DESC:Field of Invention:
The Present invention relates, generally, to medical devices to occlude a hole, a cavity, an appendage, and particularly, but not exclusively, to occlude a hole or a cavity of a left atrial appendage.
Background:
Abnormal heart rhythm, commonly called arrhythmia, is characterized by rapid and irregular beating of the heart. It often begins as short periods of abnormal beating and in critical cases the pulse rate increases up to 300 or more beats per minute and effective atrial systolic function is lost. A sustained condition is called Atrial fibrillation that increases the probability of stroke by three to five times.
There is no single cause for arterial fibrillation. Blood clotting, blood leakage through holes in heart walls or in coronary arteries/veins, weak heart chambers or valves are some of the reasons. These causes can be divided in vulvular arterial fibrillation and non-vulvular arterial fibrillation. The human body has some natural cavities which are either non-functional or have a function that is required in rare occasions. However, in some cases, they may cause an issue that interrupts the normal functioning of the human body. These issues can be due to their abnormal growth, or they develop an ailment in themselves. Left atrium has one cavity termed as left atrium appendage that is a little pouch present in the wall of the left atrium and used as a decompression chamber in situation of high blood pressure. However, in some cases, blood collects here and forms blood clots that may go in blood stream and cause a stroke. Such cases are categorized in non-vulvular arterial fibrillation. The situation worsens if this appendage grows in size and the shape of the appendage also changes.
At present, either surgically or percutaneously, an occluder is implanted at the entry of the appendage. Sometimes, the occluder dislodge due to poor control on positioning of the occluder and improper design of the occluder. Appendage size also varies from person to person and selection of an oversized or undersized device also causes embolization. An oversized device is under excess compressive force on deployment and the anchors present on the periphery of the device penetrates excessively into the walls of the appendage and causes discomfort to patients. On the other hand, the undersized device could not get fixed inside the cavity, and it may fall inside or outside of appendage cavity into the left atrium. The shape and/or anchoring features of occluder should provide adequate radial strength for atraumatic fixation or anchoring support at the implantation location. Also, there should not be any blood leakage from sides or through the occluder. In addition, sometimes, the edges of the occluder cause erosion of the tissue wall due to frictional stress generated at sharp edges of the occluder due to continuous movement of heart mascles (contraction and expansion at each pulse). This may result in device failure in few days to few months. It may cause additional complications as well. Hene, the tissue erosion should be minimal after occluder implantation.
Another failure of such devices is formation of thrombus on the device that slip to the blood stream and may cause atrial fibrillation.
Hence, there is need for an occluder to address above mentioned shortcomings and it is an objective of the present invention to provide a medical device, specifically an occluder for deployment and to treat such appendages with no dislodgement and minimized thrombus formation.
Summary:
The invention, as per the present disclosure, explains a medical device, specifically an occluder, that can be percutaneously implanted in a human body to close or obstruct an appendage or a hole or a cavity. The structure of the occluder is of dumbbell shape wherein both the ends have different or same shape and the waist may have a length or it may just be a contacting point. The occluder is made of a plurality of wires that are woven together in a particular pattern to form a braided structure. The material to make the wires used in preparing the braided structure is selected from shape memory alloy, shape memory polymer, metal, alloy, polymer or a combination thereof.
Further, one part of the occluder is covered, partially or fully, using a fabric cover to minimize thrombus formation and thrombus leakage. Also, optionally, the occluder comprises a plurality of anchors to keep the device at its deployed location.
Brief Description of Drawing:
The Detail description is described with reference to the accompanying figures.
FIG. 1 illustrates an isometric view of an occluder, according to an embodiment of present invention;
FIG. 2 illustrates a front-side view of an occluder without a fabric cover, according to an embodiment of present invention;
FIG 3. Illustrates a cross-sectional, front view of an occluder, according to an embodiment of present invention;
FIG. 4 illustrates a cross-sectional, front-view of the occluder (100) with indications of DA, DB, DC, Ø1, Ø2, Ø3 and Ø4, according to an embodiment of present invention.
Detail Description of the Invention:
The invention is described below in detail with reference to accompanying drawings to make the purposes, technical solutions and advantages of invention understood more clearly with help of the specific embodiment of the invention.
Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or the like parts. Wherever possible, corresponding, or similar reference numbers will be used throughout the drawings to refer to the same or corresponding parts.
Where the term “comprising” is used in the present description and claims, it does not exclude other elements or steps. Where an indefinite or definite article is used when referring to a singular noun, e.g. “a” “an” or “the”, this includes a plural of that noun unless something otherwise is specifically stated.
