Claims:WE CLAIM
1 An implant (100) for treatment of regurgitation in a mitral valve, the implant 100 comprising:
a. a plurality of fasteners (10) with each fastener including a head (11) and a body (13), the head (11) including a ring (11a) and an actuator (11b), the body (13) including a plurality of first threads T1;
b. a plurality of sleeves (20) with each sleeve including an inner wall (20a) and an opening (21), the inner wall (20a) including a plurality of second threads complementary to the plurality of first threads T1 of the body (13) of the fastener (10); and
c. a plurality of crowns (30) with each crown including a first arm (30a) and a second arm (30b), the crown (30) including a first connecting structure (31a) and (31b) at a proximal end (31) of each of the first arm (30a) and the second arm (30b) respectively;
wherein the opening (21) of the sleeve (20) includes two side slots (21a, 21b) and a central slot (21c) to pass the first arm (30a), the second arm (30b) and the fastener (10) respectively,
wherein the first connecting structures (31a), (31b) are connected with a plurality of slots (11a’) of the ring (11a) of the fastener (10), and
wherein the actuator (11b) is rotated in a predefined direction resulting in radial contraction of the crowns (30) leading to actuation of an implant (100) at an implantation site.
2 The implant (100) for treatment of regurgitation in the mitral valve as claimed in claim 1 wherein the plurality of fasteners (10) includes 7 to 11 fasteners.
3 The implant (100) for treatment of regurgitation in the mitral valve as claimed in claim 1 wherein the plurality of sleeves (20) includes 7 to 11 sleeves.
4 The implant (100) for treatment of regurgitation in the mitral valve as claimed in claim 1 wherein the plurality of crowns (30) includes 7 to 11 crowns.
5 The implant (100) for treatment of regurgitation in the mitral valve as claimed in claim 1 wherein the implant (100) includes a plurality of anchors (40).
6 The implant (100) for treatment of regurgitation in the mitral valve as claimed in claim 5 wherein the plurality of anchors (40) includes 7-11 anchors (40).
7 The implant (100) for treatment of regurgitation in the mitral valve as claimed in claim 5 wherein the plurality of anchors (40) including a hook (41a) at a proximal end (41) are provided to facilitate anchoring of the implant (100).
8 The implant (100) for treatment of regurgitation in the mitral valve as claimed in claim 1 wherein the first arm (30a) and the second arm (30b) are curved.
9 The implant (100) for treatment of regurgitation in the mitral valve as claimed in claim 1 wherein each of the first connecting structure (31a) and (31b) includes at least one slot (31a’) and (31b’) respectively to secure at least one marker.
10 The implant (100) for treatment of regurgitation in the mitral valve as claimed in claim 1 wherein the crown (30) includes a second connecting structure (33a) at a distal end (33).
11 The implant (100) for treatment of regurgitation in the mitral valve as claimed in claim 1 wherein the actuator (11b) is rotated with the help of a spanner.
12 The implant (100) for treatment of regurgitation in the mitral valve as claimed in claim 1 wherein the predefined direction is one of a clockwise and anti-clockwise direction. , 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:
CIRCULARLY EXPANDABLE MITRAL VALVE REPAIRMENT DEVICE
2. APPLICANT:
Meril Life Sciences Pvt. Ltd., an Indian company of the address Survey No. 135/139 Bilakhia House, Muktanand Marg, Chala, Vapi- 396191, Gujarat, India

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

FIELD OF INVENTION
[001] The present invention relates to a medical device. More specifically, the present invention relates to a medical device for repairing a mitral valve.
BACKGROUND
[002] Human heart has four valves namely, a tricuspid valve, a bicuspid valve (mitral valve), an aortic valve and a pulmonary valve. A bicuspid valve is also known as the mitral valve. The mitral valve is positioned between the left atrium and the left ventricle and has two flaps. Mitral regurgitation is the most critical condition in which the leaflets of the mitral valve do not close enough resulting in abnormal backward blood flow from the left ventricle to the left atrium. In mitral regurgitation, the left ventricle is unable to consume blood as per the volume of the ventricle while excessive blood flows back into the left atrium.
[003] There are various causes leading to mitral valve regurgitation such as valve prolapse, damaged tissue cord, rheumatic fever, endocarditis, abnormality of heart muscle, heart failure, etc. Treatment of mitral valve regurgitation depends on severity of the condition. Generally, treatment of mild leakage is performed by drugs dedicated to improve functioning of the heart. However, in case of acute leakage, a surgery may be performed.
