Need for a “self-sustaining” retraction instrument that would provide circumferential retraction to the mitral valve leaflets in order to provide access and exposure to the intra-ventricular site and the sub-valvular apparatus, without the need for additional operator manipulation in a limited access setting. Device needed to be able to be easily delivered and positioned and then be able to retract the mitral valve leaflets safely and securely without the need for supportive assistance in order to allow the operator to use both hands without having the need for additional support instruments/structures in the working field. Need for different sizes to accommodate varying mitral valve annular dimensions.
Designed a flexible retractor which could be rolled into a smaller dimension and delivered into the mitral annulus easily/efficiently/securely and then the flexible retractor has the ability to “unfurl” under its own biasing to provide circumferential mitral valve leaflet retraction. Designed a flange on the leading edge of the device which would engage with the posterior side of the mitral annulus to prevent the device from “popping out”, and added traction raisings on the outer device wall surface to engage with the mitral valve leaflets to prevent the device from rotating and in order to keep the device securely seated in-situ without the need for additional manipulation. Design uses a soft and smooth material with all outer edges curved, blunted and atraumatic, for safe delivery and deployment purposes, and incorporated design into two different sizes to accommodate varying mitral valve annular dimensions.
Has been utilized commercially in over 3,000 clinical procedures to date.