FORM-2
THE PATENT ACT,1970
(39 OF 1970)
AND
THE PATENT RULES, 2003
(As Amended)
COMPLETE SPECIFICATION (See section 10;rule 13)
"A SYSTEM AND METHOD FOR MANUFACTURING AN OCCLUDER FOR OCCLUDING AN ATRIAL APPENDAGE AND
OCCLUDER THEREOF"
MERIL LIFE SCIENCES PVT LTD, a corporation organized and existing under the laws of India, of Bilakhia House, Muktanand Marg, Chala, Vapi, Gujarat - 396191, India.
The following specification particularly describes the invention and the manner in which it is to be performed:

TITLE OF THE INVENTION
A system and method for manufacturing an occluder for occluding an atrial appendage and occluder thereof
FIELD OF THE INVENTION
[001] The present invention relates to a system and method for manufacturing an occluder for occluding an atrial appendage and occluder thereof.
BACKGROUND OF THE INVENTION
[002] Atrial fibrillation (AF or A-fib) is a medical condition which is characterized by rapid and irregular beating of the atria or an abnormal heart rhythm. Initially the person suffering from AF doesn't show any symptoms, provided occasionally there may be heart palpitations, lightheadedness, shortness of breath, fainting, or chest pain. As a consequence, AF is associated with an increased risk of heart failure, dementia and stroke etc. Therefore, once period of abnormal beating becomes longer and possibly constant over time, an appendage is formed in the atrium which is called an atrial appendage. The atrial appendages are formed either on the left atria or the right atria.
[003] Left atrial appendage (LAA) is an outgrowth on a left wall of primary atrium. The LAA is a long, tubular structure, which has a narrow junction with the venous component of the atrium. It has developmental, ultra structural

and physiological characteristics distinct from the normal left atrium. LAA lies within the confines of the pericardium in close relation to the free wall of the left ventricle and thus its emptying and filling may be significantly affected by left ventricular function.
[004] Generally blood thinning medications, also called oral anticoagulants (includes warfarin and other newer approved blood thinners), which reduces the chance for blood clots to form are used to treat AF strokes. However, some patients find that blood thinning medications are difficult to tolerate or are risky, because they prevent blood clots by thinning the blood. In this regard, blood thinners can increase the risk of indefinite bleeding as clots are not formed easily.
[005] An alternative solution to blood thinner medicines is an occluder which is an implant-based alternative to blood thinners. The occluder is placed inside the outgrowth at left atrial wall to occlude or seal the hole and block the blood flow entering into a LAA defect thereby eliminating the risk of thrombus formation in the LAA defect. The shape of the LAA defect varies significantly, and LAA defects are generally named to reflect the shape of the same, e.g. cactus-shape, chicken-wing-shape, broccoli-/cauliflower-shape, and windsock-shape etc.
[006] The occluder is a one-time implant typically implanted under general anesthesia with Trans-Esophageal Echo guidance (TEE). Similar to a coronary stent procedure, the occluder is guided into the heart through a flexible tube called catheter, inserted through the femoral vein in the upper

leg. The occluder is introduced into the right atrium and is then passed into the left atrium through a puncture-hole. These small iatrogenic atrial septal defects usually disappear eventually within six months. Once the position is confirmed, the implant is released and is left permanently fixed in the heart. The implant does not require open heart surgery and does not need to be replaced.
[007] Current LAA defect treatment option includes catheter procedure and surgery. Catheter procedures are much easier on patients than surgery. They involve only a needle puncture in the skin where the catheter (thin flexible tube) is inserted into a vein or an artery. It does not require surgically opening the chest or operating directly on the heart to repair the defect. This means that recovery may be easier and quicker with minimal invasive catheter procedure. When the catheter reaches the defected region, the metal occlusion device is pushed out of the catheter and the device is implanted. It’s secured in place and the catheter is withdrawn from the body. Within six months, normal heart tissues grow in and over the device. The metal occlusion device does not need to be replaced as it will be a life time implant. A patient may need open-heart surgery if his or her heart defect can't be fixed using a catheter procedure.
[008] Generally, metal occlusion device is used to treat LAA defects in the heart. Upon implant these devices possess significant risks including thrombus formation on the device, metal allergy, tissue erosion, etc. Tissue erosion is one of the major issues which may be life-threatening for a patient