[004] Conventionally, for cardiac operations, open heart surgeries are performed. Such operations typically involve cutting and opening the chest of a patient (e.g., via a median sternotomy or a thoracotomy approach). These procedures can be painful and very invasive, and often lead to medical complications and also have a slow recovery time. In addition, patients who are in poor medical condition may not be eligible to receive open heart surgery due to the risks associated with such operations, thereby preventing the much-needed surgical treatment of the heart disease.
[005] A transcatheter based approach is used for the surgery which may reduce the operation time.
[006] In such approaches, regurgitation in mitral valve can be treated by repairing or reshaping the valve leaflets of the native mitral valve. The mitral valve can be repaired by replacing supportive cords and/or removing excessive valve tissue, so that the leaflets can close tightly thereby, reducing valve regurgitation. The reshaping of the mitral valve (annular reduction) can be performed by attaching an artificial annuloplasty ring with the annulus. Alternatively, a clip may be used to close the leaflets. Such devices may involve critical procedure which may take longer time duration.
[007] Or, a resizable device may also be used to resize and/or reshape the mitral valve. One such implant is disclosed in an application JP2020504651A. However, the implant disclosed in the said application may present several limitations such as more time consumption for actuation of the implant at the implantation site which may lead to increase in risks and complications associated with the surgery.
[008] Therefore, there exists a need for an improved implant which can overcome limitations of the conventional ones.
SUMMARY
[009] The present invention relates to an implant for treatment of regurgitation in a mitral valve. The implant includes a plurality of fasteners including a ring and an actuator, a plurality of sleeves including an inner wall and an opening and a plurality of crowns. The plurality of crowns includes a first arm and second arm. The crown includes a first connecting structure and at a proximal end of each of the first arm and the second arm respectively. The opening of the sleeve includes two side slots and a central slot to pass the first arm, the second arm and the fastener respectively. The actuator is rotated in a predefined direction resulting in radial contraction of the crowns leading to actuation of an implant at an implantation site.
[0010] The foregoing features and other features as well as the advantages of the invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.
BRIEF DESCRIPTION OF DRAWINGS
[0011] 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 instrumentalities disclosed herein. Moreover, those in the art will understand that the drawings are not to scale.
[0012] FIG.1 depicts a peripheral view of an implant 100 in accordance with an embodiment of the present invention.
[0013] Fig.1a depicts an enlarged view of a fastener 10 in accordance with an embodiment of the present invention.
[0014] Fig.1b depicts an enlarged view of a sleeve 20 in accordance with an embodiment of the present invention.
[0015] FIG.1c depicts a crown 30 of the implant 100 in accordance with an embodiment of the present invention.
[0016] FIG.1d depicts an anchor 40 of the implant 100 in accordance with an embodiment of the present invention.
[0017] Fig.2a depicts the implant 100 placed at the regurgitated mitral valve in accordance with an embodiment of the present invention.
[0018] Fig2b depicts the implant 100 repaired mitral valve in accordance with an embodiment of the present invention.
[0019] Fig.3 depicts a process of manufacturing of the implant 100 in accordance with an embodiment of the present invention.
[0020] Fig.4 depicts a delivery device 300 in accordance with an embodiment of the present invention.
DETAILED DESCRIPTION OF DRAWINGS
[0021] 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.
[0022] 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.
[0023] 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.
[0024] 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.
[0025] In accordance with the present disclosure, a medical implant (implant) is disclosed. The implant is used to treat mitral valve regurgitation in a patient. However, it should be noted that the application of the implant of the present invention may also be extended to treat the tricuspid valve regurgitation in a patient as well.
[0026] The implant may include one or more of, sleeves, fasteners, crowns and anchors. The said components may be coupled together in a predefined manner enabling circular expansion of the implant. Each of the fasteners may be equipped with a ring on one of the ends to facilitate actuation of the implant. The crowns of the implant may include at least one cavity at one of the ends for placement of at least one marker. Further, the sleeve is provided with at least one cavity for accommodating a bolt assembly and one or more slots to pass a crown through it thereby providing smooth yet firm arrangement of all components.
[0027] The implant may be a circularly expandable implant. The implant may be used to treat annular regurgitation of the mitral valve in case size of the native annulus in between 28mm to 40mm.
[0028] Now moving specifically to drawings, Fig.1 depicts an implant 100. The implant 100 may be deployed at an annulus of a mitral valve in order to reshape and/or reconnect leaflets of the mitral valve, thereby reducing annular diameter and regurgitation of the mitral valve.
