Dynamic Rigidity Control for Supportive Sheaths in Endovascular Procedures.

Abstract

Endovascular procedures require sheaths with contradictory mechanical properties: flexibility for navigation through tortuous vessels, yet rigidity for device delivery. Current approaches rely on multiple device exchanges, increasing procedure time and complication risks. Here we present a novel endovascular sheath design scheme with dynamically controllable flexural rigidity along its entire length. The device incorporates axially aligned metal string arrays between inner and outer lumens, enabling transition between flexible and rigid states through suction actuation. Three-point bend testing demonstrated that actuation increases flexural rigidity from the range associated with diagnostic catheters to that associated with support sheaths. In simulated contralateral access procedures, the device reduced access time to 1/3 of the time required when using conventional approaches. In vivo porcine studies validated the sheath?s ability to navigate tortuous anatomy in its flexible state and successfully support advancement of increasingly rigid therapeutic devices when actuated. The technology enables single-sheath delivery of treatment, potentially reducing procedural complexity, decreasing complication rates, and improving patient outcomes across various endovascular interventions. This design represents a promising approach to combined catheter and sheath design that benefit both peripheral and neurovascular procedures.