with metal occluder implanted on him. The occluder rubbing against the wall of the heart and LAA wall can erode the tissue and create a hole. It can also lead to further scraping. This scraping may also cause separate or simultaneous holes, potentially leading to blood building up in the sacs or holes surrounding the heart (cardiac tamponade). If too much blood builds up in this sac, the heart will not be able to work properly. Therefore, Immediate open heart surgery may then be necessary to remove the device, close the holes or other defects caused by erosion, and close the original defect the device was meant to treat less invasively. Tissue erosion can also cause fistulas - abnormal scar tissue that connects parts of the heart that were not previously connected. Fistulas are not life-threatening, but do require surgery for treatment and could result in congestive heart failure.
[009] Therefore, there exists a need in the technology for an occluder which addresses at least the abovementioned problems.
SUMMARY OF THE INVENTION
[010] Accordingly, in one aspect the invention provides a self-expandable occluder for occluding an atrial appendage comprising a braided structure extending between a proximal end and a distal end, the braided structure is formed by braiding plurality of filaments on a mandrel of a circular braiding machine, and an anchor portion provided adjacent to the distal end along the periphery of the braided structure, the anchor portion being formed by mounting plurality of laterally extending anchors along the periphery of the

braided structure, wherein the anchor portion anchors the braided structure
to an opening of the atrial appendage when the braided structure is placed
inside the atrial appendage.
[011] In some embodiments, a radiopaque ring is mounted at the distal end.
[012] In some embodiments, a radiopaque jacket is mounted at the proximal
end.
[013] In some embodiments, plurality of filaments are made of poly-l-lactic
acid (PLLA), poly-d-lactic acid (PDLA), poly lactic-co-glycolic acid (PLGA),
polydioxanone (PDO) or a combination thereof.
[014] In some embodiments, the PLGA filament is extruded from medical
grade granules comprising of 85% mol L-lactide and 15% mol glycolide with
IV range from 1.80 decilitre per gram (dl/g) to 2.50 dl/g.
[015] In some embodiments, at least one radiopaque C-shaped marker is
mounted on the braided structure.
[016] In another embodiment, the invention provides a system for
manufacturing a self-expandable occluder for occluding an atrial appendage,
the system comprising a circular braiding machine for forming a braided
structure, the circular braiding machine having a mandrel where the braided
structure is formed by braiding plurality filaments on the mandrel, the mandrel
having plurality of circular holes along its periphery adjacent to a top end
thereof, plurality of laterally extending anchors are mounted on the braided
structure along the circular holes thereby forming an anchor portion along the
periphery of the braided structure, an annealing unit for annealing the braided

structure thereby providing shape memory to the braided structure, and a
mold assembly for molding the braided structure into a desired shape.
[017] In some embodiments, the mold assembly comprising a top part, a
proximal waist part having an internal cavity, the top part configured to be
placed on the top of proximal waist part, a distal waist part having a shape
corresponding to a desired shape of the occluder, the distal waist part is
placed inside the cavity of the proximal waist part, and a bottom part
configured to support the proximal waist part and the distal waist part at the
bottom.
[018] In some embodiments, plurality of filaments are made of poly-l-lactic
acid (PLLA), poly-d-lactic acid (PDLA), poly lactic-co-glycolic acid (PLGA),
polydioxanone (PDO) or a combination thereof.
[019] In some embodiments, the PLGA filament is extruded from medical
grade granules comprising of 85% mol L-lactide and 15% mol glycolide with
IV range from 1.80 decilitre per gram (dl/g) to 2.50 dl/g.
[020] In some embodiments, the mandrel is dome shaped and the diameter
of the mandrel is between 16 millimetre (mm) to 34 mm.
[021] In some embodiments, the braiding parameters include a take up
speed between 1 volts per hertz (V/Hz) – 5 V/Hz, a rotation speed between
20 V/Hz- 50 V/Hz and a braid angle between 90-180 degrees.
[022] In another embodiment, the invention provides a method for
manufacturing a self-expandable occluder for occluding an atrial appendage,
the method comprising steps of forming a braided structure by braiding

