DESC:TECHNICAL FIELD
[0001] The present invention relates, generally, to medical devices to occlude a hole, a cavity or an appendage in an organ, lumen, duct or a tract, and, particularly, but not exclusively, to occlude coronary holes or appendage openings.

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 beats per minute and effective atrial systolic function is lost. A sustained condition is called Atrial fibrillation and it increases the probability of heart stroke by three to five times. There is no single cause for arterial fibrillation but blood leakage through holes in heart walls, atrial appendage or in coronary arteries/ veins, blood clotting, weak heart muscles, inefficient valves are some of the reasons.
A human heart sometimes have a hole in the septum or in the walls of the main vessels. In some cases, they don’t significantly affect the normal functioning of the heart or may get filled naturally with time. However, in some cases, they may cause an interruption in the normal functioning of the human heart due to significant blood leakage from one chamber or vessel to another. Further, the human heart has a cavity that is a little pouch-like, roughly triangular shaped, structure present in the wall of the left atrium. It is called left atrial appendage. In normal course, it functions as a decompression chamber in situations of high blood pressure. However, sometimes, the appendage grows abnormally and with growth, the shape of the appendage also changes. In such cases, blood gets accumulated in the left atrial appendage and forms blood clots that may go in blood circulation system and cause complications. Such conditions interrupt normal functioning of the heart by breaking the rhythm of the blood circulation or by disturbing the blood pressure or by increasing the probability of blood clotting.
At present, either surgically or percutaneously, an occluder is implanted in the hole in the septum or at the entry location of the left atrial appendage to prevent blood leakage, blood mixing, blood accumulation, clot forming and preventing the already present clots from entering the blood stream. To hold the implanted device at its location, the occluder is provided with hooks to anchor into the heart muscles but it may cause discomfort to patient. Sometimes, the devices do not cover the entire hole or entry part of the appendage and the risks still persist. In addition, some devices dislodge from their location due to poor positional controllability and pose greater risks to the patient.
[0002] Therefore, there is a need for an occluder to implant at such holes or appendages to prevent blood leakage and to prevent blood clots from entering the blood stream. The occluder should not dislodge from the location and causes no additional discomfort to the patient. Hence, it is an objective of the invention to provide an occluder that provides better radial coverage and ensures robust deployment of itself at the desired location.

SUMMARY OF THE INVENTION
[0003] In one aspect of the present invention, an occluder for closing a hole or an appendage is provided. The occluder includes a top disk having a conical frustum shaped structure with slightly rounded edges. The occluder also includes a middle disk. The occluder further includes a bottom disk. The occluder is inserted into the opening of the appendage or hole from the top disk side. In case of the appendage, the shape of the top disk facilitates anchoring of the occluder by effectively abutting the conical frustum shaped peripheral surface of the occluder with the walls of the appendage. The appendage shape is usually irregular, however, occluder peripheral surface to wall contact area will be higher due shape and material of the top disk. In case of the hole, the bottom side of the top disk affixes with one side of the hole, opposite to an entry side. The stabilizing wires can be added along the periphery of the disk for enhanced anchoring.
[0004] According to the present invention, the bottom disk is inverted saucer shaped with largest diameter among the disks and affixes at an entry of the appendage or another side of the hole, the entry side.
[0005] According to the present invention, the middle disk is conical-shaped which supports the top disk in anchoring and affixes at a neck portion of the appendage or the hole.
[0006] According to the present invention, any two disks are connected through a waist whose diameter is smaller than the connected disks.
[0007] According to the present invention, the occluder is made of a braided structure. The braided structure is made of a plurality of wires that are knitted to form the disks and the waists.
[0008] According to the present invention, the ends of the wires are collected and attached to at least a cap or attached to at least a connector.
[0009] According to the present invention, the connector has a connecting part to attach the occluder to a loading device or a delivery cable.

BRIEF DESCRIPTION OF ACCOMPANYING DRAWINGS
[0010] The detailed description is described with reference to the accompanying figures.
FIG. 1 illustrates a side view of an occluder, according to an embodiment of the present invention.
FIG. 2 illustrates a cross-sectional side view of an occluder, specifically showing cross sectional view of a cap and a connector, according to an embodiment of the present invention.
FIG. 3 illustrates an isometric view of a top disk of an occluder, according to an embodiment of the present invention.
FIG. 4 illustrates a side view of a middle disk of an occluder, according to an embodiment of the present invention.
FIG. 5 illustrates an isometric view of a bottom disk of an occluder, according to an embodiment of the present invention.

