 220 may have a different width. For example, the first portion is not tapered while the second portion is tapered for easy locking. In an embodiment, the first portion 220a has a width of 0.7 mm and the second portion 220b has a width of 0.3 mm. Alternately, the first portion 220a and the second portion 220b of the first anchor 220 may have same width.
[40] While the invention is described with the help of anchors having a first portion 220a and second portion 220b, any shape that achieves the function as per the teachings of the present disclosure is within the scope of the present disclosure.
[41] The slots 210n and the first anchors 220 may be arranged in a pre-defined manner throughout the elongated body of the first structure 200. In an embodiment, after every ten slots 210n, a first anchor 220 is provided. It is to be noted that there could be more or less number of slots 210n between two consecutive first anchors 220. Further, in various embodiments, the number of slots 210n between two consecutive first anchors 220 may be same or different.
[42] The first structure 200 is provided with a locking mechanism. In an embodiment, the locking mechanism includes a male portion 230 and a female portion 240. The male portion 230 and the female portion 240 are situated towards the first end 200a and the second end 200b respectively of the first structure 200. The male portion 230 and the female portion 240 function to lock the first structure 200 in the native annulus, avoiding any unwanted displacement of the implant 100 in the annulus.
[43] The first structure 200 may attain an open configuration and a close configuration due to the aforesaid locking mechanism. Figs. 2B and 2C depict an open configuration and a closed configuration of the first structure 200 respectively. In the open configuration, the male portion 230 and the female portion 240 of the first structure 200 are uncoupled while in the closed configuration, the male portion 230 and the female portion 240 are coupled as described below.
[44] In an embodiment, the male portion 230 defines a first cavity 230c. The first cavity 230c may have a pre-defined shape such as without limitation circular, square, rectangular, triangular, zig-zag, oval etc. In an embodiment, the first cavity 230c is substantially circular shaped. The first cavity 230c is provided to accommodate the female portion 240 for locking the first structure 200.
[45] The female portion 240 is an extension having a flap 240a. In an embodiment, the flap 240a includes a taper towards the distal end of the first structure 200. In an embodiment, the dimensions of the flap 240a and the first cavity 230c complement each other.
[46] The female portion 240 may be further provided with a second cavity 240c in the flap 240a. The second cavity 240c may have a shape such as without limitations circular, square, rectangular, triangular, zig-zag, oval, etc. In an embodiment, the second cavity 240c is substantially circular shaped. In an embodiment, the second cavity 240c is provided to pass a suture during deployment of the stent.
[47] Fig. 3 depicts the second structure 300 of the implant 100. The second structure 300 includes a first end 300a and a second end 300b. In an embodiment, the second structure 300 has a tubular body. The tubular body may be obtained by braiding one or more wires. The braided patterns include without limitation,¬ crossing patterns, horizontal waveforms, longitudinal waveforms, straight vertical patterns, horizontal patterns, etc. The wires may be made of nitinol. In an embodiment, the second structure 300 has a radial strength of 250 microns. In an embodiment, the second structure 300 encloses the first structure 200 at least partially along the length of the first structure 200. The first anchors 220 of the first structure 200 protrude out from the braided tubular body of the second structure 300.
[48] In an embodiment, the second structure 300 is provided with a plurality of second anchors 320 (as shown in Fig. 4). The plurality of second anchors 320 are provided on the outer surface of the second structure 300. The second anchors 320 may define an angle B with the outer surface of the second structure 300. The angle B defined by the second anchors 320, may range between 30° to 50°. In an embodiment, the angle B is 45°. The second set of anchors 320 may have a suitable shape such as without limitation circular, square, rectangular, triangular, zig-zag, oval, etc. The second anchors 320 help in better holding the implant 100 inside the leaflet. This provides better positioning and alignment of the implant 100 and prevents it from migration.
[49] Post assembly of the first structure 200 and second structure 300, in an embodiment, the second anchors 320 and the first anchors 220 are alternately arranged. Alternate arrangement of the first anchors 220 and second anchors 320 are possible and within the scope of the present disclosure.
[50] In an embodiment, the first structure 200 and the second structure 300 may be heat set as an assembly or individually as separate structures and then assembled together to form the assembly as discussed in the above disclosure. The process of heat setting is done to achieve better compressibility.