plurality filaments on a mandrel of a circular braiding machine, the mandrel
having plurality of circular holes along its periphery adjacent to a top end
thereof, plurality of laterally extending anchors are mounted on the braided
structure along circular holes thereby forming an anchor portion along the
periphery of the braided structure, annealing the braided structure in an
annealing unit thereby providing shape memory to the braided structure,
molding the braided structure into a desired shape by using a mold assembly
and, coating the braided structure with a biodegradable polymer.
[023] In some embodiments, the method further comprising step of
mounting a radiopaque jacket at the proximal end.
[024] In some embodiments, plurality of filaments are made of poly-l-lactic
acid (PLLA), poly-d-lactic acid (PDLA), poly lactic-co-glycolic acid (PLGA),
polydioxanone (PDO) or a combination thereof.
[025] In some embodiments, the PLGA filament is extruded from medical
grade granules comprising of 85% mol L-lactide and 15% mol glycolide with
IV range from 1.80 decilitre per gram (dl/g) to 2.50 dl/g.
[026] In some embodiments, the mandrel is dome shaped and the diameter
of the mandrel is between 16 millimetre (mm) to 34 mm.
[027] In some embodiments, braiding parameters include a take up speed
between 1 volts per hertz (V/Hz) – 5 V/Hz, a rotation speed between 20
V/Hz- 50 V/Hz and a braid angle between 90-180 degrees.
[028] In some embodiments, annealing of the braided structure is performed
between 90- 110 degree Celsius for 8-24 hours.

BRIEF DESCRIPTION OF THE DRAWINGS
[029] Reference will be made to embodiments of the invention, examples of which may be illustrated in accompanying figures. These figures are intended to be illustrative, not limiting. Although the invention is generally described in context of these embodiments, it should be understood that it is not intended to limit the scope of the invention to these particular embodiments.
Figure 1 shows a sectional view of a mandrel of a circular braiding machine in accordance with an embodiment of the present invention.
Figure 2 is an exploded view of mold assembly in accordance with an embodiment of the present invention.
Figure 3a shows a braided structure in accordance with an embodiment of the present invention.
Figure 3b shows an occluder for occluding an atrial appendage in accordance with an embodiment of the present invention.
Figure 4 is a flow diagram of a method for manufacturing an occluder for occluding an atrial appendage in accordance with an embodiment of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[030] The present invention is directed towards a method and system for manufacturing an occluder for occluding an atrial appendage and occluder thereof where the occluder is self-expandable and biodegradable.
[031] In an embodiment, the invention provides a system for manufacturing a self-expandable occluder for occluding an atrial appendage. The system

comprising a circular braiding machine, an annealing unit and a mold assembly.
[032] Referring to figures 1 to 3b, a braided structure 120 is formed on the circular braiding machine. The braiding machine has a mandrel 100 where the braided structure 120 is formed by braiding plurality filaments on the mandrel 100. In an embodiment, the mandrel 100 has a top end and plurality of circular holes 110 are provided along its periphery adjacent to the top end. The plurality of laterally extending anchors 122 are mounted on the braided structure 120 along the circular holes 110 thereby forming an anchor portion along the periphery of the braided structure 120. In an embodiment, 18 holes for hooks attachment are provided along the periphery of the mandrel 100. [033] In an embodiment, plurality of filaments (monofilaments) are braided on the dome shaped tubular mandrel 100 with circular holes 110 where diameter of mandrel 100 varies from 16 mm to 34 mm or above, depending on the size of the occluder which is required to be manufactured with help of circular braiding machine.
[034] In an embodiment, the braided structure 120 formed in the circular braiding machine is extending between a distal end 120A and a proximal end 120B. As shown in figure 3a, a radiopaque ring 124 is mounted at the distal end 120A and a radiopaque jacket 126 is mounted at the proximal end 120B of the braided structure. Further an anchor portion is provided adjacent to the distal end 120A along the periphery of the braided structure 120 where the anchor portion is formed by mounting plurality of laterally extending anchors

122 along the periphery of the braided structure 120. In an embodiment, the anchor portion can anchor the braided structure 120 to an opening of the atrial appendage when the braided structure 120 is placed inside the atrial appendage.
[035] Typical braided structure 120 of thin filament mainly includes 48, 72, 96 and 144 number of carriers in a 2X1 braid pattern. It is a typical pattern when numbers of end match the number of braider carriers and able to achieve higher pick counts and smaller pore sizes than 1X1 braid pattern and it is less likely to kink when bent around tight radii. Also, a 1X1 braid pattern has lower tensile strength than 2X1 braid pattern.
[036] In an embodiment, the number of carriers can range from 32-104 to fabricate an occluder, preferably 72 carriers used to braid. Braiding parameters includes constant take-up speed between 1.0 volts per hertz (V/Hz) and 5.0 V/Hz, more preferably 3.0V/Hz - 5.0 V/Hz, and rotation vary between 20 V/Hz and 50 V/Hz, more preferably 30V/Hz - 50 V/Hz. In an exemplary embodiment, a braid angle can be vary between 90°-180°, as per size of the occluder 300 to be manufactured. Initially 36 spools are used for braiding, each spool pairs with the adjacent opposite path’s spool, i.e. same filament is winded over two opposite adjacent spools. Each filament after winding in one spool passes through a radiopaque platinum ring 124 and then winded over adjacent opposite spool, thus total 18 pairs of spools are passed through radiopaque ring 124.