[0029] The implant 100 of the present invention may be in the form of an expandable semi rigid frame. The implant 100 may include various components but not limited to, a plurality of fasteners 10, a plurality of sleeves 20, a plurality of crowns 30, and a plurality of anchors 40. These components of the implant 100 are designed to work together as a functional unit to repair a stenosed mitral valve in a patient.
[0030] The implant 100 may include a plurality of the aforesaid components to form a semi rigid frame which can undergo circular expansion at the implantation site. The number of aforesaid components may determine the diameter of the implant 100. The implant 100 may include 7 to 11 of each of the aforesaid components. In an embodiment, the implant 100 includes nine of each of the fasteners 10, sleeves 20, crowns 30 and anchors 40.
[0031] The fastener 10 may be made of a metallic material but not limited to stainless steel (SS), nitinol or cobalt chromium (CoCr) alloy or combinations thereof. In an embodiment, the fastener 10 is made of 316LVM stainless steel due to its non-magnetic properties and/or greater strength. The non- magnetic property makes it safer to use during MRI screening procedures.
[0032] An enlarged view of the fastener 10 is depicted in Fig. 1a for better representation of the same. The fastener 10 may include a head 11 and a body 13. The body 13 may include a proximal end 13a, a distal end 13b and predefined length L1 extending between the proximal end 13a and the distal end 13b. The length ‘L1’ may be in a range of 10 mm to 14 mm. In an embodiment, the length ‘L1’ is 12.5 mm. The body 13 may be a cylindrical shaped structure having diameter ranging from 1.5 mm to 2.5 mm. In an embodiment, the diameter is 1.70 mm.
[0033] The body 13 may include an outer surface 13c. The outer surface 13c may be threaded or non-threaded. In an embodiment, the outer surface 13c is threaded. The outer surface 13c of the body 13 may include a plurality of first threads ‘T1’ along the length ‘L1’ of the body 13. The pitch of the first threads ‘T1’ may be in a range of 0.3mm to 08mm. In an embodiment, the pitch of the first threads ‘T1’ is 0.4 mm.
[0034] The head 11 may be present at one of the ends of the body 13. In an embodiment, the head 11 is present at the proximal end 13a of the body 13. The head 11 may include a ring 11a and an actuator 11b. The actuator 11b may rotate the ring 11a in order to facilitate actuation of the implant 100 after being anchored at the implantation site. The actuation of the implant 100 may be defined as radial contraction of the crowns 30 leading to decrease in diameter of the implant 100 for actuation at an implantation site.
[0035] The fastener 10 may be fitted inside the sleeve 20 (depicted in Fig.1b). The sleeve 20 may be made of a metallic material but not limited to 316L SS, 316LVM SS, 304 SS, nitinol. In an embodiment, the sleeve 20 is made of 316L SS. The sleeve 20 may act as a channel to pass the fastener 10 and the crown 30 of the implant 100.
[0036] The sleeve 20 may include an inner wall 20a, and an outer wall 20b. The inner wall 20a of the sleeve 20 may include a plurality of second threads (not shown). The plurality of second threads on the inner wall 20a of the sleeve 20 may be complementary to the plurality of first threads ‘T1’ of the fastener 10. The plurality of second threads on the sleeve 20 may facilitate smooth and/or firm attachment of the fastener 10 with the sleeve 20. The plurality of second threads may have the same pitch as the pitch of the first threads ‘T1’ of the fastener 10.
[0037] The sleeve 20 may have an opening 21 which acts as a channel to pass the fastener 10 through it. The opening 21 of the sleeve 20 may have a predefined shape. In an embodiment, the opening 21 includes two side slots 21a, 21b and a central slot 21c.
[0038] The central slot 21c may be used to pass the fastener 10. The two side slots 21a and 21b may be used to pass the first arm 30a and the second arm 30b (depicted in Fig. 1c) of the crown 30. The two arms 30a and 30b may be removably coupled in the slots 21a and 21b of the sleeve 20. Owing to removable coupling, the sleeve 20 may move downwards upon actuation of the implant 100 as illustrated in Fig.2b. The sleeve 20 may include a predefined height ranging from 3 mm to 6mm. In an embodiment, the height of the sleeve 20 is 4 mm.