DESCRIPTION OF THE INVENTION
[0011] 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.
[0012] 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.
[0013] 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.
[0014] The invention explained in the present disclosure provides a medical device, specifically an occluder, that can be implanted percutaneously in a human body. The occluder is mainly used to close or obstruct opening of an appendage or a hole or a cavity. The main objectives of the occluder, as per the present invention, are to provide better occlusion, accurate positioning and firm anchoring.
[0015] The occluder comprises at least two disks, a cap and a connector. All disks are braided structure of a single wire or a plurality of wires where no part of any wire is welded with any other wire. The disks are also connected through braided wires. A first ends of the wires are collected in a bunch and tightly put together in a hollow part in the cap. Similarly, a second end of the wires are collected in a bunch and tightly put together in the hollow part in the connector. In case of using a single wire for entire braiding, the first end and the second end of the wire is put together in the hollow part of either the cap or the connector. The ends of the wire may be attached to the cap or the connector using adhesive, welding, clip, tie or any other technique known in the art. In some cases, the collected ends of the wire are welded to form a shape of the cap and a separate cap is not needed. Sometimes, a micro-sized ring is also used to hold the collected ends of the wires and on welding the micro ring also becomes a part of the welded joint that acts as a cap and a separate cap is not needed.
[0016] The wires are braided and shaped in a manner to generate disks of different shapes and sizes. In case the occluder has a plurality of disks then any two disks are connected through a waist wherein the waist is also a braided structure with a smaller diameter in comparison to the diameter of any disk present in the occluder. The diameter and the length of the waist are kept as per the requirement. The wires used are, but not limited to, made of a deformable, biocompatible metal or metal alloy. The wires are braided and then given the required shape to make the occluder. After acquiring the shape, in normal state, the occluder will remain in the given shape. The occluder can be deformed after applying a force and it will remain in deformed state till the force is applied and it will return again to its normal state as soon as the force is removed. This property is utilized in deploying the occluder percutaneously and through endovascular route to the target location.
[0017] According to an embodiment of the present invention, the occluder comprises a top disk, a bottom disk, a middle disk, the cap, and the connector. All the disks are made of braided wires where the wires do not have any joints. The first ends of the wires are collected in a bunch and tightly put together in the hollow part in the cap and the second ends of the wires are also collected in a bunch and tightly put together in the hollow part in the connector. The connector has a connecting part as well that is used to connect the connector with another device. This connection can be through threads, snap-fit, adhesive, clip, any other locking mechanism known in the domain, or combinations thereof. The top disk and the middle disk are connected through a first waist. The middle disk and the bottom disk are connected through a second waist. The diameters of the first waist and the second waist are smaller than the diameters of the disks. Further, the diameter of the first waist and the diameter of the second waist may be equal or different. In addition, the diameter of the disks may also be equal or different.
[0018] As described in the present invention, the cap and the connector are attached to the top disk and the bottom disk respectively. The wires which are braided together form the disks and the waists and the first ends of these wires are retained inside the cap and the second ends of the wires are retained inside the hollow part of the connector. During the implantation, the top disk enters the appendage first, followed by the middle disk and the bottom disk. The top disk assists in anchoring the occluder at the selected location. The middle disk occludes entirely or almost entirely the open area of the opening of the appendage at the selected location to prevent thrombus leakage from the appendage. The bottom disk provides additional support to the functioning of the middle disk and the top disk. Also, the bottom disk helps in preventing the dislodgment of the occluder. Thus, the occluder helps in preventing strokes due to obstructions caused by the blood clots formed in left atrial appendage.
[0019] According to an embodiment of the present invention, the material of the wire is selected from, but not limited to, metal, non-metal, alloy, polymer, biodegradable, bioresorbable material or combinations thereof. More specifically, the material of the wire 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, CuZnAl, CuAlNi, or combinations thereof. In addition, based on the material selected for the wire, the delivery mechanism can be a balloon catheter or a catheter for self-expanding devices.
[0020] According to an embodiment of the invention, the contour of the disks can be of any shape. In addition, the shape of the outer surface of the contour, between the waist and the periphery of the disk, is selected from, but not limited to, flat, tapered, curved, sinusoidal, wavy, irregular, step-changed, or combinations thereof.
[0021] According to an embodiment of the invention, the internal area of any disk comprises a fabric. The fabric provides a base for formation of biological cells and eventually filling the entire hollow space of the disk with biological cells. The material of the fabric is selected from a polymeric material, a non-polymeric material, silk, cotton, cellulose, lignin, or combinations thereof.
[0022] According to an embodiment of the invention, the disks 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.
[0023] 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.
[0024] 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.