[037] In an embodiment, the mandrel 100 used for braiding is dome shaped tubular formation made from stainless steel comprising of 18 holes for hooks attachment. Thus, by braiding over the mandrel 100 leads to a unique braiding pattern with unique braided structure design. Advantageously, the radiopaque ring 124 provided to initiate the braiding improves the occluder’s 300 performance and does not allow friction with filaments. The diameter of ring 124 may range between 1.0 millimeter (mm) to 2.0 mm, preferably 1.0 mm-1.5 mm. The thickness of the ring 124 may vary between 0.5 mm to 1.00 mm, preferably 0.5 mm to .75 mm where the ring provides space to move the filaments radially during heart pumping and thus helps to synchronize the occluder’s movement with heart rhythm, i.e. there will be very less friction at the distal zone of the occluder.
[038] In an embodiment, the braided structure 120 as described hereinabove can also be made of metal wire and is not limited to only bioresorbable filaments.
[039] In an embodiment, the braided structure 120 formed in the circular braiding machine is processed further in the annealing unit. In this regard, the braided structure is secured with a tie wrap at an open end of mandrel 100 to stabilize the braid pattern during heat treatment process. In the annealing unit, the braided structure 120 is kept inside aluminum pouch and sealed with inert gas purge to keep the braided structure 120 aligned on the mandrel 100 and prevent from oxygen, moisture or any other contamination while annealing.

[040] As known, annealing is a heat treatment process which alters the microstructure of a material to change its mechanical property. Therefore, annealing will restore ductility following cold working and hence allow additional processing without cracking. This process provides shape memory to filaments, i.e. the braided structure 120 acquires shape memory during annealing process. The annealing unit is designed to ensure uniform heat treatment. Annealing is done at 90°C - 110°C for 08 hours- 24 hours, to achieve strength and shape memory.
[041] In an exemplary embodiment, at the start of the annealing process, inert nitrogen gas is flushed for 05 minutes to replace maximum air inside a chamber by opening vent. Vacuum is applied to remove the air-nitrogen mixture from the chamber. The vacuum is released in the chamber by nitrogen to get inert atmosphere. Again vacuum is applied and released by nitrogen for another two times to ensure air is completely replaced inside the chamber. Finally the 650 mm to 700 mm of Hg vacuum is applied in the chamber. The chamber is programmed to rotate 05 minutes clockwise and 05 minutes anticlockwise and then again for all the cycle time. After the completion of annealing process time, nitrogen is purged again and the chamber is allowed to cool down to room temperature.
[042] In an embodiment, the braided structure 120 after heat treatment in the annealing unit is molded in the molding assembly to get a desired shape of the occluder 300 by using specific mold assembly 200 resembling an atrial defect.

[043] The mold assembly 200 is made by using medical grade stainless steel (S.S) material. The mold assembly comprises four parts namely a top part 210, a bottom part 240, a distal waist part 230 and a proximal waist part 220. The proximal waist part 220 has an internal cavity and the top part 210 is configured to be placed on the top of proximal waist part 220. In an embodiment 18 hooks which are mounted while braiding process to create the anchor portion are inclined at 45 degrees after the molding.
[044] The distal waist part 230 has a shape corresponding to a desired shape of the occluder 300 and the distal waist part 230 is placed inside the cavity of the proximal waist part 220. Further, the bottom part 240 is configured to support the proximal waist part 220 and the distal waist part 230 at the bottom. The proximal waist part 220 helps to create long inclined waist as per dimension, and bottom part 240 will support mold assembly 200 for creating the occluder 300.
[045] In an embodiment, the distal waist part 230 of mold assembly 200 can be inserted inside the braided structure 120 and assembled with the braided structure 120. The distal waist part 230 can be made to completely resemble the occluder 300 by means of structure and size, once the molding is completed.
[046] In an embodiment, the mold assembly 200 is designed in a manner in which the internal dimension after assembling the assembly parts depicts the shape of occluder 300 required the braided structure 120 with the distal waist part is assembled inside the mold assembly 200. The mold assembly 200 is