Embodiments of the present invention relates to a medical device, specifically to a percutaneously implantable occluder. The occluder comprises a first end region, a second end region and a waist . All regions are made of a braided structure wherein the braided structure is made of a plurality of wires which are woven in a particular pattern. The one ends of these wires are collected together and kept in a first cap and the other ends of these wires are also collected together and kept in a second cap. The wires are made of a shape memory material. The first end region and the second end region are connected through the waist . The first end region and the second end region are disk-shaped and both the disks have a particular diameter. These diameters, a first end diameter (DA) and a second end diameter (DC), can be either equal or unequal. The waist also has a waist diameter (DB) that is smaller than the first end diameter (DA) and the second end diameter (DC).
The first end region disk is a hollow structure, made of the braided structure, comprises of a first upper side and a first lower side. The first upper side initiates from the cap that is situated in centre of a top face of the occluder and extends till a first peripheral point that is radially farthest, within the first end region, from the centre of the top face of the occluder. The first lower side starts from the first peripheral point and extends towards the longitudinal axis (Y-axis) and meets at the waist. The first upper side and the first lower side extends at an angle with respect to the longitudinal axis (Y-axis) and meet at the first peripheral point. Due to braided structure, any plane or surface of the occluder forms a curved structure at their ends or edges. For clarity purpose, while defining angles, a tangent at the centre of such plane or surface should be drawn and should be extended till it meets the longitudinal axis (Y-axis) or radial axis (X-axis) to form an angle of definite quantifiable value. These angles may be same or different. The first peripheral point is situated on the radial axis (X-axis). The longitudinal axis (Y-axis) and the radial axis (X-axis) are situated at right angles, hence, as per basic rules of Trigonometry, the tangent drawn at the centre of the first upper side cuts the longitudinal axis (Y-axis) at an angle and cuts the radial axis at another angle (Ø1) wherein the sum of these two angles will be 90°. Similarly, the tangent drawn at the centre of the first upper side cuts the longitudinal axis (Y-axis) at an angle and cuts the radial axis at another angle (Ø1) wherein the sum of these two angles will be 90°.
Similarly, the first lower side extends at an angle with respect to the longitudinal axis (Y-axis) and the tangent drawn at the centre of the first lower side cuts the longitudinal axis (Y-axis) at an angle and cuts the radial axis at another angle (Ø2) wherein the sum of these two angles will be 90°. Also, the length of the first upper side, from the first cap till the first peripheral point, and the length of the first lower side, from the first peripheral point till the waist, may be same or different.
The second end region disk is also a hollow structure, made of the braided structure, comprises of a second upper side and a second lower side. The second upper side initiates from the waist and extends till a second peripheral point that is radially farthest, within the second end region, from the longitudinal axis that is passing through the centre of the occluder. The second lower side starts from the second peripheral point and extends towards the longitudinal axis and terminates at the second cap. The second upper side and the second lower side extends at an angle with respect to the longitudinal axis and meet at the second peripheral point. These angles may be same or different. The second peripheral point is situated on the radial axis (X-axis). The longitudinal axis (Y-axis) and the radial axis (X-axis) are situated at right angles, hence, as per basic rules of Trigonometry, the tangent drawn at the centre of the second upper side cuts the longitudinal axis (Y-axis) at an angle and cuts the radial axis at another angle (Ø4) wherein the sum of these two angles will be 90°. Similarly, the tangent drawn at the centre of the second lower side cuts the longitudinal axis (Y-axis) at an angle and cuts the radial axis at another angle (Ø3) wherein the sum of these two angles will be 90°.
Also, the length of the second upper side, from the waist till the second peripheral point, and the length of the second lower side, from the second peripheral point till the second cap, may be same or different. Wherein, optionally, the second end region, completely or partially, is covered with a fabric cover either on its outer peripheral surface or on its inner peripheral surface or on both. The fabric cover is either sutured or adhered to the occluder.
The first upper side of the first end region and the second lower side of the second end region are convex-shaped. The diameter of the curvature of the convex shape may vary with the size of the occluder depending on different values of DA, DB, DC, Ø1, Ø2, Ø3 and Ø4. In addition, the selection of these values will also affect the curvature radius at the first peripheral point and the second peripheral point. By keeping the diameter of such curvatures towards higher side, the sharp corners can be avoided at the first peripheral point and the second peripheral point. This will help in reduction or elimination of tissue wall erosion.
The wires, extending from the first cap and terminating at the second cap, mainly change direction at the first peripheral point, the waist and the second peripheral point. The wires extend either away from the longitudinal axis or towards the longitudinal axis.
According to an aspect of the present disclosure, the occluder shape also contributes to keep the occluder affixed at its deployment location. The tissue walls of the deployment location e.g. LAA mouth or opening, exert a compressive force on the occluder. As a good practice, the criteria to select size of the occluder is that the diameter of the occluder should be slightly higher than the effective diameter of the hole or cavity that need to be occluded. The occluder design should resist this compressive force i.e. the radial strength of the occluder should be higher than the compressive force exerted by the tissue wall of the hole or cavity that intended to be occluded. Also, if a significant portion of the peripheral area of the occluder is in contact of the tissue wall or abutted with the tissues of the deployment location then it also helps in atraumatic fixation of the occluder at the deployment location. Also, it helps in growth of the tissue cells over surface of the occluder. For these objectives, the diameter of the waist is kept closer to the disk diameters. This helps in formation of a dumbbell shape having a waist with a cross-sectional area that can almost cover the cross-sectional area of the hole or cavity that need to be occluded. At least one disk diameter is higher than the waist diameter and it helps in sealing the occluding hole or cavity and also provides required abutment and fixation.