[0025] 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.
[0026] According to another embodiment of the present invention, the occluder can be placed inside an organ, a lumen, a duct, or a tract of a human or animal, such as heart, artery, vein, bile duct, urinary tract, alimentary tract, tracheobronchial tree, cerebral aqueduct or genitourinary system. Specifically, the occluder can be used in atrium, ventricle, intestine, renal artery, femoral artery, superficial femoral artery, popliteal artery, tibial artery, genicular artery, cerebral artery, carotid artery, vertebral artery, subclavian artery, radial artery, brachial artery, axillary artery, coronary artery, peripheral artery, iliac artery or neuro-arteries.
[0027] Given below an embodiment of the present invention is described using accompanying drawings. Fig. 1 illustrates an occluder (100) to close a left atrial appendage. The left atrial appendage is a small cavity situated on the side wall of left atrium and acts as a decompression chamber if the pressure in the left atrium is high. The left atrial appendage is situated close to the pulmonary arteries that bring in blood from the lungs, and its position can cause blood to accumulate there instead of flowing into the left ventricle of the heart.
[0028] The occluder (100) comprises of a top disk (102), a middle disk (104), a bottom disk (106), a cap (108) and a connector (110). A single or plurality of wires (120) made of a shape memory alloy are braided together and given a shape of the occluder. In the process, two waists (112, 114) are created and three disks of desired shapes are created. The top disk (102) is of umbrella shape that provides a larger peripheral surface area. This surface area helps in anchoring the occluder. Due to umbrella-shape, similar to a conical frustum with slightly rounded edges, the top disk (102) adapts to the shape of the left atrial appendage easily. The top disk (102) abuts the peripheral surface of the appendage walls for anchoring of the occluder within the left atrium appendage. The occluder (100) is deployed in such a manner so that the top disk (102), specifically the end with a smaller diameter enters the appendage first. The gradually increasing diameter of the top disk (102) ensures increased contact of the peripheral surface with the walls of the appendage. While deploying the occluder (100), the top disk (102) applies a compressive force on the walls of the appendage and this force results in anchoring of the occluder (100) inside the appendage, specifically, barbless anchoring of the occluder (100) inside the appendage.
[0029] The middle disk (104) is of conical shape. The conical shape provides support to the top disk and also covers the mouth area of the appendage effectively. The middle disk (104) is situated between the top disk (102) and the bottom disk (106) and its diameter is almost equal or slightly lower to the large diameter of the top disk (102). During and after the deployment of the occluder (100), the middle disk (104) usually sits in neck region, near the opening of the left atrial appendage or the hole. The peripheral edge of the middle disk (104) contacts the wall of the appendage. This peripheral contact brings an additional frictional force and helps the top disk (102) in holding the anchoring. In addition, the peripheral contact also provides a second level of anchoring. Furthermore, the middle disk (104) also closes the opening of the left atrial appendage and thus prevents passage of any blood clot into the blood stream.
[0030] The bottom disk (106) is inverted saucer shaped. The bottom disk has the largest diameter among the three disks. The large diameter helps the bottom disk in affixing with the entry region of the appendage effectively and prevents the occluder from dislodgement. It also ensures complete leakage prevention. The bottom disk (106) acts as a sealing disk that completely covers the opening of the left atrial appendage. The inverted saucer-shaped design ensures better compliance of the bottom disk (106) with the local anatomy. The tapered peripheral surface of the bottom disk (106) better aligns with the opening of the left atrium appendage while the inverted saucer side of the bottom disk (106) provides better conformance with the local anatomy. After the deployment, the bottom disk (106) sits at the opening of the left atrium appendage or slightly protrudes in the left atrial space. Due to this conformance, the blood flow from the pulmonary arteries is not disturbed. This shape also helps in minimum turbulence or eddy currents close to the edges of the occluder (100). The top disk (102) is connected to the middle disk through a first waist (112) and the middle disk is connected to the bottom disk through a second waist (114).
[0031] Fig. 2 illustrates cross-sectional side view of the occluder and specifically shows the hollow part (118) in the cap (108). Similar hollow part (118), not shown, is also present in the connector (110). The connector (110) also has a connecting part (116). The first ends of the wires (120) forming the three disks are collectively put in the hollow part (118) of the cap (108). The hollow part (118) in the connector (110) is designed to receive the second ends of the wires (120). The connecting part (116) is used to connect the occluder (100) to any other device such as loading device or delivery device. The connecting part has provision such as threads etc. that are required to facilitate its connection with the loading device or delivery device.
[0032] Fig. 3 illustrates the top disk (102) and the cap (108) attached to the disk. Fig. 4 illustrates the middle disk (104) and the second waist (114). Fig. 5 illustrates the bottom disk (106) and the connector (11).
[0033] In the above description, for 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.
,CLAIMS:
1. An occluder (100) to occlude an appendage opening or a coronary hole, the occluder (100) comprising:
a top disk (102) having a conical frustum shaped structure with slightly rounded edges;
a middle disk (104) having a conical-shape; and
a bottom disk (106) having an inverted saucer shape,
wherein, the bottom disk (106) has largest diameter among the disks (102, 104, 106) and affixes at an entry of the appendage or the hole.