then subjected to shape setting process wherein the mold assembly 200 containing the braided structure 120 is annealed using a vacuum annealing unit. The shape setting is carried out at 90°C to 110°C temperature for 04 hours to 24 hours. The shape setting process is performed in order, to achieve desired strength and shape memory to the braided structure 120. [047] After shape setting, the desired shape of the occluder 300 is obtained and then the extra length of braided filaments were cut to desired size of the occluder 300 and a radiopaque Jacket 126 is mounted at the open end 120B of filaments. The cluster of filaments at open end 120B is further held together, and then a marker tube is mounted over the cluster. Thereafter, laser welding is done over the marker tube containing the filaments, to keep and hold each and every filament together with marker or the radiopaque jacket 126. A sleeve is mounted over the proximal open end of braided structure 120 with marker, and stylet inserted through the sleeves and placed at collate of laser welding machine (Make: BW Tec AG, Switzerland, Model: 1700) and locked to hold the stylet stagnant for laser welding process. The parameters for laser welding are; Laser power (W)-1.1, Rotation Speed (rpm)- 300, weld duration(S)- 9.0, which are set by the key and reflects on monitor. After positioning and setting the parameters the welding is done. Sleeve and stylet are removed after welding is completed.
[048] In an embodiment, to enhance radiopacity as well as strength of bioresorbable occluder 300, thin radiopaque platinum core Nitinol wire is stitch circularly at both the distal and proximal flairs of device. Nitinol wires

were pre-shape set and stitch circularly at the flairs in a zig-zag manner. As the platinum core Nitinol wires are pre-shape set, this will support the occluder to regain the shape during deployment process. The wire also improves the radiopacity of device post implantation. The thickness of wire may range from 40 µm to 150 µm; preferably 40 µm - 80 µm; more preferably 50 µm-60 µm thickness of wire is used to stitch.
[049] In preferred embodiment, to enhance radiopacity during deployment process and support to place the device at defect location, total 6 pairs of platinum C-shape markers 128 were mounted over the filaments (Fig. 3b). Three pairs are mounted tri-axially at distal flair near the anchors and another three pairs are mounted tri-axially at proximal flair of device. Markers were placed in a manner by which we can see the circular formation of device after deployment; i.e. device is in fully expanded state at defect zone.
[050] Following the molding, shape setting, welding process and radiopaque marker attachment process, the occluder is then coated with bioresorbable coating polymer through electro spinning coating process. The coating will provide a porous layer of bioresorbable fiber over the distal and proximal waist part of the occluder. The purpose of coating bioresorbable polymer is to improve and increase the rate of tissue growth over the occlusion device. Electro spin coating is a method which uses electrical forces to draw charged threads of polymer solution or polymer melts up to very fine and thin fiber diameter of about hundred nanometers. This process shares characteristics of both electro spraying and conventional solution dry spinning of fibers. The

occluder kept in front of jet of the electro spinning coating machine with fixture, fixture rotates as the jet starts to eject polymer in form of very fine and thin filament. The fixture rotates with a constant speed and by moving the fixture to and fro, we get dense and fine layer throughout the proximal as well as waist part of device. Through this process a highly porous film of polymer filaments has been created over the surface of device, which enhances the strength as well as supports in tissue growth throughout over the implant. [051] Coating provides strength to the device by forming film and holding the braided filaments intersection of device, which in turn helps to maintain the structure of device. Coating of bioresorbable occluder can be done with either, PGS [Poly (glycerol sebacate)] or PCL (Poly-Caprolactone) with or without cross linker, preferably PCL used for electro spinning coating. [052] In one embodiment, Poly lactic-co-glycolic Acid (PLGA) can be used for coating which improves strength of device. The molecular weight of PLGA can be range from 100000 Da - 250000 Da, preferably 140000 Da - 240000 Da, more preferably PLGA of 180000 Da - 230000 Da molecular weight used for coating, and Inherent viscosity can be between 1.80 decilitre per gram (dl/g) to 2.50 dl/g.The coating formulation of PLGA polymer can be prepared by using solvents such as, Tetrahydrofuran (THF), acetone, Chloroform, DCM, and Dimethyl formamide (DMF). The flow rate of electro spinning for PLGA solution can be range from 1-5ml/hour, more preferably 1.5ml/hour -3.00ml/hour. The needle to sample distance can be range between 10-20 centimeters, more preferably sample placed at 15-20 centimeter distance