[0039] The crown 30 may be used to perform expansion and compression of the implant 100 at the implantation site. The crown 30 (depicted in Fig.1c) may include a proximal end 31, a distal end 33 and a predefined length L2 extending between the proximal end 31 and the distal end 33. The length L2 may be in a range of 18 mm to 25 mm. In an embodiment, the length L2 is 21 mm. Further, the crown 30 may include at least two arms, a first arm 30a and a second arm 30b. The first arm 30a and the second arm 30b may bifurcate at the distal end 33.
[0040] The first arm 30a and the second arm 30b may have a predefined thickness. The thickness may play a crucial role in imparting adequate stress on the annulus of the tissue wall of the mitral valve. The thickness of the two arms 30a, 30b should be less so that the implant 100 does not damage tissue of the mitral valve.
[0041] The first arm 30a and the second arm 30b may have similar and/or different thickness. In an embodiment, the two arms 30a and 30b have similar thickness ranging from 300 microns to 750 microns. In an embodiment, the two arms 30a and 30b have 550 microns thickness.
[0042] The two arms 30a and 30b may be curved and/or straight. In an embodiment, the two arms 30a and 30b include a slight curve with a radius of curvature in a range of R40mm to R45mm. In an embodiment, the radius of curvature of the two arms 30a and 30b is R42. The slight curve of the two arms 30a and 30b may help in stress distribution of the implant 100 at the implantation site.
[0043] The crown 30 may include at least one first connecting structure 31a, 31b at the proximal end 31 of each of the first arm 30a and the second arm 30b respectively. The first connecting structure 31a, 31b may be provided to assemble the fastener 10 with the crown 30. The first connecting structure 31a, 31b may be fitted inside a plurality of slots 11a’ (depicted in Fig. 1a) of the ring 11a of the fastener 10.
[0044] The first connecting structures 31a, 31b may be manufactured in a predefined shape such as but not limited to, a beak shaped structure, a T-shaped structure, etc. In an embodiment, the first connecting structure 31a, 31b is a beak shaped structure. Further, each of the first connecting structure 31a and 31b may include at least one slot 31a’ and 31b’ respectively. The slots 31a’ and 31b’ may be used to secure at least one marker (not shown). The marker may facilitate visibility of the implant 100 during fluoroscopy.
[0045] The markers may include radiopaque marker, made of but not limited to gold, platinum, platinum-iridium, silver, tantalum, niobium, zirconium, hafnium, etc. In an embodiment, the markers are made of tantalum.
[0046] The distal end 33 may include a second connecting structure 33a. The second connecting structure 33a may be used to assemble the anchors 40 with the crown 30. The second connecting structure 33a may be manufactured in a predefined shape such as but not limited to, a rectangular shape, square shape, oval shape, etc. In an embodiment, the second connecting structure 33a is rectangular shaped. The second connecting structure 33a may include a plurality of slots 33a’ to attach the anchor 40 on the crown 30 as illustrated in Fig. 1. The plurality of slots 33a’ may be used to provide smooth movement of the anchor 40 at the time of actuation.
[0047] The implant 100 may include a predefined number of crowns 30 depending upon the diameter of the annulus of a mitral valve. In an embodiment, the implant 100 includes nine crowns. The diameter of the implant 100 plays a crucial role in effective treatment of mitral valve regurgitation. The diameter of the implant 100 should be in accordance with the diameter of the native annulus in a patient such that the diameter should not be too large or too small in comparison to the native annulus of the patient. The diameter of the implant 100 may be in a range of 25 mm to 40 mm. In an embodiment, the diameter of the implant 100 is 40 mm.
[0048] The crown 30 may be made of a biocompatible metallic material but not limited to SS (stainless steel) alloy, nitinol alloy (TiNi-SS, TN3, TNC, TiNi-YY, Ti-Ni-01, and Ti-Ni-02), CoCr (cobalt chromium) alloy, etc. In an embodiment, the crowns 30 of the implant 100 are made of nitinol alloy due to its super elastic and shape memory property.
[0049] The anchor 40 may be a resilient member such as a spring, a coil etc. In an embodiment, the anchor 40 is a coil. The implant 100 may include a predefined number of anchors 40. In an embodiment, the implant 100 includes nine anchors. The anchor 40 may facilitate anchoring of the implant 100 at the annulus of the mitral valve as illustrated in Fig.2a and 2b. The anchor 40 may be inserted at the native annulus and fixed at the targeted position.
[0050] The anchor 40 may be manufactured by coiling a wire of diameter ranging between 0.1mm to 0.4mm. In an embodiment, the diameter is 0.2 mm. The anchor 40 may have a predefined pitch ranging from 0.5mm to 3mm. In an embodiment, the pitch of the anchor 40 is 1 mm.
