Devices and methods for left atrial appendage closure

Inventors

Fung, Gregory W. • Lee, Randall J. • PONG, Russell • Clark, III, Robert L. • Escano, Arnold M.

Assignees

Atricure Inc

Abstract

Described here are devices, systems, and methods for closing the left atrial appendage. The methods described here utilize a closure device for closing the left atrial appendage and guides or expandable elements with ablation or abrading elements to ablate or abrade the left atrial appendage. In general, these methods include positioning a balloon at least partially within the atrial appendage, positioning a closure assembly of a closure device around an exterior of the atrial appendage, inflating the balloon, partially closing the closure assembly, ablating the interior tissue of the atrial appendage with the inflated balloon, removing the balloon from the atrial appendage, and closing the atrial appendage with the closure assembly.

Core Innovation

The invention relates to minimally invasive closure of an atrial appendage by positioning a balloon at least partially within the interior of the atrial appendage while positioning a closure assembly of a closure device around an exterior of the atrial appendage, the closure assembly comprising a loop. The balloon is inflated within the atrial appendage and the loop is partially closed to close the atrial appendage around the inflated balloon. Interior tissue of the atrial appendage is ablated with the inflated balloon as part of the closing sequence.

After the interior tissue ablation, the balloon is removed from the atrial appendage through the closure assembly and the atrial appendage is closed with the closure assembly. The interior tissue is ablated using an inflatable balloon, including variants where interior tissue is ablated using heated fluid contained in the balloon or where the balloon comprises an electrode for ablating interior tissue at the balloon exterior surface. At least one electrode can be used to monitor a tissue parameter during interior tissue ablation.

Further aspects of the invention use guide elements aligned across the heart to facilitate positioning of the balloon catheter and the closure assembly. A distal end of a first guide element is positioned in the interior of the atrial appendage and a distal end of a second guide element is positioned in a pericardial space externally of the atrial appendage, with the first guide element aligned across the second guide element on opposite sides of the heart. The procedure includes withdrawing the first guide element from the interior of the atrial appendage and advancing a portion of the first guide element into contact with tissue around an ostium of the closed atrial appendage, followed by ablating the contacted tissue, including cryoablation variants and cryoablating exterior surfaces using the closure assembly.

Claims Coverage

The partial set includes two independent method claims. The claim coverage centers on the coordinated use of a balloon inside the atrial appendage with a loop-containing closure assembly outside the appendage, followed by interior ablation, balloon withdrawal, and completion of closure, with additional inventive features introduced by guide-element alignment and ostial/exterior tissue ablation.

Across the independent claims, the core inventive coverage is the combination of balloon-based interior tissue ablation performed during loop-based closure of an atrial appendage, followed by balloon removal and completed closure, with an additional inventive framework that aligns guide elements across the heart and enables subsequent ablation of tissue around the ostium of the closed atrial appendage.

Stated Advantages

Documented Applications