Steerable Sheath Access Device for Epicardial Ablation
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Solution Overview
Problem
Traditional medical devices for treating atrial fibrillation and ventricular tachycardias are too long and inflexible to effectively access and ablate epicardial neuroganglia, requiring multiple ablations and being unable to maneuver to reach the epicardial surface for targeted treatment.
Innovation Solution
A steerable short sheath access device with an elongated member having primary and secondary curvatures, composed of materials with varying rigidity, allowing for deflection and precise access to epicardial surfaces, coupled with a handle assembly for controlling movement and a lumen for tool insertion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Length of moving object
If traditional long and rigid catheters are used to access epicardial surfaces, then the device can reach deep internal chambers of the heart, but the device cannot be maneuvered to reach the epicardial surface for targeted treatment and requires multiple ablations
Solution Approach 1:
The catheter incorporates a steerable distal section that can be dynamically deflected to change its curvature and orientation, allowing the operator to maneuver the catheter tip to reach epicardial surfaces. The handle assembly includes deflection controls that enable real-time adjustment of the catheter's shape during insertion and positioning, transforming a static rigid structure into a dynamically adaptable one.
Solution Approach 2:
The catheter is divided into distinct sections with different mechanical properties: a proximal section with higher rigidity for structural support and a distal section with lower rigidity for flexibility and steering. This segmentation allows each portion to perform its specific function optimally while working together as an integrated system.
2Strength
If traditional rigid catheters are used for epicardial access, then structural support is maintained, but the catheter cannot be deflected to provide precise access to target areas
Solution Approach 1:
Different sections of the catheter are assigned different mechanical properties tailored to their specific functional requirements. The proximal section maintains higher rigidity for structural support and force transmission, while the distal section has lower rigidity to enable deflection and adaptation to anatomical structures. This localized differentiation of material properties resolves the contradiction between overall strength and local adaptability.
Solution Approach 2:
The catheter employs composite construction with materials of varying rigidity combined in a single device. The proximal and distal sections are made from materials or structures with different mechanical characteristics, creating a composite system that exhibits both the strength needed for structural integrity and the flexibility required for precise positioning and deflection.
3Length of moving object
If shorter steerable access sheaths are used for epicardial procedures, then precise access to epicardial surfaces is enabled, but the device requires new configurations different from traditional introducers
Solution Approach 1:
The shorter access sheath incorporates integrated steering mechanisms that enable dynamic positioning despite its reduced length. The steering capability is achieved through deflection sections and control mechanisms that allow the operator to navigate the sheath to target epicardial areas, compensating for the shorter overall length through enhanced maneuverability.
Data Source
AI summary
The present invention relates to steerable access sheath assembly including at least one electrode. Moreover, the present invention relates to a steerable sheath access device for use in cardiovascular procedures. Embodiments of the present invention including steerable access sheaths or introducers may provide cardiovascular access for various ablation tools and devices for the performance of various ablation procedures or procedures involving alternate energy sources.