DESC:LEFT ATRIAL APPENDAGE CLOSURE DEVICE AND METHOD TECHNICAL FIELD
[0001] The present invention relates to devices and methods for left atrial appendage (LAA) closure in mammalians thereby preventing blood clots from leaving there and entering the bloodstream. The present invention also relates to braided Nitinol pre-shaped multi-disc occluder. Further, the invention relates to braided Nitinol occluder based LAA devices and methods. Further, the present invention specifically relates to left atrial appendage closure device and method for providing complete closure of the appendage of the left atrium.
BACKGROUND OF THE INVENTION
[0002] The Left Atrial Appendage is a vestigial structure attached to the lateral wall of the Left Atrium just above the Mitral valve. It has a mouth and a small body which can act as a nidus for clot formation. The current invention is a new method to occlude the lumen of the LAA and to prevent clot formation and propagation thus preventing clot dissemination and stroke.
[0003] Left Atrial Appendage (LAA) closure devices are well-known in the art. One such prior art embodiments teaches the design and development of Let Atrial appendage Occlusion device. The PLAATO Device (Percutaneous Left Atrial Appendage Transcatheter Occlusion device) discussed in the art consists of a self-expanding Nitinol wire mesh covered with Polytetrafluoroethylene (PTFE). It has rows of hooks along the circumference of the wire mesh to support anchoring the device to the Left Atrial Appendage. Similarly, another prior art teaches a watchman device which is consisted of a Nitinol framework which is partially covered by PTFE with bare ends and hooks placed distally which enables anchoring the device to the LAA wall. In alternate embodiment of prior art, amplatzer LAA occluder is invented where a Nitinol based structure is used with Polyester fabric which comprises of a LA disc, a narrow waist, a cylindrical lobe with stabilizing wires.
[0004] Additionally, US7566336B2 teaches an occlusion device for occluding a left atrial appendage, the occlusion device comprising a center post having a proximal end and a distal end; a plurality of ribs extending radially outward from the proximal end of the center post to the distal end of the center post to form a frame, wherein a diameter of the frame near the proximal end of the center post is greater than a diameter of the frame near the distal end of the center post and is shaped to securely fit within a left atrial appendage; and a PVA foam sheet attached to the ribs, the sheet extending between the ribs and forming a sack shaped barrier supported by the ribs that is closed at the proximal end and extends toward the distal end a distance sufficient to close an entrance to the left atrial appendage and to prevent blood from entering or exiting the left atrial appendage.
[0005] US20070270891A1 teaches a device for closing a left atrial appendage of a patient comprising a containment member having a first configuration for passage into the left atrial appendage and a second larger configuration, and a wire movable into the containment member in situ to expand the containment member in the left atrial appendage to the second configuration.
[0006] US20150250482A1 teaches an atrial appendage closure device that includes an insertion rod having a first end and a second end. An occluding member having an outer surface and an inner surface is connected to the first end of the insertion rod. The occluding member is moveable between a retracted position and a deployed position such that, in the deployed position, the occluding member is configured to provide a seal between a left atrial appendage and a left atrium of a heart. An anchoring member is further connected to the insertion rod and is configured to slide along the insertion rod to secure the device to a wall of a left atrial appendage. Methods for occluding a left atrial appendage that make use of the closure devices are also provided.
[0007] US20170042550A1 teaches exemplary occlusion device includes a cap chamber and a bulb chamber for occluding a left atrial appendage (LAA). In embodiments, after delivery to the LAA, the cap chamber and the bulb chamber are each inflated via various amounts of fluid(s) to occlude the LAA.
[0008] Also, US 11,419,611 B2 teaches a structure that of similar to the previous devices with PTFE coating and nitinol cage. The device is used to treat a left atrial appendage (LAA) of a patient includes a tissue ingrowth member, at least one connector, a tine, and a plurality of struts connected to the tissue ingrowth member and at least one connector.