[0051] The anchor 40 may have a proximal end 41, a distal end 43 and a length L3 extending between the proximal end 41 and the distal end 43. The length L3 of the anchor 40 may vary as per thickness of the native annulus at the implantation site. The length L3 may be in a range of 5mm to 20mm. In an embodiment, the length L3 is 12 mm. The anchor 40 may include a hook 41a at the proximal end 41. The hook 41a may facilitate anchoring of the implant 100.
[0052] The distal end 43 of the anchor 40 may have a sharpened edge which may facilitate effective penetration of the implant 100 on the tissue wall of the mitral valve with minimum damage to the tissue.
[0053] The anchor 40 may be made of a metallic material, including, but not limited to, 316L SS, 304 SS, 316LVM SS, etc. In an embodiment, the anchor 40 is made of 316L SS.
[0054] In an exemplary embodiment, the implant 100 is shown to be placed at the native annulus of the mitral valve as depicted in Figs. 2a and 2b. The anchors 40 of the implant 100 may penetrate the annulus tissue wall of the mitral valve leading to effective gripping of the implant 100 at the annulus. Upon anchoring, the implant 100 may be actuated by means of the actuator 11b with the help of a spanner (not shown). The actuator 11b may be rotated in a predefined direction to facilitate actuation of the implant 100. The predefined direction may be one of a clockwise or anti-clockwise direction. In an embodiment, the actuator 11b is rotated in the clockwise direction. Rotation of the actuator 11b may lead to downward movement of the sleeve 20 and inward movement of the crown 30. The inward movement of the crown 30 leads to decrease in diameter of the implant 100. Once the diameter of the implant 100 is decreased, the leaflets of the mitral valve come close to each other as illustrated in Fig.2b. Thus, the annular diameter of the mitral valve is decreased.
[0055] In accordance with the present invention, Fig. 3 depicts a flow chart of a process involved in manufacturing of the implant 100. The process commences at a step 401. At step 401, a tube made of nitinol is subjected to a process of cutting to form the crown 30. The nitinol tube may be an oxide free tube. The cutting may be performed by any means such as without limitation liquid jet machining, laser cutting, abrasive jet machining, etc. In an embodiment, the cutting of the nitinol tube is performed by means of laser cutting. The tube may have an outer diameter in a range of 4mm to 6mm. In an embodiment, the outer diameter of the tube is 5.5mm. Further, the tube may have a predefined wall thickness ranging from 0.40mm to 0.90mm. In an embodiment, the thickness of the tube is 0.6mm.
[0056] The laser cutting may be performed with gas such as but not limited to argon gas, or oxygen gas. In an embodiment, the laser cutting is performed with argon gas. The pressure of argon gas may be maintained in a range of 2 bars to 18 bars.
[0057] At step 403, the crown 30 obtained at previous step is subjected to a process of grinding and honing to produce a smooth surface. The process of grinding may be performed by means of diamond and/or abrasive files. In an embodiment, honing is performed by means of using abrasive stones of 3.4mm to 3.5mm. Alternatively, an abrasive gel may also be used to remove burrs generated during the laser cutting process.
[0058] At step 405, the crown 30 is subjected to a process of shape setting post grinding and honing at the previous step. The process of shape setting may be performed by means of heat treatment using a mold. The process of shape setting is performed in multiple steps. Firstly, the laser cut crown 30 is expanded from a crimped diameter ranging from 3mm to 5mm to an expanded diameter ranging from 20mm to 45mm using a mandrel. Post expansion, the crown 30 may be subjected to a process of moulding to impart a predefined radius of curvature to the crown 30. The process of moulding is performed in three steps. The process of moulding may be performed at a temperature of 505°C for 10 minutes to 15 minutes. In an embodiment, the moulding is performed at a temperature of 505°C for time duration of 15 minutes.
[0059] At step 407, the crown 30 is subjected to a process of sand blasting. The process of sand blasting may be performed by means of aluminium oxide powder. The aluminium oxide powder is allowed to strike on the crown 30 at a predefined frequency for a predefined period of time. The predefined frequency and the predefined time may be in a range of 45 to 85 Hz and 3minutes to 10 minutes respectively. In an embodiment, the frequency is in range of 55 to 65 Hz and time is 5minutes to 8minutes. The pressure exerted by the powder may vary in a range of 20 psi to 90 psi, preferably in a range of 30 psi to 60 psi. The process of sand blasting may produce highly smooth outer surface of the crown 30 due to abrasion with the aluminium powder. The process of sand blasting may also remove oxide layers, striations left by laser cutting in previous step, decrease propensity for micro cracking and/or provide light texture to the outer surface of the crown 30.