from the needle. The voltage applied for electro spinning of PLGA can be range from 10-20 kV more preferably 15-18 KV. On application of voltage between needle and sample, the solution droplet was forced to leave the needle in the form of ultra-fine fibers, which were deposited on sample. The sample is detached after reaching an appropriate thickness and placed in vacuum for the evaporation of residual solvent. The thickness of coating can be range from 50µm - 200µm; more preferably 80µm - 160µm thick coating is done over the device.
[053] In another embodiment, PGS can be used for coating which improves the elasticity as it is elastomeric in nature. The poly glycerol sebacate (PGS) polymer can be cured to the desired level of cross-linking, enabling the tuning of physical properties that range from an elastomer to a thermoset. Its flexibility and inherent elastomeric properties offer limitless possibilities for scale-up production for a variety of in-vivo applications for cardiovascular, neurovascular, orthopedics and tissue engineering.
[054] In preferred embodiment, PCL improves the strength and bonds the intersections of braided structure. PCL is a hydrophobic, semi-crystalline polymer; its crystallinity tends to decrease with increasing molecular weight. The good solubility of PCL, its low melting point (59°C - 64°C) and exceptional blend-compatibility has stimulated extensive research into its potential application in the biomedical field. These included tailor able degradation kinetics and mechanical properties, ease of shaping and manufacture enabling appropriate pore sizes conducive to tissue in-growth.

[055] In preferred embodiment, coating formulation is prepared by dissolving PCL with dichloromethane (DCM) solvent in a specific ratio into a flask and sonicated for half an hour, which is further sonicated to homogenized solution suitable for electro spinning coating. Electro spinning process provides very thin filaments of polymer by using electric force to draw threads of polymer solution. High voltage is applied to a liquid droplet, the body of the liquid becomes charged, and electrostatic repulsion counteracts the surface tension and the droplet is stretched; at a critical point a stream of liquid erupts from the surface. If the molecular cohesion of the liquid is sufficiently high, stream breakup does not occur, and a charged liquid jet form leading to formation of droplets which are further electro sprayed on to device. [056] Electro spinning coating parameters for PCL coating over the occlusion device play vital role to achieve desired and uniform coating. PCL coating formulation is taken into the syringe fitted with needle at electro spinning coating machine. The flow rate may range from 1ml/hour to 4ml/hour, more preferably the flow rate kept maintained between 2ml/hour and 3ml/hour. Voltage may vary from 10kV-30kV. Needle to sample distance can be range from 10-20 centimeters, preferably 15 centimeter. On application of voltage between needle and sample, the solution droplet was forced to leave the needle in the form of ultra-fine fibers, which were deposited on sample. The coated sample is detached after desired thickness is achieved. The formed coated occlusion device produced by above parameters has smooth and uniform coating layers throughout the proximal

and waist part of device. Further coated device is placed in vacuum for the evaporation of residual solvent. The thickness of coating can be range from 50µm - 200µm; more preferably 80µm - 160µm thick coating is done over the device. Bioresorbable electro spinning coating over the device improves device performance as well as it degrades eventually after occluding the defect.
[057] Coated device were kept for drying in desiccators for 16 hours to 24 hours to evaporate the residual solvents. Coated device is then kept in mold for heat curing process at between 40°C and 80°C temperature for 08 hours to 16 hours and then allow cooling at ambient temperature. The process of coating polymer and heat curing helps to further increase strength of bioresorbable filament and overall strength of LAA occluder thus reducing chances of deformation of device upon loading and deployment. Final packaging of occluder is done in aluminum pouch. The packed device is sterilized by E-beam radiation.
[058] The occluder delivery system consists of delivery sheath, compatible with 12F to 16F as per the size of device. Device is attached with the delivery cable and loaded inside the sheath prior to implantation. Delivery sheath is marked with radiopaque marker to ease the delivery process as the tip of sheath reaches the defect zone. Delivery sheath is placed at the defect and device is deploy inside the defect and elastically released to ensure the perfect closure of defect. Once the device is deployed successfully the delivery cable and sheath is removed from the body.

[059] The bioresorbable occluder as described hereinabove is designed to fill the atrial defect. Advantageously, better & fast tissue growth with excellent radiopacity/ visibility under fluoroscopy is achieved. To cover the various defects of atrial appendage/defect, various molds with varied dimension can be designed as per below table:

Devic e Diameter at proximal side (mm) Diameter at distal side (mm) Device height (mm)
LAA
Occlu
der 18 19 12

