Nitinol alloy composition for sheath deployable and...

A - Human Necessities – 61 – F

Patent

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A61F 2/01 (2006.01)

Patent

CA 2406498

An embolic protection device that employs a superelastic alloy self-expanding strut assembly with a small profile delivery system for use with interventional procedures is disclosed. The expandable strut assembly is covered with a filter element and both are compressed into a restraining sheath for delivery to a deployment site downstream and distal to the interventional procedure. Once at the desired site, the restraining sheath is retracted to deploy the embolic protection device, which captures flowing emboli generated during the interventional procedure. The expandable strut assembly is made from a superelastic alloy such as nickel-titanium or nitinol, and includes a ternary element in order to minimize the stress hysteresis of the superelastic material. The stress hysteresis is defined by the difference between the loading plateau stress and the unloading plateau stress of the superelastic material. The resulting delivery system including the restraining sheath has a small profile and has a thin wall.

L'invention concerne un dispositif de protection embolique qui utilise un ensemble support en alliage superélastique auto-dilatable associé à un système de distribution à profil réduit à utiliser lors d'interventions. L'ensemble support dilatable est recouvert d'un élément de filtre et tous deux sont comprimés en une gaine de retenue destinée à être déposée à un emplacement en aval et distant du point d'intervention. Une fois que l'emplacement est atteint, la gaine de retenue est escamotée afin de déployer le dispositif de protection embolique qui stoppe tout écoulement d'emboles généré au cours de l'intervention. L'ensemble support dilatable est constitué d'un alliage superélastique, tel que le nickel-titane ou le nitinol, et comprend un troisième élément servant à réduire l'hystérésis de contrainte du matériau superélastique. Cette hystérésis de contrainte est définie par la différence entre la contrainte du plateau de chargement et la contrainte du plateau de déchargement du matériau superélastique. Le système de distribution ainsi obtenu comprenant la gaine de retenue présente un profil réduit et une paroi fine.

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