According to an aspect of the present disclosure, the ratio of DA to DB is in range of 1:0.98 to 1:0.51, specifically in range of 1:0.95 to 1:0.6 and more specifically in the range of 1:0.9 to 1:0.7.
According to an aspect of the present disclosure, the ratio of DC to DB is in range of 1:0.98 to 1:0.51, specifically in range of 1:0.95 to 1:0.6 and more specifically in the range of 1:0.9 to 1:0.7.
According to an aspect of the present disclosure, the value of the angle (Ø1) formed between the radial axis (X-axis) and tangent drawn at the centre of the first upper side is in the range of 3° to 20°, specifically in the range of 5° to 17° and more specifically in the range of 7° to 15°.
According to an aspect of the present disclosure, the value of the angle (Ø2) formed between the radial axis (X-axis) and tangent drawn at the centre of the first lower side is in the range of 95° to 150°, specifically in the range of 100° to 140° and more specifically in the range of 110° to 130°.
According to an aspect of the present disclosure, the value of the angle (Ø3) formed between the radial axis (X-axis) and tangent drawn at the centre of the first upper side is in the range of 3° to 20°, specifically in the range of 5° to 17° and more specifically in the range of 7° to 15°.
According to an aspect of the present disclosure, the value of the angle (Ø4) formed between the radial axis (X-axis) and tangent drawn at the centre of the first lower side is in the range of 95° to 150°, specifically in the range of 100° to 140° and more specifically in the range of 110° to 130°.
Further, optionally, a plurality of anchors are situated on the periphery of either the first end region or the second end region projecting outwardly from the outer contour of the occluder. These anchors are primarily hook shaped, but not limited to. The anchors are either part of the braided structure or attached separately to the outer contour of the occluder.
During the deployment of the occluder, the first end region enters the deployment site i.e. anatomical cavity or hole, followed by the waist and the second end region. On deployment, the first end region takes shape of a disk that occupies some part of the internal volume of the cavity or hole e.g. left atrial appendage. The first end region comes in contact with the walls of the cavity or hole at a peripheral circle formed at the first peripheral point. Based on the anatomy, including, but not limited to, shape, diameter and depth, of the hole and the space between the walls and the first end region, a part of the first end region’s outer peripheral surface area abuts with the walls of the cavity or hole. This anchors the occluder within the cavity or hole. The waist and the second end region also occlude some part of the cavity or hole. The second end region, at another peripheral circle formed at the second peripheral point, abuts with the walls of the cavity or hole at either the entrance of such cavity or hole or just inside the entrance of such cavity or hole.
Usually, the occluder selected for deployment is of larger diameter then the diameter of the cavity or hole. Hence, after the deployment, the first end region and the second end region experience compressive force exerted by the walls of the cavity or hole. The occluder also exerts a resistive force in a direction opposite to the compressive force. The resultant force decides the shape deformation of the occluder at a particular contacting point and also keeps the occluder at its location. Convex-shaped end regions help in deformation of the occluder on deployment. Further, the anchors present on the outer peripheral surface penetrates the cavity walls and aids in preventing dislodgement or embolization thus increasing stability. (The fabric cover, covering the second end region, prevents thrombus formation as well as thrombus slippage from the occluder.
According to an embodiment of the present invention, the occluder may have additional means for sealing.
According to an embodiment of the present invention, the occluder may have radiopaque markers at suitable points on its peripheral surface.
According to an embodiment of the present invention, the occluder is recapturable and repositionable up to its complete length provided the occluder is not detached from the delivery cable.
According to an embodiment of the present invention, the material of the occluder is selected from, but not limited to, metal, non-metal, alloy, polymer, biodegradable, bioresorbable material or combinations thereof. Specifically, the material of the occluder is selected from, but not limited to, Stainless steel, Cobalt alloys, pure Iron, Nickel-Titanium alloys, Tantalum, Niobium, Nickel alloys, Magnesium alloys, Zinc alloys, L605, MP25N, Nitinol, Co-Cr, CuZnAl, CuAlNi, or combinations thereof. In addition, based on the material selected for the occluder, the delivery mechanism can be a balloon catheter or a catheter for self-expanding devices.
According to an embodiment of the present invention, the material of the fabric cover is selected from, but not limited to polymer, cotton, bio-derived, silk or a combination thereof. Specifically, the material of the fabric cover is non-woven Polypropylene (spun-bound).
According to an embodiment of the invention, the occluder, the fabric cover or both are coated, completely or partially, with a coating. The coating composition may be selected from polymeric, metallic, metallic alloy based, non-metallic, clay-based, biological, pharmaceutical, chemical, non-polymeric or combinations thereof. In addition, the coating may contain at least an active agent, an additive to enhance either physical, chemical or biological performance, a biodegradable polymer, a hydrophilic compound, or combinations thereof.
