Pre-Curved Outer Sheath with Variable Stiffness for Shunt Placement
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Solution Overview
Problem
Existing shunt devices for treating elevated pressure in the left atrium of the heart, such as those used for heart failure, face challenges in effectively reducing pressure while minimizing the risk of paradoxical stroke and anatomical disruption.
Innovation Solution
A pre-curved outer sheath for a delivery device with varying stiffness along its length, designed to facilitate the precise placement of a shunt device between the left atrium and coronary sinus, ensuring minimal disruption and enhanced stability through a combination of distal and proximal arms that grip the tissue wall.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If a straight outer sheath is used for delivery, then the device structure is simple, but the placement precision and stability in curved anatomical pathways is poor
Solution Approach 1:
The outer sheath incorporates a pre-curved section with a specific radius of curvature to match the anatomical pathway from the jugular vein through the superior vena cava to the right atrium. This pre-curving allows the sheath to naturally follow the body's contours during insertion, improving placement precision without requiring complex active control mechanisms or multiple articulation points.
2Ease of operation
If uniform stiffness is used throughout the outer sheath, then the manufacturing process is simple, but the navigability through curved vessels and control during deployment is compromised
Solution Approach 1:
The outer sheath features varying stiffness along its length, with the pre-curved section having different mechanical properties than the straight proximal and distal sections. This gradient stiffness design allows the pre-curved portion to flex and conform to anatomical pathways while maintaining sufficient structural integrity for precise positioning and controlled deployment of the shunt device.
Solution Approach 2:
The outer sheath is constructed from composite materials or multi-layer structures that enable spatially varying stiffness characteristics. By combining materials with different mechanical properties or creating layered constructions, the sheach achieves the desired stiffness gradient without requiring complex active control systems or multiple interchangeable components.
3Reliability
If the shunt device is deployed without secure anchoring, then the deployment process is simple, but the stability and effectiveness of pressure reduction is compromised
Solution Approach 1:
The distal and proximal arms of the shunt device are pre-configured in a compressed state within the outer sheath, positioned to engage with the tissue wall at predetermined locations. Upon deployment, these arms automatically expand and grip the tissue, providing secure anchoring without requiring complex active actuation mechanisms or multiple deployment steps.
Data Source
AI summary
An outer sheath for surrounding and covering components of a delivery device includes a straight section including an aperture extending fully through the straight section. The outer sheath further includes a pre-curved section extending distally from an end of the straight section and including an aperture extending fully through the pre-curved section. The straight section and the pre-curved section include a varying stiffness along a length of the straight section and the pre-curved section.