Kink Resistant Peel Away Sheath with Laminated Support Layer
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Solution Overview
Problem
Current peel away sheaths used in intravascular medical procedures are prone to kinking and bending, which obstructs the passageway and complicates medical procedures, requiring additional steps to prevent kinking such as suturing or taping.
Innovation Solution
A kink-resistant peel away sheath is developed with a laminated structure comprising an inner layer, an outer layer, and a support layer, along with shear lines formed by voids created after removing monofilaments, allowing for easy separation and increased pushability without kinking.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If a single extruded plastic tube is used for the sheath, then the manufacturing process is simple, but the sheath is prone to kinking and bending which obstructs the passageway
Solution Approach 1:
The sheath is constructed as a composite structure with an inner layer, an outer layer, and a support layer positioned between them. The support layer comprises a braided or woven mesh structure that provides kink resistance and structural integrity. This composite material approach allows the sheath to maintain its shape and resist bending while still being manufacturable through layer-by-layer construction processes.
Solution Approach 2:
The sheath is divided into distinct functional layers: an inner layer that contacts the medical device, an outer layer that provides structural protection, and a support layer with braided or woven mesh that prevents kinking. This segmentation allows each layer to be optimized for its specific function while maintaining overall manufacturability through modular construction.
2Reliability
If additional procedures such as suturing or taping are applied to prevent kinking, then the sheath stability is improved, but the device complexity and procedure time increase
Solution Approach 1:
The support layer with its braided or woven mesh structure provides inherent kink resistance and self-stabilization properties to the sheath. This self-service feature eliminates the need for additional external procedures such as suturing or taping to prevent kinking, as the sheath structure itself resists deformation through its integrated support layer design.
3Ease of operation
If larger pushing forces are applied to the sheath to secure it further, then the anchoring is improved, but the sheath forms kinks or bends which obstructs the passageway
Solution Approach 1:
The composite structure with the support layer provides the necessary structural reinforcement to withstand larger pushing forces during anchoring without forming kinks. The braided or woven mesh of the support layer distributes mechanical stresses evenly, allowing the sheath to be pushed further into the vasculature while maintaining passageway patency.
Data Source
AI summary
Devices and methods for providing a kink resistant peel away sheath are disclosed. One device includes a sheath for insertion into a vasculature of a patient. The sheath comprises a sheath body having an outer surface, a longitudinal axis and a lumen formed therethrough. The sheath body comprises an inner layer arranged about the longitudinal axis, an outer layer coaxially arranged with the inner layer, and a support layer positioned between the inner and outer layers, wherein the inner, outer and support layers are laminated together to form the sheath body. The sheath also comprises at least one shear line positioned beneath the outer surface of the sheath body, and configured to facilitate the longitudinal separation of the sheath body along the at least one shear line.