According to an embodiment of the present invention, the polymer used in the coating are selected from, but not limited to biodegradable polymers, non-biodegradable polymers, polymers of L-lactide, Glycolide or combinations of thereof, poly(hydroxybutyrate), polyorthoesters, poly anhydrides, poly(glycolic acid), poly(glycolide), poly(L-lactic acid), poly(L-lactide), poly(D-lactic acid), poly(D-lactide), poly(caprolactone), poly(trimethylene carbonate), polyester amide, polyesters, polyolefins, polycarbonates, polyoxymethylenes, polyimides, polyethers, and copolymers and combinations thereof.
According to an embodiment of the present invention, the term “active agent” refers to any biologically active compound or a pharmaceutical compound or a drug compound that can be used in a composition that is suitable for administration in mammals including humans. According to one embodiment of the present disclosure, the active agent is anti-cancer drug, antiproliferation drug, anti-restenosis drugs, neurolytic agents, Quaternary ammonium salts, Sodium channel blockers, anesthetics, amino acids, amines, Calcium channel blockers, diuretics, vasovasorum constrictors, neurotransmitter chemicals, venom, sclerosant agents, anti-nerve growth agents, aminosteroids, neurotoxins, antithrombotics, antioxidants, anticoagulants, antiplatelet agents, thrombolytics, anti-inflammatories, antimitotic, antimicrobial, smooth muscle cell inhibitors, antibiotics, fibrinolytic, immunosuppressive, antiangiogenic, antirestenotic, antineoplastic, antimigrative, anti-antigenic agents, or a combination thereof. Examples of the drug include, but are not limited to, everolimus, sirolimus, pimecrolimus, tacrolimus, zotarolimus, biolimus, paclitaxel, rapamycin and combination thereof. In another embodiment, there can be more than one active agent in the coating to deliver at the target lesion.
According to another embodiment of the present invention, the coating formulation can be coated on the occluder through spray coating, dip coating, chemical vapor deposition, physical vapor deposition, Plasma enhanced chemical vapor deposition, evaporating deposition, sputtering deposition, ion plating, atmospheric pressure plasma deposition, sol-gel method and 3-D printing.
Given below is an embodiment of the present invention described using accompanying drawings.
FIG 1. Illustrates an isometric view of an occluder (100) comprising a first end region (102), a second end region (104) and a waist (106). The one ends of these wires (114) are collected together and kept in a first cap (110). The first end region (102) and the second end region (104) are connected through the waist (106). The waist (106) has a smaller diameter in comparison to the first end region (102) and the second end region (104). The first end region (102) and the second end region (104) are disk-shaped. Multiple anchors (108) are attached to periphery of the first end region (102). The second end region (104) is covered by a fabric cover (120).
Fig. 2 Illustrates a side view of an occluder (100), specifically showing structure of the occluder (100) without a fabric cover (120) to show the second end region (104) that is also a braided structure made from a plurality of wires (114).
FIG. 3 illustrates a cross-sectional, front-view of the occluder (100) that is made of a braided structure wherein the braided structure is made of a plurality of wires (114) which are woven in a particular pattern. The first end region (102) having the first upper side (115) and the first lower side (116). The first upper part (115) of the first end region (102) initiates from the first cap (110) that is situated in centre of the top face of the occluder (100) and extends till a first peripheral point (122) that radially extends away from the longitudinal axis. The first lower side (116) starts from the first peripheral point (122) and extends towards the longitudinal axis and meets the waist (106). The first end region (102) and the second end region (104) are connected through the waist (106). The second end region (104) has a second upper side (117) and a second lower side (118). The second upper side (117) initiates from the waist (106) and extends till a second peripheral point (124) that radially extends away from the longitudinal axis that is passing through the centre of the occluder (100). The second lower side (118) starts from the second peripheral point (124) and extends towards the longitudinal axis and terminates at the second cap (112). The one ends of these wires are collected together and kept in the first cap (110) and the other ends of these wires are also collected together and kept in the second cap (112). The second cap (112) and the first cap (110) are divided in two sections longitudinally wherein the ends of the wires are collected and put together in a section towards the braided structure. The other sections comprise threads on inner periphery that are used to connect the occluder with a delivery apparatus.
FIG. 4 illustrates a cross-sectional, front-view of the occluder (100) with indications of DA, DB, DC, Ø1, Ø2, Ø3 and Ø4.
In the above description, for the purpose of explanation, specific details are set forth in order to provide an understanding of the present disclosure. It will be apparent, however, to one skilled in the art that the present disclosure may be practiced without these details. One skilled in the art will recognize that embodiments of the present disclosure, one of which is described below, may be incorporated into a number of systems. Further, structures and devices shown in the figures are illustrative of exemplary embodiment of the present disclosure and are meant to avoid obscuring the present disclosure.
100 Occluder
102 First end region
104 Second end region
106 Waist
108 Anchor
110 First Cap
112 Second Cap
114 Wire
115 First upper side
116 First lower side
117 Second upper side
118 Second lower side
120 Fabric cover
122 First peripheral point
124 Second peripheral point

