Patent foramen ovale closure method
Inventors
Chen, Chao-Chin • Grishaber, Randy David B • Kammerer, Gene W • Khan, Isaac John • Park, Jin
Assignees
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Publication Number
US-10945716-B2
Publication Date
2021-03-16
Expiration Date
Abstract
The present invention relates to devices for closing a passageway in a body, for example a patent foramen ovale (PFO) in a heart, and related methods of using such closure devices for closing the passageway. The method includes introducing a mechanical closure device into an atrium of the heart and transeptally deploying the closure device across the interatrial septum to provide proximation of the septum secundum and septum primum.
Core Innovation
The invention facilitates closure of a patent foramen ovale (PFO) by introducing a mechanical closure device into an atrium and penetrating the interatrial septum from a first atrium to a second atrium. The interatrial septum includes a septum primum and/or a septum secundum, and the delivery sequence places distal and proximal portions of the closure device across the atria to address atrial shunting. The core deployment concept uses transeptal delivery with distal placement in the second atrium and proximal placement in the first atrium.
The mechanical closure device includes proximal and distal expandable anchors connected by a flexible closure line. Each expandable anchor has a radially expandable portion comprising a plurality of longitudinally oriented legs attached between proximal and distal end rings, where the proximal and distal end rings are held in a longitudinally extended constrained position by a constraining force. Deployment advances constrained anchors out of distal end portions of delivery lumens, releases the constraining force, and allows the legs to expand radially outward.
After deploying the proximal and distal expandable anchors, the method radially expands the anchors into a flat shape by tensioning the closure line. Tensioning of the flexible closure line brings septal tissues into proximation to minimize atrial shunting. The described concepts include embodiments for septal aneurysm (ASA) and a short-tunnel PFO, and further refinements that adjust the proximal anchor relative to the distal anchor and/or perform uni-axial adjustment relative to the closure line to enhance proximation.
Claims Coverage
The independent claim set centers on a method to facilitate closure of a PFO by transeptal delivery of a mechanical closure device having distal and proximal radially expandable anchors connected by a flexible closure line, with deployment through septal penetration and flat-shape expansion by tensioning to radially approximate septal tissues. The claim structure includes four dependent refinements, narrowing introduction, specifying septal penetration by drilling, and adding anchor- and closure-line-based adjustments to enhance proximation.
Transeptal delivery using an elongated delivery member and distal catheter positioning against the interatrial septum
introducing an elongated delivery member into the first atrium with a distal catheter and positioning the distal end against the interatrial septum for transeptal delivery from the first atrium to the second atrium
Septal penetration by extending a needle and advancing the distal catheter into the second atrium
penetrating through the interatrial septum from the first atrium to the second atrium at a first location by extending a needle from the distal catheter and advancing the distal catheter so that at least the distal end portion of the distal catheter is located in the second atrium
Mechanical closure device with proximal and distal expandable anchors connected by a flexible closure line
deploying a mechanical closure device within a distal portion of a lumen, the closure device comprising a flexible closure line coupled to proximal and distal expandable anchors having radially expandable leg structures between proximal and distal end rings held in a longitudinally extended constrained position by a constraining force
Distal and proximal anchor deployment by release of a constraining force followed by radially expanding into a flat shape by tensioning the closure line
deploying the distal expandable anchor into the second atrium by advancing a tubular member through the distal catheter to release the constraining force, partially withdrawing, deploying the proximal expandable anchor into the first atrium through a coaxial lumen with constraining force release, and radially expanding the proximal and distal expandable anchors into a flat shape by tensioning the closure line
Across the independent claim, closure is achieved by transeptal delivery of a mechanical closure device that includes radially expandable proximal and distal anchors connected by a flexible closure line. Deployment uses septal penetration to place the distal and proximal anchors into respective atrial chambers, release of constrained radially expandable leg structures, and final flat-shape expansion driven by tensioning the closure line.
Stated Advantages
Documented Applications
Facilitate closure of a patent foramen ovale (PFO) in a heart by deploying a mechanical closure device across the interatrial septum between first and second atria.
Address atrial shunting by bringing septal tissues into proximation using tensioning of a flexible closure line.
Embodiments include closure related to septal aneurysm (ASA).
Embodiments include closure for a short-tunnel PFO.
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