Stent Delivery Sheath with Translucent Reinforcing Member
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Solution Overview
Problem
Current stent delivery systems lack effective visualization and deployment methods, particularly in visualizing the stent during deployment and managing the radial forces exerted by self-expanding stents, which can lead to increased deployment forces and stent deformation.
Innovation Solution
A stent delivery system incorporating a deployment sheath with a translucent reinforcing member, such as a braid or polyetheretherketone, that allows visualization of the stent and reduces deployment forces by distributing radial forces more evenly, along with a handle and actuation member for controlled stent deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If a traditional opaque deployment sheath is used, then the structural strength and radial force management are improved, but the visualization of the stent during deployment deteriorates
Solution Approach 1:
The deployment sheath is constructed as a composite structure with an inner translucent or transparent layer that allows visualization of the stent, and an outer opaque layer containing radiopaque material that provides structural strength and fluoroscopic visibility. This composite design resolves the contradiction by combining materials with complementary properties - the translucent inner layer enables direct visualization while the structured outer layer maintains mechanical integrity.
2Ease of operation
If a self-expanding stent is used, then the ease of deployment is improved, but the deployment forces required increase due to radial expansion
Solution Approach 1:
The deployment sheath is designed with controlled friction characteristics and gradual release mechanics that cushion and distribute the deployment forces over time and space. The sheath maintains sufficient friction to control stent expansion gradually, preventing sudden force spikes that could cause deformation, while still allowing the self-expanding stent to deploy with minimal manual intervention.
3Ease of operation
If the deployment sheath is made translucent for visualization, then the ease of operation is improved, but the structural strength and radial force management deteriorate
Solution Approach 1:
The deployment sheath employs a composite construction where a translucent or transparent inner layer provides visualization capability, while an outer layer with radiopaque material and reinforced structure provides the necessary structural strength. This layered composite design allows each layer to fulfill its specific function without compromising the other.
Solution Approach 2:
The outer opaque layer of the deployment sheath serves multiple functions: it provides structural strength to maintain sheath integrity, contains radiopaque material for fluoroscopic visualization of sheath position, and works in conjunction with the translucent inner layer to enable both direct and indirect visualization methods.
4Loss of information
If radiopaque material is added to the deployment sheath, then the fluoroscopic visualization is improved, but the translucency for direct visualization deteriorates
Solution Approach 1:
The deployment sheath is constructed with a translucent inner layer that allows direct visualization of the stent through the sheath wall, and an outer layer containing radiopaque material that enables fluoroscopic visualization. The radiopaque material is positioned in the outer layer where it does not interfere with light transmission through the inner translucent layer, thus both visualization methods can operate simultaneously without compromising each other.
Data Source
AI summary
Stent delivery systems and methods for making and using the same are disclosed. An example stent delivery system may include an inner member. A deployment sheath may be disposed about the inner member. A stent may be disposed between the inner member and the deployment sheath. The deployment sheath may include a translucent reinforcing member that allows for visualization of the stent during stent deployment.