Guide Sheath Stabilization Wire Lower Limb Access
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Solution Overview
Problem
Existing vascular access devices face challenges in accessing tortuous and angulated aortic bifurcations, lower extremity vessels, and maintaining the pushability of endovascular tools, often resulting in arterial injuries and complications.
Innovation Solution
A guide sheath apparatus with an integrated stabilization wire is introduced, which includes an elongate member with a lumen for guide wire passage and a bifurcating stabilization wire for enhanced support and stability during endovascular procedures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If rigid guide catheters, guide sheaths and guide wires are used to access tortuous anatomies, then navigation capability through difficult vessels is improved, but arterial injuries such as perforation and dissection occur
Solution Approach 1:
The guide catheter incorporates a distal balloon that can be inflated and deflated to dynamically change the catheter's profile and interaction with the vessel wall. When inflated, the balloon provides gentle radial force to navigate tortuous anatomies without the need for excessive rigidity, thereby avoiding arterial injuries while maintaining navigation capability.
Solution Approach 2:
The catheter design changes the physical parameters of the guide system by using a compliant, collapsible distal section that can transition between different states. This allows the catheter to adapt its rigidity and flexibility based on the procedural needs, enabling navigation through tortuous vessels while minimizing trauma to the arterial wall.
2Length of stationary object
If long delivery systems are used to reach distal treatment sites, then access to distal most blood vessels is improved, but pushability performance deteriorates
Solution Approach 1:
The delivery system is segmented into distinct functional zones: a proximal rigid section for operator control and force transmission, a transitional section, and a distal compliant section with the balloon. This segmentation allows each segment to perform its specific function optimally, maintaining pushability over long delivery distances by ensuring force can be effectively transmitted from the proximal to distal sections.
Solution Approach 2:
The guide catheter employs composite construction with different material properties in different sections. The proximal portion uses stiffer materials for structural integrity and force transmission, while the distal portion uses more compliant materials that can flex and adapt to tortuous anatomy, thereby maintaining pushability performance throughout the entire length of the delivery system.
3Ease of operation
If retrograde contralateral approach is used for vascular access, then technical simplicity and feasibility are improved, but access to tortuous peripheral vessels and distal lesions becomes challenging or impossible
Solution Approach 1:
The guide catheter with distal balloon is designed as a universal access system that can be used through the retrograde contralateral approach while also being capable of accessing tortuous peripheral vessels and distal lesions that were previously inaccessible. The balloon mechanism provides the additional adaptability needed to navigate complex anatomies while maintaining the technical simplicity of the retrograde approach.
Solution Approach 2:
The dynamic balloon component enables the catheter to adapt to various vascular anatomies encountered during retrograde access. By inflating the balloon at strategic locations, the operator can navigate through tortuous aortic bifurcations and peripheral vessels, making the retrograde approach versatile enough to handle complex cases while retaining its inherent technical simplicity.
Data Source
AI summary
A guide sheath device with an integrated stabilization wire is provided. The guide sheath device includes an elongate member having a proximal and distal end and a lumen there between and a stabilization wire integrated to the elongate member.