[0009] Each of the prior art devices described above have a main limitation due to the difficulty in anchoring and precise positioning thereby causing protrusion into the LAA, device instability and perforation. There are also concerns of incomplete closure and residual shunt as they all have a single post deployment shape which do not conform to the variation in the morphology of the LAA. These devices cannot be adequately repositioned to allow exact placement with stability.
[0010] Based on the foregoing, it is believed that a need exists for an improved device design to obtain complete occlusion attitudinally appropriate for the morphology of the appendage providing ease of placement and repositioning without the risk of embolization.
[0011] SUMMARY OF THE INVENTION
[0012] The following summary is provided to facilitate an understanding of some of the innovative features unique to the disclosed embodiment and is not intended to be a full description.
[0013] It is, therefore, one aspect of the disclosed embodiments to provide for an improved Left Atrial Appendage (LAA) device and method.
[0014] It is another aspect of the disclosed embodiments to provide for an improved braided Nitinol pre-shaped multi-disc occluder device.
[0015] It is further aspect of the disclosed embodiments to provide for an improved left atrial appendage closure device and method for providing complete closure of the appendage of the left atrium.
[0016] Left atrial appendage closure device and method. The left atrial appendage (LAA) closure device (100) comprises of Nitinol braided pre-shaped multi-disc occluder confirming the shape of the LAA which anchors the most proximal LA disc (110) against the mouth of the LAA by providing complete closure of the appendage. The LAA closure device (100) comprises of a body (120) comprising of multiple scallops (such as scallops 130 and 140) wherein the body (120) is connected to the LA disc (110) using a narrow waist (145) on the first end of the body (120) and the second of the body (120) is connected to a distal elliptical (150) using the narrow waist (155) respectively. The LA disc (110) of the LAA closure device (100) is covered with an ePTFE covering material with multiple expansile discs of decreasing dimensions which ends in the distal elliptical (150) wherein the neck of the device (100) connecting to the distal disc (150) and LA disc (110) are covered with a Dacron patch and the distal discs and the elliptical (150) are uncovered/uncovered. The number of minor discs used in the device (100) varies in sizes to accommodate the variation in the internal lumen and morphological characteristics of the LAA closure device (100). The elliptical may be of a closed nitinol cage that can be filled with embolization liquid or particles that could provide adequate anchoring of the device. The attachment of the elliptical to the central body could be designed in such a way that it has a expansile spring like action to adjust and accommodate variations in the length of the appendage.
[0017] In one embodiment of the present invention, the device (100) can have a flat or concave LA disc (110) coated with ePTFE membrane and a proximal disc (210) which has a body (220) to it and a Dacron patch sutured to the inside of the disc or coated on the outer surface (220). Subsequent discs are covered or uncovered and takes varying dimensions in accordance with the variation in the morphology of the LAA (100). The connection between the LA disc and the central body could vary in dimensions and distensibility to accommodate different size and morphology of the appendage. Like wise the connection between the body and distal elliptical.
[0018] The distal discs and elliptical (150) takes the purpose of anchoring the device (100) to the LAA while the proximal disc ensures complete occlusion of the lumen of the body of the LAA and LA disc (110) prevents blood entering the LAA by guarding the mouth of the LAA. There could be additional hooks for stabilization either in the body or the elliptical for further anchoring of the device
[0019] In an alternative embodiment of the present invention, the LA disc (110) can be coated within a hydrophilic, CD31 or chemical coating which prevents clot formation or inflammation. The device (100) can have a central screw or a bulb which will be used for repositioning of the device (100) any number of times until complete and satisfactory deployment of the device (100) is attained.
[0020] In an alternative embodiment of the present invention, in the LA disc a pressure sensing system or other biochemical molecules like Pro BNP, Troponin etc. or high frequency electrocardiogram (ECG) sensors can be incorporated for non-invasive monitoring.
[0021] In an alternative embodiment of the present invention, the elliptical may be modified into micro coils or a bag with injectable liquids or particles for better anchoring and visualization. It may also have additional hooks incorporated for anchoring and stability.