21 24 14

24 25 16

27 28 18

30 31 20

33 34 22
[060] The required size of occluder is determined by the diameter of the atrial defect hole, which should be equal to, or slightly larger than the measured size of the defect. After implant the proximal end of device occludes the defect from the open side of the defect, and anchors hold the device securely in the place.
[061] In an embodiment, a method for manufacturing a self-expandable occluder is provided. The method is implemented on the system as described hereinabove. Figure 4 shows a method for manufacturing an occluder for occluding an atrial appendage in accordance with an embodiment of the present invention. The method starts at step 4A where a braided structure is formed by braiding plurality filaments on a mandrel of a circular braiding

machine. In an embodiment, plurality of filaments are Poly lactic-co-glycolic Acid (PLGA) monofilaments, extruded from medical grade granules which comprises of 85% mol L-Lactide and 15% mol Glycolide with IV range 1.80 dl/g - 2.50 dl/g, preferably ranging from 1.90dl/g to 2.30dl/g, more preferably ranges from 1.90dl/g to 2.10dl/g, and comply heavy metal test with USP. The melting range of the filaments is around 126.7 °C - 144.8 °C. According to published data (Middleton JC, Tipton AJ. Medical Plastics and Biomaterials), the degradation of 50:50 PLGA, 75:25 PLGA, and 85:15 PLGA begins in 1–2 months, 4–5 months and 5–6 months respectively. Advantageously, the monofilaments are high in strength because of orientation process done while extrusion. At the orientation stage the filaments are placed under high tension. Orientation stretches the filaments, the molecules straighten out and line up parallel to the filaments axes, thereby giving great strength to the filaments. Oriented tensile strength of filaments is more than ten times the strength of un-oriented polymer. Also, PLGA monofilaments fabricated as per above process exhibits high strength and modulus.
[062] At step 4B, annealing of the braided structure is carried out in an annealing unit thereby providing shape memory to the braided structure. [063] At step 4C, molding of the braided structure into a desired shape is carried out by using a mold assembly.
[064] At step 4D, welding and jacketing processes are carried out on the braided structure. In this regard, in jacketing process a radiopaque jacket is mounted at a Proximal end of the braided structure.

[065] At step 4E, to enhance radiopacity during deployment process and support to place the device at a defect location, total 06 pairs of platinum C-shape markers are mounted over the braided structure. In an embodiment, three pairs are mounted tri-axially adjacent to a distal end near the anchors and another three pairs are mounted tri-axially adjacent to the proximal end of the braided structure.
[066] At step 4F, the occluder is then coated with bioresorbable coating polymer through electro spinning coating process.
[067] At step 4G, the coated occluder is then kept in a mold assembly for heat curing process at between 40°C and 80°C temperature for 08 hours to 16 hours and then allow cooling at ambient temperature.
[068] At step 4H, primary packaging of the occluder is done. In this regard, primary packaging of occluder is done in aluminum pouch with inert gas purge.
[069] At step 4I, the packed occluder is sterilized by E-beam radiation. [070] Thereafter, at step 4J, E-beam sterilized aluminium pouch is finally packed with outer box. Advantageously, the process of coating polymer and heat curing helps to further increase strength of bioresorbable filament and overall strength of LAA occluder thus reducing chances of deformation of device upon loading and deployment.
[071] While the present invention has been described with respect to certain embodiments, it will be apparent to those skilled in the art that various

changes and modification may be made without departing from the scope of the invention as defined in the following claims.

WE CLAIM:
1. A self-expandable occluder 300 for occluding an atrial appendage, the
occluder 300 comprising:
a braided structure 120 extending between a distal end 120A and a proximal end 120B, the braided structure 120 is formed by braiding plurality of filaments on a mandrel 100 of a circular braiding machine; and an anchor portion provided adjacent to the distal end 120A along the periphery of the braided structure 120 , the anchor portion being formed by mounting plurality of laterally extending anchors 122 along the periphery of the braided structure;
wherein the anchor portion anchors the occluder 300 to an opening of the atrial appendage when the occluder 300 is placed inside the atrial appendage.
2. The occluder 300 as claimed in claim 1, wherein plurality of filaments are made of poly-l-lactic acid (PLLA), poly-d-lactic acid (PDLA), poly lactic-co-glycolic acid (PLGA), polydioxanone (PDO) or a combination thereof.
3. The occluder 300 as claimed in claim 2, wherein the PLGA filament is extruded from medical grade granules comprising of 85% mol L-lactide and 15% mol glycolide with IV range from 1.80 decilitre per gram (dl/g) to 2.50 dl/g.
4. The occluder 300 as claimed in claim 1, wherein at least one radiopaque C-shaped marker 128 is mounted on the braided structure 120.

