Fastener and techniques therefor
Inventors
Brauon, Haim • Sheps, Tal • Galon, Aviv • Pintor, Rafael
Assignees
Edwards Lifesciences Innovation Israel Ltd
Publication Number
US-11890191-B2
Publication Date
2024-02-06
Expiration Date
2039-07-11
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Abstract
A method for use with a heart of a subject includes advancing a tool distally along a flexible elongate contracting member, toward an anchor implanted at the heart. Tension is applied to the contracting member such that the contracting member slides proximally through a fastener disposed at the heart while a stop coupled to the fastener maintains the fastener in an open state. Using the tool, the stop is pulled proximally (i) away from the fastener, such that the fastener responsively clamps to the contracting member, thereby locking the tension in the contracting member, and (ii) against a cutting element of the tool such that the cutting element moves in a manner that severs the contracting member. Other embodiments are also described.
Core Innovation
The invention relates to systems, assemblies, methods, devices, and apparatuses for valve repair, particularly for repairing a dilated annulus of a cardiac valve such as the mitral valve. It involves an implantable annuloplasty structure comprising a primary body portion and a flexible elongate contracting member extending along and away from the primary body portion. The system includes a multi-component tubular catheter system with steerable catheters for delivering and anchoring the implant along the valve annulus via anchors. A contracting-member-uptake tool is used to feed the contracting member through various tubes and through a fastener disposed at the heart, enabling application of tension to contract the annuloplasty structure.
The contracting-member-uptake tool comprises a distal snare to ensnare and pull the contracting member through the tool's lumen, a clamping fastener biased toward a closed state to lock the contracting member under tension, a stop removably coupled to the fastener to maintain it open, and a fastener-ejector movable within the tool to release the stop and clamp the fastener onto the contracting member. The tool also includes a cutting element which severs the contracting member when the fastener is clamped and the stop is pulled against the cutting element. The system supports locking the tensioned contracting member and severing excess portions safely and effectively.
Claims Coverage
The independent claims define inventive features relating to a method for locking and severing a contracting member at the heart and an apparatus configured to perform these functions.
Method for locking and severing a contracting member at the heart
Advancing a tool distally along a flexible elongate contracting member toward an implanted anchor at the heart with an integrated cutting element; applying tension to the contracting member so it slides proximally through a fastener held open by a removable stop; and pulling the stop proximally with the tool to move the stop away from the fastener so the fastener clamps onto the contracting member and simultaneously pushing the stop against the cutting element to sever the contracting member.
Apparatus for locking and severing a contracting member
A fastener configured to receive and clamp onto a flexible elongate contracting member, with a clamping structure biased toward a closed clamping state and maintainable in an open state by a removable stop; and a tool comprising a cutting element configured to proximally pull the stop both away from the fastener to allow clamping and against the cutting element to sever the contracting member. The tool has graspers to engage the stop and provide a safety mechanism making cutting possible only by pulling the stop against the cutting element.
The claims cover methods and apparatuses for tensioning, locking, and safely severing a contracting member using a tool that manipulates a stop associated with a fastener implanted at the heart, ensuring secure fixation and controlled cutting of the member.
Stated Advantages
The system allows controlled and simultaneous locking of the contracting member tension and severing of excess contracting member portions, preventing unintended cutting prior to secure fastening.
Use of a stop coupled to the fastener maintains the fastener in an open state during adjustment, and the tool's ejector mechanism allows safe transition to a closed and locked state.
The multi-component steerable catheter system enables precise delivery and orientation control of the annuloplasty structure at the cardiac valve annulus.
The contracting-member-uptake tool includes a tension meter for measuring the degree of tension, enabling accurate adjustment of the annulus perimeter.
The safety mechanism prevents severing of the contracting member unless the stop is pulled against the cutting element, reducing procedural risks.
Documented Applications
Repair of a dilated atrioventricular valve annulus, such as mitral valve repair, using an adjustable annuloplasty structure implanted at the heart.
Application in procedures accessing the heart transluminally or transthoracically with steerable catheters to deliver and anchor an annuloplasty structure.
Use in treating ischemic heart disease complications involving valve regurgitation by contracting the annulus to restore proper valve function.
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