[0060] Lastly, at step 409, the crown 30 are subjected to a process of electro-polishing. The process of electro-polishing is performed by immersing the crown 30 in a solution of electrolytes and passing the current at a predefined voltage for a predefined time duration. The solution of electrolytes may be a concentrated acid solution such as a mixture of 20% to 25% purfluoric acid and 75% to 80% acetic acid. The voltage used for electro polishing is from 8V to 12V, and the current is from 0.3A to 1.5A, preferably from 0.8A to 0.10A. The predefined time duration is in a range of 1 minute to 8 minutes, preferably 2 to 6 mins.
[0061] At step 411, the components such as the fastener 10, the sleeve 20, the crown 30 and the anchor 40 are assembled together as depicted above in Fig. 1a to Fig. 1d to form the implant 100.
[0062] At step 413, the implant 100 is loaded onto a delivery device 300 as depicted in Fig.4.
[0063] The delivery device 300 may include a shaft 310 and a body 320. The shaft 310 may include a proximal end 311 and a distal end 313. The shaft 310 may include a head 315 at the proximal end 311.
[0064] The body 320 may include one or more rollers, for example, a set of proximal rollers 321, a set of distal rollers 322, and at least one guide plate 323. The proximal roller 321 and the distal roller 322 of the delivery device 300 are attached to the anchor 40 and fastener 10 of the implant 100 respectively. The proximal roller 321 and the distal roller 322 may include two shafts, for example, a plain shaft 324 and a threaded shaft 325. The threaded shaft 325 may provide rotational movements in clockwise and counter clockwise direction. The plain shaft 324 of the roller 321 provides axial movement in forward and backward direction.
[0065] The proximal rollers 321 are connected to the anchors 40 with the help of wires 327 at the hook 41a of the anchors 40 in order to anchor 40 the implant 100 on the tissue annulus. The distal rollers 322 are connected to the actuator 11b with the help of the wires 327 in order to rotate the fastener 10 for actuating the implant 100. The guided plate 323 is placed between the rollers 321,322 and the implant 100, which is mainly used to guide the wires 327 to the components and provide individual movement to the implant 100.
[0066] At step 415, the implant 100 is subjected to a process of primary packaging. The implant 100 with the delivery deice 300 may be packaged in a pouch made of aluminium.
[0067] Post primary packaging, the implant 100 is subjected to a process of primary sterilization at step 417. The process of primary sterilization may be performed by means of gas sterilization using gases such as ETO (Ethylene oxide) gas, nitrogen gas. In an embodiment, the process of primary sterilization is performed by means of ETO (Ethylene oxide) gas.
[0068] At step 419, the implant 100 is subjected to a process of secondary packaging. During the process of secondary packaging, the implant 100 may be packaged in a plastic box, cardboard box, etc. In an embodiment, the implant 100 is packaged in a plastic box.
[0069] Post-secondary packaging, the implant 100 may be stored at a predefined temperature at step 421. In an embodiment, the implant 100 is stored at the room temperature.
[0070] The present invention will now be explained with the help of following examples.
[0071] Example 1 (Present invention): An in-vitro tissue model of the mitral valve including leaflets of size 38 mm initial diameter was used. The implant having 40mm diameter in a circular expandable configuration was prepared and implanted onto the in-vitro tissue model. The implant was placed over the leaflets of the mitral valve and anchored with the help of anchors. Once the anchors were positioned and fixed onto the leaflets of the in-vitro model, the implant was actuated by rotating the fasteners. As the fasteners were rotated with the help of a spanner, the sleeves moved downward to actuate the expanded crowns and decrease the diameter of leaflet from 38mm to 30mm. This shows that the leaflets come closer to each other thus the implant helped in reducing the back flow in the In-vitro tissue model. The time taken for the whole procedure was 45 minutes in the In-vitro tissue model with effective manner.
[0072] Prior art: An in-vitro tissue model of the mitral valve including leaflets of size 38mm initial diameter was used. An implant having V shaped multiple crowns was used at the treatment site. It was found that the V shaped crowns were subjected to more stress at the treatment site. Also, the time taken to repair the valve was comparatively more than the present invention.
[0073] 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.