[51] Referring to Figs. 5A and 5B, the implant 100 is further provided with a third structure 500. The third structure 500 partially enclose the second structure 300 along the length of the second structure 300. The third structure 500 has a first end 500a and a second end 500b (not shown). The third structure 500 may be a layer of knitted fabric, manually wrapped around the second structure 300 and stitched thereafter. The third structure 500 may be made up of a material such as without limitation DACRON, polyethylene terephthalate (PET), etc. In an embodiment, the third structure 500 is made up of polyethylene terephthalate (PET). In an embodiment, the third structure 500 encloses the second structure 300 thereby forming a tube extending throughout the length of the implant 100. The third structure 500 helps in maintaining the shape and flexibility of mitral annulus. The third structure 500 provides a smooth and durable interface to the implant 100 and facilitates integration of the implant 100 with the native tissues.
[52] In an embodiment, the third structure 500 may be provided with a plurality of holes. The holes of the third structure 500 help to accommodate the first anchors 220 of the first structure 200. In an alternate embodiment, the holes of the third structure 500 help to accommodate the first anchors 220 of the first structure 200 and the second anchors 320 of the second structure 300. The holes additionally permit tissue growth and flexibility to the implant 100.
[53] Fig. 6 depicts an exemplary method 600 to manufacture the implant 100, according to an embodiment of the present disclosure.
[54] The method 600 commences at step 601 by cutting a sheet of a biocompatible material (herein Nitinol). The sheet is then laser cut to introduce slots and anchors in the sheet yielding the first structure 200. The parameters used for laser cutting the sheet include without limitation maintaining pressure of an inert gas, water pressure, laser beam cutting speed, power, frequency, etc. The parameters of the laser may be adjusted according to requirement.
[55] Additionally, and optionally, the first structure 200 is then processed to remove any abnormalities arising from laser cutting. In an exemplary embodiment, the first structure 200 is processed via grinding and honing processes.
[56] At step 603, the first structure 200 is subjected to a shape setting process on a mandrel to yield a circular configuration of the first structure 200 (as shown in Fig. 2B-2C). The first structure 200 may be annealed over the mandrel at a predefined temperature thereby, permanently deforming the first structure 200 corresponding to the mandrel. The predefined temperature ranges from 501°C to 510°C. In an exemplary embodiment, the first structure 200 is annealed at 505°C for a duration of 5 mins to yield the curved configuration of the first structure 200.
[57] At step 605, a plurality of nitinol wires is braided to form the second structure 300. The plurality of nitinol wires is interwoven in a braided configuration to form a tubular structure of the second structure 300 (shown in Fig. 3). The braided configuration enhances the flexibility and provides structural integrity to the second structure 300. It ensures uniform stress distribution and enhances mechanical strength of the implant 100.
[58] At step 607, the second structure 300 is subjected to a shape setting process on a mandrel to define the shape and dimensions of the second structure 300. The mandrel may have a pre-defined geometry, such as, without limitations, circular, oval, or other customized geometry, etc. The second structure 300 may be annealed over the mandrel at a predefined temperature thereby, permanently deforming the first structure 200 corresponding to the mandrel. The predefined temperature ranges from 502°C to 506°C. In an exemplary embodiment, the braided second structure 300 is annealed at 504°C for a duration of 4mins.
[59] At step 609, the second structure 300 is subjected to cooling. The cooling process may be one at a pre-defined temperature ranging from 20°C to 30°C or at room temperature to attain its final structure.
[60] Thereafter, a layer of fabric that corresponding to the third structure 500, is wrapped over the second structure 300 (as shown in Fig. 5A-5B).
[61] The implant 100 is delivered at the target site via a transcatheter technique. Fig. 7A depicts an exemplary method 700 of deployment of the implant 100 at the target site.
[62] The method 700 commences at step 701, where the implant 100 may be pre-loaded on a delivery catheter of the delivery system in the undeployed configuration. The implant 100 may be constrained by a sheath (not shown) to prevent the implant 100 from attaining a circular configuration. Further, proper pre-loading of the implant 100 is vital for uniform loading and deployment of the stent without any damage. The delivery system may have one or more radiopaque markers (not shown) on the delivery catheter of the delivery system to help positioning of the delivery system in the target site.
[63] At first step 703, a guide wire is advanced to a target location (the target site) through an introducer sheath via the septum wall in the human anatomy. Advancement of guidewire before the delivery catheter offers less trauma to the vessels.
[64] At step 705, the delivery system is advanced over the guidewire. The delivery system may be advanced until it reaches the target site. A position of the delivery system may be verified by inspecting the radiopaque marker of the delivery system under fluoroscopy.