[0022] The device can be compressed into a delivery system appropriate to the compressed state off the device (100) and on positioning the device (100) into the LAA the distal elliptical (150) is deployed first followed by the proximal discs and depending on the length and size of the LAA the middle discs will be engaged into the LAA and finally releasing the LA disc (110).
DETAILED DESCRIPTION
[0023] The values and configurations discussed in these non-limiting examples can be varied and are cited merely to illustrate at least one embodiment and are not intended to limit the scope thereof.
[0024] The embodiments now will be described more fully hereinafter with reference to the accompanying drawings, in which illustrative embodiments of the invention are shown. The embodiments disclosed herein can be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. Like numbers refer to like elements throughout. As used herein, the term "and/or" includes all combinations of one or more of the associated listed items.
[0025] Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein.
[0026] Invention: Left atrial appendage closure device and method. FIG. 6 illustrates a graphical representation of the LAA closure device (100). The left atrial appendage (LAA) closure device (100) comprises of Nitinol braided pre-shaped multi-disc occluder confirming the shape of the LAA which anchors the most proximal LA disc (110) against the mouth of the LAA by providing complete closure of the appendage. The LAA closure device (100) comprises of a body (120) comprising of multiple scallops (such as scallops 130 and 140) wherein the body (120) is connected to the LA disc (110) using a narrow waist (145) on the first end of the body (120) and the second of the body (120) is connected to a distal elliptical (150) using the narrow waist (155) respectively. The LA disc (110) of the LAA closure device (100) is covered with an ePTFE covering material with multiple expansile discs of decreasing dimensions which ends in the distal elliptical (150) wherein the neck of the device (100) connecting to the distal disc (150) and LA disc (110) are covered with a Dacron patch and the distal discs and the elliptical (150) are uncovered. The number of minor discs used in the device (100) varies in sizes to accommodate the variation in the internal lumen and morphological characteristics of the LAA closure device (100).
[0027] Working of the Invention: FIG. 2-7 illustrates various embodiments of implementing the LAA closure device (100) within the scope of the proposed invention. The purpose of illustration of FIG. 2-7 is to demonstrate the various possibilities of working of the invention in achieving the LAA closure device (100) without limiting the scope of the working of the invention. A person skilled in the art shall appreciate the different implementations of the device (100).
[0028] FIG. 2 illustrates the device (100) without the elliptical (150) showing the LA disc (110) and the central body (120). Similarly, FIG. 3 illustrates the device (100) with the LA disc (110) connecting to the body (120) with a narrow waist and a broad connection connecting to the elliptical (150) and the central body (120). FIG. 4 illustrates configuration of the device (100) with medium sized waist and varying scallops (130 and 140) to the body (120). FIG. 5 illustrates the device (100) where the LA disc (110) is connected to the body (120) with a broad waist whereas the body (120) is connected to the elliptical (150) with an intermediate waist. FIG. 6 illustrates a modification of the device configuration with a larger distal elliptical (150).
[0029] FIG. 8 illustrates the LAA closure device (100) retracted into the delivery system (810) prior to deployment. FIG. 9 illustrates the expected profile of the device (100) post deployment. The device is deployed into the distal most segment of the LA disc with the elliptical configuring to the morphology of the tail of the appendage and the body of the device engaging the body of the appendage and LA disc covering the orifice of the mouth of the LAA. FIG. 10 illustrates the Device Configuration.
[0030] In one embodiment of the present invention, the device (100) can have a flat LA disc (110) coated with ePTFE membrane and a proximal disc (210) which has a body (220) to it and a Dacron patch sutured to the inside of the disc (220). Subsequent discs are uncovered and takes varying dimensions in accordance with the variation in the morphology of the LAA (100).
[0031] The distal discs and elliptical (150) takes the purpose of anchoring the device (100) to the LAA while the proximal disc ensures complete occlusion of the lumen of the body of the LAA and LA disc (110) prevents blood entering the LAA by guarding the mouth of the LAA.
[0032] In an alternative embodiment of the present invention, the LA disc (110) can be coated within a hydrophilic coating which prevents clot formation. The device (100) can have a central screw or a bulb which will be used for repositioning of the device (100) any number of times until complete and satisfactory deployment of the device (100) is attained.
