Sizing Catheter Radiopaque Marker Retention
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Solution Overview
Problem
Sizing catheters with axially spaced radiopaque markers face the risk of dislodgment during advancement, especially through tortuous paths and hemostasis valves, leading to potential complications within the patient.
Innovation Solution
A sizing catheter design featuring a resilient elongate shaft with radiopaque markers secured to its outer surface, surrounded by a snugly fitting outer member that extends over the markers, preventing dislodgment by distributing forces and maintaining contact along the marker span, potentially using heat shrinking or adhesives for bonding.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If radiopaque markers are disposed on the outside of the elongate shaft, then the markers can be visualized using X-ray techniques, but the markers may become dislodged or disassociated from the elongate shaft during advancement
Solution Approach 1:
The patent incorporates the radiopaque markers within the elongate shaft structure rather than placing them on the outside surface. The markers are embedded in the shaft wall, creating a nested configuration where the marker is contained within the shaft structure. This eliminates the risk of dislodgment while preserving X-ray visualization capability, as the markers remain positioned along the shaft length for accurate imaging.
Solution Approach 2:
The patent combines the radiopaque marker and elongate shaft into a single integrated structure. The marker is formed as part of the shaft wall itself, merging two previously separate components (marker and shaft) into one unified element. This integration ensures the marker cannot become disassociated from the shaft, eliminating the reliability issue while maintaining measurement precision.
2Adaptability or versatility
If the catheter is advanced along a tortuous path, then the catheter can reach the target location, but forces applied at the marker locations may cause markers to become disassociated from the shaft
Solution Approach 1:
By nesting the radiopaque markers within the elongate shaft wall structure, the patent creates an integrated configuration where the markers are protected from external forces applied during navigation through tortuous paths. The shaft wall provides structural support that prevents marker disassociation, allowing the catheter to navigate complex anatomical paths while maintaining marker integrity.
3Ease of operation
If the sizing catheter is advanced through a hemostasis valve, then the catheter can be delivered to the target location, but forces from the valve can destabilize the marker/shaft interface
Solution Approach 1:
The patent merges the radiopaque marker and shaft into a single integrated structure, eliminating the marker/shaft interface that would otherwise be vulnerable to destabilizing forces from the hemostasis valve. This integration ensures that forces applied during valve traversal are distributed throughout the unified structure, preventing interface failure and marker dislodgment.
Data Source
AI summary
Sizing catheters that include an inner member and an outer member. The inner member includes an elongate shaft and a plurality of radiopaque markers spaced axially from each other and secured to an outer surface of the shaft, the span of radiopaque markers defining a first portion of the inner member. The outer member that is disposed snugly around and in substantial contact with the inner member along at least the first portion of the inner member.