[65] At step 707, the sheath of the delivery catheter of the delivery system is pulled thereby, exposing the implant 100. The male portion 230 situated at the first end 100a of the implant 100 is first exposed onto the native annulus at the targeted site. After the male portion 230 is positioned at the target site, the sheath is further pulled back. The medical practitioner facilitating the procedure, ensures that as the sheath is pulled back, the exposed portion of the implant 100 is seated on the target site in a desired position and the first anchors 220 and the second anchors 320 puncture the native annulus at the desired spot. This ensures proper fixing of the implant 100 at the target site and prevents migration of the implant 100.
[66] At step 709, the delivery system is retracted from the implant 100 completely. The implant 100 forms a circular configuration corresponding to the anatomy of the native annulus post implantation. Once the implant 100 surrounds the native valve, specifically the leaflets of the valve from the outer side, a suture is passed from the second cavity 240c of the female portion 240 to the first cavity 230c of the male portion 230.
[67] At step 711, the suture is then pulled to make sure that the female portion 240 is inserted in the first cavity 230c of the male portion 230 locking the implant 100. The female portion 240 is then bend at a particular angle to lock the implant 100 on the targeted site to achieve the deployed configuration of the implant 100 (as depicted in Fig. 7B and 7C).
[68] It is to be noted that an artificial heart valve can be implanted in the central opening of the implant 100 if required. The artificial heart valve may be delivered via surgery and chathereization also. The advantage of delivering the artificial heart valve on the central opening of the implant 100 versus without the implant 100 is, it support the artificial heart valve and due to its braided with fibered covered help them tissue growth from its surrounding make more stable to artificial heart valve.
[69] 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. a first structure (200) having a first end (200a) and a second end (200b) defining a length therebetween, the first structure (200) includes:
i. multiple slots (210n) provided along the length;
ii. a plurality of first anchors (220) provided along the length of the first structure (200) such that each subsequent first anchor (220) of the plurality of first anchors (220) is provided after a predefined number of slots (210n) of the multiple slots (210n) from a previous first anchor (220), the plurality of first anchors (220) being pivotably adjustable to form an angle A with an elongated body of the first structure (200);
iii. a male portion (230) provided at the first end (200a), including a first cavity (230c), and
iv. a female portion (240) provided at the second end (200b), including a flap 240a,
wherein the male portion (230) mates with the female portion (240) thereby locking the first structure (200).
2. The implant (100) as claimed in claim 1, wherein the implant (100) comprises a second structure (300) at least partially enclosing the first structure (200) along the length of the first structure (200).
3. The implant (100) as claimed in claim 2, wherein the second structure (300) includes a plurality of second anchors (320) provided at an outer surface of the second structure (300) forming an angle B with the outer surface of the second structure (300).
4. The implant (100) as claimed in claim 3, wherein the angle B defined by the second anchors (320) ranges between 30° to 50°.
5. The implant (100) as claimed in claim 2, wherein the second structure (300) includes a braided tubular body.
6. The implant (100) as claimed in claim 1, wherein the implant (100) comprises a third structure (500) at least partially enclosing a second structure (300) along a length of the second structure (300).
7. The implant (100) as claimed in claim 6, wherein the third structure (500) includes a plurality of holes to accommodate the first anchors (220) and second anchors (320).
8. The implant (100) as claimed in claim 1, wherein two consecutive slots (210n) of the multiple slots 210n are arranged at a pre-defined interval ranging from 0.1 mm to 0.5 mm.
9. The implant (100) as claimed in claim 1, wherein the angle A defined by the first anchor (220) with the elongated body of the first structure (200) ranges from 30° to 50°.
10. The implant (100) as claimed in claim 1, wherein the predefined number of slots 210n includes ten slots (210n).
11. The implant (100) as claimed in claim 1, wherein the first anchor (220) has a pre-defined length ranging from 1 mm to 10 mm.
12. The implant (100) as claimed in claim 1, wherein the female portion (240) is provided with a second cavity (240c) to pass a suture during the deployment of the stent.
13. The implant (100) as claimed in claim 5, wherein the first anchors (220) of the first structure (200) protrude out from the braided tubular body of the second structure (300).
14. The implant (100) as claimed in claim 2, wherein the first anchors (220) and second anchors (320) are alternately arranged.
15. The implant (100) as claimed in claim 1, wherein the first structure 200 is annealed over the mandrel at a predefined temperature ranging from 501°C to 510°C.