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Publication Number
US-11253261-B2
Publication Date
2022-02-22
Expiration Date
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, the following shapes: an outer bell-shaped structure; an inner bell-shaped structure disposed within the outer bell-shaped structure to conformingly engage an inner side of the outer bell-shaped structure; a tubular connector having a diameter substantially smaller than the inner bell-shaped structure, the tubular connector extending away from an apex of the inner bell-shaped structure; an inner plate-shaped structure; an outer plate-shaped structure; and a releasable connector. The bell shape is placed on one side of the opening, and the plate shape is placed on the other side of the opening, the connector passing through the opening.
Core Innovation
The invention provides a catheter-delivered device for occluding an appendage inside a living body that forms an elongate passage with an entrance and a hollow interior. The device includes at least one elongate resilient tube formed of a mesh of shape memory alloy, compressible for delivery within a catheter and self-expanding as it is released from the catheter. Upon deployment, the device contiguously forms sequentially an outer bell-shaped structure and an inner bell-shaped structure within the appendage.
The outer bell-shaped structure is elongate on a side portion of the bell-shape and is sized to flexibly conform to a longitudinal anatomy of an interior surface of the appendage along a longitudinal axis. The inner bell-shaped structure is sized along an elongate contact area to flexibly and conformingly contact an interior of the side portion of the outer bell-shaped structure so that the inner and outer structures mutually conform to the interior surface together when deployed. The inner bell-shaped structure forms a snap fit with the outer bell-shaped structure due to a shape memory effect of folding, and frictionally engages the outer bell-shaped structure along the elongate contact area to resist displacement of the outer bell-shaped structure along the longitudinal axis, defining a single double-walled bell-shaped structure with a hollow bell interior.
A tubular connector extends away from an apex of the double-walled bell-shaped structure and through the hollow bell interior, with a diameter substantially smaller than the double-walled bell-shaped structure and the entrance. The device further includes an inner plate-shaped structure and an outer plate-shaped structure opposing one another to form a plate-shaped structure that is spaced apart and away from the double-walled bell-shaped structure by the tubular connector. The plate-shaped structure is positioned spaced away and outside of the hollow bell interior of the double-walled bell-shaped structure and is sized and dimensioned to completely occlude the entrance, and the device includes a releasable connector to coordinate retention and release.
Claims Coverage
The partial content identifies one independent claim. The independent claim includes six inventive features: catheter-delivered self-expanding mesh of shape memory alloy, outer and inner bell-shaped structures with snap fit and frictional engagement, single double-walled bell-shaped structure defining a hollow bell interior, tubular connector through the hollow bell interior, spaced inner/outer plate-shaped structure completely occluding the entrance, and a releasable connector.
Catheter-delivered self-expanding mesh of shape memory alloy
At least one elongate resilient tube formed of a mesh of shape memory alloy compressible to be delivered to the appendage within a catheter and self-expanding as the tube is released from the catheter to contiguously form sequentially an outer bell-shaped structure and an inner bell-shaped structure within the appendage.
Outer and inner bell-shaped structures with snap fit and frictional engagement
An outer bell-shaped structure sized to flexibly conform to a longitudinal anatomy along a longitudinal axis, and an inner bell-shaped structure sized along an elongate contact area to conformingly contact an interior of the outer bell-shaped structure so the two mutually conform to the appendage interior surface. The inner bell-shaped structure forms a snap fit with the outer bell-shaped structure due to a shape memory effect of folding and frictionally engages the outer bell-shaped structure along the elongate contact area to resist displacement of the outer bell-shaped structure along the longitudinal axis.
Single double-walled bell-shaped structure defining a hollow bell interior
The inner and outer bell-shaped structures together form a single double-walled bell-shaped structure defining a hollow bell interior.
Tubular connector through the hollow bell interior
A tubular connector having a diameter substantially smaller than the double-walled bell-shaped structure and the entrance of the appendage, extending away from an apex of the double-walled bell-shaped structure and through the hollow bell interior.
Spaced inner/outer plate-shaped structure completely occluding the entrance
An inner plate-shaped structure and an outer plate-shaped structure opposing the inner plate-shaped structure to form a plate-shaped structure spaced apart and away from the double-walled bell-shaped structure by the tubular connector, with the plate-shaped structure positioned spaced away and outside of the hollow bell interior and sized and dimensioned to completely occlude the entrance.
Releasable connector
A releasable connector associated with the occlusion device.
The independent claim centers on a self-expanding catheter-delivered occlusion device using a mesh of shape memory alloy that deploys into a snap-fit outer and inner bell-shaped double-walled structure with frictional engagement for longitudinal displacement resistance, includes a tubular connector through the hollow bell interior, and employs a spaced inner/outer plate-shaped structure sized to completely occlude the entrance, together with a releasable connector.
Stated Advantages
Resists displacement of the outer bell-shaped structure along the longitudinal axis of the appendage due to snap fit and frictional engagement.
Documented Applications
Occluding an appendage inside a living body forming an elongate passage with an entrance and a hollow interior, including deployment within the appendage.
Application to an appendage associated with a left atrial appendage opening as referenced by the partial content summary.
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