[0033] In an alternative embodiment of the present invention, in the LA disc a pressure sensing system or other biochemical molecules like Pro BNP, Troponin etc. or high frequency electrocardiogram (ECG) sensors can be incorporated for non-invasive monitoring.
[0034] Method of Use: The device can be compressed into a delivery system appropriate to the compressed state off the device (100) and on positioning the device (100) into the LAA the distal elliptical (150) is deployed first followed by the proximal discs and depending on the length and size of the LAA the middle discs will be engaged into the LAA and finally releasing the LA disc (110).
[0035] It will be appreciated that variations of the above-disclosed and other features and functions, or alternatives thereof, may be desirably combined into many other different systems or applications. Also, that various presently unforeseen or unanticipated alternatives, modifications, variations or improvements therein may be subsequently made by those skilled in the art which are also intended to be encompassed by the following claims.
,CLAIMS:I/We Claim:
1. A left atrial appendage closure device, comprising of:
a left atrial appendage (LAA) closure device (100) comprises of Nitinol braided pre-shaped multi-disc occluder confirming the shape of the LAA which anchors the most proximal LA disc (110) against the mouth of the LAA by providing complete closure of the appendage wherein the LAA closure device (100) comprises of a body (120) comprising of multiple scallops (such as scallops 130 and 140) wherein the body (120) is connected to the LA disc (110) using a narrow waist (145) on the first end of the body (120) and the second of the body (120) is connected to a distal elliptical (150) using the narrow waist (155) respectively.
2. The device as claimed in claim 1 wherein the LA disc (110) of the LAA closure device (100) is covered with an ePTFE covering material with multiple expansile discs of decreasing dimensions which ends in the distal elliptical (150) wherein the neck of the device (100) connecting to the distal disc (150) and LA disc (110) are covered with a Dacron patch and the distal discs and the elliptical (150) are uncovered/uncovered.
3. The device as claimed in claim 1 wherein the number of minor discs used in the device (100) varies in sizes to accommodate the variation in the internal lumen and morphological characteristics of the LAA closure device (100).
4. The device as claimed in claim 1 wherein the elliptical may be of a closed nitinol cage that can be filled with embolization liquid or particles that could provide adequate anchoring of the device wherein the attachment of the elliptical to the central body has an expansile spring action in order to adjust and accommodate variations in the length of the appendage.
5. The device as claimed in claim 1 wherein the device (100) can have a flat or concave LA disc (110) coated with ePTFE membrane and a proximal disc (210) which has a body (220) to it and a Dacron patch sutured to the inside of the disc or coated on the outer surface (220) wherein the subsequent discs are covered or uncovered and takes varying dimensions in accordance with the variation in the morphology of the LAA (100).
6. The device as claimed in claim 5 wherein the connection between the LA disc (110) and the central body (220) vary in dimensions and distensibility to accommodate different size and morphology of the appendage.
7. The device as claimed in claim 1 wherein the distal discs and elliptical (150) takes the purpose of anchoring the device (100) to the LAA while the proximal disc ensures complete occlusion of the lumen of the body of the LAA and LA disc (110) prevents blood entering the LAA by guarding the mouth of the LAA wherein additional hooks are provided for stabilization either in the body or the elliptical for further anchoring of the device (100).
8. The device as claimed in claim 1 wherein the LA disc (110) can be coated (hydrophilic, CD31 or chemical coating) to prevent clot formation or inflammation.
9. The device as claimed in claim 1 wherein a central screw or a bulb for repositioning of the device (100) any number of times until complete and satisfactory deployment of the device (100) is attained.
10. The device as claimed in claim 1 wherein a pressure sensing system and biochemical molecules (Pro BNP and Troponin) is configured at the LA disc (110) for non-invasive monitoring.
11. The device as claimed in claim 1 wherein the elliptical may be modified into micro coils or a bag with injectable liquids or particles for improved anchoring and visualization wherein additional hooks are incorporated for anchoring and stability.