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Abstract
An elongate resilient tube of a mesh of shape memory alloy is used to therapeutically occlude an opening in body tissue. The tube is compressible so that it can be delivered to the opening in the body within a catheter. The tube self-expands as it is released from the catheter to contiguously form, sequentially an outer perimeter structure and an inner perimeter structure disposed within the outer perimeter structure to conformingly engage an inner side of the outer perimeter structure, a plate shaped structure, and a flexible connector between them. J-shaped hooks extend from the perimeter structure to flexibly engage tissue of the body opening without piercing the tissue.
Core Innovation
The invention relates to a device for occluding an appendage inside a living body forming an elongate passage with an open entrance and a hollow interior. At least one elongate resilient tube formed of a mesh of shape memory alloy is compressible to be delivered to the appendage within a catheter and self-expanding as it is released from the catheter. When deployed, the tube contiguously forms an outer perimeter structure and an inner perimeter structure, and the inner perimeter structure frictionally engages the outer perimeter structure to resist displacement along a longitudinal axis while forming a single double-walled perimeter structure defining a hollow interior.
The device further includes a double-walled plate-shaped structure connected to the double-walled perimeter structure. The plate-shaped structure is positioned outside of the hollow interior and is sized and dimensioned to completely occlude the entrance to the appendage while the double-walled perimeter is positioned inside the appendage. In an alternative form, the double-walled perimeter is a single double-walled bell-shaped structure defining a hollow bell interior, and the outer bell-shaped structure flexibly conforms and contacts an interior surface region along a longitudinal axis while the inner bell-shaped structure frictionally engages the outer bell-shaped structure to resist displacement.
A plurality of hooks is affixed to the outer perimeter structure or to the outer bell-shaped structure to extend away therefrom. The hooks form barbs having a J-shape and each barb forms a sharp free end profile at an end of the barb. In the described forms, the appendage is specified as a left atrial appendage (LAA), and the hooks can be pulled straight when the tube is returned to the catheter and re-form the J-shape after the tube is again released from the catheter.
Claims Coverage
The partial content provides two independent claims covering a catheter-delivered self-expanding shape-memory-alloy mesh tube that forms a double-walled perimeter structure or a double-walled bell-shaped structure, with mutual conforming frictional engagement to resist longitudinal displacement, and a plurality of J-shaped hooks with sharp free end profiles. One claim form further includes a double-walled plate-shaped structure that completely occludes the entrance to the appendage, and one claim form limits hook height relative to tissue depth.
Catheter-delivered self-expanding mesh tube forming a double-walled outer and inner perimeter structure
An elongate resilient tube formed of a mesh of shape memory alloy is compressible to be delivered to the appendage within a catheter and self-expanding as it is released to contiguously form an outer perimeter structure and an inner perimeter structure that together form a single double-walled perimeter structure defining a hollow interior, wherein the inner perimeter structure frictionally engages the outer perimeter structure along an elongate contact area to resist displacement along the longitudinal axis of the appendage.
Double-walled plate-shaped entrance occlusion connected to the double-walled perimeter
A double-walled plate-shaped structure connected to the double-walled structure is positioned outside of the hollow interior and is sized and dimensioned to completely occlude the entrance to the appendage while the double-walled perimeter is positioned inside the appendage.
Plurality of J-shaped hooks with sharp free end profiles extending from the outer structure
A plurality of hooks each affixed to the outer perimeter structure to extend away therefrom, forming a barb having a J-shape and forming a sharp free end profile at an end of the barb.
Catheter-delivered self-expanding bell-shaped double-walled structure with frictional engagement to resist longitudinal displacement
An outer bell-shaped structure and an inner bell-shaped structure form a single double-walled bell-shaped structure defining a hollow bell interior, where the outer bell-shaped structure flexibly contacts an interior surface of the appendage along a longitudinal axis and the inner bell-shaped structure frictionally engages the outer bell-shaped structure along the elongate contact area to resist displacement along the longitudinal axis of the appendage.
J-shaped hooks with a height limited relative to tissue depth on the bell-shaped occluder
A plurality of hooks each affixed to the outer bell-shaped structure to extend away therefrom, forming a barb having a J-shape and forming a sharp free end profile at an end of the barb, wherein the hook height extending from the external contacting surface is not greater than a depth of the tissue of the longitudinal anatomy of an interior surface of the appendage.
Across the two independent claims, the core coverage is for a catheter-delivered self-expanding shape-memory-alloy mesh tube that forms a double-walled internal structure with mutual conforming frictional engagement to resist longitudinal displacement, combined with entrance occlusion in the plate-shaped form. Both independent claims further require a plurality of hooks forming J-shaped barbs with sharp free end profiles extending from the outer structure, with one claim form additionally limiting hook height to not greater than tissue depth.
Stated Advantages
Documented Applications
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