In:
Journal of Medical Devices, ASME International, Vol. 14, No. 2 ( 2020-06-01)
Abstract:
A cranial bypass can be a last resort procedure for patients suffering from complex neurovascular pathology. Since the clinically proven excimer laser-assisted nonocclusive anastomosis (ELANA) technique has become available, it is no longer necessary to temporarily close the recipient artery to facilitate an anastomosis. Aiming to simplify and shorten the operation time of the ELANA technique, a sutureless ELANA, the so-called SELANA slide (SEsl) was developed, but it failed during clinical study. We developed an improved device, the SELANA clip (SEcl).We describe the SEcl design and the first in vitro test results. The SEsl design was optimized with a clip at the backside, creating the SEcl which facilitates smooth and friction-free insertion in the recipient artery. Subsequently, the laser catheter was optimized by adding a grid and conus to provide an improved vacuum and flat reaction surface during lasing. We aimed to compare the SEcl to the current ELANA regarding application time difference, anastomosis success (“flap retrieval”) and technical difficulties. Hereto 32 ELANA and 32 SEcl anastomoses were performed on pressurized rabbit arteries in the ELANA practice system. Mean application time difference was 14.0 min (95%CI 13.0–15.0). The flap retrieval rate of the ELANA anastomoses was 94% (30/32) and 100% (32/32) for the SEcl technique. During the experiments no technical difficulties were encountered. The SEcl is technical feasible with promising simplicity and application times. However, extensive in vivo short-term and long-term experiments are indispensable before clinical application.
Type of Medium:
Online Resource
ISSN:
1932-6181
,
1932-619X
Language:
English
Publisher:
ASME International
Publication Date:
2020