,CLAIMS:
1. An occluder (100) to occlude an appendage opening or a coronary hole, the occluder (100) comprising:
a first end region (102) having a first end diameter (DA), a convex-shaped first upper side (115), and a first lower side (116);
a second end region (104) having a second diameter (DC), a second upper side (117) and a convex-shaped second lower side (118); and
a waist (106) having a waist diameter (DB) that is smaller than the first end diameter (DA) and the second end diameter (DB),
wherein, the first lower side (116) and the second upper side (117) meet at the waist.

2. The occluder (100) as claimed in claim 1, wherein the ratio of the first diameter (DA) to the waist diameter (DB) is in range of 1:0.98 to 1:0.51.

3. The occluder (100) as claimed in claim 1, wherein the ratio of the second diameter (DC) to the waist diameter (DB) is in range of 1:0.98 to 1:0.51.

4. The occluder (100) as claimed in claim 1, wherein the first upper side (115) and the first lower side (116) meet at a first peripheral point (122) and the angle (Ø2) made by the first lower side (116) with the radial axis, passing through a first cap (110) and a second cap (112), is higher than the angle (Ø1) made by the first upper side (115) with the radial axis.

5. The occluder (100) as claimed in claim 4, wherein the angle (Ø1) ranges between 3° to 20°.

6. The occluder (100) as claimed in claim 4, wherein the angle (Ø2) ranges between 95° to 150°.

7. The occluder (100) as claimed in claim 1, wherein the second upper side (117) and the second lower side (118) meet at a second peripheral point (124) and the angle (Ø3) made by the second lower side (118) with the radial axis is lower than the angle (Ø4) made by the second upper side (117) with the radial axis.