2. The occluder (100) as claimed in claim 1, wherein any two disks are connected through a waist (112, 114) whose diameter is smaller than the connected disks.

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

4. The occluder (100) as claimed in claim 3, wherein the braided structure is made of a plurality of wires (120) that are knitted to form the disks (102. 104, 106) and the waists (112, 114).

5. The occluder (100) as claimed in claim 4, wherein the ends of the wires (120) are collected and attached to at least a cap (108) or attached to at least a connector (110).

6. The occluder (100) as claimed in claim 5, wherein the connector (110) has a connecting part to attach the occluder (100) to a loading device or a delivery cable.

7. The occluder (100) as claimed in claim 4, wherein the material of the wire (120) is selected from metal, non-metal, alloy, shape memory alloy, shape memory polymer, polymer, biodegradable material, bioresorbable material or combinations thereof.

8. The occluder (100) as claimed in claim 7, wherein the material of the wire (120) 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.

9. The occluder (100) as claimed in claim 1, wherein the disks (102, 104, 106) are hollow and, optionally, comprises a fabric.

10. The occluder (100) as claimed in claim 1, wherein material of the fabric is selected from a polymeric material, a non-polymeric material, silk, cotton, cellulose, lignin, or combinations thereof.

11. The occluder (100) as claimed in claim 1, wherein the disks (102, 104, 106) are coated, completely or partially, with a coating.

12. The occluder (100) as claimed in claim 11, wherein the coating is selected from polymeric, metallic, metallic alloy based, non-metallic, clay-based, biological, biodegradable, pharmaceutical, chemical, non-polymeric coatings or combinations thereof.

13. The occluder (100) as claimed in claims 11 or 12, wherein the coating comprises at least one active agent.

14. The occluder (100) as claimed in any of claims 11 to 13, wherein the coating comprises at least one additive to enhance either physical, chemical, therapeutical or biological performance of the coating.

15. The occluder (100) as claimed in claim 12, 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..

16. The occluder (100) as claimed in claim 13, 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.

17. The occluder (100) as claimed in claim 11, 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.

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

19. The occluder (100) as claimed in claim 1, wherein the top disk (102) facilitates anchorage by abutting the conical frustum shaped peripheral surface with the appendage walls or by abutting the bottom cross-sectional surface with the hole.

20. The occluder (100) as claimed in claim 1, wherein the middle disk (104) supports the top disk (102) in anchoring and affixes at a neck portion of the appendage or the hole.