5. The occluder 300 as claimed in claim 1, wherein a radiopaque ring 124 is mounted at the distal end 120A.
6. The occluder 300 as claimed in claim 1, wherein a radiopaque jacket 126 is mounted at the proximal end 120B.
7. A system for manufacturing a self-expandable occluder 300 for occluding an atrial appendage, the system comprising:
a circular braiding machine for forming a braided structure 120, the circular
braiding machine having a mandrel 100 where the braided structure 120 is
formed by braiding plurality filaments on the mandrel 100, the mandrel 100
having plurality of circular holes 110 along its periphery adjacent to a top
end thereof, plurality of laterally extending anchors 122 are mounted on
the braided structure 120 along the circular holes 110 thereby forming an
anchor portion along the periphery of the braided structure 120;
an annealing unit for annealing the braided structure 120 thereby providing
shape memory to the braided structure 120; and
a mold assembly for molding the braided structure 120 into a desired
shape.
8. The system as claimed in claim 7, wherein the mold assembly
comprising:
a top part 210;
a proximal waist part 220 having an internal cavity, the top part 210
configured to be placed on the top of proximal waist part 220;

a distal waist part 230 having a shape corresponding to a desired shape of the occluder 300, the distal waist part 230 is placed inside the cavity of the proximal waist part 220; and
a bottom part 240 configured to support the proximal waist part 220 and the distal waist part 230 at the bottom.
9. The system as claimed in claim 7, wherein plurality of filaments are made of poly-l-lactic acid (PLLA), poly-d-lactic acid (PDLA), poly lactic-co-glycolic acid (PLGA), polydioxanone (PDO) or a combination thereof.
10. The system as claimed in claim 7, wherein the PLGA filament is extruded from medical grade granules comprising of 85% mol L-lactide and 15% mol glycolide with IV range from 1.80 decilitre per gram (dl/g) to 2.50 dl/g.
11. The system as claimed in claims 5 or 6, wherein the mandrel 100 is dome shaped and the diameter of the mandrel 100 is between 16 millimetre (mm) to 34 mm.
12. The system as claimed in claims 7 or 8, wherein the braiding parameters include a take up speed between 1 volts per hertz (V/Hz) – 5 V/Hz, a rotation speed between 20 V/Hz- 50 V/Hz and a braid angle between 90-180 degrees.
13. A method for manufacturing a self-expandable occluder 300 for
occluding an atrial appendage, the method comprising steps of:
forming a braided structure 120 by braiding plurality filaments on a mandrel 100 of a circular braiding machine, the mandrel 100 having plurality of circular holes 110 along its periphery adjacent to a top end

thereof, plurality of laterally extending anchors 122 are mounted on the
braided structure 120 along circular holes thereby forming an anchor
portion along the periphery of the braided structure 120;
annealing the braided structure 120 in an annealing unit thereby providing
shape memory to the braided structure 120;
molding the braided structure 120 into a desired shape by using a mold
assembly 200; and
coating the braided structure 120 with a biodegradable polymer.
14. The method as claimed in claim 13, further comprising step of mounting a radiopaque jacket at the distal end.
15. The method as claimed in claim 13, wherein plurality of filaments are made of poly-l-lactic acid (PLLA), poly-d-lactic acid (PDLA), poly lactic-co-glycolic acid (PLGA), polydioxanone (PDO) or a combination thereof.
16. The method as claimed in claim 15, wherein the PLGA filament is extruded from medical grade granules comprising of 85% mol L-lactide and 15% mol glycolide with IV range from 1.80 decilitre per gram (dl/g) to 2.50 dl/g.
17. The method as claimed in claim 13, wherein the mandrel 100 is dome shaped and the diameter of the mandrel is between 16 millimetre (mm) to 34 mm.
18. The method as claimed in claim 13, wherein braiding parameters include a take up speed between 1 volts per hertz (V/Hz) – 5 V/Hz, a

rotation speed between 20 V/Hz- 50 V/Hz and a braid angle between 90-180 degrees.
19. The method as claimed in claim 13, wherein annealing of the braided structure is performed between 90-110 degree Celsius for 8-24 hours.
20. The method as claimed in claim 13, wherein the mold assembly comprising:
a top part 210;
a proximal waist part 220 having an internal cavity, the top part 210 configured to be placed on top of the proximal waist part 220; a distal waist part 230 having a shape corresponding to a desired shape of the occluder 300, the distal waist part 230 is placed inside the cavity of the proximal waist part 220; and
a bottom part 240 configured to support the distal waist part 230 and the proximal waist part 220 at the bottom.
21. The method as claimed in claim 13, wherein the braided structure 120 is coated with a biodegradable coating polymer through an electro spinning coating process.
22. The method as claimed in claim 21, wherein the coating polymer is made of poly glycol sebacate (PGS) or poly- caprolactone (PCL) with or without cross linker or PLGA.
23. The method as claimed in claim 22, wherein the molecular weight of
PLGA is between 100000 Dalton (Da) -250000 Da.