8. The occluder (100) as claimed in claim 7, wherein the angle (Ø3) ranges between 3° to 20°.

9. The occluder (100) as claimed in claim 7, wherein the angle (Ø4) ranges between 95° to 150°

10. The occluder (100) as claimed in claim 1, wherein the waist (106) has a cylindrical shape.

11. The occluder (100) as claimed in claim 1, wherein the occluder (100) is made of a braided structure.

12. The occluder (100) as claimed in claim 11, wherein the braided structure is made of a plurality of wires (114) that are knitted to form the braided structure.

13. The occluder (100) as claimed in claim 12, wherein the ends of the wires (114) are collected and attached to a first cap (110) and other ends of the wires (114) are collected and attached to a second cap (112).

14. The occluder (100) as claimed in claim 12, wherein the material of the wire (114) is selected from metal, non-metal, alloy, shape memory alloy, shape memory polymer, polymer, biodegradable material, bioresorbable material or combinations thereof.

15. The occluder (100) as claimed in claim 14, wherein the material of the wire (114) is selected from Stainless steel, Cobalt alloys, Iron, Nickel-Titanium alloys, Tantalum, Niobium, Nickel alloys, Magnesium alloys, Zinc alloys, L605, MP25N, Nitinol, CuZnAl, CuAlNi, or combinations thereof.

16. The occluder (100) as claimed in claim 1, wherein the first end region (102), the second end region (104) and the waist (106) are hollow and, optionally, comprises a fabric cover (120).

17. The occluder (100) as claimed in claim 16, wherein the fabric cover (120) is selected from a polymeric material, a non-polymeric material, silk, cotton, cellulose, lignin, or combinations thereof.

18. The occluder (100) as claimed in claim 1, wherein the first end region (102), the second end region (104) and the waist (106) are coated, completely or partially, with a coating.

19. The occluder (100) as claimed in claim 18, wherein the coating is selected from polymeric, metallic, metallic, metallic alloy based, non-metallic, clay-based, biological, biodegradable, pharmaceutical, chemical, non-polymeric coatings or combinations thereof.

20. The occluder (100) as claimed in claims 18 or 19, wherein the coating comprises at least one active agent.

21. The occluder (100) as claimed in any of claims 18 to 20, wherein the coating comprises at least one additive to enhance either physical, chemical, therapeutical or biological performance of the coating.

22. The occluder (100) as claimed in claim 19, wherein the polymer used in the coating is selected from biodegradable polymers, nonbiodegradable polymers, polymers of L-lactide, Glycolide, poly(hydroxybutyrate), polyorthoesters, poly anhydrides, poly(glycolic acid), poly(glycolide), poly(L-lactic acid), poly(L-lactide), poly(D-lactic acid), poly(D-lactide), poly(caprolactone), poly(trimethylene carbonate), polyester amide, polyesters, polyolefins, polycarbonates, polyoxymethylenes, polyimides, polyethers or combinations thereof..

23. The occluder (100) as claimed in claim 20, wherein the active agent is selected from anti-cancer drug, antiproliferation drug, antirestenosis drugs, neurolytic agents, Quaternary ammonium salts, Sodium channel blockers, anesthetics, amino acids, amines, Calcium channel blockers, diuretics, vasovasorum constrictors, neurotransmitter chemicals, venom, sclerosant agents, anti-nerve growth agents, aminosteroids, neurotoxins, antithrombotics, antioxidants, anticoagulants, antiplatelet agents, thrombolytics, antiinflammatories, antimitotic, antimicrobial, smooth muscle cell inhibitors, antibiotics, fibrinolytic, immunosuppressive, antiangiogenic, antirestenotic, antineoplastic, antimigrative, anti-antigenic agents, everolimus, sirolimus, pimecrolimus, tacrolimus, zotarolimus, biolimus, paclitaxel, rapamycin or combinations thereof.

24. The occluder (100) as claimed in claim 19, wherein occluder is coated by a method selected from spray coating, dip coating, chemical vapor deposition, physical vapor deposition, Plasma enhanced chemical vapor deposition, evaporating deposition, sputtering deposition, ion plating, atmospheric pressure plasma deposition, sol-gel method, 3-D printing or combinations thereof.

25. The occluder (100) as claimed in claim 1, wherein the occluder (100) is sized according to a coronary hole or a left atrial appendage.

26. The occluder (100) as claimed in claim 1, wherein periphery of the first end region or the second end region comprises a plurality of anchors (108).

27. The occluder (100) as claimed in claim 1, wherein the occluder is completely recapturable.