Steerable Catheter Tip Orientation Sheaths
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Solution Overview
Problem
Steerable electrophysiology catheters often face challenges in maintaining precise control over the tip section's deflection within a single plane, leading to out-of-plane deflection issues due to the flexible material used.
Innovation Solution
The catheter incorporates flexible plastic tubing with diametrically opposed lumens and orientation sheaths to enhance deflection control, featuring puller wires and orientation sheaths that allow for bidirectional deflection within specific planes, reducing out-of-plane movement and improving tip section stability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If flexible material is used for the tip section to enable steerability, then the catheter can be deflected, but out-of-plane deflection occurs and control precision deteriorates
Solution Approach 1:
The tip section is divided into multiple segments (first tip segment, second tip segment, third tip segment) with different flexibility characteristics. The first tip segment has higher flexibility for initial deflection, while the second and third tip segments have progressively lower flexibility to constrain out-of-plane deflection and maintain precision in the desired deflection plane.
Solution Approach 2:
Different portions of the tip section are assigned different material properties and structural characteristics. The first tip segment uses more flexible material, while the second and third tip segments use progressively stiffer material, creating a gradient of local qualities that simultaneously enables steerability and prevents excessive out-of-plane deflection.
2Adaptability or versatility
If bidirectional puller wires are used to enable deflection in two directions, then the catheter becomes more versatile, but the complexity of the control mechanism increases
Solution Approach 1:
The control mechanism merges the control of multiple puller wires into a single integrated control handle. The control handle simultaneously controls the first puller wire (for first direction deflection) and the second puller wire (for second direction deflection) through a unified mechanism, reducing operational complexity while maintaining bidirectional versatility.
Solution Approach 2:
The control handle is designed as a multi-functional device that can control deflection in multiple directions. The single control handle integrates the control functions for both the first puller wire and the second puller wire, allowing one operator to manage bidirectional deflection without requiring separate control mechanisms for each direction.
3Ease of operation
If the tip section is made highly flexible for easy deflection, then the catheter is easier to maneuver, but the stability and contact force against heart tissue are reduced
Solution Approach 1:
The tip section is segmented into multiple portions with progressively decreasing flexibility. The first tip segment remains highly flexible for easy maneuvering, while the second and third tip segments progressively increase in stiffness to provide stability and maintain contact force against heart tissue during procedures.
Solution Approach 2:
The tip section employs a dynamic flexibility gradient where the first tip segment provides high flexibility for initial maneuvering, and the second and third tip segments progressively constrain flexibility to provide stability. This dynamic characteristic allows the tip section to adapt its flexibility based on the operational phase - maneuvering versus stable contact.
Data Source
AI summary
A bi-directional electrophysiology catheter having improved steerability which includes orientation sheaths, or thin walled tubes, placed in diametrically opposed lumen at the distal portion of the catheter for producing in-plane deflection of the distal portion of the catheter.