The Challenge:
Need for a “self-sustaining” retraction instrument that would provide circumferential retraction to the aortic walls 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 aortic wall 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 aortic root dimensions.
The Solution:
Designed a flexible retractor which could be rolled into a smaller dimension and delivered into aortic root easily/efficiently/securely and then the flexible retractor has the ability to “unfurl” under its own biasing to provide circumferential atrial wall retraction. Designed a flange on the bottom of the device which would engage with the sino-tubular junction 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 three different sizes to accommodate varying aortic root dimensions.
The Results:
Has been utilized commercially in over 5,000 clinical procedures to date.
